Subject:
Explantation of Breast Implants
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Silicone gel-filled or saline-filled breast implants may be inserted for reconstructive or cosmetic purposes. Reconstructive implant insertion is commonly done in post-mastectomy patients either immediately at the time of mastectomy or sometime afterward in conjunction with previous use of tissue expander.
Local complications of breast implants are frequent and may require explantation or removal with or without subsequent insertion of another implant. Contractures is the most common local complication and has been graded as follows based on the Baker classification:
Grade I - augmented breast feels as soft as a normal breast.
Grade II - breast is less soft and the implant can be palpated but is not visible.
Grade III - breast is firm, palpable, and the implant (or its distortion) is visible.
Grade IV - breast is hard, painful, cold, tender, and distorted.
Potential systemic complications of implants, most prominently various connective tissue diseases or chronic fatigue syndrome, have been hotly debated for the past years. In particular, it has been hypothesized that leakage of silicone, due either to an implant rupture or to "bleeding" of silicone through an intact capsule, may incite an autoimmune response with the development of systemic symptoms. However, to date, large epidemiologic studies have not demonstrated that women with breast implants are overrepresented among all those with connective tissue disease. In addition, there are inadequate empiric studies to demonstrate that removal of breast implants is associated with resolution of systemic symptoms.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Eligibility of procedures and/or services related to a prior cosmetic procedure including, but not limited to, complications resulting from cosmetic procedures is determined by the member’s specific contract benefits.
[INFORMATIONAL NOTE: For more information on the eligibility and medical appropriateness of breast implants for purposes of augmentation to achieve breast symmetry, please refer to separate policies on Post-Mastectomy Reconstructive Breast Surgery (Policy #011) and Reduction Mammaplasty (Policy #028) under the SURGERY Section of this database.]
2. When a member’s contract excludes treatment of complications related to cosmetic procedures, explantation of a breast implant(s) which was (were) originally inserted for cosmetic purposes is not contractually eligible for reimbursement regardless of the reason for the explantation.
3. When a member’s contract does not exclude treatment of complications related to cosmetic procedures, explantation of either a silicone gel-filled or saline-filled breast implant is covered for any of the following medically necessary indications:
- documented implant rupture
- infection
- extrusion
- Baker class IV contracture
- explantation in conjunction with surgical treatment of breast cancer.
- Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
(NOTE: Additional breast cancer screening or prophylactic breast implant removal is NOT recommended for women with implants who are asymptomatic, even for those with a familial susceptability to cancer. Per UpToDate based on FDA recommentations)
4. Subsequent implantation of another breast implant after explantation is only covered for those members who had originally undergone breast implantation for reconstructive purposes (e.g., reconstruction after breast cancer surgery or reconstruction secondary to trauma).
5. Indications for explantation of breast implants which are considered not medically necessary include, but are not limited to, the following:
- member anxiety;
- pain not related to contractures or rupture;
- systemic symptoms, attributed to connective tissue diseases, autoimmune diseases, etc.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has determined that this service is covered when the LCD criteria is met. Please refer to Novitas Solutions Inc, LCD L35090 Cosmetic and Reconstructive Surgery. Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.
Local Coverage Article: Billing and Coding: Cosmetic and Reconstructive Surgery (A56587). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Explantation of Breast Implants
BIA-ALCL
Breast Implant-Associated Anaplastic Large Cell Lymphoma
Breast Implants, Explantation of
Implants, Removal of Breast
Removal of Breast Implants
Rupture, Breast Implants
References:
1. Gabriel SE, Woods JE, O’Fallon WM et al. Complications leading to surgery after breast implantation. N Engl J Med 1997; 336(10):677-82.
2. Samuels JB, Rohrich RJ, Weatherall PT et al. Radiographic diagnosis of breast implant rupture: current status and comparison of techniques. Plast Reconstr Surg 1995; 96(4):865-77.
3. Netscher DT, Weizer G, Malone RS et al. Diagnostic value of clinical examination and various imaging techniques for breast implant rupture as determined in 81 patients having implant removal. South Med J 1996; 89(4):397-404.
4. Chung KC, Wilkins EG, Beil RJ Jr. et al. Diagnosis of silicone gel breast implant rupture by ultrasonography. Plast Reconstr Surg 1996; 97(1):104-9.
5. Baker JL. Augmentation mammoplasty. In: Symposium on Aesthetic Surgery of the Breast. Owsley JQ, Peterson RA (eds.). St. Louis: Mosby, 1978.
6. American Society of Plastic and Reconstructive Surgeons Citizens’ Petition to the Food and Drug Administration submitted by the American Society of Plastic and Reconstructive Surgeons which requests that silicone gel-filled implants remain available because the device is necessary for the public health. Nov. 29, 1991. Arlington Heights, Ill.
7. Gabriel SE, O’Fallon WM, Kurland LT et al. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994; 330(24):1697-702.
8. Hennekens CH, Lee IM, Cook NR et al. Self-reported breast implants and connective-tissue disease in female health professionals. A retrospective cohort study. JAMA 1996; 275(8):616-21.
9. Sanchez-Guerrero J, Colditz GA, Karlson EW et al. Silicone breast implants and the risk of connective-tissue disease and symptoms. N Eng J Med 1995; 332(25):1666-70.
10. Silverman BG, Brown SL, Bright RA et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med 1996; 124(8):744-56.
11. FDA Breast Implant Consumer Handbook – 2004. Available at: http://www.fda.gov/cdrh/breastimplants/indexbip.PDF .
12. Washer LL, Gutowski K. Breast implant infections. Infect Dis Clin North Am 2012 Mar;26(1):111-25.
13. UpToDate. Breast reconstruction in women with breast cancer. Litearture review current through April 2014.
14. UpToDate. Breast implant infections. Literature review current through May 2016. Topic last updated Oct 29, 2016.
15. UpToDate. Complications of reconstructive and aesthetic breast surgery. Literature review current through May 2016. Topic last updated Mar 07, 2016.
16. Nahabedian M. Overview of breast reconstruction. In: UpToDate, Chagpar AB, Butler CE, Collins KA (Eds), UpToDate, Waltham, MA. (Accessed on May 29, 2017.)
17. Nahabedian M. Complications of reconstructive and aesthetic breast surgery. In: UpToDate, Butler CE, Collins KA (Eds), UpToDate, Waltham, MA. (Accessed on May 08, 2017.)
18. Nahabedian M. Complications of reconstructive and aesthetic breast surgery. In: UpToDate, Butler CE, Collins KA (Eds), UpToDate, Waltham, MA. (Accessed on April 2, 2018.)
19. Nahabedian M, Gutowski KA. Complications of reconstructive and aesthetic breast surgery. Butler CE, Collins KA Eds. In UpToDate, Waltham, MA. (Accessed on April 23, 2019.)
20. Clemens MW, Jacobsen E. Breast Implant-Associated Anaplastic large cell Lymphoma. Butler CE, Freedman AS, Collins KA Rosmarin AG, eds. In UpToDate, Waltham, MA. (Accessed on April 23, 2019.)
21. Nahabedian M, Gutowski KA. Complications of reconstructive and aesthetic breast surgery. Butler CE, Collins KA Eds. In UpToDate, Waltham, MA. (Accessed on June 8, 2020.)
22. Clemens MW, Jacobsen E. Breast Implant-Associated Anaplastic large cell Lymphoma. Butler CE, Freedman AS, Collins KA Rosmarin AG, eds. In UpToDate, Waltham, MA. (Accessed on June 8, 2020.)
23. Nahabedian M. Implant-based breast reconstruction and augmentation. Butler CE, Collins KA, Eds. In UpToDate, Waltham, MA. (Accessed on June 8, 2020.)
21. FDA note. Breast Implant-Associated Anaplastic Large Cell Lymphoma. Content current as of 4/2/2019. Available at: https://www.fda.gov/medical-devices/breast-implants/breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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