The U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has declined to approve Bluebird Bio’s proposed fertility support program linked to its gene therapy, Zynteglo.
Bluebird Bio’s gene therapy, Zynteglo (betibeglogene autotemcel), was granted approval by the U.S. Food and Drug Administration (FDA) last year for treating beta thalassemia, priced at $2.8 million. However, the therapy necessitates chemotherapy, which poses a risk of infertility for patients.
To address this, Bluebird Bio had sought an advisory review for a support program intended to cover travel and fertility preservation costs, potentially reaching up to $22,500 per patient. The aim was to ensure that such financial support would not breach the federal Anti-Kickback Statute.
The OIG has now determined that payments under Bluebird Bio’s fertility support program could lead to sanctions as outlined under the Social Security Act and the Anti-Kickback Statute. This ruling affects patients with federal insurance, such as Medicaid, who are undergoing Zynteglo treatment.
This development follows a similar situation involving Vertex Pharmaceuticals, which recently faced legal action against the federal government over its fertility support initiative for its gene therapy, Casgevy (exagamglogene autotemcel), also targeting beta thalassemia. Vertex’s program, aimed at aiding Medicaid patients with fertility services, was also deemed non-compliant with anti-kickback regulations by the OIG.
The HHS stated that it lacks sufficient data on the program’s costs and healthcare access to determine whether it presents a “low risk” of fraud and abuse under federal anti-kickback rules.
The federal Anti-Kickback Statute is designed to prevent fraud and abuse within the healthcare system by prohibiting the exchange of anything of value for referrals to services covered by federal programs like Medicare or Medicaid.
In its advisory opinion, the OIG clarified, “In exercising its enforcement discretion, OIG declines to offer prospective immunity—through a favorable advisory opinion—to the Fertility Support offered under the Proposed Arrangement.”
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