Medicare Molecular Test Coverage with MolDX

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What is a Medicare’s MolDX program?

Palmetto GBA developed the Molecular Diagnostic Services (MolDX) Program to consolidate expertise in reviewing molecular diagnostic tests for coverage reimbursement under the Medicare program. MolDX currently provides uniform policies for 28 states, across four Medicare Administrative Contractors (MACs).

What does the MolDX program do?

​The MolDX program creates LCDs, articles, and coding edits that address molecular diagnostic tests. It does this by:

  • Registering molecular diagnostic tests to improve identification, speed claims processing and to monitor utilization.
  • Evaluating molecular diagnostic tests for clinical utility, analytic validity and clinical validity.
  • Completing technical assessments of published test data to validate clinical utility and determine coverage.
  • Determining reimbursement rates.
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What do I need to do to get MolDX coverage?

Navigating the complex world of obtaining MolDX coverage for your molecular diagnostic test can be overwhelming. At Gettysburg Healthcare Consulting, we understand the intricacies of the MolDX and Medicare coverage process. With our expertise and guidance, you can eliminate the guesswork and expedite the pathway to coverage. Trust the Medicare and Medicaid policy pros at Gettysburg Healthcare Consulting to help you every step of the way.
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How can we help?

At Gettysburg Healthcare Consulting, our team of Medicare and Medicaid policy pros are dedicated to helping you navigate the complex landscape of MolDX coverage. With our expertise and insider knowledge, we ensure your molecular diagnostic test receives the necessary coverage, allowing you to generate income quickly. Trust our reliable and honest approach to healthcare consulting, and let us guide you towards success.

Our Expertise Shines

  • Working with an experienced healthcare consultant with over 30 years of experience with the Medicare program provides you with a level of knowledge and skill unmatched in the industry.
  • Our comprehensive understanding of Medicare coverage rules and requirements will help to avoid pitfalls and mistakes that might occur.
  • Clients trust us to review their novel diagnostics and determine the best coverage approach for their unique needs.


How do I know if MolDX is for me?

Take a look at our Clinical Laboratory Coverage Jurisdiction map. If you operate in any of the light green states, you must follow the MolDX program.

When should I start thinking about a MolDX coverage?

We recommend starting this process as soon as possible. Starting the process of evaluating your molecular diagnostic test and building your coverage dossier 12-18 months before launch is a good benchmark.

What kinds of information do I need to support coverage?

At Gettysburg Healthcare Consulting, we are dedicated to providing exceptional Medicare and Medicaid policy expertise. Our team of experienced professionals is committed to helping you navigate the complex world of healthcare coverage. With our extensive knowledge and understanding, we can guide you through the necessary information required to support coverage. Whether you need assistance with analytic validity, clinical validity, or clinical utility, we have the expertise to ensure your success.

How is MolDX coverage different than Medicare coverage?

The scope of MolDX coverage sets it apart. Unlike Medicare national coverage, MolDX only applies specifically to claims filed in 28 states across the US. This type of coverage, known as a local coverage determination, is limited to those states where it is applicable. At Gettysburg Healthcare Consulting, we provide expert guidance on navigating the complexities of MolDX coverage and its distinctions from Medicare coverage.

Do I have to seek MolDX coverage?

If your test is a molecular diagnostic test, and you have a lab in one of the 28 states that MolDX covers, you must obtain coverage through MolDX before you test can be paid by Medicare.

What do I do next?

Book a free 30 minute consultation and we can discuss your options. Visit the contact us page.

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