CurrentPremera BluecrossPolicy N/A

Reconstructive breast surgery and explantation of breast implants

Defines medical necessity criteria for reconstructive breast surgery (including reconstruction after mastectomy, nipple/areola reconstruction, autologous tissue procedures, symmetry procedures) and criteria for explantation/removal of breast implants, plus site-of-service determinations and related documentation and coding guidance.

Policy Summary

PayerPremera Bluecross

PolicyReconstructive breast surgery and explantation of breast implants

Policy CodePolicy N/A

Change TypeCoding and clinical indication additions

Effective DateJul 2, 202618d

Next Review Date

Key ActionSubmit clinical documentation supporting the indication for reconstructive surgery or that the original implant was placed for a medically necessary reconstructive reason when requesting reconstruction or explantation.

SourceLink

POLICY UPDATE CHANGES

Poland syndrome added to list of breast diseases for which reconstructive breast surgery may be considered medically necessary when criteria are met.

CPT 15769 and HCPCS C1789 added to coding list.

Clarified that Baker class III contractures and rupture of a saline implant in individuals with implants for cosmetic purposes are considered not medically necessary.

HCPCS codes S2067 and S2068 removed from the policy.

Changed wording from 'patient' to 'individual' throughout the policy for standardization.

Added BIA-ALCL as an indication for removal of implants placed for cosmetic purposes.

2Effective/Last Revised Dates provided

MultipleCovered procedure categories

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Coverage Summary

This policy (subject: Reconstructive breast surgery and explantation of breast implants) is CURRENT and effective July 2, 2026 with last review on March 10, 2026. It has a mixed coverage stance: it defines specific circumstances when reconstruction and explantation are medically necessary and also lists conditions considered not medically necessary.

Reconstructive indications covered at a high level include reconstruction following mastectomy or partial mastectomy for breast disease (e.g., breast cancer, severe fibrocystic disease unresponsive to medical therapy), reconstruction to restore symmetry, treatment after breast injury/trauma, prophylactic mastectomy for risk reduction, and Poland syndrome (added 04/01/26 and effective 07/02/26 when criteria are met).

Explantation (implant removal) is covered when the original implant was placed for medically necessary reconstructive purposes (not cosmetic) and one or more qualifying conditions are present (for example, Baker Class III or IV contracture, documented implant rupture with imaging, extrusion, infection, surgical treatment for breast malignancy, or BIA-ALCL). The policy clarifies that removal of implants originally placed for cosmetic purposes is generally not covered except with interval development of breast cancer, BIA-ALCL, or other disease requiring mastectomy/partial mastectomy.

Key thresholds and quick facts

Effective dateJuly 2, 2026

Last reviewMarch 10, 2026

MELD score threshold (liver risk)> 8

Morbid obesity site-of-service threshold (BMI)>= 50

FEV1 threshold — COPD< 50%

FEV1 threshold — poorly controlled asthma< 80% despite treatment

Prolonged surgery criterion for hospital setting> 3 hours

Medical-Necessity Criteria

Elective Surgical Procedures Reviewed for Medical Necessity

We will review for medical necessity these elective surgical procedures.

ANY of the following

Reduction mammaplasty
Listed as an elective surgical procedure to be reviewed for medical necessity

Site of Service for Elective Surgical Procedures

Medically necessary sites of service and criteria when hospital outpatient is allowed

ALL of the following

Hospital outpatient allowable IF
- There is no qualifying ASC within 30 miles that can provide the necessary care due to lack of equipment

Coding

Covered/Relevant CPT codes for breast reconstruction/explantation procedures and related servicesCPTCovered

11920	Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq. cm or less
11921	Tattooing; 6.1 to 20.0 sq cm
11922	Tattooing; each additional 20.0 sq cm
11970	Replacement of tissue expander with permanent implant
11971	Removal of tissue expander without insertion of implant
15769	Grafting of autologous soft tissue, other, harvested by direct excision (eg, fat, dermis, fascia)
15771	Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; 50 cc or less injectate
15772	Grafting of autologous fat; each additional 50 cc injectate
19316	Mastopexy
19318	Breast reduction

1–10 of 20

1/2

Relevant HCPCS codes / prosthesisHCPCSCovered

C1789	Prosthesis, breast (implantable)
L8600	Implantable breast prosthesis, silicone or equal

Added/Updated CPT codes and historic coding changesCPT

11921	CPT added 08/18/17 (policy history)
11922	CPT added 09/07/18 (policy history)
11970	CPT added 09/07/18 (policy history)
11971	CPT added 09/07/18 (policy history)
15769	CPT added effective 04/01/26 (policy update)
15771	CPT added 06/10/20 (policy history)
15772	CPT added 06/10/20 (policy history)
19324	CPT previously included; terminated 1/1/2021 and removed 09/01/22
19366	CPT previously included; terminated 1/1/2021 and removed 09/01/22
19380	CPT description updated 03/01/23

Added/Updated HCPCS codes (policy update)HCPCS

C1789

HCPCS added effective 04/01/26 (policy update)

Removed HCPCS codes (historic)HCPCS

S2067	Removed 04/01/23 (policy history)
S2068	Removed 04/01/23 (policy history)

Provider Actions & Billing Rules

Documentation Required

Document indication for reconstructive surgery

Submit clinical documentation supporting prior mastectomy/partial mastectomy and indication (breast cancer, severe fibrocystic disease unresponsive to therapy, Poland syndrome with defined criteria, trauma, or prophylactic mastectomy) or documentation that reconstruction is to restore symmetry.

Documentation Required

Document original implant indication for explantation requests

For explantation, submit documentation that the original implant was placed for a medically necessary reconstructive reason (not cosmetic) and evidence of one or more qualifying conditions (Baker III/IV contracture, documented rupture with imaging, extrusion, infection, surgical treatment for breast malignancy, or BIA-ALCL).

Documentation Required

Imaging confirmation for suspected implant rupture

Rupture of implants requires documentation with an imaging study such as mammography, MRI, or ultrasonography; lack of imaging confirmation with persistent local symptoms is considered case-by-case.

Background & Evidence

Reconstructive breast surgery is defined as procedures to restore normal breast appearance after surgery, accident, or trauma and is distinguished from cosmetic procedures that are performed primarily to improve appearance. The policy emphasizes reconstruction is typically performed after mastectomy and includes related services such as nipple/areola reconstruction, tattooing, autologous tissue flaps, and contralateral procedures to achieve symmetry.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is described as a rare T-cell lymphoma occurring around textured implants (not a breast cancer), diagnosed by CD30-positive large anaplastic T cells in aspirated fluid with histologic confirmation. The registry and epidemiology context note FDA-reported totals of 1380 confirmed cases worldwide with 64 deaths (as of June 30, 2024) and PROFILE registry reporting (458 US suspected/confirmed cases as of May 30, 2025). Management includes explantation and capsulectomy per guideline recommendations.

Regulatory history referenced includes the 2019 Allergan (Natrelle Biocell) recall of certain textured implants and the FDA's October 2021 orders strengthening implant labeling (boxed warning, patient decision checklist, updated rupture screening). The FDA has not recommended removal of textured implants in asymptomatic individuals, but regulatory actions and professional society statements have informed surveillance and management recommendations.

Federal mandates are summarized: the Women's Health and Cancer Rights Act of 1998 requires coverage for reconstruction following mastectomy, including reconstruction of the affected breast, surgery to achieve symmetry, and prostheses and treatment of complications. State mandates (examples cited) also require coverage in some jurisdictions.

The rationale supporting reconstructive surgery and explantation criteria includes clinical benefit evidence (case series supporting psychosocial improvements from reconstruction; case series supporting explantation for local complications) and pragmatic considerations: local complications (contracture, rupture, infection, extrusion) commonly necessitate removal, and BIA-ALCL requires complete surgical excision when diagnosed. The policy also notes insufficient evidence that prophylactic explantation reduces ALCL risk, while professional consensus recognizes circumstances where prophylactic removal of high-risk textured implants may be considered reasonable after shared decision-making.

Medicare Determinations

Type	Name	Number	Effective Date
NCD	No national coverage determination
NCD	Breast reconstruction following mastectomy	NCD #140.2	1997-01-01

Revision History

02/97history

New policy created; added to Surgery section.

03/01/17format_move

Policy moved into new format; no change to policy statements.

06/10/20added

Added BIA-ALCL as an indication for removal of implants placed for cosmetic purposes; added CPT codes 15771 and 15772.

Policy Summary

PayerPremera Bluecross

PolicyReconstructive breast surgery and explantation of breast implants

Policy CodePolicy N/A

Change TypeCoding and clinical indication additions

Effective DateJul 2, 202618d

Next Review Date

SourceLink

On This Page

Increased risk criteria (one or more present may necessitate hospital setting)

Anesthesia risk: ASA classification III or higher
Anesthesia risk: Personal history of complication of anesthesia
Anesthesia risk: Documentation of alcohol dependence or history of cocaine use
Anesthesia risk: Prolonged surgery (greater than 3 hours)> 3 hours
Cardiovascular risk: Uncompensated chronic heart failure (NYHA class III or IV)
Cardiovascular risk: Recent MI (<3 months)< 3 months
Cardiovascular risk: Poorly controlled, resistant hypertension
Cardiovascular risk: Recent CVA (<3 months)< 3 months
Cardiovascular risk: Increased risk for cardiac ischemia (DES <1 year or angioplasty <90 days)DES <1 year or angioplasty <90 days
Cardiovascular risk: Symptomatic cardiac arrhythmia despite medication
Cardiovascular risk: Significant valvular heart disease
Liver risk: Advanced liver disease (MELD score > 8)> 8
Pulmonary risk: COPD with FEV1 < 50%FEV1 < 50%
Pulmonary risk: Poorly controlled asthma (FEV1 < 80% despite treatment)FEV1 < 80%
Pulmonary risk: Moderate to severe obstructive sleep apnea (OSA)
Renal risk: End stage renal disease (on dialysis)
Other: Morbid obesity (BMI ≥ 50)BMI ≥ 50
Other: Pregnancy
Other: Bleeding disorder requiring replacement factor, blood products, or special infusion product (DDAVP does not meet criterion)
Other: Anticipated need for transfusion(s)

Reconstructive Breast Surgery - Medical Necessity

Reconstructive breast surgery may be considered medically necessary in ANY of the following circumstances:

ANY of the following

Prior mastectomy or partial mastectomy performed to treat breast disease (including breast cancer or severe fibrocystic breast disease unresponsive to medical therapy)
Poland syndrome branch
- Congenital absence or hypoplasia of the pectoralis major and/or minor muscles
- Breast hypoplasia
- Congenital partial absence of the upper costal cartilages of ribs
Prior mastectomy or partial mastectomy performed to treat breast injury or trauma
Reconstruction to reduce risk of breast cancer occurrence (prophylactic mastectomy)
Reconstruction to restore symmetry between the unaffected breast and the affected breast

Medically Necessary / Not Medically Necessary Criteria (historical references in this part)

Policy statements (as referenced in history) define medical necessity for reconstructive breast surgery and explantation; this part documents additions and clarifications over time.

ALL of the following

Reconstructive surgery considered medically necessary when performed as a result of mastectomy or trauma (historical policy statements)
Explantation (removal) of implants is medically necessary if the original surgery met medically necessary criteria (historical)
Included indications added historically
- Indication to reduce risk of breast cancer occurrence
- Treat disease such as severe fibrocystic disease unresponsive to medical therapy
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as an indication for removal
- Poland syndrome added as a breast disease for which reconstructive surgery may be medically necessary when criteria are met (added 04/01/26)
Specific not medically necessary clarifications (historic)
- Services are considered cosmetic when medical necessity criteria are not met (clarified historically)
- Baker class III contractures and rupture of a saline implant in individuals with implants for cosmetic purposes are considered not medically necessary (clarified 09/01/24)

Evidence item	Value
FDA reported BIA-ALCL cases worldwide (as of 2024-06-30)	1380 confirmed cases with 64 deaths
PROFILE registry US suspected/confirmed cases (as of 2025-05-30)	458 cases
Evidence strength: reconstruction improving psychosocial outcomes	Sufficient (case series)
Evidence strength: prophylactic explantation to reduce ALCL risk	Insufficient (no evidence that removal reduces ALCL risk)
References summary	Multiple peer-reviewed studies, systematic reviews, consensus guidelines, FDA communications, and registries (e.g., Clemens et al., PROFILE reports, FDA statements) updated through 2024-2025