The COVID-19 pandemic has resulted in a unique set of circumstances for many healthcare providers. Delivering quality patient care, while at the same time trying to navigate existing laws and regulations, has many providers questioning whether the arrangements they are making in response to this public health emergency will not get them into trouble with…

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The Office of Inspector General (OIG) in a Jan. 21 Advisory Opinion (No. 20-02) approved an agreement under which a pharmaceutical manufacturer would provide travel, lodging and other expenses to financially needy patients prescribed the manufacturer’s personalized medication. In doing so, the OIG noted that such an arrangement could potentially violate the Anti-Kickback Statute, (AKS)…

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Teva Pharmaceuticals earlier this month agreed to pay $54 million to settle a whistleblower lawsuit brought against it by two former sales representatives. Charles Arnstein and Hossam Senousy filed suit against the Israeli-based pharmaceutical company alleging it paid speaker fees to neurologists for participation in “sham” speaker programs in exchange for their prescribing the multiple…

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A nonprofit, federally qualified health center look-alike (FQHC) can use grant funds to provide telehealth equipment and services for free to facilitate encounters with patients of a county-run clinic that provides testing, treatment and counseling for HIV, based on a recent advisory opinion issued by the Department of Health and Human Services Office of the…

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An ostomy product distributor can give free samples to Medicare patients without worrying about violating the federal Anti-Kickback Statute, according to a recent advisory opinion from the Office of Inspector General for the U.S. Department of Health and Human Services. The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit…

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