Newsletter
Healthcare & Life Sciences: Drug Pricing Digest — Number 65
February 9, 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
TRUMPRX GOES LIVE
On February 5, 2026, President Trump announced the release of the TrumpRx.gov website. Key aspects of TrumpRx are described on the site in the form of frequently asked questions:
- “TrumpRx is a website that lists discounted drug prices from manufacturers that have agreed to Most Favored Nation (MFN) pricing. Americans can use TrumpRx to purchase drugs in cash (outside of their insurance). These drugs can be obtained at participating pharmacies using coupon cards displayed on TrumpRx or directly through manufacturers’ websites.”
- “Some drugs are available through coupon offers displayed on TrumpRx. These coupon programs can be used at local pharmacies on a nationwide basis, with the exception of certain specialty drugs. Other drugs are only available at discounted prices through the manufacturer's website.”
- “TrumpRx displays discounted drug pricing offers but does not sell or dispense drugs. Patients can access the drugs through the instructions shown for each individual drug offer.”
- “At this time, TrumpRx discounted pricing is only available for cash-paying patients.”
Participation in TrumpRx was reportedly a term in the drug pricing agreements that 16 manufacturers have entered into, and various manufacturers have announced direct-to-consumer distribution programs in recent months.
Sources: Bloomberg Law (first, second), InsideHealthPolicy (first, second), Pink Sheet, PoliticoPro, StatNews (first, second).
Register here for the upcoming Latham webcast “DOJ Enforcement Priorities: What Pharmaceutical Companies Need to Know,” which will take place on February 12, 2026.
HHS ISSUES GUIDANCE REGARDING DIRECT-TO-CONSUMER PROGRAMS
On January 27, 2026, the Department of Health and Human Services (HHS) issued a Special Advisory Bulletin addressing “the application of the Federal anti-kickback statute to a pharmaceutical manufacturer’s offer and sale of prescription drugs through a [direct-to-consumer] program to cash-paying patients, including Federal health care program enrollees.” The bulletin makes specific reference to TrumpRx, and in an accompanying press release, HHS states that the “new guidance [is] clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients — including Medicare and Medicaid enrollees — in a manner that’s low risk under the federal anti-kickback statute, so long as key safeguards are met.”
Sources: BloombergLaw, InsideHealthPolicy, Pink Sheet, BioWorld, 340B Report.
CMS PUBLISHES IRA DRUG SELECTION FOR 2028
On January 27, 2026, the Centers for Medicare & Medicaid Services (CMS) published the third set of drugs that will be subject to negotiation under the Inflation Reduction Act (IRA). Maximum fair prices for these 15 drugs would go into effect in 2028. For the first time, CMS also published the list of 50 negotiation-eligible drugs.
Sources: BioWorld (first, second), Pink Sheet (first, second), BloombergLaw, PoliticoPro, StatNews, 340B Report.
As part of the announcement, CMS identified, for the first time, a previously selected drug that will be subject to renegotiation.
Source: InsideHealthPolicy.
TRUMP SEEKS TO IMPLEMENT MFN POLICY THROUGH CONGRESS
The Trump health framework, which we discussed in issue No. 64 of this digest, calls on Congress to codify the MFN deals that manufacturers have entered into with the government. The administration is reportedly engaging with lawmakers to build support for Congressional action.
Source: StatNews.
IRA LEGAL CHALLENGES CONTINUE
Drug manufacturer litigation against the IRA drug-pricing negotiation program continues.
Source: InsideHealthPolicy.
Medicaid Drug Rebate Program (MDRP)
No developments to report.
340B Program
HHS INITIATES RULEMAKING AFTER WITHDRAWING THE REBATE PILOT
On February 6, 2026, HHS initiated formal rulemaking regarding the rebate model by submitting a proposed regulation to the Office of Management and Budget (OMB). The regulation is titled “340B Drug Pricing Program Manufacturer Rebate Models.”
This development occurred shortly after HHS agreed to withdraw the current rebate model in response to a legal challenge brought by hospital groups. The litigation had already halted implementation of the current rebate model, which was originally due to commence on January 1, 2026.
Sources: BloombergLaw, 340B Report (first, second).
MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES
As we discussed in issue No. 64 of this digest, as of February 1, 2026, a major pharmaceutical manufacturer is requiring covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. Stakeholders are reacting to the policy.
Sources: StatNews, InsideHealthPolicy, PoliticoPro, 340B Report (first, second).
LITIGATION REGARDING CHILD SITE REGISTRATION REQUIREMENTS CONTINUES
In response to the COVID-19 pandemic, the Health Resources & Services Administration (HRSA) waived certain registration requirements for covered entity child sites and then withdrew the waiver in 2023. Litigation brought by covered entities challenging that withdrawal 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.
Source: 340B Report (first, second, third, fourth).
MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE
Drug manufacturer litigation challenging the 340B laws enacted by various states continue.
Source: 340B Report (first, second, third, fourth).
Medicare Part B
No developments to report.
Medicare Part D
No developments to report.
State Law Developments
CONGRESSIONAL RESEARCH SERVICE ISSUES REPORT ON PDABS
On January 27, 2026, the Congressional Research Service (CRS) issued a report regarding state prescription drug affordability boards (PDABs).
Source: InsideHealthPolicy.
DRUG DISTRIBUTOR CHALLENGE TO CONNECTICUT PRICE CAP LAW CONTINUES
Litigation challenging Connecticut’s price cap law continues, with the Second Circuit rejecting a bid to halt enforcement of the law. We discussed this litigation in issue No. 57 of the digest.
Source: Law360.
FLORIDA DRUG IMPORTATION PLAN REMAINS ON HOLD
Florida’s plan to import drugs from Canada, the only such plan authorized by the Food and Drug Administration (FDA) to date, remains on hold. Reportedly, a key reason for the delay is opposition from the Canadian government and Canada’s pharmaceutical industry.
Source: PoliticoPro.
Endnotes
This publication is produced by Latham & Watkins as a news reporting service to clients and other friends. The information contained in this publication should not be construed as legal advice. Should further analysis or explanation of the subject matter be required, please contact the lawyer with whom you normally consult. The invitation to contact is not a solicitation for legal work under the laws of any jurisdiction in which Latham lawyers are not authorized to practice. See our Attorney Advertising and Terms of Use.