In December 2019, the International Society for the Advancement of Spine Surgery (ISASS) released two new policy guidelines.
One guideline is focused on the surgical treatment of lumbar disc herniation (LDH) with radiculopathy and the second guideline addressed intraosseous ablation of the basivertebral nerve to relieve chronic low back pain.
According to Dr. Morgan Lorio, MD, FACS, a leading spine surgeon and lead author on both ISASS guidelines, "The policy aim of ISASS LDH Policy Statement is to discuss the evidence from randomized controlled trials, prospective cohort studies, and recent meta-analyses to inform treatment and coverage recommendations for primary discectomy and annular repair in indicated patients with LDH and radiculopathy."
In developing the ISASS policy guideline on the surgical treatment of LDH with radiculopathy, the authors reviewed peer-reviewed, published literature and current clinical evidence to determine whether surgery was medically necessary to treat lumbar disc herniation. The policy guideline authors found that current evidence supports discectomy — either open, microtubular or endoscopic discectomy — to treat lumbar disc herniation and identified new scientific evidence supporting bone-anchored annular closure in patients with large annular defects. Those patients are at a greater risk for recurrent disc herniation.
https://www.ijssurgery.com/content/14/1/1
"The current level of evidence supports the discectomy over non-surgical care as a means of alleviating pain and reducing disability as well as delivering higher patient satisfaction," said Dr. Lorio. "We got involved with developing clinical policy guidelines several years ago when insurance carriers were not approving discectomy procedures to treat radiculopathy. Those insurers prompted ISASS to take action and review the evidence for payers and develop policy guidelines."
According to reimbursement experts, "It will likely take some time before insurers change their non-coverage policies on LDH, but the clinical experts have demonstrated that the evidence exists to support all methods of LDH surgery and the use of bone-anchored annular closure in patients with large annular defects."
Right now, insurance companies often require patients to undergo non-surgical treatment and physical therapy for six weeks and, if that's not successful, epidural steroid injections. Clinical evidence indicates that some patients may not do well with those medical treatments and begin to regress. "It is better for patients to undergo LDH surgery rather than delay, delay, delay," said Dr. Lorio. "The authors also found that some insurance companies focus on the technique that a surgeon uses to perform LDH surgery and use that as a basis to deny coverage. The authors found that all the various surgical techniques, including microtubular and endoscopic LDH procedures provide positive patient outcomes."
Cary Hagan, CEO of Intrinsic Therapeutics, said he and others involved in developing new spine technology and conducting Level 1 studies to develop robust clinical evidence appreciate ISASS and other specialty societies taking a proactive approach. As clinical experts, their collective efforts reviewing the clinical evidence and publishing information is essential to obtaining coverage for both long-standing and new procedures.
ISASS also developed the guideline on intraosseous ablation of the basivertebral nerve in response to growing requests for literature and evidence.
Evidence for the procedure includes the SMART Trial, the SMART 24-month outcome, the INTRACEPT study, and a case series supported by Relievant. The guideline authors concluded that although intraosseous ablation of the basivertebral nerve is a new minimally invasive treatment for chronic lower back pain, it is supported by Level I evidence as well as multiple randomized controlled trials showing a significant pain decrease and function improvement sustained through at least two years postoperatively.
The Intracept procedure is a specific solution that can help patients with chronic low back pain who are identified by Modic changes that have failed conservative treatment. These patients are likely to see a decrease in pain and an improvement in function that is durable. "Patients frequently present to their doctor having tried multiple treatments and are taking opioids. They are frustrated by the lack of relief," said Dr. Michael Marks, Senior Medical Director at Relievant Medsystems. "Intracept is another tool in the armamentarium of spine surgeons to treat a specific subset of patients who failed other treatment options. However, as it's a new procedure, there are challenges obtaining insurance company approval."
Chronic lower back pain patients may experience the initial pain relief from non-operative options, but it may not be sustainable. The other challenge is that chronic lower back pain is a non-specific diagnosis, so it's challenging to identify the right treatment. Intracept is a minimally invasive procedure that uses an objective biomarker to denote the pain that originates in the endplate and is transmitted through the basivertebral nerve. The basivertebral nerve ablation is a structure-preserving treatment option for these patients.
"In addition to being based upon basic science and an objective biomarker to isolate a specific subset of chronic lower back pain, the Intracept procedure differs from the other therapies in that ablation of the basivertebral nerve, a non-myelinated nerve within the vertebra, is durable with a single procedure, whereas other interventional pain management treatments need to be repeated. Additionally, basivertebral nerve ablation does not use an implant, thus preserving the structure of the spine," according to a statement from Relievant.
Relievant can now use the ISASS guideline in their discussion with payers about covering the procedure. Going forward, Relievant aims to extend the basic science on vertebrogenic pain and continue conducting research on Intracept.