Coverage and policy
Federal Register actions covering GLP-1 and incretin drugs: Medicare and Medicaid coverage rules, drug price negotiation, and the FDA bulk-substance lists that set what compounding pharmacies may legally make. Published rules and notices only. Each row links to the document on federalregister.gov.
Coverage decisions change who can afford these drugs faster than any trial result does, and they get a fraction of the attention. The 503B lists matter for a related reason. Compounded versions are only lawful while a drug is formally in shortage, so these documents and the supply records move together.
18
documents on file
9
rules and proposed rules
7
Medicare or Medicaid
4
years covered
| Published | Type | Action | Agency | Molecules |
|---|---|---|---|---|
| 2026-08-20 | Notice | Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Co… | Health and Human Services Department | — |
| 2026-06-26 | Notice | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 50… | Health and Human Services Department | liraglutide semaglutide tirzepatide |
| 2026-06-16 | Proposed Rule | Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program This proposed rule would codify the Medicare Drug Price Negotiation Program ("Negotiation Program") and would establish certain new policies for the Negotiation Program and the Medicare Pres… | Health and Human Services Department | — |
| 2026-05-20 | Rule | Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk … | Health and Human Services Department | — |
| 2026-05-01 | Notice | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients… | Health and Human Services Department | liraglutide semaglutide tirzepatide |
| 2026-04-30 | Notice | Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness The Food and Drug Administration (FDA or Agency) has determined that OZEMPIC (semaglutide) solution, 2 milligrams (mg)/1.5 milliliter (mL), was not withdrawn from sale for reasons of safety … | Health and Human Services Department | semaglutide |
| 2026-04-06 | Rule | Medicare Program; Contract Year 2027 and Certain Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program This final rule revises the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), and Medicare cost plan regulations to implement changes related to Star Ratings, marketi… | Health and Human Services Department | — |
| 2025-04-15 | Rule | Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly This final rule revises the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulation… | Health and Human Services Department | — |
| 2025-01-15 | Rule | Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year u… | Health and Human Services Department | — |
| 2024-12-20 | Notice | Hazardous Drugs: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 and Final Reevaluation Determinations for Liraglutide and Pertuzumab The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the… | Health and Human Services Department | liraglutide |
| 2024-12-10 | Proposed Rule | Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, Medicare cost plan, and Programs of All-Inclusive Care for the Elderly… | Health and Human Services Department | — |
| 2024-04-23 | Rule | Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE) This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regula… | Health and Human Services Department | — |
| 2024-04-15 | Rule | Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans (QH… | Health and Human Services Department | — |
| 2024-02-29 | Notice | Determination of Regulatory Review Period for Purposes of Patent Extension; MOUNJARO The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOUNJARO and is publishing this notice of that determination as required by law. FDA has … | Health and Human Services Department | tirzepatide |
| 2024-01-16 | Notice | Request for Public Comment on NIOSH Initial Recommendations To Change the Status of Liraglutide and Pertuzumab on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), requests publ… | Health and Human Services Department | liraglutide |
| 2023-11-24 | Proposed Rule | Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program This proposed rule includes payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans … | Health and Human Services Department | — |
| 2023-08-24 | Notice | Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The general fun… | Health and Human Services Department | — |
| 2023-08-24 | Notice | Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing The Food and Drug Administration (FDA) announces an alternative form of hearing regarding the Center for Drug Evaluation and Research's (CDER's) proposal to refuse to approve ITCA 650 (exena… | Health and Human Services Department | exenatide |