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

To embed, copy and paste the code into your website or blog: 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 did not

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