Breast Implant Removal and Reimplantation Policy Number: PG0012 ADVANTAGE | ELITE | HMO Last Review: 02/11/2021
INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO
GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or guarantee regarding coverage or reimbursement/payment. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This medical policy is solely for guiding medical necessity and explaining correct procedure reporting used to assist in making coverage decisions and administering benefits.
SCOPE X Professional _ Facility
DESCRIPTION Breast implants are surgical implanted device (prosthesis) used for breast reconstruction; to re-establish symmetry between the two breasts and may include reconstruction of a non-diseased breast to achieve balance (symmetry) between the two breasts Medically indicated breast implants are prosthesis originally inserted for reconstructive purposes: Following a mastectomy Following a lumpectomy Following other surgical treatment of breast disease Post-accidental injury or trauma
Breast implants are also used for breast enlargement for primarily cosmetic reasons. Cosmetic surgery performed to alter or reshape normal breast structures in order to improve appearance.
Prosthetic breast implants are silicone or saline-filled sacs. Breast implants vary in shell surface (e.g., smooth versus textured), shape (e.g., round or shaped), profile (i.e., how far it protrudes), volume (i.e., size) and shell thickness. The primary components of most breast implants are a shell, otherwise known as the envelope or lumen, filler (e.g., saline, silicone gel or alternative) and a patch to cover the manufacturing hole.
Breast implants are typically inserted under local or general anesthesia in an outpatient setting. If the procedure is done for cosmetic reasons, the incision is most commonly made along the lower edge of the areola, in the axilla or in the inframammary fold. For postmastectomy reconstruction, the surgical incision is used, and the implant is placed either deep in the breast on the pectoral fascia (i.e., submammary) or beneath the pectoralis major.
If a patient has adverse reactions to the implants, the implants must be removed. Contracture is the most common local complication of breast implants. Capsular contracture occurs when the scar tissue or capsule that normally forms around the implant tightens, ultimately squeezing the implant. Significant contracture may result in severe pain or may be associated with subclinical infection. The presence of a contracture may also interfere with the ability to diagnose or treat breast cancer. The degree of periprosthetic contracture is often classified by using the Baker grading system. The four Baker classes/stages are as follows: Grade I: breast absolutely natural; augmentation not apparent on observation Grade II: minimum contracture; augmentation apparent on observation, but the patient has no complaints
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Grade III: moderate contracture; patient feels some firmness Grade IV: severe contracture; obvious on observation
Although implantable breast prostheses may be inserted for either reconstructive or cosmetic reasons, clinically significant post-implant complications may occur, necessitating removal of the implants. Local complications associated with implanted breast prostheses include: capsular contracture, persistent infection, silicone implant extrusion, tissue necrosis and silicone implant rupture. These conditions, when they become clinically significant, may require removal of the implant. Additionally, the presence of an implant may interfere with the diagnosis or treatment of breast cancer. Infections that may occur in or around an implant include wound infections, as well as infections within a capsular contracture or as a result of a ruptured implant. Removal of the implant may be necessary when the infection does not respond to antibiotics. Unstable or weakened tissue and/or interruption in wound healing may result in the implant breaking through the skin or extrusion. Necrotic tissue may form around the implant, requiring implant removal. Silicone gel-filled implant rupture may cause the contents to leak into the surrounding tissues. Breast implant--associated anaplastic large cell lymphoma (BIA-ALCL) is another complication that that can occur with breast implants. B
POLICY HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage
Breast implant removal and reimplantation (19328, 19330, 19340, 19342, 19370, and 19371) requires prior authorization for all product lines.
With the following exception: Breast implant removal and reimplantation (19328, 19330, 19340, 19342, 19370, and 19371) will be reimbursed WITHOUT PRIOR AUTHORIZATION, when there is a predetermined cancer diagnosis, as listed, the diagnosis must be in the first diagnosis position: C50.011, C50.012, C50.019, C50.021, C50.022, C50.029, C50.111, C50.112, C50.119, C50.121, C50.122, C50.129, C50.211, C50.212, C50.219, C50.221, C50.222, C50.229, C50.311, C50.312, C50.319, C50.321, C50.322, C50.329, C50.411, C50.412, C50.419, C50.421, C50.422, C50.429, C50.511, C50.512, C50.519, C50.521, C50.522, C50.529, C50.611, C50.612, C50.619, C50.621, C50.622, C50.629, C50.811, C50.812, C50.819, C50.821, C50.822, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C79.81, D05.00, D05.01, D05.02, D05.10, D05.11, D05.12, D05.80, D05.81, D05.82, D05.90, D05.91, D05.92, D48.60, D48.61, D48.62, N64.81, N64.89, N65.0, N65.1, T85.41xA, T85.42xA, T85.43xA, T85.44xA, T85.49xA, Z42.1, Z85.3, Z90.10, Z90.11, Z90.12, Z90.13
COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage Coverage for breast implant removal varies across plans and may be governed by federal and/or state mandates. Please refer to the federal mandate on breast reconstruction and the member’s benefit plan document for coverage details.
Paramount utilizes InterQual® criteria sets for medical necessity determinations.
The following are considered medically necessary indications for the removal of breast implant(s), may not be all- inclusive: documented implant rupture implant exposure/extrusion through skin/into the subcutaneous tissue infection or rejection siliconoma or granuloma Baker Class IV contracture (breast is hard, painful, cold, tender, and distorted) interference with diagnosis of breast cancer, including siliconoma, granuloma
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interference with adequate treatment of know breast cancer (e.g., obstructing radiation therapy) surgical treatment of breast disease in close proximity to the implant Baker Class III contracture (breast is firm, palpable, and the implant [or its distortion] is visible) only when the implant(s) was placed as part of a medically necessary reconstructive procedure individuals diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Pain related to the Baker Classification or a diagnosis of rupture. Pain as an isolated symptom is an inadequate indication of implant removal.
Mandated Benefit: The Women's Health and Cancer Rights Act (WHCRA) was enacted as a federal mandate in October 1998. The federal mandate addresses reconstructive breast surgery following for trauma, breast cancer or a prophylactic mastectomy, and requires coverage for: All stages of reconstruction of the breast on which a diagnosis of breast cancer has been performed, i.e. mastectomy and lumpectomy; Surgery and reconstruction of the other breast to produce a symmetrical appearance; and Prostheses and physical complications of mastectomy, including lymphedemas.
Required Documentation To support the medical necessity of the removal of a breast implant, the medical record documentation must include: Documentation of the original indication for implantation and the type of implant, either silicone gel-filled or saline-filled Reason for the implant removal and the results of any mammogram, ultrasound, and/or magnetic resonance imaging (MRI) as appropriate
Not Covered The following breast removal are considered NOT medically necessary and/or cosmetic unless associated with breast reconstruction following mastectomy, lumpectomy, surgical treatment of breast disease, post-accidental injury or trauma: not all-inclusive removal of a ruptured saline-filled implant in the absence of one of the indications listed above, is considered cosmetic removal of any type of breast implant when performed for ANY of the following: o solely to treat psychological symptomatology or psychosocial complaints, i.e. not all-inclusive . member anxiety or fear of silicone gel-filled or saline-filled implant(s) rupture and/or contracture . member anxiety or fear of cancer risk . member anxiety or fear of potential systemic conditions o solely to improve, correct or further alter and/or improve physical appearance o solely because of shifting or migration of the implant o removal of the implant in the opposite/contralateral breast, unless criteria are otherwise met for that breast implant o solely for suspected autoimmune disease or connective tissue disease or breast cancer prevention replacement of an implant following removal, except as identified below.
Breast Implant Reimplantation Breast implant reimplantation may be considered medically necessary for an individual with both of the following: When a subsequent disease process (e.g., infection with necrosis) has resulted in a clinically significant structural abnormality of the adjacent native breast tissue Breast implant was originally inserted for covered reconstructive purposes (e.g., after mastectomy, lumpectomy, or other surgical treatment of breast disease) Creation of a symmetrical appearance in the contralateral/nondiseased breast following mastectomy or lumpectomy in the opposite breast The reinsertion of the breast implant(s) is considered cosmetic if the original insertion was for a cosmetic, not a reconstructive reason.
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CODING/BILLING INFORMATION The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in this clinical policy are for informational purposes only. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES 19328 Removal of intact mammary implant 19330 Removal of ruptured breast implant, including implant contents (e.g., saline, silicone gel) 19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction 19342 Delayed insertion of breast prosthesis following mastopexy, mastectomy, or in reconstruction 19370 Revision of peri-implant capsule, breast, including capsulotomy, capsulorrhaphy, and/or partial 19371 Peri-implant capsulectomy, breast, complete, including removal of all intracapsular contents
DIAGNOSIS CODES Malignant Neoplasms of Breast(s) C50.011 Malignant neoplasm of nipple and areola, right female breast C50.012 Malignant neoplasm of nipple and areola, left female breast C50.019 Malignant neoplasm of nipple and areola, unspecified female breast C50.021 Malignant neoplasm of nipple and areola, right male breast C50.022 Malignant neoplasm of nipple and areola, left male breast C50.029 Malignant neoplasm of nipple and areola, unspecified male breast C50.111 Malignant neoplasm of central portion of, right female breast C50.112 Malignant neoplasm of central portion of, left female breast C50.119 Malignant neoplasm of central portion of, unspecified female breast C50.121 Malignant neoplasm of central portion of, right male breast C50.122 Malignant neoplasm of central portion of, left male breast C50.129 Malignant neoplasm of central portion of, unspecified male breast C50.211 Malignant neoplasm of upper-inner quadrant of, right female breast C50.212 Malignant neoplasm of upper-inner quadrant of, left female breast C50.219 Malignant neoplasm of upper-inner quadrant of, unspecified female breast C50.221 Malignant neoplasm of upper-inner quadrant of, right male breast C50.222 Malignant neoplasm of upper-inner quadrant of, left male breast C50.229 Malignant neoplasm of upper-inner quadrant of, unspecified male breast C50.311 Malignant neoplasm of lower-inner quadrant of, right female breast C50.312 Malignant neoplasm of lower-inner quadrant of, left female breast C50.319 Malignant neoplasm of lower-inner quadrant of, unspecified female breast C50.321 Malignant neoplasm of lower-inner quadrant of, right male breast C50.322 Malignant neoplasm of lower-inner quadrant of, left male breast C50.329 Malignant neoplasm of lower-inner quadrant of, unspecified male breast C50.411 Malignant neoplasm of upper-outer quadrant of, right female breast C50.412 Malignant neoplasm of upper-outer quadrant of, left female breast C50.419 Malignant neoplasm of upper-outer quadrant of, unspecified female breast C50.421 Malignant neoplasm of upper-outer quadrant of, right male breast C50.422 Malignant neoplasm of upper-outer quadrant of, left male breast C50.429 Malignant neoplasm of upper-outer quadrant of, unspecified male breast C50.511 Malignant neoplasm of lower-outer quadrant of, right female breast C50.512 Malignant neoplasm of lower-outer quadrant of, left female breast C50.519 Malignant neoplasm of lower-outer quadrant of, unspecified female breast C50.521 Malignant neoplasm of lower-outer quadrant of, right male breast C50.522 Malignant neoplasm of lower-outer quadrant of, left male breast
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C50.529 Malignant neoplasm of lower-outer quadrant of, unspecified male breast C50.611 Malignant neoplasm of axillary tail of, right female breast C50.612 Malignant neoplasm of axillary tail of, left female breast C50.619 Malignant neoplasm of axillary tail of, unspecified female breast C50.621 Malignant neoplasm of axillary tail of, right male breast C50.622 Malignant neoplasm of axillary tail of, left male breast C50.629 Malignant neoplasm of axillary tail of, unspecified male breast C50.811 Malignant neoplasm of overlapping sites of, right female breast C50.812 Malignant neoplasm of overlapping sites of, left female breast C50.819 Malignant neoplasm of overlapping sites of, unspecified female breast C50.821 Malignant neoplasm of overlapping sites of, right male breast C50.822 Malignant neoplasm of overlapping sites of, left male breast C50.829 Malignant neoplasm of overlapping sites of, unspecified male breast C50.911 Malignant neoplasm of unspecified site of, right female breast C50.912 Malignant neoplasm of unspecified site of, left female breast C50.919 Malignant neoplasm of unspecified site of, unspecified female breast C50.921 Malignant neoplasm of unspecified site of, right male breast C50.922 Malignant neoplasm of unspecified site of, left male breast C50.929 Malignant neoplasm of unspecified site of, unspecified male breast C79.81 Secondary malignant neoplasm of breast D05.00 Lobular carcinoma in situ of unspecified breast D05.01 Lobular carcinoma in situ of right breast D05.02 Lobular carcinoma in situ of left breast D05.10 Intraductal carcinoma in situ of unspecified breast D05.11 Intraductal carcinoma in situ of right breast D05.12 Intraductal carcinoma in situ of left breast D05.80 Other specified type of carcinoma in situ of unspecified breast D05.81 Other specified type of carcinoma in situ of right breast D05.82 Other specified type of carcinoma in situ of left breast D05.90 Unspecified type of carcinoma in situ of unspecified breast D05.91 Unspecified type of carcinoma in situ of right breast D05.92 Unspecified type of carcinoma in situ of left breast D48.60 Neoplasm of uncertain behavior of unspecified breast D48.61 Neoplasm of uncertain behavior of right breast D48.62 Neoplasm of uncertain behavior of left breast N64.81 Ptosis of breast N64.89 Other specified disorders of breast N65.0 Deformity of reconstructed breast N65.1 Disproportion of reconstructed breast T85.41xA Breakdown (mechanical) or breast prosthesis and implant, initial encounter T85.42xA Displacement of breast prosthesis and implant, initial encounter T85.43xA Leakage of breast prosthesis and implant, initial encounter T85.44xA Capsular contracture of breast implant, initial encounter T85.49xA Other mechanical complication of breast prosthesis and implant, initial encounter Z42.1 Encounter for breast reconstruction following mastectomy Z85.3 Personal history of malignant neoplasm of breast Z90.10 Acquired absence of unspecified breast and nipple Z90.11 Acquired absence of right breast and nipple Z90.12 Acquired absence of left breast and nipple Z90.13 Acquired absence of bilateral breast and nipple
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REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 02/11/2014 Date Explanation & Changes 02/11/14 Policy created and approved by Medical Policy Steering Committee Policy reviewed and updated to reflect most current clinical evidence per Medical Policy 03/13/18 Steering Committee 12/10/2020 Medical policy placed on the new Paramount Medical Policy Format Medical Policy title changed from Breast Implant Removal to Breast Implant Removal and Reimplantation 02/11/2021 Add Diagnosis Codes that would not require a prior authorization r/t to the WHCRA benefit mandate, procedure-to-diagnosis. Updated the medical policy to the most up-to-date Industry Standard Coverage Criteria
REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services
Ohio Department of Medicaid
American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services
Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets
Hayes, Inc.
Industry Standard Review
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