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those whose DL specimens or FDS findings demonstrated the presence of atypical or cancerous cells or macroscopic abnormalities, and it frequently was not clear how or whether patients with negative test results were followed in order to confirm the absence of malignancy. Therefore, there was a lack of independent confirmation of negative DL or FDS results. None of the studies systematically evaluated the impact of DL or FDS on clinical decision-making, such as follow-up testing or treatment, use of chemoprevention agents, etc, or on health outcomes such as mortality. In addition, none of the available studies investigated whether the results of DL or FDS can be used to aid in the estimation of a woman's risk of breast cancer and, therefore, to guide clinical decision-making regarding preventive or therapeutic strategies. Definitive conclusions regarding the roles of DL and FDS in the diagnosis and management of breast cancers and precancers require data from well-designed clinical trials employing strict patient inclusion criteria and long-term follow-up and through the refinement of risk-assessment models incorporating DL and FDS results.
Nipple Aspirate Fluid:
Only one study on the use of the HALO NAF Collection System for testing nipple aspirate fluid was identified in the published, peer-reviewed medical literature. Proctor et al. conducted a multi-center prospective observational clinical trial involving 500 asymptomatic women for the purpose of assessing fluid production, adequacy, safety and patient acceptance of the HALO NAF Collection System. Thirty-eight percent (190/500) produced fluid and 187 were available for cytologic analysis. Cytologic classification showed 50% (93/187) had insufficient cellular material, 38% (71/187) had benign non-hyperplasic ductal epithelial cells, 10% (18/187) had benign hyperplasic ductal epithelial cells, 3% (5/187) had atypical ductal epithelial cells and there were no cells of unequivocal malignancy. Overall, 19% of the subjects produced NAF with adequate cellularity and 1% were found to have cytologic atypia. Although this study had a fairly large sample, the number of subjects who were able to produce NAF with cellularity and the yield of cytologic atypia found in that population does not support the efficacy of this method of screening for breast cancer. (Proctor et al., 2005) Professional Societies The American Society of Breast Surgeons (ASBS) issued a policy statement in 2003 (updated 2007) supporting the use of ductal lavage as a cell-based risk assessment tool in high-risk or borderline-risk women to assist them in making more informed decisions regarding risk reduction and management options, including closer surveillance, chemoprevention, or prophylactic mastectomy. They indicated that physicians should be prepared to counsel patients regarding results, offer psychological support and be able to further evaluate the patient when atypia is identified. However, the Society cautioned that the cytologic interpretation of breast epithelial cells must be standardized to ensure accurate risk Cytological Examination of Breast Fluids for Cancer Screening- Commercial Medical Management Guideline assessment information, and it stated that DL is not a cancer detection technique and should not replace standard cancer screening methods. Long-term studies are necessary to better define the risk assessment contribution of cytologic atypia detected via these and other methods.The ASBS encourages participation in such trials.
The National Comprehensive Cancer Network (NCCN, 2009), Clinical Practice Guidelines in Oncology™ on Breast Cancer Screening and Diagnosis, version 2, 2009 notes that the current evidence does not support the routine use of ductal lavage as a screening modality for breast cancer.
American Cancer Society (ACS, 2008): The ACS notes that the use of mammograms, clinical breast exam, and breast self-exam offers women the best opportunity for reducing the breast cancer death rate through early detection. A breast physical exam without a mammogram may miss the opportunity to detect many breast cancers that are too small for a woman or her doctor to feel but can be seen on mammograms. Although a mammogram is the most sensitive screening method, a small percentage of breast cancers do not show up on mammograms but can be felt by a woman or her doctor.
References and Resources Resources Badve S, Wiley E, Rodriguez N. Assessment of utility of ductal lavage and ductoscopy in breast cancer-a retrospective analysis of mastectomy specimens. Mod Pathol. 2003; 16(3):206-209.
Badve S. Ductal lavage and its histopathologic basis: a cautionary tale. Diagn Cytopathol. 2004; 30(3):166-171.
Brogi E, Robson M, Panageas KS, et al. Ductal lavage in patients undergoing mastectomy for mammary carcinoma: a correlative study. Cancer. 2003; 98(10):2170-2176.
Carruthers CD, Chapleskie LA, et al. The use of ductal lavage as a screening tool in women at high risk for developing breast carcinoma. American Journal of Surgery 2007 Oct.194 (4):463-6.
Dooley WC, Ljung BM, Veronesi U, et al. Ductal lavage for detection of cellular atypia in women at high risk for breast cancer. J Natl Cancer Inst. 2001; 93(21):1624-1632.
Dooley WC. Routine operative breast endoscopy for bloody nipple discharge. Ann Surg Oncol. 2002; 9(9):920-923.
ECRI Health Technology Assessment Information Service (HTAIS). Ductal Lavage and Nipple Aspiration for Identifying Women at High Risk of Breast Cancer. February 10, 2009.
Evron E, Dooley WC, Umbricht CB, et al. Detection of breast cancer cells in ductal lavage fluid by methylation-specific PCR. Lancet. 2001; 357(9265):1335-1336.
Francescatti DS, Kluskens L, Shah L. Ductal lavage in the high-risk patient. The American Journal of Surgery 2005;
Hartman AR, Daniel BL, Kurian AW, et al. Breast magnetic resonance image screening and ductal lavage in women at high genetic risk for breast carcinoma. Cancer. 2004; 100(3):479-489.
HAYES, Inc. HAYES Technology Assessment. Breast Ductal Lavage and Fiberoptic Ductoscopy for Breast Cancer Diagnosis and Screening. August 2004. Update Search December 2, 2008.
Hunerbein M, Estevez Schwartz L, Schneider U, Schlag PM. Evaluation of pathologic nipple discharge with ductoscopy.
Cytological Examination of Breast Fluids for Cancer Screening- Commercial Medical Management Guideline J Am Coll Surg. 2003; 197(4):697-698.
Khan SA, Wiley EL, Rodriguez N. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst. 2004 Oct; 96(20):1510-7.
King BL, Tsai SC, Gryga ME, et al. Detection of chromosomal instability in paired breast surgery and ductal lavage specimens by interphase fluorescence in situ hybridization. Clin Cancer Res. 2003; 9(4):1509-1516.
Lindsey H. Ductal lavage may not detect breast cancer. The Lancet Oncology. Dec. 2004; 5:704.
Proctor KA, Rowe LR, Bentz JS. Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study. BMC Women's Health. 2005; 5:10.
Shen KW, Wu J, Lu JS, et al. Fiberoptic ductoscopy for breast cancer patients with nipple discharge. Surg Endosc. 2001;
Yamamoto D, Senzaki H, Nakagawa H, et al. Detection of chromosomal aneusomy by fluorescence in situ hybridization for patients with nipple discharge. Cancer. 2003; 97(3):690-694.
Yamamoto D, Shoji T, Kawanishi H, et al. A utility of ductography and fiberoptic ductoscopy for patients with nipple discharge. Breast Cancer Res Treat. 2001; 70(2):103-108.
Contact Information Cytological Examination of Breast Fluids for Cancer Screening- Commercial Medical Management Guideline For questions regarding this policy, send an email to the Medical Technology Interpretation Service at email@example.com with the word "Medical" in the subject line.
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: 19499 Unlisted procedure, breast
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 Cytological Examination of Breast Fluids for Cancer Screening- Commercial Medical Management Guideline TITLE: Deep Brain Stimulation Authorized By: Medical Management Guideline Committee
Adoption Date: 09/16/09 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.
Deep Brain Stimulation- Commercial Medical Management Guideline This policy describes the use of deep brain stimulation (DBS) for the treatment of disorders of movement such as Parkinson's disease and for other conditions such as depression and epilepsy.
Deep brain stimulation is proven for treating essential tremor when standard recognized medical therapy has either failed to relieve the symptoms, or the side effects of the medications prohibit their continued use.
Deep brain stimulation is proven for treating chronic, intractable primary dystonia (occurs on its own, apart from any illness), including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis).
Deep brain stimulation is unproven for treating secondary dystonia (occurs with illness, after trauma or following exposure to certain medications or toxins). Patients with secondary dystonia may experience limited to moderate short-term relief. However, questions remain with regard to patient selection criteria and long-term benefits and safety compared with standard treatments.
Formal comparisons, with large randomized controlled or comparative trials of pallidotomy, thalamotomy, and deep brain stimulation, are required before conclusions can be drawn regarding the use of deep brain stimulation for patients with secondary dystonia.
Deep brain stimulation is unproven for treating conditions other than those listed above. Some studies have examined the use of deep brain stimulation for treating major depression, obsessivecompulsive disorder (OCD), epilepsy, Tourette syndrome, cluster headache, impulsive or violent behavior, stroke pain, chronic pain, phantom limb pain, trigeminal neuralgia and movement disorders of multiple sclerosis (MS). However, because of limited studies, small sample sizes, weak study designs and heterogenous patient characteristics, there is insufficient data to conclude that deep brain stimulation is safe and/or effective for treating these indications.
Deep Brain Stimulation- Commercial Medical Management Guideline Regulatory Requirements U.S. Food and Drug Administration (FDA): The FDA approved the Activa® Tremor Control System (Medtronic) on July 31, 1997. The device is indicated for unilateral thalamic stimulation for the suppression of tremor in the upper extremity in patients who are diagnosed with essential tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a
significant functional disability. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm?ID=10325. Accessed April 2009.
A January 14, 2002 Premarket Approval (PMA) supplement (S007) expanded use to include bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson`s disease that are not adequately controlled with medication.
Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm?ID=10332.
Accessed April 2009.