On March 18, 2021, OIG issued Advisory Opinion 21-01, addressing whether a pharmaceutical manufacturer may provide a personalized medicine made from a patient’s own cells as a one-time, potentially curative treatment (the Drug) to a patient. Under the arrangement, the pharmaceutical manufacturer offers the Drug at no charge to patients unable to afford the Drug who are either uninsured or insured under plans that will not cover the Drug (the Arrangement). OIG concluded that it would not impose administrative sanctions under the federal Anti-Kickback Statute and that the Arrangement does not implicate the beneficiary inducement provision of the Civil Monetary Penalties Law.
The pharmaceutical manufacturer’s patient eligibility requirements for the Arrangement are as follows:
Federal Anti-Kickback Statute
In concluding that although the arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute if the requite intent were present, OIG would not impose administrative sanctions on Requestor, OIG relied on the following:
Civil Monetary Penalties
OIG also evaluated whether the pharmaceutical manufacturer would know, or should know, that the remuneration it offers to beneficiaries is likely to influence their selection of a particular provider, practitioner, or supplier for the order or receipt of any item or service for which payment may be made, in whole or in part, by Medicare or a State healthcare program. OIG concluded that the remuneration offered by the pharmaceutical manufacturer under the Arrangement is not likely to influence a beneficiary to select a particular provider, practitioner, or supplier to administer the Drug, and therefore the beneficiary-inducement prohibition of the Civil Monetary Penalty Law is not implicated by the Arrangement. In reaching this conclusion, OIG reasoned that the pharmaceutical manufacturer does not make eligibility for the free Drug dependent on a beneficiary’s use of a particular provider, practitioner, or supplier.
As a reminder, the Advisory Opinion may not be relied upon by anyone other than the Requestor. A copy of Advisory Opinion 21-01 is available here.