Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules; Senator Welch (D-VT) Introduced a Bill Intended to Protect the 340B Drug Pricing Program

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, the Departments of Labor, Health and Human Services, and the Treasury issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules and the 340B PATIENTS Act was introduced in the Senate.

I. Regulations, Notices & Guidance

• On September 10, 2024, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device. FDA is classifying the whole exome sequencing constituent device into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole exome sequencing constituent device’s classification. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On September 10, 2024, FDA released a notice entitled, Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; OPZELURA (ruxolitinib). FDA is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that OPZELURA (ruxolitinib), approved September 21, 2021, meets the criteria for redeeming a priority review voucher.
• On September 10, 2024, the Department of Health and Human Services (HHS) issued an interim final rule entitled, World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders. This interim final rule updates existing regulations governing the WTC Health Program, which provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. This rulemaking expands existing eligibility criteria for enrollment of new Pentagon and Shanksville responders, caps those new members at 500, and makes various conforming amendments to the WTC Health Program regulations to align with statutory changes.
• On September 10, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice of Supplemental Award; Autism Longitudinal Data Project. HRSA is announcing supplemental award funds through the Patient-Centered Outcomes Research Trust Fund to the current HRSA award recipient to expand activities under the Autism Longitudinal Data Project (ALDP). The funding will be used to create and share a combined de-identified dataset from the Boston Birth Cohort (BBC), Massachusetts Pregnancy to Early Life Longitudinal Data System, and Agency for Healthcare Research and Quality Social Determinants of Health database.
• On September 10, 2024, HRSA released a notice entitled, Notice of Funding Extension for Rural Behavioral Health Workforce Centers – Northern Border Region. HRSA will provide a performance period extension with supplemental funds to three fiscal years 21 award recipients with a period of performance ending on August 31, 2025. The supplemental funding will extend their current period of performance by 12 months to align with the FY 2022 award to an additional recipient, which has a period of performance from September 1, 2022, to August 31, 2025.
• On September 11, 2024, FDA released a notice entitled, The Food and Drug Administration’s Draft Strategy Document on Innovative Manufacturing Technologies. FDA is announcing the publication of a draft Strategy Document for public comment outlining specific actions FDA will take during fiscal years FYs 2023-2027 to facilitate the use of innovative manufacturing technologies. As part of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures FYs 2023-2027 (PDUFA VII), FDA committed to advance the use and implementation of innovative manufacturing. In connection with this effort, on June 8, 2023, FDA participated in a public workshop on the use of innovative manufacturing technologies for products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), including barriers to their adoption. FDA also committed to issuing this draft Strategy Document for public comment. The actions described in the draft Strategy Document are based on lessons learned from FDA’s experiences with submissions involving advanced manufacturing technologies as well as feedback from the workshop and other public input.
• On September 11, 2024, HHS released a notice entitled, Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act. HHS proposes to amend the regulations implementing the National Organ Transplant Act of 1984 (NOTA), as amended, to remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the HHS Secretary proposes to determine that participation in such clinical research should no longer be a requirement for transplantation of HIV positive kidneys and livers from donors with HIV to recipients with HIV. This proposed rule serves as publication of the Secretary’s proposed determination and proposes to amend the regulations to reflect this determination. Consistent with NOTA and current regulatory requirements, the Secretary’s proposed determination and the proposed corresponding regulatory revision, if finalized, will necessitate that the Organ Procurement and Transplantation Network (OPTN) adopt and use standards of quality concerning kidneys and livers from donors with HIV, as directed by the Secretary, consistent with NOTA and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation.
• On September 12, 2024, HHS released a notice entitled, Public Health Service Policies on Research Misconduct. This final rule revises the regulations governing Public Health Service Policies on Research Misconduct. The final rule reflects both substantive and non-substantive revisions in response to public comments and to improve clarity. The purpose of the final rule is to implement policy changes and respond to technological changes that occurred over the past several years applicable to research misconduct.
• On September 12, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Notice of Award of a Sole Source Cooperative Agreement to Fund Northwestern Provincial Health Office in Zambia. CDC announced an award of approximately $4,450,000, for Year 1 funding to Northwestern Provincial Health Office (NWPHO) in Zambia. The award will provide NWPHO with CDC Technical Assistance and financial support to maintain and sustain the province’s overall oversight and quality assurance for the implementation of high-impact HIV combination prevention, treatment, and support services, including clinical, surveillance, and laboratory services as well as to identify and mitigate emerging disease threats for people living with HIV (PLHIV). Funding amounts for years 2-5 will be set at continuation.
• On September 12, 2024, FDA released a notice entitled, Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability. This guidance describes FDA’s enforcement policy for the final rule, Tobacco Products; Required Warnings for Cigarette Packages and Advertisements, which established new required cigarette health warnings for cigarette packages and advertisements. The guidance is intended to assist entities required to comply with the rule.
• On September 12, 2024, FDA released a notice entitled, New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments. FDA is seeking public comments on the New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose is to seek public comments/feedback on the Integrated Review documentation generated by the Integrated Assessment of Marketing Applications for new drug products developed as part of the New Drugs Regulatory Program Modernization. The agency hopes to receive public feedback on how this Integrated Review documentation can continue supporting stakeholders’ needs.
• On September 13, 2024, FDA released a notice entitled, Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0. The FDA CDER and CBER are announcing support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.
• On September 13, 2024, FDA released a notice entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System. FDA is classifying the clozapine test system into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the clozapine test system’s classification. FDA is taking this action because it has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On September 13, 2024, FDA released a notice entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the Device to Detect or Measure Nucleic Acid from Viruses Associated with Head and Neck Cancers. FDA is classifying the device to detect or measure nucleic acid from viruses associated with head and neck cancers into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect or measure nucleic acid from viruses associated with head and neck cancers’ classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On September 13, 2024, FDA released a notice entitled, Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal. FDA is classifying the pediatric continuous renal replacement therapy system into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for the pediatric continuous renal replacement therapy system’s classification. FDA is taking this action because it has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.

Event Notices

September 17, 2024: The National Institutes of Health (NIH) announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. This is a hybrid meeting open to the public.

September 17, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a joint meeting of the Tribal Technical Advisory Committee (TTAC) and the Indian Health Service (IHS) National Tribal Advisory Committee on Behavioral Health (NTAC). This is a hybrid meeting open to the public.

September 18, 2024: FDA announced a meeting of the Pediatric Advisory Committee (PAC). This is a virtual meeting open to the public.

September 19-20, 2024: CDC announced a joint meeting of the Subcommittee on Privacy, Confidentiality, and Security and the Subcommittee on Standards, two subcommittees of the National Committee on Vital and Health Statistics. This is a virtual meeting open to the public.

September 20, 2024: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.

September 23, 2024: HHS announced a meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. This is a hybrid meeting open to the public.

September 23, 2024: NIH announced a meeting of the Center for Scientific Review. This is a hybrid meeting open to the public.

September 23, 2024: NIH announced a meeting of the Office of the Secretary. This is a virtual meeting open to the public.

September 23, 2024: CDC announced a meeting of the World Trade Center Health Program Scientific/Technical Advisory Committee. This is a virtual meeting open to the public.

September 25-26, 2024: HHS announced a meeting of the 2025 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.

September 26, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting open to the public.

October 7, 2024: FDA announced a meeting of the Science Board to the FDA. This is a virtual meeting open to the public.

October 8, 2024: NIH announced a meeting of the NIH Office of the Director. This is a virtual meeting open to the public.

October 10, 2024: FDA announced a meeting of the Cardiovascular and Renal Drugs Advisory Committee. This is a hybrid meeting open to the public.

October 16-17: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.

October 16-17, 2024: CDC announced a meeting of the Community Preventive Services Task Force. This is a virtual meeting open to the public.

October 21-22, 2024: HHS announced a meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and Sexually Transmitted Disease (STD) Prevention and Treatment. This is a hybrid meeting open to the public.

October 22, 2024: CDC announced a meeting of the Advisory Committee to the Director (ACD). This is a hybrid meeting open to the public.

October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.

October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual meeting open to the public.

November 6, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.

November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.

November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.

II. Hearings & Markups

• On September 10, 2024, the House Committee on Energy & Commerce Subcommittee on Health, held a legislative hearing entitled, Evaluating FDA Human Foods and Tobacco Programs. Witnesses included: Mr. James Jones, Deputy Commissioner for Human Foods, FDA; and Dr. Brian King, Ph.D., Director, Center for Tobacco Products, FDA.
• On September 10, 2024, the House Committee on Education & the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, ERISA’s 50th Anniversary: The Value of Employer-Sponsored Health Benefits. Witnesses included: Ms. Ilyse Schuman, Senior Vice President, Health and Paid Leave Policy, American Benefits Council; Ms. Holly Wade, Executive Director, National Federation of Independent Business Research Center; Mr. Anthony Wright, Executive Director, Families USA; and Dr. Paul Fronstin, Director, Health Benefits Research, Employee Benefit Research Institute.
• On September 10, 2024, the House Committee On Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing entitled, A Hearing with former New York Governor Andrew Cuomo. The witnesses was The Honorable Andrew Cuomo, Former Governor, State of New York.
• On September 11, 2024, the House Committee on Veterans’ Affairs Subcommittee on Health held a legislative hearing entitled, Subcommittee on Health Legislative Hearing. Witnesses included: Dr. Carolyn Clancy, Assistant Undersecretary for Health, Discovery, Education, and Affiliate Networks, U.S. Department of Veterans Affairs, on behalf of Veterans Health Administration; Dr. Matthew Miller, Executive Director, Office of Suicide Prevention, U.S. Department of Veterans Affairs, on behalf of Veterans Health Administration; Dr. Ajit Pai, Executive Director, Office of Rehabilitation and Prosthetic Services, U.S. Department of Veterans Affairs, on behalf of Veterans Health Administration; Dr. Ryan Heiman, Acting Director, Member Services, U.S. Department of Veterans Affairs, on behalf of Veterans Health Administration; Mr. Brian Dempsey, Director of Government Relations, Wounded Warrior Project; Ms. Missy Meyer, Director of Community Integration, America’s Warrior Partnership; Mr. Clark Pennington, Chief Operating Officer, The Independence Fund; and Mr. Jon Retzer, Deputy National Legislative Director, Disabled American Veterans.
• On September 11, 2024, the House Committee on Energy & Commerce Oversight and Investigations Subcommittee held a hearing entitled, A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network Act Implementation. Witnesses included: Greg Segal, Founder & CEO, Organize; Dr. Robert Cannon, M.D., Associate Professor of Surgery, University of Alabama at Birmingham, Surgical Director for Liver Transplant; Dr. Seth Karp¸ M.D., Surgeon-in-Chief, Vanderbilt University Medical Center; and Dr. Jesse Roach, Senior Vice President of Government Relations, National Kidney Foundation.
• On September 12, 2024, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, Examining the Bankruptcy of Steward Health Care: How Management Decisions Have Impacted Patient Care. Witnesses included: Ellen MacInnis, R.N., Nurse at St. Elizabeth’s Medical Center; Audra Sprague, R.N., Former Nurse at Nashoba Valley Medical Center; Rep. Michael Charles Echols, Louisiana House of Representatives; and Mayor Staci Albritton Mitchell, West Monroe, LA.

III. Reports, Studies, & Analyses

• On September 11, 2024, the Government Accountability Office (GAO) released a report entitled, Behavioral Health: Information on Cost-Sharing in Medicare and Medicare Advantage. The report highlights the coverage of behavioral health services in Medicare and Medicare Advantage (MA) plans for 2024. While both traditional Medicare and MA plans cover a range of inpatient and outpatient behavioral health services, beneficiaries face significant out-of-pocket costs. In traditional Medicare, beneficiaries are required to pay a $1,632 deductible for inpatient stays up to 60 days and 20 percent coinsurance for many outpatient services. MA plans typically charge co-payments for both inpatient and outpatient care, with amounts varying by plan. Some MA plans offer supplemental behavioral health benefits not covered by traditional Medicare. With an estimated quarter of Medicare’s 66.7 million beneficiaries affected by behavioral health conditions in 2023, these findings underscore ongoing concerns about the accessibility of mental health and substance use disorder (SUD) treatments, even for those with coverage.
• On September 10, 2024, the Kaiser Family Foundation (KFF) released a report entitled, KFF Health Tracking Poll September 2024: Harris v. Trump on Key Health Care Issues. The report reveals that 38 percent of voters identify the economy and inflation as their most important issue, but health care costs are also a major factor influencing both Democratic and Republican voters. Among Democratic voters, 20 percent want Vice President Kamala Harris to focus on general health care costs, while 15 percent emphasize the need to lower prescription drug prices, and 6 percent express concerns about insurance premiums. KFF finds that nearly half of Republican voters (45 percent) want former President Donald Trump to prioritize health care costs in his campaign, with Medicare, Medicaid, and Social Security also being critical issues. Abortion continues to be a significant issue, particularly for Democratic women of reproductive age. Abortion is less central for Republican voters, though it continues to motivate some Democratic and independent women.

IV. Other Health Policy News

• On September 9, 2024, the Department of Labor (DOL), HHS, and the Department of the Treasury issued final rules entitled, Requirements Related to the Mental Health Parity and Addiction Equity Act. These rules aim to ensure that, under private insurance, mental health and SUD benefits are covered on par with medical and surgical benefits and without any additional burdens. Key aspects of the new rules include additional protections against restrictive treatment limitations (such as prior authorization), prohibition of the use of biased information in plan benefit designs, and requirements for health plans to collect and evaluate data related to limitations on mental health and SUD care. Plans must also address any disparities in access between mental health/SUD care and medical/surgical care, with an emphasis on careful plan design and management of provider networks. Most provisions will take effect for plan years beginning on or after January 1, 2025, with some requirements starting a year later. The text of the final rule is available here. A fact sheet is available here. A press release is available here.
• On September 10, 2024, the Biden Administration announced $68 million in funding for suicide prevention and mental health care programs. These funds are part of President Biden’s Unity Agenda, aimed at addressing the nation’s mental health crisis. The broader goal of this funding is to improve mental health resources nationwide, ensuring that those most in need receive timely and effective support. This investment aims to support various initiatives, including $13 million to enhance the 988 Suicide & Crisis Lifeline, expanding its capacity to handle increased demand and reach vulnerable populations. The initiative also includes $11 million for veterans’ mental health services, recognizing the unique challenges faced by this group. In addition, the funding will provide grants for community-based mental health programs and suicide prevention efforts. These grants will focus on at-risk youth, individuals in marginalized communities, and populations struggling with access to care. A press release with more information is available here.
• On September 11, 2024, Senator Peter Welch (D-VT) introduced the bicameral 340B Pharmaceutical Access to Invest in Essential, Needed Treatments & Support (PATIENTS) Act, which is intended to protect the 340B Drug Pricing Program. Representative Doris Matsui (D-CA) introduced a companion bill in the House of Representatives earlier this year. The 340B Drug Pricing Program enables safety-net providers like rural hospitals and community health centers to purchase outpatient prescription drugs at reduced prices, ensuring access to affordable care for underserved populations. The bill aims to prevent pharmaceutical companies from restricting pharmacies that dispense discounted medications, a practice that has disproportionately affected rural areas. The PATIENTS Act clarifies that drug manufacturers must provide 340B discounts regardless of how or where the medications are dispensed, including through contract pharmacies. Additionally, it includes penalties for companies that do not comply with these requirements. The legislation has garnered support from multiple healthcare organizations, such as the American Hospital Association and 340B Health. A press release with more information is available here. The text of the bill is available here.
• On September 11, 2024, the House Education and Workforce Committee advanced legislation to prohibit hospitals from charging facility fees for care given virtually. The Transparent Telehealth Bills Act is sponsored by Representative Aaron Bean (R-FL) and garnered a vote of 34-0. The American Hospital Association released a statement in opposition to the bill stating that the prohibition of facility fees “would endanger the critical roles hospitals and health systems play in their communities, including providing access to care for patients.” The text of the bill is available here.

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