**_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:

\- Medicare beneficiaries who are symptomatic, or who have already been
diagnosed with HBV infection, or who are nonpregnant and have already received
a hepatitis B vaccination are non-covered.

**D. Other**

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

(NCD updated September 2016)