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Courtney Potts

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In an advisory opinion released June 30th, the U.S. Department of Health and Human Services Office of Inspector General (OIG) confirmed that it would not seek to impose monetary sanctions on a medical device manufacturer for its efforts to reimburse purchasers of its device for accidental needle stick injuries caused by a failure of the device’s safety mechanism.

According to the OIG, the manufacturer’s plan fits under the federal Anti-Kickback Statute’s regulatory safe harbor for warranties and does not generate prohibited remuneration under that statute, despite the offer to pay purchasers for failure of the device which might induce purchasers to choose the manufacturer’s product.Continue Reading OIG Advisory Opinion Supports Plan to Reimburse for Needle Stick Injuries

In its first advisory opinion of the year, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on January 15, 2025 that addressed an arrangement by a pharmaceutical manufacturer to offer certain patients free access to a pharmaceutical product that has limited coverage by Federal health care programs.

The opinion, offers guidance to pharmaceutical companies and administering providers about the mechanics of free or discount programs for their products or services that present low risk of fraud and abuse. The opinion aligns with the OIG’s recent assessment of a supplier’s loyalty program issued in December 2024.Continue Reading OIG Issues Favorable Opinion on Free Access to Pharmaceutical Products

After a long line of opinions scrutinizing the use of rewards programs offered by providers, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued Advisory Opinion 22-16 on August 19, 2022– a favorable opinion for the provision of gift cards to Medicare Advantage (“MA’) plan enrollees who complete educational modules as part of an online surgical treatment learning tool.

The opinion adds flexibility to existing opinions on gift cards and patient engagement programs and, while binding only on the requestor, provides insight into the OIG’s evolving view of these programs.Continue Reading OIG Approves Rewards Program for Medicare Advantage Organizations

Representatives Jackie Speier (D-California) and Dina Titus (D-Nevada) have introduced HR 2143, the Promoting Integrity in Medicare Act of 2019 (PIMA), which – if enacted – would narrow the “Stark” law’s exceptions and have a direct impact on the services provided by physicians who self-refer for the performance of certain designated health services. The 2019…

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a final rule implementing its statutory authority under the Affordable Care Act (ACA) to expand the exclusion regulations applicable to persons or entities receiving funds, directly or indirectly, from federal health care programs.

Specifically, the final rule expands OIG’s…

On January 12, 2017, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a final rule to expand the exclusion regulations applicable to persons or entities receiving funds, directly or indirectly, from federal health care programs (“Final Rule”).  The Final Rule, which implements Affordable Care Act authority, …