HHS OIG Publishes Two Advisory Opinions
The Department of Health and Human Services Office of Inspector General (“OIG”) issued two advisory opinions:
- Advisory Opinion 24-05 looks at a proposed arrangement in which the Requestor, a biotechnology company offering gene therapies, would provide two independent forms of support to qualifying patients receiving one of two of the Requestor’s gene therapy treatments. One form of support is for travel, whereby the Requestor would provide financial assistance to patients and caregivers for certain travel, lodging, and associated expenses during various stages of treatment. Fertility support is the other, whereby the Requestor would cover some or all costs associated with specified fertility preservation services. The OIG analyzed each form of support independently and reached different conclusions for each. Regarding the travel support, the OIG concluded that this support did not generate prohibited remuneration under the Beneficiary Inducements CMP. The OIG did conclude, however, that while this travel support would generate prohibited remuneration under the Anti-Kickback Statute if the requisite intent were present, the OIG would not impose administrative sanctions under that statute. Regarding the fertility support, the OIG was less favorable, concluding that this support would generate prohibited remuneration under both the Anti-Kickback Statute and the Beneficiary Inducements CMP, which would constitute grounds for the imposition of sanctions under those statutes.
- On a similar note, Advisory Opinion 24-06 looks at another proposed arrangement in which the Requestor, a manufacturer of a gene therapy product, would provide up to $70,000 in financial support for fertility services, which could include counseling, fertility drugs, collection/storage, genetic testing, and in-vitro fertilization procedures, as applicable, to qualifying patients prescribed the Requestor’s gene therapy product. Regarding this fertility support, the OIG reached the same unfavorable conclusion that it had for the fertility support in Advisory Opinion 24-05: it would generate prohibited remuneration under both the Anti‑Kickback Statute and the Beneficiary Inducements CMP, which would constitute grounds for the imposition of sanctions.
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