Friday, September 4, 2015

What is the AMP comment on the MolDX Next Gen Sequencing Analytic Performance Guidance?

The Medicare Palmetto MolDX program has finalized an LCD that provides next generation sequencing panels in patients with lung cancer who have met certain preconditions (here).

Along with this LCD, MolDX published guidance as to its analytical standards for comprehensive gene panel testing, typically by NGS.  The Association of Molecular Pathologists has released a public comment.  Details after the break.

The MolDX program was released on 5/22/2015 and is still current as of 9/4/2015.   MolDX webpage here; cloud archive version here.  

The Association for Molecular Pathology, whose policy groups have been very active this year, published a public comment on the analytical validity standards.  AMP posts its comment publicly on, here, dated July 22, 2015.

To my eye, key points that AMP makes are:

  • LCD process.
    • To the extent that the article defines which genomic tests are and are not reasonable (and necessary) for CMS patients, AMP wants the standards to go through the LCD process.
  • MD not PhD.
    • The article states that the variants, clinical interpretations, and therapeutic recommendations "must be reported by a physician...a PhD is not a recognized Medicare provider."  AMP states that under CLIA PhDs can be the lab directors and the providers of molecular pathology reports.
  • NYS or CAP required.
    • Palmetto requires that the test submitted to Medicare must be accredited by CAP or NY State.  AMP opposes this as a requirement (as a mandate).
  • Particular standards excessive.
    • AMP argues that the standards proposed by Palmetto exceed appropriate and adequate standards already set in guidelines by College of American Pathologists (CAP).