Percutaneous Intradiscal Electrothermal Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty

Number 7.01.72*

Effective Date September 23, 2014

Revision Date(s) 09/08/14; 09/09/13; 09/11/12, 09/13/11; 10/12/10; 06/09/09; 05/13/08; 12/12/06; 03/14/06; 09/15/04

Replaces 7.01.514

*Medicare has a policy


Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, percutaneous intradiscal radiofrequency thermocoagulation, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.

Related Policies


Automated Percutaneous and Endoscopic Discectomy


Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty)


Artificial Intervertebral Disc: Cervical Spine

Policy Guidelines




Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level


1 or more additional levels (list separately in addition to code for primary procedure)


Injection procedure for discography, each level: lumbar


Injection procedure for discography, each level: cervical or thoracic


Discography, cervical or thoracic, radiological supervision and interpretation


Discography, lumbar, radiological supervision and interpretation


Intradiscal annuloplasty therapies use energy sources to thermally treat discogenic low back pain arising from annular tears. Thermal annuloplasty techniques are designed to decrease pain arising from the annulus and enhance its structural integrity.


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 (RF) 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 RF energy with IDET™ include precise temperature feedback and control and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct RF needle.

Another procedure, referred to as percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), uses direct application of RF energy. With PIRFT, the RF 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 RF Disc Catheter System has been specifically designed for this purpose.

A more recently developed annuloplasty procedure, referred to as intradiscal biacuplasty (Baylis Medical Inc., Montreal, Canada) involves the 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 kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described.

Regulatory Status

IDET™, Oratec Nucleotomy Catheter, received marketing clearance through FDA’s 510(k) process in 2002. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. Radionics (Burlington, MA; a division of Tyco Healthcare group) RF (Radiofrequency) Disc Catheter System received marketing clearance through FDA’s 510(k) process in 2000. Valleylab (Boulder, CO; a division of Tyco Healthcare) is marketing the DiscTRODE™ RF catheter electrode system for use with the RFG-3CPlus™ RF lesion generator in the U.S. FDA product code: GEI.

The Baylis Pain Management Cooled Probe received marketing clearance through 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.”

Note: This policy does not address DISC Nucleoplasty™, a technique based on a device offered by ArthroCare (Austin, TX). With the ArthroCare system, a bipolar RF device is used to provide lower energy treatment (Coblation®) 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 in an effort to provide decompression of a bulging disc. DISC Nucleoplasty and laser discectomy are considered separately in policy. (See Related Policies)


Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

Intradiscal electrothermal therapy may be performed in the setting of a pain management clinic.


This policy is based in part on TEC Assessments from 2002 and 2003, with periodic updates of the literature using the MEDLINE database. (1, 2) The most recent literature review was performed through June 3, 2014.

As with any therapy for pain, a placebo effect is anticipated, and thus randomized placebo-controlled trials are necessary to investigate the extent of the placebo effect and to determine whether any improvement with annuloplasty exceeds that associated with a placebo. Therefore, evidence reviewed for this policy focuses on randomized controlled trials (RCTs).

Systematic Reviews

A 2013 review of the evidence for American Society of Interventional Pain Physicians guidelines found limited to fair evidence for intradiscal electrothermal annuloplasty (IDET) and biacuplasty and limited evidence for percutaneous intradiscal radiofrequency thermocoagulation (PIRFT). (3) Based on the evidence of 1 positive randomized trial (Pauza et al) and 4 positive observational studies that met the inclusion criteria, and negative evidence from another randomized trial that they considered to be flawed (Freeman et al) and an observational study, the review concluded that evidence for IDET is fair. They identified one randomized trial by Kapural for biacuplasty that showed modest benefits. The single study evaluating PIRFT (Kvarstein et al) (sections that follow further describe all of these studies) showed no benefit from the procedure.

In 2007, a systematic review of IDET and PIRFT was published that followed the criteria recommended by the Cochrane Back Review Group. (4) Four randomized and 2 nonrandomized studies, totaling 283 patients, were included in the review (key studies are described next). A 2012 systematic review by some of the same authors identified 3 RCTs and one observational study that met their criteria on thermal annular procedures. (5) No new controlled trials were identified. The included evidence was found to be fair for IDET and poor for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic low back pain. Of the 2 randomized studies that evaluated IDET, (6, 7) one showed weak evidence of effectiveness, and the other, which reported no improvement in either the active or sham treatment group, was rejected for methodologic shortcomings. The single randomized trial with the discTRODE device that was included in the review was considered to be a high-quality study that showed lack of efficacy.(8) There were no high-quality studies that evaluated the efficacy of biacuplasty, although it was noted that this procedure is being investigated in 2 ongoing RCTs.

A number of other systematic reviews that focused on related issues have come to various and different conclusions about the efficacy of these procedures. (9-11) Freeman and Mehdian reported that the evidence for IDET was mixed and that the evidence showed that PIRFT was ineffective for discogenic back pain. (9) Levin concluded that IDET was modestly effective for discogenic pain in carefully selected patients. (10) Helm et al. concluded that the literature was limited, but supported that IDET led to significant benefit in approximately half of appropriately chosen patients and that there was minimal evidence for the efficacy of intradiscal biacuplasty. (11)

An industry-funded meta-analysis and systematic review were published that support the use of IDET. (12, 13) However, the quality of the studies included in these reviews was poor; 14 of the 18 studies reviewed did not have appropriate controls.


Randomized Controlled Trials. Pauza et al. published the results of a RCT, (6) which was the focus of discussion in the 2003 TEC Assessment. The study included 64 patients with low back pain of more than 6 months in duration who were randomly assigned to receive either IDET™ or a sham procedure. Visual analog scale (VAS) pain was reduced by an average of 2.4 cm in the IDET™ group, compared with 1.1 cm in the sham group, a significant difference between groups (p=0.045). The mean change in the Oswestry Disability Index (ODI) was also significantly greater for the IDET™ group compared with the sham group. The improvement on the 36-Item Short Form Health Survey (SF-36) Bodily Pain subscale was nearly significantly higher for the IDET group. The study also reported the percentage with a change in VAS of more than 2.0 cm, which is greater than the minimally clinically significant improvement of 1.8 to 1.9. When the VAS is dichotomized in this way, a relative risk of 1.5 is observed with a 95% confidence interval of 0.82 to 2.74. In summary, the Pauza et al. trial is well-designed with respect to randomization, clear description of intervention, and use of valid and reliable outcomes measures. However, this single -center trial does not permit conclusions about the relative effects of IDET™ and placebo, and it is unclear whether IDET™ achieves clinically and statistically significant improvements in measures of pain, disability, and quality of life.

An industry-sponsored double-blinded, sham-controlled trial RCT was published by Freeman et al. in 2005. (7) This trial enrolled patients with chronic discogenic low back pain, marked functional disability, magnetic resonance imaging evidence of degenerative disc disease, and failure of conservative management. Both the active IDET 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 IDET™, 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 (LBOS) of at least 7 points; and (3) improvements in the SF-36 physical functioning and bodily pain scales of at least 1 SD. No subject in either group achieved a successful treatment response, and IDET™ was no more effective than sham stimulation on any of the outcomes. Outcomes were similar between the IDET™ and sham groups on the LBOS (38.31 vs. 37.45), ODI (39.77 vs. 41.58), SF-36 subscales (35.10 vs. 30.40), the Zung Depression Index (41.39 vs40.82), and the Modified Somatic Perception Questionnaire (8.67 vs. 8.67, IDET vs. sham, all respectively). None of the sub-group analyses showed statistically or clinically significant differences in the study outcomes. There were no serious adverse events reported in either group.

Non-randomized Trials

In a controlled study by Kapural et al., comparison of 21 electrothermal (IDET) and 21 radiofrequency (RF) procedures found significant improvements in most IDET patients but not in matched RF-treated patients at 1-year follow-up; the study did not have a placebo-control group. (14)

Percutaneous Intradiscal Radiofrequency Thermocoagulation

There is relatively minimal published data on PIRFT. In 2001, Barendse et al. reported on a double-blind trial that randomly assigned 28 patients with chronic low back pain to undergo PIRFT or to a sham control group. (15) The primary outcome was the percentage of success at 8 weeks, as measured by changes in pain level, impairment, ODS, and analgesics taken. At the end of 8 weeks, there were 2 treatment successes in the sham group compared with one in the treatment group. The authors concluded that PIRFT was not better than the placebo procedure in reducing pain and disability.

In 2009, Kvarstein et al. published 12-month follow-up from an RCT of intra-annular RF thermal disc therapy using the discTRODE™ probe from Radionics. (8) 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 2 groups. Two patients from each group reported an increase in pain. Although this controlled study did not find evidence for a benefit of PIRFT, it may not have been powered to detect a small or moderate effect of the procedure.


Randomized Controlled Trials

Kapural et al. have published several articles on the use of transdiscal RF annuloplasty using two transdiscal probes (biacuplasty), including a 2013 industry-sponsored small Phase I double-blind RCT (NCT00750191). (16) Out of 1,894 patients who were screened, 1,771 (94%) did not meet inclusion criteria. Sixty-four subjects were consented and enrolled in the study. Outcome measures were the SF-36 physical functioning subscore (0-100), the numeric rating scale (NRS) for pain (0-10), and the ODI (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), NRS (-2.19 vs. -0.64), and ODI (-7.43 vs. 0.53). Mean SF-36 and NRS scores were considered to be clinically significant, but mean ODI 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 the 2 groups.

Observational Studies

In 2007; Kapural et al published a case report of biacuplasty, which they reported to be the first publication with this procedure.(17) Aside from several publications from the group of Kapural et al, 1 report from Turkey was identified with a case series of 15 patients treated with biacuplasty.(18)

Section Summary

One RCT has been published on the use of biacuplasty to treat chronic low back pain. In this report, only 6% of the 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 be post-hoc. Additional study in a broader population of patients is needed to determine with greater certainty the effect of this treatment on health outcomes.

Ongoing Clinical Trials

A search of online site in June 2014 identified one industry-sponsored study on biacuplasty.

  • NCT01263054 is a manufacturer-sponsored Phase IV randomized, multi-center, open-label clinical trial comparing disc biacuplasty with the TransDiscal system versus medical management for discogenic lumbar back pain. The study was scheduled to begin in December 2010 with an estimated enrollment of 136 subjects. Study completion is expected in December 2014 with a total of 60 subjects.


There is limited evidence on the efficacy of intradiscal thermal annuloplasty, consisting of a small number of randomized controlled trials and case series. The two randomized controlled trials (RCTs) on intradiscal electrothermal annuloplasty report different results, with one reporting benefit for intradiscal electrothermal annuloplasty (IDET) and the other reporting no benefit. There is a lack of evidence to support a role for radiofrequency annuloplasty with a single probe. One recent RCT on biacuplasty suggests that this procedure may provide modest benefit in a proportion of highly selected patients; confirmation of these results in a broader population is needed. Overall, evidence is insufficient to conclude that these procedures improve health outcomes. Therefore, annuloplasty (i.e., IDET™, percutaneous intradiscal radiofrequency thermocoagulation [PIRFT], biacuplasty) is considered investigational.

Practice Guidelines and Position Statements

American Society of Interventional Pain Physicians

A 2013 review of the evidence for American Society of Interventional Pain Physicians guidelines found limited to fair evidence for IDET and biacuplasty and limited evidence for PIRFT). (3) This updates 2007 guidelines that concluded that the evidence is moderate for management of chronic discogenic low back pain with IDET™.(19) Complications include catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage. The evidence for radiofrequency posterior annuloplasty (PIRFT) was reported to be limited, with complications similar to IDET. (19)

National Institute for Health and Clinical Excellence (NICE)

The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) guidance, published in 2004, indicates that the current evidence on safety and efficacy of PIRFT for lower back pain does not appear adequate to support its use. (20)

The NICE guidance on electrothermal annuloplasty was updated in 2009. (21) NICE considers evidence on the safety and efficacy of percutaneous intradiscal electrothermal therapy for low back pain to be inconsistent. NICE recommends that this procedure only be used with special arrangements for clinical governance, consent, and audit or research.

U.S. Preventative Services Task Force Recommendations

Annuloplasty is not a preventive service.

Medicare National Coverage

The Centers for Medicare and Medicaid Services has determined that thermal intradiscal procedures, including IDET and PIRFT, are not reasonable and necessary for the treatment of low back pain. Therefore, thermal intradiscal procedures, which include procedures that employ the use of a RF energy source or electrothermal energy to apply or create heat and/or disruption within the disc for the treatment of low back pain, are noncovered. (22)


  1. Blue Cross and Blue Shield Association technology Evaluation Center (TEC). Intradiscal electrothermal therapy for chronic low back pain. TEC Assessments 2002; Volume 17, Tab 11.
  2. Blue Cross and Blue Shield Association technology Evaluation Center (TEC). Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic low back pain. TEC Assessments 2003; Volume 18, Tab 19.
  3. 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.
  4. Urrutia G, Kovacs F, Nishishinya MB et al. Percutaneous thermocoagulation intradiscal techniques for discogenic low back pain. Spine (Phila Pa 1976) 2007;32(10):1146-54.
  5. Helm S, Deer TR, Manchikanti L et al. Effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician 2012; 15(3):E279-E304.
  6. 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.
  7. 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) 2005;30(21):2369-77; discussion 78.
  8. Kvarstein G, Mawe L, Indahl A et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up. Pain 2009; 145(3):279-86.
  9. Freeman BJ, Mehdian R. Intradiscal electrothermal therapy, percutaneous discectomy, and nucleoplasty: what is the current evidence? Curr Pain Headache Rep 2008; 12(1):14-21.
  10. Levin JH. Prospective, double-blind, randomized placebo-controlled trials in interventional spine: what the highest quality literature tells us. Spine J 2009; 9(8):690-703.
  11. Helm S, Hayek SM, Benyamin RM et al. Systematic review of the effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician 2009; 12(1):207-32.
  12. Andersson GB, Mekhail NA, Block JE. Treatment of intractable discogenic low back pain. A systematic review of spinal fusion and intradiscal electrothermal therapy (IDET). Pain Physician 2006;9(3):237-48.
  13. Appleby D, Andersson G, Totta M. Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET). Pain Med 2006;7(4):308-16.
  14. Kapural L, Hayek S, Malak O et al. Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the treatment of discogenic pain: a prospective matched control trial. Pain Med 2005; 6(6):425-31.
  15. 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) 2001; 26(3):287-92.
  16. 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 2013; 14(3):362-73.
  17. Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract 2007; 7(2):130-4.
  18. Karaman H, Tufek A, Kavak GO et al. 6-month results of TransDiscal Biacuplasty on patients with discogenic low back pain: preliminary findings. Int J Med Sci 2010; 8(1):1-8.
  19. Boswell MV, Trescot AM, Datta S et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007; 10(1):7-111.
  20. National Institute for Health and Clinical Excellence. IPG83 Percutaneous intradiscal radiofrequency thermocoagulation for lower back pain. 2004. Available online at: Last accessed August, 2014.
  21. National Institute for Health and Clinical Excellence. IPG319 Percutaneous intradiscal electrothermal therapy for low back pain: guidance. 2009. Available online at: Last accessed August 8, 2014.
  22. Centers for Medicare and Medicaid Services. NCD for Thermal Intradiscal Procedures (TIPs) (150.11). 2008. Available online at: Last accessed August 8, 2014.
  23. BlueCross BlueShield Association (BCBSA). Percutaneous Intradiscal Electrothermal Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty. Medical Policy Reference Manual, Policy No. 07.01.72, 2014.







Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level



one or more additional levels (List separately in addition to code for primary procedure)



Injection of substance other than anesthetic, antispasmodic, contrast, or neurolytic agents



Injection procedure for discography, each level; lumbar



cervical or thoracic



Injection procedure for chemonucleolysis, including discography, single or multiple levels, lumbar



Injection, single (not via indwelling catheter), not including neurolytic substances, with or without contrast (for either localization or epidurography), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opoid, steroid, other solution), epidural or subarachnoid; cervical or thoracic



Lumbar, sacral (caudal)



Destruction by neurolytic agent; other peripheral nerve or branch



Unlisted procedure, nervous system



Discography, cervical or thoracic, radiological supervision and interpretation



Discography, lumbar, radiological supervision and interpretation

Type of Service



Place of Service









Add to Surgery Section - New Policy, replaces PR.7.01.514—effective September 15, 2004


Replace Policy - Policy updated with literature search; no change in policy statement.


Disclaimer and Scope update - No further changes.


Replace Policy - Policy updated with literature review; references added; no change in policy statement.


Replace Policy - Policy updated with literature search. Policy statement revised to include biacuplasty as investigational. Title updated to add “annuloplasty” and deleted “thermocoagulation”. References added.


Code Update - 62310 and 62311 added, deleted 62288, no other changes.


Cross Reference Update - No other changes.


Replace Policy - Policy updated with literature search; no change in policy statement. References added.


Replace Policy - Policy updated with literature review through June 2010. References have been added and reordered; the policy statement remains unchanged.


Codes Updates - Deleted codes 0062T and 0063T removed from policy.


Replace Policy – Policy updated with literature search through May 2011; reference 13 added and references reordered; policy statement unchanged.


Related Policies updated; the title of 7.01.18 now includes endoscopic discectomy.


Replace policy. Rationale section revised based on literature search through May 2012. Reference 4 added and other references renumbered. Policy statement unchanged.


Replace policy. Rationale updated based on a literature review through June 2013. References 3, 16 added; others renumbered/removed. Policy statement unchanged.


Annual Review. A literature review through June 3, 2014 did not prompt the addition of new references. Policy statement unchanged.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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