News & Analysis as of

Office of the Inspector General Anti-Kickback Statute

Arnall Golden Gregory LLP

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more

Morgan Lewis - Health Law Scan

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

Ropes & Gray LLP on

On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

Baker Donelson

OIG Advisory Opinion 25-08: Unfavorable DME – Vendor Payment Arrangement

Baker Donelson on

On July 1, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 25-08, an unfavorable opinion discussing a proposed arrangement in which a medical device company...more

Hogan Lovells

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

Hogan Lovells on

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

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

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

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

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

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

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Epstein Becker & Green

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

Epstein Becker & Green on

On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

DLA Piper on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

Robinson+Cole Health Law Diagnosis

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more

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