CurrentPremera BluecrossPolicy N/A

Reconstructive breast surgery and explantation criteria

Defines medical necessity criteria for reconstructive breast surgery (including types of reconstruction, nipple/areola procedures, revisions, and explantation of implants) and site-of-service rules for elective surgical procedures; includes documentation and coding guidance and references/definitions. Part 1 of 2.

Policy Summary

PayerPremera Bluecross

PolicyReconstructive breast surgery and explantation criteria

Policy CodePolicy N/A

Change TypeClarification; Related policy added; Minor revisions

Effective Date

Next Review Date

Key ActionSubmit clinical documentation supporting reconstructive indications or explantation indications (including original implant indication, implant type, symptoms, and imaging for suspected rupture) and follow site-of-service requirements when applicable.

POLICY UPDATE CHANGES

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

Added Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures criteria as related policy, effective November 7, 2025 following 90-day provider notification.

Minor update to BCBSA Reference policy section and Related Policy section updates.

MultipleCovered procedure categories (reconstructive types)

SeveralNot medically necessary explantation examples

1Federal mandate referenced (WHCRA)

MultiplePolicy history entries

YesBIA-ALCL noted as medically necessary indication

YesExplicit not-covered scenarios clarified 09/01/24

Coverage Summary

This policy (Part 1 of 2) defines medical necessity criteria for reconstructive breast surgery and for explantation (removal) of breast implants, specifies site-of-service rules for elective surgical procedures (including ASC and hospital outpatient criteria), and provides coding and documentation guidance. It applies when implants or reconstruction are performed for medically necessary reconstructive indications (for example, after mastectomy, trauma, or to restore symmetry) and distinguishes those scenarios from purely cosmetic procedures. The policy status is CURRENT.

High-level facts (coverage & evidence)

Covered procedure categories (reconstructive types)Autologous tissue flaps, implant-based reconstruction, tissue expansion, fat grafting, nipple/areola reconstruction and tattooing, contralateral symmetry procedures

Explantation considered medically necessary when original implant was reconstructive and one or more conditions presentBaker Class III or IV contracture; documented implant rupture after medically necessary mastectomy/partial mastectomy; extrusion; infection; surgical treatment of breast cancer or other malignancy; BIA-ALCL

Not medically necessary explantation examples (selected)Baker Class III contractures and rupture of saline implant when implants were placed for cosmetic purposes; pain alone; patient anxiety; systemic symptoms alone

Federal mandate referenced (WHCRA)Women's Health and Cancer Rights Act (mandates coverage for reconstruction after mastectomy)

BIA-ALCL listed as medically necessary indication (policy history)Added as indication for explantation July 1, 2019; referenced in policy and guidance

Evidence metrics (FDA & PROFILE registry)FDA: 1,380 confirmed BIA-ALCL cases worldwide with 64 known deaths (as of June 30, 2024); PROFILE registry: 458 US suspected/confirmed cases (as of May 30, 2025)

Medical-Necessity Criteria

Reconstructive breast surgery - medical necessity

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

ANY of the following

A prior mastectomy or partial mastectomy was performed to treat breast disease (breast cancer or severe fibrocystic breast disease unresponsive to medical therapy).
A prior mastectomy or partial mastectomy was performed to treat breast injury or trauma.
A prior mastectomy or partial mastectomy was performed to reduce risk of breast cancer occurrence (prophylactic mastectomy).
Reconstruction is to restore symmetry between the unaffected breast and the affected breast.

Site-of-Service Rules

Numeric perioperative/site-of-service thresholds

Prolonged surgery> 3 hours

ASA classification thresholdASA III or higher

FEV1 threshold - COPDFEV1 < 50%

FEV1 threshold - asthmaFEV1 < 80% despite treatment

MELD score threshold> 8

BMI morbid obesity thresholdBMI >= 50

Coding

Covered/relevant CPT codes (reconstructive & explantation procedures, tattooing, fat grafting, expansion)CPTCovered

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, or part thereof (add-on).
11970	Replacement of tissue expander with permanent implant.
11971	Removal of tissue expander without insertion of implant.
15771	Grafting of autologous fat harvested by liposuction; 50 cc or less injectate.
15772	Grafting of autologous fat; each additional 50 cc injectate (add-on).
19316	Mastopexy.
19318	Breast reduction.
19325	Breast augmentation with implant.

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Covered HCPCS codes (implantable prosthesis)HCPCSCovered

L8600

Implantable breast prosthesis, silicone or equal.

Historic/mentioned CPT and HCPCS code updates (document references numerous coding changes across history)mixed

11921	CPT code added 08/18/17 (no description in text).
11922	CPT code added 09/07/18 (no description in text).
11960	CPT code removed 01/03/20 (no description in text).
11970	CPT code added 09/07/18 (no description in text).
11971	CPT code added 09/07/18 (no description in text).
15771	CPT code added 06/10/20 (no description in text).
15772	CPT code added 06/10/20 (no description in text).
17106	Referenced earlier in extraction rules example, not present in this part.
19303	CPT code removed 10/01/19 (no description in text).
19304	CPT code removed 10/01/19 (no description in text).

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Provider Actions & Documentation Requirements

Documentation Required

Documentation for reconstructive surgery

Submit clinical documentation supporting prior mastectomy/partial mastectomy indication (breast cancer, severe fibrocystic disease unresponsive to therapy, injury/trauma, or prophylactic mastectomy) or documentation that reconstruction is to restore symmetry between the unaffected breast and the affected breast.

Documentation Required

Documentation for explantation

For explantation, document the original indication for implantation (reconstructive versus cosmetic), the implant type (saline or silicone gel), current symptoms (local or systemic), and provide imaging confirmation for suspected rupture (mammography, MRI, or ultrasound) where applicable.

Background and Evidence

Background: Reconstructive breast surgery restores breast form after all or part of a breast has been removed (most commonly following mastectomy for cancer) or after injury or trauma, and includes autologous tissue flaps, fat grafting, implant-based reconstruction, nipple/areola reconstruction, and contralateral procedures to achieve symmetry. Implant explantation is addressed differently depending on the original indication: removal after implants placed for medically necessary reconstruction may be covered for complications (eg, infection, extrusion, documented rupture, or Baker Class III/IV contracture) or for treatment of malignancy including BIA-ALCL

Epidemiology, regulation, and guidelines: BIA-ALCL is a rare T-cell lymphoma associated predominantly with textured implants; onset ranges from about 2 to 28 years (average ~8 years). As of June 30, 2024 the FDA reported 1380 confirmed cases worldwide with 64 deaths, and the PROFILE registry reported 458 US suspected/confirmed cases as of May 30, 2025. Regulatory actions include the 2019 voluntary recall of certain textured Allergan (Natrelle Biocell) implants and strengthened FDA labeling/orders in 2021 (boxed warnings, patient decision checklist, updated rupture screening). Professional guidance (eg, AAPs 2023 consensus, NCCN BIA-ALCL guidance, ACR imaging appropriateness) recommends surveillance, standardized management of BIA-ALCL (surgical excision/capsulectomy), and cautions that evidence is limited regarding prophylactic explantation to reduce future BIA-ALCL risk; decisions should be individualized and shared between patient and surgeon.

Key evidence & guideline items

FDA confirmed BIA-ALCL cases (global)

Medicare Determinations

Effective Date	Determination
1997-01-01
Breast reconstruction following mastectomy — NCD #140.2

Revision History

09/01/24annual_review / material_change

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

11/01/24minor_update

Minor update to the BCBSA Reference policy section; reference policy 7.01.09 removed.

07/03/25minor_update

Minor update to Related Policy section: Policy 7.01.113 replaced with 7.01.582 (Bioengineered Skin and Soft Tissue Substitutes).

Policy Summary

PayerPremera Bluecross

PolicyReconstructive breast surgery and explantation criteria

Policy CodePolicy N/A

Change TypeClarification; Related policy added; Minor revisions

Effective Date

Next Review Date

On This Page

Covered reconstructive procedures (examples)

Reconstructive breast surgery may include, but is not limited to, ANY of the following:

ANY of the following

Autologous reconstruction using autologous tissue (eg, latissimus dorsi flap, TRAM flap, or free flap).
Autologous fat grafting obtained by liposuction.
Immediate or delayed insertion of breast implant(s) with or without associated tissue expansion.
Mastopexy or reduction mammaplasty or augmentation on the contralateral breast to achieve symmetry.
Nipple/areola reconstruction and nipple tattooing when the breast reconstruction is considered eligible for coverage.
Revision of a reconstructed breast, including reconstruction after removal of a breast implant previously placed for medically necessary reconstructive purposes.

Explantation (removal) of breast implants - medical necessity

Explantation of a silicone gel or saline-filled breast implant may be considered medically necessary if the original implant was placed for medically necessary reconstructive purposes and ONE or more of the following conditions are present:

ALL of the following

ONE or more of
- Baker Class III or IV contracture.
- Documented implant rupture placed after a medically necessary mastectomy or partial mastectomy due to illness, injury, or disease.
  Imaging confirmation (mammography, MRI, or ultrasound) expected where applicable.
- Extrusion.
- Infection.
- Surgical treatment of breast cancer or other malignancy involving the breast.
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Documentation Required
Site-of-service justification
When choosing hospital outpatient rather than an ambulatory surgical center (ASC), document one of the following: no geographically accessible ASC within 30 miles with necessary equipment; no geographically accessible ASC at which the individual's physician has privileges; an ASC guideline prohibiting use related to the individual's condition or weight; the individual is aged 18 or younger; or the service is performed with an additional service requiring a hospital outpatient department in the same operative session. Alternatively, document increased perioperative risk factors (examples include ASA III or higher, prolonged surgery >3 hours, significant cardiovascular, pulmonary, liver, renal risks, morbid obesity, pregnancy, bleeding disorders, or anticipated need for transfusion) to justify hospital outpatient setting.

Billing Rule
Site of service considerations
This policy references site-of-service requirements and a related policy (11.01.525 Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures) added with an effective date of November 7, 2025 (following 90-day provider notification). When applicable, providers must follow the related policy for ASC/site-of-service determinations.

Documentation Required
Consult member benefit booklet
Follow the member's benefit booklet or contact a customer service representative to verify member-specific coverage, benefit limitations, and any contractual exclusions prior to proceeding.

Documentation Required
Medical necessity evaluation
Company staff use this policy as a guide when determining medical necessity based on literature, guidelines, and standards of practice. Providers should supply documentation supporting reconstructive indications, explantation indications (including BIA-ALCL), or the cosmetic status of the original implant.

1,380 confirmed cases with 64 known deaths (FDA data as of June 30, 2024)

PROFILE registry (US) cases458 suspected/confirmed US cases reported to PROFILE (as of May 30, 2025)

NCCN guidance citedNCCN Breast Cancer guidelines v.3.2025 (includes principles of breast reconstruction and prior NCCN BIA-ALCL guidance)

Notable guideline referencesAAPS consensus statement on BIA-ALCL (2023/2024), ACR Appropriateness Criteria Breast Implant Evaluation (2023), ASPS BIA-ALCL resources, FDA communications

Regulatory actions notedAllergan Natrelle Biocell recall (July 2019); FDA strengthened labeling/orders Oct 2021 including boxed warning and recommendations

Definitions (include these exact definitions when populating content):

- Reconstructive surgery: surgeries performed on abnormal structures caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease, generally performed to improve function.

- Cosmetic: services primarily intended to preserve or improve appearance; surgery to improve appearance or self-esteem.

- Baker Classification: Grade I — augmented breast feels as soft as a normal breast; Grade II — less soft, implant palpable but not visible; Grade III — breast firm, implant or distortion visible; Grade IV — breast hard, painful, cold, tender, and distorted.

- ASA score: American Society of Anesthesiologists physical status classification (ASA I–V as described).

- BIA-ALCL: Breast implant-associated anaplastic large cell lymphoma (listed as an indication for explantation and surgical excision).

07/08/25interim_update / related_policy_changeLatest

Interim update approved July 8, 2025: Removed related policy 11.01.524 (Site of Service: Select Surgical Procedures) and added related policy 11.01.525 (Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures); ASC criteria effective November 7, 2025 following 90-day provider notification.