CMS Updates HCV Screening Coverage Policy (NCD 361): What Medicare Billers Need to Know in 2026

The Centers for Medicare & Medicaid Services has modified its national coverage determination for Hepatitis C Virus screening in adults, policy code NCD 361, effective March 12, 2026. This update affects how Medicare reimburses HCV screening ordered in primary care settings — and if your practice sees Medicare beneficiaries with documented risk factors or birth years between 1945 and 1965, your billing team needs to understand exactly who qualifies.

CMS HCV Screening Coverage Under NCD 361: What Medicare Covers

CMS established coverage for HCV screening under §1861(ddd) of the Social Security Act, which authorizes Medicare Part B to cover additional preventive services when the USPSTF assigns a grade of A or B recommendation. HCV screening carries a grade B USPSTF recommendation, clearing the statutory bar for Medicare coverage.

Coverage has been effective for services performed on or after June 2, 2014, and this 2026 modification updates how that coverage is applied and documented. The policy covers screening using FDA-approved or FDA-cleared laboratory tests, used consistent with FDA-approved labeling, and performed in compliance with Clinical Laboratory Improvement Act (CLIA) regulations.

The key structural requirement that catches many billing teams off guard: the screening must be ordered by the beneficiary's primary care physician or practitioner within the context of a primary care setting. A specialist ordering HCV screening does not satisfy this requirement — even if the patient otherwise qualifies.

Medical Necessity Criteria: Who Qualifies for Medicare HCV Screening

NCD 361 defines two distinct covered populations. Your documentation must clearly support which category applies to each beneficiary before the claim goes out.

Population 1: Adults at High Risk for HCV Infection

CMS defines "high risk" as:

For high-risk patients, repeat annual screening is covered when the patient continues to have ongoing risk factors.

Population 2: The Birth Cohort Screening Group (Born 1945–1965)

CMS covers a one-time HCV screening for any Medicare beneficiary born between 1945 and 1965, regardless of risk factors. This cohort has a disproportionately high prevalence of HCV infection — often undiagnosed — because widespread routine screening did not exist during the decades when this group was most exposed.

This is a one-time benefit. If a beneficiary in this birth cohort has already received a Medicare-covered HCV screening under this provision, a repeat screening under the birth cohort category is not covered.

Coverage Conditions That Must All Be Met

All of the following conditions must be satisfied for Medicare to cover the screening:

1. The beneficiary meets at least one of the two qualifying criteria above
2. The order comes from a primary care physician or practitioner
3. The order is issued within the context of a primary care setting
4. The test used is FDA-approved or FDA-cleared for HCV detection
5. The test is used consistent with FDA-approved labeling
6. The performing laboratory is CLIA-compliant
7. The performing provider is an eligible Medicare provider

Missing any one of these conditions is grounds for a claim denial. In particular, the "primary care setting" requirement is a documentation issue as much as a clinical one — the medical record should clearly reflect that HCV screening was initiated and ordered during a primary care encounter.

Why HCV Goes Undetected — and Why This Policy Matters for Your Patients

HCV is frequently asymptomatic for decades. The virus attacks the liver, triggering an immune response that causes chronic inflammation — and that inflammation, sustained over 20 to 30 years, can progress to cirrhosis, liver failure, and hepatocellular carcinoma. HCV is the leading cause of chronic hepatitis, cirrhosis, and liver cancer in the Western world, and a primary driver of liver transplant listings.

Because patients rarely present with symptoms until disease is advanced, screening is the only reliable mechanism for early detection. For billing and RCM purposes, this means HCV screening is legitimately preventive — not diagnostic — and should be billed and documented accordingly. The distinction matters both for patient cost-sharing and for coverage qualification.

Affected Codes

The policy document for NCD 361 does not list specific CPT or HCPCS codes within the version data available at this time. CMS NCD policies frequently reference covered services without enumerating specific procedure codes at the NCD level, with coding guidance issued separately through Local Coverage Articles (LCAs) or CMS transmittals. Your billing team should cross-reference the applicable Medicare Administrative Contractor (MAC) local coverage article for the specific laboratory and office visit codes that apply to HCV screening in your jurisdiction.

When this policy's associated coding guidance is published, PayerPolicy will update this entry with the applicable codes. You can track this policy directly at https://app.payerpolicy.org/p/cms/361-v1.

What Your Billing Team Should Do