National Coverage Analysis (NCA) View Public Comments

Screening for Hepatitis C Virus (HCV) in Adults

Public Comments

Commenter Comment Information
Fisher, Vanessa Organization: Boehringer Ingelheim Pharmaceuticals, Inc.
Date: 04/03/2014
Comment:

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

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Dering-Anderson, Allison Title: Clinical Assistant Professor of Pharmacy Practice
Organization: University of Nebraska College of Pharmacy
Date: 04/03/2014
Comment:

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

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Smith, William Title: Executive Director
Organization: National Coalition of STD Directors
Date: 04/03/2014
Comment:

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

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Roth, Jessica Title: Director, Health Policy & Reimbursement
Organization: Roche Diagnostics Corporation
Date: 04/03/2014
Comment:

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

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Buchanan, Sarah Title: Member
Organization: Corporate Hepatitis Alliance
Date: 04/03/2014
Comment:

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

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Krupp, Aaron Date: 04/03/2014
Comment:

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

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Salay, Becky Title: Director of Government Relations
Organization: Trust for America's Health
Date: 04/02/2014
Comment:

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

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Hanen, Laura Title: Chief, Government and Public Affairs
Organization: National Association of County and City Health Officials
Date: 04/02/2014
Comment:

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

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Rodriguez, Andres Title: Director, Practice & Payment Policy
Organization: Infectious Diseases Society of America
Date: 04/02/2014
Comment:

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,

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Gallant, MD, FIDSA, Joel Title: Chair
Organization: HIVMA Board of Directors
Date: 04/02/2014
Comment:

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

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Bocchino, Carmella Title: Executive Vice President
Organization: America's Health Insurance Plans
Date: 04/01/2014
Comment:

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

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Klepser, Michael Title: Professor
Organization: Ferris State University
Date: 04/01/2014
Comment:

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

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Clary, Ryan Title: Executive Director
Organization: National Viral Hepatitis Roundtable
Date: 04/01/2014
Comment:

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

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Lusk, Heather Title: Director
Organization: Hep Free Hawaii
Date: 03/31/2014
Comment:

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

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Yao, Joseph Date: 03/31/2014
Comment:

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

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Buchanan, Sarah Title: Washington Representative
Organization: OraSure Technologies, Inc.
Date: 03/25/2014
Comment:

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

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Cathcart, Exec. Dir., Sherrie Organization: American Association for the Study of Liver Diseases
Date: 03/24/2014
Comment:

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

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Porter, Lucinda Date: 03/23/2014
Comment:
If we test adults born between 1945 and 1965, we may identify 800,000 Baby Boomers who might slip through the cracks if we only did risk-based hepatitis C screening. Furthermore, we may save 120,000 lives. This is a cost-effective and reasonable screening strategy.
Idaho Hepatitis Advisory Council, Idaho Date: 03/21/2014
Comment:
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

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Galbraith, James Title: Associate Professor
Organization: University of Alabama at Birmingham
Date: 03/20/2014
Comment:

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

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Sepe MD, Thomas Title: Director- The Liver Center
Organization: University Gastroenterology
Date: 03/08/2014
Comment:
Screening should be covered given the vast majority of patients with HCV in the US are not aware of its presence and health care effects, in light of the extraordinary improvements in antiviral therapy at present and into the next year or two when MOST ( >95%) patients will be easily cured of HCV. We MUST identify patients with infection to pursue viral eradication and prevent the long term consequences of HCV.
WARD, STEVEN Date: 03/05/2014
Comment:

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,

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Blackman, Ruth Date: 03/05/2014
Comment:
I request that coverage of HCV screening for Medicare beneficiaries be extended to screening offered in emergency departments, convenient care units and inpatient hospitals. For some patients, their most frequent contact with healthcare is still, unfortunately, through these sites of care.