Diagnosis:
Orthopedic/ Musculoskeletal
Treatment:
Surgical Services
Health Plan:
United Healthcare Ins. Co. of NY
Decision:
Upheld upheld
Appeal Type:
Experimental/Investigational
Gender:
Female
Age Range:
50-59
Decision Year:
2022
Appeal Agent:
IPRO
Case Number:
202203-147290
Summary (1)

Diagnosis: Chronic low back pain. Treatment: 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. The insurer denied coverage for 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. The denial is upheld. The patient is a female with a history of chronic low back pain. She reports low back pain which is rated 1/10 (on a pain scale of 1-10) at rest and 10/10 with activity. She has associated numbness and tingling in the left leg towards the knee. She had failed chiropractic care, physical therapy and meloxicam. Her past medical history is positive for spondylolisthesis. There is sufficient scientific evidenced in peer-reviewed literature to support improvements in health outcomes for patients with vertebrogenic pain per the International Society for the Advancement of Spine Surgery. (1) The procedure is FDA (food and drug administration) approved and states that the Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L (lumbar) 3 through S (sacral) 1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care and is also accompanied by either Type 1 (bone marrow oedema and inflammation) or Type 2 (marrow ischemia) Modic changes on an MRI (magnetic resonance imaging). (2) Based on the documentation, she complains of low back and left leg pain to the knee. Her exam is showing weakness in the bilateral hip flexors 4/5 and a positive straight leg raise on the left which would indicate a radiculopathy. Her lumbar MRI shows a spondylolisthesis at L4-5 with degenerative disc changes at L4-5 and L5-S1. The MRI does not state that she has any Modic changes of the endplates which would be needed in order to meet criteria. Furthermore, there is no flexion/extension x-ray to determine if she has mobility at the L4-5 level that would cause back pain. It appears she has a radicular pain as well as axial pain that may not be addressed with this procedure and she would not clearly benefit from Intracept. She does not meet the indications for the Intracept procedure as noted by ISASS (International Society for the Advancement of Spine Surgery) guidelines: Intraosseous ablation of the BVN (basivertebral nerve) from the L3 through S1 vertebrae may be considered medically indicated for individuals with chronic low back pain when all of the following criteria are met: - Chronic axial low back pain (CLBP) of at least 6 months duration; and Failure to respond to at least 6 months of non-surgical management and MRI demonstrated Modic Type 1 or 2 changes in at least one vertebral endplate, at one or more levels from L3 to S1. (1) Is Intracept Procedure the best available treatment for this patient at this time? No. Based on the medical records, it does not appear that the Intracept procedure is the best available treatment at this time due to her back and radicular pain and her MRI not showing Modic changes and a spondylolisthesis where it is unknown if this is unstable. Are the adverse risks increased over standard treatment/services? The adverse risks to this procedure are minimal compared to a lumbar fusion, and more than conventional therapies. The Intracept procedure has an excellent safety profile. (1) The carrier's denial of 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum should be upheld. It is not more beneficial than any other standard treatments.

Summary (2)

Diagnosis: Chronic low back pain. Treatment: 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. The insurer denied coverage for 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. The denial is upheld. The Intercept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Mobic changes. The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients who no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons nor spine surgeon. There are no National Organizations which provide guidelines nor indications. The facts are no specific pain generator has been defined for this patient as well. The physician has recommended the procedure to L(lumbar) 5-S (sacral)1 yet there are significant changes to L4-5. He has also recommended ESI (epidural steroid injection) which does not support discogenic pain as a pathologic site. The findings were this procedure is currently I/E (investigational/experimental). There were small numbers of people evaluated for a short duration. The procedure is currently being performed by an investigative group and likely an IRB (Investigational Review Board). The procedure is not mainstay nor current accepted treatment by the practicing medical community. The procedure is essentially a thermoablation performed within the vertebral body. There are several level 1 studies showing the benefit of this procedure up to 2 years after treatment compared to controls. However, all of these studies were either funded by the manufacturer and/or authored by consultants from the manufacturer. No high-quality study exists that does not have a significant conflict of interest with the manufacturer. As such, at this time, the Intracept procedure is experimental/investigational and therefore not medically necessary. The carrier's denial of 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum should be upheld. It is not more beneficial than any other standard treatments.

Summary (3)

Diagnosis: Chronic low back pain. Treatment: 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. The insurer denied coverage for 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. The denial is overturned. This case involves a female who presented with a history of low back pain and degenerative disc disease. Records indicated she tried and failed multiple conservative modalities to include chiropractic care, physical therapy, and NSAIDs (non-steroidal anti-inflammatory drugs). A reference was made to an unofficial MRI (magnetic resonance imaging) showing diffuse degenerative disc bulging with mild stenosis from L (lumbar) 5-S (sacral) 1. She had spondylolisthesis with diffuse degenerative disc bulging at L4-L5 and mild to moderate stenosis at the same level. The requesting physician was recommending intracept interosseous nerve ablation to treat L5-S1 vertebra for the relief of vertebra genic chronic low back pain. The requested services were denied for coverage with reports that the proposed treatment has not been shown to be effective for the patient's condition. An appeal letter was submitted from the treating physician stating that all available treatment options have been considered and that the Food and Drug Administration has approved the intercept treatment. This review pertains to the denial of coverage for 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum. CLBP (chronic low back pain) patients treated with BVN (basivertebral nerve) ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP. In this case the patient has failed nonoperative management to include physical therapy, chiropractic management and Mobic. She has type 1 (bone marrow oedema and inflammation) and type 2 (marrow ischemia) Modic changes on MRI. Per the attached literature she is a good candidate for Intracept procedure as outcomes have been good in this patient population. It is the opinion of this reviewer that the original denial be overturned in this case. The carrier's denial of 22899 Unlisted procedure, spine (INTRACEPT) C9752 destruction of intraosseous basivertebral nerve, first two vertebral bodies including imaging guidance (fluoroscopy), lumbar/sacrum should be overturned. It is more beneficial than any other standard treatments.

References (1)
References (2)

1) A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Khalil JG, Smuck M, Koreckij T, Keel J, Beall D, Goodman B, Kalapos P, Nguyen D, Garfin S; INTRACEPT Trial Investigators. Spine J. 2019 Oct;19(10):1620-1632. doi: 10.1016/j.spinee.2019.05.598. Epub 2019 Jun 20. 2) Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2- Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, Yeung C, Truumees E, Schaufele M, Yuan P, Vajkoczy P, Depalma M, Anderson DG, Thibodeau L, Meyer B. Int J Spine Surg. 2019 Apr 30;13(2):110-119. doi: 10.14444/6015. eCollection 2019 Apr. 3) A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Truumees E, Macadaeg K, Pena E, Arbuckle J 2nd, Gentile J 2nd, Funk R, Singh D, Vinayek S. Eur Spine J. 2019 Jul;28(7):1594-1602. doi: 10.1007/s00586-019-05995-2. Epub 2019 May 21. 4) Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain. Markman JD, Rhyne AL, Sasso RC, Patel AA, Hsu WK, Fischgrund JS, Edidin AA, Vajkoczy P. Neurosurgery. 2019 Apr 29. pii: nyz093. doi: 10.1093/neuros/nyz093. [Epub ahead of print] 5) Transforaminal Epiduroscopic Basivertebral Nerve Laser Ablation for Chronic Low Back Pain Associated with Modic Changes: A Preliminary Open-Label Study. Kim HS, Adsul N, Yudoyono F, Paudel B, Kim KJ, Choi SH, Kim JH, Chung SK, Choi JH, Jang JS, Jang IT, Oh SH. Pain Res Manag. 2018 Aug 14;2018:6857983. 6) Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, Yeung C, Truumees E, Schaufele M, Yuan P, Vajkoczy P, DePalma M, Anderson DG, Thibodeau L, Meyer B. Eur Spine J. 2018 May;27(5):1146-1156. 7) Ablation of the basivertebral nerve for treatment of back pain: a clinical study. Becker S, Hadjipavlou A, Heggeness MH. Spine J. 2017 Feb;17(2):218-223. 8) Spine J. 2017 Feb;17(2):218-223. doi: 10.1016/j.spinee.2016.08.032. Epub 2016 Sep 1.Ablation of the basivertebral nerve for treatment of back pain: a clinical study.Becker S1, Hadjipavlou A2, Heggeness MH3.

References (3)

1) J Pain Res. 2021 Jun 23;14:1887-1907. doi: 10.2147/JPR.S287275. eCollection 2021. Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M.Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25. 2) Vinicius Tieppo Francio 1, David Sherwood 2, Eric Twohey 3, Brandon Barndt 4, Robert Pagan-Rosado 5, James Eubanks 6, Dawood Sayed 7. 3) Khalil JG, Smuck M, Koreckij T, Keel J, Beall D, Goodman B, Kalapos P, Nguyen D, Garfin S; INTRACEPT Trial Investigators.Spine J. 2019 Oct;19(10):1620-1632. doi: 10.1016/j.spinee.2019.05.598. Epub 2019 Jun 20. 4) Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M.Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25.