The following summary is derived from Manatt on Health, a subscription service by Manatt offering comprehensive insights and analysis on legal, policy, and market developments.
On July 22 and July 23, the Health and Human Services (HHS) Office of Inspector General (OIG) released two advisory opinions regarding proposals from pharmaceutical manufacturers to offer fertility support to patients undergoing gene therapy treatments. These patients are required to undergo chemotherapy before treatment, which can lead to infertility.
In the first proposal assessed by the OIG, the manufacturer suggested providing travel support—covering airfare or ground transportation, lodging, and other daily expenses—for patients and their caregivers needing to travel significant distances for treatment. Additionally, the manufacturer proposed offering up to $22,500 in financial support for fertility services, including fertility preservation procedures and storage.
The second proposal reviewed by the OIG involved a manufacturer offering up to $70,000 in financial support for fertility services, encompassing the collection and storage of oocytes or sperm and in-vitro fertilization. Both proposals aimed to assist federal health care program enrollees whose insurance plans do not cover these fertility services.
In its advisory opinions, the OIG highlighted that the fertility support services in both proposals could potentially violate the federal Anti-Kickback Statute (AKS) or the Beneficiary Inducement Provision of the Civil Monetary Penalties Law, unless a safe harbor or exception applied. However, regarding the travel support services in the first proposal, the OIG issued a favorable opinion, indicating a sufficiently low risk of AKS violation.
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