On November 10, 2021, OIG issued Advisory Opinion No. 21-16 permitting an arrangement whereby a drug manufacturer (Requestor) provides free samples of a long-acting injectable atypical antipsychotic drug (the Drug) to certain hospitals. Under the proposed arrangement, hospitals that do not accept and dispense Prescription Drug Marketing Act of 1987 (PDMA)-compliant samples in their facilities are permitted to request up to a maximum number of free units of the Drug to be dispensed solely to inpatients. After careful consideration of the facts presented, OIG determined that although this arrangement implicated the federal Anti-Kickback Statute, it presented a sufficiently low risk that OIG would not impose administrative sanctions under that law.
OIG noted that the arrangement implicates the Anti-Kickback Statute because the free trial units of the Drug are remuneration provided to the hospitals, and the hospitals are referral sources for the Drug. However, OIG considered the following factors in deciding that the arrangement presented a low risk under the Anti-Kickback Statute:
The risk of a participating hospital steering inpatients to the Drug is low because for the first 14 days after the initial administration of the Drug, a patient must receive concurrent treatment with daily antipsychotics. These daily antipsychotics are not provided for free and therefore the hospital does not benefit from administering the Drug under the arrangement. Further, the patient may...
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