Newsletter
Healthcare & Life Sciences: Drug Pricing Digest — Number 74
June 15, 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 ISSUES PROPOSED IRA NEGOTIATION RULE
On June 12, 2026, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule regarding the Medicare drug price negotiation program established by the Inflation Reduction Act (IRA). The IRA permitted CMS to implement the program through guidance for the initial three years, and CMS issued guidance for 2026, 2027, and 2028. CMS “anticipates publishing the final version of this rule in Fall 2026,” which would then first apply, prospectively, in 2029. In the regulation, CMS proposes “to codify policies established in final guidance … with limited modification.”
The proposed rule is scheduled to be published in the Federal Register on June 16, 2026, in which case the comment period will end on August 17, 2026.
Source: InsideHealthPolicy
APPLICATION PERIOD CLOSES
The manufacturer application period for the voluntary Generous (GENErating cost Reductions fOr U.S. Medicaid) payment model closed on June 11, 2026. CMS reportedly stated that it had received a “significant” number of applications.
Source: PinkSheet.
TRUMPRX DRUG LIST EXPANDS
On June 5, 2026, President Trump announced that 160 further drugs had been added to the TrumpRx portal.
Source: The Hill.
STAKEHOLDERS CONTINUE TO DISCUSS MFN IMPLICATIONS
Stakeholders continue to discuss the implications of the most favored nation (MFN) drug pricing policy, including for ex-US markets.
Dr. Mehmet Oz, the Administrator of CMS, confirmed that the expiration of the 17 MFN agreements that major manufacturers have entered into is timed to coincide with the end of the term of the current administration. He also again urged Congress to enact the MFN deals through legislation to make them permanent.
Sources: InsideHealthPolicy (first, second), PinkSheet (first, second), PoliticoPro, StatNews.
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
HRSA PUBLISHES REBATE PILOT PAPERWORK REDUCTION ACT NOTICE
On June 12, 2026, the Health Resources & Services Administration (HRSA) published a notice in the Federal Register regarding the stakeholder burdens for submitting data and other information in connection with the future 340B rebate pilot. The notice explains that the scope of the pilot will be limited to manufacturers with “Medicare Drug Price Negotiation Program Agreements” for initial price applicability years 2026 and 2027, and it assumes that 11 manufacturers will submit applications. The notice also states that “approved manufacturers will be required to submit data to the 340B Prime Vendor on a monthly basis.”
Source: 340B Report.
MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES
As discussed in issue No. 64 of this digest, a growing number of 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 evolving manufacturer policies.
Sources: StatNews, InsideHealthPolicy, BloombergLaw, Law360, Pink Sheet, 340B Report (first, second, third, fourth).
DISTRICT COURT OPINION ON GPO PROHIBITION POLICY NOT APPEALED
As discussed in issue No. 69 of this digest, on April 1, 2026, the US District Court for the District of Columbia issued an opinion striking down HRSA guidance that addressed the group purchasing organization (GPO) prohibition. The deadline for appeal has passed without an appeal having been filed.
Source: 340B Report (first, second).
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Drug manufacturer litigation challenging the 340B laws enacted by various states continues.
Sources: Law360 (first, second, third, fourth, fifth, sixth), BloombergLaw (first, second), 340B Report (first, second, third, fourth, fifth, sixth).
ADDITIONAL STATES ADOPT OR CONSIDER 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
MINNESOTA AND ILLINOIS CONSIDER PDAB LEGISLATION
The Minnesota and Illinois legislatures are considering bills that would establish Prescription Drug Affordability Boards (PDABs) in those states.
Source: Law360.
Endnotes
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