News & Analysis as of

Department of Health and Human Services (HHS) Medicaid

Polsinelli

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

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Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 8, July 2025

Welcome to our eighth issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the rural health "slush fund" included in the Federal budget bill, the effect of Medicaid...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

King & Spalding

The Fourth Circuit Rejects a Non-Delegation Doctrine Challenge to the Anti-Kickback Statute

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On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more

Alston & Bird

Health Care Week in Review | CMS Finalizes FY 2026 Medicare Payment Rules, Senate Appropriations Committee Advances Labor-HHS...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

Holland & Knight LLP

Holland & Knight Health Dose: July 29, 2025

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This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...more

McDermott+

McDermott+ Check-Up – July 25, 2025

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CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more

Mintz - Health Care Viewpoints

Challenges Facing Managed Care Organizations under the Current Administration

Within the first six months of President Trump’s second term, his Administration and the GOP have already implemented significant policies that are reshaping health care in the United States. Through his Administration’s...more

McDermott+

McDermott+ Check-Up – July 11, 2025

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THIS WEEK’S DOSE - - President Trumps signs OBBBA into law. After months of debate, Congress passed and President Trump signed H.R. 1, the One Big Beautiful Bill Act (OBBBA), into law on July 4, 2025. - Senate HELP...more

Rivkin Radler LLP

DOJ and HHS Announce FCA Working Group

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On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance...more

Cozen O'Connor

Democratic AGs Sue HHS, DHS Over Alleged Health Data Sharing

Cozen O'Connor on

20 Democratic AGs sued HHS and DHS for allegedly sharing personal health data with ICE. The complaint alleges that the Centers for Medicare & Medicaid Services—a division of HHS—transferred millions of individuals’ Medicaid...more

Holland & Knight LLP

Holland & Knight Health Dose: July 8, 2025

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With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Dorsey & Whitney LLP

DOJ & HHS Announce Reinvigoration of False Claims Act Working Group and Healthcare Fraud Enforcement Priorities

Dorsey & Whitney LLP on

The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more

Stevens & Lee

HHS and DOJ Announce False Claims Act Joint Working Group and Identify Enforcement Priorities

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The U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced on July 2 their formation of a False Claims Act Working Group. The announcement and the formation of the Working Group...more

Venable LLP

OIG Issues Favorable Advisory Opinion on Physician-Telehealth Arrangement

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On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-03 (Opinion), which provided favorable guidance for physician practices seeking to contract with...more

Wiley Rein LLP

DOJ Health Care Fraud Takedown and FCA Working Group Signal New Era of Enforcement and Compliance Risks

Wiley Rein LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the next phase of the Administration’s “Whole-of-Government” approach to fighting health care...more

Skadden, Arps, Slate, Meagher & Flom LLP

HHS and DOJ Launch FCA Working Group With New Joint Enforcement Priorities

On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more

WilmerHale

DOJ and HHS Announce New False Claims Act Working Group

WilmerHale on

On July 2, 2025, the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced a joint DOJ-HHS False Claims Act Working Group (the “Working Group”) that will focus on enhanced enforcement...more

Morgan Lewis

DOJ and HHS Announce Joint False Claims Act Working Group

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The US Departments of Justice and Health and Human Services recently issued a press release on the formation of a new False Claims Act Working Group, signaling to the healthcare industry an increased focus on anti-fraud...more

Foley & Lardner LLP

DOJ-HHS False Claims Act Working Group: Focus on Medicare Payment Suspensions

Foley & Lardner LLP on

n a July 2, 2025, press release, the U.S. Department of Justice (DOJ) announced a new “DOJ-HHS False Claims Act Working Group” (the Working Group) and identified multiple priority enforcement efforts for the Working Group to...more

Benesch

DOJ and HHS Launch Joint False Claims Act Working Group: Heightened Enforcement Risk Ahead for Healthcare and Government-Funded...

Benesch on

The U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) have formed a new False Claims Act (FCA) Working Group, according to a joint announcement issued by DOJ on July 2, 2025....more

BakerHostetler

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

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In a joint announcement, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) unveiled the formation of the new DOJ-HHS False Claims Act Working Group (Working Group) – a strategic...more

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