As Medicare Covers Hepatitis C Testing for At-Risk Americans, New Challenges Arise

Executive Editor

All individuals born from 1945 through 1965, as well as people who fit the definition of "high risk" for hepatitis C (HCV) infection, will have the costs of HCV screening covered by Medicare, according to an announcement from the U.S. Centers for Medicare & Medicaid Services (CMS) earlier this month. The move marks the latest development in a trend toward greater coverage of HCV testing costs in the U.S. -- and toward increased awareness about hepatitis C among patients and providers alike.

The June 2 "decision memo" from CMS carries two notable caveats:

  • The screening must be ordered by a patient's primary care provider "within the context of a primary care setting," a designation described in detail within the memo.
  • The physician or practitioner requesting the screening must be an eligible Medicare provider.

The screening is available to Medicare enrollees who fit the following risk profiles:

  • All adults born between (and including) the years 1945 and 1965.
  • Any person who has ever used "illicit injection drugs."
  • Any person who received a blood transfusion before 1992.

The CMS memo adds that current users of illicit injection drugs who are found to be HCV negative will be covered for annual repeat screenings.

CMS's policy change comes amidst a dramatic shift in our understanding of HCV epidemiology and our approach to HCV clinical care. Though the vast majority of the estimated 3.2 million people in the U.S. with chronic HCV infection are believed to have been infected by sharing needles or other injection drug equipment, research has increasingly shown that transmission through sexual contact is not as uncommon as once thought, particularly among individuals with HIV. Results from a massive prospective study last year revealed dramatically higher HCV incidence rates among HIV-positive men who have sex with men (MSM) compared to HIV-negative MSM, as well as an incidence rate that appeared to generally be on the rise. Unprotected, receptive anal intercourse with multiple partners was identified as "the sexual behavior carrying the greatest risk" for HCV transmission.

Although the CMS memo does not identify any type of sexual behavior as a risk factor that will trigger Medicare coverage of HCV screening, expert guidelines released earlier this year by a trio of medical associations specifically recommend one-time HCV testing for all people with HIV, and annual testing for HIV-positive men who have unprotected sex with men.

Meanwhile, HCV treatment is emerging from a vast desert, with newer, less-toxic, more successful medications and regimens increasingly replacing the difficult-to-tolerate standard of an interferon plus ribavirin. The greater likelihood of achieving cure with a single (short) course of HCV treatment is refashioning the landscape of HCV care -- as is the concept of treatment as prevention, which has similarly caught fire in HIV prevention.

These converging trends have helped lead to the CMS policy change in screening coverage. In addition, these trends have also highlighted a peculiar divergence: Although there appears to be increased awareness of, and attention to, HCV prevention, care and management in the U.S., there is also an increased understanding about the extent to which the public and the health care community at large remain in the dark about HCV messaging and patient care. "There might be providers that now feel that they need to screen, but then don't know what to do with people once they have a positive antibody test," Tracy Swan, hepatitis/HIV project director at Treatment Action Group, said in an interview with earlier this year. Similarly, New York state has experienced a range of challenges, including a poor HCV care infrastructure and lack of HCV knowledge, since it passed the country's first state law mandating HCV screening, which went into effect on Jan. 1.

"Hepatitis C has last-on-the-list syndrome. It doesn't progress quickly. ... Treatment's too expensive," Swan said. "Hopefully, the new drugs will really push the envelope, and people who need to be treated and cured will be. But it's not really clear how that's going to play out."

Myles Helfand is the editorial director of and

Follow Myles on Twitter: @MylesatTheBody.