News & Analysis as of

Advisory Opinions Department of Health and Human Services (HHS) Safe Harbors

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

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

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

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

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 Favorable Opinion Concerning Bonus Payments to Employed Physicians

Stevens & Lee on

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more

Holland & Knight LLP

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

Bass, Berry & Sims PLC

OIG Approves Paying Employed Physicians Profits from ASCs Operated by Employer

Bass, Berry & Sims PLC on

On October 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07, approving a physician practice’s proposal to pay its physician-employees a portion of the...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

Proskauer - Health Care Law Brief

OIG Publishes Favorable Advisory Opinion Related to the Employment Safe Harbor

In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in...more

Saul Ewing LLP

OIG Issues Favorable Advisory Opinion For Hospital/Physician ASC Joint Venture

Saul Ewing LLP on

In a recent advisory opinion, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) concluded that an investment by a health system, a management company, and surgeons in an...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

Foley & Lardner LLP

Some Helpful Managed Care Guidance Provided in Advisory Opinion 18-11

Foley & Lardner LLP on

Practitioners in the Medicare or Medicaid managed care space place heavy reliance on the protection of the Anti-Kickback Statute (AKS) Safe Harbor found at 42 C.F.R. § 1001.952(t), generally known as the “EMCO [eligible...more

Proskauer Rose LLP

Payment by MCOs to Encourage Preventive Screenings Not a Kickback

Proskauer Rose LLP on

On October 11, 2018, the Office of the Inspector General ("OIG") for the Department of Health and Human Services ("HHS") issued an advisory opinion clarifying that an arrangement between a managed care organization and its...more

Sheppard Mullin Richter & Hampton LLP

How Broad is the Managed Care Safe Harbor?

In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and...more

Mintz - Health Care Viewpoints

OIG Opinion Illustrates the Need for New AKS Safe Harbors

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

Baker Donelson on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

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