Medicare officials propose to cover screening for hepatitis C virus for adults at high risk of infection as well as a one-time screening for Baby Boomers.
The plan, announced in a coverage memo on March 4, would provide Medicare coverage for all screening tests approved by the Food and Drug Administration when they are ordered by a primary care physician or other primary care clinician.
Officials at the Centers for Medicare & Medicaid Services initially floated the idea of hepatitis C (HCV) screening coverage last September. The response was overwhelmingly positive, with nearly all of the 65 public comments advocating in favor of coverage.
HCV screening is already recommended by the U.S. Preventive Services Task Force and the American Academy of Family Physicians. The AAFP recommends screening for HCV infection in high-risk adults. But the 2013 USPSTF recommendation goes further, calling on physicians to screen high-risk adults as well as to provide a one-time screening to all patients born between 1945 and 1965.
The Medicare proposal echoes the USPSTF recommendations.
For the proposal, the CMS deems the following patients as at high risk for HCV infection: adults who use illicit injection drugs or have a history of such drug use, as well as individuals who had blood transfusions before 1992. The proposal calls for coverage of an initial screening test for high-risk adults, followed by annual rescreening for those who continue to use illicit injection drugs after the first test.
“We acknowledge the limited evidence concerning health outcomes of HCV screening,” agency officials wrote in the coverage memo. “However, CMS believes that screening for HCV infection provides an opportunity for appropriate interventions to benefit the infected person by permitting for the early detection of, and potentially the prevention of, HCV-related liver disease.”
Treatment options for hepatitis C are expanding, the CMS noted in its coverage memo. Over the past several years, the FDA has approved three protease inhibitors, boceprevir (Victrelis), telaprevir (Incivek), and simeprevir (Olysio), for the treatment of patients with genotype 1 infection. Each of these three drugs can be used in combination with pegylated interferon and ribavirin for the treatment of genotype 1 infection.
Last year, the FDA approved sofosbuvir (Sovaldi), which is indicated for the treatment of hepatitis C infection from genotypes 1, 2, 3, or 4. But access to that drug could be impacted by its hefty price tag, which is $1,000 a pill or about $84,000 for a 12-week course of treatment.
Comments on the CMS screening proposal can be made until April 3. The CMS is scheduled to issue a final decision on coverage in June.
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