Status Active Medical and Behavioral Health Policy Section: Surgery Policy Number: IV-14 Effective Date: 03/23/2015 Blue Cross and Blue Shield of Minnesota medical policies do not imply that members should not receive specific services based on the recommendation of their provider. These policies govern coverage and not clinical practice. Providers are responsible for medical advice and treatment of patients. Members with specific health care needs should consult an appropriate health care professional. BREAST IMPLANT, REMOVAL OR REPLACEMENT Description: Breast implants are generally considered cosmetic except as part of reconstructive surgery for treatment of breast cancer or prophylactic mastectomy. The Federal Women’s Health and Cancer Rights Act of 1998 (PL 105-277) and Minnesota law require coverage of all stages of reconstruction of the breast on which a mastectomy was performed, as well as surgery and reconstruction of the other breast to produce a symmetrical appearance. Capsular contracture is the most common complication associated with breast implants, and severity is graded according to the Baker classification (see Definitions). Other complications such as hematoma, seroma, or infection are initially addressed through medical intervention. In those instances where complications are not responsive to repeated medical treatment, removal of the implant may be required to resolve the condition. In 1991, the U.S. Food and Drug Administration (FDA) began evaluating health concerns related to the rupture and leakage of silicone breast implants, including development of autoimmune disease. There is no conclusive evidence to support a causal relationship between silicone implants and autoimmune disease. Definitions: Baker classification of capsular contracture: Grade I: The breast is soft without palpable thickening. Grade II: The breast has some firmness. The implant can be palpated but is not visible. Grade III: The breast is firm. The implant can be palpated easily. The implant or its distortion may be visible. Grade IV: The breast is hard, painful, and tender with significant distortion. Policy: I. Initial Insertion/Placement of Breast Implants A. Initial insertion/placement of breast implants may be considered MEDICALLY NECESSARY for reconstructive purposes following: 1. Mastectomy for breast cancer; OR 2. Prophylactic mastectomy. B. Initial insertion/placement of breast implants is considered COSMETIC for all other indications, including but not limited to breast augmentation. II. Removal of Breast Implants A. Removal of breast implants may be considered MEDICALLY NECESSARY when: 1. The original implants were placed for reconstructive purposes post-mastectomy, as described in section IA; OR 2. The original implants were placed for cosmetic purposes, as described in section IB, AND one or more of the following complications are present: a. Capsular contracture of Baker Class IV causing severe pain or hardening of the implant; b. Confirmed leakage/rupture of a silicone implant with silicone migration resulting in pain, lumps, granulomas and increasing fibrosis; c. Recurrent infection secondary to the implant that does not resolve with medical treatment including antibiotics; d. Recurrent seroma or hematoma that does not resolve with repeated drainage; or e. Implant extrusion through the skin; or f. Implant interference with diagnostic evaluation of suspected breast cancer or treatment of known breast cancer. B. Removal of breast implants originally placed for cosmetic purposes, as described in section IB, is considered COSMETIC for all other indications, including but not limited to: 1. Aesthetic appearance; 2. Malposition of the implant; or 3. Anxiety related to the implant. III. Replacement of Breast Implants A. Replacement of breast implants may be considered MEDICALLY NECESSARY when the original implants were placed for reconstructive purposes post-mastectomy, as described in section IA. B. Replacement of breast implants is considered COSMETIC when the original implants were placed for cosmetic purposes, as described in section IB. Coverage: Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. Receipt of benefits is subject to all terms and conditions of the member’s summary plan description (SPD). As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. Blue Cross reserves the right to revise, update and/or add to its medical policies at any time without notice. For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites. Refer to the Pre-Certification/Pre-Authorization section of the Medical Behavioral Health Policy Manual for the full list of services, procedures, prescription drugs, and medical devices that require Precertification/Pre-Authorization. Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met. Coding: The following codes are included below for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. CPT: 11970 Replacement of tissue expander with permanent prosthesis 19325 Mammaplasty, augmentation; with prosthetic implant 19328 Removal of intact mammary implant 19330 Removal of mammary implant material 19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction 19342 Delayed insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction 19396 Preparation of moulage for custom breast implant HCPCS: C1789 Prosthesis, breast (implantable) L8600 Implantable breast prosthesis, silicone or equal Policy History: Developed April 20, 1994 Most recent history: Reviewed October 12, 2011 Revised November 14, 2012 Reviewed November 13, 2013 Revised January 14, 2015 Cross Reference: Mastopexy, IV-33 Current Procedural Terminology (CPT®) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. Copyright 2015 Blue Cross Blue Shield of Minnesota.
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