The Roadblock May Not Be the FDA After All

A colleague and I visited with a startup company last week, one that was designing a product that can detect certain ailments through your breath. Named Menssana Research, the company is housed across the street from the New Jersey Institute of Technology, in a building owned by the college (which just happens to be my alma mater).

One test that company claims to have perfected is a non-invasive breath test for markers which can predict the probability of a Grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. Called the Heartsbreath, it consists of a breath collection apparatus (BCA) that resembles a small telescope.


The BCA collects volatile organic compounds found in a person’s breath using a sorbent trap. You can see it in action in this clip, showing MD+DI Managing Editor Maria Fontanazza breathing into the BCA.

At the same time, the device collects a separate sample of room air. An analysis of the two samples is performed by gas chromatography and mass spectroscopy. Hence, a patient may not have to go through an invasive endomyocardial biopsy. The data collection is shown in the next video clip.

The company received what it thought was great news when it obtained FDA approval as a Humanitarian Device. Unfortunately, that news was shortly followed by news from Medicare, who denied the request for reimbursement from patients making use of this procedure. Medicare claims that additional testing is needed before they will approve the procedure.

Here’s the summary from The Centers for Medicare and Medicaid Services (CMS):

The Centers for Medicare and Medicaid Services (CMS) has reviewed Menssana’s request for a national coverage determination (NCD) for the Heartsbreath diagnostic test used as an adjunct to the endomyocardial biopsy to detect grade 3 heart transplant rejection in patients who have had a heart transplant within the last year and an endomyocardial biopsy within the prior month. We believe that the available evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to predict grade 3 heart transplant rejection improves health outcomes in Medicare beneficiaries. Therefore, we are proposing that the Heartsbreath diagnostic test is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

So what gives here? It’s good enough for the FDA but not good enough for Medicare. I was led to believe that the FDA was Big Brother. But in the case of Menssana Research, that’s not the case.
The current biopsy is performed in roughly 2500 patients per year who receive a heart transplant. The test is not a simple one for the patient, and costs about $3500, according to Dr. Michael Phillips, President and CEO of Menssana.

The bottom line is that Medicare wants Menssana to do more testing, which it is currently doing. So even though it’s good enough for the FDA, it’s not good enough for Medicare.

Richard Nass