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 AMP.org, 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).