Bluebird Bio’s Fertility Support Program for Gene Therapies Rejected by HHS Inspector General

1. HHS Inspector General's Decision: The U.S. Department of Health and Human Services' (HHS) Office of the Inspector General issued a negative advisory opinion on Bluebird Bio's fertility support program for patients undergoing gene therapy treatment with Zynteglo and Skysona.
2. Program Details: The program aimed to provide up to $22,500 to cover fertility preservation services for patients who might otherwise forgo treatment due to the risk of infertility associated with the chemotherapy required for gene therapy.
3. Anti-Kickback Rules: The inspector general cited concerns that the program could violate anti-kickback payment rules, particularly for patients covered by federal insurance programs like Medicaid.
4. Impact on Patients: The decision may exacerbate the inequity between patients insured by Medicaid and those with commercial insurance, as the program was intended to aid patients who might forgo treatment due to infertility concerns.
5. Comparison to Vertex Pharmaceuticals: Vertex Pharmaceuticals recently sued the federal government over a similar block of its fertility support program for patients receiving its gene therapy Casgevy.
6. Pilot Program: The Centers for Medicare and Medicaid Services are implementing a pilot program to test different payment schemes for gene therapies, which may provide more data on the costs and access to healthcare services.