Molecular Diagnostic Services, or MolDX Program, was created in 2011 to help identify and establish coverage and reimbursement for molecular diagnostic testing. It defines a consolidated set of LCDs, articles, and coding edits for participating MACs. By facilitating unique and detailed identification through molecular diagnostic testing, labs are able to facilitate the claims process while tracking utilization. This program currently provides uniform policies for 28 states, across four Medicare Administrative Contractors. 


What Is A Z-Code?


In order to approve tests and for labs to acquire reimbursement, they will need to create a Z-code for tests that require one. 

A Z-code is a unique five-character alpha-numeric code associated with certain molecular diagnostics tests and is specific to a lab’s MDT or LDT. It is used by some payers as an adjunct to non-specific CPT codes. Not all tests are eligible for a Z-code and must be FDA approved or a modified version of an FDA-approved test. 


How Do I Obtain A Z-Code?


There are 3 steps in the Z-code process. 

  1. Register Lab Administrator with the DEX diagnostic exchange. Since there are only two users per lab, one of those users should be on the technical team.
  2. Register Test: Once registration is received, you will need to add your test which includes the Test ID, Test Title, and a few other details from the lab.
  3. Technical Assessment: LDTs will require a technical assessment and the DEX Exchange will request the technical assessment once it is registered. 


How Does This Impact My Lab?


Before this program was developed and utilized, ID panels testing for more than 5 pathogens were not reimbursed, regardless of the reason. Only three to five of those pathogens were determined to be medically necessary. 

The expanded panels are:

  1. Respiratory panels
  2. Pneumonia panels
  3. Gastrointestinal panels
  4. Urogenital panels
  5. Anogenital panels
  6. Meningoencephalitis panels
  7. Bloodstream Infection panels
  8. Urinary Tract Infection panels

The panels not mentioned in this LCD, but that are affected by it, could include:

  1. Sexually Transmitted Infection panels
  2. Women’s Health panel
  3. Wound panels
  4. Nail and Fungal panels

These expanded panels require an ID specialist to order; however, there are exceptions for labs in rural or remote areas with limited access to these specialists. 


What are our next steps?


Most of your lab ID panels will need to be registered and have a Z-code assigned to them, which will then establish the pricing of each test. This process of registering can take 60 to 90 days to complete, so it is essential for your organization to begin as soon as possible. By receiving fixed rates for your tests, your lab will be able to remain consistent in its pricing model, which will help in reducing denials and helping your team get their reimbursements faster. 

For more information and help in your lab’s medical billing, please contact our team of experts at Credence Global Solutions today!