Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Percutaneous Intradiscal Annuloplasty (IDET/PIRFT)

Policy #:11.14.14e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Although the US Food and Drug Administration (FDA) has approved devices for percutaneous intradiscal annuloplasty (e.g., intradiscal electrothermal therapy [IDET], percutaneous intradiscal radiofrequency thermocoagulation [PIRFT]), the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, percutaneous intradiscal annuloplasty is considered experimental/investigational by the Company and not covered.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, percutaneous intradiscal annuloplasty is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA)

The Smith & Nephew SPINECATH™ Intradiscal ElectroThermal Catheter (Smith & Nephew Inc., Andover, MA) was approved by the FDA on December 17, 1999. The original FDA approval for the device was obtained under the name Oratec® SpineCATH™.

The Smith & Nephew ElectroThermal® 20S Spine Generator (Smith & Nephew Inc., Andover, MA) was approved by the FDA on February 25, 2004.

The Radionics RF Disc Catheter Electrode System (Integra Radionics, a Division of Tyco Healthcare Group LP, Burlington, MA) was approved by the FDA on October 23, 2000.

Description

Percutaneous intradiscal annuloplasty is a minimally invasive procedure intended to treat chronic discogenic low back pain related to tears of the annulus fibrosus (i.e., outer portion of the intervertebral disc). Two of the most common types of thermal intradiscal annuloplasty techniques are intradiscal electrothermal therapy (IDET) and percutaneous intradiscal radiofrequency thermocoagulation (PIRFT). Devices approved by the US Food and Drug Administrative (FDA) are used to perform IDET or PIRFT and are indicated for the coagulation and decompression of disc material to treat symptomatic individuals who have annular disruption of contained herniated discs. It is theorized that the procedure allows collagen fibers within the disc annulus to be compressed without causing excessive damage. Additionally, it is believed that intradiscal annuloplasty thermocoagulates nerve tissue, which may provide pain relief. However, the theorized mechanism of action for pain relief is not fully understood. Percutaneous intradiscal annuloplasty is typically performed in an outpatient setting using local anesthesia.

INTRADISCAL ELECTROTHERMAL THERAPY (IDET)

IDET, which is also known as intradiscal electrothermal annuloplasty (IEA), is performed by inserting the SPINECATH™ intradiscal catheter (Smith & Nephew Inc., Andover, MA) posteriolaterally into the annulus or nucleus of the affected disc and feeding it circumferentially. The navigable catheter completes a circuit around the disc and is returned posteriorly. A thermal resistive coil in the catheter generates electrothermal heat, which warms the disc material.

PEER-REVIEWED LITERATURE
In a prospective randomized controlled trial, Pauza et al. (2004) evaluated the safety and effectiveness of IDET for the treatment of discogenic low back pain. Sixty-four patients with persistent low back pain lasting longer than 6 months were randomized to IDET (n=37) or sham control (n=27). Both groups were matched for demographic and clinical features. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as the IDET procedure, in which the posterior annulus or the painful disc was heated to 90 degrees centigrade. Ultimately 85% of the patients (n=32) randomized to the IDET group and 89% of the patients (n=24) randomized to the sham group were available for postoperative follow-up. Outcome measurements included visual analog scale (VAS) pain scores, SF-36 health survey (a standardized questionnaire used to measure an individual's overall subjective health status), and the Oswestery disability index (ODI, a self-report questionnaire that examines perceived levels of disability in 10 everyday activities of daily living). Patients in both groups exhibited improvements, but mean improvement in pain, disability, and depression were statistically significantly greater in the IDET group. Approximately 50% of the patients experienced no appreciable benefit, however. The authors concluded that IDET appears to provide relief in a small proportion of strictly defined patients who have intractable low back pain. The study is limited in its small sample size. Additionally, data was excluded from 8 patients, including 5 from the IDET group. One patient died, 1 was lost to follow-up, 1 had unsatisfactory electrode placement, 1 had post-treatment bone fracture, and 2 had new injuries unrelated to low back pain and were excluded due to compensation claims or opioids. The statistical analysis is limited because the technique for comparing group scores on continuous variables was described as a t-test analysis. More appropriate techniques for comparing changes between groups include analysis of covariance and repeated measure analysis of variance. Intent-to-treat analyses were not conducted, and it is unclear whether IDET achieves clinically and statistically significant improvements in measures of pain, disability, and quality of life.

In a prospective, double-blind, randomized controlled trial, Freeman et al. (2005) evaluated the safety and effectiveness of IDET compared with a sham control for the treatment of chronic discogenic low back pain. The authors referenced the Paula et al. (2004) study, noting that while statistically significant improvements following IDET were demonstrated, the clinical significance of the improvements was questionable. Freeman et al. (2005) included 57 patients who were randomized with a 2:1 ratio (38 IDET, 19 sham control). Surgeon, patient, and independent outcome assessor were all blinded to the treatment. Outcome measurements included a low back outcome score (LBOS), ODI, and SF-36 at baseline and at 6 months. Successful outcomes were defined as no neurologic deficit, improvement of LBOS of greater than 7 points, and improvement in SF-36 greater than 1 standard deviation. No subject in either arm showed improvement of greater than 7 points in LBOS or an improvement of SF-36 greater than 1 standard deviation. The authors noted that while the IDET procedure appeared safe with no permanent complications, no subject in either arm of the trial met criteria for successful outcome. They concluded that the study demonstrated no significant benefit from IDET over placebo. The study is limited in its small sample size and short-term follow-up period.

In a meta-analysis, Appleby et al. (2006) evaluated the effectiveness of IDET in terms of pain relief, reduction of disability, and risk of complications. Sixty-two peer-reviewed articles identifying the IDET procedure were identified. Ultimately, 45 articles with low quality of evidence (e.g., case series with small sample sizes) were excluded. Outcome measurements included VAS pain scores, SF-36, and ODI. The overall mean improvement in pain was 2.9 points, with an overall mean improvement in bodily pain of 18 points as measured by SF-36. The overall mean improvement in disability was 7 points. The overall incidence of complications was 0.8%. The authors concluded that the IDET procedure was relatively safe and effective. The study is limited in its heterogeneity.

PERCUTANEOUS INTRADISCAL RADIOFREQUENCY THERMOCOAGULATION (PIRFT)

Other percutaneous intradiscal procedures are distinct from IDET because they involve different methods of delivering thermal energy. PIRFT is performed with the Radionics RF Disc Catheter System (Integra Radionics, a Division of Tyco Healthcare Group LP, Burlington, MA), which uses a radiofrequency probe to administer a direct application of radiofrequency energy into the center of the disc. The device is activated for 90 seconds at 70 degrees centigrade.

PEER-REVIEWED LITERATURE
In a prospective randomized controlled trial, Oh and Shim (2004) evaluated the effectiveness of PIRFT of the ramus communicans nerve in patients suffering from chronic discogenic low back pain. Forty-nine patients with persistent single-level vertebral pain refractory to IDET were randomized to PIRFT (n=26) or a control group (n=23). Patients in the control group received lidocaine injections without radiofrequency. Patient-reported VAS pain scores and overall patient satisfaction were determined. The average follow-up period was 4 months. VAS pain scores were statistically significantly lower in the PIRFT group when compared with the control group (p < 0.05). One patient in the PIRFT group complained of mild lower limb weakness, but had symptom resolution at 15 days postoperatively. The authors concluded that PIRFT should be considered as a potential treatment option for patients with chronic discogenic low back pain.

In a prospective matched control trial, Kapural et al. (2005) evaluated the effectiveness of IDET and PIRFT for the treatment of persistent pain related to internal disc disruption. The authors matched 42 patients (21 IDET, 21 PIRFT) for age, sex, weight, smoking history, manual labor, and number of intervertebral discs treated. Patients completed pain disability index (PDI) questionnaires preoperatively and at 2 weeks, 2, 3, 6, 9, and 12 months postoperatively. The patients in the IDET group had statistically significantly lower mean pain scores than the PIRFT group, with VAS pain scores decreasing from 6.6 ± 2.0 preoperatively to 4.4 ± 2.4 at 1 year follow-up following the IDET procedure, compared with VAS scores of 7.4 ± 1.9 preoperatively to 1.4 ± 1.9 at 1-year follow-up following the PIRFT procedure (p = 0.001). PDI scores had a statistically significant improvement among patients who underwent IDET than among those who underwent PIRFT. The authors concluded that patients who underwent IDET had statistically significantly improved pain scores compared with patients who underwent PIRFT. The study is limited in its small sample size, short-term follow-up period, and lack of a comparative control group that is an established treatment (e.g., conservative management, standard discectomy).

In a systematic review, Urrutia et al. (2007) evaluated the safety and effectiveness of percutaneous intradiscal techniques for the treatment of discogenic low back pain. The review included analysis of IDET and PIRFT. Six studies representing 283 patients were included. The authors noted that two open, non-randomized trials showed positive results for IDET when compared with rehabilitation and PIRFT, respectively. Results from 2 randomized controlled trials showed no differences between PIRFT and placebo or between different PIRFT techniques. Two additional randomized controlled trials compared IDET with placebo. One suggested differences only in pain and in disability, while the best-designed randomized controlled trial showed no differences. The authors concluded that the current available evidence does not support the effectiveness of IDET or PIRFT for the treatment of discogenic low back pain. The study is limited in its heterogeneity.

In a systematic review, Helm et al. (2009) evaluated the safety and effectiveness of thermal annular procedures, including PIRFT, in treating discogenic low back pain. The authors noted that the thermal annular procedures continue to remain controversial, coupled with a paucity of evidence. A comprehensive review of relevant literature was performed and evaluated according to Cochrane Review criteria for randomized controlled trials and the Agency for Healthcare Research and Quality (AHRQ) for observational studies. The primary outcome measurement was pain relief. Secondary outcomes included functional improvement, improvement of psychological status, and return to work. The authors concluded that there was a general paucity of literature and that there was minimal evidence supporting the use of PIRFT.

In a prospective, double-blind, randomized controlled trial, Kvarstein et al. (2009) evaluated the safety and effectiveness of PIRFT for the treatment of chronic discogenic low back pain. Twenty patients with chronic low back pain and single-level pressure controlled provocation discography were randomized to intra-annular PIRFT or intra-annular sham treatment. The primary outcome measurement was VAS pain scores. The authors noted that at 6 month follow-up analysis did not reveal any statistically significant differences between PIRFT and sham treatment or from baseline in VAS pain scores. At 12 month follow-up, the overall reduction from baseline pain reached statistical significance, but there was no statistically significant difference between the two groups. Additionally, several patients reported increased pain levels in both groups. The authors concluded that they could not recommend PIRFT for the treatment of chronic discogenic low back pain. The study is limited in its small sample size and short-term follow-up period.

SUMMARY

There are very few randomized controlled trials evaluating the effectiveness of percutaneous intradiscal annuloplasty, including IDET and PIRFT, compared to conservative management or conventional surgical approaches (e.g., standard discectomy, spinal fusion). Additionally, there exist studies that do not support the use of percutaneous intradiscal annuloplasty due to concerns about persistent and increased pain following the procedure.

In 2006, Airaksinen et al. published the European guidelines for the management of chronic nonspecific low back pain. In these guidelines, it is noted that there is conflicting evidence regarding the safety and effectiveness of procedures such as IDET or PIRFT. In fact, in patients with discogenic low back pain, these procedures may not be more effective than sham treatments. Therefore, the use of intradiscal radiofrequency or electrothermal coagulation for the treatment of either nonspecific or discogenic low back pain was not recommended.

In 2008, a National Coverage Determination (NCD) from the Centers for Medicare and Medicaid Services (CMS) addressed thermal intradiscal procedures to relieve low back pain. CMS determined that thermal intradiscal procedures were not reasonable and necessary for the treatment of low back pain. Therefore, procedures which employed the use of a radiofrequency energy source or electrothermal energy to apply or create heat and/or disruption within the disc for the treatment of low back pain would not be covered.

In a 2009 guideline, the National Institute for Health and Clinical Excellence (NICE) addressed percutaneous intradiscal electrothermal therapies for low back pain. Noted adverse events related to the procedure included postprocedural pain, infection, and vertebral osteonecrosis. Concerns about potential nerve root injury, bleeding, cerebrospinal fluid leak, and postprocedural disc herniation were indicated as well. NICE concluded that the current evidence on the safety and effectiveness of percutaneous intradiscal electrothermal therapy for low back pain was inconsistent. Therefore, NICE recommended that the procedure be performed in the context of research.

In a 2013 guideline, the American Society of Interventional Pain Physicians highlighted a number of studies concluding that IDET was not effective in treating discogenic back pain. They noted several studies which were of low quality and concluded that there was limited to fair evidence for IDET.

The current available peer-reviewed literature and scientific evidence is insufficient to permit conclusions regarding the safety and effectiveness of percutaneous intradiscal annuloplasty, including IDET and PIRFT. The majority of the available literature consists of prospective case series and randomized controlled trials that do not compare IDET or PIRFT to established treatment methods (e.g., standard discectomy, spinal fusion) or conservative management. Larger randomized controlled trials with appropriate follow-up and valid comparative control groups are necessary to help determine the safety, effectiveness, and long-term outcomes of percutaneous intradiscal annuloplasty procedures.
References


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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):237-248.

Appleby D, Andersson G, Totta M. Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET). Pain Med. 2006;7(4):308-316.

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, et al. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006;15(S2):s192-s300.

Barendse GA, van Den Berg SG, Kessels AH, Weber WE, van Kleef M. 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(3):287-292.

BlueCross BlueShield Association (BCBSA) Technology Evaluation Center. Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic low back pain [technology assessment]. Assessment Program Volume 18, No. 19. February 2004. Also available on the BCBS Web site at: http://blueweb.bcbs.com/global_assets/special_content/tec_assessments/vol18/18_19.pdf. Accessed July 9, 2015.

Bogduk N, Karasek M. Two-year follow-up of a controlled trial of intradiscal thermal annuloplasty for chronic low back pain resulting from internal disc disruption. Spine J. 2002;2(5):343-350.

Boswell MV, Trescot AM, Datta S, et al; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007;10(1):7-111.

Bryce DA, Nelson J, Glurich I, Berg RL. Intradiscal electrothermal annuloplasty therapy: a case series study leading to new considerations. WMJ. 2005;104(6):39-46.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).150.11: Thermal intradiscal procedures (TIPs). [CMS Web site]. 09/29/08. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=324&ncdver=1&NCAId=215&IsPopup=y&bc=AAAAAAAAAgAAAA%3D%3D&. Accessed July 9, 2015.

Chou LH, Lew HL, Coelho PC, Slipman CW. Intradiscal electrothermal annuloplasty. Am J Phys Med Rehabil. 2005;84(7):538-549.

Cohen SP, Larkin T, Polly DW Jr. A giant herniated disc following intradiscal electrothermal therapy. J Spinal Disord Tech.2002;15(6):537-541.

Cohen SP, Williams S, Kurihara C, Griffith S, Larkin TM. Nucleoplasty with or without intradiscal electrothermal therapy (IDET) as a treatment for lumbar herniated disc. J Spinal Disord Tech. 2005;18 Suppl:S119-S124.

Derby R, Eek B, Chen Y, O'Neill C, Ryan D. Intradiscal electrothermal annuloplasty (IDET): a novel approach for treating chronic discogenic back pain. Neuromodulation. 2000;3(2):82-88. Also available on the Blackwell Synergy Web site at: http://www.blackwell-synergy.com/doi/abs/10.1046/j.1525-1403.2000.00082.x [via subscription only]. Accessed July 9, 2015.

Derby R, Seo KS, Kazala K, et al. A factor analysis of lumbar intradiscal electrothermal annuloplasty outcomes. Spine J. 2005;5(3):256-262.

Djurasovic M, Glassman SD, Dimar JR 2nd, Johnson JR. Vertebral osteonecrosis associated with the use of intradiscal electrothermal therapy: a case report. Spine. 2002;27(13):E325-E328.

Endres SM, Fiedler GA, Larson KL. Effectiveness of intradiscal electrothermal therapy in increasing function and reducing chronic low back pain in selected patients. WMJ. 2002;101(1):31-34.

Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2005;30(21):2369-2377.

Gerszten PC, Welch WC, McGrath PM, Willis SL. A prospective outcomes study of patients undergoing intradiscal electrothermy (IDET) for chronic low back pain. Pain Physician. 2002;5(4):360-364.

Hägg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12(1):12-20.

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Hsia AW, Isaac K, Katz JS. Cauda equina syndrome from intradiscal electrothermal therapy. Neurology. 2000;55(2):320.

Kapural L, Hayek S, Malak O, Arrigain S, Mekhail N. Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the treatment of discogenic pain: a prospective matched control trial. Pain Med. 2005;6(6):425-431.

Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract. 2007;7(2):130-134.

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.

Kapural L, Vrooman B, Sarwar S, et al. Radiofrequency intradiscal biacuplasty for treatment of discogenic lower back pain: a 12-month follow-up. Pain Med. Mar 2015;16(3):425-431.

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. 2000;25(20):2601-2607.

Lachin JL. Statistical considerations in the intent-to-treat principle. Control Clin Trials. 2000;21(5):526.

Lutz C, Lutz GE, Cooke PM. Treatment of chronic lumbar diskogenic pain with intradiskal electrothermal therapy: a prospective outcome study. Arch Phys Med Rehabil. 2003;84(1):23-28.

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National Institute for Health and Clinical Excellence (NICE). Percutaneous intradiscal electrothermal therapy for lower back pain. [NICE Web site]. 08/25/04. Available at: http://www.nice.org.uk/guidance/ipg319. Accessed July 9, 2015.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT INTRADISCAL ELECTROTHERMAL THERAPY (IDET)

22526, 22527


THE FOLLOWING CODE IS USED TO REPRESENT INTRADISCAL ANNULOPLASTY, ANY METHOD EXCEPT ELECTROTHERMAL (IDET)

22899


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This procedure is experimental/investigational for all diagnoses.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions for 11.14.14e:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 07/03/2013
Version Issued Date: 07/03/2013
Version Reissued Date: 11/27/2018

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