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Date Printed: December 18, 2017: 03:26 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

02-61000-20

Original Effective Date: 09/15/01

Reviewed: 01/22/15

Revised: 11/01/15

Subject: Thermal Intradiscal Procedures (e.g., IDET, IDB, PIRFT)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates    

DESCRIPTION:

Intradiscal electrothermal annuloplasty (IDET™) using FDA-approved devices such as the Oratec SpineCath system specifically describes a minimally invasive annuloplasty procedure used to treat chronic low-back pain related to disc disease. First, the affected disc is identified using pressure-based diskography. Next, a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally (behind and to the side) into the disc annulus or nucleus. The catheter is then snaked through this area of the disc and returned posteriorly. Using radiofrequency energy, electrothermal heat is then generated within the thermal resistive coil at a temperature of 90 degrees centigrade; the disc material is heated for up to 20 minutes. IDET™ is not designed to coagulate, burn, or ablate tissue. The mechanism of action of pain relief is not precisely understood, but is thought to be related to either shrinkage of the collagen fibers within the annulus or destruction of the adjacent nociceptive pain fibers.

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) refers to the direct application of radiofrequency energy. In this procedure, the radiofrequency probe is placed into the center of the disc rather than around the annulus and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The Radionics RF Disc Catheter System has been specifically designed for this purpose. The mechanism of action of this procedure is not precisely understood, but thought to be related to reduce the nociceptive pain input from the free nerve ending in the outer annulus fibrosis. Based on the destruction of nociceptive pain fibers, the Radionics Disc Catheter System is similar in concept to IDET but the method of delivering the thermal energy is distinctly different. The proposed advantages of electrothermal delivery of energy (i.e., the IDET procedure) compared to a radiofrequency needle (i.e., the Radionics device) is related to the fact that IDET provides electrothermocoagulation to a broader tissue segment and allows precise temperature control and temperature feedback.

Intradiscal biacuplasty (IDB) is similar to IDET and has been investigated in the treatment of chronic low back pain. IDB is performed using a bipolar approach in conjunction with internally water-cooled radiofrequency probes for coagulating and decompressing the disc material. Two introducers are placed bilaterally in the posterolateral discs and the TransDiscal probes are then inserted into the introducers. Radiofrequency energy is then applied and directed through the disc between the two probe electrodes. The cooling system is designed to maintain and balance the temperature in each probe, allowing the radiofrequency energy to be delivered with greater power to heat a larger volume of disc tissue, while avoiding overheating adjoining tissue. This procedure is performed using the Baylis TransDiscal™ system.

POSITION STATEMENT:

Intradiscal electrothermal annuloplasty (IDET) is considered experimental or investigational, as there is insufficient clinical evidence to support the use of intradiscal electrothermal annuloplasty to treat chronic low-back pain.

Intradiscal biacuplasty (IDB) is considered experimental or investigational as there is insufficient published clinical studies to determine health outcomes or long- term effects of the procedure.

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) is considered experimental or investigational, as there is insufficient clinical evidence to support the use of PIRFT to treat chronic low-back pain.

For thermal intradiscal procedures there is a lack of sufficient clinical studies in the published peer reviewed literature that reports the long-term effects on net health outcomes.

NOTE: IDET and PIRFT procedures include discography (e.g., provocative discography, stimulation discography).

BILLING/CODING INFORMATION:

The following codes describe intradiscal electrothermal annuloplasty (IDET) and percutaneous intradiscal radiofrequency thermocoagulation (PIRFT):

CPT Coding:

22526

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

22527

Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; 1 or more levels (list separately in addition to code for primary procedure) (investigational)

NOTE: CPT code 62292 has been most commonly used to describe the injection of chymopapain and has been reported for coding of intradiscal annuloplasty. However, intradiscal annuloplasty does not involve chemonucleolysis, and thus does not describe annuloplasty. Similarly, thermal annuloplasty does not involve neurolytic agents (as described by CPT code 64640), and does not involve injection of substances (as described by CPT code 62288).

There is no specific CPT code for intradiscal biacuplasty (IDB).

REIMBURSEMENT INFORMATION:

Refer to Section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determinations (NCD) were reviewed on the last guideline reviewed date: Laser Procedures (140.5) and Thermal Intradiscal Procedures (TIPS) (150.11) located at cms.gov.

DEFINITIONS:

Annuloplasty: can refer to plastic repair of a cardiac valve or to the “molding” or “reshaping” of the annulus of a vertebral disk.

Disk annulus (anulus): fibrous ring of intervertebral disk; the circumferential ring-like portion of an intervertebral disk, composed of fibrocartilage and fibrous tissue; also called annulus fibrous disci intervertebralis; fibrous ring of intervertebral disk.

Diskectomy: excision of an intervertebral disk.

Diskography: roentgenography (x-ray) of the spine for visualization of an intervertebral disk after injection of contrast media into the disk.

Electrothermal: an electrosurgical appliance used for cutting.

Nociceptive pain: pain that is detected by specialized sensory nerves. These nerves are located throughout the soft tissues, such as muscles and skin, as well as the internal organs. There are two types of nociceptive pain: somatic pain and visceral pain. Somatic pain comes from the joints, bones, muscles and other soft tissues, while visceral pain comes from the internal organs.

Thermocoagulation: coagulation of tissue by the action of high-frequency currents; used in the removal of growths and also to produce stereotactic lesions in the brain.

RELATED GUIDELINES:

Percutaneous Decompression of Intervertebral Discs, 02-61000-32

OTHER:

Note: 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.

Other terms associated with thermal intradiscal procedures:

Accutherm

discTRODE

SpineCath

TransDiscal electrodes

REFERENCES:

  1. American Society of Anesthesiologists Task Force on Chronic Pain Management, American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010 Apr; 112(4):810-33.
  2. American Society of Interventional Pain Physicians - An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part II: Guidance and Recommendations. Pain Physician 2013; 16:S49-S283.
  3. American Academy of Orthopaedic Surgeons (AAOS); online service fact sheet for IDET, 03/02, accessed at aaos.org on 06/01/07.
  4. An H, Boden, SD, Kang J, Sandhu HS, Abdu W, Weinstein J. Summary statement: emerging techniques for treatment of degenerative lumbar disc disease. Spine. 2003 Aug 1: 28(15 Suppl): S24-5.
  5. Andersson GB, Mekhail NA, Block JE. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2006 Jun 15; 31(14): 1637-8; author reply 1638.
  6. 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 Jul; 9(3):237-48.
  7. Biyani A, Andersson GB, Chaudhary H, An HS. Intradiscal Electrothermal therapy: a treatment option in patients with internal disc disruption. Spine. 2003 Aug 1; 28(15 Suppl): S8-14
  8. Blue Cross Blue Shield Association Technology Evaluation Center “Percutaneous Intradiscal Radiofrequency Thermocoagulation for Chronic Discogenic Low Back Pain”, Volume 18, No. 19 February 2004.
  9. Blue Cross Blue Shield Association. Medical Policy Reference Manual. 7.01.72 – Percutaneous Intradiscal Electrothermal (IDET) Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty 07/10/14.
  10. Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan; 10(1): 7-111.
  11. California Technology Assessment Forum (CTAF). IDET-Intradiscal Electrothermal Therapy for Treatment of Back Pain. Technology Assessment. San Francisco, CA: October 8, 2003.
  12. Canadian Coordinating Office for Health Technology Assessment. Intradiscal electrothermal therapy (IDET) for the treatment of chronic, discogenic low back pain. Ottawa: Canadian Coordinating Office for Health Technology Assessment (CCOHTA), 2003.
  13. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination for Laser Procedures (140.5). 05/01/97.
  14. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination for Thermal Intradiscal Procedures (TIPS) (150.11). 09/29/08.
  15. Cohen SP, Larkin T, Abdi S, Chang A, Stojanovic M. Risk factors for failure and complications of intradiscal electrothermal therapy: a pilot study. Spine. 2003 Jun 1; 28(11): 1142-7.
  16. Danish Centre for Evaluation and Health Technology Assessment. Intradiscal electrocoagulation therapy (IDET) for chronic back pain – Early Warning on New Health Technology 2003 2(7). Copenhagen: Danish Centre for Evaluation and Health Technology Assessment (DACEHTA), 2003
  17. ECRI Health Technology Assessment Information Services. Custom Hotline Response. Intradiscal Electrothermal Therapy (IDET) for Discogenic Pain. Updated 07/10/06.
  18. ECRI. Emerging Technology (TARGET) Evidence Report. Intradiscal Electrothermal Annuloplasty for discogenic pain. Plymouth Meeting, PA: ECRI. February 2008.
  19. ECRI Product Brief. Intradiscal Electrothermal Therapy (NeuroTherm, Inc.) for Treating Discogenic Pain (09/2012).
  20. Florida Medicare Part B Local Coverage Determination. L5780 NCSVCS The List of Medicare Noncovered Services (07/01/08).
  21. 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 Nov 1; 30(21): 2369-77.
  22. Gibson JNA, Waddell G. Surgery for degenerative lumbar spondylosis. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD001352. DOI: 10.1002/14651858.CD001352.pub3.
  23. HAYES Medical Technology Directory. “Intradiscal Electrothermal Therapy” – (05/06/03), Update performed 01/30/08.
  24. Hayes, Inc. Hayes, Inc., Disc Nucleoplasty® (Perc™-D® SpineWand™) (ArthroCare Corp.) for Percutaneous disc Decompression, 04/25/07.
  25. Heary RF. Intradiscal Electrothermal Annuloplasty: the IDET procedure. J Spinal Disord. 2001 Aug; 14(4): 353-60.
  26. Hegmann KT, ed. Low back disorders. In: Glass LS, editor(s). Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2007. p. 366.
  27. Helm S, Hayek SM, Benyamin RM, Manchikanti L. Systematic review of the effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician. 2009 Jan-Feb;12(1):207-32.
  28. Helm S, Deer TR, Manchikanti L, Datta S, Chopra P, Singh V, Hirsch JA. Effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician. 2012 May-Jun;15(3):E279-304.
  29. Institute for Clinical Systems Improvement. Health Care Guideline: Assessment and Management of Chronic Pain. Bloomington, MN: Institute for Clinical Systems Improvement (ICSI), November 2005.
  30. Institute for Clinical Systems Improvement. Intradiscal electrothermal therapy (IDET) for low back pain. Technology Assessment Report #62. Bloomington, MN: Institute for Clinical Systems Improvement (ICSI), 2002.
  31. 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 Nov-Dec; 6(6): 425-31.
  32. Kapural L, Mekhail N. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2006 Jun 15; 31(14): 1636; author reply 1636-7.
  33. Karaman H, Tüfek A, Kavak GÖ, Kaya S, Yildirim ZB, Uysal E, Celik F. 6-month results of TransDiscal Biacuplasty on patients with discogenic low back pain: preliminary findings. Int J Med Sci. 2010 Dec 14;8(1):1-8.
  34. Manchikanti L, Boswell MV, SinghV, Benyamin RM, Fellows B, Abdi S, Buenaventura R, Conn A, Datta S, Derby R, Falco F, Erhart S, Diwan S, Hayek S, Helm II S, Parr AT, Schultz D, Smith H, Wolfer LR, Hirsch JA. Comprehensive Evidence-Based Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain. Pain Physician 2009; 12:699-802.
  35. Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-S283.
  36. National Guideline Clearinghouse. Low back disorders. Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2007. Updated by ECRI Institute 04/13/11.
  37. National Institute for Health and Clinical Excellence. IPG83 Percutaneous intradiscal radiofrequency thermocoagulation for lower back pain. 2004; Available online at: http://guidance.nice.org.uk/IPG83. Accessed 12/10/13.
  38. National Institute for Health and Clinical Excellence. IPG319 Percutaneous intradiscal electrothermal therapy for low back pain: guidance. 2009; Available online at: http://guidance.nice.org.uk/IPG319/Guidance/pdf/English. Accessed 12/10/13.
  39. North American Spine Society. Diagnosis and treatment of lumbar disc herniation with radiculopathy. Burr Ridge (IL): North American Spine Society; 2012. 100 p.
  40. Ohio Bureau of Workers’ Compensation (BWC). Position Paper on Intradiscal Electrothermal (IDET) Treatment for Low Back Pain. Medical Position Papers. Columbus, OH: Ohio BWC; December 2005
  41. Park SY, Moon SH, Park MS, Kim HS, Choi YJ, Lee HM. Intradiscal electrothermal treatment for chronic lower back pain patients with internal disc disruption. Yonsei Med J. 2005 Aug 31; 46(4): 539-45.
  42. Pauza KJ, Howell S, Dreyfuss P, Peloza JH, Dawson K, Bogduk N. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004 Jan-Feb; 4(1):27-35.
  43. Wetzel FT, McNally TA, Phillips FM. Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions. Spine. 2002 Nov 15; 27(22): 2621-6.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/22/15.

GUIDELINE UPDATE INFORMATION:

09/15/11

Scheduled review; position statement unchanged; references updated.

01/15/13

Scheduled review; position statement unchanged; references updated.

02/15/14

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

02/15/15

Annual review; formatting changes; position statement unchanged; Program Exceptions section updated; references updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: December 18, 2017: 03:26 PM