Through collaboration we are working to bring clarity to molecular diagnostic testing
At the beginning of the McKesson initiative, there was no national registry of commercially available tests; no resource to assist physicians with which molecular diagnostics (MDx) tests to order for their patients; no central repository for evidence supporting appropriate testing. There was no way to consistently and uniquely identify tests in lab and financial systems across all healthcare providers and payers. And so, in 2007, McKesson created a solution to these challenges – the McKesson Z-Code™ Identifier. These identifiers are a system of tracking codes, one code for each unique test, patterned after HCPCS codes. Each Z-Code Identifier begins with the letter ‘Z’ followed by 4 alphanumeric characters – a roster of more than 1.3 million possible identifiers. McKesson introduced the concept of unique identification and use of the identifiers with industry leaders and ignited a dialogue that continues today.
The McKesson Diagnostics Exchange™ (DEX) is created
McKesson believed there was a gap in its solution suite for MDx management and a vehicle for the continued assignment of Z-Code Identifiers was the missing link. McKesson created the McKesson Diagnostics Exchange as a national online catalog for all molecular diagnostics tests accompanied by this new unique identifier, the Z-Code Identifier, to be used from order to claim.
Pilot with Palmetto GBA
The solution was piloted with Palmetto GBA, a Medicare Administrative Contractor which administers the CMS MolDX program. Since the Palmetto GBA pilot began in 2011, it has been extended to additional states and another CMS administrator. As the pilot progressed, it was clear that a structured process for reviewing new tests coming to market was needed to address coverage policy gaps. This was the driving force for the development of the Test Assessment module within the McKesson Diagnostics Exchange. The Test Assessment module is now the communication vehicle payers and laboratories use for the test specifics including methodology, molecular components and supporting evidence for the purpose and best utility for the test. With the Test Assessment module, both parties participate in a structured workflow designed for the specific payer’s requirements.
Momentum for the McKesson Diagnostics Exchange continues to grow and the first commercial payer organization began using the product in 2014 along with additional labs including two of the largest lab chains in the country. New challenges are always emerging in the advanced and molecular diagnostic test industry especially with the introduction of new methodologies like next generation sequencing test panels. McKesson remains at the forefront of these discussions and the McKesson Z-Code Identifier is increasingly becoming the accepted industry standard for unique test identification.
Using the McKesson Z-Code Identifier to uniquely identify MDx tests could have additional benefits that add value to our healthcare system such as:
- Clinical Research Trials and Comparative Effectiveness Studies. By assigning a unique identifier to MDx tests earlier in the process, research used to establish clinical efficacy could cite the specific diagnostic. This would help minimize confusion with any comparable laboratory service.
- Experimental Research Protocols. Experimental research protocols utilizing a specific MDx test could cite the unique McKesson Z-Code Identifier during the research phase, prior to the full evaluation and review of the test. This could promote the rapid development and adoption of companion diagnostic services.
- Medical Documentation. Referencing the specific MDx tests by including the McKesson Z-Code Identifiers within medical documents or medical records would significantly help improve the usefulness of the test information in that clinical scenario.
Throughout our history and as we look forward to future developments, McKesson remains committed to bringing greater clarity to MDx testing to support patient and business health.