Vertex Sues HHS Over Fertility Support Program For Patients Prescribed Gene Editing Therapy

Reuters (7/15, Stempel, Satija) reports, “Vertex Pharmaceuticals 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 [exagamglogene autotemcel] does not violate federal anti-kickback laws.” The Office of Inspector General “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.’” For its part, “Vertex said anti-kickback laws do not prohibit support such as the one its program provides.” Bloomberg (7/15, Smith, Subscription Publication) reports, “Vertex said in the suit that it’s trying to overturn the inspector general’s ‘erroneous legal positions’ that are holding back patients from getting the therapy.”