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OIG Nixes Pharmaceutical Cost-Sharing Subsidy Program Under AKS | Baker Ober Health Law


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In Advisory Opinion No. 20-05, posted September 23, 2020, OIG was unwilling to approve a pharmaceutical company s proposed cost-sharing subsidy program for beneficiaries seeking to use its expensive new drug for treatment of a rare cardiovascular disease. While OIG stated it was not in a position to reach a definitive conclusion regarding whether a violation of the federal Anti-Kickback Statute (AKS) existed, OIG was unwilling to issue a favorable advisory opinion. In particular, OIG was concerned that the arrangement would make beneficiaries less sensitive to the costs of their treatment, thereby risking an increase in the costs to the federal health care programs, and influencing clinical and beneficiary decision-making. Notably, OIG highlighted its use of publicly available information in reaching its conclusion under the AKS. With respect to the beneficiary inducement statute, OIG found the proposed arrangement d ....

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Communication between pharma, patients and wider healthcare has helped to create a solid foundation upon which the general public understands disease and, crucially, trusts emerging therapies. Now that vaccines promise a ‘way out’ of the COVID-19 impasse, pharma’s direction has never (ever) been more important
Just as the last track of the pitiful one-star-rated 2020 album played out, vaccines seemed to start dropping out of the sky like strikingly beautiful life-saving confetti. Suddenly, footage of tiny bottles amassing on factory apparatus punctuated every news bulletin. It was akin to a piece of installation art, with every identical vial appearing to represent one of us, while the endlessly moving conveyor seemed the perfect metaphor for our salvation; our great escape. Cautiously, we were dancing to a different tune – albeit socially distanced and, of course, wearing an absolutely bizarre array of face coverings. ....

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