Experimental/Investigational services are defined as a treatment, procedure, facility, equipment, drug, service or supply (“intervention”) that has been determined not to be medically effective for the condition being treated. Charges submitted for these services listed on this policy should be denied as experimental/investigational. These determinations are based on one or more of the following reasons:

1. The intervention does not have FDA approval to be marketed for the specific relevant indication(s); or
2. Available scientific evidence does not permit conclusions concerning the effect of the intervention on health outcomes; or
3. The intervention is not proven to be as safe or effective in achieving an outcome equal to or exceeding the outcome of alternative therapies; or
4. The intervention does not improve health outcomes; or
5. The intervention is not proven to be applicable outside the research setting.

NOTE:

The CPT codes listed on this policy are not all inclusive of all services that may deny experimental/investigational.

A participating, preferred, or network provider can bill the member for the denied experimental/investigational item or service.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits are determined by the Federal Employee Program.

Procedure Code 0126T

The Association for Medical Ultrasound. AIUM Practice Guideline for the Performance of an Ultrasound Examination of the Extracranial Cerebrovascular System.October 1, 2007

Newman A, Naydeck B, Ives D, et. al. Coronary Artery Calcium, Carotid Artery Wall Thickness, and Cardiovascular Disease Outcomes in Adults 70-99 Years Old. Am J Cardiol. January 2008;101(2):  186 - 192

Folsom A, Fronmal R, Detrano R, et. al. Coronary Artery Calcification Compared with Carotid Intima-Media Thickness in the Prediction of Cardiovascular Disease Incidence. Arch Intern Med. June 23, 2008;168(12): 1333 – 1339

Baroncini L, de Oliveira A, Vidal E, et. al. Appropriateness of carotid plaque and intima-media thickness assessment in routine clinical practice. Cardiovascular Ultrasound. 2008;6: 52–56 

Stein J, Korcarz C, Hurst R., et. al. Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force Endorsed by the Society for Vascular Medicine. J Am Soc Echocardiogr. February 2008;21(2): 93-111

Prati P, Tosetto A, Vanuzzo D, et. al. Carotid Intima Media Thickness and Plaques Can Predict the Occurrence of Ischemic Cerebrovascular Events. Stroke. Sept. 2008;39:2470-2476

Sipilä K, Moilanen L, Nieminen T, et. al. Metabolic syndrome and carotid intima media thickness in the Health 2000 Survey. Atherosclerosis. 2009;204: 276 – 281

Adolphe A, Cook L, Huang X. A Cross-sectional Study of Intima-Media Thickness, Ethnicity, Metabolic Syndrome, and Cardiovascular Risk in 2268 Study Participants. Mayo Clin Proc. March 2009;84(3): 221-228

Dogan S, Plantiga Y, Evans G, et. al. Ultrasound protocols to measure carotid intima-media thickness: a post-hoc analysis of the OPAL study. Current Medical Research and Opinions. 2009;25(1): 109-122

Djaberi R, Schuijf J, de Koning E, et. al. Usefulness of Carotid Intima-Media Thickness in Patients with Diabetes Mellitus as a Predictor of Coronary Artery Disease. Am J Cardiol. October 2009; 104(8): 1041-46

Sharma K, Blaha M, Blumenthal R, Musunuru K. Clinical and Research Applications of Carotid Intima-Media Thickness. Am J Cardiology. May 2009;103(9): 1316 - 1320

Nguyen-Thanh H, Benzaquen B. Screening for Subclinical Coronary Artery Disease Measuring Carotid Intima MediaThickness. Am J  Cardiol. November 2009;104(10): 1383 - 1388

Ozguven I, Ersoy B, Ozguven A, Ozkol M, Onur E.  Factors affecting carotid intima media thickness predicts early atherosclerosis in overweight and obese adolescents. Obesity Research & Clinical Practice. January 2010;4(1)  www.mdconsult.com.  Accessed May 2, 2010

The National Heart, Lung, and Blood Institute

National Cholesterol Education Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults. National Institutes of Health.  NIH Publication No. 02-5215. September 2002.  www.nhibi.nih.gov/guidelines/cholesterol/atp3xsum.pdf

U.S. Preventive Services Task Force. Using Nontraditional Risk Factors in Coronary Heart Disease Risk Assessment: Recommendation Statement. AHRQ Publication No. 10-05141-EF-2, October 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/uspstf09/riskcoronaryhd/coronaryhdrs.htm

Procedure Code 0193T

Appell RA. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation. Expert Rev Med Devices. 2007 Jul; 4(4): 455-61

Elser DM, Mitchell GK, Miklos JR, Nickell KG, Cline K, Winkler H, Wells WG. Nonsurgical Transurethral Collagen Denaturation for Stress Urinary Incontinence in Women: 12-Month Results from a Prospective Long-term Study. The Journal of Minimally Invasive Gynecology. 2009 Jan; 16 (1): 56-62

Appell R. Transurethral Collagen Denaturation for Women with Stress Urinary Incontinence. Current Urology Reports. 2008 Sept; 9 (5): 373-379

National Blue Cross Blue Shield Association Medical Policy 2.01.60, Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence, 12/ 2008

Procedure Codes 0200T and 0201T

Frey ME, DePalma MJ, Cifu DX, et al. Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures. Spine. 2007:32(15):1635-1640.

Betts A. Sacral vertebral augmentation: confirmation of fluoroscopic landmarks by open dissection. Pain Physician. 2008;11(1):57-65.

Briem D, Grossterlinden L, Begemann PG, et al. Ct-guided balloon-assisted sacroplasty. Preliminary results of a feasibility study. Unfallchirurg. 2008;111(6):381-6

Frey ME, Depalma MJ, Cifu DX, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J. 2008:8)2):367-373.

Ji Zhang, Chun-gen Wu, Yi-feng Gu, et al. percutaneous sacroplasty for sacral metastatic tumors under fluoroscopic guidance only. Korean J Radiol. 2008;9(6):572-576.

Bayley E, Srinivas S, Boszcayk BM. Clinical outcomes of sacroplasty in sacral insufficiency fractures: a review of literature, Eur Spine j. 2009;18(9):1266-71.

Jayaraman MV, Chang H, Ahn SH. An easily identifiable anatomic landmark for fluoroscopically guided sacroplasty: Anatomic description and validation with treatment in 13 patients. American Journal of Neuroradiology. 2009;30:1070-1073.

Kamel EM, Binaghi S, Guntern D, et al. Outcome of long-axis percutaneous sacroplasty for the treatment of sacral insufficiency fractures. Eur Radiol. 2009;30:1070-1073.

Thomas EN, Cyteal C, Herisson C, et al. Osteoporotic fracture of the sacrum: sacroplasty and physical medicine. Ann Phys Rehabil Med. 2009;52(5):427-35.

Procedure Codes 0245T, 0246T, 0247T

Richardson JD, Franklin GA, Heffley S, Seligson D, et al.  Operative fixation of chest wall fractures: An underused procedure? /Discussion. Find Articles.com. June 2007. Accessed October 4, 2010.

Nirula R, Diaz JJ, Trunkey DD, Mayberry JC. Rib fracture repair: Indications, technical issues, and future directions. World Journal of Surgery. 2008;33(1):14-22.

Campbell N, Conaglen P, Martin K, Antippa P. Surgical stabilization of rib fractures using Inion OTPS wraps - techniques and quality of life follow-up. J Traum. 2009;67(3):596-601.

Marasco S, Cooper J, Pick A, Kossmann T. Pilot study of operative fixation of fractured ribs in patients with flail chest. ANZ Journal of Surgery. 2009;79(11):804-11.

Baragas M, Otero P, Sanchez-Gracian D, et al. Surgical fixation of rib fractures with rib clips and titanium bars (STRATOS System), preliminary experience. Cir Esp. 2010;88(3):180-6.