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 Senate Finance Committee released a plan to improve the Medicare Graduate Medical Education (GME) program to address workforce shortages, and the DC Circuit Court ruled that manufacturers can limit the number of contract pharmacies dispensing 340B drugs.

I. Regulations, Notices & Guidance

• On May 20, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, National Institute for Occupational Safety and Health; Human Factors Considerations for the Fire Fighter Fatality Investigation and Prevention Program. CDC’s National Institute for Occupational Safety and Health (NIOSH) requests feedback about its Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) investigation and report process for traumatic injuries. NIOSH is interested in how human factors might be considered during investigations including but not limited to communication, team dynamics, psychological stress, and safety culture, and how these factors impact decision-making during responses. If applicable, information will be used to improve reporting templates and processes to provide a holistic lens into the causes and prevention of line-of-duty deaths (LODD).
• On May 21, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review. AHRQ is seeking scientific information submissions from the public to inform the agency’s review entitled, Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review. The review is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
• On May 21, 2024, AHRQ released a notice entitled, Supplemental Evidence and Data Request on Management of Suicidal Thoughts and Behaviors in Youth. AHRQ is seeking scientific information submissions from the public to inform the agency’s review entitled, Management of Suicidal Thoughts and Behaviors in Youth. The review is currently being conducted by the AHRQ’s EPC Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
• On May 21, 2024, the Food and Drug Administration (FDA) issued a proposed rule comment extension entitled, Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period. FDA is extending the comment period for the proposed rule entitled, Labeling Requirements for Approved or Conditionally Approved New Animal Drugs, which was published in the Federal Register of March 12, 2024, by 60 days. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
• On May 21, 2024, FDA released a notice entitled, Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.
• On May 21, 2024, the National Institutes of Health (NIH) released a notice entitled, NIH Office of Science Policy (OSP): Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning. NIH is proposing to develop and implement a new policy within its Intramural Research Program (IRP) to promote access to products stemming from taxpayer-funded inventions. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
• On May 22, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act of 1974; Matching Program. In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, CMS is providing notice of the establishment of a matching program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration (VHA) for Identification and Recovery of Duplicate Payments for Medical Claims.
• On May 22, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Announcing the Call for Nominations for the 2024 President’s Council on Sports, Fitness & Nutrition Awards. The President’s Council on Sports, Fitness & Nutrition (PCSFN) is calling for nominations from the public for its three awards – the Lifetime Impact Award, the Community Leadership Award, and the PCSFN Hero Award. Nominations will be accepted through July 1, 2024.
• On May 22, 2024, FDA released draft guidance entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are required, including the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food.
• On May 23, 2024, CMS released a notice entitled, Medicare Program; Announcement of the Re-Approval of the Joint Commission as an Accreditation Organization under the Clinical Laboratory Improvement Amendments of 1988. This notice announces the application of the Joint Commission for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. CMS has determined that the Joint Commission meets or exceeds the applicable CLIA requirements. CMS grants the Joint Commission deeming authority for a period of 6 years.
• On May 24, 2024, FDA released a notice entitled, Progynon Associates, et al.; Proposal to Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing. FDA’s Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of four new drug applications (NDAs) and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for those NDAs.
• On May 24, 2024, FDA released a notice entitled, Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets, approved on May 25, 2023, manufactured by Pfizer, Inc., meets the criteria for a material threat MCM priority review voucher.

Event Notices

• May 30, 2024: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a virtual 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 3, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual 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. This meeting is open to the public.
• June 4, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory Board (DTAB). This is a hybrid meeting open to the public.
• June 5, 2024: HHS announced a meeting of the National Committee on Vital and Health Statistics. This is a virtual meeting open to the public.
• June 5-6, 2024: HHS announced a meeting of the Presidential Advisory Council on HIV/AIDS. This is a hybrid meeting open to the public.
• June 6, 2024: CDC announced a meeting of the Advisory Committee to the Director, CDC. This is a virtual meeting open to the public.
• June 6, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting 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 7, 2024: FDA announced a meeting of the National Advisory Eye Council. This is a virtual meeting open to the public.
• June 10, 2024: SAMHSA announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee. This is a virtual meeting open to the public.
• June 13-14: HHS announced a meeting of the National Vaccine Advisory Committee. This is a hybrid meeting open to the public.
• June 20, 2024: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a virtual meeting open to the public.
• June 26, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
• June 26, 2024: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
• June 26-28, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
• June 28-29, 2024: AHRQ announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a hybrid meeting open to the public.
• July 11-12, 2024: FDA announced a meeting entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. This is a hybrid meeting open to the public.

II. Hearings & Markups

• On Tuesday, May 21, 2024, the Senate Judiciary Committee held a hearing entitled, Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market. Witnesses included: William Feldman, MD, DPhil, MPH, Associate Physician, Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital; David Mitchell, President and Founder, Patients for Affordable Drugs; Adam Mossoff, Professor of Law, Antonin Scalia Law School, George Mason University; Arti Rai, Elvin R. Latty Distinguished Professor of Law, Duke Law; and Jocelyn Ulrich, Vice President, Policy & Research, PhRMA.
• On Tuesday, May 21, 2024, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Feeding a Healthier America: Current Efforts and Potential Opportunities for Food is Medicine. Witnesses included: Jean Terranova, Senior Director of Policy and Research, Community Servings; Erin Martin, MASM Gerontologist, Founder & Director, FreshRx Oklahoma; Dariush Mozaffarian, MD, DrPH, Director, Food is Medicine Institute, Tufts University; and James Carter Williams, CEO and Managing Principal, iSelect Fund.
• On Wednesday, May 22, 2024, the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, Nutritious Foods in the Supplemental Nutrition Assistance Program (SNAP). Witnesses included: Dr. Angela Rachidi, Senior Fellow and Rowe Scholar, American Enterprise Institute; Mr. Michael Gay, Independent Grocer; Mr. Robert Seligson, Chief Executive Officer, The Physicians Foundation; and Dr. Robert Lustig, Emeritus Professor, Department of Pediatrics, University of California San Francisco.
• On Wednesday, May 22, 2024, the House Committee on Energy & Commerce (E&C) Health Subcommittee held a hearing entitled, Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices. Witnesses included: Dr. Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research; Dr. Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research; and Dr. Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health.
• On Thursday, May 23, 2024, the Senate Finance Committee held a hearing entitled, Front Lines of the Fentanyl Crisis: Supporting Communities and Combating Addiction through Prevention and Treatment. Witnesses included: Tony Vezina, Executive Director, 4th Dimension Recovery Center (4D); Abigail J. Herron, DO, Vice President and Chief Behavioral Health Officer, The Institute for Family Health; Caleb J. Banta-Green, Ph.D., MPH, MSW, Research Professor, University of Washington School of Medicine; and Jeanmarie Perrone, MD, Director, Center For Addiction Medicine and Policy, University of Pennsylvania.
• On Thursday, May 23, 2024, the Senate HELP Committee held an executive session entitled, S. 3679, S. 3765, S. 4351, S. 3775, S. 4325, S. 3757, S. 4045, and Nomination. The Committee considered the below legislation:
  • 3679,Dr. Lorna Breen Health Care Provider Protection Reauthorization Act;
  • 3765,Emergency Medical Services for Children Reauthorization Act of 2024;
  • 4351,A bill to amend the Public Health Service Act to reauthorize certain poison control programs;
  • 3775,BOLD Infrastructure for Alzheimer's Reauthorization Act of 2024;
  • 4325,A bill to amend the Public Health Service Act to reauthorize the program relating to lifespan respite care, and for other purposes;
  • 3757,Congenital Heart Futures Reauthorization Act of 2024; and
  • 4045,East Palestine Health Impact Monitoring Act of 2024.
• Outcome: All bills were adopted and reported favorably.
• On Thursday, May 23, 2024, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, A Review of the President’s Fiscal Year 2025 Budget Request for the National Institutes of Health. Witnesses included: Dr. Monica M. Bertagnolli, M.D., Director, National Institutes of Health; Dr. W. Kimryn Rathmell, M.D., Ph.D., M.M.H.C., Director, National Cancer Institute; Dr. Jeanne Marrazzo, M.D., M.P.H., Director, National Institute of Allergy and Infectious Diseases; Dr. Nora D. Volkow, M.D., Director, National Institute on Drug Abuse; Dr. Richard J. Hodes, M.D., Director, National Institute on Aging; and Dr. Gary H. Gibbons, M.D., Director, National Heart, Lung, and Blood Institute.
• On Thursday, May 23, 2024, the House Ways and Means Health Subcommittee held a hearing entitled, The Collapse of Private Practice: Examining the Challenges Facing Independent Medicine. Witnesses included: Dr. Jennifer Gholson, MD, Family Practitioner, Summit, Mississippi; Dr. Timothy Richardson, MD, Independent Physician, Wichita Urology; Ms. Chris Kean; COO, The San Antonio Orthopaedic Group; Dr. Seemal Desai, MD; Founder, Innovative Dermatology; Dr. Ashish Jha, MD, Dean, Brown School of Public Health.
• On Thursday, May 23, 2024, the House Budget Committee held a hearing entitled, Breaking Up Health Care Monopolies: Examining the Budgetary Effects of Health Care Consolidation. Witnesses included: Dr. Chapin White, Director of Health Analysis, Congressional Budget Office; Dr. Benedic Ippolito, Senior Fellow in Economic Policy Studies, American Enterprise Institute; and Dr. Adam Bruggeman, Orthopaedic Surgeon, Texas Spine Care Center.

III. Reports, Studies, & Analyses

• On May 21, 2024, the HHS Office of Inspector General (OIG) released a report entitled, California Improperly Claimed $52.7 Million in Federal Medicaid Reimbursement for Capitation Payments Made on Behalf of Noncitizens With Unsatisfactory Immigration Status. States are typically barred from federal Medicaid reimbursement for services provided to individuals with unsatisfactory immigration status (UIS), except for emergency medical services. California, however, allows for broader coverage of services for individuals with UIS and would generally need to use state funds to cover these non-emergency services. To avoid federal reimbursement for these services, California applied a 39.87 percent proxy percentage to capitation payments made to managed care organizations (MCOs) on belief of individuals with UIS. OIG conducted an audit to determine if California claimed federal Medicaid reimbursement for capitated payments for individuals with UIS. OIG found that from October 1, 2018, to June 30, 2019, California improperly received $52.7 million in federal Medicaid funding for non-emergency services provided to individuals with UIS. OIG recommended that California refund CMS the $52.7 million and work with the agency to determine any additional improper payments that were outside of the audit’s timeframe.
• On May 24, 2024, the Kaiser Family Foundation (KFF) released a report entitled Racial and Ethnic Disparities in Mental Health Care: Findings from the KFF Survey of Racism, Discrimination and Health. The analysis shed light on racial and ethnic disparities in mental health care access and utilization. Results found that Black and Hispanic adults experiencing fair or poor mental health are notably less likely than their White counterparts to report receiving mental health services in the past three years. Barriers such as cost concerns, time constraints, and difficulty finding culturally competent providers disproportionately affect people of color. These disparities are particularly troubling amidst a national mental health crisis exacerbated by the COVID-19 pandemic. Furthermore, awareness of the 988 mental health hotline remains low among minority groups. Additionally, negative experiences or unfair treatment by health care providers significantly deter individuals from seeking needed mental health care. Addressing these systemic barriers is crucial to ensuring equitable access to mental health services for all communities.

IV. Other Health Policy News

• On May 21, 2024, CMS launched a new online patient portal to educate patients on the protections offered by the Emergency Medical Treatment and Labor Act (EMTALA) and to provide information on how to file a complaint under the Act. The website describes what is an “emergency department” under the Act and what a hospital emergency department must provide as required by EMTALA.
• On May 21, 2024, the U.S. DC Circuit Court of Appeals ruled in favor of Novartis and United Therapeutics who sued HRSA to protect the right of manufacturers to limit the use of contract pharmacies in the distribution of 340B discounted drugs. The circuit court held that HRSA was incorrect in its position that manufacturer’s restrictions were in violation of the 340B statute. Early last year a ruling by the Third Circuit Court of Appeals also sided in favor of manufacturers although another appeal is still pending in the Seventh Circuit Court of Appeals.
• On May 23, 2023, Congressman Vern Buchanan (R-FL-16), alongside Congresswoman Gwen Moore (D-WI-4), announced the launch of the Congressional Preventive Health and Wellness Caucus, a bipartisan initiative aimed at addressing the obesity epidemic in the U.S. With obesity contributing significantly to chronic diseases and healthcare costs, the caucus seeks to raise awareness and advocate for policy-driven solutions. Key objectives include quantifying the economic impact of obesity; introducing legislation for prevention and treatment; hosting congressional hearings on obesity-related healthcare strategies; and organizing roundtable discussions to address regional challenges.
• On May 24, 2024, Senate Finance Committee Chair Ron Wyden (D-OR), alongside seven bipartisan members of the Senate Finance Committee, unveiled a policy outline aimed at enhancing the Medicare Graduate Medical Education (GME) program. The proposal addresses critical physician workforce shortages, particularly in primary care and psychiatry, while also targeting the equitable distribution of physicians to rural and underserved communities. Recognizing the pressing need to bolster the healthcare workforce, the Senators emphasize the importance of additional Medicare GME initiatives. Key components of the outline include expanding and refining Medicare-supported GME residency training positions in rural areas and underserved specialties, assisting rural hospitals in establishing residency training programs, and enhancing federal data collection to ensure effective allocation of GME funds.

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