What Is MolDX?

The Molecular Diagnostic Services (MolDX) Program was developed in 2011 by Palmetto. The program is established and administered by the MAC Palmetto GBA for evaluating the analytical and clinical validity and clinical utility of individual assays, including laboratory-developed molecular tests, to determine coverage and reimbursement.

In April 2022, a new Local Coverage Determination (LCD), “Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing,” was announced that would impact the reimbursement for infectious disease testing for labs that are billing Medicare Part B for Medicare Administrative Contractors (MACs) in the MolDX region.

Does this sound like you?


How We Can Help


Our team of experts will help you identify your panels that are impacted and potential roadblocks.


Together we will work with your lab to devise a strategy tailored to your situation.


After the strategy is in place, we will design a plan around your tests to help determine the medical necessity.


Once the plan is designed, we will assist you through the diagnostic exchange registry process.

laboratory compliance

What Has Changed?

The new LCD announced in 2022 will impact infectious disease panels with more than five targets. Suppose your panel has more than five targets. In that case, your lab must register for a Z-Code and conduct a technical assessment to assign to determine the medical necessity of the test. Without taking the necessary steps outlined in the LCD, you will be denied reimbursement from Medicare.

What does your lab need to do?
  1. You will need to ensure you are registered in the diagnostic exchange registry.
  2. Once registered for the DX exchange, you can register your test, and Medicare will provide a Z-Code.
  3. After the Z-Code is provided, a technical assessment will need to be completed on the test enrolled into Medicare.
  4. Once you have obtained a Z-Code and the technical assessment is completed, a reimbursement will be assigned, and the medical necessity for the test will be validated.


Where do I register for the Diagnostic Exchange Registry?
How do I learn more about MolDX for my specific situation?

Contact the team of experts at Doc Lab Inc. for answers on your specific situation.

How can I read more on General MoDX questions?

Contact Us For Help Navigating MolDX

Better Health Care is Our Business

(360) 991-0755

1915 NE Stucki Ave,

Suite 400

Hillsboro, OR, 97006