PSPS ReActiv8 Position Statement

The Pacific Spine and Pain Society (PSPS) is dedicated to bridging the gap between spine surgery and pain medicine which often encounter the same patients. PSPS serves as an open forum to promote and criticize emerging technologies; it is rooted in research, clinical excellence, and patient-centric care. This includes advocacy and policy for access to care through our collaboration with other societies, the government, and third-party payers.

Patients with intractable axial or mechanical chronic low back pain are commonly seen by our disciplines. Many are refractory to physical therapy and medication, have no indications for surgery and may be chronic consumers of opioids. Their symptoms may be caused by impaired neuromuscular control of the multifidus muscles, which normally provide functional stability to the lumbar spine. This condition is specific, well understood and described in the literature, and diagnosable with simple functional tests. Because historically there were no effective and durable treatments for functional instability, we often resorted to palliative treatment of its symptoms with medication, injections, and rhizotomy and in some cases patients opted for lumbar fusion as a last resort.

Restorative neurostimulation targets the root cause of functional instability. Through bilateral stimulation of the L2 medial branch of the dorsal ramus nerve it (re)activates the multifidus muscles and afferent proprioception to facilitate restoration of neuromuscular control.

Several clinical studies, including the randomized, sham-controlled, double blinded pivotal trial, have consistently documented that this therapy is safe, fully reversible and provides substantial clinical benefits with up to 4-year durability evidence. Furthermore, published Real World Evidence is consistent with those of the RCT and other prospective studies.

Restorative neurostimulation addresses a real and important treatment gap we are facing and therefore exemplifies an ‘emerging technology, rooted in research, clinical excellence’ requiring our advocacy and policy for access to ‘patient-centric care’. Therefore, the PSPS Advocacy and Policy Committee is of the opinion that the current evidence base supports coverage of restorative neurostimulation for patients with intractable CLBP associated with multifidus dysfunction who are refractory to available conventional treatments and not indicated for spine surgery.

The members of PSPS urge commercial insurers and other third-party payers to take immediate steps towards creating a coverage policy that recognizes the unmet clinical need and the ample evidence in support of restorative neurostimulation in this very specific and severely affected patient group. This is an appropriate action that affords well indicated patients the opportunity to access this novel therapy while allowing appropriate governance of utilization. We are happy to contribute to any of the policy development work that might be required. Please don’t hesitate to reach out to us if we can be of assistance.

Respectfully,
The Pacific Spine and Pain Society Advocacy and Policy Committee

PSPS Position Statement

Centers for Medicare Services,

The leadership and membership of the Pacific Spine and Pain Society has determined to provide a statement in response to the multiple Centers for Medicare Services Medicare Administrative Contractors (MACs) that have posted draft local coverage determinations (LCDs) for sacroiliac joint procedures indicating that these are not medically necessary. Those MACs include: NGS, Noridian, Palmetto and WPS. These LCD decisions impact not only Medicare beneficiaries but patients with Medicare Advantage and commercial plans.

The Pacific Spine and Pain Society is comprised of a multidisciplinary collegium of physicians and advanced practice providers who are committed to the evidence-based treatment of chronic pain. The providers of this society aim to educate themselves so as to provide patients with safe and effective treatments. Interventional techniques are an important option and often an alternative to initiation of opiate therapy.

In the instance of sacroiliac joint pain, radiofrequency ablation has proven an important interventional treatment option. Pain originating from the sacroiliac joint is a common cause of back pain. It is estimated that 15-30% of mechanical low back pain is from this anatomic source [1]. Conventional treatments for this condition include physical therapy, anti-inflammatory medications, chiropractic and intraarticular steroid injections.

Sacroiliac joint radiofrequency ablation was described as a treatment to reduce pain involving the sacroiliac joint in 2003 [2]. Leveraging established knowledge of the innervation of the sacroiliac (SI) joint this procedure applies the known therapy of radiofrequency ablation to the lateral branches of the sacral nerves [3]

There are multiple well-designed research studies which have demonstrated the efficacy of this therapy. This year, Dr. Lowe published a systematic review of 16 randomized controlled trials (RCTs) that reported on long-term results of SI joint radiofrequency ablation [4]. Fifteen of these RCTs shared positive results of this therapy as measured by Oswestry Disability Index & Numerical Rating Scale.

It is the position of the Pacific Spine and Pain Society that denying patient access to SI joint RFA leaves a significant treatment gap when conservative measures have been exhausted. Over decades of research, some of which has been summarized in Dr. Lowe’s systemic review, have demonstrated that SI joint RFA is safe and effective. Without this option, patients may be driven to options with greater risk such as chronic opioid therapy or those that are more invasive, such as SI joint fusion. It is the request of the Pacific Spine and Pain Society that the Centers for Medicare Services preserve this treatment option for our patients suffering with chronic sacroiliac joint pain.

1. Cohen, et al. Expert Review of Neuroptherapeutics. 2013 Jan;13(1):99-116.
2. Cohen et al. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):113-9.
3. Pino et al. Reg Anesth Pain Med. 2005 Jul-Aug;30(4):335-8.
4. Lowe et al. Cureus. Jun 2022;14(6):e26327.