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Hospitals Advisory Opinions

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

Holland & Knight LLP

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

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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

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

Epstein Becker & Green

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

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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

Baker Donelson

Relocation of Physician-Owned Hospitals: CMS Advisory Insights

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The Centers for Medicare and Medicaid Services (CMS) issued CMS Advisory Opinion No. CMS-AO-2025-1 on February 26, 2025, blessing the relocation of a physician-owned hospital. The hospital planned to relocate eight miles from...more

McGuireWoods LLP

CMS Opinion Offers Guidance on Relocation of Physician-Owned Hospitals

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On Feb. 26, 2025, McGuireWoods successfully assisted a physician-owned hospital in obtaining a favorable advisory opinion from the Centers for Medicare & Medicaid Services (CMS) regarding its proposal to relocate the entire...more

Sheppard Mullin Richter & Hampton LLP

Navigating Gainsharing Pitfalls in Value-Based Models

As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more

Bass, Berry & Sims PLC

OIG Approves Hospital’s Redemption Offer to Retiring Physician-Owners

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On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 23-12, approving a physician-owned hospital’s offer to redeem over a two-year period the...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture

On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more

Holland & Knight LLP

OIG Says Proposed Neurological Monitoring Arrangement Creates Kickback Risk

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion on Aug. 15, 2023, involving an intraoperative neuromonitoring (IONM) services arrangement. The Advisory...more

King & Spalding

OIG Issues Favorable Advisory Opinion on a Drug Manufacturer’s Provision to Hospitals of Trial Units of Antipsychotic Medication...

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On December 22, 2022, OIG issued a favorable advisory opinion concluding that it would not impose administrative sanctions on a pharmaceutical manufacturer for providing trial units of a certain antipsychotic drug (Drug) to...more

Bass, Berry & Sims PLC

OIG Approves Hospital Provision of Nurse Practitioner Services in Advisory Opinion

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently posted Advisory Opinion 22-20, approving an acute care hospital’s arrangement under which its employed nurse practitioners...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Health System’s Use of Nurse Practitioners for Services Traditionally Performed by...

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On December 19, 2022, OIG posted Advisory Opinion 22-20, responding to a request submitted by an acute care hospital (the Hospital) regarding the utilization of its employed nurse practitioners (NPs) to perform services that...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

McDermott Will & Emery

OIG Issues Unfavorable Opinion on Laboratory Specimen Collection Payments to Hospitals

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OIG has a long history of scrutinizing laboratory arrangements because of the agency’s view that these arrangements are particularly susceptible to fraud and abuse. Much of OIG’s past guidance focused on laboratory...more

Venable LLP

Contractual Safeguards That Fall Short of a Safe Harbor

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According to a recent Advisory Opinion from the Department of Health and Human Services (HHS) Office of Inspector General (OIG), a proposed fee arrangement could run afoul of the Federal anti-kickback statute, 42 USC...more

Bass, Berry & Sims PLC

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

Bass, Berry & Sims PLC

OIG Approves a Free Drug Program Limited to Hospital Inpatients

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On November 16, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published Advisory Opinion 21-16, approving an arrangement under which a pharmaceutical manufacturer provides free...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Hospital’s Warranty Program for Joint Replacement Procedures

On September 15, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a hospital’s proposal to implement a program through which patients...more

King & Spalding

OIG Issues Advisory Opinion Permitting Drug Manufacturer to Provide Travel, Lodging, and Expenses to Patients in Limited...

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On January 15, 2020, OIG issued Advisory Opinion No. 20-02 analyzing an arrangement between a pharmaceutical manufacturer and certain drug recipients whereby the manufacturer provides certain drug recipients with financial...more

Harris Beach Murtha PLLC

Health Care Group News: OIG Allows Hospital to Provide Free In-Home Patient Care

In an Advisory Opinion published March 6, 2019, the Office of Inspector General (the “OIG”) declined to impose sanctions on a nonprofit medical center for a program to provide free, in-home follow-up care to qualifying...more

Baker Donelson

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

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In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

Holland & Knight LLP

OIG Considers Drug Pricing History in an Unfavorable Advisory Opinion on Free Drugs

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• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy. • Contrary to the typical...more

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