Source: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=272&NcaName=Screening+for+Hepatitis+C+Virus+(HCV)+in+Adults&bc=AIAAAAAACAEAAA%3D%3D
Timestamp: 2015-03-03 18:47:53
Document Index: 88297124

Matched Legal Cases: ['§1833', '§1833', '§1833', '§1833', '§1861', '§410', '§ 410', '§ 410', '§1861', '§ 1861', '§ 410', '§1833', '§1833', '§1833', '§1883', '§1833', '§ 1833', '§ 410', '§147']

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The determination of “high risk for HCV” is identified by the primary care physician or practitioner who assesses the patient's history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided. For the purposes of this national coverage determination (NCD), a primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.
For the purposes of this NCD, a “primary care physician” and “primary care practitioner” will be defined consistent with existing sections of the Social Security Act (§1833(u)(6), §1833(x)(2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)). §1833(u)
AASLD – American Association for the Study for Liver
HCV is an infection that attacks the liver and leads to inflammation. The infection is often asymptomatic and can go undiagnosed for decades. It is difficult for the human immune system to eliminate the HCV and it is a major cause of chronic liver disease. The presence of HCV in the liver initiates a response from the immune system which in turn causes inflammation. Inflammation over long periods of time (usually decades) can cause scarring, called cirrhosis. A cirrhotic liver fails to perform the normal functions of the liver, which leads to liver failure. Cirrhotic livers are more prone to become cancerous and liver failure leads to serious complications, even death. HCV is reported to be the leading cause of chronic hepatitis, cirrhosis and liver cancer and a primary indication for liver transplant in the Western World. (Rosen 2011) “The morbidity and mortality associated with chronic HCV are mainly attributable to its progression toward cirrhosis and hepatocellular carcinoma.” (Rauch 2010) About 80% of people exposed to HCV develop chronic infection and of these three to 11% will develop liver cirrhosis within 20 years. (Nelson 2011) The natural history and chronicity rates for people infected with the HCV vary. The possible outcomes of HCV are diagramed below.
Infection with HCV affects more than 180 million people globally. In 2010, the CDC estimated that 2.7 to 3.9 million persons in the United States were living with HCV. (CDC MMWR/Vol.61/No. 4 August 17, 2012) A safer blood supply along with safer injection practices among intravenous drug users contributed to a decline in the number of reported cases of HCV from 1999 – 2008. (CDC MMWR/Vol61/No. 4 August 17, 2012) “While the incidence of new hepatitis C virus cases has decreased, the prevalence of infection will not peak until the year 2040. In addition, as the duration of infection increases, the proportion of new patients with cirrhosis will double by 2020 in
an untreated patient population.” (Rodriguez-Luna and Douglas 2004)
The goal of treatment of HCV in adults is to eradicate the virus and prevent long-term complications such as cirrhosis, liver failure and hepatocellular carcinoma (Chou, Hartung 2013). In the medical literature, 100% eradication of the virus from the blood is referred to as a sustained virologic response (SVR). Very recently, another type of genotype named IL-28B has been identified as a predictor of response to treatment. The presence of IL-28B is
associated with a two-fold greater SVR in European, African American and Hispanic populations. Its presence or absence is used to determine whether to initiate treatment. The standard treatment for many years consisted of a combination of pegylated interferon and ribavirin (a.k.a., dual therapy). However, this two-drug regimen leads to numerous side effects (Gravitz 2011), which can result in discontinuation of treatment prior to completing the full course. In addition, this regimen is less effective for genotype 1, which is the predominant genotype in the U.S. (about 75% of cases) and the more difficult genotype to treat. (Chou, Hartung 2013) However, treatment of HCV for adults continues to evolve. In the past several years, FDA approved two protease inhibitors, boceprevir (Victrelis) and telaprevir (Incivek), for the treatment of genotype 1 infection. These
antivirals are commonly referred to as direct acting antivirals (DAAs). Thus, the new standard of care for previously untreated (treatment naïve) patients with genotype 1 HCV infection is 12 – 32 weeks of boceprevir or telaprevir in combination with 24 – 48 weeks of pegylated interferon and ribavirin. (Lawitz 2013) The exact duration of treatment is dictated by the patient's response to therapy as well as the stage of hepatic fibrosis. (Lawitz 2013) The use of a DAA in combination with interferon and ribavirin is commonly referred to as triple therapy. On November 22, 2013 FDA approved a third antiviral called simeprevir (Olysio), which is a protease inhibitor indicated for HCV genotype 1 infection. Simeprevir is to be administered in combination with pegylated interferon and ribavirin.
III. History of Medicare Coverage Pursuant to §1861(ddd) of the Social Security Act, the Secretary may add coverage of "additional preventive services" if certain statutory requirements are met. Our regulations provide:
(a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of “preventive services” under §410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following: (1) Reasonable and necessary for the prevention or early detection of illness or disability.
(b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations. Currently, screening for HCV is not covered by Medicare.
March 4, 2014 Posted PDM. Second 30-day public comment period begins. April 3, 2014 Second public comment period closed.
Four of the seven criteria cited above (Cochrane and Holland 1971) as reasonable and necessary for screening tests (i.e., accuracy, precision, sensitivity and specificity) reflect a screening test's ability to minimize the harm of testing inaccuracy, especially from false positive or false negative results. Screening test compliance with these criteria is within the scope of FDA review of in-vitro diagnostic devices and the FDA has only reviewed evidence on the approved label indications for these tests. Primary Care and USPSTF Recommended Preventive Services
The Institute of Medicine (IOM) has provided a definition of primary care based on the function which states: “Primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community (IOM. Primary Care: America's Health in a New Era 1996).” In discussing the value of primary care, one of the elements cited supporting this definition is that primary care “…opens opportunities for disease prevention and health promotion as well as early detection of disease….” (IOM Primary Care: America's Health in a New Era 1996) The Agency for Healthcare Research and Quality (AHRQ) has adopted the IOM definition of primary care in their primary care practice based research networks (PBRNs) (http://pbrn.ahrq.gov/portal/server.pt/community/practice_based_research_networks_%28pbrn%29__about/852). Many preventive services are discussed within the context of the primary care setting and the USPSTF reviews preventive services that should be provided in the primary care setting. Primary care providers are thought of as the initial contact for patients within a complicated health system. Primary care providers are often identified as the conduit for identifying the need for preventive services by assessing the patient's individual risk factors and developing a comprehensive prevention plan that directs patients in a coordinated manner to appropriate services to address their individual health risks and provide the most efficient utilization of health care services. B. USPSTF Grade Definitions The U.S. Preventive Services Task Force (USPSTF) assigns one of five letter grades to each of its recommendations (A, B, C, D, I). In July of 2012, the grade definitions were updated to reflect the change in definition of and suggestions for practice for the grade C recommendation. The following tables from the USPSTF website provide the current grade definitions and descriptions of levels of certainty. (http://www.uspreventiveservicestaskforce.org/uspstf/grades.htm)
B The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Offer or provide this service. C The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net
benefit is small. Offer or provide this service for selected patients depending on individual circumstances. D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service. I Statement The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of
High The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as: The number,
size, or quality of individual studies. Inconsistency
of findings across individual studies. Limited
generalizability of findings to routine primary care practice. Lack of
coherence in the chain of evidence.
available, the magnitude or direction of the observed effect could change,
Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of: The limited
2b. Is the evidence sufficient to determine that 1-time screening for hepatitis C virus infection in all adults born between 1945 and 1965 improves outcomes in the prevention or early detection of illness or disability? 2c. Is the evidence sufficient to determine that 1-time screening for hepatitis C virus infection in all adults born between 1945 and 1965 is appropriate for Medicare beneficiaries?
For goal three, data for determining the diagnostic accuracy and yield of risk-based screening methods were based on four cross-sectional studies that were rated "Fair" and one case-control study rated as "Poor." Two cross-sectional studies were conducted in sexually-transmitted disease clinics and the remaining cross-sectional studies were conducted in urban primary care clinics. A wide variety of screening strategies were examined within and across each study. The demographic profile of the study population for each study also varied widely. The authors did not perform a subset analysis based on age or report results based on age. However, the authors' evidence table for these five studies (as provided in the full report) indicated that for each study the majority of the patient population was less than 65 years of age. The cross-sectional study with the lower-prevalence population "found that screening based on presence of 1 or more positive items on a 20-item questionnaire was associated with a sensitivity of 90% for identifying persons with HCV infection and a number needed to screen to identify 1 case of HCV infection of 2.4." The "Three cross-sectional studies in higher-prevalence populations found that screening strategies targeting multiple risk factors were associated with sensitivities of more than 90% and numbers needed to screen of 9.3 to 18." The authors noted that "More narrowly targeted screening strategies evaluated in these studies were associated with specificities of more than 95% and numbers needed to screen of less than 2, but missed up to two thirds of infected patients."
"The USPSTF found no direct evidence on the benefit of screening for HCV infection in asymptomatic adults in reducing morbidity and mortality. However, the USPSTF found adequate evidence that antiviral regimens result in sustained virologic response (SVR) and improved clinical outcomes." "The USPSTF found inadequate evidence that counseling or immunization of patients with HCV infection against other infections improves health outcomes, reduces transmission of HCV, or changes high-risk behaviors. The USPSTF found inadequate evidence that knowledge of positive status for HCV infection reduces high-risk behaviors. The USPSTF also found inadequate evidence that labor management and breastfeeding strategies in HCV-positive women are effective at reducing risk for mother-to-child transmission."
The authors noted that "evidence was found in the literature for all-cause mortality, HCC, SVR, SAEs, QoL" but not for HCV transmission. For the QoL outcome, the authors judged the quality of evidence to be "low" due to limited availability and study design. For all-cause mortality, the authors identified 22 relevant articles however 21 of these did not meet the inclusion criteria due to "insufficient sample sizes, unrepresentative study population, and other sources of confounding." Only one (Backus 2011) was directly applicable to the targeted birth cohort. Backus 2011 reported "that treatment-related SVR was associated with a reduction in risk for mortality among persons who had HCV infection diagnosed (Relative risk [RR] = 0.45; 95% CI = 0.41 - 0.51)." However, the authors noted that "this study only compares persons who responded to therapy with those who did not respond and does not address a screened population or an untreated population. Differences in stage of liver disease between the groups had the potential to bias these finds, but those data were not available. Therefore, the confidence in the estimate of effect was deemed to be low, and no change in rating of the quality of evidence was performed despite a large estimated treatment effect."
Regarding SVR, the authors noted that the combination of pegylated interferon plus ribavirin (PR) and first generation direct-acting antiviral agents (DAA) "increases the rate of SVR in treated persons with hepatitis C genotype 1 when compared with PR alone. Pooled estimates comparing boceprevir- and telaprevir-based regimens with PR suggest that these regimens are associated with 28% increases in SVR rates (RR = 0.28, 95% CI = 0.24 - 0.32). Although SVR was initially judged by the Work Group to be directly associated with patient-important outcomes (e.g., reduced viral transmission), further deliberation resulted in SVR being defined as an intermediary outcome
that is predictive of a reduction in morbidity and mortality, particularly from HCC."
Risk-based screening 50% 10.9% $59,938 13.50 $4439 n/a General population (15% screened) 58% 12.1% $60,269 13.54 $4450 $7900 over risk factor based screening 1945 - 1965 birth cohort (15% screened) 62% 12.6% $60,180 13.56 $4438 $5400 over risk factor based screening
The authors concluded that "Birth-cohort screening for HCV in primary care settings was cost-effective" and that it "seems to be a reasonable strategy to identify asymptomatic cases of HCV." 4. Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Meeting.
As we state in section VII of this decision memorandum, the USPSTF conducts rigorous reviews of the evidence to create evidence-based recommendations for preventive services in the primary care setting. The primary audience for the USPSTF's work are primary care clinicians. Conceivably, state and local health clinics, family planning clinics, or other specialists, if they are functioning as the primary care provider/practitioner for a Medicare beneficiary, could be eligible to order screening for HCV if they meet the definition of primary care setting provided in this NCD and are eligible Medicare providers. This NCD requires that the HCV screening test be ordered by the primary care provider/practitioner. This NCD does not require the testing be done by the primary care provider/practitioner. CMS believes that primary care practitioners are on the front lines of health care in providing prevention services. As preventive services gain recognition of their potential to improve the health status of the individual, we believe the primary care provider is in the unique position to provide a comprehensive and coordinated approach to Medicare beneficiaries' health care and this coordinated approach will help ensure the best outcomes for these services. In addition, this coverage decision for screening for HCV in adults is for Medicare beneficiaries, of which many have comorbid conditions that require multiple interactions with the healthcare system. Thus, primary care practitioners may need to carefully evaluate the results of the screening test in determining the patient's overall treatment plan. In addition, since this is a one-time screening benefit for most patients, it becomes more important to coordinate care to and avoid the unnecessary duplication and non-coverage of excessive screening tests. Comment: One commenter expressed that the limitation of coverage to screenings recommended by primary care practitioners in a primary care setting was inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. They stated that the initial preventive physical exam (IPPE) or subsequent annual wellness visits (AWV) are not limited to primary care providers or in primary care settings. They further stated that the Secretary's “authority to authorize NCDs to designate “additional preventive services” is not limited to authorization of services performed only in a primary care setting.”
Response: We do not agree that our requirement that the screening test must be ordered by primary care practitioners in a primary care setting is inconsistent with the Medicare regulations for additional preventive services codified at 42 C.F.R. § 410.64. It is true that the IPPE and AWV are established by separate statutes and regulations that have different requirements with respect to the suppliers that can furnish those
services. See 42 C.F.R. §§ 410.16, 410.15 respectively. While some preventive services, such as the IPPE and AWV are specifically provided for in statute, screening for HCV in adults is established through the NCD process pursuant to §1861(ddd) of the Social Security Act. As we have explained previously, CMS may add coverage of "additional preventive services" if certain statutory requirements are met. We have further explained our reasoning for the requirement that the screening for HCV be ordered by a primary care practitioner within the context of a primary care setting in our responses to comments and in the analysis section of the decision memorandum. Comment: One commenter expressed concern about the primary care requirement used in earlier national coverage determinations that are not currently being reconsidered and do not relate to hepatitis C screening in adults. Some other commenters identified other coverage for screening (e.g., screening for prostate cancer) that did not include the primary care requirement.
Response: Public comments about previous “additional preventive services” NCDs that are not currently being reconsidered are not within the scope of the current decision. Prostate cancer screening tests were established by statute under part B (§ 1861(oo)) and are not “additional preventive services.” Our regulations do establish qualifications for physicians and other practitioners for prostate cancer screening services that require that the physician or specified practitioner be “fully knowledgeable about the beneficiary” and be responsible for explaining the results of the screening examination or test. 42 C.F.R. § 410.39(a)(3). Although different language is used in the regulation, the requirement of a primary care physician or practitioner in a primary care setting in this NCD serves a similar function. Other General Issues
Response: We appreciate the suggestions. CMS routinely updates the informational and educational materials provided to our beneficiaries and providers to reflect the benefits that are available under the Medicare program. Comments: One commenter recommended the use of one CPT code to reflect the provision of the HCV screening. The commenter expressed that this code would ensure accurate and appropriate billing for health care providers. Another commenter suggested that a G code be created.
Response: We appreciate the comment. This NCD does not address specific coding and billing instructions for this service. The NCD establishes conditions for coverage. Comments: One commenter was concerned about the definition of “high risk” as it refers to “illicit” injection drug use. The commenter expressed that the use of the term “illicit” had a negative connotation and stigma attached to it and suggested the language be changed to remove the word “illicit”. Other commenters requested that CMS align our definition of “high risk” with the USPSTF or CDC recommendations.
Response: CMS provides the link to the FDA in Vitro Diagnostics database as a convenience for the reader. Comment: One commenter requested confirmation that coverage is for screening specifically and that follow-up confirmation testing (i.e., nucleic acid tests) is addressed under a separate coverage decision.
CMS notes that any effect of the use of these screening tests is their coordination with treatment. CMS concludes that FDA approval or clearance of screening tests used consistent with FDA approved labeling provides a greater likelihood that a potential harm of screening testing, that is, taking action based on inaccurate screening test results, can be avoided. We further conclude that compliance by testing laboratories with CLIA regulatory requirements provides an additional, on-going safeguard for screening test quality. CMS considers these conditions essential to maximize patient safety. In addition, CMS acknowledges that the USPSTF is charged with conducting rigorous reviews of scientific evidence to create evidence-based recommendations for preventive services that should be provided by primary care physicians and practitioners in primary care settings. In addition, the USPSTF Procedure Manual outlines the process for evaluating the quality and strength of the evidence for a service, determining the net health benefit (benefits minus harms) associated with the service, and judging the level of certainty that providing these services will be beneficial in primary care.
1a. Is the evidence sufficient to determine that screening for hepatitis C virus infection in all persons at high risk for infection is recommended with a grade of A or B by the USPSTF? USPSTF Summary of Recommendation (2013)
1b. Is the evidence sufficient to determine that screening for hepatitis C virus infection in all persons at high risk for infection improves outcomes in the prevention or early detection of illness or disability? CMS recognizes that the hepatitis C virus is the “most common chronic bloodborne pathogen in the U.S.” (Moyer 2013) According to the USPSTF, the “most important risk factor for HCV infection is past or current injection drug use, with most studies reporting a prevalence of 50% or more.” (Moyer 2013) In addition, “60% of new HCV infections occur in persons who report injection drug use within the past 6 months.” (Moyer 20132) Some of the evidence based guidelines specifically identify illicit or illegal injected drug use as the behavior that is considered high risk for infection. (CDC guidelines and AASLD guidelines) Additional risk factors include long-term hemodialysis, history of hemophilia, history of blood transfusion before 1992, getting an unregulated tattoo, and other percutaneous exposures (such as in health care workers). (Moyer 2013) In the USPSTF recommendation statement, in updating the previous recommendation, the USPSTF described the high-risk group as a HCV antibody prevalence of > 50%. The USPSTF identified the prevalence of the different risk groups as: injection drug users and persons with hemophilia (60% to 90%); patients receiving hemodialysis (10% to 30%); persons engaging in high-risk sexual behavior (1% to 10%); recipients of blood transfusions (6%); and persons with infrequent exposures, such as health care workers (1% to 2%). (USPSTF Screening for Hepatitis C Virus Infection in Adults, Recommendation Statement 2013) Thus, CMS concludes the high-risk population is best described as the injection drug users (current or past) and persons who had a history of blood transfusions or blood product transfusions prior to 1992. CMS notes that the USPSTF concluded “with moderate certainty” that HCV screening in adults at increased risk for infection has “moderate net benefit.” (Moyer 2013) However, as Moyer 2013 noted, there is “No evidence about how often screening should occur for persons who continue to be at risk for new HCV infection.” Neither the CDC (CDC MMWR Vol.61/No. 4 August 17, 2012; CDC 1998) nor the clinically-based guidelines from the professional societies addressed the issue of screening frequency in this particular population except to recommend “routine” screening; however, “routine” is not defined. In general, screening is only recommended if treatment of the disease at an earlier stage is more beneficial, in terms of health outcomes, than at a later stage (Wilson and Jungner 1968). Since the USPSTF recommendation and CDC evidence-based guidelines recommend screening for hepatitis C for individuals at high risk of infection, it is implicit that an appropriate treatment is available for these individuals. Since there is no guidance on the frequency of screening for the high risk population, CMS has determined that repeated screening would be appropriate annually for beneficiaries with continued high risk behavior, illicit injection drug use, since the previous negative screening test. Results from cost-effectiveness studies generally support the USPSTF conclusion. (Liu 2013; Coffin 2012; Rein 2012) Of note, both Liu 2013 and Coffin 2012 noted that cost-effectiveness is dependent on the capacity of the healthcare system, particularly with regards to the pace of adoption of the HCV recommendations by healthcare professionals, the delivery of prompt and effective antiviral treatment and access to appropriate post-diagnostic, non-antiviral interventions. After careful review of the available body of evidence, we conclude that screening for hepatitis C virus infection in all persons at high risk for infection provides improved outcomes in the prevention or early detection of illness or disability.
1c. Is the evidence sufficient to determine that screening for hepatitis C virus infection in all persons at high risk for infection is appropriate for Medicare beneficiaries? The majority of the Part B Medicare beneficiary population is comprised of persons aged 65 years and older while a smaller percentage of the beneficiary population is comprised of the disabled, and those persons in the ESRD program. We note that the non-birth cohort-related USPSTF recommendation for this screening preventive service is based on risk factors and therefore would be applicable to any Medicare beneficiary, regardless of age. CMS notes that the USPSTF, CDC and professional societies do not specifically address the various aspects of screening for the 65 year old and older population. CMS believes that the 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. While the number of beneficiaries 65 years and older enrolled in the published studies is relatively small, CMS believes that the results are generalizable to the 65 years and older population. After careful review of the available body of evidence, we conclude that screening for hepatitis C virus infection in all persons at high risk for infection is appropriate for Medicare beneficiaries.
2b. Is the evidence sufficient to determine that 1-time screening for hepatitis C virus infection in all adults born between 1945 and 1965 provides improved outcomes in the prevention or early detection of illness
or disability? CMS recognizes that persons in the 1945 - 1965 birth cohort “are more likely to be diagnosed with HCV infection, possibly because they received blood transfusions before 1992 or have a history of other risk factors for exposure decades earlier.” (Moyer 2013) CMS also acknowledges that many of these persons may be asymptomatic and thus unaware that they are infected with the virus. As noted by the USPSTF, “A risk-based approach may miss detection of a substantial proportion of HCV-infected persons in the birth cohort because of a lack of patient disclosure or knowledge about prior risk status.” (Moyer 2013) About 75% of persons in the U.S. living with HCV infection are in the 1945 – 1965 birth cohort; the peak prevalence is 4.3% in persons who were 40 to 49 years old during 1999 – 2002. (Moyer 2013)
The majority of the Part B Medicare beneficiary population is comprised of persons aged 65 years and older while a smaller percentage of the beneficiary population is comprised of the disabled, and those persons in the end-stage renal disease (ESRD) program. We note that as of the date of this final decision memorandum the majority of persons in the 1945 - 1965 birth cohort have yet to reach the age of 65 years. However, about 75% of persons in the U.S. living with HCV infection are in this birth cohort with a peak prevalence of 4.3% in persons who were 40 to 49 years old during 1999 – 2002. (Moyer 2013) Thus, a significant number of currently infected but asymptomatic future Medicare beneficiaries over time may have a progression of their HCV infection to serious and potentially life-threatening complications including cirrhosis, liver failure, HCC and death. The USPSTF noted that HCV infection “is the leading cause of complications from chronic liver disease, and HCV-related end-stage liver disease is the most common indication for liver transplants among U.S. adults. It is estimated that the total number of patients with cirrhosis will peak at 1 million in 2020; however, rates of hepatic decompensation and liver cancer are expected to increase for another 10 to 13 years because of the lengthy lag time between infection and development of cirrhosis and other complications.” (Moyer 2013) CMS notes that the USPSTF, CDC and professional societies do not specifically address the various aspects of screening for the 65 year old and older population. We acknowledge the limited evidence concerning health outcomes of HCV screening. 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. While the number of beneficiaries 65 years and older enrolled in the published studies is relatively small, CMS believes that the results are generalizable to the 65 years and older population. In general, screening is only recommended if treatment of the disease at an earlier stage is more beneficial, in terms of health outcomes, than at a later stage (Wilson and Jungner 1968). After careful review of the available body of evidence, we conclude that 1-time screening for hepatitis C virus infection in all adults born between 1945 and 1965 is appropriate for Medicare beneficiaries.
Primary Care and USPSTF Recommended Preventive Services CMS believes the primary care setting and the primary care provider are integral in the coordination of preventive services. The USPSTF creates evidence-based recommendations for preventive services that should be provided in the primary care setting by evaluating the quality and strength of the evidence for a service, determining the net health benefit (benefits minus harms) associated with the service, and judging the level of certainty that providing these services will be beneficial in primary care. (2012 USPSTF Clinical Preventive Services Guide)
CMS believes that preventive services should be provided within the context of a coordinated prevention plan based on the individual patient's needs assessed over time through the ongoing relationship established with the primary care provider. The IOM provides a definition of primary care (IOM. Primary Care: America's Health in a New Era 1996) and existing sections of the Social Security Act (§1833(u)(6), §1833(x)(2)(A)(i)(I) and §1833(x)(2)(A)(i)(II)) further defines primary care practitioners. The IOM further identifies one of the values of primary care as the opportunity for disease prevention and health promotion. Based on the charge of the USPSTF in evaluating services provided in the primary care setting, CMS concludes referrals for the USPSTF recommended screenings for HCV for the specific populations should be ordered by the beneficiary's primary care provider in the primary care setting. CMS also believes that the IOM definition of primary care and the role of primary care in disease prevention and health promotion certainly supports that the risk assessment and referral for these screening services is best coordinated by the primary care provider in the primary care setting. CMS concludes that the integrated and efficient utilization of these screening tests are best coordinated by the beneficiary's primary care provider and based on an evaluation of the patient risk factors and the appropriate referral and/or initiation of treatment. We are not indicating that the test itself must be performed by a primary care practitioner.
Screening for HCV infection provides direct benefit to the Medicare beneficiary. Test results inform the treatment of an existing infection and such treatment can also prevent future health consequences. CMS concludes the high risk population is best described as illicit injection drug users (current or past) and persons who have a history of receiving a blood transfusion prior to 1992. In addition, CMS concludes that repeated screening would be appropriate annually for beneficiaries with continued high risk behavior, e.g. needle sharing and/or syringe sharing, since the previous negative screening test. CMS also concludes that referral for screening for HCV infection is best ordered by the beneficiary's primary care provider within the context of a primary care setting.
IX. Conclusion The CMS has determined the following:
The determination of “high risk for HCV” is identified by the primary care physician or practitioner who assesses the patient's history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided. For the purposes of this decision memorandum, a primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.
1 See e.g., The American Association for the Study of Liver Disease and Infectious Disease Society of America, “HCV Testing and Linkage to Care,” available at: http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care (last visited Mar. 31, 2014); and Centers for Disease Control, “Who Is At Risk for Hepatitis C?,” available at: http://www.cdc.gov/hepatitis/c/cfaq.htm (last visited Mar. 31, 2014). 1 Arora S, Thornton K, Murata, Deming P, Kalishman S, Dion D, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med 2011; 364:2199-2207. 2 Mahajan R, Xing J, Liu SJ, Ly KN, Moorman AC, Rupp L, Xu F, Holmberg SD; for the Chronic Hepatitis Cohort Study (CHeCS) Investigators. Mortality Among Persons in Care With Hepatitis C Virus Infection: The Chronic Hepatitis Cohort Study (CHeCS), 2006-2010. Clin Infect Dis. 2014 Mar 8. [Epub ahead of print] 3 Rein DB1, Wittenborn JS, Weinbaum CM, Sabin M, Smith BD, Lesesne SB. Forecasting the morbidity and mortality associated with prevalent cases of pre-cirrhotic chronic hepatitis C in the United States. Dig Liver Dis. 2011 Jan;43(1):66-72 4 V. Lijewski, et a., Division of Epidemiology and Immunization, Bureau of Infectious Disease, Massachusetts Department of Public Health, “Mortality trends Among People Diagnosed with Hepatitis C Virus Infection: Massachusetts 1992-2009.” Abstract Submitted to the Council of State and Territorial Epidemiologists, fall 2012. 5 Regulations require that both the Initial Preventive Physical Exam (IPPE) and Annual Wellness Visits (AWVs) be performed by qualified health professionals, including physicians and/or other qualified non-physician practitioners. Physician in this context is defined by statute as a doctor of medicine or osteopathy, with no specification related to primary care as would be found in §1883(u)(6), §1833(x)(2)(A)(i)(I) or § 1833(x)(2)(A)(i)(II) of the Social Security Act. (See 42 CFR §§ 410.15-16). 6 Centers for Disease Control and Prevention, Locations and Reasons for Initial Testing for Hepatitis C Infection- Chronic Hepatitis Cohort Study, United States, 2006-2010, MMWR Morb Mortal Wkly Rep. 2013, Aug. 16; 62(32):645-8.
7 Tohme RA, Xing J, Liao Y, Holmberg SD. Hepatitis C testing, infection, and linkage to care among racial and ethnic minorities in the United States, 2009–2010, Am J Public Health 2013; 103:112–9. 8 Lowry, Fran, Babyboomer Hep C Screening Practical in Emergency Rooms, (Mar. 20, 2014), available at: http://www.medscape.com/viewarticle/822310.
9 See e.g. Cisneros GO1, Douaihy AB, Kirisci L. Access to Healthcare Among Injection Drug Users at a Needle Exchange Program in Pittsburgh, PA. J Addict Med. 2009 Jun; 3(2):89. 10 New York Department of Health, NYS Hepatitis C Testing Law Frequently Asked Questions, available at: https://www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_c/rapid_antibody_testing/faqs.htm#quest_3
12 See Transmittal 131, “Screening for the Human Immunodeficiency Virus (HIV) Infection,” (Feb, 23, 2011), available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R131NCD.pdf. 13 See Transmittal 126, “Counseling to Prevent Tobacco Use,” (Sept. 30, 2010), available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R131NCD.pdf 14 For instance, insurers may use “established techniques and the relevant evidence base” to implement “reasonable medical management techniques to determine the frequency, method, treatment, or setting” for a preventive service recommended by the USPSTF, ACIP, or HRSA to the extent not specified by those bodies. This regulation therefore implies that there is not a pre-established setting in which USPSTF guidelines must be implemented. (See 75 FR 41726 (Jul. 19, 2010), 41728-9; 45 CFR §147.130(a)(iv)(B)(4)(4)). Moreover, CMS has not provided any reference to a “relevant evidence base” with respect to its primary care restriction. References:
2. Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C virus infection among persons born between 1945-1965. Morbidity and Mortality Recomm Rep 2012; 61:1-1 3. Ly KN, Xing J, Klevens RM et al. The increasing burden of mortality from viral hepatitis in the United States between 1999-2007. Ann Intern Med 2012; 156:271-8
5. Ferrante JM, Winston DG, Chen PH, de la Torre AN. Family physicians' knowledge and screening of chronic hepatitis and liver cancer. Fam Med 2008;40:345–51; Shehab TM, Sonnad SS, Jeffries M, Gunaratnum N, Lok AS. Current practice patterns of primary care physicians in the management of patients with hepatitis C. Hepatology 1999;30:794–800; Shehab TM, Sonnad SS, Lok AS. Management of hepatitis C patients by primary care
physicians in the USA: results of a national survey. J Viral Hepat 2001;8:377–83.
6. Ghany MG, Strader DB, Thomas DL, Seeff LB, American Association for the Study of Liver D. Diagnosis, management, and treatment of hepatitis C: an update. [Practice Guideline.] Hepatology 2009;49:1335–74; Ghany M, Nelson D, Strader D, Thomas D, Seeff L. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology 2011;54:1433–44. 7. Kallman JB, Arsalla A, Park V, et al. Screening for hepatitis B, C and non-alcoholic fatty liver disease: a survey of community-based physicians. Aliment Pharmacol Ther 2009;29:1019–24.
2 2 Coffin, Phillip O, Stevens, Anne M, et al. "Patient acceptance of universal screening for hepatitis C infection." BMC Infectious Diseases. June 2011. 3 Ward JW. The epidemiology of chronic hepatitis C and one-time hepatitis C virus testing of persons born during 1945 to 1965 in the United States. Clinical Liver Dis. 2013; 17:1-11.
13 Brillman JC, Crandall CS, Florence CS, et al. Prevalence and Risk Factors Associated with Hepatitis C in ED Patients. Am J Emerg Med. 2002;20(5):476-80. i Celum, C., Bolan, G., et al. Patients Attending STD Clinics in an Evolving Health Care Environment: Demographics, Insurance Coverage, Preferences for STD Services and STD Morbidity. Sexually Transmitted Diseases. 1997 November. Volume 24, Number10, pp. 599-605. ii Centers for Disease Control and Prevention, Locations and Reasons for Initial Testing for Hepatitis C Infection- Chronic Hepatitis Cohort Study, United States, 2006-2010, MMWR Morb Mortal Wkly Rep. 2013, Aug. 16; 62(32):645-8.
References 1Spradling PR, Rupp L, Moorman AC, Lu M, Teshale EH, Gordon SC, et al. Hepatitis B and C virus infection among 1.2 million persons with access to care: factors associated with testing and infection prevalence. Ann Intern Med. 2012; 55(8):1047-55.
2Southern WN, Drainoni ML, Smith BD, Christiansen CL, McKee D, Gifford AL, et al. Hepatitis C testing practices and prevalence in a high-risk urban ambulatory care setting. J Viral Hepat. 2011;18:474-81. 3Volk ML, Tocco R, Saini S, Lok AS. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50:1750-5.
4Roblin DW, Smith BD, Weinbaum CM, Sabin ME. HCV screening practices and prevalence in an MCO, 2000-2007. Am J Manag Care. 2011;17:548-55. 5NACCHO. (2013). Local Health Department Job Losses and Program Cuts: Findings from the 2013 Profile Study. Retrieved March 28, 2014 from http://www.naccho.org/topics/infrastructure/lhdbudget/upload/Survey-Findings-Brief-8-13-13-2.pdf.
The determination of “high risk for HCV” is identified by the primary care physician or practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness
visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided. For the purposes of this decision memorandum, a primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.
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Chou R, Hartung D, Rahman B, et al. Treatment for hepatitis C virus infection in adults. Comparative effectiveness review, No. 76. (Prepared by the Oregon Evidence-based Practice Center under Contract No. 290-2007-10057-1) Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, Rockville, MD. 2012 November. Report No. 12(13)-EHC113-EF. Accessed at http://www.effectivehealthcare.ahrq.gov/ehc/products/286/1298/CER76_HepatitisC-Treatment_FinalReport_20121022.pdf on January 8, 2014. Cochrane A and Holland W. Validation of screening procedures. British Medical Bulletin 1971;27(1):3-8. PMID: 5100948. Coffin PO, Scott JD, Golden MR and Sullivan SD. Cost-effectiveness and population outcomes of general population screening for hepatitis C. Clinical Infectious Diseases 2012;54:1259.
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