Digest #58 on Drug Pricing
TL/DR –
The Centers for Medicare & Medicaid Services (CMS) has called on pharmaceutical manufacturers to implement Most Favored Nation (MFN) pricing, a policy aimed at reducing the cost of drugs. In other developments, a major manufacturer has withdrawn from the Medicaid Drug Rebate Program (MDRP) and the 340B program, raising questions on whether other manufacturers will follow the same path. Finally, the Healthcare Resources & Services Administration (HRSA) has approved eight plans for participation in the 340B Rebate Model Pilot Program, scheduled to start on January 1, 2026.
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A Review of Healthcare Policy Developments
CMS Urges Pharmaceutical Manufacturers to Adopt MFN Pricing
John Brooks, deputy administrator and Chief Policy and Regulatory Officer at the Centers for Medicare & Medicaid Services (CMS), recently called on pharmaceutical manufacturers to adopt the most favored nation (MFN) pricing policy. Speaking at an industry conference, Brooks underscored the Trump administration’s efforts to push countries outside of the US to increase their drug prices.
Consideration of the MFN Deals Continues
The potential impacts of the MFN deals introduced by the Trump administration are still being assessed. This includes a thorough examination of the details of their implementation and concerns about the TrumpRx direct-to-consumer platform.
A Major Manufacturer Withdraws from MDRP and 340B Program
A significant manufacturer has announced its withdrawal from the Medicaid Drug Rebate Program (MDRP) and the 340B program. This has led some observers to question whether other manufacturers might consider a similar move.
CBO Revises Score for IRA’s Expanded Orphan Drug Exclusion
The Congressional Budget Office (CBO) has updated its estimate of the financial impact of the expanded orphan drug exclusion in President Trump’s signature healthcare legislation, H.R. 1. This change has been made possible by amendments to the Inflation Reduction Act (IRA).
Continued Discussions on Priority Review Vouchers
Stakeholders are still reviewing the FDA’s grant of nine vouchers under the Commissioner’s National Priority Voucher (CNPV) program.
Medicaid Drug Rebate Program (MDRP)
No significant updates to report at this time.
340B Program
HRSA Approves Eight Rebate Model Plans
The Health Resources & Services Administration (HRSA) has updated its website to show that the agency has approved eight plans for participation in the 340B Rebate Model Pilot Program, starting from January 1, 2026.
Senate HELP Committee Holds Hearing on 340B Program
The Senate Committee on Health, Education, Labor and Pensions (HELP) recently held a hearing on the 340B program. It was reported that a bipartisan group of senators is working on proposed legislation aimed at reforming the 340B program.
Lawsuit Against HRSA Alleges Unreasonable ADR Delays
A group of covered entities has filed a lawsuit against HRSA related to Administrative Dispute Resolution (ADR) petitions submitted in November 2023. The petition is related to a manufacturer’s contract pharmacy policy.
Manufacturer Challenges to State 340B Laws Continue
Drug manufacturers continue to challenge the 340B laws enacted by various states.
Medicare Part B
CMS Releases 2026 Physician Fee Schedule Final Rule
On October 31, 2025, CMS released the 2026 Physician Fee Schedule (PFS) final rule. The PFS final rule will be published in the Federal Register on November 5, 2025.