National Coverage Analysis (NCA) View Public Comments

Screening for Colorectal Cancer - Stool DNA Testing

Public Comments

Commenter Comment Information
Ma-Weaver, Jacob Title: Portfolio Manager
Organization: Cable Car Capital LLC
Date: 09/10/2014
Comment:

I manage Cable Car Capital LLC, an investment adviser based in San Francisco. In full disclosure, Cable Car currently holds a short position on behalf of clients in Exact Sciences, the sponsor of Cologuard. In the process of researching Exact Sciences, I have carefully reviewed the available scientific literature on colon cancer diagnostics and spoken with several members of the medical community. My financial interest to the contrary notwithstanding, I support the proposed CMS coverage of

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Schwartz, J Sanford Title: Professor Medicine, Health Management & Economics
Organization: University of Pennsylvania School of Medicine & Wharton School
Date: 09/10/2014
Comment:

Note: My comments, questions and suggestions are informed by my 35 years of experience studying medical decision making and the clinical, comparative and cost-effectiveness of diagnostic tests and my experience as a member/former member of the US Preventive Services Task Force, CMS MEDCAC, Blue Cross and Blue Shield Associations Medical Advisory Panel, various NIH Consensus Development Committees and Clinical Guideline Committees and Centers for Disease Control and World Health Organization

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Madsen, Jennifer Date: 09/10/2014
Comment:

September 10, 2014

Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Screening for Colorectal Cancer – Stool DNA Testing (CAG-00440N)

Dear Ms. Tavenner,

The College of American Pathologists (CAP) appreciates the opportunity to submit comments to the Centers for Medicare and Medicaid Services (CMS) in

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Biale, Rocco Date: 09/10/2014
Comment:
Nice to see CMS and FDA working together in an effort to early detection @ color cancer screening...
Bocchino, Carmella Organization: America's Health Insurance Plans (AHIP)
Date: 09/10/2014
Comment:

September 9, 2014

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) Proposed Decision Memo for Screening for Colorectral™ Cancer – Stool DNA Testing (CAG-00440N)

Dear Ms. Jensen:

Thank you for the opportunity to

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Conway, Brad Organization: American College of Gastroenterology
Date: 09/09/2014
Comment:

RE: Proposed Decision Memorandum for Screening for Colorectal Cancer Using Cologuard – A Multitarget Stool DNA Test

The American College of Gastroenterology (ACG) appreciates the opportunity to offer comments in support of the Centers for Medicare and Medicaid Services’ (CMS) proposal to include Cologuard as a covered benefit in Medicare Part B. The ACG agrees with CMS that while diagnostic/therapeutic colonoscopy is a required and necessary step to complete the continuum of

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May, Donald Title: Executive Vice President
Organization: AdvaMed
Date: 09/09/2014
Comment:

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

RE: Proposed Medicare Coverage Decision Memorandum for Screening for Colorectal Cancer – Stool DNA Testing (CAG-00440N)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) and AdvaMedDx are pleased to offer

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Hansen, Christopher Title: President
Organization: American Cancer Society Cancer Action Network
Date: 09/09/2014
Comment:

The American Cancer Society Cancer Action Network (ACS CAN) appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid Services’ (CMS’) proposed decision memo on screening for colorectal cancer – stool DNA testing. We are writing to support CMS’ proposed decision memo that will provide Medicare beneficiaries with another important colorectal cancer screening option.

ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society

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Allen, MD, MBA, AGAF, John I. Title: President
Organization: AGA Institute
Date: 09/09/2014
Comment:

September 9, 2014

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

RE: Proposed Decision Memorandum for Screening for Colorectal Cancer Using Cologuard™ – A Multitarget Stool DNA Test

Dear Ms. Jensen,

The American Gastroenterological Association (AGA) is the trusted voice of

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DeKay, Becky L. Title: President
Organization: Association of Community Cancer Centers
Date: 09/09/2014
Comment:

September 9, 2014

Joseph Chin, MD, MS
Lead Medical Officer

Jamie Hermansen, MPP
Lead Health Policy Analyst

Centers for Medicare and Medicaid Services
Coverage Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

BY ELECTRONIC DELIVERY

RE: Proposed Decision Memo for Screening for Colorectal Cancer Stool DNA Testing (CAG-00440N)

Dear Dr. Chin and Ms. Hermansen:

On behalf of

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Wagner, Michael Title: Consultant
Date: 09/08/2014
Comment:

[PHI Redacted]

I am well aware that roughly 50,000 Americans die each year from colon cancer, and I think that that speaks to the fact that our current screening methodologies just aren't getting the job done. Although my family has no previous history of colon cancer, [PHI Redacted] underwent a colonoscopy 6 years ago at age 42 and his procedure was not without complications. And even though I am aware of several friends of mine that have had

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Berger, Barry Title: Chief Medical Officer
Organization: Exact Sciences Corporation
Date: 09/08/2014
Comment:

September 8, 2014

VIA electronic submission to Medicare Coverage Database

Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Service
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Screening for Colorectal Cancer – Stool DNA Testing (CAG-00440N)

Dear Ms. Tavenner:

We appreciate CMS’s issuance of the Proposed Decision Memo for Screening for Colorectal Cancer – Stool

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Schmitt, MD, MHS, FASGE, Colleen Title: President
Organization: American Society for Gastrointestinal Endoscopy
Date: 09/08/2014
Comment:

September 8, 2014

Marilyn B. Tavenner, MHA, BSN, RN
Administrator
The Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00440N; Proposed Decision Memorandum for Screening for Colorectal Cancer Using CologuardR – A Multitarget Stool DNA Test

Dear Administrator Tavenner:

The American Society for Gastrointestinal Endoscopy (ASGE)

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Leikarts, Martin Date: 09/05/2014
Comment:

As somebody who is approaching 50, I am very excited about this new colon cancer screening test.

Colonoscopy as a screening test for an average risk individual is just too invasive physically and psychologically. [PHI Redacted]

I am not sure I would ever consider FIT test either as the sensitivity is just too low and it does not really detect pre-cancerous polyps. As a result, I would learn about the cancer from FIT test when I most likely will have

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Gillis, Harvey Organization: HG Enterprises
Date: 09/04/2014
Comment:
Thank you for your timely review and support for the Cologuard diagnostic kit from Exact Sciences. I am a retired medical equipment executive with degrees in mathematical modeling, business, chemical engineering and economics. Because of colon cancer in our family, my relatives and I have endured regular colonoscopies and inaccurate FIT/FOBT tests despite the fact that we all are symptom free. With a sensitivity of over 92%, we will now schedule Colguard screenings every two or three years

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Wood, Richard Date: 09/02/2014
Comment:
I applaud CMS for enabling joint FDA/CMS review of new products and, in this case, an exciting new colon cancer screening diagnostic. Such joint review should be the norm in the future to help speed new products to patients needing them.
Nolan, Martha Title: Vice President, Public Policy
Organization: Society for Women's Health Research
Date: 09/02/2014
Comment:

August 22, 2014

Marilyn Tavenner, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20201

Re: Proposed Decision Memo for Screening for Colorectal Cancer-Stool DNA testing (CAG-00440N)

Dear Ms. Tavenner,

On behalf of the Society for Women’s Health Research (SWHR), I am writing to the Centers for

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Jenkins, Bruce Organization: Massachusetts General Hospital
Date: 08/27/2014
Comment:

Over the past 20 years we have learned that there are alternative pathways to development of CRC besides that of the conventional adenoma – carcinoma pathway. This alternative pathway has been termed the serrated neoplastic pathway and is associated with mutations in BRAF and microsatellite instabilities while conventional adenomas are not [1]. This pathway is thought to lead to about 20-30% of all CRCs [2]. A growing body of evidence suggests that these lesions may be strongly

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McGlothlin, Anita Title: Health Policy Analyst
Organization: American College of Radiology
Date: 08/27/2014
Comment:

August 27, 2014

Tamara S. Syrek Jensen, J.D.
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

By Online Submission

Re: Proposed Decision Memo for Screening for Colorectal Cancer – Stool DNA Testing (CAG-00440N)

Dear Ms. Syrek Jensen:

The American College of Radiology (ACR), representing more than 35,000 diagnostic

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Mastin, William Date: 08/27/2014
Comment:

I am a Doctor of Pharmacy certified in Geriatric Pharmacology and I am delighted to offer a comment.

Cologuard will offer our ever growing population of those at risk for CRC a reasonable approach to reduction of the incidence of a very real and age related morbidity / mortality.

Cologuard will offer a huge health benefit to the ever growing older population. Empowering patients to actively participate in their own health is a winning approach to cost effective

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Hargis, Eric Title: Chief Executive Officer
Organization: Colon Cancer Alliance
Date: 08/26/2014
Comment:

The Colon Cancer Alliance is the oldest and largest advocacy organization dedicated to the prevention of colorectal cancer and the empowerment of patients facing the challenge of this devastating disease. As a member of the National Colon Cancer Roundtable, we join with the Centers for Disease Control and Prevention and other members to achieve the goal of having 80% of at-risk adults screened for colorectal cancer by 2018.

It is a tragedy that this year almost 50,000 Americans

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Klaskin, Eben Title: MBA
Date: 08/25/2014
Comment:

I ask, that of the medical professionals recommending colonoscopy or FIT on cost alone, how is society to handle the exploding number of baby boomers?

1. There are not enough GI's to perform the greater than 100 million (and growing) population of those individuals age 50 years and older:

a. How long, and at what price, would it take to properly train physicians to reach the level of Board Certified Gastroenterologist Endoscopists? How about a

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Allison, James Title: Screening for Colorectal Cancer-Stool DNA Testing
Organization: University of California San Francisco (UCSF)
Date: 08/23/2014
Comment:

Recently the FDA approved the “Cologuard test” to screen for colorectal cancer (CRC), and the Centers for Medicare and Medicaid Services (CMS) announced proposed Medicare coverage of the test. The parallel review by the two agencies represented the first step in a pilot program to expedite approval and coverage of selected devices. CMS proposes to cover the Cologuard™ test for use once every three years for beneficiaries who meet all of the following criteria:

  1. Age 50 to

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Kim, David Title: Professor
Organization: University of Wisconsin School of Medicine and Public Health
Date: 08/19/2014
Comment:

To whom it may concern:

In the context of the past few years, I am surprised by the CMS decision to reimburse stool DNA testing for colorectal cancer screening. CMS has noticeably raised the bar for supporting data for any new screening modality. However, there is a glaring omission in the potential risks and harms section of the CMS document. In the Imperiale trial, the false positive rate for this test was substantial.(1) As the authors themselves report in the paper, in a

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Kahle, Regina Title: GI RN
Organization: Memorial Hospital & Healthcare Center
Date: 08/18/2014
Comment:
I am a GI nurse for the past 7 yrs & a RN for more than 30 yrs. I have seen more adenomatous polyps & cancerous polyps on asymptomatic patients than I care to say.
While in theory this may be a fine decision, I believe reality will prove otherwise. I believe this will give the public a false sense of security.
It would be better just to do the procedure. People have to face their fear or laziness, which is a common concern we hear. They always feel better after it's done.
Aldigé, Carolyn Title: President and Founder
Organization: Prevent Cancer Foundation
Date: 08/15/2014
Comment:

August 15, 2014

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Screening for Colorectal Cancer Using Cologuard™—A Multitarget Stool DNA Test

Dear Ms. Syrek Jensen:

As the only national nonprofit organization in the United States dedicated solely to the prevention and early detection of cancer,

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Bills, Marcia Date: 08/14/2014
Comment:
Will the DNA taken from these stool testings be put into the National DNA database? CODIS? in order to ID people
Phelps, Caitlin Title: Director of Gynecology
Organization: American College of Obstetricians and Gynecologists
Date: 08/14/2014
Comment:

August 14, 2014

SUBJECT: Proposed Decision Memorandum for Screening for Colorectal Cancer Using
Cologuard™ – A Multitarget Stool DNA Test (CAG-00440N)

Thank you for the opportunity to review the Centers for Medicare & Medicaid Services (CMS) proposal to cover Cologuard, a multitarget stool DNA test, as a colorectal cancer screening test for asymptomatic average risk beneficiaries aged 50 to 85 years. Colorectal cancer screening is an issue of great importance

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Wedlund, Peter Title: Retired Faculty
Organization: UK College of Pharmacy, Lexington, KY
Date: 08/13/2014
Comment:

Screening for Colorectal Cancer Stool DNA testing__(CAG 00440N)

ColoGuard is an advance in CRC detection, and CMS certainly was correct to approve it for reimbursement. However, as a follower and advocate of cost/benefit efforts for many years, I believe serious thought should be given to the level of reimbursement.

The incidence of CRC is about 0.06% in the US population with a 5% total lifetime risk mostly among those over 50. This means over a 35 year span of testing

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Levine, Benjamin Title: Professor of Medicine
Organization: University of Texas Southwestern Medical Center
Date: 08/12/2014
Comment:
The lower age limit is too high. Many patients with familial colorectal cancer need screening at an age < 50. Indeed, a stool based test might be even more useful in such patients as it could save them many colonoscopies of a lifetime, especially for conditions like Lynch Syndrome where screening is recommended beginning at age 25. Please reconsider your lower age limit, especially for familial cases of CRC.
Orona, Lorenzo Date: 08/12/2014
Comment:
I approve of this test as a good alternative to a colonoscopy. I need for the diagnosis to be 100 percent correct, or close to that, in that the cancer exists or it doesn't. If one of these tests is done, I hope that sometime down the road the cancer doesn't show up because the previous diagnosis was incorrect. Then the test will need to be reviewed and improved so that other people won't have the wrong diagnosis with this test.
Shuey, Linda Date: 08/12/2014
Comment:
I think good idea for checking to the full colorectal testing an option to going through the other if not needed and easier way and costs would it also save?
Swahla, Siu-lan Date: 08/12/2014
Comment:
It is a great step towards preventing colon cancer to cover cologuard. Most people are reluctant to take the invasive colonoscopy, thus increasing the incidences of undetected colon cancer which is more costly in terms of medical expenses and human lives. There is nothing to lose but everything to gain for Medicare to offer coverage for such an easy, inexpensive 'cologuard' test that helps to prevent colon cancer, the third most common cancer.
Myslinski, Mark Date: 08/12/2014
Comment:
This is a good decision and well documented. Colon cancer should be avoided and this will increase the number of people who will be appropriately screened for a colonoscopy. It is nice to see the FDA, industry and CMS working together to address a significant unmet need in the colon cancer arena. Well done.
eyre, karen Title: Mrs
Organization: individual constiuant
Date: 08/11/2014
Comment:
I think it's awesome to make this testing available and a covered item. My confusion .is with the posting of the "memorandom" what that mean? Does it have anything to do with privacy and is it a mandatory test?
Jimerson, W S Date: 08/11/2014
Comment:
I think this is a great idea, being proactive instead of reactive when colon cancer has spread. I have family history of colon cancer[PHI Redacted] GREAT IDEA!!
Grandalski, Joe Date: 08/11/2014
Comment:
Where can pricing information be found on local medical costs such as doctor visits, labs, outpatient services(diagnostic tests) and individual hospital charges? My doctors office is owned by the hospital and no one knew the cost of an office visit they suggested I call hospital billing, which I called and they did not know either. I thought that was part of the 2010 PPACA section 6218?
Bergschneider, Dr. Diane Title: President and Principal
Organization: Diane Bergschneider Consulting
Date: 08/11/2014
Comment:
This test appears to be well intentioned; however, given the stringent clinical criteria requirements, there are not many in this population that will likely qualify for Medicare coverage. Also, the costs savings of the test every 3 years compared to a colonoscopy administered every ten years at max needs to be established for real savings not to forget the clinical impact of a beneficiary's health long term relying on the DNA testing.