Wednesday, June 21, 2017

Flurry of Progress forHeartflow, But Medicare Coverage Lags Private Payers

Heartflow is a Bay Area company that has raised over $200M to create and commercialize sophisticated software that assays dynamic cardiac flow built on existing imaging technologies.   For an early, deep-dive article from 2011, see here.  For a more recent article, here.

This summer, Heartflow announces favorable assessment from BCBS Evidence Street (the successor to BCBS TEC).   See news here, here, here.   Heartflow has just completed some big hires, including former J&J Chairman William Weldon as Chairman of Heartflow's board, and experienced senior executive Michael Buck as EVP and Chief Commercial Officer.

Medicare Coverage?

The web also has some clues to the status of Medicare coverage.   An online reimbursement states that coverage is subject to LCDs and no LCDs have been announced (here; on web 6/21/2017).

A new layer was added in April 2017.  An online decision by the Departmental Appeals Board, a judicial panel at CMS, found that that Heartflow was appropriately denied enrollment in Medicare as an Independent Diagnostic Testing Facility (IDTF), and stating further that the MAC had determined "the service...was not reimbursable" (see the 25 page CMS judicial position here).
CMS argues the added software diagnostic service and novel report were bundled in prior payment for cardiac imaging test "and interpretation."  CMS maintained this, so far, despite arguments that the underlying imaging was purely spatial and anatomical while the new report was novel information about functional cardiac flow.   CMS argued that if the single Heartflow service was foreseen as not-billable, there was no need to enroll the company in Medicare. 
CMS precedents seem to fall on both sides.  In some cases in imaging, CMS has indeed made payment for additional diagnostic interpretation when clearly represented by CPT codes; see special codes for 3D rendering interpretation and mapping of CT and MRI exams.  See a 2016 story about older supplemental rendering code 76375 being replaced recently by '376 and '377.
The April 2017 decision affirms an earlier shorter negative decision in August 2016 (here).

Update: Heartflow won a classification decision in November 2017; here.

A substantial part of the 25-page judicial decision is devoted to matters of due process, miswritten deadlines, etc.