HeartFlow bags Medicare coverage for its FFRct Analysis software platform

3D, color-coded map of the coronary arteries showing blood flow
The HeartFlow FFRct Analysis software creates a model of a patient's blood flow using data from his or her CT scan. (HeartFlow)

The Centers for Medicare & Medicaid Services has finalized its payment classification for HeartFlow’s noninvasive technology for the analysis of coronary artery disease (CAD).

Specifically, CMS has finalized a New Technology Ambulatory Payment Classification (APC) for HeartFlow’s FFRct Analysis, according to a statement. Under this payment system, hospitals enrolled in Medicare that bill CMS for the technology will be eligible for reimbursement for the test, starting on Jan. 1, 2018.

FFRct Analysis received de novo clearance from the FDA in 2014. The platform uses data from a patient’s coronary CT scan to create a 3D, color-coded “map” of his or her coronary arteries. The model shows the extent to which arteries are narrowed or blocked, and whether these lesions are affecting blood flow. Physicians will then factor the analysis in treatment decisions.

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"The CMS decision … is a major milestone and will ensure that our innovative, non-invasive technology can be utilized for Medicare beneficiaries. This is a significant development, given the high prevalence of CAD in people over age 65,” said HeartFlow CEO John Stevens, M.D., in the statement.

Caused by plaque buildup in the coronary arteries, CAD is the most common type of heart disease in the U.S. FFRct Analysis can help in the diagnosis of CAD in patients with chest pain.

Earlier this year, NICE, the U.K.’s cost watchdog, supported the use of FFRct in the assessment of patients with stable, recent onset chest pain.

And in August, HeartFlow entered an R&D and commercial collaboration with Philips. In addition to working with Heartflow to develop improved diagnostics for CAD based on FFR (fractional flow reserve) or iFR (instant wave-free ratio) measurements, Philips will promote the FFRct test alongside its own offerings.