Health Care Organizations Urged To Strengthen Right Of Conscience Defenses As HHS Opens 2 Right Of Conscience Investigations Within 1 Month Of Opening New Child Chemical Or Surgical Mutilation Whistleblower Portal

May 12, 2025

Health care organizations should move quickly to verify the defensibility of their current and past practices and actions for offering and providing religious accommodation and avoiding religious discrimination in light of the announcements by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of the opening of two new Church Amendment right of conscience investigations less than a month after of OCR published a new right of conscience guidance and launched a new online portal for whistleblowers to use to submit tips or complaints regarding the chemical and surgical mutilation of children. These developments are particularly concerning in light of the sharp reversal of the policies of the prior administration and the apparent current readiness of the agencies to treat actions taken under the previous administration’s policies as grounds for investigation or enforcement.

Federal Statutes Protect “Right of Conscience” In Health Care

While Federal protections against religious discrimination and infringement on rights of conscience and longstanding and well-established through the religious freedom and discrimination provisions of the First Amendment to the United States Constitution and the Civil Rights Act of 1964 (the “CRA”), and health care specific laws such as the Church Amendment, Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) and other federal laws, President Trump’s policy directions on right of conscience and other religious freedom and discrimination are fueling new requirements and risks for health care organizations and other businesses and government organizations.

HHS interpretation and enforcement of the prohibitions against religious or other discrimination under Sectio 1557 and other federal rules protecting Rights of Conscience in health care is now rapidly evolving in response to recent Executive Orders of President Trump. Its announcement of two right of conscience investigations against health care organizations in less than a month illustrate the exploding risks that health care providers and other organizations receiving HHS funding face for excluding or discriminating against health care providers, patients, and certain other federal program participants who refuse on religious or moral grounds to participate in certain health care services under these federal health care right of conscience rules including the following:

Church Amendment

Enacted in the 1970s to protect the rights of individuals and entities to object to performing or assisting in the performance of certain procedures because of their religious beliefs or moral convictions, the Church Amendment:

  • Prohibits public officials and authorities from requiring recipients of certain federal financial assistance to provide or make their facilities available for abortion or sterilization when the recipient has a religious or moral objection to sterilization or abortion.
  • Prohibits entities that receive certain federal financial assistance from discriminating against physicians and health care personnel:
    • because they performed a lawful sterilization, abortion, or other lawful health service or research activity,
    • because they refused to perform a lawful sterilization, abortion, or other lawful health service or research activity, or
    • because of their religious beliefs or moral convictions about sterilization, abortion, or any other lawful health services or research activities.
  • Protects individuals who object because of their religious or moral beliefs to performing or assisting in the performance of any part of a federally funded health service program or research activity.
  • Prohibits entities that receive certain federal financial assistance from discriminating against applicants for training or study because the applicant is reluctant or willing to participate in abortions or sterilizations due to their religious or moral beliefs.
Coats-Snow Amendment

The Coats-Snowe Amendment codified as Section 245 of the Public Health Service Act,  prohibits the federal government and any state or local government receiving federal financial assistance from discriminating against any health care entity on the basis that the entity:

  • Refuses to undergo training in the performance of abortions;
  • Refuses to require or provide abortion training;
  • Refuses to perform abortions, or to provide referrals for abortion training or for abortions;
  • Refuses to make arrangements for any of the above activities related to abortion; or
  • Attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide, or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.
Weldon Amendment.

The Weldon Amendment provides that none of the funds made available in those HHS appropriations acts may be made available to a Federal agency or program, or to a state or local government, if the agency, program, or government discriminates against any institutional or individual health care entity on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions. It defines “health care entity” to include “an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.”

Trump Policy Directives Drive New Risks By Changing Prior Religion & Other Discrimination Interpretations & Prioritizing New Rule Enforcement For Past, Current & Future Actions

Although U.S. law long has protected religious freedom through the protections of the First Amendment to the United States Constitution, the Civil Rights Act of 1964 (the “CRA”), Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) and other federal laws, President Trump’s policy directions on right of conscience and other religous freedom and discrimination, HHS interpretation and enforcement of these Rights of Conscience now are rapidly evolving in response to recent Executive Orders of President Trump. 

Most directly, HHS’ new emphasis on investigation and enforcement of Rights of Conscience directly responds to Executive Orders of President Trump on religious freedom.  On his Executive Order 14188 – Additional Measures To Combat Anti-Semitism (January 29, 2025), for instance, President Trump in declaring his administration’s commitment to combating the rise of anti-Semitism and anti-Semitic incidents in the United States and around the world and directing the Justice Department and other agencies to vigorously enforce Civil Rights Act Title VI, specifically noted the current prohibitions against anti-Semitism embedded in U.S. religious freedom laws, stating:

Title VI of the Civil Rights Act of 1964 (Title VI) prohibits discrimination on the basis of race, color, and national origin in programs and activities receiving Federal financial assistance. While Title VI does not cover discrimination based on religion, individuals who face discrimination on the basis of race, color, or national origin do not lose protection under Title VI for also being a member of a group that shares common religious practices. Discrimination against Jews may give rise to a Title VI violation when the discrimination is based on an individual’s race, color, or national origin.

In Executive Order 14202, Eradicating Anti-Christian Bias (February 6, 2025), President Trump ordered HHS and other agencies to review and recommend policy changes and other remedial actions to correct any unlawful anti-Christian policies, practices of the Biden Administration and develop other strategies to protect the religious liberties of Americans.

Subsequently, in his May 11, 2025, Executive Order 14291, Establishment of the Religious Liberty Commission, President Trump took aim at threats to religious freedom from efforts of certain Federal, state and local policies that President Trump views as infringing longstanding conscience protections, preventing parents from sending their children to religious schools, threatening loss of funding or denial of non-profit tax status for faith-based entities, and singling out religious groups and institutions for exclusion from governmental programs. To redress these threats, President Trump announced it is “the policy of the executive branch to vigorously enforce the historic and robust protections for religious liberty enshrined in Federal law” and to “promote citizens’ pride in our foundational history, identify emerging threats to religious liberty, uphold Federal laws that protect all citizens’ full participation in a pluralistic democracy, and protect the free exercise of religion.”

To implement this policy, President Trump established a “Religious Liberty Commission” to prepare a comprehensive report on the foundations of religious liberty in America, the impact of religious liberty on American society, current threats to domestic religious liberty, strategies to preserve and enhance religious liberty protections for future generations, and programs to increase awareness of and celebrate America’s peaceful religious pluralism. In defining the directives of the Commission, President Trump expressly included among the topics for consideration by the Commission “[c]onscience protections in the health care field and concerning vaccine mandates” and the Permitting time for voluntary prayer and rright of all Americans to freely exercise their faith without fear or Government censorship or retaliation. See Executive Order 14291, Establishment of the Religious Liberty Commission (May 1, 2025).

The Trump Administration’s emphasis on protecting federal right of conscience and other religious freedom protections is made more perilous by his sharp disagreement, revocation, and characterization as patently illegal various key aspects of the interpretation and enforcement policies of the Biden, Obama and other previous administration regarding federal right of conscience and other religious freedom, sexual orientation, reproductive rights and other civil rights policies and protections. See e.g., Executive Order 14281 -Restoring Equality of Opportunity and Meritocracy (April 23, 2025);

Beyond these religious freedom directives, President Trump also has issued other Executive Orders reversing key Biden Administration policies on politically sensitive policies often overlapping with issues of religious conscience.  For instance, in one of his earliest actions upon commencing his second Presidency, President Trump overruled previous administrations’ policies that promoted and protected the right of individuals to self-define their own sex regardless of biological sex at birth and associated safeguards and protection by directing[1] that U.S. law recognize only two genders, male and female, the assignment of which is determined by the gender of an individual at birth.

Subsequently, in Executive Order 14187, Protecting Children From Chemical and Surgical Mutilation (January 28, 2025) overruled Biden Administration policies protective of gender transition and other treatments for gender dysphoria by ordering HHS to end take action to terminate all regulations and other policies and practices that allow or support chemical and surgical mutilation of children as a treatment of gender dysphoria.

Meanwhile, in his Executive Order 14182-Enforcing the Hyde Amendment (January 24, 2025), President Trump reversed key policies undertaken by the Biden Administration to mitigate the effects of the Supreme Court’s landmark Dobbs vs. Jackson Women’s Health Organization decision that overturned Roe vs. Wade by declaring the U.S. Constitution does not protect a woman’s right to an abortion.

In response to these and other Trump Executive Orders, HHS on April 14, 2025, published its new Guidance for Whistleblowers on the Chemical and Surgical Mutilation of Children (the “Whistleblower Guidance”).  The Whistleblower Guidance explains the conditions under which the Health Insurance Portability & Accountability Act of 1996 (“HIPAA”) allows health care providers, health plans, health care clearinghouses or their business associates (“HIPAA Entities”) to disclose information about chemical or surgical mutilation of children in violation of Executive Order and key federal anti-retaliation protections for whistleblowers making these disclosures or engaging in other exercises of their Rights of Conscience under the Church Act.

New HIPAA Whistleblower Guidance

The HIPAA Privacy Rule generally prohibits use, disclosure, and protection of protected health information (“PHI) by HIPAA Entities.  The Whistleblower Guidance notes that since its inception, the Privacy Rule has provided various pathways for HIPAA Entities to use and disclose PHI in connection with whistleblowing actions of their workforce members or business associates.  

Along with the option to use de-identified information in whistleblower disclosures, the Whistleblower Guidance also notes that the whistleblower provision of the Privacy Rule provides that a HIPAA Entity is not considered to violate the Privacy Rule when a workforce member or business associate discloses PHI in the following circumstances:

  • The workforce member or business associate has a good faith belief that the conduct being reported is unlawful or otherwise violates professional or clinical standards, or that the care, services, or conditions provided by the covered entity potentially endangers one or more patients, workers, or the public[2], and
  • The workforce member or business associate of the covered entity discloses PHI to any of the following:
  • A health oversight agency[3] or public health authority[4] authorized by law to investigate or otherwise oversee the relevant conduct or conditions of the covered entity.
  • An appropriate health care accreditation organization[5], such as a state medical board, for the purpose of reporting the allegation of failure to meet professional standards[6] or misconduct by the covered entity.
  • An attorney retained by or on behalf of the workforce member or business associate for the purpose of determining his or her legal options with respect to whistleblowing.

Thus, the Whistleblower Guidance states the Privacy Rule protects a HIPAA Entity from liability for the good-faith whistleblower action of a member of its workforce or a business associate in these situations, but does not protect the HIPAA Entity where, for example, a member of its workforce or its business associate discloses PHI to a member of the media or in some other manner not in accordance with an allowable exception to the Privacy Rule.

Since the HIPAA Entities bear responsibility for inappropriate disclosures of PHI by whistleblowers from their workforce, the Whistleblower Guidance sends a strong message to HIPAA Entities to properly document and train workforce members about when and how HIPAA allows or prohibits the use of PHI when reporting known or suspected violations of the law.

Along with discussing when HIPAA allows whistleblowers to uses or disclose PHI to report illegal behavior, the Whistleblower Guidance also highlights the following as among the federal laws most likely pertinent for “protecting whistleblowers who take action related to ensuring compliance with” the Executive Order. EO 14187:

  • The National Defense Authorization Act of 2013 (“NDAA”) contains a broad whistleblower protection for employees of federal contractors and grantees by providing that “[a]n employee of a contractor, subcontractor, grantee, subgrantee, or personal services contractor may not be discharged, demoted, or otherwise discriminated against as a reprisal for disclosing to” certain statutorily defined officials and entities “information that the employee reasonably believes is evidence of gross mismanagement of a Federal contract or grant, a gross waste of Federal funds, an abuse of authority relating to a Federal contract or grant, a substantial and specific danger to public health or safety, or a violation of law, rule, or regulation related to a Federal contract (including the competition for or negotiation of a contract) or grant.”
  • The False Claims Act (“FCA”) anti-retaliation provisions protect “employee[s], contractor[s], [and] agent[s]” from discharge, demotion, suspension, or any other manner of discrimination “in the terms and conditions of employment” because of lawful acts taken by the individual in furtherance of a claim under the FCA or “other efforts to stop one or more violations of [the FCA]”  where an individual must generally show that: (1) he or she is a covered “employee, contractor, or agent”; (2) he or she was engaged in activity protected by the statute; (3) he or she was retaliated against; and (4) the retaliation was “because of” protected activity.
  • The Church Amendments prohibits entities that receive certain federal financial assistance from discriminating “in the employment, promotion, or termination of employment of any physician or other health care personnel” or discriminating “in the extension of staff or other privileges to any physician or other health care personnel” because that individual “refused to perform or assist in the performance” of a “lawful sterilization procedure” “on the grounds that his performance or assistance in the performance of the procedure . . . would be contrary to his religious beliefs or moral convictions,” or “because of his religious beliefs or moral convictions respecting sterilization procedures[.]”  In addition, 42 U.S.C. § 300a-7(d) provides: “No individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or in part under a program administered by the Secretary of Health and Human Services if his performance or assistance in the performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions.”  
  • The HIPAA Privacy Rule generally requires HIPAA Entities to have and apply appropriate sanctions against members of its workforce who failed to comply with their privacy policies or procedures or with the requirements of the rule. However, Privacy Rule § 164.530€(1) explicitly excludes the application of sanctions to a member of the HIPAA Entity’s workforce for whistleblowing activity.

2 New Right Of Conscience Investigations Signal Growing Enforcement Risks

OCR’s announcement of its opening of two Right of Conscience investigations sends a clear warning to health care providers and other HHS-funded entities to ensure the defensibility of their own practices and policies for honoring the rights of conscience of their workforce and others they do business with in the course of their operations.

  • 1st Right Of Conscience Investigation Announcement On April 14

On April 14, 2025, OCR announced its initiation of its first investigation of a major pediatric teaching hospital for allegedly terminating the employment of a whistleblower nurse for exercising her federally protected rights of conscience.  According to the OCR announcement, the pediatric teaching hospital allegedly terminated the employment of a whistleblower nurse for exercising her federally protected rights of conscience. The OCR announcement states that the investigation will examine whether the pediatric hospital violated the Church Amendments by firing a whistleblower nurse after she requested a religious accommodation to avoid administering puberty blockers and cross-sex hormones to children, which she opposed due to religious beliefs about the sterilization effects of these interventions.  The announcement also quotes Acting HHS OCR Director Anthony Archeval as stating, “The Department will robustly enforce Federal laws protecting these courageous whistleblowers, including laws that protect health care professionals from being forced to violate their religious beliefs or moral convictions.” 

  • 2nd Right of Conscience Investigation Announcement On May 12

Less than one month after announcing its first investigation, OCR on May 12, 2025, announced its second right of conscience investigation against a hospital which is part of a larger health care system.  According to the announcement, the investigation will focus on how the hospital accommodates its health care personnel who decline to perform or assist in the performance of abortion procedures contrary to their religious beliefs or moral convictions. 

The second announcement notes that the investigations are “part of a larger effort to strengthen enforcement of laws protecting conscience and religious exercise.” It also quotes Acting OCR Director Archeval as stating, “The Department is committed to enforcement of our nation’s laws that safeguard the fundamental rights of conscience and religious exercise,” …  “Health care professionals should not be coerced into, fired for, or driven out of the profession for declining to perform procedures that Federal law says they do not have to perform based on their religious beliefs or moral convictions.” 

The new emphasis of HHS and other agencies on investigation and enforcement of federal protections for rights of conscience and other religious freedoms and other civil rights laws alone should prompt all health care and other HHS-regulated authorities prospectively to reevaluate and update their own practices to strengthen their defensibility under new standards. When assessing the adequacy of their existing policies and practices, health care and other covered organizations also should anticipate the likely need to defend past actions taking into account the Trump Administration’s sharp redirection of interpretations and enforcement away from the policies of the Biden Administration. Since the investigation and enforcement actions announced by HHS and other agencies so far retroactively apply the newly announced Trump-era interpretations and standards to investigations of events and actions that occurred during the Biden Administration, prospective changes to enhance the defensibility of current and future actions alone may not be enough. Rather, health care and other organizations need to prepare for the possibility that HHS or other agencies may require their organization to defend Biden-era events under the new Trump Administration interpretations of the Church Amendments, the CRA, Section 1557, and other federal rules on religious or other Civil Rights law discrimination. In the face of these developments, all health care organizations receiving funding from HHS should review their current and past policies and actions implicating potential exercises of rights of conscience regarding to the treatment of children for gender dysphoria, abortion and other reproductive rights and other areas likely to implicate the Church Amendments or other federally protected religious rights to assess their potential past exposures and mitigate future risks. 

The author of this update, Cynthia Marcotte Stamer has decades of experience advising, representing, and defending health care providers, Medicare and Medicaid Advantage and other public and private health plans and plan sponsors, public and private employers, government contractors and grant recipients, educational organizations, child care facilities, employers, technology, data, third party administrators, and other managed care and other health care, defense, technology, life sciences and other clients about Civil Rights Laws and other religious, civil rights and other discrimination, HIPAA and other privacy and data security, False Claims Act and other billing and reimbursement, quality, technology, licensing and accreditation, whistleblower and other workforce, enforcement, governmental affairs, dispute resolution, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her. 

For More Information

We hope this update is helpful. For more information about the  or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.

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 her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.

Ms. Stamer’s work throughout her career has focused heavily on working with health care, health insurance and managed care, insurance and financial services, defense contractors, and other workforce and data sensitive businesses domestically and internationally on employment, benefits, data and other knowledge use and protection, Federal Sentencing Guidelines and other workforce and heath care management, internal and operational controls, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has had extensive involvement in Civil Rights Laws, Section 1557 and other discrimination compliance, training, risk management and defense.

In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. 

Author of many highly regarded compliance, training and other resources on cybercrime and other data privacy and security, health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy in these matters.  

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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[1] See e.g., Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government (January 20, 2025).

[2] 45 CFR 164.502(j)(1)(i).

[3] 45 CFR 164.501.

[4] 45 CFR 164.501.

[5] 65 Fed. Reg. at 82492.

[6] See 65 Fed. Reg. at 82727

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Posted by Cynthia Marcotte Stamer

Trump 4/15 Executive Order Targets Prescription Drug Cost, Transparency and Competitiveness Reforms

April 17, 2025

Health care providers, health plans and insurers, pharmaceutical and prescription drug companies, prescription benefit manager and consumers should prepare for increased regulation of prescription drug benefit management arrangements and other changes in federal rules on prescription drug pricing, coverage and related practices in response to directives in President Trump’s April 15, 2025 Executive Order on Lowering Drug Prices By Once Again Putting Americans First (the “Executive Order”).

Intended to address widely shared concerns about prescription drug availability, cost and coverage, by the Executive Order declares optimization of health care programs, intellectual property protections, and safety regulations to provide access to prescription drugs at lower costs to American patients and taxpayers the policy of the United States. Persons potentially concerned or impacted by these concerns should monitor the affected agencies for calls for stakeholder input, proposed guidance, and other activities in furtherance of the shaping and implementation of these new policy initiatives.

Medicare-Focused Prescription Drug Reforms

To promote this policy, the Executive Order directs the Department of Health and Human Services (“HHS”) and various other federal agencies to take certain steps to implement this policy.  The Executive Order includes several directives to HHS and certain other agencies that President Trump intends to lower the cost of prescription drugs within and outside the Medicare program.

By April 15, 2026, the Executive Order directs HHS to develop a better payment model to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biological products covered by Medicare, including those not subject to the Medicare Drug Price Negotiation Program.   

In addition, the Executive Order:   

  • Directs HHS to work with the Congress to modify the Medicare Drug Price Negotiation Program to align the treatment of small molecule prescription drugs with that of biological products so as to end the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries;
  • By June 14, 2025,   
    • Requires HHS to propose changes to the Medicare Drug Price Negotiation Program regulations for the initial price applicability year 2028 and manufacturer implementation of maximum fair price under such program in 2026, 2027, and 2028 to improve the transparency of the Medicare Drug Price Negotiation Program, prioritize the selection of prescription drugs with high costs to the Medicare program, and minimize any negative impacts of the maximum fair price on pharmaceutical innovation within the United States; and
    • Requires HHS to require health centers receiving Public Health Service Act Section 330(e) grants to establish practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to low income individuals who have a high cost-sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or have no healthcare insurance.
    • Requires the Assistant to the President for Domestic Policy (“APDP”) in coordination with the Secretary, the Director of the Office of Management and Budget (“OMB Director”), and the Assistant to the President for Economic Policy (“APECP”), to provide recommendations to the President on how best to stabilize and reduce Medicare Part D premiums;
    • Requires the HHS Secretary to publish a plan to conduct a survey under the Site-of-Service Price Transparency rules of Social Security Act Section 1833(t)(14)(D)(ii) to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments and propose appropriate adjustments to align Medicare payment with the cost of acquisition, consistent with the budget neutrality requirements;
    • Requires HHS to evaluate and propose regulations to ensure that payment within the Medicare program is not encouraging a shift in drug administration volume away from less costly physician office settings to more expensive hospital outpatient departments.

Other Prescription Drug Reforms

In addition to these predominantly Medicare-focused programs, the Executive Order also orders federal agencies to

  • Requires the Secretary of Labor  to propose regulations pursuant to section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers by October 12, 2025;
  • Requires the APDP, in coordination with the HHS Secretary, the OMB Director, and the APECP, to provide recommendations to the President on how best to promote a more competitive, efficient, transparent, and resilient pharmaceutical value chain that delivers lower drug prices for Americans by June 14, 2025;
  • Requires the Food and Drug Administration to streamline and improve the Importation Program under the Federal Food, Drug, and Cosmetic Act to make it easier for States to obtain approval without sacrificing safety or quality;
  • Requires the OMB Director, the APDP, and the Assistant to the President for Economic Policy )”APECP, and HHS Secretary to provide joint recommendations on how best to ensure that manufacturers pay accurate Medicaid drug rebates consistent with section 1927 of the Social Security Act, promote innovation in Medicaid drug payment methodologies, link payments for drugs to the value obtained, and support States in managing drug spending;
  • Requires the HHS Secretary, through the Commissioner of Food and Drugs, to issue a report providing administrative and legislative recommendations to  accelerate approval of generics, biosimilars, combination products, and second-in-class brand name medications; and improve the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter;
  • Requires HHS, the Department of Justice, the Department of Commerce, and the Federal Trade Commission to conduct listening sessions and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.

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Posted by Cynthia Marcotte Stamer

State Medicaid Programs Can Deny Out-Of-State Providers Supplemental Payments

April 9, 2025

While Medicaid rules require state Medicaid programs to provide reimbursements for out-of-state services provided to beneficiaries, the District Of Colombia Court of Appeals has ruled that states can limit supplemental payments funded through a tax or assessment on in-state providers to in-state providers.

In Asante v. Kennedy, No. 23-5055 (D.C. Cir. 2025), border hospitals caring for California residents covered by California’s Medi-Cal program argued California violated the Commerce Clause and the Equal Protection Clause of the Constitution by refusing to pay Medi-Cal supplemental payments provided to in-state hospitals caring for Medi-Cal beneficiaries to the border hospitals treating Medi-Cal beneficiaries seeking care outside California. 

The Medi-Cal program is the program through which California participates in Medicaid. Federal Medicaid funding is available to States for expenditures related to the provision of a covered Medicaid service to a Medicaid beneficiary under 42 U.S.C. § 1396b.

For purposes of Asante, the Court distinguished between two types of State Medicaid expenditures:

  • Base payments, which CMS has defined as payments made to providers “on a per-claim basis for services rendered to a Medicaid beneficiary,” and
  • Supplemental payments, which are payments to providers separate from (and in addition to) the “per-claim” base payments for services rendered to a beneficiary.

See Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting, 89 Fed. Reg. 40,876, 40,925 (June 21, 2024) (citing 42 U.S.C. § 1396b(bb)); 42 C.F.R. § 438.6(a).

The Medicaid law does not require states to fund their share of Medicaid expenditures entirely on their own. Instead, States may tax providers in accordance with specified criteria to generate funds that the federal government then matches. In 2009, California exercised this taxing authority by establishing a Quality Assurance Fee (“QAF”) as part of its administration of Medi-Cal. The QAF program operates by: (i) assessing a provider tax, which California calls a quality assurance fee, on nonexempt in-state hospitals; (ii) using those funds to generate matching federal Medicaid funding; and (iii) distributing the collected funds as supplemental payments to qualifying private in-state hospitals. Id. §§ 14169.50, 14169.52, 14169.54, 14169.55.

Following California’s original creation of the QAF program, a group of out-of-state hospitals located near the California border challenged the program in federal court in California, claiming an entitlement to receive the QAF supplemental payments, which by California law were to go solely to instate hospitals. At that time, California chose to settle rather than fight the out-of-state hospitals.  Consequently, California entered into settlement agreements under which it gave QAF supplemental payments to those out-of-state hospitals through 2019. Those settlement agreements expired in 2019.

When California sought and obtained in 2020 CMS approval of the QAF program with payments restricted to in-state hospitals for the next two-year cycle, California again faced challenges from out-of-state hospitals along its border.  A group of out-of-state hospitals located near the California border again argued in federal court that their exclusion from the QAF supplemental payments violates the Commerce Clause, the Equal Protection Clause, and federal Medicaid regulations. After district court granted summary judgment approving the California exclusion of the out-of-state providers, Asante v. Azar, 656 F. Supp. 3d 185, 190 (D.D.C. 2023), the border hospitals appealed.

In its ruling upholding California’s limitation of eligibility for the supplemental payments, the Court rejected each of the border hospital’s Constitutional challenges to their ineligibility.1

Regarding the Commerce Clause, the Court of Appeals rejected the border hospitals’ Commerce Clause’s claim that the QAF program discriminates against interstate commerce because California pays QAF supplemental payments only to in-state hospitals. The Appeals Court noted that both the QAF provider tax assessed against in-state hospitals and the QAF supplemental payments given to in-state hospitals are calculated based solely on the in-state provision of medical care to in-state patients. The QAF program does not assess a tax against out-of-state hospitals. Since California makes no “obvious effort to saddle those outside the State” with the costs of the QAF program.  Since out-of-state hospitals neither incur the costs (the provider tax) nor receive the benefits (the supplemental payments) of the QAF program, the Appeals Court held that the program does not discriminate against interstate commerce—as it imposes no “differential burden on any part of the stream of commerce” here. See W. Lynn Creamery, Inc. v. Healy, 512 U.S. 186, 202 (1994).

The Court likewise rejected the border hospital’s claim that California violated the Equal Protection Clause. Noting that a challenged state law such as the California statute that does not include factors justifying heightened scrutiny must be upheld under the Equal Protection Clause “if there is any reasonably conceivable state of facts that could provide a rational basis” for it, the Court ruled that limiting eligibility for the supplemental payments to the in-state hospitals that paid the taxes that funds it.  Accordingly, the Court ruled the border hospitals were not entitled to receive supplemental payments under the Equal Protection Clause.

Finally, the Appeals Court also rejected the border hospitals’ last argument that California’s QAF program violated HHS Regulations by denying the supplemental payments to the border hospitals because the supplemental payments are not reimbursements for services and therefore not covered by 42 C.F.R. § 431.52.

Accordingly, the Appeals Court ruled that California does not violate the Commerce Clause or Equal Protection Clause of the United States Constitution by excluding out-of-state hospitals located along the California border (“border hospitals”) that treat California residents enrolled in Medi-Cal from eligibility to collect Medi-Cal supplemental payments paid to California hospitals for treating Medi-Cal-covered Californians.

The author of this update, Cynthia Marcotte Stamer has decades of experience advising health care providers, Medicare and Medicaid Advantage and other public and private health plans and plan sponsors, government contractors and grant recipients, government health and social security programs, and their technology, data, third party administrators, and other managed care and other health care, defense, technology, life sciences and other clients about health industry quality, technology, reimbursement, licensing and accreditation, compliance, enforcement, governmental affairs, dispute resolution, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her. 

For More Information

We hope this update is helpful. For more information about the  or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452-8297.

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 her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on workforce and other risk management and compliance.

Ms. Stamer’s work throughout her career has focused heavily on working with health care, health insurance and managed care, insurance and financial services, defense contractors, and other workforce and data sensitive businesses domestically and internationally on employment, benefits, data and other knowledge use and protection, Federal Sentencing Guidelines and other workforce and heath care management, internal and operational controls, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has had extensive involvement in the design, enforcement, investigation, mitigation and defense of trade secret and other information privacy and confidentiality, HRIS, claims, electronic medical records, payment, and other systems and technologies; HIPAA and other health industry, DOD,  FACTA, GLB, EU, and other data privacy and security, trade secret and other confidential information; and other information privacy and security laws, policies, practices, contracts and requirements. 

In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. 

Author of many highly regarded compliance, training and other resources on cybercrime and other data privacy and security, health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy in these matters.  

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

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Posted by Cynthia Marcotte Stamer

HHS Issues Southern California Fire Public Health Emergency Disaster Relief

January 10, 2025

Health care providers, health plans and insurers, child care facilities, schools and other Southern California organizations impacted by the California fires that are regulated by the Department of Health and Human Services (“HHS”) may qualify for temporary waivers or modification of certain HHS regulatory obligations under the Declarations of a Public Health Emergency (“PHE”) published by HHS today.

The relief provided by the PHE includes:

An extensive list of resources and guidance to help health plans, health care providers and others to understand and cope with HHS requirements in disaster or other emergency situations such as:

Health care providers and other HHS regulated entities impacted by the fire or other disasters should carefully review this guidance to understand the scope and availability of the current relief. Additionally, health care providers, health plans, health care providers, business associates and other HHS-regulated entities not currently impacted by today’s or another public health emergency declaration should keep in mind that they likely are subject to HHS and other regulatory, statutory, common law, or ethical obligations to make advance arrangements to prepare in advance to deal with responsibilities during a disaster. Accordingly, providers and others not currently affected by the current disaster should heed the reminder from the disaster to reconfirm before they are impacted by a disaster the adequacy of their own policies, plans and arrangements to provide for their continued ability to fulfill HHS regulatory and other obligations in the event of a disaster.

Health care providers and other HHS-regulated entities planning to rely upon the PHE relief should keep in mind the limited duration and scope of the relief provided by this PHE or any other HHS public health emergency declaration. Entities planning to rely on the PHE relief must review the scope, conditions and duration requirements and ensure their ability to defend their continued compliance taking into account these limited waivers and modifications.

Also, the PHE guidance documents are not a final agency action, do not legally bind persons or entities outside the Federal government, and may be rescinded or modified at the Department’s discretion. Noncompliance with any voluntary standards (e.g., recommended practices) contained in these documents will not, in itself, result in any enforcement action.

Furthermore, health care providers, health plans and insurers, and other HHS regulated entities typically face a myriad of responsibilities beyond those imposed by the HHS under various federal and state laws, other agency regulations, contracts, common law and ethical or other standards or rules. Consequently, providers and other HHS entities intending to rely on the HHS PHE also should check other agencies disaster declaration webpages to determine what additional relief from other agency requirements, if any, their organization may qualify as a result of the disaster. Except to the extent covered by other declared disaster relief, coverage by or compliance with the HHS PHE guidance and policies typically provide no protection against liability for failure to fulfill duties or responsibilities under these other laws, regulations or standards or beyond the specific relief granted in the HHS PHE. Accordingly, entities impacted by the fire or another disaster are urged to take necessary steps before, during and after any disaster to position themselves to demonstrate fulfillment of duties and mitigate the seriousness of any alleged deficiencies in their compliance.

The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, who has decades of experience advising health care providers, health plans and insurers, third party administrators, managed care and other health care payers and providers, technology, and other businesses about crisis preparedness and response and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her. 

For More Information

We hope this update is helpful. For more information about these or other health or other employee benefits, human resources, or health care developments, please contact the author, Cynthia Marcotte Stamer, via e-mail or telephone at (214) 452-8297.

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 her more than 35 years of health, insurance, employment and employee benefits and other industry management work, public policy leadership and advocacy, coaching, teachings, and publications including leading-edge work on crisis preparedness, response and recovery.

Author of many highly regarded compliance and risk management tools, training and other resources on health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy on these matters.  

In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. 

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2025 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.

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Posted by Cynthia Marcotte Stamer

FTC Faces PBM Lawsuit For Report Critical Of PBMs And Their Practices

September 19, 2024

Health care providers, independent pharmacies, employer and other health plan sponsors and fiduciaries, and individuals concerned about prescription drug prices and access should carefully follow the rapidly accelerating battle between the Federal Trade Commission (“FTC”) and pharmacy benefit managers (“PBMs”), which threatens to reshape how pharmaceutical products are priced and sold to health plans and consumers.

At the center of the complex pharmaceutical distribution chain that delivers prescription medicines from manufacturers to patients, PBMs generally are vertically integrated organizations that simultaneously serve and regulate health plans and pharmacists and play other roles in the drug supply chain.

This vertical integration allows these six PBMs to wield enormous power and influence over health plans’ and patients’ access to drugs and the prices they pay, as well as pharmacies’ access to prescription drugs and the price and other terms under which pharmacies qualify for health plan coverage or payment for these medications.

PBMs also exert substantial influence over independent pharmacies by imposing contractual terms imposed by PBMs as a condition of accessing medications, covering the pharmacies under health plans contracted with the PBMs, or both. Physicians and health care prescribers also often complain that these PBM-imposed restrictions inappropriately interfere with appropriate physician prescribing practices and pit pharmacists against physicians to the detriment of patients.

Mergers and consolidations within the PBM, pharmacy and health benefit industries that brought ownership of the largest PBMs under common ownership with large insurers and retail pharmacies they purport to both manage and work has increased the already significant power of PBMs to use their integration to control these and other aspects of prescription drug availability, access, distribution, and pricing/ Consequently, the sixth largest PMBs -Caremark Rx, LLC; Express Scripts, Inc.; OptumRx, Inc.; Humana Pharmacy Solutions, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. – now collectively negotiate and enforce access, coverage, pricing and other key terms and conditions governing the availability, access to, and cost of prescription drugs for hundreds of millions of Americans.

With the consolidation of ownership of large PBMs, payers and pharmacies further tightening these PBMs’ control over prescription drug distribution, pricing, and coverage and prescription drug costs continuing to rise, PBMs and their practices increasingly face scrutiny, challenges and calls for reform by employers and other plan sponsors, health care providers, independent pharmacies, the FTC and other regulators, Congress, state legislatures and regulators, consumers, and others. See Report on Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.

FTC July 2024 Interim Report On 6th Largest PBMs

In response to these and other growing concerns about consolidation, lack of transparency and other potential abuses about the PBM industry and prescription drug costs, the FTC began investigating the PBM industry in 2022.  In July 2024, the FTC released its Report on Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies (the “FTC Report”) that reports the FTC’s interim findings from its ongoing study of the six largest PBMs – Caremark Rx, LLC; Express Scripts, Inc.; OptumRx, Inc.; Humana Pharmacy Solutions, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. use their vertical integration and concentration to inflate drug costs, squeeze Main Street pharmacies and engage in other practices harmful to patients and independent pharmacies.

The FTC Report shares interim findings based on the FTC staff’s review of more than 1,200 public comments to identify predominant areas of concern, initial submissions of internal documents and data from PBM respondents and their affiliates, interviews of various industry experts and participants and review of other public data and information.  The FTC Report also discloses that certain PBMS have yet to produce the data and documents required in response to FTC orders issued more than two years ago. While stating its study continues and promising that the FTC will continue efforts to force the PBMs to produce the evidence demanded in the orders, the FTC Report also promises to share regular updates about its progress and findings.

While the investigation continues, the FTC Report shares the FTC’s interim findings that:

  • The market for pharmacy benefit management services has become highly concentrated, and the largest PBMs are now also vertically integrated with the nation’s largest health insurers and specialty and retail pharmacies;
  • As a result of this high degree of consolidation and vertical integration, the leading PBMs can now exercise significant power over Americans’ access to drugs and the prices they pay;
  • Vertically integrated PBMs may have the ability and incentive to prefer their own affiliated businesses, which in turn can disadvantage unaffiliated pharmacies and increase prescription drug costs;
  • Evidence suggests that increased concentration may give the leading PBMs the leverage to enter into complex and opaque contractual relationships that may disadvantage smaller, unaffiliated pharmacies and the patients they serve;
  • PBMs and brand drug manufacturers sometimes negotiate prescription drug rebates that are expressly conditioned on limiting access to potentially lower cost generic alternatives in exchange for higher rebates from the manufactures in a manner that may cut off patient access to lower-cost medicines and warrant further scrutiny by the Commission, policymakers, and industry stakeholders.

The FTC Report also shares the FTC’s concern that the six largest PBMs improperly use their integration and market control over 95 percent of all prescriptions filled in the United States:

  • To profit at the expense of patients and independent pharmacists;
  • To hike the cost of and overcharge for drugs
  • To squeeze independent pharmacies that many Americans—especially those in rural communities—depend on for essential care;
  • To wield enormous power over patients’ ability to access and afford their prescription drugs, allowing PBMs to significantly influence what drugs are available and at what price; and
  • To impose unfair, arbitrary, and harmful contractual terms that can impact independent pharmacies’ ability to stay in business and serve their communities.

The FTC Report concludes that PBMs’ have an “outsized influence” that comes not only from the expansion of their traditional, middlemen administrative services in processing patients’ pharmacy prescription claims but also from decades of consolidation and vertical integration across the healthcare delivery system where “the largest PBMs have come under common ownership with the largest, most dominant health insurers … [that] operate some of the largest retail, mail order, and specialty pharmacies in the country, which compete with local independent pharmacies. Given these relationships, PBMs and their affiliated entities may have the incentive and ability to engage in steering a growing share of prescription revenues to their own pharmacies through specialty drug classification, self-preferential pricing, and pharmacy contracting procedures to target and control the business operations of pharmacies. While the FTC Report principally focuses on the impact of these changing market dynamics on the operation and vitality of the nation’s pharmacies, the FTC Report also states that initial evidence about PBM and brand pharmaceutical rebating practices “urgently warrant further scrutiny and potential regulation.”

The FTC Report concludes that these interim findings underscore the importance and urgency of scrutinizing the role and influence of PBMs in the nation’s healthcare system, particularly as federal and state governments are the largest purchasers of healthcare.

Express Scripts Sues FTC Demanding Retraction Of FTC Report

Not surprisingly, the PBMs subject to the FTC Report generally have protested the reported findings. On September 17, 2024, CIGNA-owned Express Scripts sued the FTC, demanding the FTC retraction of the FTC Report. In the Express Scripts, Inc. v. FTC complaint, Express Scripts characterizes the FTC Report as “unfair, biased, erroneous, and defamatory.” In the Complaint, Express Scripts alleges:

“According to the Commission’s press release announcing the Report, the Report stems from special orders issued under Section 6(b) of the FTC Act to six PBMs, including Express Scripts, demanding data and information about the PBM industry. But the Report is not an analysis of the data and information produced by the PBMs. Instead, it is seventy-four pages of unsupported innuendo leveled against Express Scripts and other PBMs under a false and defamatory headline and accompanied by a false and defamatory press release. The Commission disregarded the millions of documents and terabytes of data produced and relied instead on unverified comments from the very companies that PBMs negotiate against in order to help lower drug costs. Not surprisingly, those entities are incentivized to point the finger at PBMs for allegedly driving drug costs up, when it is PBMs who are, in fact, bringing drug costs down.”

Charging that the FTC Report “followed prejudice and politics, not evidence or sound economics, and wrongly concluded that PBMs inflate drug costs and harm independent pharmacies” and harmed Express Scripts’ business and reputation by the FTC’s “unlawful, unconstitutional, and arbitrary and capricious conduct and defamatory statements,” the Complaint alleges that the FTC Report “gets nearly everything wrong” as a result of FTC Chair Khan’s and the FTC’s bias against PBMs and failure to consider the evidence before them. For example, the Complaint asserts:

“It falsely accuses Express Scripts and other PBMs of “controlling” access to drugs and drug pricing when it is manufacturers who set drug prices and plan sponsors who decide which drugs to cover for their members.

It attacks Express Scripts for disadvantaging independent pharmacies when the evidence produced shows that on average independent pharmacies not affiliated with PBMs receive higher reimbursements than unaffiliated chain pharmacies, independent pharmacies are profitable, and the number of prescriptions filled at independent pharmacies is increasing.

It falsely claims that Express Scripts is “profiting by inflating drug costs,” including by taking rebates from drug manufacturers in return for putting high cost drugs on formularies when, in truth, the bulk of rebates and fees received by PBMs get passed through to plan sponsors and lower the net cost of drugs to plan sponsors and members. Moreover, Express Scripts prefers drugs with the lowest net cost to its plan sponsors on its largest standard formularies.

It makes the broad-brush claim that the PBMs failed to comply with the Commission’s 2022 6(b) orders, which demanded extensive data and information for production—without identifying who the supposed offenders are—even while Express Scripts had long ago complied with the Commission’s requests, which

the Commission knew and verbally acknowledged before and after issuing its Report. It falsely states that PBMs, including Express Scripts, “profit at the expense of patients by inflating drug costs” when the evidence shows that PBMs compete for the business of plan sponsors by offering lower costs for covered drugs than their competitors. PBMs have low and declining operating margins and any PBM that sought to inflate the cost of covered drugs would quickly lose its clients.

Due to these alleged false conclusions, the Complaint charges that the FTC Report violates federal and state law several times over, including in at least the following ways:

  • By exhibiting bias against PBMs and prejudgment of the facts, the Report violates Express Scripts’ right to due process under the Fifth Amendment to the U.S. Constitution.
  • It contains (i) assertions that will predictably be and have been interpreted as conclusions adverse to all PBMs and (ii) false statements unsupported by the record that demonstrate the Commission’s failure to consider the available contrary evidence and render its decision arbitrary and capricious.
  • It is not in the public interest and therefore exceeds the Commission’s statutory authority under Section 6(f) of the FTC Act.
  • It is unlawful because Commissioners exercise executive authority while enjoying statutory removal protections in violation of Article II of the U.S. Constitution.
  • And the Commission’s claim both in the Report and the accompanying press release that PBMs, including Express Scripts, are “inflating drug costs” and “profit by inflating drug costs at the expense of patients,” is false and defamatory.

Claiming that Express Scripts has suffered and continues to financial, business and reputational harm by the FTC Report’s allegedly false statements about its business practices and the insinuation that Express Scripts’ successful efforts to fight for lower prices for plan including being sued in multiple lawsuits invoking the FTC Report as evidentiary support for plaintiffs’ claims and faces multiple demands for information from state regulators and federal legislative committees. Contending these harms “have only just begun and will only be compounded over time,” Express Scripts asks the District Court:

  • To vacate and require the FTC to set aside the FTC Report;
  • Make the FTC correct the false statements it has made about PBMs; and
  • Require the recusal of FTC Chair Khan from further FTC proceedings regarding Express Scripts in light of her evident bias against PBMs, including Express Scripts.

Regardless of how the Express Scripts lawsuit plays out, employers and other health plan sponsors, fiduciaries, third party administrators, insurers, pharmacies, health care providers and individual Americans can expect to see continued challenges and attempts to reform PBMs to address perceived abuses. The direction and specifics of those challenges and changes remain unclear. Since political pressure is likely to significantly influence the ultimate outcome of any reforms, concerned individuals and organizations should carefully monitor and provide input.

Meanwhile, employer and other health plan sponsors and fiduciaries should also anticipate that the FTC Report and similar Congressional and other studies and investigations may increasingly fuel and provide evidence to support participants’ and beneficiaries’ questions and challenges to PBM features and practices within their health plans.

More Information

We hope this update is helpful. For more information about the  or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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 her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on PBM, pharmacy and pharmaceutical and other health care, managed care, insurance, and insured and self-insured contracting, design, administration and regulation.. 

Author of numerous highly regarded works on PBM and other health plan contracting and design,  Immediate Past Chair of the ABA International Section Life Sciences Committee and the Tort Trial and Insurance Practice Section Medicine and Law Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and past Group Chair and current Welfare Benefit Committee Co-Chair of the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. 

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; third party administrators and other health benefit service providers; hospitals, health care systems and other health care providers, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

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

Author of publications on “Transparent PBM Contracting,” “ACOs, Direct Contracting: Legal & Practical Challenges For Employers, Providers & TPAs,” “The Medicare Advantage Contracting Manual,” “Third Party Administrator (TPA) Contracting Principles and Strategies and a multitude of other highly regarded publications and presentations,  Stamer is widely recognized for her thought leadership on PBM and other managed care and health plan contracting and design, and a multitude of other health care, health plan and other health industry matters.  In addition, Ms. Stamer contributes her time and leadership to numerous policy, professional, civil and other organizations including service as the, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources 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 information and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any  fact or law specific nuance, change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2024 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.

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Posted by Cynthia Marcotte Stamer

Cleveland Clinic Foundation Pays $7.6M To Settle FCA Charges Relating To NIH Grants

May 20, 2024

The Cleveland Clinic Foundation (“CCF”) has agreed to pay $7,600,000 to resolve allegations that it violated the False Claims Act (“FCA”) by submitting to the National Institutes of Health (“NIH”) federal grant applications and progress reports in which CCF failed to disclose that a key employee involved in administering the grants had pending and/or active financial research support from other sources.

The settlement resolves allegations that CCF made false statements to NIH, a component of the Department of Health and Human Services (“HHS”), in connection with three federal grant awards. Despite NIH requirements to do so, federal officials charged CCF repeatedly failed to disclose that the employee who it designated as the Principal Investigator on each grant had pending and/or active grants from foreign institutions that provided financial assistance to support the employee’s research and already obligated that employee’s research time. CCF falsely certified that the grants submissions were true and accurate. The settlement also resolves allegations that CCF violated NIH password policies by permitting CCF employees to share passwords. Some of the false submissions wherein CCF failed to disclose the Principal Investigator’s foreign grant support were made by CCF employees who were inappropriately given access to NIH’s online grant reporting platform.

NIH requires full transparency in applications and throughout the life of the grants it awards. This includes a requirement that grant applicants disclose all sources of research support, from any source, on grant applications and on follow-up documents relating to grant awards. NIH uses this information to determine if the applicant has the time necessary to allocate to the proposed research project, and if the research proposal has other sources of funding that are duplicative. It also assists NIH in determining if an applicant’s financial interests may affect its objectivity in conducting research.

Under the Cleveland Clinic Settlement Agreement, CCF will pay $7.6 million settlement and be subject to additional NIH imposed Specific Award Conditions on all CCF’s grants for a one-year period.

Federal regulations allow NIH to impose Specific Award Conditions on grant recipients, including on recipients that do not comply with the terms of a federal award. In this case, NIH is requiring a high-level CCF employee to personally attest to the truth, completeness, and accuracy of all “other grant support” information CCF provides to NIH. CCF must also develop a corrective action plan that includes an assessment of internal controls related to other grant support and foreign-component reporting; create a mandatory training program addressing requirements for disclosing other grant support, research security, and cyber security; and develop an improvement plan for its internal controls, ensuring that CCF has oversight at the institutional level to confirm that the information its Principal Investigators disclose is true, complete, and accurate, among other requirements. The Specific Award Conditions will begin Oct. 1, 2024, and remain in effect through Sept. 30, 2025, or until NIH is satisfied that CCF has successfully completed the Corrective Action Plan.

The Department of Justice FCA enforcement and settlement illustrate the importance for researchers receiving NIH grants to ensure the accuracy of information reported in applications and other documentation related to federal grants. U.S. Attorney Rebecca C. Lutzko for the Northern District of Ohio said, “Today’s settlement illustrates the importance of being truthful at every stage of the grants process.”

For More Information

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

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

About the Author 

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of compliance, risk management, regulatory affairs, operations, strategy and other work with health, employee benefits, insurance, hospitality, retail, construction and other clients, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair and Chair Elect of its International Employment Law Committee, Chair of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of t and Che ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer has decades of experience advising employers, investigating and helping employers to defend wage and hour, worker classification, discrimination and other labor and employment, employee benefits and other compliance.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Her experience includes extensive involvement advising clients about preventing, investigating and defendingWHD, CAS, Davis-Bacon and other federal and state wage and hour and other compensation; EEOC, OFCCP, DOD, HUD, HHS and other Civil Rights Act, Section 1557 and other federal and state discrimination; EBSA, IRS, and PBGC employee benefit and compensation; DEA and other Justice Department; CDC, OSHA and other safety and other compliance, investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws. 

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. 

About Solutions Laws Press, Inc.™

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

ABOUT THIS COMMUNICATION

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication. 

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2024 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

FLSA Salary Threshold Increases, Other Proposed Changes To Rules & Enforcement Alert Health Care Employers To Confirm Salaried Employee Defensibility

May 14, 2024

Overtime awards like the $152,000 in back wages and liquidated damages a Bronx Urgent Care, P.C. (“Bronx”) must pay for wrongfully misclassifying as exempt and routinely failing to pay overtime to nine employees for hours over 40 in a workweek (“overtime”) and recently announced increases in the salary threshold required for salaried employees strongly signal the need for all medical practices and other health care providers to reassess and re-verify the defensibility of their classification and pay practices for each salaried employee of their organizations and related management services organizations to confirm each salaried employee both the earnings and job duties requirements to qualify as an exempt employee under the Fair Labor Standards Act (“FLSA”).  The precautionary warning sent by the judgment comes on the heels of the announcement by the Department of Labor Wage and Hour Division (“WHD”) of two increases in the minimum salary that an employer must pay an employee who otherwise satisfies the job duties requirements for payment by an employer on a salaried basis between July 1, 2024, and January 1, 2025.  The salaried classification reviews both should confirm current fulfillment of each salaried classified employee and identify and begin preparations for necessary adjustments to classifications or salary for any salaried employee currently earning less than the higher minimum salary requirements set to take effect this Summer.

Bronx $152,000 Back Pay & Liquidated Damages Award

The Brox overtime judgement is part of a growing number of enforcement actions targeting health industry employers for overtime and other labor and employment violations. See, e.g., Nearly $900K FLSA Backpay Award Warns Other Home Health Employers.

On May 10, 2024, the U.S. District Court for the Southern District of New York ordered Bronx Urgent Care P.C. to pay $152,000 – $76,000 in back wages and an equal amount in liquidated damages – to the affected workers. The court also affirmed $8,000 in civil money penalties the WHD assessed by because the court found the FLSA violations willful. In addition to the wage recovery, damages and penalties assessed, the court order also forbids Bronx from future FLSA violations.

The judgment resulted after a WHD investigation found the employer operating Bronx, its owner Basil Bruno, and operations manager Samuel Singer violated the FLSA by misusing the salaried employee exemption and failing to pay time and a half overtime pay for overtime hours worked to nine employees improperly treated as salaried. 

WHD Raising Salary Threshold Salaried Exemption

The FLSA requires employers to treat and pay each employee as an hourly employee subject to the minimum wage, overtime, and recordkeeping requirements unless the employer proves that the employee qualifies as exempt.  To treat an employee as a salaried employee exempt from the FLSA requirements, an employer bears the burden of proving both that the employee’s salary meets or exceeds the required salaried threshold and that the actual duties and responsibilities of the employee fulfill the job duties test. 

The judgment follows WHD’s April 23, 2024, adoption of a final rule that will twice increase the salary threshold of two upcoming increases to the minimum salary an employee must earn to qualify for treatment as an exempt employee eligible for the employer to pay on a salaried basis. On July 1, 2024, the Final Rule will increase the salary threshold from the current required annual equivalent salary threshold of $35,568 to an annual salary of $43,888. On January 1, 2025, the Final Rule further increases the salary threshold to an annual salary equivalent of $58,656.

The impending changes mean the Final Rule will prohibit an employer from paying any employee on a salaried basis and must comply with the FLSA’s minimum wage, overtime, and recordkeeping requirements for any employee whose an annual equivalent salary is less than $43,888 after June 30, 2024 or less than $58,656 after December 31, 2024.  Consequently, employers that currently pay employees whose job duties fulfill the job duties test paid less than the applicable salary threshold must either increase the employees’ salaries above the threshold or reclassify and compensate the employee as non-exempt employees, subject to the FLSA’s minimum wage and overtime requirements.

WHD and private litigation challenges overturning health industry and other salaried classification and other wage and hour practices demonstrate that many organizations rely upon inaccurate or overly optimistic perceptions of their ability to defend their salaried employee characterizations. Defending even the most realistically grounded salaried worker classification would become even more difficult if proposed changes to WHD proposed changes to its “White Collar” exemption rules announced earlier this year. When considering whether to raise salaries or reclassify, a health care or other organization should conduct documented compliance reviews on both workers the organization directly employs and any workers providing services to the organization through management services organizations, employee leasing, staffing, manpower, consultant, independent contractor, or other similar service arrangements where the potential exists for reclassification of the worker as a employee of the employer or the employer as a joint employer of the employee taking into account, the more aggressive regulatory and enforcement positions of the Biden Administration that make defending salaried characterizations more difficult for employers. 

The process should both realistically assess the defensibility of the classification and capture documentation of the employer’s compliance efforts, as this documentation can help mitigate exposure to willfulness penalties in the event the WHD or a court rejects the salaried classification of a particular employee in the future.The review of each salaried employee’s classification should begin with a review of whether each salaried employee currently meets the job duty and salaried threshold tests to qualify for salaried status.  If the review raises concerns about the defensibility of any employee’s current salaried classification, the organization should work with counsel to pursue options for resolving potential exposures.  

An employer should conduct this review on all salaried employees, not just those whose current salary is below the current or upcoming increased minimum salaried threshold level. Reevaluation of the defensibility of all salaried workers classification is recommended because many employers mistakenly misclassify workers as salaried rather than hourly due to an overly optimistic misunderstanding of the duties requirements for a worker to qualify as salaried. The risk of misclassification is heightened under the current administration’s enforcement policies. Employers currently aggressively classifying workers as salaried currently are at risk for FLSA wage and hour backpay, penalty, interest, and enforcement cost liability for record-keeping and overtime violations for misclassified workers under the FLSA and other applicable federal and state laws. Raising the salary of a misclassified worker will only make matters worse by increasing the overtime liability that the employer will be required to pay for failure to pay overtime after the salary increases take effect.  As the impending salary threshold increases will heighten already the already high enforcement interest of the WHD and private class action and individual litigants, employers are cautioned to consider their heightened risks of enforcement when evaluating the aggressiveness of their current and future salaried classification and other worker classification and pay practices.

For More Information

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

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

About the Author 

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of compliance, risk management, regulatory affairs, operations, strategy and other work with health, employee benefits, insurance, hospitality, retail, construction and other clients, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair and Chair Elect of its International Employment Law Committee, Chair of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of t and Che ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer has decades of experience advising employers, investigating and helping employers to defend wage and hour, worker classification, discrimination and other labor and employment, employee benefits and other compliance.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Her experience includes extensive involvement advising clients about preventing, investigating and defendingWHD, CAS, Davis-Bacon and other federal and state wage and hour and other compensation; EEOC, OFCCP, DOD, HUD, HHS and other Civil Rights Act, Section 1557 and other federal and state discrimination; EBSA, IRS, and PBGC employee benefit and compensation; DEA and other Justice Department; CDC, OSHA and other safety and other compliance, investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws. 

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. 

About Solutions Laws Press, Inc.™

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

ABOUT THIS COMMUNICATION

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication. 

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2024 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

Health Care Facilities Should Ensure Their Patient, Employment and Other Operational Defensibility Against Religious Discrimination Charges Amid Rising Risks

February 3, 2024

Hospitals, long term care facilities and other facilities funded by the Department of Health and Human Services (HHS) should audit and tighten their visitation, employment and other policies, oversight and training about federal prohibitions against religious or other discrimination in response to guidance issued by the HHS Office of Civil Rights (OCR) on January 25, 2024 and other developments signaling heightened exposures to religious discrimination liabilities and enforcement.

The January 25, 2024 guidance titled FAQs on Patient Visitation at Certain Federally Funded Entities and Facilities (FAQ) reiterates that hospital, long-term care and other facilities receiving funding under HHS-regulated programs must have and enforce written policies to prohibit and ensure their facility visitation policies do not discriminate based on religion or other prohibited grounds at all times including during a public health emergency. Part of a series of recent guidance and other actions by HHS demonstrating its commitment to enforce federal civil rights religious and other discrimination prohibitions, the FAQ warns covered facilities and providers to ensure their ability to defend their facilities’ compliance with these and other federal civil rights laws and regulations.

Section 1557 & Other Rules Prohibit Religious & Other Discrimination

CMS regulations generally prohibit hospitals, long term care facilities, and critical access hospitals from restricting, limiting, or otherwise denying visitation privileges based on race, color, national origin, religion, sex, gender identity, sexual orientation, or disability and require these facilities have written visitation policies, procedures, and practices regarding such prohibitions. These and other civil rights prohibitions generally apply to facilities receiving funding from HHS adminstered programs including:

  • Hospitals and health clinics
  • Medicaid and Medicare agencies
  • Alcohol and drug treatment centers
  • Extended care facilities
  • Public assistance programs
  • Nursing homes
  • Adoption agencies and
  • Day care, mental health and senior citizen center

Additionally, other federal civil rights laws also prohibit discrimination based on race, color, national origin, sex (including sexual orientation and gender identity), age, and disability in certain federally funded programs.

HHS OCR January 25 Warning Against Facilities Visitation Religious Discrimination

OCR published the January 25, 2024 FAQ in response to directives announced in the Biden-Harris Administration’s recently announced U.S. National Strategy to Counter Antisemitism.  The FAQ reminds covered facilities OCR enforces CMS regulations prohibiting religious and other discrimination and provides examples of the following “concerning” fact patterns where OCR feels facilities need to use extra care to ensure adequate consideration of the religious needs of patients and other individuals when implementing visitation policies and procedures.

  • Hospitals prevented family members from bringing patients Kosher food or halal food that met the patient’s religious dietary restrictions while allowing other visitors to bring patients food items.
  • Members of certain religious groups were subjected to more rigorous screening processes and/or denied opportunities for visitation based on the patient’s and/or visitor’s religious affiliation.   
  • Hospitals adopted policies during the COVID-19 pandemic that allowed patients to visit with family members or friends but prohibited them from visiting with clergy. 

This guidance also contains information OCR intends to help covered facilities and entities effectively communicate with patients and others regarding their visitation policies, procedures, and practices.

Previous HHS OCR Religious Discrimination Enforcement

The January 25, 2024 FAQ is not the first time OCR has warned HHS-funded and regulated health care and other facilities against discriminatory facilities access policies or actions. 

During the COVID-19 Pandemic emergency, OCR published OCR’s policies for protecting conscience and religious freedom during COVID-19. In addition, on December, 26, 2020, for instance, OCR warned facilities against religious discrimination when it announced its resolution of a religious discrimination complaint against Mt. Sinai Health System in New York (Mt. Sinai) that required Mt. Sinai to ensure clergy access to patients for religious purposes during the COVID-19 pandemic systemwide.

The Ms. Sinai resolution agreement resulted after OCR investigated an August 5, 2020 complaint filed by a Jewish community advocacy organization that alleged that several hospitals in various hospital systems in New York, including Mt. Sinai in Manhattan, were denying Jewish patients access to clergy and engaging in other discrimination in both COVID and non-COVID units.

In one instance at Mt. Sinai, the complaint alleged that when a Jewish patient asked for his rabbi to visit to assist in the location of Kosher food that the patient had been unable to access at the facility, hospital staff told the patient that his rabbi could not visit due to concerns about COVID-19.

The complaint also alleged Mt. Sinai denied another Jewish patient access to a spiritual care volunteer when she requested a spiritual care volunteer after giving birth to a stillborn baby. The organization explained to OCR that religious visitation was important to their community because rabbis provide assistance with prayer rituals, including end-of-life rituals; spiritual comfort; translation services for those members of their community who do not speak English; and with other needs specific to their faith tradition.

According to OCR, its Conscience and Religious Freedom Division (CRFD) responded by offering Mt. Sinai technical assistance accepted by Mt. Sinai to ensure that its visitation policy was consistent with best practices under federal guidance, which Mt. Sinai accepted. This acceptance of technical assistance likely played a big role in Mt. Sinai’s avoidance of penalties based on the complaint.

In response to this technical assistance, Ms. Sinai reportedly updated its visitation policies to address identified religious discrimination concerns. The updated Mt. Sinai visitation policy applies to all seven of its hospital locations, including Mt. Sinai Hospital in Manhattan.

Under the updated visitation policy, visiting clergy are to comply with the safety policies in place, which include COVID-19 screening, proper use of hand sanitizer and hand washing, and wearing of an approved face mask.  Visitors also continue to be required to visit during designated hours, unless an exception, such as an imminent end-of-life situation, applies. Mt. Sinai clarified that, although its visitation policy did not say so explicitly, one of the two visitors permitted to visit a patient each day could be a clergy member. Mt. Sinai then updated its visitation policy to include that clarification. Additionally, the updated visitation policy now includes an exemption to out of state quarantine requirements for end-of-life visitations provided that proper precautions are taken, which allows clergy to be with patients in imminent end-of-life circumstances, even if they travel to Mt. Sinai from out of state.

In announcing the resolution, then Director of OCR Roger Severino, commended Mt. Sinai Health System for modifying its policy to clarify that patients can receive safe clergy access for religious purposes during the COVID-19 pandemic, concluding, “We applaud the hospital for ensuring that it will treat the needs of the body without sacrificing the needs of the soul.”

In addition to these and other guidance and enforcement activities, HHS has engaged in a number of other actions to combat religious discrimination over the past several months. For instance, HHS:

  • Offers training on HHS’s antidiscrimination laws to medical schools nationwide to train future health care providers;
  • Offers support for Holocaust survivors by helping to ensure they receive person-centered trauma care through the Administration for Community Living;
  • Holds listening sessions with Jewish and Muslim chaplains on religious discrimination in healthcare settings to promote increased cultural and religious competence in healthcare settings, including through multifaith partnerships;
  • Issued a toolkit of resources for those working with and supporting individuals and communities emotionally impacted by the recent escalation of conflict between Israel and Hamas created by Substance Abuse and Mental Health Services Administration (SAMHSA);
  • Joined numerous other agencies in marking International Holocaust Remembrance Day on January 27, 2024; and
  • Launched a digital campaign led by members of the President’s Council on Sports, Fitness & Nutrition to encourage the public to share personal stories of how activities like sports or cooking have promoted connection, inclusion, and cross-community solidarity.

OCR also has taken specific steps to prevent and punish antisemitic, Islamophobic, and related forms of discrimination and bias as prohibited discrimination based on ancestry or national origin. In September, 2023, for instance, HHS joined seven other federal agencies in clarifying, for the first time in writing, that Title VI of the Civil Rights Act of 1964 prohibits discrimination based on shared ancestry or ethnic characteristics, including certain forms of antisemitic, Islamophobic, and related forms of discrimination and bias, in federally funded programs and activities. HHS continues to take other steps to raise awareness of Title VI and other civil rights laws—both among entities that are prohibited from discriminating in these ways, and by informing communities of their rights to be free from discrimination. For example, HHS translated its information about Title VI into Arabic, Hebrew, Punjabi, Spanish, Urdu, and Yiddish.

Facilities & Other Organizations Also Face Rising Employment Religious Discrimination Risks

Religious discrimination in facilities access is not the only religious discrimination concern impacting health industry and other businesses. Title VII of the Civil Rights Act of 1964 prohibits discrimination based on religion and requires employers to reasonably accommodate an employee’s religious observance or practice, unless an accommodation would impose an undue hardship. The Civil Rights Act prohibits discrimination in any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoff, training, fringe benefits, and any other term or condition of employment. It also prohibits:

  • Forcing an employee to participate (or not participate) in a religious activity as a condition of employment;
  • Subjecting an applicant or employee to offensive remarks about a person’s religious beliefs or practice or other harassment that creates a hostile or offensive work environment or results in an adverse employment decision or other job detriment or certain other types of harassment, whether by the victim’s supervisor, a supervisor in another area, a co-worker, or someone who is not an employee of the employer, such as a client or customer;
  • Workplace or job segregation based on religion including religious garb and grooming practices;
  • Failing to reasonably accommodate an employee’s religious beliefs or practices, unless doing so would cause a burden that is substantial in the overall context of the employer’s business taking into account all relevant factors, including the particular accommodation at issue and its practical impact in light of the nature, size, and operating cost of the employer; and
  • Retaliating against an employee or applicant based on good faith exercise of his right to be free from religious discrimination or cooperation in investigations or other protected activities.

The duty to provide religious accommodation applies not only to schedule changes or leave for religious observances, but also to such things as dress or grooming practices that an employee follows as part of the employee’s religious reasons such as wearing particular head coverings or other religious dress or hairstyles or facial hair. It also includes an employee’s observance of a religious prohibition against wearing certain garments such as pants or miniskirts. 

Under the Civil Rights Act, the obligation to provide religious accommodation generally applies unless the employer demonstrate that the accommodation of the employee’s religious beliefs or practices would cause undue hardship to the employer. The burden of proving an undue hardship rests on the employer, who must show that the accommodation burden is substantial in the overall context of an employer’s business, taking into account all relevant factors in the case at hand, including the particular accommodation at issue and its practical impact in light of the nature, size and operating cost of the employer. The Supreme Court’s 2023 decision in Groff v. DeJoy, 143 S. Ct. 2279 (2023), makes clear that employers should not expect to meet this burden unless more than a “de minimis cost” or other burden is proven. Rather, employers denying a request for religious accommodation must be prepared to produce evidence proving the accommodation burden “is substantial in the overall context of an employer’s business” “taking into account all relevant factors in the case at hand, including the particular accommodations at issue and their practical impact in light of the nature, size and operating cost of an employer.” Id. See also EEOC Notice Concerning the Undue Hardship Standard in Title VII Religious Accommodation Cases.

The EEOC’s lawsuit and resulting recently announced settlement with Blackwell Security Services, Inc. (Blackwell) is illustrative of one common scenario in which these religious discrimination cases often arises. On January 31, 2024, the EEOC announced Blackwell Security Services, Inc. will pay $70,000 and provide other relief to settle the EEOC’s religious discrimination lawsuit that charged Blackwell wrongfully refused to accommodate a Muslim employee’s religious practice of wearing a beard in observance of his religious beliefs. Shortly after Blackwell hired the employee, the EEOC alleged that a Blackwell supervisor told the employee company policy required all employees be clean-shaven. When the employee requested an exemption from the policy to accommodate his religious practice, Blackwell told him to shave his beard or be terminated even though the EEOC determined accommodating his religious practice would impose no cost or operational burden on the business. To avoid losing his job, the employee complied and shaved his beard, causing him significant distress. Under the consent decree resolving the EEOC lawsuit, Blackwell will pay $70,000 in compensation to the now-former employee. Blackwell will also provide training to relevant management employees on federal laws prohibiting religious discrimination and will report any additional complaints of religious discrimination to the EEOC for the decree’s duration.

The EEOC charge and lawsuit against Blackwell is one of a deluge of religious discrimination charges filed with the EEOC in recent years. In fact, EEOC enforcement data shows that religious discrimination charges received by the EEOC soared from 2,111 in 2021 to 13,814 in 2022 while over the same period settlements rose from 146 in 2021 to 730 in 2022.

Religion-Based Charges (Charges filed with EEOC) FY 2013 – FY 2022
 FY 2013FY 2014FY 2015FY 2016FY 2017FY 2018FY 2019FY 2020FY 2021FY 2022*
Receipts3,7213,5493,5023,8253,4362,8592,7252,4042,11113,814
Resolutions3,8653,5753,7363,8273,9973,6533,0012,5702,0807,453
Settlements331268275266233151171144146730
Reasonable Cause1681161391211192821231035960
Monetary Benefits (Millions)**$11.2$8.7$10.8$10.1$11.2%$9.2$9.9$6.1$9.5$12.8
The chart represents the total number of charges filed and resolved under Title VII alleging religion-based discrimination as compiled by the Office of Enterprise Data and Analytics from data compiled from the EEOC’s Integrated Mission System.  This does not include charges filed with state or local Fair Employment Practices Agencies.  *EEOC notes, “In FY 2022, there was a significant increase in vaccine-related charges filed on the basis of religion. As a result, FY 2022 data may vary compared to previous years.”  ** Does not include monetary benefits obtained through litigation. See https://www.eeoc.gov/data/religion-based-charges-charges-filed-eeoc-fy-1997-fy-2022.

The New EEOC religious accommodation guidance issued during the COVID-19 pandemic health care emergency and demands for religious accommodation exemptions to COVID-19 mask and vaccination mandates heightened religious accommodation claims by the EEOC. Unsurprisingly, charges from these COVID-19 related and other religious accommodation claims brought since the COVID-19 pandemic health care emergency has and continues to fuel litigation, settlements and judgements. See, e.g., Children’s Hospital Pays $45K To Resolve COVID Vaccine Religious Discrimination Suit.

Furthermore, these religious sensitivities in many instances could be further heightened by the newly emerging religious and personal sensitivities, EEOC and other governmental outreach and widespread media coverage arising around religious and national origin discrimination concerns arising in relation to the latest Israeli/Palestinian conflict. See, e.g., Resolution of the U.S. Equal Employment Opportunity Commission Condemning Violence, Harassment, and Bias Against Jewish Persons in the United States; What to Do If You Face Antisemitism at Work; Anti-Arab, Anti-Middle Eastern, Anti-Muslim, and Antisemitic Discrimination are Illegal; Religious Garb and Grooming in the Workplace: Rights and Responsibilities; Fact Sheet on Religious Garb and Grooming in the Workplace: Rights and Responsibilities‘ Employment Discrimination Based on Religion, Ethnicity, or Country of Origin; Q&A for Employees: Responsibilities Concerning the Employment of Individuals Who Are, or Are Perceived to Be, Muslim or Middle Eastern; Q&A for Employers: Responsibilities Concerning the Employment of Individuals Who Are, or Are Perceived to Be, Muslim or Middle Eastern. With these and other events continuing to escalate sensitivities and awareness of federal laws against religious discrimination, health care and other organizations should act to strengthen their ability to recognize and respond defensibly to religious accommodation and other religious discrimination risks whether arising from patients and other customers, employees or others.

Act To Mitigate Religious Discrimination Risks

In the face of the prioritization that the Biden Administration generally and OCR specifically is placing on religious and national origin in connection with the current Israeli-Palestinian hostilities, all covered facilities should brace for heightened oversight and enforcement by OCR the EEOC and other federal agencies, as well as private litigants. These organizations also should guard against retaliation liability, which can result even where the discrimination claim fails.

As a starting point, health care and other organizations should begin by reviewing their existing complaint history, policies, practices, training, reporting and investigation practices within the scope of attorney-client privilege and revise these policies as needed to strengthen their defensibility.

In connection with this review, health care and other organizations should ensure that their policies, procedures and notices clearly prohibit religious discrimination as well as communicate procedures for persons that believe their religious beliefs merit accommodation or otherwise believe they are subject to religious harassment or other discrimination to communicate their request to a representative of the organization appropriately trained to receive, evaluate and respond to the accommodation request defensibly. Most organizations will want to arrange for qualified legal counsel to be readily available to assist the responsible party with these activities. 

Organizations should consider adopting carefully crafted and documented internal procedures for receiving, investigating and responding to religious accommodation request in a manner that promotes their organization’s ability to demonstrate each request is assessed in accordance with the law free from the inappropriate application of assumptions or stereotypes about what constitutes a religious belief or practice or what type of accommodation is appropriate. Organizations should train managers and supervisors to grant religious accommodation requests whenever possible and to refer any questions about the appropriateness or response to any religious accommodation request to the designated responsible party.

When faced with a request for a religious accommodation which the organization believes cannot be implemented without undue hardship, most organizations will want to seek the advice of legal counsel while exploring opportunities to allow the requested or an alternative accommodation on a temporary basis pending further exploration of the requested more permanent accommodation. Appropriate communication and documentation processes also are important. In addition, all organizations will want to ensure that their organization takes appropriate steps to prevent and defend against potential retaliation claims.

For More Information

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

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications on HIPAA and other medical record and data privacy and scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws. 

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. 

About Solutions Law Press, Inc.™

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

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication. 

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2024 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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No Surprises Act IDR Portal Now Open For All Covered Health Claims; Added Deadline Extensions Announced

December 15, 2023

The No Surprises Act (“NSA”) Federal Independent Dispute Resolution (“IDR”) portal now is reopened for processing all health benefit disputes covered by the NSA between health care providers, facilities, and providers of air ambulance services (“providers”), and group health plans, health insurance issuers, and Federal Employee Health Benefits Program carriers (“payers”) (collectively, “disputing parties”). The Departments of Health & Human Resources, Labor and Treasury (“Departments”) reopened the IDR Portal on December 15, 2023 for all types of NSA-covered claims including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. 

As part of its provisions to protect patients from “surprise bills” or out-of-network services covered bu the NSA, the NSA establishes rules and procedures for providers and payers to determine the appropriate out-of-network payment rate for out-of-network services received by patients enrolled in covered payer programs. Where payers and providers cannot agree about the appropriate payment rate using other NSA procedures, the IDR portal is the online system established under the NSA for disputing payers and health care providers arrange for a certified IDR entity to resolve disagreements about the appropriate out-of-network payment rate for items and services subject to the surprise billing protections in the NSA through a process in which the certified IDR entity reviews offers made by each disputing party along with supporting information about the dispute. Once established under the NSA, payers are required to pay providers the appropriate payment rate for the covered out-of-network services provided to the member patient and the provider is prohibited from balance billing charges in excess of the appropriate payment rate for those services. The Departments previously suspended the operation of the IDR portal earlier this year after a federal court ruled that rules adopted by the Departments implementing the NSA violated the NSA. 

In connection with the reopening of the IDR Portal, the Departments also announced the following extensions of the applicable IDR deadlines for the initiation of new batched disputes and new single disputes involving air ambulance services, resubmission of disputes determined by certified IDR entities to be improperly batched, and selection or reselection of a certified IDR entity.

  • Parties for whom the IDR initiation deadline under applicable regulations fell on any date between August 3, 2023 and December 15, 2023 will have until the 20th business day after the Federal IDR portal reopens, which is January 16, 2024, to initiate a new batched dispute or a new single dispute involving air ambulance services. Parties for whom the IDR initiation deadline falls between December 16, 2023 and January 15, 2024 will also have until January 16, 2024 to initiate a batched or air ambulance dispute. Parties whose initiation deadline falls on January 16, 2024 or after will have the usual 4 business days after the end of the Open Negotiation Period, or if the dispute is subject to the 90-calendar-day suspension period following a payment determination, the usual 30 business day period, to initiate a batched or air ambulance dispute in the Federal IDR portal.
  • For batched disputes and single disputes involving air ambulance services initiated under extensions of deadlines after the Federal IDR portal reopens, the deadline for the parties to jointly select a certified IDR entity will be 10 business days after initiation.
  • For disputing parties that were engaged in certified IDR entity selection for batched disputes when the Federal IDR portal temporarily closed, the deadline for parties to jointly select a certified IDR entity will be 10 business days after the Federal IDR portal reopens, which is December 29, 2023.
  • An initiating party that has received a notification from a certified IDR entity that a dispute initiated before August 3, 2023 was improperly batched will have one opportunity to resubmit the improperly batched items and services for reconsideration within 10 business days of being notified by the certified IDR entity, provided that the initiating party’s 4-business-day period to resubmit the batched dispute expired between August 3 and August 9, 2023.
  • The deadline to submit fees and offers will remain 10 business days after certified IDR entity selection.
  • Disputing parties with batched disputes that were impacted by the temporary suspension of use of the notice of offer form will be granted an additional 10 business days to submit offers, as communicated to impacted disputing parties by email from the Federal IDR Inbox.

The deadline extensions announced December 15, 2023 supplement extensions the Departments previously announced in November, 2023. On November 22, 2023, the Departments used their statutory authority (Internal Revenue Code Section 9816(c)(9), ERISA Section 716(c)(9), and PHS Act Section 2799A-1(c)(9)) to grant extensions in the following circumstances:

  • Disputing parties may request additional time, beyond the current business day deadline, to respond to the certified IDR entity’s requests for additional information. The Departments instructed certified IDR entities to grant such requests through January 16, 2024.
  • Certified IDR entities may provide parties, upon request, an additional 10 business days after the original offer deadline to submit an offer. Certified IDR entities may provide parties this additional time, as needed, through January 16, 2024.

On November 29, 2023, the Departments also announced another extension of the timeline for disputing parties to select a certified IDR entity. Under this extension, disputing parties will have 10 business days to select a certified IDR entity for all disputes through January 16, 2024. This extension will be provided automatically and does not require a request by disputing parties.

The Departments already announced the November 22, 2023 and November 29, 2023 extensions until January 16, 2023 for new single and bundled disputes and these extensions will persist for all disputes until January 16, 2023.

In connection with their full reopening of the IDR portal, the Departments renewed prior reminders to parties accessing or using the IDR portal to clear their computer’s cache or open the Federal IDR initiation web forms in a private or incognito window to see all the new features at least once a week to ensure access to the most up-to-date version of the initiation form as the Departments continue to implement Federal IDR web forms to accommodate guidance-related and system enhancements. Users failing to follow this recommendation risk additional follow-up with certified IDR entities or system errors.  

Users also are encouraged to review other previously published guidance, including No Surprises Act (NSA) Independent Dispute Resolution (IDR) Batching and Air Ambulance Policy Frequently Asked Questions (FAQs), FAQs about Affordable Care Act and Consolidated Appropriations Act, 2023 Implementation Part 63 (FAQs Part 63), FAQs about Consolidated Appropriations Act, 2021 Implementation Part 62 (FAQs Part 62), and the August 2023 IDR Administrative Fees FAQs for further information. Parties can also reference

Parties should reference the No Surprises Act (NSA) Independent Dispute Resolution (IDR) Batching and Air Ambulance Policy Frequently Asked Questions (FAQs), FAQs about Affordable Care Act and Consolidated Appropriations Act, 2023 Implementation Part 63 (FAQs Part 63), FAQs about Consolidated Appropriations Act, 2021 Implementation Part 62 (FAQs Part 62), and the August 2023 IDR Administrative Fees FAQs for further information. Parties can also reference updated IDR system job aids and updated guidance documents for further information.

Questions can be directed to the Federal IDR mailbox at FederalIDRQuestion@cms.hhs.gov. Any additional updates will be provided at www.cms.gov/nosurprises as they become available.

Parties should reference the No Surprises Act (NSA) Independent Dispute Resolution (IDR) Batching and Air Ambulance Policy Frequently Asked Questions (FAQs), FAQs about Affordable Care Act and Consolidated Appropriations Act, 2023 Implementation Part 63 (FAQs Part 63), FAQs about Consolidated Appropriations Act, 2021 Implementation Part 62 (FAQs Part 62), and the August 2023 IDR Administrative Fees FAQs for further information. Parties can also reference updated IDR system job aids and updated guidance documents for further information.

For More Information

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

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws. 

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. 

About Solutions Law Press, Inc.™

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

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication. 

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2023 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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6/16 Feedback Deadline For CDC Legal Epidemiology Competency Model; Other Legal Epidemiology Resources

June 1, 2017

Public health and other health care, employer and other business, education, community services, law enforcement and other government and community leaders and their legal and other advisers should check out and provide feedback to the Centers for Disease Control (CDC) on the new draft Legal Epidemiology Competency Model (LECM) and other CDC resources designed to help the U.S., its organizations, communities and people prepare for and respond to epidemic and other public health and disease concerns.

National and international concern about the outbreak and management of deadly Ebola and other pandemics, bioterrorism and other terrorism attacks, national disasters and other public health risks have sensitized Americans and their business, community and governmental leaders to the potential community wide risks of these and other public health events, the legal and operational challenges that often arise in the course of responding to these risks, and the helpfulness if not necessity of community-wide involvement, preparation and collaboration to the effectiveness of efforts to prepare for and respond to these occurrences.

In recognition of these realities, the CDC is stepping up its efforts both to understand better, and to to educate and support relevant components of U.S. communities, their advisers, researchers and leaders about these public health challenges including the relationships and influences between the occurrence and management of these public health events and the law (“legal epidemiology.”)

Widespread public and private concern and coverage of terrorism attacks and pandemic outbreaks have reinvigorated CDC’s emphasis and efforts to outreach to health care providers, public health, school, and other community organizations, employers and other business leaders and others.  In response to government and public Ebola and other epidemic and pandemic out breaks, for instance, the CDC in recent years has stepped up both its public communications about epidemic and other public health risks and its emphasis upon understanding and developing legal epidemiology practices and resources.   For instance, the death of an Ebola patient in Dallas and subsequent diagnosis of various other victims of Ebola and other pandemic diseases within or potentially traveling to the United States, reinvigorated the emphasis and efforts of  the CDC and other federal and state agencies and other public and private organizations and groups to help law and policy makers prepare for and respond to pandemic and other public health concerns.

While much of the increased or updated CDC knowledge and guidance focuses on improving understanding and communications targeting a specific public health risk or situation, such as the updated State Ebola Protocols Table specifically to support preparedness for and responsiveness Ebola-related situations, the CDC also now recognizes the need to understand and address more generally the emerging area of legal epidemiology.

As part of its efforts to promote better understanding and resources to address legal epidemiology challenges, CDC recently released and now is inviting input on a new draft LECM developed by the CDC in collaboration with a “multidisciplinary expert review  workgroup” as a resource to provide helpful information and support to lawyers, researchers, and others whose work explores how laws can play a role in the cause, distribution, and prevention of disease and injury or otherwise engaged in projects focused at the intersection of law and epidemiology, referred to as “legal epidemiology.”

Recognizing the growing importance of legal epidemiology, the CDC now is inviting input from the broad public health community, as well as from those engaged directly in legal epidemiology work to help CDC further refine the LECM.  While the CDC is inviting interested persons to review the draft LECM and share thoughts on any aspect of the model, CDC has indicated that CDC particularly is interested in reactions and suggestions related to any of the following questions:

  • Does the LECM reflect the requirements for truly effective performance of legal epidemiology?
  • Are there concepts that should be added or removed?
  • Are the behavioral statements in the draft LECM representative of how legal epidemiologists demonstrate competency in their work?
  • Does the draft LECM accurately reflect the knowledge, skills, and abilities that legal epidemiologists must demonstrate in your organization?
  • How might you use the LECM in your work?

Parties wishing to provide feedback should submit their feedback by Friday, June 16, 2017 in accordance with the instructions shared here or by email to Janelle Nichols at jnichols@phf.org.

Coincident with CDC’s release of the draft LECM for public comment, the CDC PHLP is working to expand awareness and understanding of the emerging field of legal epidemiology.

As part of these efforts, CDC recently released an updated version of its Criminal and Epidemiological Investigations Handbook. Offered in English, Spanish and French, this latest version provides an overview of criminal and epidemiological investigation procedures involving interactions between law enforcement and public health. It is designed to help teach public health and law enforcement how to work together to identify the biological agent, prevent the spread of the disease, avoid public panic, and apprehend those responsible.

CDC also is offering in collaboration with the National Environmental Health Association, a series of webinars on legal epidemiology.  The second webinar in a three-part series of free programs on legal epidemiology titled “Legal Epidemiology, Part 2: A Tool for Evaluating the Impact of Environmental Public Health Laws,” scheduled to take place on June 14, 2017, 1:00–2:30 pm (EDT) will feature speakers from PHLP, highlight variations in state law provisions related to environmental public health issues, and describe related legal epidemiology methods. It will also offer abbreviated training in the principles of legal epidemiology, give examples of its application to environmental public health law, and allow participants to ask questions.  For more details about the program or participation, see here.

About The Author

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

Ms. Stamer works domestically and internationally with health, insurance and financial services, data and technology, services and consulting, energy, retail, hospitality and other businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. Her day-to-day work encompasses both labor and employment issues, as well as independent contractor, outsourcing, employee leasing, management services and other nontraditional service relationships. She supports her clients both on a real-time, “on demand” basis and with longer term basis to deal with all aspects for workforce and human resources management, including, recruitment, hiring, firing, compensation and benefits, promotion, discipline, compliance, trade secret and confidentiality, noncompetition, privacy and data security, safety, daily performance and operations management, 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, insurance, financial services, technology, energy, manufacturing, retail, hospitality and governmental employers, her nearly 30 years’ of experience encompasses domestic and international businesses of all types and sizes.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 concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association; Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Gulf Coast TEGE Council Exempt Organization Coordinator; a founding Board Member and past President of the Alliance for Healthcare Excellence; former board member and Vice President of the Managed Care Association; past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; a member and advisor to the National Physicians’ Council for Healthcare Policy; 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; immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council; past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a former member of the Board of Directors, Treasurer, Member and Continuing Education Chair of the Southwest Benefits Association and others.

Author of “Privacy & Pandemic: A Workshop & Materials” presented to the ASTHO and a multitude of other pandemic, occupational health and other public health law and management matters, Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health care, privacy, human resources, labor and employment, employee benefits, compensation, occupational safety and health, and other regulatory and operational risk management for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, 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 symposia and 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 and speaks and conducts training for a broad range of professional organizations and for clients on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications.

Want to know more? See here for details about the author of this update, attorney Cynthia Marcotte Stamer, e-mail her here or telephone Ms. Stamer at (469) 767-8872.

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 at www.SolutionsLawPress.com.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please provide your current contact information and preferences including your preferred e-mail by creating or updating 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, 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 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 publisher and the author expressly disclaim all liability for this content and any responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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Posted by Cynthia Marcotte Stamer

6/26 Deadline To Comment On Proposed Medicare SNF (Nursing Home) Rule Changes

May 10, 2017

June 26, 2017 is the deadline to submit comments to the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) on changes to Medicare’s Skilled Nursing Facility (nursing home) reimbursement, quality reporting and various other proposed by CMS in the Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Proposal To Correct the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020 (Proposed Rule) published May 4th.  With the U.S. aging population making SNF expenditures both a significant Medicare cost driver and a major care concern for American families and communities, SNF and other health care providers, payers, community leaders, caregivers and other concerned stakeholders should act promptly to review the proposed changes and timely submit feedback in response to the Proposed Rule.

Among other things, the Proposed Rule as currently proposed would revise Medicare reimbursement and terms of participation rules for SNFs to:

  • Update the Skilled Nursing Facility (SNF) prospective payment rates and other background information for Fiscal Year (FY) 2018 in response to §§ 1888(e)(4)(E) and (H) of the Social Security Act (the Act);
  • Update the requirements for the Skilled Nursing Facility Quality Reporting Program (SNF QRP) and additional proposals for the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP);
  • Clarify requirements related to survey team composition and investigation of complaints under 42 C.F.R §§ 488.30, 488.301, 488.314, and 488.308;
  • Add a proposal related to the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP); and
  • Solicits comments about potential changes to the recently finalized Requirements for Long-Term Care Facilities that CMS intends to reduce regulatory burdens as well as potential CMMI models and other demonstration projects that would reduce cost and increase quality of care for SNF, or more generally Post-Acute Care patients.

The Proposed Rule regulatory burden reduction proposals primarily focus on three areas also invites input about other areas of burden reduction and cost changes that could be accomplished by revising current SNF requirements for Medicare participation:

  • The Grievance and Abuse/Neglect Reporting Processes
  • Quality Assurance and Performance Improvement (QAPI)
  • Discharge Notices

SNF and other healthcare providers, payers, accreditation and oversight, payers, caregivers and others concerned about SNF care and reimbursement for patients in SNFs should carefully evaluate these proposals and share their input on the proposals and other opportunities to improve the Medicare SNF quality and reimbursement rules as soon as possible.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition 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 “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has 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.

Throughout her career, she has helped health industry clients manage workforce, medical staff, vendors and suppliers, medical billing, reimbursement, claims and other provider-payer relations, business partners, and their recruitment, performance, discipline, compliance, safety, compensation, benefits, and training ;board, medical staff and other governance; compliance and internal controls; strategic planning, process and quality improvement; change management; assess, deter, investigate and address staffing, quality, compliance and other performance; meaningful use, EMR, HIPAA and other data security and breach and other health IT and data; crisis preparedness and response; internal, government and third-party reporting, audits, investigations and enforcement; government affairs and public policy; and other compliance and risk management, government and regulatory affairs and operations concerns.

Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other laws.

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, 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 has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services 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.

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 health care, disability, aging, workforce, retirement 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.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, 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 symposia and 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, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional 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 (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.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.

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Posted by Cynthia Marcotte Stamer