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.
In the period before the new code goes into effect, Vermillion will continue to use its miscellaneous CPT code to garner reimbursement for OVA1. The test analyzes five biomarkers (B-2 microglobulin, apolipoprotein A1, CA 125, transferrin, and transthyretin) and yields a numerical score that correlates with the likelihood that a gynecological mass is malignant and should be surgically removed.
At a reimbursement conference in San Diego last week, Mark Erwin, senior director of reimbursement and government affairs at Prometheus Therapeutics & Diagnostics, said that by using the unlisted code, Vermillion had been able to improve the reimbursement amount it was receiving for its tests.
Erwin, who at the meeting was representing the laboratory and diagnostic industry interest group Coalition for 21st Century Medicine, cited data from Health Advances, which showed that if Vermillion had stacked existing CPT codes to bill payors for each of the five analytes assessed in OVA1 plus for the interpretation and reporting of test results, the company would have received around $112 for each test performed. With the miscellaneous code — which, according to Erwin, can cost between $100 and $150 per performed assay to negotiate payor-by-payor — the company is reimbursed approximately $650 per test.
At this time, it is unknown how the new Category 1 code will affect reimbursement levels for OVA1. The new MAAA Category 1 code will likely allow payors to better track utilization of OVA1 within their systems, which may or may not improve reimbursement prospects for the test over time.
Medicare reimbursement has been a point of concern for the company. As previously covered in PGx Reporter sister publication ProteoMonitor, there have been reports that Medicare has been denying OVA1 claims at a rate of more than 80 percent (PM 12/23/2011).
The Centers for Medicare & Medicaid Services has not listed AMA's new CPT codes for molecular diagnostics in its fee schedule. However, the agency last year began asking labs to submit the AMA's new codes alongside standard CPT code stacks to inform claims adjudication but not for payment (PGx Reporter 12/21/2011).
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