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, CMS announced a data request for information (RFI) in an effort to increase Medicare Advantage (MA) transparency and the Senate Finance Committee released a plan to prevent and mitigate generic drug shortages.

I. Regulations, Notices & Guidance

• On January 22, 2024, the Food and Drug Administration (FDA) issued a notice entitled, Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher. FDA announced 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 determined that the supplemental application for ZEPOSIA (ozanimod), approved May 27, 2021, meets the criteria for redeeming a priority review voucher.
• On January 22, 2024, FDA issued a notice entitled, Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher. FDA announced the issuance of approval of a product redeeming a priority review voucher. The 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 determined that VEOZAH (fezolinetant), approved May 12, 2023, meets the criteria for redeeming a priority review voucher.
• On January 22, 2024, FDA issued a notice entitled, Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review. FDA announced the issuance of approval of a product redeeming a priority review voucher. The 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 determined that the supplemental application  for COSENTYX (secukinumab), approved June 16, 2020, meets the criteria for redeeming a priority review voucher.
• On January 22, 2024, FDA issued a notice entitled, Notice of Approval of Product under Voucher: Rare Pediatric Disease Priority Review Voucher. FDA announced the issuance of approval of a product redeeming a priority review voucher. The 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  determined that XYWAV (calcium, magnesium, potassium, and sodium oxybates), approved July 21, 2020, meets the criteria for redeeming a priority review voucher.
• On January 22, 2024, FDA issued a notice entitled, Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA announced the availability of the draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices. This draft guidance provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface of the device. This draft guidance is not final nor is it for implementation at this time.
• On January 24, 2024, FDA issued a notice entitled, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability. FDA announced the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to Coronavirus Disease 2019 (COVID-19). FDA issued the Authorizations listed in this document under the FD&C Act. These Authorizations contain, among other things, conditions on the emergency use of the authorized products.
• On January 24, 2024, FDA issued a notice entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability. FDA announced the availability of a draft guidance for industry (GFI) #286 (VICH GL60) entitled “Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products.” 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). The objective of this draft guidance is to provide recommendations regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
• On January 24, 2024, FDA issued a notice entitled, Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Final Guidance for Industry; Availability. FDA announced the availability of a final guidance for industry entitled “Revising ANDA Labeling Following Revision of the RLD Labeling.” This guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following revisions to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates. This guidance finalizes the draft guidance for industry of the same title issued on January 27, 2022.
• On January 24, 2024, FDA issued a notice entitled, Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program. FDA announced an opportunity for a limited number of establishments to participate in a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a prototype assessment protocol to evaluate quality management maturity (QMM). The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain experience with the prototype assessment protocol and to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment’s quality management practices while providing useful feedback for the establishment. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.
• On January 24, 2024, the Health Resources and Services Administration (HRSA) issued a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. HRSA published this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service Act (PHSA), 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 January 24, 2024, HRSA issued a notice entitled Solicitation of Nominations for Membership to Serve on the National Advisory Council on Nurse Education and Practice. HRSA is seeking nominations of qualified candidates to consider for appointment as members of the National Advisory Council on Nurse Education and Practice (NACNEP). NACNEP provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning the activities under Title VIII of the PHSA, including the range of issues relating to the nurse workforce, education, and practice improvement. NACNEP also prepares and submits an annual report to the Secretary of HHS and Congress describing its activities, including NACNEP’s findings and recommendations concerning activities under Title VIII, as required by the PHSA. HRSA is seeking nominations of qualified candidates to fill up to 11 open positions on NACNEP.
• On January 25, 2024, FDA issued a notice entitled, Conducting Remote Regulatory Assessments--Questions and Answers; Revised Draft Guidance for Industry; Availability. FDA announced the availability for comment of a revised draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the FD&C Act. When finalized, this guidance will describe FDA’s current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.
• On January 26, 2024, the Centers for Disease Control and Prevention (CDC) released a proposed rule entitled, Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins. In accordance with the PHSA, the CDC reviewed the HHS list of select agents and toxins with the potential to pose a severe threat to public health and safety. HHS/CDC proposes to amend the list by removing three biological agents, raising one toxin’s exclusion amounts, renaming a virus, designating a current agent as a Tier 1 agent, and removing the designation of Tier 1 status from one agent.
• On January 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Request for Information on Medicare Advantage Data. This request for information (RFI) seeks input from the public regarding various aspects of Medicare Advantage (MA) data. Responses to this RFI may be used to inform general efforts to strengthen CMS’s MA data capabilities and guide policymaking.

Event Notices

January 29, 2024: The National Institutes of Health (NIH) announced a meeting of the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee. This is a virtual meeting open to the public.

January 29, 2024: NIH announced a meeting of the Interagency Coordinating Committee on the Validation of Alternative Methods entitled “Implementing Computational Approaches for Regulatory Safety Assessments.” This is a virtual meeting open to the public.

January 29, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This is a hybrid meeting open to the public.

February 1, 2024: CMS announced a virtual meeting of the Advisory Panel on Outreach and Education (APOE). This meeting is open to the public.

February 2, 2024: FDA announced a meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. This meeting is open to the public.

February 6, 2024: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This meeting is open to the public.

February 13-14, 2024: HHS announced a meeting of the Office of Minority Health. The meeting is open to the public. Individuals who wish to attend must register by emailing OMH-ACMH@hhs.gov by 5:00 p.m. EST on January 30, 2024. Each registrant should provide their name, affiliation, phone number, email address, days attending, and if participation is in-person or via webcast.

February 14, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This meeting is open to the public, but without a public comment period. The public can join the meeting by teleconference.

February 16, 2024: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.

February 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.

February 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). This is a hybrid meeting open to the public.

February 27, 2024: SAMHSA announced a meeting of SAMSHA’s Center for Mental Health Services National Advisory Council. This is a hybrid meeting open to the public.

February 28-29, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.

March 6, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Center for Health Statistics. This meeting is open to the public.

March 13, 2024: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.

March 25-26, 2024: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.

II. Hearings & Markups

Senate

• On January 25, 2024, the Senate Special Committee on Aging held a hearing entitled, Senate Special Committee on Aging Hearing on Assisted Living Facilities: Understanding Long-Term Care Options for Older Adults. Witnesses present included Patricia (Patty) Vessenmeyer, Advocate; Dr. Jennifer Craft Morgan, Director and Professor, The Gerontology Institute, Georgia State University; Julie Simpkins, Co-President, Gardant Management Solutions; and Richard Mollot, Executive Director, Long Term Care Community Coalition.

III. Reports, Studies, & Analyses

• On January 24, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Another Year of Record ACA Marketplace Signups, Driven in Part by Medicaid Unwinding and Enhanced Subsidies. Enrollment in the Affordable Care Act (ACA) Marketplaces reached a record high of 21.3 million individuals, exceeding last year’s total enrollment by nearly 5 million, or 30 percent. Roughly half of the growth in enrollment came from Texas, Florida, and Georgia. KFF attributes this growth to the ongoing Medicaid unwinding, continued enhanced subsidies from the Inflation Reduction Act, and, to a lesser extent, the Biden Administration’s amelioration of the family glitch, which prevented families from accessing Marketplace subsidies.
• On January 25, 2024, the Government Accountability Office (GAO) released a report entitled, Hospital Financing: Volume Limits and Reporting Could Help Manage Risks of Expanding FHA's Mortgage Insurance Program. The report focused on the Federal Housing Administration’s (FHA) Hospital Mortgage Insurance Program, which currently insures over $6 billion in loans for acute care hospital expansions. The report outlines the program's varied usage from 2000 to 2022 and discusses FHA’s proposal to extend eligibility to non-acute care hospitals, such as psychiatric facilities considering their smaller size and lower revenues. GAO found the potential expansion could include around 2,600 additional hospitals, but estimating those meeting FHA’s standards is challenging. To manage associated risks, the report recommends Congress consider practices like initially limiting new loan volumes and requiring regular program activity reporting, ensuring effective risk monitoring and control.

IV. Other Health Policy News

• On January 22, 2024 the CMS published new information on Emergency Medical Treatment and labor Act (EMTALA) rights to serve as a resource for hospitals and their patients.  The CMS release stated that they will be taking a series of action to help educate the public about their rights to emergency medical care.  As a part of this plan CMS stated they will:
  • Publish new informational resources on CMS’s website to help individuals understand their rights under EMTALA and the process for submitting a complaint if they are denied emergency medical care;
  • Partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA;
  • Convene hospital and provider associations to discuss best practices and challenges in ensuring compliance with EMTALA; and
  • Establish a dedicated team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.
• This CMS publication may be a response to legal questions raised on whether EMTALA supersedes state law. The Supreme Court of the United States will consider whether EMTALA preempts the Idaho state abortion law and will hear arguments on this case in April.

• On January 25, 2024, Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) announced a bipartisan initiative to address and prevent shortages of critical generic drugs in the United States. The commitment to developing bipartisan health care legislation is outlined in a white paper released by Senator Wyden and Senator Crapo and highlights concerns raised by experts during a Senate Finance Committee hearing on December 5, 2023, entitled, Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective. The white paper outlines potential policy options under Medicare and Medicaid to address factors contributing to drug shortages. The legislators expressed their urgency in tackling the generic drug shortage crisis, particularly for patients with chronic conditions, and emphasize their commitment to leveraging the power of Medicaid and Medicare to address these challenges. The areas under consideration for legislative development include Medicare Part A and B payment reforms, incentives for stakeholders in the drug supply chain to engage in shortage prevention activities, reforms or pilot programs in Medicare Part D, and potential changes to the Medicaid Drug Rebate Program targeting generic medicines in shortage.

• On January 24, 2024, Senators Bill Cassidy (R-LA) and Mike Braun (R-IN) introduced the Medicare Transaction Fraud Prevention Act, proposing the use of artificial intelligence (AI) to combat Medicare fraud related to durable medical equipment (DME) and clinical laboratory testing. The legislation would create a pilot program within CMS that uses a AI model to target irregular billing activity for specific items or services used by five percent of beneficiaries receiving electronic notices. The proposed two-year pilot aims to oversee Medicare-covered purchases of DME and diagnostic testing-related. By engaging beneficiaries in verifying purchases, the bill intends to provide CMS with crucial predictive data, test the proof of concept for future use, and potentially save hundreds of millions of dollars without a complete system overhaul. The legislation addresses the issue of Medicare losing approximately $60 billion annually due in part to fraud and abuse involving health professionals and others. Fraudulent billing for unapproved diagnostic tests and DME contributes to this annual loss, prompting the call for stronger fraud detection processes within CMS. The bill does not authorize additional funding, and beneficiaries have the option to opt out at any time.

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