8/19/2025 10:45:51 PM HHS-OIG Issues Favorable Advisory Opinion to Device Manufacturer under the Small Entity Safe Harbor By Jessica Christensen The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 25-09 on August 12,...
7/18/2025 2:00:00 PM OIG Says Proposal to Pay for Third Party Billing Portal Poses Unacceptable AKS Risk By Sarah Cummings Stewart The Department of Health and Human Services, Office of Inspector General (OIG) recently released an advisory opinion (Advisory Opinion...
7/16/2025 3:50:49 PM OIG Green-Lights Travel Assistance for Pediatric Gene Therapy By Cailin Harrington The Department of Health and Human Services Office of Inspector General (OIG) has issued an advisory opinion, concluding that it would...
6/24/2025 11:18:31 AM OIG Issues Favorable Advisory Opinion 25-03 Regarding Telehealth Arrangement By Nicole Aiken-Shaban Matthew Loughran On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) released Advisory Opinion 25-03, offering...
12/18/2024 4:03:43 PM OIG Issues Voluntary Compliance Guidance for Nursing Facilities By Sonia Nguyen Allie Klimkiewicz A year after issuing its General Compliance Program Guidance, the Department of Health and Human Services Office of Inspector General...
9/26/2024 6:52:21 PM OIG Issues Unfavorable Opinion on Medicare Advantage Gainsharing Arrangements By Brittney Cafero The Office of Inspector General of the Department of Health and Human Services (OIG) has published an unfavorable advisory opinion...
8/5/2024 3:23:52 AM OIG Issues Opinions On Arrangements Involving Gene Therapy Treatments By Craig Anderson The Department of Health and Human Services Office of Inspector General (OIG) recently issued two advisory opinions related to proposed...
5/3/2024 1:28:20 PM OIG Exercises Discretion in Independent Charity Patient Assistance Program By Peter Terreri On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 24-02,...
11/2/2023 12:55:00 PM OIG Issues Unfavorable Advisory Opinion Concerning Pathology Lab’s Proposed Purchased Services Arrangements By James Hennessy Brittney Cafero Jessica Christensen On September 28, 2023, the Office of Inspector General of the Department of Health and Human Services (OIG) issued Advisory Opinion...
3/9/2023 7:20:48 PM OIG allows drug company to provide free medication during coverage determination delay By Ellen Pighini On February 28, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory...
9/28/2022 4:05:37 AM Eighth Circuit Finds “But-For” Causation Standard for AKS-Premised FCA Cases By Ryan Pate The U.S. Court of Appeals for the Eighth Circuit recently weighed in on the causation standard for False Claims Act (“FCA”) cases...
2/10/2021 4:08:48 PM What happens when the clock strikes midnight: A Primer on “Midnight Regulations” By Andrew Lu With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are...
11/24/2020 12:20:10 AM Final Rules Modernizing Stark Law and Anti-Kickback Statute Released By Selina Coleman Hatmaker Pawlitz James Segroves Nicole Aiken-Shaban James Hennessy Andrew Lu +3 more... Show less The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and...
7/28/2020 6:02:17 PM Final rules modernizing Anti-Kickback Statute and Stark Law under review by OMB: anticipating the future of value-based care By Rebecca Dittrich David Bender The much-anticipated final rules modernizing the safe harbors under the Anti-Kickback Statute (AKS) and the physician self-referral...