MolDX Updates NGS Coverage; Comes Up With Surprising Definitions

The MolDX program released several coverage and policy updates between December 16 and 18, with some surprises.  The MolDX program uses a distinctive approach to coding, billing, and pricing, which cannot always be predicted by the use of the AMA CPT code book and CMS CLFS price tables alone.

NGS Coding and Billing Guidelines (M00127, V1  V2)

This article on NGS coding is on the MolDX website here (in V2 as of 2/16/2016), or in the cloud, here as V1from December 2015 and here as V2 from February 2016 (the differences are minimal.*)

This article establishes a MoLDX policy that sharply distinguishes between "hotspot" tumor panels (e.g. 5-50 genes, 51+ genes) versus "sequencing" tumor panels and states they cannot be submitted using the same AMA CPT codes.

AMA's Term: Genomic Sequencing Procedures
AMA created "genomic sequencing procedure" codes 81445 (solid tumor, 5-50 genes), 81450 (hematologic tumor, 5-50 genes), and any tumor > 50 genes, 81455.

Per MolDX, these three AMA CPT codes are confined to use with "hotspot panels." This may be a relief to some labs, because two of these codes were given very low list prices by CMS through the 2015 gapfill method, and effective on 1/1/2016 (81445, 81450, each circa $700).

MolDX Term: Comprehesive Genomic Profiling
If you perform sequencing, NGS, indels, etc, MolDX instructs you to bill with an unlisted code  81479, after which, MolDX will assign a price it determines appropriate.  MolDX carefully uses the term "comprehensive genomic sequencing" or CGP to describe something that doesn't fit under the AMA CPT codes 81445, 81450, or 81455.

It would not necessarily be clear from the AMA CPT text alone for 81445, etc, that NGS tests were excluded and do not fall under the umbrella of AMA "genomic sequencing procedures" for tumors.

Of interest, the AMA CPT meeting of February 2016 will be considering a proposal to add NGS and indel analysis, etc, to these CPT codes.   AMA CPT might find it advantageous to create new codes for the NGS versions of these procedures to avoid the very low prices assigned by CMS to the existing GSP codes for tumors.


Approved Gene Testing (M00041, V14)

This article released determinations on covered versions of several BRCA tests, and on one covered version of a 5-50 gene hotspot tumor test.  It appeared on December 18, MolDX website here, in the cloud here.

MolDX lists 146 genes by name, some with specific CPT codes and some with "tier 2 Level N" CPT codes and some named but directed to coding under an unlisted code, 81479.

MolDX next lists "proprietary" tests.  Of the highest interest are those now covered for AMA CPT 81126, the new AMA CPT code for BRCA 1-2 full sequencing with indels.   This is a new code for 1/1/2016, and it has not yet formally priced by CMS.

Ambry, Myriad [BRCA CDX], Labcorp, and Quest all have their BRCA 1-2 offerings listed under 81162 -- meaning, they are properly coded here AND they have been reviewed as technologically acceptable by MolDX medical directors.

The Myriad laboratory also has four additional listings.  These are for 81211/81213 [BRCA 1-2 plus BRCA indels], BRCA1 alone [81414], and finally for "Integrated BRCA Analysis" which is listed for coding under 81479.

One 88145 test (tumor, solid, 5-50 genes, and per the MolDX program, hotspots only) is listed, the CANCER26 test by MUSC [Medical University of South Carolina].

The Foundation One test is listed as covered under CPT code 81479, rather than under CPT 81455 (the AMA CPT code for 50+ tumor genes).

Proprietary Test Name	Manufacturer	Effective Date	CPT	MCD #	MolDX Article #
BRCA1/2	Ambry	3/1/2014	81162	L36082
BRACAnalysis CDx	Myriad Genetics	12/19/2014	81162	L36082	M00120
BRCAssureSM	LabCorp	3/1/2014	81162	L36082
BRCAvantage, Comprehensive	Quest	3/1/2014	81162	L36082
Comprehensive BRACAnalysis®	Myriad Genetics	12/1/2006	81211	L36082
BRACAnalysis® Rearrangement Test (BART)	Myriad Genetics	12/1/2006	81213	L36082
BRCA1 Analysis	Myriad Genetics	12/1/2006	81214	L36082
Integrated BRAC Analysis ®	Myriad Genetics	12/1/2006	81479	L36082
HERmark	LabCorp	12/9/2011	81479	A53103	M00028
Cancer26	MUSC	10/3/2013	81445	NA
FoundationOne®	Foundation One	10/1/2015	81479	L36143

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[*] If there are people who are even nerdier than I am, enjoy this redline comparison between MolDX's 12/2015 article on comprehensive genomic sequencing coding, and the update 2/2016 as V2.  Here.