What Labs Need to Know About MolDX®

Many clinical laboratory professionals are aware of the MolDX^® program, which aims to facilitate and expedite coverage and reimbursement for molecular diagnostics services. But even laboratorians who work within the program’s jurisdiction may not be fully conversant with it—particularly when it comes to complex tests or documentation labs don’t see every day. That’s why Lab Industry Advisor went directly to the MolDX^® program itself for answers to common questions about how it works, what it covers, and where to go for support.

Q: Can you give us a brief overview of MolDX^®?

A: The MolDX^® program was founded to establish Medicare payer controls, coverage, and reimbursement for molecular diagnostic tests. The program is administered by Palmetto GBA on behalf of Medicare, with joint operation by several Medicare Administrative Contractors (MACs) encompassing 28 states. Its aim is to provide the Medicare population with access to molecular diagnostics through development of local coverage determinations (LCDs), test pricing, and test identification (through registration and technical assessment in the DEX^® Diagnostics Exchange).

Q: How does MolDX^® simplify billing and coding?

A: MolDX^® provides an automated process for the payer to precisely identify the laboratory service rendered and determine medical necessity without the need for manual review and preauthorization.

MolDX^® assigns a unique identifier (Z-code) to each laboratory service, including laboratory-developed and modified tests. Each service is catalogued in the DEX^® Diagnostics Exchange using its Z-code; the entry includes key lab-provided elements such as the test description, intended clinical use, analytes measured, and methodology. The MolDX^® team reviews submissions with a technical assessment by experts in clinical molecular genetics and molecular genetic pathology, who evaluate the service for analytical validity, clinical validity, and clinical utility. Once completed, payers can use the Z-code to clearly identify that service for billing purposes. A successful technical assessment determination indicates quality assurance and clinical utility, eliminating the need for manual review prior to payment authorization. This process provides the payer with finer granularity regarding the services rendered and allows labs to accurately represent their tests. Although this creates upfront work for the labs and MolDX^®, it enables consistent, reproducible, automated claims processing.

Q: What tests are covered by MolDX^®?

A: The scope of the MolDX^® program includes molecular diagnostic tests, including DNA- and/or RNA-based tests, as defined in LCD MolDX: Molecular Diagnostic Tests (MDT)¹ and the associated reference article, Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT).² The program was recently expanded to include proteomics, as defined in Billing and Coding: MolDX: Proteomics Testing.³

Medicare coverage for in-scope services is established through LCDs; services must meet policy criteria for coverage and undergo a successful technical assessment. Coverage for tests and services that are outside existing policy, but within the scope of the MolDX^® program, is granted through the LCD development process. To generate policy for a new test or service, relevant clinical evidence is reviewed to establish benefit to the Medicare population using Medicare’s “reasonable and necessary” requirement.⁴

Q: What are the most common challenges labs face when onboarding or using the MolDX^® program?

A: Laboratories may initially have difficulty navigating the DEX^® portal and completing the technical assessment. There are helpful FAQs⁵ available on the website and our staff is always available to answer questions via email. Experience is also key; submissions become easier as labs gain familiarity with the process and expectations. It is not unusual for the primary submission to be unsuccessful—a negative determination should be viewed as constructive criticism with the intent of clarification and as an opportunity for improvement.

Another novel concept is that of a laboratory test viewed as a “laboratory service.” MolDX^® considers tests that are always performed together for a single clinical intended use to be a service identified and billed with a single Z-code reflective of the testing being performed. This enables more precise characterization of the testing and avoids code-stacking because the price for the entire service is rendered inclusive of its parts.

Q: What are the most common errors labs make when using the MolDX^® program?

A: In our experience, labs undergo the smoothest onboarding with MolDX^® when a laboratory director is involved with the technical assessment submission. Each laboratory service undergoes assessment by the MolDX^® team of clinical genetics experts, who develop a solid understanding of the test or service rendered, its intended clinical use, and how it was validated (with resultant analytical and clinical validity metrics). It is beneficial for the person most familiar with these aspects—typically the laboratory director—to be involved in the submission process to clearly convey this information. Director involvement can save significant time in the review process because it avoids the clarifying questions that frequently arise when submissions are prepared by external personnel who lack familiarity with the test or service.

Other common errors include not submitting all the required paperwork and filling out the worksheets incorrectly. MolDX^® medical directors and staff are available to engage with laboratories by email or teleconference to facilitate smooth navigation of the MolDX^® process. We prefer to clear up any confusion prior to submission, because this allows for more efficient review and allocation of resources.

Q: With the rapid pace of advancement in molecular diagnostics, how does the MolDX^® program ensure that it stays up-to-date?

A: The MolDX^® staff consists of a team of clinical laboratory scientists and five medical directors who hold MD, PhD, or MD/PhD degrees. They have training and experience in laboratory medicine, are board-certified in molecular genetics or molecular pathology, and actively participate in professional organizations. In addition to regular attendance and presentation at national conferences, directors and staff dedicate several hours each week to engagement with laboratories to discuss lab services. These meetings include MolDX^® technical assessments submitted under existing policy and new technologies at various stages of development for future LCDs. This consistent real-time engagement with the field of molecular diagnostics, along with monitoring for updated guidelines from major societies, keeps the program up-to-date.

Q: What would you like all clinical lab professionals to know about MolDX^®?

A: The MolDX^® program’s goal is to facilitate Medicare beneficiaries’ access to quality molecular diagnostics. At its core, the program has an understanding and expertise in molecular diagnostics and believes in its value to the Medicare population. MolDX^® aims to make these diagnostics accessible to Medicare beneficiaries—and sustainable for laboratories—through more precise coding and pricing. The technical assessment process ensures the quality of such services, increases pricing accuracy, and enables the laboratory and the payer to communicate with transparency regarding the service being rendered, facilitating swift reimbursement for quality services.

References:

1. Centers for Medicare & Medicaid Services. MolDX: Molecular Diagnostic Tests (MDT) L35025. Medicare Coverage Database. April 26, 2023. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=35025.
2. Centers for Medicare & Medicaid Services. Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A56853. Medicare Coverage Database. June 28, 2024. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56853.
3. Centers for Medicare & Medicaid Services. Billing and Coding: MolDX: Proteomics Testing A59636. Medicare Coverage Database. June 28, 2024. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=59636.
4. 42 CFR Part 405. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”. Federal Register. January 14, 2021. https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf.
5. Palmetto GBA. Frequently Asked Questions. MolDX. July 25, 2024. https://www.palmettogba.com/palmetto/moldxv2.nsf/DID/9A7MFG4181.