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 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.…
This article is the 2nd in our series on H.R. 1 (known as the One Big Beautiful Bill or “OBBB”), in which we select specific areas of Medicaid impacted by the OBBB and drill down into the full weight and effect of not only the OBBB, but also recent Federal rules, guidance, and policies on these…
On July 4, 2025, President Trump signed into law H.R. 1, known as the One Big Beautiful Bill (“OBBB”). While the OBBB is massive and the sections that address Medicaid topics are vast, this series of articles will select specific areas of Medicaid impacted by the Bill and drill down into the full…
Indiana recently enacted Senate Enrolled Act 140 (SEA 140), a significant overhaul of pharmacy reimbursement practices intended to greatly impact pharmacy benefit manager (“PBM”) vertical integration. SEA 140 introduces multiple changes to how pharmacy benefits are managed and delivered in Indiana,…
In a significant development for healthcare employment law, Indiana’s Senate Enrolled Act No. 475 (“SEA 475”) broadens existing restrictions on physician noncompete agreements to include nearly all physician types—not just primary care providers. Building on Senate Enrolled Act No. 7, which took…
After months of back and forth, with the fate of tele-prescribing in limbo, the Department of Health and Human Services (“HHS”) signaled its continued commitment to some COVID-19 era telemedicine expansions by the recent issuance of two final rules: (1) Expansion of Buprenorphine Treatment via…
A recent advisory opinion from the Office of Inspector General (“OIG”) provides welcome clarity and encouragement to community health centers looking for ways to incentivize patient access to care. Advisory Opinion 25-02 continues the OIG’s favorable support of strategies designed to connect…
