“It was critical for us, because otherwise we would have had to go through a multiyear process for FDA approval, stop everything, and run another clinical trial geared toward Medicare patients to get the evidence for Medicare coverage,” said Kevin Conroy, CEO of Madison, Wis.-based Exact Sciences Corp, which makes the test. “That could have added three to four years to the process. We're a small company—we can't afford that.”
The largest integrated health systems such as Kaiser Permanente and the Veterans Health Administration also have provided a path for devicemakers to generate faster payment acceptance. They have physician expertise and their own technology-assessment staffs, and new product approvals can lead to significant sales because of their size.
But devicemakers continue to complain about the broader insurance industry, claiming they're not getting adequate guidance. How much clinical trial evidence is enough? How large should the trials be? Many payers want longer studies on more patients.
“There are no rules, no guidelines from any of the insurance companies to say if you have this (result), this meets the checkbox,” said Jeffrey Dunn, CEO of SI-BONE, maker of iFuse, a titanium implant for treatment of lower back pain. “It's a very unclear system that we, as inventors and company builders trying to help these patients, have to work with.”
At least one effort is underway to offer providers more transparency into what payers are looking for in trial data. The Payer Communication Task Force includes the FDA-CMS parallel review along with a group of private payers and technology assessment organizations that have offered to give devicemakers input on clinical trial design and evidence before their FDA-focused trial begins. The group includes the Blue Cross and Blue Shield Association, Duke University's Evidence Synthesis Group, ECRI Institute, Humana, Kaiser Permanente, the National Institute for Health and Care Excellence and Intermountain Healthcare's SelectHealth.
“Use that contact to help design trials and what you intend to publish, because there often are parameters that we for sure—and probably other plans and technology assessment institutions—would like to see included in trials,” said Naomi Aronson, the BCBSA's executive director of clinical evaluation.
Working with large, integrated health systems can be the quickest path to wider acceptance. ReWalk won a major victory recently when the VA fully covered its exoskeleton for take-home use.
Unlike private payers and providers, the VA doesn't have to wait for CMS coverage codes before it will pay for a device. It has its own staff of researchers and subject experts for making coverage decisions.
“We don't have to have debates on whether something is going to be covered or not by someone's insurance” because the VA directly purchases devices for veterans, said Dr. Barry Goldstein, acting executive director of the VA's office for spinal cord injury and disorders. “We feel that our mission in this particular office is to restore as much function and quality of life as possible in a person's life.”