Healthcare & Life Sciences: Drug Pricing Digest — Number 77

Inflation Reduction Act, Healthcare Reform, and General Developments

CMS RELEASES PROPOSED 2027 PHYSICIAN FEE SCHEDULE

The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2027 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2026. The comment period ends on September 14, 2026.
Among other things, the PFS proposed rule would “require Medicare providers and suppliers that are 340B covered entities to submit Part D 340B claims data to the Medicare Part D Claims Data 340B Repository… beginning with claims with a date of service on or after January 1, 2027.” This data submission is currently voluntary, and CMS states that the goal of mandating the data submission is to improve the agency’s “ability to accurately assess potential future use of the 340B repository to exclude 340B units from [manufacturer] Part D [inflation] rebate calculations.”

The proposed rule would also make various changes to the Part D inflation rebate program, such as introducing a definition of the term “first marketed date.”

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

CMS ISUSES PROPOSED GUIDANCE FOR IPAY 2028 MFP IMPLEMENTATION

On July 16, 2026, CMS published draft guidance addressing manufacturer effectuation of the Maximum Fair Price (MFP) in 2028 under the Medicare Drug Price Negotiation Program. The guidance was accompanied by a fact sheet. CMS “is voluntarily soliciting comments on the topics in this draft guidance,” with comments due by September 18, 2026. 

As discussed in issue No. 56 of this digest, CMS previously issued final guidance for Initial Price Applicability Year (IPAY) 2028, which was largely limited to Part D drugs. The new proposed guidance “does not intend to materially change” the published policy, but “expands upon these policies to incorporate processes for the flow of data and payment for selected drugs payable under Part B in 2028.”

Source: BloombergLaw.

TRUMP THREATENS TARIFFS ON GENERIC DRUGS

In a social media post on July 21, 2026, President Trump stated that “effective August 1st, 2026, all Generic Drugs being brought into the United States will continue to have a TARIFF of ZERO PERCENT for a two year period of time, after which the TARIFF will be raised to 100% for a one year period of time, and 200% thereafter.”

Sources: Law360, PoliticoPro (first, second), BloombergLaw (first, second, third), InsideHealthPolicy (first, second, third), PinkSheet, Scrip, Generics Bulletin (first, second), BioWorld.

STAKEHOLDERS CONTINUE TO DISCUSS MFN IMPLICATIONS

Stakeholders continue to discuss the implications of the most favored nation (MFN) drug pricing policy, including with respect to ex-US markets. 

Sources: PinkSheet (first, second, third), PoliticoPro (first, second).

STAKEHOLDERS CONTINUE TO DISCUSS GLOBE AND GUARD

As discussed in issue No. 75 of this digest, the Globe and Guard final regulations are currently under review by the Office of Management and Budget (OMB). Stakeholders continue to discuss the possible impact of these regulations.

Source: StatNews.

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

340B COALITION SUMMER CONFERENCE CONCLUDES IN WASHINGTON 

The annual 340B Coalition Summer Conference concluded in Washington, D.C. on July 15, 2026. It was noteworthy that there were no speakers from the Health Resources & Services Administration (HRSA), while two senior CMS representatives presented.

Source: 340B Report (first, second).

REBATE MODEL DEVELOPMENTS

As discussed in issue No. 73 of this digest, the HRSA 340B rebate proposal remains under review with OMB. Additional stakeholders have reportedly met with the administration regarding the rebate proposal. 

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

CIRCUIT COURT AFFIRMS HRSA REBATE MODEL WIN

As discussed in issue No. 46 of this digest, on May 16, 2025, the US District Court for the District of Columbia issued an opinion stating that HRSA “did not act contrary to law by requiring [manufacturers] to obtain approval before implementing their proposed rebate models.” In an opinion issued on July 21, 2026, the US Court of Appeals for the D.C. Circuit affirmed the district court opinion, holding that “Section 340B requires the Secretary to ‘provide’ for rebates before manufacturers can permissibly implement them” and noting that the statute “does not ‘delegate[] discretionary authority’ to the agency in this respect.”

Sources: BloombergLaw, Law360, PoliticoPro, 340B Report.

ARKANSAS INITIATES ENFORCEMENT OF ITS 340B STATUTE

The Arkansas attorney general has filed litigation against multiple pharmaceutical manufacturers alleging violations of the Arkansas 340B contract pharmacy statute.

Sources: BloombergLaw, 340B Report.

LITIGATION REGARDING “PATIENT” DEFINITION CONTINUES

Litigation brought by a major pharmaceutical manufacturer to challenge the definition of “patient” under the 340B program is proceeding. We discussed the litigation in issue No. 70 of this digest.

Sources: InsideHealthPolicy, 340B Report.

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

Drug manufacturer litigation challenging the 340B laws enacted by various states continues.

Source: 340B Report.

Medicare Part B

No developments to report.

Medicare Part D

No developments to report.

State Law Developments

COLORADO PDAB LEGAL CHALLENGE 

As discussed in issue No. 76 of this digest, the US District Court for the District of Colorado issued a preliminary injunction stopping the Colorado Prescription Drug Affordability Board’s (PDAB) upper payment limit (UPL) from going into effect. Stakeholders continue to discuss the possible implications of the ongoing legal challenge. 

Source: Law360.

Other states are continuing to consider PDAB laws.

Source: InsideHealthPolicy.