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Government Shutdown Does Not Slow HRSA’s 340B Rebate Pilot Program

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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Decoding Medicaid Changes in the “Big Beautiful Bill,” with Meghan Linvill McNab

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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FTC Sends Warning Letters to Health Care Employers in Latest Noncompete Development

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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Post-Issuance Compliance: Safeguarding Your Hospital’s Access to Low-Cost Capital

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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Current IRS Audit Activity and Compliance Overview of IRC §501(r) Requirements for Indiana Licensed Hospitals

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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Government Shutdown and Reversion of Medicare Telehealth Coverage

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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Shifting the 340B Model: Rebates on the Horizon

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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One Big Beautiful Bill, Part II

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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One Big Beautiful Bill, But More

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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With SEA 140, Indiana Joins Other States in Limiting Pharmacy Benefit Manager Vertical Integration

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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The 340B Drug Pricing Playbook, with Brandon Shirley

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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The End of Physician Noncompetes in Indiana Hospitals: A Look into Indiana Senate Enrolled Act No. 475 

By: Marsha Jean-Baptiste and Scott S. Morrisson on April 28, 2025

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…

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