National Coverage Analysis (NCA) View Public Comments

Screening DNA Stool Test for Colorectal Cancer

Public Comments

Commenter Comment Information
DeWilde, Leticia Flores Title: Sr. Policy Analyst
Organization: American Cancer Society Cancer Action Network
Date: 02/29/2008
Comment:

February 29, 2008

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, MD 21244

RE: CAG-00144N; Medicare Program; Proposed Decision Memo for Screening DNA Stool Test for Colorectal Cancer

Dear Dr. Phurrough:

The American Cancer Society Cancer Action Network (ACS CAN), the sister advocacy organization of the American Cancer Society,

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Bocchino, Carmella Title: Exec. VP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans
Date: 02/28/2008
Comment:

February 29, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed national coverage decision (NCD), Screening DNA Stoll Test for Colorectal Cancer (CAG-00144N).

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Kobierowski, Phil Title: Concerned American Citizen
Date: 02/28/2008
Comment:

How many people have to die of colorectal cancer before the beaurocrats allow the public access to this life-saving screening test?!?!?! It has been proven more effective than the currently approved fecal occult blood tests that can''t be relied on, it poses no possible harm to the patient (unlike virtual colonoscopies and CT scans tests), and it would save taxpayers many millions of dollars by catching cancer while it is still curable in medicare/medicaid patients.

Is the

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trembley, jason Date: 02/13/2008
Comment:

While i understand that CMS wants the stool based DNA test to be covered from a regulatory standpoint, The comment from Richard Justman of United Healthcare regarding a pending study funded by the "NCI" regarding 4000 average risk patients and comparing fDNA to FOBT was competed four years ago. Thus; his negative comments regarding fDNA should be considered moot.

Here is what the "NCI" concluded

"As the NCI has recognized, recent publications also offer evidence for the superiority

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Justman, Richard Title: National Medical Director
Organization: UnitedHealthcare
Date: 02/08/2008
Comment:

Conclusion and Recommendation: We agree with the proposed non-coverage decision for stool DNA testing for colorectal cancer. We believe that this decision should extend to both average-risk and persons at high-risk for colorectal cancer. We base our conclusion not on the current level of FDA review and approval, but the quality of clinical evidence supporting the use of stool DNA testing for colorectal cancer screening.

About UnitedHealth Group: UnitedHealth Group is a

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Gong, Rodney Title: MD
Date: 02/06/2008
Comment:

ADDENDUM:
The signifcance of the false negative DNA Stool Test can be highlighted by the November 15, 2007, press release by the manufacturer EXACT Science.

Using Version 2 technology, 82 colonoscopy proven colorectal cancers were tested. The results showed an 83% sensitivity. This means that 68 of the 82 colorectal cancers were correctly diagnosed by the DNA Stool Test. However, this also means that 14 of the colorectal cancers were missed by the DNA Stool Test.

The

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Gong, Rodney Date: 02/03/2008
Comment:

Using the Screening DNA Stool Test with a sensitivity of only 88%,then 1 out of every 8 patients with colorectal cancer will get a false negative test. This should be unacceptable because these patients will falsely assume that they are cancer free and should not need another test for 5 years as recommended by the manufacturer. During this time, the progression of the cancer would result in several fatalities that could have been prevented by the current colonoscopy

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Tromblay, Linda Date: 02/02/2008
Comment:

As a prime candidate for colorectal cancer I would very much like to see this type of screening offered. As of now I have a colonscopy every five years...however, in between 5 years..that is long time for a polyp to grow...if this testing were offered it would be affordable even if my insurance company did not cover it...and it would be something I would have done in between the colonoscopies...

The ease alone, will encourage those that do not want to go through the discomfiture

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Reed, Tom Title: Registered Professional Engineer
Date: 01/30/2008
Comment:

As a taxpayer, and as a son with parents enrolled under Medicare, I am very disappointed with the CMS decision to decline national coverage for DNA Stool testing for Colorectal Cancer. To decline this simple, cost effective, and non-invasive test procedure because it lacks official FDA approval is an absurd and purely political decision that borders on criminal negligence. It is also a decision to waste thousands of future of taxpayer dollars and displays a gross lack of concern for

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