Genomics come to HIE

McKesson, Texas offer different twists on molecular test exchange
By Mike Miliard
12:00 AM

By now, the term health information exchange has evolved to the point where it has a wide array of meanings. The fact that more varieties of health data are being shared across more platforms with more people is a good thing, from anyone's perspective.

As medical and scientific knowledge increases, so are the types of exchanges. With genomics opening up a whole new galaxy of complex and detailed data, the details get even intriguing.

Although it's been around since 2011, McKesson's Diagnostics Exchange is billed by McKesson officials as "the healthcare exchange you haven't heard of." It's an online registry of genetic tests that tracks and labels them so physicians, laboratories and payers can get information about them and judge their merit.

In addition to serving payers and providers, the exchange is beneficial to test developers themselves, enabling their tests to have wider visibility and offering the chance have evidence collected on their accuracy, according to McKesson.

In the wake of the Human Genome Project, genetic testing has increased exponentially. There were more than 11,000 tests for 3,400 conditions in the NIH's Genetic Test Registry as of late 2013, with new ones cropping up constantly. Frost & Sullivan has called molecular diagnostics the fastest piece of clinical pathology labs; a 2012 report said the industry's revenues would exceed $6.2 billion by this year.

That makes the need for an organized clearinghouse to keep track of it all that much more critical, say McKesson officials. Ultimately, it's hoped that by directing clinicians to the correct and most accurate tests, it will make for a 30 percent reduction in wasteful spending on molecular diagnostics annually.

Critical to the exchange is the McKesson-developed Z-Code Identifier, a 5-character tag that's assigned to each test as it's cataloged for reference and review.
Prior to this exchange, genetic tests "did not have a unique identifier in any location in our industry," explains Doug Moeller, MD, medical director at McKesson Health Solutions.

"The conventional codes for lab tests" – American Medical Association's Current Procedural Terminology codes and ("to some extent, much less so") Centers for Medicare & Medicaid Services' Healthcare Common Procedure Coding System (HCPCS) process – "basically were not specific enough," he said.

"They specified general results but not specific tests with a unique tracking identifier," said Moeller. "We wanted to create a catalog so providers, health plans and even laboratories could identify what tests were available, anywhere in the United States, in an online catalog."

The relationship between CPT and Z-Codes has been a complicated one. In 2011, Medicare contractor Palmetto GBA, looking to learn more about the molecular diagnostics reimbursed by CMS, announced plans to use the McKesson Diagnostics Exchange module to gather data about the tests.

Labs were required to submit Z-Code with each test to enable Palmetto to track utilization. AMA objected, concerned that using McKesson's codes would eventually undermine the use of CPT codes, and even lodged a complaint with CMS.

Just over a year later, in February 2013, the AMA entered into a licensing relationship with McKesson under which Z-Code identifiers will be grouped and indexed with corresponding CPT codes, working together to create a comprehensive reference for tracking MDx tests.

“The McKesson Diagnostics Exchange provides an infrastructure that will support the AMA’s efforts to advance personalized medicine, promote access to innovative diagnostic capabilities and improve patient outcomes,” said AMA's CEO James L. Madara, MD, in a press statement.

Moeller likens the exchange to "an electronic marketplace – not unlike Amazon or Travelocity," that lets providers pick and choose the right test for them.
"We take that information, match it to the catalog selections, and you can look up who the manufacturer is and so forth," he says. "It makes the data more transparent, so the physician ordering the test knows what they need."

The results, so far, have been encouraging, from a cost perspective. Palmetto has been live on the exchange for nearly two years, and "they have seen a significant reduction in test orders for non-covered services – to the tune of about $5 million per month change from pre-system to post-system," says Moeller.

Genomics are making an impact on other, more traditional HIEs as well. Greater Houston Healthconnect, a 20-county exchange in Texas, announced in January that it would be one of the first HIEs in the country to sign-on a pharmacogenomics lab, Companion Dx, for dissemination of genetic tests. Unlike normal labs, which only offer a snapshot of data, officials point out, genomic profiles make for lifelong record that could help inform decisions indefinitely.

"According to the CDC, chronic disease accounts for nearly 70 percent of the deaths in the United States," said Osama Mikhail, a Healthconnect board member, in a press statement. "Many of those illnesses are related to a genetic predisposition. With genomic testing certain chronic diseases may be identified more readily and healthy lifestyle choices could be encouraged that would help to mitigate the course of a disease even before its onset.”

Genomic testing and health information exchange are both very new paradigms of care. As they work in tandem, the future looks promising.

Speaking of the knowledge to be gleaned from the McKesson exchange, Moeller says there's "tremendous interest" in using the knowledge it enables for more effective approaches to "episode of care, medical management requirements, and starting to look at the latest wave of technology: panel tests which use next-generation sequencing and even, down the road, exome or whole genome sequencing."

The hope, of course, is that the more wisdom that can be gleaned in these envelope-pushing areas, the wider it can be disseminated for care improvement.