On April 9, 2025, OIG posted Advisory Opinion No. 25-02, a favorable advisory opinion allowing a community health center operating under Section 330 of the Public Health Service Act (the Requestor) to ask individuals, to whom...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-01 (the “Opinion”), to a Medicare Supplemental Health Insurance...more
On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...more
The Final Rule of the Stark Law revises the definitions of Fair Market Value and includes a definition of General Market Value to better align with actual practices without unduly restricting innovative relationships between...more
Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
On July 24, 2020, OIG issued an Advisory Opinion (AO), AO 20-04, regarding whether an arrangement where a charitable organization purchases or receives donations of unpaid medical debt from health care providers, and then...more
In light of the COVID-19 pandemic, on March 30, 2020, the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) released blanket waivers (the “Waivers”) under Section 1135 of the Social Security Act...more
CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more
The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more
With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more
On December 31, 2012 the U.S. Department of Health and Human Services Office of Inspector General ("OIG") issued a favorable Advisory Opinion No.12-22 for a hospital cardiology group compensation arrangement that includes a...more