National Coverage Analysis (NCA) Tracking Sheet

Screening for Hepatitis C Virus (HCV) in Adults

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:

  1. 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.
  2. 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.

Benefit Category

Additional Preventive Services

Requestor Information

Requestor Name Requestor Letter
Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute (with co-signers National Viral Hepatitis Roundtable, Caring Ambassadors, NASTAD, and The AIDS Institute) View Letter
Lee H. Hilborne, MD, MPH, DLM(ASCP)CM, Senior Medical Director, Medical Affairs, Quest Diagnostics View Letter
Joshua Riel, MHA, BSN, RN, CCM, Clinical Denial Education and Quality Coordinator, Cleveland Clinic Foundation, Revenue Cycle Management View Letter
Lisa Satterfield, MS, MPH, CAE, CPH, Senior Director, Health Economics & Practice Management, American College of Obstetricians and Gynecologists (ACOG) View Letter
Sarah Harm, MD, University of Vermont Medical Center Pathology and Laboratory Medicine View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
09/23/2026
Expected NCA Completion Date
06/21/2027
Public Comment Period
09/23/2026 - 10/23/2026
Proposed Decision Memo Due Date
03/23/2027
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

September 23, 2026

CMS initiates this national coverage analysis for Screening for HCV in adults. The initial 30-day public comment period begins with this posting date and ends after 30 calendar days. CMS considers all public comments and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: https://www.cms.gov/medicare/coverage/determination-process/public-comments

To submit a comment, please use the blue "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.