April 6, 2026

Healthcare & Life Sciences: Drug Pricing Digest - March 2026 #2

Jennifer Bragg, Jason Caron, Daniel Machado, Nicole Liffrig Molife, Christopher Schott, Amy Speros Latham & Watkins LLP + Follow Contact LinkedIn Facebook X Send Embed

Inflation Reduction Act, Healthcare Reform, and General Developments

ALL IPAY 2028 MANUFACTURERS AGREE TO NEGOTIATE

On March 13, 2026, the Centers for Medicare & Medicaid Services (CMS) announced that all manufacturers with drugs selected for forced negotiation under the Inflation Reduction Act (IRA) for Initial Price Applicability Year (IPAY) 2028 have agreed to participate in the negotiations.

Sources: InsideHealthPolicy (first, second), 340B Report.

CMS REGULATION REGARDING IRA SELECTION OF COMBINATION DRUGS

CMS has submitted a proposed regulation for review to the Office of Management and Budget (OMB), which is the first step to initiate notice-and-comment rulemaking. Commenters believe the proposed regulation will address how fixed-dose combination drugs will be treated in the IRA selection process, a topic that CMS deferred to future rulemaking in the IPAY 2028 final guidance. We discussed the final guidance in issue No. 56 of this digest.

Sources: BloombergLaw, InsideHealthPolicy (first, second).

TRUMP CONTINUES PUSH FOR MFN CODIFICATION

The Trump administration is continuing to call on Congress to codify most favored nation (MFN) drug pricing policies in legislation.

Sources: InsideHealthPolicy, Pink Sheet, Stat News (first, second).

TRUMP PURSUES FURTHER MFN DEALS

CMS officials have reportedly stated that the administration expects to negotiate voluntary MFN deals with additional manufacturers. To date, 16 manufacturers have announced such deals.

Source: InsideHealthPolicy.

STAKEHOLDERS CONTINUE TO DISCUSS GLOBE AND GUARD PAYMENT MODELS, MFN IMPLICATIONS

Stakeholders continue to discuss the proposed Globe and Guard mandatory Medicare payment models, which we discussed in issue No. 62 of this digest, including broader implications of the MFN policy, such as in ex-US markets.

Sources: BloombergLaw, InsideHealthPolicy (first, second, third), Pink Sheet, PoliticoPro, Endpoints News.

CMS EXPLORES ENCOURAGING US DOMESTIC PRODUCTION, AS TRUMP THREATENS FURTHER TARIFF PROBE

CMS recently issued an advance notice of proposed rulemaking that aims to encourage domestic US production of essential medicines by incentivizing hospitals that participate in Medicare to “demonstrate their commitment to domestic procurement.”

At the same time, Trump administration officials have reportedly discussed plans for a new tariff investigation under Section 301 of the Trade Act of 1974, focusing on foreign drug pricing policies.

Sources: Pink Sheet, InsideHealthPolicy.

MEDICARE MAXIMUM FAIR PRICE IMPLEMENTATION

Pharmacies and other stakeholders continue to discuss the implementation of Maximum Fair Prices (MFPs) for the first set of drugs that were subject to forced negotiations under the IRA.  These MFPs took effect on January 1, 2026.

Sources: InsideHealthPolicy, 340B Report.

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

CIRCUIT COURT REMANDS FALSE CLAIMS ACT CASE RELATED TO PENNY PRICING

On March 17, 2026, the US Court of Appeals for the Ninth Circuit issued an opinion in a case brought by covered entities under the False Claims Act. The opinion reversed the dismissal of the action by the US District Court for the Central District of California and remanded the case for further action. The covered entity plaintiffs, purporting to be whistleblowers, claim that certain practices pharmaceutical manufacturers allegedly engaged in prior to 2019 — when a 340B regulation became effective that mandates penny pricing — violated the False Claims Act.

Sources: BioWorld , BloombergLaw ( first , second ), Law360 , Reuters , 340B Report.

HOUSE ENERGY & COMMERCE HEALTH SUBCOMMITTEE DISCUSSES 340B PROGRAM

The Health Subcommittee of the House Committee on Energy and Commerce held a hearing on March 18, 2026, that included a discussion of the 340B program.

Sources: Pink Sheet , 340B Report.

MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES

Stakeholders continue to discuss the policies implemented by two major pharmaceutical manufacturers that require covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. We discussed the policies in issue No. 67 of this digest.

Sources: BloombergLaw , 340B Report.

HRSA ISSUES FURTHER ADR DECISION

On March 9, 2026, the Health Resources & Services Administration (HRSA) updated its Administrative Dispute Resolution (ADR) website with the summary of a new ADR decision, bringing the total number of decisions issued under the revised ADR process to six. All of the actions 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.”

We discussed the prior ADR decisions in issues No. 47, No. 64, and No. 67 of this digest.

Source: 340B Report.

STAKEHOLDERS CONTINUE TO DISCUSS REBATE MODEL

Stakeholders continue to discuss implications of the 340B rebate model, after HRSA extended the deadline for responding to the related Request for Information until April 20, 2026.

Source: Law360.

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

Drug manufacturer litigation challenging the 340B laws enacted by various states continues. The Department of Health and Human Services (HHS) has filed amicus briefs in four cases, supporting the manufacturers’ position that the state contract pharmacy laws in question are preempted by federal 340B law.

Sources: Law 360 , BloombergLaw , 340B Report ( first , second , third ).

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 ( first , second ).

Medicare Part B

No developments to report.

Medicare Part D

No developments to report.

State Law Developments

No developments to report.

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