Screening for Hepatitis C Virus (HCV) in Adults

CMS NCA document | source_status=Open | review_type=1st Recon | public_comment_open=True | document_id=CAG-00436R

Issue: Currently, CMS has a National Coverage Determination (NCD 210.13) covering Screening for HCV in Adults with the appropriate U.S. Food and Drug Administration (FDA)-approved/cleared laboratory tests, used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act regulations, when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting, and performed by an eligible Medicare provider for these services, for beneficiaries who meet either of the following conditions: A screening test is covered for adults at high risk for HCV infection. “High risk” is defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk persons is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test. A single screening test is covered for adults who do not meet the high risk definition above, but who were born from 1945 through 1965. CMS received five complete formal requests to reconsider the NCD. This NCD analysis will align with the scope of the requests and focus on screening for hepatitis C virus (HCV) infection in adults aged 18 to 79 years, as recommended by the US Preventive Services Task Force (USPSTF). CMS is soliciting public comment on this topic. We are particularly interested in any peer-reviewed literature that describes the specific screening interval that should occur in persons who continue to be at risk for new HCV infection and screening in non-primary care settings.