A Diagnostics & Imaging Week
The Centers for Medicare & Medicaid Services offered earlier this year to take a look at a test of biomarkers in the breath of heart transplant patients to detect tissue rejection, but the plea seems to have fallen on deaf ears as CMS has issued a proposed finding of "not reasonable and necessary" in the use of the diagnostic, made by Menssana Research (Newark, New Jersey).
The memo indicates that CMS is seeking further public comment on the matter for 30 days after the publication of the proposed decision, which was published Sept. 29, and that a decision to investigate the matter further via the Coverage with Study Participation mechanism was still possible. At present, no local carriers have opted to cover the test, either, which is intended as an adjunct to a biopsy from one of the patient's ventricles.
According to CMS, the pivotal PMA study for the Heartsbreath, the HARDBALL (Heart Allograft Rejection; Detection with Breath Alkanes in Low Levels) study, covered more than 500 patients to evaluate the diagnostic as an adjunct to tissue biopsy for grade 3A rejection. The study did not cover patients who are experiencing grade 3B and grade 4 rejection.
One of the issues for CMS appears to be the "clinical utility" of the Heartsbreath test. The memo states that the usefulness of a determination of grade 3A rejection "is unknown, especially given the controversy in the transplant community regarding what grade of rejection should indicate a change in clinical management."
On the other hand, the agency also has questions about the nine volatile organic compounds (VOCs) found in the pivotal FDA study. CMS said "it is unclear if these specific VOCs are representative of grade 3A rejection in all patients or are representative of only the sample of patients" in the study.
CMS notes in the memo that "a non-invasive test is preferable if it can yield the same or similar benefit as an invasive test," but that the benefit of a test hinges on "clear technical characteristics," which CMS hinted was in doubt over the question of the VOCs.
Robert Zirkelbach, spokesman for America's Health Insurance Plans (AHIP; Washington), told Diagnostics & Imaging Week that for AHIP, "the focus is that we need to ensure that patients are receiving the most effective treatments available." On the one hand, "early studies have shown that this treatment offers some promise," he said, but payers are of the opinion that "more evidence is needed to find out under what circumstances this test is needed."