National Coverage Analysis (NCA) Tracking Sheet

Heartsbreath Test for Heart Transplant Rejection

CAG-00394N

Issue

The Heartsbreath test is a non-invasive breath test for markers of oxidative stress which may predict the probability of grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. It consists of: 1) A breath collection apparatus for collection of volatile organic compounds in alveolar breath onto a sorbent trap, as well as for the collection of a separate sample of room air. 2) Analysis of the volatile organic compounds in alveolar breath and room air by gas chromatography and mass spectroscopy. 3) Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of grade 3 heart transplant rejection. The conventional procedure used in the diagnosis of all grades of heart transplant rejection is endomyocardial biopsy.

The requestor, Menssana Research, is asking CMS to consider national coverage for the Heartsbreath test for grade 3 heart transplant rejection. The device used in this test has been reviewed and approved by the FDA through a Humanitarian Device Exemption (HDE) application. The device is indicated for use as an adjunct to, and not as a substitute for, endomyocardial biopsy to diagnose grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.

There is no NCD for the Heartsbreath test at this time.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Michael Phillips, MD, Menssana Research, Inc. View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/10/2008
Expected NCA Completion Date
12/28/2008
Public Comment Period
04/10/2008 - 05/10/2008
Proposed Decision Memo Due Date
Proposed Decision Memo Released
09/29/2008
Proposed Decision Memo Public Comment Period
09/29/2008 - 10/29/2008
Decision Memo Released
12/08/2008
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Eileen Pencek
Lead Medical Officers
Lori Paserchia, MD

Medicare Benefit Category Determination Date

Actions Taken

April 10, 2008

Reviewed and accepted formal request for NCD.

CMS is requesting public comments on coverage for the Heartsbreath test for grade 3 heart transplant rejection in the Medicare population.

CMS is requesting public comments and is particularly interested in the quality of data and evidence cited in public comments.

The initial 30-day public comment period begins with this posting date and ends 30-days following this posting. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review. Instructions on submitting comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

To submit a comment, please use the orange "Comment" button at the top of the page.

September 29, 2008

Proposed decision memorandum posted and second 30-day public comment period begins. CMS invites public comments on this proposed decision memorandum. We are especially interested in evidence that validates the technical characteristics of the Heartsbreath test.

CMS requests comments that include relevant new evidence about clinical studies and other scientific information for this technology under review. We consider all public comments and maintain an interest in short and long-term health benefit outcomes in the Medicare population.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html. To submit a comment, we strongly urge the use of the orange "Comment" button at the top of the page. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

December 8, 2008