Screening for Hepatitis B Virus (HBV) Infection

A. General

Hepatitis B Virus (HBV) is transmitted by exposure to blood or blood-containing body fluids such as serum, semen or saliva. HBV infection attacks the liver and leads to inflammation. An infected person may initially develop symptoms such as nausea, anorexia, fatigue, fever and abdominal pain, or may be asymptomatic. An acute HBV infection may become a chronic infection and progress to serious and potentially life-threatening complications including cirrhosis, liver failure, hepatocellular carcinoma and death.

Pursuant to §1861(ddd) of the Social Security Act, the Secretary may add coverage of "additional preventive services" if certain statutory requirements are met.

B. Nationally Covered Indications

Effective for services performed on or after September 28, 2016, CMS has determined that the evidence is sufficient to cover screening for HBV infection 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 (CLIA) 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 asymptomatic, nonpregnant adolescents and adults at high risk for HBV infection. "High risk" is defined as persons born in countries and regions with a high prevalence of HBV infection (i.e., ≥ 2%), US born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infection (i.e., ≥ 8%), HIV-positive persons, men who have sex with men, injection drug users, household contacts or sexual partners of persons with HBV infection. In addition, CMS has determined that repeated screening would be appropriate annually only for beneficiaries with continued high risk (i.e., men who have sex with men, injection drug users, household contacts or sexual partners of persons with HBV infection) who do not receive hepatitis B vaccination.


2. A screening test at the first prenatal visit is covered for pregnant women and then rescreening at time of delivery for those with new or continuing risk factors. In addition, CMS has determined that screening during the first prenatal visit would be appropriate for each pregnancy, regardless of previous hepatitis B vaccination or previous negative HBsAg test results.

The determination of "high risk for HBV" is identified by the primary care physician or practitioner who assesses the patient's history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided.

For the purposes of this decision memorandum, a primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.

For the purposes of this decision memorandum, a "primary care physician" and "primary care practitioner" will be defined consistent with existing sections of the Social Security Act (§1833(u)(6), §1833(x) (2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)).

§1833(u)
(6) Physician Defined.—For purposes of this paragraph, the term "physician" means a physician described in section 1861(r)(1) and the term "primary care physician" means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist.

§1833(x)(2)(A)(i)
(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or

(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)).

C. Nationally Non-Covered Indications

Effective for claims with dates of service on and after September 28, 2016:

D. Other

Medicare coinsurance and the Part B deductible are waived for this "additional preventive service."

(NCD updated September 2016)

04/2017 - CMS has determined that effective September 28, 2016, screening for HBV infection will be covered 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 (CLIA) regulations. Effective date 09/28/2016. Implementation date 01/01/2018. (TN 195) (CR9859)

06/2017 - NOTE: This instruction is being re-issued to correct formatting within the document. The Transmittal number, date issued will remain the same. Transmittal 195, Pub. 100-03 and 3761, Pub. 100-04 dated April 28, 2017, are being rescinded and replaced by Transmittal 197, and Transmittal 3793 respectively dated, June 9, 2017 to change the January implementation date. All other information remains the same. (TN 197) (CR9859)

06/2017 - NOTE: Transmittal 197, Pub. 100-03, and Transmittal 3793, Pub. 100-04 dated June 9, 2017, are being rescinded and replaced by Transmittals 198 and Transmittal 198, dated June 29, 2017 to correct the verbiage in split release dates to state the following: October 2, 2017 analysis and design. January 2, 2018 Testing and implementation. All other information remains the same. (TN 198) (CR9859)

08/2017 - NOTE: Transmittal 3804, dated June 29, 2017, is being rescinded and replaced by Transmittal 3831, dated, August 4, 2017 to provide clarification in Pub. 100-04 Business Requirement 9859.04.13 and to revise the note. The new note will read, "Payment for HBV is not separately payable for ESRD facilities (72X TOB) unless reported with Modifier AY." The corresponding update to note is being made in the Pub. 100-04 claims processing manual. All other information remains the same. (TN 3831) (CR9859)

02/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2033) (CR10473)

02/2018 - Transmittal 2033, dated February 16, 2018, is being rescinded and replaced by Transmittal 2039, dated, February 28, 2018 to correct instructions in business requirement 7, NCD210.3, Colorectal Cancer Screening, and its accompanying spreadsheet. All other information remains the same. (TN 2039) (CR10473)

10/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10432) (CR12027)

12/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10515) (CR12027)

01/2021 - Transmittal 10515, dated December 10, 2020, is being rescinded and replaced by Transmittal 10566, dated, January 14, 2021 to remove FISS Reason Codes (RCs) 59041, 59042, 59209, and 59210 from the spreadsheet for NCD 160.18. All other information remains the same. (TN 10566) (CR12027)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 11546) (CR12842)

10/2022 - Transmittal 11546, dated August 4, 2022, is being rescinded and replaced by Transmittal 11636, dated, October 5, 2022, to remove ICD-10 dx codes added in error to NCD 150.3, business requirement 12842.4, and restore ICD-10 dx C91.92 removed in error to NCD 110.23, business requirement 12842.3. All other information remains the same. (TN 11636) (CR12842)