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September 30, 2015 - Updated 03.05.18

Molecular Diagnostic Services Program (CM00008)

The Molecular Diagnostic Services Program (MolDX™) was developed in 2012 to identify and establish coverage and reimbursement for molecular diagnostic tests. For dates of service on and after January 1, 2014, MolDX covers tests reported with Tier 1 CPT codes, 81161-81393, Tier 2 CPT codes, 81400-81408, Molecular Multianalyte Assays (MAA), 81410-81471, MAA with Algorithmic Analyses, 81500-81599, Proprietary MAA, 0001M-0008M, Immunology 86152-86153, Microbiology 87505-87507 and not otherwise classified codes (NOC), 81479, 84999, 85999, 86849, 87999, 88199, 88299, 88399, and 89398.

MolDX is powered by the McKesson Diagnostics Exchange™External Website to enable standardized, time-bound test registration and coverage determination processes. This online registry will provide secure information access levels for CMS, administrators, and the provider community. Confidential and propriety information provided will only be accessible by Palmetto GBA.

Unique Test Identifiers

In order to establish appropriate coverage and reimbursement for MolDX claims, CGS and the MolDX contractor requires additional information on each MolDX test. The online registration process offered by the McKesson Diagnostic Exchange™, collects the required test information so providers ONLY have to submit test information one time. Upon completion of the registration process, a Z-Code Identifier is assigned for each registered test. Test providers enter this identifier in the SV101-7 claim field adjacent to every CPT code used to report the test. During claims processing, the MolDX staff matches the identifier to the test information in the registry and determines coverage for claims payment. To facilitate MolDX claims adjudication, the MolDX contractor has developed a MolDX Master Edit File to automate MolDX claims payment. (MolDx Registration)

Technology Assessments (TA)

MolDX tests in a prelaunch status will be evaluated to determine analytical and clinical validity and clinical utility. Palmetto GBA uses subject matter experts to evaluate the scientific data for each test. Once completed, Palmetto GBA will make and publish a coverage determination based on the final assessment.

All registered tests are reviewed to validate that each test meets the Medicare criteria for coverage. During the registration and application review process, Palmetto GBA may request additional documentation to clarify or determine coverage on any test reported to Medicare for reimbursement.

(Technical Assessment)

Reimbursement Determination

Based on the information provided for the TA, Palmetto GBA will apply multiple methodologies appropriate to the specific test to determine an equitable value for each submitted test. (Technical Assessment)

MolDX Details

What: The program will affect diagnostic services reported with the following CPT/HCPCS codes:

Code Category/Description 2018 MolDx Code Range
Tier 1 81161-81383
Tier 2 81400-81408
Genomic Sequencing Molecular Multianalyte Assays (MAA) 81410-81471
MAA Admin Codes All Codes
PLA All Codes
Immunology 86152-86153
Cytology 88120-88121
NOC 81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, 89398

Where: The MolDX program will cover the following Medicare Jurisdictions:

  • JE A/B MAC, which covers California, Nevada, Hawaii and the US Pacific Territories of Guam, American Samoa and the Northern Marianas, administered by Noridian Healthcare Solutions
  • JF A/B MAC, which covers Oregon, Washington, Idaho, Utah, Montana, Wyoming, Nevada, Arizona, North Dakota, South Dakota, Alaska, and the Aleutian Islands, administered by Noridian Healthcare Solutions
  • JM A/B MAC, which covers North Carolina, South Carolina, Virginia, and West Virginia, administered by Palmetto GBA
  • J15 A/B MAC, which covers Ohio and Kentucky, administered by CGS Administrators, LLC

Why: The program defines a clear, evidence-based process to ensure clinical quality, manage molecular diagnostic services, and measure the impact they have on cost and care.

How: Laboratory Provider Requirements:

For more information, please refer to the MolDX Frequently Asked Questions sectionExternal Website.

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