CMS Updates HBV Infection Screening Coverage: What Billing Teams Need to Know (NCD 369)

The Centers for Medicare & Medicaid Services (CMS) has modified National Coverage Determination (NCD) 369, which governs Medicare coverage for Hepatitis B Virus (HBV) infection screening. This update—effective March 12, 2026—has implications for primary care practices, OB/GYN offices, and any provider ordering HBV screening for Medicare beneficiaries. If your practice bills for preventive screening services, you need to understand exactly who qualifies, where the service must be delivered, and what documentation CMS expects.

CMS HBV Screening Coverage Under NCD 369: What's Covered

CMS covers HBV infection screening as an "Additional Preventive Service" under §1861(ddd) of the Social Security Act. Coverage applies to FDA-approved or FDA-cleared laboratory tests used consistent with FDA-approved labeling and performed in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations.

Coverage has been in effect for services performed on or after September 28, 2016, and this 2026 modification updates the operative framework that billing teams and compliance officers need to apply now. The benefit falls under Medicare's Additional Preventive Services category—meaning it carries distinct rules around who can order it and in what setting.

Who Qualifies: Medical Necessity Criteria for CMS HBV Screening

CMS covers HBV screening for two distinct patient populations. Both require the screening to be ordered by the beneficiary's primary care physician or practitioner within a primary care setting.

Population 1: Asymptomatic, Nonpregnant Adolescents and Adults at High Risk

"High risk" is specifically defined by CMS as individuals who meet one or more of the following criteria:

For this population, repeated annual screening is covered—but only for beneficiaries with continued high risk (specifically MSM, injection drug users, and household contacts or sexual partners of HBV-infected persons) who have not received hepatitis B vaccination. This is a critical distinction: a vaccinated patient who meets a high-risk category does not qualify for annual repeat screening under CMS policy.

Population 2: Pregnant Women

CMS covers HBV screening at the first prenatal visit. For pregnant patients who present with new or continuing risk factors, rescreening at the time of delivery is also covered. Importantly, CMS has determined that first-prenatal-visit screening is appropriate for each pregnancy—regardless of previous hepatitis B vaccination status or a prior negative HBsAg result. There is no "once and done" exclusion based on a clean prior test.

The Primary Care Setting Requirement—A Billing Risk You Can't Overlook

One of the most operationally significant elements of NCD 369 is the strict definition of "primary care setting." CMS defines it as a setting where integrated, accessible health care services are provided by clinicians accountable for addressing a large majority of personal health care needs, who develop sustained patient partnerships and practice in the context of family and community.

CMS explicitly excludes the following settings from qualifying:

• Emergency departments
• Inpatient hospital settings
• Ambulatory surgical centers
• Skilled nursing facilities
• Inpatient rehabilitation facilities
• Clinics providing a limited focus of health care services
• Hospice

This matters for claims. If HBV screening is ordered outside a qualifying primary care setting, the claim does not meet CMS coverage criteria—regardless of the patient's risk status. Billing teams supporting multi-site practices or health systems with diverse care settings need to build facility-level checks into their workflow.

Documentation Requirements: What the Medical Record Must Show

CMS expects the determination of "high risk for HBV" to be made by the primary care physician or practitioner as part of a comprehensive patient history assessment. This assessment is described as a standard component of an annual wellness visit and should feed into the development of a comprehensive prevention plan.

The medical record must reflect the service provided. That means:

• The ordering provider must be a qualified primary care physician or practitioner (consistent with existing definitions under the Social Security Act)
• The risk determination must be documented—not assumed
• For annual repeat screenings, continued high-risk status must be evident in the record, and vaccination status must be noted

If your practice uses templated annual wellness visit documentation, verify that your HBV risk assessment fields capture the specific CMS-defined risk categories, not just a generic "high risk for infectious disease" notation.

Affected Codes

The policy document for NCD 369 does not list specific CPT, HCPCS, or ICD-10-CM codes in the data provided. Billing teams should consult their Medicare Administrative Contractor (MAC) for the applicable laboratory test codes associated with FDA-approved HBV screening (typically HBsAg testing), as code applicability may vary by contractor jurisdiction. Confirm that any codes billed align with the FDA-approved/cleared test requirement and CLIA compliance standards outlined in the NCD.

What Your Billing Team Should Do