Wednesday, July 22, 2020

New NCCN Lynch Guidelines: Extensive Discussion of Panel Testing

Genomeweb has a detailed article - I think it may be open access - about new genetic testing guidelines for Lynch syndrome, just released by the National Cancer Center Network - NCCN.   

See the Genomeweb article here, see the NCCN guideline here (look for High Risk Assessment/Colorectal).  The NCCN guideline, currently 129 pages, can be downloaded after email registration.

See the chapter paginated as GENE (GENE-1, GENE-2, etc.) which currently begins on page 72 of the PDF.   There is an extensive discussion of terms like multi-gene panel, syndrome-specific panel, cancer-specific panel, "comprehensive" panel [their quotes].   They also have several pages of tables of gene names, with strength of evidence ratings, expected risk level for CRC, associated disorders (e.g. polyposis), and citations.

Medicare MACs and Lynch Syndrome Testing

Recently, some MACs have begun pointing to authoritative external guidelines in their most current edition to guide coverage.   MOLDX MACs now do with with pharmacogenetics (LCD points to CPIC guidelines and FDA labeling), and NGS MAC does this with BRCA syndromes (LCD simply points to most recent NCCN guideline).   

However, in the case of Lynch syndrome, MolDx MACs are burdened with a published, tedious stepwise "one gene at a time" algorithm through a large panel of genes, which could result in gene-by-gene payment in the many thousands of dollars when panel pricing (for AMA and CMS) is closer to $1000.   The MolDx Lynch Syndrome LCD, such as L36370 for Jurisdiction E, is more than overdue for an update (here).