«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»
Professional Societies The American Cancer Society (ACS): In the 2003 American Cancer Society Guidelines for Breast Cancer Screening, which include an adaptation of the 2001 Institute of Medicine assessment of the evidence for various breast cancer screening modalities, thermography was classified as a method that is ineffective as a screening tool based on the clinical evidence (Smith RA et al., 2003).
References and Resources Resources Canavan D, Gratt BM. Electronic thermography for the assessment of mild and moderate temporomandibular joint dysfunction. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995; 79(6):778-786.
Digital Infrared Thermal Imaging - Commercial Medical Management Guideline Cherkas LF, Howell K, Carter L, et al. The use of portable radiometry to assess Raynaud's phenomenon: a practical alternative to thermal imaging. Rheumatology (Oxford). 2001; 40(12):1384-1387.
Coughlin PA, Chetter IC, Kent PJ, Kester RC. The analysis of sensitivity, specificity, positive predictive value and negative predictive value of cold provocation thermography in the objective diagnosis of the hand-arm vibration syndrome. Occup Med (Lond). 2001; 51(2):75-80.
DiBenedetto M, Yoshida M, Sharp M, Jones B. Foot evaluation by infrared imaging. Mil Med. 2002; 167(5):384-392.
Graff-Radford SB, Ketelaer MC, Gratt BM, Solberg WK. Thermographic assessment of neuropathic facial pain. J Orofac Pain. 1995; 9(2):138-146.
Gratt BM, Graff-Radford SB, Shetty V, et al. A 6-year clinical assessment of electronic facial thermography.
Dentomaxillofac Radiol. 1996; 25(5):247-255.
Gratt BM, Shetty V, Saiar M, Sickles EA. Electronic thermography for the assessment of inferior alveolar nerve deficit.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995; 80(2):153-160.
Harper CM Jr, Low PA, Fealey RD, et al. Utility of thermography in the diagnosis of lumbosacral radiculopathy.
Neurology. 1991; 41(7):1010-1014.
HAYES, Inc. HAYES brief. Digital infrared imaging (Thermography) for detection of breast cancer. July 7, 2006. Update search on July 23, 2008. Accessed October 23, 2008.
Lai HS, Duh YC, Tsai WS, Sun WZ. Role of thermography in the diagnosis of undescended testes. Eur Urol. 1998;
McGimpsey JG, Vaidya A, Biagioni PA, Lamey PJ. Role of thermography in the assessment of infraorbital nerve injury after malar fractures. Br J Oral Maxillofac Surg. 2000; 38(6):581-584.
Merla A, Di Donato L, Di Luzio S, et al. Infrared functional imaging applied to Raynaud's phenomenon. IEEE Eng Med Biol Mag. 2002; 21(6):73-79.
Ohashi Y, Uchida I. Applying dynamic thermography in the diagnosis of breast cancer. IEEE Eng Med Biol Mag. 2000;
Parisky YR, Sardi A, Hamm R, et al. Efficacy of computerized infrared imaging analysis to evaluate mammographically suspicious lesions. AJR Am J Roentgenol. 2003; 180(1):263-269.
Smith RA, Saslow D, Sawyer KA, et al. American Cancer Society (ACS) Guidelines for Breast Cancer Screening. CA Cancer J Clin. 2003; 53 (3):141-169.
U.S. Food and Drug Administration (FDA) [Web site]. Computerized thermal Imaging, Inc. BCS 2100.
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3918b1_sponsor-Final.pdf. Accessed October 23, 2008.
U.S. Food and Drug Administration (FDA) [Web site]. 501(k) clearance notification. Telesis Digital Infrared Thermal Image System (K020783). Dorex Spectrum 9000MB Thermography System (K023434). Mark I Thermal Imager (K023925). MHS 7000 Thermal Imaging System (K030018). IRIS-IV Infrared Imaging System (K030165).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed October 23, 2008.
Digital Infrared Thermal Imaging - Commercial Medical Management Guideline Zhang HY, Kim YS, Cho YE. Thermatomal changes in cervical disc herniations. Yonsei Med J. 1999; 40(5):401-412.
Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.
Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.
CPT Codes: 93740 Temperature gradient studies
This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.
Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.
Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Digital Infrared Thermal Imaging - Commercial Medical Management Guideline TITLE: Treatment of Discogenic Pain Authorized By: Medical Management Guideline Committee
Adoption Date: 10/14/09 Revision Date:
Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.
This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.
Member benefit coverage and limitations may vary based on the member’s benefit plan.
This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.
Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.
This policy describes the use of electrothermal therapy and other nonsurgical or percutaneous intradiscal procedures for the treatment of low back pain associated with herniated discs.
Discogenic Pain, Treatment - Commercial Medical Management Guideline
Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.
Coverage Rationale Intradiscal electrothermal therapy (IDET) (including annulorraphy) and intradiscal biacuplasty (IDB) are unproven for the treatment of low back pain caused by a herniated intervertebral disc.
The evidence base for this procedure remains limited. Case series and prospective studies report that some patients improve after IDET therapy; however these studies had small sample sizes and report varied results. The best available evidence was two randomized controlled trials. One reported a positive effect on pain severity only. The other trial demonstrated no substantial benefit.
Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) is unproven for the treatment of low back pain caused by a herniated intervertebral disc.
The evidence for this procedure remains limited. Positive results were reported only in uncontrolled cohort studies. More and better designed studies are needed to confirm the efficacy and long-term effects of PIRFT.
Nucleoplasty, also known as percutaneous disc decompression, is unproven for the treatment of low back pain caused by a herniated intervertebral disc.
There is inadequate evidence demonstrating the short or long-term health outcomes of this procedure. All of the published studies are small uncontrolled case series with subjective outcomes. Conclusions about safety, efficacy, and the long-term effects of radiofrequency ablation of the disc are unknown at this time.
Automated percutaneous lumbar discectomy (APLD) and percutaneous laser disc decompression (PLDD) are unproven for the treatment of low back pain caused by a herniated intervertebral disc.
The available evidence regarding the efficacy of minimally invasive surgery performed under indirect visualization, such as automated percutaneous lumbar discectomy (APLD) or percutaneous laser disc decompression (PLDD) for lumbar disc herniation, is weak and does not include adequately blinded evaluation of patients or randomized comparison to conservative treatments or placebo. Controlled studies with assessment of the results of APLD and PLDD are needed to conclude that these procedures are beneficial for health outcomes in patients with low back pain.
Percutaneous intradiscal annuloplasty including radiofrequency annuloplasty is unproven for the treatment of back pain.
There is inadequate evidence demonstrating the short or long-term health outcomes of this procedure.
Percutaneous sacral augmentation (sacroplasty) with or without a balloon or bone cement is unproven for the treatment of back pain.
There is limited and insufficient evidence to support the use of sacroplasty for the treatment of back pain. Controlled studies with long-term assessment of the results of percutaneous sacroplasty are needed to conclude that sacroplasty is beneficial for health outcomes in patients with low back pain.
Regulatory Requirements Smith & Nephew manufactures the SpineCATH (TM) Intradiscal Catheter and ElectroThermal® 20S Spine System for use in IDET procedures. This system received U.S. Food and Drug Administration (FDA) 510 (k) clearance for marketing in the U.S. in 1998 and 1999.
There were two 510(k) approvals for the SpineWand device (2). There are additional approvals for the Controller (radiofrequency electrosurgical generator); these listings are available from the Center for Devices and Radiological Discogenic Pain, Treatment - Commercial Medical Management Guideline Health 510(k) PercD Spinewand. Arthrocare Corporation. [decision date 04/16/03].
PercD Spinewand. Arthrocare Corporation. [decision date 05/31/01].
The ArthroCare System 2000 (K001588) received 510(k) approval on August 17, 2000. It is a bipolar, high-frequency electrosurgical system that has three components: an electrosurgical generator (Controller), disposable, single use Wand, and a reusable cable. The ArthroCare 8000S Coblator Surgery System received a special 510(k) approval on December 6,
2005. The Perc™ received 510(k) approval (K010811) on May 30, 2001 for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Three subsequent 510(k) approvals (K020621, K030954, K053447) were issued for the ArthroCare® Perc-D® SpineWand™ on March 28, 2002, April 16, 2003, and December 27 2005, respectively, noting modifications in dimensional and performance specifications, materials, and labeling for the device. Indications for both approvals for use, technology, principle of operation, packaging, and sterilization parameters of the wands were unchanged from those of the predicate device. The ArthroCare System 2000 received CE marking. Endoscopes, catheters, and needles that can be used for epidural lysis of adhesions are regulated by the FDA as Class II devices and a number of these devices have been approved via the FDA 510(k) process. The Racz Catheter received FDA approval on October 8, 1996 (K954584). The Myelotec Myeloscope received 510(k) approval on September 4, 1996 (K960194).
See the following website for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
(Use product codes HRX, BSO, and BSP). Accessed March 2009.
The Radionics RF Disc Catheter Electrode System received FDA 510(k) clearance in October 2000. See the following
Web site for more information:
http://www.fda.gov/cdrh/pdf/k001741.pdf. Accessed March 2009.
Percutaneous sacroplasty involves injection of PMMA bone cement to repair the fracture. This type of cement is regulated as a Class II (moderate risk) device that is regulated via the FDA 510(k) process. Although the list of commercially available PMMA bone cements is too extensive for inclusion here, a recently approved cement that appears suitable for sacroplasty is Vertaplex Radiopaque Bone Cement (Stryker Instruments) (K072118), which was approved for
vertebroplasty on December 7, 2007. See the following Web site for more information:
http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072118.pdf. Accessed June 2009.
Research Evidence Background Intradiscal electrothermal therapy (IDET) or intradiscal electrothermal annulorrhaphy is a minimally invasive procedure that uses a disposable intradiscal catheter and an electrothermal generator to treat the pain associated with degenerative disc disease.
Intradiscal biacuplasty (IDB) is a modification of IDET and is also a minimally invasive transdiscal radiofrequency technique for treatment of back pain. IDB uses two internally water-cooled radiofrequency probes to lesion nociceptors in the intervertebral disc. The bilateral approach is intended to facilitate controlled lesioning between the electrodes in the disc.