Knowledge Base Article

Over the past several weeks, our newsletter has focused attention on the transition of the Jurisdiction J (Alabama, Georgia, and Tennessee) Medicare Administrative Contractor (MAC) from Cahaba to Palmetto GBA.  For those providers affected by this transition, please pay special attention to this article as you will be required to participate in this program under the Palmetto contract.  Special information affecting Jurisdiction J is included at the end of this article.

If you are a regular reader of our Wednesday@One newsletter, you may already know that my original role in healthcare was as a clinical laboratory scientist (CLS) or Medical Technologist (MT). I loved working in the clinical laboratory, but my detail oriented brain also loves my current work with Medicare regulations. In the realm of healthcare compliance, I keep up with the rapid and never-ending changes of Medicare healthcare regulations.  Unfortunately, since Compliance is now my focus, I no longer keep up with the also rapid and never-ending changes to laboratory medicine. 

Molecular diagnostic testing (MDT) is one area of laboratory advancements that is having a tremendous impact on the practice of medicine overall.  Human genomics is reshaping the medical approach to therapy and diagnosis in areas such as inherited genetic diseases, infectious disease, oncology, human leucocyte antigen typing to predict immune function, coagulation, and pharmacogenomics—the genetic prediction of which drugs will work best.  As this testing has become more common, healthcare payers have struggled with determining the appropriate coverage and payment for these tests.

Some of the challenges for Medicare related to molecular diagnostic testing were:

• HCPCS and CPT descriptions for these codes describe the pathology and laboratory categories but do not identify a specific test.
• The Clinical Laboratory Fee Schedule pricing methodology does not account for the unique characteristics of these tests.
• Who determines if the tests fall within a Medicare benefit category?
• Some tests have not been assessed for clinical and analytical validity and clinical utility.

Medicare’s solution was the Molecular Diagnostic Services (MolDX) Program, which was developed by Palmetto GBA in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. Palmetto GBA currently administers the MolDX Program and all its information. 

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.

How does the MolDX Program address the above challenges?

The MolDX program performs the following functions, which solve the challenges noted above concerning 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

How does the MolDX Program work?

Obtain a DEX Z-Code

Laboratories must apply for and obtain a unique test identifier for each MDT or LDT (lab developed test) they perform.

Attention Hospitals - You are NOT expected to submit tests to obtain Z-Codes for tests sent to another laboratory to perform.  You submit tests to obtain a Z-code only for those tests you perform in-house.  However, the MolDX FAQs state 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.

These are the steps required for participation in the MolDX program:

• You are required to register your organization in the DEX Diagnostics Exchange if you plan to submit claims for the MolDX codes to MACs participating in the MolDX program (see list of Participating MACs below). 
• Providers billing Part A for molecular tests performed by a proprietary or reference laboratory will “Request Sharing” in DEX, from your reference lab, to get access to the Z-Code for billing purposes. You must obtain the DEX Z-CodeTM for the molecular test(s) from the performing laboratory, either directly or through the DEX system. 
• 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. 

Obtain a Technical Assessment Approval (Coverage Determination)

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 (M00115) provides the steps to submit a dossier.

All new test services will be denied as noncovered until the test completes the TA process and reasonable and necessary criteria is established. Claims submission for tests in the TA process should be suspended until a final coverage determination is made. Labs should not provide lab tests pending a TA approval until coverage is approved and appropriate billing and coding guidelines are published.

Once a coverage determination has been established, the results will be published to the provider community. A Local Coverage Determination (LCD) or Coverage Article may be developed if the test requires administration of reasonable and necessary limitations.

Report Z-Code on Claim

When the unique test identifier (DEX Z-Code™) is reported in conjunction with the appropriate CPT/HCPCS code on the claim, it allows Medicare to determine the exact test that has been performed, facilitating the process of making pricing and/or coverage determinations. The MolDX Manual provides instructions on the claim line detail fields for reporting the Z-codes.

• Part B providers – Paper claim - Block 19 of the CMS 1500 claim form; electronic claims (837P) - SV101-7 field adjacent to the applicable CPT code.
• Part A providers – Paper claim - block 80 of the UB04 claim form; electronic claims (837I) - line SV202-7.
• 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.

Adjudication

The molecular test is adjudicated in accordance with the MAC’s LCDs and coverage articles.

Palmetto GBA’s “Molecular Diagnostic Tests (MDT)” LCD provides coverage for MDTs and LDTs that are identified as covered in the LCD. Palmetto has also developed and published specific LCDs, and/or coverage articles for some MolDX tests. 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.

Participating MACs

Although Palmetto “owns” the MolDX program, several other MACs also participate in the program.  These include Noridian JE and JF, CGS J15, and WPS J5 and J8.  Each of these MACs have coverage policies and websites dedicated to the MolDX program.  If you are a provider in one of these jurisdictions, please check you MACs website for more information.  At this time CMS has not determined how MolDX will be expanded.

Jurisdiction J Transition

Medicare Part A and Part B providers in the Palmetto GBA Jurisdiction J will be required to register all molecular tests with the Diagnostics ExchangeTM (DEX), an online test registry.  There will be a phase in for Jurisdiction J to allow time for test providers to obtain their Z-codes. We strongly suggest labs and other test providers begin the process now to avoid any claim processing delays once the Z-code is required on the claim, which is currently projected to be no later than claims submitted on or after June 1, 2018 (note this is not Date of Service driven). 

Refer to the Steps for Participating in the MolDX Program listed above to determine exactly what actions are needed for JJ providers billing for molecular diagnostic testing.  JJ providers should carefully study all the information on the MolDX website and become familiar with Palmetto’s MolDX LCDs.  This is a necessary piece of the JJ transition.