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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.
A variety of minimally invasive techniques have been investigated over the years as a treatment of low back pain related to disc disease. Techniques can be broadly divided into techniques that are 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 nucleoplastyTM.
Techniques that alter the biomechanics of the disc (disc annulus) include intradiscal electrothermal annuloplasty (i.e., the percutaneous intradiscal electrothermal annuloplasty [IDET] procedure) or percutaneous intradiscal radiofrequency thermocoagulation (PIRFT). It should be noted that 3 of these procedures use radiofrequency energy -- disc nucleoplasty, IDET and PIRFT – but apply the energy in distinctly different ways such that the procedures are unique.
Patients considered candidates for DISC nucleoplasty™ or laser discectomy include patients with bulging discs and sciatica. In contrast, the presence of a herniated disc is typically considered a contraindication for the IDET or PIRFT procedure. The IDET and PIRFT procedures, chymopapain injection, and automated percutaneous lumber discectomy are considered in separate policies. Laser discectomy and DISC nucleoplasty™ are the subjects of this 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 according to the length of treatment, but typically the laser is activated for brief periods only.
The Disc nucleoplastyTM procedure uses bipolar radiofrequency energy in a process referred to as coblation technology. The technique consists of small, multiple electrodes that emit a fraction of the energy required by traditional radiofrequency energy systems. The result is that a portion of nucleus tissue is ablated, not with heat, but with a low-temperature plasma field of ionized particles. These particles have sufficient energy to break organic molecular bonds within tissue, creating small channels in the disc. The proposed advantage of this coblation technology is that the procedure provides for a controlled and highly localized ablation, resulting in minimal therapy damage to surrounding tissue.
A number of laser devices have received FDA 510(k) clearance 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 Ho1mium:Yttrium Aluminum Garnet (Ho1mium:YAG), RevoLix Duo™ Laser System in 2007, and Quanta System LITHO Laser System in 2009. 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.
ArthroCare’s Perc-D SpineWand™ received 510(k) clearance in 2001 based on equivalence 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 Percutaneous Lumbar Discectomy.
POLICYLaser Discectomy and radiofrequency coblation (DISC nucleoplastyTM) 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.
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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