Federal Register · drug pricing policy
Federal policy on drug pricing: rules, proposed rules and notices
Federal Register documents that shape what Medicare negotiates and what people pay, grouped by document type and newest first. Each entry links the Federal Register and, where there is one, the PDF. This is the policy record behind the prices on the negotiated drug pages.
Rules
- Improving Transparency Into Pharmacy Benefit Manager Fee DisclosureFederal Register document 2026-22306; Published November 2, 2026; effective January 4, 2027
The Department is issuing a final regulation that will require providers of pharmacy benefit management services and affiliated providers of brokerage and consulting services to disclose information about their compensation to fiduciaries of large, self-insured group health plans subject to the...
Labor Department; Employee Benefits Security Administration | PDF - Medicaid Program; Community Engagement Requirement for Certain IndividualsCorrection to an earlier document. Federal Register document C1-2026-11094; Published June 29, 2026Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-2454-IFC | PDF
- Medicaid Program; Community Engagement Requirement for Certain IndividualsFederal Register document 2026-11094; Published June 3, 2026; effective July 31, 2026
This interim final rule with comment period (IFC) interprets and implements the community engagement requirement in Medicaid under section 1902(xx) of the Social Security Act. States are required to implement the new requirement no later than January 1, 2027. This IFC specifies the requirements and...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-2454-IFC | PDF - 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 ProgramFederal Register document 2026-06600; Published April 6, 2026; effective June 1, 2026
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, marketing and communications, drug coverage, enrollment processes, special needs plans, and other programmatic areas.
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4208-F3 and CMS-4212-F | PDF - 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 ElderlyFederal Register document 2025-06008; Published April 15, 2025; effective June 3, 2025
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) regulations to implement changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4208-F | PDF - Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare OverpaymentsFederal Register document 2024-25382; Published December 9, 2024; effective January 1, 2025
This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1807-F and CMS-4201-F5 | PDF - Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate ProgramFederal Register document 2024-21254; Published September 26, 2024; effective November 19, 2024
This final rule implements policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which address drug misclassification, as well as drug pricing and product data misreporting by...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-2434-F | PDF - Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation SpecificationsFederal Register document 2024-12842; Published June 17, 2024; effective July 17, 2024
This final rule will revise the Medicare Prescription Drug Benefit (Part D) and ONC regulations to implement changes related to required standards for electronic prescribing and adoption of health information technology (IT) standards for HHS use.
Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary | CMS-4205-F2 | PDF - 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)Federal Register document 2024-07105; Published April 23, 2024; effective June 3, 2024
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) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation...
Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary | CMS-4201-F3 and CMS-4205-F | PDF - 340B Drug Pricing Program; Administrative Dispute Resolution RegulationFederal Register document 2024-08262; Published April 19, 2024; effective June 18, 2024
The Health Resources and Services Administration administers section 340B of the Public Health Service (PHS) Act, which is referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers and covered entities that participate in the 340B...
Health and Human Services Department | Docket No. 2021-0004 | PDF - Action to Delay Effective Date Consistent With Congressionally Enacted MoratoriumFederal Register document 2023-28775; Published December 29, 2023
This action stays certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule ("Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain...
Health and Human Services Department; Inspector General Office, Health and Human Services Department | PDF - Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health ProgramFederal Register document 2023-24184; Published November 16, 2023; effective January 1, 2024
This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; payment for dental services...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1784-F | PDF - Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022Federal Register document 2023-24407; Published November 8, 2023; effective January 8, 2024
This final rule describes the agency's actions on remand from the United States (U.S.) District Court for the District of Columbia to craft a remedy in light of the U.S. Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1793-F | PDF - Medicare Program; Contract Year 2024 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 ElderlyFederal Register document 2023-07115; Published April 12, 2023; effective June 5, 2023
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) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider...
Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary | CMS-4201-F | PDF - Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID-19 Interim Final RulesFederal Register document 2022-23873; Published November 18, 2022; effective January 1, 2023
This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1770-F, CMS-1751-F2, CMS-1744-F2, CMS-5531-IFC | PDF - Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health EmergencyFederal Register document 2022-09375; Published May 9, 2022; effective June 28, 2022
This final rule will revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4192-F, CMS-1744-F, and CMS-3401-F | PDF
Proposed rules
- Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026Federal Register document 2026-21420; Published October 20, 2026; comments closed December 15, 2026
This proposed rule would implement section 6219 (Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals), section 6220 (Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act), and section 6224 (Modernizing and Ensuring Pharmacy Benefit Manager...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4214-P | PDF - Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data CollectionFederal Register document 2026-12344; Published June 18, 2026; comments closed July 20, 2026
This request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4218-NC | PDF - Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit ProgramFederal Register document 2026-12059; Published June 16, 2026; comments closed August 17, 2026
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 Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4215-P | PDF - Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure; Extension of Comment PeriodFederal Register document 2026-04084; Published March 2, 2026; effective January 30, 2026; comments closed April 15, 2026
This document extends the comment period on the Department's Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure proposed rule. The proposed rule would require providers of pharmacy benefit management services and affiliated providers of brokerage and consulting services to disclose...
Labor Department; Employee Benefits Security Administration | PDF - Improving Transparency Into Pharmacy Benefit Manager Fee DisclosureFederal Register document 2026-01907; Published January 30, 2026; comments closed March 31, 2026
The Department is proposing a regulation that would require providers of pharmacy benefit management services and affiliated providers of brokerage and consulting services to disclose information about their compensation to fiduciaries of self-insured group health plans subject to the Employee...
Labor Department; Employee Benefits Security Administration | PDF - Statutory Updates to Branded Prescription Drug Fee RegulationsFederal Register document 2025-24153; Published January 2, 2026; comments closed March 3, 2026
This document proposes amendments to regulations regarding the annual fee imposed on covered entities engaged in the business of manufacturing or importing certain branded prescription drugs. In response to the replacement of the Coverage Gap Discount Program with the new Manufacturer Discount...
Treasury Department; Internal Revenue Service | REG-103430-24 | PDF - Guarding U.S. Medicare Against Rising Drug Costs (GUARD) ModelFederal Register document 2025-23705; Published December 23, 2025; comments closed February 23, 2026
This proposed rule would implement the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model to test a new Medicare payment model under section 1115A of the Social Security Act. The model proposes a test of an alternative payment method for calculating inflation rebates for certain Part D...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-5546-P | PDF - Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan ProgramFederal Register document 2025-21456; Published November 28, 2025; comments closed January 26, 2026
This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), and Medicare cost plan regulations to implement changes related to Star Ratings, marketing and communications, drug coverage, enrollment processes, special needs plans, and other...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4212-P | PDF - 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 ElderlyFederal Register document 2024-27939; Published December 10, 2024; comments closed January 27, 2025
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 (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4208-P | PDF - Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare OverpaymentsFederal Register document 2024-14828; Published July 31, 2024; comments closed September 9, 2024
This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of, and...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1807-P | PDF - Medicare Program; 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; Health Information Technology Standards and Implementation SpecificationsFederal Register document 2023-24118; Published November 15, 2023; comments closed January 5, 2024
This proposed rule would 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) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker...
Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary | CMS-4205-P | PDF - Medicare Program: Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022; Extension of Comment PeriodFederal Register document 2023-19070; Published September 5, 2023; comments closed September 11, 2023
This document extends the comment period for the proposed rule titled "Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022" that was published in the July 11, 2023 Federal Register. The comment period for...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1793-N | PDF - Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health ProgramFederal Register document 2023-14624; Published August 7, 2023; comments closed September 11, 2023
This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; payment for dental services...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1784-P | PDF - Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022Correction to an earlier document. Federal Register document C1-2023-14623; Published July 14, 2023Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1793-P | PDF
- Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022Federal Register document 2023-14623; Published July 11, 2023; comments closed September 5, 2023
This proposed rule describes the agency's proposed actions to comply with the remand from the district court to craft a remedy in light of the United States Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1793-P | PDF - Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate ProgramFederal Register document 2023-10934; Published May 26, 2023; comments closed July 25, 2023
This proposed rule would seek to implement policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which are needed to address drug misclassification, as well as drug pricing and...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-2434-P | PDF - Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation SpecificationsFederal Register document 2022-26956; Published December 27, 2022; comments closed February 13, 2023
This proposed rule would 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) regulations to implement changes related to Star Ratings, medication therapy management, marketing and...
Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary | CMS-4201-P | PDF - 340B Drug Pricing Program; Administrative Dispute ResolutionFederal Register document 2022-25752; Published November 30, 2022; comments closed January 30, 2023
The Health Resources and Services Administration implements section 340B of the Public Health Service (PHS) Act, which is referred to as the "340B Drug Pricing Program" or the "340B Program." This notice of proposed rulemaking (NPRM) proposes to revise the current 340B administrative dispute...
Health and Human Services Department | Docket No. 2021-0004 | PDF - Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicare and Medicaid Provider Enrollment Policies, Including for Skilled Nursing Facilities; Conditions of Payment for Suppliers of Durable Medicaid Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing Requirements for Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded AmountsFederal Register document 2022-14562; Published July 29, 2022; comments closed September 6, 2022
This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1770-P | PDF - Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit ProgramsFederal Register document 2022-00117; Published January 12, 2022; comments closed March 7, 2022
This proposed rule would revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4192-P | PDF
Notices
- Privacy Act of 1974; Matching ProgramFederal Register document 2026-22015; Published October 29, 2026; comments closed November 30, 2026
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), is providing notice of a computer matching program between CMS and participating State-Based Administering Entities (AEs)...
Health and Human Services Department; Centers for Medicare & Medicaid Services | PDF - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; AvailabilityFederal Register document 2026-20817; Published October 13, 2026
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2024-D-2581 | PDF - Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy DocumentFederal Register document 2026-19166; Published September 18, 2026; comments closed November 17, 2026
The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2025-N-2787 | PDF - Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance DisordersFederal Register document 2026-17991; Published September 2, 2026; comments closed September 17, 2026
The National Institute of Diabetes and Digestive and Kidney Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the patents and patent applications...
Health and Human Services Department; National Institutes of Health | PDF - Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; AvailabilityFederal Register document 2026-15630; Published August 3, 2026; comments closed October 2, 2026
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts." This draft guidance is intended to help...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2026-D-4272 | PDF - Notice Regarding 340B Rebate Model Pilot ProgramFederal Register document 2026-15633; Published August 3, 2026; effective January 1, 2027
The U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a revised 340B Rebate Model Pilot...
Health and Human Services Department; Health Resources and Services Administration | PDF - Biosimilar User Fee Rates for Fiscal Year 2027Federal Register document 2026-15346; Published July 30, 2026
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2026-N-7707 | PDF - Medicare Program; Inflation Reduction Act of 2022 (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment RequestFederal Register document 2026-14583; Published July 20, 2026; comments closed September 18, 2026
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the Medicare Drug Price Negotiation Program regarding manufacturer effectuation of the maximum fair price in 2028 for the implementation of the Inflation Reduction...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4219-N | PDF - 340B Rebate Model Pilot Program Application, Implementation, and Evaluation, CorrectionFederal Register document 2026-12442; Published June 22, 2026
HRSA published a 30-day Federal Register Notice (FRN) on June 15, 2026, related to the proposed Information Collection Request for the 340B Rebate Model Pilot Program Application, Implementation and Evaluation, which listed 793,080 as the number of total estimated responses. This Notice corrects...
Health and Human Services Department; Health Resources and Services Administration | PDF - New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; AvailabilityFederal Register document 2026-04664; Published March 10, 2026; comments closed May 11, 2026
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)." The question and answer (Q&A) format is intended to inform prospective...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2011-D-0611 | PDF - Request for Information: 340B Rebate Model Pilot Program ExtensionFederal Register document 2026-03838; Published February 26, 2026; comments closed April 20, 2026
The Health Resources and Services Administration (HRSA) is extending the comment period for Request for Information: 340B Rebate Model Pilot Program from 30 days to 60 days. The change will provide stakeholders additional time to submit meaningful comments for HRSA's review in evaluating...
Health and Human Services Department; Health Resources and Services Administration | PDF - Request for Information: 340B Rebate Model Pilot ProgramFederal Register document 2026-03042; Published February 17, 2026; comments closed March 19, 2026
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHS Act), referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA is issuing this Request for Information (RFI) to gather input from interested parties regarding the...
Health and Human Services Department; Health Resources and Services Administration | PDF - Annual Update of the HHS Poverty GuidelinesFederal Register document 2026-00755; Published January 15, 2026; effective January 13, 2026
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Health and Human Services Department; Office of the Secretary | PDF - Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To ParticipateFederal Register document 2025-22619; Published December 12, 2025
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). The...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2025-N-5997 | PDF - Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; AvailabilityFederal Register document 2025-22427; Published December 10, 2025
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2019-D-5473 | PDF - Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Final GuidanceFederal Register document 2025-21501; Published November 28, 2025
The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of CMS' final guidance for the third cycle of the Medicare Drug Price Negotiation Program (hereafter the "Negotiation Program"), the first cycle of renegotiation, and manufacturer effectuation of the maximum fair...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4210-N2 | PDF - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; AvailabilityFederal Register document 2025-20380; Published November 20, 2025; comments closed January 20, 2026
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies." This...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2011-D-0605 | PDF - Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Industry; AvailabilityFederal Register document 2025-17226; Published September 9, 2025
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations." This guidance describes the Agency's...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2019-D-2102 | PDF - Classification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; AvailabilityFederal Register document 2025-17290; Published September 9, 2025
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2023-D-1954 | PDF - 340B Program Notice: Application Process for the 340B Rebate Model Pilot Program; CorrectionFederal Register document 2025-14998; Published August 7, 2025; comments closed September 8, 2025
The U.S. Department of Health and Human Services (HHS) Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a 340B Rebate Model Pilot Program as a...
Health and Human Services Department; Health Resources and Services Administration | PDF - 340B Program Notice: Application Process for the 340B Rebate Model Pilot ProgramFederal Register document 2025-14619; Published August 1, 2025; comments closed September 2, 2025
The U.S. Department of Health and Human Services (HHS) Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a 340B Rebate Model Pilot Program as a...
Health and Human Services Department; Health Resources and Services Administration | PDF - Biosimilar User Fee Rates for Fiscal Year 2026Federal Register document 2025-14416; Published July 30, 2025
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2025-N-2273 | PDF - Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Guidance for Industry; AvailabilityFederal Register document 2025-13682; Published July 21, 2025
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2018-D-1922 | PDF - Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment RequestFederal Register document 2025-08607; Published May 15, 2025; comments closed June 26, 2025
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the third cycle of the Medicare Drug Price Negotiation Program, the first cycle of renegotiation, and manufacturer effectuation of the maximum fair price for 2026...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-4210-N | PDF - Annual Update of the HHS Poverty GuidelinesFederal Register document 2025-01377; Published January 17, 2025
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Health and Human Services Department; Office of the Secretary | PDF - Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Final GuidanceFederal Register document 2024-23418; Published October 10, 2024
The Centers for Medicare & Medicaid Services (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...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1800-N4 | PDF - Biosimilar User Fee Rates for Fiscal Year 2025Federal Register document 2024-16884; Published July 31, 2024
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2024-N-3423 | PDF - Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and CommentsFederal Register document 2024-16405; Published July 25, 2024; comments closed October 23, 2024
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing how best to advance the development of new biosimilar biological products (biosimilars or biosimilar products), as part of the...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2024-N-3228 | PDF - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; AvailabilityFederal Register document 2024-16128; Published July 23, 2024; comments closed September 23, 2024
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This draft guidance provides answers to commonly asked...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2024-D-2581 | PDF - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar ApplicantFederal Register document 2024-15237; Published July 11, 2024
The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a "subsection (k) applicant") notified FDA that an action for...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2017-N-4853 | PDF - Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment RequestFederal Register document 2024-09750; Published May 6, 2024; comments closed July 2, 2024
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price for 2026 and 2027 for the implementation of...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1800-NC3 | PDF - Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; AvailabilityFederal Register document 2024-08886; Published April 25, 2024; comments closed June 24, 2024
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2019-D-5473 | PDF - Annual Update of the HHS Poverty GuidelinesFederal Register document 2024-00796; Published January 17, 2024
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Health and Human Services Department; Office of the Secretary | PDF - Inflation Reduction Act (IRA) Revised Program GuidanceFederal Register document 2023-27551; Published December 15, 2023
The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of CMS' revised guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional Inflation Reduction...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1800-N2 | PDF - Registration Requirements in the 340B Drug Pricing ProgramFederal Register document 2023-23702; Published October 27, 2023
HRSA is issuing this Notice to inform and remind stakeholders of the registration requirements for off-site, outpatient hospital facilities to participate in the 340B Drug Pricing Program (340B Program). This Notice applies to all hospital types that participate in the 340B Program.
Health and Human Services Department; Health Resources and Services Administration | PDF - Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry; AvailabilityFederal Register document 2023-20141; Published September 18, 2023; comments closed November 17, 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Labeling for Biosimilar and Interchangeable Biosimilar Products." This draft guidance is intended to help applicants develop draft labeling for proposed biosimilar and...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2016-D-0643 | PDF - Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; AvailabilityFederal Register document 2023-17261; Published August 11, 2023; comments closed October 10, 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This draft guidance provides recommendations to industry on formal meetings between FDA and...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2018-D-1922 | PDF - Classification Categories for Certain Supplements Under the Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry; AvailabilityFederal Register document 2023-17262; Published August 11, 2023; comments closed October 10, 2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This draft guidance provides recommendations for applicants and FDA review staff on classification...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2023-D-1954 | PDF - Biosimilar User Fee Rates for Fiscal Year 2024Federal Register document 2023-15918; Published July 28, 2023
The Food and Drug Administration (FDA, the Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2023-N-2966 | PDF - Inflation Reduction Act (IRA) Revised Program GuidanceFederal Register document 2023-14097; Published July 3, 2023
The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of CMS' revised guidance for the Medicare Drug Price Negotiation Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional Inflation Reduction Act-related guidance; all can be...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1800-N | PDF - Inflation Reduction Act (IRA) Initial Program Guidance; Comment RequestFederal Register document 2023-05411; Published March 17, 2023; comments closed April 14, 2023
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' initial guidance for the Medicare Drug Price Negotiation Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional Inflation Reduction Act-related...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1800-NC2 | PDF - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar ApplicantFederal Register document 2023-04583; Published March 7, 2023
The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a "subsection (k) applicant") notified FDA that an action for...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2017-N-4853 | PDF - Inflation Reduction Act (IRA) Initial Program Guidance; Comment RequestFederal Register document 2023-02974; Published February 13, 2023; comments closed March 11, 2023
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' initial guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional...
Health and Human Services Department; Centers for Medicare & Medicaid Services | CMS-1800-NC | PDF - Annual Update of the HHS Poverty GuidelinesFederal Register document 2023-00885; Published January 19, 2023
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Health and Human Services Department; Office of the Secretary | PDF - Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; AvailabilityFederal Register document 2022-25622; Published November 23, 2022
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's regulatory and...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2022-D-2922 | PDF - Biosimilar User Fee Rates for Fiscal Year 2023Federal Register document 2022-21965; Published October 7, 2022
The Food and Drug Administration (FDA or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2022-N-2352 | PDF - Benefit-Risk Considerations for Product Quality Assessments; Draft Guidance for Industry; AvailabilityFederal Register document 2022-10030; Published May 10, 2022; comments closed July 11, 2022
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Benefit- Risk Considerations for Product Quality Assessments." This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2022-D-0168 | PDF - Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients With Type 2 Diabetes Mellitus; Guidance for Industry and Food and Drug Administration Staff; AvailabilityFederal Register document 2022-09738; Published May 6, 2022
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus." This guidance...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2021-D-0131 | PDF - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar ApplicantFederal Register document 2022-02799; Published February 10, 2022
The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a "subsection (k) applicant") notified FDA that an action for...
Health and Human Services Department; Food and Drug Administration | Docket No. FDA-2017-N-4853 | PDF - Annual Update of the HHS Poverty GuidelinesFederal Register document 2022-01166; Published January 21, 2022
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Health and Human Services Department; Office of the Secretary | PDF
Questions
What is on this list?
Federal Register documents on Medicare drug pricing, Part D, drug price negotiation, the maximum fair price, Medicaid drug rebates and related Medicaid rules, 340B, PBMs, biosimilars, insulin, drug shortages and the poverty guidelines, each with the date it was published and a link to the Federal Register.
What is the difference between a rule, a proposed rule and a notice?
A rule is a final regulation. A proposed rule asks for public comment before a rule is made. A notice announces something that is not a regulation, such as a guideline, a meeting or a program update.
Does a proposed rule change anything today?
No. A proposed rule only becomes binding if a final rule follows. The entry shows when comments closed; it does not say whether a final rule will follow.
For developers: recent changes as data
The change feed for the last 30 days (shortage rows, program status and NADAC prices) as one file, each event with a receipt.
Example file: https://omnirx.org/api/v1/changes/last-30-days.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. Federal Register documents (federalregister.gov), read November 7, 2026; federal work with no restriction on reprinting. Abstracts are shortened where long. Library edition 2026-11. Every figure is stored with its source and date in the OmniRx library: see where every figure comes from. Not medical, legal or financial advice. Licence the data.