Genetic testing raises difficult questions for payers


A new database helps payers understand which genetic tests are available, which genes they test for, and which tests would be appropriate to use to inform patient management.

Precision medicine is about finding the treatments that work best in an individual patient, often that means understanding a patient’s genetic profile with regard to the disease or condition being treated.

In cancer, for example, depending on the type and stage of cancer, certain genetic characteristics may mean one treatment will work better than others for an individual. 


“Navigating the complex universe of genetic tests is a challenge for payers and providers,” says Vivian Coates, vice president, information services and health technology assessment, ECRI Institute, a nonprofit health services research organization. “With so many ways to go astray, public and private payers were asking ECRI Institute how to determine which tests matter and which don’t, and which ones could lead to patient harm or increased costs.”

That’s why ECRI Institute created ECRIgene, a genetic test resource meant to helps payers and providers understand which genetic tests are available, which genes they test for, and which tests would be appropriate to use to inform patient management.

The database has been populated through a proprietary approach developed by ECRI that culls from the 60,000 or more genetic tests on the market a subset of the most clinically relevant, complex, and controversial. ECRI's multidisciplinary research team assesses which tests to include in the database. While many of the genetic tests are for cancers, there are other conditions included in the database: hypertrophic cardiomyopathy, cystic fibrosis, folate deficiency, anxiety disorder, miscarriage and pregnancy, Crohn’s disease, stroke, and myocardial infarction.

“As the number of available tests has rapidly doubled and quadrupled-both single gene and multigene panels-payers are struggling to keep up with all of the complexities,” Coates says. “It’s been hard for payer organizations to keep track of all of the tests and be able to compare them in terms of evidence base and scope. Our goal … is to not pass judgment on the individual tests, but to dive into the available evidence and answer questions related to clinical practice, regulation, and reimbursement.”

Each entry in the database includes the test’s description and purpose, genes in each test or multigene panel, and CPT code.

A stakeholder roundtable meeting convened by ECRI Institute with chief medical officers and healthcare executives in 2014 uncovered a number of dilemmas that third-party payers encounter while trying to get a handle on genetic testing, according to Coates.

“A common refrain we heard was, ‘We don’t know what we’re paying for,’” she says. “The addition of more CPT codes for tests has helped, but discerning from claims forms about potential patient harms that can arise from tests that offer unclear clinical value can lead to more testing or invasive procedures that may not benefit patients.”

Clinicians have dilemmas as well. For example, according to Coates, in daily care, they are tasked with figuring out which tests to order and when it’s appropriate to order.

“Even sophisticated, world-renowned health systems and their clinical laboratories wring their hands over genetic test utilization and management,” she says.


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