MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Reconstructive Breast Surgery/Management of Breast Implants

Number 7.01.533

Effective Date March 08, 2013

Revision Date(s) 03/18/13; 03/13/12; 09/13/11; 11/09/10; 05/11/10; 06/09/09; 08/12/08; 07/10/07; 10/16/03; 12/10/02; 12/07/99; 06/25/98; 02/97

Replaces 7.01.22

Policy

Reconstructive Breast Surgery

Reconstructive breast surgery may be considered medically necessary after a medically necessary mastectomy or lumpectomy, accidental injury, or trauma. Medically necessary mastectomies or lumpectomies are most typically done as treatment for cancer.

Note: After reconstructive breast surgery on one side, insertion of an implant or performance of a reduction mammaplasty on the contralateral side may be considered medically necessary in order to achieve symmetry.

Explantation of Implants Placed for Reconstructive Purposes

Explantation of a silicone gel or saline-filled breast implant may be considered medically necessary in those patients who had originally undergone breast implantation for reconstructive purposes. Medically necessary indications for explantation include:

  • documented implant rupture,
  • infection,
  • extrusion,
  • Baker Class III or IV contracture, or
  • surgical treatment of breast cancer or other malignancies involving the breast.

The following indications for explantation of implants initially placed for reconstructive purposes are considered not medically necessary:

  • systemic symptoms attributed to connective tissue diseases, autoimmune diseases, etc.;
  • patient anxiety; and
  • pain not related to contractures or rupture.

Reconstructive breast surgery after explantation of an implant may be considered medically necessary only in those patients who had originally undergone breast implantation for medically necessary reconstructive purposes.

Explantation of Implants Placed for Cosmetic Purposes

Explantation of silicone or saline implants initially placed for cosmetic purposes will be covered:

  • Only in the instance of surgical treatment for breast cancer or other malignancies involving the breast.

All other indications for explantation of implants placed for cosmetic purposes may be contractually excluded as a non-covered service, irrespective of the existence of any medical necessity criteria described in the above section devoted to explantation of implants placed for reconstructive purposes.

Please refer to the member contract for coverage associated with complications of non-covered procedures.

Related Policies

7.01.129

Autologous Fat Grafting to the Breast and Adipose-Derived Stem Cells

7.01.503

Reduction Mammaplasty for Breast-related Symptoms

10.01.514

Cosmetic and Reconstructive Services

Policy Guidelines

Reconstructive breast surgery may consist of any of the following procedures:

  • immediate or delayed insertion of breast prosthesis with or without associated tissue expansion; or
  • autologous reconstruction using autologous tissue (e.g., latissimus dorsi flap, transverse rectus abdominis myocutaneous flap, or free flap); or
  • revision of reconstructed breast; or
  • nipple/areola reconstruction and nipple tattooing when the breast reconstruction is considered eligible for coverage; or
  • mastopexy or reduction mammaplasty or augmentation on the contralateral breast to achieve symmetry.

Description

Reconstructive breast surgery is defined as those surgical procedures that are designed to restore the normal appearance of the breast after surgery, accidental injury, or trauma. The most common indication for reconstructive breast surgery is a prior mastectomy; in fact, benefits for reconstructive breast surgery in these patients are mandated in many states. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone surgery, accidental injury, or trauma. Reduction mammaplasty is a common example of cosmetic breast surgery. Surgery to alter the appearance of a developmental variant of the breasts, such as tubular breasts, would also be considered cosmetic in nature.

The most common type of reconstructive breast surgery is insertion of a silicone gel- filled or saline-filled breast implant, either inserted immediately at the time of mastectomy (CPT code 19340) or sometime afterward in conjunction with the previous use of a tissue expander (19342, 19357). 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 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

Other types of reconstruction include nipple/areola reconstruction, nipple tattooing, and/or the use of autologous tissue, such as a transverse rectus abdominis myocutaneous flap (TRAM procedure) or a latissimus dorsi flap. In addition, augmentation, mastopexy, or reduction mammaplasty on the contralateral breast may be performed in order to achieve symmetry with the reconstructed breast.

The following policy describes different types of reconstructive breast surgery and establishes criteria for the explantation of breast implants based on whether the original implant was cosmetic or reconstructive in nature, and whether the implant is silicone gel-filled or saline-filled. Please see the Rationale section for further discussion.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

Services addressed in the policy may be subject to contract restrictions or exclusions and subject to state and federal mandates regarding breast reconstruction.

For the purposes of this policy, the following definitions apply:

Cosmetic: Cosmetic services are those which are primarily intended to preserve or improve appearance. Cosmetic surgery is performed to reshape structures of the body in order to improve the patient’s appearance or self-esteem.

Physical Functional Impairment: In this policy, functional impairment means a limitation from normal (or baseline level) of physical functioning that may include, but is not limited to, problems with ambulation, mobilization, communication, respiration, eating, swallowing, vision, facial expression, skin integrity, distortion of nearby body parts or obstruction of an orifice. The physical functional impairment can be due to structure, congenital deformity, pain, or other causes. Physical functional impairment excludes social, emotional and psychological impairments or potential impairments.

Reconstructive Surgery: In this policy, reconstructive surgery refers to surgeries performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. It is generally performed to improve function.

Rationale

Reconstructive breast surgery is considered medically necessary after a medically necessary mastectomy or after accidental trauma or injury. The most common type of reconstruction is insertion of a breast implant, either a silicone gel-filled or saline-filled prosthesis. The breast may also be reconstructed using autologous tissues, such as a free flap (19364), a latissimus dorsi flap (19361), or more commonly using a transverse rectus abdominis flap (TRAM procedure, 19367, 19369). Nipple areola reconstruction (19350) or nipple tattooing (11920) may also be considered reconstructive breast surgery. Since the purpose of reconstructive breast surgery is to restore the normal appearance of the breast, on some occasions procedures are performed on the contralateral, normal breast in order to achieve symmetry, such as mastopexy (19316) and reduction mammaplasty (19318) or augmentation (19325). These procedures fall into the category of reconstructive breast surgery only when performed in conjunction with a contralateral mastectomy for cancer with associated reconstruction. Except for medically necessary reduction mammaplasty, these procedures are considered cosmetic in other circumstances.

Complications of breast implants are common and may require explantation of the implant. (1) Determining the medical necessity of explantation requires documentation of the type of implant and its original indication; i.e., whether reconstructive or cosmetic. The basic underlying principle is that cosmetic implants require explantation only for absolute medical indications, which pose significant health consequences, while the criteria for explantation of reconstructive implants are broader. Since the purpose of reconstructive implants is the restoration of normal breast appearance, in a small subset of patients, explanation may be warranted in cases of unsatisfactory aesthetic outcome.

Complications can be subdivided into local or systemic complications. Local complications include implant contracture, rupture, extrusion, or infections. Extrusion or infection are considered absolute medical indications for explantation in all cases, whether the implant was originally cosmetic or not. Documented rupture of a silicone gel-filled implant is considered an absolute indication for explantation in all cases. However, explantation of a ruptured saline implant is considered medically necessary only in the setting of prior reconstruction. Since normal saline is physiologic, rupture poses no health threat, and thus explantation would be considered not medically necessary in patients with cosmetic implants. However, a ruptured saline implant compromises the aesthetic outcome and thus explantation may be considered appropriate in cases of reconstructive implants.

Rupture of the breast implant may be difficult to document, but physical exam, mammography, ultrasonography, or MRI have been used. There is no consensus on which method affords the best sensitivity and specificity. (2-4) Although it has been suggested that older implants are associated with a higher incidence of rupture, there is no consensus that screening implants for rupture is warranted. Specifically, in the hearings on breast implants by the U.S. Food and Drug Administration (FDA) held in 1992, the FDA did not recommend screening for asymptomatic ruptures. Instead, work-up for a potential rupture is typically initiated at the onset of local symptoms, such as sudden change in the size or consistency of an implant, or the development of local pain.

Contracture is a more subjective finding, which is graded according to the Baker Classification. (5) Baker Classification ranges from Grade I, describing a normal implant, to Grade IV, which describes an implant that is hard, cold, painful, tender, and distorted. Grade IV contractures interfere with adequate mammography screening and thus their presence constitutes a health risk. (6) Therefore, explantation may be considered medically necessary in all cases, regardless of whether the implant was originally inserted for cosmetic or reconstructive purposes. Grade III contractures, which describe firm, palpable implants, do not interfere with mammography; therefore, explantation of these implants is not considered an absolute indication for explantation. However, since Grade III contractures do have an impact on the normal appearance of the breast, explantation may be appropriate in implants inserted for reconstructive purposes, since the goal of restoration of the normal appearance of the breast is not achieved.

Potential system complications of implants, most prominently various connective tissue diseases or chronic fatigue syndrome, have been hotly debated for the past five 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 over-represented among all those with connective tissue disease. (7-10) In addition, there are inadequate empiric studies to demonstrate that removal of breast implants is associated with resolution of systemic symptoms.

Patients with cosmetic implants may develop breast cancer. While lumpectomy can be accomplished without removal of the implant, in general, explantation as an adjunct to surgical treatment for breast cancer would be considered medically necessary. However, explantation is not necessary in patients who are undergoing chemotherapy or radiation therapy for breast cancer.

Once an implant has been removed, patients who originally underwent reconstructive implantation are candidates for additional reconstructive breast surgery, either insertion of another breast implant or for autologous reconstruction of the breast as described above. Patients who originally underwent implantation of a cosmetic breast implant are not candidates for additional reconstructive breast surgery after explantation.

2007 Update

A literature search for the period of January 2004 through April 2007 did not identify any studies which would alter the policy statement and it remains unchanged.

2008 Update

A literature search for the period of May 2007 through June 2008 did not identify any studies which would alter the policy statement and it remains unchanged.

2009 Update

Kreymerman and colleagues reviewed their experience with using breast magnetic resonance imaging to evaluate breast implant integrity and to offer a decision tree to assist physicians in managing these patients. Data were available for 81 patients with 146 implants placed either unilaterally or bilaterally for either cosmesis or breast reconstruction. The chief complaint for a majority of patients (n = 24) was breast pain. Thirty-two patients were found to have 44 ruptured implants, the majority of whom were found to have either contracture (n = 7) or negative findings (n = 7) on physician examination. The likelihood of rupture increased with number of years in place. The number of years in place was available for 120 implants; the median was 18 years (range 1-45years); 98% of implants were intact at five years; 94% at 10 years; and 59% at more than 20 years. When a patient presents for a possible implant rupture, the initial concern is to rule out malignancy but clinical and radiologic findings are often convoluted and complicated. A management algorithm may be useful to help determine which imaging modality is appropriate and when to use MRI in the implant evaluation process.

2010 Update

A literature search for the period of June 2009 through April 2010 did not identify any studies which would alter the policy statement and it remains unchanged.

2011 Update

Cassileth and colleagues acknowledged that the current standard of care for breast implant reconstruction after mastectomy is 2-stage reconstruction with placement of tissue expanders followed by implants. However, the immediate use of implants at the time of mastectomy, which eliminates the need for a second operative procedure, has been sparsely reported and is not yet accepted as the standard of care. They published a study describing a 1-stage immediate implant reconstruction technique and evaluated its risks.

Between 2005 and 2010, immediate implant reconstruction was performed in 43 sequential patients on a total of 78 breasts. Permanent silicone implants were placed at the time of mastectomy with the assistance of acellular dermal matrix (ADM). Follow-up was for an average of 575 days. Implant sizes varied widely from 175 to 800 mL. In order to create the correct breast shape and implant placement, specific techniques of acellular dermal matrix placement in the reconstruction were critically important. Aesthetic evaluation of the patients was performed, evaluating pre- and postoperative photos by 20 evaluators. Pictures were rated according to a 4-point Harris breast scale. A 2-sided paired test was then used to compare the rating scores.

They reported complication rates as follows: seroma occurred in 6.4% of breasts; infection resolving with antibiotics occurred in 2.6%; infection requiring implant removal occurred in 3.8%; and hematoma occurred in 1.3%. Neither preoperative breast size nor implant size correlated to an increased risk of complications. Complication rate increased with age. The average score for the preoperative images was 2.1, whereas the postoperative average was 2.4. This represented a statistically significant improvement above the baseline (preoperative) breasts with a P < 0.001, according to a 2-sided paired test.

They concluded that with complication rates similar to previously reported tissue expander reconstructions, immediate implant reconstruction is a viable alternative to 2-stage expander reconstruction, presenting many advantages over expander reconstruction while offering the same risk profile and eliminating the additional risks, costs, and discomfort of a second procedure. Additionally, they stated that aesthetic results were highly satisfactory according to patients themselves and based on evaluation by independent observers.

2012 Update

A literature search for the period of September 2011 through January 2012 did not identify any studies which would alter the policy statement and it remains unchanged.

2013 Update

A literature search for the period of February 2012 through January 2013 did not identify any studies which would alter the policy statement; therefore it remains unchanged.

References

  1. Gabriel SE, Woods JE, O’Fallon M et al. Complications leading to surgery after breast implantation. N Eng J Med 1997; 336(10):677-82.
  2. Samuels JB, Rihrich 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, Wiezer 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. Plas Reconstruct Surg 1996; 97(1):104-9.
  5. Baker JL. Augmentation mammaplasty. In Owsley JG, Peterson RA, (eds): In Symposium on Aesthetic Surgery of the Breast. 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, IL.
  7. Gabriel SE, O’Fallon WM, Kurland LT et al. Risk of connective-tissue disease and other disorders after breast implantation. N Eng J Med 1994; 330(24):1697-702.
  8. Hennekens CH, Lee I-Min, Cook NR et al. Self-reported breast implants and connective tissue disease in female health professionals. J Amer Med Assoc 1996; 275(8):616-62.
  9. Guerrero JS, Colditz, Karlson EW. 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 R et al. Reported complications of silicone gel breast implants: An epidemiologic review. Ann Int Med 1996; 124(8):744-56.
  11. Edlich RF, Winters KL, Faulkner BC et al. Advances in breast reconstruction after mastectomy. J Long Term Eff Med Implants 2005;15(22):197-207.
  12. Fentiman IS, Mamed H. Breast reconstruction. Int J Clin Pract 2006;60(4):471-4.
  13. Kreymerman P, Patrick RJ, Rim A et al. Guidelines for using breast magnetic resonance imaging to evaluate implant integrity. Ann Plast Surg. 2009 Apr;62(4):355-7.
  14. Cassileth L, Kohanzadeh S, Amersi F. One-Stage Immediate Breast Reconstruction With Implants: A New Option for Immediate Reconstruction. Ann Plast Surg. 2012 Aug. Last accessed January 21, 2013.
  15. Hold PM, Alam S, Pilbrow WJ, et al. How should we investigate breast implant rupture? Breast J. 2012 May-Jun;18(3):253-6

Coding

Codes

Number

Description

CPT

11920

Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq cm or less

 

19316

Mastopexy

 

19318

Reduction mammaplasty

 

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

 

19350

Nipple/areola reconstruction

 

19357

Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion

 

19361

Breast reconstruction with latissimus dorsi flap, with or without prosthetic implant

 

19364

Breast reconstruction with free flap

 

19366

Breast reconstruction with other technique

 

19367

Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), single pedicle, including closure of donor site;

 

19368

With microvascular anastomosis (supercharging)

 

19369

Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), double pedicle, including closure of donor site

 

19370

Open periprosthetic capsulotomy, breast

 

19371

Periprosthetic capsulectomy, breast

 

19380

Revision of reconstructed breast

ICD-9 Procedure

85.31

Unilateral reduction mammaplasty

 

85.32

Bilateral reduction mammaplasty

 

85.53

Unilateral breast implant

 

85.54

Bilateral breast implants

 

85.6

Mastopexy

 

85.70

Total reconstruction of breast, not otherwise specified; perforator flap, free

 

85.71

Latissimus dorsi myocutaneous flap

 

85.72

Transverse rectus abdominis myocutaneous (TRAM) flap, pedicled (excludes transverse rectus abdominis myocutaneous (TRAM) flap, free)

 

85.73

Transverse rectus abdominis myocutaneous (TRAM) flap, free (excludes transverse rectus abdominis myocutaneous TRAM flap, pedicled

 

85.74

Deep inferior epigastric artery perforator (DIEP) flap, free

 

85.75

Superficial inferior epigastric artery (SIEA) flap, free

 

85.76

Gluteal artery perforator (GAP) flap, free

 

85.79

Other total reconstruction of breast

 

85.83

Full thickness graft to breast

 

85.84

Pedicle graft to breast

 

85.85

Muscle flap graft to breast

 

85.87

Other repair or reconstruction of nipple

 

85.93

Revision of implant of breast

 

85.94

Removal of implant of breast

 

85.95

Insertion of breast tissue expander

 

85.99

Other operations on breast

 

86.02

Injection or tattooing of skin lesion or defect

ICD-9 Diagnosis

174.0

Malignant neoplasm of female breast, nipple and areola

 

174.1

Central portion

 

174.2

Upper-inner quadrant

 

174.3

Lower-inner quadrant

 

174.4

Upper-outer quadrant

 

174.5

Lower-outer quadrant

 

174.6

Axillary tail

 

174.8

Other specified sites of female breast

 

174.9

Breast (female), unspecified

 

233.0

Carcinoma in situ of breast

 

996.54

Mechanical complication due to breast prosthesis (e.g., rupture, extrusion, contracture)

 

996.69

Infection and inflammatory reaction due to other internal prosthetic device, implant, graft (includes breast prosthesis)

 

996.79

Other complications due to internal prosthetic device, implant, and graft (e.g., pain)

 

V10.3

Personal history of malignant neoplasm of breast

 

V16.3

Family history of malignant neoplasm of breast

HCPCS

L8600

Implantable breast prosthesis, silicone or equal

 

S2068

Breast reconstruction with deep inferior epigastric perforator (DIEP) flap or superficial inferior epigastric artery (SIEA) flap, including harvesting of the flap, microvascular transfer, closure of donor site and shaping the flap into a breast, unilateral

Appendix

N/A

History

Date

Reason

02/97

New Policy. Add to Surgery section.

06/25/98

Replace Policy. Reviewed with changes; discussion of reconstructive breast surgery, revised indications for removal of breast implants.

12/07/99

Replace Policy. Policy description revised.

12/10/02

Replace Policy. Policy reviewed without literature review; new review date only

10/16/03

Replace Policy. Policy reviewed by consensus without literature review; new review date only.

02/06/06

Disclaimer and Scope Update

06/09/06

Codes updated. No other changes.

07/10/07

NEW PR POLICY. Policy replaces BC.7.01.22. Policy updated with literature review; references added. Policy statement revised to indicate medical necessity for reconstructive surgery as a result of mastectomy or trauma, and explanataion of implants as medically necessary if the original surgery met medically necessary criteria; explantation as not medically necessary under indicated circumstances; and as a contract exclusion based upon cosmetic purposes. Benefit Application section updated with definitions for cosmetic, physical functional impairment and reconstructive surgery.

08/24/07

Cross Reference Update. No other changes.

11/13/07

Cross Reference Update. No other changes.

05/13/08

Cross Reference Update. No other changes.

08/12/08

Policy updated with literature search. Policy statement updated to include “or other malignancies involving the breast” under the reconstructive and cosmetic purposes criteria. Under Cosmetic Purposes “irrespective of the existence of any medical necessity criteria described in the section devoted to explantation of implants placed for reconstructive purposes above” was added to the last statement. Codes added, effective 10/1/08.

06/09/09

Replace Policy. Replace Policy. Policy updated with literature search. No change to policy statements. Codes added.

05/11/10

Replace Policy. Policy updated with literature search. No change to policy statements.

11/09/10

Replace Policy. Policy statement revised to allow lumpectomies, previously not addressed, as a medically necessary indication for reconstructive breast surgery.

09/15/11

Replace Policy. Policy updated with literature search. Reference added. No change to the policy statement. Related Policies updated; 10.01.514 added.

03/23/12

Replace Policy – Policy updated with literature search. No change to the policy statement.

04/16/12

Related Policies updated: 7.01.09 removed as this policy has been archived.

03/08/13

Replace policy. Policy updated with literature search. No change to the policy statement. Reference 15 added.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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