Health Care Week in Review | CMS releases CY 2027 Medicare Advantage and Part D Proposed Rule; Trump Administration Announces Negotiated Drug Prices for 2027

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. 

Regulations, Notices & Guidance

• On November 25, 2025, the Food and Drug Administration (FDA) released a notice entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath. FDA is classifying the anchored esophageal sheath as a class II device (special controls). The special controls that apply to the device type are identified in this notice and will be part of the codified language for the classification of the anchored esophageal sheath. FDA 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, in part by reducing regulatory burdens.
• On November 25, 2025, FDA released a notice entitled, Medical Devices; Neurological Devices; Classification of Field Generator Positioning. FDA is classifying the field generator positioning device as a class I device (general controls). FDA has determined that classifying the device into class I (general 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 in part by reducing regulatory burdens.
• On November 25, 2025, FDA released draft guidance entitled, Cross-Center Master Files: Where to Submit. The draft guidance provides recommendations to industry regarding where to submit a master file that is referenced in and intended to support multiple regulatory submissions. These recommendations apply when the lead center for those submissions may vary or when the information in the master file must be accessed and reviewed by more than one center to support review of the referencing submission(s). The recommendations apply to master files submitted to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and certain types of master files submitted to the Center for Veterinary Medicine (CVM).
• On November 26, 2025, the Department of Health and Human Services (HHS) released a notice entitled, Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children’s Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2026, through September 30, 2027. The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for fiscal year (FY) 2027 have been calculated pursuant to the Social Security Act (SSA). These percentages will be effective from October 1, 2026, through September 30, 2027. This notice announces the calculated FMAP rates that HHS will use in determining the amount of Federal matching for Medicaid, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments and Kinship Guardianship Assistance payments, and the eFMAP rates for the Children’s Health Insurance Program (CHIP) expenditures.
• On November 26, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Final Guidance. The Inflation Reduction Act of 2022 established the Medicare Drug Price Negotiation Program to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs and biological products. The Working Families Tax Cuts Act, which was signed into law on July 4, 2025, expanded protections for orphan drugs. The final guidance describes how CMS will implement the Negotiation Program for Initial Price Applicability Year (IPAY) 2028, which includes renegotiation, and specifies the requirements for manufacturer effectuation of the MFPs in 2026, 2027, and 2028.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• December 1, 2025: The National Institutes of Health (NIH) announced a peer review meeting of the draft National Toxicology Program (NTP) Developmental and Reproductive Toxicity Technical Report on 2-Hydroxy-4-methoxybenzophenone. This is a hybrid meeting open to the public.
• December 1, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• December 2, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• December 3, 2025: FDA announced a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• December 3, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. This is a hybrid meeting open to the public.
• December 4, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a hybrid meeting with some sessions open to the public.
• December 4, 2025: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
• December 4-5, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• December 5, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices. This is a hybrid meeting open to the public.
• **December 9, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting open to the public.
• December 9, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• December 10, 2025: CMS announced a town hall meeting on FY 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• December 10, 2025: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• December 10, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a virtual meeting open to the public.
• **December 15-18, 2025: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Commission on Childhood Vaccines. This is a virtual meeting open to the public.
• December 16, 2025: FDA announced a public workshop entitled, Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine. This is a virtual workshop open to the public.
• December 17-18, 2025: CMS announced the second biannual virtual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2025. This is a virtual meeting open to the public.
• **December 18, 2025: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
• January 22, 2025: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• January 26-27, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• January 28-29, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• May 4, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On November 25, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Medicare Payments for Continuous Glucose Monitors and Supplies Exceeded Supplier Costs and Retail Market Prices, Indicating Medicare Can Save At Least Tens of Millions of Dollars in One Year. The report compared Medicare payments for continuous glucose monitors (CGMs) and related supplies to suppliers’ acquisition costs and retail prices to assess potential savings. OIG found that between July 2022 and June 2023, Medicare payments for CGMs and supplies exceeded suppliers’ acquisition costs by $377 million (69 percent) and their total estimated costs by $70 million (8 percent). CGM supplies represented the largest potential savings, with payments exceeding suppliers’ acquisition costs by $359 million and total estimated costs by $61 million. In one year, Medicare payments for CGM supplies were $290 million greater than retail market prices. The report also identified $7 million in potential overpayments due to improper coding, in which suppliers billed for higher payment-rate items but provided lower-rate CGMs and supplies. OIG recommended that CMS pursue reductions to Medicare payment rates for CGMs and supplies and implement measures to prevent overpayments caused by suppliers’ improper use of billing codes for CGMs and supplies. CMS concurred with both recommendations.
• On November 26, 2025, OIG released a report entitled, Gaps in NIH’s Oversight Put Millions in Funding for Other Transactions at Greater Risk of Fraud, Waste, or Abuse. The report examined NIH’s use of Other Transactions (OTs), which support high-impact, cutting-edge, or urgent public health research. Unlike traditional funding mechanisms, OTs have fewer requirements, allowing for greater flexibility in negotiating intellectual property rights and attracting non-traditional recipients. OIG found that NIH did not consistently apply the required OT safeguards, increasing the risk of fraud, waste, and abuse. Of the 15 OTs examined, NIH staff failed to fully justify their use under statutory and policy requirements in 12 cases. Additionally, three of seven NIH Institutes, Centers, and Offices (ICOs) lacked required internal control policies for OTs. OIG recommended that NIH evaluate the benefits of OTs to inform future OT policies, strengthen justifications for their use, improve risk management across all OTs, and establish internal controls to prevent mismanagement and fraud by OT staff and recipients. NIH concurred with all recommendations.

Other Health Policy News

• On November 25, 2025, CMS released a proposed rule entitled, Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program. The proposed rule would revise the Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), and Medicare cost plan regulations by implementing changes related to Star Ratings, marketing and communications, drug coverage, enrollment processes, special needs plans, and other programmatic areas.
  
  CMS proposes not to implement the Excellent Health Outcomes for All reward, formerly the Health Equity Index (HEI) reward, in the 2027 Star Ratings system. It also proposes removing 12 measures for the 2027 measurement year, including those focused on administrative processes and areas where beneficiaries cannot distinguish performance between plans due to high performance and little variation. Instead, CMS would introduce a new Part C Depression Screening and Follow-Up measure to address behavioral health gaps.
  
  The agency also seeks to modify a special enrollment period (SEP) for enrollees to switch plans when their providers leave their plan’s network by eliminating the requirement that MA organizations deem the network change “significant.” CMS would further codify its current policy requiring prior CMS approval for certain SEPs.
  
  In the proposed rule, CMS issued three Requests for Information (RFIs) seeking feedback on: (1) opportunities to enhance competition within the MA program; (2) potential solutions to address the significant growth in chronic condition special needs plans (C-SNPs) enrollment; and (3) tools and policies to improve well-being and nutrition among MA beneficiaries.
  
  CMS proposes to codify changes to the Medicare Part D prescription drug benefit that were temporarily implemented under the IRA. These policies include eliminating the coverage gap phase, lowering the annual out-of-pocket threshold, removing cost sharing for enrollees in the catastrophic phase, and implementing the Manufacturer Discount Program that replaced the Coverage Gap Discount Program on January 1, 2025. Additional updates would address True Out-Of-Pocket (TrOOP) cost calculations, specialty-tier rules, reinsurance payment methodologies, and implementation of the Selected Drug Subsidy.
  
  CMS also proposes to amend current regulatory language to more explicitly state that cannabis products that are illegal under state or federal law are not allowable as Special Supplemental Benefits for the Chronically Ill (SSBCI).
  
  In accordance with a Trump Administration Executive Order entitled, Unleashing Prosperity Through Deregulation, the proposed rule includes several measures to reduce burden and remove requirements that are duplicative or no longer necessary or applicable.
  
  The proposed rule can be found here. A press release can be found here. A fact sheet can be found here.
• On November 25, 2025, CMS announced it had negotiated discounts on 15 drugs for patients in Medicare as part of the second round of negotiated prices between manufacturers and CMS under the Medicare Drug Price Negotiation Program.
  
  Through the program, CMS directly negotiates prices for certain high-expenditure, single-source drugs without generic or biosimilar competition. For the second negotiation cycle, CMS selected 15 drugs covered under Medicare Part D for the initial price applicability year 2027 and engaged in voluntary negotiations with manufacturers. The agreed-upon prices, known as MFPs, will take effect on January 1, 2027, and have been published on the CMS website.  Additionally, the agency published a  public file that includes the MFP for a 30-day equivalent supply of each drug, National Drug Code (NDC)-specific per-unit and per-package prices, and associated NDC updates. CMS will update this file annually to reflect inflation-adjusted prices.
  
  Negotiated discounts vary by drug, ranging from 38 percent to 85 percent off of 2024 list prices. Notably, Novo Nordisk’s diabetes and weight-loss drugs, Ozempic and Wegovy, will see a 71 percent reduction, while Pfizer’s breast cancer treatment, Ibrance, will be discounted by 50 percent. GSK’s asthma medication, Trelegy Ellipta, will receive a 73 percent cut, and Xtandi, a prostate cancer drug, will be reduced by 48 percent. These price reductions are expected to generate substantial savings for Medicare beneficiaries and the program overall. Between January and December 2024, approximately 5.3 million Medicare Part D enrollees used these drugs, accounting for $42.5 billion in gross covered prescription costs, or about 15 percent of total Part D spending.
  
  Notably, CMS also announced the removal of Entresto, Stelara, and Xarelto from the selected drugs list effective January 1, 2027, after determining that at least one approved generic or biosimilar version of each drug is being marketed.
  
  A press release can be found here. A fact sheet on the drug negotiation program can be found here. The public file can be found here.

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