Office of the Inspector General
HHS OIG Issues Unfavorable Opinion on Gene Therapy Developer's Fertility Preservation Program
Without more data on the risk of abuse associated with these programs, the agency won't provide immunity to drugmakers offering to pay for fertility services.
Vertex Pharmaceuticals Sues HHS, OIG Over Legality of Fertility Preservation Program
The firm is asking a court to determine that its program to pay for fertility treatments for patients on Casgevy doesn't violate anti-kickback and inducement laws.
Sickle Cell Gene Therapy Fertility Risks Spur Calls for Changes Allowing Industry Support Services
Gene therapy companies aren't covering fertility preservation for Medicaid patients due to anti-kickback laws, but CMS is exploring solutions in a model.