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August 17, 2015 - Updated 05.10.21

CGS Administrators Announces MolDX Expansion to J15 (Vol 4)

CGS Administrators is happy to announce that we are working with the MolDx contractor, Palmetto GBA concerning Molecular Diagnostic Testing (MDT). All laboratory service providers in the Jurisdiction 15 providing Molecular Diagnostic Testing (MDT) must register those MDT procedures/services with the MolDx contractor and submit coverage requests prior to being considered for reimbursement. Providers will have until December 28, 2015 to complete this process for current and any new tests billed before the claim is returned unable to process if the unique identifier is not present on the claim. At this time, Part A providers are not required but are encouraged to obtain an identifier and use the TA process, if needed, as this will expedite claims processing. Part A providers when billing MolDx tests, since the notepad is for the entire claim please, please enter L, line number, and the short description /identifier,(L2-APC,fgs). This will allow us to distinguish which test is for which line. (Effective March 1, 2017 Part A providers will need to bill MolDX codes with a Z-identifier in addition to billing the CPT code. Providers who submit to Part A please see the Part A MolDX Claim Submission Instructions CM00098 article.)

As a CMS contractor, the MolDx contractor must determine reasonable and necessary services and apply fair reimbursement to services that are provided to Medicare beneficiaries. In the AMA's instructions for use of the CPT codebook, providers are instructed to select the name of the procedure/service that accurately identifies the service provided. Providers are not to select a CPT code that merely approximates the service provided. When no such specific code exists, providers are required to report the service using the appropriate unlisted procedure/service code.

For a wide range of laboratory and molecular diagnostic services, correct coding is complicated because the available code descriptions do not identify the specific test/service performed.

The vast numbers of new diagnostic and molecular assays entering the market magnify these issues. To address these vulnerabilities, the MolDx contractor has expanded to a laboratory and molecular diagnostic services program to meet the following objectives:

  • Identify the specific services performed and billed to Medicare
  • Collect and analyze claim submission data
  • Develop correct coding/billing guidelines to report services
  • Determine coverage for services
  • Determine a fair reimbursement for services within current CMS guidelines

This program will affect diagnostic services reported with AMA CPT code found in A56973 Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT):

Effective for services performed on or after January 1, 2013

MolDx defines a clear, evidence-based process to ensure clinical quality and manage molecular diagnostic services and the associated impact that they have on cost.

Four major challenges are addressed in this project:

  • No standardized process to evaluate the safety and efficacy of each test/assay
  • No standardized process to correlate clinical information with patient outcomes
  • No standardized process to describe and assign a value for the assay service
  • No unique identifier to track assay utilization

The project will require a registration process to address these challenges in the following manner:

  • Create/maintain a master catalog/test registry

    Identification and cataloging of all known molecular diagnostic tests, assessment status, and the final CMS coverage determination and code assignments will be maintained in an electronic, readily accessible, Internet-based registry with secure information access levels for CMS, administrators, and the provider community. Click here to find out more about the master catalog/test registry or to register a test.

  • Provide objective, evidence-based assessments for each test

    In addition to evaluating analytical and clinical validity data, this project will provide a comprehensive assessment of clinical utility. Subject-matter experts will evaluate tests and develop coverage recommendations to CMS. For more information, please refer to the Test Assessment ProcessExternal Website section at the MolDx contractor website.

  • Provide test specific description recommendation

    Subject-matter experts will review new test literature and design unique descriptions or designate current appropriate descriptions to facilitate the CMS development of unique codes for appropriate utilization tracking and potential payment.

  • Provide reimbursement recommendation

    The MolDx contractor will review the overall test elements and make a value based determination for each test.

MolDx will be supported by the LCD Laboratory and Molecular Diagnostics Testing LCD Program, establishes a clear, evidence-based process to ensure clinical quality and to manage molecular diagnostic services and the associated healthcare cost impact. The MolDx contractor has contracted with McKesson Health Solutions to configure and maintain a Master Test Code Registry that will increase the efficiency and transparency of the evaluation and valuation of the affected procedures/assays.

  • A/B MAC affected by this Project: Jurisdiction 15
  • Diagnostic services affected: Molecular Diagnostic Testing (MDT) refers to any laboratory assay that quantifies a measurable characteristic of the patient care process at the molecular level. This includes gene tests (e.g. DNA or RNA, reported with codes listed in the above tables), infectious disease probes, tumor markers (any type), pharmacogenomic assays, selected predictive and/or risk assessment interpretative scores, and any other molecular test, with or without an existing CPT or HCPCS code that does not specify ONE test per ONE code. Multi-variant Molecular testing (MVMT) is considered a subset of Molecular Diagnostic Testing (MDT).
  • Provider Requirements: Register MDT procedures/services with MolDx contractor and submit coverage requests.
  • Timelines: Claims for MDT will NOT be considered for adjudication unless the test in question has been submitted to the test registry for review and a McKesson Z-Code Identifier has been assigned to the test. Please refer to Palmetto GBA MolDx J11 Program Timelines section for more information

For more information, please refer to the MolDx contractor websiteExternal Website.


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