October 4, 2013
Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
600 Security Boulevard
Baltimore, MD 21244
Re: National Coverage Analysis for Screening for Hepatitis C Virus (HCV) in Adults
Dear Dr. Jacques:
The National Minority Quality Forum (The Forum) is pleased to submit this comment regarding the CMS National Coverage Analysis for Hepatitis C Virus (HCV). The Forum strongly recommends that CMS provide to Medicare beneficiaries coverage of HCV screening in a manner that is consistent with the U.S. Preventive Services Task Force (USPSTF) Recommendation for screening for Hepatitis C Virus Infection in Adults, which was issued on June 25, 2013.
The Forum welcomes this focus by CMS on HCV screening in order to prevent the ravages of this disease that can include cirrhosis, end-stage liver disease and hepatocellular carcinoma. The Forum is a Washington, DC-based not-for-profit, non-partisan, independent research and education organization founded in 1998 that is dedicated to improving the quality of healthcare that is available for and provided to all populations. The Forum has launched the Hepatitis C Index to help health-care practitioners, policy makers, advocacy groups and industry identify and quantify Hepatitis C geographically and by age, gender and race/ethnicity.
As with many amendable conditions that lead to devastating illness and death, early diagnosis and treatment is key. Accordingly, in the update of their 2004 recommendation on screening for and treatment of hepatitis C virus (HCV) infection in asymptomatic adults, “The USPSTF recommends screening for HCV infection in persons at high risk for infection. The USPSTF also recommends offering 1-time screening for HCV infection to adults born between 1945 and 1965.”[i]
In 2010, the overall incidence rate of acute HCV infection was 0.3/100,000, and varied by race or ethnicity. Persons born between 1945 and 1965 are more likely to be diagnosed with HCV infection than other birth cohorts, possibly because they received blood transfusions before the introduction of screening in 1992, or were exposed decades earlier as a result of other risk factors.[ii] The incidence rate for acute hepatitis C was lowest among persons of Asian or Pacific Islander descent, and highest among American Indians and Alaskan natives. Black/African American persons had the highest mortality rates from HCV, at 6.5 to 7.8 deaths per 100,000.[iii]
Hepatitis C is the most common chronic bloodborne pathogen in the United States. Hepatitis C-related end-stage liver disease is the most common indication for liver transplants among U.S. adults, accounting for more than 30% of cases. Studies suggest that approximately one-half of the recently observed 3-fold increase in the incidence of hepatocellular carcinoma is related to acquisition of HCV infection 2-4 decades earlier.[iv]
Given the importance of early detection, and the increased availability of effective treatments, improved screening and surveillance of HCV will not only increase the potential for successful intervention for the patient and the physician, but also stimulate additional research and innovation.
The Forum strongly encourages CMS to take this critical step toward preventing the avoidable morbidity and mortality associated with the Hepatitis C virus.
Gary A. Puckrein, PhD
President and Chief Executive Officer
[i] Moyer, V, on behalf of the U.S. Preventive Services Task Force. Screening for Hepatitis C Virus Infection in Adults: U.S. Preventive Services Task Force Recommendation Statement, Clinical Guideline, Annals of Internal Medicine, June 25, 2013.
[ii] Smith BD, Patel N, Beckett FA, Jewett A, Ward JS. Hepatitis C virus antibody prevalence, correlates and predictors among persons born from 1945 through 1965, United States, 1999-2008 [Abstract], Hepatology, Supplement 1, 2011.
[iv] Chou R, Cottrell EB, Wasson N, Rahman B, Guide JM. Screening for Hepatitis C Virus Infection in Adults, Comparative Effectiveness Review no 69. AHRQ publication no. 12-EHC090-EF, Agency for Healthcare Research and Quality, 2012.