Thursday, June 9, 2016

Genomeweb: The Appearing, Vanishing Medicare Breast Cancer LCD (May 2016)

Genome has two articles on the appearance and disappearance of Noridian MolDX LCD DL36730, which briefly proposed to lockstep Medicare breast cancer test coverage to recent ASCO guidelines.

Genome's May 20 article is here, and their May 25 article is here.

Between 2006 and 2016, Medicare had accumulated at least four different LCDs regarding breast cancer prognostic/predictive MAAA tests (Oncotype, Mammaprint, BCI, and Prosigna).   The LCD posted was a "MolDX" LCD and appeared on the Noridian contractor website in preparation for its June CAC meeting.  (Copy of the LCD, DL36730, in the cloud, here.)   The LCD essentially proposed to convert Medicare coverage to a direct copy of February 2016 ASCO guidelines for breast cancer molecular tests (Harris et al., online here, open access.)  For example, coverage of minimally node-positive cases would have been withdrawn for the Oncotype and Prosigna tests, while coverage of Mammaprint would have stopped entirely.

The May 20 Genomeweb article notes that the LCD was rapidly picked up by financial analysts, like Cowen & Company's Doug Schenkel.   Stakeholders rapidly pointed out that trials like MINDACT and TAILORx were not reviewed yet by ASCO panelists, making the guideline in some respects out of date.

The May 25 article simply quotes a brief online announcement from Noridian that stated: "Since the drafting of this policy, additional information has been identified that we feel will significantly impact this policy and will likely result in a significant revision.  As such, we are retiring this draft LCD."

Noridian's article, with a posting date of May 23, here.