About Us

About Our Services

Palmetto GBA offers products and services in the molecular diagnostics space that seek to create payer controls in test quality, pricing, utilization, and claim adjudication automation. These include the DEX® Diagnostics Exchange Registry, the MolDX program for Medicare, and data and professional services for commercial insurance plans.

Our products leverage technology and rigorous procedures we have and continue to develop. These services ensure that medical services performed and billed in the molecular diagnostic space are accurate, effective, properly tested and performed, have established medical value, are used for the correct patient population, and are appropriately priced and billed. Below we provide an overview of the key components of our services and products.

DEX® Diagnostics Exchange Registry

All relevant services billed to participating payers require tests to register and be evaluated a priori (prior to any claim submission). Tests are submitted for review through the DEX® Registry by a registered laboratory that performs the service.  This ensures that participating payers have transparency in the specific service rendered and its intent.  Required information for all tests include intended use, analytes measured, methodologies used, test categorization, and billing information.  Each unique test is provided a Z-Identifier (Z-Code®) that is used in billing to ensure the payer knows exactly what service was rendered in addition to the relevant CPT® code expected to be billed for that service. A Z-Code is assigned within 2 weeks of a complete test submission. Registrations and Z-Codes are only required for services that are within scope of our offering.  At this time, this includes services in the Molecular Pathology CPT code set for the Medicare beneficiary population, and additional genetic tests as identified by private payers to their providers in other populations based on their perceived need for test clarity and quality. The program scope will expand to the entire Molecular Pathology CPT code set for all patients over time and may further expand to other test types.

Test Evaluation

To date, Palmetto GBA has assessed over 20,000 molecular diagnostic tests, a vast majority described as lab-developed tests (LDTs). We evaluate over 1,500 tests per year. All tests are reviewed for medical necessity according to best practices, societal guidelines, available evidence, technical reviews, and expert opinion.  Tests submitted to Palmetto GBA through the DEX registry are evaluated via the Technical Assessment (TA) process, which reviews the test’s Analytical Validity (AV), Clinical Validity (CV) and Clinical Utility (CU). A guide to defining these terms in compliance with our programs can be seen here. Depending on the test’s complexity and potential risk to the patient, additional information beyond the DEX test submission requirements may be requested for a TA to be performed.  Palmetto GBA creates specific procedures for each test type evaluated to have medical value, and as such, not all tests may be evaluated by Palmetto GBA until such a procedure is generated. These procedures are established based on policy or internal evidentiary review. Low complexity and risk tests may require a review of only the test data submitted to DEX for the Z-Code, whereas higher complexity or risk tests require a dossier of additional information, including TA worksheets found on this website (or the MolDX website), and additional supplemental information including validation documentation and sample-level data. The TA process is designed to distinguish services that have demonstrated expected test performance and medical value from those that have not with as little provider abrasion as possible.

Test evaluations are performed by trained and qualified personnel according to our established procedures. This includes masters’ level staff with lab management and testing experience for low complexity and risk tests and MDs and PhDs (or MD/PhDs) with expertise and board certification in the field of Genetics and Molecular Genetic Pathology for higher complexity or risk tests.  

When these services are applied to Medicare, the MolDX program additionally writes policy to establish “reasonable and necessary” requirements for coverage in addition to the evaluation of tests and ensures test compliance with these policies and sets coverage.  These policies, requirements, and processes are adopted by 4 Medicare Administrative Contractors and affect providers in 28 states. TAs must be successfully completed for coverage in the MolDX jurisdictions and may also be required by other commercial payers. Despite having the most progressive and comprehensive policies in molecular diagnostics, the MolDX program saves Medicare hundreds of millions of dollars every year by only reimbursing for appropriate and high-quality testing with a high-level of precision and precluding improper billing practices.

TA success rate varies and is approximately 30-40% of submissions, with great variance depending on the type and complexity of the laboratory medical service rendered.  TAs are completed within 60 days of a submission.  It may take multiple submissions to complete the process, assuming all requirements are met. Tests determined to lack medical necessity or not to have met reasonable and necessary thresholds because of a lack of AV, CV, or CU will not successfully complete a TA. CV and CU for analytes are demonstrated through peer-reviewed, published literature. The highest complexity tests may require medical judgement as part of the evaluation.

Test Pricing

Palmetto GBA has developed an Equitable Pricing Model (EPM) for pricing novel molecular testing services.  This process is compliant with 42 CFR 414 subsection G: Payment for Clinical Diagnostic Laboratory Tests.  It seeks to accurately price tests at rates that are fair and allow the provider to operate the service at industry standard profitability.  This precludes high and low valuations to tests, that can either lead to market imbalance or eliminate the provider incentive to perform necessary medical services.

Claim Adjudication and Edits

Palmetto GBA offers data from the DEX Registry and TA and other procedures for use to automate claim adjudication.  This is a central component of the MolDX program for Medicare but is also being implemented by private commercial payers.  Our data allow for the implementation of a priori decisions, based on payer policy, allowing automated reviews of services on claim or pre-authorization submissions.  It is expected that deployment of these tools to payers will reduce discrepancies between payers for coverage, payment, and pricing, and will reduce or eliminate wait times for claims processing; this may also reduce or eliminate the need for pre-authorization for participating payers.

Current Directors

Directors that oversee our procedures and perform complex TAs include:

• Gabriel A. Bien-Willner, MD, PhD, FCAP
  • Director, MolDX program
  • Board Certifications:
    • Molecular Genetic Pathology
    • Anatomic Pathology
  • PhD in Human Molecular Genetics and Genomics
• Megan Landsverk, PhD, ABMGG
  • Board Certification in Molecular Genetics and Genomics
  • PhD in Biochemistry
• Angella Charnot-Katsikas, MD
  • Board Certifications:
    • Medical Microbiology
    • Molecular Genetic Pathology
    • Clinical Pathology
• Magdalena Jurkiewicz, MD, PhD, MPH
  • Board Certifications:
    • Clinical Pathology
    • Molecular Genetic Pathology
  • PhD in Genetics
  • MPH in Chronic Disease Epidemiology