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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline Cryopreservation of unfertilized oocytes is another option for fertility preservation, particularly in patients for whom a partner is unavailable, or who have religious or ethical objections to embryo freezing. The oocytes are thawed later and fertilized in vitro. Research indicates that unfertilized oocytes are more prone to damage during cryopreservation procedures than embryos, and as a result, the overall pregnancy rates may be lower than standard IVF procedures. Further research is needed to delineate the current success rates and safety, as well as to improve the efficiency of this procedure.

Ovarian tissue cryopreservation is an investigational method of fertility preservation but has the advantage of requiring neither a sperm donor nor ovarian stimulation. Ovarian cryopreservation and transplantation procedures should only be performed in centers with the necessary expertise under IRB approved protocols that include follow-up for recurrent cancer.

References and Resources Resources

American Cancer Society (ACS). Fertility and cancer: what are my options? Available at:

http://www.cancer.org/docroot/MBC/MBC_2x_Fertility_and_Cancer.asp?sitearea=&level=. Accessed March 20, 2009.

American College of Obstetricians and Gynecologists (ACOG). Committee Opinion #405. Ovarian tissue and oocyte cryopreservation. Obstet Gynecol. 2008 May;111(5):1255-6.

American Society for Reproductive Medicine (ASRM). Ethics Committee Report. Fertility preservation and reproduction in cancer patients. Fertil Steril. 2005 Jun;83(6):1622-8.

American Society for Reproductive Medicine (ASRM). Patient Factsheet. Cancer and fertility preservation. 2004.

Available at: http://www.asrm.org/Patients/FactSheets/cancer.pdf. Accessed March 20, 2009.

Borini A, Bonu MA, Coticchio G, et al. Pregnancies and births after oocyte cryopreservation. Fertil Steril 2004;82(3):601FIGO Committee for the Ethical Aspects of Human Reproduction and Women's Health. Ethical considerations and recommendations on oocyte and ovarian cryopreservation. Int J Gynaecol Obstet. 2006 Mar;92(3):335-6.

Lee SJ, Schover LR, Partridge AH, et al. American Society of Clinical Oncology recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006 Jun 20;24(18):2917-31.

McPherson R, Pincus M, et al. Henry's Clinical Diagnosis and Management by Laboratory Methods, 2007. 21st ed.;

Chapter 37. Tissue Bank Activities.

National Cancer Institute (NCI). Sexuality and reproductive issues PDQ. July 2006. Available at:

http://www.cancer.gov/cancertopics/pdq/supportivecare/sexuality/patient/allpages. Accessed March 20, 2009.

National Institute for Clinical Excellence (NICE). Fertility: assessment and treatment for people with fertility problems.

February 2004. Available at: http://www.nice.org.uk/nicemedia/pdf/CG011niceguideline.pdf. Accessed March 20, 2009.

Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril. 2006 Jul;86(1):70-80.

American Society for Reproductive Medicine/Society for Assisted Reproductive Technology (ASRM/SART). Practice Committee. Ovarian tissue and oocyte cryopreservation. Fertil Steril. 2006 Nov;86(Suppl 4):S142-7.

Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline Quintans CJ, Donaldson MJ, Bertolino MV, et al. Birth of two babies using oocytes that were cryopreserved in a cholinebased freezing medium. Human Reproduction. 2002;17(12):3149-3152.

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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:

89258 Cryopreservation; embryo 89259 Cryopreservation; sperm 89335 Cryopreservation, reproductive tissue, testicular 89342 Storage, (per year); embryo(s) 89343 Storage, (per year); sperm/semen 89344 Storage, (per year); reproductive tissue, testicular/ovarian 89346 Storage, (per year); oocyte(s) 89352 Thawing of cryopreserved; embryo(s) 89353 Thawing of cryopreserved; sperm/semen, each aliquot 89354 Thawing of cryopreserved; reproductive tissue, testicular/ovarian 89356 Thawing of cryopreserved; oocytes, each aliquot Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline

HCPCS Codes:

S4030 Sperm procurement and cryopreservation services; initial visit S4031 Sperm procurement and cryopreservation services; subsequent visit S4040 Monitoring and storage of cryopreserved embryos, per 30 days Coding Clarification Cryopreservation may be done to preserve reproductive tissue for use at a later time. Some treatments for cancer and other conditions may impact an individual's fertility. For example, the diagnosis code range for cancer is 140 - 239.8.

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 Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline TITLE: Cytological Examination of Breast Fluids for Cancer Screening 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.

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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 ductal lavage (DL), fiberoptic ductoscopy (FDS) and nipple aspiration for evaluation of patients at risk for breast cancer. DL and nipple aspiration involve collection of breast ductal epithelial cells for cytological analysis and FDS involves direct visualization of the breast duct lining.

Cytological Examination of Breast Fluids for Cancer Screening- 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 Breast ductal lavage (DL) is unproven for use in breast cancer screening of either low-risk or high-risk women.

There is inadequate clinical evidence that breast ductal lavage either allows for better clinical decision-making or reduces breast cancer mortality. Further studies are necessary to determine the efficacy of cytological examination of ductal fluid in detecting atypical cells to identify women at increased risk of breast cancer as well as comparing the results to established methods of detecting and diagnosing breast cancer. Ductal lavage is intended for use in high-risk women but no definite patient selection criteria for ductal lavage of the breast have been established.

Fiberoptic ductoscopy (FDS) with or without DL is unproven for use in breast cancer diagnosis or screening or as an intraoperative tool to guide surgery.

Inadequate clinical evidence exists that the use of FDS-guided resection allows for better clinical decision-making, reduces breast cancer mortality, or serves as a useful adjunct to or replacement of open surgical excision.

The use of the HALO NAF Collection System for the collection of nipple aspirate fluid is unproven.

Inadequate clinical evidence exists on the use of the HALO NAF Collection System. 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. 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.

Regulatory Requirements

U.S. Food and Drug Administration (FDA):

A search for devices used to perform ductal lavage and nipple aspiration under product code KNW, found 219 510(k) approvals for this general code which includes devices used collect specimens from various types of tissue.

Cytyc Corporation bought ProHealth Inc (formerly named Windy Hill Technology), and renamed the three devices listed below as: FirstCyte® The Viaduct Microendoscope (Acueity Inc, Palo Alto, CA),which received 510(k) approval on July 16, 2001.

The previous names for FirstCyte® were as follows:

• ProHealth Micro-Stylet™ Model STY01 (ProHealth Inc, Menlo Park, CA) (May 18, 2000)

• DucPrep™ Breast Aspirator (Windy Hill Technology, Menlo Park, CA) (December 23, 1999)

• ProCatheter™ Model CTH03 (ProHealth Inc, Menlo Park, CA) (April 10, 2000) (Note: Cytyc merged with Hologic in October 2007) HALO NAF Collection System (NeoMatrix), a Class II device, was registered in the FDA Device Listing database on October 6, 2005. It is not required to submit an application for FDA approval.

To view approvals for these and other devices please visit the FDA web site @ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed September 1, 2009.

Research Evidence Background Breast cancer is a common nonskin cancer in women and is one of the leading causes of death. In addition to seeking Cytological Examination of Breast Fluids for Cancer Screening- Commercial Medical Management Guideline more effective therapies, a strategy for reducing mortality from breast cancer involves earlier detection. Standard methods for early breast cancer detection are monthly breast self-examination, clinical breast examination (CBE) and screening mammography. These are effective interventions in women at standard risk. However, some women are at higher-than-normal risk of breast cancer, and physicians are investigating newer technologies with the hope of earlier detection in such women before a mass is large enough to be palpated or found on an imaging study.

Minimally invasive methods for collecting and analyzing epithelial cells and other biomarkers of early breast cancer in fluid specimens obtained from the ducts of the breast have been evaluated. Studies have shown that breast cancer risk is increased when atypical hyperplasia is found in nipple aspirate fluid (NAF) specimens, and following a diagnosis of atypical hyperplasia by periareolar fine-needle aspiration (FNA) cytology. However, nipple aspiration by current methods has limited utility for diagnosis since inadequate NAF specimens are collected in up to 50% of women.

The HALO NAF Collection system is a suction collection system that can be used to collect ductal epithelial cells. In this system, small breast cups are placed on the breast and adjusted to fit. The system warms the breast and applies light suction to bring nipple aspirate fluid to the surface. The fluid is then analyzed microscopically for cytologic abnormalities.

Breast ductal lavage (DL) has been found to yield a greater number of breast duct epithelial cells for cytological analysis than nipple aspiration and is less invasive than needle aspiration. In ductal lavage, a microcatheter is inserted into each NAF-producing duct, local anesthetic is infused, and saline is introduced to wash out the ductal contents, which are analyzed cytopathologically. Fiberoptic ductoscopy (FDS), the direct visualization of the breast duct lining using a very thin fiberoptic scope, has been employed to identify the source of atypical cells found on DL. It also allows for evaluation of abnormal nipple discharge in conjunction with aspiration cytology, biopsy, or surgical excision. FDS systems have microendoscopes with an outer air channel on the fiberscope, which permits instillation and re-collection of saline to retrieve cells from the breast ductal system.

Clinical Evidence The published evidence on ductal lavage (DL) and fiberoptic ductoscopy (FDS) is limited to several cross-sectional studies and case series on the feasibility, efficacy, and safety of DL and/or FDS. Patient populations consist mainly of women with high risk for breast cancer due to one or more of the following: personal history of invasive breast cancer;

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