TL;DR: The Centers for Medicare & Medicaid Services modified NCD 361, the CMS hepatitis C virus screening coverage policy, with an effective date of 2026-02-25. Here's what billing teams need to know.
This update to NCD 361 in the CMS Medicare system reaffirms and clarifies coverage for HCV screening in adults — a service that has been covered since June 2, 2014, but continues to generate claim denials when documentation doesn't match the specific eligibility criteria. The policy does not list specific CPT or HCPCS codes, which means your HCV screening billing depends entirely on correct ICD-10 coding, proper ordering documentation, and matching the right patient to the right coverage bucket. If your primary care billing is already tight, this is a policy to audit before you have a problem.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Screening for Hepatitis C Virus (HCV) in Adults |
| Policy Code | NCD 361 |
| Change Type | Modified |
| Effective Date | 2026-02-25 |
| Impact Level | Medium |
| Specialties Affected | Primary care, internal medicine, infectious disease, gastroenterology, hepatology, FQHCs, RHCs |
| Key Action | Audit your HCV screening claims to confirm documentation supports either the high-risk or birth-cohort eligibility criteria before billing |
CMS Hepatitis C Virus Screening Coverage Criteria and Medical Necessity Requirements 2026
The CMS HCV screening coverage policy covers two distinct patient populations. Getting these wrong is the fastest path to a claim denial. Know which bucket your patient falls into before the claim goes out the door.
Population One: High-Risk Adults
CMS covers HCV screening for adults at high risk for HCV infection. "High risk" is defined specifically — not clinically, but by CMS criteria. It means persons with a current or past history of illicit injection drug use, and persons who received a blood transfusion before 1992. Periodic repeat screening is covered for persons who continue to be at high risk.
The medical necessity standard here is straightforward, but your documentation has to match. The ordering physician or practitioner must document the risk factor. "Patient requests HCV test" is not sufficient. The note needs to reflect the actual qualifying criterion — injection drug use history or pre-1992 transfusion history — or you're looking at a medical necessity denial.
Population Two: Birth-Cohort Screening (Born 1945–1965)
CMS covers one-time screening for adults born between 1945 and 1965. This is the baby boomer cohort that carries a disproportionate burden of undiagnosed HCV infection. These patients often have no known risk factors — the screening is justified by birth year alone.
One-time means one-time. If a patient in this cohort has already received a covered HCV screening under Medicare, a repeat screen is not covered under this indication unless they also qualify under the high-risk criteria. Your billing team should check claim history before submitting a second screen for this population.
Ordering Requirements
Both coverage categories require the test to be ordered by the beneficiary's primary care physician or practitioner, within the context of a primary care setting. This is not a specialist-ordered benefit in the typical sense. If a gastroenterologist orders the screen during a specialist visit without a primary care context, coverage becomes questionable. Flag that scenario for your compliance officer before billing.
The test itself must use FDA-approved or FDA-cleared laboratory tests, consistent with FDA-approved labeling, and must be performed in compliance with CLIA regulations. This isn't new, but it's a documentation requirement that labs and billing teams sometimes overlook.
Prior Authorization
This policy does not require prior authorization for covered HCV screening under either indication. That's good news. But the absence of prior auth doesn't mean the claim is automatic — it shifts the burden to documentation at the time of service.
Statutory Authority
CMS covers this service under §1861(ddd) of the Social Security Act, as an additional preventive service under 42 CFR §410.64. The USPSTF gives HCV screening a Grade B recommendation — which is the statutory trigger for Medicare coverage under this pathway. That Grade B is also why no prior authorization is required. Grade A and B USPSTF preventive services are a protected category under the ACA and Medicare statute.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Adults at high risk — current or past illicit injection drug use | Covered | No specific CPT/HCPCS listed in NCD 361 | Must be ordered by primary care physician/practitioner in primary care setting; documentation of risk factor required |
| Adults at high risk — blood transfusion before 1992 | Covered | No specific CPT/HCPCS listed in NCD 361 | Same ordering and documentation requirements as above |
| Periodic repeat screening — adults who remain at high risk | Covered | No specific CPT/HCPCS listed in NCD 361 | Ongoing risk must be documented; not a routine annual benefit without documented continued risk |
| One-time screening — adults born 1945–1965 | Covered | No specific CPT/HCPCS listed in NCD 361 | One-time only under this indication; repeat screens for this cohort require a separate qualifying high-risk indication |
| Repeat screening — birth cohort (1945–1965) with no high-risk factors | Not Covered | — | Birth-year eligibility is exhausted after one covered screen |
| HCV screening ordered outside primary care context | Not Covered | — | Policy requires ordering within a primary care setting by primary care physician or practitioner |
| Tests not FDA-approved/cleared or non-CLIA-compliant | Not Covered | — | Laboratory compliance is a coverage condition, not just a regulatory one |
CMS Hepatitis C Virus Screening Billing Guidelines and Action Items 2026
This policy has been active since 2014, but the 2026-02-25 modification means it's time to re-examine your workflows. Here are the specific steps your billing team should take now.
| # | Action Item |
|---|---|
| 1 | Audit your HCV screening documentation templates before February 25, 2026. Your EHR's HCV screening order or encounter note needs to capture the qualifying criterion explicitly — injection drug use history, pre-1992 transfusion, or birth year 1945–1965. A general "preventive screening" notation without the specific criterion documented is a claim denial waiting to happen. Update your templates to prompt the ordering provider for this information at the point of care. |
| 2 | Build a claim history check into your HCV billing workflow for the birth-cohort population. One-time means one-time. Before billing a birth-cohort HCV screen, check whether Medicare has already paid for one. This is especially important if your practice sees patients who may have had this screening at another facility. A duplicate screen for a 1945–1965 patient with no documented high-risk factors is a non-covered service — and you should know that before the claim goes out. |
| 3 | Confirm that HCV screening orders are coming from primary care. If you bill for specialist practices that also provide primary care-type preventive services, clarify internally whether those encounters qualify as "within the context of a primary care setting." This is a gray area. If you're not sure, your compliance officer needs to weigh in before you bill those claims. |
| 4 | Verify your lab's CLIA compliance and FDA test approval status. This is a billing requirement, not just a lab operations question. If the test wasn't performed with an FDA-approved or -cleared test in a CLIA-compliant setting, the claim is not covered. Make sure you have a mechanism to confirm this before you bill — especially if you're working with reference labs. |
| 5 | Check your reimbursement rates against your fee schedule for the HCV lab test codes you're currently using. NCD 361 doesn't list specific CPT or HCPCS codes, which means your HCV screening billing relies on the lab codes your team has been using. Confirm those codes align with what your Medicare Administrative Contractor recognizes for HCV antibody screening. If there's been any drift in how your lab codes are mapped, now is the time to correct it. |
| 6 | For practices billing through FQHCs or RHCs: Preventive service billing in these settings follows different reimbursement rules. Confirm your billing guidelines are current for the encounter-based payment model and that HCV screening is properly captured within that framework. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for HCV Screening Under NCD 361
NCD 361 does not specify particular CPT or HCPCS codes in the policy document. This is a real issue for HCV screening billing — and it's one reason denials happen. The coverage policy defines who is eligible and under what conditions, but the specific procedure codes used to bill the screening test are determined by the laboratory performing the test and must align with what your Medicare Administrative Contractor recognizes.
Talk to your billing team and your reference lab to confirm the exact codes in use. Your MAC's local coverage determination or LCD-level guidance may provide additional coding direction that NCD 361 does not.
The table below reflects the actual code data available in this policy:
Covered CPT Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| No specific codes listed in NCD 361 | — | CMS does not enumerate specific CPT or HCPCS codes in this NCD. Verify applicable lab codes with your MAC and reference lab. |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| No ICD-10 codes enumerated in NCD 361 | — |
The absence of specific codes in this policy is not unusual for preventive screening NCDs. What it means practically: your coding team owns the code selection, and it needs to be defensible if audited. Make sure your charge capture reflects the actual test performed and the actual qualifying indication documented.
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.