Screening for Hepatitis C Virus (HCV) in Adults

April 3rd, 2014

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Screening for Hepatitis C (HCV) in Adults (CAG-00436N)

Dear Ms. Jensen,

Boehringer Ingelheim Pharmaceuticals, Inc. (BI) is pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) regarding its recently proposed decision memo on screening for the Hepatitis C virus (HCV) in adults as published on the CMS website March 4, 2014.

BI is a leading global research organization with extensive expertise developing therapies to treat a variety of chronic and life threatening diseases, including an emerging focus on HCV. We are committed to ensuring that our patients have access to innovative medical treatments. We therefore appreciate the opportunity to submit the following comments for your consideration to ensure that the final National Coverage Determination (NCD) supports access for high risk patients to HCV screening tests and is aligned with the extensive clinical evidence and consensus guidelines endorsing HCV screening for at risk populations.

BI commends CMS' efforts to develop a uniform coverage policy for HCV screening for Medicare beneficiaries in support of access to critical treatments. HCV is one of the most common blood borne infections in the United States.¹ Between 2.9 and 3.7 million peoplein the United States are infected with HCV, and approximately 45-85 percent of these patients are unaware of their infection.^2,3 Screening plays a critical role in diagnosing HCV, allowing for timely and appropriate treatment of infected individuals, and possibly reducing further transmission of the virus.

BI Encourages Expansion of Screening Coverage to Align More Closely with the United States Preventive Services Task Force (USPSTF) and Other Evidence-Based Organizations

As the agency is aware, in June 2013 USPSTF issued an updated Grade B recommendation statement recommending screening for HCV in all high-risk adults, and a one-time screening for individuals born between 1945 and 1965.⁴ Several other professional societies and governmental organizations have also issued consensus guideline recommendations endorsing HCV screening for these two patient populations; these groups include: the American Association for the Study of Liver Disease (AASLD), the Infectious Diseases Society of America (IDSA), the American College of Gastroenterology (ACG), and the Center for Disease Control (CDC).^5,6,7,8 BI fully supports the USPSTF's updated recommendation and encourages CMS to finalize a coverage policy fully aligned with the Task Force's recommendations, specifically with regards to the definition of "high risk."

Clinical evidence has long documented the importance of screening high-risk individuals for HCV. In this context, "high-risk" is defined as individuals who;

• inject drugs (past or present)
• engage in unprotected sexual intercourse with multiple partners (past or present)
• received blood transfusions prior to 1992
• receive long-term hemodialysis
• are born to an HCV infected mother
• have been incarcerated
• engage in intranasal drug use
• received an unregulated tattoo

CMS' proposed coverage policy narrowly defines the high-risk patient category to include only those patients with a history of past or current intravenous drug use or who have received a blood transfusion prior to 1992. While BI strongly supports the inclusion of those two risk factors, limiting the definition of "high risk" to only two of the eight risk factors listed by the USPSTF may lead to asymptomatic patients in high risk groups remaining misdiagnosed or undiagnosed. A lack of awareness about their disease status may result in increased utilization of high-cost healthcare services, losses of economic productivity, and suboptimal health outcomes.^9,10 For example, treatment for HCV-related cirrhosis costs between $14 million to $2 billion.¹¹ HCV screening, when accompanied by appropriate care and treatment, can reduce the risk of hepatocellular carcinoma by 70 percent and all-cause mortality by 50 percent,¹² alleviating some of these associated costs. We recognize CMS has prioritized coverage for patients with the two risk factors due to the higher prevalence of HCV among these populations (greater than 50 percent); however, we feel this may exclude patients who could benefit from screening and recommend CMS expand coverage to include all risk factors considered in USPSTF's final recommendation in line with evidence presented in evidence-based clinical practice guidelines.

In addition to concerns regarding the prevalence of misdiagnosed and undiagnosed highrisk patients, inconsistencies between guideline-recommended care and services covered under CMS may cause confusion to providers, and subsequently impact their ability to provide the highest quality of evidence-based care.

BI Encourages CMS to Expand the Coverage Policy to Include Patient Care Settings Beyond the Primary Care Setting

The coverage policy proposed by CMS creates a defined limit in patient coverage, specifically restricting orders to only primary care providers for high-risk group screening. This limitation creates an additional barrier to effective HCV screening which is not in alignment with the USPSTF recommendation's intent of patient screening or the current practice of medicine.

Patients who do not have or do not typically visit a primary care provider are often seen in hospital emergency rooms or urgent care centers. Providers assisting a patient presenting with HCV risk factors would be required to refer the patient to a primary care provider for screening, for which they may not have access to. Research has demonstrated a need for screening in other care settings, particularly during emergency department visits. One study found that in an analysis of 223 blood samples taken from emergency department patients, 18 patients were positive for HCV, 12 of which were new diagnoses.¹³ By limiting screening coverage to a specific provider type, poor access to primary care providers may cause significant patient populations to remain undiagnosed and untreated, increasing the likelihood for poor patient outcomes and increased economic burden.

Similarly, limiting coverage for patient screening to primary care providers inhibits specialists who are most able to make an assessment regarding appropriate follow-up treatment and screening. Specialists such as hepatalogists, gastroenterologists, HIV specialists, infectious disease specialists, and addiction specialists who have specific expertise in diagnosing and treating patients with HCV, are well-positioned to conduct point-of-care screening for high-risk patients. Excluding these specialists as eligible providers under this draft coverage policy significantly limits the opportunity to screen high-risk patients, which may lead to delayed diagnoses and treatments initiation.

BI appreciates the opportunity to comment on CMS' Proposed Decision Memorandum on the NCD for HCV screening in adult patients. We strongly encourage CMS to adopt a coverage policy supporting HCV screening in all high-risk adult patients identified by the USPSTF HCV recommendation and support patient access in provider screening. We look forward to working with CMS to improve HCV preventive services and care delivery, and to ensuring continued beneficiary access to high quality care.

Respectfully submitted,

SENT ELECTRONICALLY

Dr. Sabine Luik
Regional Medical Director-US
Senior Vice President, Medicine and Regulatory
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
PO Box 368
Ridgefield, CT 06877-0368

SENT ELECTRONICALLY

Paul Romness
Vice President, Government Affairs & Public Policy
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
PO Box 368
Ridgefield, CT 06877-0368

1 USPSTF Recommendation Statement: Screening for Hepatitis C Infection in Adults. Release date- June 25, 2013. Available online at: http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm#ref19
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.
4 USPSTF Recommendation Statement: Screening for Hepatitis C Infection in Adults. Release date- June 25, 2013. Available online at: http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm#ref19
5 Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335-74.
6 European Paediatric Hepatitis C Virus Network. Three broad modalities in the natural history of vertically acquired hepatitis C virus infection. Clin Infect Dis. 2005; 41(1):45-51.
7 Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006; 130(1):225-30.
8 Centers for Disease Control and Prevention. Recommendations for the prevention and control of hepatitis C (HCV) infection and HCV-related chronic disease. MMWR Recomm Rep. 1998; 47(RR-19):1-39.
9 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
10 Centers for Disease Control and Prevention. Recommendations for the prevention and control of hepatitis C (HCV) infection and HCV-related chronic disease. MMWR Recomm Rep. 1998; 47(RR-19):1-39.
11 Neff et al. 2011. Gastroenterol Hepatol (N Y). 2011 October; 7(10): 661-671
12 Rein, DB, et al. The Cost-Effectiveness of Birth Cohort Hepatitis C Antibody Screening in U.S. Primary Care Settings. American Association for the Study of Liver Diseases. 2011
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.

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Before I comment directly on the CMS proposal for Hepatitis C Screening, I need to be clear that I am a faculty member at the University of Nebraska College of Pharmacy and I am responding on my own behalf and not representing my institution.

I am disappointed to see that the possible role for screening by pharmacists in community pharmacies has been omitted from this proposal. Patients trust their pharmacists and the patients see members of my profession many more times than any other health care provider. Pharmacists offer culturally appropriate care to many immigrant and minority communities who otherwise have no health care providers who look like them; and pharmacies often have longer hours of service than traditional health offices. Pharmacists are trained to perform rapid screening tests, pharmacists have training in sample collection and the safe and environmentally friendly disposal of testing supplies. Screening has been identified as important. One would hope that along with the value placed on the screening that CMS would also see the value in using the nation's community pharmacists to provide this service.

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Thank you for the opportunity to provide public comments on the Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults. The National Coalition of STD Directors (NCSD) represents the state STD programs in every state, territory, and seven large cities funded by the Centers for Disease Control and Prevention (CDC), and in many states, our members also oversee Hepatitis prevention and control as well. NCSD applauds the Centers for Medicare and Medicaid Services (CMS) for outlining the need for increased HCV testing and support strongly support the decision for Medicare to cover HCV screenings for all high-risk adults and a single screening test for each adult born between 1945 and 1965. However, NCSD would like to highlight the importance of state, county, and local health departments in the screening and treatment of HCV. We suggest a change to this memo to include state and local health departments and all of their affiliated health centers, such as STD clinics, as eligible entities under the Proposed Decision Memo.

The Role of Public Health Partners, Including State and Local Health Departments

We agree with CMS regarding the important role of primary care practitioners in screening individuals for HCV and coordinating appropriate follow-up care and treatment. However, given the scope of the epidemic and the urgent need to identify individuals in the Medicare population whose HCV-related liver disease requires immediate treatment to prevent development of complications and/or death, we strongly urge CMS to expand this coverage to screenings performed by practitioners in settings outside of primary care, to explicitly include state, county and local health departments.

The sole eligibility of primary care physicians providing these services in primary care settings does not take into account the reality of those in need of this screening and the vital role that health departments fill in screening for key populations in need. The National Coalition of STD Directors would like to suggest that state and local health departments, including all of their affiliated health centers, also qualify to receive Medicare reimbursement for providing HCV screening

State and local health departments have long served an important role in protecting population and individual health within communities. For treatment and prevention, particularly regarding infectious diseases, such as HCV, health departments serve as a hub of excellence, employing staff possessing specialized knowledge needed to diagnose, treat, and provide appropriate follow-up for such infections. Moreover, health department staff is often best situated to be able to respond quickly and to effectively provide outreach to the partner(s) of an infected individual or others who may have been potentially exposed to infection. For many communities, the health department is the only place where this expertise and experience exist. Allowing for these additional, qualified health professionals to receive reimbursement for HCV testing ensures that patients have high quality choices in their health care.

Health Departments Are Key to Reaching Populations in Need of HCV Screening

The Proposed Decision Memo outlines in good detail the importance of HCV screening for the prevention of disease, including the fact that HCV is often asymptomatic and can go undiagnosed for decades. The memo also notes the costly nature of HCV-related disease and the fact that HCV is often diagnosed when symptoms present late in the disease, adding to the costly nature of HCV infections. Populations most at risk for HCV are often marginalized populations, including injection drug users. In addition, HCV can also be sexually transmitted, and given the long-term costs of HCV disease, the small number of sexually transmitted HCV cases should not be discounted. Locations where these cases can receive expert care, such as STD clinics run by state and local health departments, should be eligible to receive Medicare reimbursement for these HCV cases.

Safety net providers, such as state and local public health departments, are a primary source of care for vulnerable and marginalized populations. As such, they possess unique insights into, and familiarity with, the needs and challenges faced by these populations. Patients at clinics run by health departments, specifically STD clinics, tend to be young, minority, and poorⁱ, populations that often have fewer options for health care. These populations are also less likely to have primary care physicians which should be taken into account when determining what entities are eligible for HCV reimbursement under Medicare.

Limiting HCV reimbursement through Medicare to primary care settings only does not reflect where HCV testing is currently occurring. For example, a recent study published in the Morbidity and Mortality Weekly Report (MMWR) examined locations and reasons for initial testing for HCV infection among patients who received care at four different integrated health-care systems in the United States. This study found that while 60.4 percent of patients were tested by a physician, one-third of the patients were tested in a location other than a physician’s office.ⁱⁱ As a result, the authors suggest that increasing testing in both physician’s offices and alternative locations could be important.

Specifically, this MMWR study found that patients who were initially tested for HCV, 7.4 percent were tested in clinics outside a primary care location, clinics such as family planning clinics, STD clinics and infectious disease clinics. While this study does not specify if these clinics are run by state and local health departments, it should be noted that across the country, many of these types of clinics are indeed run by state or local health departments. For those born before 1945 or after 1965, however, a smaller proportion of HCV tests occurred in physician’s offices, and a larger percentage, almost 12 percent, occurred in clinics.

In fact, when looking at those born after 1965, those receiving HCV tests in clinics increases to 16.7 percent and over 97 percent of those born after 1965 stated that they received HCV testing because due to injection drug use.ⁱⁱⁱ In addition, of those born after 1965, 14 percent of those patients reported being tested for HCV because they had sexual contact with HCV.^iv Again, given the costly nature of the HCV epidemic, where these populations are receiving testing should be reflected in Medicare reimbursement.

Another study which looked specifically at HCV testing and linkage to care in minority populations found that 51.6 percent of non-Hispanic blacks, 52.7 percent of Hispanics, and 62.8 percent of American Indian/Alaska natives were tested in a setting other than in a physician’s office.^v As these data show, limiting coverage of HCV screening to primary care may miss infected individuals either in the baby-boomer cohort or among high-risk groups, particularly those in minority populations that may be most at risk for developing acute infection (American Indian/Alaska natives) and/or for dying from HCV-related illness (non-Hispanic blacks).

The Proposed Decision Memo also notes that “there remain racial, ethnic, and socioeconomic disparities in the incident and prevalence of acute and chronic viral hepatitis, the outcomes of chronic viral hepatitis, and the health care access and quality.” NCSD could not agree more. If we are serious, however, about addressing these health disparities, the Medicare reimbursement structure should reflect where the populations experiencing these disparities are receiving care, and that is often through state and local health department clinics.

Additionally, those who inject drugs are a key population for HCV, as the Proposed Decision Memo notes, and they are also at increased risks for STDs, including HIV. Medicare reimbursement should also be available for HCV screening of this key population where they can also receive expertise care for those co-infections, such as STD clinics and other clinics associated with health departments.

The National Coverage Determination Does Not Need to Be Limited to Primary Care Settings

NCSD also acknowledges that in its Proposed Decision Memo, CMS responds to the research reviewed by the U.S. Preventive Services Task Force (USPSTF), which was created to study evidence of preventive services carried out in the primary care setting. Despite this, there is not an explicit requirement in the USPSTF recommendation that these HCV screenings be performed by a primary care provider in a primary care setting. Nor is there an explicit statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers only under these circumstances. In fact, insurers must provide justification if they place additional limitations on recommendations that are not specifically put in place by the USPSTF.

Additionally, CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Though there is no statutory or regulatory requirement that the Secretary limit HCV screening to primary care, there is also no analysis of data or research in the National Coverage Determination that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals and those in the baby-boomer generation, for example, are not limited to primary care.

Finally, NCSD, along with many partners, has been at the forefront of facilitating billing and reimbursement for services at state and local health departments. Denying these safety net clinics vital reimbursement for covered services which they are currently providing, such as HCV screening, undermines the provision of good public health. This is particularly true now at a time of expanded health insurance coverage and insurance coverage of preventive services.

For all of the reasons listed above, we request that the Proposed Decision Memo for HCV Screening in Adults be changed to include state and local health departments and all of their affiliated health centers as eligible entities.

Again, thank you for the ability to comment on this Proposed Decision Memo and for your consideration of these comments. Should you require any additional information regarding these concerns, please contact Stephanie Arnold Pang at sarnold@ncsddc.org or 202-842-4660.

Sincerely,

William A. Smith
Executive Director
National Coalition of STD Directors

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.
iii Ibid.
iv Ibid.
v 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.

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Dear Ms. Tamara, Dr. Paserchia, and Ms. O’Connor:

On behalf of Roche Diagnostics Corporation (Roche), manufacturer of the Elecsys Anti-HCV assay—an in vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (package insert enclosed), I am writing to support Medicare coverage for screening for Hepatitis C Virus (HCV) in persons at high-risk for infection as well as one-time screening for HCV in adults born between 1945 and 1965. Roche is a research-focused healthcare company that discovers, develops, and provides innovative diagnostic and therapeutic products and services that deliver significant benefits to patients and healthcare professionals – from early detection and prevention of diseases to diagnosis, treatment, and treatment monitoring.

Roche supports generally the Proposed Decision Memorandum and encourages CMS to finalize Medicare coverage for screening for HCV in persons at high-risk for infection as well as one-time screening for HCV in adults born between 1945 and 1965. Prior to finalizing the decision memo, however, Roche respectfully requests that CMS consider the following:

• Expanding coverage to settings of care beyond the primary care setting;
• Expanding coverage to testing that is ordered by physicians other than primary care specialties when those physicians are primary caregivers for patients;
• Confirming that the coverage policy comprehends HCV screening specifically, and that coverage of follow-up confirmation testing for cases that test positive (i.e., nucleic acid tests) is addressed under separate coverage decisions; and
• Clarifying that the FDA In Vitro Diagnostics database includes all FDA cleared and approved tests, regardless of whether they are commercially available.

We encourage CMS to finalize the Decision Memorandum, with consideration given to the issues raised above. At Roche, improving patient outcomes is at the core of what we do and we therefore strongly support screening and preventive service efforts, such as HCV screening.

If you have any questions, please do not hesitate to contact Jessica Roth at (202) 347-0843 or by electronic mail at jessica.roth@roche.com.

Sincerely,

/jr/

Jessica Roth, MPH
Director, Health Policy & Reimbursement
Roche Diagnostics Corporation

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April 3, 2014

Ms. Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) Tracking Sheet for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)

Dear Administrator Tavenner:

Thank you for the opportunity to comment on the Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N). The Corporate Hepatitis Alliance (CHA) strongly supports coverage for HCV screening in adults at high risk for HCV infection, and for those in the 1945-1965 birth cohort. This determination recognizes that there is a significant burden of chronic HCV within the United States and that HCV screening is the first critical step. Diagnosis followed by appropriate medical evaluation and potential treatment of chronic HCV may lead to the avoidance of many of the complications seen with end stage liver disease including the need for liver transplantation, and the development of hepatocellular carcinoma.

The CHA encourages the Centers for Medicare and Medicaid Services (CMS) to clarify that all HCV screening tests approved by the Food and Drug Administration (FDA) are eligible for coverage under the final decision. This is consistent with January 2014 guidance by the American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) entitled “Recommendations for Testing, Managing, and Treating Hepatitis C” www.hcvguidelines.org, that states “All persons recommended for testing should first be tested for HCV antibody (anti-HCV) (Centers for Disease Control and Prevention) [CDC], 2013; (Alter, 2003) using an FDA-approved test.”

The CHA also encourages CMS to clarify that they propose to cover screening for HCV when ordered by the beneficiary’s primary care physician or practitioner within any healthcare setting, including hospital ERs and specialty clinics, not just a primary care setting.

Created in August 2009, the CHA is a coalition of companies committed to identifying ways in which industry can play a more central role in advocating for increased access to quality health care and strengthening infrastructures for the diagnosis and care of people with viral hepatitis.

The CHA commends CMS for the proposal to cover HCV screening in adults and urges CMS to finalize a National Coverage Decision that ensures all forms of HCV screening in adults are covered by Medicare and are covered within any healthcare setting. The CHA stands ready to partner with Medicare physicians and beneficiaries to implement recommended screening practices that will save the lives of millions of Americans with HCV.

Sincerely,

Debra Fraser-Howze
Senior Vice President of Government and External Affairs
OraSure Technologies, Inc.
Member of the Corporate Hepatitis Alliance

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April 2, 2014

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Blvd.
Mailstop S3-02-01
Baltimore, MD 21244

Re: Proposed National Coverage Decision for Screening for Hepatitis C Virus (HCV) in Adults

Dear Ms. Jensen:

AbbVie appreciates the opportunity to comment on the Proposed National Coverage Decision (NCD) for Screening for Hepatitis C Virus (HCV) in Adults. We commend the Centers for Medicare and Medicaid Services (CMS) for proposing to cover screening for adults at high risk for HCV infection and adults born from 1945 through 1965. We strongly believe Medicare coverage of screening will significantly advance the government’s goal of combatting the HCV epidemic in the United States.

AbbVie is a U.S.-based company headquartered in Illinois, which employs more than 11,000 employees in all 50 states. Our worldwide workforce of 21,000 employees is committed to addressing many of the world’s most pressing health challenges. AbbVie’s HCV portfolio includes investigational medicines with three different mechanisms of action, including protease (ABT-450/r), polymerase (ABT-333) and NS5A (ABT-267) inhibitors, currently being studied in clinical trials. ABT-450 is being developed with low dose ritonavir, which enhances the pharmacokinetic properties of ABT-450. The use of ritonavir 100mg with ABT-450 for the treatment of HCV is investigational.

AbbVie strongly supports Medicare coverage of screening for HCV. The fact that, in 2010, the CDC estimated that 2.7 to 3.9 million persons in the United States were living with HCV illustrates the importance of this proposed coverage decision (1).

In August 2012, the Centers for Disease Control and Prevention (CDC) released guideline recommendations advocating a one-time screening antibody test for hepatitis C virus (HCV) infection among persons born from 1945 to 1965 (2). Support for this recommendation was partly based on data from the 1999-2008 National Health and Nutrition Examination Survey (NHANES), which found that HCV seroprevalence was four-fold higher in the birth cohort than that of the general population (3.25 percent versus 0.8 percent). Since the overall prevalence of HCV infection in the US is 1.5%, the birth cohort represents 75 percent of all those who are HCV-infected nationwide and contributes 73 percent towards the total HCV mortality rate. In fact, in 2007, deaths related to HCV exceeded those for HIV and most of these deaths occurred in middle-aged persons (ie, 45 to 64 years of age) (3). The relatively early death of HCV-infected patients speaks to the large burden of disease that is increasing at an alarming rate. Unfortunately, it is estimated that 800,000 HCV-infected persons within the birth cohort are unaware of their HCV serostatus (4).

As detailed in the proposed decision, the evidence is adequate to conclude that screening for HCV, consistent with the U.S. Preventative Services Task Force (USPSTF) grade B recommendations, is reasonable and necessary for the prevention or early detection of HCV. We applaud CMS for swiftly moving to cover HCV screening subsequent to the release of the USPSTF grade B recommendations.
Primary Care Limitation

Although CMS is taking an important step to cover HCV screening, AbbVie believes its benefits will not be fully realized due to the proposed coverage criteria requiring a primary care physician or practitioner to order the screening. We agree with CMS that primary care physicians play a critical role in ensuring patients receive important preventive services, including HCV screening. We also recognize that many primary care physicians will indeed order the screenings.

However, data and real world experience suggests that CMS should not limit coverage to the primary care setting. Specialists who treat patients most at risk of contracting HCV, such as hepatologists, gastroenterologists, and infectious disease specialists, should also be permitted to order screening for HCV. Barriers exist at the provider level, limiting the success of the risk-based approach to HCV testing. Providers lack knowledge about hepatitis serology and treatment; studies indicate that providers' level of knowledge regarding HCV infection prevalence, natural history, available tests, and testing procedures is low (5). Although up-to-date professional guidelines on HCV testing are available from the American Association for the Study of Liver Disease (AASLD), one survey found that 41.7% of primary care physicians reported being unfamiliar with these guidelines (6-7). We also know that many patients do not have a primary care physician and/or receive their care from specialists.

CMS sites the charge of the U.S Preventative Services Task Force (USPSTF) in evaluating services provided in the primary care setting as justification for its decision to limit Medicare coverage to the primary care setting. However, this reasoning is flawed in light of the fact that USPSTF’s own HCV screening recommendation is not limited to the primary care setting.

It is important to note that CMS has not included such a restriction in other NCDs. For example, the NCD for prostate cancer screening states, “This screening must be ordered by the beneficiary's physician or by the beneficiary's physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (the term "attending physician" is defined in §1861(r)(1) of the Act to mean a doctor of medicine or osteopathy and the terms "physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife" are defined in §1861(aa) and §1861(gg) of the Act) who is fully knowledgeable about the beneficiary's medical condition, and who would be responsible for using the results of any examination (test) performed in the overall management of the beneficiary's specific medical problem.”

Therefore, AbbVie urges CMS to expand coverage beyond primary care physicians in order to reach as many patients as possible.

Screening Tests Covered

The NCD explicitly references “laboratory” screening. Historically, specifying only “laboratory tests” has raised confusion as to whether other FDA-approved tests, like point-of-care, are also covered. AbbVie recommends that CMS clarify in the final coverage decision that all FDA-approved tests are covered to ensure patient access to screening.

Definition of High Risk

According to the NCD, “High risk” is defined as “persons with current or past history of illicit injection drug use.” The word “illicit” has a negative connotation and stigma attached to it. AbbVie is concerned that the use of the word will deter some patients from getting screened. We also do not believe such word usage serves a substantive purpose in the context of the NCD.

Therefore, AbbVie recommends that CMS remove “illicit” in the final NCD. In addition, we suggest CMS replace the current language with “People Who Inject Drugs” (PWID), which is used more often in the literature and was also cited in the recent HCV treatment guidelines published in Clinical Infectious Diseases.

Once again, AbbVie appreciates the opportunity to offer our perspective on this important proposed coverage decision for millions of patients living with HCV. If you have any questions, please contact Aaron Krupp at 202-378-1429.

Sincerely,

Andrew Kaplan
Vice President, Federal Government Affairs & Reimbursement

References:
1. CDC MMWR/Vol.61/No.4 August 17, 2012
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
4. 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
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.

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Dear Ms. Tavenner:

Thank you for the opportunity to offer comments on the Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N). I am writing on behalf of Trust for America’s Health (TFAH), a non-profit, non-partisan organization dedicated to improving the health of all Americans by making disease prevention a national priority.

We strongly support Medicare coverage of HCV screening as recommended by the U.S. Preventive Services Task Force (USPSTF) for adults at high risk, including those born from 1945 through 1965. As this population – particularly the latter segment – ages into Medicare, the program will see increasing numbers of people with liver cancer, cirrhosis, and over sequelae of HCV infection. There is now significant evidence for improved clinical outcomes when people infected with HCV are identified and treated. The new availability of more powerful drugs to fight HCV means that providers can offer patients a meaningful promise of improvement, or even a cure.

Despite our overall support for the proposed decision memo, we are concerned that coverage is proposed only for screening ordered by a “primary care physician or practitioner within the context of a primary care setting.” We agree that, in many cases, coordination of screening and preventive services by a primary care provider is ideal. However, this restriction would limit the reach of HCV screening by other providers, such as GI specialists, or in other settings, such as emergency rooms.

CMS’ narrow view of the appropriate providers and settings for HCV screening is particularly puzzling given that the underlying USPSTF recommendation is not limited to primary care providers or settings. Furthermore, the key studies on accuracy and yield of HCV screening on which USPSTF appeared to rely in developing the recommendation were from a mix of settings: STD clinics, an “urban primary care clinic,” gastroenterology clinics and primary care clinics.

The Proposed Decision Memo seeks to justify its narrow application by noting that the USPSTF’s “primary audience” – according to a preface to the Task Force’s own “pocket guide” – is primary care clinicians. While that may be the case, it is by no means the only audience, nor should it be. Preventive services play an important role across a range of healthcare settings. And in fact, the USPSTF has been charged by Congress to develop recommendations not solely for primary care clinicians but “for the health care community.”

Unfortunately, this is not the first example of Medicare making a puzzlingly narrow coverage decision with regard to preventive services. On at least three prior occasions, CMS has announced that it will provide Medicare coverage of an important USPSTF-recommended preventive service only to primary care providers in a primary care setting, despite broader underlying USPSTF recommendations:

• Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to Prevent STIs includes a number of USPSTF-recommended STI screenings, plus high-intensity behavioral counseling on STI prevention for all sexually active adolescents, and for adults at increased risk. The USPSTF recommendation states that “[h]igh-intensity behavioral counseling may be delivered in primary care settings or in other sectors of the health system after referral from the primary care clinician or system. In addition, risk-reduction counseling may be offered by community organizations.” However, the CMS National Coverage Determination (NCD) states that Medicare will cover counseling sessions only “if referred for this service by a primary care provider and provided by a Medicare eligible primary care provider in a primary care setting.”


• Intensive Behavioral Therapy for Cardiovascular Disease includes three components: counseling on aspirin use for certain ages; blood pressure screening for all adults 18 and over; and intensive behavioral counseling on healthy diets for adults with certain risk factors. The USPSTF recommendation states that “[i]ntensive counseling can be delivered by primary care clinicians or by referral to other specialists, such as nutritionists or dietitians.” However, the Medicare NCD states that CMS will cover one such counseling visit annually only when “furnished by a qualified primary care physician or other primary care practitioner in a primary care setting.”


• Intensive Behavioral Therapy (IBT) for Obesity includes screening for obesity; a dietary/nutritional assessment; and intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise. USPSTF states that “[a]lthough intensive interventions may be impractical within many primary care settings, patients may be referred from primary care to community-based programs for these interventions.” However, the CMS NCD states that “[eligibility is limited to] Medicare beneficiaries with obesity (BMI = 30 kg/m2) who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner in a primary care setting.”

We are extremely concerned about this pattern at CMS, and find no meaningful rationale in the current HCV Proposed Decision Memo or in these earlier examples. Furthermore, the policy is not consistent: a 2009 NCD on HIV screening does not restrict coverage to screening ordered by a primary care provider or in a primary care setting.

We are strong supporters of the provision of preventive services by primary care providers in primary care settings, but not only by primary care providers in primary care settings. If Medicare is going to promote access to evidence-based preventive services, it should cover them when provided by any appropriate Medicare-eligible clinician in any appropriate setting. We urge you to amend this proposed decision, as well as the prior NCDs described above, to remove the unnecessarily limiting requirements related to primary care providers and settings.

If you have any questions, please feel free to contact Becky Salay, TFAH’s Director of Government Relations, at 202-223-9870 x15. Thank you for your consideration.

Sincerely,

Jeffrey Levi, Ph.D.
Executive Director

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April 2, 2014

Marilyn Tavenner
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)

Administrator Tavenner:

On behalf of the National Association of County and City Health Officials (NACCHO), I am writing to support Medicare coverage, without cost-sharing, of screening for HCV in adults. NACCHO is the voice of the approximately 2,800 local health departments across the country. These city, county, metropolitan, district, and tribal departments work every day to protect and promote health and well-being for all people in their communities.

NACCHO strongly supports CMS’ proposal to cover screening for HCV and facilitate implementation of the U.S. Preventive Services Task Force grade B recommendation for HCV screening in persons at high risk for infection and one-time screening for HCV infection in adults born between 1945 and 1965. Covering this lifesaving, preventive service for recommended individuals is a critical step in helping healthcare providers and local health departments to identify the estimated 45 percent to 85 percent of adults chronically infected with HCV, yet do not know they are infected.^1-4

However, NACCHO urges CMS to expand the scope of coverage for this screening to include providers beyond primary care physicians and practitioners in primary care settings. Local health departments are involved in every aspect of viral hepatitis prevention, detection, care, treatment, and control and are critical safety net providers for populations at high risk for HCV infection and do not have a primary care medical home. Yet, budget cuts have compromised local health departments’ abilities to identify individuals infected with HCV. A NACCHO report on LHD job losses and program cuts indicated that nine percent of LHDs that had a communicable disease screening or treatment program in 2012 reduced or eliminated it that year.⁵ As the public health, healthcare system, and people recommended for HCV screening continue to face increasing costs amidst shrinking resources, it is imperative to remove the cost barriers to detecting HCV infection and prevent progression to more complex disease and costly care.

Identifying adults infected with HCV will enable local health departments to better characterize the burden of HCV infection and disease in their communities. Furthermore, improving their understanding of how HCV impacts their community can subsequently help local health departments to raise awareness within their communities, target prevention efforts, and work with healthcare providers and community partners to better provide treatment and linkage to care.

NACCHO lauds the leadership at CMS in recognizing and addressing the challenge public health, healthcare providers, and other stakeholders face in preventing, providing care for, and treating viral hepatitis. NACCHO stands ready to work with CMS in improving the identification of adults infected with HCV. Thank you for the opportunity to provide comments to this proposed decision memorandum and input on this important matter.

Sincerely,

Robert M. Pestronk, MPH
Executive Director

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.

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The Infectious Diseases Society of America (IDSA)represents nearly 10,000 infectious diseases physicians and scientists devoted to patient care, prevention, public health, education, and research in the area of infectious diseases (ID). The Society's members focus on the epidemiology, diagnosis, investigation, prevention and treatment of infectious diseases in the United States and abroad. Our members care for patients of all ages with serious infections, including meningitis, pneumonia, tuberculosis, surgical infections, those with cancer or transplants who have life-threatening infections caused by unusual or drug-resistant microorganisms, people living with HIV, AIDS, chronic viral hepatitis, and new and emerging infections, such as severe acute respiratory syndrome (SARS) and H1N1 influenza.

We strongly support the decision for Medicare to cover HCV screenings for all high-risk adults and a single screening test for each adult born between 1945 and 1965. However, we feel it would be ideal if CMS expand the authorization to conduct screening beyond the narrow definition of primary care (i.e., general practitioner, family practice practitioner, general internist, obstetrician or gynecologist), to include infectious diseases specialists. We feel that the scope and urgency to treat this “silent epidemic” calls for an expansion beyond primary care. As well, with the new advanced therapies to treat and effectively “cure” HCV, the infectious diseases specialists are well-suited to initiate an evidenced-based treatment approach as necessary, following screening.

IDSA appreciates the opportunity to provide comments on this draft NCD and looks forward to supporting CMS’s efforts to address the treatment of HCV in the Medicare population.

Respectfully,
Barbara E. Murray, MD, FIDSA
President

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Ms. Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) Tracking Sheet for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)

Dear Administrator Tavenner:

The HIV Medicine Association (HIVMA) is pleased that the Centers for Medicare and Medicaid Services (CMS) is moving forward with a “national coverage analysis” process for adding hepatitis C (HCV) testing to the list of preventive services offered to Medicare beneficiaries. HIVMA represents nearly 5,000 clinicians and researchers on the front lines of the HIV/AIDS epidemic in the U.S. and abroad whose clinical management and research on common comorbidities of HIV disease includes HCV infection.

In public comments responding to CMS’s initial coverage determination proposal in October 2013, HIVMA strongly supported the addition of HCV testing as a preventative service to be offered at no cost to Medicare beneficiaries – including the nearly 8 million individuals who qualify due to a disability – who were born between 1945 and 1965 or who are at risk. We remain concerned that the USPSTF’s definition of “at risk” populations that should be screened for HCV infection did not reflect our recommendation to include individuals with an HIV diagnosis, concurrent with the most recent treatment guidelines,¹ and considering that about one-quarter of the HIVinfected population in the United States is co-infected with HCV.²

However, we are concerned that CMS is proposing to limit the type of medical providers that are eligible for Medicare reimbursement of HCV screening to primary care physicians or practitioners. This proposal may limit access for undiagnosed individuals whose primary contact with the health care system is not with a traditional primary care provider. As an important example, Medicare beneficiaries with HIV are at high risk for HCV and often their primary care provider is an infectious diseases or other specialist. Therefore, we strongly urge CMS to revise the proposal to specify that specialists who also serve as primary care providers are also eligible for Medicare reimbursement of HCV screening.

To advance the goal of reducing costly under-diagnosis of HCV infection, we further recommend revising the proposed guidance to allow for Medicare reimbursement of HCV screening in non-primary care settings, such as emergency departments, STD and family planning clinics, and other relevant community-based organizations.

Again, we appreciate the work CMS has done to support expanded coverage of HCV screening. However, we urge you to consider revising the final proposed decision memo for Screening for Hepatitis C Virus (HCV) in Adults to reflect the changes requested above. If we can provide further information or assistance, please reach us through HIVMA Policy Officer, Kimberly Miller, at kmiller@hivma.org or (703) 740-4957.

Sincerely,

Joel Gallant, MD, FIDSA
Chair, HIVMA Board of Directors

1 Centers for Disease Control and Prevention 9CDC), Fact Sheet accessed online 4/1/2014 at: http://www.cdc.gov/hepatitis/Populations/hiv.htm
2 Aberg, et al, “Primary Care Guidelines for the Management of Persons Infected With HIV: 2013 Update by the HIV Medicine Association of the Infectious Diseases Society of America,” Clin Infect Dis. (2013) doi: 10.1093/cid/cit665 (accessed online 34/1/2014).

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo for Screening for Hepatitis C Virus in Adults (CAG-004369N). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member plans support CMS’s efforts to ensure that Medicare beneficiaries have access to evidence-based preventive services that can improve health outcomes. Health insurance plans have a long history of offering evidence-based preventive services to individuals, and are strongly committed to improving access to preventive and other needed healthcare.

Health plans are currently in the process of implementing the USPSTF recommendation on Screening for Hepatitis C Virus Infection in Adults: “The USPSTF recommends (Grade B recommendation) screening for hepatitis C virus (HCV) infection in persons at high risk for infection. The USPSTF also recommends offering one-time screening for HCV infection to adults born between 1945 and 1965.”

Our member health plans support offering one-time screening for HCV infection to adults born between 1945 and 1965. In addition, our members support screening for HCV infection in persons at high risk for infection (“high risk” defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992), and support CMS’s decision to cover repeat screening for high risk persons annually only for persons who have had continued illicit injection drug use since the prior negative screening test.

Our members also agree with CMS’s decision to cover hepatitis C screening when ordered by a primary care physician or practitioner within the context of a primary care setting, as defined in the proposed decision memo.

Thank you for the opportunity to comment on this important issue.

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Owing to the problems with access to primary care physicians and services and the fact that HCV antibody tests are CLIA-waived, consideration should be given to improving patient access to care by allowing for reimbursement of tests performed in non-traditional laboratory settings such as pharmacies. Appropriateness of test performance is straightforward, especially among the baby boomer population.

If the site of performance possesses a CLIA waiver, have appropriately trained personnel to conduct tests, have data sharing plans in place, and have mechanisms for referral of patients with reactive tests for follow-up, why would we limit accessibility to the tests. In many states pharmacists may act in collaboration with physicians to conduct rapid diagnostic tests and should be allowed to receive reimbursement.

Every year there are 13 billion visits to pharmacies in the United States and only 470 million physician office visits. By not utilizing pharmacies as testing centers we are missing out on literally billions of opportunities to reach asymptomatic patents every year.

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April 1, 2014

RE: Comments on the Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)

To Whom It May Concern:

We appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) decision of the Centers for Medicare & Medicaid Services (CMS) regarding coverage of screening for hepatitis C virus (HCV) in adults (CAG-00436N). We are writing on behalf of the National Viral Hepatitis Roundtable (NVHR), a coalition of more than 250 organizations dedicated to the eradication of chronic viral hepatitis, and the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School.

We strongly support the decision for Medicare to cover HCV screenings for all high-risk adults and a single screening test for each adult born between 1945 and 1965.

This NCD is consistent with recommendations of both the Centers for Disease Control (CDC) and the United States Preventive Services Task Force (USPSTF). We thank you for your commitment to ending the HCV epidemic and for taking this important step towards helping to identify the estimated 75% of individuals who are living with HCV but do not realize they are infected.

However, we are concerned about the definition of “high risk” as it refers to “illicit” injection drug use. The word “illicit” has a negative connotation and stigma attached to it, which could deter some patients from obtaining screening. Because the use of the term “illicit” does not serve any substantive purpose in the context of the NCD, we join with other groups in recommending that the relevant language regarding “high-risk” be changed to “people who inject drugs, or people who have a previous history of injecting drugs,” and “people who have continued to inject drugs since the prior negative screening test.” Defining “high-risk” without using the term “illicit” would be in line with more recent testing and treatment guidelines, such as those published by the Centers for Disease Control (CDC), as well as the American Association for the Study of Liver Disease (AASLD) and The Infectious Disease Society of America (IDSA).¹

To ensure the maximum effectiveness of this coverage, we also urge CMS to include information about this HCV screening benefit in the “Welcome to Medicare” packet received by all new enrollees. This could be particularly effective given that many baby-boomers are not yet Medicare-eligible but will become new Medicare enrollees in the next few years.

In addition, we interpret this NCD to encompass HCV tests that have received CLIA waivers, including the HCV rapid test, and request that CMS provide clarity as to this point.
We support the important role primary care practitioners can play in screening individuals and providing appropriate follow-up care and treatment for HCV.

We agree with CMS regarding the important role of primary care practitioners in screening individuals for HCV and coordinating appropriate follow-up care and treatment. From the moment screening takes place, there are needs for case management and care coordination for individuals who have been diagnosed with HCV. Such needs include for instance, managing the logistics of helping patients access specialty care services and/or managing necessary follow-up work-ups, such as HCV RNA testing and ultrasounds. Much of this management may be performed or facilitated by primary care providers. In addition, new research also demonstrates that with appropriate support, primary care providers can successfully provide anti-viral treatment for some individuals, resulting in cure rates that are comparable to treatments provided in a specialist setting.¹

As such, the role of the primary care physician in both the initial screening process and in necessary follow up care and treatment can be a critical one. This role is underscored by numerous health reform provisions that support coordinated primary care models for individuals living with chronic illnesses, including those receiving care from Accountable Care Organizations and/or through new initiatives that specifically target dual-eligibles with complex medical conditions. For these reasons, we agree that HCV screening would ideally be done by primary care providers.

However, given the scope of the epidemic and the urgent need to identify individuals in the Medicare population whose HCV-related liver disease requires immediate treatment to prevent development of complications and/or death, we strongly urge CMS to expand this coverage to screenings performed by practitioners in settings outside of primary care.

This NCD comes at a critical juncture in the course of the HCV epidemic. New research has led to the development of medication regimens that can effectively cure HCV infection (produce sustained virologic response (SVR)) in the majority of individuals, and additional all-oral regimens are expected to be approved in October of this year. At the same time, the majority of HCV-infected individuals in the baby-boomer cohort are unaware that they have developed chronic disease, and many of those individuals may not realize that they are also in danger from the development of cirrhosis or other complications caused by HCV. For instance, in 2007, over 15,000 people died from HCV related causes, more than the number of deaths cause by HIV/AIDS. New research suggests that even this high number may be an underestimate.² Moreover, other models estimate that if left untreated, between 2030 and 2035, there will be a peak of “38,600 incident cases of end-stage liver disease; 3200 referrals for [liver] transplant; and 36,100 deaths.”³

Only treatment can effectively prevent the development of potentially life-threatening liver disease and damage caused by HCV. Because most individuals in the baby-boomer generation have been living with HCV for 20 to 40 years, they cannot afford to wait any longer before being identified and linked to cure. Analysis of death records between 1992 and 2009 by the Massachusetts Department of Public Health for example, found that of those who died of HCV related causes in Massachusetts, 73% died within five years of diagnoses.⁴ These findings underscore the emergent need to diagnose infected individuals and get them into treatment.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings.

We support the recommendation that the determination of whether an individual is “high-risk” for purposes of HCV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan” (p. 3). To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.⁵ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend an HCV screening. This could necessitate a separate appointment with a different provider for just that purpose, thwarting the stated goals of promoting care coordination and efficiency. By extending coverage of screening to a broader array of providers and settings, CMS could ensure that HCV screenings may be a part of these preventive service visits.

Limiting coverage to HCV screenings performed by a primary care practitioner in a primary care setting will miss key opportunities to screen baby-boomers and other at-risk individuals who access the health care system through other settings.

For example, a recent study published in the Morbidity and Mortality Weekly Report (MMWR) examined locations and reasons for initial testing for HCV infection among patients who received care at four different integrated health-care systems in the United States. This study found that while 60.4% of patients were tested by a physician, one-third of the patients were tested in a location other than a physician’s office.⁶ As a result, the authors suggest that increasing testing in both physician’s offices and alternative locations could be important. Another study which looked specifically at HCV testing and linkage to care in minority populations found that 51.6% of non-Hispanic blacks, 52.7% of Hispanics, and 62.8% of American Indian/Alaska natives were tested in a setting other than in a physician’s office.⁷ As these data show, limiting coverage of HCV screening to primary care may miss infected individuals either in the baby-boomer cohort or among high-risk groups, particularly those in minority populations that may be most at risk for developing acute infection (American Indian/Alaska natives) and/or for dying from HCV-related illness (non-Hispanic blacks).

Recent research has also demonstrated the efficacy of HCV screenings of the baby-boomer cohort in emergency rooms, a location explicitly excluded for coverage by this NCD. For instance, HCV screening of baby-boomers in emergency departments has been successfully implemented at both the University of Alabama at Birmingham and at Texas Memorial Hermann Medical Center in Houston: 1259 individuals were screened at Alabama, with 11.1% testing positive for HCV antibodies; and 1421 baby boomers were tested at Memorial Hermann, with 9.9% testing positive.⁸

In addition, it is well documented that injection drug users (IDUs), one of the groups most at risk for HCV, are less likely to seek health services in a primary care setting and more likely to enter the healthcare system through the emergency room or visits to an infectious disease provider.⁹ Reluctance to access primary care can also be driven by experiences of stigma, and therefore allowing providers with whom IDUs have established trusting relationships (such as infectious disease providers) to perform HCV screenings may be more likely to identify and diagnose all those at risk.

Finally, anecdotal evidence also suggests that some seniors have their main interactions with the health care system through their gastroenterologist, who they see for colonoscopies. Moreover, both infectious disease doctors and gastroenterologists often have particular expertise and experience in diagnoses, management and treatment of HCV, making both practices ideal settings for screening.

Limiting coverage to HCV screenings performed by a primary care practitioner in a primary care setting will hamper existing state and local provider-level efforts to screen and identify all baby-boomers living with HCV.

In light of recommendations by the CDC and USPSTF to implement non-risk based HCV screening among all baby-boomers, there are efforts underway in various state legislatures to pass laws that require medical providers to offer an HCV test to all individuals in the baby-boomer cohort. While some of these laws focus exclusively on primary care practitioners, others, such as the one most-recently passed in New York, require that both primary care providers and inpatient hospital settings offer HCV screening.¹⁰ This NCD would explicitly prohibit coverage of any screenings in the latter setting, potentially interfering with these efforts.

In addition to state legislation, many medical institutions are responding to the epidemic by implementing HCV testing prompts through electronic health records (EHR). For example, Beth-Israel Deaconess Medical Center (BID) in Massachusetts has been an emerging leader in the use of EHR to help screen and diagnose individuals with HCV, and has developed a specific prompt for HCV testing of the 1945 to 1965 birth cohort. This prompt is on the patient dashboard and is seen by a network of about 5,500 providers. In the seven months since implementing this prompt, HCV screening of baby-boomers at BID has increased from 400 tests per month to about 1,260 tests per month.

Yet administrators and providers at BID report that limiting Medicare coverage of HCV screening to primary care providers would be almost impossible to implement through their EHR system, largely because there would be no feasible means to limit the viewing of this prompt to only primary care providers. In the alternative, with such a large network of participating providers, they report that it would only increase confusion if attempts were made to limit testing to just primary care through education on utilization (i.e. without actually changing the system). BID is not alone in these efforts and such a limitation would likely have the same detrimental effect on other systems. These outcomes would be particularly senseless given that the goal of EHR systems is to ensure increased coordination among health care providers for a given patient. Using EHR, the enrollee’s primary care provider can easily see whether a patient has been screened for HCV and/or referred for additional follow-up if tested by a different provider within the system, and can assume facilitation of care coordination.

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.

CMS cites the “charge of the USPSTF” as the basis for its decision that referrals for HCV screening should be ordered by the primary care provider in a primary care setting. While the USPSTF does include in its mission a statement indicating that it makes recommendations for preventive services performed by primary care providers, the Secretary’s authority in this context is not so limited. Medicare covers a number of preventive services that are specifically defined by statute. The authority to add “additional preventive services” stems from the Medicare Improvements for Patients and Providers Act (MIPPA). This authority has never been limited either by the MIPPA or subsequently by the ACA, to designating preventive services that can only be provided by a primary care provider and/or in a primary care setting.¹¹ Indeed, in two previous instances when the Secretary has added additional preventive services pursuant to this same authority and as recommended by the USPSTF, “Screening for the Human Immunodeficiency Virus (HIV) Infection,” (updated February 23, 2011),¹² and “Counseling to Prevent Tobacco Use,” (implemented January 3, 2011), the services were not specifically limited to primary care.¹³

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting.

Though there is no statutory or regulatory requirement that the Secretary limit HCV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals and those in the baby-boomer generation, for example, are not limited to primary care. In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Nor is there a statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.¹⁴

We thank you for considering our comments. We truly appreciate the efforts of CMS in initiating this NCD, and strongly support its goals of identifying individuals living with HCV and linking them to appropriate care and treatment. Medicare coverage of HCV screening for both at-risk adults and individuals in the baby-boomer cohort is a huge step forward towards ending the epidemic. Should you have any questions about these comments, or if we may be of any further assistance in this process, please contact Ryan Clary, Executive Director, NVHR at (415) 235-8593 or at rclary@nvhr.org, or Robert Greenwald, Executive Director and Clinical Professor of Law, Center for Health Law and Policy Innovation of Harvard Law School, at (617) 390-2584 or at rgreenwa@law.harvard.edu.

Sincerely,

Ryan Clary
Executive Director
National Viral Hepatitis Roundtable
1537 Franklin Street, #311
San Francisco, CA 94109

Robert Greenwald
Director, Center for Health Law and Policy Innovation
Clinical Professor of Law
Harvard Law School
122 Boylston Street
Jamaica Plain, MA 02130

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
11 See e.g. 73 FR 69726 (Nov. 19, 2008); 75 FR 73170 (Nov. 29, 2010), and 42 CFR §410.64.
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.

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Thank you for the opportunity to provide comments. This NCA is consistent with recommendations of both the Centers for Disease Control (CDC) and the United States Preventive Services Task Force (USPSTF). We thank you for your commitment to ending the HCV epidemic and for taking this important step towards helping to identify the estimated 75% of individuals who are living with HCV but do not realize they are infected.

To ensure the maximum effectiveness of this coverage, we urge CMS to include information about this HCV screening benefit in the “Welcome to Medicare” packet received by all new enrollees. This could be particularly effective given that many baby-boomers are not yet Medicare-eligible but will become new Medicare enrollees in the next few years.

Given the scope of the epidemic and the urgent need to identify individuals in the Medicare population whose HCV-related liver disease requires immediate treatment to prevent development of complications and/or death, we strongly urge CMS to expand this coverage to screenings performed by practitioners in settings outside of primary care.

Thank you.
Heather Lusk

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March 31, 2014

Lori Paserchia, MD, Lead Medical Officer
Deidre O’Connor, Lead Analyst
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Screening for Hepatitis C Virus in Adults (CAG-00436N)

Dear Dr. Paserchia and Ms. O’Connor,

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis Tracking Sheet for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N). Mayo Clinic is a not-for-profit health care system dedicated to medical care, research and education. With more than 3,600 physicians and 60,000 employees, Mayo Clinic demonstrates a relentless and unwavering commitment to excellence which has spawned a rich history of health care innovation. Each year, more than one million people from all 50 states and 140 countries come to Mayo Clinic to receive the highest quality care at sites in Minnesota, Arizona and Florida. In addition, Mayo Clinic Health System, a family of clinics, hospitals and health care facilities, serves communities in Iowa, Georgia, Minnesota and Wisconsin.

HCV is an asymptomatic infection that can cause chronic liver disease. Expanding coverage of screening services to everyone born between 1945 and 1965 and to those individuals that are high risk, promotes improved patient outcomes and effective delivery of high-quality care. Knowing in advance that a patient has the risk of liver disease due to HCV, allows physicians to optimize their treatments and deliver better care, more efficiently, and in a cost effective manner. Mayo Clinic agrees with the Task Force of expanding coverage to these groups of individuals.

Because an individual may be considered high-risk and born between 1945 and1965, Mayo Clinic recommends the use of one CPT code to reflect the provision of Hepatitis C Screening. This will ensure accurate coding and appropriate billing for health care providers administering this medically necessary test.

Mayo Clinic respectfully requests a coverage analysis conclusion favoring the coverage for these individuals so that health care providers across the country can identify and provide treatment to those with HCV and can continue to put the needs of the patient first.

Thank you,

Joseph D. Yao, MD
Department of Laboratory Medicine and Pathology,
Associate Professor, College of Medicine
Mayo Clinic

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March 25, 2014

Ms. Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) Tracking Sheet for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)

Dear Administrator Tavenner:

Thank you for the opportunity to comment on the Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N) recently issued by the Centers for Medicare and Medicaid Services. The decision memo is very thorough and comprehensive. We enthusiastically support the basic recommendation of the decision memo to provide coverage for one-time screening of the 1945-1965 birth cohort and believe that the implementation of this screening coverage represents a historic opportunity to reverse the devastating impact of hepatitis C in this nation.

We write to express concerns about terminology that appears throughout the proposed decision memo. This terminology, detailed below, may confuse providers and third-party payers, could limit access to screening for vulnerable populations, and does not recognize updated screening technology and recent guidance from respected scientific organizations involved in screening activities.

The proposed decision memo, in several places, states:

We strongly recommend that the final decision memo be revised to state:

Updating this language throughout the document would provide clarity to hepatitis providers and the greater community. Historically, stating the term ‘laboratory’ only has raised questions about screening using other technologies, and OraSure has received similar questions from the community since the proposed decision memo was issued. The clarification above would allow the opportunity for approved providers to utilize the most appropriate FDA-approved screening tools, and would have the impact of unintentionally limiting the provider or beneficiary to laboratory testing, or creating confusion among providers or third-party payers.

Please also consider the January 2014 guidance by the American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) entitled “Recommendations for Testing, Managing, and Treating Hepatitis C” www.hcvguidelines.org. These guidelines state “All persons recommended for testing should first be tested for HCV antibody (anti-HCV) (Centers for Disease Control and Prevention) [CDC], 2013; (Alter, 2003) using an FDA-approved test. FDA-approved tests include laboratory-based assays, and a point-of-care assay (ie, OraQuick HCV Rapid Antibody Test [OraSure Technologies]) (Lee, 2011) The latter is an indirect immunoassay with a sensitivity and specificity similar to those of FDA-approved laboratory-based HCV antibody assays.”

Thank you for the opportunity to provide comments on this important decision memo for screening for hepatitis C. Please consider making the above-recommended changes to provide clarity and reduce confusion among providers and third-party payers.

Sincerely,

Debra Fraser-Howze
Senior Vice President
Government and External Affairs
OraSure Technologies, Inc.

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March 24, 2014

Ms. Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) Tracking Sheet for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N)

Dear Administrator Tavenner:

On behalf of the American Association for the Study of Liver Diseases (AASLD), the leading organization of healthcare professionals and scientists committed to preventing and curing liver disease, thank you for the opportunity to submit these comments on the Proposed Decision Memo for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N). We believe that it is critical that this screening be a covered preventive service given the silent HCV epidemic in this country and commend CMS for taking this necessary step to ensure at-risk patients are screened.

With an estimated 3.2 million chronically infected persons nationwide, HCV is the most common blood-borne infection in the United States. Approximately 75 to 85 percent of newly infected persons develop chronic infection. HCV is an asymptomatic disease and can remain so for decades. Three out of four of those currently infected are unaware. Allowing the disease to progress to the point where a patient is demonstrating symptoms greatly increases the danger of the disease, decreases physicians’ abilities to treat these patients, and often results in the development of liver cancer. Liver cancer is one of the few cancers increasing in frequency and has one of the highest mortality rates.

Because of the absence of a HCV vaccine and the high burden of chronic HCV infection in the United States, national guidelines emphasize primary prevention activities, including screening. Diagnosis of infection is made on the basis of HCV blood test results, and early detection drastically increases the opportunity to successfully treat patients. The Food and Drug Administration (FDA) recently approved point-of-care tests for HCV infection, which can facilitate screening, notification of results, post-test counseling, and referral to care at the time of the testing visit.

Although HCV treatments are available and are improving, they are not 100 percent effective. The effectiveness of treatment varies according to the genotype of the virus, the most common of which is genotype 1 in the United States. This genotype is the hardest to treat with a success rate of up to 60 percent. Treatment is much less effective in patients with cirrhosis and is associated with more serious side effects often leading to discontinuation of the medication.

Once cirrhosis develops from undetected HCV, liver cancer, liver failure and the need for liver transplantation ensue, all of which come at great expense. Cirrhosis is associated with high morbidity and mortality, loss of work productivity, decrease in quality of life, and substantial healthcare costs. The costs of HCV screening should be considered in relation to these.

For those patients fortunate enough to receive a liver transplant, HCV recurs at a rate of 100 percent, making it critical to diagnose and treat HCV before a liver transplant is necessary. Based on these facts, the AASLD strongly urges CMS finalize a National Coverage Decision that ensures all forms of HCV blood test screening in adults is covered by Medicare. This decision will save lives while reducing healthcare system expenditures. CMS has taken the first step; therefore, we urge you to finalize this coverage decision and begin the work of preparing the educational materials that will be necessary to educate medical providers and beneficiaries about HCV screening.

Again, thank you for the opportunity to submit these comments. The AASLD looks forward to working with you on this important issue. If you have any questions, please do not hesitate to contact Erika Miller at (202) 484-1100 or emiller@dc-crd.com.

Sincerely,

/s/
Adrian M. Di Bisceglie, MD, FACP
AASLD President

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Idaho, as a rural state, faces the challenges of reaching individuals at risk for hepatitis c. We also serve a large percentage of individuals eligible for Medicare and Medicaid. Covering the cost of this screening would further our efforts to reach those at-risk individuals and normalize the screening process. The ability to have public entities (i.e. District Health Depts.) bill for these screenings would be most beneficial to identifying acute illness, thus saving significant costs later due to chronic disease progression.
Thank you for the opportunity to offer comment on this important CMS consideration.

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CMS coverage for a one-time HCV screening test for Medicare Part A/Part B enrolled individuals is certainly an important and essential step towards the reduction of morbidity and mortality for persons infected with HCV. However, due to known disparities among the “at-risk” HCV infected population, including U.S.“baby boomers”, screening in the primary-care setting alone may fall short of it’s intended aims.

Data from NHANES suggests that >50% of persons born between 1945 and 1965 are unaware of their HCV status. Those unaware are more likely to lack a “usual source of medical care.” This suggests that HCV screening through the primary care setting alone may be inadequate.

Results from our ED-based HCV screening of the “baby boomer” birth cohort have revealed an 8.0% antibody prevalence among Medicare recipients who were by self-report unaware of their HCV-status. These Medicare enrolled individuals accounted for 23% of all HCV-antibody persons identified at our ED site.

Due to the known disparities in access to a primary-care physician in the U.S., I encourage the consideration of expansion of coverage for this screening test to include higher-yield environments, including but not limited to: emergency departments, inpatient hospital settings, and ambulatory surgical centers.

James Galbraith, MD
Associate Professor of Emergency Medicine
University of Alabama at Birmingham

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I believe further clarification and further allowance for HVC testing in adults should be considered and allowed. Specifically in such cases as [PHI Redacted] which is:

1. NOT an illicit drug user, ever.
2. Born in 1950
3. In 2010 had daily transfusions for 24 consecutive days in two different hospitals due to uncontrolled bleeding that was not resolved for over 3 weeks.

I believe that the large, very large, number of blood transfusions and the large amount of plasma transfused is a valid reason to require periodic testing for HVC.

For that matter, [PHI Redacted], I believe it justifies periodic testing (at least annual) for a number of possible infectious contaminants (HIV and others) that could have occurred in such a massive episode of transfusions.

Sincerely,

Steven Ward

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