On August 3, 2026, the Health Resources and Services Administration (HRSA) published notice of its revised 340B Rebate Model Pilot Program, which would permit participating drug manufacturers to provide 340B discounts through post-dispense rebates rather than traditional upfront discounts for a…
On May 22, 2026, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) that would implement, and in several respects expand beyond, the Medicaid state directed payment (“SDP”) provisions enacted in the One Big Beautiful Bill (“OBBB”). If finalized, the…
This is the second article in a two-part series regarding Senate Enrolled Act (“SEA”) 282 (2026). Part 1 of the series can be found here: Compounding Oversight—New Regulations for Medical Spas and Compounding Pharmacies.
The second major substantive component in SEA 282 consists of new restrictions…
This is the first article in a two-part series regarding Senate Enrolled Act (“SEA”) 282 (2026)
One of two major substantive components enacted in SEA 282 is a new framework for regulating medical spas. States across the country have begun to pass and implement similar laws due to the rising…
"Legal issues intersect with non-legal issues in [the] 340B space,” says Brandon Shirley, a partner at Krieg DeVault, who teams up with Jason Prokopik, PharmD, Senior Manager & Pharmacy Consultant at Blue & Co., LLC to host this rapid-fire 340B review. Following the 340B Coalition Conference in San…
During the 2026 legislative session, the Indiana General Assembly passed a new law, Senate Enrolled Act (“SEA”) 90, requiring additional, separate informed consent for patients who are scheduled to receive certain exams. Effective July 1, 2026, the new law will be important for health care…
Beginning April 1, 2026, and every year thereafter, 340B hospital covered entities with an Indiana service address must file an annual 340B report with the Indiana Department of Health (“IDOH”) covering activity from the prior calendar year. The requirement applies to DSH hospitals, children’s…
The 340B Coalition Winter Conference wrapped up its annual conference last week in San Diego, California. A consistent message throughout the conference was that the 340B Program remains a critical lifeline for covered entities, but it is operating in an environment of heightened legal risk,…
House and Senate appropriations leaders have reached a bipartisan, bicameral agreement to keep the federal government funded through fiscal year 2026 while advancing several long-anticipated health care policy changes. The U.S. House of Representatives passed the funding package last week, and the…
On December 31, 2025, the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) announced that that they were issuing a Fourth Temporary Extension of the COVID-19 Telemedicine Flexibilities for the Prescription of Controlled Medication. This was done right in…
On January 7, 2026, the First Circuit Court of Appeals denied the federal government’s emergency motion to stay a district court injunction blocking implementation of HRSA’s 340B Rebate Model Pilot Program, leaving the longstanding system of upfront 340B discounts in place while the litigation…
340B Covered Entities are breathing a sigh of relief in light of a court ruling that halted the 340B rebate model from taking effect at the beginning of the year. On December 29, 2025, the U.S. District Court for the District of Maine issued a ruling preventing the Health Resources and Services…
