Jurisdiction J Starts MolDX Program
Get Ready for Some Z Codes
If you scan through the coverage updates from the Medicare Administrative Contractors (MACs) found at the end of this article, you will notice several new draft Local Coverage Determinations (LCDs) for molecular diagnostic tests. The descriptions of these LCDs begin with “MolDX.” This is not surprising as molecular diagnostic testing (MDT) is one area of laboratory advancements that is having a tremendous impact on the practice of medicine overall. New molecular diagnostic tests are being developed and approved for coverage on a regular basis. Human genomics is reshaping the medical approach to therapy and diagnosis in areas such as inherited genetic diseases, infectious disease, oncology, coagulation, predicting immune function, and predicting the efficacy of certain drugs. As this testing has become more common, healthcare payers have struggled with determining the appropriate coverage and payment for these tests.
Medicare’s solution was the Molecular Diagnostic Services (MolDX) Program, which was developed by Palmetto GBA in 2011. The MolDX program performs the following functions, which solve the challenges of appropriate coverage and payment for molecular diagnostic tests:
- Facilitates detailed and unique identification through registration of molecular diagnostics tests to facilitate claims processing and to track utilization.
- Establishes clinical utility expectations
- Completes technical assessments of published test data to determine clinical utility and coverage
- Establishes reimbursement
Palmetto GBA currently administers the MolDX Program and all its information. Several MACs participate in the program, including Palmetto JM, Noridian JE and JF, CGS J15, and WPS J5 and J8. Each participating MAC has coverage policies and websites dedicated to the MolDX program.
Since Jurisdiction J transitioned to Palmetto as their MAC earlier this year, providers in JJ will begin participation in the MolDX program effective July 1, 2018. Specifically, claims received on or after July 1, 2018 with dates of service on or after February 26, 2018 will require a Z-code on the claim line if the service is covered under the MolDX Molecular Diagnostic Testing (MDT) LCD L35025.
The program applies to all private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare Part A or Part B. The following molecular diagnostic assays/tests are included in MolDX.
|Code Category/Description||2018 MolDX CPT Code Range|
|Tier 1||81105-81112, 81120-81121, 81161-81383|
|Genomic Sequencing Procedures||81410-81471|
|Molecular Multianalyte Assays (MAAA)||81490-81595|
|MAAA Admin Codes||All codes|
|NOC||81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, 89398|
Affected providers start by registering in the DEX Diagnostics Exchange if they plan to submit claims for the MolDX codes to MACs participating in the MolDX program. Then they must apply for and obtain a unique test identifier for each MDT or LDT (lab developed test) they perform. Hospital providers billing for molecular services performed by their hospital-based laboratory must register and obtain a unique DEX Z-CodeTM for each molecular test in the MolDX code ranges designated above. See MolDX Registration and Claims Submission webpage for more information.
Hospital laboratories are NOT expected to submit tests to obtain Z-Codes for tests sent to another laboratory to perform. They can obtain the DEX Z-CodeTM for the molecular test(s) from the performing laboratory, either directly or through the DEX system. Providers billing Part A for molecular tests performed by a proprietary or reference laboratory will “Request Sharing” in DEX, from the reference lab, to get access to the Z-Code for billing purposes. However, as stated in the MolDX FAQs, it is the responsibility of the billing provider to obtain a DEX Z-Code™ identifier, such as in cases where the performing lab is not in a jurisdiction under the MolDX program. Since reference labs performing genetic testing generally offer services across the nation, most will have already obtained the necessary Z-codes.
Once a Z-code is assigned, coverage is determined through a technical assessment (TA). Established FDA-approved tests with proven utility that are performed within labeling indications may not require a technical assessment. A TA is required for molecular assays that are laboratory developed tests (LDT), employ new or novel technology, or have undefined or unproven clinical utility. For these tests, labs/developers must submit a detailed dossier of clinical data to substantiate the test meets Medicare’s requirements for coverage. The Technical Assessment Submission Instructions provide the steps to submit a dossier. It is unlikely tests performed in a hospital-based laboratory would require a technical assessment since they generally already have proven utility.
Through the MolDX program assessment of clinical utility, the MACs will determine appropriate coverage. An LCD or Coverage Article will be developed conveying the reasonable and necessary limitations of coverage. MDTs and LDTs not identified as covered in an NCD, LCD, or coverage article are not covered. Palmetto GBA will continue to accept and consider requests on excluded genetic tests. You can find a link to Palmetto’s LCDs, as well as list of covered and excluded tests, on Palmetto’s MolDX website.
Once approved and assigned, the unique test identifier (DEX Z-Code™) must be reported in conjunction with the appropriate CPT/HCPCS code on the claim. This allows Medicare to determine the exact test that has been performed, facilitating the process of making pricing and/or coverage determinations. Refer again to the MolDX Registration and Claims Submission webpage for claim submission information. Part A providers will need to specify which lines are billed for MolDX and the appropriate DEX Z-Code per line within the remarks section of the claim.
If you are a laboratory in Jurisdiction J, you need to be ready to start submitting Z codes by the first of next month. For all providers currently or soon to be affected by the MolDX program, we encourage you to check your MAC’s coverage policies and instructions on the MolDX program.
LCD updates since last month for all MACs are listed below.
Article by Debbie Rubio
This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.