1. Program Overview

To identify molecular diagnostic tests, determine coverage, and determine reimbursement on behalf of the Medicare program.

MolDX uses the DEX Registry as a critical business process. The DEX Registry is used to track accurate information about molecular diagnostic tests and allow for the application of appropriate payer controls in claim adjudication.

The Z-Code is a unique identifier that clearly identifies the test being performed on a claim, allowing the payer to know exactly what service was rendered. Providing the Z-Code on a claim, with the appropriate Recommended CPT® Code, may reduce the administrative burden labs may encounter surrounding billing for these services as it provides a means for the payer to automate adjudication or pre-authorization of claims. The Z-Code allows the payer to reproducibly and reliably assess medical necessity based on registered test information (such as intended use, methodology, and performance).

Once the required information is received and a DEX Z-Code® identifier is assigned, coverage and reimbursement will be assigned to the Z-Code. This simplifies the claim submission process and ensures consistent and accurate adjudication of claims.

All private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare in JE, JF, JJ, JM, J15, J5 or J8 on forms CMS 1500 (Part B), UB04 (Part A) or electronic claims on a 5010-837P (Part B) or 837I (Part A) are affected by this program. (Please reference the specific jurisdiction MDT policy for effective dates.)

• JM A/B (N.C., S.C., Va., W.Va.) and JJ A/B (Tenn., Ga., Ala.) administered by Palmetto GBA
• JE A/B (American Samoa, Calif., Guam, Hawaii, Nev., North Marina Islands) and JF A/B (Alaska, Ariz., Idaho, Mont., N.D., Ore., S.D., Utah, Wash., Wyo.) administered by Noridian Healthcare Solutions.
• J5 A/B (Iowa, Mo., Kan., Neb.) and J8 A/B (Mich., Ind.) administered by WPS Government Health Administrators.
• J15 A/B (Ky., Ohio) administered by CGS Administrators, LLC.

The roll out of JJ by Palmetto GBA began in early 2018. Labs that perform services for patients in those states were notified to begin DEX Z-Code registration. Claims submitted after June 1, 2018, must have a Z-Code.

The scope of the MolDX Program is outlined in LCD MolDX: Molecular Diagnostic Tests (MDT) (L35025), and associated Billing and Coding articles: Billing and Coding Article MolDX: Molecular Diagnostic Tests (MDT) (A56853) and Billing and Coding: MolDX: Proteomics Testing (A59636).

For questions about specific tests/assays not described above, please Contact Us.

Yes. Effective March 1, 2017, hospitals must add the DEX Z-Code in block 80 of the UB04 claim form or on line SV202-7 of the 837I electronic claim.

Providers submitting institutional claims are required to submit claims with DEX Z-Codes. Physicians submitting professional claims (-PC or -26) are not required to use DEX Z-Codes.

Gabriel Alejandro Bien-Willner, MD, PhD, is the Medical Director of the MolDX program at Palmetto GBA, which seeks to understand the molecular testing landscape to implement payer controls and coverage, and to set policy. He is a leader in the Precision Medicine space and practices as a board-certified Anatomic Pathologist and Molecular Genetic Pathologist. Dr. Bien-Willner received his MD and PhD from Baylor College of Medicine, with a doctorate in Human Molecular Genetics. His clinical training and academic tenure were at Washington University in St. Louis. Throughout his career, he has been active in research, development and advancement of molecular diagnostic services, specifically next-generation sequencing. His experience spans both academia and industry. He has worked closely with clinicians to develop clear clinical diagnostic and treatment pathways directing Precision Medicine programs for community cancer centers.

Angella Charnot-Katsikas, MD, FCAP, is a Medical Director for the MolDX program at Palmetto GBA. She is a board-certified Clinical Pathologist, Medical Microbiologist, and Molecular Genetic Pathologist with additional fellowship training in Clinical Medical Ethics. Dr. Charnot-Katsikas received her MD degree from Rush Medical College in Chicago, and then completed her residency and fellowship training at the University of Chicago, where she later served as an Associate Professor of Pathology. She has served as the Medical Director of multiple hospital and community-based laboratories and has led numerous research, education, quality, and diagnostic stewardship initiatives throughout her career.

Magdalena Jurkiewicz, MD, PhD, MPH, is a Medical Director for the MolDX program at Palmetto GBA. She is a board-certified Clinical and Molecular Genetic Pathologist. Dr. Jurkiewicz received her MD and PhD degree in Genetics from SUNY Stony Brook following completion of the Medical Scientist Training Program. She also holds an MPH from the Yale School of Public Health and completed her residency and fellowship training at New York-Presbyterian Hospital/Columbia University in New York City. She has authored numerous research articles in the field of human genetics and molecular diagnostics and has clinical industry experience as a laboratory director of oncology and molecular pathologist.

Megan Landsverk, PhD, MB(ASCP)^CM, FACMG, is a Director for the MolDX program at Palmetto GBA. She is a board-certified Molecular Geneticist. Dr. Landsverk received her PhD in Biochemistry and Molecular Biology from Baylor College of Medicine, received postdoctoral training in Medical Genetics at the University of Washington and completed her molecular genetics fellowship training at Baylor College of Medicine. She has served as a laboratory director in several clinical genetics laboratories, has held multiple academic faculty positions and has numerous publications in the field of genetics.

Jacqueline Lekostaj, MD, PhD, is a Medical Director for the MolDX program at Palmetto GBA. She is a board-certified Anatomic and Clinical Pathologist and Molecular Genetic Pathologist. Dr. Lekostaj received her MD and PhD in Tumor Biology from Georgetown University. She completed her residency at Northwestern Memorial Hospital in Chicago and fellowship training at the University of Iowa Hospitals and Clinics in Iowa City. She has experience in clinical industry as a molecular pathologist and laboratory director, specializing in molecular oncology.