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Medicare to Cover Hep B Screening for High-risk Individuals

On September 29, 2016. The Centers for Medicare and Medicaid Services (CMS)  released its final decision memo for adding hepatitis B screening as a covered Medicare preventive service. CMS will now cover hepatitis B screening at no cost to Medicare beneficiaries who are at high risk as defined by the United States Preventive Services Task Force. To be covered by Medicare, the test would need to be 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. You can read this decision memo here.

This coverage is the result of advocacy by NVHR, the Association of Asian Pacific Community Health Organizations, Hep B United, the Hepatitis B Foundation, and the National Hepatitis B Task Force on Hepatitis B: Focus on Asian and Pacific Islander Americans. In May, 2015, we submitted a formal request to CMS asking for the initiation of a National Coverage Determination process to add hepatitis B screening as a covered Medicare preventive service. CMS initiated this process in January, 2016 and completed its work after nine months of deliberation and two public comment periods.

The CMS decision is a vital new tool in implementing U.S. Preventive Services Task Force and Centers for Disease Control and Prevention hepatitis B screening recommendations. However, by limiting coverage to primary care, CMS is creating barriers to hepatitis B screening in other vital health care settings, such as emergency departments. Similar restrictions have created significant challenges in hepatitis C screening and other covered preventive services. NVHR will work with our advocacy partners to identify strategies to overcome these barriers, including urging the new Administration to direct CMS to expand settings for viral hepatitis screening.

For more information, please contact Ryan Clary.

The CMS Decision Memo explains:

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that screening for Hepatitis B Virus (HBV) infection, consistent with the grade A and B recommendations by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B, as described below.

Therefore, CMS will 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 hepatitis B surface antigen (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, independent diagnostic testing facilities, 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));

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