News & Analysis as of

Healthcare Department of Health and Human Services (HHS)

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

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

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

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Hogan Lovells

An evolving ‘nexus’: OIG approves sponsored testing program involving companion diagnostic

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more

Phelps Dunbar

Trump Administration Bolsters FCA Health Care Fraud Enforcement With New DOJ-HHS Working Group

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Emphasizing its commitment to enforcing the False Claims Act (FCA) and combating health care fraud, the Trump Administration recently instituted a DOJ-HHS False Claims Act Working Group dedicated to “combating health care...more

Davis Wright Tremaine LLP

Healthcare Industry in the Crosshairs at DOJ and HHS

Any suggestion that the Trump Administration might not be committed to healthcare fraud enforcement was definitively quashed by two recent developments. First, on July 2, 2025, the U.S. Department of Justice (DOJ) and the...more

Ballard Spahr LLP

Courts Split on Enforcement of No Surprises Rules

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The Fifth Circuit and the Federal District Court of Connecticut have issued conflicting decisions on whether service providers may sue to enforce arbitration awards under the No Surprises Rules in the Consolidated...more

Harris Beach Murtha PLLC

Changed Laws and Regulations Impact Reproductive Health Care Providers

Within the past few months, the legal landscape for reproductive health care law has changed on both the federal and state levels. The Trump Administration has changed its approach, revising positions in administrative...more

Alston & Bird

New York Department of Health Issues Urgent Cybersecurity Warning Following U.S. Strikes on Iranian Nuclear Facilities

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The New York State Department of Health has issued an urgent cybersecurity advisory (the Advisory) warning of increased threat levels and a higher likelihood of cybersecurity attacks from Iranian state-backed actors following...more

Holland & Knight LLP

Holland & Knight Health Dose: July 15, 2025

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The U.S. House of Representatives returns from a district work period. The U.S. Senate is expected to consider the $9.4 billion rescissions package that passed the House last month. If not passed by July 18, 2025, the...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

King & Spalding

Trump Administration Revamps Working Group to Focus on False Claims Act

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On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a...more

Epstein Becker & Green

Latest Moves by Federal Agencies Regarding Gender-Affirming Care: Risks Mount for Providers

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Since day one, a policy priority of the Administration has been to discourage and prevent gender-affirming care for children and adolescents that involves surgery or medication....more

Alston & Bird

Health Care Week in Review | HHS Blocks Access to Select Federal Health Programs for Undocumented Individuals; Senate HELP...

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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

Alston & Bird

Getting the Band Back Together: DOJ and HHS Launch New False Claims Act Enforcement Working Group

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The Department of Health and Human Services and the Department of Justice have formed a False Claims Act (FCA) enforcement working group to target health care fraud. Our Health Care Litigation Group highlights what industry...more

Sheppard Mullin Richter & Hampton LLP

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

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...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

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

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Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Tucker Arensberg, P.C.

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

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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

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

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