MolDX & Molecular Syndromic Panel Testing LCD

The MolDX Program was developed by Palmetto GBA to identify and establish coverage and reimbursement standards for molecular diagnostic tests.

A Medicare Administrative Contractor (MAC) provides high-volume claims and transaction processing, contact-center operations, and technical services to the federal government. MACs are selected by Medicare and Medicaid to administer programs in certain jurisdictions.

In addition to Palmetto GBA, Noridian Healthcare Solutions, WPS Health Solutions, and CGS Administrators have adopted MolDX and its associated policies. These MACs serve a combined 28 states.

Local Coverage Determinations (LCDs) are policies issued by MACs that determine whether to cover a particular item or service within their jurisdiction.

It offers limited coverage for outpatient testing with molecular syndromic panels designed to identify infectious-disease pathogens — panels that simultaneously detect more than one pathogen with similar, overlapping clinical symptomatology.

Because MolDX governs reimbursement of syndromic panel testing, knowing the LCD helps labs improve the likelihood of reimbursement. Once a test is approved under the LCD, the MAC can generally determine coverage without documentation review, expediting payment.

Tests that fall under the policy and require MolDX registration are: non-FDA-approved/cleared tests (Lab Developed Tests, or LDTs) and modified versions of FDA-approved/cleared in vitro diagnostic tests (IVDs).

Per Palmetto, CLIA-waived syndromic panels should be unmodified FDA-approved/cleared tests, and registration would not be required. For CLIA-waived tests remaining under EUA status, the manufacturer may submit the test to DEX® for a Z-Code.

In jurisdictions where MolDX and this LCD have been adopted, all private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare are affected.

April 17, 2022.

For each in-scope LDT, the CLIA lab must apply for a DEX® Z-Code and complete a Technical Assessment (a MolDX review of clinical validity, analytical performance, and intended use). If the test meets coverage criteria, a CPT® code is assigned; the CPT® code and Z-Code are used to obtain reimbursement.

An online catalog used by MolDX to identify tests and establish transparency in the evidence base for coverage. Labs can confidentially share test information and obtain a Z-Code.

Labs register their organization on the DEX® Diagnostics Exchange platform and submit information related to their test for review.

A Z-Code is assigned about two weeks after submission but isn't effective for claims until the DEX® clinical team reviews the application, determines coverage, and assigns a CPT® code. You're notified by email once complete.

Coverage applies when the patient has a clinical indication and criteria are met — including presumption of active infection, results that impact clinical management per peer-reviewed literature, testing per intended use, and expanded panels only when targeted panels are insufficient (CMS LCD ID 39044).

If performed as a test of cure, or if the patient was tested by molecular methods for the same pathogens within 14 days for the same indication — with limited exceptions (one additional panel between 1 and 14 days if the first was negative, suspicion remains, and the patient isn't improving).

Palmetto GBA (palmettogba.com), MolDX (palmettogba.com/moldx), and the DEX® Diagnostics Exchange (dexzcodes.com).