Industry groups and some members of Congress lobbied hard against the CMS rule, saying prior authorization would create “significant barriers to access to medically necessary procedures.”įor patients who are desperate for pain relief, who find medication ineffective or difficult to obtain, spinal cord stimulation may be one of the few options remaining. “After reviewing all available data, we found no evidence suggesting other plausible reasons for the increases, which we believe means financial motivation is the most likely cause," CMS said. – but it could find no medical reason to justify the increasing number of procedures. The agency said there has been significant expansion in the use of spinal cord stimulators – about 50,000 are now implanted every year in the U.S. On July 1, CMS implemented a new rule requiring Medicare patients to get prior authorization before a stimulator is implanted. The Center for Medicare Services (CMS) is also taking a harder look at spinal cord stimulators. Researchers found the system relies too heavily on adverse events reported by device manufacturers. Even worse, the review identified nearly 500 deaths linked to the devices between 20.Ī new study published this week in JAMA Internal Medicine concluded that the FDA’s adverse events reporting system for medical devices may significantly underestimate the number of deaths that actually occur. An FDA review of adverse events involving spinal cord stimulators found that nearly a third were reports of unsatisfactory pain relief. The FDA responded to the Public Citizen report by sending a letter to healthcare providers reminding physicians to only implant stimulators after a trial period that demonstrates the device provides effective pain relief. “Importantly, no evidence was provided that spinal cord stimulators reduce the use of opioids.” “In the midst of the opioid crisis, medical device companies and medical centers that implant spinal cord stimulators increasingly have been marketing spinal cord stimulation as an alternative to opioids for chronic pain,” the report found. Ironically, the report noted that spinal cord stimulators are often touted as safer alternatives to opioid medication. A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths. Until now, most spinal cord stimulators were only approved for patients with severe back pain.įDA approval also comes at a time when the agency is under growing scrutiny for its regulation of medical devices, particularly spinal cord stimulators. Of the 34 million Americans with diabetes, about one in five have painful neuropathy, a condition that develops when high blood glucose levels damage peripheral nerves. "I'm grateful to my co-investigators and the patients who participated in this study, as the results and this approval will have far-reaching impact on the lives of PDN patients." ‘Dangerously Lax’ OversightįDA approval of the Nevro stimulator for PDN is a significant expansion of the medical device market. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. "The substantial pain relief and improved quality of life demonstrates that 10 kHz Therapy can safely and effectively treat this patient population," said lead investigator Dr. The Senza stimulators are unique because they use high frequency electric pulses of 10 kHz, a frequency that doesn’t create an uncomfortable tingling sensation that’s common with other stimulators. The overall results were so promising that the Food and Drug Administration recently approved Nevro’s Senza stimulators for the treatment of PDN, making it the only spinal cord stimulation system approved for that condition. The ease of the pain that it gave me,” Cagle said. The device emits mild electrical pulses to disrupt pain signals before they reach the brain. Last year Cagle heard about a clinical trial for people with painful diabetic neuropathy (PDN) and decided to take a chance, enrolling in the study to see if a Nevro spinal cord stimulator could relieve his pain. “I only used them on the worst of worse days, when I could not fall asleep because I was in so much pain.” I’ve seen people hooked on pain meds and I didn’t want that for myself,” Cagle told PNN. “I don’t want to get hooked on pain meds. The 33-year-old Arkansas man tried pain medications such as hydrocodone and gabapentin (Neurontin), but didn’t like their side effects or potential for addiction. Like many other people with diabetic neuropathy, Lee Cagle suffered from burning and stinging sensations in his legs – pain so severe that he used sheets at night to build a small tent around his feet so that the fabric didn’t touch his skin and trigger another flare.
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