AMA Document on New Category IV CPT Code

This week, AMA circulated a document proposing a new Category IV CPT Code for “in vitro diagnostic multivariate index assays” (IVDMIA). This comes after the IVDMIA Workgroup was asked to review procedural coding and propose a CPT code solution.

The minimum requirements for the granting of a Category IV code are:

• FDA approval, if required, for the technology, service, or procedure
• A minimum of two peer-reviewed US journal articles studying separate patient populations that demonstrate clinical utility
• A commercially available product for clinical use within the United States.

IVDMIAs are analyses that utilize multiple results derived from molecular pathology assays, as well as fluorescent in situ hybridization and other non-nucleic acid based assays, that are used in proprietary algorithmic analyses to derive a single result, reported typically as a numeric score or probability. The IVDMIA codes include all analytical services performed in the assay(s) required for the algorithmic analysis (eg, cell lysis, nucleic acid stabilization, extraction, digestion, amplification, hybridization and detection) in addition to the algorithmic analysis itself. Procedures that are required prior to cell lysis (eg, microdissection, codes 88380 and 88381) should be reported separately. If a specific In Vitro Diagnostic Multivariate Assay is not precisely described in the descriptor, then the Category I IVDMIA unlisted code (8XX99) should be utilized.

Category IV code descriptor structure (for IVDMIA): 000XM In vitro diagnostic multivariate assay; clinical indication, testing platform, indication of number of analytical inputs (trade name, company performing test)

This is an effort by the AMA to find a solution for the challenges of coding multivariate tests in a way that potentially could shorten the coding process and require criteria that could be more easily met.

But, will category IV codes be perceived in the same way as Category III? With lower levels of evidence demanded, will payors regard them as experimental and investigational?

What do you think about the proposed concept, descriptor format, minimum requirements, relationship to other categories, limitations and modifications?