*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.
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.
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.