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Laser energy (laser discectomy) and radiofrequency (RF) coblation (nucleoplasty) are being evaluated for decompression of the intervertebral disc. For laser disectomy under fluoroscopic guidance, a needle or catheter is inserted into the disc nucleus, and a laser beam directed through it to vaporize tissue. For disc nucleoplasty, bipolar radiofrequency energy is directed into the disc to ablate tissue. These minimally invasive procedures are being evaluated for the treatment of discogenic back pain.
Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptoms findings, in conjunction with radiologically confirmed degenerative disc disease. Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.
A variety of minimally invasive techniques have been investigated as a treatment of low back pain related to disc disease. Techniques can be broadly divided into those designed to remove or ablate disc material, and thus decompress the disc, and those designed to alter the biomechanics of the disc annulus. The former category includes chymopapain injection, automated percutaneous lumbar discectomy, laser discectomy, and, most recently, disc decompression using radiofrequency energy, referred to as a disc nucleoplasty.
Techniques that alter the biomechanics of the disc (disc annulus) include a variety of intradiscal electrothermal procedures that are discussed in the Percutaneous Intradiscal Electrothermal (IDET) Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty medical policy.
A variety of different lasers have been investigated for laser discectomy, including YAG, KTP, holmium, argon, and carbon dioxide lasers. Due to differences in absorption, the energy requirements and the rate of application differ among the lasers. In addition, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary by length of treatment, but typically the laser is activated for brief periods only.
RF coblation uses bipolar low- frequency energy in an electrical conductive fluid (eg, saline) to generate a high-density plasma field around the energy source. This creates a low-temperature field of ionizing particles that break organic bonds within the target tissue. Coblation is used in a variety of surgical procedures, particularly related to otolaryngology. The disc nucleoplasty procedure is accomplished with a probe mounted with a RF coblation source. The proposed advantage of coblation technology is that the procedure provides for a controlled and highly localized ablation, resulting in minimal damage to surrounding tissue.
The ArthroCare SpineWand used coblation technology (ArthroCare, Austin, TX). ArthroCare was acquired by Smith & Nephew in 2014; as of 2017, Smith & Nephew has not provided any information about coblation devices specific to spine surgeries on its website.
A number of laser devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for incision, excision, resection, ablation, vaporization, and coagulation of tissue. Intended uses described in FDA summaries include a wide variety of procedures, including percutaneous discectomy. Trimedyne Inc. received 510(k) clearance in 2002 for the Trimedyne® Holmium Laser System Holmium:Yttrium, Aluminum Garnet (Holmium:YAG), in 2007 RevoLix Duo™ Laser System, and in 2009 Quanta System LITHO Laser System. All were cleared, based on equivalence with predicate devices for percutaneous laser disc decompression/discectomy, including foraminoplasty, percutaneous cervical disc decompression/discectomy, and percutaneous thoracic disc decompression/discectomy. The summary for the Trimedyne® system states that indications for cervical and thoracic decompression/discectomy include uncomplicated ruptured or herniated discs, sensory changes, imaging consistent with findings, and symptoms unresponsive to 12 weeks of conservative treatment. Indications for treatment of cervical discs also include positive nerve conduction studies.
In 2001, the Perc-D SpineWand™ (ArthroCare) was cleared for marketing by FDA through the 510(k) process. FDA determined that this device was substantially equivalent to predicate devices. It is used in conjunction with the ArthroCare Coblation® System 2000 for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs. Smith and Nephew acquired ArthroCare in 2014.
See separate policy for Automated Percutaneous and Endoscopic Discectomy.
POLICYLaser discectomy and radiofrequency coblation (disc nucleoplasty) are considered investigational as techniques of disc decompression and treatment of associated pain.
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.
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 HISTORY11/2002:Approved by Medical Policy Advisory Committee (MPAC)
8/26/2003: ICD-9 diagnosis code ranges 722.51-722.52, 722.90-722.93 listed separately
3/10/2004: Code Reference section reviewed, no changes
3/25/2004: Reviewed by MPAC, title "Laser Discectomy" renamed "Decompression of Intervertebral Discs Using Laser (Laser Discectomy) or Radiofrequency Energy (DISC NucleoplastyTM)", Laser discectomy remains investigational, DISC nucleoplastyTM considered investigational, Description section revised to be consistent with BCBSA policy # 7.01.93
5/3/2004: Code Reference section updated, CPT code 62287 "For fluoroscopic guidance, use 76003" added, CPT code 76003 added, ICD-9 diagnosis code 722.0, 722.10, 722.2, 722.4, 722.51, 722.52, 722.6, 722.90, 722.91, 722.92, 722.93 deleted
8/1/2005: Code Reference section updated, HCPCS S2348 with effective date 1/1/2005 added
12/27/2006: Code Reference section updated per the 2007 CPT revisions
9/18/2007: Policy reviewed, no changes
12/31/2008: CPT 62267 added as non-covered; CPT 62287 description revised
4/6/2009: Policy reviewed, no changes
07/15/2010: Policy title updated to change the term "Radiofrequency Energy" to "Radiofrequency Coblation." Policy description updated to include information regarding the availability and FDA status of laser devices. 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.
11/06/2013: Policy reviewed; no changes.
09/04/2014: Policy reviewed; description updated. Policy statement revised to add "radiofrequency coblation." Intent of policy statement unchanged. Removed deleted CPT code 76003 from the Code Reference section. Removed "For fluoroscopic guidance, use 76003" from CPT code 62287 description in Code Reference section.
08/28/2015: Code Reference section updated for ICD-10. Replaced CPT code 77002 with 77003. Updated the description of CPT code 62287.
11/03/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in policy guidelines section.
05/31/2016: Policy number A.7.01.93 added.
12/30/2016: Code Reference section updated to revise code descriptions for CPT codes 62287 and 77003.
01/30/2017: Policy description updated regarding discogenic low back pain and coblation. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.93
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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