Charges submitted for the services listed on this medical policy should be denied as noted in the text below.

Experimental or Investigational

Experimental/Investigational services are defined as a treatment, service, 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.

The following services are to be denied as experimental/investigational. This is not an all inclusive list. A participating, preferred, or network provider can bill the member for the denied experimental/investigational item or service.

• Adoptive immunotherapy (S2107) DLR 07/2007

• Carbon monoxide, expired gas analysis (e.g., ETCO/hemolysis breath test) DLR 01/2009

• Cellular function assay involving stimulation (e.g., mitogen or antigen) and detection of biomarker (e.g., ATP) (86352) DLR 01/2010

• Electrical stimulation of the ear DLR 04/2009

• Endoscopic cryospray ablation of the esophagus DLR 08/2007

• Endoscopic radiofrequency ablation of the esophagus DLR 09/2009

• Insertion of a temporary prostatic urethral stent including urethral measurement (53855) DLR 01/2010

• Intraepidermal nerve fiber density testing (e.g., Therapath's ENFE) DLR 10/2008

• Keratoprosthesis, insertion of (Prosthokeratolplasty) (65770) DLR 10/2008

• Neuro-selective current perception threshold (CPT)/Sensory Nerve Conduction Test (sNCT) (G0255) DLR 07/2008

• Nitric oxide expired gas determination (95012) DLR 09/2009

• Ocular photoscreening (99174) DLR 01/2008

• *Outpatient intravenous insulin treatment (OIVIT) either pulsatile or continuous, by any means, guided by the results of measurements for: respiratory quotient; and/or urine urea nitrogen (UNN); and/or arterial, venous, or capillary glucose; and/or potassium concentrations (G9147) DLR 04/2010

• pH; exhaled breath condensate (83987) DLR 02/2009

• Posturography (dynamic or static) (92548) DLR 03/2010

• Saliva test, hormone level; to assess preterm labor (S3652) DLR 11/2008

• Saliva test, hormone level; during menopause (S3650) DLR 11/2008

• Sperm evaluation, DNA integrity (e.g., sperm chromatin assays and sperm DNA fragmentation assays) DLR 05/2008

• SuperDimension Bronchus System DLR 08/2008

• Tenotomy of elbow, lateral or medial (e.g., epicondylitis, tennis elbow, golfer's elbow); percutaneous (24357) DLR 01/2008

• Thromboxane metabolite(s) including thromboxane if performed, urine (84431) DLR 01/2010

The service is beyond the investigational/experimental stage but is not generally accepted by the medical community as clinically useful in diagnosing or treatment of medical conditions. Therefore, it is considered not medically necessary. A participating, preferred or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

• Body Composition Analyzers/Analysis (e.g., Bioelectrical Impedance Analysis)

• Collagen crosslinks, any method (82523)

• Defecography

• Hair analysis (P0231)

• Hamster egg and sperm penetration assay (89329, 89330)

• Lixiscope Service

• Optic nerve decomparession for non-arteritic ischemic optic neuropathy (67570)

• Rhinomanometry (92512)

• Temperature gradient study (93740)

No Professional Service Rendered

The following services are to be denied because there is no direct patient care or contact. A participating, preferred, or network provider can bill the member for the denied item or service. Denial of a service based on this reason is not applicable to facility expenses. Facility expenses should be processed according to the member's contractual benefits for the service.

• Broken appointments

• Glucola (glucose preparation)

• Mileage for medical visit

• Team conferences (99366-99368)

• Telephone calls (98966-98968)(99441-99443)

Benefit Exclusion

The following services are not covered under the member's benefit. This is not an all inclusive list. A participating, preferred, or network provider can bill the member for the denied item or service.

• ***Casted impressions for special shoes

• EROS-Clitoral Therapy Device as a Treatment of Female Sexual Dysfunction (A9270)

• ***Hearing aid evaluation (92590-92595, S0618, V5010)

• ***Intersex surgery (55970, 55980)

• ***Nicotene cessation programs (S9075)

• Recreational or educational therapy (inpatient)

• Smoking cessation counseling (99406, 99407, G9016)

• ***Work related injuries

***Under Managed Care programs, payment or denial for this item is based on the individual's contractual benefits.

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.

Endoscopic Radiofrequency Ablation of the Esophagus

Fleischer DE, et al. Endoscopic Ablation of Barrett's Esophagus: a Multicenter Study with 2.5-Year Follow-Up. Gastrointestinal Endoscopy. 2008 Nov; 68(5): 867-76

Nitric Oxide Expired Gas Determination

Smith AD, Cowan JO, Brassett KP et al. Use of Exhaled Nitric Oxide Measurements to Guide Treatment in Chronic Asthma. The New England Journal of Medicine. 2005; 352 (21): 2163-2173

Deykin A. Targeting Biologic Markers in Asthma - Is Exhaled Nitric Oxide the Bull’s-Eye? The New England Journal of Medicine. 2005; 352 (21): 2233-2235

Szefler SJ, Mitchell H, Sorkness CA, et al. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: A randomised controlled trial, The Lancet. 2008;372(9643):1065-1072.

Petsky HL, Cates CJ, Li A, et al; Tailored interventions based on exhaled nitric oxide versus clinical symptoms for asthma in children and adults. Cochrane Database Syst Rev 2008 Apr 16; (2):CD006340.

Shaw DE, Berry MA, Thomas M, et al. The use of exhaled nitric oxide to guide asthma management: A randomized controlled trial. Am J Respir Crit Care Med. 2007(3);176:231-237.

Sivan Y ; Gadish T ; Fireman E ; Soferman R, The use of exhaled nitric oxide in the diagnosis of asthma in school children, J Pediatr. 2009; 155(2):211-6.

National Institutes of Health, National Heart, Lung, and Blood Institute, Asthma Education and Prevention Program, Clinical Practice Guidelines. Expert Panel Report 3, Guidelines for the Diagnosis and Management of Asthma. Aug 28, 2007. Accessed September 9, 2009. Available at URL address: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm.

Ocular Photoscreening

Kirk VG, Clausen MM, Armitage MD, Arnold RW, Preverbal photoscreening for amblyogenic factors and outcomes in amblyopia treatment: early objective screening and visual acuities. Arch Ophthalmol. 2008 Apr; 126(4):489-92

Outpatient Intravenous Insulin Treatment (OIVIT)

National Blue Cross Blue Shield Association Medical Policy 2.01.43, Chronic Intermittent Intravenous Insulin Therapy (CIIIT), 09/2009

American Diabetes Association. Clinical Practice Recommendations 2010. Standards of Medical Care in Diabetes-2010; 33(suppl 1). Accessible at http://care.diabetesjournals.org/content/32/Supplement_1.

American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus. Endocr Pract 2007; 13(suppl 1):3-68. Accessible at http://www.aace.com/pub/pdf/guidelines/DMGuidelines2007.pdf

Percutaneous Elbow Tenotomy

Housener JA, Jacobson JA, Misko R. Sonographically guided percutaneous needle tenotomy for the treatment of chronic tendinosis. J Ultrasound Med. 2009 Sep;28(9):1187-92.

McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for the treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44.

Radwan YA, Elsobhi G, Badawy WS, Reda A, Khalid S. Resistant tennis elbow: shock-wave therapy versus percutaneous tenotomy. Int Orthop. 2008 Oct;32(5):671-7.

Posturography (dynamic or static)

Gabilan YP, Perracini MR, Munhoz MS, Gananc FF. Aquatic physiotherapy for vestibular rehabilitation in patients with unilateral vestibular hypofunction: exploratory prospective study. J Vestib Res. 2008;18(2-3):139-46.

Brasseux R., Greve KW, Gianoli GJ, Soileau JS, Bianchini KJ. The relationship between the modified somatic perception questionnaire and dynamic platform posturography. Otol Neurotol. 2008 Apr;29(3):359-62.

Mallinson Al, Longridge NS, Morley RE. Evaluation of the effects of ethanol on static and dynamic gait. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):856-9.

Lewis NL, Brismee JM, James CR, Sizer PS, Sawyer SF. The effect of stretching on muscle responses and postural sway responses during computerized dynamic posturography in women and men. Arch Phys Med Rehabil. 2009 Mar;90(3):454-62.

Vanicek, N, Strike S, McNaughton L, Polman R. Postural responses to dynamic perturbations in amputee fallers versus nonfallers: a comparative study with able-bodied subjects. Arch Phys Med Rehabil. 2009 Jun;90(6):1018-25.

Mishra A, Davis S, Speers R, Shepard NT. Head shake computerized dynamic posturography in peripheral vestibular lesions. AM J Audiol. 2009 Jun;18(1):53-9.

Rossi M, Soto A, Santos S, Sesar A, Labella T., A prospective study of alterations in balance among patients with Parkinson’s Disease. Protocol of the postural evaluation. Eur Neurol. 2009;61(3):171-6.

Sevilla-Garcia MA, Boleas-Aguirre MA, Perez-Fernandez N. The limits of stability in patients with Meniere’s disease. Acta Otolaryngol. 2009 Mar;129(3):281-8.