CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Risk Reducing Mastectomy

Defines medical necessity and coverage stance for risk-reducing (prophylactic) mastectomy (including bilateral and contralateral procedures) for individuals at high risk of breast cancer; provides background, guideline references, and a covered CPT code for Medicare Advantage/commercial products. Prior authorization and explicit medical criteria sections state 'Not applicable.'

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Risk Reducing Mastectomy

Policy CodePolicy N/A

Change TypeClarified

Effective DateJun 1, 2001

Next Review Date

Key ActionDocument clinical evidence of high-risk status and counseling by a clinician skilled in risk assessment, including alternatives such as surveillance and chemoprevention.

SourceLink

POLICY UPDATE CHANGES

Policy statement affirms risk-reducing mastectomy is medically necessary for individuals at high risk of breast cancer.

1Explicit covered CPT code listed

MultipleGuideline sources referenced

>20%High-risk lifetime risk threshold

Coverage Summary

Medical-Necessity Criteria

Medical Necessity Criteria

Risk reducing mastectomy is considered medically necessary in individuals at high risk of breast cancer:

ANY of the following

BRCA variants: Known deleterious/pathogenic BRCA1 or BRCA2 variant
LCIS: Lobular carcinoma in situ
Prior chest RT: History of prior radiotherapy to the chest between ages 10 and 30 years
Other high-penetrance syndromes: Other syndromic or high-penetrance genetic conditions (examples given: PTEN [Cowden syndrome], TP53 [Li-Fraumeni], CDH1) that confer high risk
Examples provided in policy: PTEN (Cowden), TP53 (Li-Fraumeni), CDH1
Strong family history/high lifetime risk: Strong family history of breast cancer or other circumstances where clinical assessment estimates a high lifetime risk (generally described as >20%)> 20% (generally considered high risk)
Policy states some combinations of risk factors may indicate high risk and risk estimates may need individualization
Contralateral RRM: Contralateral risk-reducing mastectomy may be considered in patients who have previously undergone or are undergoing mastectomy for invasive cancer in the opposite breast (i.e., patients with unilateral cancer seeking contralateral risk-reducing mastectomy)

Counseling and Decision-making

Requirements/Recommendations before surgery:

ALL of the following

Counseling by skilled clinician: Candidates are strongly recommended to undergo counseling regarding cancer risks from a health professional skilled in risk assessment other than the operating surgeon
Discussion of alternatives and implications: Discussion should include alternative risk-reduction strategies such as increased surveillance and chemoprevention (eg, tamoxifen or raloxifene), and consideration of reconstructive implications and potential adverse effects on body image and sexuality

Provider Actions

Documentation Required

Risk assessment documentation

Document clinical evidence of high-risk status and counseling. Include objective evidence such as genetic test results, history of chest radiotherapy in the specified age range, presence of lobular carcinoma in situ, or a strong family history, and document that counseling about alternatives (surveillance, chemoprevention) was performed by a clinician skilled in risk assessment (not the operating surgeon).

Genetic test results (eg, known deleterious/pathogenic BRCA1 or BRCA2 or other high-penetrance syndromic variants)
History of prior chest radiotherapy between ages 10 and 30
Lobular carcinoma in situ (LCIS)
Strong family history of breast cancer or other circumstances estimating lifetime risk generally >20%

Billing Rule

Report covered mastectomy code(s)

Report the covered CPT code for mastectomy when applicable for Medicare Advantage Plans and commercial products as specified in the policy coding section.

19303

Background and Evidence

Risk-reducing mastectomy is removal of breast tissue in the absence of malignancy to reduce future breast cancer risk and is typically bilateral but may be unilateral or contralateral in patients with existing unilateral invasive cancer. Appropriateness requires individualized risk–benefit assessment using validated risk models and clinical factors (eg, family history, genetic variants, prior chest radiotherapy) and must consider reconstructive consequences, potential adverse effects on body image and sexuality, and patient preferences.

Guideline consensus sources summarized include the Society of Surgical Oncology, joint ASCO/ASTRO/SSO guidelines, NCCN, and the American Society of Breast Surgeons; these support individualized decision-making regarding risk-reducing mastectomy, and the quality and strength of evidence vary by specific recommendation.

Risk-reducing mastectomyRemoval of the breast in the absence of malignant disease to reduce risk of breast cancer occurrence (also called prophylactic mastectomy).

Contralateral risk-reducing mastectomy (CRRM or CPM)Prophylactic removal of the contralateral breast in a patient with unilateral breast cancer to reduce risk of contralateral breast cancer.

Revision History

2001-06-01policy_effective

Policy effective date establishes coverage framework; risk-reducing mastectomy defined and consideration for high-risk individuals described.

2023-08-02policy_review/clarificationLatest

Policy statement affirms risk-reducing mastectomy is medically necessary for individuals at high risk of breast cancer; guidance clarifies high-risk examples (BRCA1/2, lobular carcinoma in situ, chest radiotherapy between ages 10–30, other high-penetrance syndromes) and recommends counseling and individualized risk assessment prior to surgery. (This is a clarification and not a material change.)