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DESCRIPTIONProphylactic mastectomy (PM) is defined as the removal of the breast in the absence of malignant disease to reduce the risk of breast cancer occurrence. Prophylactic mastectomies may be considered in women considered at high risk of developing breast cancer, either due to a family history, presence of a BRCA1 or BRCA2 mutation, or the presence of lesions associated with an increased cancer risk. Such lesions include atypical hyperplasia and lobular carcinoma in situ (LCIS). Although LCIS is labeled as a cancer, it is thought not to have invasive potential, but patients with LCIS are at increased risk of developing an invasive breast cancer elsewhere in either breast. Therefore, bilateral prophylactic mastectomy is performed not to excise the LCIS lesion itself, but to eliminate the risk of cancer arising elsewhere. Prophylactic mastectomies are typically bilateral, but can also describe a unilateral mastectomy in a patient who has previously undergone a mastectomy in the opposite breast for an invasive cancer.
Two types of prophylactic mastectomies can be performed; either total (also referred to as simple) mastectomy, in which the intent is to remove the entire breast and nipple areolar complex, and subcutaneous mastectomy, where the nipple areolar complex is left intact for a more natural appearance. While breast tissue is certainly left behind in a subcutaneous mastectomy, residual breast tissue in the axillary tail and skin flaps may be identified after a total mastectomy. However, from a purely prophylactic standpoint, a total mastectomy is generally preferred over a subcutaneous mastectomy because there is less residual breast tissue.
The appropriateness of a prophylactic mastectomy is a complicated risk-benefit analysis that requires estimates of a patient's risk of breast cancer, typically based on the patient's family history of breast cancer and other factors. Two models are most frequently used, the Claus model and the Gail model. The Gail model uses the following five risk factors: age at evaluation, age at menarche, age at first live birth, number of breast biopsies, and number of first-degree relatives with breast cancer.
See Genetic Testing for Hereditary Breast and/or Ovarian Cancer medical policy.
POLICYProphylactic mastectomy may be considered medically necessary in patients at high risk of breast cancer. (For definitions of risk levels, see policy guidelines, below).
Prophylactic mastectomy may be considered medically necessary in patients with lobular carcinoma in situ.
Prophylactic mastectomy may be considered medically necessary in patients with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible.
Prophylactic mastectomy is considered investigational for all other indications, including but not limited to contralateral prophylactic mastectomy in women with breast cancer who do not meet high risk criteria.
POLICY GUIDELINESPatients with a high risk of breast cancer may be defined as one or more of the following:
It is recommended that all candidates for prophylactic mastectomy consider undergoing counseling regarding cancer risks from a health professional skilled in assessing cancer risk other than the operating surgeon. Cancer risk should be assessed by performing a complete family history, use of the Gail or Claus model to estimate the risk of cancer, and discussion of the various treatment options, including increased surveillance or chemoprevention with tamoxifen or raloxifene.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
POLICY HISTORY2/2001: Approved by Medical Policy Advisory Committee (MPAC)
5/14/2002: Code Reference section updated; 173.5, 174.0-174.9, 175.0-175.9, 198.81, 238.3, 239.3, and 611.72 (malignant codes) deleted
1/17/2003: Policy reviewed; no changes based on Hayes report
11/19/2004: Code Reference section updated, ICD-9 procedure code range 85.33-85.36, 85.41-85.44 listed separately, ICD-9 diagnosis code V50.41 "Note: Must be filed in conjunction with one of the diagnosis codes listed above." added
12/27/2006: Code Reference section updated per the 2007 CPT revisions
1/5/2009: Policy reviewed, additional definitions of "high risk of breast cancer" added to the policy
04/20/2011: Policy description and statement unchanged. Removed deleted CPT codes 19180 and 19182 from the Code Reference section.
03/27/2012: Policy reviewed. Policy description updated. Deleted outdated references from the Sources section.
09/03/2013: Definition of high risk clarified and medically necessary indication for those at moderately increased risk of breast cancer removed, except for women with extensive mammographic abnormalities. Add policy statement to indicate that prophylactic mastectomy may be considered medically necessary in patients with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible. Also added that prophylactic mastectomy is considered investigational for all other indications, including but not limited to contralateral prophylactic mastectomy in women with breast cancer who do not meet high risk criteria. Updated high-risk criteria in the policy guidelines and deleted the moderate risk information.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.09
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.