Healthcare & Life Sciences: Drug Pricing Digest — Number 75

Inflation Reduction Act, Healthcare Reform, and General Developments  

GLOBE AND GUARD FINAL REGULATIONS UNDER OMB REVIEW

The Globe and Guard final regulations have been submitted to the Office of Management and Budget (OMB). The OMB website gives their status as “pending review.” OMB received the Globe final regulation on June 26, 2026, and the Guard final regulation on June 15, 2026. As discussed in issue No. 62 of this digest, the Globe payment model has a proposed start date of October 1, 2026, while the Guard payment model has a proposed start date of January 1, 2027.

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 and how MFN prices could impact Maximum Fair Price (MFP) negotiations.

Sources: PinkSheet, PoliticoPro.

In a related development, the US has initiated a tariff investigation of Germany over alleged underpayment for innovative pharmaceutical products.

Sources: Law360, InsideHealthPolicy, BloombergLaw (first, second, third), PoliticoPro (first, second), PinkSheet, Reuters.

CONGRESSIONAL DRUG PRICING INITIATIVES

Democratic members of the Senate Finance Committee are soliciting input on drug pricing initiatives that they intend to advance should the Democratic Party take control of Congress following the midterms.

Sources: InsideHealthPolicy, PinkSheet.

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

LAWMAKERS IN CONGRESS CONSIDER 340B REFORM

There appears to be a renewed focus on 340B reform among lawmakers in Congress, including some measures with bipartisan support.  Senator Bill Cassidy, M.D., chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, published a 340B legislation discussion draft and requested comments by August 28, 2026.  Senator Cassidy published a report last year calling for 340B reform, which we discussed in issue No. 45 of this digest.

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

REBATE MODEL DEVELOPMENTS

Various stakeholders have reportedly met or sought meetings with the Health Resources & Services Administration (HRSA) to discuss the upcoming 340B rebate model.

Sources: PinkSheet; 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: InsideHealthPolicy, StatNews, 340B Report (first, second, third).

LITIGATION REGARDING “PATIENT” DEFINITION CONTINUES

As discussed in issue No. 70 of this digest, 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. That litigation is proceeding.

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

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

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

Source: 340B Report.

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

CMS RESPONDS TO COMMENTS REGARDING BONA FIDE SERVICE FEE REQUIREMENTS

On June 16, 2026, the Centers for Medicare & Medicaid Services (CMS) published responses to comments received pursuant to an information collection request under the Paperwork Reduction Act. As we discussed in issue No. 59 of this digest, CMS is seeking to implement new and enhanced standards regarding bona fide service fees (BFSF). The new requirements were scheduled to become effective with Average Sales Price (ASP) submissions following Q1 of this year, but CMS delayed the effectiveness until the Q2 reporting deadline.

CMS is also holding a webinar on July 7, 2026, regarding the requirements.

Medicare Part D

CMS DETAILS PART D INFLATION REBATE DEDUPLICATION

On June 18, 2026, CMS issued a companion guide regarding the implementation of the Part D claims data repository. The repository is intended to support the exclusion of 340B-purchased units from consideration in Medicare Part D inflation rebates.

Source: 340B Report.

State Law Developments  

FDA APPROVES COLORADO DRUG IMPORTATION PLAN

The Food & Drug Administration (FDA) authorized a Colorado plan to import drugs from Canada, marking only the second approval of such a state importation plan, after Florida. As we discussed in issue No. 65 of this digest, the Florida importation plan remains on hold.

Sources: PoliticoPro, StatNews.

ARKANSAS LIMITED DISTRIBUTION LAW CHALLENGE CONTINUES

As we discussed in issue No. 46 of this digest, an Arkansas statute that will become effective September 1, 2026, prohibits pharmaceutical manufacturers from restricting or limiting the distribution of prescription medications to limited networks of out-of-state pharmacies, particularly for drugs paid for by state and public health benefit plans. Legal challenges to this statute continue, with an additional manufacturer filing suit.

Source: BloombergLaw.

OREGON DRUG PRICE TRANSPARENCY LAW CHALLENGE CONTINUES

The Supreme Court is considering whether to hear a lawsuit challenging Oregon’s drug price transparency law.

Source: Law360.