As the use of molecular diagnostics increases — amid the race to $1,000-or-less personal genomic sequencing — McKesson and the American Medical Association (AMA) have entered into a licensing partnership to create a registry of the growing list of genomic, metabolomic, proteomic and other molecular tests.
McKesson’s Z-Code identifiers will be indexed with the AMA’s current procedural terminology code set to create a reference guide for molecular diagnostics. The two organizations say the organized library of molecular diagnostics will help payers, physicians and hospitals better consider how to provide and cover molecular diagnostic services.
More than 3,000 metabolomic, genomic and other molecular diagnostic tests are currently marketed for clinical uses, according to Frost & Sullivan. The field is the fastest growing pathology testing sector, with revenues expected to reach $6.2 billion next year.
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Over the past decade, medicine has been gradually incorporating more personalized treatments based on molecular assays of patients and their diseases, especially for cancer. Memorial Sloan-Kettering Cancer Center in New York, for instance, sequences the genomes of all colon and lung cancers and is developing treatment regimens for a variety of cancers based on a growing library of cancer subtypes and genetic mutations and patients’ own genomic characteristics.
With molecular diagnostics evolving so quickly, McKesson Health Solutions President Emad Rizk, MD, said in a media release, “Greater clarity will bring healthcare stakeholders one step closer to the collaboration needed to assess these tests and make the most informed test selection, coverage and payment decisions.”
A McKesson-sponsored white paper outlined a few scenarios showing how providers, patients and payers might benefit from a molecular diagnostics registry, to help ease physician and patient confusions and reimbursement issues for payers.
Patients with coronary artery disease taking the antiplatelet drug clopidogrel (sold under the trade name Plavix) on a long-term basis might wonder whether they should consider genetic testing, for instance. The Food and Drug Administration (FDA) ordered a black box warning for clopidogrel in 2010, after findings that one-third of patients weren’t effectively metabolizing the drug and faced increased risk of rare blood clots around coronary stents.
Currently, several genetic and liver metabolism tests can determine a patient’s metabolic response to clopidogrel, and doctors can switch patients to aspirin as an anticoagulant. But some health plans may only cover the cost of clopidogrel-specific genetic testing and not liver metabolism tests, according to the white paper. With a registry of available molecular assays, payers and providers could determine if both or either of the tests are warranted, and could sort diagnostic reimbursement policies ahead of time for clopidogrel and hundreds of other drugs and conditions.
The diagnostic reference library will work with McKesson’s Diagnostics Exchange, a software-as-a-service catalog that labs and manufacturers can use to share information on new advances and that payers and providers can use for evaluation of tests. The new product will be licensed by the AMA, available early next year.
So far, about 100 codes have been developed for reporting innovative diagnostic services, and McKesson and the AMA are also sharing terminology with the National Institutes of Health’s Genetic Testing Registry.