By Turna Ray
The American Medical Association is seeking feedback from key stakeholders about its proposed current procedural terminology coding structure for multi-analyte assays that employ algorithmic analysis, previously known as in vitro diagnostic multivariate index assays.
Earlier this year, the AMA's Molecular Pathology Coding Workgroup issued two types of proposed codes for molecular diagnostic tests — Tier 1 codes for commonly performed analyte-specific tests and Tier 2 resource-level codes describing less common tests (PGx Reporter 03/16/2011).
One subset of tests that remains for the coding workgroup to tackle is IVDMIAs, which the AMA has now dubbed multi-analyte assays with algorithmic analyses, or MAAAs. These MAAAs are distinguished from other molecular diagnostics in that the individual procedures of such tests are not reported separately, they are performed and available through a single laboratory; and the tests use algorithmic analysis to yield a single score or result
Deriving a coding structure for MAAAs has been controversial, mainly because the AMA has balked at adding proprietary names to CPT codes that would distinguish such tests as being sold by so-called "boutique labs." In a paper, "Tempest in the Melting Pot: Genomics Reimbursement in 2012," Bruce Quinn, senior health policy specialist at law firm Foley Hoag, states that one reason for the AMA's hesitation to identify single-source lab tests by "highly specific and branded CPT codes" might be because such unique identifiers may result in raising the reimbursement level for branded tests.
"[S]ince codes are based on the market expense of inputs, a sole-source manufacturer who raised prices sharply would see 'his' proprietary CPT code rise as well, in a lockstep fashion, as his branded device became more expensive," Quinn wrote in the paper. "Conversely, at least in principle, if the code is unbranded and workable equipment is multi-source, the provider would aim to buy the least expensive equipment compatible with the service provided, creating market competition rather than a monopoly among the corresponding suppliers."
Meanwhile, labs and payors would likely object to using a general code for branded MAAAs. "The most common high-value tests (with the exception of complex cystic fibrosis testing) are branded tests, such as [Genomic Health's] Oncotype DX, [Monogram Bioscience's] HIV diagnostic Trofile, and [Myriad Genetics'] BRCAnalysis test," Quinn wrote. "Labs and payors might worry that if the descriptor for such tests was sufficiently general (e.g., 'prognostic test for breast cancer, 5 or more genes') then some labs might substitute very thinly validated tests for highly validated ones while receiving payment and coverage under the same CPT code."
The AMA held a meeting in July to receive input on how MAAAs — such as Oncotype DX and Agendia's MammaPrint breast cancer recurrence tests — should be described under its new coding system for molecular diagnostics. Afterwards, the organization publicly disseminated a meeting summary in which the group said it was considering creating a new category for IVDMIAs under which such tests would receive unique identifiers.
Currently there are three types of CPT codes: Category I, II, and III. Many sponsors of IVDMIAs are currently using unlisted or miscellaneous codes under Category I. For example, Oncotype DX is reimbursed with a miscellaneous CPT code and 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.
The AMA's MAAA proposal, circulated last week to an inner circle of industry officials and reimbursement experts, recommends that those MAAAs that the CPT Editorial Panel has fully vetted and found to meet a certain set of criteria will receive Category I codes. MAAAs that the AMA has not reviewed or that have not met coding criteria under Category I will be listed under a new category or section of codes, provisionally called "Appendix X." MAAA codes under Category I would have the same naming conventions as those found in Appendix X, while only the codes in the proposed appendix would include the proprietary name of the tests.
In order for MAAAs to receive a Category I code, they would have to have received approval from the US Food and Drug Administration for their specific use, although AMA indicates that this would not be a strict requirement for code assignment. Many MAAAs don't have FDA approval and the agency is currently evaluating its regulatory criteria with regard to such tests.
Additionally, for a Category I code, the procedure must be a "distinct service" performed widely by healthcare providers in the US and there must be published data on its clinical efficacy. MAAAs under Category I cannot be procedures that are a part of another existing procedure that already has a CPT code, the AMA states in its proposal.
What distinguishes MAAAs under Category I from those in Appendix X is whether the test has been reviewed by AMA and found to have sufficient clinical utility for a Category I code. "The codes in [Appendix X] are provided as an administrative convenience to facilitate accurate reporting of MAAA services. The minimum standard for inclusion in the list is that an analysis is generally available for patient care," the AMA states in a document outlining the coding proposal. "The AMA has not reviewed or evaluated these services to determine clinical utility."
If tests don't have a Category I code or aren't listed under Appendix X, then test service providers should report the test using Category I unlisted codes.
In materials circulated by the AMA about these proposed changes, it appears that in order to determine whether a test would fall under a particular coding category, the vendor requesting a code change would have to provide information about where testing is performed, how widely that test is available and used, and provide published data on the clinical utility of the test.
The AMA is instructing MAAA providers who feel their tests fulfill Category I criteria to complete a Code Change Proposal and submit it to the AMA. If the change request is received before Nov. 15, the test will be considered for the 2013 listing of CPT codes. Labs that feel their MAAAs are more appropriate for Appendix X can also submit their analysis to the AMA for possible inclusion in the Administrative MAAA code list. But in order to be listed under Appendix X providers don't have to undergo an application process similar to that which is required to get a Category I code.
The downside to AMA's proposed structure for MAAAs is that Appendix X may become "a sort of dumping ground for nearly any test on which a company applies for a code," a source knowledgeable of the process told PGx Reporter. "It will be a sort of holding tank for MAAA names and temporary codes. If any of them are ever elevated to Category I status, then they will appear in Category I and also in Appendix X."
The source asked to remain anonymous since the AMA's proposed structure for MAAAs hasn't yet been publicly distributed.
If Appendix X gains a reputation for being a category synonymous with tests that lack sufficient clinical utility, then it is likely that developers of MAAAs will not want to submit their diagnostics to this list. Such a scenario could result in the majority of MAAAs still not having CPT codes under AMA's new system. The AMA is slated to finalize its coding plans for MAAAs at its February 2012 CPT meeting.
While the AMA is mulling new codes for molecular diagnostics, the Centers for Medicare & Medicaid Services is figuring out where to list genetic tests that have received codes from the AMA: in the clinical lab fee schedule or the physicians' lab fee schedule. The CMS held a meeting in July to garner stakeholder input on the positives and negatives of listing genetic test codes in one or the other fee schedule. The specific fee schedule in which a CPT code is listed has implications for how the services of pathologists and laboratory professionals are reimbursed (PGx Reporter 7/20/2011).
CMS has not listed genetic test codes in its CLFS for 2011 or its PFS for 2012. The agency has indicated that it will list genetic test codes in one of its schedules by 2013 at the earliest, which means that AMA's new codes would not take effect until then and stacked CPT codes will continue to be used in the meantime.
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