National Coverage Analysis (NCA) View Public Comments

Pharmacogenomic Testing for Warfarin Response

Public Comments

Commenter Comment Information
Johnson, John Organization: Osmetech Molecular Diagnostics
Date: 06/03/2009
Comment:

June 3, 2009

Dear CMS Panel Members,

Thank you for the opportunity to respond to the CMS memo: Proposed Decision Memo for Pharmacogenomic Testing for Warfarin Response. Osmetech Molecular Diagnostics asks the panel to consider the following in support of the value of pharmacogenetic guided dosing of warfarin as we believe pharmacogenomic guided dosing is indeed of benefit to and improves health outcomes in Medicare beneficiaries.

We believe everyone agrees that the

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Bocchino, Carmella Title: EVP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans (AHIP)
Date: 06/02/2009
Comment:

June 3, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Ms. Syrek Jensen:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage determination (NCD), Pharmacogenomic Testing for Warfarin Response (CAG-00400N).

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Lazarus, Tadd Title: Medical Director
Organization: Roche Diagnostics Corporation
Date: 05/26/2009
Comment:

May 26, 2009

Ms. Maria Ciccanti
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Pharmacogenomic Testing to Predict Warfarin Responsiveness (CAG- 00400N)

Dear Ms. Ciccanti:

I am writing on behalf of Roche Diagnostics Corporation (Roche) to support the Centers for Medicare & Medicaid Services (CMS) proposed coverage under evidence development (CED)

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Brodie, Carol Date: 05/18/2009
Comment:

At this time, the current evidence regarding the use of genotyping tests for the determination of drug metabolizer status indicates that while the available testing methods accurately identify the genetic makeup of patients, there is insufficient data to demonstrate that such testing, and the clinical decisions made based on them, results in a significant impact on health outcomes. Specifically, there have not been any clinical trials that have adequately demonstrated that such testing

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Gere, Maxine Title: Program Manager
Organization: Blue Cross and Blue Shield Association
Date: 05/11/2009
Comment:

May 11, 2009

Centers for Medicare & Medicaid Services
Via online comment posting
Re: Pharmacogenomic Testing for Warfarin

The Blue Cross and Blue Shield Association (BCBSA), an association of 39 independent Blue Cross and Blue Shield Plans that collectively provide health insurance benefits to 102 million Americans, appreciates the opportunity to comment on the national coverage determination proposed by the Centers for Medicare and Medicaid Services (CMS) on the

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Cundiff, David Title: MD
Date: 05/07/2009
Comment:

Your proposed ruling on genetic testing for warfarin says, “we do believe the available evidence suggests that Coverage with Evidence Development (CED) under §1862(a)(1)(E) of the Social Security Act is appropriate.” I oppose this proposed coverage of further research of this test and submit as evidence two of my articles that have been published in the medical literature:

  • A Systematic Review of Cochrane AnticoagulationReviews.1
  • Clinical Evidence For

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