MCR-1 GENE ISOLATEDMCR-1 gene isolated from human for first time in Brazil.
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244
RE: National Coverage Analysis on Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)
The American Society for Microbiology (ASM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services National Coverage Analysis on Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N) issued on September 5, 2013. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents over 38,000 microbiologists professionally employed in a variety of areas, including biomedical, agriculture and environmental microbiology, as well as public health and clinical microbiology and immunology.
ASM members play important roles in many areas of clinical laboratory medicine. ASM professionals include directors of clinical microbiology, immunology and molecular diagnostic laboratories; individuals licensed or accredited to perform laboratory testing; researchers involved in developing and evaluating laboratory diagnostic tools; and industry representatives marketing products for clinical use. The ASM also includes clinician members involved in infectious disease prevention and management and members dealing with public health issues pertaining to infectious diseases. Therefore, the ASM has significant interest in the process of establishing national coverage decisions for medically necessary procedures including infectious disease screening and prevention in select circumstances to ensure the health and well-being of all Medicare beneficiaries.
ASM supports the proposals outlined in CAG-00436N to expand preventive services coverage to include screening for HCV in the groups identified in the 2013 United State Preventive Services Task Force (USPSTF) recommendations (5). We support the strategy outlined to offer screening services on a periodic basis for individuals identified at risk based on exposure potential and as a one-time testing event in the age cohort of individuals born between 1945 and 1965. It should be noted that these recommendations are now in line with previous recommendation issued by the Centers for Disease Control and Prevention in 2012, also supported by ASM (1).
The epidemiology of HCV infection in the U.S. is such that expanded Hepatitis C Virus screening can promote opportunities for both patient care improvement and public health benefit (6). Chronic hepatitis infections remain a major health problem in the U. S. with an estimated 2.7 to 3.9 million individuals affected (4). Without timely diagnosis and treatment, 15-40% of patients will progress to cirrhosis or liver cancer, and HCV is the leading reason for liver transplantation. In addition, many individuals remain asymptomatic for long periods and 45-85% are unaware that they have an HCV infection (8). Thus, failure to identify infected individuals is a major contributing factor to disease progression as well as to ongoing transmission. A strategy to provide coverage for screening for HCV infection in Medicare beneficiaries is expected to reduce morbidity and mortality associated with HCV infections, reduce costs associated with chronicity and long term complications, and reduce the potential for both transmission and for risk-related exposure situations.
With regard to testing strategies, ASM strongly supports the USPSTF recommendations to employ a 2- step approach with initial anti-HCV antibody testing followed by a nucleic acid amplification test (NAAT) to identify antibody positive patients who have a currently active infection (5). This recommendation is in compliance with previous guidance outlined by the CDC for testing for HCV infection (3). The testing strategy is a true reflex situation as defined by the Office of the Inspector General which “occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate” (7). For HCV screening, the initial anti-HCV antibody test indicates that an individual has likely been infected with HCV, and the reflex NAAT establishes that the infection remains current. Current infections indicate a need for appropriate counseling and link to medical care and treatment. Current infections also place the individual at risk for disease progression in the absence of effective therapeutic intervention and at risk to transmit the infection via a high risk exposure situation. As a valid reflex strategy, a national coverage decision must allow for reimbursement for both the initial HCV antibody test as well as the reflex HCV NAAT procedure. It is of note that in as many as 1/3 to 1/2 of antibody positive patients, there is an apparent failure to obtain the NAAT required to establish a current infection thus reinforcing the need for a coverage policy to address both test procedures (2).
In addition, patients who are identified as HCV antibody positive with negative HCV NAAT test results still require counseling regarding implications of the results. Because biological false positives may occur, repeat testing by a second unique antibody test may be required to firmly establish a true past infection. It is strongly recommended that these tests, initial and subsequent, be separately codeable. A precedent for this recommendation may be found with other significant infections where biological false positivity is a concern including syphilis and HIV infection (3).
With regard to frequency, ASM supports a one-time benefit for the birth cohort group. For individuals who exhibit risk behaviors, we urge CMS to be expansive and inclusive in identifying risk behaviors or settings. Risk factors should include at a minimum those described by the USPSTF including IV drug use, hemodialysis, tattoos obtained in an unregulated environment, other percutaneous needle exposure situations, co-existing HIV infection, incarceration, intranasal drug use, and high risk sexual exposure (5). As recommendations for periodicity for testing in these individuals is lacking, we also urge CMS to establish coverage policies that encourage testing and suggest that testing at least annually be allowed. As HCV infection and Human Immunodeficiency Virus (HIV) infection commonly occur concomitantly, it is reasonable for the frequency be comparable to the annual HIV screening benefit described in CAG-00409N.
The claims processing requirements for the HIV screening benefit serves as a model for claims processing for an HCV screening benefit (http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM6786.pdf) and we recommend that CMS establish G-codes that identify the required tests for reliable screening for HCV infection to guide subsequent patient management strategies.
Thank you for your attention. Please feel free to contact ASM if there are additional questions we can assist with or concerns requiring clarification.
Vickie S. Baselski, Ph.D.
Chair, Committee on Professional Affairs