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 published the 2025 Medicare Advantage (MA) and Part D Star Ratings and released a Request for Information (RFI) on a proposed Medicare $2 Drug List Model.
I. Regulations, Notices & Guidance
- On September 8, 2024, the Administration for Community Living (ACL) released a notice entitled, Announcing the Intent to Award a Single-Source Supplement for University Center for Excellence in Developmental Disabilities Core Function Activities. ACL is announcing the intent to award a single-source supplement to the current grant held by the Oregon Health and Science University Center for Excellence in Developmental Disabilities. The purpose of this supplemental funding is to support one or more core function activities to address the needs of and provide support for individuals with intellectual and developmental disabilities (I/DD) who use Augmentative and Alternative Communication (AAC) or could benefit from AAC to ensure access to needed community services, individualized supports, and other forms of assistance that promote self-determination, independence, productivity, and integration and inclusion in all facets of community life. The administrative supplement for fiscal year (FY) 2024 will amount to $270,000.
- On October 9, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Final Guidance. CMS is announcing the availability of CMS’ final guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price in 2026 and 2027 for the implementation of the Inflation Reduction Act (IRA). This and other IRA-related guidance can be viewed on the dedicated IRA section of the CMS website.
- On October 10, 2024, the Food and Drug Administration (FDA) released a notice entitled, Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2025 Proposed Guidance Development. FDA is announcing the website location where FDA will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH) intends to publish in FY 2025. In addition, FDA has established a docket where interested parties may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with interested parties. This feedback is critical to the CDRH guidance program to ensure that we meet the needs of interested parties.
- On October 11, 2024, FDA released a notice entitled, Endosseous Dental Implants and Endosseous Dental Implant Abutments--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability. The device-specific guidance identified in this notice was developed in accordance with the finalized guidance entitled Safety and Performance Based Pathway. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the agency’s good guidance practices.
- On October 11, 2024, CMS released a final rule entitled, Medicare Program: Appeal Rights for Certain Changes in Patient Status. This final rule implements an order from the Federal district court for the District of Connecticut in Alexander v. Azar that requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria.
Event Notices
October 7, 2024: FDA announced a meeting of the FDA Science Board. This is a virtual meeting open to the public.
October 8, 2024: The National Institutes of Health (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: The Health Resources and Services Administration (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: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Community Preventive Services Task Force. This is a virtual meeting open to the public.
October 21, 2024: The Department of Health and Human Services (HHS) announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid 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.
October 31, 2024: FDA announced a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This is a hybrid 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 12, 2024: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a hybrid meeting open to the public.
November 14, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual 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.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This meeting is open to the public.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
II. Reports, Studies, & Analyses
- On October 11, 2024, the Kaiser Family Foundation (KFF) released an issue brief entitled, Recent Trends in Medicaid Outpatient Prescription Drugs and Spending. The analysis found that Medicaid’s prescription drug spending has risen significantly, driven by high-cost specialty drugs like cell and gene therapies. From 2017 to 2023, net spending after rebates increased 72 percent, reaching $51 billion. Rebates, which reduce costs by over half, declined slightly as a share of gross spending. The number of prescriptions per enrollee decreased, while gross spending on outpatient drugs grew 62 percent. States are implementing cost-control measures like value-based purchasing, and the IRA seeks to curb further cost growth.
- On October 9, 2024, the Office of the Inspector General (OIG) released a report entitled, Massachusetts Could Better Ensure That Nursing Homes Comply With Federal Requirements for Life Safety, Emergency Preparedness, and Infection Control. In this audit, OIG found 236 deficiencies related to life safety, emergency preparedness, and infection control at 20 nursing homes in Massachusetts. These issues increased risks to residents, staff, and visitors during fires, emergencies, or disease outbreaks. OIG recommended that Massachusetts ensure corrective actions at these facilities, collaborate with CMS to identify homes needing frequent inspections, and improve overall health and safety measures. Massachusetts agreed with the recommendations and outlined actions to address the findings.
- On October 8, 2024, the Congressional Budget Office (CBO) released a report entitled, How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget? The report found that authorizing Medicare to cover anti-obesity medications (AOMs) would likely result in a net federal spending increase of approximately $35 billion from 2026 to 2034. CBO estimates that direct costs of covering these medications, like GLP-1 receptor agonists, would rise from $1.6 billion in 2026 to $7.1 billion by 2034. According to the report, although the potential health improvements from weight loss would offer some savings, these are projected to be small relative to the cost of the medications. By 2034, around 1.6 million beneficiaries would use AOMs, with ongoing cost reductions and potential savings expected after that period.
III. Other Health Policy News
- On October 10, 2024, CMS released the 2025 Medicare Advantage (MA) and Part D Star Ratings. CMS publishes the MA and Medicare Part D Star Ratings each year to measure the quality of health and prescription drug services received by consumers enrolled in MA and Part D prescription drug plans (PDPs). Contracts are rated on up to 40 measures, and about 40 percent of contracts received four or more stars, covering 62 percent of enrollees. Nonprofit organizations typically perform better than for-profits, and contracts with more than 10 years in the program are more likely to earn higher ratings. Factors influencing cut points included improved post-pandemic performance and measures such as cancer screenings. A total of eleven contracts received five stars; seven were MA-PD contracts and two were PDPs. Eight contracts were marked as low performers. A fact sheet with more information is available here.
- On October 9, 2024, CMS released a Request for Information (RFI) on the Medicare Two Dollar Drug List Model (Model), developed as part of President Biden’s Executive Order 1408, Lowering Prescription Drug Costs for Americans. Under the Model, Medicare beneficiaries would access certain generic drugs for common chronic conditions‒such as high cholesterol, high blood pressure, diabetes, and heart disease‒at a fixed copayment of two dollars. The program, set to launch by 2027, aims to improve affordability, medication adherence, and health outcomes. CMS is requesting public input on the development of the drug list, updates, and implementation processes to ensure the Model is comprehensive and accessible. As the Model develops, new drugs may be added, and the list will be updated regularly to keep up with changing medical needs and pricing trends. The deadline to respond to the RFI is December 9, 2024. A press release with more information is available here. Additional information on the Model can be found here. A link to the RFI is available here.
- On October 7, 2024, the U.S. Supreme Court denied a petition by HHS to review a decision by the U.S. Court of Appeals for the Fifth Circuit which held that Texas’ abortion law was not bound by HHS’ interpretation of a hospital’s obligations under the Emergency Medical Treatment and Labor Act (EMTALA). The Fifth Circuit’s decision held that HHS’ memorandum asserting that EMTALA preempts state law when an abortion is a stabilizing medical treatment “establishes or changes a substantive legal standard” and thus HHS was statutorily required to undergo a notice and comment period before its implementation. The Fifth Circuit also ruled that EMTALA does not establish a national standard of care nor mandate a specific type of medical treatment, such as an abortion. The Supreme Court’s decision not to hear this case comes just a few months after the Court considered a similar case and upheld a preliminary injunction preventing the full implementation of Idaho’s abortion law because it conflicts with EMTALA.
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