News & Analysis as of

Department of Health and Human Services (HHS) Medicare

Baker Donelson

HRSA Announces 340B Rebate Pilot Program

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Structure & Timing of the Pilot Program - On August 1, 2025, the Health Resources and Services Administration (HRSA), administrator of the 340B Drug Pricing Program, announced its voluntary 340B Rebate Model Pilot Program in...more

BakerHostetler

Analysis of Healthcare Changes Under the 2025 Tax Legislation

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The Legislation combines spending and policy priorities from 11 congressional committees and will reshape federal policy across nearly every sector of the U.S. economy. With respect to healthcare, more than 35 provisions...more

Blank Rome LLP

Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?

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The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more

King & Spalding

CMS Issues Final Rule for Updates to Medicare Payment Rates for Skilled Nursing Facilities Under the Skilled Nursing Facility...

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On August 4, 2025, CMS issued a final rule (Final Rule) updating payment rates, policies, and quality programs for Skilled Nursing Facilities (SNFs) under the Medicare Prospective Payment System (SNF PPS) for Fiscal Year (FY)...more

King & Spalding

OIG Issues Series of Reports on Patient Harm in Hospitals and Gaps in Reporting

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On July 24, 2025, the OIG released reports evaluating the prevalence of patient harm in hospitals and the extent to which hospitals detect and report such events. These evaluations follow up on OIG’s 2022 report and provide...more

Alston & Bird

Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

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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

Epstein Becker & Green

HRSA Seeks Applicants to Test 340B Rebate Model Pilot Program

On August 1, 2025, the U.S. Department of Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) issued a call for applications for a 340B Rebate Model Pilot Program (the “Pilot Program”)....more

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

McDermott+

McDermott+ Check-Up – August 1, 2025

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Senate HELP Committee advances legislation, examines healthcare affordability. The legislation would reauthorize expiring programs, including the Over-the-Counter Monograph Drug User Fee Program. Senate Appropriations...more

Ropes & Gray LLP

HRSA Announces 340B Rebate Model Pilot Program

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On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more

Wilson Sonsini Goodrich & Rosati

CMS Announces Creation of Health Tech Ecosystem for Improving Access to Patient Data

During a “Make Health Tech Great Again” event on July 30, 2025 at the White House, the Centers for Medicare & Medicaid Services (CMS) announced its intent to create a digital health ecosystem, in partnership with private...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

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Troutman Pepper Locke

HHS Sets Its Sights on $50B in Cost Savings: Medicare Payments to Nonhospice Providers Potentially Under Fire

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In May 2025, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a review, titled “Potential Cost Savings HHS Programs – HHS Actions,” which provided some insight into the OIG’s...more

Holland & Knight LLP

HHS and DOJ Revitalize False Claims Act Working Group

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The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2025

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter,...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

McDermott+

Healthcare Preview for the Week of: July 28, 2025

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Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

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In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

Holland & Knight LLP

Holland & Knight Health Dose: July 22, 2025

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With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more

Goodwin

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

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The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims...more

McDermott+

Healthcare Preview for the Week of: July 21, 2025

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Two long weeks until August recess - This is the last week with both chambers in session until September, and things are relatively slow as lawmakers count down the days to the month-long August recess. With reconciliation...more

Stevens & Lee

New Changes to Medicare and Private Prior Authorization Processes

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Both the Centers for Medicare & Medicaid Services (CMS) and dozens of the nation’s largest insurance companies have revealed upcoming changes to their prior authorization processes. These changes aim to reduce the prevalence...more

Morrison & Foerster LLP

DOJ and HHS Announce Formation of False Claims Act Working Group and Results of National Health Care Fraud Takedown

As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more

McDermott+

McDermott+ Check-Up – July 18, 2025

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THIS WEEK’S DOSE - - OBBBA implementation begins. While the administration focuses on implementing the new law, some lawmakers are already discussing adjustments to health provisions in the One Big Beautiful Bill Act...more

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