TL/DR –
The Centers for Medicare & Medicaid Services (CMS) have proposed a rule requiring 340B covered entities to submit Part D 340B claims data. President Trump has declared that tariffs on generic drugs entering the US will rise to 100% after a two-year 0% period, then to 200% afterwards. There are ongoing discussions and legal challenges regarding state laws and systems for drug pricing, including the Colorado Prescription Drug Affordability Board’s upper payment limit.
New Proposals and Actions in Healthcare and Inflation Regulation
Physician Fee Schedule for 2027 Released by CMS
The calendar year 2027 Physician Fee Schedule (PFS) proposed rule was unveiled by the Centers for Medicare & Medicaid Services (CMS). The proposal, which was published on July 16, 2026, is open for public comments until September 14, 2026.
One of the significant proposals under the PFS would mandate Medicare providers and suppliers to submit Part D 340B claims data to a dedicated repository, effective January 1, 2027. This is a departure from previous regulations where data submission was voluntary. The purpose of the mandated submission is to enhance CMS’s potential future use of the 340B repository for assessing and excluding 340B units from manufacturer Part D inflation rebate calculations.
The proposed rule also introduces various amendments in the Part D inflation rebate program, including a refined definition for the term “first marketed date.”
Sources: BloombergLaw, PinkSheet, InsideHealthPolicy (first, second), 340B Report (first, second).
Draft Guidance on Maximum Fair Price (MFP) Published by CMS
A draft guidance on the operation of Maximum Fair Price (MFP) in 2028 under the Medicare Drug Price Negotiation Program was issued by CMS on July 16, 2026. The document, which includes a fact sheet, is open for public comments until September 18, 2026.
This guidance follows CMS’s previous final guidance for Initial Price Applicability Year (IPAY) 2028, which primarily targeted Part D drugs. The new guidance does not intend to change the published policy but aims to expand on these policies regarding the data and payment processes for selected drugs payable under Part B in 2028.
Source: BloombergLaw.
President Trump Announces Tariffs on Generic Drugs
President Trump made an announcement via social media post dated July 21, 2026, declaring that all Generic Drugs imported into the United States would continue to enjoy a tariff of zero percent for two years starting August 1, 2026. Following this period, tariffs would increase to 100% for one year and then 200% thereafter.
Sources: Law360, PoliticoPro (first, second), BloombergLaw (US Economic News