By Turna Ray

The American Medical Association's Current Procedural Terminology Editorial Panel has approved Vermillion's application for a Category 1 CPT code for its OVA1 test.

According to a published summary of the panel's February meeting, the AMA "accepted establishment of code 814XX1 to describe the OVA1 test." The OVA1 test will also be listed in a new appendix for multi-analyte assays with algorithmic analysis, a subset of tests also known as in vitro diagnostic multivariate index assays.

The AMA decided a few months back that it would grant Category 1 codes to MAAAs that its CPT panel has vetted and found to meet a certain set of criteria. In addition to being listed under Category 1 codes, these tests will also be listed in a special section for MAAAs, called Appendix X. MAAAs that the AMA has not reviewed or that have not met coding criteria under Category 1 will only be listed in Appendix X. Tests in this appendix will be referenced by their proprietary names (PGx Reporter 11/9/2011).

At the February meeting, AMA's CPT panel added a new Category I subheading and guidelines in the "pathology and laboratory" section for MAAAs; established codes (ie. 81499X) to describe unlisted MAAAs with algorithmic analyses; established three new MAAA codes for listing in Appendix X; and revised its chemistry guidelines to include instructions for reporting unlisted MAAA codes.

Other than OVA1, the other two MAAAs that will be listed in Appendix X include a qualitative serum test that uses an algorithm to combine the results of two analytes and women's menopausal status into a numeric score, and a "diabetes pre-diagnostic risk screen" that analyzes multiple analytes to give a single risk score correlated with the probability of developing the disease.

The new MAAA codes will be effective Jan. 1, 2013.

According to Vermillion, in order to garner approval from the AMA for a Category 1 code, the company submitted several peer-reviewed publications on OVA1. Furthermore, the company said the fact that the test has been accepted for coverage by other payers, including Medicare contractor Highmark Medicare Services, also helped. "The new CPT code is a critical step in advancing the commercialization of OVA1, as we believe it will help streamline claims processing and accelerate further coverage and adoption by private payers," Vermillion CEO Gail Page said in a statement.

Currently there are three types of CPT codes payors use to process claims: Category I, II, and III. Many sponsors of IVDMIAs are currently using unlisted or miscellaneous codes under Category I to garner reimbursement for performed tests.

For example, Genomic Health's Oncotype DX is reimbursed with a miscellaneous CPT code and Agendia's MammaPrint uses the CPT code 84999 for "an unlisted chemistry procedure." Some MAAA providers claim to have good reimbursement through this process, but most have acknowledged that reimbursement agreements for tests with miscellaneous or unlisted codes have to be secured payor by payor, which is a costly and time-consuming process.

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AMA Approves Vermillion MAAA Category 1 Code for OVA1; Will it Improve Reimbursement?