BlueCross and BlueShield of Montana Medical Policy/Codes
Breast Implant, Removal and/or Insertion
Chapter: Surgery: Procedures
Current Effective Date: September 24, 2013
Original Effective Date: September 24, 2013
Publish Date: June 24, 2013
Description

Breast implant, removal and/or insertion, is a surgical removal or replacement of either a silicone gel-filled or a saline-filled breast implant with a new implant.

Saline-filled implants currently are the only product generally available to women who seek breast implants.  Although they have silicone rubber envelopes like silicone gel-filled implants, saline-filled implants present a lower degree of risk than silicone gel-filled implants, according to the FDA, because leakage or rupture would release only salt water into the body. 

Local complications of breast implants are frequent and may require removal of the implant.  Contracture is the most common local complication of breast implants.  Contractures have been graded according to the Baker Classification as follows:

Grade I:  Augmented breast feels 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.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Many contracts have exclusions for services or supplies provided as a result complications following a non-covered procedure. For example, none of the services listed below would be covered for a cosmetic breast implant augmentation (unilateral or bilateral) which is unrelated to post mastectomy reconstruction with contralateral breast surgery, post accidental injury or trauma:

  • Diagnostic evaluation, OR
  • Preparation for surgery, OR
  • Provided in conjunction with treatment, OR
  • Removal of implant, OR
  • Replacement insertion of implant.

Removal of a silicone gel-filled or saline-filled breast implant with or without replacement of a silicone gel-filled or saline-filled breast implant may be considered a cosmetic exclusion (CE) when the original implant was performed for cosmetic breast augmentation. Those cosmetic exclusion services are identified in the grid by “CE”.

Removal of a silicone gel-filled or saline-filled breast implant with or without replacement of a silicone gel-filled or saline-filled breast implant is considered medically necessary (MN) and services are eligible for reimbursement when there is documented evidence of the clinical conditions provided in the grid below.

Those allowed services are identified in the grid by “MN” based upon symptoms, type of implant, and documentation of original indication for implant, along with mammographic evidence.

Removal of a silicone gel-filled or saline-filled breast implant that was placed as a part of breast reconstructive purposes, with or without replacement of a silicone gel-filled or saline-filled breast implant, is considered not medically necessary (NMN) when the clinical condition poses no health threat to the patient. The NMN designation includes imaging of breast implants when the original breast implant was done for cosmetic breast augmentation. Refer to Medical Policy – MRI of the Breast (RAD603.009) for explanation of coverage. Those not allowed services are identified in the grid by “NMN”, which includes imaging of breast implants when the original breast implant was done for cosmetic breast augmentation.

Clinical Conditions

Post Reconstructive Implant Removal (*see note)

Post Reconstructive Implant Reinsertion or Replacement (*see note)

Post Cosmetic Implant Removal (**see note)

Post Cosmetic Implant Reinsertion or Replacement (**see note)

Mammographic evidence of silicone gel-filled implant rupture with extrusion of contents into the subcutaneous tissue

MN

MN

CE

CE

Mammography evidence of saline-filled implant rupture

MN

MN

CE

CE

Baker Class IV (four) contracture as a result of a silicone gel-filled implant

MN

MN

CE

CE

Baker Class IV (four) contracture as a result of a saline-filled implant

MN

MN

CE

CE

Baker Class III (three) contracture as a result of a silicone gel-filled implant

MN

MN

CE

CE

Baker Class III (three) contracture as a result of a saline-filled implant

MN

MN

CE

CE

Baker Class II (two) contracture as a result of a silicone gel-filled implant

NMN

NMN

CE

CE

Baker Class II (two) contracture as a result of a saline-filled implant

NMN

NMN

CE

CE

Recurrent breast infection related only to contracture from or rupture of silicone gel-filled implant

MN

MN

CE

CE

Recurrent breast infection related only to contracture from or rupture of saline-filled implant

MN

MN

CE

CE

Chronic breast pain related ONLY to recurrent breast infection, contracture from, or rupture of a silicone gel-filled implant

MN

MN

CE

CE

Chronic breast pain related ONLY to recurrent breast infection, contracture from, or rupture of a saline-filled implant

MN

MN

CE

CE

Pain not related to contractures or rupture.

NMN

NMN

CE

CE

Patient anxiety or fear of silicone gel-filled or saline-filled implant(s) rupture and/or contracture.

NMN

NMN

CE

CE

Patient anxiety or fear of cancer risk associated with components of implant envelope (sleeve or covering) whether silicone gel-filled or saline-filled implant.

NMN

NMN

CE

CE

Potential systemic conditions from silicone gel-filled implant, such as:

  • Connective tissue disease, OR
  • Autoimmune disease, OR
  • Rheumatic conditions, OR
  • Neurologic symptoms, OR
  • Fibromyalgia, OR
  • Chronic fatigue syndrome.

NMN

NMN

CE

CE

*Reconstructive removal with or without replacement or reinsertion of silicone gel-filled or saline-filled implant(s) when the initial surgery was due to cancer or an approved prophylactic mastectomy for a benign disease (such as cancer risk). There are some instances where reconstructive use of a breast implant has been done following trauma or accident.

**Cosmetic removal with or without replacement or reinsertion of silicone gel-filled or saline filled implant, unrelated to cancer or cancer risk, trauma, or accident, are intended primarily to improve physical appearance, performed primarily for psychological purposes and/or to restore form that does not correct or materially improve a bodily function.

NOTE: If the patient is unable to use saline-filled implants as a replacement for silicone gel-filled implants, the patient must be part of a FDA approved clinical study group or trial to obtain benefits for silicone gel-filled implants. Documentation must accompany the request or claim for silicone gel filled implant(s).

Examples of documentation include but are not limited to at least two of the following:

  • Photographs, OR
  • Mammography, Magnetic Resonance Imaging, or Ultrasonography, OR
  • Consultations, OR
  • Operative reports and/or other applicable hospital records, such as, laboratory or pathology report(s), history and physical, AND/OR
  • Treating Physician office records.

Rationale

Complications of breast implants are common and may require removal.  Determining medical necessity of removal requires documentation of the type of implant and its original indication for initial insertion or placement, such as whether cosmetic or reconstructive.  Since the purpose of reconstructive implants is the restoration of normal breast appearance following treatment of cancer, there are small subsets of patients requiring restoration of normal breast appearance following treatment of accident or trauma.  This small subset may experience complications of breast implants and may require removal.  However, removal of cosmetic implants, whether clinical conditions appear or not, are not a covered benefit as their initial placement was a cosmetic augmentation procedure which was not a covered benefit.  Patients who have originally undergone implantation of a cosmetic breast implant are not candidates for additional re-insertion of another breast implant or reconstructive breast surgery after the implant has been removed.

Post implant insertion complications can be subdivided into local or systemic complications:

  • Local complications include implant contracture, rupture, extrusion, and/or infection.  Infection is considered absolute medical indication for removal in all cases, whether the implant was originally cosmetic or not.  Rupture with extrusion of silicone gel-filled implant is considered medical indication for removal in cases where the implant was originally done as a reconstructive treatment.   However, saline-filled implant rupture with extrusion is not considered an absolute medical indication for removal, except in cases where the original indication for implant insertion was done as a reconstructive treatment.  Since normal saline is physiologic, rupture and extrusion does not pose a health risk; thus, removal of saline-filled implants are not medically necessary for patients with cosmetic implants.  Documentation of rupture with extrusion is considered an absolute requirement for removal in all cases, whether the implant was originally cosmetic or not. 
  • Potential systemic complications of implants, most prominently various connective tissue diseases or chronic fatigue syndrome, have been hotly debated for several years.  In particular, it has been hypothesized that leakage of silicon, due to either 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 over represented 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.

Post implant insertion contracture is a more subjective finding, which is graded according to the “Baker Classification” and ranked from Grade I (a normal breast with implant) to Grade IV (a breast with implant that is hard, cold, painful, tender, and distorted).  Surgical removal of an implant, whether Grade III or Grade IV contractures develop, is considered a cosmetic procedure when the implant was originally inserted for a cosmetic purpose.  Once an implant has been removed, patients who have originally undergone reconstructive implantation are candidates for additional reconstructive breast surgery, either by re-insertion of another breast implant or for autologous reconstruction of the breast.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

85.53, 85.54, 85.93, 85.94, 611.0, 611.71, 611.72, 611.8, 686.1, 909.3, 996.54, 996.69, 996.79, 998.51, 998.59, 998.83, V10.3, V16.3, V45.71, V50.1, V50.41, V51

Procedural Codes: 19328, 19330, 19340, 19342, 19380, 19396, L8600
References
  1. Berkow, R. and A.J. Fletcher, eds. 1992. The Merck Manual, 16th edition.  New Jersey: Merck & C., Inc.: 1812-1822.
  2. Nemecek, J.A. and V.L. Young.  How safe are silicone breast implants? Southern Medical Journal (August 1993) 86(8): 932-44.
  3. Breast Implant Update, FDA Electronic Bulletin Board Service, T94-27, June 1, 1994.
  4. Saline-Filled Breast Implant Update, FDA Electronic Bulletin Board Service, T94-61, December 23, 1994.
  5. TDA and Polyurethane Breast Implants, FDA Electronic Bulletin Board Service, T95-31, June 28, 1995.
  6. Texas Insurance Code. 1997 Edition.  “Coverage for Reconstruction Surgery After Mastectomy.” Article 21.53I.. Web Site: http://www.capitol.state.tx.us .
  7. U.S. Department of Labor. 1998 Edition. “Your Rights After A Mastectomy. . . Women’s Health & Cancer Rights Act of 1998 (WHCRA).” Web Site: http://www.dol.gov .
  8. “FDA – Effective Date of Requirement for Premarket Approval of the Silicone Inflatable Breast Prosthesis.” 21 CFR Part 878 (1999 August 19) 64(160): 1-14. Web Site: http://www.fda.gov .
  9. “Breast Implants – An Informational Update – 2000.” Prepared by FDA – Center for Devices and Radiological Health. (2000 September): 1-78. Web Site: http://www.fda.gov .
  10. Illinois Administrative Code. 2002 Edition. “Required Coverage for Reconstructive Surgery Following Mastectomies.” Section 2016.30.  Web Site: http://www.legis.state.il.us .
  11. Brody, G.S. “Breast implants, silicone: safety and efficacy.” E-Medicine.com. (2002 June 20): 1-24. Web Site: http://www.emedicine.com .
  12. Morrison, JJ. “Fact or fiction: silicone filled implants pose a health threat to women.” American College of Osteopathic Family Physicians. Position Paper. (2003 January) : 1-10. Web Site: www.acofp.org .
  13. “Reconstructive Breast Surgery/Management of Breast Implants.” BCBSA Medical Policy Reference Manual (2003 February) Surgery: 7.01.22.
  14. FDA – “Saline-Filled Breast Implant Surgery: Making An Informed Decision.” (2004 January): 1-39.  Web Site: http//: www.fda.gov .
History
June 2013 New 2013 BCBSMT medical policy.  Previously part of the "Reconstructive Breast Surgery/Management of Breast Implants" policy.
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Breast Implant, Removal and/or Insertion