Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, Biacuplasty and Intraosseous Basivertebral Nerve Ablation

POLICY NUMBER

A.7.01.72

DESCRIPTION

Electrothermal intradiscal annuloplasty therapies use radiofrequency energy sources to treat discogenic low back pain arising from annular tears. These annuloplasty techniques are designed to decrease pain arising from the annulus by thermocoagulating nerves in the disc and tightening of annular tissue.

Discogenic Low Back Pain

Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptom findings, in conjunction with radiologically confirmed degenerative disc disease.

Treatment

Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.

A number of electrothermal intradiscal procedures have been introduced to treat discogenic low back pain; they rely on various probe designs to introduce radiofrequency energy into the disc. It has been proposed that heat-induced denaturation of collagen fibers in the annular lamellae may stabilize the disc and potentially seal annular fissures. Pain reduction may occur through the thermal coagulation of nocioceptors in the outer annulus.

With the intradiscal electrothermal annuloplasty procedure, a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. Using indirect radiofrequency 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 intradiscal electrothermal annuloplasty 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. Annuloplasty using a laser-assisted spinal endoscopy kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described.

Percutaneous intradiscal radiofrequency thermocoagulation uses direct application of radiofrequency energy. With percutaneous intradiscal radiofrequency thermocoagulation, 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 Radiofrequency Disc Catheter System has been specifically designed for this purpose.

Intradiscal biacuplasty uses 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.

Vertebral body endplates have been proposed as a source of lower back pain, caused by intraosseous nerves. The basivertebral nerve enters the posterior vertebral body and sends branches to the superior and inferior endplates. Vertebrogenic pain, transmitted via the basivertebral nerve, has been purported to occur with endplate damage or degeneration.

A variety of radiofrequency coagulation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA), some of which are designed for disc nucleotomy. In 2002, the Oratec Nucleotomy Catheter (ORATEC Interventions, Menlo Park, CA, acquired by Smith & Nephew in 2002) was cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. The Radionics (a division of Tyco Healthcare group) Radiofrequency Disc Catheter System received marketing clearance by the FDA through the 510(k) process in 2000. FDA product code: GEI.

In 2005, the Baylis Pain Management Cooled Probe was also cleared for marketing by the FDA through the 510(k) process. It is intended for use “in conjunction with the Radio Frequency Generator to create radiofrequency lesions in nervous tissue.” FDA product code: GXI

The Intracept Intraosseous Nerve Ablation System “is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care.” The FDA reviewed the device and issued a substantially equivalent designation in August 2017 (K170827). In March of 2022, the FDA issued a substantially equivalent designation for an additional Intracept Intraosseous Nerve Ablation System (Relievant Medsystems, Inc.; K213836). The prior device (K170827) is listed as the reference access instrument and the new indication adds a description of accompanying use case features, "...is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change)." FDA product code: GXI.

Note: This policy does not address disc nucleoplasty, a technique based on the bipolar radiofrequency device (Coblation®; ArthroCare, Austin, TX, acquired by Smith & Nephew, 2014). With the coblation system, a bipolar radiofrequency device is used to provide lower energy treatment 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 to provide decompression of a bulging disc. Disc nucleoplasty and laser discectomy are considered separately in the Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty) medical policy.

POLICY

Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.

Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered investigational.

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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.

POLICY HISTORY

11/1999: 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.

05/31/2016: Policy number A.7.01.72 added.

03/08/2017: Policy title changed from "Percutaneous Intradiscal Electrothermal (IDET) Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty" to "Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty." Policy description updated regarding discogenic low back pain and devices. Policy statement updated to change "percutaneous intradiscal radiofrequency thermocoagulation" to "intradiscal radiofrequency annuloplasty."

02/08/2018: Policy description updated. Policy statement unchanged.

05/13/2019: Policy reviewed; no changes.

05/22/2020: Policy description updated. Policy statement unchanged.

07/21/2021: Policy description updated. Policy statement unchanged.

12/15/2021: Code Reference section updated to add new CPT codes 64628 and 64629, effective 01/01/2022.

11/09/2022: Policy title changed from "Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty" to "Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, Biacuplasty and Intraosseous Basivertebral Nerve Ablation." Policy description updated regarding vertebral body endplates and devices. Policy section updated to add that intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered investigational. Code Reference section updated to add CPT code 22899.

05/23/2023: Policy reviewed; no changes.

10/13/2023: Policy reviewed; no changes.

05/21/2024: Policy reviewed; no changes.

05/14/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.72

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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