Newsletter
Healthcare & Life Sciences: Drug Pricing Digest — Number 72
May 18, 2026
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law.
Inflation Reduction Act, Healthcare Reform, and General Developments
CMS SENIOR COUNSELOR DISCUSSES POLICY LANDSCAPE
Tune in to the latest episode of the Latham Drug Pricing and Market Access podcast, where Senior Counselor to the Centers for Medicare & Medicaid Services (CMS) Rujul Desai shares updates on a host of current policy topics, from most favored nation (MFN) pricing and TrumpRx to 340B and program integrity initiatives.TRUMP RELEASES REPORT ON PROJECTED SAVINGS FROM MFN POLICY
On May 5, 2026, the White House Council of Economic Advisers (CEA) released a report on savings the CEA projects will result from the MFN drug pricing policy.
Sources: BioWorld, InsideHealthPolicy, StatNews, PBS.
Check out our Client Alert about the new RAPID coverage pathway for Medicare coverage of breakthrough medical devices.
TRUMP CONTINUES PUSH FOR MFN CODIFICATION
The Trump administration is continuing to call on Congress to enact its MFN drug pricing policies in legislation.
Source: InsideHealthPolicy.
STAKEHOLDERS CONTINUE TO DISCUSS MFN IMPLICATIONS
Stakeholders continue to discuss the implications of the MFN drug pricing policy, including for ex-US markets.
Source: Pink Sheet, Scrip, Stat News.
COMMERCE DEPARTMENT ISSUES NOTICE REGARDING SECTION 232 TARIFFS
On May 13, 2026, the Department of Commerce published a notice in the Federal Register announcing the procedures that pharmaceutical manufacturers must follow “to apply for company-specific agreements … to onshore manufacturing” in order to become “eligible for a reduced Section 232 duty rate for imports of their pharmaceutical products and associated ingredients.” We discussed the Section 232 tariffs in issue No. 69 of this digest.
Sources: BioWorld, Law360, Pink Sheet.
IRA LEGAL CHALLENGES CONTINUE
Drug manufacturer litigation against the Inflation Reduction Act (IRA) drug pricing-negotiation program continues.
Sources: Law360, InsideHealthPolicy.
STAKEHOLDER ADVOCACY REGARDING IRA NEGOTIATION REGULATIONS
The proposed rule for initial price applicability year (IPAY) 2029, which will mark the transition from guidance to regulation, remains under review by the Office of Management and Budget. We discussed this proposed rule in issue No. 68 of this digest. Stakeholders are reportedly discussing key aspects of the regulation with CMS.
Source: InsideHealthPolicy (first, second).
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES
As discussed in issue No. 64 of this digest, some manufacturers have begun requiring covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. Stakeholders continue to discuss these requirements.
Sources: InsideHealthPolicy, 340B Report (first, second, third, fourth).
LITIGATION REGARDING CHILD SITE REGISTRATION REQUIREMENTS CONTINUES
In response to the COVID-19 pandemic, the Health Resources & Services Administration (HRSA) had initially waived certain registration requirements for covered entity child sites and then withdrew the waiver in 2023, as discussed in issue No. 65 of this digest. Litigation brought by covered entities challenging that withdrawal remains ongoing, with HRSA appealing the decision of the US District Court for the District of Columbia. We discussed the opinion in issue No. 67 of this digest.
Source: 340B Report.
COVERED ENTITY CHALLENGE TO STD CLINIC REMOVAL CONTINUES
As discussed in issue No. 53 of this digest, there are two lawsuits related to HRSA policies for certifying sexually transmitted disease (STD) clinics as eligible for the 340B program, one brought by manufacturers (as discussed in issue No. 69 of this digest) and the other brought by covered entities. The covered entities challenged HRSA’s termination of certain STD clinics from the 340B program (as discussed in issues No. 43, No. 44, and No. 50 of this digest). The US District Court for the District of Columbia has now upheld the terminations.
Source: 340B Report.
HRSA ISSUES FURTHER ADR DECISION
HRSA has updated its Administrative Dispute Resolution (ADR) website with summaries of additional ADR decisions. All of the actions disclosed so far were brought by covered entities against manufacturers alleging overcharges in connection with manufacturer contract pharmacy policies, and all actions were resolved with a finding of “no overcharge violation.”
Source: 340B Report.
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Drug manufacturer litigation challenging the 340B laws enacted by various states continues.
Sources: Law360, 340B Report (first, second, third, fourth).
Medicare Part B
No developments to report.
Medicare Part D
No developments to report.State Law Developments
PDAB LEGISLATION ADVANCES IN VIRGINIA
The Virginia General Assembly has adopted legislation that would establish a Prescription Drug Affordability Board (PDAB) and has rejected Governor Abigail Spanberger’s attempt to delay certain provisions of the legislation.
Sources: InsideHealthPolicy, 340B Report.
Endnotes
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