Drug Pricing Legal Updates, IRA Challenges, 340B Program
Summary
Latham & Watkins' April 2026 Drug Pricing Digest reports ongoing IRA legal challenges with the US Supreme Court weighing certiorari, stakeholder discussions on MFN policy and Section 232 tariffs, and multiple 340B program developments including a major manufacturer's litigation challenging the HRSA patient definition and third-party data reporting requirements.
What changed
This digest summarizes regulatory and litigation developments affecting pharmaceutical pricing. The IRA faces continued legal challenges as the Supreme Court weighs certiorari, while stakeholders debate MFN pricing and Section 232 tariff implications. Multiple 340B program disputes persist—manufacturers continue challenging HRSA's patient definition, data reporting requirements for in-house pharmacies, and state-level 340B laws.
Pharmaceutical manufacturers and 340B covered entities should monitor ongoing litigation developments, as court rulings on the patient definition and state pharmacy laws could significantly reshape program compliance obligations. CMS's ongoing drug acquisition cost survey may also affect future 340B reimbursement methodology.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
April 21, 2026
Healthcare & Life Sciences: Drug Pricing Digest - April 2026 #2
Jennifer Bragg, Jason Caron, Daniel Machado, Nicole Liffrig Molife, Christopher Schott, Amy Speros Latham & Watkins LLP + Follow Contact LinkedIn Facebook X ;) Embed
Inflation Reduction Act, Healthcare Reform, and General Developments
IRA LEGAL CHALLENGES CONTINUE
Drug manufacturer litigation against the Inflation Reduction Act (IRA) drug pricing-negotiation program continues, with the US Supreme Court currently weighing whether to grant certiorari.
Source: Law360.
STAKEHOLDERS CONTINUE TO DISCUSS GLOBE AND GUARD PAYMENT MODELS, MFN IMPLICATIONS
Stakeholders continue to discuss the implications of the most favored nation (MFN) policy and the recent presidential proclamation regarding Section 232 tariffs, which we discussed in issue No. 69 of this digest.
Sources: InsideHealthPolicy , PoliticoPro , NBC News , Pink Sheet ( first , second , third , fourth , fifth ), BioWorld .
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
MANUFACTURER CHALLENGES “PATIENT” DEFINITION
A major pharmaceutical manufacturer has filed litigation in the US District Court for the District of Columbia, challenging the definition of “patient” under the 340B program. The current definition was issued by the Health Resources & Services Administration (HRSA) in the form of guidance in 1996, and subsequent attempts to update the definition have failed. The patient definition was previously challenged by a covered entity in the context of a HRSA audit finding of diversion, as discussed in issue No. 31 of this digest.
Sources: BloombergLaw , Law360 , InsideHealthPolicy , Pink Sheet , 340B Report.
MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES
A third manufacturer is requiring covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. We discussed these manufacturer requirements in issue No. 64 of this digest.
Sources: BloombergLaw , 340B Report .
CMS EXTENDS COST SURVEY DEADLINE
In the 2026 Outpatient Prospective Payment System (OPPS) final rule, which we discussed in issue No. 60 of this digest, the Centers for Medicare & Medicaid Services (CMS) announced that the agency will conduct an OPPS hospital drug acquisition cost survey with the intent to use the results to potentially modify the reimbursement amount for drugs purchased under the 340B program. CMS extended the deadline for 340B covered entities to respond to the survey to April 7, 2026.
Source: 340B Report.
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Drug manufacturer litigation challenging the 340B laws enacted by various states continues.
Sources: BloombergLaw ( first , second ), Law360 , 340B Report ( first , second , third ).
After siding with manufacturers in their challenge to West Virginia’s contract pharmacy law, as discussed in issue No. 69 of this digest, the US Court of Appeals for the Fourth Circuit has now also issued a similar opinion with respect to a Maryland contract pharmacy statute.
Sources: BloombergLaw , BioWorld ( first , second ), InsideHealthPolicy , Law360 , 340B Report ( first , second ).
ADDITIONAL STATES ADOPT CONTRACT PHARMACY LAWS
More states have enacted or proposed legislation that would bar drug manufacturers from restricting contract pharmacy access. Some bills would require covered entities to make disclosures regarding 340B discounts. We note that legislative action related to the 340B program may have occurred in other states but has not yet been reported in the trade press.
Source: 340B Report.
Medicare Part B
No developments to report.
Medicare Part D
No developments to report.
State Law Developments
VIRGINIA CONTINUES TO DISCUSS PDAB BILL
Discussion continues in Virginia regarding a bill that would establish a Prescription Drug Affordability Board (PDAB). We discussed the legislation in issue No. 64 of this digest.
Source: InsideHealthPolicy.
MARYLAND PDAB IMPLEMENTATION CONTINUES
The Maryland PDAB has proposed an upper payment limit (UPL) for one drug. If implemented, Maryland would be the second state to impose a UPL.
Sources: BloombergLaw , StatNews .
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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