February 20, 2016

RE: Centers for Medicare and Medicaid National Coverage Analysis for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

As participants in the Adult Vaccine Access Coalition (AVAC), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis for hepatitis B screening for Medicare beneficiaries who are at high risk for hepatitis B (HBV) infection as defined by the United States Preventive Services Task Force (USPSTF).

AVAC consists of 45 organizational leaders in health and public health that are committed to tackling the range of barriers to adult immunization and to raising awareness of the importance of adult immunization. AVAC works towards common legislative and regulatory solutions that will strengthen and enhance access to adult immunization across the health care system. Our mission is informed by a growing body of scientific and empirical evidence in support of the benefits immunizations provide by improving health, protecting lives against a variety of debilitating and potentially deadly conditions and saving costs to the healthcare system and to society as a whole.

AVAC priorities and objectives are driven by a consensus process with the goal of enabling the range of stakeholders to have a voice in the effort to improve access and utilization of adult immunizations. One of our key coalition priorities is to advocate for policies that will improve access to the full complement of vaccines recommended for adults by the Advisory Committee on Immunization Practices (ACIP).

While up to 2 million Americans have chronic HBV infection, 67% are unaware of their condition, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is the leading cause of primary liver cancer (hepatocellular carcinoma, HCC), which is the 2nd deadliest cancer and remains the only cancer that continues to rise rising in both incidence and mortality among men and women in the U.S. According to the Centers for Disease Control and Prevention (CDC), “Hepatitis B vaccination is the most effective measure to prevent hepatitis B virus (HBV) infection and its consequences, including cirrhosis of the liver, liver cancer, liver failure, and death.”

In 2014, the USPSTF gave a grade of “B” for risk-based HBV screening, which includes those born in countries and regions with a high prevalence of HBV infection (>2%); people born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%); HIV-positive individuals; injection drug users; men who have sex with men and household partners and sexual partners of people who are HBV infected. ACIP recommendations issued as part of a comprehensive immunization strategy to eliminate transmission of Hepatitis B virus infection in the United States also identifies these target populations as being at high risk for the disease.

The revised USPSTF hepatitis B screening recommendations compliment long standing ACIP recommendations for hepatitis B vaccination and will further advance efforts to identify those with chronic HBV and link them to care. We urge CMS to allow for access to hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Seniors who are Medicare beneficiaries and are unware of HBV infection are likely to have been living with the disease for a very long time and it is vital to ensure they are linked to care and treatment before they develop advanced liver disease or liver cancer.

AVAC supports including HBV screening under Medicare Preventive Services to improve identification of beneficiaries at high risk for the disease and improve health outcomes for these target populations. Thank you for the opportunity to offer our perspective. Please contact the AVAC Coalition Manager (202) 540-1070 or info@adultvaccinesnow.org if you wish to discuss our comments or adult immunization issues.

— Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group Center for Clinical Standards and Quality Centers for Medicare & Medicaid Services