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Ineffective medical devices can trigger significant increases in the cost of a workers compensation claim, but insurers have no recourse but to pay for the devices in most instances, experts say.
Spinal cord stimulators are some of the most problematic implants, according to various insurers, with a recent study showing a high removal rate of the pain relief devices. More information on the devices should be shared with health care providers, patients and others to resolve the problem, experts say.
Spinal cord stimulators are implanted and deliver low-voltage electrical current to the spinal cord to block pain, according to the American Association of Neurological Surgeons in Rolling Meadows, Illinois, which estimates that about 50,000 spinal cord stimulators are implanted worldwide each year. Since 2005, the devices have been recalled at least 20 times, according to a search of the U.S. Food and Drug Administration’s recall database.
“Spinal cord stimulators are a problem for all of us when they fail,” said Julie Fortune, chief claims officer for Charlotte, North Carolina-based insurer Arrowpoint Capital Corp.
“They can balloon the cost and add to the length of a claim.”
One of the biggest challenges with the devices is that there is no objective way to know if a spinal cord stimulator works, said Dr. Teresa Bartlett, senior medical director at Memphis, Tennessee-based Sedgwick Claims Management Services Inc. Whereas a physician can tell whether a heart defibrillator is working based on a patient’s heartbeat, a patient self-reports whether a spinal cord stimulator has effectively reduced his or her pain. And despite the issues, if it’s deemed reasonable and necessary, the comp insurer must pay for it.
“There are doctors who specialize in (spinal cord stimulators) and will convince patients that it will help them, but we don’t see a lot of success with them at all,” she said. “It’s frustrating — I wish the rest of the states would go by the way of Washington.”
In Washington state, the Division of Labor and Industries will not pay for spinal cord stimulators in workers compensation for any reason. Likewise, the state will not pay for intrathecal pumps, which use a catheter to deliver medications near the spinal cord, or lumbar fusion surgeries if degenerative disk disease is present, said Gary Franklin, the division’s medical director and a research professor at the University of Washington in Seattle, who says his research revealed that the average cost of a spinal cord stimulator over five years is more than $100,000.
Washington state, which has a monopolistic workers comp program, passed legislation in 2006 to create its Health Technology Assessment program, which reviews the efficacy, safety and cost effectiveness of medical devices, and followed that up with legislation in 2012 requiring that state covered health care insurers — which includes workers comp — can only pay for medical devices determined to be safe and effective under the HTA program.
No other state has a similar law at this time, he said.
A quarter of patients who had failed back surgeries and received spinal cord stimulation surgery had their devices removed within six years, according to a May study published in the medical journal Neurosurgery.
In a 2018 study published in the Journal of Biology and Medicine, researchers said that the spine implant and devices industry is expected to reach $16 billion by 2020, and that the average cost of a surgery is around $30,000 with an annual maintenance cost of $10,000 if the patient has post-operative complications, which the researchers said was “quite frequent.” Business Insurance reached out to AANS and the International Neuromodulation Society, but neither association responded to requests for comment.
Coding in workers compensation has made it very difficult to find how many of the devices fail the patients, said Christine Sims, medical case management director at Denver-based Pinnacol Assurance. But her research of Pinnacol claimants revealed significant costs associated with spinal cord stimulator failure, including one claim from 1985 that has racked up more than $3 million in claims costs and is still active.
Spinal cord stimulators are the most frequent failed medical device for workers compensation claimants at Portland, Maine-based The MEMIC Group, said Tom Wiese, vice president of claims. The devices “more often fail than succeed,” and he estimates that they cause complications in MEMIC comp patients 90% of the time, and that many will undergo multiple surgeries before the device is removed.
When the insurer finds out a spinal cord stimulator has been proposed, the claim goes through utilization review and alternative pain management programs are offered “because (spinal cord stimulators) are just not successful,” said Mr. Wiese.
“It’s not just the additional cost of the surgery and surgical instruments, but also the cost of the disability that you’re paying on the claim.”
Robert Baer, claims executive at Arrowpoint, said he would like to see more information regarding the problems with spinal cord stimulators in the medical community that treats workers comp patients, as well as the quasi-judicial bodies that make care determinations.
“The injured worker needs to have the understanding that this may not be the answer and may not address their chronic pain,” Mr. Baer said, “and keep that in mind going through the process to have one of these implanted.”
“We need to start being a little more proactive with alternative therapies … we’ve got to find a way to help patients deal with the pain rather than a surgery,” said Dr. Bartlett of Sedgwick. “It ends up causing more problems.”
Workers compensation insurers are generally required to cover any medical care that is “reasonable and necessary,” and implanted medical devices are no exception, but some states have workers compensation statutes that specifically exclude experimental treatments.