The Molecular Diagnostics (MolDx)¹ Program was developed by Palmetto GBA in 2011. This program has been implemented across 28 states to identify and establish coverage and reimbursement for molecular diagnostic tests. This was done as an effort to have uniform policies across four Medicare Administrative Contractors (MACs), namely Palmetto GBA, Noridian, CGS Administrators, and Wisconsin Physicians Service (WPS). The jurisdictions for each of these MACs are given below:

1. Palmetto GBA Jurisdiction
   1. J (JJ): Alabama, Georgia, Tennessee
   1. M (J11): North Carolina, South Carolina, Virginia, West Virginia
2. Noridian Healthcare Solutions
   1. E (JE): California, Nevada, Hawaii, American Samoa, Guam
   1. F (JF): Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming
3. CGS Administrators
   1. B (JB): Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, Wisconsin
4. Wisconsin Physicians Service (WPS)
   1. 5 (J5): Iowa, Kansas, Missouri, Nebraska
   1. 8 (J8): Indiana, Michigan

Their primary function is to facilitate detailed and unique identification by registration of molecular diagnostic tests to facilitate claims processing.

The DEX^® Diagnostics Exchange is a molecular diagnostic (MDx) test identification and policy management solution that connects payers and labs to bring clarity to MDx testing. MDx tests are uniquely identified and cataloged using DEX Z-Code^® Identifiers – Palmetto GBA’s unique and proprietary 5-character alpha-numeric codes assigned within the DEX Diagnostics Exchange. For coverage, labs located in MolDx jurisdiction must obtain a Z-Code and complete Technical Assessment (TA) if required.

MolDx also tracks utilization, establishes clinical utility expectations and performs technical assessment of test data to determine clinical utility and coverage. This allows the participating MACs and Centers for Medicare & Medicaid Services (CMS) to establish reimbursement rates for molecular diagnostic tests. If required, an application for registration of the test, ID assignment, coverage determination and reimbursement need to be submitted to the MolDx Program.

The initial review for Z-Code assignment takes approximately 2 weeks from test submission. Additional Technical Assessment (TA) documentation may be required dependent on test complexity and TA evaluation procedure established. If the test is identified as requiring additional TA documents, the manufacturer will receive an email from DEX. For tests that require TA documentation, this process can take up to 60 days.² A summary of the process is provided in the diagram below.

References

1. MolDX® Program (Administered by Palmetto GBA); https://www.palmettogba.com/MolDX
2. UnitedHealthcare® Commercial Plan Phase 4 Test Registrations for Molecular Diagnostic Testing. https://www.dexzcodes.com/palmetto/dex.nsf/DID/XHHX62A8AE#:~:text=What%20to%20expect%20after%20you,2%20weeks%20from%20test%20submission.