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, HHS finalized its 340B Administrative Dispute Resolution rule, and the House and Senate held hearings on the President’s proposed fiscal year (FY) 2025 HHS budget with HHS Secretary Becerra.

I. Regulations, Notices & Guidance

• On April 15, 2024, the Food and Drug Administration (FDA) released a notice entitled, Center for Drug Evaluation and Research Center for Clinical Trial Innovation. FDA is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making. C3TI’s mission is to promote existing and future CDER clinical trial innovation activities through enhanced communication and collaboration. Existing CDER clinical development innovation programs will continue to operate according to their established processes with C3TI serving to synthesize lessons learned across those programs. C3TI will also be providing additional opportunities for sponsors of innovative clinical trials in specified project areas to interact with CDER staff with the goal of fostering knowledge sharing both internally and externally.
• On April 17, 2024, FDA released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LENMELDY (atidarsagene autotemcel). FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award of the priority review voucher. FDA has determined that LENMELDY (atidarsagene autotemcel), approved on March 18, 2024, manufactured by Orchard Therapeutics (Europe) Ltd., meets the criteria for a priority review voucher.
• On April 18, 2024, the Department of Health and Human Services (HHS) issued a final rule entitled, 340B Drug Pricing Program; Administrative Dispute Resolution Regulation. The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service (PHS) Act, which is referred to as the 340B Drug Pricing Program. This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process. This final rule revises the 340B administrative dispute resolution process set forth in the Code of Federal Regulations.
• On April 18, 2024, HRSA released a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program, as required by the PHS Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On April 19, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). CHAC consists of 18 experts in fields associated with public health; epidemiology; laboratory practice; immunology; infectious diseases; substance use disorder; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; health equity; and healthcare financing, who are selected by the HHS Secretary.
• On April 19, 2024, HRSA released a notice entitled, Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act. HRSA is updating income levels used to identify a “low-income family” for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in titles III, VII, and VIII of the PHS Act. HHS periodically publishes in the Federal Register low-income levels to be used by institutions receiving grants or cooperative agreement awards to determine eligibility for programs providing training for disadvantaged individuals, individuals from disadvantaged backgrounds, or individuals from low-income families.

Event Notices

April 30, 2024: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.

May 6, 2024: CDC announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a virtual meeting open to the public.

May 7, 2024: The National Institutes of Health (NIH) announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting open to the public.

May 9, 2024: FDA announced a meeting of the Blood Products Advisory Committee. This is a virtual meeting open to the public.

May 9-10, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a hybrid meeting open to the public.

May 15-16, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.

May 21, 2024: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This is a virtual meeting open to the public.

May 21-22, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a hybrid meeting open to the public.

June 3, 2024: FDA announced a meeting of the AIDS Research Advisory Committee. This is a hybrid meeting open to the public.

June 4, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Dose Reconstruction Review, National Institute for Occupational Safety and Health. This meeting is open to the public.

June 6, 2024: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a virtual meeting open to the public.

June 26, 2024: CDC announced a meeting of the Meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.

II. HEARINGS & MARKUPS

• On April 16, 2024, the House Committee on Energy and Commerce (E&C) Health Subcommittee held a hearing entitled, Examining Health Sector Cybersecurity In The Wake Of The Change Healthcare Attack. Witnesses present included: Greg Garcia, Executive Director for Cybersecurity, Healthcare Sector Coordinating Council; Robert Sheldon, Senior Director of Public Policy and Strategy, CrowdStrike; John Riggi, National Advisor for Cybersecurity and Risk, American Hospital Association; Scott MacLean, Board Chair, College of Healthcare Information Management Executives (CHIME); and Dr. Adam Bruggeman, MD, Orthopedic Surgeon, Texas Spine Center.
• On April 16, 2024, the House E&C Oversight And Investigations Subcommittee held a hearing entitled, Examining How Improper Payments Cost Taxpayers Billions And Weaken Medicare And Medicaid. Witnesses present included: The Honorable Gene Dodaro, Comptroller General, Government Accountability Office; The Honorable Christi Grimm, Inspector General, Health and Human Services; Timothy Hill, MPA, Medicaid and CHIP Payment and Access Commission Member; and Michael Chernew, PH.D. Medicare Payment Advisory Commission Chair.
• On April 16, 2024, the House Education & the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, ERISA's 50th Anniversary: The Path to Higher Quality, Lower Cost Health Care. Witnesses present included: Russell DuBose, Vice President of Human Resources, Phifer Inc.; Mairin Mancino, Senior Advisor, Policy, Peterson Center on Healthcare; Karen L. Handorf, Senior Counsel, Berger Montague; and Scott Behrens, Senior Vice President, Director of Government Relations, Lockton Companies.
• On April 16, 2024, the Senate Special Committee on Aging held a hearing entitled, The Long-Term Care Workforce: Addressing Shortages and Improving the Profession. Witnesses present included: Nicholas Smith, Direct Support Professional/Behavioral Health Specialist Lead, SPIN; Brooke Vogleman, Licensed Practical Nurse, TLC Management; Matthew Connell EdD, Sector Vice President for Healthcare, Ivy Tech Community College; Jasmine Travers PhD, MHS, RN, AGPCNP-BC, Assistant Professor, New York University Rory Meyers College of Nursing.
• On April 16, 2024, the Senate Appropriations Committee held a hearing entitled, A Review of the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services. The witness was The Honorable Xavier Becerra, Secretary, HHS.
• On April 17, 2024, the House E&C Innovation, Data, and Commerce Subcommittee held a hearing entitled, Legislative Solutions to Protect Kids Online and Ensure Americans’ Data Privacy Rights. Witnesses present included: Ava Smithing, Director of Advocacy, Young People’s Alliance; The Honorable Maureen K. Ohlhausen, Co-chair, 21 Century Privacy Coalition; Katherine Kuehn, Member, Board of Directors and CISO-in-Residence, National Technology Security Coalition; Kara Frederick, Director, Tech Policy Center, The Heritage Foundation; Samir C. Jain, Vice President of Policy, Center for Democracy & Technology; and Mr. David Brody, Managing Attorney, Digital Justice Initiative, Lawyers’ Committee for Civil Rights Under Law.
• On April 17, 2024, the House E&C Health Subcommittee held a hearing entitled, Fiscal Year 2025 Department of Health and Human Services Budget. The witness was The Honorable Xavier Becerra, Secretary, HHS.
• On April 18, 2024, the House Appropriations Committee held a hearing entitled, Fiscal Year 2025 Budget Request for the Food and Drug Administration. The witness was Dr. Robert M. Califf, Commissioner of Food and Drugs, FDA.

III. Reports, Studies, & Analyses

• On April 15, 2024, the Government Accountability Office (GAO) released a report entitled, Prescription Drugs: Selected States' Regulation of Pharmacy Benefit Managers. This report examined five states—Arkansas, California, Louisiana, Maine, and New York—and found that each state has enacted various laws to regulate Pharmacy Benefit Managers (PBMs). These regulations cover a range of areas including fiduciary duties, drug pricing and pharmacy reimbursement, transparency requirements, and pharmacy network and access. According to the report, state regulators emphasized the importance of providing broad regulatory authority over PBMs, allowing them to address emerging issues without the need for new legislation. Additionally, robust enforcement of PBM laws, effective penalties, and clear reporting requirements were highlighted as essential to ensure consistent enforcement and protect consumer interests in the face of rising prescription drug spending, which reached nearly $152 billion in 2021—a rise of 18 percent from 2016.
• On April 16, 2024, GAO released a report entitled, Medicare and Medicaid: Additional Actions Needed to Enhance Program Integrity and Save Billions. In this report, GAO highlighted the substantial issue of improper payments within Medicare and Medicaid, amounting to over $100 billion in fiscal year (FY) 2023. The report states that these payments represent a significant portion of the government-wide total of improper payments. GAO discussed various recommendations made to CMS and Congress which have resulted in substantial savings and enhanced program integrity, including CMS’s implementation of fraud prevention measures in Medicare and improved oversight of Medicaid managed care. According to the report, several recommendations from GAO remain unimplemented, including congressional action to address site neutrality, which the report states could save Medicare $141 billion over a decade. Additionally, GAO urged CMS to expand its review of states’ implementation of provider screening and enrollment requirements in Medicaid.
• On April 16, 2024, the Congressional Budget Office (CBO) released a report entitled, Medicare Accountable Care Organizations: Past Performance and Future Directions. The report found that certain types of Accountable Care Organizations (ACOs), particularly those led by independent physician groups with a higher proportion of primary care providers and with initial baseline spending above the regional average, were associated with greater savings for the Medicare program. The report also highlighted several factors that limit the savings from Medicare ACOs. These include weak incentives for ACOs to reduce spending, insufficient resources for providers to participate in ACO models, and the ability of providers to selectively enter or exit the program based on anticipated financial benefits or losses. To enhance the savings generated by ACOs, researchers and experts suggested various policy approaches, such as increasing providers’ incentives to participate and reduce spending, as well as raising beneficiaries’ awareness and engagement with ACO models. The report stated that CBO has not yet assessed the effects of these policy recommendations or determined their net budgetary impact.

IV. Other Health Policy News

• On April 16, 2024, the White House launched the U.S. Global Health Security Strategy (GHSS). The strategy outlines a coordinated, intergovernmental approach to bolster global health security. It also incorporates lessons learned from the COVID-19 pandemic, including the importance of diplomatic partnerships, strong health systems, and robust community engagement efforts. The strategy sets the following three goals: 1) strengthen global health security capacities through bilateral partnerships; 2) catalyze political commitment, financing, and leadership to achieve health security; and, 3) increase linkages between health security and complementary programs to maximize impact. GHSS lays out the following guiding principles to achieve these goals: communication and cooperation; a whole-of-government, science-based approach; country ownership; and equity and inclusion. The strategy seeks to bolster U.S. capabilities to prevent, detect, and mitigate global health emergencies and enhance international partnerships. The strategy is available here. A fact sheet is available here.
• On April 16, 2024, Senator Ron Wyden (D-OR), along with 42 other Senate and House Democrats sent a letter to America’s Essential Hospitals, the American Hospital Association, the Children’s Hospital Association, the Federation of American Hospitals, and the National Rural Health Association, urging hospitals to protect patients’ medical privacy from legal demands by state attorneys general (AGs). According to a Senate Finance Committee report, AGs in at least four states have demanded hospitals disclose complete and identifiable medical and billing records of transgender patients, potentially endangering vulnerable patients. The letter highlighted examples of hospitals that have either protected patient privacy or failed to do so. The letter emphasized that while the Health Insurance Portability and Accountability Act (HIPAA) sets minimum standards for safeguarding patient information, hospitals should proactively protect sensitive, identifiable patient data and push back against law enforcement requests for unredacted records, especially when requests come from out-of-state AGs. Additionally, the letter urges hospitals to establish best practices for medical privacy, implement data minimization and destruction policies, and notify patients about any record disclosures to law enforcement entities and AGs. The letter concluded by encouraging hospitals to utilize already available strategies (e.g., HIPAA) and work with relevant stakeholders to develop best practices and create a resource toolkit to assist hospitals in protecting patients’ privacy rights. The letter is available here.
• On April 17, 2024, Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, sent a letter to FDA Commissioner Robert Califf, criticizing FDA’s decision to classify clinical decision support (CDS) software as medical devices. CDS software can help providers efficiently analyze patient records to determine the best treatment course. In the 21^st Century Cures Act, Congress excluded CDS software from the definition of medical device. However, subsequent FDA guidance has classified CDS software as a medical device, vastly expanding FDA’s oversight capabilities of these software. Senator Cassidy critiqued FDA’s guidance, saying it ignored the Congressional intent of 21^st Century Cures Act, and posed a series of questions about why and how FDA made the guidance decision. The letter is available here. A press release is available here.
• On April 19, 2024, HRSA issued a final rule entitled, 340B Drug Pricing Program; Administrative Dispute Resolution. This final rule aligns with Section 340B(d)(3) of the PHS Act, mandating the establishment of an ADR process to handle claims by covered entities alleging they have been overcharged for covered outpatient drugs by manufacturers, as well as claims by manufacturers asserting that a covered entity has violated the prohibition on diversion or duplicate discounts after conducting an audit. The final rule introduces new requirements and procedures aimed at enhancing the accessibility and efficiency of the ADR process for stakeholders. This rule will come into effect on June 18, 2024. In the coming weeks, HRSA plans to provide additional information, including hosting informational webinars, to guide stakeholders on how to file a claim under the new ADR process. The text of the final rule is available here.

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