Article - Billing and Coding: MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing (A58761)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claimCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing L39044.To report a service for Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing, please submit the following claim information:Select the appropriate CPTor PLA codeIf the panel being used does not have its own proprietary CPTor PLA code, select the appropriate CPT code and follow the additional instructions for the given panel in the relevant Group paragraphs below. If no specific CPT code exists for the test submitted, bill with CPTcode 87999.CPTcodes that are not billed with the appropriate accompanying ICD-10 codes listed in this Billing and Coding Article will be denied. Tests with other indicated uses may therefore submit for a Z-code and undergo a Technical Assessment (TA) by MolDX. Tests using CPTcode 87999 will also require a Z-code and a TA.Tests that are FDA-approved/cleared and performed in ways consistent with their intended use labeling directions do not require a Z-code when billed with an appropriate accompanying ICD-10 code. However, the performance of multiple (>1) FDA-approved/cleared molecular Infectious Disease pathogen identification tests on the same date of service (DOS) for the same intended use on the same patient sample is considered as one distinct service and requires a Z-Code and a TA. If an existing CPTcode does not identify the service, it requires the use of CPTcode 87999.Add modifier 59 for different species or strains reported by the same code, as allowed by the policy.Enter 1 unit of service (UOS)If applicable, enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimIf applicable, enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM codeNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.ICD-10-CM diagnosis codes supporting medical necessity must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary.Any diagnosis submitted must have documentation in the patients record to support coverage and medical necessity.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.Additional information:Panels intended for home use (including those that have been FDA approved or cleared) do NOT meet the coverage criteria of the policy.This contractor expects that critically ill patients will be tested and managed in the appropriate critical care facility.The test panel is a single test with multiple components and is characterized by a single unit of service (UOS =1). A panel cannot be unbundled and billed as individual components regardless of the fact that the test reports multiple individual pathogens and/or targets. If additional organisms are not included in a panel, testing for those organisms separately may be reasonable and necessary when ordered in addition to the panel and supported by documentation in the medical record.As outlined in the policy, for a given date of service for the same clinical indication, the performance of an additional panel for content that is non-duplicative can only be billed for the non-duplicative content, if supported by documentation in the medical record and all other criteria outlined in the associated policy.When 2 or more codes within a given Group OR from 2 related Groups (i.e., Groups 1 and 6 which pertain to Respiratory panels, or Groups 2 and 7 which pertain to Gastrointestinal panels) are submitted for the same beneficiaryon the same date of servicefor the same (or highly similar) intended use, the claims processing system will reject every code submitted after the first service. As outlined in the policy, exceptions may be allowed in limited circumstances for bloodstream and meningoencephalitis panels testing fornon-duplicativecontent. For such cases, if a lab runs more than 1 distinct procedural service from this list on a single date of service, then the lab must use the 59 modifier with each additional service billed as an attestation that it is a distinct procedural service.Repeat panel tests for the same clinical indication will NOT be reimbursed, except according to the criteria outlined in the related LCD (i.e.,1 additional panel test may be performed between 1 and 14 days after the initial panel test, so long as the test fulfills the criteria for coverage as set forth in the policy).Laboratories that are billing for multiple individual pathogens using the 59 modifier rather than panels may be subject to medical review as outliers. Similarly, laboratories billing for multiple related panels may be subject to medical review as outliers.It is understood that in certain instances in which only targeted testing is appropriate, institutions may not have access to small panels and may have to perform larger panels for technical reasons. In such cases, this contractor will pay only for components of a service that are reasonable and necessary.For Expanded (>5 pathogens) RP, PNP, and GI Panels the following additional conditions apply:Testing is billed according to 1 of the following:(a) Places of service (POS) 19, 21, 22, 23 OR(b) The test is ordered as follows (for healthcare POS other than the POS listed in 1a):(1)For immune-competent beneficiaries, the test must be ordered by an Infectious Disease Specialist or 1 of the following: Pulmonologist (for the RP and PNP panels) or Gastroenterologist (for the GI panels) who is diagnosing and treating the beneficiary.(2)For immune-compromised beneficiaries, the test must be ordered by a clinician specialist in 1 of the following: Infectious Diseases, Oncology, Transplant (for any panel), Pulmonologist (for the RP and PNP panels), or Gastroenterologist (for the GI panels) who is diagnosing and treating the beneficiary.(3) Regarding (1) and (2), An exception may be made in geographic locations where the specialist(s) cannot be reasonably reached by the beneficiary, and the ordering provider is located closer to the beneficiarys place of residence than the nearest specialist. We would generally expect that beneficiaries for whom the test is ordered under this exception to be living in rural locations, islands, or some other location where access to care is limited.(4) An ICD-10 diagnosis code from Group 6 or Group 7 must be on the claim, in addition to the sign or symptom (from Groups 1 or 2) for which there is suspicion of respiratory or gastrointestinal illness in order to bill for the RP/PNP or GI panels, respectively. See the specific instructions in Groups 6 and 7 below. The exception to this is testing that is performed as part of a pre-transplant evaluation of an immune-compromised beneficiary, regardless of the presence of symptoms. In such cases, clear documentation of the pre-transplant evaluation must accompany the claim.The expanded/targeted panel distinction is not applicable to all panels, except as otherwise indicated in the related policy.