CMS Updates COVID-19 Accelerated and Advance Payments FAQs

July 8, 2021

Providers that received COVID-19 accelerated and advance payments should read the Centers for Medicare and Medicaid Services (“CMS”) updated FAQs (PDF) about repayment of COVID-19 accelerated and advance payments to learn how recoupment works and how it affects the provider’s Medicare claims payment amounts.

The new FAQ updates the Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021 (PDF) guidance.

For more information and to follow future updates, see the COVID-19 Accelerated and Advance Payments webpage or contact the author of this update.

More Information

If you are interested in a more detailed description of this or other developments discussed in this article, see here.

If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.  For specific information or counsel about the these or other legal, management or public policy developments,  Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297,  follow her on FacebookLinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.

Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.

Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others.  A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health  care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress;  and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.

A former lead advisor to the Government of Bolivia on its pension  project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member,  past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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.  ©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™


Comment & Begin Preparation For Compliance With Proposed HIPAA Privacy Rule Changes

December 21, 2020

Health care providers, health plans and health insurers, health care clearinghouses (“Covered Entities”) and their business associates should budget and begin compliance plans, even as they comment on proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule announced by the Department of Health & Human Services Office of Civil Rights (“OCR”) in its December 10, 2020 Notice of Proposed Rulemaking (“Proposed Rule).  While the official Federal Register publication date has yet to be announced, OCR already is accepting comments pending the official publication. To assure consideration, comments must be received by OCR no later than 60 days from that official Federal Register publication date. 

More than 300 pages in length, the proposed HIPAA Privacy Rule changes include changes OCR intends to strengthen individuals’ rights to access their own electronic and other health information; improve information sharing for care coordination and case management for individuals; facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhance flexibilities for disclosures in the Opioid and COVID-19 public health emergencies or other emergency or threatening circumstances; and reduce administrative burdens on HIPAA covered health care providers and health plans. Highlights of some of the more significant proposed changes that the Proposed Rule will make if adopted as proposed include:

Individual Access Rights Expanded

The Proposed Rule includes a number of changes that if adopted as proposed, will increase significantly the burdens upon Covered Entities of complying with the individual access requirements of the Privacy Rule.  Among other things, these include the following:

  • Responding To Access Requests.  The Proposed Rule calls for:
  • Reducing the maximum period that Covered Entities have to respond to requests to “as soon as practicable,” but in no case later than 15 calendar days after receipt of the request” instead of current 30 calendar days; 
  • Clarifying the current requirement for Covered Entities to provide PHI in the form and format requested by the individual if “readily producible” in that form and format by providing that “readily producible” includes secure, standards-based APIs using applications chosen by the individuals, such as a “personal health application” and protect individual’s rights to take notes, videos, and photographs, or use other personal resources to view or capture PHI in person;
  • Requiring Covered Entities to allow individuals access to inspect or obtain copies of their own PHI Free of charge when inspecting in person or accessing PHI on the internet, but continue to permit certain fees for labor, supplies, and postage for certain other means of access in accordance with Privacy Rules parameters.  In acquiescence to the District Court’s January, 2020 holding that the prohibition against Covered Entities charging for third party copies in the current regulations exceeded its statutory authority in Ciox Health, LLC v. Azar, however the Proposed Rule would allow Covered Entities to charge limited fees to an individual directing transmission of an electronic copy of PHI to a third party under specified circumstances.  The Proposed Rule also would require Covered Entities to provide advance notice of estimated fee schedules on their websites (if they have one) for common types of requests for copies of PHI and, upon request, provide individualized estimates of fees for copies and an itemized list of actual costs for requests for copies. 
  • Right to Direct Copies to Third Parties.  The Proposed Rule will require  Covered Entities to transmit electronic PHI in an electronic health record to another Covered Entity as part of the individual’s access right.  In addition, also in response to the Coix Health, LLC ruling, the Proposed Rule will limit the current right of an individual to direct a copy of PHI to a third party to an electronic copy and will specify that third party direction request need not be in writing as long as it is “clear, conspicuous, and specific.”
  • Verification. The Proposed Rule also would prohibit a Covered Entity from imposing “unreasonable” identity verification measures on an individual, including notarization of requests, requiring the individual to provide proof of identity in person when remove verification would be practicable, or requiring the individual to complete a full HIPAA authorization form for an access request.

Encouraging Care Coordination and Case Management Activities

The Proposed Rule also would make a number of changes that OCR believes will remove the barriers created in the current Privacy Rule to Covered Entities, whether a health care provider or health plan, engaging in individual-level care coordination and case management activities.  Some of the key elements of these changes include the following:

  • Clarification of Rules For Individual-Level Care Coordination. The Proposed Rule would revise existing rules regarding sharing of information for individual-level care coordination to apply to Covered Entities involved in such coordination activities, whether or not the participating Covered Entity is participating in the actual care or treatment of the individual by:
    • Revising the definition of “health care operations” in the current version of the Privacy Rule to clarify that the Privacy Rule allows sharing of PHI for individual-level care coordination among Covered Entities whether or not the participating Covered Entity is one involved in treatment or non-treatment involved Covered Entities such as health plans;
    • Revises the current minimum necessary restriction on the disclosure of PHI for purposes of individual-level care coordination to treat all Covered Entities engaging in individual-based care coordination and case management activities the same, regardless of whether performing the activities under the “treatment” or “health care operations” functions as defined by HIPAA.  Currently non-treatment involved Covered Entities participating in care coordination and case management can only receive and share the minimum necessary PHI as their lack of involvement in treatment disqualifies them for reliance upon the treatment exception to the Privacy Rule’s general requirement to limit disclosures to the minimum necessary.
    • The Proposed Rule also would allow Covered Entities to disclose PHI to community-based organizations, home and community-based services (HCBS) providers, social services agencies, and other similar third parties providing health-related services for individual-level care coordination and case management without obtaining a valid authorization from the individual.

Required Updates To Notices of Privacy Practices

The Proposed Rule also would change the Privacy Rule Notice of Privacy Practices (“NPP”) requirements in a manner that would require most Covered Entities to update their NPPs and associated privacy policies. In the Proposed Rule, OCR proposes:

  • Replacing the requirement that certain Covered Entities that have a direct treatment relationship with an individual obtain, and retain copies of, written acknowledgements from that individual confirming their receipt of the NPP with a right for the individual to discuss the NPP with a designee of the Covered Entity.
    • Modification of the required NPP content to include an additional description and instruction as to how individuals can exercise their access rights and a new, more detailed and instructive, required header meeting new specifications about the information the NPP provides to individuals with respect to their rights, how to exercise them, and the availability of the Covered Entity’s designated contact person.

Disclosures to Family Members and Other Caretakers in Certain Situations

Continuing a trend that OCR has followed over the past several years in its other guidance, the Proposed Rule also would modify the Privacy Rule under specified conditions to facilitate if not encourage health care providers more broadly to disclose PHI to family members or other caretakers of individuals with substance use disorders (SUD) or serious mental illness (SMI) and in emergency situations with less concern about exposing themselves to liability under HIPAA.  The key elements of these changes are accomplished as follows:

  • The Proposed Rule would replace the current language that allows Covered Entities to make certain uses and disclosures of PHI based on their “exercise of professional judgment” with  language allowing disclosure based on a Covered Entity’s “good faith belief” that the use or disclosure is in the best interests of the individual and add a presumption of good faith by the health care provider for this purpose.
    • The Proposed Rule would enable Covered Entities to disclose PHI to avert a threat to the health or safety of a person or the public when a harm is “serious and reasonably foreseeable,” instead of the current stricter requirement that the Covered Entity see a “serious and imminent” threat to health or safety.

Clarification Regarding Disclosures to TRS Providers

The Proposed Rule also would amend the current Privacy Rules to remove  telephone relay service providers (“TRS providers”) from the definition of “business associates” and expressly to allow disclosures to TRS communications assistants for persons who are deaf, hard of hearing, deaf-blind, or who have a speech disability.

Act Now

HIPAA Covered Entities, business associates and other concerned or impacted persons immediately should begin evaluating the Proposed Rule as soon as possible.  As the current comment will end 60 days after the impending publication of the Proposed Rule in the Federal Register, concerned persons desiring a change to any provision of the Proposed Rule should prepare and submit appropriate comments to OCR in a timely fashion within the comment period.  In addition, all Covered Entities and their business associates should review the rule  in preparation for its provisions taking effect with a particular eye toward understanding the actions necessary to comply with the modified rules and to budget the financial and operational resources likely to be required to accomplish that compliance.

More Information

We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as: 

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.


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.


CME Credit Offered For Providers Completing Online Replay Of 4/16 CDC Training On Certifying COVID-19 Deaths

April 16, 2020

Healthcare providers, the Centers for Disease Control and Prevention (“CDC”) can get continuing education credit for completing free heath care provider training available online on “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” originally presented by CDC live on April 16, 2020.

In addition to providing training about proper classification of COVID-19 related deaths on death certificates, health care providers participating in the call may qualify for continuing education credit.

About CDC’s 4/16 COVID-19 Death Reporting Training

The training covers updated rules on completing death certificates for patients believed to have died when infected with COVID-19 published April 2. Monitoring the emergence of Coronavirus Disease 2019 (COVID-19) and guiding public health response requires accurate and timely mortality data. As death certificates are one of the few sources of health-related data that are comparable for small geographic areas and are available over a long time period in the United States, mortality data from the National Vital Statistics System (NVSS) derived from information reported on death certificates to monitor deaths due to COVID-19 versus other causes of death.

During this COCA Call, the following presenters from the CDC provide an overview of the importance of mortality data, discuss the NCHS publication and the guidance it provides to clinicians who may need to certify a death involving COVID-19, and present a summary of COVID-19 surveillance through the NVSS.

  • Robert N. Anderson, PhD, Chief, Mortality Statistics Branch, National Center for  Health Statistics;
  • Margaret Warner, PhD,  Injury Epidemiologist, National Center for Health Statistics;
  • Lee Anne Flagg, PhD, Statistician (Health), National Center for Health Statistics; and
  • Farida Ahmad, MPH, Mortality Surveillance Lead, National Center for Health Statistics.

An advance copy of the program Slides is currently available on the CDC website and CDC plans to post a transcript of the program following the presentation.

Continuing Education Credit 

Health care providers participating in today’s training may be able to qualify for continuing education credit.  CDC says that health care providers wishing to receive continuing education for participation should complete the online between May 19, 2020, and May 19, 2022, and use course code WD2922. The access code is COCA041620. Continuing education certificates can be printed immediately upon completion of your online evaluation. A cumulative transcript of all CDC/ATSDR CEs obtained through the CDC Training & Continuing Education Online System will be maintained for each user.

Interested providers and others can learn mre at this CDC Clinician Outreach and Communication Activity (COCA) here.

More Information

We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations 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 most widely recognized for her career long  pragmatic, leading edge work, scholarship and thought leadership  domestic and international, public and private sector health care and managed care, workforce and employee benefits, insurance and financial services, their technology, data, and other service providers and advisors, and governments domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; creditation, peer review and quality committees and organizations;  health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers, and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thoughtleadership through her extensive and diverse involvement in a broad range of other professional and civic organizations.  Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative;  past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee;  former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations . For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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 Solutions Law Press, Inc.™ All other rights reserved.


4/15 ONC Briefing Covers New Health IT Funding Opportunities

April 14, 2020

Working or interested in working on the development and testing of data sharing functionalities to support clinical care, research, and improved health care outcomes?  Listen in tomorrow (April 15, 2020) at 1:30 p.m. Eastern, 12:30 p.m. Central time to an informational briefing about newly announced funding opportunities issued by the Office of the National Coordinator for Health Information Technology under its Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)  whose specific aims address one of the following areas:

  • Advancing Registry Infrastructure for a Modern API-based Health IT Ecosystem

  • Cutting Edge Health IT Tools for Scaling Research
  • Integrating Health Care and Human Services Data to Support Improved Outcomes

The new funding opportunities are part of efforts to promote the interoperability of heath care data to enhance health care quality and affordability that continues to be a top ONC priority since ONC released its 2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (“Report”).

Under the 21st Century Cures Act, Congress gave ONC authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:

  • The development and use of upgraded health IT capabilities;
  • Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
  • Improvement of the health IT end user experience, including by reducing administrative burden.

The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act and  to increase nationwide interoperability of health information and reduce clinician burden.

ONC’s resulting emphasis on health data interoperability  raises new business and compliance planning opportunities and challenges for health care providers, health insurers and other payers, health data and information technology (IT) providers and others.    The new funding opportunities are intended to produce new capabilities for achieving these objectives.

For more information, visit LEAP in Health IT.

More Information

We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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 Solutions Law Press, Inc.™ All other rights reserved.


OCR Adds HIPAA Privacy Rule Enforcement Relief For Community-Based COVID-19 Testing Sites; Updated HIPAA Risk Assessments Advisable For COVID-19 Impacted Operational Changes

April 9, 2020

All Health Care Providers & Business Associates Reminded To Conduct Documented Risk Assessments In Response To COVID-19 Operational Changes

The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS).  The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.

While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis.  Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief.  While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems.  Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency.  See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released;  OCR Grants HIPAA Telemedicine Relief During COVID-19 Crisis.

April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities

According to Director Roger Severino, the limited enforcement relief  in the Notice is intended  “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.”  Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency.  The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.

The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS.   According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing.  Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers  or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS.  Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,

While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:

  • Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
  • Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
  • Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
  • Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
  • Using secure technology at a CBTS to record and transmit electronic PHI.
  • Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.

While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.

Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief

Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief,  the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance.  In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements.  To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events.  Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.

More Information

We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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 Solutions Law Press, Inc.™ All other rights reserved.


COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released

March 24, 2020

The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS).  The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.

While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis.  Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief.  While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems.  Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency.  See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released;  OCR Grants HIPAA Telemedicine Relief During COVID-19 Crisis.

April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities

According to Director Roger Severino, the limited enforcement relief  in the Notice is intended  “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.”  Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency.  The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.

The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS.   According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing.  Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers  or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS.  Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,

While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:

  • Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
  • Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
  • Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
  • Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
  • Using secure technology at a CBTS to record and transmit electronic PHI.
  • Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.

While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.

Today, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released two comprehensive toolkits on telehealth:

  • The Telehealth Toolkit for General Practitioners available here;
  • The End-Stage Renal Disease Providers Toolkit available here.

The Toolkits’ release follows up on last week’s Centers for Medicare & Medicare Services (“CMS”) loosening of requirements for Medicare coverage of telehealth services and privacy and data security requirements so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.

COVID-19 Emergency TeleHealth Waivers & Rules

Under this temporary new waiver, Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence starting March 6, 2020.  The waiver applies to a range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to their patients.

  • New TeleHealth Toolkits

Each of the telehealth toolkits released today contains electronic links to reliable sources of information on telehealth and telemedicine, which will reduce the amount of time providers spend searching for answers and increase their time with patients. HHS intends these links to help providers choose learn about the general concept of telehealth, choose telemedicine vendors, initiate a telemedicine program, monitor patients remotely, and develop documentation tools. Additionally, the information contained within each toolkit also outlines temporary virtual services that could be used to treat patients during this specific period of time.

  • COVID-19 Temporary Limited Scope HIPAA Privacy Telehealth Relief

The HHS COVID-19 emergency teleheath waivers follow up on the HHS Office for Civil Rights (OCR) March 20, 2020 Notification of Enforcement Discretion on Telehealth Remote Communications (the “Notice”) announcing temporary, limited scope enforcement relief from some, but not all of the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules for health care providers using “non-public facing” communication technologies to provide telemedicine services during the COVID-19 health care emergency

Intended to allow health care providers greater latitude under HIPAA to  communicate with patients and provide telehealth services through remote communications technologies during the COVID-19 national emergency, the Notice allows covered health care providers wishing to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency the option to  any availabe “non-public facing” remote communication product to communicate with patients if the platform by verifying the platform is HIPAA compliant and securing the necessary business associate agreement (“BAA”) with the communication provider.

Specifically the Notice announces OCR is exercising its enforcement discretion  not to impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using non-public facing audio or video communication products during the COVID-19 nationwide public health emergency in accordance with the requirements set forth in the Notice.  The non-enforcement policy applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19.   During the COVID-19 emergency, this relief for non-public facing remote communications allows a health care providers  the flexibility when it determines appropriate in his or her professional judgement to request to examine a patient using a video chat application connecting the provider’s or patient’s phone or desktop computer in order to assess a greater number of patients while limiting the risk of infection of other persons who would be exposed from an in-person consultation.

The relief does not apply to “public facing” remote communications however,  Facebook Live, Twitch, TikTok, and similar video communication applications are considered “public facing.”  The OCR bulletin states health care providers should not use any of these or other public facing remote communications to provide telehealth services under the Bulletin.

The Notice also alerts health care providers providing telemedicine services under the Notice need to ensure they have in place appropriate business associate agreements {“BAAs”) with each technology vendors used to conduct these communications and that the vendor is otherwise HIPAA compliant.  The Notice lists the following as some vendors that have represented to OCR that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA include:

  • Skype for Business
  • Updox
  • VSee
  • Zoom for Healthcare
  • me
  • Google G Suite Hangouts Meet

Providers should note that the Notice also states that OCR does not endorse, recommend or certify any of these vendors or the adequacy of their BAAs.  Consequently, providers intending to use any of thes platforms should conduct their own documented due diligence to confirm that the necessary HIPAA requirements are met.    Providers also should keep in mind that the OCR Notice does not modify any otherwise applicable federal or state law, contractual or ethical requirements that may apply to their use of these telemedicine platforms.  As many provider’s HIPAA notices may have included statements inconsistent with the use of these technologies, the provider should consider providing notification of the change of its practices that includes disclosures about potentially lower privacy protections.  Because the relief is limited in scope and duration, providers relying on the relief also will need to closely monitor developments and adjust practices as necessary when the emergency waivers expire or are modified.

Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief

Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief,  the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance.  In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements.  To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events.  Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.

More Information & 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.  To learn more about Ms. Stamer, her services, experience, publications or involvements; to review or request other developments, publications, resources and tools; or to register for future updates, see www.cynthiastamer.com, see www.cynthiastamer.com; connect on LinkedIn or Facebook; or contact us via e-mail or via telephone at (214) 452 -8297

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.

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NOTICE:   These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.  Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.  Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™.


Gastroenterology Practices Pays $100K For HIPAA Noncompliance

March 3, 2020

The $100,000 settlement payment the medical practice of Steven A. Porter, M.D., has agreed to pay $100,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services to settle a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule Serves as a warning to other physicians and healthcare providers that they too could pay big bucks for failing to comply with HIPAA. The resolution agreement and corrective action plan may be found here.

Dr. Porter’s medical practice provides gastroenterological services to over 3,000 patients per year in Ogden, Utah.

OCR began investigating Dr. Porter’s medical practice after it filed a breach report with OCR related to a dispute with a business associate. OCR’s investigation determined that Dr. Porter had never conducted a risk analysis at the time of the breach report, and despite significant technical assistance throughout the investigation, had failed to complete an accurate and thorough risk analysis after the breach and failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level.

Many physician and other small healthcare providers underestimate their responsibilities or their exposure for noncompliance. Many have never conducted the necessary risk analysis or initially adopted the requisite policies and procedures to comply. Furthermore, practices relying upon outsourced management or compliance services for their HIPAA compliance need to ensure that they have appropriate business associates agreements with those and all other service providers. While OCR typically takes into account efforts to obtain services as evidence of a culture of compliance, when breaches happen in the practice or at the business associate, A physician or other healthcare provider can expect OCR to investigate their compliance and potentially their culpability for the breach.  physicians and other healthcare providers also should not assume that their engagement of a service HIPAA to comply with or provide HIPAA compliant services equates to making that service provider accountable for the quality in adequacy of the services.Typically service providers and consultants limit their liability contractually and otherwise when providing these services, often do not have adequate compliance themselves, or both. Licensing agreements and other services contracts typically include various provisions excusing or limiting the service provider from liability for deficiencies in compliance resulting from inadequacies in their procedures, operational noncompliance or both. In some instances, business associates may include provisions in their business associate agreement or other related agreements that actually obligate the healthcare provider to defend and indemnify the service provider for breaches and other liabilities arising out of HIPAA noncompliance. Since the cost of investigating and defending an alleged complaint can be very expensive even if no penalties are sought by OCR, most physicians and other healthcare providers should explore the availability of insurance coverage to help protect against these expenses.

“All health care providers, large and small, need to take their HIPAA obligations seriously,” said OCR Director Roger Severino. “The failure to implement basic HIPAA requirements, such as an accurate and thorough risk analysis and risk management plan, continues to be an unacceptable and disturbing trend within the health care industry.”

In addition to the monetary settlement, Dr. Porter will undertake a corrective action plan that includes two years of monitoring.

Physicians and other healthcare providers need to keep in mind that OCR penalties are not the only risk of HIPAA violations. Noncompliance with these requirements also commonly gives rise to licensing board, peer review, and other professional, employment or contractual consequences as well as negative publicity. 

The resolution agreement demonstrates OCR requires physicians shouldn’t expect OCR to look the other way when they violate HIPAA. Given the potential professional and monetary liability risk that result from complaints and violations, physicians and other healthcare Should consult with qualified legal counsel for assistance with assessing the adequacy of their current clients within the scope of attorney-client privilege. Additionally, in the event of a complaint or threaten complaint, physicians and other healthcare providers should take appropriate steps to conduct a documentary investigation. As discussions and activities conducted in association with such investigations can involve sensitive communications and information, it also is advisable to consult with legal counsel at the beginning of an issue to determine whether the investigation or other activities should be conducted within the scope of attorney-client privilege so as to minimize exposure of sensitive communications as admissions or another discoverable evidence for administrative or litigation proceedings.

More Information

We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.  

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.  

This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.  

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.  

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:  

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.


ONC Adds Reducing Provider EHR Burdens & Promoting Electronic Health Data Use In Research To Health IT Priorities

February 25, 2020

Reducing health care providers burdens from using electronic health records (“EHRs”) and promoting the better uses of electronic medical data in medical research are the focus of two new health information technology (“health IT”) policy documents released this week by the Department of Health & Human Services (“HHS”) Office of the National Coordinator for Health Information Technology (“ONC”).   Health care providers, health researchers, health plans, health care clearinghouses and other health data collectors or users, as well as health IT providers and other interested persons will want to evaluate carefully these new ONC releases for insights about policy and other efforts ONC is promoting to shape the use of health IT and data.

Reducing Health IT and EHR Burdens On Providers

On February 21, 2020, ONC moved forward on its efforts to implement “a comprehensive strategy to reduce the regulatory and administrative burden related to the use of health IT, including EHRs” by publishing its “Strategy on Reducing Regulatory and Administrative Burdens Relating to the Use of Health IT and EHRs” (the “EHR Report”) targets burdens tied to regulatory and administrative requirements that HHS can directly impact through the rulemaking process.  A collaborative effort between ONC and the Centers for Medicare & Medicaid Services (CMS), the report’s strategies was developed in response to a Congressional mandate in the 21st Century Cures Act, which directed HHS to develop a plan of action to reduce regulatory and administrative burden relating to the use of health IT and EHRs and finalizes the draft version of this strategy  ONC released in November 2018. Based on stakeholder input, the final HER Report outlines three overarching goals designed to reduce clinician burden:

  • Reduce the effort and time required to record health information in EHRs for clinicians;
  • Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations; and
  • Improve the functionality and ease of use of EHRs.

ONC says reducing unnecessary regulatory burden will alleviate time spent on administrative tasks. For example, during listening sessions with clinicians, we heard criticism that the documentation guidelines for Evaluation and Management (E/M) visits were a source of EHR-related burden and overly complicated. They told us these requirements result in “pajama time,” where physicians spend hours after clinic sessions and on weekends entering data to satisfy billing and quality reporting requirements. Poor usability features within EHRs can further exacerbate this issue, as clinicians find it difficult to navigate long records within the EHR interface. Based on this feedback, the report covers four key areas:

  • Clinical documentation
  • Health IT usability (or ease of use of health IT tools and systems)
  • Federal health IT and EHR reporting requirements
  • Public health reporting (including coordination with prescription drug reporting programs and electronic prescribing of controlled substances).

In addition to responding to the direction included in the EHR Report, health care and health IT providers also will want to continue to monitor and communicate with ONC.  While moving forward on the implementation of the objectives identified in the EHR Report, ONC says it plans to continue to reach out and engage the clinician community and other key stakeholder communities and to monitor emerging and ongoing burdens related to the use of EHRs, such as burdens related to EHR inbox management and other efforts to enable further automation in health care, with a focus on prior authorization, quality reporting, and other aspects of our current system that can reduce time spent using health IT.

Leveraging Health IT For Research

On February 24, 2020, ONC followed up by releasing its National Health IT Priorities for Research: A Policy and Development Agenda. The Agenda articulates its latest vision of a health information technology infrastructure that supports alignment between the clinical and research ecosystems in research.

The Agenda identifies two overarching goals along with nine associated priority areas ONC believes stakeholders can take to achieve the respective visions more quickly and effectively:

Read the Agenda here.

More Information  

The Agenda is the latest in a series of priorities, agendas and other initiatives adopted by ONC since its establishment in furtherance of its legislative mandate under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009 to improve the health and well-being of individuals and communities through the use of technology and health information.  

Health care providers, plans, technology vendors and providers and other stakeholders impacted by ONC and other electronic medical record or health IT systems should take into account the likely implications of these and other ONC pronouncements on their programs and practices when planning and updating them.

We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.  

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.  

This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.  

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.  

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:  

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.  


OCR Warns HIPAA Entities To “Get Serious” About HIPAA Compliance In Announcing Latest Settlement Against Ambulance Company

December 31, 2019

The $65,000 payment and corrective action plan commitments West Georgia Ambulance, Inc. (“West Georgia”) is making to settle Department of Health & Human Services Office for Civil Rights (“OCR”) charges it recurrently violated the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule sends a warning to all oher HIPAA-covered health care providers, health plans, health care clearighouses  and their business associates (“covered entities”)maintain and be prepared to defend their own HIPAA compliance under a Resolution Agreement and Corrective Action Plan (“Resolution Agreement”) OCR announced on December 30, 2019.

The Resolution Agreement resolves charges resulting from an OCR investigation initiated in response to a HIPAA breach report the Georgia based ambulance company filed in 2013 in which the company, which provides emergency and non-emergency ambulance services in Carroll County, Georgia,  disclosed the loss of an unencrypted laptop containing the protected health information (PHI) of 500 individuals. The breach occurred when an unencrypted laptop fell off the back bumper of an ambulance. The laptop was not recovered.  West Georgia reported that exactly 500 individuals were affected by the breach.

In the course of its investigation of the breach report, OCR’s investigation uncovered long-standing noncompliance with the HIPAA Rules, including failures to conduct a risk analysis, provide a security awareness and training program, and implement HIPAA Security Rule policies and procedures. Specifically, the Resolution Agreement states that West Georgia:

  • Did not conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. See 45 C.F.R. § 164.308(a)(1)(ii)(A);
  • Failed to have a HIPAA security training program, and failed to provide security training to its employees. See 45 C.F.R. § 164.308(a)(5);
  • Failed to implement Security Rule policies or procedures. See 45 C.F.R. § 164.316; and
  • Despite OCR’s investigation and technical assistance, “did not take meaningful steps to address their systemic failures.”

To resolve its exposure to the substantially higher civil monetary penalties that OCR could impose for violations of this nature, West Georgia agreed to pay a $65,000 resolution payment to OCR and implement and comply with a corrective action plan that in addition to requiring West Georgia to correct the compliance deficiencies, also subjects West Georgia to two years of OCR monitoring and oversight.

The Resolution Agreement and corrective action plan carry a number of important messages for other health care providers and other Covered Entities.  First, the OCR enforcement action against West Georgia coming at the end of yet another heavy HIPAA enforcement year by OCR reminds Covered Entities that OCR is serious about HIPAA enforcement on the heels of its 2018 HIPAA record setting collection of $28.7 million in civil monetary penalties and resolution payments including the single largest individual HIPAA settlement in history of $16 million with Anthem, Inc. See OCR Concludes 2018 with All-Time Record Year for HIPAA Enforcement.  While not topping this record, OCR during 2019 now has collected civil monetary penalties and resolution payments totaling more than $15 million from HIPAA Covered Entities and their business associates including:

Second, the Resolution Agreement and various other smaller settlements during the year show HIPAA compliance and enforcement is a concern for smaller provideres and other covered entities, not juswt the huge ones.  While the $65,000 settlement payment required by the Resolution Agreement is substantially smaller than the amounts of the civil monetary penalties and many of resolution payments OCR collected in its other 2019 enforcement actions, the West Georgia and other 2019 enforcement actions demonstrate the teeth behind the warning in the OCR Press Release announcing the West Georgia Resolution Agreement from OCR Director Roger Severino that“All providers, large and small, need to take their HIPAA obligations seriously.”  With OCR promises to keep up its vigorous investigation and enforcement of the HIPAA requirements, every Covered Entity and business associate should take the necessary steps to verify and maintain their HIPAA compliance and to be prepared to defend their compliance under the Privacy, Security, Breach Notification and HIPAA access and other individual rights mandates of HIPAA.

Third, OCR’s statement in the Resolution Agreement about the failure by West Georgia to meaningfully act to correct compliance deficiencies and cooperate in other corrective action during the period following the breach report highlights the importance for covered entities involved in a breach or other dealings with OCR on a potential compliance concern to behave appropriately to  express and exhibit the necessary concern OCR expects regarding the compliance issue to position themselves to request and receive the clemency OCR is empowered under HIPAA to extend when deciding the sanctions for any noncompliance.

Of course meeting the requirements of HIPAA is not the only concern that covered entities should consider as they review and tightened their HIPAA and other privacy and data security procedures.  Health care providers and other covered entities also should keep in mind their other obligations to protect patient and other confidential information under other federal laws, the requirements of which also are ever-evolving.  For instance, on January 1, 2020 Texas providers like other Texas businesses will become subject to a shortened deadline for providing notice of data breaches under a new law enacted by the Texas Legislature in its last session.  Arrangements should be designed to fulfill all of these requirements as well as any ethical or contractual.

Covered entities also should keep in mind that violations of HIPAA can have implications well beyond HIPAA.ramifications beyond HIPAA itself.  For instance, heath care providers can face disqualification from federal program participation, licensing and ethics discipline and other professional consequences.  Health plans and their fiduciaries also may face Department of Labor and other fiduciary claims, while insurers can face licensing and other regulatory consequences.

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 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

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with the Department of Health & Human Services Office of Civil Rights, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer has extensive legal, operational, and public policy experience advising and representing health care, health care and other entities about HIPAA and other privacy, data security, confidentiality and other matters.

Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services, public and private primary, secondary, and other educational institutions, and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has recurrently worked extensively with public school districts and public and private primary and secondary schools, colleges and universities, academic medical, and other educational institutions, insured and self-insured health plans; 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; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, employers; and federal and state legislative, regulatory, investigatory and enforcement bodies and agencies on health care, education, and other data privacy, security, use, protection and disclosure; disability and other educational rights; workforce, and a host of other risk management and compliance concerns.

Ms. Stamer is most widely recognized 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, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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.


New Texas Law Requiring Anti-Retaliation Policies For Nonprofit Healthcare Org’s Takes Effect 1/1

December 27, 2019

Nonprofit health organizations must develop anti-retaliation policies for doctors and submit biennial reports to the Texas Medical Board in response to a House Bill 1532 mandate that takes effect January 1, 2020.

Passed by the Texas Legislature on September 1, 2019, the Bill also amends the Medical Practice Act to require the Texas Medical Board to accept and process complaints against a certified nonprofit health organization in the same manner it would handle complaints against a health professional.

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 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

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services, public and private primary, secondary, and other educational institutions, and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has recurrently worked extensively with public school districts and public and private primary and secondary schools, colleges and universities, academic medical, and other educational institutions, insured and self-insured health plans; 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; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, employers; and federal and state legislative, regulatory, investigatory and enforcement bodies and agencies on health care, education, and other data privacy, security, use, protection and disclosure; disability and other educational rights; workforce, and a host of other risk management and compliance concerns.

Ms. Stamer is most widely recognized 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, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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.


$1.6M HIPAA Penalty Mostly Due To Inadequate Security Assessment & Oversight

December 16, 2019

The $1.6 million civil monetary penalty (“CMP”) assessed against the Texas Health and Human Services Commission (“TX HHSC”) for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules between 2013 and 2017 committed by a predecessor agency, the Department of Aging and Disability Services (“DADS”) illustrates the critical need for all HIPAA covered entities and business associates to confirm the adequacy of their enterprise wide security assessment, oversight, and other HIPAA Privacy and Security compliance and risk management including documentation of the reassessment and updating of these materials and assessments in connection with any update or change in software, systems or other system and security relevant developments.

OCR imposed the CMPs against TX HHSC for violations of HIPAA OCR found DADS committed from 2015 to 2017, before it was reorganized into TX HHSC in September 2017.  Like most other large HIPAA CMPs and settlements paid to avoid CMPs, a review of the TX HSSC CMP events makes clear that the large penalty resulted mostly because of inadequate assessment and oversight of security, rather than the actual breach itself that prompted the investigation leading to the CMP assessment.

Before its merger into TX HHSC, DADS was the Texas agency primarily responsible for providing and administering the state’s long-term care services for aging and intellectually and physically disabled people.  TX HHSC now administers and provides the services previously provided by DADS as part of its broader operation of state supported living centers; provision of mental health and substance use services; regulation of child care and nursing facilities; and administration of hundreds of other programs for people needing supplemental nutrition benefits, Medicaid and certain other assistance including those previously provided by DADS.

DADS Breaches & Violations

The $1.6 million CMPs assessment against TX HHSC resulted after OCR investigated a 2015 breach report made by DADS.  On June 11, 2015, DADS submitted a Breach Notification Report (“Report”) notifying OCR that on April 21, 2015 names, addresses, social security numbers, treatment information and other electronic protected health information (“ePHI”) of 6,617 individuals was viewable over the internet when a software coding flaw allowed prohibited access to ePHI with access credentials when DADS moved an internal application from a private, secure server to a public server.  OCR’s investigation determined that, in addition to that impermissible disclosure, DADS violated the HIPAA Security Rule by failing to conduct an enterprise-wide risk analysis and implement access and audit controls on Community Living Assistance and Support Services and Deaf Blind with Multiple Disabilities (“CLASS/DBMD”) program information systems and applications intended to collect and report information about “Utilization Management and Review” activities to the Centers for Medicare & Medicaid Services (“CMS”) for the CLASS/DBMD waiver programs.. The CMS waiver programs required DADS to collect and report to CMS applicant and enrollee community and institutional service choice, Level of Care, Plan of Care, waiver provider choice  and other waiver program performance data for CLASS and DBMD as part of a required evidentiary report on all §1915(c) waiver programs.  The CLASS/DBMD application glitch compromised the ePHI by allowing an undetermined number of unauthorized users to view the ePHI without verifying user credentials. TX HHSC learned of the breach from an unauthorized user who accessed ePHI in the application without being required to input user credentials. Because of inadequate audit controls, DADS was unable to determine how many unauthorized persons accessed individuals’ ePHI.

OCR initiated a compliance review of DADS on June 23, 2015 in response to the breach notification. As HIPAA Security Rule at 45 C.F.R. ·§ 164.312(a)(l) requires a covered entity to implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs properly granted access rights under HIPAA Security Rule § 164.308(a)(4), OCR found that by placing the CLASS/DBMD application on their public server without requiring users to provide access credentials, TX HHSC violated HIPAA by failing to implement access controls on all of its systems and applications throughout its enterprise in violation of 45 C.F.R. § 164.312(a)(l).

The HIPAA Security Rule at 45 C.F.R. § 164.312(b) requires a covered entity to implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI.  In the course of its investigation, OCR requested in its June 23, 2015 Data Request that DADS provide a copy of its current HIPAA administrative and technical policies and procedures.  As DADS provided no evidence that the application was capable of auditing user access after it was moved to the unsecure public server as required by 45 C.F.R. § 164.312(b) with its response, OCR also concluded from its investigation that TX HHSC failed to implement audit controls to all of its systems and applications, like the application involved in the breach, as required by 45 C.F.R. § 164.312(b).

Beyond these violations, OCR also found that DADS also violated the HIPAA Security Rule by failing to conduct the required accurate and thorough enterprise wised risk analysis required by the HIPAA Security Rule.  In this respect, the HIPAA Security Rule at 45 C.F.R. § 164.308(a)(1)(ii)(A) requires a covered entity to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI it holds.  In its August 31, 2015 response to OCR’s Data Request dated July 23, 2015, DADS acknowledged that, while it had performed ”risk assessment activities” on individual applications and servers, it never performed an “agency-wide” security risk analysis.   On July 28, 2017, OCR received the documentation that DADS represented to be the documentation of its risk analysis.  After reviewing this evidence, OCR additionally found DADS violated the HIPAA Security Rule by failing to conduct an enterprise-wide risk analysis and implement access and audit controls.

Calculation & Assessment CMPs Totaling $1.6 Million

On May 23, 2018, OCR issued a Letter of Opportunity and informed TX HHSC that OCR’s investigation indicated that TX HHSC failed to comply with the Privacy and Security Rules, which remained unresolved despite OCR’s attempts to do so. The letter stated that pursuant to 45 C.F.R. § 160.312(a)(3), OCR was informing TX HHSC of the preliminary indications of non-compliance and providing TX HHSC with an opportunity to submit written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 45 C.F.R. § 160.410 for OCR’s consideration in making a CMP determination under 45 C.F.R. § 160.404. The letter identified each area of noncompliance.  It also stated that TX HHSC also could submit written evidence to support a waiver of a CMP for the indicated areas of non-compliance.

Although the designated representative for TX HHSC as DADS successor received the Letter of Opportunity on May 24, 2018, . TX HHSC did not provide any written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 4S C.F.R. § 160.410 for OCR’s consideration in making the CMP determination or submit any written evidence to support a waiver of a CMP for the indicated areas of non-compliance.  Accordingly, after securing the requisite approval from the Justice Department, OCR issued a Notice of Proposed Determination of Civil Monetary Penalties (“Proposed CMP”) on July 29, 2019.

As explained by the Proposed CMP, as amended by the HITECH Act, Section 13410, 42 U.S.C. § 1320d-5(a)(3), HIPAA authorizes OCR as the designated representative of the Secretary of HHS to impose CMPs against a covered entity for post-February 18, 2009 HIPAA Privacy or Security Rule violations.  These current CMP provisions provide the following rules for the assessment of CMPs for such violations:

  • A minimum of$100 for each violation where the covered entity or business associate did not know and, by exercising reasonable diligence, would not have known that the covered entity or business associate violated such provision, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $25,000.
  • A minimum of$1,000 for each violation due to reasonable cause and not to willful neglect, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $100,000. Reasonable cause means an act or omission in which a covered. entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.
  • A minimum of $10,000 for each violation due to willful neglect and corrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $250,000.
  • A minimum of$50,000 for each violation due to willful neglect and uncorrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $1,500,000.

By law, OCR adjusts the CMP ranges and calendar year cap for each penalty tier for inflation.  The adjusted amounts are applicable only to CMPs whose violations occurred after November 2, 2015.

The Proposed CMP included notice of the CMPs OCR intended to impose CMPs totaling $1.6 million for the violations.  Characterizing each of the violations as due to reasonable cause and not willful neglect, the Proposed CMP Notice made note that OCR was authorized by statute to assess penalties of up to $50,000 per day for each day of the identified violations due for reasonable cause, rather than willful neglect, but authorized OCR to adjust the penalties in light of aggravating and mitigating factors.  The Proposed CMP stated that in arriving at the lesser daily penalty amount, OCR considered as mitigating factors that:

  • The violations did not result in any known physical, financial, or reputational harm to any individuals nor did it hinder any individual’s ability to obtain health care;  and
  • TX HHSC immediately removed the application once it received a report that unauthorized users could access the ePHI of individual beneficiaries.

However, OCR also took note that it viewed DADS failure to act promptly to remediate the breach and to keep a commitment made to OCR in August, 2015 timely to conduct and complete the agency wide risk analysis by August 31, 2016 as an aggravating factor.  Considering these factors, the Proposed CMP notified TX HHSC that OCR intended to assess a daily penalty amount of$1,000 per day ($1,141 after November 2, 2015) per violation capped at $100,000 per calendar year per violation. Applying these amounts, the CMP notified TX HHSC that OCR intended to impose CMPs totaling $1.6 million, as follows:

  • Impermissible disclosures in violation of 45 C.F.R. § 164.502(a), a $100,000 CMP
  • Inadequate access controls in violation of 45 C.F .R. § 164.312(a)(l), a $500,000 CMP
  • Inadequate audit controls in violation of 45 C.F.R. § 164.312(b), a $500,000 CMP
  • Failure to perform required enterprise wide risk analysis in violation of 45 C.F.R. § 164.308(a)(l)(ii)(a), a $500,000.

After TX HHSC , as successor to DADS, did not file a request for hearing before an administrative law judge within the 90 days, OCR imposed the $1.6 million CMP in dated  October 25, 2019 made public on November 7, 2019.

Lessons For Other Health Care Providers, Health Plans, Clearinghouses & Business Associates

The latest in a growing series of multimillion dollar CMPs and Resolution Payments assessed and collected by OCR, the TX HHSC CMP illustrates the critical necessity for all covered entities and business both to take appropriate, well-documented action to prevent, timely discover and redress, and report ePHI breaches and otherwise comply with the otherwise applicable requirements of the HIPAA Privacy, Security and Breach Notification Rules including the conduct and continuous maintenance of appropriate enterprise wide security assessments, audits, and oversight.  With OCR promising to continue its enforcement, all covered entities and business associates should verify the existence and adequacy of their existing enterprise wide risk assessments and safeguards and procedures for monitoring, investigating potential security risks and other breaches and other HIPAA compliance oversight.  Beyond these compliance efforts, the TX HHSC and other CMP actions also drive home the strong advisability for covered entities or business associates that experience a known or potential breach or other violation promptly to investigate and mitigate potential breaches and other violations.  As part of these efforts, covered entities and business associates should seek assistance in conducting their assessments as well as responding to any preexisting and emergent breach or other compliance concerns within the scope of attorney-client privilege from qualified legal counsel with the necessary knowledge and experience of HIPAA and other federal and state laws, regulations and administrative and judicial decisions that define and shape their exposure.  In the event of a breach or other compliance concern, timely guidance and representation by legal counsel with both experience of these requirements and with dealing with OCR and other agencies may help mitigate exposures by expediting timely and appropriate response.

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 by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation GroupMs. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Ms. Stamer is most widely recognized for her decades-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 www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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.


University of Rochester Medical Center Paying $3 Million For Unencrypted Laptop & Flash Drive

November 6, 2019

$3 million is the hefty price that the University of Rochester Medical Center (URMC) has agreed to pay to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules arising from the loss of unencrypted laptops and other mobile devices containing protected health information (PHI).  Like prior settlements and civil monetary penalties OCR previously assessed against HIPAA-covered entities for using or storing electronic protected health information (ePHI) on unencrypted mobile devices, the $3 million sanction and other requirements imposed in the   URMC Resolution Agreement and Corrective Action Plan  made public after the close of business on November 5 reaffirm OCR’s readiness to sanction harshly health care providers, health plans, healthcare clearinghouses and businesses associates for the loss or compromise of ePHI due to the covered entity’s failure to appropriately encrypt mobile devices.  Any HIPAA covered entity or business associate that has not already done so must act to avoid a similar fate by establishing and enforcing systematic procedures to ensure all mobile devices using, accessing, storing or otherwise dealing with  ePHI are properly encrypted at all times.

URMC Breach & Resolution Agreement

The URMC Resolution Agreement resolves potential charges resulting from an OCR investigation commenced in response to breach reports UMRC filed with OCR in 2013 and 2017. The breach reports disclosed UMRC’s discovery of the impermissible disclosure of PHI through the loss of an unencrypted flash drive and theft of an unencrypted laptop, respectively. URMC includes healthcare components such as the School of Medicine and Dentistry and Strong Memorial Hospital. URMC is one of the largest health systems in New York State with over 26,000 employees.

OCR’s investigation revealed that URMC failed to conduct an enterprise-wide risk analysis; implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level; utilize device and media controls; and employ a mechanism to encrypt and decrypt electronic protected health information (ePHI) when it was reasonable and appropriate to do so. Of note, in 2010, OCR investigated URMC concerning a similar breach involving a lost unencrypted flash drive and provided technical assistance to URMC. Despite the previous OCR investigation, and URMC’s own identification of a lack of encryption as a high risk to ePHI, URMC permitted the continued use of unencrypted mobile devices.

OCR made a point of reaffirming the requirement to encrypt laptops and other mobile devices containing ePHI when announcing the new Resolution Agreement. “Because theft and loss are constant threats, failing to encrypt mobile devices needlessly puts patient health information at risk,” said Roger Severino, OCR Director. “When covered entities are warned of their deficiencies, but fail to fix the problem, they will be held fully responsible for their neglect.”

As part of its punishment for allowing the ePHI breaches by failing to encrypt mobile devices, URMC must pay a $3 million monetary settlement as well as undertake a corrective action plan that includes two years of monitoring their compliance with the HIPAA Rules.

Mobile Device Encryption Requirement Well-Established

OCR repeatedly through published guidance and reported sanctions repeatedly  has warned covered entities and business associates not to permit ePHI to be used, accessed or stored on unencrypted laptops or other mobile devices.  In 2017, Children’s Medical Center of Dallas (Children’s) paid a  $3,217,000.00 Civil Monetary Penalty (CMP) after OCR issued its January 18, 2017 Final Determination that Children’s for years knowingly violated HIPAA by failing to encrypt or otherwise properly secure ePHI on laptops and other mobile devices and failing to comply with many other HIPAA requirements.  See Learn From Children’s New $3.2M+ HIPAA CMP For “Knowing” Violation of HIPAA Security Rules.   An OCR Newsletter Article on  Guidance on  Mobile Devices and Protected Health Information (PHI), for instance, states:

Entities regulated by the HIPAA Privacy, Security, and Breach Notification Rules (the HIPAA Rules) must be sure to include mobile devices in their enterprise-wide risk analysis and take action(s) to reduce risks identified with the use of mobile devices to a reasonable and appropriate level.
The article also shared insights about some of the steps OCR considers necessary to meet this expectation,  as including:

  • Implement policies for use of mobile devices that are used to handle PHI;
  • Consider using Mobile Device Management (MDM) software to secure mobile devices;
  • Install or enable automatic lock/logoff functions;
  • Require authentication to access devices;
  • Keep devices’ security features updated;
  • Procure encryption, anti-virus/anti-malware software, and remote wipe capabilities;
  • Use a privacy screen to prevent viewing by third-parties;
  • Assure that Wi-Fi networks used are secure;
  • Use a secure Virtual Private Network (VPN);
  • Institute policies regarding downloading third-party apps on devices which access PHI;
  • Delete all PHI from device before disposing of; and
  • Provide training on secure use of mobile devices for all employees.

Covered entities and business associates should promptly and continuously act to ensure on a systematic and carefully documented basis that their organization is taking these and and other steps necessary to ensure that all mobile device with ePHI are always appropriately encrypted.

We hope this information was helpful.  For more information about HIPAA or other related concerns, 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 services, experience and involvements, e-mail Ms. Stamer here or contact Ms. Stamer via telephone at (214) 452-8297 or see here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides legal risk management and compliance, business strategy and operations,  management, leadership  and other publications, coaching, , training and education tools and other resources on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, we invite you to register to receive other updates and review our other Solutions Law Press, Inc.™ resources available 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.


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.


Cognitive Disability Exclusion from Heart Transplant List Placement Prohibited

February 13, 2019

Exclusion of a cognitively impaired patient from its heart transplant list landed University of North Carolina Healthcare System (“UNC Healthcare”) in hot water with the Department of Health and Human Services Office of Civil Rights (OCR). The OCR enforcement action highlights the need for health care organizations to re-evaluate long-standing practices for limiting or denying access to transplants, research or other restricted treatment based on cognitive, mental or other impairments of the patient.

OCR announced February 12 that it resolved a complaint against UNC Health Care alleging that it unlawfully denied an individual the opportunity to be placed on the United Network for Organ Sharing (UNOS) list on the basis of their disability.  UNC Health Care is a public academic medical center comprised of North Carolina Memorial Hospital, North Carolina Children’s Hospital, North Carolina Neurosciences Hospital, and North Carolina Women’s Hospital.

Federal law generally prohibits health care providers from discriminating against patients based on disability. Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794 (“Section 504”) prohibits discrimination on the basis of disability by recipients of Federal financial assistance.

In addition, the Americans with Disabilities Act of 1990, 42 U.S.C. § 12101 et seq. (“ADA”), prohibits discrimination on the basis of disability by both public and private entities, whether or not they receive Federal financial assistance. Providers covered by Section 504 and/or the ADA may not deny benefits or services to qualified individuals with disabilities or provide lesser benefits than they provide to others. In general, an individual with a disability is “qualified” if that person meets the essential eligibility requirements for receipt of services or participation in the program or activity with or without reasonable modification to rules, policies or practices. The purpose of these laws is to ensure that covered programs are as accessible to persons with disabilities as they are to nondisabled individuals.

In September 2018, OCR received a complaint alleging that an individual with an intellectual disability was in need of a heart transplant, but a doctor on staff at UNC Health Care determined that they were not a good candidate for heart transplant because of their developmental learning disabilities and because they do not live independently.  The complainant asserted that without the transplant, they would eventually die. 

OCR used the Early Complaint Resolution (ECR) process to achieve a successful resolution of this matter.  ECR is a facilitated negotiation between the parties to an OCR complaint with the goal of achieving a resolution that quickly provides a remedy to the individual that has been allegedly discriminated against as well as securing additional measures that can be implemented to reduce the likelihood of future incidents of alleged discrimination.

In January 2019, UNC Health Care agreed that the individual’s medical records will be amended to clarify that they are eligible to be considered for placement on the UNOS transplant list.  OCR will provide technical assistance to UNC Health Care in the development of their transplant eligibility policy.

The UNC Healthcare enforcement and resolution is the latest in a lengthy and growing list of disability discrimination enforcement actions OCR has taken against health care providers and plans. Cognitive disorders and mental disabilities are frequently the basis of these actions. Additionally health care providers and health plans also can incur liability from private lawsuits for prohibited discrimination. In the light of growing awareness and enforcement of these disability discrimination prohibitions, health care providers should review and correct procedures to mitigate risks.

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.


Year-End $3 Million HIPAA Settlement Pushes 2018 OCR HIPAA Recoveries Over $28 Million; Act Promptly To Strengthen Compliance & Share Ideas For Simplification

February 7, 2019

Health care providers, health plans, health care clearinghouse and their business associates (“Covered Entities”) should reconfirm the adequacy of their organization’s Health Insurance Portability and Accountability Act (“HIPAA”) compliance in light the U.S Department of Health and Human Services Office of Civil Rights (“OCR”) February 7, 2019 announcement that OCR reached a 2018 year-end $3 Million Resolution Agreement with California-based Cottage Health that pushed OCR’s already record-setting 2018 enforcement HIPAA recoveries to more than $28.7 million in a year already distinguished by OCR’s record-setting $16 million resolution payment collection from Anthem.

Along with acting to ensure their own organization’s ability to defend their HIPAA compliance, Covered Entities and their leaders also should take advantage of the opportunity to provide input to OCR on opportunities for simplifying and improving OCR’s HIPAA regulations and enforcement by submitting relevant comments by February 12, 2019 in response to a Request for Information published by OCR in December that invites public input.

Learn more de

2018 Cottage Health Resolution Agreement

According to OCR’s February 7, 2019 announcement, Cottage Health agreed in OCR’s final settlement of 2017 to pay OCR $3 million and to adopt a substantial corrective action plan to settle charges of HIPAA violations resulting from OCR’s investigations into two HIPAA Breach notifications Cottage Health filed regarding breaches of unsecured electronic protected health information (ePHI) affecting over 62,500 individuals.

  • A December 2, 2013 breach notification that the removal of electronic security protections by a Cottage Health contractor rendered ePHI such as patient names, addresses, dates of birth, diagnoses/conditions, lab results and other treatment information of 33,349 individuals on a Cottage Health server accessible for download without a username or password from the internet to anyone outside Cottage Health.  In an update to its original report filed on July 2, 2014, Cottage Health increased the number of individuals affected by this breach to 50,917. OCR’s investigation determined that security configuration settings of the Windows operating system permitted access to files containing ePHI without requiring a username and password.  As a result, patient names, addresses, dates of birth, diagnoses, conditions, lab results and other treatment information were available to anyone with access to Cottage Health’s server.
  • A December 1, 2015, that the misconfiguration of a server following an IT response to a troubleshooting ticket, exposed unsecured ePHI including patient names, addresses, dates of birth, social security numbers, diagnoses, conditions, and other treatment information of 11,608 individuals over the internet.

Based upon its investigation into the two breach reports, OCR concluded Cottage Health violated HIPAA by failing to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the ePHI; failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level; failed to perform periodic technical and non-technical evaluations in response to environmental or operational changes affecting the security of ePHI; and failed to obtain a written business associate agreement with a contractor that maintained ePHI on its behalf.

To resolve its exposure to potentially must greater civil monetary sanctions that OCR might seek for such potential violations under HIPAA’s civil monetary sanction rules, Cottage Health entered into December, 2018 Resolution Agreement to pay the $3 million settlement and undertake what OCR characterizes as “a robust corrective action plan to comply with the HIPAA Rules.” Among other things, the corrective action plan requires Cottage Health to:

  • Conduct an enterprise-wide risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by Cottage Health (“Risk Analysis”) that OCR views as satisfactory to meet the requirements of 45 CFR 164.308(a)(1)(ii)(A);
  • Develop and implement a risk management plan to address and mitigate any security risks and vulnerabilities identified in the Risk Analysis acceptable to OCR;
  • Implement a process for regularly evaluating environmental and operational changes that affect the security of Cottage Health’s  ePHI;
  • Develop, maintain, and revise, as necessary, written policies and procedures to comply with the Federal standards that govern the privacy and security of individually identifiable health information under 45 C.F.R. Part 160 and Subparts A, C, and E of Part 164 (the “Privacy Rule” and “Security Rule”).
  • Distribute to and conduct training on the HIPAA policies and procedures from all existing and new members of the Cottage Health workforce with access to PHI.  Additionally, Cottage Health require all workforce members that have access to PHI to certify their receipt of, understanding and commitment to comply with the HIPAA Policies before allowing access to PHI and must deny access to PHI to any workforce member that has not provided the required certification.
  • Submit to ongoing notification and reporting requirements to keep OCR informed about its compliance efforts.

2018 Record Setting HIPAA Enforcement Year

The final Resolution Agreement negotiated by OCR in 2018, the $3 million Cottage Health Resolution Agreement signed on December 11, 2018 added to an already record-setting year of HIPAA enforcement recoveries by OCR.  In addition to recovering the single largest individual HIPAA settlement in history of $16 million with Anthem, Inc.  OCR’s recovery of the following HIPAA settlements and fines totaling nearly $28.7 million surpassed its previous 2016 record of $23.5 million by 22 percent.

Date Name

Amount

Jan. 2018 Filefax, Inc (settlement) $      100,000
Jan. 2018 Fresenius Medical Care North America (settlement) $   3,500,000
June 2018 MD Anderson (judgment) $   4,348,000
Aug. 2018 Boston Medical Center (settlement) $      100,000
Sep. 2018 Brigham and Women’s Hospital (settlement) $      384,000
Sep. 2018 Massachusetts General Hospital (settlement) $      515,000
Sep. 2018 Advanced Care Hospitalists (settlement) $      500,000
Oct. 2018 Allergy Associates of Hartford (settlement) $      125,000
Oct. 2018 Anthem, Inc (settlement) $ 16,000,000
Nov. 2018 Pagosa Springs (settlement) $      111,400
Dec. 2018 Cottage Health (settlement) $   3,000,000
Total (settlements and judgment) $ 28,683,400

Aside from the previously discussed Cottage Health Resolution Agreement OCR announced on February 7, 2019, these OCR 2018 enforcement recoveries included:

  • FileFax Resolution Agreement.  In January 2018, OCR settled for $100,000 with Filefax, Inc., a medical records maintenance, storage, and delivery services provider.  OCR’s investigation found that Filefax impermissibly disclosed protected health information (PHI) by leaving the PHI in an unlocked truck in the Filefax parking lot, or by granting permission to an unauthorized person to remove the PHI from Filefax, and leaving the PHI unsecured outside the Filefax facility.
  • Fresenius Medical Care North America Resolution Agreement.  In January 2018, OCR also settled for $3.5 million with Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure.  FMCNA filed five breach reports for separate incidents occurring between February 23, 2012 and July 18, 2012, implicating the electronic protected health information (ePHI) of five FMCNA owned covered entities.  OCR’s investigation revealed that FMCNA failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI.  Additional potential violations included failure to implement policies and procedures and failure to implement a mechanism to encrypt and decrypt ePHI, when it was reasonable and appropriate to do so under the circumstances.
  • MD Anderson ALJ Ruling.  In June 2018, an HHS Administrative Law Judge ruled in favor of OCR and required The University of Texas MD Anderson Cancer Center (MD Anderson), a Texas cancer center, to pay $4.3 million in civil money penalties for HIPAA violations.  OCR investigated MD Anderson following three separate data breach reports in 2012 and 2013 involving the theft of an unencrypted laptop from the residence of an MD Anderson employee and the loss of two unencrypted universal serial bus (USB) thumb drives containing the unencrypted ePHI of over 33,500 individuals.  OCR’s investigation found that MD Anderson had written encryption policies going back to 2006 and that MD Anderson’s own risk analyses had found that the lack of device-level encryption posed a high risk to the security of ePHI. Despite the encryption policies and high risk findings, MD Anderson did not begin to adopt an enterprise-wide solution to encrypt ePHI until 2011, and even then it failed to encrypt its inventory of electronic devices containing ePHI between March 24, 2011 and January 25, 2013.  This matter is under appeal with the HHS Departmental Appeals Board.
  • MMC/BWH/MGH Resolution Agreements.  In September 2018, OCR announced that it has reached separate settlements totaling $999,000, with Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH) for compromising the privacy of patients’ PHI by inviting film crews on premises to film an ABC television network documentary series, without first obtaining authorization from patients.
  • ACH Resolution Agreement.  In September 2018, OCR also settled with Advanced Care Hospitalists (ACH), a contractor physician group, for $500,000.  ACH filed a breach report confirming that ACH patient information was viewable on a medical billing services’ website.  OCR’s investigation revealed that ACH never had a business associate agreement with the individual providing medical billing services to ACH, and failed to adopt any policy requiring business associate agreements until April 2014.  Although ACH had been in operation since 2005, it had not conducted a risk analysis or implemented security measures or any other written HIPAA policies or procedures before 2014.
  • Allergy Associates Resolution Agreement.  In October 2018, OCR settled with Allergy Associates, a health care practice that specializes in treating individuals with allergies, for $125,000.  In February 2015, a patient of Allergy Associates contacted a local television station to speak about a dispute that had occurred between the patient and an Allergy Associates’ doctor. OCR’s investigation found that the reporter subsequently contacted the doctor for comment and the doctor impermissibly disclosed the patient’s PHI to the reporter.
  • Anthem Resolution Agreement.  In October 2018, Anthem, Inc. also paid $16 million to OCR and agreed to take substantial corrective action to settle potential violations of the HIPAA Rules after a series of cyberattacks led to the largest U.S. health data breach in history.  Anthem filed a breach report after discovering cyber-attackers had gained access to their IT system via an undetected continuous and targeted cyberattack for the apparent purpose of extracting data, otherwise known as an advanced persistent threat attack.  After filing their breach report, Anthem discovered cyber-attackers had infiltrated their system through spear phishing emails sent to an Anthem subsidiary after at least one employee responded to the malicious email and opened the door to further attacks. OCR’s investigation revealed that between December 2, 2014 and January 27, 2015, the cyber-attackers stole the ePHI of almost 79 million individuals, including names, social security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information.
  • Pegosa Springs Medical Center.  In November 2018, Pagosa Springs Medical Center (PSMC), a critical access hospital, paid $111,400 to OCR to resolve potential violations concerning a former PSMC employee that continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ ePHI, after separation of employment. OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a business associate agreement in place.

These 2018 Resolution Agreements reaffirm the growing risks that Covered Entities and their business associates run by failing to take adequate steps to prevent and respond to breaches of ePHI and otherwise to maintain their compliance with HIPAA.  Covered entities and business associates and their leaders should recognize and respond to these growing risks by reevaluating and strengthening their HIPAA compliance and risk management efforts to minimize the likelihood of violations and enhance their ability to mitigate potential liability that can result from breaches of HIPAA by responding efficiently and effectively.

Other Regulatory & Enforcement Developments

In addition to reaffirming their ongoing compliance with the longstanding requirements of HIPAA and other related federal and state laws, Covered Entities also should use care to carefully monitor and respond to new regulatory and other developments that might create new responsibilities or new opportunities to simplify their HIPAA compliance.  In this respect, Covered Entities should take note of the 2018 and ongoing efforts by OCR to develop and publish new rules and other guidance intended to help health care providers and other Covered Entities, patients and caregivers and others understand their rights and responsibilities when dealing with protected health information in relation to patients afflicted with substance abuse and mental illness.   Undertaken as part of the Trump Administration’s broader effort to combat opiate and other substance abuse within the United States, OCR in October published a package of guidance on How HIPAA Allows Doctors To Respond To The Opioid Crisis.  Covered Entities and others concerned with the management of patients afflicted with substance abuse and mental illness should evaluate this guidance to understand and tailor their practices to respond to OCR’s perspectives of how HIPAA impacts the use, access and disclosure of protected health information as part of these efforts.

Covered Entities and others concerned about HIPAA compliance and interpretation also should carefully monitor and provide appropriate and timely input on developing HIPAA guidance that could impact their operations.  In this regard, Covered Entities with ideas about opportunities for improving existing HIPAA guidance are encouraged to submit comments to OCR by February 12, 2019 in response to its Request for Information on improving care coordination and reducing the regulatory burdens of the HIPAA Rules  published on December 12, 2018.  In that RFI, OCR invites input from the public on how the HIPAA Privacy Rule, could be modified to:

  • Encourage information-sharing for treatment and care coordination;
  • Facilitate parental involvement in care;
  • Address the opioid crisis and serious mental illness;
  • Account for disclosures of PHI for treatment, payment, and health care operations as required by the HITECH Act;
  • Change the current requirement for certain providers to make a good faith effort to obtain an acknowledgment of receipt of the Notice of Privacy Practices; and/or
  • Otherwise simplify or improve the existing HIPAA rules.

As a part of these efforts, Covered Entities and other concerned parties also should anticipate that OCR will be focusing heavily in the upcoming year on the potential HIPAA privacy and security implications of efforts by its sister agency, the Office of the National Coordinator for Health Information Technology (“ONC”), to promote greater interoperability of electronic medical records discussed in ONC’s recent 2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (“Report”).

Under the 21st Century Cures Act, Congress gave ONC authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:

  • The development and use of upgraded health IT capabilities;
  • Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
  • Improvement of the health IT end-user experience, including by reducing administrative burden.

These priorities seek to increase nationwide interoperability of health information and reduce clinician burden.  The Report says increases in the adoption of health IT means most Americans receiving health care services now have their health data recorded electronically. However, this information is not always accessible across systems and by all end users—such as patients, health care providers, and payers—in the market in productive ways.  While the Report states ONC intends to move forward to promote efforts to help ensure that electronic health information can be shared safely and securely where appropriate to improve the health and care of all Americans, these activities inherently will raise many HIPAA concerns and challenges.  Covered Entities and others concerned with these activities will want to carefully monitor the concurrent activities of OCR and ONC as these efforts progress, both to help tailor their planning and compliance efforts to respond to the anticipated demand for greater interoperability as required by ONC and to help shape these rules by providing timely input as appropriate in response to these developments.

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.™

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NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal 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.


ONC Report Signals New Interoperability Demands Coming

January 8, 2019

Interoperability will be a key priority for the Office of the National Coordinator for Health Information Technology (“ONC”) going forward.

That’s the message in the just released 2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (“Report”).

The plan to promote interoperability raises new business and compliance planning opportunities for health care providers, health insurers and other payers, health data and information technology (IT) providers and others.

The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act.

Under the 21st Century Cures Act, Congress gave HHS authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:

  • The development and use of upgraded health IT capabilities;
  • Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
  • Improvement of the health IT end user experience, including by reducing administrative burden.

These priorities seek to increase nationwide interoperability of health information and reduce clinician burden..

Current Status

The Report says increases in the adoption of health IT means most Americans receiving health care services now have their health data recorded electronically. However, this information is not always accessible across systems and by all end users—such as patients, health care providers, and payers—in the market in productive ways. For example:

  • Despite the individual right to access health information about themselves established by the HIPAA Privacy Rule, patients often lack access to their own health information, which hinders their ability to manage their health and shop for medical care at lower prices;
  • Health care providers often lack access to patient data at the point of care, particularly when multiple health care providers maintain different pieces of data, own different systems, or use health IT solutions purchased from different developers; and
  • Payers often lack access to clinical data on groups of covered individuals to assess the value of services provided to their customers.
  • The Report says these limitations create several problems, including:
    • Patients should be able to easily and securely access their medical data through their smartphones. Currently, patients electronically access their health information through patient portals that prevent them from easily pulling from multiple sources or health care providers. Patient access to their electronic health information also requires repeated use of logins and manual data updates.
    • For health care providers and payers, interoperable access and exchange of health records is focused on accessing one record at a time.
    • Payers cannot effectively represent their members if they lack computational visibility into which health care providers offer the highest quality care at the lowest cost. Without the capability to access multiple records across a population of patients, health care providers and payers will not benefit from the value of using modern computing solutions—such as machine learning and artificial intelligence—to inform care decisions and identify trends.
    • Payers and employer group health plans which purchase health care have little information on health outcomes. Often, health care providers and payers negotiate contracts based on the health care provider’s reputation rather than on the quality of care that health care provider offers to patients. Health care providers should instead compete based on the entire scope of the quality and value of care they provide, not on how exclusively they can craft their networks. Outcome data will allow payers to apply machine learning and artificial intelligence to have better insight into the value of the care they purchase.
  • Current Barriers
  • According to the Report, HHS heard from stakeholders over the past year that barriers to interoperable access to health information remain, including technical, financial, trust, and business practice barriers. These barriers impede the movement of health information to where it is needed across the care continuum. In addition, burden arising from quality reporting, documentation, administrative, and billing requirements that prescribe how health IT systems are designed also hamper the innovative usability of health IT.
  • Current and Upcoming Actions
  • The Report states HHS has many efforts to help ensure that electronic health information can be shared safely and securely where appropriate to improve the health and care of all Americans.
  • ONC also reports Federal agencies, states, and industry have taken steps to address technical, trust, and financial challenges to interoperable health information access, exchange, and use for patients, health care providers, and payers (including insurers). HHS aims to build on these successes through the ONC Health IT Certification Program, HHS rulemaking, health IT innovation projects, and health IT coordination.
  • In accordance with the Cures Act, HHS is actively leading and coordinating a number of key programs and projects. These include continued work to deter and penalize poor business practices and that HHS conducted multiple outreach efforts to engage the clinical community and health IT stakeholders to better understand these barriers, challenges, and health care provider burden.
  • Recommendations
  • The Report makes the following overarching recommendations for future actions HHS plans to support through its policies and that the health IT community as a whole can take to accelerate progress:
    • Focus on improving interoperability and upgrading technical capabilities of health IT, so patients can securely access, aggregate, and move their health information using their smartphones (or other devices) and health care providers can easily send, receive, and analyze patient data.
      Increase transparency in data sharing practices and strengthen technical capabilities of health IT so payers can access population-level clinical data to promote economic transparency and operational efficiency to lower the cost of care and administrative costs.
      Prioritize improving health IT and reducing documentation burden, time inefficiencies, and hassle for health care providers, so they can focus on their patients rather than their computers.

    The Report also says interoperable access underpins HHS’s efforts to pursue a health care system where data are available when and where needed.

    ONC intends to particularly focus on promoting open APIs. Open APIs are technology that allow one software program to access the services provided by another software program and can improve access and exchange of health information. ONC says APIs can:

    • Support patients’ ability to have more access to information electronically through, for example, smartphones and mobile applications. HHS applauds the emergence of patient-facing applications that allow patients to access, aggregate, and act on their health information; and
    • Allow payers to receive necessary and appropriate information on a group of members without having to access one record at a time.
    • Increase institutional accountability, support value- based care models, and lead to competitive medical care pricing that benefits patients.

    The Report claims patients, health care providers, and payers with appropriate access to health information can use modern computing solutions to generate value from the data. Improved interoperability can strengthen market competition, result in greater quality, safety, and value for the healthcare system, and enable patients, health care providers, and payers to experience the benefits of health IT.

    Prepare For Enhanced Operability Requirements

    ONC’s plan to achieve greater interoperability presents new business and compliance planning opportunities and challenges for health care providers, health insurers and other payers, health data and information technology (IT) providers and others. Among other things, participants in the healthcare system and their suppliers will need to prepare to comply with new expectations and mandates for interoperability. Meeting these demands will require financial expenditures as well as present technological challenges.The increased availability and access to electronica medical records and information resulting from these changes also a can be expected to drive new challenges and demands. Among other things, businesses relying on control of health information or records to influence or control patience, reimbursement, or other business value need to reevaluate and adjust their business models accordingly.

    Improve accessibility and interoperability also is likely to create new expectations and demands by patients, payers, other providers and perhaps most significantly for providers and payers, regulators. Participants in the system will need to understand these applications and prepare to both defend their business performance as well as their compliance taking into account these new demands.

    Amid all of this, of course, providers, pears, and their business associates can anticipate continued if not enhanced demands for enhanced data security and privacy protections and accompanying enforcement of these standards.

    As ONC move forward on its plans to enhance interoperability, all concerned stakeholders will want to monitor developments and provide thoughtful and timely input. The time to get started is now. ONC and it’s sister agency, the Office of Civil Rights currently are inviting public comments about how to achieve these and other health IT and privacy improvements. Those interested in providing input should make sure their comments are submitted by the applicable deadlines next month.

    Read the full Report here and share your input by the specified deadlines.

    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 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; 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; 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.


    2/11/19 Deadline To Comment On Reducing HIPAA Regulatory Burden

    December 13, 2018

    February 12, 2019 is the deadline for health care providers, health plans, health care clearinghouses, their business associates, health care consumers, employer and other plan sponsors and fiduciaries, and other concerned persons to provide input on reducing the regulatory burdens of the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security and Breach Notification Rules in response to the December 12, 2018 invitation of the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR).

    OCR issued the invitation for public comment in a December 12, 2019 Request for Information (RFI).  The RIF seeks input from the public on how OCR’s HIPAA Privacy and other Rules could be modified to further the HHS Secretary’s goal of promoting coordinated, value-based healthcare. This RFI is a part of the Regulatory Sprint to Coordinated Care, an initiative led by HHS Deputy Secretary Eric Hargan.

    HHS developed the HIPAA Rules to protect individuals’ health information privacy and security interests, while permitting information sharing needed for important purposes. However, in recent years, OCR has heard calls to revisit aspects of the Rules that may limit or discourage information sharing needed for coordinated care or to facilitate the transformation to value-based health care. The RFI requests information on any provisions of the HIPAA Rules that may present obstacles to these goals without meaningfully contributing to the privacy and security of protected health information (PHI) and/or patients’ ability to exercise their rights with respect to their PHI.

    OCR’s December 12, 2018 press release concerning the RFI indicates that OCR is looking for candid feedback about how the existing HIPAA regulations are working in the real world and how OCR can improve them to improve quality of care and eliminate undue burdens on covered entities while maintaining robust privacy and security protections for individuals’ health information.

    In addition to requesting broad input on the HIPAA Rules, the RFI also seeks comments on specific areas of the HIPAA Privacy Rule, including:

    • Encouraging information-sharing for treatment and care coordination
    • Facilitating parental involvement in care
    • Addressing the opioid crisis and serious mental illness
    • Accounting for disclosures of PHI for treatment, payment, and health care operations as required by the HITECH Act
    • Changing the current requirement for certain providers to make a good faith effort to obtain an acknowledgment of receipt of the Notice of Privacy Practices

    Public comments on the RFI are due by February 11, 2019.

    The RFI follows up on OCR’s announcement of another series of high dollar resolution agreements against covered entities and business associates for alleged breaches of HIPAA’s Privacy or Security Rules, as well as publication of various new guidance intended to help patients, their families, covered entities, business associates and others understand when HIPAA restricts or allows the release of protected health information by covered entities and business associates in mass shooting or other disaster situations, when dealing with patients with substance abuse or mental health conditions and in various other scenarios.  Covered entities, their business associates as well as employer and other health plan sponsors, fiduciaries and others involved with protected health information transactions and disclosures should review this new guidance and evaluate its implications on their actions and practices in addition to sharing input with OCR about opportunities to improve existing HIPAA Rules.

    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 care and health benefit arrangements, contracts, systems, and processes throughout her career.  In addition to her extensive provider and payer contracting work, Ms. Stamer also is recognized for her knowledge, experience and leadership on health benefit, health care, health, financial and other information technology, data and related process and systems development, policy and operations throughout her career, and 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. 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 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; 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; 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.

    As a key part of this work, Ms. Stamer throughout her career regularly has worked with health care providers and payers, employer and other health benefit plan sponsors and vendors, health industry, insurers, health IT, life sciences and other health and insurance industry clients design, document and enforce managed care and other contracts, benefit plans and insurance arrangements, practices, policies, systems and solutions; manage regulatory, contractual and other legal and operational compliance; vendors, supplier, and patient and member relations and requirements; deal with Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA, state insurance law and other private payer rules and requirements; contracting; licensing; terms of participation; medical billing, reimbursement, claims administration and coordination, and other provider-payer relations; reporting and disclosure, government investigations and enforcement, privacy and data security; and other 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; HIPAA administrative simplification, 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, HEDIS 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.

    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.

    ©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.


    Allergy Practice $125,000 Settlement Reminds Health Care Providers, Other HIPAA Entities Of Press-Related HIPAA Risk

    November 27, 2018

    Physician practices and other health care providers, health plans and insurers, health care clearinghouses (“Covered Entities”) and their business associates should learn from the costly schooling the Allergy Associates of Hartford, P.C. (“Allergy Associates”) is paying to settle charges that its physician violated the Privacy Rules of the Health Insurance Portability and Accountability Act (“HIPAA”) by commenting to a reporter on a patient complaint under a Resolution Agreement and Corrective Action Plan (“Resolution Agreement”) announced by the Department of Health & Human Services (HHS) Office of Civil Rights (“OCR”) yesterday (November 26, 2018).  The latest in a series of OCR HIPAA settlements arising from health care providers improperly discussing or disclosing protected health information (PHI) with the press or other media, the Resolution Agreement reminds health care providers and other HIPAA-Covered Entities and their business associates not to discuss or disclose PHI  with the media or others without first obtaining a HIPAA compliant authorization even to respond to accusations made by the patient or others.

    Allergy Associates HIPAA Complaint Charge & Resolution

    On November 26, 2018, OCR announced  that Allergy Associates, a three doctor health care practice that specializes in treating individuals with allergies at four locations across Connecticut, has agreed to pay OCR $125,000 and take corrective action under the Resolution Agreement to resolve charges that the comments a physician made to a reporter on a patient dispute with the practice in 2015 violated HIPAA.

    According to OCR, the disclosure of patient information that prompted OCR’s HIPAA charges resulted from a physician associated with the practice commenting to a local television station reporter doing on a story about a disabled patient’s complaint to the station that Allergy Associates turned her away from a scheduled appointment because of her use of a service animal.  After the patient contacted the television statement to complain about being turned away by the practice when accompanied by her service animal, the Resolution Agreement indicates that the station contacted the doctor for comment about the dispute between the Allergy Associates’ doctor and the patient.  Although OCR reports its investigation revealed that Allergy Associates’ Privacy Officer instructed the doctor to either not respond to the media or respond with “no comment,” the doctor nevertheless accepted the television station reporter’s invitation to comment and discussed the dispute with the reporter.

    The physician’s comments to the reporter were brought to the attention of OCR when OCR received a copy of an October 6, 2015, HHS civil rights complaint filed on behalf of the patient with the Department of Justice, Connecticut, U.S. Attorney’s Office (DOJ) by the Connecticut Office of Protection and Advocacy for Persons with Disabilities (OPA).  In response to this complaint, OCR initiated a joint investigation with DOJ into the civil rights allegations against Allergy Associates. The complaint also alleged that Allergy Associates impermissibly disclosed the patient’s PHI in violation of HIPAA.

    OCR found the physician’s discussion of the patient’s complaint without first obtaining a HIPAA-complaint authorization from the patient both violated HIPAA and demonstrated a reckless disregard for the patient’s HIPAA privacy rights.  Additionally, Resolution Agreement also states that OCR’s investigation revealed that Allergy Associates did not take any disciplinary or other corrective action against the doctor after learning of his impermissible disclosure to the media.

    To resolve the HIPAA charges, Allergy Associates agrees in the Resolution Agreement and Corrective Action Plan to pay $125,000 as well as to undertake a corrective action plan that includes two years of monitoring their compliance with the HIPAA Rules.

    Other Providers Also Paid High Price To OCR For Sharing PHI With Media

    Of course, OCR enforcement action against and Resolution Agreement with Allergy Associates is just one of several reported OCR actions against health care providers for improperly disclosing or allowing the press or other media access to PHI without patient authorization.

    For instance, a Resolution Agreement announced by OCR on June 14, 2013 required Shasta Regional Medical Center (SRMC) to pay OCR $275,000 and implement a series of corrective actions for using and disclosing to the media PHI of a patient while trying to perform public relations damage control against accusations reported in the media that SRMC had engaged in fraud or other misconduct when dealing with the patient.   That Resolution Agreement resulted from OCR investigating a January 4, 2012 Los Angeles Times article report that two SRMC senior leaders had met with media to discuss medical services provided to a patient.  OCR’s investigation indicated that SRMC failed to safeguard the patient’s PHI from impermissible disclosure by intentionally disclosing PHI to multiple media outlets on at least three separate occasions, without a valid written authorization. OCR’s review also revealed senior management at SRMC impermissibly shared details about the patient’s medical condition, diagnosis and treatment in an email to the entire workforce.  Further, SRMC failed to sanction its workforce members for impermissibly disclosing the patient’s records pursuant to its internal sanctions policy.

    The sanctions were even greater in the May 10, 2017 Resolution Agreement and Corrective Action Plan OCR announced with the largest not-for-profit health system in Southeast Texas, Memorial Hermann Health System (MHHS) for issuing a press release with the name and other PHI  about a patient arrested and charged with presenting an allegedly fraudulent identification card to MHHS office staff to fraudulently obtain care without first obtaining a HIPAA-compliant authorization from the patient. MHHS paid OCR a $2.4 million resolution payment to resolve HIPAA charges OCR brought against MHHS as well as agreed to implement a detailed corrective action plan.  See $2.4M HIPAA Settlement Warns Providers About Media Disclosures Of PHI.

    The costs of resolution have been even higher when OCR has addressed disclosures to media made by health care providers or other Covered Entities that allowed their desire for media publicity and coverage of their organizations ahead of patient privacy.  For instance, OCR collected a $2.2 million resolution payment from New York Presbyterian Hospital (NYP) for allowing unauthorized filming and photographing of patients in its facility by a television film crew and other staff filming for the television program “NY Med”  in the hospital.  See $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use.

    Furthermore, earlier this year OCR collected a total of $999,0000 from Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH)(collectively, the “Hospitals”) for putting publicity before patient privacy by allowing ABC News documentary film crews to film patients and access other patient information for a news documentary without obtaining prior patient authorization under three settlement agreements with the Hospitals announced by OCR in September, 2018.  The payments were made under three separate settlement agreements between OCR and each respective Hospital made public by OCR in connection with the September 20, 2018 announcement stemming from the Hospital’s allowing ABC film crews to film in patient treatment and other areas for  the ABC medical documentary “Save My Life: Boston Trauma” series.  See $999K Price Hospitals Pay To Settle HIPAA Privacy Charges From Allowing ABC To Film Patients Without Authorization.

    OCR’s concern about and intolerance for improper disclosures of PHI to the media by health care providers and other Covered Entities is further demonstrated by OCR’s publication of  its 2016 Frequently Asked Question (Media FAQ) addressing Covered Entities’ responsibilities when dealing with the media coincident with OCR’s announcement of its Resolution Agreement with NYP in 2016.   The Allergy Associates’ Resolution Agreement further reinforces OCR’s continuing commitment to hold health care providers and other Covered Entities and their business associates accountable for complying with HIPAA when dealing with the press and other media.  In the fact of this commitment, health care providers and other Covered Entities must take the necessary steps to implement the appropriate policies, training and controls to ensure that they and their staff and representatives comply with these directives when dealing with press and other media.

    Resolution Agreement Also Highlights Need For Sensitivity When Dealing With Disabled Patients With Service Animals

    Beyond the HIPAA charges and settlement discussed in the Resolution Agreement, health care providers and other Covered Entities also should heed the factual circumstances that prompted the television interview of the Allergy Associates’ physician that prompted the OCR HIPAA enforcement action as a precautionary warning to ensure that their policies, procedures and staff training for dealing with disabled patients supported by service animals are defensible legally and in the court of public opinion.

    The Allergy Associates Resolution Agreement states that OCR’s HIPAA investigation was conducted in response to and in tandem with a Department of Justice (“Justice Department”) Office of Civil Rights investigation of a complaint that Allergy Associates violated the patient’s civil rights by improperly refusing to allow the patient’s service animal to accompany the patient during the patient’s appointment.  The patient’s complaint about the practice that the television reporter asked for and obtained the comments from the Allergy Associates’ physician that OCR found violated HIPAA related to Allergy Associates refusing to allow the patient to be accompanied by her service animal during her appointment with Allergy Associates.

    While research as of the date of the publication of this article did not uncover any published record of any Justice Department prosecution or settlement or other official notification concerning the Justice Department civil rights investigation against Allergy Associates, the Justice Department Office of Civil Rights as well as the HHS OCR Civil Rights Division have in the past pursued enforcement action against health care providers and others for improperly restricting or denying access to care or facilities by disabled persons based on their accompaniment by service animals.

    Title III of the Americans With Disabilities Act (“ADA”) generally prohibits places of public accommodations, including the professional office of a health care provider, from discriminating against any individual on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation, by any person who owns, leases (or leases to), or operates a place of public accommodation, including health care services. 42 U.S.C. § 12182(a); 28 C.F.R. § 36.201. The ADA also requires that such entities make reasonable modifications in policies, practices, or procedures to permit the use of service animals by people with disabilities. 42 U.S.C. § 12182(b)(2)(A)(ii); 28 C.F.R. § 36.302(c).  Health care providers also generally are prohibited from discriminating against and required to provide accommodation to individuals with disabilities under the Rehabilitation Act and the Medicare statutes.

    The Justice Department, HHS and courts have interpreted these disability prohibition and accommodation laws as making it illegal for a health care provider or its agent to fail to make reasonable accommodations for a person with a service animal unless the health care provider proves (1) the accommodations would fundamentally alter the nature of the facility or service it provides; or (2) based upon an individual assessment, the hospital determines that the service animal poses a substantial and direct threat to health or safety which cannot be mitigated by reasonable accommodations.  See, e.g., Tamara v. El Comino Hospital, 964 F.Supp.2d 1077 (N.D.Ca. 2013).

    While other types of discriminatory actions by health care providers found to be in violation of these rules often trigger substantial damage awards, administrative penalties, disqualification or restriction of Medicare and other federal program participation for violation of Conditions of Participation, to date the reported agency and judicial enforcement actions brought against health care providers for improperly refusing to allow service animals to accompany patients when accessing facilities or receiving care generally have ordered injunctive or other corrective action but have not imposed substantial damage or administrative penalties upon the culpable provider.  Health care providers should avoid the temptation to underestimate the potential seriousness or liability that their organization is likely to incur based on the current lack of substantial financial damage awards or administrative sanctions, however.  The 11th Circuit’s ruling in Sheely v. MRI Radiology Network, P.A., 505 F.3d 1173 (11th Cir. 2007), that noneconomic compensatory damages were available as a remedy for the emotional distressed caused by the violation under the Rehabilitation Act and that the voluntary correction of its policies during the pendency of the litigation did not render moot Sheely’s claim for monetary relief clearly opens the door for a jury to award substantial damages against a health care provider when the jury perceives the circumstances warrant.   Furthermore, health care providers need to keep in mind the typically financial and operational burdens of defending litigation or a Justice Department or HHS OCR Civil Rights investigation and costs of implementation and compliance with administrative or injunctive orders to take corrective action as well as the negative public relations attend these types of complaints, their investigation and resolution. Moreover, health care providers participating in Medicare, Medicaid or other federal health care programs also need to take into account the possibility that an alleged violation of these nondiscrimination rules also can serve as a basis for investigation of compliance with applicable Conditions of Participation for program participation and reimbursement.  Considering these risks, physician and other health care providers should heed the reminder of their obligations to offer and provide proper accommodation to allow appropriate access to disabled individuals with disabilities  requiring service animal support and take steps to review and update their policies, practices and staff training to minimize the risk of potential charges of violation of these requirements.

    Health Care Providers, Other Covered Entities Encouraged To Act To Manage HIPAA & Disability Accommodation Risks

    The Allergy Associates and other HIPAA Resolution Agreements arising from improper sharing of PHI with the press or other media make clear the need for health care providers and other Covered Entities to exercise great care when dealing with the press and other media.

    Clearly, health care providers and other Covered Entities should heed the warning by conducting a risk assessment of their organization’s susceptibility to potential improper disclosures to media or others and reviewing and implementing necessary written policies, procedures and training to prevent the improper disclosure of patient PHI to media or others unless the Covered Entity either secures prior HIPAA-compliant authorization from the patient or can prove the disclosure falls squarely under an exception to the Privacy Rule’s prohibition against disclosure of PHI without authorization except as allowed by the Privacy Rule.

    Based on experiences reported in the Allergy Associates and other Resolution Agreements and OCR guidance concerning media disclosures, Covered Entities also generally will want to ensure that their policies, procedures and training extend to all potential sources of communications that could involve patient information and make clear that the Privacy Rule restrictions must be followed even if the circumstances involve allegations of misconduct, special performance by healthcare providers or others that it would benefit the organization or certain individuals to have known to the public, or other circumstances likely to be of interest to the media or other parties.

    As part of this process, health care providers and other Covered Entities should ensure they look outside the four corners of their Privacy Policies to ensure that appropriate management, supervision, training and direction is provided to address media, practice transition, workforce communication and other policies and practices that may be covered by pre-existing or other policies of other departments or operational elements not typically under the direct oversight and management of the Privacy Officer such as media relations. Media relations, physician and patients affairs, outside legal counsel, media relations, marketing and other internal and external departments and consultants dealing with the media, the public or other inquiries or disputes should carefully include and coordinate with the privacy officer both to ensure appropriate policies and procedures are followed and proper documentation created and retained to show authorization, account, or meet other requirements.

    In conducting this analysis and risk assessment, it also is important that Covered Entities include, but also look beyond the four corners of their Privacy Policies to ensure that their review and risk assessment identifies and assesses and addresses compliance risks on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer.

    For this reason, Covered Entities also generally will not only to adopt and implement specific policies, processes and training in these other departments to prohibit and prevent inappropriate disclosures of PHI in the course of those departments operations. As part of these processes, Covered Entities generally will want to implement a  pre-established process for reviewing media or other communications for potential PHI content which includes a requirement for  prior review of any proposed public relations and other internal or external communications containing patient PHI or other information by the privacy officer, legal counsel or another suitably qualified party.

    Because of the high risk that the preparation or review of media or other public communications reports will involve the use and disclosure of PHI, Covered Entities also generally should verify that all outside media or public relations, legal, or other outside service providers participating in the investigation, response or preparation or review of communications to the media or others both are covered by signed business associate agreements that fulfill the Privacy Rule and other requirements of HIPAA as well as possess detailed knowledge and understanding of the Privacy and Security Rules suitable to participate in and help safeguard the Covered Entity against violations of these and other Privacy Rules. See e.g., Latest HIPAA Resolution Agreement Drives Home Importance Of Maintaining Current, Signed Business Associate Agreements.

    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 care and health benefit arrangements, contracts, systems, and processes throughout her career.  In addition to her extensive provider and payer contracting work, Ms. Stamer also is recognized for her knowledge, experience and leadership on health benefit, health care, health, financial and other information technology, data and related process and systems development, policy and operations throughout her career, and 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. 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 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; 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; 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.

    As a key part of this work, Ms. Stamer throughout her career regularly has worked with health care providers and payers, employer and other health benefit plan sponsors and vendors, health industry, insurers, health IT, life sciences and other health and insurance industry clients design, document and enforce managed care and other contracts, benefit plans and insurance arrangements, practices, policies, systems and solutions; manage regulatory, contractual and other legal and operational compliance; vendors, supplier, and patient and member relations and requirements; deal with Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA, state insurance law and other private payer rules and requirements; contracting; licensing; terms of participation; medical billing, reimbursement, claims administration and coordination, and other provider-payer relations; reporting and disclosure, government investigations and enforcement, privacy and data security; and other 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; HIPAA administrative simplification, 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, HEDIS 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.

    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.

    ©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.


    Record $16M HIPAA Sanction Shows Need For Current Enterprise Risk Assessment; ONC/OCR Share New Tool To Help HIPAA Covered Entities Comply

    October 17, 2018

    Following on the heels of Monday’s announcement that Anthem, Inc. is paying a record setting $16 million to resolve charges its violations of the enterprise risk assessment and other requirements of the Health Insurance Portability & Accountability Act (HIPAA) Security Rule allowed cybercriminals to breach the electronic protected health information (ePHI) of more than 79 million patients, physicians and other health care providers, health plans and health insurers, health care clearinghouses (covered entities) and their service providers acting as their business associates (business associates) (hereafter collectively “HIPAA Entities”) should reconfirm their own and their business associates’ compliance with the HIPAA Security Rule’s enterprise risk assessment and other ePHI security requirements.

    When conducting these assessments, HIPAA Entities generally will want to ensure that their new enterprise risk assessment documents their consideration of the newly updated Security Risk Assessment (SRA) Tool jointly announced yesterday (October 16, 2018) by the Department of Health & Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and OCR, lessons shared in OCR’s $16 million Anthem, Inc. resolution agreement, $5.55 million resolution agreement with Memorial Healthcare System and other OCR HIPAA resolution agreements, civil monetary penalty assessments and other Security Rule guidance, as well as other emergent internal and external data suggesting potential susceptibilities of their own systems and data to breach or loss.

    HIPAA Entities are reminded that HIPAA requires that all HIPAA covered entities and business associates to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by their organization.  Any HIPAA Entity that hasn’t already conducted a recent, appropriately documented enterprise wide risk analysis or updated their analysis in response to changes in equipment, vendors or emerging threats and developments should do so as soon as possible.

    HIPAA’s requirement that HIPAA entities conduct and maintain an appropriately comprehensive and timely updated enterprise-wide risk analysis of potential security threats to ePHI both an affirmative requirement of the HIPAA Security Rule and an indispensable process to help healthcare organizations understand their security posture to prevent, detect, respond to and mitigate potential legal, operational and reputational costs that commonly result when ePHI or other sensitive information is breached or destroyed.

    The importance of HIPAA entities having and being able to produce in the event of a breach or OCR audit an up-to-date, comprehensively enterprise risk assessment and response plan cannot be overstated.  Beyond OCR’s publication of extensive regulatory guidance and educational outreach discussing the responsibility to conduct and maintain documentation of appropriate enterprise risk assessments, virtually every announced HIPAA Security Rule civil monetary penalty assessment and other enforcement action identifies violation of the HIPAA Security Rule’s enterprise risk assessment requirements among the material transgressions committed and required to be corrected by HIPAA entities like Anthem, Inc. subjected to Security Rule enforcement.

    The updated SRA Tool jointly released by OCR and ONC on October 16, 2018 further reinforces the importance of complying with the enterprise wide risk assessment requirement while simultaneously encouraging and facilitating compliance by small to medium sized health care practices.  Particularly designed with an eye to helping health care providers that work as solo practitioners or in groups with 10 or less health care providers and their business associates identify risks and vulnerabilities to ePHI, OCR says the updated SRA Tool “provides enhanced functionality to document how such organizations can implement or plan to implement appropriate security measures to protect ePHI” and incorporates new features to make the tool “more user friendly.” New features OCR hopes will make the SRA tool more user friendly include:

    • Enhanced User Interface
    • Modular workflow with question branching logic
    • Custom Assessment Logic
    • Progress Tracker
    • Improved Threats & Vulnerabilities Rating
    • Detailed Reports
    • Business Associate and Asset Tracking
    • Overall improvement of the user experience

    HIPAA Entities should take note, however, that as of its October 16, 2018 released date, the updated version of the SRA Tool currently is only available in Windows format.  OCR has indicated that the OCR and ONC have not yet updated the OS iPad version of the previously published version of the SRA Tool. While the previous OS iPad version remains available at the Apple App Store exit disclaimer icon (search under “HHS SRA Tool”), HIPAA Entities that presently use or plan to use the OS iPad tool should consider comparing the prior tool against the updated Windows SRA Tool to verify the continued suitability of its continued use and any adjustments in understanding or application that might be warranted by these differences.  Additionally, HIPAA Entities also should review the revised User Guide available on the SRA Tool’s website before starting the assessment.

    While the SRA Tool provides valuable guidance to help HIPAA Entities to conduct their own enterprise wide risk assessment, HIPAA Entities should keep in mind that the responsibility to assess their enterprise wide risk and to update their security safeguards to respond to these risks is a continuous one.  While using the SRA Tool is an excellent starting point for beginning this assessment, HIPAA Entities need to realize that OCR expects HIPAA Entities to tailor their assessments to identify and respond to the full range of risks and exposures to their ePHI and associated systems and to constantly reevaluate and adjust these assessments in response to emerging system and ePHI threats identified in the course of their operations as well as external developments suggesting previously unidentified or inadequately appreciated threats.  Moreover, in addition to conducting the risk assessment, OCR regulatory guidance and guidance drawn from OCR’s civil monetary settlements resolution agreements and other enforcement and audit activities also make clear that in addition to conducting the enterprise wide risk analysis, HIPAA entities also need to be prepared to produce documentation that their organizations took appropriate and timely action to address the risks identified in the risk assessment in accordance with the HIPAA Security Rule.

    In addition to mitigate their exposure to potentially substantial HIPAA civil monetary penalties for violating the HIPAA Security Rule, HIPAA Entities also should keep in mind the potential role that their conduct and maintenance of appropriately comprehensive enterprise wide security risk assessments can play in helping to mitigate other legal, financial, operational and reputational risks that commonly also arise along with the HIPAA exposures associated with a breach of HIPAA.  In addition to HIPAA’s Security Rules for ePHI, HIPAA Entities typically also are subject to a hodgepodge of non-HIPAA statutory, regulatory and/or contractual obligations to safeguard patient, employee, business partners and other individual, financial, health, tax, peer review and credentialing, trade secrets and other confidential information against improper use, access, destruction or disclosure.  Examples of such obligations include the privacy and data security rules of the Fair and Accurate Credit Transaction Act (FACTA), the Internal Revenue Code and other tax laws, federal and state consumer debt and information, electronic crime, data security and identity theft statutes; federal and state trade secret and intellectual property laws; and others, for which violations often equal or substantially exceed the civil monetary penalty liability that commonly arise under the HIPAA Security Rule.  The experience of Anthem, Inc. illustrates this point.  While the $16 million resolution payment that OCR announced Anthem, Inc. is paying to resolve its HIPAA civil monetary penalty exposures for allowing the breach of the ePHI of 79 million individuals, this payment reflects only a very small portion of the overall liability that Anthem, Inc. incurred from data breach that lead to this resolution payment.  Anthem, Inc. also separately already reportedly also has paid more than $115 million to settle other statutory and contractual liabilities arising from the breach separate as well as substantial investigatory and defense costs in addition to the HIPAA liabilities settled under the resolution agreement announced Monday.  Other HIPAA Entities subjected to HIPAA civil monetary penalties or paying resolution payments to OCR also typically also have incurred substantial non-HIPAA sanctions and settlements, as well as other defense, investigation, operational and reputational losses as a result of their breaches.  HIPAA Entities should strive to ensure that their HIPAA enterprise wide risk assessment and compliance efforts are properly coordinated and administered to manage these overall risks and responsibilities in addition to their HIPAA-specific responsibilities and liabilities.

    Because enterprise wide risk assessments and discussions of their structuring, scope and findings are likely to produce legally sensitive evidence, HIPAA Entities are encouraged to seek the advice of qualified and suitably experienced legal counsel about the advisability of conducting all or certain aspects of an enterprise wide risk analysis and their documentation of their risk evaluation and response to take advantage of possible attorney-client privilege, work-product or other evidentiary rules before or throughout the risk assessment and response process and deliberations.

    About The Author

    A practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C, Cynthia Marcotte Stamer’s more than 30 years’ of leading edge work as an practicing attorney, author, lecturer and industry and policy thought leader have resulted in her recognition as a “Top” attorney in employee benefits, labor and employment and health care law.

    Board certified in labor and employment law by the Texas Board of Legal Specialization, a Fellow in the American College of Employee Benefit Counsel, Scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) Annual Agency Meeting with the Office of Civil Rights and a former JCEB Council Representative; former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; and past Chair, former Welfare Benefit Committee Co-Chair and current Fiduciary Responsibility Committee Co-Chair of the American Bar Association (ABA) RPTE Section Employee Benefits Group, former Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, Ms. Stamer is recognized nationally and internationally for her practical and creative insights and leadership on HIPAA and other health care, managed care and insurance, and other employee benefit, human resources, and related antitrust, corporate, privacy and data security, tax and other internal controls, regulatory affairs and public policy concerns.

    Ms. Stamer’s legal and management consulting work throughout her career has focused on helping organizations and their management use the law and process to manage people, process, 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 helps public and private, domestic and international health, insurance and financial security, and other businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

    In this respect, Ms. Stamer works with businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, regulatory compliance and operational and performance management. She supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

    Well known for her extensive work with health care, insurance and other highly regulated entities on corporate compliance, internal controls and risk management, her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes.

    As a key part of this work, Ms. Stamer uses her deep and highly specialized health, insurance, labor and employment and other knowledge and experience to help health industry, insurance and financial services and other employers and other employee benefit plan sponsors; health, pension and other employee benefit plans, their fiduciaries, administrators and service providers, insurers, and others design legally compliant, effective compliance and internal controls, risk management, human resources and other workforce performance, discipline, compensation, employee benefits and related programs, products and arrangements.

    In the course of this work, Ms. Stamer has accumulated an impressive resume of experience advising and representing clients on HIPAA and other privacy and data security concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights for several years, Ms. Stamer has worked extensively with health plans, health care providers, health care clearinghouses, their business associates, employer and other sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, 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 enforcement, and a host of other related concerns. Her clients include public and private health plans, health insurers, health care providers, banking, technology and other vendors, and others. Beyond advising these and other clients on privacy and data security compliance, risk management, investigations and data breach response and remediation, Ms. Stamer also advises and represents clients on OCR and other HHS, Department of Labor, IRS, FTC, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also is the author of numerous highly acclaimed publications, workshops and tools for HIPAA or other compliance including training programs 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, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

    Ms. Stamer also is deeply involved in helping to influence the health care, workforce, insurance and financial services, employee benefit, privacy and data security and other federal, state and local laws, regulations and enforcement actions. She both helps her clients respond to and resolve emerging regulations and laws, government investigations and enforcement actions and helps them shape the rules through dealings with Congress and other legislatures, regulators and government officials domestically and internationally. A former lead consultant to the Government of Bolivia on its Social Security reform law and most recognized for her leadership on U.S. health and pension, wage and hour, tax, education and immigration policy reform, Ms. Stamer works with U.S. and foreign businesses, governments, trade associations, and others on workforce, social security and severance, health care, immigration, privacy and data security, tax, ethics and other laws and regulations. Founder and Executive Director of the Coalition for Responsible Healthcare Policy and its PROJECT COPE: the Coalition on Patient Empowerment and a Fellow in the American Bar Foundation and State Bar of Texas. She also works as a policy advisor and advocate to health, insurance and financial services, employee benefits and other business, professional and civic organizations.

    Author of the thousands of publications and workshops these and other employment, employee benefits, health care, insurance, workforce and other management matters, Ms. Stamer also is a highly sought out speaker and industry thought leader known for empowering audiences and readers. Ms. Stamer’s insights on employee benefits, insurance, health care and workforce matters in Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, Modern Healthcare, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications. Ms. Stamer also regularly serves on the faculty and planning committees for symposia of LexisNexis, the American Bar Association, ALIABA, the Society of Employee Benefits Administrators, the American Law Institute, ISSA, HIMMs, and many other prominent educational and training organizations and conducts training and speaks on these and other management, compliance and public policy concerns.

    Ms. Stamer also has a lifelong history of involvement with and service with a diverse range of professional, community and charitable organizations and causes including as founder and Executive Director of the Coalition for Responsible Health Care Policy and its PROJECT COPE: Coalition for Patient Empowerment; technical advisor to the National Physicians’ Council for Health Care Policy; a founding Board Member and President of the Alliance for Healthcare Excellence and its Patient Empowerment and Health Care Heroes Projects; a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; a member of the Dallas United Way Long Range Planning Committee; as well as leadership involvement in the ABA Joint Committee on Employee Benefits Council, the North Texas Healthcare Compliance Professionals Association; the ABA RPTE Employee Benefits & Other Compensation Committee, the ABA Health Law Section, the ABA International Section Life Sciences Committee, and the ABA TIPS Employee Benefit Committee; TEGE Coordinator of the Gulf Coast TEGE Council TE Division; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association; Dallas, Regional and State BACPAC Chair of the Texas Association of Business; SHRM Regional Chair and National Advisory Board Chair; WEB Network of Benefits Professionals National and Dallas Boards; as a contributing author and the Advisory Board member of the BNA EBCD CD, InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications and as chair or planning faculty of a multitude of symposia.. For additional information about Ms. Stamer, see www.cynthiastamer.com, or contact Ms. Stamer via email here or via telephone to (214) 452.8297.

    About Solutions Law Press, Inc.™

    Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also may be interested reviewing other Solutions Law Press, Inc.™ resources at www.solutionslawpress.com 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 or updating your profile here.

    ©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.

     


    Key House Committee Votes To Advance HSA & Other Health Choice Reforms; Plans 7/17 Health Care Fraud Hearings

    July 13, 2018

    A flurry of activity in the House Ways & Means Committee and other Congressional committees over the past few weeks signals the advisability of keeping a close eye on health care and health benefit reform proposals this Summer in anticipation of both the Fall health benefit enrollment and renewal season and the mid-term November Congressional elections.

    Certainly continued Congressional commitment to pursue reform is evident from the House Ways & Means Committee’s health care heavy agenda of hearings and votes that this week alone resulted in its voting in favor of 11 health care reform bills promising new flexibility for employers about how to design their health plans and American families more health care choices and choice about how to pay for it and what coverage to buy popular with many providers, patients and employer and other health plan sponsors. While it remains to be seen if the House and Senate can agree on any or all of these proposal, the bi-partisan sponsorship of many of these proposals and the intensity of the focus of the Committee and others in Congress reflects a strong interest in health care reform by both parties leading up to November that could impact health benefit and other health care choices for providers, employers and American families in the Fall annual enrollment season.

    The legislation passed by the Ways & Means Committee this weeks include bills that would:

    • Provide relief for employers relief from the Obamacare’s employer mandate and delay for an additional year the effective date of the widely disliked “Cadillac Tax;”
    • Overrule the “Use it Or Lose It” requirement in current Internal Revenue Regulations for healthcare flexible spending arrangement plans (HFSAs) that currently forces employers sponsoring HFSAs to draft their plans to require employees to forfeit unused salary reduction contributions in their HFSA accounts at the end of the year;
    • Offer individuals and families eligible for Obamacare created health premium subsidies more choice about where to obtain that coverage using their subsidies; and
    • Expand expand the availability and usability of HSAs in a multitude of ways.

    While the recurrent stalling of past reform efforts over the past few years calls into question whether any or all of these proposals can make it through the highly politicized and divided Congress, bi-partisian sponsorship of most of the bills reported out this week at least raises the possibility that some of these proposals enjoy sufficient bi-partisan support to potentially pass before the elections. With both parties viewing health care reform as a key issue in the upcoming elections, voter feedback on these proposals could play a big role in determining the prospects for passage this Summer.

    Passage of any or all of these proposed reforms between now and year end likely will fuel the need for last minute reconsideration and potential adjustments in plan design choices of employers and other health plan sponsors and administrators, reconsideration of health benefit enrollment choices of individual Americans and their families and a reconsideration of practice billing and health plan participation decisions of physicians and other health care providers. Accordingly, health care providers, employers and other health plan sponsors, American taxpayers and their families and others impacted by health care and health benefit policies will want to carefully monitor these reforms as the Summer progresses:

    • To provide timely input to Congress on proposed reforms of particular benefit or concern;
    • To help plan for and deal with rules changes that could impact their options and choices during the upcoming health plan renewal and enrollment season this Fall and going forward; and
    • To be prepared to make informed choices when voting in the upcoming mid-term Congressional elections in November.

    To learn more details about this proposed legislation, its potential implications or other related concerns, see here or contact the author.

    About the Author

    After holding hearings on health savings account reforms and passing a flurry of health care reform bills intended to give employers relief from two key Obamacare mandates, to allow Obamacare subsidy-eligible Americans the choice to use the subsidies to purchase health care coverage not offered by the Obamacare exchanges,  and a host of bills that would expand availability and usability of health savings account (HSA) and health care flexible spending account (HFSA) programs this week, the House Ways and Means Committee will turn its attention to health care fraud oversight and reform next week by holding hearings Tuesday on those health concerns.  Health care providers, employer and other health plan sponsors, individual Americans and their families, and others interested in health benefit and health care reform will want to keep a close eye on these and other developments as Congress continues to debate health care reform in the runup to the upcoming 2018 health benefit plan renewal and annual enrollment season and November’s mid-term elections.

    Committee Approved 11 Health Care Reform Bills This Week

    As a part of its health reform efforts this week, the Committee voted to advance 11 health care reform bills offering new flexibility for employers about how to design their health plans and American families more health care choices and choice about how to pay for it and what coverage to buy popular with many providers, patients and employer and other health plan sponsors.

    Among the approved legislation is a bill that would provide key relief for employers from certain key Obamacare mandates that have been widely unpopular with employers.  H.R. 4616, the “Employer Relief Act of 2018,” sponsored by Rep. Devin Nunes (R-CA) and Rep. Mike Kelly (R-PA), which would give employers sponsoring health plans for their employees retroactive relief from Obamacare’s onerous employer mandate and delay for an additional year the effective date of another Obamacare requirement that when effective, will forces employers to pay the 40 percent tax on amounts paid for employer sponsored health care coverage  that exceeds cost limits specified in the Obamacare legislation commonly known as the “Cadillac Tax.”  Relief from the Cadillac Tax is widely perceived as benefiting bother employers and their employees, as its provisions penalize employers for spending more for employee health coverage than limits specified in the Obamacare law.  These provisions also are particularly viewed by many as unfair because rising health plan costs since Obamacare’s passage make it likely that many employers will incur the tax penalty simply by sponsoring relatively basic health plans meeting the Obamacare mandates.

    In addition to H.R. 4616,  the Committee also voted to approve H.R. 6313, the “Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018,” sponsored by Rep. Steve Stivers (R-OH), which would overrule the “Use it Or Lose It” requirement in current Internal Revenue Regulations for HFSAs.  Currently, this rule forces employers sponsoring HFSAs to draft their plans to require employees to forfeit unused salary reduction contributions in their HFSA accounts at the end of the year.  The bill would allow employers to eliminate this forfeiture requirement so that employees could carry over any remaining unused balances in their HFSAs at the end of the year to use in a later  year.

    The Committee also voted to advance legislation to offer individuals and families eligible for Obamacare created health premium subsidies more choice about where to obtain that coverage.  H.R. 6311, the “Increasing Access to Lower Premium Plans Act of 2018,” sponsored by Chairman Peter Roskam (R-IL) and Rep. Michael C. Burgess, M.D. (R-TX), would provide individuals receiving subsidies to help purchase health care coverage through the Obamacare-created health insurance exchange the option to use their premium tax credit to purchase health care coverage from qualified plans offered outside of the exchanges.  Currently, subsidies may only be used to purchase coverage from health plans offered through the exchange, which often are much more costly and offer substantially fewer coverage options and less provider choice.  In addition, the bill would expand access to the lowest-premium plans available for all individuals purchasing coverage in the individual market and allows the premium tax credit to be used to offset the cost of such plans.

    Along with these reforms, the Committee also voted to pass a host of bills that would expand the availability and usability of HSAs including:

    • H.R. 6301, the “Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act of 2018,” co-sponsored by Health Subcommittee Chairman Peter Roskam (R-IL) and Rep. Mike Thompson (D-CA), which seeks to expand access and enhance  the utility of Health Savings Accounts (HSAs) by offering patients greater flexibility in designing their plan design while still being able to maintain their eligibility for HSA contributions.
    • H.R. 6305, the “Bipartisan HSA Improvement Act of 2018,” sponsored by Rep. Mike Kelly (R-PA) and Rep. Earl Blumenauer (D-OR), which also would expand HSA access and  utility by allowing spouses to also make contributions to HSAs is their spouse has an FSA and lets employers offer certain services to employees through on-site or retail clinics.
    • H.R. 6317, the “Primary Care Enhancement Act of 2018,” co-sponsored by Rep. Erik Paulsen (R-MN) and Rep. Earl Blumenauer (D-OR), which seeks to protect HSA-eligible individuals who participate in a direct primary care (DPC) arrangement from losing their HSA-eligibility merely because of their participation in a DPC. In addition, it allows DPC provider fees to be covered with HSAs.
    • H.R. 6312, the “Personal Health Investment Today (PHIT) Act,” sponsored by Rep. Jason Smith (R-MO) and Rep. Ron Kind (D-WI), which seeks to fight obesity and promote wellness by allowing taxpayers to use tax-preferred accounts to pay costs of gym membership or exercise classes, children’s school sports programs and certain other wellness programs and activities.
    • H.R. 6309, the “Allowing Working Seniors to Keep Their Health Savings Accounts Act of 2018,” sponsored by Rep. Erik Paulsen (R-MN), which would expand HSA eligibility to include Medicare eligible seniors who are still in the workforce.
    • H.R.6199, the “Restoring Access to Medication Act of 2018,” sponsored by Rep. Lynn Jenkins (R-KS) and Rep. Grace Meng (D-NY), which would reverse Obamacare’s prohibition on using tax-favored health accounts to purchase over-the-counter medical products and would add feminine products to the list of qualified medical expenses for the purposes of these tax-favored health accounts.
    • H.R. 6306, the “Improve the Rules with Respect to Health Savings Accounts,” sponsored by Rep. Erik Paulsen (R-MN), which would increase the contribution limits for HSAs and further enhances flexibility in plans by allowing both spouses to contribute to make catch-up contributions to the same account and creating a new grace period for medical expenses incurred before the HSA was established.
    • H.R. 6314, the “Health Savings Act of 2018,” sponsored by Rep. Burgess (R-TX) and Rep. Roskam (R-IL), would expand eligibility and access to HSAs by allowing plans categorized as “catastrophic” and “bronze” in the exchanges to qualify for HSA contributions.

    Committee Considers Health Care Fraud Next Week 

    The Committee next week will turn its attention to health care fraud by holding two hearings on Tuesday.

    Both hearings are scheduled to take place in Room 1100 Longworth and their proceedings will be live streamed on YouTube.

    The Committee’s health care reform focus this week and next are reflective of the continued emphasis of members of Congress in both parties on health care reform legislation as they prepare for the impending mid-term elections in November.  As a part of these efforts,  the House and Senate already over the past several months have held a wide range of hearings in various committees and key votes on a multitude of reform proposals.  Numerous other hearings and votes are planned over the next several months as Congressional leaders from both parties work to advance their health care agendas in anticipation of the upcoming elections.

    Key health care and health benefit reform  proposals that the Republican Majority has designated for priority consideration include:

    • Prescription drug costs by checking perceived negative effects of health industry and health plan consolidations involving large health insurers, pharmacy benefit  management companies (PBMs), pharmacy companies and other health industry and health insurance organizations on health care costs and patient, plan sponsor and plan sponsor choice and health care quality;
    • Oversight and reform of existing STARK, anti-kickback and other federal health care rules and exemptions relied upon by PBMs and other health industry organizations;
    • Efforts to understand and address health care treatment, health care and coverage costs and related social concerns associated with mental health and opioid and other substance abuse conditions and their treatment;
    • Efforts promote health  benefit and health care choice, affordability and coverage;  improve patient and employer choice; promote broader health care access and quality; reduce counterproductive regulation; and other health insurance and care improvements through expanded availability of health savings accounts, direct primary care and other consumer directed health care options, association health plan and other program options, streamlining quality reporting and regulation, billing and coding, physician and other health care provider electronic billing and recordkeeping,  and other provider,  payer, employer, individual and other health insurance mandates and other federal health care and health plan rules; and
    • More.

    Health care providers, employers and other health plan sponsors, American taxpayers and their families and others will want to carefully monitor these reforms as the Summer progresses:

    • To provide timely input to Congress on proposed reforms of particular benefit or concern;
    • To help plan for and deal with rules changes that could impact their options and choices during the upcoming health plan renewal and enrollment season this Fall and going forward; and
    • To be prepared to make informed choices when voting in the upcoming mid-term Congressional elections in November.

    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


    Check Out CMS 2018 Qualified Clinical Data Registry

    February 23, 2018

    Physicians and other practitioners should check out the measure specifications for the approved 2018 Qualified Clinical Data Registry (QCDR) measures posted by the Centers for Medicare & Medicaid Services (CMS) yesterday (February 22, 2018).

    Rather than being grouped by QCDR, this file allows users to group measures by specialty and topic to see what QCDR measures are most applicable to their practice and/or specialty.

    CMS also says, the posting of this specification file will act as a reference tool for existing and potential new QCDR vendors who may be interested in developing their own QCDR measures, and should help them to avoid developing and submitting measures that are duplicative of existing QCDR measures.

    About The Author

    Repeatedly 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, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Nationally recognized for her work, experience, leadership and publications on HIPAA and other medical privacy and data use and security, FACTA, GLB, trade secrets and other privacy and data security concerns, Ms. Stamer has worked extensively with health care providers, health plans, insurers and financial services, and other clients and the government on cybersecurity, technology and processes and other issues involved in the use and management of medical, insurance and other financial, workforce, trade secrets and other sensitive data and information throughout her career.  Scribe or co-scribe of the ABA Joint Committee on Employee Benefits Agency meeting with OCR since 2011 and author of a multitude of highly regarded publications on HIPAA and other health care, insurance, financial and other privacy and data security, Ms. Stamer is widely known for her extensive and leading edge experience, advising, representing, training and coaching health care providers, health plans, healthcare clearinghouses, business associates, their information technology and other solutions providers and vendors, and others on HIPAA and other privacy, data security and cybersecurity design, documentation, administration, audit and oversight, business associate and other data and technology contracting, breach investigation and response, and other related concerns including extensive involvement representing clients in dealings with OCR and other Health & Human Services, Federal Trade Commission, Department of Labor, Department of Treasury, state health, insurance and attorneys’ general, Congress and state legislators and other federal officials.

    Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers.    Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

    About Solutions Law Press, Inc.™

    Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including:

    Fresenius Medical Care Pays $3.5 Million HIPAA Settlement

    CDC Director Fitzgerald Resigns

    Development of Potentially Preventable Hospitalization Measures for Home Health Agencies Panelist Nominations Due 9/22

    MAC Operations Continue During Shutdown

    HHS Proposes “Conscience Rule” Expanding Abortion And Other Religious Choice

    New Medicaid Guidance Gives States More Flexibility On Abortion

    New Trump Executive Order Directs More Veterans Health Care Choice, Mental Health Care

    Bankrupt Oncology Provider’s $2.3M Settlement Payment & Other HIPAA Breach Consequences Shows Why To Prioritize HIPAA Compliance In 2018

    Bill Allowing FDA Emergency Use Authorizations To Protect Military From Biological Warfare Threats Sent to President

    OIG Tells Texas Stop Paying Medicaid MCOs For Dead Patients

    Michigan Doctor Pleads Guilty To Billing Medicare For Illegally Prescribed Drugs

    Anesthesiology Practice Nailed For Improperly Billing For Moderate Sedation

    Florida Doctor Sentenced For Multi-Million Dollar Drug & Alcohol Addiction Treatment Health Care Fraud, Money Laundering & Forced Prostitution Scheme

    CMS Announces New Medicare Provider Ombudsman

    Comment By 1/8 on Guidance for Industry on Expedited Programs for Serious Conditions– Drugs and Biologics

    Time To Tighten Business Travel Policies

    DOL Spending Reports Required As Taxpayer Tool Need Improvement

    Check & Protect Health & Other Electronic Systems & Data Against New Security Threat

    Success 2018

    April 1 New Deadline To Update Benefit Plan Disability Determination Claims & Appeals Procedures; Hear More on 1/26

    Arizona Proposal To Ban Sexual Harassment Confidentiality Agreements Sign Of Growing Employer Risks

    $23M Penalty Small Part of 21st Century’s Data Breach Fallout; Offers Data Breach Lessons For Other Businesses

    Take Care of Your Good People

    Read Tax Cuts and Jobs Act Conference Report For Tax Reform From Source

    Check How IRS 2018 Retirement & Saving Plan Limits and Amounts Cost Of Living Adjustments Impact Your HR & Retirement Plan Administration & Planning

    Confirm Your Benefit Plans Ready For New Disability Determination Rules on 1/1/18

    Individual Accountability For Performance Matters

    Give NLRB Your Input On Union Representation Election Regulations

    IRS Prepares To Nail Employers Under Obamacare Mandate While Giving Some Individual Mandate Relief 

    HHS Picks Hargan As Acting HHS Secretary

    OCR Gives Health Care Providers, Other Covered Entities Post-Las Vegas Shooting HIPAA Medical Privacy Guidance On Disclosures To Family, Media & Others For Notification & Other Purposes

    RAISE Act Immigration Visa, Visa Holder Public Benefit Limits Create Potential Health Industry Concerns 

    SCOTUS Bars State Law Restrictions On Health, Other Arbitration Agreement Enforceability 

    Health Care, Health Plan & Other Health IT Systems Warned of E-Mail Cyber Attack 

    $2.4M HIPAA Settlement Warns Providers About Media Disclosures Of PHI

    CardioNet $2.5M HIPAA Resolution Agreement Schools HIPAA Entities To Clean Up Their Acts 

    Medical Clinic HIPAA Resolution Agreement Shows Need For Current Business Associate Agreements

    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.

    ©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.


    Fresenius Medical Care Pays $3.5 Million HIPAA Settlement

    February 2, 2018

    Fresenius Medical Care North America (FMCNA) is paying $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopting a comprehensive corrective action plan, under a voluntary resolution agreement that settles FMCNA exposures to OCR for violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules OCR asserts it found from an investigation it conducted into five separate HIPAA breach reports FMCNA filed in January 21, 2017.

    Widespread publicity and fallout from data breaches involving Equifax, Blue Cross, the Internal Revenue Service and many other giant organizations have ramped up public awareness and government concern about health care and other data security.  The resulting pressure is adding additional fuel to the already substantial concern of OCR and other agencies about compliance with HIPAA and other data security and breach laws.  Like the $2.3 million HIPAA resolution agreement OCR announced with now bankrupt radiation oncology and cancer care provider 21st Century Oncology, Inc. (21CO) earlier this year,  see, e.g., $23M Penalty Small Part of 21st Century’s Data Breach Fallout; Offers Data Breach Lessons For Other Businesses, the growing list of OCR resolution agreements and other enforcement actions against FMCNA, 21CO and other covered entities and other legal and market fallout that covered entities and other organizations experience following the announcement of breaches or other security deficiencies make the case for why HIPAA-covered health care providers, health plans, health care clearinghouses and their business associates (covered entities) must prioritize HIPAA compliance and other medical and other data security protection, privacy and risk management a top priority in 2018.

    HIPAA Privacy, Security & Breach Notification Rule Responsibilities & Risks

    The Privacy Rule requires that health plans, health care providers, health care clearinghouses (covered entities) and their vendors that qualify as “business associates” under HIPAA comply with detailed requirements concerning the protection, use, access, destruction and disclosure of protected health information.  As part of these requirements, covered entities and their business associates must adopt, administer and enforce detailed policies and practices, assess, monitor and maintain the security of electronic protected health information (ePHI) and other protected health information, provide notices of privacy practices and breaches of “unsecured” ePHI, afford individuals that are the subject of protected health information certain rights and comply with other requirements as specified by the Privacy, Security and Breach Notification Rules.  In addition, covered entities and business associates also must enter into a written and signed business associate agreement that contains the elements specified in Privacy Rule § 164.504(e) before the business associate creates, uses, accesses or discloses PHI of the covered entity. Furthermore, the Privacy Rule includes extensive documentation and keeping requirements require that covered entities and BAs maintain copies of these BAAs for a minimum of six years and to provide that documentation to OCR upon demand.

    Violations of the Privacy Rule can carry stiff civil or even criminal penalties.  Pursuant to amendments to HIPAA enacted as part of the HITECH Act, civil penalties typically do not apply to violations punished under the criminal penalty rules of HIPAA set forth in Social Security Act , 42 U.S.C § 1320d-6 (Section 1177).

    Resolution Agreements like the $3.2 million FMCNA resolution agreement allow covered entities and business associates to resolve potentially substantially larger civil monetary penalty liabilities that OCR can impose under the civil enforcement provisions of HIPAA.  As amended by the HITECH Act, the civil enforcement provisions of HIPAA empower OCR to impose Civil Monetary Penalties on both covered entities and BAs for violations of any of the requirements of the Privacy or Security Rules.  The penalty ranges for civil violations depends upon the circumstances associated with the violations and are subject to upward adjustment for inflation.  As most recently adjusted here effective September 6, 2016,  the following currently are the progressively increasing Civil Monetary Penalty tiers:

    • A minimum penalty of $100 and a maximum penalty of $50,000 per violation, for violations which the CE or BA “did not know, and by exercising reasonable diligence would not have known” about using “the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances;”
    • A minimum penalty of $1,000 and a maximum penalty of $50,000 per violation, for violations for “reasonable cause” which do not rise to the level of “willful neglect” where “reasonable cause” means the “circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the violated Privacy Rule requirement;”
    • A minimum penalty of $10,000 and a maximum penalty of $50,000 per violation, for violations attributed to “willful neglect,” defined as “the conscious, intentional failure or reckless indifference to the obligation to comply” with the requirement or prohibition; and
    • A minimum penalty of $50,000 and a maximum penalty of $1.5 million per violation, for violations attributed to “willful neglect” not remedied within 30 days of the date that the covered entity or BA knew or should have known of the violation.

    For continuing violations such as failing to implement a required BAA, OCR can treat each day  of noncompliance as a separate violation.  However, sanctions under each of these tiers generally are subject to a maximum penalty of $1,500,000 for violations of identical requirements or prohibitions during a calendar year.  For violations such as the failure to implement and maintain a required BAA where more than one covered entity bears responsibility for the violation, OCR an impose Civil Monetary Penalties against each culpable party. OCR considers a variety of mitigating and aggravating facts and circumstances when arriving at the amount of the penalty within each of these applicable tiers to impose.

    In addition to these potential civil liability exposures, however, covered entities, their business associates and other individuals or organizations that wrongfully use, access or disclose electronic or other protected health information also can face civil liability under various circumstances.  The criminal enforcement provisions of HIPAA authorize the Justice Department to prosecute a person who knowingly in violation of the Privacy Rule (1) uses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person, punishable by the following criminal sanctions and penalties:

    • A fine of up to $50,000, imprisoned not more than 1 year, or both;
    • If the offense is committed under false pretenses, a fine of up to $100,000, imprisonment of not more than 5 years, or both; and
    • If the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, a fine of up to $250,000, imprisoned not more than 10 years, or both.

    Because HIPAA Privacy Rule criminal violations are Class A Misdemeanors or felonies, Covered Entities and business associates should include HIPAA compliance in their Federal Sentencing Guideline Compliance Programs and practices and need to be concerned both about criminal exposure for their own direct violations, as well as imputed organizational liability for violations committed by their employees or agents under the Federal Sentencing Guidelines, particularly where their failure to implement or administer these required compliance policies and practices or failure to properly investigate or redress potential violations enables, perpetuates or covers up the criminal breach.

    Fresenius Breach, Charges & Settlement Agreement Illustrate Civil Exposures

    The FMCNA resolution agreement is another example of a growing list of resolution agreements various HIPAA covered entities have entered into to resolve their exposure to potentially greater liability should OCR assess civil monetary penalties under HIPAA’s civil sanction scheme.

    The breach reports filed on January 21, 2017 reported five separate breach incidents occurring between February 23, 2012 and July 18, 2012 implicating the electronic protected health information (ePHI) of five separate FMCNA owned covered entities (FMCNA covered entities):  Bio-Medical Applications of Florida, Inc. d/b/a Fresenius Medical Care Duval Facility in Jacksonville, Florida (FMC Duval Facility); Bio-Medical Applications of Alabama, Inc. d/b/a Fresenius Medical Care Magnolia Grove in Semmes, Alabama (FMC Magnolia Grove Facility); Renal Dimensions, LLC d/b/a Fresenius Medical Care Ak-Chin in Maricopa, Arizona (FMC Ak-Chin Facility); Fresenius Vascular Care Augusta, LLC (FVC Augusta); and WSKC Dialysis Services, Inc. d/b/a Fresenius Medical Care Blue Island Dialysis (FMC Blue Island Facility).

    OCR concluded its investigation showed the breaches resulted because FMCNA failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI.  OCR also concluded:

    • The FMCNA covered entities impermissibly disclosed the ePHI of patients by providing unauthorized access for a purpose not permitted by the Privacy Rule.
    • FMC Ak-Chin failed to implement policies and procedures to address security incidents.
    • FMC Magnolia Grove failed to implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain ePHI into and out of a facility; and the movement of these items within the facility.
    • FMC Duval and FMC Blue Island failed to implement policies and procedures to safeguard their facilities and equipment therein from unauthorized access, tampering, and theft, when it was reasonable and appropriate to do so under the circumstances.
    • FMC Magnolia Grove and FVC Augusta failed to implement a mechanism to encrypt and decrypt ePHI, when it was reasonable and appropriate to do so under the circumstances.

    In addition to a $3.5 million monetary settlement, a corrective action plan requires the FMCNA covered entities to complete a risk analysis and risk management plan, revise policies and procedures on device and media controls as well as facility access controls, develop an encryption report, and educate its workforce on policies and procedures.

     

    HIPAA Enforcement A Growing Risk

    Covered entities, their business associates and members of their workforce need to recognize that the FMCNA and other resolution agreements are part of a growing trend, rather than isolated incidents of enforcement.

    While civil monetary penalty enforcement remains much more common than criminal prosecution, covered entities, their business associates and members of their workforce must understand that HIPAA enforcement and resulting liability is growing.

    While Department of Justice federal criminal prosecutions and convictions under HIPAA remain relatively rare, they occur and are growing.  See e.g.,  Former Hospital Employee Sentenced for HIPAA Violations (Texas man sentenced to 18 months in federal prison for obtaining protected health information with the intent to use it for personal gain); Three Life Sentences Imposed On Man Following Convictions For Drug Trafficking, Kidnapping, Using Firearms and HIPAA Violations (drug king pin gets multiple 10 year consecutive prison terms for unauthorized access to private health information in violation of HIPAA; his health care worker friend sentenced for accessing electronic medical files and reporting information to him); Former Therapist Charged In HIPAA Case; Hefty Prison Sentence in ID Theft Case (former assisted living facility worker gets 37 months in prison after pleading guilty to wrongful disclosure of HIPAA protected information and other charges); Hefty Prison Sentence in ID Theft Case (former medical supply company owner sentenced to 12 years for HIPAA violations and fraud).  While the harshest sentences tend to be associated with health care fraud or other criminal conduct, lighter criminal sentences are imposed against defendants in other cases as well. See e.g., Sentencing In S.C. Medicaid Breach Case (former South Carolina state employee sentenced to three years’ probation, plus community service, for sending personal information about more than 228,000 Medicaid recipients to his personal e-mail account.); HIPAA Violation Leads To Prison Term (former UCLA Healthcare System surgeon gets four months in prison after admitting he illegally read private electronic medical records of celebrities and others.)

    While criminal enforcement of HIPAA remains relatively rare and OCR to date only actually has assessed HIPAA civil monetary penalties against certain Covered Entities for violating HIPAA in a couple isolated instances, the growing list of multi-million dollar resolution payments that FMCNA and other covered entities caught violating HIPAA make clear that HIPAA enforcement is both meaningful and growing.   See e.g., Learn From Children’s New $3.2M+ HIPAA CMP For “Knowing” Violation of HIPAA Security Rules ($3.2 million Children’s Medical Center HIPAA Civil Monetary Penalty); 1st HIPAA Privacy Civil Penalty of $4.3 Million Signals CMS Serious About HIPAA Enforcement;  $400K HIPAA Settlement Shows Need To Conduct Timely & Appropriate Risk Assessments$5.5M Memorial HIPAA Resolution Agreement Shows Need To Audit.  For more examples, also see here.

    Coming on the heels of  an already lengthy and growing list of OCR high dollar HIPAA enforcement actions, the FMCNA and other resolution agreements and civil monetary penalties these and other announced enforcement actions clearly reflect that OCR takes HIPAA compliance seriously and stands ready to impose substantial penalties when it finds violations in connection with breach notice investigations.  Viewed in the context of these and other enforcement actions, the FMCNA Resolution Agreement and others clearly reflect the time for complacency in HIPAA compliance and leniency in HIPAA HIPAA enforcement are passed.  Rather, these and other enforcement actions make clear why health care providers, health plans, healthcare clearinghouses and their business associates must make HIPAA compliance a priority now.

    Covered entities and business associates also should recognize their potential responsibilities and risks for breaches or other improper conduct concerning patient or other sensitive personal financial information, trade secrets or other data under a wide range of laws beyond HIPAA and its state law equivalents.  As documented by the media coverage of the legal and business woes of Alteryx, eBay, Paypal owner TIO Networks, Uber, Equifax and a long list of other previously trusted prominent businesses have and continue to incur from data breaches within their organizations, health care or other covered entities experiencing breaches often also face FTC or other government investigations and enforcement under the Fair and Accurate Credit Transactions Act (FACTA) and other federal or state identity theft, data privacy and security, electronic crimes and other rules as well as business losses and disruptions; civil litigation from breach victims, shareholders and investors, and business partners as well as OCR, FTC, and state data security regulation enforcement.  Amid this growing concern, OCR has indicated that it intends to continue to diligently both seek to support and encourage voluntary compliance by covered entities and their business associates and  investigate and enforce HIPAA against HIPAA covered entities and their business associates that fail to adequately safeguard PHI and ePHI in accordance with HIPAA. In the face of these growing risks and liabilities, covered entities and their business leaders face a strong imperative to clean up and maintain their HIPAA compliance and other data security to minimize their exposure to similar consequences.

    In light of these rises, leaders, investors, insurers, lenders and others involved with covered entities and their business associates should take steps to verify that the covered entities and their business associates not only maintain compliance with HIPAA, but also comply with data security, privacy and other information protection requirements arising under other laws, regulations, and contracts, as well as the practical business risks that typically follow the announcement of a breach.  Considering these risks, covered entities and their business associates must recognize and take meaningful, documented action to verify their existing compliance and ongoing oversight to ensure their organizations can demonstrate appropriate action to maintain appropriate practices, insurance and other safeguards to prevent, respond to and mitigate exposures in the event of a breach of protected health information or other sensitive data.

    In response to these growing risks and concerns, covered entities and their business associates should ensure that they have conducted, and maintain and are ready to produce appropriate policies and procedures backed up by a well documented, up-to-date industry wide risk assessment of their organization’s susceptibility to breaches or other misuse of electronic or other protected health information.  The starting point of these efforts should be to adopt and enforce updated written policies, procedures, technical and physical safeguards, processes and training to prevent the improper use, access, destruction or disclosure of patient PHI.  Processes also should create, retain and be designed to cost effectively track, capture, and retain both all protected health information, its use, access, protection, destruction and disclosure, and the requisite supportive documentation supporting the appropriateness of those action to position the organization  cost-effectively and quickly to fulfill required accounting, reporting and other needs in the event of a data breach, audit, participant inquiry or other event.

    As part of this process, covered entities and business associates should start by reviewing and updating their policies, HIPAA audits and assessments and other documentation and processes.  In doing so, they must use care to look outside the four corners of their Privacy Policies and core operating systems to ensure that their policies, practices, oversight and training address all protected health information within their operations on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer.

    In connection with these efforts, the enforcement actions make clear that Covered Entities and business associates should adopt, implement and monitor PHI privacy, and security on an entity wide basis.  These efforts should include both general policies, practices and procedures as well as specifically tailored policies, processes and training to protect PHI and preserve HIPAA compliance throughout their organization  as well as the business associate agreements and other processes to provide for HIPAA compliance with respect to protected health information created, used, accessed or disclosed to business associates or others not part of their direct workforce or operating outside the core boundaries of their facilities.

    Covered entities and their business associates also must recognize and design their compliance efforts and documentation recognizing that HIPAA compliance is a living process, which require both constant diligence about changes in systems or other events that may require reevaluation or adjustments, whether from changes in software, systems or processes or external threats.

    Because the cost of responding to and investigating breaches or other compliance concern can be quite burdensome, covered entities and their business associates also generally will want to pursue options to plan for and minimize potential expenses in the design and administration of their programs as well as to minimize and cover the potentially extraordinary costs of breach or other compliance investigation and results that commonly arise following a breach or other compliance event.  As a part of this planning, covered entities and their business associates also generally will want to add consideration of changes to federal tax rules on the deductibility of compliance penalty and other related compliance expenditures.

    While the Internal Revenue Code traditionally has prohibited businesses and individuals from deducting penalties, fines and other expenditures arising from violations of federal or state laws under Section 162(f) of the Internal Revenue Code, Section 13306 of the Tax Cuts and Jobs Creation Act creates a new exception for amounts  (other than amounts paid or incurred any amount paid or incurred as reimbursement to the government or entity for the costs of any investigation or litigation) that a taxpayer establishes meet the following requirements:

    • Constitute restitution (including remediation of property) for damage or harm which was or may be caused by the violation of any law or the potential violation of any law, or
    • Are paid to come into compliance with any law which was violated or otherwise involved in the investigation or inquiry into a violation or potential violation of any law;
    • Are identified as restitution or as an amount paid to come into compliance with such law, as the case may be, in the court order or settlement agreement, and
    • In the case of any amount of restitution for failure to pay any tax imposed under this title in the same manner as if such amount were such tax, would have been allowed as a deduction under this chapter if it had been timely paid.

    Because the true effect of these modifications will be impacted by implementing regulations and a number of other special conditions and rules may impact the deductibility of these payments and the reporting obligations attached to their payment, covered entities will want to consult with legal counsel about these rules and monitor their implementation to understand their potential implications on compliance expenditures and penalties.

    About The Author

    Repeatedly 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, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Nationally recognized for her work, experience, leadership and publications on HIPAA and other medical privacy and data use and security, FACTA, GLB, trade secrets and other privacy and data security concerns, Ms. Stamer has worked extensively with clients and the government on cybersecurity, technology and processes and other issues involved in the use and management of medical, insurance and other financial, workforce, trade secrets and other sensitive data and information throughout her career.  Scribe or co-scribe of the ABA Joint Committee on Employee Benefits Agency meeting with OCR since 2011 and author of a multitude of highly regarded publications on HIPAA and other health care, insurance, financial and other privacy and data security, Ms. Stamer is widely known for her extensive and leading edge experience, advising, representing, training and coaching health care providers, health plans, healthcare clearinghouses, business associates, their information technology and other solutions providers and vendors, and others on HIPAA and other privacy, data security and cybersecurity design, documentation, administration, audit and oversight, business associate and other data and technology contracting, breach investigation and response, and other related concerns including extensive involvement representing clients in dealings with OCR and other Health & Human Services, Federal Trade Commission, Department of Labor, Department of Treasury, state health, insurance and attorneys’ general, Congress and state legislators and other federal officials.

    Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers.    Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

    About Solutions Law Press, Inc.™

    Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including:

    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.

    ©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.


    New Medicaid Guidance Gives States More Flexibility On Abortion

    January 19, 2018

    On Friday, January 19, 2018, The Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Director Letter restoring state flexibility to establish reasonable standards for their Medicaid programs regarding abortion.

    The letter rescinds State Medicaid Directors Letter #16-005 that limited states’ long-standing authority to regulate providers operating within their states issued in April 2016.

    The 2016 letter had said that states that attempted to protect the integrity of their program standards by disqualifying abortion providers from their Medicaid programs would come under CMS scrutiny, and would be required to present to CMS evidence of criminal action or unfitness to perform healthcare services.

    The letter to State Medicaid directors published Friday states CMS is concerned that the 2016 letter may have gone beyond merely interpreting what the statute and current regulations require.

    The new letter returns CMS policy to what it was prior to the issuance of the 2016 letter while requiring States to comply with all applicable statutory and regulatory requirements, including the requirement that provider qualification standards be reasonable.

    Concurrent with the issuance of the letter, CMS also is issuing new regulations requiring certain conscience protections in programs and facilities funded in whole or part by the Department of Health and Human Services and follows the Trump Administration’s announcement Thursday of a new Conscience and Religious Freedom Division within the HHS Office of Civil Rights.

    In addition to these regulatory actions, legislation regarding Medicaid abortion coverage also has been introduced. See, e.g., H.R. 4848 (requiring States Report Medicaid payments for abortion); H.R. 4844 (to ensure that women seeking an abortion receive an ultrasound and the opportunity to review the ultrasound before giving informed consent to receive an abortion).

    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 care, workforce, employee benefits and compensation, insurance and financial services,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 U.S. and international private sector and government health industry, health and managed care plans and insurers, health IT, life sciences and other 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.

    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.


    Bankrupt Oncology Provider’s $2.3M Settlement Payment & Other HIPAA Breach Consequences Shows Why To Prioritize HIPAA Compliance In 2018

    December 29, 2017

    The just-announced agreement $2.3 million (Resolution Amount) settlement by now bankrupt radiation oncology and cancer care provider 21st Century Oncology, Inc. (21CO)  is paying to settle Health Insuran