mp-041 - Medical Policies - Alabama
Percutaneous Intradiscal Electrothermal Annuloplasty (IDET), Radiofrequency Annuloplasty, Biacuplasty, and Intraosseous Basivertebral Nerve Ablation
Policy Number: MP-041
Latest Review Date: October 2022
Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.
Intraosseous radiofrequency nerve ablation of basivertebral nerve for the treatment of vertebrogenic back pain is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Electrothermal intradiscal annuloplasty therapies use radiofrequency energy sources to treat discogenic low back pain arising from annular tears. These annuloplasty techniques are designed to decrease pain arising from the annulus by thermocoagulating nerves in the disc and tightening of annular tissue. Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptoms findings, in conjunction with radiologically confirmed degenerative disc disease. Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.
A number of electrothermal intradiscal procedures have been introduced to treat discogenic low back pain; they rely on various probe designs to introduce radiofrequency (RF) energy into the disc. It has been proposed that heat-induced denaturation of collagen fibers in the annular lamellae may stabilize the disc and potentially seal annular fissures and that pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.
With the intradiscal electrothermal annuloplasty procedure (IDET™, Oratec SpineCath System), a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. The catheter is then snaked through the disc circuitously to return posteriorly. Using indirect radiofrequency energy, electrothermal heat is generated within the thermal resistive coil at a temperature of 90 degrees centigrade; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with IDET include precise temperature feedback and control, and the ability to provide electro-thermocoagulation to a broader tissue segment than would be allowed with a direct radiofrequency needle.
Another procedure, referred to as percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), uses direct application of radiofrequency energy. With PIRFT, the radiofrequency probe is placed into the center of the disc and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics RF Disc Catheter System has been specifically designed for this purpose. Intradiscal biacuplasty involves use of 2 cooled RF electrodes placed on the posterolateral sides of the intervertebral annulus fibrosus. It is believed that by cooling the probes a larger area may be treated than could occur with a regular needle probe. Annuloplasty using a laser-assisted spinal endoscopy (LASE) kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty or PELA) has also been described.
Intraosseous radiofrequency nerve ablation is an emerging technology intended for treatment of chronic low back pain. Intraosseous nerves are reportedly found within the vertebrae, are referred to as basivertebral nerves and are present in the basivertebral foramen. Authors contend the nerves may be a source of intraosseous back pain and that interruption of the nerve pathway using radiofrequency will relieve the associated pain. The Intracept intraosseous nerve ablation procedure targets the basivertebral nerve with radiofrequency energy. Treatment occurs with the individual in a prone position; either general anesthesia or conscious sedation is used. For the procedure, the radiofrequency probe is inserted into a channel leading to the trunk of the basivertebral nerve. A radiofrequency generator is used to ablate the basivertebral nerve, with the temperature at the tip of the probe maintained at 85°C for 15 minutes. One device under investigation, The INTRACEPT® System (Relievant MedSystems, Inc, Redwood City, CA) recently received FDA approval for use as a minimally invasive radiofrequency system for treatment of chronic lumbar back pain at one or more levels (i.e., L3 to S1), when back pain is present despite at least six months of conservative care and is accompanied by either Type I or Type 2 Modic changes on MRI.
This policy does not address disc nucleoplasty, a technique based on the bipolar RF device. With the coblation system, a bipolar RF device is used to provide lower energy treatment to the intervertebral disc, which is designed to provide tissue removal with minimal thermal damage to collateral tissue. Disc nucleoplasty is closer in concept to a laser discectomy in that tissue is removed or ablated to provide decompression of a bulging disc. Disc nucleoplasty and laser discectomy are discussed in medical policy #090- Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty).
This policy has been updated regularly with searches of the PubMed database. The most recent literature search was performed through September 16, 2022.
Summary of Evidence
For individuals who have discogenic back pain the evidence includes a small number of randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs on intradiscal electrothermal annuloplasty reported conflicting results, with one reporting benefit for intradiscal electrothermal annuloplasty and the other reporting no benefit. Further study in a sham-controlled trial with a representative population of patients is needed. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have discogenic back pain who receive intradiscal radiofrequency annuloplasty, the evidence includes 2 RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Neither RCT found evidence of benefit with the treatment. More sham-controlled trials are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have discogenic back pain who receive intradiscal biacuplasty, the evidence includes 2 industry-sponsored RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One trial reported significant improvements at 6 months post treatment, but not at 1 and 3 months. The other trial also showed a significant reduction in VAS scores at 6 months that appeared to continue to the 12-month follow-up; however, it is unclear whether this trial was sufficiently powered. More sham-controlled trials are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have vertebrogenic back pain who receive ablation of basivertebral nerves, the evidence includes 2 RCTs (the SMART and INTRACEPT trials). Relevant outcomes are symptoms, functional outcomes, QOL, and treatment-related morbidity. The SMART trial was unable to show a significant improvement in the Oswestry Disability Index with basivertebral nerve ablation compared to sham control at 3 months post-randomization in the intent-to-treat population. The INTRACEPT trial showed a significant improvement in the Oswestry Disability Index with basivertebral nerve ablation compared to standard care at 3 and 6 months post-randomization; however, the trial is limited by its lack of sham control.
Both trials are further limited by the fact that the majority of patients assigned to control crossed over to receive active treatment, thus, long-term comparative data are not available. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
American Society of Interventional Pain Physicians
A 2013 systematic review for the American Society of Interventional Pain Physicians guidelines found limited to fair evidence for IDET and biacuplasty and limited evidence for PIRFT. This updates 2007 guidelines that concluded that the evidence is moderate for management of chronic discogenic low back with IDET. Complications include catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage. The evidence for (PIRFT) was reported to be limited, with complications similar to IDET.
National Institute for Health and Care Excellence
A National Institute for Health and Care Excellence (NICE) guidance, updated in 2016, indicated that the evidence on safety and efficacy of PIRFT for low back pain was “limited” and should only be used by “special arrangement”.
The NICE guidance on electrothermal annuloplasty was updated in 2016. NICE considers evidence on the efficacy of PIRFT for low back pain to be inconsistent and of poor quality, although no major safety concerns were identified. NICE recommends PIRFT only with special arrangements for clinical governance, consent, and audit or research.
U.S. Preventive Task Force Recommendations
Intradiscal annuloplasty, annuloplasty, electrothermal annuloplasty, IDET, intradiscal electrothermal therapy, percutaneous intradiscal radiofrequency, PIRFT, Oratec SpineCath System, Radionics RF Disc Catheter System, disc biacuplasty, TransDiscal™ System, DiscTRODE™, radiofrequency posterior annuloplasty, Intracept, intraosseous radiofrequency nerve ablation of basivertebral nerve, BVN, Relievant
APPROVED BY GOVERNING BODIES:
In 2002, the Oratec Nucleotomy Catheter (ORATEC Interventions, Menlo Park, CA, acquired by Smith & Nephew in 2002) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. Radionics (a division of Tyco Healthcare group) RF (Radiofrequency) Disc Catheter System received marketing clearance through FDA’s 510(k) process in 2000.
The Baylis Pain Management Cooled Probe received marketing clearance through the FDA’s 510(k) process in 2005. It is intended for use “in conjunction with the Radio Frequency Generator to create radiofrequency lesions in nervous tissue.”
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 L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that hs not responded to at least 6 months of conservative care.” FDA reviewed the device and issued a substantially equivalent designation in August 2017. In March of 2022, FDA issued a substantially equivalent designation for an additional Intracept Intraosseous Nerve Ablation System (Relievant Medsystems, Inc.; K213836). The prior device (K170827) is listed as the reference access instrument and the new indication adds a description of accompanying use case features, "...is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change)."
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level
Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; one or more additional levels (list separately in addition to code for primary procedure)
Unlisted procedure, spine
|64628||Thermal destruction of intraosseous basivertebral nerve, first 2 vertebral bodies (Effective 01/01/22)|
|64629||Thermal destruction of intraosseous basivertebral nerve, each additional vertebral body (Effective 01/01/22)|
The following codes should not be used to report IDET:
Injection procedure for diskography, each level: lumbar
Injection procedure for diskography, each level: cervical
Injection procedure for chemonucleolysis, including discography, single or multiple levels, lumbar
Destruction by neurolytic agent; peripheral nerve or branch
Injection of substance other than anesthetic, antispasmodic, contrast, or neurolytic agents
Diskography, cervical, radiological supervision and interpretation
Diskography, lumbar, radiological supervision and interpretation
- Barendse GA, van Den Berg SG, et al. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation from chronic discogenic low back pain: lack of effect from a 90 second 70 C lesion. Spine 2001; 26(3): 287-292.
- Boswell MV. Interventional techniques: Evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician, January 2007; 10(1): 7-111.
- Desai MJ, Kapural L, Petersohn JD, et al. A prospective, randomized, multicenter, open-label clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Spine (Phila Pa 1976). Jul 01 2016; 41(13):1065-1074.
- Desai MJ, Kapural L, Petersohn JD, et al. Twelve-month follow-up of a randomized clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Pain Med. Apr 1 2017;18(4):751-763.
- Fischgrund JS, Rhyne A, Franke J et al. 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. Int J Spine Surg. 2019; 13(2):110-119.
- Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018; 27(5):1146-1156.
- Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatmentarm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. Aug 2020; 29(8): 1925-1934.
- Freeman BJ, Fraser RD, Cain CM et al. A randomized, double-blind, controlled trial. Intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine 2005; 30(21):2369-2377.
- Kapural L, Vrooman B, Sarwar S, et al. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. Mar 2013; 14(3):362-373.
- Kapural L, Vrooman B, Sarwar S, et al. Radiofrequency intradiscal biacuplasty for treatment of discogenic lower back pain: a 12-month follow-up. Pain Med. Mar 2015; 16(3):425-431.
- Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. SpineJ. Oct 2019; 19(10): 1620-1632.
- Koreckij T, Kreiner S, Khalil JG, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results. N Am Spine Soc J. Dec 2021; 8: 100089.
- Kvarstein G, Mawe L, Indahl A et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy—a12 month follow-up. Pain 2009; 145(3):279-286.
- Lorio M, Clerk-Lamalice O, Beall DP, Julien T. International Society for the Advancement of Spine Surgery Guideline-Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain. Int J Spine Surg. Feb 2020;14(1):18–25.
- Manchikanti L, Abdi S, Atluri S et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician 2013; 16(2 Suppl):S49-S283.
- National Institute for Health and Care Excellence. Percutaneous electrothermal treatment of the intervertebral disc annulus for low back pain and sciatica [IPG544]. 2016; https://www.nice.org.uk/guidance/IPG544.
- National Institute for Health and Care Excellence. Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus for low back pain [IPG545]. 2016; https://www.nice.org.uk/guidance/ipg545.
- Pauza KJ, Howell S, Dreyfus R, et al. A randomized, placebo-controlled trial of intradiskal electrothermal therapy (IDET) fro the treatment of discogenic low back pain. Spine J. Jan-Feb 2004; 4(1):27-35.
- Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-monthresults. Reg Anesth Pain Med. Aug 2021; 46(8): 683-693.
Medical Review Committee, January 1999
Medical Policy Reference Manual, December 1999
TEC, August 2000
Medical Policy Group, February 2002
Medical Review Committee, February 2002
Medical Review Committee, March 2002
Available for Comment April 15-May 29, 2002
Medical Policy Group, May 2003 (2)
Medical Review Committee, June 2003
Medical Policy Administration Committee, August 2003
Available for comment August 12-September 26, 2003
Medical Policy Group, January 2006 (2)
Medical Policy Group, January 2007 (2)
Medical Policy Group, July 2007 (1)
Medical Policy Administration Committee, July 2007
Available for comment July 27-September 10, 2007
Medical Policy Group, April 2008 (1)
Medical Policy Panel, April 2009
Medical Policy Group, July 2009 (2)
Medical Policy Panel, August 2010
Medical Policy Group, September 2010 (2)
Medical Policy Group, August 2011; Updated Key Points & References
Medical Policy Panel, July 2012
Medical Policy Group, July 2012 (2); Updated Key Points, Key Words, &References
Medical Policy Panel, July 2013
Medical Policy Group, July 2013 (2): 2013 Update to Key Points and References; no change in policy statement
Medical Policy Panel, July 2014
Medical Policy Group, July 2014 (4): Updated Key Points. No change to the policy statement at this time.
Medical Policy Panel, July 2015
Medical Policy Group, July 2015 (2): 2015 Updates to Key Points and References; no change to policy statement.
Medical Policy Panel, January 2017
Medical Policy Group, January 2017 (7): 2017 Updates to Title, Description, Key Points, and References. Policy statement clarified to reflect title changes, no change in intent.
Medical Policy Panel, January 2018
Medical Policy Group, January 2018 (7): 2018 Updates to Description, Key Points and References. No change in Policy Statement.
Medical Policy Panel, April 2019
Medical Policy Group, April 2019 (7): 2019 Updates to Key Points and References. No change in Policy Statement.
Medical Policy Panel, April 2020
Medical Policy Group, April 2020 (7): 2020 Updates to Key Points, Approved by Governing Bodies, and References. Investigational statement added regarding intraosseous radiofrequency nerve ablation of basivertebral nerve to Policy Statement; has been previously listed on Investigational Listing. Keywords added: “Intracept, intraosseous radiofrequency nerve ablation of basivertebral nerve, BVN, Relievant”
Medical Policy Panel, April 2021
Medical Policy Group, April 2021 (7): Minor update to Key Points. No new references added. Policy section updated to remove “not medically necessary” statement. No change in intent.
Medical Policy Panel, October 2021
Medical Policy Group, October 2021 (7): Updates to Title, Key Points and References. No change in Policy Statement.
Medical Policy Group, December 2021: 2022 Annual Coding Update. Added CPT codes 64628 and 64629 to the Current coding section.
Medical Policy Panel, October 2022
Medical Policy Group, October 2022 (7): Updates to Key Points, Approved by Governing Bodies and References. Clarification to Policy Statement- added “for the treatment of chronic discogenic back pain” and “for the treatment of vertebrogenic back pain.” No change in policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
- The technology must have final approval from the appropriate government regulatory bodies;
- The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
- The technology must improve the net health outcome;
- The technology must be as beneficial as any established alternatives;
- The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
- In accordance with generally accepted standards of medical practice; and
- Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
- Not primarily for the convenience of the patient, physician or other health care provider; and
- Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.