(Reuters) – Vertex Pharmaceuticals Inc. sued the U.S. Department of Health and Human Services on Monday seeking a court declaration that its fertility support program for patients prescribed its gene-editing treatment Kasgevi does not violate federal anti-kickback laws.
Casgevy is approved to treat two genetic disorders — sickle cell disease and transfusion-dependent beta-thalassemia — in the United States.
Treatment involves patients receiving high doses of chemotherapy, with the possibility of infertility.
While fertility preservation methods such as egg freezing and sperm storage are covered under commercial insurance plans, government-backed plans such as Medicaid do not offer coverage.
Vertex (NASDAQ:) provides financial support to certain Casgevy patients who meet certain eligibility criteria.
The Office of the Inspector General, which was named as a defendant in the lawsuit, had previously told the company that its program may violate anti-kickback laws because it “poses more than a low risk of fraud and abuse of federal health care programs.”
The inspector general’s office declined to comment, while the other defendants in the lawsuit — the Department of Health and Human Services, Health Secretary Xavier Becerra, and Inspector General Christi Grimm — did not immediately respond to requests for comment.
Anti-bribery provisions prohibit transactions based on the “quid pro quo” principle, in which a reward, such as a bribe or kickback, is requested or offered to influence medical decisions.
Vertex said anti-bribery laws do not prohibit support like the one its program offers.
The company said in its court filing that the program “removes financial or medical barriers to care and thus allows patients to receive appropriately prescribed medical treatment.”
The lawsuit was filed in federal court in Washington, D.C.
