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.

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

The following services are to be denied as experimental/investigational. This is not an all inclusive list.

• Adoptive immunotherapy (S2107) DLR 09/2010

• *Arthroscopy, hip surgical:

  With femoroplasty (i.e., treatment of cam lesion)-29914

  With acetabuloplasty (i.e., treatment of pincer lesion)-29915

  With labral repair-29916

  DLR 01/2011

• *Bioimpedance spectroscopy for lymphedema (0239T) DLR 08/2010

• 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 08/2009

• 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 01/2010

• *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 07/2010

• SuperDimension Bronchus System DLR 08/2008

• Tenotomy of elbow, lateral or medial (e.g., epicondylitis, tennis elbow, golfer's elbow); percutaneous (24357) DLR 01/2009

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

• *Transcranial magnetic stimulation (90867, 90868) DLR 01/2011</<li>

• *Transluminal dilation of aqueous outflow canal; without retention of device or stent (66174) DLR 01/2011

• *Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence (53860) DLR 01/2011

See Medical policy Z-11 for the definition of medical necessity. 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 providers records.

The following services are to be denied as not medically necessary. This is not an all inclusive list.

• 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-NPSR 

The following services are to be denied because there is no direct patient care or contact.

NOTE: 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)

***Work related injuries

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

NOTE: This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition, 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.

Adoptive immunotherapy

Dudley ME, Yang JC, Sherry R et al. Adoptive cell therapy for patients with metastatic melanoma: evaluation of intensive myeloablative chemoradiation preparative regimens. J Clin Oncol. 2008; 26(32): 5233-9.

Johnson LA, Morgan RA, Dudley ME et al. Gene therapy with human and mouse T-cell receptors mediates cancer regression and targets normal tissues expressing cognate antigen. Blood. 2009 Jul 16;114(3): 535-46.

Rosenberg SA, Dudley ME. Adoptive cell therapy for the treatment of patients with metastatic melanoma. Curr Opin Immunol. 2009 Apr; 21(2): 233-40.

Kimura H, Iizasa T et al. Prospective phase II study of post-surgical adjuvant chemo-immunotherapy using autologous dendritic cells and activated killer cells from tissue culture of tumor-draining lymph nodes in primary lung cancer patients. Anticancer Res. 2008 Mar-Apr; 28(2B): 1229-38.

Kondo H, Hazama S et al. Adoptive immunotherapy for pancreatic cancer using MUC1 peptide-pulsed dendritic cells and activated T lymphocytes. Anticancer Res. 2008 Jan-Feb; 28(1B): 379-87.

Arthroscopy, hip, surgical

Byrd JW, Jones KS. Arthroscopic Femoroplasty in the Management of Cam-type Femoroacetabular Impingement. Clin Orthop Relat Res. 2009;467(3): 739-746.

Mardones RM, Nemtala F, Tomic A. Arthroscopic Treatment of femoroacetabular impingement in patients over 60 years old: Preliminary report of a pilot study. Sage Journals Online [serial online]. Accessed October 4, 2010.

Lee J, Hwang D, Kang C, et al. Arthroscopic management of femoroacetabular Impingement in early osteoarthritis of the hip: 2 to 5 year results. J Korean Orthop Assoc. 2010; 45(3):188-197.

Leunig M, Beaule PE, Ganz R. The concept of femoroacetabular impingement: current status and future perspectives. Clinorthop [serial online]. March 2008;467(3). Accessed October 4, 2010.

Ilizaliturri Jr., VM. Complications of arthroscopic femoroacetabular impingement treatment: A review. 2008;467(3) Journal?

Graves ML, Mast JW. Femoroacetabular Impingement: Do outcomes reliably improve with surgical dislocations? Clin Orthop Relat Res. 2009;467(3):717-723

Bioimpedance Spectroscopy for Lymphedema

Ward L C, Czerniec S, Kilbreath S L. Quantitative bioimpedance spectroscopy for the assessment of lymphedema. Breast Cancer Res Treat. 2009 Oct;117(3):541-7.

York S L, Ward L C, Czerniec S, Lee M J, Refshauge K M, Kilbreath S L. Single frequency versus bioimpedance spectroscopy for the assessment of lymphedema. Breast Cancer Res Treat. 2009 Sep;117(1):177-82.

Hayes S, Janda M, Cornish B, Battistutta D, Newman B. Lymphedema secondary to breast cancer: how choice of measure influences diagnosis, prevalence and identifiable risk factors. Lymphology. 2008 Mar;41(1):18-28.

Ridner SH, Dietrich MS, Deng J. Bonner CM, Kidd N. Bioelectrical impedance for detecting upper limb lymphedema in nonlaboratory settings. Lymphat Res Biol. 2009;7(1):11-5.

Czerniec S A, Ward L C, Refshauge K M, Beith J, Lee M J, York S, Kilbreath S L. Assessment of breast cancer-related arm lymphedema – comparison of physical measurement methods and self-report. Cancer Invest. 2010 Jan;28(1):54-62.

Ward Leigh C, Ph.D, Czerniec Sharon, M.HI, Sci., Kilbreath Sharon L, Ph.D. Operational equivalence of bioimpedance indices and perometry for the assessment of unilateral arm lymphedema. Lymphat Res Biol. 2009;7(2):81-5.

Gergich NL Stout, PT, MPT, CLT-LANA, Pfalzer LA, PT, MA, PhD, McGarvey C, PT DPT, MS, Springer B, PT, Phd, OCS, SCS, Gerber LH, MD, Soballe, MD. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Interdisciplinary International Journal of the American Cancer Society. June 15, 2008;112(12).

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.

Sperm evaluation, DNA integrity (e.g., sperm chromatin assays and sperm DNA framentation assays)

Zini A, Sigman M. Are tests of sperm DNA damage clinically useful? Pros and cons. Journal of Andrology. 2009;30(3):219-229.

Zini A, Boman JM, Belzile E, Ciampi A. Sperm DNA damage is associated with an increased risk of pregnancy loss after IVF and ICSI: systematic review and meta-analysis Hum Reprod. 2008;23(12):2663-2668.

Collins JA, Barnhart KT, Schlegel PN. Do sperm DNA integrity tests predict pregnancy with in vitro fertilization? Fertil Steril. 2008;89(4):823-831.

American Society for Reproductive Medicine (ASRM). The clinical utility of sperm DNA integrity testing. Fertil Steril. 2008 Nov;90(5 Suppl):S178-S180.

American Urological Association, Inc. (AUA). The Optimal Evaluation of the Infertile Male. AUA Best Practice Statement. Published 2001. Revised 2010. Accessed July 7,2010. Available at URL address: http://www.auanet.org/guidelines/

Transurethral Radiofrequency Micro-Remodeling of the Female Bladder Neck and Proximal Urethra for Stress Urinary Incontinence

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

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

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