BlueCross BlueShield of Tennessee Medical Policy Manual

Intradiscal  Annuloplasty for Treatment of Discogenic Back Pain

DESCRIPTION

Intradiscal annuloplasty therapies use energy sources to thermally treat discogenic low back pain arising from tears in the tough outer wall, or annulus of the spinal disc. Thermal annuloplasty procedures are done under fluoroscopy and are intended to decrease low back pain and enhance the structural integrity of the disc.

With the intradiscal electrothermal annuloplasty (IDET™) procedure, a navigable catheter is inserted posterolaterally into the disc. The catheter is then navigated through the disc to the desired position. Using indirect radiofrequency energy, heat is generated to a temperature of 90 degrees centigrade (195’F) for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy include precise temperature feedback, and heat-induced shrinkage of collagen fibers to seal annular fissures without excessive damage and thermocoagulate nerve tissue, thereby stabilizing the disc and reducing pain.

Another procedure, referred to as percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), uses direct application of radiofrequency energy. With PIRFT, the radiofrequency probe is placed into the center of the disc, and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The procedure is not designed to coagulate, burn, or ablate tissue.

A more recently developed annuloplasty procedure, referred to as intradiscal biacuplasty, involves the use of two cooled radiofrequency 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.

Examples of devices used for these procedures include the IDET™, Oratec SpineCath®, discTRODE™, Radionics RF Disc Catheter System® and Baylis Pain Management Cooled Probe.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

There is insufficient evidence to permit conclusions regarding the use of these technologies compared to established alternative treatments; therefore, these procedures remain investigational.

SOURCES 

American Society of Interventional Pain Physicians. (2013). An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Retrieved October 10, 2016 from the National Guideline Clearinghouse (NGC: 009842).

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017). Percutaneous intradiscal electrothermal annuloplasty, radiofrequency annuloplasty, and biacuplasty (7.01.72) Retrieved October 2, 2017 from BlueWeb. (15 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for thermal intradiscal procedures (TIPs) (150.11). Retrieved December 2, 2015 from https://www.cms.gov.

Desai, M., Kapural, L., Petersohn, J., Vallejo, R., Menzies, R, Creamer, M., & Gofeld, M. (2017). Twelve-month follow-up of a randomized clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Pain Medicine, 18 (4), 751-763. Abstract retrieved October 2, 2017 from PubMed database.

Helm, S., Simopoulos, T., Stojanovic, M., Abdi, S., El Terany, M. (2017). Effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician, 20 (6), 447-470. Abstract retrieved October 2, 2017 from PubMed database.

National Institute for Health and Care Excellence. (2016, January). Percutaneous electrothermal treatment of the intervertebral disc annulus for low back pain and sciatica. Retrieved October 2, 2017 from www.nice.org.uk/guidance/ipg544.

National Institute for Health and Care Excellence. (2016, January). Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus for low back pain. Retrieved October 2, 2017 from www.nice.org.uk/guidance/ipg545.

U. S. Food and Drug Administration (2013, January) Center for Devices and Radiologic Health, 510(k) Premarket Notification Database. K122854. Retrieved October 10, 2016 from http://www.fda.gov.

ORIGINAL EFFECTIVE DATE:  8/1/2000

MOST RECENT REVIEW DATE:  10/26/2017

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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