The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion (No. 26-14) to a pharmaceutical manufacturer that is proposing to offer free antibody testing to patients.
In the proposed arrangement, the manufacturer would offer free antibody testing to determine whether patients would qualify for a prescribed drug to treat a rare condition (the exact condition was redacted for the published OIG opinion). The manufacturer has a contractual arrangement with a third-party lab to provide the testing and through such contract the lab is prohibited from billing patients or third-party payors for the testing, using the arrangement to market other lab services, or offering any inducement to healthcare providers to prescribe the drug that treats the underlying condition.
OIG concluded that the arrangement presents a low risk of fraud and abuse based on several factors. First, OIG recognized that the free test is unlikely to result in overutilization or inappropriate utilization of the drug that would be prescribed to eligible patients as a result of the test. The test would only be used to determine whether the drug is appropriate and there is a low risk that clinicians would be steered or incentivized to prescribe the drug where it is not appropriate, because the marketing efforts by the manufacturer and contracted lab are limited to marketing the test and not the drug or other products of the manufacturer or the lab. OIG also noted that the test could improve patient access to care and awareness with respect to a potential diagnosis and treatment.
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