Kathleen Peterson on Medicare

HRSA issues notice regarding 340B Rebate Model Pilot Program, limited to drugs subject to a maximum fair price (MFP) for 2026

On July 31, 2025, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register (Rebate Model Notice) announcing a 340B Rebate Model Pilot Program (Pilot Program). Notably, the Pilot...more

8/4/2025 / Centers for Medicare & Medicaid Services (CMS) , Covered Entities , Drug Pricing , HRSA , Medicaid , Medicare , Pharmaceutical Industry , Pilot Programs , Reporting Requirements , Section 340B

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

7/21/2025 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Manufacturers , Medicare , Outpatient Prospective Payment System (OPPS) , Pharmaceutical Industry , Proposed Rules , Regulatory Requirements , Reimbursements , Reporting Requirements

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

5/14/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Medicaid , Medicare , Pharmaceutical Industry , Proposed Rules , Rulemaking Process , Trump Administration

White House issues Executive Order directing efforts to lower drug prices

On April 15, 2025, the White House issued an Executive Order (EO) entitled “Lowering Drug Prices by Once Again Putting Americans First.” The EO directs various agencies to engage in a number of distinct efforts to lower...more

4/18/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Medicaid , Medicare , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Trump Administration

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

10/8/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Final Guidance , Inflation Reduction Act (IRA) , Manufacturers , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more

5/7/2024 / Centers for Medicare & Medicaid Services (CMS) , Draft Guidance , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Prescription Drugs

CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...more

12/19/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Manufacturers , Medicaid Drug Rebate Program , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more

7/5/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Popular , Prescription Drugs

CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS issues Medicare Part B and Part D inflation rebate guidance

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of 2022...more

2/14/2023 / Centers for Medicare & Medicaid Services (CMS) , Inflation Reduction Act (IRA) , Medicare , Medicare Part B , Medicare Part D , Prescription Drugs

HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP)....more

1/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Health Care Providers , Medicare , Medicare Part B , OIG

Senate Passes Drug Pricing Legislation

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...more

8/8/2022 / Drug Pricing , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , Medicare , Pharmaceutical Industry , Prescription Drugs

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

5/19/2022 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Health Care Providers , Medicaid , Medicaid Drug Rebate Program , Medicare , Pharmacy Benefit Manager (PBM) , PHRMA

MDRP multiple best prices option and territory exclusion update plus Part B discarded drug refund

While Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for manufacturers that report prices into the...more

11/22/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Medicaid Drug Rebate Program , Medicare , Medicare Part B , Pharmaceutical Industry , Prescription Drugs

CMS considers linking Medicare drug payment rates to international prices

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more

10/30/2018 / Advanced Notice of Proposed Rulemaking (ANPRM) , Biologics , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Medicare , Medicare Part B , Pharmaceutical Industry , Physician Medicare Reimbursements , Prescription Drugs , Regulatory Oversight , Regulatory Requirements

Kathleen Peterson

Hogan Lovells

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