Frequently Asked Questions Regarding MolDX and Its Molecular Syndromic Panel Testing LCD

The MolDX Program was developed by Palmetto GBA to identify and establish coverage and reimbursement standards for molecular diagnostic tests.

A Medicare Administrative Contractor (MAC) is a provider of high volume claims and transaction processing, contact center operations and technical services to the federal government and other commercial customers. They are selected by Medicare and Medicaid to be the government’s program administrators in certain jurisdictions.

Since its inception, other MACs have also adopted Palmetto’s MolDX Program to apply within their jurisdictions. Thus far, in addition to Palmetto GBA, Noridian Healthcare Solutions, WPS Health Solutions, and CGS Administrators have adopted MolDX and its associated policies. These MACs serve a combined 28 states.

Local Coverage Determinations (LCDs) are policies issued by MACs that determine whether to cover a particular item or service within their jurisdiction.

This policy offers limited coverage for outpatient testing with molecular syndromic panels designed to identify infectious disease pathogens. Syndromic panels are defined as panels that simultaneously detect >1 pathogen with similar and overlapping clinical symptomatology. 

More details can be found on: https://www.palmettogba.com/moldx

Since MolDX governs the reimbursement of syndromic panel testing, knowledge of the LCD should help labs offering these services improve the likelihood of reimbursement.

Once a test is approved for reimbursement under this LCD, the MAC can generally determine coverage and payment without documentation review. This can expedite payment by removing the need to submit large amounts of additional information with every claim.

Specifically, the tests that fall under the scope of this policy and require registration with MolDX are:

• Non-FDA-approved/cleared tests (e.g., “Lab Developed Tests,” or LDTs)
• Modified versions of FDA-approved/cleared in vitro diagnostic tests (IVDs) (i.e., tests that have been altered from their original FDA-approved/cleared configuration)

Per Palmetto, “syndromic panels that are CLIA waived should be unmodified FDA-approved/cleared tests and registration of these tests would not be required. For CLIA waived tests that remain under Emergency Use Authorization (EUA) status, the manufacturer may submit the test to DEX® for a Z-Code and we will contact them if additional documentation is required.”

In jurisdictions where MolDX and this LCD have been adopted, all private, reference and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare are affected by this program. 

April 17, 2022.

For each LDT in scope, the CLIA lab must apply for:

• DEX® Z-Code: A special group of codes provided in ICD-10-CM for the reporting of factors influencing health status and contact with health services. Z-Codes are designated as the principal/first-listed diagnosis in specific situations such as to indicate that a person with a disease or chronic condition is being seen for specific aftercare.
• Technical Assessment: A review process conducted by MolDX to evaluate a test’s clinical validity, analytical performance, and intended use.

If the assessment determines that the test meets coverage criteria, a corresponding Current Procedural Terminology (CPT®) code is assigned. The CPT® code and Z-Code are then used to obtain reimbursement for the covered test.

MolDX only provides coverage for MDTs and LDTs that demonstrate three key elements:

• Analytical validity
• Clinical validity (AVCV)
• Clinical utility (CU)

The DEX® Diagnostics Exchange is an online catalog used by MolDX designed to identify tests and establish transparency in the evidence-base for their coverage. For labs, this tool allows you to confidentially share test information with MolDX online and obtain a Z-Code for a test.

Labs must register their organization on the DEX® Diagnostics Exchange platform and submit information related to their test for review. The full registration process can be found on the website.

While a Z-Code is assigned approximately two weeks after a test is submitted in the DEX® application, it is not effective for claims until the DEX® clinical team reviews the application, determines coverage, and assigns a CPT® code (which may be different than the one you initially submitted in your application). After this, you will receive an email notification once this process is complete.

The patient has a clinical indication for the infectious disease testing:

1. For immunocompetent patients, the clinical indication includes a presumption of active infection OR infection-associated complications (which may include exacerbation of underlying disease) that require the identification of a causative organism for appropriate management. 
   
   
2. For immunocompromised patients (i.e., those with weakened immune systems or patients who are taking immunosuppressive medications such as chemotherapy, biologics, transplant-related immunosuppressive drugs, high-dose systemic corticosteroids) and those with inherited diseases that affect the immune system (i.e., congenital immunoglobulin deficiencies), atypical clinical presentations of disease are considered appropriate indications for testing.
   
   
3. When the results of testing will impact clinical management in a manner already demonstrated in the peer-reviewed published literature to improve patient outcomes.
   
   
4. When testing is performed according to the intended use of the test in the intended patient population for which the test was developed and validated.
   1. This includes performing the test using the intended sample types along with parallel testing that must accompany the test. (i.e., the meningoencephalitis and bloodstream pathogen tests include requirements for parallel testing using conventional Gram stain and culture-based detection for correlation of results).
   2. This also includes the provision—by the laboratory to ordering providers—of the major limitations of a given panel test.
      
      
5. When an evaluation for more than one pathogen by molecular testing is necessary for patient management. 

   (testing for a single pathogen is NOT reasonable and necessary for the specific infection, patient, or indication). The panel performed includes at least the minimum pathogens required for clinical decision making for its intended use that can be reasonably detected by the test.

6. Expanded panel testing is only indicated when targeted panel testing is not appropriate (i.e., will not provide sufficient information for the appropriate clinical management of the patient).

Reference: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39044

• If the test is performed as a test of cure.
• If the patient has been previously tested by molecular diagnostic methods for the same pathogens within 14 days for the same clinical indication. 
  • If a previous panel test was performed with a similar/duplicative intended use, a subsequent test is only reasonable and necessary if the non-duplicative content of the second test is reasonable and necessary.
  • Exception: Repeat panel testing for the same clinical indication will only be covered if first panel yielded a negative result AND there is a high index of suspicion for a pathogen as the cause of symptoms AND the patient’s clinical condition is not improving or is deteriorating after a clinically appropriate length of time. In such cases, 1 additional panel test may be covered between 1 and 14 days after the initial panel test, so long as the test fulfills the criteria for coverage as set forth in this policy.
    
    

There a number of online resources for learning more about the MolDX program:

• Palmetto GBA website: https://www.palmettogba.com/
• MolDX (administered by Palmetto) website: https://www.palmettogba.com/moldx
• DEX® informational website: https://www.dexzcodes.com/
• DEX® registration website: https://app.dexzcodes.com/login