Article - MolDX: Defining panel services in MolDX (A59700)

CMS National Coverage PolicyN/AArticle TextMedical testing services have become more comprehensive and complex over time. In the past, it was generally considered that any given condition could be diagnosed or defined with a single analyte test. Additionally, limits in technology meant that if any additional testing was necessary, an independent and subsequent service would need to be performed. Neither condition above is true today. First, many diseases require multiple genetic or other relevant analytes to be assessed simultaneously for either diagnosis or to inform the clinician on subsequent medical interventions; second, tests today are more comprehensive and parallelized, such that many analytes can be obtained at once, reducing waste and turnaround time while also increasing accuracy. As such, the old model of one gene/analyte for one disease must be wholly discarded for a majority of disorders known today.The National Correct Coding Initiative (NCCI) reflecting CMS policy, provides instruction with this line of thinking, as outlined in Chapter 10, particularly section F pertaining to Molecular Pathology. Effectively, if a multianalyte test is performed, it should be billed as a single service. If no specific code exists for that panel, it is not appropriate to bill for the components of that service (this constitutes unbundling) and should be billed with the NOC codes such as 81479, 81599, or 87999, depending on analytes measured.Additionally, the role of the payor is to pay for services that have demonstrated medical value (reasonable and necessary in the case of Medicare), and the role of coding with the payor is to ensure clarity on the service performed. Ensuring panels are appropriately billed as a single service greatly reduces the complexity and confusion in billing.Here, we define a distinction between the performance of a medical service as a panel or a discrete single analyte service. Of note this was similarly defined for germline panels in article A57880 in the Medicare Coverage Database.Defining criteria:A service is a panel if:If a clinician orders a group of molecular analytes (more than 1) marketed as a single service;The service contains multiple analytes (more than 1) that would result in a single result or single report or several independent services are performed that would result in a single result; ORThe medical value of the service/s performed is only obtained if more than one analyte is measured and the analytes are generally performed together. As an example, if 2 analytes (A and B) are tested, and BOTH must be performed together to have medical value, then it is a panel because analyte A or B alone is insufficient to provide medical value even if each analyte independently provides partial medical information; ORIf multiple analytes (more than 1) are measured in parallel, regardless of how they are performed or reportedOf note, it is not particularly relevant if the analytes are measured with different instruments or reagents. We consider these internal lab processes that are not relevant to the test ordered, the relevance of the analytes measured, and the resultant report.A service is NOT a panel if a single analyte is measured defined by a single CPT code, and that single analyte alone provides the necessary information for proper patient management without other analytes being measured for the same disease indication.Examples of a panel:A service of 2, 5, 10, or 500 genes for evaluating a patient with colorectal cancer, with or without RNA analysisA screening test looking for 5 commonly mutated genes in the prenatal settingA test that measures multiple alterations within a gene with one or more assays that have more than one associated CPT code, such as DMD sequence AND copy number analysisA respiratory pathogen test that includes 2 or more pathogens that must generally be tested together for relevance, for example Influenza A/B, RSV, and COVID-19