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Meditech, FDB Integration Aims to Bring Genomic Clinical Decision Support to Point of Care

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CHICAGO – Electronic health records vendor Meditech recently introduced Expanse Genomics, an add-on to its core EHR platform that is designed to deliver actionable intelligence based on patient-specific genetic tests to clinicians within the standard clinical workflow.

While Westwood, Massachusetts-based Meditech is not the first EHR vendor to incorporate genomics into clinical decision support processes — Epic Systems introduced a genomics module in 2019 and Allscripts Healthcare Solutions launched its 2bPrecise precision medicine subsidiary several years earlier, for example — Meditech is going a step further.

The vendor not only is combining pharmacogenomics and disease predisposition information at the point of care — derived from discrete data rather than noncomputable PDF files — but also is the first EHR developer to incorporate First Databank's pharmacogenomic content for clinical decision support.

Hoda Sayed-Friel, executive VP of Meditech, said that FDB is not doing anything proprietary with Meditech. In fact, the content developer will take the genomics development work from this Meditech collaboration and make it available to other vendors.

"They did it the way we kind of wanted it to work, so we got first dibs on how it should work. I appreciate that they kind of hung in there for the long haul as we kind of put the pieces together," Sayed-Friel said.

To achieve this integration, FDB, a South San Francisco, California-based developer of drug and medical device databases, built an extension of its application programming interface to send drug-gene pharmacogenomic guidance directly to clinicians when they order prescriptions through the EHR. "From an end-user perspective, this is simply an extension of medication decision support" such as the drug-drug interaction or drug-disease contraindication checking that FDB has historically supplied, according to George Robinson, senior project manager at FDB.

Robinson, a pharmacist by training, said that FDB and Meditech have been working together on clinical decision support for more than 25 years.

Meditech has supported pharmacogenomics in its core EHR since 2017, but not always with clinical decision support, and, until now, had not been able to include genetic disease proclivity in clinician workflows. The firm had convinced FDB several years ago to add drug-gene interaction checking to its engine that powers clinical decision support for Meditech and other EHR vendors.

Robinson said that FDB and Meditech have been wanting for several years to include pharmacogenomic decision support in clinical workflows, but there was an issue related to variant terminology sent from genetic testing labs that has been addressed in Expanse Genomics. He said that FDB clinical decision support now helps EHRs "normalize" output from labs.

"I think we've solved what we thought was the biggest impediment to deploying in the workflow, the terminology issue and the idea that a health system wouldn't be tied to one reference lab as part of the solution," Robinson said. "It gives the flexibility [to] community hospitals to use whatever reference lab they would like."

The integration also automates the processing of genetic test results by pulling in computable data to power the clinical decision support.

Sayed-Friel noted that traditional laboratory companies have been exchanging orders and results with clinicians by snail mail, telephone, fax, and noncomputable PDF files for a century but are now looking to modernize. "They haven't worked with EHRs to exchange data in an interface-like way," she said.

Products like Expanse Genomics bridge the divide between EHR vendors, which long have had all kinds of phenotypic data, and genetic testing companies — including direct-to-consumer firms like 23andMe and Ancestry — that have not been able to pull in clinical records on patients, according to Sayed-Friel.

For the last several years, EHR vendors and providers of laboratory information systems alike have relied on the Common Clinical Data Set, a minimum group of data elements that the US Department of Health and Human Services used to certify EHR products for Medicare and Medicaid incentives under the "meaningful use" federal incentive program last decade.

But Sayed-Friel said that this minimum dataset, developed when genetic sequencing was still uncommon, has not been particularly helpful for pharmacogenomics or even all that great for any form of clinical decision support because meaningful use emphasized technical functionality over usability. "I see a little bit of a race as to who's going to have the most data about a patient locally for use," Sayed-Friel said of releases like Expanse Genomics.

According to Robinson, the time is right to bring pharmacogenomics into community hospitals and primary care for several reasons. 

He said that the falling cost of genomic testing as well as the increased prevalence of value-based reimbursement offer incentives for health systems to invest in technology like Expanse Genomics to help improve patient outcomes. "Consumers may increasingly be aware of genomic variants that may impact the safety or efficacy of medications and may prefer to be cared for by healthcare providers that use pharmacogenomic decision support services," Robinson added.

Sayed-Friel said that technology like Expanse Genomics can help doctors address issues such as opioid addiction.

"You do a simple genetic test on how well they can actually metabolize codeines and hydrocodones and [oxycodones], then you can actually say whether they're going to be an ultrametabolizer," she explained. Someone who is an ultrametabolizer of narcotics might only get short periods of pain relief and crave more doses, which could turn them into drug seekers and addicts.

Similarly, those who are poor metabolizers might not be good candidates for opioids because the drugs will be ineffective.

Genomically informed clinical decision support also could save payors millions of dollars per year on unnecessary procedures like angioplasty and stent implantation in patients who do not actually need it, according to Sayed-Friel.

"Medicare is spending all of this money on therapies that actually aren't going to work," Sayed-Friel said, for example. "They could save a lot of money if they just did some genetic testing."

Sayed-Friel said that Meditech wants to avoid overwhelming clinicians with all the data from full genetic tests such as whole-exome or low-pass whole-genome sequencing by delivering only the parts relevant to each patient's current situation.

"We want to say, 'I'm treating this patient to get a stent. Give me the CYP2C19 [because] I'm looking for a particular marker at a particular time," Sayed-Friel said. "There's no way that we can take a terabyte of every person's genetic mapping into our EHR. It's just untenable. But we need to know where it is and be able to request it."

Jennifer Ford, product manager for laboratory information systems and genomics at Meditech, said that patient engagement is part of the future vision for Expanse Genomics. She noted that patients tend to be very engaged with consumer genetics, since they are the ones who initiate the testing in the first place.

An early goal for Meditech in this arena is to bring clinical genetics to physicians "so that they're armed with the resources when a patient brings to them a medication they hear about on TV or some information that they got from a commercial laboratory," Ford said. "They'll be able to back it up with their knowledge from within the system."

She also said that the vendor expects to make the clinical decision support available to patients in a future update of Expanse Genomics, with the blessing of their physicians.

"A simple mutation could be life-changing to a patient's direction," Ford noted.

Sayed-Friel said that Meditech and its partners have to tread carefully for the purpose of patient-physician encounters when moving beyond pharmacogenomics.

The pharmacogenomic side is "just a regular lab test," according to Sayed-Friel. "Once we move into the predisposition of disease, we have to think carefully about how to share, when to share, and who to share with," she said.

According to Sayed-Friel, there are no real ethical issues for companies like Meditech and FDB around sharing pharmacogenomic information with patients, in part because clinical decision support is not regulated like a medical device in the US. "But when we get to predisposition of disease and some of the more complicated somatic-related items, that actually needs to be a discussion with a physician," she said.

She said that it would be irresponsible to say in a patient portal that an individual has a gene marker for Huntington's disease, for example, which could lead the patient onto the internet and into severe depression.

Marsha Fearing, a physician specialist at Meditech, noted that a mutation may not be pathologic now, but could trigger a disease later on. She said that vendor is grappling with how to process this kind of information without alarming people.

"What happens when that diagnosis is made when a patient is a minor?" Fearing added.

For now, Expanse Genomics is still technically in the testing phase among early adopters, including Golden Valley Memorial Healthcare in rural Clinton, Missouri. Sayed-Friel said that Meditech hopes to have it generally available to all its users by the fall, but, as always, it will be up to customers whether and how to make the upgrade.

She said that hundreds of Meditech hospitals are using clinical decision support for pharmacogenomics.

Fearing said that Meditech put out a "call to action" to its customers a few weeks ago to educate them about Expanse Genomics and let them know when it will be available.

Major competitor Epic released its own genomics module a year and a half ago, but many of that firm's customers have not migrated to that upgrade because it can cause disruption to workflows.

Meditech's customer mix is slightly different, including independent hospitals and community healthcare organizations of all sizes, whereas Epic tends to cater to some of the largest academic and integrated health systems.

Ford said that Meditech is ready when its customers and ancillary providers are. "We have the flexibility. We have the infrastructure. We have everything in place," she said.

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