Z-Codes Unveiled: Expert Responses to the Most Pressing Questions
August 18, 2023
This blog is part of a series. Read Part 1 here.
Kyle Fetter, XiFin Chief Operating Officer, recently participated in the Dark Daily webinar, “Essential Guide to Obtaining Z-Codes for Molecular and Genetic Tests” with Dr. Gabriel Bien-Willner, the Medical Director of Molecular Diagnostic Services (MolDX) and Chief Medical Officer, of Palmetto GBA, and Valerie Collier, Access and Reimbursement Manager with ARUP Laboratories. If you missed his blog article summarizing the key takeaways from the webinar, you can find it here.
At the end of the presentation, the discussion was opened up to questions. There were so many good questions that we decided to include many of them in this separate article.
If our organization fails a Technical Assessment (TA), can we appeal?
Dr. Bien-Willner responded to this question. The technical assessment is based on a pre-defined process. That said, every test is different, so the exact same procedure cannot be applied to each and every TA. Depending on the test’s intended use and the services being rendered, the performance characteristics may be different. If you don’t successfully complete the technical assessment, we will collaborate with you to discuss what explicitly was found to be insufficient. We allow you to supplement or correct the initial submission and resubmit the TA. If you feel that we didn’t understand something or misinterpreted data, you’re welcome to explain why you think we misinterpreted it. So yes, you can appeal in that sense.
How long does it take to put together a technical assessment and who in the lab works on it?
Valerie Collier responded to this question. It’s fairly time-consuming and depends on the test. Generally, I have been able to complete a technical assessment in a week, if I can dedicate my time to it and there aren’t any issues that I need to address with our medical directors or R&D scientists.
We used to assign out the work to various staff members in different test areas, but we found that having it all assigned to a single MolDX coordinator makes it much more streamlined. Then a single resource is responsible for putting together the documentation required for the TA. We find this makes more sense than having to get lots of staff members in different areas up to speed on the process and how to pull the data together for the TA. It still requires collaboration with our medical directors and R&D scientists, however.
What amount of change to a lab procedure requires notification to MolDX and submission of a new technology description? If we need to resubmit a technology description, do we have to wait for a new Z-Code?
Dr. Bien-Willner responded to this question. We understand that lab-developed tests are constantly being optimized. In general, as long as the description of the test, what the analytes measure, or the intended use for the test don’t change, there is no need to update MolDX. For example, if you change the brand of the analyzer used in the process, we expect that you’re internally validating that change and you don’t need to notify us. Likewise, if you improve your process to extract DNA more efficiently, that’s not something we need to know about.
If you fundamentally change the test, however, and you will no longer offer the old version, we ask you to tell us that you’re doing that and send us information about the validation that you performed. You would just need to update the DEX registry to reflect what service is rendered. For example, if you’re expanding a gene panel of 12 genes to 25 genes, you’ll need to tell us what you’re doing and why. We will let you know if any additional information for a review or assessment is required.
You never need a new Z-Code unless you plan on creating a separate test and maintaining the old test.
Are requirements the same for FDA-approved and lab-developed tests?
Dr. Bien-Willner addressed this question. The requirements are designed to determine the medical value of the test and understand the service rendered. FDA approval doesn’t change that. Certainly, part of the FDA approval process looks at things like analytical validity, and we’ll take into consideration for FDA-approved tests that those requirements are met. However, the FDA generally doesn’t look at clinical utility. So just FDA approval in and of itself is not usually sufficient.
How long does it take for the review process to be completed and the Z-Code to be issued?
After a test is registered, a Z-Code is typically assigned within two weeks. If a technical assessment is required for the test, the submitter is notified by email. Once the technical assessment test is submitted, the review process takes up to two months. For less complex tests, the review is often done faster. This process can be delayed if the lab needs to respond to comments or questions about its TA.
Does the panel expect that UnitedHealthcare will start rejecting claims without Z-Codes?
Yes, for the tests included in Wave 1, the panel expects UnitedHealthcare (UCHC) to begin rejecting claims without Z-Codes on or shortly after October 1, 2023.
If a lab is in a non-MolDX state, is it required to utilize Z-Codes?
Dr. Bien-Willner answered this question. The MolDX program is a Medicare program that is only effective in the MolDX jurisdictions, currently 28 states. So, if a laboratory is not in a MolDX state, it does not need to put Z-Codes on Medicare claims to its Medicare MAC.
That said, if the lab processes claims with UHC and UHC requires labs to register and get Z-Codes for specific molecular and genetic tests, then yes, that lab would need to register and get Z-Codes for those services that are going to be submitted to UHC. When commercial payors require Z-Codes for you to participate in their programs like Medicare Advantage or now commercial plans, you have to register your test.
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