Additional Preventive Services
This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.
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.
Indications and Limitations of Coverage
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.
- 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%), USborn 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.
- 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 whoassesses 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 offamily 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)).
(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.
(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.
Medicare coinsurance and the Part B deductible are waived for this "additional preventive service."
(NCD updated September 2016)
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