Tuesday, April 19, 2016

Surprise Press Release: MolDX Prices BRCA Panel Code at $622.

In November 2015, the final CMS Clin Lab Fee Schedule for CY2016 was released and locked in some surprisingly low prices for gene panel tests.  Receiving the most attention, the code for 5-50 genes, solid tumors, was priced at $597, and the code for 5-50 genes, hematopoetic tumors, was priced at $648.   Getting a little less attention, the gene panel for Lynch syndrome was priced at $796 (sequencing) and $796 for a sister code for large indels.  (The 2016 CLFS is here).

On April 19, 2016, the San Francisco genetics company Invitae announced that it was being covered for the hereditary breast and colon cancer code 81432 at $622.   This payment comes from the Jurisdiction E contractor, Noridian, but presumably reflects pricing that will apply through the 24-state MolDX policy system (here).   Code 81432 is defined as BRCA1 and BRCA2, full sequencing, plus 12 or more additional hereditary breast cancer related genes.  More details after the break.

A few weeks ago, MolDX announced it would cover one-shot panel based Lynch syndrome sequencing (here).   Until that announcement, MolDX only covered Lynch genes one by one in a detailed step by step process laid out in an LCD.   This suggests payers are moving toward panel coverage at new panel prices, at least for well-characterized syndromes.  MolDX has relatively complex positioning on the use of coding for NGS testing, as mentioned in the Invitae press release (the MolDX next gene policy coding article, now in V2, is here.)

Sometime during March or April or May 2016 - a three month window of which six weeks are now behind us - CMS will post a listing of all MAC proposed prices for all new 2016 genomic CPT codes that weren't priced by CMS's administrative process last summer and fall.

AMA Creates 81432, 81433 for Dup Del; MolDX says "no" to the '33 code

Note that while MolDX pays $622 for 81432, there is a sister code, 81433, for the same gene series with added Dup Del analysis (e.g. an add-on code).  MolDX does not recognize the use of this code, as indicated by its placement on the MolDX non-covered test spreadsheet, last updated April 6, 2016.