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…
In 2024, CMS issued regulations implementing certain requirements in the Affordable Care Act regarding the disclosure of ownership, managerial and other information for Medicare and Medicaid participating nursing facilities (“SNFs”). The new requirements included robust reporting requirements,…
A recent lawsuit challenging the Health Resources and Services Administration's (“HRSA”) 340B Rebate pilot program is giving 340B covered entities even more uncertainty as they plan for January 1, 2026. The lawsuit, filed in a federal district court in Maine, is asking the federal court to…
The Indiana Consumer Data Protection Act (INCDPA), effective January 1, 2026, introduces new requirements for businesses that handle personal data of Indiana residents. If your company operates in Indiana or targets Indiana consumers, now is the time to ensure compliance with the INCDPA.
Despite the ongoing government shutdown, the Health Resources and Services Administration (“HRSA”) has approved eight drug manufacturer plans for participation in its 340B rebate pilot program, which is set to launch on January 1, 2026. Under this pilot model, 340B covered entities must purchase…
The Trump administration's "One Big Beautiful Bill" is poised to significantly impact healthcare providers by changing Medicaid financing and reimbursement. Meghan Linvill McNab, a partner at Krieg DeVault who focuses on Medicare and Medicaid reimbursement, describes key contours of the new…
The Federal Trade Commission (“FTC”) sent letters on September 10 prompting many large health care employers and staffing firms to review their noncompete agreements (“noncompetes”) for compliance with Section 5 of the FTC Act, 15 U.S.C. § 45, which empowers the FTC to investigate and prevent…
