News & Analysis as of

Office of the Inspector General

Hogan Lovells

OIG issues two unfavorable decisions, cautions against some customer service fees paid by manufacturers

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued two unfavorable decisions in Advisory Opinions (AOs) 25-04 and 25-08 (the “Opinions”), finding that some service fees paid by...more

Hogan Lovells

Investigation highlights risks of collaboration between pharmaceutical manufacturers and telehealth providers

Hogan Lovells on

Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

ArentFox Schiff on

On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

Hogan Lovells on

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

WilmerHale

DOJ Antitrust Announces New Whistleblower Program

WilmerHale on

On July 8, 2025, the Department of Justice, Antitrust Division (“Antitrust Division”) announced that it is creating the Antitrust Whistleblower Rewards Program (the “Whistleblower Program”) in partnership with the U.S. Postal...more

Dentons

Ep. 70 – Use Caution Before Charging Patients Extra Fees

Dentons on

As healthcare providers face mounting administrative burdens and tighter reimbursement rates, some are exploring the idea of charging patients for “extra” services, such as administrative tasks or added “perks.” But before...more

Venable LLP

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

Venable LLP on

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

King & Spalding

Trump Administration Revamps Working Group to Focus on False Claims Act

King & Spalding on

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

Cranfill Sumner LLP

Navigating Stark Law and the Anti-Kickback Statute (AKS) in 2025: A Snapshot Guide for Medical Practices

Cranfill Sumner LLP on

In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more

Arnall Golden Gregory LLP

CMS Announces Changes for SNFs on Care Compare Website

The Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality recently announced upcoming changes to skilled nursing facility (“SNF”) profiles on the Medicare Care Compare website. Care...more

Rivkin Radler LLP

DOJ and HHS Announce FCA Working Group

Rivkin Radler LLP on

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

McGuireWoods LLP

OIG Approves Multi-MSO Telehealth Arrangement That Meets AKS Safe Harbor

McGuireWoods LLP on

On June 6, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion concerning a proposed telehealth staffing and services arrangement involving a management...more

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

Holland & Knight LLP

Office of Inspector General Highlights Flat Fee Structures Not Immune From Anti-Kickback Statute

Holland & Knight LLP on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-08 (Opinion) on July 7, 2025, highlighting the limitations of the often-leveraged Personal Services and...more

Venable LLP

OIG Issues Favorable Advisory Opinion on Physician-Telehealth Arrangement

Venable LLP on

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

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...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

Harris Beach Murtha PLLC

OMIG Announces 12-Month Review Period for its Compliance Program Reviews

The New York State Office of the Medicaid Inspector General (“OMIG”) issued a Listserv Notice on June 26, 2025 advising that its Compliance Program Reviews (“CPRs”) beginning after July 1, 2025, will use a 12-month Review...more

Bass, Berry & Sims PLC

OIG Declines to Approve Medical Device Company's Proposal to Subsidize Screening Costs

On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical device company (Requestor) to pay the...more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-03: Navigating Anti-Kickback Rules and Safe Harbors in Telehealth Contractual Arrangements

On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more

Health Care Compliance Association (HCCA)

HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance

In November 2024, the Office of Inspector General at Health and Human Services released its Nursing Facility: Industry Segment-Specific Compliance Program Guidance. The document is part of an effort to modernize how HHS OIG...more

Ballard Spahr LLP

Independent Fed Inspector General assigned to CFPB investigating administration’s actions at the CFPB

Ballard Spahr LLP on

The independent Office of Inspector General (OIG) for the Federal Reserve System (FRS) and Consumer Financial Protection Bureau (CFPB) is investigating the bureau’s workforce reductions and its canceled contracts, according...more

Epstein Becker & Green

HHS OIG Continues to Highlight How Medicaid Fraud Control Units Recovered $1.4 Billion in FY 2024

On June 25, 2025, the Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) released a short video containing the highlights of the Medicaid Fraud Control Units (“MFCUs”) Annual...more

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