Thursday, May 18, 2017

MolDX Issues Draft LCD: Covers Liquid Biopsy in Selected Lung Cancer Patients (Guardant360 Coverage)

On May 18, 2017, the MolDX program released a draft LCD that would provide coverage under several special conditions for a gene panel somatic mutation liquid biopsy test in lung cancer.

The LCD is online at CMS here or in the cloud here.


The proposed policy provides coverage in circumstances when an invasive biopsy is medically contraindicated or quantity-of-tissue failed to be sufficient for necessary genomic profiling.  The LCD cites 2017 NCCN guidelines that when tissue biopsy is unenviable, plasma genomic profiling should be considered.  The comment period runs from June 5 to July 20.

Guardant Health has had several successful funding rounds, totalling $550M, according to Forbes, here.  Its liquid biopsy test has also been recently approved by the New York Clinical Lab Evaluation Program (here).

See also a general article about liquid biopsy in Genetic Engineering News, here. Coverage of the new LCD at Genomeweb, here.  Press release here.  More after the break.

MolDX's LCD Discussions of Data Collection Evolve

Like several other recent MolDX policies, this LCD proposes coverage that will be reviewed annually and is dependent on ongoing publications.

Unlike several recent policies, which concluded with that statement (here), this LCD proposes that data collection on the G360 tests will include a minimum of six separate data points.  Data collection is requested for EGFR mutations (the most common of driver mutations and thus the most easily studied), with some specifically defined clinical response endpoints.  See the LCD for details.

In CY2016, MolDX LCDs for lung cancer had variably used a long, a very long, or "no" list of general requirements for eligible registries (here).  The new LCD refers only to use of an "independent registry."

Detailed Analysis

The LCD is thorough, clocking in at about 2200 words, with 21 literature citations.  Previously, MoLDX had provided several technical documents forecasting its requirements for liquid biopsy technical performance (here).

MolDX Highly Productive

In the current CMS "What's New" database, MolDX has a total of 20 draft LCDs and articles that have recently been released or updated (here).  The organization recently named a new medical director, Dr. James Almas (here).  MolDX sets laboratory test policies for 6 MACs covering 25 states (here).

PubMed Central; PubMed; Google

For open access articles on liquid biopsy at PubMedCentral, here.  For all Pubmed articles, here.  For Google hits on "liquid biopsy," here.   For Google News articles, here.  For Google News articles on liquid biopsy + venture capital, here.

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LCD Short link  http://tinyurl.com/DL37338