Coverage Policy Manual
Policy #: 2001012
Category: Radiology
Initiated: June 2001
Last Review: August 2018
  Radiofrequency Treatment, Chronic Back Pain

Description:
Nucleoplasty is a percutaneous method of decompressing herniated vertebral discs that uses bipolar radiofrequency energy for ablating soft tissue and thermal energy for coagulating the soft tissue, combining both approaches to decompress the disc and thermally alter the disc tissue.  Nucleoplasty uses the patented Coblation (coagulation and ablation) technology developed by ArthroCare Corporation.  Coblation ablates tissue via a low-temperature, molecular dissociation process to create small channels within the disc.  A series of channels are created by advancing a catheter (Perc-D Coblation Channeling Wand or Perc-D SpineWand) into the disc while ablating tissue.  After the Wand reaches a predetermined depth, the device is slowly withdrawn.  On withdrawal, the channel is thermally treated to 40-70 C, producing a zone of thermal coagulation.  The Wand is then rotated clockwise and another channel is created.  The exact number of channels is dependent on the desired amount of tissue reduction.  Nucleoplasty is performed on an outpatient basis using local anesthetic and fluoroscopic guidance.  Nucleoplasty is proposed as an alternative to Intradiscal Electrothermal Annuloplasty (IDET).  Nucleoplasty's proposed benefit is the avoidance of the thermal injury risks of IDET because the Perc-D Coblation Wand produces lower temperatures within the disc.  
 
The instruments used in the nucleoplasty procedure are FDA approved (510(k)) for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.  
 
The Intracept Intraosseous Nerve Ablation System is a recently developed specialized radiofrequency ablation device which has been granted US Food and Drug Administration (FDA) approval strictly for destruction of the basivertebral nerve of the L3-S1 vertebrae. It is proposed as a treatment option for low back pain.

Policy/
Coverage:
Effective February 2019
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Radiofrequency ablation to the basivertebral nerve for the relief of chronic low back pain (intraosseous nerve ablation) (eg Intracept Intraosseous Nerve Ablation System) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, radiofrequency ablation to the basivertebral nerve for the relief of chronic low back pain (intraosseous nerve ablation) (eg Intracept Intraosseous Nerve Ablation System), is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Effective Prior to February 2019
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 

Rationale:
Disc Nucleoplasty is a relatively new technology. Key studies and controlled studies evaluating this technology are discussed below.
 
Bokov and colleagues reported a non-randomized cohort study comparing nucleoplasty and microsurgery in 2010 (Bokov, 2010).  Inclusion criteria were evidence of nerve root compression, pain resistant to conservative treatment including selective nerve root blocks during at least 1 month with VAS equal to or greater than 40/100 and disability equal to or greater than 40% on the Oswestry Disability Index (ODI). Only patients with mild motor and sensory deficits were included in the study. Patients undergoing nucleoplasty received pretreatment questionnaires and testing and were divided into those with a disc protrusion (< 5 mm; n=24; 6-9 mm, n=22) or a disc extrusion (n=27). The patients with disc extrusion chose nucleoplasty despite a total annulus disruption. Patients were examined at 1, 3, 6, 12, and 18 months with VAS for pain and ODI. A satisfactory result was defined as a 50% decrease in VAS and a 40% decrease in ODI, and the rates of satisfactory and unsatisfactory responses were compared between nucleoplasty and microdiscectomy (n=65). There were no significant differences in outcomes for patients with a disc protrusion equal to or less than 5 mm versus 6-9 mm, and these groups were combined. For all patients with a disc protrusion treated with nucleoplasty, satisfactory results were obtained in 36 (78%, 95% confidence interval [CI]: 66-90%). For the microdiscectomy group, a satisfactory result was observed in 61 patients (94%, 95% CI: 85-98%). For patients with a disc extrusion, nucleoplasty had a significantly higher rate of unsatisfactory results; clinically significant improvements were observed in 12 cases (44%), and 9 patients (33%) with disc extrusion treated with nucleoplasty subsequently underwent microdiscectomy for exacerbation of pain. These results support the conclusion that nucleoplasty is not as effective as microdiscectomy for disc extrusion. Prospective controlled trials are needed to evaluate efficacy and time for recovery in patients with disc protrusion.
 
In 2009, Birnbaum reported a series of 26 patients with cervical disc herniation (29 discs) treated with disc nucleoplasty who had 2 years of follow-up (Birnbaum, 2009).  He compared their outcomes with a group of 30 patients who received conservative treatment. It does not appear that patients were randomly assigned to either treatment group but that the control patients were randomly chosen. Conservatively treated patients received perineural injections with bupivacaine and prednisolone acetate during the first week of treatment. Baseline VASs were 8.4 in the control group and 8.8 in the nucleoplasty group. At 1 week, scores were 7.3 and 3.4, respectively, and at 24 months, 5.1 and 2.3, respectively. No other outcome data were provided.
 
A prospective study from 2007 assessed outcomes in 52 consecutive patients treated with radiofrequency nucleoplasty of lumbar discs (Mirzai, 2007). Included in the study were patients younger than 60 years of age with radicular pain that was resistant to at least 3 months of conservative treatment, combined with magnetic resonance imaging (MRI) evidence of small and medium-sized herniated discs (less than 6 mm) that correlated with the patient’s symptoms. Patients with a disc height of less than 50% of adjacent discs, severe degenerated or fractured disc material, or evidence of extruded disc herniation were excluded. Independent assessment at 2 weeks, 6 months, and 1 year (94% follow-up) found a decrease in VAS pain scores from 7.5 to 2.1, a change from 42 to 21 on the ODI, and a reduction or complete stopping of use of analgesics in 94% of patients.
 
Cuellar et al. reported accelerated degeneration after failed nucleoplasty in 2010 (Cuellar, 2010). Of 54 patients referred for persistent pain after nucleoplasty, 28 patients were evaluated by MRI to determine the source of their symptoms. The total number of procedures performed could not be determined. VAS for pain in this cohort was 7.3. At a mean follow-up of 24 weeks (range, 6 to 52) after nucleoplasty, no change was observed between the baseline and postoperative MRI for increased signal hydration, disc space height improvement, or shrinkage of the preoperative disc bulge. Of 17 cervical levels treated in 12 patients, 5 (42% of patients) appeared to show progressive degeneration at treated levels. Of 17 lumbar procedures in 16 patients, 4 (15% of patients) showed progressive degeneration. Overall, a total of 26% of the patients in this series showed progressive degeneration at the treated level less than 1 year after nucleoplasty. The proportion of discs showing progressive degeneration out of the total nucleoplasty procedures performed cannot be determined from this study. It is also unknown whether any morphologic changes occur after nucleoplasties that were considered to be successful. Additional study of this potential adverse effect of nucleoplasty is needed.
 
Additionally, reports of 4 case series of patients receiving disc nucleoplasty were found. Li and colleagues report on a prospective study of 126 patients from China with contained cervical disc herniations who underwent nucleoplasty. VAS pain scores were significantly improved at 1, 3, 6, and 12 months’ follow-up (Li, 2008). Two smaller studies also report statistically significant reduction in pain. Calisaneller et al report on 29 patients who had lumbar nucleoplasty. Mean pre-operative VAS score was 6.95, and postoperative scores were 2.45, 4.0, and 4.53 at 24 hours, and 3 and 6 months, respectively (Calisaneller,2007).  In a retrospective study from a U.S. center of 22 patients with 12 months of follow-up after lumbar nucleoplasty, statistically significant improvement on measures of pain, functional status, and medication use were reported (Yakovlev, 2007). Al-Zain and colleagues report outcomes for 69 patients for whom 12-month data were available from a cohort of 96 patients who underwent nucleoplasty for back pain and/or radiating pain in the lower extremities. (Seven patients were lost to follow-up, 11 were excluded due to secondary disc sequestration at the treated segment or elsewhere, and data for 8 patients is available only up to 6 months.) Seventy-three percent (73%) of patients improved more than 50% in early postoperative VAS score; this was reduced to 61% of patients at 6 months and to 58% after 1 year (Al-zain, 2008).
 
Practice Guidelines published in 2009 by the American Society of Interventional Pain Physicians (Manchikanti, 2009) report U.S. Preventive Services Task Force (USPSTF) report Level II-3 evidence for disc nucleoplasty in managing predominantly lower extremity pain due to contained disc herniation and state that there is no evidence available for axial low back pain. The guidelines make a weak recommendation for radiofrequency disc nucleoplasty in managing radicular pain due to contained disc herniation. No recommendation for nucleoplasty is given regarding managing axial low back pain.
 
Summary
While numerous case series and uncontrolled studies report improvements in pain and functioning following nucleoplasty, the lack of well-designed and conducted controlled trials limits interpretation of reported data. Questions remain about the safety and efficacy of this treatment. Reconsideration of the policy position awaits randomized trials with adequate follow-up (at least 1 year) that control for selection bias, the placebo effect, and variability in the natural history of low back pain.
 
2012 Update
A literature search was conducted through September 2012.  There were no new randomized trials, practice guidelines, position statements or other publications identified that would prompt a change in the coverage statement.
 
A search of the online site www.clinicaltrials.gov in June 2012 identified two studies listed as completed and one study listed as status unknown. An industry-sponsored randomized controlled trial of nucleoplasty compared to conservative care (NCT00940810) is listed with an estimated enrollment of 46 patients with completion expected November 2011. There were no publications provided.
 
Another industry-sponsored sham-controlled randomized trial on nucleoplasty is listed as completed as of March 2008 (NCT00124774). No publications from this trial have been identified.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  No new information was identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
A 2013 systematic review by Manchikanti et al. identified 1 RCT and 14 observational studies on nucleoplasty that met inclusion criteria, concluding that evidence on nucleoplasty was limited to fair (Manchikanti, 2013).
 
Randomized Controlled Trials
An industry-sponsored RCT from 2010 was an unblinded multi-center comparison of coblation nucleoplasty versus 2 epidural steroid injections (Gerstzen, 2010). The 85 patients included in the study had a focal disc protrusion and had failed conservative therapy. In addition, all patients had received an epidural steroid injection 3 weeks to 6 months previously with no relief, temporary relief, or partial relief of pain. At the 6-month follow-up, the mean improvement in VAS for leg pain, back pain, the Oswestry Disability Index (ODI), and Short Form (SF)-36 subscores were significantly greater in the nucleoplasty group. A greater percentage of patients in the nucleoplasty group also had a minimum clinically important change for leg pain, back pain, ODI and SF-36 scores. A similar percentage of patients (27% of the nucleoplasty group and 20% of the epidural steroid group) had unresolved symptoms and received a secondary procedure during the first 6 months of the study. At 1-year follow-up, secondary procedure rates increased to 42% of the nucleoplasty group and 68% of the steroid group. By the 2-year follow-up, 44% of the nucleoplasty group and 73% of patients in the steroid group had secondary procedures, including 20 patients who had crossed over from steroid treatment to nucleoplasty.
 
A 2012 unblinded RCT from Asia compared nucleoplasty with conservative treatment in 64 patients (Chitragran, 2012). VAS at 15 days after treatment was reduced from a baseline of about 9 to about 5. The nucleoplasty group was reported to have a reduction in pain and medication use compared to conservatively treated controls at 1, 3, 6, and 12 months following treatment, although the data were not presented in this brief report. Comparison of MRI at baseline and after treatment showed a decrease in the bulging of the disc from 5.09 mm to 1.81 mm at 3 months after nucleoplasty.
 
Ongoing Clinical Trials
A search of the online site www.clinicaltrials.gov in June 2013 identified 1 new trial from Europe that will compare nucleoplasty with pulsed radiofrequency of the nerve or dorsal root ganglion (DRG) (NCT01797172). Thirty-eight patients will be enrolled with completion expected in 2014.
 
Two recent trials are listed as completed but no publications have been identified:
  • An industry-sponsored randomized controlled trial of nucleoplasty compared to conservative care (NCT00940810). The study has an estimated enrollment of 46 patients with completion noted July 2012.
  • An industry-sponsored sham-controlled randomized trial on nucleoplasty is listed as completed as of March 2008 (NCT00124774).
 
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement.  
 
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. No new literature was identified that would prompt a change in the coverage statement.
 

CPT/HCPCS:
62287Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar
C9752Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum
C9753Destruction of intraosseous basivertebral nerve, each additional vertebral body, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum (list separately in addition to code for primary procedure)
S2348Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar

References: 2000 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 5.

Al-Zain F, Lemcke J, Killeen T et al.(2008) Minimally invasive spinal surgery using nucleoplasty: a 1-year follow-up study. Acta Neurochir (Wien) 2008; 150(12):1257-62.

Barendse GAM, van den Berg SGM, Kessels AHF, et al.(2001) Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain. Lack of effect from a 90-second 70 C lesion. Spine 2001; 26:287-292.

Birnbaum K.(2009) Percutaneous cervical disc decompression. Surg Radiol Anat 2009; 31(5):379-87.

Boswell MV, Trescot AM, et al.(2007) Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician, 2007; 10:7-111.

Calisaneller T, Ozdemir O, et al.(2007) Six months post-operative clinical and 24 hour post-operative MRI examinations after nucleoplasty with radiofrequency energy. Acta Neurochir (Wien), 2007; 149:495-500.

Chitragran R, Poopitaya S, Tassanawipas W.(2012) Result of percutaneous disc decompression using nucleoplasty in Thailand: a randomized controlled trial. J Med Assoc Thai 2012; 95 Suppl 10:S198-205.

Cuellar VG, Cuellar JM, Vaccaro AR et al.(2010) Accelerated degeneration after failed cervical and lumbar nucleoplasty. J Spinal Disord Tech 2010; 23(8):521-4.

Gerszten PC, Smuck M, Rathmell JP et al.(2010) Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial. J Neurosurg Spine 2010; 12(4):357-71.

Gerszten PC, Welch WC, King JT.(2006) Quality of life assessment in patients undergoing nucleoplasty-based percutaneous discectomy. J Neurosurg Spine. 2006; 4:36-42.

Karasek M, Bogduk N.(2000) Twelve-month follow-up of a controlled trial of intradiscal thermal annuloplasty for back pain due to internal disc disruption. Spine 2000; 25(20):2601-7.

Li J, Yan DL, Zhang ZH.(2008) Percutaneous cervical nucleoplasty in the treatment of cervical disc herniation. Eur Spine J 2008; 17(21):1664-9.

Manchikanti L, Derby R, Benyamin RM et al.(2009) A systematic review of mechanical lumbar disc decompression with nucleoplasty. Pain Physician 2009; 12(3):561-72.

Manchikanti L, Falco FJ, Benyamin RM et al.(2013) An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty. Pain Physician 2013; 16(2 Suppl):SE25-54.

Masala S, Massari F, et al.(2007) Nucleoplasty in the treatment of lumbar diskogenic back pain: one year follow-up. Cardiovasc Intervent Radiol, 2007; 30:426-32.

Mirzai H, Tekin I, et al.(2007) The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Spine J, 2007; 7:88-92.

Mirzai H, Tekin I, Yaman O et al.(2007) The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Spine J 2007; 7(1):88-92; discussion 92-3.

Percutaneous Intradiscal Radiofrequency Thermocoagulation for Chronic Discogenic Low Back Pain. 2002 Blue Cross Blue Shield Association Technology Evaluation Center Assessment.

Radiofrequency ablation for chronic spinal pain. Hayes Technology Assessment 2004.

Saal JA, Saal JS.(2000) Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcomes study with minimum 1-year follow-up. Spine 2000; 25(20):2622-7.

Singh V, Piryani C, Liao K.(2003) Evaluation of percutaneous disc decompression using coblation in chronic back pain with or without leg pain. Pain Physician, 2003; 6:273-80.

www.oratec.com/products/spine/referencerev11.pdf.

Yakovlev A, Tamimi MA, et al.(2007) Outcomes of percutaneous disc decompression utilizing nucleoplasty for the treatment of chronic discogenic pain. Pain Physician, 2007; 10:319-28.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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