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Advisory Opinions Safe Harbors Hospitals

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

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

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

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

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 18-07 Permits GPO Expansion to Serve Wholly Owned Members

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In Advisory Opinion No. 18-07, issued July 30, 2018, the OIG permitted a group purchasing organization (GPO) to serve health care facilities owned by the same parent organization as the GPO. While acknowledging that the...more

Baker Donelson

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

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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

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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

Holland & Knight LLP

Healthcare Law Update: March 2017

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Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

Baker Donelson

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

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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 Medigap Policy Contracts with Preferred Hospital Networks

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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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