News & Analysis as of

Advisory Opinions Safe Harbors Civil Monetary Penalty

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

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Bass, Berry & Sims PLC

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more

Hinshaw & Culbertson - Health Care

New OIG Guidance Permits Federally Qualified Health Centers to Offer Remote Patient Monitoring, Big-Box Store Gift Cards, and...

Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net providers,...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement

As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more

Dorsey & Whitney LLP

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes...

Dorsey & Whitney LLP on

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal...more

Baker Donelson

It's Déj Vu All Over Again as OIG Approves Yet Another Medigap/PHO Arrangement in Advisory Opinion 18-09

Baker Donelson on

With Advisory Opinion 18-09, the OIG continued its trend of approving arrangements between Medicare Supplemental Health Insurance (Medigap) insurers and preferred hospital network organizations (PHOs). As in prior advisory...more

Baker Donelson

OIG Allows Cost-Sharing Waivers Among Fire Departments for Ambulance Services in Advisory Opinion 18-08

Baker Donelson on

A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more

Baker Donelson

OIG Approves (Again) Another Medigap/PHO Arrangement in Advisory Opinion 18-06

Baker Donelson on

With Advisory Opinion 18-06, issued July 11, 2018, the OIG added to the ever-growing number of favorable advisory opinions addressing an agreement between a Medicare Supplemental Health Insurance (Medigap) insurer and a...more

Baker Donelson

OIG Advisory Opinion 18-04: Another Favorable Medigap/PHO Arrangement

Baker Donelson on

On June 7, 2018, the OIG issued favorable Advisory Opinion 18-04, thereby approving another arrangement between a group of Medicare Supplemental Health Insurance (Medigap) insurers and a preferred hospital organization (PHO)....more

Baker Donelson

OIG Approves Another Medigap/Preferred Hospital Network Arrangement in Advisory Opinion 16-11

Baker Donelson on

On November 3, 2016, the OIG issued another favorable Advisory Opinion, No. 16–11, regarding an agreement between a Medigap insurer and preferred hospital network. The OIG has issued several opinions regarding similar...more

Baker Donelson

OIG Approves Another Medigap/Preferred Hospital Network in Advisory Opinion 16-04

Baker Donelson on

On April 18th, the OIG issued a new favorable Advisory Opinion, No. 16–04, regarding an agreement between a Medigap insurer and preferred hospital network. The opinion tracked other, similar opinions in favorably addressing...more

Baker Donelson

OIG Approves Medigap Policy Contracts with Preferred Hospital Networks

Baker Donelson on

On February 20, the U.S. Department of Health & Human Services, Office of the Inspector General (OIG) released Advisory Opinion 14-02, concerning the use of preferred hospital networks as part of certain Medicare Supplemental...more

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