Inflation Reduction Act, Healthcare Reform, and General Developments
“Most Favored Nation” Drug Pricing Policy Discussions Continue
Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a recent press release by the Department of Health & Human Services (HHS) would be forthcoming. The MFN pricing policy was discussed in issues No. 46 and No. 47 of this digest. Reportedly, an HHS spokesperson stated that HHS expects pharmaceutical manufacturers to “negotiate” US prices based on MFN prices. Further, HHS reportedly indicated that the MFN-priced drugs should be made available directly to patients through direct-to-consumer distribution models. Meanwhile, three major pharmaceutical manufacturers are reportedly engaged in ongoing policy discussions with the Trump administration, but no further details regarding the meetings have emerged. There is also ongoing interest in MFN pricing in Congress, with Bill Cassidy, Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, reportedly preparing legislation that includes international reference pricing.
Sources: InsideHealthPolicy (first, second), StatNews (first, second, third).
Stakeholders continue to discuss the possible impacts that an MFN pricing policy could have on the US pharmaceutical sector. A leading trade group has estimated that an MFN pricing policy would cost pharmaceutical manufacturers $1 trillion over the next 10 years. Stakeholders are also concerned that an MFN policy could financially harm Medicare patients, state Medicaid programs, hospitals, and providers.
Sources: BloombergLaw, Bloomberg, Law360, MSN.
There are also concerns about how imposing an MFN pricing policy in the US could impact international markets.
Source: Pink Sheet (first, second, third).
IRA IMPLEMENTATION CONTINUES WITH PUBLICATION OF MTF USER GUIDE
The Centers for Medicare & Medicaid Services (CMS) updated the website devoted to the Medicare Transaction Facilitator (MTF). The MTF is an essential component of how CMS guidance seeks to require manufacturers to make the maximum fair price available pursuant to the Inflation Reduction Act (IRA). CMS has published an MTF user guide and a video regarding the MTF enrollment process for manufacturers.
LAWSUITS CHALLENGING THE IRA CONTINUE
Drug manufacturer litigation against the drug pricing negotiation program established under the IRA continues. The US Court of Appeals for the Sixth Circuit held oral argument in one case.
Source: Law360.
CONTINUED FOCUS ON THE CGT ACCESS MODEL
The Cell and Gene Therapy (CGT) Access Model, which we discussed in issues No. 43 and No. 45 of this digest, was the focus of recent remarks by government officials. They stated that they view the CGT access model, which has as its initial focus the treatment of sickle cell disease, as a test case for expanding access to other cell and gene therapy treatments.
Source: InsideHealthPolicy.
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
REBATE MODEL GUIDANCE AT OMB; LITIGATION CONTINUES
The Health Resources and Services Administration (HRSA) has submitted guidance regarding 340B rebate models to the Office of Management and Budget (OMB). The OMB website lists the document, titled “340B Rebate Guidance,” with a “received date” of June 1, 2025.
Sources: InsideHealthPolicy, 340B Report (first, second).
The litigation regarding 340B rebate models continues with certain drug manufacturers asking the court to expedite their appeal of the ruling that we discussed in issue No. 46 of this digest.
Source: 340B Report.
TRUMP BUDGET PROPOSES TO MOVE 340B PROGRAM OVERSIGHT TO CMS
In the budget proposal released May 30, 2025, President Trump proposed to move oversight of the 340B program from HRSA to CMS. The proposal would shift the Office of Pharmacy Affairs (OPA) from HRSA to CMS.
Sources: InsideHealthPolicy, 340B Report (first, second, third).
FIRST ADR PANEL DECISION ISSUED UNDER NEW REGULATION
HRSA replaced its ADR regulation with a revised regulation that took effect June 18, 2024. The first decision under the new regulation has now been issued, but the HRSA website, under the heading “Final Agency Decisions,” shows only limited detail.
LITIGATION REGARDING GPO PROHIBITION CONTINUES
As discussed in issues No. 46 and No. 47 of this digest, litigation filed on November 1, 2024, by a group purchasing organization (GPO) challenging how HRSA has implemented the GPO prohibition remains ongoing.
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.
Sources: 340B Report (first, second, third, fourth, fifth, sixth, seventh).
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Lawsuits challenging the 340B laws enacted by various states continue.
Sources: 340B Report (first, second, third).
Medicare Part B
No developments to report.
Medicare Part D
No developments to report.
State Law Developments
ARKANSAS PHARMACY OWNERSHIP LAW CHALLENGED IN COURT
An Arkansas law that seeks to regulate the ownership of pharmacies has been challenged in court.
Sources: New York Times, BloombergLaw, Pink Sheet.
DISCUSSION OF PDABS CONTINUES
At a recent industry conference, the executive director of Maryland’s Prescription Drug Affordability Board (PDAB) stated that an upper limit is just one of multiple policies that the PDAB would consider.
Source: Pink Sheet.
MINNESOTA DRUG PRICE TRANSPARENCY LAW LITIGATION CONTINUES
The US Court of Appeals for the Eighth Circuit left in place a preliminary injunction that prevents Minnesota from enforcing its drug price transparency law.
Sources: Bloomberg Law, Law 360, StatNews.
