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Intradiscal annuloplasty therapies use energy sources to treat discogenic low back pain arising from annular tears. Thermal and radiofrequency 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 nocioceptors 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 90ºC; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency 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 radiofrequency needle.
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 70ºC. 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, Montreal, Canada), 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.
Annuloplasty using a laser-assisted spinal endoscopy kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described.
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 (Covidien) is marketing the discTRODE™ RF catheter electrode system for use with the RFG-3CPlus™ RF lesion generator in the United States.
The Baylis Pain Management Cooled Probe received marketing clearance through the U.S. Food and Drug Administration’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 radiofrequency 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 the Decompression of Intervertebral Discs Using Laser (Laser Discectomy) or Radiofrequency Energy (DISC Nucleoplasty™) policy.
POLICYPercutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, percutaneous intradiscal radiofrequency thermocoagulation, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/1999: Approved by Medical Policy Advisory Committee (MPAC)
5/21/2001: Code Reference section revised
2/12/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
10/1/2002: Description section revised to be consistent with BCBSA policy, Policy number added to Sources
9/29/2003: HCPCS S2370, S2371 added
11/2003: Reviewed by MPAC, remains investigational
1/21/2004: Code Reference section reviewed; no changes
2/18/2005: Policy reviewed, CPT code 0062T, 0063T added
3/22/2005: CPT code 64999 Note: "There is no specific CPT code for this investigational procedure" deleted and Note: "To report services on or after 1-1-2005, see CPT codes 0062T-0063T" added
4/4/2006: Policy updated.
1/2/2007: Code Reference section updated per the 2007 CPT/HCPCS revisions
1/5/2007: Policy reviewed, no changes
4/3/2008: Revised policy statement to include disc biacuplasty as investigational. CPT 0062T added. Policy title changed to "Percutaneous Intradiscal Electrothermal Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty." Previous title was "Intradiscal Electrothermal Annuloplasty (IDET)."
4/24/2008: Policy reviewed, no changes
12/17/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions
09/09/2010: Policy reviewed. Added link to related policy. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
08/03/2011: Policy reviewed. Policy statement unchanged. Deleted outdated references from the Sources section.
09/25/2012: Policy reviewed; no changes.
10/22/2013: Policy reviewed; no changes to policy statement. Removed deleted CPT codes 0062T and 0063T from the Code Reference section.
09/03/2014: Policy reviewed; description updated. Policy statement unchanged.
08/26/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 03.99 from the Code Reference section. Removed deleted HCPCS codes S2370 and S2371.
11/05/2015: Policy description updated regarding devices. Policy statement unchanged. Investigative definition updated in the policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.72
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.