340B Rebate Model Pilot Program

Federal Health Policy Update for January 15

The following is the latest health policy news from the federal government for January 9-15.  Some of the language used below is taken directly from government documents. The White House The White House has unveiled “The Great Healthcare Plan,” which it describes as “… a broad healthcare initiative that will slash prescription drug prices, reduce insurance premiums, hold big insurance companies accountable, and maximize price transparency in the American healthcare system.”  The major components of the plan, and the key steps for each, are: lower drug prices slash prescription drug prices allow more over-the-counter medicines lower insurance premiums send the [...]

340B Pilot in Limbo After Court Acts – Twice

The future of the Department of Health and Human Services’ 340B Rebate Model Pilot Program is in jeopardy after two setbacks in federal court. A federal court issued a preliminary injunction preventing HHS from implementing the limited model, which was to test replacing the discounts that pharmaceutical companies provide to eligible providers participating in the section 340B prescription drug program when they purchase prescription drugs with post-purchase rebates for products they have already purchased. In issuing its injunction, the court wrote that … the Administrative Procedure Act’s (APA) arbitrary and capricious standard imposes vanishingly minimal requirements that a federal agency [...]

2026-01-13T16:50:39-05:00January 15, 2026|340b|

Federal Health Policy Update for November 6

The following is the latest health policy news from the federal government for October 31 – November 6.  Some of the language used below is taken directly from government documents. Please note that most HHS and other health care-related agencies have indicated that they will not be announcing new policies, publishing proposed regulations, or updating their web sites during the current federal government shutdown; some are engaging in limited exceptions. Congress and the Shutdown Senate Majority Leader John Thune (R-SD) today told his caucus that he plans to bring the House-passed CR to yet another vote in the Senate on [...]

HHS Sets 340B Rebate Model

The Department of Health and Human Services’ Health Resources and Services Administration has approved eight plans from pharmaceutical companies to participate in its 340B Rebate Model Pilot Program. Currently, eligible 340B providers receive discounts when they purchase covered drugs but under the rebate model, covered entities continue to make purchases through their 340B wholesaler and will seek rebates from the pharmaceutical companies for the ten affected drugs dispensed to 340B-eligible patients after a purchase is made. Providers argue that the new approach creates a new, significant administrative burden for them and could affect their cash flow while pharmaceutical companies maintain [...]

2025-11-05T12:45:32-05:00November 6, 2025|340b|

Federal Health Policy Update for September 18

The following is the latest health policy news from the federal government for September 12-18.  Some of the language used below is taken directly from government documents. Congress Funding for the federal government expires on September 30.  Members of Congress have not yet coalesced around a plan to fund the federal government when the new federal fiscal year begins on October 1, with House Republican and Democratic leaders releasing competing legislative texts for a short-term continuing resolution (CR). House Republicans have proposed a CR to last through November 21 with very few anomalies, or policy changes, outside of regular spending.  [...]

Providers Objecting to New HHS Programs

Health care providers are expressing concern about two new programs recently announced by the Department of Health and Human Services:  the Centers for Medicare & Medicaid Services’ Medicare WISeR (Wasteful and Inappropriate Service Reduction) Model and HHS’s 340B Rebate Model Pilot Program. The WISeR model, to be tested in six states, will require doctors to obtain prior authorization before providing a limited group of services.  That prior authorization is expected to be delivered primarily through the use of AI.  Participation will be mandatory in the states involved in the program and providers are concerned that it will increase their administrative [...]

Federal Health Policy Update for August 7

The following is the latest health policy news from the federal government for August 2-7.  Some of the language used below is taken directly from government documents. Congress The House and Senate are both in recess.   When Congress returns in September its top priority will be funding the federal government before the fiscal year ends on September 30, likely requiring a continuing resolution to avoid a shutdown.  Several major health care programs and extenders are set to expire at the end of the fiscal year, including Medicaid disproportionate share (Medicaid DSH) allotments, telehealth flexibilities, the Acute Hospital Care at Home [...]

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