Friday, January 23, 2015

MOLDX LCD for Comprehensive Genomic Profiling in NSCLC

Palmetto GBA has published a draft LCD to provide coverage for large-scale gene panel tests in non small cell lung cancer.   The LCD is available here at the CMS website.  A public comment period is open from February 10 to March 27, 2015.  Details after the break.

What the Policy Says

Coverage Indications, Limitations, and/or Medical Necessity

This policy provides limited coverage for comprehensive somatic genomic profiling (hereafter called CGP) for patients with metastatic non-small cell lung cancer (NSCLC) who are lifetime non-smokers (also known as never-smokers) or former light smokers (≤15 pack year history) and who tested negative for epidermal growth factor receptor (EGFR) mutations and EML4-ALK translocations when initial testing was done by an FDA-approved companion diagnostic (CDx) or by a laboratory developed test (LDT) for these genomic alterations. Alterations detected by CGP, if positive, may allow individuals to be treated with a targeted therapy for which they were previously ineligible. At the current time, CGP for germline (i.e. inheritable) mutations is not a Medicare benefit. 

The policy defines "comprehensive genomic profiling" as detecting four classes of mutations:  (1) base pair substitutions, (2) indels, (3) copy number variations, and (4) translocations.

Labs participating would be requested to report certain information to Palmetto, such as "for each identified EGFR/ALK translocation, the response status and duration."

The policy reflects recent publications, such as an in-press report that NGS can capture mutations missed by conventional genetic testing (e.g. hot spot PCR).  See Drilon et al., 2015, Clinical Cancer Research, here.  The policy's focus on non smokers might seem puzzling but MolDX relates this to findings reported by Drilon et al.

Cancer Letter (subscription, here) rapidly put up a 1700 word article on the draft LCD.

Clinical Data Reporting Required

Many readers of the LCD may miss the brief section requiring labs paid for the genomic tests to report future clinical outcome data to Medicare.   Over the past year, there has been a groundswell of interest and planning for the capture of genomic and outcomes data from the routine pathways of oncology care, including the use of molecular diagnostics.  This is captured under the umbrella of "real world evidence" or RWE.   One startup company in this space, FLATIRON, has raised substantial capital -- over $130M (here).

Not cited in the LCD, over the past year in several publicly available forums, Palmetto MolDX has discussed a "MED-C" program to organize and manage data and outcomes in genomic oncology.  For an example of publicly available trade press on MED-C, see here, page 7 ff.  MED-C and ASCO's TAPUR program were also discussed in the December 22, 2014 issue of BIOCENTURY (here, subscription).  ASCO's initiatives were also discussed in a 2014 article by Richard Schilsky in Nature Review Clinical Oncology last summer (11:432-438; here).  Finally, there is a thorough and thought provoking issue brief (11/2014) on new approaches to capturing outcomes from clinical genomic oncology by Mark McClellan of the Brookings Institution along with major stakeholder groups including Wellpoint, FDA, and ASCO, here.  This latter public white paper also discusses both ASCO and MolDX MED-C initiatives.

Linkages to Foundation Medicine 

On January 28, 2015, Boston Business Journal discussed the draft LCD in the context of Massachusetts-based Foundation Medicine, describing Palmetto's role as an "opinion leader" MAC, here.  Financial analyst Dan Leonard of Leerink is quoted in the BBJ article.

In addition, the Foundation Medicine website has an online announcement about the LCD, here.  The organization writes,

While Palmetto GBA is not Foundation Medicine’s MAC, it is viewed as a leader in assessing coverage and reimbursement for complex molecular diagnostic services due to efforts such as the MolDx Program and the recently announced Molecular Evidence Development Consortium (MED-C). As such, MolDx and MED-C are  influential platforms in the ongoing paradigm shift in cancer treatment. 
Palmetto’s announcement today and its continued focus in this area both on its own and in conjunction with MED-C can have a significant impact in shaping the future reimbursement landscape for molecular diagnostics. We are excited to continue our collaborative work with Palmetto and NGS [New England Medicare] to implement this new guidance and work towards coverage in our jurisdiction [New England], and to work with MED-C to expand the initial scope of covered indications over time. 
For an interview in October 2014 with MolDX medical director Dane Dickson, see here.

For trade press coverage on February 2, 2015 from Genomeweb (subscription), see here.

To discuss how the changing healthcare system and Medicare policy affects your company, association, or investments, contact Dr Quinn through FaegreBD Consulting