Zubiller cropped Musacchio cropped
Matthew   Zubiller Robert Musacchio, PhD


   The American Medical Association (AMA), Chicago, and McKesson Health Solutions, Newton, Mass, recently announced they are joining forces to help labs identify and track molecular diagnostic (MDx) tests.
With more than 3,000 molecular and genetic diagnostics in use, and next-generation and whole genome sequencing poised to swell that number and add to the complexity of testing, this joint effort aims to get a handle on the sea of data about how all of this testing impacts labs and bottom-line health care costs—and ultimately, to help patients get optimal care and control the cost of providing it to them.

       McKesson Z-Code™ Identifiers will be categorized and indexed with corresponding molecular pathology codes in the AMA’s Current Procedural Terminology (CPT®) code set.
       The McKesson Diagnostics Exchange™—a cloud-based solution where labs/test makers input information about MDx tests and health care providers/insurance companies extract information about tests—provides unique Z-Code identifiers for every test, which can be easily accessed by all parties.
        Not all Z-Code Identifiers will immediately map to a CPT code, and, in many cases, multiple Z-Code Identifiers will map to a single CPT code.
       The new product, the fruit of the labors of McKesson and the AMA, will be available for licensing from the AMA early in 2014. CLP spoke with Matthew Zubiller, vice president of decision management at McKesson Health Solutions, and the Robert Musacchio, PhD, senior vice president of business products and services, AMA, to learn more.

What are McKesson Z-Code Identifiers
       Clinicians, hospitals, labs, and health plans have become accustomed to the nomenclature for tests and treatments. But in the world of molecular and genetic testing, there simply hasn’t been a method of keeping up. Most of the molecular diagnostic and genetic tests on the market are unidentifiable through today’s methods. This presents a significant challenge for the future of personalized medicine. To address this challenge, the Z-Code Identification system was created. The Z-Code process assigns a unique 5-character, alphanumeric identity to every test submitted to the online registry, acting as a unique tracking identifier. The Z-Code Identifier can then be used by health plans, clinicians, labs, and hospitals to ensure all parties involved clearly understand which test is being performed. All assigned Z-Code Identifiers will be housed online in the McKesson Diagnostics Exchange™ Test Catalog. The Z-Code Identifier assigned by this mechanism serves ONLY as a unique identifier in the McKesson Diagnostics Exchange Test Catalog and does not imply that a particular test does or does not have additional value, or valid usefulness in the billing or claims process.
—SOURCE: McKesson website


CLP: What checks and balances are used to ensure impartial assignment of Z-Code Identifiers to CPT?
Zubiller: Laboratories have the option to participate in the Z-Code Identifier to CPT map process by submitting their tests to get Z-Code Identifiers and by opting-in to have their tests mapped. The application processes for applying for a Z-Code Identifier and CPT code are separate and unrelated. Laboratories are assigned a Z-Code Identifier through the McKesson Diagnostics Exchange, which is an open, online test registry and marketplace for information and evidence for molecular diagnostic tests.

Musacchio: The AMA will rely on the clinical expertise of authorities in the field to determine appropriate mapping for the CPT codes and Z-Code Identifiers. The AMA recognizes the importance of transparency and will work to accommodate an open process whereby stakeholders can provide input to the new reference map product.

CLP: What safeguards are in place to allow independent lab assignment of the CPT codes when a lab disagrees with the automatic assigned Z-Code cross-referenced to a specific CPT code?
Mapping the CPT code set with Z-Code Identifiers will not be an automatic process. The AMA envisions a careful process whereby stakeholders, including labs, will have the opportunity to provide input into the reference map prior to publication. 

CLP: How will this not be used by payers as an exclusionary mechanism?
This coordinated effort between the AMA and McKesson brings specificity to the use, identification, reporting, and tracking of tests within systems that will improve communication and collaboration between clinicians, hospitals, laboratories, and payers.

Musacchio: Our aim is to respond to stakeholder requests from many labs, payers, and provider organizations for a tool that would uniquely identify the tests available on the market. Payers who determine coverage and reimbursement policies based on an added capability to identify, track, and analyze each test are ultimately responsible for aligning their decisions with market demands and the clinical judgment of physicians.

CLP: Is the reimbursement that CMS is setting on the various codes something that the new system will automatically identify, and when and how will that be loaded in and updated, especially when reimbursement will vary dramatically across the United States, depending on the Medicare jurisdiction?
The mapping process brings specificity to identification of unique molecular diagnostic tests but it does not provide reimbursement information. Reimbursement information is left to the individual payers and other stakeholders who are responsible for reimbursement systems.

CLP: Is there anything else you would like to share?
Zubiller: Connecting Z-Code Identifiers with CPT codes enables all stakeholders in the health care system to better understand what tests have been used—when, in what quantity, and to what effect, in order to enable smarter clinical and financial decision-making regarding test selection, coverage, and payment.

Musacchio: Providing the health care system with the added capability to identify, report, and track specific tests will support the goal of reducing disease burdens and improving health outcomes while enabling innovation and broader adoption of personalized medicine.

Ronald A. Blum, PhD, and Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, contributed to this article. For more information, contact Editor Judy O’Rourke, [email protected]