Why legal challenges could slow down precision medicine
BOSTON -- While researchers and providers continue to make strides to make precision medicine more of the norm, obvious barriers like government regulations are hindering widespread implementation.
But providers also need to be aware of the legal entanglements, once they begin to incorporate genetics and precision medicine into operations.
To Sharon Zehe, attorney for Mayo Clinic Department of Laboratory Medicine and Pathology, there are four major legal challenges to precision medicine: Navigating research and privacy protections on gathered data; providing affordable testing for patients without breaking fraud and abuse laws; responsibly using results as the data evolves; and discrimination
“The issue that I see for the most part is discrimination,” Zehe said at the HIMSS Precision Medicine Summit on Monday. “People are refusing genetic testing and research, as they’re concerned about discrimination.”
While the Genetic Information Nondiscrimination Act became law in 2008, which prohibits discrimination in health insurance, it doesn’t cover life insurance, disability insurance or long-term care insurance, said Zehe. And patients are worried about results of these tests because of these purposes.
“And no, genetic data can’t be kept out of the medical record,” said Zehe.
“Providers are in an awkward position,” she added. While the FDA is making strides on better educating providers on what’s expected when it comes to testing, there is still a long way to go.
The FDA published draft guidance for NGS testing in July 2016 and is in the process of creating a workable regulatory platform to encourage innovation, while ensuring accuracy.
“Genetic data is PHI, but the genetic sequence is not considered PHI,” said Zehe. But the minute the sequence is interpreted it becomes PHI. There’s a delicate balance between sharing sequencing data and related data, while protecting identity of participants or patients.”
Another issue involves who pays for testing, as there are many ways providers and labs can find themselves in legal trouble.
For example, Zehe said, “We’re seeing pharma companies teaming with labs to offer free testing for patients. Pharma companies say ‘I will pay for all tests. Providers can order tests and don’t need to worry about reimbursement, as a test sent to that lab would be paid by the pharma company.”
“While it appears the pharma company is doing that to be altruistic, they’re doing it for the data,” sahe continued.
Labs are also running tests in exchange for data. Entering into that type of collaborating involves the lab sharing a lot of data -- but all of that data sharing must be HIPAA-compliant, said Zehe. “Do your patients know the data is being given to pharma?”
Health plans also often lack coverage and may require preauthorization.
“Providers may want to use a lab with limited charges to patients,” Zehe said. But there are several lawsuits from payers on these fee forgiveness programs to patients, who never receive a bill.
“While financial assistance is ok, a lab can’t come in and say a patient doesn’t have to pay, as it breaches the insurance contract -- tortious interference,” she continued.