Health Care
By: Brandon W. Shirley
on October 31, 2025
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…
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October 13, 2025
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…
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By: Thomas M. Abrams and Stephanie T. Eckerle
on October 10, 2025
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…
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By: Kendall A. Schnurpel and Scott C. Frissell
on October 9, 2025
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,…
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By: Kendall A. Schnurpel
on October 8, 2025
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…
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By: Meghan M. Linvill McNab and Brandon W. Shirley
on October 1, 2025
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…
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By: Brandon W. Shirley and Madison Hartman Harada
on August 21, 2025
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.…
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By: Meghan M. Linvill McNab, Grant M. Achenbach, and Brandon W. Shirley
on August 12, 2025
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…
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By: Meghan M. Linvill McNab and Grant M. Achenbach
on July 28, 2025
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…
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By: Brandon W. Shirley, Madison Hartman Harada, and Thomas M. Abrams
on June 25, 2025
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,…
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By: Brandon W. Shirley
on May 1, 2025
Clients have asked Brandon Shirley about acquiring a health entity that would qualify for the 340B Drug Pricing Program because, as he explains, “it does enable substantial benefits if you can get into it.” But the program is also complex. A healthcare Senior Associate at Krieg DeVault, Brandon…
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