Thursday, August 13, 2020

Very Brief Blog: CMS Updates NCD Instructions, Covers Myriad MyChoice CDx Test (0172U)

Myriad has two companion diagnostic tests - BRACAnalysis, which is a Sanger BRCA test, and MyChoice CDx, which is an NGS based test that includes BRCA along with other repair defect genes.

Every quarter, CMS issues an update to its NCD coding instructions (typically effective 6 months in the future).   On July 31, 2020, CMS released CR11905 "Coding Revisions to National Coverage Determinations."  Here.

Scroll down and instruction 11905.2 covers the 0172U test, MyChoice CDx, under the NCD.  The exact coverage is found by reference to ICD10 codes in an associated Excel spreadsheet.

MyChoice has not only a PLA code, but status as an ADLT, priced at $4040.  So, the pricing and coverage did not require any CMS decision making.  ADLT price is automatically set at list price, and NCD coverage (per FDA labeling) is automatic as long as an NGS cancer test has CDx status.

When you get to the CMS Excel spreadsheet, the 0172U coverage is for ovarian cancer: