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AMA's CPT Workgroup Still Mulling Coding Structure for Multi-Analyte, Single-Lab Tests

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After receiving stakeholder input at a meeting last month on potential coding structures that would facilitate accurate payment for in vitro diagnostic multivariate index assays, an expert panel advising the American Medical Association said it has not yet decided on the best path forward but plans to provide an update on the issue at an upcoming meeting.

"The labors of this workgroup will continue over the next few months with the anticipation of presenting an update report at the October [current procedural terminology] meeting," the AMA said in a summary of the July 20 meeting of its Molecular Pathology Coding Workgroup.

The AMA held the meeting last month to receive input on how multi-analyte, algorithm-based tests — such as Genomic Health's Oncotype DX and Agendia's MammaPrint for gauging women's risk of breast cancer recurrence — should be coded under a new coding system it is developing for molecular diagnostics. Although the AMA has proposed a two-tier coding system for single-analyte tests, no code structure has yet been established for IVDMIAs.

At last month's meeting dedicated to this topic, the workgroup and industry stakeholders discussed potential options.

Currently there are three types of CPT codes: Category I, II, and III. One proposal discussed at the July meeting was the possibility of creating a fourth category under which IVDMIAs would receive unique identifiers instead of using unlisted or miscellaneous codes under Category I.

Many sponsors of IVDMIAs are currently using unlisted or miscellaneous codes under Category I, and they claim to have good reimbursement through this process. Oncotype DX is currently reimbursed with a miscellaneous CPT code and MammaPrint uses the CPT code 84999 for "an unlisted chemistry procedure."

In order to receive a Category I code, tests must be widely used by medical practitioners — a criteria that if applied to IVDMIAs may characterize them as being performed by multiple laboratories or vendors, some stakeholders observed during the meeting, according to the AMA summary.

The new category of codes, meantime, would recognize that unlike most tests that fall in Category I, IVDMIAs may not have FDA approval or clearance and may not be broadly used by doctors. Minimum requirements for IVDMIAs to receive a Category IV code under this proposal would include FDA approval of the test if it is required; demonstrated clinical utility in two peer-reviewed US journals; and the commercial availability of the test in the US (PGx Reporter 7/31/2011).

According to AMA's meeting notes, the workgroup still needs to determine "how best to describe the multi-analyte assay algorithm-based analyses; how to facilitate straightforward reporting of these services such that once payers establish payment policies for individual tests, the policy can be easily and rapidly adjudicated; and how to reconcile the unique nature of each test with the CPT convention not to place proprietary names into CPT code descriptors."

The AMA traditionally doesn't include proprietary names in code descriptors, but the workgroup is considering alternative solutions, such as potential tables of unique codes to crosswalk proprietary names to services. "Extensive discussion also centered around the consideration that a table, unique to these services, be generated with unique code identifiers that would facilitate unambiguous reporting, payer processing, and potential reimbursement (if deemed appropriate by the individual payer)," the AMA said in the meeting summary.

The proposal to create a system of unique codes for IVDMIAs is favored by Genomic Health, since it is similar to the company's current practice of using a miscellaneous CPT code. "What we already do as a practice is actually where the AMA and the payors are trying to move the industry" by advancing the use of "unique codes for assays as opposed to a somewhat imprecise use of code stacking and payment," Kathy Hibbs, Genomic Health's senior VP and general counsel, said during a recent earnings call (PGx Reporter 08/10/2011).

While the workgroup and stakeholders at the meeting recognized that most IVDMIAs wouldn't be appropriately described by Category I testing criteria, they noted that some IVDMIAs do fall under this coding section.

While the workgroup is figuring out the right coding structure for IVDMIAs, the AMA believes that there will likely be disruptions to the reimbursement received by labs and diagnostic firms once code stacking is eliminated. As such, the AMA advised labs with services that fall under existing Category I criteria to submit code change proposals in a "timely manner" in order to avoid payment processing difficulties that may arise from the use of unlisted codes.

The AMA recommended submitting any such code changes by Nov. 2 in order to be considered at the February 2012 CPT meeting.

"With the impending deletion of the molecular pathology stacking codes 83890-83914 announced in March 2011 on the CPT web site, and the potential for addition of an unlisted code for multianalyte assays, it is anticipated that there will be substantial difficulty in reporting and reimbursement of these services, particularly since there has been a paucity of CPT code applications for sole-source tests currently reported with the stacking codes," the AMA said in its meeting summary.

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