Inflation Reduction Act, Healthcare Reform, and General Developments
TRUMP RELEASES “THE GREAT HEALTHCARE PLAN”
On January 15, 2026, President Trump released a one-page health policy framework. Among other things, the document includes calls for lowering prescription drug prices “by codifying the Trump Administration’s Most-Favored-Nation deals,” noting that “voluntarily negotiated deals… will be grandfathered in.”
Sources: PoliticoPro (first, second, third, fourth), InsideHealthPolicy (first, second, third), BioWorld, StatNews, Scrip, 340B Report.
TWO ADDITIONAL MANUFACTURERS ANNOUNCE DRUG PRICING AGREEMENTS
On January 9, 2026, another major pharmaceutical manufacturer announced that it has entered into a drug pricing agreement with the Trump administration.
Sources: BloombergLaw, PinkSheet, InsideHealthPolicy, Scrip, BioWorld.
On January 12, 2026, an additional major pharmaceutical manufacturer announced its drug pricing agreement with the Trump administration.
Sources: BloombergLaw, InsideHealthPolicy, BioWorld.
This brings the total number of manufacturers that have entered into such agreements to 16. Like the prior agreements, which we discussed in issues No.56, No. 57, No. 59, and No. 62 of this digest, the new agreements remain confidential, and the manufacturers agreed to participate in the TrumpRx website.
IRA LEGAL CHALLENGES CONTINUE
Drug manufacturer litigation against the Inflation Reduction Act (IRA) drug-pricing negotiation program continues.
Sources: Law360.
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
MAJOR MANUFACTURER REQUIRES CLAIMS DATA FOR IN-HOUSE PHARMACY DISPENSES
On January 15, 2026, a major pharmaceutical manufacturer announced that, beginning February 1, 2026, it will require covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies.
Source: 340B Report.
COVERED ENTITIES QUESTION OBLIGATION TO COMPLETE CMS SURVEY
In the 2026 Outpatient Prospective Payment System (OPPS) final rule, which we discussed in issue No. 60 of this digest, the Centers for Medicare & Medicaid Services (CMS) announced that the agency will conduct an OPPS hospital drug acquisition cost survey in early 2026 with the intent to use the results to potentially modify the reimbursement amount for drugs purchased under the 340B program.
On January 12, 2026, hospital trade groups sent a letter to CMS, taking issue with a statement on the CMS website that “hospitals paid under the OPPS between July 1, 2024, and June 30, 2025… are to participate in the survey by reporting their drug acquisition costs.”
The letter claims that “absent any statutory consequences for not completing the survey, it is wrong to tell hospitals and health systems that they ‘are to’ complete it.”
Source: 340B Report.
HRSA ISSUES THREE FURTHER ADR DECISIONS
On January 20, 2026, the Health Resources & Services Administration (HRSA) updated its Administrative Dispute Resolution (ADR) website with summaries of three new ADR decisions, bringing the total number of ADR decisions issued under the revised ADR process to four. The decisions involve three different manufacturers and the allegation of “overcharges.” The HRSA website indicates that in all three cases, the decision was “there is no overcharge violation,” and that for one decision, “reconsideration was requested by petitioner,” and that HRSA affirmed the original decision.
We discussed the first ADR decision in issue No. 47 of this digest.
Source: 340B Report.
REBATE PILOT LITIGATION AND DEVELOPMENTS
Litigation regarding the 340B rebate model continues at the appellate level.
Sources: Law360 (first, second), BloombergLaw (first, second), InsideHealthPolicy (first, second), PinkSheet, StatNews, 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.
Sources: 340B Report (first, second, third).
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Drug manufacturer litigation challenging the 340B laws enacted by various states continues.
Sources: BloombergLaw, 340B Report (first, second, third, fourth).
Medicare Part B
No developments to report.
Medicare Part D
No developments to report.
State Law Developments
PDAB BILL REINTRODUCED IN VIRGINIA
A revised bill to establish a Prescription Drug Affordability Board (PDAB) has been reintroduced in Virginia. The original bill was vetoed by former Republican Governor Glenn Youngkin. Commenters expect that the revised bill will have a greater chance of enactment under current Democratic Governor Abigail Spanberger.
Source: InsideHealthPolicy.
