The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announcement of its fifth investigation examining compliance with Federal laws that safeguard conscience rights for health care professionals during President Trump’s second Administration warns States and other federal health program recipients against discriminating against or failing to appropriately accommodate faith-based organization and providers.
On December 8, 2025, OCR announced the launch of “a major investigation” into a State health department to assess whether its licensing policies, interpretations, or enforcement practices for behavioral health residential facilities and licensed behavioral health personnel violate Federal law by:
Discriminating against faith-based organizations in the administration and/or enforcement of licensing requirements, including requiring any facilitation of sex-rejecting procedures and female genital mutilation (FGM) and treating religious objections as grounds for adverse licensure action, including denial or termination of professional licenses;
Discriminating against institutional and/or individual health care entities for their religious objections to provide, pay for, provide coverage of, or refer for abortion, including through licensing, certification, or other determinations of legal status or participation; or
Requiring any individual in a health service program funded by HHS to perform or assist in the performance of services contrary to that individual’s religious beliefs or moral convictions, including counseling or other assistance related to abortion, sex-rejecting procedures, or FGM.
According to OCR, OCR’s investigation will proceed under applicable laws including:
The Equal Treatment for Faith-Based Organizations rule (45 C.F.R. part 87), which prohibits discrimination against faith-based providers in HHS-supported programs; and
Federal health care conscience protection statutes administered under 45 C.F.R. part 88, including the Weldon Amendment, the Coats-Snowe Amendment (42 U.S.C. § 238n), and the Church Amendments (42 U.S.C. § 300a-7).
The announcement also demonstrates continued efforts across HHS to preserve the fundamental rights of conscience and religious exercise.
Since OCR enforces Federal protections against discrimination based on conscience and religion in specific programs funded by HHS Federal financial assistance and grant and block grant programs that prohibit discrimination against individuals on the basis of religion, all entities involved in of these programs should reaffirm their compliance and mitigate exposures based on the Administration’s enforcement policies and priorities.
If you have questions about this or other health care concerns, contact the author.
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We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Peer recognized as “Top Rated Lawyer” and “LEGAL LEADER™ “Top Rated Lawyer” and “Best Lawyer” for her work in Health Care Law, Labor and Employment Law; ERISA & Employee Benefits,” and “Business and Commercial Law,” Cynthia Marcotte Stamer is an A Martindale-Hubble “AV-Preeminent” (Top 1%) attorneys board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on PBM, pharmacy and pharmaceutical and other health care, managed care, insurance, and insured and self-insured contracting, design, administration and regulation..
Author of numerous highly regarded works on PBM and other health plan contracting and design, Immediate Past Chair of the ABA International Section Life Sciences Committee and the Tort Trial and Insurance Practice Section Medicine and Law Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and past Group Chair and current Welfare Benefit Committee Co-Chair of the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; third party administrators and other health benefit service providers; hospitals, health care systems and other health care providers, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
She also has extensive experience helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of publications on “Transparent PBM Contracting,” “ACOs, Direct Contracting: Legal & Practical Challenges For Employers, Providers & TPAs,” “The Medicare Advantage Contracting Manual,” “Third Party Administrator (TPA) Contracting Principles and Strategies and a multitude of other highly regarded publications and presentations, Stamer is widely recognized for her thought leadership on PBM and other managed care and health plan contracting and design, and a multitude of other health care, health plan and other health industry matters. In addition, Ms. Stamer contributes her time and leadership to numerous policy, professional, civil and other organizations including service as the, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
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NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Academic medicine and other education, health care, Medicare or Medicaid Advantage insurers, and other organizations received another warning to update and strengthen the defensibility of their policies and practices system-wide for preventing anti-Semitism, and other race, color, national origin, race, religious or other discrimination from the Department of Health & Human Service’s May 13, 2025, announcement of another investigation of another university for anti-Semitism in violation of the Civil Rights Act of 1964 (“CRA”) and other federal civil rights laws.
The Civil Rights Act of 1964 (the “CRA”), the Equal Protection Clause of the 14th Amendment to the United States Constitution, Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) and various other federal laws discrimination on the basis of race, national origin, color and certain other status by covered government or private organizations by health care, Medicare and Medicaid Advantage, academic medicine and other education, child care, research and other HHS-funded organizations, employers and other entities.
Since President Donald J. Trump (“President Trump”) took office in January, HHS OCR, the Departments of Education and Justice, the Equal Employment Opportunity Commission (“EEOC”) and other federal agencies are aggressively investigating anti-Semitism, anti-Christianity, and certain other race, color, national origin and religious discrimination by academic medicine and other educational institutions, health care organizations, health insurers, employers and other organizations covered by these civil rights laws. These investigations and enforcement actions target prohibited discrimination in all forms, including the use of race, national original, color, sex, religion and other non-merit based criteria, even when those criteria are applied to promote racial balancing, diversity or other similar goals.
Trump Merit-Based Civil Rights Executive Orders Heighten Public & Private Civil Rights & Other Discrimination Risks
As part of these directives, President Trump specifically singled out anti-Semitism for special attention and concern, In Executive Order 14188, for instance, President Trump directed HHS, the Justice Department and other agencies to vigorously enforce the Civil Rights Act to combat the rise of anti-Semitism and anti-Semitic incidents in the U.S. and around the world. While Executive Order 14188 specifically targeted the use of the Civil Rights Act and other federal prohibitions against race, color and national origin discrimination to fight anti-Semitism, Executive Order 14188 also noted that anti-Semitism also can violate federal protections against religious discrimination, stating:
…[Title VII] prohibits discrimination on the basis of race, color, and national origin in programs and activities receiving Federal financial assistance. While Title VI does not cover discrimination based on religion, individuals who face discrimination on the basis of race, color, or national origin do not lose protection under Title VI for also being a member of a group that shares common religious practices. Discrimination against Jews may give rise to a Title VI violation when the discrimination is based on an individual’s race, color, or national origin.
The Trump Administration’s emphasis on protecting federal right of conscience and other religious freedom protections is made more perilous by his sharp disagreement, revocation, and characterization as patently illegal various key aspects of the interpretation and enforcement policies of the Biden, Obama and other previous administration regarding federal right of conscience and other religious freedom, sexual orientation, reproductive rights and other civil rights policies and protections. See e.g., Executive Order 14281 -Restoring Equality of Opportunity and Meritocracy (April 23, 2025). These directives and widespread coverage and publicity of the actions by HHS and other federal agencies to implement and enforce the Administration’s Merit Based interpretation and enforcement of civil rights laws are fueling a a slew of new federal investigations and enforcement, as well as encouraging and shaping private discrimination claims by both parties advantaged or disadvantaged by the Administration’s interpretations.
As reflected by OCR’s May 13, 2025 announcement of its investigation of complaints against a “prestigious” midwestern university (“University”), OCR and other federal agencies are responding by zealously investigating complaints of anti-Semitism or other race, color, national origin and religious discrimination by academic and other health care, education, health insurance and other organizations receiving federal funding under programs managed by HHS.
Announced OCR Investigations Since February Show HHS Enforcement Risks
According to OCR, the investigation announced on May 13, 2025, and other investigations “[are] part of a broader effort by the Administration’s multi-agency Joint Task Force to Combat Anti-Semitism. OCR opened the investigation against the University in response to a complaint from a multi-stakeholder advocacy organization that alleges “systemic concerns regarding the University’s actions to maintain a campus climate, academic direction, and institutional policy that ensures nondiscrimination on the basis of race, color, and national origin.” OCR says its investigation will examine whether the University complied with its obligations under Title VI not to discriminate against Jewish students, such that it denied them an educational opportunity or benefit.
Before OCR issued is May 13, 2025, announcement, OCR and other federal agencies previously had announced Civil Rights Act and other investigations of illegal anti-Semitism at four academic medical centers based on their response to protests and other anti-Semitic activity during graduation and other activities. In addition, OCR also had announced similarly high-profile investigation or enforcement actions against Harvard University and Harvard Law Review, a HHS-funded health services research scholarship program; eight medical schools and hospitals; a HHS-funded health research program; a California-based medical school; the State of Maine and others for impermissibly applying race, color, national origin, sex, religious or other prohibited criteria in operating their programs.
The message from these and other HHS investigations and enforcements is clear. “Institutions of higher education receiving HHS Federal financial assistance are responsible for complying with Title VI’s nondiscrimination mandates,” said Anthony Archeval, Acting Director of the Office for Civil Rights at HHS. “OCR is committed to ensuring students’ education, safety, and well-being are not disrupted due to discrimination at institutions funded by taxpayer dollars.”
Dear Colleague Letter Advises Academic Medicine & Other HHS-Funded Organizations On Implementing Merit Based Decisionmaking
While warning academic medical and other health care and other HHS-funded organizations against the application of non-merit based criteria and other prohibited race, national origin, color, sex and religious discrimination, OCR also has sought to encourage covered entities to adapt their policies and practices to comply with President Trump’s merit based interpretation of the Civil Rights Act and other federal civil rights law prohibitions against race, color, national origin, sex and religious discrimination through a May 6, 2025, “Dear Colleague” Letter. In the dear Colleague Letter, OCR ‘clarifies’ its updated policies interpreting and enforcing what constitutes race-based discrimination under Title VI, Section 1557, and the Equal Protection Clause of the United States Constitution as applied to student admissions, academic and campus life, and the operation of university hospitals and clinics.
The Dear Colleague Letter reiterates that Title VI and Section 1557 prohibit academic medical and other covered organizations from relying on race-based criteria, racial stereotypes, and facially neutral criteria that operate as a pretext for race. Instead, citing to the Supreme Court’s decision in Students for Fair Admissions v. Harvard, 600 U.S. 181 (2023) and President Trump’s Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity, the Dear Colleague Letter warns HHS funded academic medicine and other organizations that these federal rules require health care providers, and those in the health professions pipeline make their selections and decisions “based on merit and clinical skills, not race” or other non-merit based criteria even when the purpose of the use of the criteria is to promote diversity or racial-balancing.
The Dear Colleague Letter discloses that in applying its merit-based interpretation of Title VI and Section 1557, OCR will prioritize enforcement against HHS funded organizations that:
Use race as part of their application or employment processes;
Require diversity, equity, and inclusion statements in connection with hiring or promotion; or
Lack clear policies demonstrating compliance with Students for Fair Admissions v. Harvard.
Accordingly, the Dear Colleague Letter advises medical schools and other HHS-funded organizations to:
Ensure their policies and procedures comply with existing federal civil rights laws;
Discontinue criteria, tools, or processes that serve as substitutes for race or are intended to advance race-based decision-making; and
End reliance on third-party contractors, clearinghouses, or data aggregators that engage in prohibited uses of race.
Act Now To Mitigate Risks From Past, Current & Future Non-Merit Based Decisions & Other Prohibited Discrimination
The new emphasis of HHS and other agencies on investigation and enforcement of federal protections for race, national origin, and other civil rights laws alone should prompt all health care and other HHS-regulated authorities prospectively to reevaluate and update their own practices to strengthen their defensibility under new standards.
As the Trump Administration civil rights directives and interpretations apply to all federal agencies, all organizations should consider and redress their exposure to civil rights or other discrimination under EEOC and other workforce, Department of Justice, and other applicable agency rules when assessing the adequacy of their existing policies and practices.
Organizations also should anticipate the likely need to defend past actions taking into account given the practice of HHS and other agency to apply the merit-based civil rights law interpretations of the Trump Administration even to events and actions that occurred while organizations were subject to the diversity, equity and inclusion friendly interpretations of federal civil rights laws during the Biden Administration. Since the investigation and enforcement actions announced by HHS and other agencies so far retroactively apply the newly announced Trump-era interpretations and standards to investigations of events and actions that occurred during the Biden Administration, prospective changes to enhance the defensibility of current and future actions alone may not be enough. Rather, health care and other organizations need to prepare for the possibility that HHS or other agencies may require their organization to defend Biden-era events under the new Trump Administration interpretations and enforcement policies. In the face of these developments, all health care organizations receiving funding from HHS should review their current and past policies and actions implicating federally civil rights laws to assess and manage their potential past exposures and mitigate future risks.
Because the process of reviewing and revising their policies and practices inevitably will require medicine and other HHS-funded institutions to identify and engage in legally and politically sensitive discussions of past and current policies, events, and actions affecting the competing interests of individuals or organizations whose opportunities are either helped or hurt by the Trump Administration’s transition to a merit-based interpretation of civil rights laws as well as potential whistleblower and retaliation exposures, academic medicine and other HHS-funded organizations generally should work with within the scope of attorney-client privilege with legal counsel experienced with these and other civil rights laws and dealing with OCR and other agencies in relation to investigations and enforcement actions under these rules.
The author of this update, Cynthia Marcotte Stamer has decades of experience advising, representing, and defending health care providers, Medicare and Medicaid Advantage and other public and private health plans and plan sponsors, public and private employers, government contractors and grant recipients, educational organizations, child care facilities, employers, technology, data, third party administrators, and other managed care and other health care, defense, technology, life sciences and other clients about Civil Rights Laws and other religious, civil rights and other discrimination, HIPAA and other privacy and data security, False Claims Act and other billing and reimbursement, quality, technology, licensing and accreditation, whistleblower and other workforce, enforcement, governmental affairs, dispute resolution, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.
Ms. Stamer’s work throughout her career has focused heavily on working with health care, health insurance and managed care, insurance and financial services, defense contractors, and other workforce and data sensitive businesses domestically and internationally on employment, benefits, data and other knowledge use and protection, Federal Sentencing Guidelines and other workforce and heath care management, internal and operational controls, regulatory and public policy and other legal and operational concerns. As a part of this work, she has had extensive involvement in Civil Rights Laws, Section 1557 and other discrimination compliance, training, risk management and defense.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
Author of many highly regarded compliance, training and other resources on cybercrime and other data privacy and security, health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy in these matters.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides health care, human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on health care, leadership, governance, human resources, employee benefits, data security and privacy, insurance, and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources including the following recent publications about related emerging developments:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
June 16, 2025 is the deadline to share input on designing a seamless, secure, and patient-centered digital health infrastructure that will help seniors and their families use modern technology to control of their health and well-being, manage chronic conditions, and access care more efficiently in response to the request for information (“RFI”) of the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”).
Following up on the CMS Interoperability and Patient Access Final Rule and part of Secretary Kennedy’s effotts to “Make America Healthy Again,” the RFI invites input from patients, caregivers, providers, payers, technology developers, and other stakeholders on how CMS and ONC can:
Drive the development and adoption of digital health management and care navigation applications;
Strengthen interoperability and secure access to health data through open, standards-based technologies;
Identify barriers preventing the seamless exchange of health information across systems; and
Reduce administrative burden while accelerating progress toward value-based, patient-centered care.
Many health care providers and others in the health industry have made significant investments in and have experience with patient focused health and wellness technologies. Sharing input can promote awareness of helpful design ideas and help deter investments or mandates of counterproductive technologies.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
With the financial impact to businesses suffering data breaches in 2024 now averaging nearly $5 million and the announcement by the Department of Health and Human Services Office of Civil Rights (“OCR”) two additional Health Insurance Portability & Accountability Act (“HIPAA”) “Risk Analysis Initiative” settlements in seven days, health care providers, health plans, healthcare clearinghouses (“Covered Entities”) and their business associates (collectively “Regulated Entities”) face a growing imperative to act now to promote the defensibility of their practices under the Risk Analysis and other HIPAA Privacy, Security, and Breach Notification Rule requirements. Coupled with OCR’s steady announcement of enforcement actions like those announced this month against NERAD and others under its Risk Analysis Initiative, OCR clearly is warning health care providers and other Regulated Entities to clean up and strengthen their Risk Analysis and other HIPAA Security Rule compliance.
The need for Regulated Entities to ensure their fulfillment of HIPAA’s Risk Analysis requirements to prevent and mitigate their legal, financial and operational exposures from breaches of electronic protected health information (“ePHI”) and to defend against a potential OCR Risk Analysis enforcement action or audit is demonstrated by OCR’s announcement of HIPAA Security Rule enforcement actions and settlements with Northeast Radiology, P.C. (NERAD) on April 10, 2025, and Guam Memorial Hospital Authority (“GMHA”) on April 17, 2025, the sixth and seventh under OCR’s recently announced HIPAA “Risk Analysis Initiative” .
Risk Analysis Longstanding HIPAA Requirement
The HIPAA Privacy, Security, and Breach Notification Rules require Regulated Entities to meet specific standards to protect the privacy and security of protected health information. Violation of these requirements exposes Regulated Entities to civil monetary penalties or even criminal penalties depending on the nature of the violation.
Since the HIPAA Security Rule first took effect, risk analysis is one of the four required implementation specifications Regulated Entities must meet under the Security Management Process standard in 45 CFR § 164.308.
To fulfill this Risk Analysis requirement, a Regulated Entity must conduct an “accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI” and “[i]mplement policies and procedures to prevent, detect, contain, and correct security violations.”
Additionally, in 45 CFR § 164.402 the HIPAA Breach Notification Rule requires a Regulated Entity that experiences an impermissible acquisition, access, use, or disclosure (“breach”) of unsecured ePHI to conduct a documented risk assessment to determine whether the Regulated Entity must notify affected individuals, OCR and in the case of breaches involving the ePHI of 500 or more individuals, the media. As consistently interpreted and applied by OCR, experiencing a breach or the existence of evidence putting the Regulated Entity on notice of a potential susceptibility creating a risk of a breach triggers a duty by the Regulated Entity to conduct a Risk Assessment to assess the susceptibility of its ePHI to the risk and the actions reasonably necessary to mitigate it under the Security Rule.
OCR views Risk Analysis as foundational to the protection of ePHI. As OCR Acting Director Anthony Archeval recently stated to explain OCR’s emphasis on Risk Analysis compliance and enforcement, “Ransomware and hacking are the primary cyber-threats to electronic protected health information within the health care industry. Failure to conduct a HIPAA risk analysis puts this information at risk and vulnerable to future ransomware attacks and other cyber-threats[.]” Consequently, OCR constantly has urged Regulated Entities to fulfill their Risk Analysis obligations since the earliest days of HIPAA. To promote compliance, OCR persistently has communicated the necessity and importance of the Risk Analysis in guidance and sought to reinforce the consequences of inadequate Risk Analysis by discussing the role of Risk Analysis deficiencies in creating the circumstances leading to enforcement actions against Regulated Entitles in its civil monetary penalty assessments and HIPAA settlement announcements.
Despite OCR’s constant and ever-rising efforts to promote compliance with the Risk Analysis requirements, however, OCR consistently has found deficiencies in Regulated Entities’ Risk Analysis in its breach investigations and audit findings since these rules became effective. As the number and magnitude of reported breaches of ePHI skyrocketing and massive breaches like those experienced in 2024 by UnitedHealthcare subsidiary Change Health, Ascension and others demonstrating the serious consequences ransomware and other cyberattacks can inflict on health care delivery, payment, and patient privacy, OCR is placing new emphasis on tightening both the requirements for Risk Analysis and its enforcement of compliance with the Risk Analysis requirements.
On December 27, 2024, for instance, OCR published a notice of proposed rulemaking that proposes to clarify and tighten significantly the Risk Analysis requirements and other elements of the HIPAA Security Rule. Along with proposing these heightened Risk Analysis requirements, OCR announced and now is zealously enforcing the current Risk Analysis requirements through its Risk Analysis Initiative to hold Regulated Entities accountable for failing to fulfill their Risk Analysis responsibilities as part of its heightened efforts to improve Regulated Entities’ fulfillment of their Risk Analysis obligations. With OCR’s announcement of the NERAD and GMHA enforcement actions on April 10 and April 17, respectively bringing to seven the number of Risk Analysis Initiative enforcement settlements in recent months, health care providers and other Regulated Entities should heed the schooling these and other similarly sanctioned organizations as a call to action to ensure their own Risk Analysis and other HIPAA Privacy, Security and Breach Rule compliance.
The first of two Risk Analysis Initiative settlements announced in seven days in April and the sixth enforcement action and settlement specifically labeled as taken under the “Risk Analysis Initiative,” the NERAD enforcement action and settlement announced April 10, 2025 resolves liabilities for violation of the Risk Analysis Rule arising from OCR’s investigation of a breach of ePHI stored on NERAD’s Picture Archiving and Communication System (“PACS”) server for storing, retrieving, managing, and accessing radiology images.
OCR initiated its investigation of NERAD after receiving a NERAD breach report that between April 2019 and January 2020, unauthorized individuals accessed radiology images stored on NERAD’s PACS server. NERAD notified the 298,532 patients whose information was potentially accessible on the PACS server of this breach. OCR’s investigation found that NERAD had failed to conduct an accurate and thorough Risk Analysis to determine the potential risks and vulnerabilities to the ePHI in NERAD’s information systems.
To avoid potentially much greater HIPAA civil monetary penalties under the terms of the resolution agreement, NERAD paid OCR $350,000 and agreed to implement a corrective action plan that OCR will monitor for two years. Under the corrective action plan, NERAD will take steps to improve its compliance with the HIPAA Security Rule and protect the security of ePHI, including:
Conducting an accurate and thorough Risk Analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
Developing and implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in its Risk Analysis;
Developing and implementing a written process to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports;
Developing, maintaining, and revising, as necessary, its written policies and procedures to comply with the HIPAA Rules; and
Augmenting its existing HIPAA and security training program to all of its workforce members who have access to PHI.
Seven days after announcing the NERAD Risk Analysis enforcement action and settlement, OCR reaffirmed its commitment to enforcement of the Risk Analysis enforcement when it announced its first HIPAA settlement under the new Trump Administration with GMHA, a public hospital on the U.S. Territory, island of Guam, on April 17, 2025.
The seventh Risk Analysis Initiative enforcement action and eleventh ransomware enforcement action announced by OCR, the GMHA settlement arose from OCR’s investigation of two complaints alleging that GMHA impermissibly allowed the disclosure of ePHI of GMHA patients. OCR originally initiated its investigation in response to a January 2019 complaint alleging that GMHA experienced a ransomware attack affecting the ePHI of approximately 5,000 individuals. During the investigation, OCR received another complaint in March 2023 alleging that hackers accessed patient records. OCR’s investigation determined that GMHA had failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to ePHI held by GMHA.
Under the terms of the resolution agreement, GMHA paid OCR $25,000 and agreed to implement a corrective action plan that OCR will monitor for three years. In the corrective action plan, GMHA must take a number of steps to ensure compliance with the HIPAA Security Rule and protect the security of ePHI, including:
Conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
Develop and implement a risk management plan to address and mitigate security risks and vulnerabilities identified in its risk analysis;
Develop a written process to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports;
Develop, maintain, and revise, as necessary, written policies and procedures to comply with the HIPAA Privacy, Security and Breach Notification Rules;
Augment its existing HIPAA and security training program so all workforce members with access to PHI understand the HIPAA requirements and GMHA’s HIPAA policies and procedures;
Enhance workforce security and information access management by reviewing all access credentials that have been granted access to ePHI; and
Conduct breach risk assessments and provide evidence to OCR that all breach notification obligations have been conducted.
Required & Recommended Actions To Promote Defensibility Of Risk Analysis Compliance
With cyberattacks targeting health care and other Regulated Entities soaring and OCR stepping up its scrutiny of Regulated Entities’ Risk Analysis compliance in audits and enforcement actions, each health care provider and other Regulated Entity should review and tighten its Risk Analysis practices and documentation to reduce its susceptibility to potential breaches and to promote its ability to defend its compliance with the Risk Analysis requirements in the event of a breach investigation or audit.
Fulfill Current Risk Analysis Standards
To fulfill the “Risk Analysis” implantation specification, the Security Management Process Standard requires Regulated Entities enforce appropriate administrative, physical, and technical safeguards for the confidentiality, integrity, and security of electronic protected health information (“ePHI”) based on an up-to-date conduct of an up-to-date accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by that organization (“Risk Analysis”).
The Security Rule requires Regulated Entities to document each Risk Analysis in writing, to keep Risk Analysis documentation for six years, and to provide Risk Analysis documentation to OCR upon request.
Among other things, the Risk Analysis implementation standard requires regulated entities adequately to:
Identify where ePHI is located in the organization, including how ePHI enters, flows through, and leaves the organization’s information systems.
Integrate Risk Analysis and risk management into the organization’s business processes.
Ensure that audit controls are in place to record and examine information system activity.
Implement regular reviews of information system activity.
Utilize mechanisms to authenticate information to ensure only authorized users are accessing ePHI.
Encrypt ePHI in transit and at rest to guard against unauthorized access to ePHI when appropriate.
Incorporate lessons learned from incidents into the organization’s overall security management process.
Provide workforce members with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.
Follow Proposed Rules & Enforcement Actions To Mitigate Risks
The proposed rule published by OCR on December 27, 2024, seeks to clarify and expand the original requirements of the Risk Assessment implementation standard based on OCR’s past HIPAA Security and Breach Rule investigation and enforcement experience. Under the proposed rule, a Regulated Entity’s Risk Analysis also would be required to include:
Require the development and revision of a technology asset inventory and a network map that illustrates the movement of ePHI throughout the regulated entity’s electronic information system(s) on an ongoing basis, at least once every 12 months and in response to a change in the regulated entity’s environment or operations that may affect ePHI.
Require greater specificity for conducting a risk analysis, including a written assessment that contains, among other things:
A review of the technology asset inventory and network map;
Identification of all reasonably anticipated threats to the confidentiality, integrity, and availability of ePHI;
Identification of potential vulnerabilities and predisposing conditions to the regulated entity’s relevant electronic information systems;
An assessment of the risk level for each identified threat and vulnerability, based on the likelihood that each identified threat will exploit the identified vulnerabilities; and
A review of the technology asset inventory and network map.
Other changes included in the proposed rule would further heighten the Risk Analysis and other Security Standard requirements for Regulated Entities. For instance, the proposed rule would require Regulated Entities:
To establish written procedures to restore the loss of certain relevant electronic information systems and data within 72 hours;
To perform an analysis of the relative criticality of their relevant electronic information systems and technology assets to determine the priority for restoration;
To establish written security incident response plans and procedures documenting how workforce members are to report suspected or known security incidents and how the regulated entity will respond to suspected or known security incidents;
To implement written procedures for testing and revising written security incident response plans;
To conduct a compliance audit at least once every 12 months to ensure their compliance with the Security Rule requirements;
To require business associates to verify at least once every 12 months for covered entities (and that business associate contractors verify at least once every 12 months for business associates) that they have deployed technical safeguards required by the Security Rule to protect ePHI through a written analysis of the business associate’s relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate;
To encrypt ePHI at rest and in transit, with limited exceptions;
To establish and deploy technical controls for configuring relevant electronic information systems, including workstations, in a consistent manner including deployment of anti-malware protection, removal of extraneous software, and disabling network ports in accordance with the regulated entity’s risk analysis;
Use of multi-factor authentication, with limited exceptions;
Vulnerability scanning at least every six months and penetration testing at least once every 12 months;
Network segmentation;
Separate technical controls for backup and recovery of ePHI and relevant electronic information systems;
To review and test the effectiveness of certain security measures at least once every 12 months, in place of the current general requirement to maintain security measures;
Business associates to notify covered entities (and subcontractors to notify business associates) upon activation of their contingency plans without unreasonable delay, but no later than 24 hours after activation;
Group health plans to include in their plan documents requirements for their group health plan sponsors to: comply with the administrative, physical, and technical safeguards of the Security Rule; ensure that any agent to whom they provide ePHI agrees to implement the administrative, physical, and technical safeguards of the Security Rule; and notify their group health plans upon activation of their contingency plans without unreasonable delay, but no later than 24 hours after activation.
To help Regulated Entities understand and fulfill these responsibilities, OCR alone and in conjunction with the Office of the National Coordinator for Health Information Technology (“ONC”) also has published guidance like the HIPAA Security Risk Assessment (SRA) Tool. OCR guidance reflects that fulfillment of the Tool can help Regulated Entities may help defend but does not guarantee fulfillment of the Risk Assessment requirements, as the adequacy of the Risk Assessment always depends upon the unique facts and circumstances of the Regulated Entity at a particular time. This guidance confirms the importance of conducting timely and appropriate Risk Analysis in a manner that shows the Regulated Entity appropriately evaluated the risks to its e-PHI and acted reasonably in designing, administering, and updating that Risk Analysis to reasonably defend its e-PHI against breaches or other susceptibilities.
Since OCR’s guidance makes clear that the adequacy of a Regulated Entity’s Risk Analysis and other HIPAA Security compliance based on its evaluation and response to known and suspected susceptibility threats as conducted and documented pursuant to the Risk Analysis rule, health care providers and other Regulated Entities should view Risk Analysis as a ongoing process. While the Security Rule does not currently dictate how frequently a regulated entity must perform Risk Analysis, a proposed rule published by OCR on December 27, 2024 seeks to amend the existing Security Rule to expand the requirement to require regulated entities to develop and revise a technology asset inventory and a network map that illustrates the movement of ePHI throughout the regulated entity’s electronic information system(s) on an ongoing basis, at least once every 12 months and in response to a change in the regulated entity’s environment or operations that may affect ePHI. Although OCR has not yet officially adopted this and other changes contained in the proposed rule, substantial evidence exists that it already regularly administers the Risk Analysis requirement with the expectation that regulated entities will perform Risk Analysis at least this frequently. For instance, current OCR resolution agreements require impacted organizations to conduct Risk Analysis to identify and address vulnerabilities at least annually, and more frequently as needed in response to signs of potential breach or susceptibility. Likewise, since OCR developed the proposed rule from its past enforcement experience, wise Regulated Entities also will recognize the value of drawing upon the changes set forth in the proposed rule for helpful insights to strengthen the security of their ePHI generally and promoting the defensibility of the adequacy of their Risk Assessments.
Use Appropriate Process To Audit, Update & Strengthen Risk Defensibility
With the continued explosion in ransomware and other cyberthreats heightening the risk of experiencing a breach or other incident likely to draw the attention of OCR, each health plan or other Regulated Entity should take assess and confirm the adequacy of their current Risk Analysis, both to protect its ePHI and to promote its ability to defend its compliance with the HIPAA Security Rule’s Risk Analysis and other requirements in light of OCR’s heightened emphasis on Risk Analysis compliance and enforcement. For purposes of conducting this analysis, Regulated Entities generally will want to use a process like the following to structure their evaluation of their existing Risk Analysis to take advantage of the opportunity to use attorney-client privilege and other evidentiary rules to help protect discoverability of sensitive discussions about possible deficiencies in their existing Risk Analysis and discussions about potential tradeoffs considered in current or future Risk Analysis response:
Engage legal counsel experienced with HIPAA and other cybersecurity-related risks and liabilities to advise and assist your organization in designing and administering your Risk Analysis processes and response within the scope of attorney-client privilege;
Appoint and designate leadership and technical leadership for team responsible for design and administration of your organization’s initial and ongoing cybersecurity Risk Analysis and response (“Cyber-Risk Team”) and process for board and senior management reporting of the Cyber-Risk Team;
Select and engage outside consulting service providers, cyber-liability insurers and other risk service providers expected to participate in the process; work with qualified legal counsel to contract with these business associates to include the business associate agreement and other reassurances required by the HIPAA Privacy, Security and Breach Notification Rule and other performances, cooperation to provide and back services in accordance with agreed-upon protocols in the contract;
Train Cyber-Risk Team in the appropriate processes for working with internal teams, outside service providers, leadership, and designated legal counsel to conduct Risk Analysis, investigation and response using attorney-client privilege and other evidentiary tools and processes to maximize defensibility;
Require the Cyber-Risk Team conduct an updated, document assessment of cyber-risk within scope of attorney-client privilege and work with legal counsel to develop a documented cyber-risk policy that captures analysis and determinations for your justification for the size, scope and timing of your periodic Risk Analysis and rules and processes for interim risk identification, reassessments and response in reaction to potential cyber-risk signs between periodic Risk Analysis for presentation and approval by the Board taking into account the insights from published final and proposed guidance, enforcement actions and industry standards;
Require, oversee and enforce Cyber-Risk Team’s documented administration of the initial and subsequently required Risk Analysis and response pursuant to the adopted cyber-risk policy to identify vulnerabilities and work with legal counsel within the scope of privilege to document your analysis and justifications for addressing identified vulnerabilities and other required actions in response to identified susceptibilities or event;
Review adequacy of incident detection and response arrangements, including reporting and response mechanisms, insurance and indemnification protection, and other critical elements for mitigation and recovery; and
Other actions as warranted based on advice of counsel taking into account emerging threats, guidance, and risk susceptibility.
Although civil monetary penalties or settlements are the most common sanction imposed for HIPAA Security and Breach Notification rule violations, willful and certain other violations of HIPAA can trigger criminal liability subject to the Federal Sentencing Guidelines. Consequently, beyond fulfilling the specific requirements of HIPAA, an adequate Risk Assessment also can be an invaluable tool for helping mitigate Federal Sentencing Guideline exposures of a Regulated Entity and its leaders under the Federal Sentencing Guidelines Organizational Liability rules.
Beyond these specific HIPAA-associated exposures, Regulated Entities and their leaders should keep in mind that HIPAA is likely only one of many laws that define their responsibilities to secure, report, and respond to breaches of ePHI or other sensitive data. Depending on the location, nature and other circumstances, Regulated Entities and their leaders also may have additional responsibilities and liability exposures under a variety of other federal and state laws, ethical or other professional standards, and contractual obligations. For instance, inadequate data safeguards for ePHI also can trigger liability under the Fair and Accurate Credit Transactions Act, the Federal Trade Commission Act, and various electronic crimes statutes. The Securities and Exchange Commission rules can trigger disclosure and other obligations for publicly traded hospital or other health care providers, insurers, or their business associates. Health care providers, payers and others are likely to face specific additional health care or insurance-specific licensing and ethics rules, as well as other confidential information privacy, cybersecurity and breach reporting obligations and liability under various state statutes and regulations. Regulated Entities and their leaders generally will want to fully evaluate and manage these risks in conjunction with their compliance with the Risk Analysis and other requirements of the HIPAA Security and Breach Notification Rules.
The author of this update, Cynthia Marcotte Stamer is nationally known and celebrated for her experience providing advice and representation to health care providers, health insurers, employers and other health plan sponsors, health plans, health plan fiduciaries and administrators, third party administrators, human resources and health plan technology, and other businesses about HIPAA and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
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We hope this update is helpful. For more information about these or other health or other employee benefits, human resources, or health care developments, please contact the author, Cynthia Marcotte Stamer, via e-mail or telephone at (214) 452-8297.
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About the Author
Cynthia Marcotte Stamer is a Martindale-Hubble AV-Preeminent (highest/top 1%) practicing attorney recognized as a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Health Care Law and Labor and Employment Law; among the “Best Lawyers In Dallas” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law recognized for her experience, scholarship, thought leadership and advocacy on HIPAA and other data and technology use, security and compliance in connection with her work with health care and life sciences, employee benefits, insurance, education, technology and other highly regulated and performance-dependent clients.
Board certified in labor and employment law by the Texas Board of Legal Specialization and a Fellow in the American College of Employee Benefits Counsel, Ms. Stamer works with these and other highly regulated or data and performance reliant businesses to design, risk manage, and defend their employment and other workforce, data and technology and other operations to promote legal and operational compliance, reduce regulatory and other liability and promote other operational goals.
Along with her decades of legal and strategic consulting experience, Ms. Stamer also contributes her leadership and experience to many professional, civic and community organizations. She currently serves as Co-Chair of the ABA Real Property Trusts and Estates (“RPTE”) Section Welfare Plan Committee, Co-Chair of the ABA International Section International Employment Law Committee and its Annual Meeting Program Planning Committee, Chair Emeritus and Vice Chair of the ABA Tort Trial and Insurance (“TIPS”) Section Medicine and Law Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee.
Additionally,more her ABA involvements include than a decade of service as a Scribe for the Joint Committee on Employee Benefits (“JCEB”) annual agency meetings with the Department of Health and Human Services and JCEB Council Representative, International Section Life Sciences Committee Chair, RPTE Section Employee Benefits Group Chair and a Substantive Groups Committee Member, Health Law Section Managed Care & Insurance Interest Group Chair, as TIPS Section Medicine and Law Committee Chair and Employee Benefits Committee and Workers Compensation Committee Vice Chair, Tax Section Fringe Benefit Committee Chair, and in various other ABA leadership capacities. Ms. Stamer also is a former Southwest Benefits Association Board Member and Continuing Education Chair, SHRM National Consultant Board Chair and Region IV Chair, Dallas Bar Association Employee Benefits Committee Chair, former Texas Association of Business State, Regional and Dallas Chapter Chair, a founding board member and Past President of the Alliance for Healthcare Excellence, as well as in the leadership of many other professional, civic and community organizations. She also is recognized for her contributions to strengthening health care policy and charitable and community service resolving health care challenges performed under PROJECT COPE Coalition For Patient Empowerment initiative and many other pro bono service involvements locally, nationally and internationally.
Ms. Stamer is the author of many highly regarded works published by leading professional and business publishers, the ABA, the American Health Lawyers Association, and others. Ms. Stamer also frequently speaks and serves on the faculty and steering committee for many ABA and other professional and industry conferences and conducts leadership and industry training for a wide range of organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see http://www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
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NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. Solutions Law Press and its authors reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. Solutions Law Press and its authors disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
While Medicaid rules require state Medicaid programs to provide reimbursements for out-of-state services provided to beneficiaries, the District Of Colombia Court of Appeals has ruled that states can limit supplemental payments funded through a tax or assessment on in-state providers to in-state providers.
In Asante v. Kennedy, No. 23-5055 (D.C. Cir. 2025), border hospitals caring for California residents covered by California’s Medi-Cal program argued California violated the Commerce Clause and the Equal Protection Clause of the Constitution by refusing to pay Medi-Cal supplemental payments provided to in-state hospitals caring for Medi-Cal beneficiaries to the border hospitals treating Medi-Cal beneficiaries seeking care outside California.
The Medi-Cal program is the program through which California participates in Medicaid. Federal Medicaid funding is available to States for expenditures related to the provision of a covered Medicaid service to a Medicaid beneficiary under 42 U.S.C. § 1396b.
For purposes of Asante, the Court distinguished between two types of State Medicaid expenditures:
Base payments, which CMS has defined as payments made to providers “on a per-claim basis for services rendered to a Medicaid beneficiary,” and
Supplemental payments, which are payments to providers separate from (and in addition to) the “per-claim” base payments for services rendered to a beneficiary.
See Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting, 89 Fed. Reg. 40,876, 40,925 (June 21, 2024) (citing 42 U.S.C. § 1396b(bb)); 42 C.F.R. § 438.6(a).
The Medicaid law does not require states to fund their share of Medicaid expenditures entirely on their own. Instead, States may tax providers in accordance with specified criteria to generate funds that the federal government then matches. In 2009, California exercised this taxing authority by establishing a Quality Assurance Fee (“QAF”) as part of its administration of Medi-Cal. The QAF program operates by: (i) assessing a provider tax, which California calls a quality assurance fee, on nonexempt in-state hospitals; (ii) using those funds to generate matching federal Medicaid funding; and (iii) distributing the collected funds as supplemental payments to qualifying private in-state hospitals. Id. §§ 14169.50, 14169.52, 14169.54, 14169.55.
Following California’s original creation of the QAF program, a group of out-of-state hospitals located near the California border challenged the program in federal court in California, claiming an entitlement to receive the QAF supplemental payments, which by California law were to go solely to instate hospitals. At that time, California chose to settle rather than fight the out-of-state hospitals. Consequently, California entered into settlement agreements under which it gave QAF supplemental payments to those out-of-state hospitals through 2019. Those settlement agreements expired in 2019.
When California sought and obtained in 2020 CMS approval of the QAF program with payments restricted to in-state hospitals for the next two-year cycle, California again faced challenges from out-of-state hospitals along its border. A group of out-of-state hospitals located near the California border again argued in federal court that their exclusion from the QAF supplemental payments violates the Commerce Clause, the Equal Protection Clause, and federal Medicaid regulations. After district court granted summary judgment approving the California exclusion of the out-of-state providers, Asante v. Azar, 656 F. Supp. 3d 185, 190 (D.D.C. 2023), the border hospitals appealed.
In its ruling upholding California’s limitation of eligibility for the supplemental payments, the Court rejected each of the border hospital’s Constitutional challenges to their ineligibility.1
Regarding the Commerce Clause, the Court of Appeals rejected the border hospitals’ Commerce Clause’s claim that the QAF program discriminates against interstate commerce because California pays QAF supplemental payments only to in-state hospitals. The Appeals Court noted that both the QAF provider tax assessed against in-state hospitals and the QAF supplemental payments given to in-state hospitals are calculated based solely on the in-state provision of medical care to in-state patients. The QAF program does not assess a tax against out-of-state hospitals. Since California makes no “obvious effort to saddle those outside the State” with the costs of the QAF program. Since out-of-state hospitals neither incur the costs (the provider tax) nor receive the benefits (the supplemental payments) of the QAF program, the Appeals Court held that the program does not discriminate against interstate commerce—as it imposes no “differential burden on any part of the stream of commerce” here. See W. Lynn Creamery, Inc. v. Healy, 512 U.S. 186, 202 (1994).
The Court likewise rejected the border hospital’s claim that California violated the Equal Protection Clause. Noting that a challenged state law such as the California statute that does not include factors justifying heightened scrutiny must be upheld under the Equal Protection Clause “if there is any reasonably conceivable state of facts that could provide a rational basis” for it, the Court ruled that limiting eligibility for the supplemental payments to the in-state hospitals that paid the taxes that funds it. Accordingly, the Court ruled the border hospitals were not entitled to receive supplemental payments under the Equal Protection Clause.
Finally, the Appeals Court also rejected the border hospitals’ last argument that California’s QAF program violated HHS Regulations by denying the supplemental payments to the border hospitals because the supplemental payments are not reimbursements for services and therefore not covered by 42 C.F.R. § 431.52.
Accordingly, the Appeals Court ruled that California does not violate the Commerce Clause or Equal Protection Clause of the United States Constitution by excluding out-of-state hospitals located along the California border (“border hospitals”) that treat California residents enrolled in Medi-Cal from eligibility to collect Medi-Cal supplemental payments paid to California hospitals for treating Medi-Cal-covered Californians.
The author of this update, Cynthia Marcotte Stamer has decades of experience advising health care providers, Medicare and Medicaid Advantage and other public and private health plans and plan sponsors, government contractors and grant recipients, government health and social security programs, and their technology, data, third party administrators, and other managed care and other health care, defense, technology, life sciences and other clients about health industry quality, technology, reimbursement, licensing and accreditation, compliance, enforcement, governmental affairs, dispute resolution, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.
Ms. Stamer’s work throughout her career has focused heavily on working with health care, health insurance and managed care, insurance and financial services, defense contractors, and other workforce and data sensitive businesses domestically and internationally on employment, benefits, data and other knowledge use and protection, Federal Sentencing Guidelines and other workforce and heath care management, internal and operational controls, regulatory and public policy and other legal and operational concerns. As a part of this work, she has had extensive involvement in the design, enforcement, investigation, mitigation and defense of trade secret and other information privacy and confidentiality, HRIS, claims, electronic medical records, payment, and other systems and technologies; HIPAA and other health industry, DOD, FACTA, GLB, EU, and other data privacy and security, trade secret and other confidential information; and other information privacy and security laws, policies, practices, contracts and requirements.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
Author of many highly regarded compliance, training and other resources on cybercrime and other data privacy and security, health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy in these matters.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides health care, human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on health care, leadership, governance, human resources, employee benefits, data security and privacy, insurance, and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
The $1,500,000 civil monetary penalty (“CMP”) the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) imposed against online prescription and nonprescription eyewear manufacturer and online retailer Warby Parker, Inc., for Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule violations warns other HIPAA-covered health care providers health plans, healthcare clearinghouses (“covered entities”) and their business associate service providers (collectively, “HIPAA Entities”) to protect electronic systems with electronic protected health information (“ePHI”) from ransomware and other hacking attacks.
The HIPAA Security Rule establishes national standards to protect individuals’ ePHI created, received, used, disclosed, maintained, or transmitted by a HIPAA Dntity. It also requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, availability, and security of ePHI.
OCR guidance and enforcement make clear it considers protecting ePHI from improper access, use, disclosure, and destruction of other unavailability due to ransomware and other hacking threats.
Violation of HIPAA can trigger either civil monetary penalties or criminal penalties under HIPAA. As amended by the the HITECH Act, HIPAA provides for the following civil monetary penalties for HIPAA violations:
A minimum of $100 for each violation where the covered entity or business associate did not know and, by exercising reasonable diligence, would not have known that the covered entity or business associate violated such provision, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $25,000
A minimum of $1,000 for each violation due to reasonable cause and not to willful neglect, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $100,000. Reasonable cause means an act or omission in which a covered entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.
A minimum of $10,000 for each violation due to willful neglect and corrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $250,000.
A minimum of $50,000 for each violation due to willful neglect and uncorrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $1,500,000.
As required by law, OCR adjusts the CMP ranges for each penalty tier for inflation3 for violations after November 2, 2015.
Along with these potentially substantial civil penalty exposures, HIPAA’s potential criminal penalties make HIPAA compliance a required element of the Federal Sentencing Guideline Compliance programs Covered Entities and their leaders need to mitigate their exposures to organizational liability under the Guidelines.
HIPAA breaches also generally expose HIPAA Entities and their leaders to potential liability for breach liability under federal and state electronic crimes and other data breach and security laws; Federal Trade Commission and other federal and state fraud and deceptive business laws; securities laws; Federal Sentencing Guideline and other liability for health care or other fraud and other crimes enabled by inadequate compliance or response; create licensing or ethical sanctions; create shareholder, tort or contractual liabilities; trigger public company disclosure and executive compensation clawback responsibilities; and a host of other legal, operational and business partner and public relations headaches.
Warby Parker’s Hard Lesson
Warby Parker is the latest in a fast-mounting list of HIPAA Entities nailed for hacking-related HIPAA breaches
The $1.5 million Warby Parker civil money penalty announced February 20, 2025 resulted from an OCR investigation of a December 2018 breach report of a hacking incident involving customer accounts filed by Warby Parker. The report stated that in November 2018, Warby Parker became aware of unusual, attempted log-in activity on its website. Warby Parker reported that between September 25, 2018, and November 30, 2018, unauthorized third parties gained access to Warby Parker customer accounts by using “credential stuffing.” Hackers used usernames and passwords obtained from other, unrelated websites that were presumably breached to access the Warby Parker data.
In September 2020, Warby Parker filed an addendum to its December 2018 breach report, updating the number of individuals affected by the breach to 197,986.
The compromised ePHI included customer names, mailing addresses, email addresses, certain payment card information, and eyewear prescription information.
Warby Parker also filed subsequent breach reports (each breach report affecting fewer than 500 persons) in April 2020, and June 2022, following similar attacks.
OCR’s investigation of the breach reports found evidence of three violations of the HIPAA Security Rule. These included:
Failure to conduct an accurate and thorough risk analysis to identify the potential risks and vulnerabilities to ePHI in Warby Parker’s systems;
Failure to implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level; and
Failure to implement procedures to regularly review records of information system activity.
Ransomware & Other Hacking Now OCR #1 HIPAA Enforcement Priority
All HIPAA Entities should learn from the costly lessons of Warby Parker and the many other HIPAA Entities sanctioned or awaiting their consequences for hacking incidents and consult with qualified legal counsel for assistance in conducting an assessment of the adequacy of their current compliance.
Hacking, ransomware and other cyberattacks collectively and individually account for the breaches of ePHI affecting the largest number of individuals by far and away.
OCR announced various other hacking or other cyberattack related large breaches intermittently across the years.
Hacking-related HIPAA investigations and enforcement actions date back to the 2015 hacking breach at Premera Blue Cross that impacted more than 10.4 million individuals’ records and led to Premera paying OCR $6.85 million to settle resulting OCR HIPAA charges.
After periodically warning HIPAA Entities to address ransomware and hacking through its announcement of occasional hacking-related breach enforcement actions and other guidance, epidemic ransomware and other large scale cyber breaches targeting UnitedHealthcare subsidiary Change Health, Ascension Health, and many other large health care and health insurance organizations prompted OCR to identify HIPAA Security Rule breaches involving ransomware and other cyberattacks a top prevention, investigation and enforcement priority. Since then, the list of HIPAA entities paying OCR civil monetary penalties or settlements to resolve cyberattack related HIPAA charges has quickly and steadily grown. with the number of cyber attacks, impacting HIPAA entities accelerating, the number and magnitude of penalties assessed will only grow.
OCR has published a long list of guidance and alerts to help HIPAA Entities fulfill their HIPAA duties to safeguard their ePHI from ransomware and other cyberattacks and resulting HIPAA liabilities.
Among other things, OCR recommends that HIPAA Entities take the following steps to mitigate or prevent cyber-threats:
Identify where ePHI is located in the organization, including how ePHI enters, flows through, and leaves the organization’s information systems;
Integrate risk analysis and risk management into the organization’s business processes;
Ensure that audit controls are in place to record and examine information system activity;
Implement regular reviews of information system activity;
Utilize mechanisms to authenticate information to ensure only authorized users are accessing ePHI;
Encrypt ePHI in transit and at rest to guard against unauthorized access to ePHI when appropriate;
Incorporate lessons learned from incidents into the organization’s overall security management process; and
Provide workforce members with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.
OCR regulations, resolution agreements, civil monetary penalty, assessments, also make clear HIPAA Entities must carefully document their original risk assessments, their timely monitoring and response to new threats, the analysis underlying their risk assessments and response, and other critical details and be prepared to produce that risk assessment in the event of an OCR investigation or audit.
This guidance also reflects HIPAA Entities should capture their ongoing use of appropriate procedures to monitor and respond to signs of threat or compromise to their own systems as well as OCR and other agency and industry alerts about emerging threats and susceptibilities as part of their ongoing risk assessment and response process.
Given the high threat environment and the growing HIPAA and other liabilities that commonly follow a cyberattack breach, HIPAA entities and their leaders should consider the advisability of conducting these assessments and any known or suspected breach investigation and response with the benefit of guidance from HIPAA experienced legal counsel within the scope of attorney-client privilege
HIPAA entities also should ensure appropriate plans and resources to investigate and respond to any breach that might occur promptly. Most entities will want to secure liability insurance coverage as well as require suitable credential information, indemnification, insurance and other assurances from their business associates and other vendors with access to systems or data that includes electronic PHI.
The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, who has decades of experience advising health care providers, health plans and insurers, third party administrators, managed care and other health care payers and providers, technology, and other businesses about crisis preparedness and response and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
For HIPAA Help or Information
We hope this update is helpful. For more information about these or other health or other employee benefits, human resources, or health care developments, please contact the author, Cynthia Marcotte Stamer, via e-mail or telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health, insurance, employment and employee benefits and other industry management work, public policy leadership and advocacy, coaching, teachings, and publications including leading-edge work on crisis preparedness, response and recovery.
Author of many highly regarded compliance and risk management tools, training and other resources on health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy on these matters.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides health care, insurance, human resources and employee benefit, data and technology, regulatory and operational performance, and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education. These include extensive resources on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
The Centers for Medicare & Medicaid Services (CMS) has opened data submission for the 2024 performance year of the Quality Payment Program (“QPP). Providers can submit and update data until 8 p.m. ET on March 31, 2025.
Submit your data for the 2024 performance year or review the data reported on your behalf by a third party. (You can’t correct errors with your data after the submission period, so it’s important to make sure the data submitted on your behalf is accurate.)
To sign in and submit data, clinicians will need an HCQIS Authorization Roles and Profile (HARP) account and a QPP role. For help enrolling with HARP, please refer to “Step 1. Register for a HARP Account” in the QPP Access User Guide (ZIP, 4MB). For help obtaining a QPP role, please refer to “Step 2. Connect to an Organization” in the QPP Access User Guide (ZIP, 4MB).
CMS encourages all users with an existing HARP account to sign into the QPP websitenow to ensure they don’t lose access.
Note: Clinicians unsure about their eligibility to participate in the Merit-based Incentive Payment System (MIPS) for the 2024 performance year can check their final eligibility status using the QPP Participation Status Tool. Clinicians and groups that are opt-in eligible must make an election to opt-in or voluntarily report before they can submit data. (No election is required for opt-in eligible clinicians and groups that don’t want to participate in MIPS.)
Reminder: Preliminary Scoring No Longer Available During Submission
As a reminder, CMS eliminated the preliminary score and preliminary category-level scores from submission. We’ll release 2024 MIPS final scores in mid-June 2025.
Submit Early
CMS encourages providers to submit 2024 MIPS performance period data early during the submission period to allow plenty of time for Service Center assistance if needed.
The QPP Service Center projects an increase in volume between January 2, 2025, and March 31, 2025.
There are a variety of ways to contact the QPP Service Center for submitters needing help:
You can schedule a call with a QPP Service Center Representative at a time that works best for you. Just go to the CCSQ Support Central page and click on Schedule a Call.
You can also submit a ticket for support by clicking on Request Support and selecting Call Scheduling Options from the dropdown menu.
Live Chat: CCSQ Support Central Chat and Resource Line (CARL). The Support Central Chat feature, CARL, is another option to use for assistance. To contact the QPP Service Center via Chat, go to the CCSQ Support Central page and click on the Chat icon in the lower right area:
Due to the anticipated increase in volume at the QPP Service Center and to minimize a backlog, CMS asks providers to use only one method of reporting for the same issue (email, phone, or CCSQ Support Central). CMS processes cases in the order received, regardless of how the Service Center was contacted. Please allow time for processing.
For additional information please visit the QPP Resource Library to review new and existing resources or contact the author.
The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, who has decades of experience advising health care providers and their technology and other service providers health plans and insurers, third party administrators, managed care and other health care industry clients about Medicare another healthcare quality, technology, reimbursement,compliance, enforcement, governmental affairs, dispute resolution, compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.
Ms. Stamer’s work throughout her career has focused heavily on working with businesses domestically and internationally on employment, benefits, Federal Sentencing Guidelines and other workforce management, regulatory and public policy and other legal and operational concerns.
Author of many highly regarded compliance, training and other resources on health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy on these matters.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides health care, human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on health care, leadership, governance, human resources, employee benefits, data security and privacy, insurance, and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
March 14, 2025 now is the deadline for eligible hospitals and critical access hospitals (“CAHs”) to submit calendar year (“CY”) electronic clinical quality measure (“eCQM”) data and attestations for the 2024 Medicare Promoting Interoperability Program.
The Hospital Quality Reporting (“HQR”) System currently is open to accept this data.
The March 14 deadline is an extended deadline. Previously, submissions were due on February 28, 2025. However the Department of Health and Human Services now has delayed the ceadlone to Friday, March 14, 2025, at 11:59 p.m. Pacific Time(PT).
By March 14, 2025, at 11:59 p.m. PT, Medicare Promoting Interoperability Program participants are required to complete all required data reporting and attestations.
The CY 2024 HQR User Guideprovides the necessary tools to register, log in, and navigate within the HQR system. It contains the steps needed to submit data for the Medicare Promoting Interoperability Program, including eCQM data. Refer to the CY 2024 QRDA I Submission Checklist for more help on submitting eCQM data.
Facilities that experience difficulty successfully meeting the Medicare Promoting Interoperability Program requirements for certain reasons may apply for a Hardship Exception. A granted Hardship Exception avoids a downward payment adjustment for the Medicare Promoting Interoperability Program.
To be considered for an exception (to avoid a downward payment adjustment), eligible hospitals and CAHs must complete and submit a Hardship Exception application. If approved, the Hardship Exception is valid for only one payment adjustment year. Eligible hospitals and CAHs would need to submit a new application for subsequent years provided no eligible hospital or CAH can receive more than five exceptions in a lifetime.
For more information on CY 2024 Medicare Promoting Interoperability Program Requirements, reference the resources below or contact the author of this update:
For information about the HQR System, including user roles, reports, data upload, and troubleshooting error messages, please submit questions to the Center for Clinical Standards and Quality (CCSQ) Service Center at QnetSupport@cms.hhs.gov or (866) 288-8912
The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, who has decades of experience advising health care providers and their technology and other service providers health plans and insurers, third party administrators, managed care and other health care industry clients about Medicare another healthcare quality, technology, reimbursement,compliance, enforcement, governmental affairs, dispute resolution, compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.
Ms. Stamer’s work throughout her career has focused heavily on working with businesses domestically and internationally on employment, benefits, Federal Sentencing Guidelines and other workforce management, regulatory and public policy and other legal and operational concerns.
Author of many highly regarded compliance, training and other resources on health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy on these matters.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides health care, human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on health care, leadership, governance, human resources, employee benefits, data security and privacy, insurance, and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
2025 federal surprise billing Prevent Errors & Delays independent dispute resolution fees applicable to health care providers, health plans, and health insurers will remain are holding steady.
The IDR Fees Final Rule, effective as of January 22, 2024, set forth the 2024 IDR entity fee ranges. The Departments announced these fees will remain unchanged for 2025.
The 2025 IDR entity fees now published on the NSA website are effective for disputes initiated on or after January 1, 2025. For these disputes, the administrative fee amount is $115 per party per dispute, and the certified IDR entity fee ranges are $200-$840 for single determinations and $268-$1,173 for batched determinations. The website now includes information on the fee set by each certified IDR entity within these ranges.
Along with confirming the 2025 fees, the Departments caution plans and providers to monitor the website for updates to the IDR web form to accommodate guidance-related and system enhancements. The Departments ask plans and providers who have initiated an IDR dispute previously, to clear their computer’s cache or open the IDR initiation web form in a private or incognito window at least once a week to see all the new features. The Departments warn to clear the cache or open this form in private/incognito mode could result in additional follow-up with certified IDR entities or system errors.
The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, who has decades of experience advising health plans and insurers, third party administrators, managed care and other health care payers and providers with surprise billing and other claims, payment and other design, administration, regulatory and other enforcement, dispute resolution, compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.
Ms. Stamer’s work throughout her career has focused heavily on working with businesses domestically and internationally on employment, benefits, Federal Sentencing Guidelines and other workforce management, regulatory and public policy and other legal and operational concerns.
Author of many highly regarded compliance, training and other resources on health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy on these matters.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
A just-announced settlement warns health care providers, health plans, healthcare clearinghouses and their business associates (“Covered Entities”) to fulfill their responsibility to ensure the privacy of patient reproductive health and other personally identifiable health care information (“PHI”) under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) HIPAA Privacy, Security, and Breach Notification Rules (the “Privacy Rules”). Covered Entities should ensure they have updated their policies, privacy notices, training and practices to comply with changes with the Privacy Rules made by the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule (the “Reproductive Privacy Rule”) adopted in April.
Covered Entities Required To Update Policies To Comply With New Reproductive Privacy
The HIPAA Privacy Rule enforced by Department of Health and Human Rights Office for Civil Rights (“OCR”) establishes national standards to protect individuals’ medical records, requires appropriate safeguards to protect the privacy of protected health information and sets limits and conditions on the uses and disclosures that may be made of such information without an individual’s authorization, (such as disclosures for health oversight activities or for law enforcement purposes), and gives individuals rights such as the ability to access their own medical records.
On April 22, 2024, OCR adopted the Reproductive Privacy Rule to expand protections for reproductive health care privacy and other reproductive rights following the Supreme Court’s landmark abortion decision in Dobbs v. Jackson. The Reproductive Privacy Rule:
Requires Covered Entities to modify their Notice of Privacy Practices to support reproductive health care privacy;
Prohibits the use or disclosure of PHI when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities;
Requires a regulated health care provider, health plan, clearinghouse, or their business associates, to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes.
Covered Entities that have not already done so should review and update their policies, privacy notices, procedures and practices to ensure their compliance with these updated requirements.
New Holy Redeemer Reproductive Privacy Settlement
The new settlement with Pennsylvania hospital Holy Redeemer Family Medicine (“Holy Redeemer”) announced December 2, 2024, resolves charges that Holy Redeemer violated HIPAA by impermissibly disclosing reproductive health care and other PHI about a female patient. The settlement arose from a September 2023 complaint received by OCR that Holy Redeemer impermissibly disclosed surgical history, gynecological history, obstetric history, and other sensitive health information concerning reproductive health care of a female patient to the patient’s prospective employer when the patient only authorized Holy Redeemer to send one specific test result unrelated to her reproductive health to that prospective employer. OCR’s investigation found that Holy Redeemer disclosed the patient’s full medical record, including information concerning her reproductive health care without the patient’s authorization for the broad disclosure of her PHI. OCR also found that the disclosure was not otherwise permitted under the Privacy Rule.
Under the terms of the resolution agreement, Holy Redeemer paid $35,581 and agreed to implement a corrective action plan that identifies specific steps it will take to comply with the HIPAA Rules and protect patient privacy to prevent this from happening again. OCR will monitor the implementation of this corrective action plan for two years.
The Holy Redeemer Settlement demonstrates the advisability for each Covered Entity to ensure that its policies, privacy notices, training, practices and other controls for protecting the wrongful use, access or disclosure of reproductive and other sensitive health care information are up to date and defensible. The author of this update, Cynthia Marcotte Stamer has worked extensively with covered entities and business associates on these and other HIPAA and other compliance and risk management.
Along with their exposure to civil monetary penalties under HIPAA, improper sharing of reproductive health or other personal health care information also could expose health care providers to ethical or licensing discipline, malpractice invasion of privacy or other civil suits and other liabilities. While the preemption provisions of the Employee Retirement Income Security Act (“ERISA”) generally insulate employment-based insured and self-insured health plans and their fiduciaries against state law invasion of privacy and other state tort claims, employment-based health plans, their fiduciaries, insurers and administrators breaching the Privacy Rule risk liability under HIPAA as well as ERISA breach of fiduciary duty. Where ERISA preemption does not apply, insurers, brokers or other insurance industry businesses violating these rules likewise also can face licensing or other regulatory discipline as well as potential damage liability for invasion of privacy and other tort claims.
If you have questions or need advice or help evaluating or addressing your HIPAA compliance or other concerns, contact her.
For More Information
We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on PBM, pharmacy and pharmaceutical and other health care, managed care, insurance, and insured and self-insured contracting, design, administration and regulation..
Author of numerous highly regarded works on PBM and other health plan contracting and design, Immediate Past Chair of the ABA International Section Life Sciences Committee and the Tort Trial and Insurance Practice Section Medicine and Law Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and past Group Chair and current Welfare Benefit Committee Co-Chair of the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with HIPAA and other legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; third party administrators and other health benefit service providers; hospitals, health care systems and other health care providers, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Author of many highly regarded compliance, training and other resources on HIPAA and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership on HIPAA and many other health care, health plan and other health industry matters.
In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Nursing homes and other health care facilities competing for staffing with these facilities should begin preparing to cope with expected wage costs and other pressures expected to result from new staffing and other changes to staffing requirements for Meficare and Medicaid participating long-term care favorites released by the Department of Health and Human Services Centers for Medicare & Medicaid Services (“”CMS”) on April 22, 2024.
The mandates of the Final Rule and resulting increases in compensation and competition will impact both participating LTCs and other health care providers competing for staffing.
Total Nurse Staffing
CMS says its new minimum nurse staffing standards “will set a national and broadly applicable baseline that will significantly reduce the risk of unsafe and low-quality care for residents across all LTC facilities.”
Subject to certain limited temporary exceptions, the TNS requirements for long-term care (“LTC”) facilities aim to significantly reduce the risk of residents receiving unsafe and low-quality care within LTC facilities by specifying required minimum nurse staffing.
The Final Rule generally will require LTC facilities to meet a total nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care. LTCs may use any combination of registered nurse (“RN”), licensed practical nurse (“LPN”), licensed vocational nurse (“LBN”), or nurse aide) to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard.
In addition, the Final Rule will require LTCs to have at least one RN on site 24 hours a day, 7 days a week to provide skilled nursing care.
Some “limited temporary exceptions” may apply to all the requirements for qualifying LTCs in areas with workforce shortages that meet other criteria. While an estimated 25% of nursing homes would be eligible for exceptions, these are “limited, temporary exceptions,” LTC must be in a workforce shortage area and report the amount of their income spent on wage and other information to prove their “good faith” efforts to hire by paying competitive wages.”
While these are minimum staffing standards, CMS expects LTC facilities to use the updated and newly strengthened facility assessment to determine whether their staffing needs to be set above these minimums, based on resident acuity and individual care needs. CMS is committed to continued examination of staffing thresholds, including work to review quality and safety data resulting from initial implementation of these finalized policies, as well as robust public engagement.
Additionally, to increase transparency related to compensation for workers, CMS will also require states to collect and report on the percent of Medicaid payments that are spent on compensation for direct care workers, and support staff, delivering care in nursing facilities and intermediate care facilities, for individuals with intellectual disabilities.
CMS Tightening LTC Assessments
LTC facilities are already required to conduct, document, and review, annually and as necessary, a facility-wide assessment to determine what resources are necessary to care for residents competently during both day-to-day operations and emergencies. ensure that facilities are utilizing the assessment as intended by making thoughtful, person-centered staffing plans, and decisions focused on meeting resident needs, including staffing at levels above the finalized minimums as indicated by resident acuity, the Final Rule raises the assessment requirements as follows:
Facilities must use evidence-based methods when care planning for their residents, including consideration for those residents with behavioral health needs.
Facilities must use the facility assessment to assess the specific needs of each resident in the facility and to adjust as necessary based on any significant changes in the resident population.
Facilities must include the input of the nursing home leadership, including but not limited to, a member of the governing body and the medical director; management, including but not limited to, an administrator and the director of nursing; and direct care staff, including but not limited to, RNs, LPNs/LVNs, and NAs, and representatives of direct care staff as applicable. The LTC facility must also solicit and consider input received from residents, resident representatives, and family members.
LTC facilities may qualify for a temporary hardship exemption from the minimum nurse staffing HPRD standards and the 24/7 RN requirement only if they meet the following criterion for geographic staffing unavailability, financial commitment to staffing, and good faith efforts to hire:
The facility is located in an area where the supply of RN, NA, or total nurse staff is not sufficient to meet area needs as evidenced by the applicable provider-to-population ratio for nursing workforce (RN, NA, or combined licensed nurse and nurse aide), which is a minimum of 20% below the national average, as calculated by CMS using data from the U.S. Bureau of Labor Statistics and the U.S. Census Bureau.
The facility may receive an exemption from the total nurse staffing requirement of 3.48 HPRD if the combined licensed nurse and nurse aide to population ratio in its area is a minimum of 20% below the national average.
The facility may receive an exemption from the 0.55 RN HPRD requirement, and an exemption of eight hours a day from the RN on-site 24 hours per day for seven days a week requirement, if the RN to population ratio in its area is a minimum of 20% below the national average.
The facility may receive an exemption from the 2.45 NA HPRD requirement if the NA to population ratio in its area is a minimum of 20% below the national average.
Eligible LTC facilities that meet the criteria will receive a temporary hardship exemption by completing the following:
The facility provides documentation of good faith efforts to hire and retain staff, such as through job postings, the number and duration of vacancies, job offers made, and competitive wage offerings.
The facility provides documentation of the facility’s financial commitment to staffing, including the amount the facility expends on nurse staffing relative to revenue.
Before being considered, the LTC facility must be surveyed for compliance with the LTC participation requirements. CMS will coordinate with state survey agencies to determine if the facility meets the criteria for a hardship exemption noted above.
Facilities granted an exemption will be required to: 1) post a notice of its exemption status in a prominent and publicly viewable location in each resident facility; 2) provide notice of its exemption status, and the degree to which it is not in compliance with the HPRD requirements, to each current and prospective resident; and 3) send a copy of the notice to a representative of the Office of the State Long-Term Care Ombudsman.
Facilities are not eligible for an exemption if any one of the following is true:
They have failed to submit their data to the Payroll Based Journal System.
They have been identified as a special focus facility (SFF).
They have been identified within the preceding 12 months as having: widespread, or a pattern of, insufficient staffing that resulted in actual harm to a resident; or an incident of insufficient staffing that caused or is likely to cause serious harm or death to a resident.
Facilities that meet the hardship exemption criteria are eligible from the time at which the exemption is granted until the next standard recertification survey, unless the facility meets any of the above-mentioned criteria for not being eligible for the exemption during that time. The hardship exemption may be extended on each standard recertification survey, after the initial period, if the facility continues to meet the exemption criteria.
Implementation Deadlines
The Final Rule has staggered implementation timeframe for its minimum nurse staffing standards and 24/7 RN requirement based on geographic location as well as possible exemptions for qualifying facilities for some parts of these requirements based on workforce unavailability and other factors.
CMS is implementing the minimum nurse staffing requirements to occur in three phases over a three-year period for all non-rural facilities. The following deadlines apply for non-rural facilities:
Phase 1 — Within 90 days of the final rule publication, facilities must meet the facility assessment requirements.
Phase 2 — Within two years of the final rule publication, facilities must meet the 3.48 HPRD total nurse staffing requirement and the 24/7 RN requirement.
Phase 3 — Within three years of the final rule publication, facilities must meet the 0.55 RN and 2.45 NA HPRD requirements.
The Final Rule sets later deadlines for rural facilities in acknowledgment of the unique challenges that rural LTC facilities may face in staffing as follows:
Phase 1 — Within 90 days of the final rule publication, facilities must meet the facility assessment requirements.
Phase 2 — Within three years of the final rule publication, facilities must meet the 3.48 HPRD total nurse staffing requirement and the 24/7 RN requirement.
Phase 3 — Within five years of the final rule publication, facilities must meet the 0.55 RN and 2.45 NA HPRD requirements.
Qualification as a rural facility is determined by the Office of Management and Budget.
CMS Nursing Home Staffing Campaign
CMS continues efforts to encourage the availability to increase the number of nurses in nursing homes. As part of these efforts, CMS plans to promote awareness of the many career pathways in the nursing field that are available to help recruit all types of individuals, from NAs to LPNs/LVNs and RNs. It also plans to offer financial incentives like tuition assistance for nurses to work in the nursing home environment in qualifying facilities or state oversight roles and to make it easier for individuals to become nurse aides by streamlining the process for enrolling in training programs and finding placement in a nursing home.
Additionally, CMS plans to partner with states to bolster nurse recruitment.
CMS says more announcements are expected later this year and it anticipates beginning distribution of financial incentives in 2025.
Begin Preparing Now
All nursing homes and other health care facilities competing for staffing should begin preparing for these changes immediately. Obviously, LTC is participating in Medicare, Medicaid or other covered programs will face the most immediate and direct impact from these rules. Facility should begin documented efforts to meet the staffing requirements and where applicable, evidence and other materials needed to prepare for required surveys and to establish, other criteria necessary to qualify for exemption if needed.
It is not just the facilities directly covered by the rules that the new staffing requirements will impact.
While the new requirements technically apply only to LTCs participating in Medicare, Medicaid or other CMS regulated programs, their applicability likely will impact non-participating programs as well. the new minimum requirements will affect standards of care for negligence and other purposes.
Likewise, increases in compensation and other terms and conditions of employment at covered facilities will affect other types of providers. Non-participating nursing homes, home health, hospice, rehabilitation, hospitals, rehabilitation, facilities, assisted living facilities and other providers should expect greater scrutiny of their staffing and greater pressure to pay better wages and improve other work conditions and benefits in response to greater competition for workers.
Facilities that have used noncompetition agreements or other restraints on post employment eligibility to work are cautioned that these types of restraints could run afoul of the federal trade commissions new Non-Competition Clause Final Rule slated to take affect in September, 2024 if the current judicial stay against it is lifted by that time.
Likewise, long-term care another healthcare employers planning to increase wages, or other terms of employment are cautioned to use care to comply with any applicable duties to bargain or other requirements if subject to union organization or contracts.
Given the complicated maze of employment, benefits, and healthcare regulations that facilities working to deal with these new requirements must negotiate, healthcare providers working with these and other recruitment rules are encouraged to consult with qualified legal counsel with experience in both the healthcare and employment issues involved.
If you need have questions or need assistance with this or other cybersecurity, health, benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, to inquire about arranging for compliance audit or training, or need legal representation on other matters, contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of workforce, risk management, compliance, regulatory and government affairs and other work with health care, employee benefit, managed care and other insurance, education, workforce and other performance and data dependent organizations, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with government and private health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services, education and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications, her experience includes extensive involvement throughout her career advising and representing health care and life sciences and other clients about preventing, investigating and defending HHS CMS, OIG, CIICO, OCR; , DOL WHD, EEOC, EBSA, OSHA; DOJ, OFCCP; NLRB; DOE; ICE; state attorney general licensing, Department of Health, Aging, Disability, Insurance, and other federal and state, JCHO and other accreditation and quality, peer review, employment and other workforce, contract and other investigations, audits, and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Laws Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Health care providers, heath plans, health care clearinghouses and their business associates (covered entities) should verify that any online tracking technology used in their or their business partner websites or mobile applications comply with the Department of Health and Human Services, Office of Civil Rights (OCR) updated guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” published March 18, 2024.
The Guidance reminds covered entities that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules (HIPAA Rules) apply to their use of online tracking technologies like Google Analytics or Meta Pixel, collect and analyze information about how users are interacting with a regulated entity’s website or mobile application.
The HIPAA Rules apply when the information that regulated entities collect through tracking technologies or disclose to tracking technology vendors includes electronic protected health information (ePHI).
OCR’s information bulletin reminds covered entities that they can only use online tracking technologies provided that the entities comply with their obligations under the HIPAA Rules. Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of ePHI to tracking technology vendors or any other violations of the HIPAA Rules.
OCR’s Bulletin provides a general overview of how the HIPAA Rules apply to covered entities use of tracking technologies. It also updates to the Bulletin include:
Additional examples of when visits to an unauthenticated webpage may or may not involve the disclosure of ePHI.
Additional tips for complying with the HIPAA Rules when using online tracking technologies.
Guidance about OCR’s enforcement priorities in investigations involving regulated entities’ use of online tracking technologies.
Covered entities need to understand that online tracking technologies commonly are included in Website, mobile application, and other Internet based tools. These tools frequently include online tracking even if not specifically requested by the covered entity.
Covered entities should conduct a documented inventory of all website, mobile app, and other Internet, based tools that they or their business associates use, which includes an assessment of whether those tools include online tracking, or other technologies, covered by the guidance. For any online tools using tracking capability, cupboard entities, must ensure that the tool is designed and administered to comply with the HIPAA requirements. Overed entities also should adopt a process for regularly reevaluating and monitoring compliance with this and other HIPAA security requirements in their Internet based in other electronic applications that collect, use, store, access, or disclose electronic, protected health information.
Along with specifically evaluating the existence and compliance of any online tracking technologies, covered entities, also should reevaluate and reconfirm the adequacy of their electronic security overall. The HIPAA Rules require healthcare providers and other covered entities to regularly conduct documented risk assessments to verify the adequacy of their security safeguards, and to make updates to guard against emerging threats based on these recurrent assessments. The importance of compliance with this ongoing recurrent risk assessment obligation is repeatedly reinforced in each HIPAA settlement announced by OCR. See, e.g., OCR Nails Second HIPAA Covered For Allowing Ransomware Breach.
Covered entities should ensure that they and their business associates maintain compliance with these other HIPAA obligations.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management, or public policy developments, please get in touch with the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications on HIPAA and other medical record and data privacy and scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Laws Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here, such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Health care providers, health plans, health care clearinghouses and their business associates (covered entities) that fail to appropriately safeguard their protected health information and systems against randomware and other malware threats as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) should expect to pay hefty amounts to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) if an attack occurs. That is the clear message sent by OCR’s February 22, 2022 announcement of its second ransomware settlement since October, 2023.
Duty To Guard Against Malware
OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules, which sets forth the requirements that HIPAA covered entities (most health care providers, health plans, and health care clearinghouses) and their business associates must follow to protect the privacy and security of protected health information.
Ransomware and hacking are the primary cyber-threats in health care. A type of malware (malicious software) designed to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker who deployed the malware, until a ransom is paid, OCR has seen large breaches affecting more than 500 individuals reported to OCR involving hacking increase 256% and those from ransomware increase 264% increase over the past five years,
In 2023, hacking accounted for 79% of the large breaches reported to OCR. The large breaches reported in 2023 affected over 134 million individuals, a 141% increase from 2022.
In light of the growing threat, OCR is prioritizing enforcement, education and compliance outreach to HIPAA covered entities.
OCR’s February 22, 2024 announcement of its second ever and second settlement of a malware related enforcement action in less than five months demonstrates OCR’s readiness to hold covered entities accountable for failing to fulfill this responsibility.
Green Ridge Ransomeware Breach
OCR’s February 22, 2022 announcement of its second ever ransomware related resolution agreement and corrective action plan reaffirms OCR’s readiness to hold covered entities accountable for failing to guard against ransomware and other cyber risks.
Green Ridge Behavioral Health, LLC, (Green Ridge), a Maryland-based practice that provides psychiatric evaluations, medication management, and psychotherapy. This marks the second settlement that OCR has reached with a HIPAA regulated entity for potential violations identified during an investigation following a ransomware attack.
The settlement resolves an investigation following a ransomware attack that affected the protected health information of more than 14,000 individuals.
OCR learned of the breach after Green Ridge filed a breach report with OCR in February 2019 that stated that its network server had been infected with ransomware resulting in the encryption of company files and the electronic health records of all patients.
In keeping with its policy of investigating all breaches affecting more that 500 individuals (large breaches), OCR opened an investigation in April, 2019.
OCR’s investigation of the breach found evidence of potential violations of the HIPAA Privacy and Security Rules leading up to and at the time of the breach. Other findings included that Green Ridge Behavioral Health failed to:
Have in place an accurate and through analysis to determine the potential risks and vulnerabilities to electronic protected health information;
Implement security measures to reduce risks and vulnerabilities to a reasonable and appropriate level; and
Have sufficient monitoring of its health information systems’ activity to protect against a cyber-attack.
Under the terms of the settlement, Green Ridge agreed to pay $40,000 and implement a corrective action plan that will be monitored by OCR for three years to avoid exposure to potentially much greater HIPAA monetary penalties.
The plan also requires Green Ridge to take many actions to resolve potential HIPAA violations and to protect electronic protected health information, including:
Conducting a comprehensive and thorough analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information;
Designing a Risk Management Plan to address and mitigate security risks and vulnerabilities found in the Risk Analysis;
Reviewing, and as necessary, developing, or revising its written policies and procedures to comply with the HIPAA Rules;
Providing workforce training on HIPAA policies and procedures;
Conducting an audit of all third-party arrangements to ensure appropriate business associate agreements are in place, where applicable; and
Reporting to OCR when workforce members fail to comply with HIPAA.
First Malware Settlement
Prior to this week’s announcement of the Green Ridge resolution agreement, OCR already had announced its first ever malware related resolution agreement on October 31, 2023.
That $100,000 settlement resolved a potentially much greater HIPAA liability business associate Doctors’ Management Services (DMS) could have faced for alleged HIPAA violations OCR found investigating a large breach report DMS filed on April 22, 2019.
The DMS breach report disclosed that a ransomware attack affected DMS’ network server with GandCrab ransomware beginning with an initial unauthorized access to the network that occurred on April 1, 2017; however, DMS did not detect the intrusion until December 24, 2018, Once the DNS system was accessed, ransomware was used to encrypt their files. The attack affected the electronic protected health information of 206,695 individuals
OCR’s investigation of the DNS breach found evidence of potential failures by DMS to have in place an analysis to determine the potential risks and vulnerabilities to electronic protected health information across the organization. Other findings included insufficient monitoring of its health information systems’ activity to protect against a cyber-attack, and a lack of policies and procedures in place to implement the requirements of the HIPAA Security Rule to protect the confidentiality, integrity, and availability of electronic protected health information.
Under the terms of the DMS settlement agreement paid $100,000 to OCR and agreed to implement a corrective action plan that requires:
DMS to submit to OCR monitoring for three years to ensure compliance with HIPAA
Review and update its Risk Analysis to identify the potential risks and vulnerabilities to Doctor’s Management Services data to protect the confidentiality, integrity, and availability of electronic protected health information.
Update its enterprise-wide Risk Management Plan (strategy to protect the confidentiality, integrity, and availability of ePHI) to address and mitigate any security risks and vulnerabilities found in the updated Risk Analysis.
Review and revise, if necessary, its written policies and procedures to comply with the Privacy and Security Rules.
Provide workforce training on HIPAA policies and procedures.
Warning To All Covered Entities
Along with announcing the two recent resolution agreements, OCR also is warning all covered entities to tighten their malware and ransomware safeguards.
OCR’s announcement of the Green Ridge resolution agreement, for instance, quotes OCR Director Melanie Fontes Rainer as stating, “Health care providers need to understand the seriousness of these attacks and must have practices in place to ensure patients’ protected health information is not subjected to cyber-attacks such as ransomware.”
To assist covered entities to meet this responsibility, OCR has developed Fact Sheet guidance that recommends covered entities to take at least the following steps to guard against breaches from ransomware and other malware attacks:
Review all vendor and contractor relationships to ensure business associate agreements are in place as appropriate and address breach/security incident obligations.
Risk analysis and risk management should be integrated into business processes; conducted regularly and when new technologies and business operations are planned.
Ensure audit controls are in place to record and examine information system activity.
Implement regular review of information system activity.
Utilize multi-factor authentication to ensure only authorized users are accessing ePHI.
Encrypt ePHI to guard against unauthorized access to ePHI.
Incorporate lessons learned from incidents into the overall security management process.
Provide training specific to organization and job responsibilities and on regular basis; reinforce workforce members’ critical role in protecting privacy and security.
two recent resolutions agreements and other guidance and enforcement actions make clear that all covered entities should ensure their ability to demonstrate their completion of these and other actions a risk analysis shows are needed to defend against a ransomware or other malware threats. This guidance also alerts covered entities to stay vigilant and update risk assessments and safeguards in response as to evolving threats.
Covered entities should not assume the relatively modest settlement amounts collected in the two new ransomware settlements compared to exponentially greater resolution settlements like the $4.75 million settlement payment New York based Montefiore Medical Center made last year reflect greater tolerance for ransomware related threats versus internal or external hacking. To the contrary, the Montefiore Medical Center resolution makes clear the randomware threat is one of a multitude of internal and external threats covered entities must defend their protected health information against to comply with HIPAA.
Moreover, covered entities and their leaders also should take steps to understand and fully address all other statutory, ethical, contractual or other privacy or confidentiality requirements beyond those imposed by HIPAA. For example, health care providers, health plans and their fiduciaries, brokers, administrators and insurers also may bear responsibilities under the Employee Retirement Income Security Act fiduciary responsibility rules, the Fair and Accurate Credit Transactions Act, federal and state electronic crimes, privacy data security, artificial intelligence, workforce, tax, and other laws.
Publicly traded organizations and their leaders also may face responsibilities and liability under new Securities and Exchange Commission regulations, clawback rules and other laws arising from the occurrence or bungled response to a breach.
Likewise, got businesses sponsoring or administering employment-based health plans, Employee Benefit Security Administration considers managing cybersecurity risks a part of the fiduciary obligations of fiduciaries of employment-based health plans. Meanwhile, health care providers, insurance organizations and brokers, third party administrators, government contractors, attorneys and other advisors and others also may be subject to medical confidentiality and other data privacy and security obligations under federal and state electronic crimes, identity theft, ethics, professional licensure, contractual, common law privacy and other statutory and common laws. Since HIPAA and many of these other laws involve potential criminal as well as civil liability, organizations and leaders in covered entities generally should ensure their HIPAA and other cybersecurity compliance efforts are included in and administered according to their Federal Sentencing Guidelines Compliance program.
While it commonly is necessary or advisable to involve consulting or other technical support in the conduct of these activities, HIPAA entities should keep in mind the likelihood that their analysis and review is likely to uncover and prompt discussion of potentially legally or politically sensitive information. For this reason, HIPAA entities and their leaders generally will want to engage experienced legal counsel for assistance in structuring and executing these activities to maximize their ability to claim attorney-client privilege or other evidentiary protections against discovery or disclosure of certain aspects of these activities.
In planning for an implementing these procedures, Covered Entities also are reminded that the effectiveness of these efforts requires that the Covered Entities incorporate appropriate processes and policies for monitoring and investigating compliance with the policies and procedures implemented to comply with HIPAA. Conducting this monitoring and investigation by necessity is likely to involve surveillance, investigation and cooperation of employees, contractors, vendors and others for which Fair Credit Reporting Act background check notification and consent and other procedures are necessary or advisable.
Finally, HIPAA entities should keep in mind that HIPAA and other cybersecurity compliance and risk management is an ongoing process requiring constant awareness and diligence. Consequently, HIPAA entities should both monitor OCR and other regulatory and enforcement developments as well as exercise ongoing vigilance to monitor and maintain compliance within their organizations.
For More Informational
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Health care providers, health plans, and health care clearinghouses (“Covered Entities”) should ensure their compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) Right of Access Rule in light of the announcement by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) that Optum Medical Care of New Jersey (“Optum”) has agreed to pay $160,000 to OCR and take other steps to settle OCR’s forty-sixth enforcement action under its Right of Access Rule enforcement initiative.
HIPAA Right of Access Rule
The HIPAA Right of Access Rule guarantees individuals the right to access a broad array of health information about themselves maintained by or for health care providers and other Covered Entities. Under the Right of Access Rule, Covered Entities generally must provide individuals or their personal representatives copies or other acceptable access to the individual’s protected health information in a Covered Entity’s “designated record set” for a reasonable cost as soon as possible and within 30 days of receiving a request for a reasonable cost. However, the Right of Access Rule does not grant any right for an individual to access protected health information that is not part of a designated record set because the information is not used to make decisions about individuals.
The request for protected health information triggering the duty for a Covered Entity to provide access to the protected health information may come from the individual who is the subject of the protected health information or from the “personal representative” of that individual. When considering a request for protected health information from an individual other than the subject of the protected health information, health care providers and other Covered Entities also must use care to verify that the requesting party, in fact, qualifies as the individual’s “personal representative” as defined for purposes of HIPAA.
Once a health care provider or other Covered Entity receives a request protected health information from the individual or his personal representative, the Right of Access Rule requires the Covered Entity to provide access to all requested protected health information that is included within any “designated record set” within 30 days unless the requested information falls within one of two exceptions to the Rule. For this purpose, a “designated record set” generally is defined at 45 CFR 164.501 as any item, collection, or grouping of information that includes protected health information that is maintained, collected, used, or disseminated by or for a Covered Entity that comprises the:
Medical records and billing records about individuals maintained by or for a covered health care provider;
Enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or
Other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals. This last category includes records that are used to make decisions about any individuals, whether or not the records have been used to make a decision about the particular individual requesting access.
However, information is not considered part of the designated record set if it is not used by or for the Covered Entity to make decisions about the individual. Examples of such records might include certain quality assessment or improvement records, patient safety activity records, or business planning, development, and management records that are used for business decisions more generally rather than to make decisions about individuals.
Even where the information falls within the definition of a designated record set, however, HIPAA expressly excludes two categories of information from the Right of Access right:
Psychotherapy notes, which are the personal notes of a mental health care provider documenting or analyzing the contents of a counseling session maintained separately from the rest of the patient’s medical record as described in 45 CFR 164.524(a)(1)(i) and 164.501.
Information complied in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding described under 45 CFR 164.524(a)(1)(ii).
However, it is critical that Covered Entities not overestimate the reach of either of these two exceptions. The exception only applies to the narrow range of records meeting the requirements of the exception. The underlying protected health information from the individual’s medical or payment records or other records used to generate the above types of excluded records or information remains part of the designated record set and is subject to access by the individual under the Right of Access Rule. Providers and other Covered Entities should use care to comply with the Right of Access Rule without providing more information than allowed as HIPAA liability can arise from failing to timely deliver access to all protected health information required by the Right of Access Rule or from sharing protected health information with an individual who is not either the individual or personal representative when the disclosure otherwise is not allowed by HIPAA To help negotiate these requirements, Covered Entities should become familiar with and process all requests for protected health information following the latest Right of Access Rule guidance. When in doubt, Covered Entities should seek the advice of experienced legal counsel within the scope of attorney-client privilege about proper fulfillment of their obligations under the Right of Access Rule in coordination with any other applicable responsibilities the Covered Entities has to provide access, disclose, or prevent disclosure of the requested information under otherwise applicable federal or states laws and regulations, ethical or other professional standards, contractual or other medical, insurance, financial, employee benefit or other rules relating to the requested records.
Optum Settlement 46th Right Of Access Enforcement Settlement
The Optum settlement resulted from OCR’s investigation of six complaints in the Fall of 2021 that Optum violated the Right of Access Rule by failing to provide timely access to medical records when requested by an adult patient or by the parents of minor patients.
In February 2022, OCR initiated investigations of these Right of Access complaints. The investigation revealed that patients received their requested records between 84 and 231 days after submitting their respective requests. Since the Right of Access Rule requires that Covered Entities deliver the records no later than 30 days from receiving the individual’s requests, those timeframes fell well outside of the deadline for delivery required by the HIPAA Right of Access Rule. Accordingly, OCR concluded that Optum’s failure to provide timely access to the requested medical records was a potential violation of HIPAA.
Under the Resolution Agreement reached with Optum, Optum agreed to pay $160,000 to OCR as well as implement a corrective action plan that requires workforce training, reporting records requests to OCR, and reviewing and revising as necessary its right of access policies and procedures to provide timely responses to requests. Under the plan, OCR will monitor Optum Medical Care for one year.
Right Of Access Remains OCR Investigation & Enforcement Priority
Despite the importance OCR has placed on compliance with the Right of Access Rule, OCR has and continues to receive thousands of Right of Access Rule complaints each year. In response to these persistent compliance issues, OCR continues to make enforcement of the Right of Access Rule a key enforcement priority through its Right Of Access Initiative.
In light of OCR’s commitment to continue to investigate and enforce compliance with the Right of Access Rule, health care providers and other Covered Entities and their business associates are urged to review their existing practices for receiving and processing patient record requests to confirm their own compliance with the Right of Access Rule and other applicable federal and state statutory regulatory and contractual requirements. To reduce risks of violations, all health care providers and other Covered Entities should seek assistance from experienced legal counsel within the scope of attorney-client privilege with auditing their past and current Right of Access Rule compliance for any necessary or advisable steps to prevent future violations and mitigate potential liabilities arising from potential past or future violations of the Right of Access Rule. Aside from confirming documented timely response to past requests for protected health information, among other things, most Covered Entities will want to consider:
Verifying that their current policies, privacy practices notices, training and other materials are updated to comply with all applicable policies and properly identify and provide current contact information for the Privacy Officer or other party responsible for receiving and responding to protected health information requests;
Appropriate procedures are in place to ensure that the Covered Entity can produce required documentation showing the individuals are appropriately notified of the Right of Access and other HIPAA rules, and that the Covered Entity captures the necessary documentation to show its receipt of all requests, and timely investigation and response to such requests;
Appropriate and documented processes for collecting, investigating or resolving any potential concerns, complaints, or other issues, their evaluation and resolution;
Appropriate workforce, business associates and other policies, training, oversight and enforcement to require and enforce compliance with applicable laws and policies; and
Appropriate processes, procedures, and training to ensure that staff fully understands and complies with both the specific processes and procedures of the Covered Entity for complying with the Right of Access Rule, as well as related procedures necessary to manage risks and responsibilities arising under verification of identity, personal representative, disclosure, recordkeeping or other HIPAA’ rules; medical, insurance, financial, or other data or privacy; licensure and market conduct; civil rights and nondiscrimination; fiduciary; licensure; marketing or other rules.
While involving outside consultants or other service providers generally is valuable if not required to conduct some of these tasks, Covered Entities are encouraged to use experienced outside legal counsel to help plan, conduct, evaluate and decide and implement responses to findings from these compliance and risk management activities both to benefit from legal counsel’s substantive legal expertise and experience and to take advantage of the opportunity to conduct sensitive discussions within the protection of attorney-client privilege or other evidentiary rules. Experienced outside legal counsel can guide Covered Entities about the best way to work with consulting and other vendors to maximize these benefits.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications on HIPAA and other medical record and data privacy and scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
A newly-announced settlement agreement and corrective action plan (the “Settlement”) between a prominent New York academic medical center and the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (“OCR”) arising from disclosures and access allowed a reporter covering the COVID-19 pandemic warns health care providers, health plans, healthcare clearinghouses (“covered entities”), their business associates and workforce members (collectively, “HIPAA entities”) to prevent their organizations and workforce members not to share protected health information (“PHI”) or allow reporters or other media to access patients or PHI without first obtaining the legally required patient authorizations as well as evaluate their own organization’s potential exposure to OCR enforcement from known or suspected unauthorized disclosures of PHI by their own organizations or workforce during the COVID-19 pandemic or other events over the past two years.
HIPAA-Compliant Authorization Required Before Media Access To Patients Or Patient Information
The HIPAA Privacy Rule prohibits SJMC and other HIPAA entities from disclosing any patient’s PHI unless::
The individual who is the subject of the information (or the individual’s personal representative) authorizes the disclosure in writing in the form required by the Privacy Rule; or
The Privacy Rule otherwise expressly permits or requires the disclosure.
OCR guidance makes clear that these prohibitions continue to apply when health care providers or other HIPAA entities are dealing with have print, television, or other media reporters.
SJMC Settlement
The Settlement between OCR and St. Joseph’s Medical Center (“SJMC”) resolves potential OCR charges that SJMC violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule by allowing an Associated Press (“AP”) reporter to access, photograph, and review clinical information of three COVID-19 patients without appropriate HIPAA authorization. Although the dated documents governing the Settlement reflect the parties reached the Settlement Agreement in August, OCR only made the Settlement public on November 20, 2023.
The OCR investigation that prompted the settlement began shortly an AP article about SJMC’s response to the COVID-19 public health emergency containing photographs and information about three COVID-19 patients came to OCR’s attention. The nationally distributed article included pictures of the three patients as well as details about the patients’ COVID-19 diagnoses, current medical statuses and medical prognoses, vital signs, treatment plans, and other PHI.
OCR determined from the investigation that SJMC allowed the AP reporter to observe and access clinical information of three patients receiving treatment for COVID on April 20, 2020 without first obtaining the necessary patient authorization required by HIPAA and that the disclosures were not otherwise allowed by any other exception to the Privacy Rule.
To avoid potentially much larger civil monetary penalties authorized by HIPAA, SHMC entered into the Settlement under which it agreed to pay $80,000 to OCR and agreed to develop written policies and procedures and train its workforce to comply with the HIPAA Privacy Rule. Under the Settlement, OCR also will monitor SHMC’s HIPAA compliance for two years.
Prior OCR Enforcement & Guidance Warned HIPAA Entities About Media Disclosures
OCR guidance and enforcement actions alerted SJMC and other HIPAA entities of their HIPAA responsibility not to disclose or allow access by the media or other third parties long before SJMC allowed the media access and disclosures that resulted in the new Settlement.
2013 Shasta Regional Medical Center Enforcement
Shasta Regional Medical Center (“SRMC”) holds the distinction of being the first covered entity punished for wrongfully disclosing PHI to the media. Under a resolution agreement OCR announced on June 14, 2013, OCR required SRMC to pay OCR $275,000 and implement a series of corrective actions for using and disclosing to the media PHI of a patient while trying to perform public relations damage control against accusations reported in the media that SRMC had engaged in fraud or other misconduct when dealing with the patient. That SRMC resolution Agreement followed an OCR investigating a January 4, 2012 Los Angeles Times article report that two SRMC senior leaders had met with media to discuss medical services provided to a patient. OCR’s investigation indicated that SRMC failed to safeguard the patient’s PHI from impermissible disclosure by intentionally disclosing PHI to multiple media outlets on at least three separate occasions, without a valid written authorization. OCR’s review also revealed senior management at SRMC impermissibly shared details about the patient’s medical condition, diagnosis and treatment in an email to the entire workforce. Further, SRMC failed to sanction its workforce members for impermissibly disclosing the patient’s records pursuant to its internal sanctions policy.
2016 NY-Presby Resolution Agreement & OCR Media Guidance
OCR’s next warnings to covered entities about their HIPAA responsibilities when dealing with the media came in 2016, when OCR concurrently announced a $2.2 million settlement with New York-Presbyterian Hospital and published its 2016 Frequently Asked Question (“Media FAQ”) addressing the obligation to comply with HI)PAA when dealing with the media.
According to the NY-Presby Resolution Agreement, OCR’s investigation revealed that NY-Presbyterian “blatantly” violated HIPAA when it allowed ABC film crews and staff virtually unfettered access to its health care facility. OCR says the access NY-Presbyterian allowed ABC effectively created an environment where patients PHI could not be protected from impermissible disclosure to the ABC film crew and staff filming the episode. While the Resolution Agreement reflects allowing the filming and other access to ABC without prior HIPAA-compliant authorization from patients in the facility itself violated HIPAA, OCR also particularly found “egregious” the facility allowing ABC film crews and staff to film a dying patient and another patient in significant distress without first obtaining a HIPAA-compliant authorization from each of those patients and even more so that NY-Presbyterian failed stop the filming even after a medical professional urged the crew to stop.
Based on its investigation, OCR charged NY-Presbyterian with violating 45 C.F.R. §§ 164.502(a) and 164.530(c) by:
Impermissibly disclosing the PHI of two identified patients to the film crew and other staff of “NY Med;”
Failing appropriately and reasonably to safeguard its patients’ PHI from disclosure during the filming of “NY Med” on its premises; and
Failing to implement policies, procedures, and practices to protect the privacy of the filming of the television show.
OCR collected $2.2 million from New York-Presbyterian Hospital as the required settlement payment under that resolution agreement.
2016 Media FAQ Guidance
Coincident with its announcement of the NYPH Settlement, OCR published the 2016 Media FAQ addressing HIPAA entities’ responsibilities when dealing with the media that outlined its interpretation of HIPAA as requiring HIPAA entities to protect patients and their PHI against unauthorized filming, photography, observation, and other access by news or other media or even other staff, patients or visitors.
Among other things, the Media FAQ states that HIPAA prohibits health care providers and other HIPAA entities from inviting or allowing media personnel into treatment or other areas where patients or patient PHI will be accessible in written, electronic, oral, or other visual or audio form, or otherwise making PHI accessible to the media without prior written authorization from each patient or other subject of the PHI who is or will be in the area or whose PHI otherwise will be accessible to the media except in a very limited set of circumstances set forth in the Media FAQ.
The Media FAQ also states, “It is not sufficient for a health care provider to request or require media personnel to mask the identities of patients (using techniques such as blurring, pixelation, or voice alteration software) for whom authorization was not obtained, because the HIPAA Privacy Rule does not allow media access to the patient’s PHI, absent an authorization, in the first place.
In addition, the Media FAQ states that a health care provider also must ensure that reasonable safeguards are in place to protect against impermissible disclosures or to limit incidental disclosures of other PHI that may be in the area but for which authorization has not been obtained.
Concerning the limited circumstances when a health care provider or other HIPAA entity or business associate may disclose to the media or allow unconsented filming, photographing or use of PHI to the media or other film crews, the Media FAQ also clarifies that the HIPAA Privacy Rule does not require health care providers to prevent members of the media from entering areas of their facilities that are otherwise generally accessible to the public like public waiting areas or areas where the public enters or exits the facility.
In addition, the Media FAQ states a health care provider or other HIPAA entity may:
Disclose limited PHI about the incapacitated patient to the media in accordance with the requirements of 45 C.F.R. 164.510(b)(1)(ii) when, in the hospital’s professional judgment, doing so is in the patient’s best interest; or
Disclose a patient’s location in the facility and condition in general terms that do not communicate specific medical information about the individual to any person, including the media, without obtaining a HIPAA authorization where the individual has not objected to his information being included in the facility directory, and the media representative or other person asks for the individual by name as specified in 45 C.F.R. 164.510(a).
The Media FAQ also discusses circumstances where a healthcare provider or other HIPAA entity may use the services of a contract film crew to produce training videos or public relations materials on the provider’s behalf if the provider ensures that the film crew acting as a business associate enters into a HIPAA compliant business associate agreement with the HIPAA entity which among other things ensures that the film crew will safeguard the PHI it obtains, only use or disclose the PHI for the purposes provided in the agreement, and return or destroy any PHI after the work for the health care provider has been completed as required by 45 C.F.R. 164.504(e)(2). The Media FAQ also states that as a business associate, the film crew must comply with the HIPAA Security Rule and a number of provisions in the Privacy Rule, including the Rule’s restrictions on the use and disclosure of PHI. In addition, the Media FAQ reminds HIPAA entities and business associates of the need to obtain prior authorizations from patients whose PHI is included in any materials before any of those materials are posted online, printed in brochures for the public, or otherwise publicly disseminated.
Finally, the Media FAQ states HIPAA entities can continue to inform the media of their treatment services and programs so that the media can better inform the public, provided that, in doing so, the covered entity does not share PHI with the media.
Memorial Herrman Health System Resolution Agreement
OCR’s next media coverage-related enforcement action involved the largest not-for-profit health system in Southeast Texas, Memorial Hermann Health System (MHHS). The 2017 MHHS Resolution Agreement and Corrective Action Plan resulted from HHHS issuing a press release with the name and other PHI about a patient arrested and charged with fraudulently obtaining health care by presenting an allegedly fraudulent identification card to MHHS office staff without first obtaining authorization from the patient. MHHS paid OCR a $2.4 million resolution payment as well as agreed to implement a detailed corrective action plan. See $2.4M HIPAA Settlement Warns Providers About Media Disclosures Of PHI.
Three Resolution Agreements Following Disclosures ForBoston Trauma Reality Series
OCR followed up the next year with a concurrent announcement of resolution agreements against three unrelated hospitals for allowing ABC film crews to film in patient treatment and other areas for the ABC medical documentary “Save My Life: Boston Trauma” series. Under three separate settlement agreements, OCR collected a total of $999,000 from Boston Medical Center, Brigham and Women’s Hospital, and Massachusetts General Hospital for putting publicity before patient privacy by allowing ABC News documentary film crews to film patients and access other patient information for a news documentary without obtaining prior patient authorization under three separate settlement agreements with the hospitals.
The circumstances that resulted in the three resolution agreements announced on September 20, 2018 were strikingly similar to those underlying the NY-Presby Resolution Agreement. Notably, the investigations that resulted in the three settlement agreements all arose out of each of the respective hospital’s permitting an ABC documentary film crew filming a medical documentary to access patient areas of their hospitals.
OCR’s investigation of MGH arose in response to an announcement about the impending filming on its website while OCR’s investigations of BMC and BWH started in response to a January 12, 2015 Boston Globe article that reported the Hospitals each separately had allowed ABC film crews filming a documentary to access PHI and film patients without obtaining patient authorization. See Boston Medical Center Resolution Agreement (BMC Settlement Agreement); Brigham and Women’s Hospital Resolution Agreement (BWH Settlement Agreement); and Massachusetts General Hospital Resolution Agreement (MGH Resolution Agreement)
The MGH Resolution Agreement reflects that OCR’s investigations began with an investigation of MGH on December 17, 2014 based on a news story posted to MGH’s website on October 3, 2014, indicating that ABC News would be filming a medical documentary program at MGH. The MGH Resolution Reports that the investigation revealed that before allowing the filming between October 2014 to January 2015, MGH reviewed and assessed patient privacy issues related to the filming and implemented various protections regarding patient privacy, including providing the ABC film crew with the same HIPAA privacy training received by MGH’s workforce.
Information contained in the respective settlement agreements reflect that OCR’s investigations of BMC and BWH began about a month later on January 25 and 26, 2015 respectively in response to the Boston Globe article. The BWH Settlement Agreement states that the BWH investigation revealed that like MGH, BWH reviewed and assessed patient privacy issues related to the filming and implemented various protections regarding patient privacy, including providing the ABC film crew with the same HIPAA privacy training received by BWH’s workforce before allowing the filming by the ABC film crew that occurred between October 2014 to January 2015. The BMC Settlement Agreement does not state that OCR found BMC engaged in similar deliberations or undertook the same or other efforts to safeguard patients and their PHI.
The BMC Settlement Agreement reports that the OCR concluded based on the BMC investigation showed that BMC impermissibly disclosed PHI of patients to ABC employees during the production and filming of a television program at BMC in violation of HIPAA. Meanwhile, while acknowledging the privacy deliberations and efforts undertaken at MGH and BWH, OCR also concluded that each of those organizations also violated HIPAA because in allowing the film crew access and to film patients and patient areas:
The timing at which they obtained patient authorizations showed MGH and BWH impermissibly disclosed the PHI of patients to ABC employees during the production and filming of a television program at BWH; and
Despite the various patient privacy protections in place, MGH and BWH failed to safeguard its patients’ PHI appropriately and reasonably from disclosure during a filming project conducted by ABC on its premises in 2014 and January 2015.
To resolve potential HIPAA violations, BMC has paid OCR $100,000, BWH has paid OCR $384,000, and MGH has paid OCR $515,000. In addition, each Hospital agreed to provide workforce training as part of a corrective action plan that will include OCR’s guidance on disclosures to film and media in the 2016 Media FAQ.
Allergy Associates of Hartford, P.C.Resolution Agreement
Large institutional health care organizations are not the only HIPAA entities subjected to OCR investigation or enforcement for inappropriate sharing of PHI with the media. In its November 2018
On November 26, 2018, OCR announced that Allergy Associates, the three doctor health care practice Allergy Associates of Hartford, P.C. would pay OCR $125,000 and take corrective action under a Resolution Agreement and Corrective Action Plan resolving charges stemming from comments a physician made to a reporter on a patient dispute with the practice in 2015 violated HIPAA.
According to OCR, the disclosure of patient information that prompted OCR’s HIPAA charges resulted from a physician associated with the practice commenting to a local television station reporter for a story about a disabled patient’s complaint to the station that Allergy Associates turned her away from a scheduled appointment because of her use of a service animal. After the patient contacted the television statement to complain about being turned away by the practice when accompanied by her service animal, the station contacted the doctor for comment about the dispute between the Allergy Associates’ doctor and the patient. Although OCR reports its investigation revealed that Allergy Associates’ Privacy Officer instructed the doctor to either not respond to the media or respond with “no comment,” the doctor nevertheless accepted the television station reporter’s invitation to comment and discussed the dispute with the reporter.
OCR learned of the physician’s unauthorized comments to the reporter when it received a copy of an October 6, 2015, HHS civil rights complaint filed on behalf of the patient with the Department of Justice, Connecticut, U.S. Attorney’s Office (DOJ) by the Connecticut Office of Protection and Advocacy for Persons with Disabilities (OPA). In response to this complaint, OCR initiated a joint investigation with DOJ into the civil rights allegations against Allergy Associates. The complaint also alleged that Allergy Associates impermissibly disclosed the patient’s PHI in violation of HIPAA.
OCR found the physician’s discussion of the patient’s complaint without first obtaining a HIPAA-complaint authorization from the patient both violated HIPAA and demonstrated a reckless disregard for the patient’s HIPAA privacy rights. Additionally, Resolution Agreement also states that OCR’s investigation revealed that Allergy Associates did not take any disciplinary or other corrective action against the doctor after learning of his impermissible disclosure to the media.
To resolve the HIPAA charges, Allergy Associates agrees in the Resolution Agreement and Corrective Action Plan to pay $125,000 as well as to undertake a corrective action plan that includes two years of monitoring their compliance with the HIPAA Rules.
OCR COVID-19 HIPAA Guidance & Warnings About Media-Related HIPAA Responsibilities
With the COVID-19 pandemic fueling a torrent of media inquiries and coverage of patient, workforce and other aspects of the pandemic, OCR reminded health care providers and other HIPAA entities of HIPAA’s requirement of prior authorization before sharing PHI or allowing media to access patients or areas where media could observe patients or their PHI throughout the COVID-19 pandemic.
In its May 5, 2020 Guidance on Covered Health Care Providers and Restrictions on Media Access to Protected Health Information about Individuals in Their Facilities (“5/5 Guidance”), OCR warned covered health care providers and other HIPAA entities that the Privacy Rule prohibits HIPAA entities from giving media or film crews access to PHI including access to facilities where patients’ PHI could be accessible without the patients’ prior authorization and cautioned testing facilities and other health care providers to prevent unauthorized use, access or disclosure of test results and other PHI except as specifically allowed in the applicable HIPAA Law. In this respect, the 5/5 Guidance quoted then OCR Director Roger Severino, as unequivocally stating “Hospitals and health care providers must get authorization from patients before giving the media access to their medical information; obscuring faces after the fact just doesn’t cut it.”
Consistent with this warning, the 5/5 Guidance described reasonable guidelines and safeguards that HIPAA entities should use to protect the privacy of patients whenever the media is granted access to facilities. Additionally, the 5/5 Guidance specifically warned HIPAA entities among other things that:
HIPAA does not permit covered health care providers to give the media, including film crews, access to any areas of their facilities where patients’ PHI will be accessible in any form (e.g., written, electronic, oral, or other visual or audio form), without first obtaining a written HIPAA authorization from each patient whose PHI would be accessible to the media;
Covered health care providers may not require a patient to sign a HIPAA authorization as a condition of receiving treatment; and
Masking or obscuring patients’ faces or identifying information before broadcasting a recording of a patient does not sufficiently deidentify patient information to allow unauthorized disclosure. A valid HIPAA authorization is still required before giving the media such access.
Despite these warnings, throughout the COVID-19 health care emergency videos and other media reports often incorporated videos or other images of patients and other descriptions or details about patients containing PHI reporters or media outlets obtained from accessing facilities, interviewing workforce members, or shared with the media or others allowed to access patients or facilities, often without a HIPAA-compliant patient authorization and often by workforce members without authorization or otherwise in violation of their employing HIPAA entity’s policies. See e.g. Ezekiel Elliott COVID-Test Disclosure Highlights Health Care Provider & Plan HIPAA & Other Privacy Risks From Medical Testing & Other Medical Information;, Health care workers express overwhelming fatigue as COVID-19 cases surge across the country; Pandemic takes its toll on health care workers; ABC News Special Coverage: Coronavirus Pandemic. Since the widespread media coverage makes clear SJMC was not the only health care provider or other HIPAA entity where the entity or members of its workforce allowed media access to facilities, shared or allowed the media or other third-parties to take patient photos, videos, or shared or allowed media access to other PHI, additional OCR enforcement actions or settlements arising from COVID-19 related media disclosures against other HIPAA-entities are likely.
To mitigate their own organizational exposure to potential HIPAA and other privacy-related exposures from known or as-of-yet unidentified past or future media-related HIPAA violations, all HIPAA entities should consult qualified legal counsel for advice and assistance within the scope of attorney-client privilege on investigating their organizations potential risks from any past media disclosures and opportunities for mitigating any known or uncovered HIPAA exposures by acting proactively as well as for guidance on best practices to prevent or mitigate liability from future dealings with the media.
To promote their compliance and the defensibility of their practices and efforts when compliance issues arise, HIPAA entities need conduct a well-documented assessment of their current and past compliance, policies, practices and workforce training on allowing media or others to enter, film, photograph or record within their facilities or otherwise disclosing or allowing media access to their facilities as well as their policies about when parties not involved in care of a particular patient can film, photograph, or otherwise record, observe or access areas where patients or patient PHI is or might be present without prior written consent of the patient.
Going forward, all HIPAA entities should ensure their policies clearly prohibit their entities, their business associates and their workforce from allowing film or media to film, photograph or even access areas where patients or their PHI are accessible or otherwise disclosing PHI to members of the media without first obtaining a HIPAA-compliant authorization from each patient whose presence or PHI could be observed, recorded or otherwise accessed. Adopting the policy alone is insufficient, however, HIPAA entities also need to implement and enforce appropriate procedures and training to promote compliance with those policies and processes to monitor and respond to any violations of HIPAA’s requirements.
When considering the adequacy of their current policies, practices and training concerning filming, photography and other access and disclosure to patients, patient treatment areas and other PHI, HIPAA entities should keep in mind that the obligation to prevent unauthorized filming, photography or any other PHI access or disclosure PHI extends to “any third party not involved in patient care,” not merely those to media or film crews. Consequently, HIPAA entities should address potential risks from filming, photographs or other access and disclosure to patients, patient treatment or recordkeeping areas, or PHI by all parties within or with access to their facilities or records including but not limited to staff, business associates, contractors, other patients as well as media or other visitors.
Recognizing that the NY-Presbyterian corrective action plan included a requirement that NY-Presbyterian require “all photography, video recording and audio recording conducted on NY-Presbyterian premises” be reviewed, preapproved and actively monitored for compliance with the Privacy Rule and NY-Presbyterian’s policies, HIPAA entities also should take steps to monitor and properly restrict and protect any filming, photography or other observations, records or other PHI by individuals within their workforce, as well as to regulate the access and activities of unrelated third parties. In this respect, HIPAA entities are cautioned about the need to prohibit and enforce suitable prohibitions against members of their workforce and others using their own personal devices or other equipment to film, photograph, and copy or disseminate photographs, film, recordings or other records or data that qualifies as or contains PHI without authorization in accordance with established protocols.
HIPAA entities also should take steps to ensure their policies and training make clear that these prohibitions apply whether or not the workforce member believes that identity of the patient or patient information is concealed or otherwise not discoverable.
Moreover, even with respect to photographs, films or other recordings or records legitimately created for treatment, payment or operations purposes, HIPAA entities generally need to take steps to restrict use, access and disclosure of the photographs or other recordings to individuals legitimately involved in patient treatment, operations, payment or other activities allowed by the Privacy Rule and to safeguard those materials against use, access or disclosure to others within or outside their workforce except as allowed by HIPAA and other applicable law. .
Since HIPAA entities also are likely to be subject to other statutory, ethical, contractual or other privacy or confidentiality requirements beyond those imposed by the Privacy Rule, most HIPAA entities also will want to consider and take steps to identify and address these other potential legal or ethical responsibilities such as medical confidentiality duties applicable to physicians and other health care providers under medical ethics, professional licensure or other similar rules, contractual responsibilities, as well as common law privacy or other related exposures when conducting this review. Additionally, most HIPAA entities also will want to take into account and manage their potential exposure to privacy, theft of likeness or other intellectual property, or other statutory or common law tort or contractual claims that might attached to the unauthorized filming, photographing, or surveillance of individuals under federal or state common or statutory laws.
Since this analysis and review in most cases will result in the uncovering or discussion of potentially legally or politically sensitive information, HIPAA entities should consider consulting with or engaging experienced legal counsel for assistance in structuring and executing these activities to maximize their ability to claim attorney-client privilege or other evidentiary protections against discovery or disclosure of certain aspects of these activities.
Finally, HIPAA entities should keep in mind that HIPAA compliance and risk management is an ongoing process requiring constant awareness and diligence. Consequently, HIPAA entities should both monitor OCR and other regulatory and enforcement developments as well as exercise ongoing vigilance to monitor and maintain compliance within their organizations.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and VIce-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
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The November 13th sentencing of a Katy, Texas woman to 56 months imprisonment for using her ex-husband’s provider number to defraud Medicaid of more than $600,000 reminds physicians and other health care providers of the need for careful oversight and diligence of all workers including family and friends.
Kay Le Farmer Farmer is the former office manager for her ex-husband – a therapist and Medicaid provider in the Houston area. Following their separation, Farmer pleaded guilty on March 22, 2023 to using her ex-husband’s provider number to submit fraudulent claims to Medicaid, unbeknownst to him, for counseling services that were never provided as well as to other frauds.
Hearing testimony revealed Farmer fraudulently obtained information of over 300 patients, her attempts to lie and cover-up her crimes and that she appeared to be searching for more employment opportunities to steal more information.
In 2017, Farmer admitted to using her employment at a pediatrician’s office to obtain patient information. She then submitted more fraudulent claims to Medicaid under her ex-husband’s provider number. In total, from 2013 until 2018, Farmer submitted, or caused the submission of, approximately $617,983.86 in claims for psychotherapy services that were not provided. Farmer admitted she was paid approximately $432,924.69 on those claims.
For these crimes, U.S. District Judge George C. Hanks ordered Farmer to serve 56 months in federal prison followed by two years of supervised release.
The conviction and sentencing warns other providers to remain vigilant in overseeing office managers and other workers with access to sensitive information and responsibilities including family or friends presumed trustworthy. Providers also should endure all staff including themselves, family and friends are included in required checks for status as disqualified persons and other credentials confirmations.
Providers that suspect or discover fraud or other suspicious conduct by members of their team should contact qualified legal counsel for assistance investigating and redressing concerns. Ideally, providers should seek to avoid making unprivileged statements or engaging in potentially sensitive discussions about these concerns or events until obtaining legal representation to minimize the risk those statements might undermine or complicate the defensibility of their actions.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and VIce-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
The Department of Health & Human Services (“HHS-OIG”) just updated the 2023 Fraud Risk Indicator for the fourth quarter.
Based on information from False Claims Act settlements, HHS-OIG assesses the future trustworthiness of the settling parties to decide whether to exclude them from federal health care programs government’s primary civil tool for addressing health care fraud is the False Claims Act (“FCA”). Most FCA cases are resolved through settlement agreements in which the government alleges fraudulent conduct and typically the settling parties do not admit liability.
Depending on the facts and circumstances presented, OIG will usually pursue one of the following approaches when settling a health care fraud case: (1) exclusion; (2) heightened scrutiny; (3) integrity obligations; (4) take no further action; or (5) in the case of a good faith and cooperative self-disclosure, release 1128(b)(7) exclusion with no integrity obligations. OIG’s Risk Spectrum illustrates these approaches.
For more information on how OIG evaluates risk to the Federal health care programs and the criteria the OIG considers in evaluating exclusions in False Claims Act cases, see OIG’s April 18, 2016 notice.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and VIce-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
A new federal Equal Employment Opportunity Commission (“EEOC”) lawsuit reminds health industry and other employers that patient or other customer preferences do not justify or excuse an employer’s discrimination against employees in violation of the Civil Rights Act or other federal employment discrimination laws.
Brooklyn-based home health company ACARE HHC Inc., doing business as Four Seasons Licensed Home Health Care Agency (“Four Seasons”) faces a race discrimination suit for allegedly removing home health aides from their work assignments due to their race and national origin to accommodate client preferences.
According to a lawsuit (EEOC v. ACARE HHC d/b/a Four Seasons Licensed Home Health Care, 23-cv-5760), filed by the EEOC in the U.S. District Court for Eastern District of New York on July 31, 2023, Four Seasons violated the Title VII of the Civil Rights Act of 1964 (“Civil Rights Act”) by routinely acceding to racial preferences of patients in making home health aide assignments. The EEOC claims Four Seasons routinely removed Black and Hispanic home health aides based on clients’ race and national origin-based requests. Four Seasons would transfer aides to a new assignment or, if no other assignment was available, the aides lost their employment completely. The EEOC charges this alleged conduct violates the Civil Rights Act, which among other things prohibits employers from discriminating against employees on the basis of race and national origin. The EEOC seeks compensatory damages and punitive damages for the affected employees, and injunctive relief to remedy and prevent future discrimination based on employees’ race and national origin.
The lawsuit, warns employers against resigning or assigning workers to accommodate racial or other prohibited discriminatory preferences of customers, or business partners. “Making work assignment decisions based on an employee’s race or national origin is against the law, including when these decisions are grounded in preferences of the employer’s clients,” said Jeffrey Burstein, regional attorney for the EEOC’s New York District Office.
The lawsuit is one of a plethora of enforcement Civil Rights and other federal discrimination law actions by EEOC, the Department of Health and Human Services Office of Civil Rights, and other federal agencies under the Biden Administration’s prioritization of expansion and enforcement of discrimination and other discrimination and equal opportunity laws.
In light of these efforts, employers should take immediate steps to update policies, postings, training, and practices to ensure their ability to defend their compliance with race and other federal nondiscrimination laws.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and VIce-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Health care providers, health insurance issuers, health care professional associations, state and local government entities and other organizations and providers participating or receiving funds from the Department of Health and Human Services (“HHS”) funded programs should evaluate their likely responsibilities and exposures for preventing discrimination on the basis of sexual orientation and gender under the Notice of Proposed Rule Making (“NPRM”) to the Health and Human Services Grants Regulation (the “Proposed HHS Grants Rule”) the HHS Office for Civil Rights (“OCR”) and the Assistant Secretary for Financial Resources (“ASFR”) released to the public today (July 11, 2023) and scheduled for joint publication the Federal Register on July 13, 2023.
The Proposed HHS Grants Rule clarifies and reaffirms HHS’ prohibition against LGBTQI discrimination by stating, “In statutes that HHS administers which prohibit discrimination on the basis of sex, the Department interprets those provisions to include a prohibition against discrimination on the basis of sexual orientation and gender identity, consistent with the Supreme Court’s decision in Bostock v. Clayton County, 140 S. Ct. 1731 (2020), and other federal court precedent applying Bostock’s reasoning that sex discrimination includes discrimination based on sexual orientation and gender identity.”
The Proposed HHS Grants Rule represents the latest effort of HHS to finalize and implement prohibition against LGBTQI individuals in HHS first undertaken in 2016. Since HHS originally adding the prohibition against LGBTQI discrimination to its HHS Grants Rule, HHS faced various court challenges to its LGBTQI nondiscrimination provisions. These challenges included lawsuits challenging HHS’ interpretation of the sex discrimination prohibitions of Title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e-2(a)(1) (“Title VII”) as prohibiting discrimination based on sexual orientation and identity, First Amendment religious freedom challenges and challenges based on alleged violations of the Administrative Procedures Act.
In the intervening years, HHS originally granted various waivers, then subsequently adopted a blanket non-enforcement policy to address First Amendment religious freedom concerns about the LGBTQI discrimination prohibition and attempted to resolve Administrative Procedures Act challenges in subsequently published versions of the rules. Meanwhile, the U.S. Supreme Court resolved objections to HHS’ expansive interpretation of Title VII as extending to LGBTQI when it affirmed Title VII’s prohibition against discrimination on the basis of sex includes discrimination based on sexual orientation and gender identity in Bostock v. Clayton County, 140 S. Ct. 1731 (2020).
As currently proposed, the HHS Grants Rule has a sweeping reach. In the Proposed HHS Grant Rule, HHS reaffirms that discrimination against LGBTQI individuals is prohibited in virtually all HHS-funded and administered programs while revising the existing HHS Grants Rule to address when and how a provider with faith-based objections to the rules can seek exemption or other religious accommodations from HHS.
As currently proposed the Proposed HHS Grants Rule would treat LGBTQI discrimination as prohibited discrimination on the basis of sex in most HHS regulated or funded programs. The LGBTQI discrimination prohibition would apply to authorizations for domestic resettlement of and assistance to refugees; assistance in transition from homelessness; Children with Serious Emotional Disturbances; Title VII Health Workforce Programs; Nursing Workforce Development; Preventive Health Services Block Grant; Substance Abuse Treatment and Prevention Block Grant; Community Mental Health Services Block Grant; Maternal and Child Health Block Grant; Disaster relief; Low-Income Home Energy Assistance Program; Head Start; Community Services Block Grant Program; and Family Violence Prevention and Services programs.
HHS’ announcement of its plans to reaffirm its LGBTQI equal protection requirements in the HHS Grants Rule likely will prompt new attention and scrutiny from organizations and individuals with faith-based objections to its mandates, particularly given HHS’ release of the rule comes less than two weeks after the Supreme Court’s June 30, 2023 landmark ruling in 303 Creative LLC . v. Elenis, 600 U. S. ____ (2023), upholding the right of a website designer, who believes same-sex marriage contravenes her faith, to exemption from enforcement of a state law that prohibited a public business from communicating to patrons that service would be refused based on sexual orientation.
The Proposed HHS Grants Rule includes provisions requiring HHS to accommodate the religious rights of organizations or individuals with faith-based objections protected by the Religious Freedom Restoration Act (“RFRA”) or the First Amendment when administering and enforcing its provisions without specifically detailing the procedures for raising such objections or the standards HHS will apply to decide whether to approve a request for religious exemption or accommodation.
In this respect, the Proposed HHS Grants Rule provides that a recipient at any time may notify the HHS awarding agency, ASFR, or the Office for Civil Rights (OCR) of the recipient’s view that it is exempt from, or requires modified application of, certain provisions of the Rule due to the RFRA, the First Amendment or another religious freedom law. The Proposed HHS Grants Rule also directs that once the awarding agency receives notice of religious objection from a particular recipient, “any relevant ongoing compliance activity regarding the recipient shall be held in abeyance” until the applicable agencies in legal consultation with the HHS Office of the General Counsel determine whether the recipient is exempt from the application of certain provisions or entitled to modified application of the rules based on a federal religious freedom law.
While the Proposed HHS Grants Rule does not detail the procedures for requesting religious accommodation or the standards HHS will use to decide whether to approve requests, HHS does address those standards and procedures in other guidance, the current provision of which are highlighted on the HHS Conscience and Religious Freedom Webpage. It bears noting, however, that along with the Proposed HHS Grants Rule, HHS also currently is considering a separate proposal to narrow the availability of religious and conscience objections to its rules it announced in a January 5, 2023 Notice of Proposed Rule Making titled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (“Proposed Religion Rule”). While the official comment period for the Proposed Religion Rule closed on March 6, 2023, its provisions, if adopted as proposed, could materially affect the interpretation and enforcement of the HHS Grants Rule. Accordingly, organizations and other parties concerned about the likely interpretation and enforcement of the HHS Grants Rule with respect to parties claiming religious freedom objections should consider the likely implications of the Proposed Religion Rule in their evaluation of the HHS Grants Rule.
In response to the HHS Grants Rule, all health care providers, health plans and others expected to be impacted by the Proposed HHS Grants Rule should both begin preparing to adjust their existing policies and practices in anticipation of the finalization of the Proposed HHS Grants Rule as well as submit relevant concerns and other feedback on the Proposed Rule by the September 11, 2023 comment deadline established in the NPRM. Providers and other stakeholders with potential faith-based concerns about any of the requirements of the Proposed HHS Grants Rule should take particular note of the Rule’s proposed provisions regarding religious accommodation, taking into account the Proposed Religion Rule purposes of this planning as well as their timely submission of any comments by the applicable September 11, 2023 comment deadline.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Sibley Hospital (“Sibley”) and its parent company, Johns Hopkins Health System (“Johns Hopkins”) will pay the United States $5 million to resolve Physician Self-Referral Law, (commonly known as the “Stark Law”) allegations arising from claims that Sibley submitted to the Medicare Program, the Justice Department announced today.
The Stark Law prohibits a hospital from billing Medicare for certain services referred by physicians with whom the hospital has a financial relationship, unless that relationship satisfies one of the law’s statutory or regulatory exceptions. It is intended to ensure that medical decision-making is not influenced by improper financial incentives and instead is based on the best interests of the patient.
The new settlement resolves allegations that, from 2008 through 2011, Sibley violated the Stark Law by billing Medicare for services referred by ten cardiologists to whom Sibley was paying compensation that exceeded the fair market value of the services provided. These allegations arose out of conduct that Sibley and Johns Hopkins self-disclosed to the United States.
“Improper financial arrangements between hospitals and physicians can influence the type and amount of health care that is provided,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department is committed to holding accountable those who violate prohibitions designed to protect the integrity of physician decision-making.”
The high dollar settlement reminds other health care providers to ensure their own relationships with other health care providers comply with Stark, anti-kickback and other federal and state health care fraud laws.
More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
April 21 is the deadline to comment on the Centers for Medicare & Medicaid Services (CMS) National Standards Group (NSG) proposed rule that, if finalized, would adopt standards for “health care attachments” transactions, a standard for electronic signatures to be used in conjunction with health care attachments transactions, and a modification to the standard for the referral certification and authorization transaction (X12 278) published last December.
The April 21, 2023 deadline reflects a 30-day extension from the original deadline date of March 21, 2023. Comments must be received no later than 5 p.m. on April 21.
More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Nursing home and rehabilitation operator Symphony Deerbrook, LLC’s $400,000 payment and other relief to settle a pregnancy discrimination lawsuit brought by the U.S. Equal Employment Opportunity Commission (EEOC) warns other health industry and other employers about the risk of imposing special pregnancy notice, doctors, release and testing requirements on pregnant employees.
In its lawsuit, the EEOC charged that Symphony implemented a policy requiring employees to inform the company of any pregnancy and to obtain a note from their doctor releasing them to work without restrictions. The EEOC also alleged that Symphony denied employees with pregnancy-related restrictions reasonable accommodations and terminated them though other employees with similar restrictions were provided accommodations.
The EEOC charged these actions violatesd the Pregnancy Discrimination Act of Title VII, 42 U.S.C. 2000e(K) and 2000e-(2)(a)(1) and the Americans with Disabilities Act, 42 U.S.C. § 12112(d)(3)(C)(4)(a).
The Pregnancy Act prohibits employers from discrimination on the basis of pregnancy and requires that employers treat pregnant employees the same as other employees who are similar in their ability or inability to work.
The ADA which prohibits employee medical examinations that are not job related or consistent with business necessity.
The consent decree settling the suit requires Symphony to pay $400,000, which will be distributed among 11 affected employees. The two-and-a-half-year decree enjoins Symphony from discrimination on the basis of pregnancy in the future, including denying pregnant workers job modifications available to other similar employees and requiring pregnant employees to obtain doctor’s notes stating that they can work without restriction.
In 2021, Symphony sold the facility to Pearl of Joliet, who agreed for purposes of settlement to provide anti-discrimination training to all its employees at the facility, to post a notice about the resolution of the law lawsuit, and to report to EEOC certain types of information during the decree’s term. The EEOC has not alleged that Pearl engaged in any discrimination.
Suits and settlements like Symphony’s send a clear warning against discrimination based on pregnancy by health care providers and other employers. Healthcare and other organizations concerned about the safety of pregnant women working in particular positions should ask experienced legal counsel for assistance in managing the occupational health and safety risks, if any for pregnant or other employees without running afoul of discrimination prohibitions.
More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Department of Health & Human Services Office of Inspector General (“OIG”) data showing a rise in Medicaid criminal convictions arising from fraud and patient abuse or neglect investigations and prosecutions during the 2022 fiscal year (“FY”) confirms the continued robustness of its Medicaid Fraud Control Units (MFCUs).
1,327 criminal convictions, an increase over the previous 2 years, but resulted in criminal recoveries of only $416 million; and
553 civil settlements and judgments resulting in civil recoveries of $641 million.
A Statistical Chart included in the Report provides a breakdown by state of the civil and criminal convictions and recoveries by nature of the offense.
While the Report reveals that civil and criminal recoveries from Medicaid criminal and civil enforcement dropped in FY 2022, the increase in convictions and other data sends a clear warning to health care providers and others that Medicaid fraud investigation and enforcement remains a key priority of the OIG and federal prosecutors.
Criminal Convictions
Total convictions resulting from MFCU cases continued to increase from the FY 2020 level but remained lower than in FY 2019. In FY 2022, MFCU cases resulted in 946 convictions for fraud and 381 convictions for patient abuse or neglect. Exhibit 2 shows the total number of convictions during FYs 2018 through 2022. Although the proportion of patient abuse or neglect convictions to fraud convictions was similar to that in previous years, the total number of patient abuse or neglect convictions also continued to increase from the FY 2020 level.
As in previous years, significantly more convictions for fraud involved Personal Care Services (PCS) attendants than any other provider type with fraud convictions of PCS attendants, accounting for 44 percent of the fraud convictions.
MFCU convictions related to the fraudulent billing of Medicaid, fraudulent activities of Medicaid providers involving drugs diverted from legal and medically necessary uses, regardless of whether Medicaid itself was billed and other “drug diversion” cases continued to increase from the FY 2020 level. Associated criminal recoveries from drug diversion cases totaled $18 million in FY 2022. Two States, Pennsylvania and Kentucky, accounted for 79 percent of the total convictions.
In FY 2022, convictions of nurse’s aides and of nurses or physician assistants accounted for 39 percent of the total 381 convictions for patient abuse or neglect.
Criminal and Civil Recoveries
While convictions rose, criminal recoveries decreased from $857 million in FY 2021 to $416 million in FY 2022. The Report attributes the drop in atypically large criminal recovery amounts realized in FY 2021 that resulted primarily from cases prosecuted by MFCUs in Virginia and Texas that produced a combined $714 million in criminal recoveries, 83 percent of the total reported criminal recoveries in FY 2021.
The Report points out that a single Texas criminal prosecution also significantly contributed to the total criminal recoveries in FY 2022. According to the Report, $82 million of the FY 2022 criminal recoveries resulted from the prosecution and conviction of the former head of Novus and Optimum Health Services, Bradley J. Harris and other defendants by the U.S. Attorney’s Office for the Northern District of Texas for defrauding the Medicare and Medicaid programs by among other actions:
Billing Medicare and Medicaid for hospice services that were (1) not provided, (2) not directed by a medical professional, and (3) provided to patients not eligible for hospice care; and
Using blank, pre-signed controlled substance prescriptions to distribute drugs without physician input.
Recoveries from civil settlements and judgments also decreased in FY 2022, as did the total number of civil settlements and judgments associated with pharmaceutical manufacturers. In FY 2022, $395 million (62 percent) of the $641 million in civil recoveries derived from nonglobal cases. The remaining $246 million derived from global cases.
Appendixes to the report include a list of “beneficial” practices implemented by the MFCUs to prevent and discover these and other Medicaid abuses in various regions. Reviewing the granular statistics and these findings set forth in the Report provide valuable insights for health care providers, their leaders and advisors about these and other enforcement priorities and practices.
More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Phoenix-based nonprofit health system Banner Health and its affiliates (“Banner Health”) paid $1.25 million and agreed to take corrective actions to resolve its exposure to potentially much greater Health Insurance Portability and Accountability Act (HIPAA) Security Rule civil monetary penalty exposure for a 2016 cyber hacking breach that compromised the personal health information of 2.81 million consumers. OCR used its February 2 announcement of the Banner Health settlement to warn health care providers, health plans, health care clearinghouses (“covered entities”) and business associates covered by HIPAA to guard their own systems containing protected health information against breach by cyber hacking.
Banner Health Settlement
Banner Health is one of the largest non-profit health systems in the country, with over 50,000 employees and operating in six states. Banner Health is the largest employer in Arizona and one of the largest in northern Colorado.
In November 2016, OCR initiated an investigation of Banner Health following the receipt of a breach report stating that a threat actor had gained unauthorized access to electronic protected health information, potentially affecting millions. The hacker accessed protected health information that included patient names, physician names, dates of birth, addresses, Social Security numbers, clinical details, dates of service, claims information, lab results, medications, diagnoses and conditions, and health insurance information.
OCR’s investigation found evidence of long-term, pervasive noncompliance with the HIPAA Security Rule across Banner Health’s organization, a serious concern given the size of this covered entity. Organizations must be proactive in their efforts to regularly monitor system activity for hacking incidents and have measures in place to sufficiently safeguard patient information from risk across their entire network.
The potential violations OCR identified specifically included:
A lack of an analysis to determine risks and vulnerabilities of electronic protected health information across the organization;
Insufficient monitoring of its health information systems’ activity to protect against a cyber-attack;
Failure to implement an authentication process to safeguard its electronic protected health information; and
Failure to have security measures in place to protect electronic protected health information from unauthorized access when it was being transmitted electronically.
Under the Resolution Agreement and Corrective Action Plan negotiated to resolve these potential violations, Banner Health paid $1,250,000 to OCR. Banner Health also agreed to implement a corrective action plan, which identifies steps Banner Health will take to resolve these potential violations of the HIPAA Security Rule and protect the security of electronic patient health information that will be monitored for two years by OCR to ensure compliance with the HIPAA Security Rule. Under the corrective action plan, Banner has agreed to take the following steps:
Conduct an accurate and thorough risk analysis to determine risks and vulnerabilities to electronic patient/system data across the organization
Develop and implement a risk management plan to address identified risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI
Develop, implement, and distribute policies and procedures for a risk analysis and risk management plan, the regular review of activity within their information systems, an authentication process to provide safeguards to data and records, and security measures to protect electronic protected health information from unauthorized access when it is being transmitted electronically, and
Report to HHS within thirty (30) days when workforce members fail to comply with the HIPAA Security Rule.
OCR Warns Other HIPAA-Covered Entities
In the health care sector, hacking is now the greatest threat to the privacy and security of protected health information. OCR’sannouncement of the settlement reports 74 percent (74%) of the breaches reported to OCR in 2021 involved hacking/IT incidents.
The announcement also notesOCR offers an array of resources to help health care organizations bolster their cybersecurity posture and comply with the HIPAA Rules,
The settlement and OCR’s announcement warn other covered entities and business associates to use these and other necessary resources to protect their systems with protected health information from cyber hacking and other breaches.
In conjunction with reminding other covered entities of these resources, the settlement announcement quotes OCR Director Melanie Fontes Rainer as a warning, “Hackers continue to threaten the privacy and security of patient information held by health care organizations, including our nation’s hospitals, … It is imperative that hospitals and other covered entities and business associates be vigilant in taking robust steps to protect their systems, data, and records, and this begins with understanding their risks, and taking action to prevent, respond to and combat such cyber-attacks. … Cyber security is on all of us, and we must take steps to protect our health care systems from these attacks.”
Alerts issued by OCR regarding heightened security risks in recent months and a growing tide of highly publicized breaches send a strong warning to other covered entities and their business associates to reconfirm the adequacy of their own HIPAA privacy, security, breach notification and other procedures and protections by among other things:
Reviewing and monitoring on a documented, ongoing basis the adequacy and susceptibilities of existing practices, policies, safeguards of their own organizations, as well as their business associates and their vendors within the scope of attorney-client privilege taking into consideration data available from OCR, data regarding known or potential susceptibilities within their own operations as well as in the media, and other developments to determine if additional steps are necessary or advisable.
Updating policies, privacy and other notices, practices, procedures, training and other practices as needed to promote compliance and defensibility.
Renegotiating and enhancing service provider agreements to detail the specific compliance, audit, oversight and reporting rights, workforce and vendor credentialing and access control, indemnification, insurance, cooperation and other rights and responsibilities of all entities and individuals that use, access or disclose, or provide systems, software or other services or tools that could impact on security; to clarify the respective rights, procedures and responsibilities of each party in regards to compliance audits, investigation, breach reporting, and mitigation; and other relevant matters.
Verifying and tightening technological and other tracking, documentation and safeguards and controls to the use, access and disclosure of protected health information and systems.
Conducting well-documented training as necessary to ensure that members of the workforce of each covered entity and business associate understand and are prepared to comply with the expanded requirements of HIPAA, understand their responsibilities and appropriate procedures for reporting and investigating potential breaches or other compliance concerns, and understand as well as are prepared to follow appropriate procedures for reporting and responding to suspected violations or other indicia of potential security concerns.
Tracking and reviewing on a systemized, well-documented basis actual and near-miss security threats to evaluate, document decision-making and make timely adjustments to policies, practices, training, safeguards and other compliance components as necessary to identify and resolve risks.
Establishing and providing well-documented monitoring of compliance that includes board-level oversight and reporting at least quarterly and sooner in response to potential threat indicators.
Establishing and providing well-documented timely investigation and redress of reported violations or other compliance concerns.
Establishing contingency plans for responding in the event of a breach.
Establishing a well-documented process for monitoring and updating policies, practices and other efforts in response to changes in risks, practices and requirements.
Preparing and maintaining a well-documented record of compliance, risk, investigation and other security activities.
Pursuing other appropriate strategies to enhance the covered entity’s ability to demonstrate its compliance commitment both on paper and in operation.
Because of susceptibilities in systems, software and other vendors of business associates, suppliers and other third parties, covered entities and their business associates should use care to assess and manage business associate and other vendor-associated risks and compliance as well as tighten business associate and other service agreements to promote the improved cooperation, coordination, management and oversight required to comply with the new breach notification and other HIPAA requirements by specifically mapping out these details.
Beyond these HIPAA exposures, breaches and other HIPAA noncompliance carries other liability risks. Leaders of covered entities or their business associates also are cautioned that while HIPAA itself does not generally create any private right of action for victims of breach under HIPAA, breaches may create substantial liability for their organizations or increasingly, organizational leaders. For instance, the Department of Health & Human Services has warned health care providers participating in Medicare or other federal programs and Medicare Advantage health plans that HIPAA compliance is a program term of participation.
Health care providers and health insurers can face liability under state data privacy and breach, negligence or other statutory or common laws. In addition, physicians and other licensed parties may face professional discipline or other professional liability for breaches violating statutory or ethical standards.
Health plans also face a myriad of other exposures from failing to use appropriate cyber safeguards. Plan fiduciaries of employment-based health plans covered by the Employee Retirement Income Security Act (“ERISA”) risk liability under ERISA’s fiduciary responsibility rules. The Department of Labor Employee Benefit Security Administration (“EBSA”) now audits the adequacy of the cybersecurity and other HIPAA compliance of health plans and their third-party administrators and other business associates as part of EBSA’s oversight and enforcement of ERISA. Department of Labor Assistant Secretary for EBSA Lisa Gomez confirmed audit and enforcement of cybersecurity obligations is a key priority in EBSA’s current work plan in her February 4, 2023 comments to the American Bar Association.
Meanwhile, the Securities and Exchange Commission has indicated that it plans to pursue enforcement against leaders of public health care or other public companies that fail to use appropriate care to ensure their organizations comply with privacy and data security obligations.
Furthermore, appropriate cyber security practices also may be advisable elements for organizations to include in their Federal Sentencing Guideline Compliance Programs to mitigate potential organization liability risks under federal electronic crime and related laws.
In the face of these risks and warnings, all covered entities and their business associates should reassess and confirm the adequacy of their and their business associates’ cyber security defenses and breach response preparations.
More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Three consolidated False Claims Act (“FCA”) lawsuits against chiropractor Yury Gampel (“Gampel”), 15 Modern Vascular office-based labs owned primarily by Gampel located across the United States, and five Modern Vascular-affiliated companies owned by Gampel alert other chiropractic, physician and other medical providers using office-based labs send a clear warning to other health care providers and suppliers for services covered or billed to Medicare, Medicaid, TRICARE or other federal health care programs about the necessity to ensure their arrangements don’t involve illegal financial relationships or transactions.
False Claims Act Liability Arising From Participation In Or Filing Claims Involving Improper Inducements
The Justice Department suit against the defendants alleges the defendants both arose from the defendants participation in arrangements involving the offering and payment of illegal remuneration in violation of the federal Anti-Kickback Statute (“AKS”) and that the claims for benefits made to Medicare and other federal programs for care provided involving the arrangement violated the FCA.
The AKS generally prohibits any person or entity from soliciting, receiving, offering, or paying any direct or indirect prohibited remuneration as an inducement or reward for referring, recommending, ordering, or arranging for the purchase of any item or service for which payment may be made in whole or in part by a federal health care program. Parties violating the AKS commit a felony punishable with a fine of up to $100,000, imprisonment for up to 10 years or both.
In addition to any criminal liability arising under the AKS, filing claims derived or involving transactions prohibited by the AKS also can trigger liability for violation of the FCA. The FCA makes it unlawful for any person to submit, directly or indirectly, false or fraudulent claims for payment to the Government by among other things:
Knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval in violation of 31 U.S.C. § 3729(a)(1)(A) (the “presentment provision”); or
Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim in violation of 31 U.S.C. § 3729(a)(1)(B).
The FCA defines the term “knowingly” under the FCA very broadly. As defined, “knowingly” means that a person, with respect to information, (i) has actual knowledge of the information, (ii) acts in deliberate ignorance of the truth or falsity of the information, or (iii) acts in reckless disregard of the truth or falsity of the information. 31 U.S.C. § 3729(b). No proof of specific intent to defraud is required to show that a person acted knowingly under the FCA.
Violations of the FCA subject the defendant to mandatory civil penalties per FCA violation, plus three times the amount of damages that the Government sustains as a result of the defendant’s actions. 31 U.S.C. § 3729(a). Under 42 U.S.C. § 1320a-7(b)(7), health care providers submitting claims to Medicare or other federal health care programs also can face exclusion from participation in federal health care programs for FCA violations.
Health care providers filing claims for Medicare or other federal health plans can violate the FCA by knowingly presenting or causing to be presented claims for items or services that the person knew or should have known were not medically necessary, or were false or fraudulent. 42 U.S.C. §§ 1320a-7a(a)(1).
Moreover, health care providers under the Medicare statute have an affirmative duty to familiarize themselves with the statutes, regulations, and guidelines regarding coverage for the Medicare services. As a condition of program participation, Medicare regulations require providers and suppliers to certify that:
The provider or supplier meets, and will continue to meet, the requirements of the Medicare statute and regulations, 42 C.F.R. § 424.516(a)(1), including that any claims and underlying transactions made in a claim for Medicare comply with the Federal anti-kickback statute and the Stark law), and on the supplier’s compliance with all otherwise applicable conditions of participation in Medicare; and
The provider or supplier will not knowingly to present or cause to be presented a false or fraudulent claim for payment by Medicare, or to submit claims with deliberate ignorance or reckless disregard of their truth or falsity.
Additional certifications of continued compliance with these requirements also are required when claims are filed. Accordingly, since health care providers and suppliers are responsible for taking appropriate steps to familiarize themselves with the rules and regulations applicable to their claim and the transactions underlying it and certify in connection with the filing of the claim that the claim and its underlying transactions comply with the law, health care providers filing claims involving prohibited financial incentives or other transactions prohibited by law risk FCA liability.
Gampel, Modern Vascular FCA Complaint
Derived from the Justice Department’s assumption and consolidation of various qui tam lawsuits separately brought by various physicians, the United States filed its complaint in three consolidated lawsuits pending in the United States District Court for the District of Arizona under the qui tam, or whistleblower, provisions of the False Claims Act, 31 U.S.C. §§ 3729-3733 (“FCA”) which allow a private citizen to sue on behalf of the government and share in any recovery. The United States is also entitled to intervene in the lawsuits, as it did in these cases.
The resulting consolidated three consolidated Justice Department lawsuits seek to recover treble damages and civil penalties, and under common law and equitable theories of recovery from defendants for their billing of Medicare, TRICARE and other federal health care programs for claims resulting from transactions involving prohibited remuneration offered and provided in violation of the AKS under Gampel’s alleged schemes Nobility Management LLC; Modern Vascular LLC; Modern Vascular of South Florida LLC; Modern Vascular Management LLC; Modern Vascular Management – East LLC; Modern Vascular Management – West LLC; Modern Vascular Institute LLC; Modern Vascular of Mesa LLC; Modern Vascular of Glendale LLC; Modern Vascular of Sun City LLC; Modern Vascular of Tucson LLC; San Antonio Vascular Specialists Corp. dba Modern Vascular; Fort Worth Vascular Specialists Corp. dba Modern Vascular; Modern Vascular of Denver LLC; Modern Vascular – Navajo LLC; Modern Vascular of Fairfax LLC; Modern Vascular of Houston LLC; Modern Vascular of Indianapolis LLC; Modern Vascular of Southaven LLC; Modern Vascular of St. Louis LLC; and Modern Vascular of Kansas LLC.
The Justice Department complaint alleges Defendant Yury Gampel, a chiropractor, is the founder and former Chief Executive Officer (“CEO”) of a franchise of office-based labs (“OBL”) located in Arizona, New Mexico, Colorado, Texas, Indiana, Kansas, Mississippi, Missouri, Tennessee, and Virginia operating under the name Modern Vascular (collectively, the “Modern Vascular OBLs”). The Modern Vascular OBLs – each its own separate legal entity – focus on the treatment of peripheral arterial disease (“PAD”), particularly through an aggressive use of vascular intervention procedures, such as angioplasty and atherectomy. The complaint claims Gampel and the Modern Vascular defendants designed and promoted the franchises that incorporated a package of management and other services provided by various Modern Vascular defendant companies.
Defendant Nobility Management, LLC, provides management services to the Modern Vascular OBLs. Defendants Modern Vascular Management, LLC; Modern Vascular Management – East, LLC; and Modern Vascular Management – West, LLC, offer IT and management support to Modern Vascular OBLs. Defendants Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, are corporations controlled by Gampel that have various ownership interests in Modern Vascular OBLs. Through Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, and in his own capacity, Gampel is the majority owner of the Modern Vascular OBLs. (These entities that own and manage the Modern Vascular OBLs are referred to collectively below as “Modern Vascular Corporate.”)
The complaint alleges that Gampel and Modern Vascular Corporate designed and implemented a fraud scheme at Modern Vascular OBLs at the expense of patients and federal payors from at least January 1, 2018 through June 30, 2022. Among other things, the complaint charges Gampel and the Modern Vascular defendants offered physicians the opportunity to invest in Modern Vascular office-based labs to induce them to refer their Medicare and TRICARE patients to Modern Vascular for the treatment of peripheral arterial disease. More specifically, Gampel and Modern Vascular Corporate opened Modern Vascular OBLs in new markets where referring physicians and vascular surgeons had established relationships. Prior to opening an OBL in a particular location, Gampel sought out up to 20 local physicians – usually podiatrists and pain management physicians – who traditionally referred to vascular surgeons and offered each up to a two percent ownership interest in the OBL in order to induce the physicians to refer to the OBL. Gampel and Modern Vascular Corporate selected these particular physicians (hereinafter “physician investors”) to offer ownership investment because Gampel and Modern Vascular Corporate identified them as potential high-referral sources. Once they invested in an OBL, Gampel and Modern Vascular Corporate further required the physician-investors to make referrals to Modern Vascular OBLs as a condition for remaining as a physician-investor. The complaint also alleges that Gampel pressured vascular surgeons and interventional radiologists employed at the Modern Vascular office-based labs to increase the number of invasive surgical procedures performed by tracking procedures and setting aggressive weekly and monthly goals for such procedures. In particular, Gampel and Modern Vascular Corporate provided remuneration to physician investors in Modern Vascular OBLs to induce those investors to refer patients to the Modern Vascular OBL.
The Justice Department charges that using this scheme, Defendants between January 1, 2018 and June 30, 2022 submitted, and caused to be submitted, tens of millions of dollars in false or fraudulent claims to Medicare, TRICARE and other federal health care programs by offering and providing illegal remuneration to health care providers to induce referrals to the Modern Vascular OBLs in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b. To induce referrals, Gampel and Modern Vascular Corporate provided remuneration to physician-investors in the form of equity ownership interests in an OBL, which also included distributions, the prospect of future distributions, and/or the prospect of a cash-out of the equity ownership amounts when the Modern Vascular OBLs were sold. During the relevant time period, the Justice Department also claims Modern Vascular OBLs received over $50 million from Medicare Part B alone for claims submitted for patients referred by physician-investors in violation of the FCA.
Warning To Other Heath Care Providers & Suppliers
In announcing its filing of the Gambrel FCA lawsuit, the Justice Department warned other federal health program providers and suppliers and their business partners, investors, employees and agents from violating the AKS, FCA or both in the provision of or billing of health care services or supplies. “As part of our mission to protect the American people, the FBI remains committed to safeguarding patients who rely on our healthcare systems,” said Deputy Assistant Director Aaron Tapp of the FBI’s Criminal Investigative Division. “The FBI and our law enforcement partners will continue to investigate those who abuse our healthcare systems, place patients at risk, and waste taxpayer dollars.”
This warning, along with the ever-lengthening list of federal criminal and civil prosecutions, convictions and settlements by the Justice Department, the Department of Health & Human Services Office of Inspector General and other agencies provide a strong warning to health care providers, suppliers and others involved in creating or administering transactions and other arrangements for the delivery and billing for health are to be billed to Medicare, Medicaid, TRICARE and other health care arrangements covered by the AKS, the FCA or other federal or state health care fraud laws to take well documented care to ensure the care delivery arrangement does not involve transactions prohibited under the AKS or other federal or state health care fraud transactions and the care billed qualifies for reimbursement before submitting the claim. Parties who know or suspect that they may have participated in an arrangement prohibited under these laws or submitted prohibited claims should contact experienced legal counsel within the scope of attorney-client privilege for assistance in reviewing those concerns and exploring options for correction or mitigation.
For More Information
If your organization would like to learn more about the concerns discussed in this update or seeks assistance auditing, updating, administering or defending its human resources, compensation, benefits, corporate ethics and compliance practices, or other performance related concerns, contact management attorney and consultant Cynthia Marcotte Stamer.
An attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization, Ms. Stamer is recognized for work helping organizations management people, operations and risk as a Fellow in the American College of Employee Benefit Counsel, a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Labor and Employment Law and Health Care Law; a “Best Lawyers” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law.”
For 35 years, Ms. Stamer’s work has focused on advising and assisting businesses and business leaders with these and other employment and other staffing, employee benefit, compensation, risk, performance and compliance management and other operational solutions and concerns. Her experience includes helping management both manage performance and manage legal risk and compliance. While helping businesses define and manage the conduct and performance of their employees, contractors and vendors, she also assists employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, leave, and other labor and employment laws, advises and defends businesses against labor and employment, employee benefit, compensation, fraud and other regulatory compliance and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor, Department of Justice, SEC, Federal Trade Commission, HUD, HHS, DOD, Departments of Insurance, and other federal and state regulators. Ms. Stamer also speaks, coaches management and publishes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see hereor contact Ms. Stamer directly.
Other Helpful Resources & Information
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The arrest and criminal charges against Dallas anesthesiologist Raynaldo Rivera Ortiz Jr. (“Dr. Ortiz”) announced September 15, 2022 highlight the advisability of health care facilities and providers to use care to use appropriate monitoring and other safeguards to protect patients and other critical operations against potential retaliatory misconduct during professional peer review or other investigation or discipline of health care professionals or other members of their workforces.
Dr. Ortiz was arrested in Plano, Texas on Wednesday, September 14, 2022 and is scheduled to make his initial court appearance on Friday, September 16, 2022 on federal felony criminal charges that he caused the death of a patient and surgical emergencies of other patients by intentionally tampering with a consumer product and intentional drug alteration.
According to the by Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, and U.S. Attorney for the Northern District of Texas Chad E. Meacham, Dr. Ortiz was arrested and charged via criminal complaint with tampering with a consumer product causing death and intentional drug adulteration.
According the criminal complaint, on June 21, 2022, a 55-year-old female coworker of Dr. Ortiz, experienced a medical emergency and died immediately after treating herself for dehydration using an IV bag of saline taken from a Baylor Scott & White operated surgical center. An autopsy report revealed that she died from a lethal dose of bupivacaine, a nerve blocking agent that is rarely abused but is often used during the administration of anesthesia.
Two months later, on August 24, 2022, an 18-year-old male patient experienced a cardiac emergency during a routine sinus surgery. The teen was intubated and transferred to a local ICU. Chemical analysis of the fluid from a saline bag used during his surgery revealed the presence of bupivacaine, epinephrine (a stimulant), and lidocaine, drugs that could have caused the patient’s sudden symptoms.
According to the complaint, surgical center personnel concluded that the incidents involving both patients suggested a pattern of intentional adulteration of IV bags used at the surgical center.
The surgical center personnel also identified 10 additional unexpected cardiac emergencies that occurred during otherwise unremarkable surgeries between May and August 2022, which the criminal complaint alleges is an exceptionally high rate of complications over such a short period of time. According to the criminal complaint, medical personnel in each of those additional 10 cases only were able to stabilize the patient through use of emergency measures. Most of the incidents occurred during longer surgeries that used more than one IV bag, including one or more bags retrieved mid-surgery from a stainless steel bag warmer.
Surveillance video from the center’s operating room hallway allegedly also shows Dr. Ortiz placing IV bags into the stainless-steel bag warmer shortly before other doctors’ patients experienced cardiac emergencies. The complaint alleges that in one instance captured in the surveillance video, agents observed Dr. Ortiz walk quickly from an operating room to the bag warmer, place a single IV bag inside, visually scan the empty hallway, and quickly walk away. Just over an hour later, according to the complaint, a 56-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure. The complaint also states that in another instance, agents observed Dr. Ortiz exit his operating room carrying an IV bag concealed in what appeared to be a paper folder, swap the bag with another bag from the warmer, and walk away. Roughly half an hour later, a 54-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure.
According to the complaint, none of the cardiac incidents occurred during Dr. Ortiz’s surgeries, and that the series of emergencies began just two days after Dr. Oritz was notified of a disciplinary inquiry stemming from an incident during which he allegedly “deviated from the standard of care” during an anesthesia procedure when a patient experienced a medical emergency. The complaint alleges that all of the incidents occurred around the time Dr. Ortiz performed services at the facility, and no incidents occurred while Dr. Ortiz was on vacation.
The complaint further alleges that Dr. Ortiz, who had a history of disciplinary actions against him, expressed concern to other physicians over the disciplinary action at the facility and complained the center was trying to “crucify” him. A nurse who worked on one of Dr. Ortiz’s surgeries allegedly told law enforcement that Dr. Ortiz refused to use an IV bag she retrieved from the warmer, physically waving the bag off.
“Our complaint alleges this defendant surreptitiously injected heart-stopping drugs into patient IV bags, decimating the Hippocratic oath,” said U.S. Attorney Chad E. Meacham in the Department of Justice announcement of the charges. The criminal charges stemmed from these findings.
The Justice Department announcement reminds readers that a criminal complaint is merely an allegation of criminal conduct, not evidence. Dr. Ortiz is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law. If convicted, however, Dr. Ortiz faces a maximum penalty of life in prison.
Both Dr. Ortiz and the surgical facility are exposed to potential liability as a result of the alleged charges. Aside from the pending criminal charges, Dr. Ortiz also almost certainly could face potential peer review and licensing board disciplinary investigation, as well as civil lawsuits.
In addition to these liability exposures for Dr. Ortiz, the surgical facility and other providers also could face civil or potentially even criminal liability.
It seems almost inevitable that the facility and potentially some other providers might be drawn into civil lawsuits brought by affected patients and their families allegedly injured or place at risk by the alleged actions by Dr. Ortiz, as well as licensing and/or accreditation investigation arising from the alleged events.
Because Dr. Ortez’s alleged Actions constitute federal felonies, the Federal Sentencing Guidelines sentencing and organizational liability rules apply. The Sentencing Guidelines will apply to determine the sentence imposed if Dr. Ortez ultimately is convicted. In addition, the Sentencing Guidelines organizational liability provisions also raise a risk of criminal charges against the facility or other parties with knowledge or other imputed responsibility. Under the organizational guidelines, organizations can have imputedliability for the criminal acts committed by the members of their workforce. However whether criminal charges will be pursued against the organization and the level of culpability and resulting liability is determined based upon both whether the organization took appropriate steps to prevent the misconduct before it happened and the extent to which the organization acted promptly in its investigation and redress of the conduct. The apparent actions of the surgical center and its leader ship to investigate, report, and cooperate in the investigation with federal officials are likely to mitigate if not resolve their criminal exposure.
Organizations and their leaders should treat the charges against Dr. Ortiz as a reminder, at minimum carefully to credential and monitor team members including doctors or other non-employer actors working in or with their facilities, to establish appropriate safeguards to prevent and identify quickly mistakes or intentional conduct, to monitor and enforce those safeguards, and to take appropriate prompt action to investigate concerns and redress and if necessary report misconduct with the advice of counsel.
When dealing with position performance and discipline concerns, facilities typically must carefully negotiate applicable contractual and workforce issues as well as the procedural and due process requirements of applicable medical staff bylaws and federal and state peer review and discipline statutes and regulations and medical staff discipline rules.
When a medical staff member protected by peer review or other procedural safeguards commits behaviors that raise a material and continuing threat to the health and safety of patients or the public, summary suspension may be necessary. When considering or taking an action to summarily suspend a healthcare provider, however, facilities and their medical staff leaders should document both the grounds for the patient safety concerns and need for immediate action and scrupulously follow the summary suspension procedures.
Along with seeking to prevent and mitigate these legal risks, Facilities and other providers also need to consider white reporting obligations they may bear under applicable statutes, regulations and contracts.
While managing these legal risks, facilities and other involved parties also need to anticipate media and public concern about the occurrences. Facilities and their leaders should anticipate and be prepared to work in conjunction with qualified legal counsel and experienced qualified public relations experts to decide when, what, and how to communicate with the public in the media about these types of events to avoid is there a bold minefield of traps created by privacy laws, evidentiary and other legal risk management concerns, and the management of relationships with other members of the medical staff and workforce, business partners, insurance, and the public.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns. 
Ms. Stamer’s work throughout her 35 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. In the course of this work, she has worked extensively on workforce and medical staff credentialing, management, investigation, peer review and discipline, and reporting and remediation of criminal or other activity to regulatory officials.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
As qualifying individuals and companies that purchased or received health insurance await instructions on how to claim their share of the $2.67 billion In re: Blue Cross Blue Shield Antitrust Litigation private federal class action civil antitrust lawsuit settlement (“Settlement”) finally approved August 9, 2022 against the Blue Cross Blue Shield Association (“BCBSA”) and other settling individual Blue Cross Plans, employers and other plan sponsors, health care systems and providers, health insurers, pharmacy benefit managers, brokerages, and other health and health insurance market participants need to keep in mind that the private antitrust judgements are not their only exposure under federal antitrust laws. Health insurance and health industry market participants that engage in anticompetitive conduct or business transactions also risk investigation and prosecution under federal antitrust laws by the U.S. Department of Justice, the Federal Trade Commission and state regulators or attorneys general.
Market participants and others with health or health insurance industry market competitiveness concerns or interests should register and attend the September 8, 2022 Justice Department Health Industry Antitrust Enforcement Update to learn about key federal antitrust statutes regulating or prohibiting anticompetitive conduct and business transactions and hear how the Department of Justice uses these laws to promote market competition in the health care and health insurance marketplaces.
Hosted by the American Bar Association Joint Committee on Employee Benefits, the webinar will feature a discussion by U.S. Department of Justice Civil Division Healthcare and Consumer Products Section Antitrust Attorney Natalie Melada of basic federal antitrust rules and principles the Justice Department relies upon to safeguard market competitiveness and discusses selected Justice Department antitrust litigation and other compliance and enforcement initiatives the Department of Justice has undertaken to protect competition in the healthcare industry. Attorney and Solutions Law Press, Inc. editor and author Cynthia Marcotte Stamer also will provide an update on the In re: Blue Cross Blue Shield Antitrust Litigation and resulting $2.67 billion settlement approved August 9.
For more details and to register for the program, see here.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
A Massachusetts dermatology practice’s Health Insurance Portability & Accountability Act (“HIPAA”) $300,000 plus settlement with the Department of Health & Human Services Office for Civil Rights (OCR) reminds health care providers, health plans, health care clearinghouses and their business associates (“Covered Entities”) to use proper practices and safeguards when disposing of protected health information (“PHI”).
Following up on other OCR enforcement involving improper protection and disposal of paper and electronic PHI, the settlement with New England Dermatology P.C., d/b/a New England Dermatology and Laser Center (“NDELC”) OCR announced today (August 23, 2022) resolves charges that NDELC violated the HIPAA Privacy Rules when it placed specimen containers with patient identifying PHI in its parking lot garbage bin.
OCR interprets HIPAA as requiring Covered Entities to appropriate steps to ensure that safeguards are in place when disposing of patient information to keep it from being accessible by the public. ”Improper disposal of protected health information creates an unnecessary risk to patient privacy,” said Acting OCR Director Melanie Fontes Rainer.
On May 11, 2021, NEDLC filed a breach report with OCR that reported empty specimen containers with the PHI on labels were placed in a garbage bin in their parking lot. The containers’ labels included patient names and dates of birth, dates of sample collection, and name of the provider who took the specimen. On March 31, 2021, a third-party security guard found one specimen container bearing a label containing patient names, dates of birth, dates of sample collection, and name of the provider who took the specimen. During the investigation, NEDLC stated that from February 4, 2011 until March 31, 2021, it regularly discarded specimen containers with an attached label that contained PHI as regular waste, bagged and placed in an exterior dumpster accessible via the parking lot, without alteration to the PHI containing label.
OCR’s New England Regional Office found the practice of disposing of specimen containers with their labels containing PHI violated the HIPAA Privacy Rule including the impermissible use and disclosure of PHI and failure to maintain appropriate safeguards to protect the privacy of PHI.
Under the NEDLC Resolution Agreement negotiated to settle the alleged violations, NEDLC paid $300,640 to OCR and agreed to implement a “robust” corrective action plan that includes two years of OCR monitoring. Among other things, the corrective action plan requires NEDLC to:
Within 60 days, develop, maintain, and revise, as needed and present for OCR review its written policies and procedures to comply with the physical safeguard and disposal of PHI created, received or maintained by or on behalf of NEDLC and all other HIPAA Privacy, Security and Breach Notification and training protocols to ensure workforce member compliance with these policies; and sanctions for workforce members violating these requirements;
Implement the updated policies and procedures within 30 days of receipt of HHS approval;
Distribute the policies to existing members of its workforce within 30 days of receipt of HHS approval of the policies and subsequently to new members of the workforce within 30 days of their beginning of service and obtain a signed written or electronic initial compliance certification from all members of the workforce and relevant business associates stating that the workforce members have read, understand, and shall abide by such policies and procedures;
Assess, update, and revise, as necessary, the policies and procedures at least annually or as needed, provide the revised policies and procedures to HHS for review and approval, and redistribute to and obtained new compliance certifications from workforce members and business associates within 30 days of HHS approval;
If it receives information during the Compliance Term that a workforce member or business associate may have failed to comply with its policies and procedures for safeguarding PHI, promptly investigate and it the investigation finds a violation, notify HHS within 30 days of the violation and corrective action taken;
Comply with specified breach investigation and notification requirements;
Provide reports certified by a designated leader of the organization its implementation of the corrective action plan, annually and upon the occurrence of certain other events during the two-year monitoring period.
The NEDLC Resolution Agreement is not the first time OCR has nailed a Covered Entity for improper disposal of PHI. In 2015 Cornell Prescription Pharmacy paid OCR $125,000 and implemented a correction action plan to correct alleged HIPAA violations after an OCR investigation of a local news report confirmed unsecured paper documents containing PHI of more than 1600 patients were disposed of in an unlocked, open container on Cornell’s premises. The documents were not shredded and contained identifiable information regarding specific patients. See Cornell Prescription Pharmacy Resolution Agreement. See also $800,000 HIPAA Settlement in Medical Records Dumping Case.
To reduce their own exposure to potential HIPAA liability arising from improper disposal of PHI, covered entities should evaluate the adequacy of the PHI handling, security and disposal policies, procedures, training and compliance for potential weaknesses and take appropriate, timely documented corrective action to tighten their compliance with OCR’s regulations, OCR’s Frequently Asked Questions About the Disposal and other OCR enforcement actions and guidance on PHI disposal.
Since these evaluations could uncover past or ongoing compliance concerns, Covered Entities and business associates should consider engaging legal counsel experienced with HIPAA compliance to advise and aid the Covered Entity to structure, conduct, evaluate findings and determine and implement any corrective actions that the review reveals as required or advisable within the scope of attorney client privilege.
Effective protection and disposal of PHI requires that Covered Entities recognize and keep track of all PHI in the various phases of its lifecycle in the organization including when it is being disposed or or migrating through various systems. Sanctions for disposal of specimen bottles containing PHI labels should raise the need for awareness of disposal practices for other patient labeled items including identification bracelets, medication containers and labels, meal trays and the plethora of other items containing patient specific information. PHI disposal issues also can arise out of the disposal of files, storage containers, computers, copiers or other devices. For instance, under the Affinity Health Plan, Inc. Resolution Agreement, Affinity Health paid OCR $1,215,780 to settle potential HIPAA Civil Monetary Sanctions after OCR found it exposed the PHI of up to 344,579 individuals by returning photocopiers to a leasing agent without erasing the data contained on the copier hard drives.
Because HIPAA obligations continue even when a Covered Entity or business associate goes out of business, Covered Entities also need to take appropriate steps to provide for ongoing management, protection and disposal of PHI when they or a business associate ceases business. Thus, in the FileFax Resolution Agreement, for instance the receiver appointed to liquidate the assets of Filefax, Inc. agreed to pay $ 100,000 out of the receivership estate to OCR to settle potential HIPAA violations after Filefax shut its doors during the course of OCR’s investigation into alleged HIPAA violations.
Covered Entities must understand that these responsibilities generally cannot be met merely through adoption of a standard set of policies and procedures from a third-party. The HIPAA Privacy Rule requires all Covered Entities to prepare and document risk assessments and develop and enforce appropriate privacy and security policies and procedures. Security and disposal practices and procedures are among the elements of HIPAA compliance that OCR expects Covered Entities to address in the documented risk assessments the regulations require Covered Entities to prepare and maintain. See $750,000 HIPAA Settlement Underscores the Need for Organization Wide Risk Analysis. As with other HIPAA compliance responsibilities, OCR regulations require that Covered Entities include their documented assessment and decision-making about the adequacy and reasonableness of their PHI protection and destruction practices under HIPAA as part of their overall HIPAA risk assessment plan and practices.
While OCR guidance provides some examples of several practices that a Covered Entity might use that could or could not meet the destruction standards, these examples are not safe harbors. The regulations and guidance expect Covered Entities to conduct a documented review and assessment “of their own circumstances to determine what steps are reasonable to safeguard PHI through disposal and develop and implement policies and procedures to carry out those steps.” OCR guidance directs that Covered Entities should assess potential risks to patient privacy, as well as consider such issues as the form, type, and amount of PHI to be disposed. Covered entities are responsible for conducting and documenting their analysis as well as their adoption, implementation and enforcement of the resulting policies and procedures.
If circumstances come to light that indicate a breach of the standards in the course of the disposal compliance assessment or otherwise, Covered Entities also promptly should work with legal counsel timely to investigate, determine and provide any required notifications or other corrective action and document their actions to meet applicable HIPAA and other legal obligations and mitigate liability.
Of course, Covered Entities and their leaders always must keep in mind that their responsibilities and potential liability for mishandling PHI could extend well beyond HIPAA. In addition to the civil monetary penalties HIPAA authorizes, mishandling the collection, protection or disposal of PHI or other sensitive data also can trigger other legal exposures. For instance, as HIPAA compliance is part of the Conditions of Participation that Medicare participating Covered Entities and Medicare Advantage Plans must meet to qualify for program participation, noncompliance could trigger program exclusion, False Claims Act or related exposures. Deficiencies in security or destruction of credit card, banking or other PHI that also qualifies as personal financial information could trigger exposure under Federal Trade Commission, state identity theft and privacy or other laws. Public companies and their leaders also may need to evaluate if deficiencies in their security or destruction protocols trigger investor disclosure obligations under Securities and Exchange Commission rules or other federal or state laws. Considering these and other exposures, documented, compliance and defensibility of PHI and other sensitive information use, protection, disclosure and destruction should rank high among the priorities of all Covered Entities and their leaders.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
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NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
As Americans prepare to celebrate the July 4th holiday, CISA, the Federal Bureau of Investigation (FBI), the Department of the Treasury (Treasury), and the Financial Crimes Enforcement Network (FinCEN) are warning of a cyber threat for Remote Desktop users. Health care, health plan, healthcare clearing houses, their business associates and other security sensitive organizations using remote access technology should perform and document their risk assessment and any corrective actions taken as part of their continuing Health Insurance Portability and Accountability Act (“HIPAA”), Fair and Accurate Credit Transactioms Act (FACTA”), government contracting, securities law, and other data security compliance.
The joint Cybersecurity Advisory (CSA), #StopRansomware: MedusaLocker, published July 1 alerts of the risk of MedusaLocker ransomware. MedusaLocker actors target vulnerabilities in Remote Desktop Protocol (RDP) to access victims’ networks.
CISA, FBI, Treasury and FinCEN are encouraging network defenders to examine their current cybersecurity posture and apply the recommended mitigations in this joint CSA, which include:
Train users to recognize and report phishing attempts.
Enable and enforce multifactor authentication.
When assessing Remote Desktop protocol risks, covered entities, business associates and other security concerned organizations also should examine their exposures to other vulnerabilities.
A key resource for monitoring some of these vulnerabilities is the CISA Known Exploited Vulnerabilities Catalog, which lists exposures based on evidence of active exploitation. These types of vulnerabilities are a frequent attack vector for malicious cyber actors and pose significant risk federal enterprises. CISA strongly urges all organizations to reduce their exposure to cyberattacks by prioritizing timely remediation of Catalog vulnerabilities as part of their vulnerability management practice. CISA will continue to add vulnerabilities to the Catalog that meet the specified criteria.
The Department of Health & Human Services Office of Civil Rights (‘“OCR”) guidance and enforcement makes clear covered entities and business associates must monitor and take appropriate actions to update their security in response to emerging cyber security threats.
Along with monitoring and responding to this and other security threats, covered entities also should add reviewing and updating their HI-AA practices in response to new guidance OCR issued this week in response to the Supreme Court Dobbs vs. Jackson Women’s Health Organization abortion ruling. The HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care guidance generally addresses when the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule restricts or allows individuals’ private medical information (known as “protected health information” or “PHI”) relating to abortion and other sexual and reproductive health care. For more details, see here.
Beyond HIPAA, malware and other data or system security breaches and susceptibilities can create liability risks under tax, securities, government contracting, FACTA and a wide range of federal and state laws. For instance, with cybersecurity threats and compliance concerns growing, the SEC is prioritizing cybersecurity regulation, investigation and enforcement against public companies and other market participants for lack cybersecurity governance, safeguards or disclosures. See e.g., SEC Office of Compliance Inspections and Examinations Cybersecurity and Resiliency Observations. Along announcing its commitment to hold market involved and impacting regulated entities accountable for failing to maintain and enforce appropriate internal and external controls to prevent, detect and redress cybersecurity threats, including appropriate board governance and risk management, access rights and controls, data loss prevention, mobile security, incident response and resiliency, vendor management, training and awareness, investor disclosures and other practices.
Healthcare providers and other covered entities, their business associates and others with data security responsibilities or sensitivities should respond promptly and carefully document their risk analysis and response in response to these emerging concerns.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
The Department of Justice sent another strong warning to physicians and other health care provides not to violate the False Claims Act by making improper patient referrals in violation of the Anti-Kickback Statute and the Stark Law, billing federal health care programs for medically unnecessary laboratory testing or other services or both when charged six Texas physicians with federal health care fraud this week. The prosecution of the physicians for laboratory tests arranged and billed through management services organizations also reminds physicians and other providers that reliance upon management services or other third-party service providers generally does not protect a physician participating in prohibited laboratory or other testing, durable medical equipment, facility, physical therapy or other health care billing or referral arrangements from liability.
Charges Against Texas Physicians
This week, the Justice Department added the following six physicians as defendants to criminal charges filed in a False Claims Act complaint filed in January 2022 against former True Health Diagnostics LLC (THD) CEO Christopher Grottenthaler, former Boston Heart Diagnostics Corporation (BHD) CEO Susan Hertzberg, former LRH CEO Jeffrey Madison, and others:
Doyce Cartrett, Jr., M.D., of Silsbee, Texas, allegedly received over $320,000 from LRH and two management services organizations or “MSOs,” Ascend MSO of TX LLC (Ascend) and Eridanus MG LLC (Eridanus), in return for his referrals.
Elizabeth Seymour, M.D., of Corinth, Texas, allegedly received over $280,000 from two MSOs, Ascend and Eridanus, in return for her referrals.
Emanuel Paul “E.P.” Descant, II, M.D., of Spring, Texas, allegedly received over $125,000 from two MSOs, North Houston MSO and Tomball Medical Management Inc., in return for his referrals.
Frederick Brown, M.D., of Missouri City, Texas, allegedly received over $190,000 from two MSOs, Ascend and Indus MG LLC (Indus), in return for his referrals.
Heriberto Salinas, M.D., of Cleburne, Texas, allegedly received over $75,000 from two MSOs, Ascend and Herculis MG LLC (Herculis), in return for his referrals.
Hong Davis, M.D., of Lewisville, Texas, allegedly received over $70,000 from two MSOs, Ascend and Herculis, in return for her referrals.
The complaint in United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.) charges that small Texas hospitals including Rockdale Hospital dba Little River Healthcare (LRH), THD, BHD, the six physicians and others conspired to pay physicians to induce referrals to the hospitals for laboratory testing performed by THD or BHD. The charges stem from allegations made under the qui tam or whistleblower provisions of the False Claims Act by STF LLC by Felice Gersh, M.D. and Chris Riedel. The United States intervened in the qui tam action in December 2021.
The complaint alleges the charged hospitals paid a portion of their laboratory profits to recruiters, who in turn kicked back those funds to the referring physicians through MSOs allegedly set up by the recruiters to make payments to referring physicians. The Justice Department charges the alleged kickbacks were disguised as investment returns but actually were based on, and offered in exchange for, the physicians’ referrals. The complaint alleges that laboratory tests resulting from this referral scheme were billed to various federal health care programs, and that the claims not only were tainted by improper inducements but, in many cases, also involved tests that were not reasonable and necessary.
The Justice Department reports that before adding charges against the six physicians to the complaint this week, the Justice Department recovered more than $31 million relating to conduct involving BHD, THD and LRH, including False Claims Act settlements with 29 physicians, two health care executives and a laboratory company.
Health Care Fraud Liability Under False Claims Act, Anti-Kickback Statute, Stark Law
The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally-funded programs. The Stark Law forbids a hospital or laboratory from billing Medicare for certain services referred by physicians that have a financial relationship with the hospital or laboratory. The Anti-Kickback Statute and the Stark Law seek to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients.
The False Claims Act prohibits health care providers from billing federal health care programs for services resulting from referrals prohibited by the Anti-Kickback Statute or the Stark law.
Under the False Claims Act, a private party can file an action on behalf of the United States and receive a portion of the recovery. The False Claims Act also allows the Justice Department to intervene in such lawsuits and add claims and defendants, as happened in this litigation. The qui tam case is captioned United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.). If a defendant is found liable for violating the act, the United States may recover three times the amount of its losses plus applicable penalties.
The United States’ pursuit of this lawsuit illustrates the government’s emphasis on combating health care fraud generally with a special emphasis on physicians. For instance, U.S. Attorney Brit Featherston is quoted as saying, “Schemes that funnel health care referrals do not work without the participation of physicians. … They are not merely passive players in these elaborate schemes, but an integral part, without which the scheme could not exist. Our office is committed to rooting out health care fraud by pursuing all players involved the scheme, from the laboratories and their leaders to the marketers and the physicians who make it all possible. Naming these physicians in the complaint is evidence of that commitment.”
Given this clear warning, physicians and other prescribers, as well as recruiting, billing and management services organizations, laboratories and others involved in recruiting and marketing, providing or billing for laboratory or other services to double check the appropriateness of their referral and other practices keeping in mind that the Anti-Kickback Statute and Stark Law prohibitions against direct and indirect compensation can reach to a wide range of subtle value and benefits in addition to the obvious payment of cash or gifts delivered in a multitude of ways. The prosecution of these physicians for referrals made and compensation delivered under management services contracts also clearly warns physicians and other providers against expecting their reliance upon billing, management services or other staff or management service providers to shield them from liability if an improper referral or payment happens.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Today’s Supreme Court ruling that emotional distress damages are not recoverable in a private action to enforce the disability discrimination and accommodation requirements of either the Rehabilitation Act of 1973 (“Rehab Act”) or the Patient Protection and Affordable Care Act (“ACA”) prevents health care and other businesses subject to these requirements against the risk of large emotional injury awards in private actions for discrimination based on these laws. However, health care providers and other organizations subject to these requirements should use care to maintain compliance to avoid large actual damage awards to plaintiffs bringing private lawsuits, program exclusion, penalties or other governmental sanctions or both.
Cummings Supreme Court Ruling
The May 1, 2022 United States Supreme Court ruling in Cummings v. Premier Rehab Keller authored by Supreme Court Justice John Roberts resulted from a suit that sought emotional distress damages brought by filed by a deaf and legally blind woman, Jane Cummings against Premier Rehab Keller after it denied her request that it provide an American Sign Language interpreter at her physical therapy sessions. Premier Rehab told Cummings the therapist could communicate with her through other means, Claiming Premier Rehab’s failure to provide an ASL interpreter constituted discrimination on the basis of disability in violation of the Rehab Act and Section 1557 of the ACA, Cummings sued Premier Rehab seeking various damages and other relief, including emotional distress damages.
The Supreme Court took notice that Premier Rehab was subject to these laws because its receipt of Medicare and Medicaid payments qualified as federal financial assistance triggering their applicability.
The Supreme Court affirmed the previous District Court and Fifth Circuit Court of Appeals’ rulings that emotional distress damages are not recoverable in a private action to enforce either the Rehab Act or the ACA.
The Supreme Court Majority based its decision on its finding that the Rehab Act and Act both are spending statutes that condition their offer of federal funding on a promise by the recipient not to discriminate creating what amounts essentially to a contract between the Government and the recipient of funds. Following previously established Supreme Court precedent for “private spending clause actions,” the Court ruled the emotional distress or other remedy is not available unless “the funding recipient is on notice that by accepting federal funding, it exposes itself to liability of that nature.”
To decide whether emotional distress damages are available under the Spending Clause statutes in this case, the Court therefore asked if a prospective funding recipient deciding whether to accept federal funds would have had “clear notice” regarding that liability. Because the two statutes are silent on the availability of emotional injury damages, the Supreme Court followed prior precedent by looking to whether the emotional damages sought by Cummings were the type of damages traditionally available in suits for breach of contract so as to put Premier Rehab and other defendants on notice of their exposure to such damages from actions under the Rehab Act or ACA. While acknowledging some exceptional circumstances where punitive damages may be recovered where “the conduct constituting the breach is also a tort for which punitive damages are recoverable,” the Court found such damages “are generally not available for breach of contract.” Concluding that the recognized exception to the general rule was insufficient to give funding recipients the requisite notice that they could face such damages. the Supreme Court ruled that funding recipients under the Rehab Act and the ACA “have not, merely by accepting funds, implicitly consented to liability for punitive damages.”
To read the full Majority opinion and related consenting and dissenting opinions, see here.
While the Supreme Court’s ruling means private litigants cannot recover emotional injury damages in discrimination actions brought to enforce the Rehabilitation Act or the ACA, health industry and other organizations remain subject to other substantial liability risks for improper discrimination in violation of those laws. Beyond recoveries for actual damages, attorneys’ fees and costs recoverable by private litigants, covered organizations also can face substantial civil monetary penalties, program disqualification, in some instances even False Claims Act liability for billing in violation of program conditions of participation and other risks. As federal agencies continue to make enforcement of these sanctions a priority, organization covered by either of these laws should use care to maintain appropriate compliance and risk management to ensure their ability to defend against any potential charges.
HHS’ guidance announcements all include a warning like the one from OCR Director Lisa J. Pino in the February 4, 2022 announcment that “OCR will continue our robust enforcement of federal civil rights laws that protect people with disabilities from discrimination, including when Crisis Standards of Care are in effect.”
These OCR guidance and enforcement actions and similar activities by other federal agencies send a strong message that OCR and other federal agencies will continue and expand their zealous investigation and enforcement of disability and other violations by health care providers and other public and private organizations covered by the Rehabilitation Act, the ACA or other federal discrimination and civil rights laws. Health care providers and others regulated by these federal discrimination laws should consider auditing the adequacy of existing practices, reaffirming their own and their business partners’ compliance, retraining workforce and taking other appropriate steps to help prevent illegal discrimination within their organization and to position their organization to respond and defend against potential discrimination investigations or charges.
For Additional Information Or Assistance
If you need have questions or need assistance with health, health or other insurance, employee benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help. Longtime scribe for the American Bar Association Joint Committee on Employee Benefits agency meeting with OCR and author of leading publications on HIPAA and other privacy and data security concerns, Ms. Stamer regularly assists clients and provides input to Congress, OCR and other agencies, publishes and speaks extensively on medical and other privacy and cybersecurity, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.
Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications. She also is a highly-sought out speaker on privacy and data security who serves on the planning faculty and speaks for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters, e-mail Ms. Stamer or call (214) 452-8297.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
Important Information About This Communication
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Physicians and other health care prescribers must remain hyper vigilant when prescribing, documenting, billing and managing opiate and other pain management prescriptions and patients. That’s the clear message sent by the ever-growing wave of federal prosecutions and convictions like the March 2, 2022 federal conviction of Tennessee physician Mark Murphy and his wife, Jennifer Murphy and his wife for unlawfully distributing opioids, providing unnecessary services and defrauding insurers from their now-shuttered North Alabama Pain Services clinics (“NAPS”) and March 1, 2022 sentencing of former physician Patrick Titus to 20 years in prison for his conviction of unlawful distribution of opioid drug outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice.
Tennessee Doctor & Wife Convicted of Pain Management Related Unlawful Opioid Distribution, Health Care Fraud & Other Criminal Charges
The March 2 federal jury conviction of Dr. and Ms. Murphy stemmed from their ownership and operation of their now-defunct pain management clinics resulted from evidence gathered through a joint investigation by the Federal Bureau of Investigation, the Department of Health & Human Services Office of Inspector General, the Internal Revenue Service, and the Drug Enforcement Agency.
During the resulting jury trial, federal prosecutors presented evidence that during the five-year period leading up to the clinic closing its Alabama locations in 2017, Dr. Murphy and Ms. Murphy, who was the office manager, caused over $50 million in fraudulent or unnecessary medical services to be charged to Medicare, TRICARE, Blue Cross Blue Shield of Alabama and others. Evidence at trial showed that NAPS provided pre-signed prescriptions to thousands of patients a month, including prescriptions written outside the usual course of professional practice without a legitimate medical purpose. Federal prosecutors also introduced evidence that the Murphys also solicited and received unlawful payments for referring fraudulent or unnecessary services to patients.
Based on the evidence, the jury found both Dr. and Ms. Murphy guilty on numerous criminal charges including:
Conspiracy to unlawfully distribute and unlawful distribution of controlled substances;
Conspiracy to commit and commission of health care fraud;
Conspiracy to defraud the United States; and
Receiving illegal kickbacks in violation of the Anti-Kickback Statute.
Ms. Murphy also was convicted of tax-related charges for underreporting clinic income.
Currently scheduled for sentencing in June, the Murphys each face a maximum of 20 years in prison for the drug charges and a maximum of 10 years in prison for the health care fraud charges. Both defendants also face a maximum of five years in prison for charges stemming from violations of the Anti-Kickback Statute, and Ms. Murphy faces up to three years in prison for the tax charges.
Former Delaware Doctor Sentenced to 20 Years in Prison for Unlawful Opioid Distribution
The Murphy’s jury conviction came one day after the sentencing of former to 20 years in prison for his July 2021 federal jury conviction on 13 counts of unlawfully distributing and dispensing controlled substances and one count of maintaining a drug-involved premises.
Federal prosecutors presented evidence in court documents and trial that Dr. Titus unlawfully distributed or dispensed opioid drugs including fentanyl, morphine, methadone, OxyContin and oxycodone outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice. The Justice Department charged Dr. Titus frequently prescribed these dangerous controlled substances in high dosages, sometimes in combination with each other or in other dangerous combinations, mostly in exchange for cash. Evidence at trial showed he distributed over 1 million opioid pills without providing any meaningful medical care and to patients he knew were suffering from substance use disorder and/or who demonstrated clear signs that the prescribed drugs were being abused, diverted or sold on the street.
Health Care Fraud Task Force Targeting Opioid Distribution, Billing, & Related Misconduct
Both the Murphy and Titus prosecutions and convictions are two of a growing series of convictions resulted from investigations into opioid and other pain management prescribing conducted as part of efforts targeting physicians and other health care providers involved in prohibited the federal Health Care Fraud Strike Force Program. See e.g., Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme.
The Federal agencies made a point of warning to other physicians not to overprescribe, bill or engage in other prohibited dealings involving opioids or other controlled substances when announcing the Titus sentencing.
“As we continue the fight against the opioid crisis, this case serves as an important reminder that health care professionals have a duty to prescribe medication responsibly to ensure the well-being of individuals under their care. Failing to do so can endanger patients and undermines critical, ongoing public health measures,” said Special Agent in Charge Maureen Dixon of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG will continue to work with our law enforcement partners to hold bad actors accountable.”
“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’ care for their own profit.”
“DEA-registered medical practitioners have an important role in our communities to treat patients compassionately and responsibly,” said DEA Administrator Anne Milgram. “Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable.”
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
CMS recently updated its Nursing Home Resource Centerwith new pieces of informational guidance on visitation and vaccines in response to the recent surge in Omicron cases.
Visitation
As of January 6, CMS updated the Nursing Home Visitation FAQs (PDF) to give additional guidance about visitation during the Omicron surge and also created an infographic (PDF) to graphically represent how to safely conduct visits to nursing homes during this time of spiking COVID cases around the country. Nursing home providers, patients, caregivers, and CMS partners can use these 2 new resources to stay informed about CMS’ latest thinking for keeping nursing homes safe in the current COVID climate.
CMS also continues to urge long-term care settings, like nursing homes, assisted living, residential care communities, group homes, and senior housing, to ensure residents and staff get COVID-19 vaccine primary series and booster shots.
Vaccination
while long-term care and other Medicare and Medicaid participating healthcare providers continue to await the Supreme Court’s decision on the enforceability and validity of the Biden administration vaccine mandate for program participation, CMS continues to urge long-term care providers to coordinate access to COVID-19 vaccines, either in the local community or on-site using the newest CDC resources.
As a reminder, through enforcement discretion, CMS allows Medicare-enrolled immunizers, including but not limited to pharmacies working with the U.S., to bill directly and get direct reimbursement from the Medicare program for vaccinating Medicare skilled nursing facility residents. See, Medicare billing and payment information.
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of a multitude of health industry and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Federal health care fraud prosecution continues to thrive despite the ongoing COVID-19 health care emergency.
Recently announced prosecutions and other enforcement actions include Fraud & Abuse, False Claims Act and other health care fraud prosecutions commonly pursued by the Justice Department in recent decades as well as a host of new prosecutions of abuses of Covid-19 relief programs. Examples include:
These and other actions send a clear message to health care and life science organizations to continue vigorous health care fraud compliance and risk management activities as well as stay vigilant for signs of new audit and enforcement activities.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of a multitude of health industry and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
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Learn more about recent changes to the Center for Medicare & Medicaid Services (“CMS”) Quality Measurement and Value-Based Incentives Group (“QMVIG”) quality initiatives during its upcoming Bi-Monthly Forum on Tuesday, September 28 from 1:30 – 2:30 p.m. ET.
During this webinar, CMS says attendees will learn about and have opportunities to ask CMS questions about quality reporting programs and initiatives that directly impact their organizations.
CMS says forum will include updates on the following topics:
Medicare Promoting Interoperability Program
Electronic Clinical Quality Improvement (eCQI) Resource Center
Clinical Quality Language Libraries
Annual Change Review Process
Quality Payment Program (QPP)
Alternative Payment Models (APMs) and the APM Performance Pathway
CMS requires persons desiring to participate to register using the filling link and information:
If you have questions regarding registration, want to receive future communications regarding the forum, email CMS at CMSQualityTeam@ketchum.com.
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Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
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Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
This article is republished by permission of the author, Cynthia Marcotte Stamer. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns.
All Medicare and Medicaid certified health care facilities, and a broad range of other employers must prepare to meet impending new federal COVID-19 vaccine mandates announced by the Biden-Harris Administration today.
According to today’s announcements all healthcare facilities participating in Medicare or Medicaid or employing 100 or more employees will be required to ensure all staff are vaccinated against COVID-19.
The Biden-Harris Administration says the new health industry COVID-19 vaccine mandates will be implemented through emergency regulations to be issued in October.
According to today’s announcement, the Centers for Medicare & Medicaid Service (“CMS”) in collaboration with the Centers for Disease Control (“CDC”) is developing an Interim Final Rule with Comment Period that will be issued in October that will extend vaccine mandates originally announced last month for all Medicare and Medicaid participating nursing home workers to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. See CMS/CDC Mandating COVID Vaccination For All Nursing Home Staff.
The announcement of the vaccine mandates for healthcare workers coincides with the Biden-Harris Administration’s announcement of sweeping new vaccine mandates for all government workers, government contractors and employers employing more than 100 employees.
The two mandates will force most health care facilities to impose mask mandates for all staff in order to meet the requirement all staff be vaccinated.
CMS and CDC say the decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19. They claim the action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities.
According to the CDC, nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant.
In it’s announcement of the impending vaccination requirements, CDC urged health care facilities to prepare now to meet the new mandate in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements.
CDC also urged any health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately and facilities to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.
While legal challenges to the mandate requirements are likely, most facilities that have not already adopted vaccine mandates are expected to adopt these mandates rather than risk losing eligibility for Medicare and Medicaid reimbursement and other sanctions.
Beyondprogram disqualification and attendant financial pressures, announcement of the new vaccine mandates adds vaccination to the list of safety safeguards that healthcare facilities as employers can expect to be required to enforce as part of the occupational safety rules of the Occupational Safety and Health Administration (”OSHA”).
OSHA already is sanctioning employers for violating COVID-19 related OSHA requirements. For instance, OSHA nailed Lakewood Resource and Referral Center Inc., dba Center for Education Medicine and Dentistry (CHEMED) with heavy fines for allegedly violating applicable COVID-19 safety guidelines in January, 2021.
In a July 23, 2021 citation letter, OSH proposes to fine CHEMED $273,064.00 for willfully violating OSHA by not providing a medical evaluation to determine each employee’s ability to use a N95 respirator, before the employee was fit tested or required to use the respirator in the workplace to protect against SARS-CoV-2 virus while testing suspected COVID-19 individuals.
In addition to the proposed fine, the citation also orders CHEMED to take a series of corrective actions and to post notices in the workplace informing workers of the violation.
Along with the CHEMED citation, OSH also cited a staffing agency contracted to provide nursing staffing to CHEMED, Homecare Therapies for also failing to conduct medical evaluations and fit tests. It received two violations and a proposed fine of $13,653.
In the face of these potential consequences, most covered health care facilities and other employers impacted by the mandate are likely to implement mandates unless and until these requirements are struct down by the courts or withdrawn.
Assuming the Administration follows appropriate procedures to adopt the rules, most legal commentators do not expect the legal challenges opposing the mandate orders to be successful in the courts particularly after the Supreme Court refused to overturn or hear arguments for overturning a unanimous decision of a three-judge panel of the United States Court of Appeals for the Seventh Circuit in Klassen v. Trustees of Indiana University that refused to enjoin a vaccine mandate imposed by Indiana University as a condition of student or staff in person participation in classes or other activities.
While most healthcare and other covered businesses are not expected to challenge the rules, compliance us likely to trigger backlash from some unvaccinated workers strongly opposed to becoming vaccinated. Employers may find that some employees will resign their employment or take other tactics to avoid becoming vaccinated. Even those who elect to become vaccinated to retain their employment are likely to express opposition and dissatisfaction that could create liability exposures for the employers if it becomes a basis for retaliation claim.
Employers in Texas and certain other states that have adopted rules restricting or prohibiting vaccine, mask or other mandates also may face challenges based on the state rules.
In light of these and other uncertainties and challenges, Healthcare and Other or Employers generally should seek legal advice and assistance from legal counsel experienced with the relevant health care, labor and employment, privacy and other concerns.
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This article is republished by permission of the author, Cynthia Marcotte Stamer. To review the original work, see here.
Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending, and training domestic and international public and private business, charitable, community and governmental organizations and their leaders, employers, employee benefit plans, their fiduciaries and service providers, insurers, and others has published and spoken extensively on these concerns. As part of these involvements, she has worked, published and spoken extensively on these and other human resources, employee benefits, compensation, worker classification and other workforce and other services; insurance; health care; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other performance, risk management, compliance, public policy and regulatory affairs, and other operational concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns.
The Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC), announced today plans to mandate COVID-19 vaccination for all Medicare and Medicaid-participating nursing home staff.
The joint announcement released today states the agencies are developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare and Medicaid-participating nursing homes.
The agencies view the new requirement as a key component of protecting the health and safety of nursing home residents and staff.
Today’s action is in keeping with CMS’s authority to establish requirements to ensure the health and safety of individuals receiving care from all providers and suppliers participating in the Medicare and Medicaid programs. About 62% of nursing home staff are currently vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%. The emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States with the lowest staff vaccination rates.
In May, the Agency issued new regulations that require Long-Term Care (LTC) facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to educate residents, clients, and staff about COVID-19 vaccination and, when available, offer a COVID-19 vaccine to these individuals. These regulations also mandate that LTC facilities report weekly COVID-19 vaccination data for residents and staff to the CDC’s National Healthcare Safety Network (NHSN).
Today’s announcement states the agencies will continue to analyze vaccination data for residents and staff from the CDC’s National Healthcare Safety Network (NHSN) data as an additional method of compliance monitoring and in keeping with current practice, as well as deploy the Quality Improvement Organizations (QIOs)—operated under the Medicare Quality Improvement Program—to educate and engage nursing homes with low rates of vaccinations.
Meanwhile, the announcement strongly encourages nursing home residents and staff members to get vaccinated as the Agency undergoes the necessary steps in the rule-making process over the course of the next several weeks. CMS expects nursing home operators to act in the best interest of residents and their staff by complying with these new rules, which the Agency expects to issue in September.
According to today’s announcement, CMS also expects nursing home operators to use all available resources to support employees in getting vaccinated, including employee education and vaccination clinics, as they work to meet this staff vaccination requirement.
More Information
This article is republished by permission of the author, Cynthia Marcotte Stamer. To review the original work, see here.
Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns.
The Centers for Disease Control and Prevention (CDC) is exempting unaccompanied noncitizen children (UC) from the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on October 13, 2020 (October Order).
The Order published here in today’s Federal Register, took effect on July 16.
In the Order CDC finds “appropriate infrastructure in place to protect the children, caregivers, and local communities from elevated risk of COVID–19 transmission as a result of the introduction of UCs, and U.S. healthcare resources are not significantly impacted by providing UC necessary care. CDC adopted these findings despite its simultaneous alerts to schools and the public generally about the need for tighter protocols to protect children given rising infection rates among children and teens. See here. The Order highlights the challenges the Biden Administration immigration policy creates for CDC COVID containment.
CDC believes the COVID–19-related public health concerns associated with UC introduction can be adequately addressed without the UC being subject to the October Order, thereby permitting the government to better address the humanitarian challenges for these children.
Based on these findings, CDC is fully excepting UC from the October Order, and the Notice regarding the temporary exception of UC published February 17, 2021 is hereby superseded.
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If you are interested in a more detailed description of this or other developments discussed in this article, see here.
If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Responding to the July 2, announcement by IT software management company Kaseya VSA an that a supply-chain ransomware attack leveraged a vulnerability in the Kaseya RMM Tool against multiple managed service providers (MSPs) and their customers, the Office of Civil Rights (“OCR”) is urging health care providers, health plans, health care clearinghouses and their managed service providers (“MSPs”) and other business associates to follow guidance from the Cybersecurity and Infrastructure Security Agency (CISA) and Federal Bureau of Investigation (“FBI”) for customers affected by the Kaseya VSA Supply-Chain ransomware attack.
CISA and FBI also recommend affected MSPs and other parties
Contact Kaseya at support@kaseya.com with the subject “Compromise Detection Tool Request” to obtain and run Kaseya’s Compromise Detection Tool available to Kaseya VSA customers. The tool is designed to help MSPs assess the status of their systems and their customers’ systems.
Enable and enforce multi-factor authentication (MFA) on every single account that is under the control of the organization, and—to the maximum extent possible—enable and enforce MFA for customer-facing services.
Implement allow listing to limit communication with remote monitoring and management (RMM) capabilities to known IP address pairs, and/or
Place administrative interfaces of RMM behind a virtual private network (VPN) or a firewall on a dedicated administrative network.
CISA and FBI recommend affected MSP customers ensure backups are up to date and stored in an easily retrievable location that is air-gapped from the organizational network;
CISA and FBI also recommend MSP customers affected by this attack take immediate action to implement the following cybersecurity best practices. Note: These actions are especially important for MSP customer who do not currently have their RMM service running due to the Kaseya attack.For guidance specific to this incident from the cybersecurity community, see Cado Security’s GitHub page,Resources for DFIR Professionals Responding to the REvil Ransomware Kaseya Supply Chain Attack.Note: Due to the urgency to share this information, CISA and FBI have not yet validated this content.
If you are interested in a more detailed information about this or other developments discussed in this article, see here.
If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Providers that received COVID-19 accelerated and advance payments should read the Centers for Medicare and Medicaid Services (“CMS”) updated FAQs (PDF) about repayment of COVID-19 accelerated and advance payments to learn how recoupment works and how it affects the provider’s Medicare claims payment amounts.
If you are interested in a more detailed description of this or other developments discussed in this article, see here.
If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Health care organizations should brace for sharp increases in their wage and other workforce costs and risks if Senate Democrats succeed as expected in their plan to pass as early as this week the American Rescue Plan Act of 2021 (the “Act”) passed by the House of Representatives on Friday, February 24, 2021.
The Act’s amendments to the minimum wage rates and other provisions of the Fair Labor Standards Act of 1938 (“FLSA”) upon enactment immediately increase the federal minimum wage for non-exempt employees by $2.25 per hour and subsequently will continue to annually increase the federal minimum wage. The Act also phases out current rules allowing employers to pay tipped employees, new employees under age 20 and handicapped employees less than the regular minimum wage over the next five years. Furthermore, the reach and exposure resulting from these amendments are heightened further by the Biden-Harris Administration’s move to return to the proemployee Obama-era worker classification, joint-employer and other FLSA interpretation and enforcement policies and practices abandoned during the Trump Administration.
Senate Majority Leaders Chuck Schumer has announced plans to schedule a vote in the Senate on the Act the first week in March. With Congressional Democrats currently holding the majority of seats in the Senate by a narrow margin, the Act stands an excellent chance of enactment when put to the vote.
Given their heavy reliance on nonexempt employees and contract staffing, these changes obviously will hit health care and other workforce dependent industries hard.
Consequently, U.S. businesses should prepare to deal with these impending requirements. In response to these developments, most U.S. businesses should both prepare to implement anticipated changes in the federal minimum wage for their recognized employees as well assess their likely exposure to added costs and liabilities arising from workers rendering services to their businesses directly or indirectly as independent contractors, through subcontractor relationships or in other capacities that the business dues not view as an employment relationship.
Act’s Federal Minimum Wage Amendments
Introduced and promoted by House Democrats as their latest COVID-19 relief package, Section 2101 of the Act amends the FLSA to immediately increase the federal minimum wage for all employees as well as phases out special FLSA minimum wage rates for tipped employees, new employees under 20 years of age and handicapped workers covered by Labor Department FLSA certificates.
Aside from the direct impact of these increases to the base minimum wage, the significance and cost of these increases for U.S. businesses will be further heightened by the Biden-Harris Administration’s plan to reimplement Obama-era FLSA worker classification rules that treat as employees workers providing services under contract labor relationships historically characterized as independent contractor, subcontractor and other non-employee capacities as well as narrow other requirements for treating workers as exempt from the FLSA minimum wage and overtime requirements as well as step up enforcement of FLSA rules.
Regulatory & Enforcement Changes Heighten Health Industry Risks
Health industry leaders and organizations assessing their costs and exposures from the Act’s amendments to the FLSA should take into account the likely impact of the implications of the Biden-Harris Administration’s policies expanding the scope of the FLSA and other federal laws through revisions and enforcement of rules for characterizing workers as employees rather than independent contractors and enforcing expansive joint employer liability rules as well as other announced or expected Biden-Harris Administration proworker regulatory and enforcement changes expected to expand the potential reach and cost of the Act’s increases to federal minimum wage rates.
These historical exposures have been heighted as the COVID-19 crisis has taxed the staffing resources of many health care organizations and forced others to implement remote work and other COVID-19 driven adjustments disrupting typical staffing, timekeeping and other resources.
Amid these continuing challenges, policy and enforcement challenges by the Biden-Harris Administration are raising health industry exposures. Shortly after the Biden-Harris Administration took over in January, the WHD ended a Trump Administration Payroll Audit Independent Determination Program that offered noncompliance employers a pathway to voluntary compliance. See US Department Of Labor Ends Program That Allowed Employers To Self-Report Federal Minimum Wage And Overtime Violations.
Since taking office, the Biden-Harris Administration also has made clear it plans to review and challenge workers as exempt from the FLSA minimum wage and overtime rules based upon independent contractor or other characterizations of workers rendering services critical to operations as non-employees. In furtherance of these goals, the Biden-Harris Administration’s January 20, 2021 Memorandum on Regulatory Freeze Pending Review suspended the implementation of the Trump Administration led Labor Department’s Final Rule: Independent Contractor Status under the Fair Labor Standards Act slated to take effect on March 8, 2021, which sought to reinstitute and clarify historical policies for distinguishing employee versus independent contractor relationships and for determining the existence of joint employer status for purposes of the FLSA established by judicial precedent prior to the Obama Administration.
Subsequently, the Biden-Harris Administration led Department of Labor Wage and Hour Division (“WHD”) also has acted aggressively to reimplement and enforce Obama Administration-era standards and practices for distinguishing employees from independent contractors. Among other things, it has withdrawn Trump Ear WHD opinions which applied the more expansive view of independent contractor status contemplated by the now suspended Trump Administration-issued Final Regulations as compared to the more narrow standards applied for administration and enforcement during the Obama Administration.
Proactively Manage Compliance & Risks
Given these signals, health care and other organizations should prepare to defend against WHD and private plaintiffs efforts to use the Biden-Harris Administration’s more employee friendly interpretation and enforcement policies to attack employer characterizations of workers as contractors relied upon by the employing organization to justify nonpayment of minimum wage and overtime to those workers.
In making these preparations, health care organizations should scrutinize and tighten both their own wage and hour practices as well as their contracts, recordkeeping and retention and compliance auditing of any staffing, contract labor, subcontractors and other third-party service providers to reduce potential liability. Advance planning and efforts for work provided by contractors or other third parties is particularly critical as FLSA liabilities arising from misclassification of workers as independent contractors or joint employer liability claims can be both hard to defend and expensive because the organization charged often lacks sufficient management oversight, involvement or records to launch an effective defense. The Biden-Harris Administration has made clear that it plans to move quickly to reinstitute the regulatory and enforcement practices used during the Obama Administration to aggressively challenge employers’ characterization of workers as exempt from the FLSA’s minimum wage and overtime rules as independent contractors. Health care and other organizations receiving services from contractors or other third parties often can reduce reclassification or joint employer exposures by strengthening contractual, data reporting and collection, processes and other practices.
More Information
If you are interested in a more detailed description of the Act’s FLSA provisions and other developments discussed in this article, see here. The FLSA reforms are only one of a number of provisions of the Act impacting employers and their employee benefit plans.
If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Newly sworn in President Joe Biden chose to make an executive order outlining the core principles for his Administration’s policy for fighting COVID-19 the first signed in his new administration.
The American people deserve an urgent, robust, and professional response to the growing public health and economic crisis caused by the coronavirus (COVID-19) outbreak. President Biden believes that the federal government must act swiftly and aggressively to help protect and support our families, small businesses, first responders, and caregivers essential to help us face this challenge, those who are most vulnerable to health and economic impacts, and our broader communities – not to blame others or bail out corporations.
The Biden-Harris administration will always:
Listen to science Ensure public health decisions are informed by public health professionals Promote trust, transparency, common purpose, and accountability in our government President Biden and Vice President Harris have a seven-point plan to beat COVID-19.
Ensure all Americans have access to regular, reliable, and free testing.
Double the number of drive-through testing sites. Invest in next-generation testing, including at home tests and instant tests, so we can scale up our testing capacity by orders of magnitude. Stand up a Pandemic Testing Board like Roosevelt’s War Production Board. It’s how we produced tanks, planes, uniforms, and supplies in record time, and it’s how we will produce and distribute tens of millions of tests. Establish a U.S. Public Health Jobs Corps to mobilize at least 100,000 Americans across the country with support from trusted local organizations in communities most at risk to perform culturally competent approaches to contact tracing and protecting at-risk populations. Fix personal protective equipment (PPE) problems for good.
President Biden is taking responsibility and giving states, cities, tribes, and territories the critical supplies they need.
Fully use the Defense Production Act to ramp up production of masks, face shields, and other PPE so that the national supply of personal protective equipment exceeds demand and our stores and stockpiles — especially in hard-hit areas that serve disproportionately vulnerable populations — are fully replenished. Build immediately toward a future, flexible American-sourced and manufactured capability to ensure we are not dependent on other countries in a crisis. Provide clear, consistent, evidence-based guidance for how communities should navigate the pandemic – and the resources for schools, small businesses, and families to make it through.
Social distancing is not a light switch. It is a dial. President Biden will direct the CDC to provide specific evidence-based guidance for how to turn the dial up or down relative to the level of risk and degree of viral spread in a community, including when to open or close certain businesses, bars, restaurants, and other spaces; when to open or close schools, and what steps they need to take to make classrooms and facilities safe; appropriate restrictions on size of gatherings; when to issue stay-at-home restrictions. Establish a renewable fund for state and local governments to help prevent budget shortfalls, which may cause states to face steep cuts to teachers and first responders. Call on Congress to pass an emergency package to ensure schools have the additional resources they need to adapt effectively to COVID-19. Provide a “restart package” that helps small businesses cover the costs of operating safely, including things like plexiglass and PPE. “THIS ISN’T ABOUT POLITICS. IT’S ABOUT SAVING LIVES.”
PRESIDENT BIDEN, SEPTEMBER 16, 2020 Plan for the effective, equitable distribution of treatments and vaccines — because development isn’t enough if they aren’t effectively distributed.
Invest $25 billion in a vaccine manufacturing and distribution plan that will guarantee it gets to every American, cost-free. Ensure that politics plays no role in determining the safety and efficacy of any vaccine. The following 3 principles will guide the Biden-Harris administration: Put scientists in charge of all decisions on safety and efficacy; publicly release clinical data for any vaccine the FDA approves; and authorize career staff to write a written report for public review and permit them to appear before Congress and speak publicly uncensored. Ensure everyone — not just the wealthy and well-connected — in America receives the protection and care they deserve, and consumers are not price gouged as new drugs and therapies come to market. Protect older Americans and others at high risk.
President Biden understands that older Americans and others at high-risk are most vulnerable to COVID-19.
Establish a COVID-19 Racial and Ethnic Disparities Task Force, as proposed by Vice President Harris, to provide recommendations and oversight on disparities in the public health and economic response. At the end of this health crisis, it will transition to a permanent Infectious Disease Racial Disparities Task Force. Create the Nationwide Pandemic Dashboard that Americans can check in real-time to help them gauge whether local transmission is actively occurring in their zip codes. This information is critical to helping all individuals, but especially older Americans and others at high risk, understand what level of precaution to take. Rebuild and expand defenses to predict, prevent, and mitigate pandemic threats, including those coming from China.
Immediately restore the White House National Security Council Directorate for Global Health Security and Biodefense, originally established by the Obama-Biden administration. Immediately restore our relationship with the World Health Organization, which — while not perfect — is essential to coordinating a global response during a pandemic. Re-launch and strengthen U.S. Agency for International Development’s pathogen-tracking program called PREDICT. Expand the number of CDC’s deployed disease detectives so we have eyes and ears on the ground, including rebuilding the office in Beijing. Implement mask mandates nationwide by working with governors and mayors and by asking the American people to do what they do best: step up in a time of crisis.
Experts agree that tens of thousands of lives can be saved if Americans wear masks. President Biden will continue to call on:
Every American to wear a mask when they are around people outside their household. Every Governor to make that mandatory in their state. Local authorities to also make it mandatory to buttress their state orders. Once we succeed in getting beyond this pandemic, we must ensure that the millions of Americans who suffer long-term side effects from COVID don’t face higher premiums or denial of health insurance because of this new pre-existing condition. The Biden-Harris Administration will work to ensure that the protections for those with pre-existing conditions that were won with Obamacare are protected. And, they will work to lower health care costs and expand access to quality, affordable health care through a Medicare-like public option.
As the new Administration and Congress get down to work, health industry organizations as well as all other U.S. organizations and communities, their leaders, and individual employees and citizens should carefully follow, and share their input to the Administration, members of Congress, and other federal, state and local officials on the actions and proposals taken to implement this and other policy that impact their interests. The need for careful attention and scrutiny is particularly important for health, managed care and insurance and management organizations as President Biden made clear throughout his campaign his intent to pursue legislative and regulatory reforms that would reverse actions of the previous administration as well as implement addition reforms to expand coverage and regulation of health care, workforce and other critical policies.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is nationally recognized for her work and thought leadership on health and other health and employee benefit issues.
An attorney board certified in labor and employment law by the Texas Board of Legal Specialization and Fellow in the American College of Employee Benefit Counsel, Ms. Stamer has worked as an on demand, special project, consulting, general counsel or other basis with health care providers, health insurers, employer and other management organizations, health and other employee benefit plans, their sponsors, insurers, administrators, providers and others and others has published and spoken extensively on these concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor and advocate for employer and other plan sponsors, fiduciaries, administrators, insurers, technology and other service providers, managed care organizations, direct primary care and other health care providers and others on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com or contact Ms. Stamer via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Health care providers, health plans and health insurers, health care clearinghouses (“Covered Entities”) and their business associates should budget and begin compliance plans, even as they comment on proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule announced by the Department of Health & Human Services Office of Civil Rights (“OCR”) in its December 10, 2020 Notice of Proposed Rulemaking (“Proposed Rule). While the official Federal Register publication date has yet to be announced, OCR already is accepting comments pending the official publication. To assure consideration, comments must be received by OCR no later than 60 days from that official Federal Register publication date.
More than 300 pages in length, the proposed HIPAA Privacy Rule changes include changes OCR intends to strengthen individuals’ rights to access their own electronic and other health information; improve information sharing for care coordination and case management for individuals; facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhance flexibilities for disclosures in the Opioid and COVID-19 public health emergencies or other emergency or threatening circumstances; and reduce administrative burdens on HIPAA covered health care providers and health plans. Highlights of some of the more significant proposed changes that the Proposed Rule will make if adopted as proposed include:
Individual Access Rights Expanded
The Proposed Rule includes a number of changes that if adopted as proposed, will increase significantly the burdens upon Covered Entities of complying with the individual access requirements of the Privacy Rule. Among other things, these include the following:
Responding To Access Requests. The Proposed Rule calls for:
Reducing the maximum period that Covered Entities have to respond to requests to “as soon as practicable,” but in no case later than 15 calendar days after receipt of the request” instead of current 30 calendar days;
Clarifying the current requirement for Covered Entities to provide PHI in the form and format requested by the individual if “readily producible” in that form and format by providing that “readily producible” includes secure, standards-based APIs using applications chosen by the individuals, such as a “personal health application” and protect individual’s rights to take notes, videos, and photographs, or use other personal resources to view or capture PHI in person;
Requiring Covered Entities to allow individuals access to inspect or obtain copies of their own PHI Free of charge when inspecting in person or accessing PHI on the internet, but continue to permit certain fees for labor, supplies, and postage for certain other means of access in accordance with Privacy Rules parameters. In acquiescence to the District Court’s January, 2020 holding that the prohibition against Covered Entities charging for third party copies in the current regulations exceeded its statutory authority in Ciox Health, LLC v. Azar, however the Proposed Rule would allow Covered Entities to charge limited fees to an individual directing transmission of an electronic copy of PHI to a third party under specified circumstances. The Proposed Rule also would require Covered Entities to provide advance notice of estimated fee schedules on their websites (if they have one) for common types of requests for copies of PHI and, upon request, provide individualized estimates of fees for copies and an itemized list of actual costs for requests for copies.
Right to Direct Copies to Third Parties. The Proposed Rule will require Covered Entities to transmit electronic PHI in an electronic health record to another Covered Entity as part of the individual’s access right. In addition, also in response to the Coix Health, LLC ruling, the Proposed Rule will limit the current right of an individual to direct a copy of PHI to a third party to an electronic copy and will specify that third party direction request need not be in writing as long as it is “clear, conspicuous, and specific.”
Verification. The Proposed Rule also would prohibit a Covered Entity from imposing “unreasonable” identity verification measures on an individual, including notarization of requests, requiring the individual to provide proof of identity in person when remove verification would be practicable, or requiring the individual to complete a full HIPAA authorization form for an access request.
Encouraging Care Coordination and Case Management Activities
The Proposed Rule also would make a number of changes that OCR believes will remove the barriers created in the current Privacy Rule to Covered Entities, whether a health care provider or health plan, engaging in individual-level care coordination and case management activities. Some of the key elements of these changes include the following:
Clarification of Rules For Individual-Level Care Coordination. The Proposed Rule would revise existing rules regarding sharing of information for individual-level care coordination to apply to Covered Entities involved in such coordination activities, whether or not the participating Covered Entity is participating in the actual care or treatment of the individual by:
Revising the definition of “health care operations” in the current version of the Privacy Rule to clarify that the Privacy Rule allows sharing of PHI for individual-level care coordination among Covered Entities whether or not the participating Covered Entity is one involved in treatment or non-treatment involved Covered Entities such as health plans;
Revises the current minimum necessary restriction on the disclosure of PHI for purposes of individual-level care coordination to treat all Covered Entities engaging in individual-based care coordination and case management activities the same, regardless of whether performing the activities under the “treatment” or “health care operations” functions as defined by HIPAA. Currently non-treatment involved Covered Entities participating in care coordination and case management can only receive and share the minimum necessary PHI as their lack of involvement in treatment disqualifies them for reliance upon the treatment exception to the Privacy Rule’s general requirement to limit disclosures to the minimum necessary.
The Proposed Rule also would allow Covered Entities to disclose PHI to community-based organizations, home and community-based services (HCBS) providers, social services agencies, and other similar third parties providing health-related services for individual-level care coordination and case management without obtaining a valid authorization from the individual.
Required Updates To Notices of Privacy Practices
The Proposed Rule also would change the Privacy Rule Notice of Privacy Practices (“NPP”) requirements in a manner that would require most Covered Entities to update their NPPs and associated privacy policies. In the Proposed Rule, OCR proposes:
Replacing the requirement that certain Covered Entities that have a direct treatment relationship with an individual obtain, and retain copies of, written acknowledgements from that individual confirming their receipt of the NPP with a right for the individual to discuss the NPP with a designee of the Covered Entity.
Modification of the required NPP content to include an additional description and instruction as to how individuals can exercise their access rights and a new, more detailed and instructive, required header meeting new specifications about the information the NPP provides to individuals with respect to their rights, how to exercise them, and the availability of the Covered Entity’s designated contact person.
Disclosures to Family Members and Other Caretakers in Certain Situations
Continuing a trend that OCR has followed over the past several years in its other guidance, the Proposed Rule also would modify the Privacy Rule under specified conditions to facilitate if not encourage health care providers more broadly to disclose PHI to family members or other caretakers of individuals with substance use disorders (SUD) or serious mental illness (SMI) and in emergency situations with less concern about exposing themselves to liability under HIPAA. The key elements of these changes are accomplished as follows:
The Proposed Rule would replace the current language that allows Covered Entities to make certain uses and disclosures of PHI based on their “exercise of professional judgment” with language allowing disclosure based on a Covered Entity’s “good faith belief” that the use or disclosure is in the best interests of the individual and add a presumption of good faith by the health care provider for this purpose.
The Proposed Rule would enable Covered Entities to disclose PHI to avert a threat to the health or safety of a person or the public when a harm is “serious and reasonably foreseeable,” instead of the current stricter requirement that the Covered Entity see a “serious and imminent” threat to health or safety.
Clarification Regarding Disclosures to TRS Providers
The Proposed Rule also would amend the current Privacy Rules to remove telephone relay service providers (“TRS providers”) from the definition of “business associates” and expressly to allow disclosures to TRS communications assistants for persons who are deaf, hard of hearing, deaf-blind, or who have a speech disability.
Act Now
HIPAA Covered Entities, business associates and other concerned or impacted persons immediately should begin evaluating the Proposed Rule as soon as possible. As the current comment will end 60 days after the impending publication of the Proposed Rule in the Federal Register, concerned persons desiring a change to any provision of the Proposed Rule should prepare and submit appropriate comments to OCR in a timely fashion within the comment period. In addition, all Covered Entities and their business associates should review the rule in preparation for its provisions taking effect with a particular eye toward understanding the actions necessary to comply with the modified rules and to budget the financial and operational resources likely to be required to accomplish that compliance.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
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The Centers for Medicare & Medicaid Services (CMS) announced today it will allow Medicare-enrolled pharmacies and other immunizers to bill directly and receive direct reimbursement from the Medicare program for vaccinating skilled nursing facility residents under its COVID-19 discretionary enforcement. See CMS Special Edition 10/16/2020).
Typically, skilled nursing facilities are required to include and bill for the immunizations under Medicare rules but CMS is waiving this requirement temporarily as part of its effort to get residents immunized. CMS, the Centers for Disease Control, the Federal Drug Administration and other health care leaders view immunization against the flu a critical component of their effort to protect elderly nursing home patients against another surge of COVID-19 outbreaks this Fall.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years legal and operational management work, coaching, public policy and regulatory affairs leadership and advocacy, training and public speaking and publications. As a significant part of her work, Ms. Stamer has worked extensively domestically and internationally on an demand, special project and ongoing basis with health industry, health plan and insurance and other business, government and community organizations and their leaders, spoken and published extensively on HIPAA and other privacy and data security concerns, as well as other health care and health benefits; human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other management concerns.
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Board Certified in Labor and Employment Law By the Texas Board of Legal Specialization, Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, and the ABA RPTE Employee Benefits & Other Compensation Group and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive experience advising, representing, defending and training health care providers, health plans and insurers, employers, community organizations and others about HIPAA and other privacy concerns and has published and spoken extensively on these concerns.
Her involvement with HIPAA and other privacy and data concerns has taken place as part of her more than 30 years involvement working with with public and private health industry, health insurance and other employers and organizations of all sizes, employee benefit plans, insurance and financial services, health industry and a broad range of public and private domestic and international business, community and government organizations and leaders on pandemic and other health and safety, workforce and performance preparedness, risks and change management, disaster preparedness and response and other operational and tactical concerns throughout her adult life. A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on crisis preparedness and response, privacy and data security, workforce, health care and other policy and enforcement, as well as regularly advises and defends organizations about the design, administration and defense of their organizations workforce, employee benefit and compensation, safety, discipline and other management practices and actions.
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Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and shares insights and thought leadership through her extensive publications and public speaking. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
OCR Says “No” To Allocating Respirators & Other Scarce COVID-19 Care Based On Pre-Existing Medical Conditions
This week’s Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) announcement of that the Pennsylvania Department of Health (PDH) has agreed to using a list of preexisting health care conditions to decide patient priority for access to respirators and other scarce resources during the COVID-19 health care emergency flags potential civil rights discrimination violations by the multitude of other State, local, tribal, and territorial public health policymakers, healthcare systems leadership, and other public emergency decision-makers and other public or private HHS funds recipients (collectively “COVID responders”) whose pandemic emergency response plans call for the use pre-existing health conditions or other civil rights act protected status of patients to ration scarce medical resources like ventilators or other scarce resources.
Coupled with other recent guidance warning COVID responders against discrimination and to provide all legally required accommodations for individuals with pre-existing conditions or disorders constituting disabilities, English as a second language, religion, age or other protected status under Section 504 of the Rehabilitation Act of 1973 (“Section 504”), Title II of the Americans with Disabilities Act (the “ADA”), Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) and other federal civil rights laws, health care providers, public health authorities and other COVID-19 responders should act immediately to review and take any action needed to correct civil rights law deficiencies in their own COVID-19 emergency policies or operations.
PDH Enforcement Shows Agencies’ Serious About COVID-19 Civil Rights Enforcement
OCR’s April 28, 2020, OCR announcement of PDH’s agreement to revise its Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines (CSC Guidelines) to revolve an April 3, 2020 civil rights complaint that PDH’s COVID-19 pandemic response plan illegally discriminated against patients with disabilities by denying or lowing the care priority of patients with certain listed preexisting health conditions shows that OCR and other federal agencies are carrying through on promises to take quick enforcement action against COVID-19 responders that violate federal discrimination and other civil rights laws when dealing with the COVID-19 public health emergency in the March 14, 2020 Crisis Standards of Care and Civil Rights Laws guidance (“CSC Guidelines”) and in OCR’s March 28, 2020 Civil Rights, HIPAA, and the Coronavirus Disease 2019 Bulletin (the “Bulletin”).
The CSC Guidelines jointly issued by the Health Care Resilience Taskforce (composed of HHS, FEMA, and the Army Corps of Engineers) warned public health, health care providers and other pandemic decisionmakers against adopting or applying policies in for managing ventilators or other constricted resources during the COVID-19 or other emergencies that negatively impact vulnerable populations (e.g., older adults and persons with disabilities). After reminding state, local, tribal, and territorial policymakers, healthcare systems leadership, and other decision-makers that civil rights laws are not suspended or waived in times of disaster, the CSC Guidelines cautioned “Federal civil rights laws and regulations apply, and have not been suspended, during the COVID19 national health emergency. Federal fund recipients must comply with those requirements.”
OCR reaffirmed the CSC Guidelines warnings in its March 28, 2020 Bulletin reminding health care providers and other HHS fund recipients the laudable goal of providing care quickly and efficiently during the COVID-19 health care emergency still must comply with federal civil rights prohibitions against disability discrimination in HHS funded programs under Section 1557, Section 504, and other civil rights laws, stating:
“persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities or age. Decisions by covered entities concerning whether an individual is a candidate for treatment should be based on an individualized assessment of the patient based on the best available objective medical evidence.”
The PDH disability discrimination investigation and resolution announced April 28th resulted from OCR’s investigation of a civil rights complaint filed less than a week after OCR released the Bulletin by Disability Rights Pennsylvania and other disability rights groups. Like many other regional and facility pandemic response plans, the CSC Guidelines listed specific impairments or disabilities that would lead to greater deprioritization of patients for care during a pandemic emergency. The April 3 complaint against PDH charged that Pennsylvania’s CSC Guidelines violated Section 504, Title II, and Section 1557 by unlawfully authorizing the denial of treatment to individuals with disabilities when prioritizing access to critical care and ventilators. The complaint also alleged that the guidelines did not require an individualized assessment, but instead used “preexisting conditions that are disabilities” to determine a priority score.
OCR PDH COVID-19 Civil Rights Investigation & Settlement
Consistent with the warning provided in the Bulletin, OCR moved with rare speed to investigate the complaint and notify PDH of its civil rights concerns. To resolve potential OCR civil rights charges, OCR announced April 28, 2020 that PDH agreed to accept technical assistance from OCR and make the following revisions to its CDC guidelines:
Remove criteria that automatically deprioritized persons on the basis of particular disabilities,
Require individualized assessments based on the best available, relevant, and objective medical evidence to support triaging decisions, and
Ensure at no one is denied care based on stereotypes, assessments of quality of life, or judgments about a person’s “worth” based on the presence or absence of disabilities.
Based on these “responsive actions and the revisions” to its guidelines in response to OCR’s concern, the OCR announcement states that OCR is closing its complaint investigation as satisfactorily resolved without a finding of liability while noting that this does not preclude future OCR enforcement in cases of potential discriminatory implementation of Pennsylvania’s policies by any covered health care provider.
Other Public Health, Health Care & Other COVID Responders Should Confirm COVID-19 Civil Rights Response Compliance
The PDH announcement provides a strong warning to health care providers, public health authorities and other COVID-19 responders to act quickly to evaluate and make any necessary adjustments to redress any questionable disability or other civil rights concerns in their own COVID-19 or other emergency response plans or practices.
The PDH announcement clearly alerts other health care providers and COVID-19 responders that OCR does not plan to slacken civil rights discrimination investigation or enforcement against health care providers or others because of the COVID-19 health care emergency. Rather, the PDH investigaiton and resolution make clear that COVID-19 responders need to use particular care take the well-documented steps necessary to ensure they can defend their ongoing compliance with disability discrimination and other federal civil rights laws throughout the COVID-19 health care emergency.
In this respect, OCR’s PDH announcement makes a point of clearly warning other public health, health care providers and other recipients of HHS funding across the nation against using preexisting conditions or other prohibited stereotypes or classifications of patients without individual assessments to triage and prioritize access to care or other resources for purposes of their COVID-19 or other pandemic planning or response. To emphasize the importance of continued compliance with these civil rights laws, the Bulletin quotes OCR Director Roger Severino, as stating: “Triage decisions must be based on objective and individualized evidence, not discriminatory assumptions about the prognoses of persons with disabilities” and “we must ensure that triage decisions are free from discrimination both in their creation and their application, and we will remain vigilant in achieving that goal.”
These warnings and OCR’s quick enforcement action make clear that OCR’s commitment to hold health care providers, state and local public health, and other COVID-19 responders accountable for ensuring their COVID-19 pandemic plans and operations don’t impermissibly discriminate against individuals with or needing accommodations for disabilities, limited English skills, religious beliefs, age or other status protected by HHS’ civil rights rules. Meanwhile, OCR’s reported willingness to accept PHD’s prompt corrective action without imposing financial sanctions also signals the probable willingness of OCR to show similar leniency to other health care providers or COVID-19 responders that for acting promptly to self-identify and redress potentially questionable past COVID-19 restricted resource allocation practices in response to the PDH announcement and other COVID-19 civil rights compliance guidance.
Given the often multimillion dollar penalties and other heavy sanctions that OCR already regularly imposes against a long and ever-growing list of state and other health care, child care, elder care, insurance and other entities for violating its civil rights nondiscrimination and accommodation requirements and the often significant judgements awarded to private litigant victims, state and local public health, health care providers and other COVID providers generally will want to review and tighten as advisable their existing practices to reduce the risk of being incuring penalties or judgments, being sanctioned, excluded or a combination of these consequences for violation of these nondiscrimination and other civil rights requirements by among other things:
Auditing the adequacy of their pandemic response and other plans, policies, practices and actions for allocating scarce resources and care during the COVID-19 health emergency and in other scarce resource situations;
Developing a strategy and procedures for receiving, investigating and responding with appropriate documentation to complaints or other indicators of potential civil rights violations or risks;
Taking prompt, documented action to reform and strengthen civil rights policies, practices and controls, training, investigations and other compliance and risk management;
Explore potential strategies, if any, to mitigate potential liability exposure to OCR or private litigant investigations or enforcement from past, ongoing or future policies or actions; and
Other actions to maintain and demonstrate their organization-wide culture of compliance with applicable civil rights laws.
Since organization and their leaders likely will be required to uncover and discuss legally and politically sensitive information in the course of these activities, public health, health care and other COVID responders are encouraged to consider engaging qualified legal counsel with relevant experience to advise and guide them in conducting, maintaining and using attorney-client privilege and other procedures to safeguard sensitive analysis, discussions and work product from avoidable discovery and other processes to promote the legal effectiveness and defensibility of their actions.
More Information & Resources
We hope this update is helpful. If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. In addition to this update, the author of this article also is extensively published and frequent speaker on pandemic and other infectious disease, and other health industry crisis preparedness and response, and many other regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is widely recognized for her pragmatic, leading edge work, scholarship and thought leadership on domestic and international, public and private sector health care and managed care, workforce and performance, safety, legal and operational compliance and risk management, crisis preparedness and response, and other essential legal and operational concerns.
Her experience includes extensive work domestically and internationally with hospitals, health care systems, clinics, skilled nursing and other long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; accreditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thought leadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations . For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides consulting, publications and other information, education, coaching, training, tools and other resources on leadership, governance, health care, human resources, employee benefits, insurance, public policy and regulatory affairs, data security and privacy and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Healthcare providers, the Centers for Disease Control and Prevention (“CDC”) can get continuing education credit for completing free heath care provider training available online on “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” originally presented by CDC live on April 16, 2020.
In addition to providing training about proper classification of COVID-19 related deaths on death certificates, health care providers participating in the call may qualify for continuing education credit.
About CDC’s 4/16 COVID-19 Death Reporting Training
The training covers updated rules on completing death certificates for patients believed to have died when infected with COVID-19 published April 2. Monitoring the emergence of Coronavirus Disease 2019 (COVID-19) and guiding public health response requires accurate and timely mortality data. As death certificates are one of the few sources of health-related data that are comparable for small geographic areas and are available over a long time period in the United States, mortality data from the National Vital Statistics System (NVSS) derived from information reported on death certificates to monitor deaths due to COVID-19 versus other causes of death.
During this COCA Call, the following presenters from the CDC provide an overview of the importance of mortality data, discuss the NCHS publication and the guidance it provides to clinicians who may need to certify a death involving COVID-19, and present a summary of COVID-19 surveillance through the NVSS.
Robert N. Anderson, PhD, Chief, Mortality Statistics Branch, National Center for Health Statistics;
Margaret Warner, PhD, Injury Epidemiologist, National Center for Health Statistics;
Lee Anne Flagg, PhD, Statistician (Health), National Center for Health Statistics; and
Farida Ahmad, MPH, Mortality Surveillance Lead, National Center for Health Statistics.
An advance copy of the program Slides is currently available on the CDC website and CDC plans to post a transcript of the program following the presentation.
Continuing Education Credit
Health care providers participating in today’s training may be able to qualify for continuing education credit. CDC says that health care providers wishing to receive continuing education for participation should complete the online between May 19, 2020, and May 19, 2022, and use course code WD2922. The access code is COCA041620. Continuing education certificates can be printed immediately upon completion of your online evaluation. A cumulative transcript of all CDC/ATSDR CEs obtained through the CDC Training & Continuing Education Online System will be maintained for each user.
Interested providers and others can learn mre at this CDC Clinician Outreach and Communication Activity (COCA) here.
More Information
We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is most widely recognized for her career long pragmatic, leading edge work, scholarship and thought leadership domestic and international, public and private sector health care and managed care, workforce and employee benefits, insurance and financial services, their technology, data, and other service providers and advisors, and governments domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; creditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers, and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thoughtleadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations . For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Working or interested in working on the development and testing of data sharing functionalities to support clinical care, research, and improved health care outcomes? Listen in tomorrow (April 15, 2020) at 1:30 p.m. Eastern, 12:30 p.m. Central time to an informational briefing about newly announced funding opportunities issued by the Office of the National Coordinator for Health Information Technology under its Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT) whose specific aims address one of the following areas:
Advancing Registry Infrastructure for a Modern API-based Health IT Ecosystem
Cutting Edge Health IT Tools for Scaling Research
Integrating Health Care and Human Services Data to Support Improved Outcomes
Under the 21st Century Cures Act, Congress gave ONC authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:
The development and use of upgraded health IT capabilities;
Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
Improvement of the health IT end user experience, including by reducing administrative burden.
The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act and to increase nationwide interoperability of health information and reduce clinician burden.
ONC’s resulting emphasis on health data interoperability raises new business and compliance planning opportunities and challenges for health care providers, health insurers and other payers, health data and information technology (IT) providers and others. The new funding opportunities are intended to produce new capabilities for achieving these objectives.
We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.
Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
All Health Care Providers & Business Associates Reminded To Conduct Documented Risk Assessments In Response To COVID-19 Operational Changes
The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS). The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.
While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis. Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief. While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems. Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency. See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released; OCR Grants HIPAA Telemedicine Relief During COVID-19 Crisis.
April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities
According to Director Roger Severino, the limited enforcement relief in the Notice is intended “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.” Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency. The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.
The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS. According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing. Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS. Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,
While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:
Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
Using secure technology at a CBTS to record and transmit electronic PHI.
Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.
While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.
Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief
Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief, the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance. In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements. To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events. Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.
More Information
We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.
Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Skilled nursing and other long term care facilities commonly known as “nursing homes” (“LTC facilities”),[i] rehabilitation, assisted living, retirement and other facilities and communities caring for elderly, disabled, aged or other infirm patients or residents should use recently released tools to confirm the adequacy of and update their current COVID-19 and other infectious disease prevention and control and other key policies and practices with the latest Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) requirements and guidelines in light of recently announced changes to CMS nursing home inspection policies (the “Targeted Inspection Policy”)[iii] that target nursing homes with COVID-19 outbreaks or death for likely inspection announced March 23, 2020 including all existing requirements including new “recommendations” on nursing homes on COVID-19 preparedness and response announced April 2, 2020 (the “April Recommendations”).[iii]
Prompted by the continuing explosive growth in COVID-19 infection and deaths among nursing home residents and widespread deficiencies found during recent inspections at the Kirkland, Washington Life Care Center nursing homes (the “Kirkland Facilities”) made notorious by the death of 23 people and other nursing homes with COVID-19 inspections, the Targeted Inspection Policy and April Recommendations supplement and give more teeth to the CMS Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (the “3/3 Directive”)[iv] previously released by CMS released in conjunction with President Trump’s Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (“COVID Emergency Declaration”) in response to concerns raised by reports of 19 COVID-19 related deaths at the Kirkland Facilities[v] on March 13, 2020.
Despite CMS and CDC’s efforts to reign in nursing home based COVID-19 infections and deaths by ordering nursing homes in the Nursing Home Directive to limit outside visitors and take other precautions outlined in the Nursing Home Directive and release of other guidance and tools, nursing home based COVID-19 infections and deaths have continued to soar since March 13, 2020.[vi] Meanwhile, onsite audits at the Kirkland Facilities and other facilities during March uncovered concerning deficiencies in the compliance at the Kirkland Facilities and many other nursing homes across the nation, as well as the need to address other weaknesses in current CMS and CDC practices and guidelines that the agencies determined were perpetuating practices that left nursing home residents exposed to COVID-19.
The new Targeted Inspection Policy and April Recommendations attempt to address these compliance and other concerns by updating, clarifying and supplementing previously established requirements and guidance, providing new tools for nursing homes and their inspectors to use to assess nursing home compliance with the latest standards and stepping up inspections and enforcement of nursing homes that experience COVID-19 outbreaks.[vii]
April Recommendations Send Warnings, Share New Tools
To this end, the just announced April Recommendations urge nursing homes to move quickly to clean up their practices by:
Urging nursing homes to immediately ensure that they are complying with all CMS and CDC guidance related to COVID-19 and other infection control and other requirements;
Urging nursing homes immediately to implement symptom screening for all staff, residents, and visitors – including temperature checks; [viii]
Urging nursing homes to ensure all staff are using appropriate PPE when interacting with patients and residents, to the extent PPE is available and per CDC guidance on conservation of PPE;
Confirming the availability of Medicare coverage of Medicare enrolled residents performed by laboratories and that facilities can allow laboratory personnel into facilities to perform the tests;
Urging State and local leaders to consider the needs of long term care facilities with respect to supplies of PPE and COVID-19 tests as nursing homes are a critical part of the healthcare system, and because of the ease of spread in long term care facilities and the severity of illness that occurs in residents with COVID-19,
Recommending facilities use separate staffing teams for residents to the best of their ability to avoid transmission within nursing homes in response to evidence that using staff shared between multiple facilities helped to fuel the COVID-19 outbreak in the Kirkland Facilities;
Consistent previously published guidance and resources on the CDC Isolation Sites and Alternative Care Sites webpage,[ix] urging nursing homes to work with State and local leaders to designate separate facilities or units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and individuals with unknown COVID-19 status; and
Encouraging facilities to use new targeted survey assessment tools adopted by CMS to guide inspections under the Targeted Inspection Program to self-assess and make appropriate adjustments to tighten their facility compliance with applicable requirements and guidelines promptly.
While characterized as “recommendations,” the reaffirmation in the April Recommendations that CMS intends to continue to follow the new Targeted Inspection Policy announced March 23, 2020 sends a strong message to all nursing homes that CMS does not view compliance with the recommendations as optional.
Under the Targeted Inspection Policy, CMS intends to conduct targeted inspections giving prioritization for Immediate Jeopardy investigations over recertification surveys for Clinical Laboratory Improvement Amendment (CLIA) laboratories.
According to CMS’ announcement regarding the Targeted Inspection Policy, only the following types of federal inspections will be prioritized and conducted over the next few weeks:
Complaint inspections: State survey agencies will continue to conduct inspections related to complaints and facility-reported incidents that are triaged at the Immediate Jeopardy level. Inspectors will use a streamlined Infection Control review tool, regardless of the Immediate Jeopardy allegation.
Targeted Infection Control inspections: Federal and state inspectors will conduct targeted infection control inspections of providers identified through CMS collaboration with the Centers for Disease Control and Prevention (CDC). These inspectors will use a streamlined targeted review checklist to minimize the impact on provider activities, while ensuring providers are implementing actions to protect health and safety. This will consist of both onsite and offsite inspections.
Self-Assessments: The Infection Control checklist referenced above will also be shared with providers and suppliers, to allow for self-assessment of their Infection Control plans. This may be the best solution in some cases when there is a lack of personal protective equipment or state surveyors available.
During this time frame, CMS has indicated it will not conduct the following inspections:
Standard inspections for nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices; and
Revisit inspections not associated with Immediate Jeopardy.
In addition to redefining the priorities and scope for conducting inspections in the new Targeted Inspection Policy, CMS also refocused the inspection process that surveyors are expected to use when conducting inspections under the Targeted Inspection Policy which includes existing components of CMS’s infection control inspection process updated to include the latest CDC and CMS guidance. Under the Targeted Inspection Policy CMS and state inspectors will be guided by a newly developed and updated targeted assessment tool in assessing if certain facilities are prepared to meet CMS’s expectations for preventing the spread of COVID-19. When gaps are identified, CMS warns that facilities will be required to take corrective actions to close the gaps.
Facilities are well advised to follow the recommendation of CMS to use the new surveyor tools to self-assess their own ability to prevent the spread of COVID-19 in accordance with applicable CMS requirements both to mitigate potential exposures to CMS sanctions and because CMS also is encouraging residents and families to be proactive about nursing home safety by among other things asking facility staff how the facility performed on its self-assessment. Facilities and their leaders at all times should keep in mind the significant risks that they are likely to incur if significant deficiencies are found from an inspection. While the March 23, 2020 announcement of the Targeted Inspection Policy states that CMS is not seeking to be punitive, but rather to respond to urgent issues while proactively ensuring providers are compliant with federal health and safety standards. Accordingly, CMS has indicated that CMS intends to exercise enforcement discretion, unless Immediate Jeopardy situations arise. Given the conclusions announced regarding Immediate Jeopardy findings found from the inspection at the Kirkland Facility, however, nursing homes are well advised to assume that the occurrence of COVID-19 related deaths or infections at their facilities might create a significant risk of Immediate Jeopardy findings with regard to their facilities which could result in significant sanctions.
CMS and other agencies continue to tailor their response to the COVID-19 outbreak. In addition to verifying and maintaining their compliance with current COVID-19 and other CMS, CDC and state and local requirements and guidelines, nursing homes and their leaders also should continue to monitor emerging developments and guidance from CMS, CDC, the Federal Emergency Management Agency (“FEMA”) and their state and local regulatory bodies.
[i] Nursing homes (also known as “skilled nursing facilities” under the Medicare program and “nursing facilities” under Medicaid; or “long-term care facilities”).
[vii] In the initial wave of surveys during the week of March 30, CMS reports finding 36 percent of facilities inspected in recent days did not follow proper hand washing guidelines and 25 percent failed to demonstrate proper use of personal protective equipment (PPE) required by longstanding federal regulations. Press release Trump Administration Issues Key Recommendations to Nursing Homes, State and Local Governments, CMS (2020), https://www.cms.gov/newsroom/press-releases/trump-administration-issues-key-recommendations-nursing-homes-state-and-local-governments (last visited Apr 3, 2020).
[viii] Facilities that have not already done so should consult with experienced legal counsel for assistance about the advisability of providing or posting notifications and/or securing consents to these screening procedures, advisable or recommended procedures regarding the collection, use, or disclosure of screenings or their results, or other safeguards to manage relevant privacy or other legal rights or risks.
We hope this update is helpful. In addition to this update, the author also has prepared a more comprehensive discussion of these concerns scheduled for publication by the American Bar Association Health Publication in April, 2020. To request access for a prepublication unofficial manuscript of that upcoming publication or of more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.
Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
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