July 15 (Reuters) - Vertex Pharmaceuticals ( VRTX ) sued

the U.S. Department of Health and Human Services on Monday,

seeking a court declaration that a fertility support program for

patients who are prescribed its gene editing therapy Casgevy

does not violate federal anti-kickback laws.

Casgevy is approved for the treatment of two genetic

disorders - sickle cell disease and transfusion-dependent

beta-thalassemia - in the United States.

The treatment involves patients receiving high doses of

chemotherapy, with infertility being a potential risk.

While fertility preservation methods such as freezing eggs

and sperm banking are covered under commercial insurance plans,

government-supported plans like Medicaid do not offer coverage.

Vertex offers financial support for some Casgevy patients

who meet certain eligibility criteria.

The Office of Inspector General, named as one of the

defendants in the lawsuit, had previously conveyed to the

company that its program could violate anti-kickback laws as it

"poses more than a low risk of fraud and abuse to federal health

care programs".

The OIG and other defendants in the lawsuit - the HHS,

Secretary Xavier Becerra and Inspector General Christi Grimm -

did not immediately respond to requests for comment.

Anti-kickback provisions prohibit "quid-pro-quo"

transactions, in which remuneration, such as a bribe or

kickback, is sought or offered to influence medical decisions.

Vertex said anti-kickback laws do not prohibit support such

as the one its program provides.

The program "removes a financial or medical barrier to care

and thereby allows patients to receive appropriately prescribed

medical treatment," the company said in the court filing.

The lawsuit was filed in the federal court in Washington,

D.C.