On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the physician fee schedule (PFS) final rule for calendar year (CY) 2026 (Final Rule). ...more
11/26/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Filing Requirements ,
Final Rules ,
Health Insurance ,
Healthcare ,
Medicare ,
New Rules ,
OMB ,
Physician Fee Schedule ,
Regulatory Requirements ,
Reporting Requirements
On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) announced a new drug payment model designed to make Most Favored Nation (MFN)-level prices available to state Medicaid programs via manufacturer rebates....more
11/17/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicaid Drug Rebate Program ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Reporting Requirements ,
Trump Administration
On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the physician fee schedule (PFS) final rule for calendar year (CY) 2026 (Final Rule). It has been several years since this annual rulemaking...more
11/6/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Physician Fee Schedule ,
Reporting Requirements
As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently met in Boston to discuss shifting regulatory paradigms under the Trump Administration, including trade, drug pricing, and...more
10/21/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
International Trade ,
Life Sciences ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
On September 30, 2025, the Centers for Medicare & Medicaid Services (CMS) issued final guidance (Final Guidance) for initial price applicability year (IPAY) 2028 of the Inflation Reduction Act (IRA) Drug Price Negotiation...more
10/7/2025
/ Biologics ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs
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
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
On June 27, 2025, the Supreme Court in Kennedy v. Braidwood Management, Inc. upheld the structure of the U.S. Preventive Services Task Force (USPSTF, or “Task Force”), overturning a Fifth Circuit decision that had ruled that...more
On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more
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