News & Analysis as of

Regulatory Oversight Medical Devices Office of the Inspector General

Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

Arnall Golden Gregory LLP

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more

Morgan Lewis - Health Law Scan

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

DLA Piper

OIG Report Recommends Oversight for Remote Patient Monitoring in Medicare

DLA Piper on

On September 24, 2024, the Office of Inspector General (OIG) at the US Department of Health and Human Services (HHS) issued a report titled, “Additional Oversight of Remote Patient Monitoring in Medicare Is Needed” (the...more

Bass, Berry & Sims PLC

OIG Approves Arrangement Involving Physician-Owned Device Manufacturer— Distinguishes Prior Special Fraud Alert on Physician-Owned...

Bass, Berry & Sims PLC on

On April 25, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-07, approving an arrangement whereby physicians hold ownership interests in a medical...more

King & Spalding

OIG Issues Report Regarding Medicare Oversight of Cybersecurity for Networked Medical Devices in Hospitals

King & Spalding on

On June 21, 2021, OIG released a report titled “Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in Hospitals” (OEI-01-20-00220) (the OIG Report). OIG determined that CMS’s accreditation...more

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