Description　
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 annular tissue. 

Background 
Discogenic Low Back Pain
Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptom findings, in conjunction with radiologically confirmed degenerative disc disease.

Treatment
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 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. Pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.

With the intradiscal electrothermal annuloplasty procedure, a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. Using indirect radiofrequency energy, electrothermal heat is generated within the thermal resistive coil at a temperature of 90°C; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with intradiscal electrothermal annuloplasty include precise temperature feedback and control, and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct radiofrequency needle. Annuloplasty using a laser-assisted spinal endoscopy kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described.

Percutaneous intradiscal radiofrequency thermocoagulation uses direct application of radiofrequency energy. With percutaneous intradiscal radiofrequency thermocoagulation, 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°C. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics Radiofrequency Disc Catheter System has been specifically designed for this purpose.

Intradiscal biacuplasty uses 2 cooled radiofrequency 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.

Vertebral body endplates have been proposed as a source of lower back pain, caused by intraosseous nerves. The basivertebral nerve enters the posterior vertebral body and sends branches to the superior and inferior endplates. Vertebrogenic pain, transmitted via the basivertebral nerve, has been purported to occur with endplate damage or degeneration.

Regulatory Status
A variety of radiofrequency coagulation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA), some of which are designed for disc nucleotomy. In 2002, the Oratec Nucleotomy Catheter (ORATEC Interventions, Menlo Park, CA, acquired by Smith & Nephew in 2002) was cleared for marketing by FDA through the 510(k) process. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. The Radionics (a division of Tyco Healthcare group) Radiofrequency Disc Catheter System received marketing clearance by FDA through the 510(k) process in 2000. FDA product code: GEI.

In 2005, the Baylis Pain Management Cooled Probe was also cleared for marketing by FDA through the 510(k) process. It is intended for use “in conjunction with the Radio Frequency Generator to create radiofrequency lesions in nervous tissue.” FDA product code: GXI.

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 has not responded to at least 6 months of conservative care”. FDA reviewed the device and issued a substantially equivalent designation in August 2017 (K170827). 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)."^1, FDA product code: GXI.

Note: This evidence review does not address disc nucleoplasty, a technique based on the bipolar radiofrequency device (Coblation®; ArthroCare, Austin, TX, acquired by Smith & Nephew, 2014). With the coblation system, a bipolar radiofrequency 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 considered in evidence review 7.01.93.

Related Policies
70118 Automated Percutaneous and Endoscopic Discectomy

Policy:
Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, percutaneous intradiscal radiofreqeuncy thermocoagulation or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational and/or unproven and is therefore considered NOT MEDICALLY NECESSARY.      

Policy Guidelines
Coding
See the Codes table for details.

Rationale
This evidence review was created in December 1999 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through Feb. 20, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., people of color [African American, Asian, Black, Latino and Native American]; LGBTQIA [lesbian, gay, bisexual, transgender, queer, intersex, asexual]; women; and people with disabilities [physical and invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Intradiscal Electrothermal Annuloplasty
Clinical Context and Therapy Purpose
The purpose of percutaneous intradiscal electrothermal annuloplasty in individuals who have discogenic back pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with discogenic back pain.

Interventions
The therapy being considered is percutaneous intradiscal electrothermal annuloplasty.

Comparators
Relevant comparators are conservative management and surgical spinal decompression.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, quality of life (QOL), and treatment-related morbidity. Based on available literature, follow-up of at least 6 to 12 months is recommended.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
Pauza et al. (2004)2, published the results of an RCT evaluating intradiscal electrothermal annuloplasty (referred to as intradiscal electrothermal therapy in Pauza) in patients with discogenic low back pain. The trial included 64 patients with low back pain of more than 6 months in duration who were randomized to intradiscal electrothermal annuloplasty or a sham procedure. Visual analog scale scores for pain were reduced by an average of 2.4 cm in the intradiscal electrothermal annuloplasty group compared with 1.1 cm in the sham group, a statistically significant difference between groups (p = .045). The mean change in the Oswestry Disability Index score was also significantly greater for the intradiscal electrothermal annuloplasty group than for the sham group. Improvements in the 36-Item Short Form Health Survey (SF-36) bodily pain subscale score were slightly higher for the intradiscal electrothermal annuloplasty group. The trial also reported a percent change in visual analog scale scores more than 2.0 cm, which is greater than the minimal clinically significant improvement of 1.8 to 1.9. When the visual analog scale score was dichotomized in this way, a relative risk of 1.5 was observed with a 95% confidence interval (CI) of 0.82 to 2.74. While this single-center trial was well-designed with respect to randomization, clear description of the intervention, and use of valid and reliable outcomes measures, it does not permit conclusions about the relative effects of intradiscal electrothermal annuloplasty and placebo, and it is unclear whether intradiscal electrothermal annuloplasty achieves clinically and statistically significant improvements in measures of pain, disability, or QOL.

Freeman et al. (2005) reported on an industry-sponsored, double-blind, sham-controlled randomized trial evaluating intradiscal electrothermal annuloplasty (referred to as intradiscal electrothermal therapy in this report) in patients with chronic discogenic low back pain, marked functional disability, magnetic resonance imaging evidence of degenerative disc disease, and failure of conservative management.³ Both the active intradiscal electrothermal annuloplasty and sham groups had an intradiscal catheter that was navigated to cover at least 75% of the posterior annulus. Planned enrollment based on power analysis was for 75 patients; however, the trial was stopped early due to slower than expected recruitment after 57 patients (38 intradiscal electrothermal annuloplasty, 19 placebo) had been enrolled. Follow-up was for 6 months, and the outcome measure was successful treatment response, as defined by all of the following: (1) no neurologic deficit; (2) an increase on the Low Back Outcome Score of at least 7 points; and (3) improvements in the SF-36 physical functioning and bodily pain subscale scores of at least 1 standard deviation. No subject in either group achieved a successful treatment response. Outcomes were similar between the intradiscal electrothermal therapy and sham groups on the Low Back Outcome Score (38.31 vs. 37.45), Oswestry Disability Index score (39.77 vs. 41.58), SF-36 subscale scores (35.10 vs. 30.40), Zung Depression Index score (41.39 vs. 40.82), and the Modified Somatic Perception Questionnaire score (8.67 vs. 8.6), respectively. None of the subgroup analyses showed statistically or clinically significant differences in study outcomes. No serious adverse events were reported in either group.

Section Summary: Intradiscal Electrothermal Annuloplasty
Two RCTs on intradiscal electrothermal annuloplasty have reported conflicting results, with 1 finding a benefit for intradiscal electrothermal annuloplasty and the other no benefit. The most recent RCT identified was from 2005. No recent literature on intradiscal electrothermal annuloplasty has been identified.

Percutaneous Intradiscal Radiofrequency Annuloplasty
Clinical Context and Therapy Purpose
The purpose of percutaneous intradiscal radiofrequency annuloplasty in individuals who have discogenic back pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with discogenic back pain.

Interventions
The therapy being considered is percutaneous intradiscal radiofrequency annuloplasty.

Comparators
Relevant comparators are conservative management and surgical spinal decompression.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, QOL, and treatment-related morbidity. Based on available literature, follow-up of at least 6 to 12 months is recommended.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
There is relatively little published data on percutaneous intradiscal radiofrequency thermocoagulation. Barendse et al. (2001) reported on a double-blind trial that randomized 28 patients with chronic low back pain to percutaneous intradiscal radiofrequency thermocoagulation or a sham-control group.⁴ The primary outcome was the percentage of success at 8 weeks, as measured by changes in pain level, impairment, Oswestry Disability Index scores, and analgesics taken. At the end of 8 weeks, there were 2 treatment successes in the sham group and 1 in the treatment group. Trialists concluded that percutaneous intradiscal radiofrequency thermocoagulation was no better than placebo in reducing pain and disability.

Kvarstein et al. (2009) published a 12-month follow-up from an RCT of intra-annular radiofrequency thermal disc therapy using the discTRODE probe.⁵ Recruitment was discontinued when blinded interim analysis of the first 20 patients showed no trend toward overall effect or difference in pain intensity between active and sham treatment at 6 months. At 12 months, there was a reduction from baseline pain, but no significant difference between the groups. Two patients from each group reported an increase in pain.

Section Summary: Percutaneous Intradiscal Radiofrequency Annuloplasty
Two sham-controlled randomized trials showed no evidence of a benefit with percutaneous intradiscal radiofrequency thermocoagulation. One found that only 1 of 14 patients was considered a treatment success. The other was terminated after a blinded interim analysis showed no trend to benefit compared with sham.

Intradiscal Radiofrequency Biacuplasty
Clinical Context and Therapy Purpose
The purpose of intradiscal radiofrequency biacuplasty in individuals who have discogenic back pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with discogenic back pain.

Interventions
The therapy being considered is intradiscal radiofrequency biacuplasty.

Comparators
Relevant comparators are conservative management and surgical spinal decompression.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, QOL, and treatment-related morbidity. Based on available literature, follow-up of at least 6 to 12 months is recommended.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
Kapural et al. (2013), Desai et al. (2016), and colleagues have published studies on the use of transdiscal radiofrequency annuloplasty using 2 transdiscal probes (biacuplasty) in patients with discogenic lower back pain, including a 2013 industry-sponsored, phase 1, double-blind RCT and a 2016 RCT.^6,7,8,9

Kapural et al. (2013) conducted the phase 1 RCT.⁶ Of the 1,894 patients screened, 1,771 (94%) did not meet inclusion criteria. Sixty-four subjects consented and were enrolled. Outcome measures were the SF-36 physical functioning subscale (0 – 100), a numeric rating scale for pain (0 – 10), and the Oswestry Disability Index (0 – 100). There were no significant differences between the groups at 1 month or 3 months. At 6 months, the biacuplasty group showed a significantly greater change from baseline for the SF-36 (15.0 vs. 2.63), numeric rating scale (-2.19 vs. -0.64), and Oswestry Disability Index (-7.43 vs. 0.53) scores. Mean SF-36 and numeric rating scale scores were considered to be clinically significant, but mean Oswestry Disability Index scores did not achieve the minimally important difference of 10 points. With clinical success defined post hoc as a 15-point increase in physical function together with a greater than 2-point decrease in pain, 30% of biacuplasty patients and 3% of sham-treated patients were considered successful. There was no significant difference in opioid use between groups.

Kapural et al. (2015) reported on the unblinded 12-month follow-up from this phase 1 trial.⁷ Improvements continued through 12 months, with a change from baseline to post-treatment of 47.0 to 68.9 (of 100) on the SF-36 physical functioning subscale (p < .01) and 7.1 to 4.4 (of 10) on the numeric rating scale (p < .01). Although the change in numeric rating scale score was statistically significant, the magnitude of the decrease was modest, and a final numeric rating scale score (4.4) remained high. The change in Oswestry Disability Index score (from 40.37 at baseline to 32.44 at 12 months) was also modest (p = .05). Opioid usage did not decrease significantly (53.47 mg at baseline to 34.07 mg at follow-up, p = .23).

Desai et al. (2016) randomized 63 patients with lumbar discogenic pain diagnosed by provocation discography to intradiscal biacuplasty plus conservative medical management (n = 29) or medical management alone (n = 34).⁸ Another 234 patients were scheduled for diagnostic discography but did not meet inclusion criteria. The primary outcome (the mean reduction in visual analog scale score for pain at 6 months) was significantly greater in the biacuplasty group (-2.4) than in the medical management group (-0.56; p = .02). The secondary outcomes were not statistically significant, which included the proportion of responders, defined as a 2-point or 30% decrease in visual analog scale scores, which was achieved in 50% of the biacuplasty group compared to 18% of controls (p = .073). Investigators did not report whether the trial was adequately powered. Other limitations of this industry-sponsored trial were the lack of a sham-control and patient blinding, which could contribute to a placebo effect in the subjective pain outcomes.

Of the 29 patients originally randomized to intradiscal biacuplasty, 22 (76%) were available for 12-month follow-up.9, Mean 12-month change in visual analog scale score was -2.2 (from 6.7 at baseline to 4.4 at 12 months; p = .001). After 6 months, patients randomized to medical management were allowed to receive intradiscal biacuplasty and were followed for another 6 months; 25 of 34 patients crossed over. The visual analog scale scores improved from 7.0 to 4.7 (p < .001) in the crossover group, and 55% were considered to be responders.

Section Summary: Intradiscal Radiofrequency Biacuplasty
Two industry-sponsored RCTs have assessed use of biacuplasty to treat chronic low back pain. In one, only 6% of subjects screened met the strict inclusion and exclusion criteria for the study. Significant differences in outcomes were observed at 6 months, but not at 1 month or 3 months, and the definition of successful treatment appears to have been post hoc. In the second multicenter RCT, 63 patients met inclusion criteria, which included a positive result on provocation discography. There was a significant treatment effect for the primary outcome measure, but not the secondary outcome measures. This trial was not sham-controlled, and it was not reported whether it was adequately powered. Additional sham-controlled trials in a broader population of patients are needed to determine the effect of this treatment with greater certainty.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Society of Interventional Pain Physicians
A 2013 systematic review informing American Society of Interventional Pain Physicians guidelines found limited-to-fair evidence for intradiscal electrothermal therapy (IDET; another term for intradiscal electrothermal annuloplasty) and biacuplasty and limited evidence for percutaneous intradiscal radiofrequency thermocoagulation.¹⁶ These guidelines updated 2007 guidelines, which concluded that the evidence was moderate for management of chronic discogenic low back pain with IDET.¹⁷ Complications included catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage. The evidence for percutaneous intradiscal radiofrequency thermocoagulation was limited, with complications similar to IDET.¹⁷

International Society for the Advancement of Spine Surgery
In 2022, the International Society for the Advancement of Spine Surgery published updated guidelines on intraosseous basivertebral nerve ablation.¹⁸ The guideline was informed by a systematic review which included 2 randomized controlled trials (RCTs) and additional single-arm studies. The guideline authors concluded that intraosseous ablation of the basivertebral nerve from the L3 through S1 vertebrae may be considered medically indicated for individuals with chronic low back pain when all the following criteria are met:

• Chronic low back pain of at least 6 months duration.
• Failure to respond to at least 6 months of nonsurgical management.
• Magnetic resonance imaging-demonstrated MC1 or MC2 in at least 1 vertebral endplate at 1 or more levels from L3 to S1. (*Endplate changes, inflammation, edema, disruption, and/or fissuring.)
• Fibrovascular bone marrow changes (hypointense signal for Modic type 1).
• Fatty bone marrow changes (hyperintense signal for Modic type 2).

National Institute for Health and Care Excellence
A 2016 guidance update by the National Institute for Health and Care Excellence (NICE) indicated that the evidence on safety and efficacy of percutaneous intradiscal radiofrequency thermocoagulation for low back pain was “limited” and should only be used by “special arrangement”.¹⁹

In 2016, NICE guidance on electrothermal annuloplasty was also updated.²⁰ NICE considered evidence on the efficacy of percutaneous intradiscal radiofrequency thermocoagulation for low back pain to be inconsistent and of poor quality, although no major safety concerns were identified. NICE recommended percutaneous intradiscal radiofrequency thermocoagulation only with special arrangements for clinical governance, consent, and audit or research.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in February 2024 did not identify any ongoing or unpublished trials that would likely influence this review.

References 

1. U.S. Food & Drug Administration. K213836 Intracept Intraosseous Nerve Ablation System 510k Summary. 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213836. Accessed February 20, 2024.
2. Pauza KJ, Howell S, Dreyfuss P, et al. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004; 4(1): 27-35. PMID 14749191
3. 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 (Phila Pa 1976). Nov 01 2005; 30(21): 2369-77; discussion 2378. PMID 16261111
4. Barendse GA, van Den Berg SG, Kessels AH, et al. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 C lesion. Spine (Phila Pa 1976). Feb 01 2001; 26(3): 287-92. PMID 11224865
5. Kvarstein G, Måwe L, Indahl A, et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up. Pain. Oct 2009; 145(3): 279-286. PMID 19647940
6. 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): 362-73. PMID 23279658
7. 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): 425-31. PMID 25339501
8. 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. PMID 26689579
9. 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 01 2017; 18(4): 751-763. PMID 27570246
10. 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. May 2018; 27(5): 1146-1156. PMID 29423885
11. 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. Apr 2019; 13(2): 110-119. PMID 31131209
12. 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 treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. Aug 2020; 29(8): 1925-1934. PMID 32451777
13. 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. Spine J. Oct 2019; 19(10): 1620-1632. PMID 31229663
14. 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-month results. Reg Anesth Pain Med. Aug 2021; 46(8): 683-693. PMID 34031220
15. 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. PMID 35141653
16. 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. Apr 2013; 16(2 Suppl): S49-283. PMID 23615883
17. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. Jan 2007; 10(1): 7-111. PMID 17256025
18. Lorio M, Clerk-Lamalice O, Rivera M, et al. ISASS Policy Statement 2022: Literature Review of Intraosseous Basivertebral Nerve Ablation. Int J Spine Surg. Dec 2022; 16(6): 1084-1094. PMID 36266051
19. 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. Accessed February 19, 2024.
20. 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. Accessed February 20, 2024.
21. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Thermal Intradiscal Procedures (TIPs) (150.11). 2008; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?ncdid=324&ver=1. Accessed February 19, 2024.

Coding Section

Codes	Number	Description
CPT	22526	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level
	22527	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; 1 or more additional levels (List separately in addition to code for primary procedure)
	22899	Unlisted procedure code, spine (used for the Intercept procedure)
	64629 (code effective 01/01/2022)	Thermal destruction of intraosseous basivertebral nerve, each additional vertebral body
ICD-9 Procedure	80.59	Other destruction of intervertebral disc (use for IDET)
ICD-9 Diagnosis		Investigational for all diagnoses
HCPCS
ICD-10-CM (effective 10/01/15)		Investigational for all diagnoses
ICD-10-PCS (effective 10/01/15)		ICD-10-PCS codes are only used for inpatient services.
	0R530ZZ, 0R550ZZ, 0R590ZZ, 0R5B0ZZ	Destruction, upper joints, open, cervical and thoracic disc code list
	0S520ZZ, 0S540ZZ	Destruction, lower joints, open, lumbar and lumbosacral disc code list
Type of Service	Surgery
Place of Service	Outpatient

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2013 Forward     

12/01/2024	Annual review, no change to policy intent. Updating  regulatory status  and references.
10/17/2024	Interim review to remove code 64628 as that code is now addressed in CAM 394.
07/08/2024	Updating entire policy, including title to remove the Intracept procedure from it. A new CAM policy is being generated specific to Intracept. The New CAM will be CAM 394 Intraosseous Radiofrequency Ablation (Intracept) Procedure.
12/08/2023	Annual review, no change to policy intent. Updating coding, rationale, and references
12/06/2022	Annual review, no change to policy intent.
12/01/2021	Updating policy with 2022 coding. Adding code 64628 and 64629. No other change made.
12/01/2021	Annual review, no change to policy intent. Updating background, description, rationale and references.
12/01/2020	Annual review, no change to policy intent. Updating rationale and references.
11/03/2020	Interim review to add: Intraosseous radiofrequency nerve ablation of basivertebral nerve (e.g., INTRACEPT® Intraosseous Nerve Ablation System) is considered investigational and/or unproven and therefore considered not medically necessary. No other changes made.
12/02/2019	Annual review, no change to policy intent. Updating rationale and references.
12/13/2018	Annual review, no change to policy intent. Updating rationale and references.
01/12/2018	Annual review, no change to policy intent (policy verbiage updated to be consistent with new title), updating title, background, description, regulatory status, guidelines, rationale and references.
12/05/2016	Annual review, no change to policy intent.
11/16/2015	Annual review, no change to policy intent. Updating background, description, rationale and references.
12/01/2014	Annual review. Added policy guidelines and coding. Updated description, background, regulatory status, rationale and references. No change to policy intent.
12/2/2013	Annual review, added related policies, benefit application and updated references and rationale.