CMS to Cover Hepatitis C Screening In Eligible Adults

The Centers for Medicare and Medicaid Services (CMS) will cover screenings for the hepatitis C virus (HCV) in adults eligible for Medicare Part A or enrolled in Part B. In a June 2 decision memo (CAG-00436N), CMS says the evidence is adequate to conclude that screening for HCV, consistent with the grade B recommendations by the U.S. Preventive Services Task Force, is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. The agency will cover a screening in two circumstances for Medicare-covered adults: those adults who are at “high risk” of infection and those born between 1945 and 1965 who are not at high risk. Screenings must be conducted with the appropriate Food and Drug Administration approved or cleared laboratory tests, “used consistent with FDA approved labeling” and in compliance with the Clinical Laboratory Improvement Amendments regulations. The determination of “high risk for HCV” is identified by the primary care physician or practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. There are likely more than 3 million people chronically infected with HCV in the United States, though more than half are unaware that they are infected, according to national estimates. Takeaway: Given the latest coverage policy and expanded guidelines, clinical laboratories can expect to see a surge in HCV testing. Experts size the HCV testing market at about $300 million annually.