News & Analysis as of

Medical Devices Safe Harbors Healthcare

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

Bass, Berry & Sims PLC

The Philosophy for Investing in Urology: 5 Key Regulatory Risks

Bass, Berry & Sims PLC on

In the wave of physician practice management transactions, urology is poised to be one of the next hot sectors. In addition to the issues to consider in connection with any physician practice transaction, below we discuss...more

Thomas Fox - Compliance Evangelist

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion Regarding Tiered Rebate Program

Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the “Requestor”) tiered rebate program (the “Proposed Arrangement”)....more

BakerHostetler

OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations

BakerHostetler on

In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic...more

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