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…
Tax-exempt healthcare organizations rely heavily on tax-exempt bond financing to fund facilities and equipment. While these financings provide critical access to lower-cost capital, borrowers must carefully observe post-issuance compliance requirements. Failure to comply can lead to IRS penalties,…
Current IRS Audit Activity
In March 2024, in response to renewed calls from Congress for more robust oversight of tax-exempt hospitals, the Internal Revenue Service (“IRS”) Tax-Exempt and Government Entities (TE/GE) Division announced a new compliance strategy on its Compliance Program and…
In response to the October 1, 2025 shutdown of the federal government, the Centers for Medicare & Medicaid Services (“CMS”) issued an MLN Connects Special Edition email providing an Update on Medicare Operations: Telehealth, Claims Processing, and Medicare Administrative Contractors Status During…
After months of litigation and promises to issue a proposal, the Health Resources and Services Administration (“HRSA”) has released long-awaited guidance on a new 340B pilot program. While the HRSA guidance provides clarity, it does not give manufacturers or 340B covered entities much to celebrate.…
