Pennsylvania OCR Settlement Warns Others Against Disability Or Other Civil Rights Discrimination In COVID-19 Resource Allocation & Other Response

April 30, 2020

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.

Even before the COVID-19 health care emergency, disability and other civil rights law enforcment already was a high priority for OCR and other federal agencies. See e.g., Civil Rights Settlement Highlights Health Industry Discrimination Risks As OCR Prepares To Broaden RequirementsOCR’s Proposed Sex & Other Discrimination Rules Spell Headaches & New Risks For Health Care Providers, Insurers & OthersCheck Defensibility Of Policies & Practices Given New HHS/DOJ Joint Disability Law Technical AssistanceImportant Lessons For Health Care Providers From Michigan State Settlement Of OCR Larry Nassar Sexual Abuse InvestigationCognitive Disability Exclusion from Heart Transplant List Placement Prohibited.

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:

  1. 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;
  2. 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;
  3. Taking prompt, documented action to reform and strengthen civil rights policies, practices and controls, training, investigations and other compliance and risk management;
  4. 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
  5. 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.

Solutions Law Press, Inc. also 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 GroupHR & 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 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:

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. ©2020 Cynthia Marcotte Stamer.  Limited non-exclusive license to republish granted to SOlSolutions Law Press, Inc.™ All other rights reserved.


Jackson Health System Nailed With $2.15 Million Plus Penalty For Violating HIPAA

October 23, 2019

Jackson Health System (JHS) has paid a heavy price for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules between 2013 and 2016.

The $2,154,000 civil monetary penalty the Miami, Florida-based nonprofit academic medical system paid to the Department of Health & Human Services Office for Civil Rights (OCR) to settle OCR charges it violated the HIPAA Security & Breach Notifications= Rules makes clear the urgent need for other health care providers, health plans, healthcare clearinghouses and their business associates to verify the adequacy of their organizations with HIPAA’s privacy, security and breach notification rules currently and on an ongoing basis.

The $2.1 million plus payment was required to satisfy a civil monetary penalty assessment OCR imposed in a Notice of Proposed Determination and Notice of Final Determination made public by OCR on October 23, 2019 in response to findings from a series of investigations of HIPAA breach and compliance concerns raised between 2013 and 2016 raised by various HIPAA-mandated breach reports and media reports that raised concerns about improper access disclosure and use of patient PHI between 2013 and 2016.  When JHS did not challenge the findings or determination became final.  OCR reports JHS has paid the specified $2.154,000 civil monetary penalties.

JHS HIPAA Violations Found By OCR

JHS operates six major hospitals, a network of urgent care centers, multiple primary care and specialty care centers, long-term care nursing facilities, and corrections health services clinics, provides health services to approximately 650,000 patients annually, and employs about 12,000 individuals.  The OCR investigation stemmed from a series of breach and media reports spanning several years and revealed a host of long standing violations of long-standing HIPAA requirements and a failure to accurately disclose or correct those or other violations of a nature that likely continue to exist in many health care systems and other covered entities.

On August 22, 2013, JHS submitted a breach report to OCR stating that its Health Information Management Department lost paper records containing the protected health information (PHI) of 756 patients in January 2013. JHS’s internal investigation determined that an additional three boxes of patient records also were lost in December 2012; however, JHS did not report the additional loss or the increased number of individuals affected to 1,436, until June 7, 2016.

In July 2015, OCR initiated an investigation following a media report that disclosed the PHI of a JHS patient. A reporter had shared a photograph of a JHS operating room screen containing the patient’s medical information on social media. JHS subsequently determined that two employees had accessed this patient’s electronic medical record without a job-related purpose.

On February 19, 2016, JHS submitted a breach report to OCR reporting that an employee had been selling patient PHI. The employee had accessed inappropriately over 24,000 patients’ records since 2011.

According to OCR Director Roger Severino, “OCR’s investigation revealed a HIPAA compliance program that had been in disarray for a number of years. …This hospital system’s compliance program failed to detect and stop an employee who stole and sold thousands of patient records; lost patient files without notifying OCR as required by law; and failed to properly secure PHI that was leaked to the media.”

These and other findings led to the OCR determination in the Notice of Proposed Determination and Notice of Final Determination that JHS failed to provide timely and accurate breach notification to the Secretary of HHS, conduct enterprise-wide risk analyses, manage identified risks to a reasonable and appropriate level, regularly review information system activity records, and restrict authorization of its workforce members’ access to patient ePHI to the minimum necessary to accomplish their job duties.  OCR assessed the $2.1 million civil monetary penalty based on these determinations.

Lessons For Other Health Providers &  HIPAA Covered Entities Likely Similarly Exposed

The JHS civil monetary penalty is the latest in a growing series of OCR enforcement and regulatory actions that drive home the perils HIPAA-covered health care, health plan, healthcare clearinghouse and  business associates risk by failing to responsibly and effectively manage their HIPAA compliance.  A review of the available JHS record reveals that like all too many HIPAA-covered entities, JHS never adequately implemented appropriate measures to operationally comply with many of the original HIPAA requirements and perpetuated those deficiencies despite the series of breaches.  Sadly, many other health care systems and other HIPAA-covered entities are subject to the same practices. Failing to address these compliance issues makes these non-compliant entities susceptible to the same type of enforcement and other liabilities that JHS now has experienced.

OCR enforcement data documents a steady  rise in OCR investigation and enforcement activity.  OCR set all-time records for HIPAA Enforcement in 2018.  Heavy enforcement activity has continued in 2019.   Before its October 23, 2019 announcement of the JHS civil monetary penalties, OCR already had announced:

Given these and other previously announced enforcement initiatives and actions, all HIPAA covered entities and their business associates are urged to maintain hyper-vigilance about their own HIPAA compliance with long standing as well as emerging HIPAA requirements taking into account old, recent, and emerging guidance and enforcement activities of OCR.  Given the almost certain discovery or discussion of known or uncovered compliance concerns and other sensitive information, covered entities are cautioned that these activities generally should be undertaken under the guidance of an experienced attorney within the scope of attorney client privilege.

For More Information

We hope this update is helpful. For more information about this or other labor and employment 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 and join discussions about these and other human resources, health and other employee benefit and patient empowerment concerns by participating and contributing to the discussions in our Solutions Law Press Health Care Risk Management & Operations Group and registering for updates on our Solutions Law Press 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 of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

As a primary focus of this work, Ms. Stamer has worked extensively with domestic and international 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; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers, health industry advocacy and other service providers and groups and other health industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

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, the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is noted for her decades-long 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, antikickback, 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 here 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:

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 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 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.

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.

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


IRS Proposes Easing Disclosure Requirements For Certain Tax-Exempt Entities

October 9, 2019

December 10, 2019 is the deadline for charitable and other tax-exempt organizations to comment on proposed regulations the Internal Revenue Service (“IRS”) intends to use to implement clarify the reporting requirements generally applicable to tax-exempt organizations as they apply to returns filed after September 6, 2019.

The proposed regulations officially published by the IRS in the September 10, 2019 Federal Register implement changes in response to various statutory amendments and certain grants of reporting relief announced by the Treasury Department and the IRS in prior guidance to help many tax-exempt organizations generally find the reporting requirements in one place.  Among other provisions, the proposed regulations incorporate the existing exception from having to file an annual return for certain organizations that normally have gross receipts of $50,000 or less, which is found in Revenue Procedure 2011-15.

In addition, the proposed regulations also reissue relief for certain tax-exempt entities from requirements to report contributor names and addresses on annual returns filed by certain tax-exempt organizations.  Originally announced last year in Revenue Procedure 2018-38, the relief was invalidated by a district court ruling that the Treasury Department and the IRS failed to follow required notice and comment procedures.  Under the proposed regulations, filing requirements for Section 501(c)(3) organizations and Section 527 political organizations remain unchanged, and all organizations are required to keep the contributor information and make it available to the IRS upon request.

Additionally, the IRS issued Notice 2019-47 (PDF) providing penalty relief for certain exempt organizations that, consistent with the 2018 guidance from the IRS, do not report the names and addresses of contributors on annual returns for tax years ending on or after December 31, 2018, but on or before July 30, 2019.

Need more information or help evaluating or responding to this or developments?  Contact the author licensed attorney experienced in FDA and other health care and other regulatory affairs matters.

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 including extensive experience advising and representing health care systems and providers about sexual abuse, assault, harassment, discrimination and other personal and professional misconduct policies, training and other prevention and investigation, peer review and other discipline, mitigation and charges defense, as well extensively published and conducted workshops on “Sex, Drugs & Rock ‘N Role:  Preventing and Addressing Personal Misconduct In Healthcare,” “What To Do When Your Employee’s Life Becomes Your Business,” and other educational training and publications for health industry clients and others on these concerns.

In these and other legal, management, governmental affairs work and speaking and publications, Ms. Stamer When working with these and other clients, Ms. Stamer merges a talent for creative problem solving with her detailed legal and operational knowledge and experience to help her clients develop and use legally defensible, pragmatic, client-centric law, performance and risk management tools and processes to manage people, performance, quality, compliance, risk and other operational needs on a real-time, “on demand” basis as well as outsourced general, operations, regulatory affairs or other special counsel capacity on an interim, special project, or ongoing basis.  Her clients have included domestic and international 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; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients.

Her 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, discipline and defend 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, antikickback, 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 a multitude of 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 here 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:

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 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant 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.

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.

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


Important Lessons For Health Care Providers From Michigan State Settlement Of OCR Larry Nassar Sexual Abuse Investigation

August 12, 2019

Health care providers should review and tighten their policies and practices for conducting therapies or other  procedures on children and other procedures on any patient involving the exposure of the breasts, genitalia or rectum where a patient is fully or partially disrobed as well as sexual assault, abuse and harassment policies and procedures  in light of a resolution agreement between the Board of Trustees of Michigan State University (“MSU”) d/b/a Michigan State University and MSU HealthTeam (“MSU HealthTeam”) and MSU Health Care, Inc. (“MSU Health Care”) announced by the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) arising from a civil rights compliance review OCR initiated after federal and state criminal investigations found that an osteopathic physician Larry Nassar sexually abused gymnasts and others while employed as an associate professor by MSU.

OCR opened a compliance review of MSU to determine if its doctors’ offices and clinics violated Title IX of the Education Amendments of 1972 (“Title IX”) and Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) after federal and state criminal investigations found Nassar sexually abused hundreds of women and girls under his care over decades while an associate professor at MSU.

Considered alone or in conjunction with the growing awareness and concern fueled by the #me too movement, widespread publicity about the sexual misconduct of Nassar  alleged Bill Cosby, billionaire Jeffrey Einstein, who died in prison while awaiting trial last Saturday and others, and OCR’s reaffirmation of its commitment to vigorously enforce civil rights laws in connection with its May 24, 2019 proposal of changes to its Section 1557 implementing regulations, the Resolution Agreement sends a strong signal to health care organizations and individual physician and other health care providers of the advisability of proactively preventing and managing their exposure to potential sexual abuse, assault and harassment complaints brought by patients, caregivers, employees and others.

The OCR investigation that led to the Resolution Agreement arose from a compliance review OCR started after Nassar was sentenced to 40 to 125 years in prison on February 5, 2018, after entering a guilty plea to seven counts of felony criminal sexual conduct in the first degree in Eaton County, Michigan.  He also has been convicted to various other federal and state sexual offenses.  Additionally, the former dean of MSU’s College of Osteopathic Medicine, William Strampel, was convicted of felony misconduct stemming from a charge that he used his public office to sexually harass students and a separate charge of willfully neglecting to monitor Nassar after an earlier investigation.

Title IX and Section 1557 are two of a multitude of federal laws prohibiting sex discrimination enforced by OCR, Title IX prohibits discrimination on the basis of sex in federally assisted education programs or activities while Section 1557 prohibits discrimination on the basis of sex, race, color, national origin, age and disability in certain health programs or activities.

The Resolution Agreement resolves potential additional enforcement action by OCR against MSU arising from the investigation commenced in response to the Nassar convictions as well as enforcement actions OCR had initiated against the MSU Entities for failing to comply with an earlier OCR resolution agreement.

In return for OCR’s agreement to close its investigation, the Resolution Agreement requires the MSU Entities to implement specific procedures for conducting examinations and procedures involving children as well as procedures and therapies conduct on patients of any age and gender s where the patient is disrobed, in full or in part, and there is exposure of the breasts, genitalia or rectum (“sensitive examinations”) as well as strengthen its other policies, notices and practices impacting the prevention, investigation and redress of sexual abuse, sexual assault, sexual harassment and other sex discrimination against patients, staff, employees and others.

Notably, to help safeguard patients from future sexual assault or abuse, the Resolution Agreement requires the MSU Entities to adopt, communicate to patients and staff and enforce specific policies patient privacy, chaperones and informed consent and patient privacy including

  • Requiring that staff always follow Universal Precautions with conducting “sensitive examinations,” which the Resolution Agreement defines as “procedures or therapies where the Patient is disrobed, in full or in part, and there is exposure of the breasts, genitalia or rectum);
  • Require that staff provide the patient with: an explanation of the required examination, procedure or therapy before beginning the procedure and secure informed consent from the patient or if the patient lacks decision making capacity, the consent of the patient’s guardian before conducting any sensitive examination;
  • Always honor the Patient’s request to have a parent, relative or friend present as a support person present during any sensitive examination;
  • Requiring a chaperone for all sensitive examinations;
  • For sensitive examinations of patients of 10 years of age or greater that the chaperone be an authorized member of the health care team and in other cases allow patients and/or their parent or other support person, as well as providers to request a chaperone at any time;
  • Require that physical examinations of an infant, toddler or child always be performed in the presence of a patient or guardian unless the parent or guardian or, if the parent is unavailable or in situations involving suspected abuse, mental health or other instances where the parental presence would interfere with the examination, another member of the health care team;
  • Require the use of a chaperone for sensitive examinations be documented in the patient record or where a patient declines or refuses a chaperone for an examination where one is required, require that the provider document the offer and its declination in the record and have the patient or guardian sign a waiver;
  • Always honor a patient’s request to have a chaperone present even when the patient also has a support person present when conducting a sensitive examination; and
  • Allow the patient’s wishes and comfort to determine the sex of the chaperone and accommodate, to the extent practicable, a patient’s request for a same sex chaperone

Moreover, the Resolution Agreement also dictates that the MSU Entities ensure that staff always provide patients undergoing sensitive examinations with an appropriate gown, privacy for undressing and dressing, and sensitive draping to maximize physical privacy.

In addition to these specified required procedures for the actual conduct of sensitive medical examinations, the Resolution Agreement also requires that the MSU Entities significantly strengthen their policies, notifications, procedures, and training regarding sexual assault, sexual abuse, sexual harassment and sex discrimination including to:

  • Revise their existing non-discrimination notices and sexual misconduct policies to clarify Title IX’s and Section 1557’s prohibitions against sex discrimination, including sex discrimination, sexual harassment, sexual abuse and sexual assault, against men and women;
  • In the revised non-discrimination notices and sexual misconduct policies clearly communicate that patient, staff or individuals who believe they are victims of sexual harassment, abuse, assault or other sexual harassment are “encouraged” to report their concerns to the designated MSU Entities’ Title IX and Section 1557 compliance team, the MSU police and OCR and explains the procedures for making those reports;
  • Conspicuously post and distribute the revised nondiscrimination and sexual misconduct policy notices which clearly communicate the clarified non-discrimination and sexual harassment policies;
  • Improve their processes for notifying students, staff, patients and others about reporting and for investigating and resolving Title IX and Section 1557 complaints (including for MSU-students, non-MSU-student patients, faculty and staff) including specific requirements concerning reporting to and coordination between MSU Entities’ compliance staff and law enforcement;
  • Designate a responsible official to coordinate the acceptance, investigation and resolution of Title IX and Section 1557 complaints;
  • Conduct all-staff training, planning and coordination between MSU Entities’ compliance and investigation teams and law enforcement, and provide bi-annual reports to OCR during the three year term of the agreement;
  • Require that all grievances or complaints alleging sexual assault, sexual abuse, sexual harassment or other sex discrimination filed by any patient, staff or other individual related to the MSU Health Team, be reviewed and investigated by, or under the supervision of, a dedicated independent health care investigator approved by OCR, who MSU may only terminate for cause with OCR’s consent.

While neither exhaustive nor binding on any other health care providers, the conditions (CR imposed against MSU under the Resolution Agreement are concrete steps other health care organizations and providers, academic institutions and other organizations and individuals at risk of claims directly or vicariously should consider using as part of their efforts to prevent and defend themselves against potential exposures to sexual misconduct charges.

With the #metoo movement and other widespread media coverage of the Nassar, Jeffery Epstein, Bill Cosby and other sex scandals fueling growing awareness and discussion about sexual abuse, assault and harassment, physicians and other individual health care providers as well as the health care systems, clinics and other health industry organizations, educational institutions and businesses generally face heightened risks of accusations by patients, caregivers, employees, and others of sexual misconduct.  Whether founded in fact, hypersensitivity, or independent agenda, recent history proves the potentially financially costly civil judgments or settlements, as well as career if not freedom ending consequences health care providers and institutions if unable to defend these claims. In addition to the criminal sentences imposed upon Nassar and, for instance, MSU previous entered into a civil settlement with more than 300 alleged victims of 332 women and girls who alleged they were Nassar sexual assault victims. See MSU reaches $500M settlement with Nassar victims.  This huge civil liability and the fact that MSU accepteed it rather than risk a potential jury verdict reflects the significance of the this liability risk.

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 including extensive experience advising and representing health care systems and providers about sexual abuse, assault, harassment, discrimination and other personal and professional misconduct policies, training and other prevention and investigation, peer review and other discipline, mitigation and charges defense, as well extensively published and conducted workshops on “Sex, Drugs & Rock ‘N Role:  Preventing and Addressing Personal Misconduct In Healthcare,” “What To Do When Your Employee’s Life Becomes Your Business,” and other educational training and publications for health industry clients and others on these concerns.

In these and other legal, management, governmental affairs work and speaking and publications, Ms. Stamer When working with these and other clients, Ms. Stamer merges a talent for creative problem solving with her detailed legal and operational knowledge and experience to help her clients develop and use legally defensible, pragmatic, client-centric law, performance and risk management tools and processes to manage people, performance, quality, compliance, risk and other operational needs on a real-time, “on demand” basis as well as outsourced general, operations, regulatory affairs or other special counsel capacity on an interim, special project, or ongoing basis.  Her clients have included domestic and international 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; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients.

Her 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, discipline and defend 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, antikickback, 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 a multitude of 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 here 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:

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 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant 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.

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.

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


Beef Up Patient Education & Management Tools With Diabetes Alert Day Resources

March 26, 2019

Physicians and other health care providers concerned about helping patients and others prevent and deal with Type 2 Diabetes should use today’s annual Diabetes Awareness Day observances and resources to beef up their Diabetes screening and management efforts and toolkits.

With 1 in 3 adult Americans at risk for Type 2 diabetes, the Centers for Disease Control (“CDC”) and other public and private organizations partnering in The National Diabetes Prevention Program are urging all physicians and other health care providers to partner in their efforts to prevent, delay and manage Type 2 diabetes.

Celebrated every year on the fourth Tuesday in March, Diabetes Alert Day promotes awareness of the prevalence and risks of undiagnosed or unmanaged Type 2 Diabetes to Americans, American taxpayers, health benefit programs and their communities.

  • More than 30 million people in the United States have diabetes and an additional 84 million adults—over a third—have prediabetes, and 90% of them don’t know they have it.
  • Diabetes is the 7th leading cause of death in the United States (and may be underreported).
  • Type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes; type 1 diabetes accounts for about 5%.
  • In the last 20 years, the number of adults diagnosed with diabetes has more than tripled as the American population has aged and become more overweight or obese
  • Undiagnosed or unmanaged Type 2 diabetes threatens serious and disabling medical risks for afflicted individuals that also are financially costly for patients and their families, their health plans, taxpayers and communities.

While Type 2 Diabetes and its costs often can be prevented or minimized through appropriate diagnosis and treatment, Type 2 diabetes symptoms often develop over several years and go on for a long time without being noticed.  Health care providers generally recognize the need to screen patients for Type 2 Diabetes as well as educating patients to recognize the factors for Type 2 Diabetes and to contact their physician promptly when experiencing these symptoms, but often have limited time and resources to help educate patients and their families.

To start with, the CDC and its partners are encouraging all health care providers to urge their patients to take the online Type 2 Diabetes Risk, screen and educate patients and promote use of CDC-recognized lifestyle change programs to individuals suffering or at risk for Type 2 diabetes.

To help health care providers participate more effectively in the fight to prevent, detect and manage Type 2 Diabetes, the CDC and its partners provide a number of Diabetes screening and management resources for physicians and other health care providers.  These resources include a variety of patient education and screening tools, resources on Medicare and other coverage for diabetes screening and management, a list of

Physicians and other health care providers should check out the resources available from the CDC and take advantage of some of these resources to beef up their Type 2 and other Diabetes patient education, prevention, screening and management efforts, a directory of CDC-recognized lifestyle change programs and  more

Learn more about Type 2 Diabetes cost modeling, screening, prevention and other health care resources Project Cope: Coalition for Patient Empowerment Newsletter and share your own resources and ideas on diabetes and management and other health care best practices, challenges, policies and concerns by participating in our Linkedin  SLP Health Care Risk Management & Operations Group or COPE: Coalition On Patient Empowerment Group or Project COPE: Coalition on Patient Empowerment Facebook Page

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.

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, 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, antikickback, 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; 1557 and other Civil Rights; 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.

Her clients include public and private, domestic and international 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; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; 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 investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Author of leading works on a multitude of 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 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 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 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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant 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.

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.

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


FDA Announces Emergency Approval of In Vitro Diagnostic Device Ebola Detection in Congo

February 13, 2019

The Food and Drug Administration (FDA) recent approval of an Emergency Use Authorization (EUA) (the “Authorization”) for an in vitro diagnostic device for detection of Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) reminds Americans and their health care organizations the Ebola virus outbreak in the Democratic Republic of the Congo remains a public health concern for the U.S.

The Approval that was effective as of November 9, 2018 was announced in yesterday’s Federal Register here.

FDA issued the Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Chembio Diagnostic Systems, Inc. as part of a series of continuing efforts to facilitate management of a continuing Ebola outbreak in the Democratic Republic of Congo.

While the Ebola threat has slipped from the public limelight in the US, World Health Organization (WHO) statistics confirm the continuing threat. WHO says 758 confirmed cases, 61 probable cases, 819 total cases, 516 deaths (455 confirmed, 61 probable) have been reported from DRC as of 11 February 2019.

The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device.

The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under the FD&C Act.

The Approval follows the recent commencement of inoculations for Ebola of health care workers with a new vaccine approved by the FDA recently on a fast tract basis.

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 managed care and other health industry, health and other benefit and insurance, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has been continuously involved the design, regulation, administration and defense of managed care and other health and employee benefit, health care, human resources and other staffing and workforce arrangements, contracts, systems, and processes.  As a continuous component of this work, Ms. Stamer has worked closely with these and other clients on the design, development, administration, defense, and breach and data recovery of health care, workforce, insurance and financial services, trade secret and other information technology, data and related process and systems development, policy and operations throughout her career.

Scribe of the ABA JCEB annual Office of Civil Rights agency meeting, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues.

Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long-term care, rehabilitation and other health care providers and facilities; medical staff, health care accreditation, peer review and quality committees and organizations; employers and other workforce management organizations; employer, union, association, government and other insured and self-insured health and other employee benefit plan sponsors, benefit plans, fiduciaries, administrators, and other plan vendors;  managed care organizations, insurers, self-insured health plans and other payers and their management; managed care organizations, insurers, third-party administrative services organizations and other payer organizations; billing, utilization management, management services organizations; group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; claims, billing and other health care and insurance technology and data service organizations; other health, employee benefit, insurance and financial services product and solutions consultants, developers and vendors; and other health, employee benefit, insurance, technology, government and other management clients.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career. Her public policy and regulatory affairs experience encompasses advising and representing domestic and multinational private sector health, insurance, employee benefit, employer, staffing and other outsourced service providers, and other clients in dealings with Congress, state legislatures, and federal, state and local regulators and government entities, as well as providing advice and input to U.S. and foreign government leaders on these and other policy concerns.

Beyond her public policy and regulatory affairs involvement, Ms. Stamer also has extensive experience helping these and other clients to design, implement, document, administer and defend workforce, employee benefit, insurance and risk management, health and safety, and other programs, products and solutions, and practices; establish and administer compliance and risk management policies; comply with requirements, investigate and respond to government; accreditation and quality organizations; private litigation and other federal and state health care industry investigations and enforcement actions; evaluate and influence legislative and regulatory reforms and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns. Ms. Stamer’s experience in these matters includes supporting these organizations and their leaders on both a real-time, “on demand” basis with crisis preparedness, intervention and response as well as consulting and representing clients on ongoing compliance and risk management; plan and program design; vendor and employee credentialing, selection, contracting, performance management and other dealings; strategic planning; policy, program, product and services development and innovation; mergers, acquisitions, and change management; workforce and operations management, and other opportunities and challenges arising in the course of their operations.

Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending plan sponsors, administrators, insurance and managed care organizations, health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and employer and association group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions. Scribe for the ABA JCEB annual agency meeting with HHS OCR, she also has worked extensively on health and health benefit coding, billing and claims, meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical, workforce, consumer financial and other data confidentiality and privacy, federal and state data security, data breach and mitigation, and other information privacy and data security concerns.

Author of leading works on a multitude of 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long-term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about contracting, credentialing and quality assurance,  compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Author of works on Payer and Provider Contracting and many other managed care concerns, Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; an ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here 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 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 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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant 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.

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.

©2019. Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


Device Manufacturers & Health Care Providers Should Update Audits & Controls For New NIST Data Security Guidance

August 23, 2018

Medical device manufacturers whose physical devices include technology that allows them to connect to the internet or other electronic system to communicate with other devices or systems “connected medical devices”) and health care providers installing, providing or using these devices should check out the guidance on connected medical device security provided by the just released 375 page NIST Special Publication 1800-8 (Guidance) from the National Institute of Standards and Technology (NIST).

While the Guidance’s title of “Securing Wireless Infusion Pumps,” suggests a more narrow focus, the Guidance clearly can be read as relevant if not generally applicable to all connected medical devices.

Unlike prior medical devices that were once standalone instruments, today’s wireless infusion pumps and other connected medical devices transmit and/or connect to a variety of electronic health records (EHRs) and other healthcare systems, networks, and other devices. While this connectivity often helps improve certain healthcare delivery processes, a medical device’s connectivity capabilities also can create significant cybersecurity risk, which could lead to health care privacy, operational or safety risks. Tampering or other intentional or inadvertent access or interference with the data sent or received from connected medical devices can expose health care providers and their healthcare enterprises to series risks including, for example:

  • A breach of electronic protected health information (ePHI) in violation of the privacy and security standards of the Health Insurance Portability & Accountability Act (HIPAA);
  • Loss or disruption of healthcare services;
  • Malicious access by malicious actors;
  • Loss or corruption of enterprise information and patient data and health records; and
  • Resulting damage to an organization’s reputation, productivity, and bottom-line revenue.

The Guide includes a variety of information NIST intends to help organizations manage these and other risks to connected medical devices and their ePHI and other data.  It provides an example that:

  • Illustrates cybersecurity standards and best-practice guidelines for better securing the wireless infusion pump ecosystem, such as the hardening of operating systems, segmenting the network, file and program whitelisting, code-signing, and using certificates for both authorization and encryption, maintaining the performance and usability of wireless infusion pumps and other connected mobile devices;
  • Discusses risks and opportunities to reduce risks from the compromise of information, including the potential for a breach or loss of ePHI, as well as not allowing these medical devices to be used for anything other than the intended purposes;
  • Documentation of a defense-in-depth strategy to introduce layers of cybersecurity controls that avoid a single point of failure and provide strong support for availability that may include a variety of tactics: using network segmentation to isolate business units and user access; applying firewalls to manage and control network traffic; hardening and enabling device security features to reduce zero-day exploits; and implementing strong network authentication protocols and proper network encryption, monitoring, auditing, and intrusion detection systems (IDS) and intrusion prevention systems (IPS);
  • Highlights best practices for the procurement of wireless infusion pumps, by including the need for cybersecurity features at the point of purchase; and
  • Calls upon industry to create new best practices for healthcare providers to consider when onboarding medical devices, with a focus on elements such as asset inventory, certificate management, device hardening and configuration, and a clean-room environment to limit the possibility of zero-day vulnerabilities.

As the patient identifiable ePHI these connected medical devices send, store or receive are considered subject to HIPAA’s privacy, security and breach notification rules, health care providers, medical device manufacturers acting as their business associates and other entities covered by these rules as covered entities or business associates are responsible for protecting and safeguarding this ePHI in accordance with HIPAA’s requirements.  Since the Department of Health & Human Services Office of Civil Rights (OCR) often points to the NIST guidance as a relevant touchstone for HIPAA covered entities and business associates to comply with HIPAA security requirements, HIPAA covered entities can anticipate that OCR will look to and be influenced by the Guidance in formulating and applying HIPAA to connected mobile devices.  Consequently, health care providers and other HIPAA covered entities and their business associates should be prepared to demonstrate their consideration and use of the standards and practices suggested in the Guidance including their analysis and justification for not following those criteria as part of their HIPAA security rule assessments. Meanwhile, connected mobile device manufacturers also will want to evaluate the Guidance and update their products and practices both to meet customer demands and to mitigate their risks as manufacturers to potential product liability claims and associated claims likely to rise from breaches or other events that may result from the failure to address the security and other risks identified in the Guidance as well as, when applicable, their specific business associate risk under HIPAA.

To accomplish this, impacted health care providers, manufacturers and other responsible parties generally will want to assess and confirm within the scope of attorney-client privilege the compliance of the ePHI safeguards of their current connected medical devices as well as require documented verification that any connected medical devices not yet deployed take into account these new standards.  To the extent that deficiencies exist in the adherence of currently in use connected medical devices, HIPAA covered entities and their business associates should consult with qualified legal counsel experienced in addressing these HIPAA compliance and risk management concerns about the defensibility and exposures potential arising from the continued use of the devices, if any, and develop an appropriate compliance and risk management plan accordingly.

About the Author

Recognized repeatedly 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, health and other benefit, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include employer, associations, government and other health benefit sponsors and administrators, public and private, domestic and international 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; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry, insurance, technology, government and other management clients.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career.

Beyond her public policy and regulatory affairs involvement, Ms. Stamer also has extensive experience helping these and other clients to design and reform programs and practices; establish and administer compliance and risk management policies; comply with requirements, investigate and respond to government; accreditation and quality organizations; private litigation and other federal and state health care industry investigations and enforcement actions; evaluate and influence legislative and regulatory reforms and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns. supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and employer and association group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns.

Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients design, document and enforce plans, practices, policies, systems and solutions; manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, 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, antikickback, 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; 1557 and other Civil Rights; 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.

Author of leading works on a multitude of 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 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 here.

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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant 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.

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.

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


%d bloggers like this: