TL;DR: The Centers for Medicare & Medicaid Services modified NCD 369 governing HBV infection screening, with an effective date of January 9, 2026. Here's what billing teams need to know.
This CMS hepatitis B virus screening coverage policy applies to Medicare beneficiaries in two distinct groups: high-risk nonpregnant adults and adolescents, and pregnant women. The policy does not list specific CPT or HCPCS codes — more on that below, and it matters for your charge capture. If your practice bills hepatitis B screening for Medicare patients, this NCD 369 Medicare update sets the documentation and ordering requirements your claims need to reflect.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Screening for Hepatitis B Virus (HBV) Infection |
| Policy Code | NCD 369 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | Medium |
| Specialties Affected | Primary care, OB/GYN, internal medicine, infectious disease, federally qualified health centers |
| Key Action | Confirm that HBV screening orders originate from a primary care physician or practitioner in a qualifying primary care setting, and that your documentation reflects high-risk criteria before billing |
CMS HBV Screening Coverage Criteria and Medical Necessity Requirements 2026
The CMS HBV screening coverage policy covers two distinct patient populations. Medical necessity depends on which group a patient falls into — and the documentation requirements differ between them. Get this wrong, and you're looking at a claim denial.
Group 1: High-risk, asymptomatic, nonpregnant adolescents and adults
CMS defines "high risk" with specificity. The policy lists these qualifying categories:
| # | Covered Indication |
|---|---|
| 1 | Persons born in countries or regions with HBV prevalence of 2% or higher |
| 2 | U.S.-born persons not vaccinated as infants whose parents were born in regions with HBV prevalence of 8% or higher |
| 3 | HIV-positive persons |
| 4 | Men who have sex with men |
| 5 | Injection drug users |
| 6 | Household contacts or sexual partners of persons with HBV infection |
One screening test is covered for all persons in this group. Annual repeated screening is covered only for a subset — specifically, men who have sex with men, injection drug users, and household contacts or sexual partners of HBV-infected persons — and only if they have not received hepatitis B vaccination. Document the absence of vaccination if you're billing repeated annual screenings. That's your medical necessity anchor.
Group 2: Pregnant women
Screening is covered at the first prenatal visit for every pregnancy. Rescreening at the time of delivery is covered when new or continuing risk factors are present. The policy explicitly states that prior negative HBsAg results or prior hepatitis B vaccination do not eliminate coverage for first-prenatal-visit screening in a subsequent pregnancy. Every pregnancy resets eligibility.
The ordering and setting requirements are non-negotiable
The coverage policy requires that the screening be ordered by the beneficiary's primary care physician or practitioner, within the context of a primary care setting. CMS defines primary care settings to exclude emergency departments, inpatient hospital settings, ambulatory surgical centers, skilled nursing facilities, inpatient rehabilitation facilities, limited-focus clinics, and hospice. If your facility type falls on that list, this coverage does not apply to your HBV screening billing — period.
Prior authorization is not explicitly required under this NCD, but the ordering clinician must be a primary care physician or practitioner as defined by existing sections of the Social Security Act. That's a documentation requirement that functions similarly to a prior authorization gatekeeping role. Your billing team should treat the primary care ordering requirement as a hard prerequisite, not a soft preference.
The determination of high-risk status comes from the primary care physician or practitioner's assessment of patient history. CMS notes this is typically part of an annual wellness visit and part of a comprehensive prevention plan. If your practice links HBV screening to an annual wellness visit (AWV), make sure the medical record reflects the risk assessment and the screening order — the claim will need that documentation to survive a review.
Reimbursement for this service falls under the "Additional Preventive Services" benefit category, authorized under §1861(ddd) of the Social Security Act. The laboratory performing the test must use FDA-approved or FDA-cleared tests consistent with FDA-approved labeling and must be in compliance with CLIA regulations.
CMS HBV Screening Exclusions and Non-Covered Indications
The policy does not cover HBV screening in symptomatic patients under this NCD. This is a screening benefit for asymptomatic individuals — once a patient presents with symptoms, clinical diagnosis codes apply, not preventive screening coverage.
Settings matter here. Screening performed in an emergency department, an inpatient hospital, an ambulatory surgical center, a skilled nursing facility, an inpatient rehabilitation facility, a limited-focus clinic, or a hospice setting does not qualify. Bill those in a non-primary-care setting and expect a denial.
Annual repeated screening for high-risk patients is not covered if the patient has received hepatitis B vaccination. This is a meaningful restriction. If a patient in a high-risk category has been vaccinated, repeated annual screening stops qualifying under this NCD. Your documentation should reflect vaccination status when it's the reason you're not billing a repeat screen.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Asymptomatic, nonpregnant high-risk adolescents and adults — one-time screening | Covered | Not specified in NCD | Must be ordered by primary care physician/practitioner in primary care setting |
| Annual repeated screening — men who have sex with men, injection drug users, household contacts/sexual partners of HBV-infected persons (unvaccinated) | Covered | Not specified in NCD | Annual coverage only if unvaccinated; document vaccination status |
| Annual repeated screening — high-risk patients who have received HBV vaccination | Not Covered | Not specified in NCD | Vaccination eliminates eligibility for repeated annual screening |
| Pregnant women — screening at first prenatal visit, each pregnancy | Covered | Not specified in NCD | Covered regardless of prior vaccination or prior negative HBsAg; covers every pregnancy |
| Pregnant women — rescreening at time of delivery | Covered (conditional) | Not specified in NCD | Only covered when new or continuing risk factors are present at delivery |
| Screening in symptomatic patients | Not Covered under this NCD | Not specified in NCD | Symptomatic patients fall outside the preventive screening benefit |
| Screening performed in ED, inpatient, ASC, SNF, IRF, limited-focus clinic, or hospice | Not Covered | Not specified in NCD | Setting exclusion — primary care setting required |
CMS HBV Screening Billing Guidelines and Action Items 2026
The hepatitis B screening billing requirements under this updated NCD are tight on setting, ordering provider, and documentation. Here's what your team needs to do before January 9, 2026.
| # | Action Item |
|---|---|
| 1 | Confirm your facility type qualifies as a primary care setting. If you bill from an ambulatory surgical center, SNF, IRF, ED, or limited-focus clinic, you cannot bill under this NCD. Identify any locations in your system that might not meet the definition and flag those before the effective date. |
| 2 | Verify the ordering provider is a primary care physician or practitioner. Specialist-ordered HBV screening does not meet coverage criteria under this policy. Audit your order workflows to confirm that HBV screening orders route through qualifying primary care clinicians. |
| 3 | Document high-risk status explicitly in the medical record. CMS states the medical record "should be a reflection of the service provided." Vague notes won't survive a review. The risk category — born in high-prevalence country, HIV-positive, injection drug user, etc. — needs to appear in the documentation supporting the order. |
| 4 | Track vaccination status for patients who receive repeated annual screening. If a patient in a continued high-risk category receives hepatitis B vaccination, annual repeated screening coverage ends. Build a workflow to capture vaccination status changes and stop annual screening billing when vaccination occurs. |
| 5 | For OB/GYN and prenatal billing: bill first-prenatal-visit screening for each pregnancy. Do not assume a prior negative HBsAg result or prior vaccination eliminates coverage. Every pregnancy qualifies for first-visit screening. For rescreening at delivery, confirm and document new or continuing risk factors — that's your medical necessity justification for the second screen. |
| 6 | Confirm lab compliance with FDA labeling and CLIA regulations. If your practice sends HBV screening to an outside lab, verify that the lab uses FDA-approved or FDA-cleared tests and holds current CLIA certification. A lab compliance gap creates a coverage gap for your claims. |
| 7 | Talk to your compliance officer about the primary care setting definition. This definition is more restrictive than many billing teams assume. If your practice has any hybrid or specialty-adjacent service lines, loop in your compliance officer before the January 9, 2026 effective date to confirm you're billing from a qualifying setting. |
| 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 HBV Screening Under NCD 369
Covered CPT Codes (When Selection Criteria Are Met)
The NCD 369 policy document does not list specific CPT or HCPCS codes. This is a known gap in this NCD as published. Your billing team should contact your Medicare Administrative Contractor (MAC) for guidance on the applicable laboratory CPT codes for HBsAg testing and HBV screening panels under this benefit.
Common laboratory codes used for HBV screening include HBsAg testing, but CMS has not enumerated them in this NCD. Do not assume codes are covered without MAC confirmation. Using the wrong code against a preventive screening NCD is a fast path to a claim denial, and you won't always get a remittance explanation that makes the root cause obvious.
A Note on Code Specificity
The absence of listed codes in this NCD is itself important information. It means MAC-level guidance or local coverage determinations (LCDs) may fill the gap. Check with your MAC for any supporting LCDs or billing articles that specify which codes to submit for HBV screening under this NCD. Some MACs publish companion billing articles that list applicable codes alongside national coverage policies — those are your authoritative source until CMS updates this NCD with code-level detail.
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