Medical Policy

This document addresses several minimally invasive surgical procedures designed to destroy nociceptive nerve fibers with or without structural changes to the intervertebral discs. The following percutaneous vertebral disc procedures have been explored as a treatment of chronic low back pain secondary to disc disease:

• intradiscal electrothermal therapy (IDET) (also referred to as intradiscal electrothermal annuloplasty)
• percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)
• intradiscal biacuplasty (IDB)

Note: Please see the following document for percutaneous and endoscopic spinal procedures designed to remove or ablate disc material and decompress the disc (for example, percutaneous lumbar discectomy, laser discectomy, and disc decompression using radiofrequency energy):

• SURG.00071 Percutaneous and Endoscopic Spinal Surgery

Note: This document does not address intraosseous basivertebral nerve ablation (BVNA). For criteria related to BVNA, please refer to the applicable guidelines used by the plan.

Investigational and Not Medically Necessary:

The following procedures are considered investigational and not medically necessary:

1. Percutaneous intradiscal electrothermal therapy; or
2. Percutaneous intradiscal radiofrequency thermocoagulation; or
3. Intradiscal biacuplasty.

Intradiscal Electrothermal Therapy (IDET)

IDET with the SpineCath^® IntraDiscal ElectroThermal Therapy (IDET^™) System (Smith & Nephew, Inc., Andover, MA, USA) is a percutaneous intradiscal electrothermal annuloplasty procedure used to treat chronic low back pain related to degenerative disc disease. The procedure involves applying targeted thermal energy to the posterior disc annulus, which causes contraction of collagen fibers and destruction of afferent nociceptors. The intradiscal catheter system received U.S. Food and Drug Administration (FDA) 510(k) clearance in February 2008.

A randomized controlled trial (RCT) evaluating IDET published by Pauza and colleagues (2004) included 64 individuals with discogenic low back pain lasting more than 6 months. Of these, 37 participants were randomized to undergo the IDET procedure and 27 to a sham procedure. Principal outcome measures included pain and disability assessed using a visual analog scale (VAS), the 36-Item Health Short Form Survey (SF-36), and the Oswestry Disability Index (ODI) scale. A total of 56 participants (88%) were included in the per protocol analysis. Mean change at 6 months in the VAS was significantly higher in the IDET group (2.4) than the sham group (1.1), p=0.045. However, mean change in the SF-36 bodily pain scale, the SF-36 physical functioning scale and the ODI did not differ significantly between groups.

Freeman and colleagues (2005) conducted a sham-controlled RCT study on individuals with discogenic back pain and annular tears who failed to improve despite conservative treatment. The study was carried out with 38 participants undergoing IDET and 19 receiving the sham procedure. Several subjective outcomes were measured utilizing the Low Back Outcome Score (LBOS), the ODI, and the SF-36. A successful outcome was defined as: 1) no neurological deficit; 2) improvement in the LBOS of greater than 7 points; and 3) improvement in the physical function and bodily pain section of the SF-36 form of at least greater than one standard deviation. No participant in either arm of the study met the criteria for a successful outcome. The findings of this study suggest that while IDET appears to be a safe procedure with no permanent complications, there is no significant benefit of IDET over sham treatment.

An industry funded meta-analysis by Appleby and colleagues (2006) analyzed the peer-reviewed published literature on IDET from 1998 to 2005, both controlled and uncontrolled studies. The authors identified 17 unique publications, only 1 of which was an RCT (the Pauza, 2004 study, discussed above). While the authors concluded that the pooled results of the literature provided evidence of the safety and efficacy of the IDET procedure, 16 of the 17 studies reviewed were case series and lacked control or comparison groups.

Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)

The PIRFT procedure is a minimally invasive surgical technique in which radiofrequency (RF) energy is directly applied to disc material. Similar to IDET, this procedure does not ablate the disc material, but alters the biomechanics of the disc or destroys the nociceptive pain fibers.

The Radionics^® discTRODE^™ (probe) system (Radionics, Inc., Burlington, MA) received 510(k) clearance from the FDA in October 2000 to reduce pain, physical impairment and functional disability due to annular disruption of contained herniated discs. Two published double-blind sham-controlled RCTs on the Radionics device were identified. In 2001, Barendse and colleagues published an RCT with 24 individuals who had chronic discogenic low back pain. Participants in the radiofrequency treatment group (n=13) received a 90-second 70°C treatment of the intervertebral disc. Individuals in the control group (n=15) underwent the same procedure, but without use of RF current. Both the treating physician and the participants were blinded to the group assignment. Physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator prior to the beginning of treatment. At the end of 8 weeks, the VAS, global perceived effect, and ODI scores did not differ significantly between the 2 groups, suggesting that PIRFT is not effective in reducing chronic discogenic low back pain.

Kvarstein and colleagues (2009) reported on 20 individuals with chronic discogenic low back pain. Individuals were assigned to active treatment with the discTRODE probe or a sham control group. Both study groups underwent insertion of the RF probe by the treating physician while a separate operator controlled delivery of the RF therapy, thus blinding the participants as well as the treating physician to treatment or sham. The primary outcome measure was change in pain intensity. Secondary outcome measures were the individual’s categorical impression of change in experienced pain, health-related quality of life, and functional ability. The primary outcome, change in pain intensity, was not statistically significant between groups and, with the exception of individual’s impression of pain, other outcomes were similar between groups. The authors found that, at 12 months, mean change in pain intensity in the active treatment group was small and not clinically meaningful. Taking into consideration that 40% (4 of 10) of the treated individuals had increased pain 12 months after treatment, the authors concluded that the benefit of PIRFT was inconsistent and would not recommend intra-annular thermal therapy with the discTRODE probe as a treatment for chronic low back pain.

Intradiscal Biacuplasty (IDB)

In December 2006, the TransDiscal^™ System (Baylis Medical Company Inc., Montreal, QC Canada) received FDA 510(k) clearance as an IDB device proposed to reduce chronic intervertebral disc-related back pain by using cooled radiofrequency probes to ablate the neurons that generate pain sensations.

A sham-controlled RCT evaluating IDB was published by Kapural and colleagues in 2013. The study included 64 individuals with chronic discogenic low back pain (6 months duration or longer) and evaluated outcome measures of SF-36 physical functioning subscore (0-100), the numerical rating scale (NRS) for pain (0-10), and the ODI (0-100) at 1, 3, and 6 months. The investigators reported that there were no significant differences between the groups at 1 or 3 months. At 6 months, the IDB 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 IDB participants and 3% of sham-treated participants were considered successful. There was no significant difference in opioid use between the 2 groups. Limitations of this study include the lack of a formal assessment of blinding effectiveness among participants, the relatively short follow-up time of 6 months, and the limited number of participants evaluated in the sample and subgroup analysis.

A total of 22 of 27 participants in the original active treatment group were followed for 12 months and reported clinically significant improvements in physical function and NRS scores; although, the magnitude of the decrease was modest and the final NRS score of 4.4 remained high (Kapural, 2015). Participants were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB. Out of 30 participants in the sham group, 24 chose to cross over with only 20 of 24 participants followed to 6 months. In this group, improvements in physical function and pain did not differ statistically from those participants originally randomized to IDB treatment. No complications or adverse events were reported that related to the procedure.

Desai and colleagues (2016) published an open-label RCT of 63 individuals with lumbar discogenic pain diagnosed by provocation discography. Participants were randomized to IDB plus conservative medical management (IDB plus CMM; n=29) or CMM alone (n=34). At 6 months, participants in the CMM group were eligible for crossover if desired. The primary outcome measure was defined as the change in VAS from baseline to 6 months. Secondary outcome measures included treatment “responders,” defined as the proportion of participants with a 2-point or 30% decrease in VAS scores. For the primary outcome measure, the mean VAS score reduction was significantly greater in the IDB plus CMM group compared to the CMM group alone (-2.4 vs. -0.56; p=0.02). For the secondary outcome measure, the proportion of responders was greater in the IDB plus CMM group compared to the CMM (50% vs. 18%); however, the rate was not statistically significant. Limitations of this industry-sponsored study include all enrolled individuals were required to fail an initial 6 months of CMM, and the lack of a sham control group and participant blinding.

Of the 29 participants originally randomized to IDB, 22 (76%) were available for 12-month follow-up (Desai, 2017). The mean 12-month change in VAS score was -2.2 (from 6.7 at baseline to 4.4 at 12 months, p=0.001). After 6 months, participants randomized to CMM alone were allowed to choose to receive IDB and were followed for another 6 months; 25 of 34 participants crossed over to IDB plus CMM. VAS score improved from 7.0 to 4.7 (p<0.001) in the crossover group, and 55% were considered to be responders. However, only 27% of crossover participants achieved at least 50% improvement in pain, compared with 41% of participants in the original IDB plus CMM group. An important limitation of this study was that it was not statistically powered to evaluate reduction in opioid use, as the sample size was not adequate to detect statistically different changes between the study groups. It was reported that not every eligible participant in the IDB plus CMM and crossover study groups provided data at each respective follow-up time-point. Finally, CMM protocols were not standardized from clinic to clinic and participant to participant, and the physicians were permitted to treat study participants based on personal clinical preferences.

Other Considerations

The Centers for Medicare and Medicaid Services (CMS) determined for services on or after September 29, 2008, that thermal intradiscal procedures (TIPs) are not reasonable and necessary for the treatment of low back pain.

Chou and colleagues (2009) published an evidence-based guideline for the American Pain Society (APS). Their recommendations on IDET and PIRFT were:

• There is good or fair evidence from randomized trials that PIRFT thermocoagulation is not effective.
• There is insufficient (poor) evidence from randomized trials (conflicting trials, sparse and lower quality data, or no randomized trials) to reliably evaluate other interventional therapies, which include IDET.

An American Society of Interventional Pain Physicians (ASIPP) (Manchikanti, 2013) evidence-based practice guideline in the management of chronic spinal pain for thermal annular procedures states:

• The evidence for intradiscal electrothermal therapy (IDET) and biacuplasty is limited to fair and is limited for discTRODE.
• IDET and biacuplasty may be performed in a select group of patients with discogenic pain nonresponsive to conservative modalities including epidural injections.

A 2020 guideline from NASS on the diagnosis and treatment of low back pain made the following recommendations:

Intradiscal electrothermal annuloplasty is suggested to provide improvements in pain and function at up to two years. This treatment is limited in its effectiveness with roughly 40-50% of patients receiving a 50% reduction in pain. Grade of Recommendation: B

Biacuplasty is an option to produce clinically and statistically significant improvements in pain at 6 months in patients with discogenic low back pain. Grade of Recommendation: C

There is insufficient evidence to make a recommendation for or against the use of percutaneous intradiscal radiofrequency thermocoagulation. Grade of Recommendation: I

While the NASS guideline states that biacuplasty produces clinically and statistically significant improvements in pain, three of the four studies reviewed for the recommendation were rated as poor quality (Level IV).

Summary
There is insufficient evidence in the published medical literature to support the use of percutaneous vertebral disc procedures in the treatment of individuals with chronic discogenic low back pain. In sham-controlled RCTs, the procedures were either not found to result in better short-term outcomes or outcomes were mixed and did not clearly support the efficacy of active treatment. There is a lack of long-term comparative data on the efficacy and safety of percutaneous vertebral disc procedures.

The intervertebral disc is a combination of strong connective tissues which hold one vertebra to the next and acts as a cushion between the vertebrae. It is made of a tough outer layer called the annulus fibrosus and a gel-like center called the nucleus pulposus. Discs are basically shock absorbers, whose content is 70%-90% water. The center of the disc may start to lose water content, making the disc less effective as a cushion, causing displacement of the disc’s center (herniation or rupture) through a crack in the outer layer. Pain may be from the disc itself (discogenic pain) or from disc herniation or prolapse resulting in pressure on nearby nerve roots. Most disc herniations occur in the bottom two discs of the lumbar spine, at and just below the waist. A herniated disc can press on a nerve root in the spine and may cause back pain or pain, numbness, tingling or weakness of the leg called sciatica (pain radiating down the leg). Disc problems may occur as a result of injury, wear and tear, or with aging.

The IDET procedure using the Smith & Nephew SpineCath System describes a minimally invasive procedure that has been proposed as an alternative to spinal fusion for the treatment of chronic low back pain related to disc disease. In an initial step, the pathogenic disc is identified using pressure-based discography. A navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. The catheter is advanced through the disc circuitously to return posteriorly. Electrothermal heat is then generated with the thermal resistive coil; the disc material is heated for up to 20 minutes. This outpatient procedure typically requires less than 30 to 40 minutes of recovery time. The mechanism of action of pain relief is unknown, but it is thought to be related to shrinkage of the collagen fibers within the annulus, or destruction of the adjacent nociceptive pain fibers.

The PIRFT procedure differs from the IDET procedure in that radiofrequency energy is applied directly to the involved disc. The radiofrequency probe is placed into the center of the disc instead of around the annulus. The practitioner activates the probe and delivers radiofrequency energy into the center of the disc for 90 seconds at a temperature of 70°C. As in IDET, the mechanism of action of pain relief is not precisely understood, but is thought to be related to a reduction of the pain receptor input by destroying the pain receptor fibers.

The IDB procedure uses two internally cooled radiofrequency probes placed on the posterolateral sides of the intervertebral annulus fibrosus to heat nerve tissue while circulating water to cool the tissue that is adjacent to the disc. During the procedure, the individual is mildly sedated and the area to be treated anesthetized. After approximately 15 minutes, the probes and needles are removed and a bandage is placed over the treatment site. IDB is similar to PIRFT in that it uses radiofrequency energy and similar to IDET and PIRFT in that it is not designed to coagulate, burn or destroy the disc material.

Annulus: The hard, tough outer layer of the vertebral disc surrounding the center portion called the nucleus, which is a softer gel-like substance.

Biomechanics: The study of the effects of internal and external forces on the human body in movement and rest.

Discogenic pain: Pain generated by the disc itself which is externally intact, as opposed to disc prolapse or herniation which put pressure on nearby nerve roots.

Percutaneous: Through the skin (puncture as opposed to "open" surgical incision).

Percutaneous thermal intradiscal procedures (TIPS): Procedures that involve the insertion of a catheter or probe in the spinal disc under fluoroscopic guidance for the purpose of producing or applying heat or disruption within the disc to relieve low back pain.

Radiofrequency: The use of electrodes to generate heat to alter tissue structure.

Spine anatomy: The spine is divided into three major sections: the cervical (neck), the thoracic (mid-back) and lumbar spine (lower back). These sections are made up of individual bones called vertebrae, which are the primary area of weight bearing and provide a resting-place for the discs, which act as shock absorbers between the vertebrae.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Appleby D, Anderson, G, Totta, M. Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET). Pain Med. 2006; 7(4):308-316.
2. 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):287-292.
3. 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). 2016; 41(13):1065-1074.
4. 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. 2017; 18(4):751-763.
5. Freedman BA, Cohen SP, Kuklo TR, et al. Intradiscal electrothermal therapy (IDET) for chronic low back pain in active-duty soldiers: 2 year follow-up. Spine J. 2003; 3(6):502-509.
6. 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):2369-2377.
7. 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):362-373.
8. 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. 2015; 16(3):425-431.
9. Karasek M, Bogduk N. Twelve-month follow-up of a controlled trial of intradiscal thermal annuloplasty for back pain due to internal disc disruption. Spine (Phila Pa 1976). 2000; 25(20):2601-2607.
10. 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):279-286.
11. Pauza KJ, Howell S, Dreyfuss P, et al. A randomized, placebo controlled trial of intradiscal electro-thermal therapy for the treatment of discogenic low back pain. Spine J. 2004; 4(1):27-35.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD): Thermal Intradiscal Procedures (TIPs). NCD #150.11. Effective September 29, 2008. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=324&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&KeyWord=Thermal&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAA&. Accessed on June 6, 2024.
2. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). 2009; 34(10):1078-1093.
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. North American Spine Society (NASS). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Available at: https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Clinical-Guidelines. Accessed on June 6, 2024.
   • Diagnosis and Treatment of Low Back Pain. Revised 2020.

Baylis TransDiscal System
Radionics DiscTRODE
Radionics RF Disc Catheter System
SpineCath IntraDiscal ElectroThermal Therapy (IDET) System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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