To determine if a genetics panel has passed a Technical Assessment (TA) by the Molecular Diagnostic Services (MolDX) program, you’re essentially checking if it meets the criteria for coverage under Medicare’s molecular diagnostic testing framework. MolDX, run by Palmetto GBA, evaluates tests for analytical validity, clinical validity, and clinical utility to decide if they qualify for reimbursement. Here’s how you can look this up online:
Steps to Check
- Understand the Z-Code Requirement:
- MolDX assigns a unique identifier called a Z-Code to each molecular diagnostic test. A test needs this code to be submitted for a TA and considered for coverage. Labs register their tests with the DEX Diagnostics Exchange (part of MolDX) to get a Z-Code.
- Visit the DEX Diagnostics Exchange:
- Go to the DEX website (dexzcodes.com). This is the primary platform for checking test status.
- You’ll need to log in or register for access (it’s typically for labs, providers, or payers, so credentials might be required). If you’re not a healthcare professional with direct access, you might need to work through a lab or provider.
- Search the Z-Code Registry:
- Once logged in, use the search function to look up the specific genetics panel by name, lab, or Z-Code (if you have it). The registry lists tests that have been submitted.
- Check the status: If a TA has been completed, it’ll indicate whether the test passed (i.e., deemed medically reasonable and necessary) and is covered. A “passed” TA typically means a Local Coverage Determination (LCD) or coverage policy applies.
- Look at CMS Local Coverage Determinations (LCDs):
- Visit the Medicare Coverage Database (cms.gov/medicare-coverage-database).
- Search for “MolDX” under LCDs, filtering by your state or Medicare Administrative Contractor (MAC) like Palmetto GBA, Noridian, or CGS.
- LCDs like L35025 or L36021 outline covered tests. If your panel is listed (by name, CPT code, or Z-Code) with a positive coverage decision, it’s passed the TA. If it’s not listed or marked non-covered, it either hasn’t passed or hasn’t been assessed.
- Check with the Lab Directly:
- If you know the lab offering the panel (e.g., Invitae, Blueprint Genetics), their website or customer service might state if it’s MolDX-approved. Labs often advertise coverage status since it’s a big deal for reimbursement.
- Alternative: Palmetto GBA Website:
- Go to palmettogba.com, navigate to the MolDX section, and look for resources like FAQs or the MolDX Manual. These might not list every test but can guide you on covered categories (e.g., NGS panels for cancer).
What “Passing” Means
- A test passes the TA if MolDX determines it has:
- Analytical Validity: The test accurately detects what it claims (e.g., specific mutations).
- Clinical Validity: Results correlate with a disease or outcome.
- Clinical Utility: It improves patient care (e.g., guides treatment).
- If approved, it gets tied to a CPT code and Z-Code for billing, and coverage is detailed in an LCD or article.
Practical Tips
- Example Search: If you’re checking a panel like a “Hereditary Cancer Panel,” search the DEX registry or CMS database for terms like “hereditary cancer” or the lab’s name. Look for LCDs like L37788 (for NGS in oncology).
- Limitations: Public access to full Z-Code details is restricted. If you hit a wall, contact the lab or a genetic counselor—they’ll know the MolDX status.
- Today’s Context: As of February 22, 2025, the process hasn’t changed much, but check for updates on the Palmetto or CMS sites since policies evolve.
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