Treating refractory posterior sacroiliac joint complex pain in the current healthcare ecosystem: a call to action

Dear Editor,

On March 19, 2023, the decision of the Medicare Administrative Contractors (MACs) to classify sacral lateral branch radiofrequency ablation (SLBRFA) as not “reasonable and necessary” took effect.¹ As such, the MACs joined other private payers in this classification. In essence, the decision eliminates coverage and access to SLBRFA in the United States for most patients.

This policy decision has surprised and disappointed the pain medicine and musculoskeletal specialty communities, as multisociety recommendations based on decades of evidence and endorsed by the American Academy of Orthopaedic Surgeons, American Academy of Pain Medicine, American Academy of Physical Medicine and Rehabilitation, American College of Radiology, American Society of Anesthesiologists, North American Spine Society, and Spine Intervention Society support this treatment for appropriately selected patients.²

The pain medicine and musculoskeletal specialty communities have made advances in identifying subtypes of chronic low back pain (CLBP).³ With each subtype identified, we have moved toward a precision medicine approach to match the specific pathology. Posterior sacroiliac (SIJ) complex pain represents a subtype of CLBP that can now be identified. Rigorous studies of posterior SIJ complex innervation, diagnostic block technique, and radiofrequency denervation strategies provide the ability to diagnose and treat this condition with SLBRFA.^4–6 Multiple sham-controlled trials that used validated techniques for SLBRFA have demonstrated the superiority of this treatment compared to sham.⁷ A pooled between-group comparison demonstrates that participants treated with SLBRFA were approximately four times more likely to report ≥50% pain reduction at three months compared with sham (proportion rate ratio/relative risk (4.84 [95% CI 1.19–19.73]).⁸ There are 27 randomized controlled trials, prospective observational studies, and retrospective studies which have demonstrated ≥50% pain reduction and function with some lasting up to 12 months in patients who have failed conservative management.⁷ The incidence of any adverse events is low and the incidence of serious adverse events is so low that it cannot be detected in moderately-sized outcome studies.⁷

The present policy change places physicians and patients at a crossroads. It denies access to care for patients who may benefit from a low-risk procedure that improves pain and function. For patients with newly diagnosed posterior SIJ complex pain who have failed to durably respond to conservative care, what treatment should now be offered? The same question is relevant for patients who have experienced meaningful benefit from SLBRFA previously, but for whom symptoms return. SIJ fusion surgery may be a reasonable destination treatment for a subset of patients with SIJ pain of intra-articular origin in addition to posterior SIJ complex pain. Notably, SLBRFA and fusion treat different subtypes of patients: SLBRFA addresses pathology involving the densely innervated posterior ligamentous complex of the posterior sacroiliac joint complex, while fusion is intended to treat individuals with instability and/or severe degenerative osteoarthritis of the SIJ.^7–10 As with fusion surgery for pain indications in other areas of the spine, responsible physicians and surgeons should first attempt more conservation, less invasive and less costly treatment strategies that are supported by clinical evidence.

We suspect that the new SIJ intervention policy adopted by Medicare will unfortunately lead to a significant increase in unnecessary SIJ fusion surgeries in the United States, many of which will be performed for patients who might have been well-managed with SLBRFA. SIJ fusion surgery not only treats a different condition but is associated with more serious and frequent potential complications compared with SLBRFA.¹⁰ Furthermore, the biomechanics of the SIJ are altered with an SIJ fusion which may have future untold biomechanical consequences.¹¹ In addition, the cost differences between SIJ fusion surgery and SLBRFA are significant. Based on Medicare’s coverage restrictions, providers are now going to be more likely to offer patients a treatment which is more invasive, permanent, costly, and puts patients at higher risk for serious adverse events relative to SLBRFA.

In this context, we call on the pain medicine and musculoskeletal-specialty communities to help educate legislators, policy leaders, payers, and the greater medical community on the repercussions of the new policy. To restore patient access to SLBRFA in the United States, we must help others in the healthcare ecosystem understand that this new policy conflicts with (1) the medical literature, (2) the goal of providing precise and patient centered care, and (3) multisociety recommendations. Most importantly, the policy conflicts with our collective responsibility to care for patients in a manner that optimizes the risk/benefit ratio of a given treatment paradigm from safer and less invasive to more invasive and potentially higher risk, in a cost-conscious fashion. Such an effort is vital to restore our ability to provide a precision medicine approach to the care of patients with posterior sacroiliac joint complex pain, and more globally, to continue to steer our field towards pain and musculoskeletal care that is condition and pathology specific.

Funding

No funding was received for this work.

Conflicts of interest: Christine Hunt DO reports research grant from Nevro paid to the Mayo Clinic.

Robert W. Hurley MD PhD reports research support from the NIH and Avanos Medical pain directly to Wake Forest University Health Sciences. He also serves as the Editor-in-Chief of Pain Medicine.

Zachary L. McCormick MD reports service on the Board of Directors of the Spine Intervention Society, research support from Avanos Medical paid directly to the University of Utah, and consulting for SI Bone, Stryker. He also serves as the Deputy Editor-in-Chief of Pain Medicine.

David Provenzano MD has consulted for Avanos, Medtronic, Nevro, and SI Bone. Pain Diagnostics and Interventional Care has received research support from Avanos, Boston Scientific, Medtronic, Revno, Stimgenics, and Abbott.

Steven P. Cohen MD has consulted for Avanos and received research support from Avanos Medical paid directly to Johns Hopkins Medical Center. He also serves as an Executive Editor of Pain Medicine.

Lynn Kohan serves as the Section Editor for the Education & Training Section of Pain Medicine.

All other authors declare no conflicts of interest.