This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments.
On July 22 and July 23, Health and Human Services (HHS) Office of Inspector General (OIG) published two advisory opinions for proposals by pharmaceutical manufacturers to provide fertility support to patients receiving their gene therapies. In order to obtain these therapies, patients must receive chemotherapy prior to treatment, a process that can cause infertility.
In the first proposal evaluated by OIG, the manufacturer would offer travel support (the “Travel Support Services”), covering airfare or ground transportation, lodging, and certain other daily expenses for patients and their caregivers when they have to travel certain distances to receive treatment. The manufacturer also proposed offering financial support of up to $22,500 for fertility services (“Fertility Support Services”), including fertility preservation procedures and storage, to patients receiving these gene therapies. In the second proposal evaluated by OIG, the manufacturer would offer financial support of up to $70,000 for Fertility Support Services, including collection and storage of oocytes or sperm and in-vitro fertilization, to patients receiving these gene therapies. The manufacturers proposed to offer these supports to federal health care program enrollees whose insurance does not cover these fertility services. In its advisory opinions, OIG noted that the Fertility Support Services offered under each proposal could run afoul of the federal Anti-Kickback Statute (AKS) or the Beneficiary Inducement Provision of the Civil Monetary Penalties Law unless a safe harbor or exception applied. In response to the provision of Travel Support Services under the first proposal, OIG issued a favorable opinion, stating that there is a sufficiently low risk of violating the AKS.
