7.01.533_2026 07 02

Coverage summary & scope

This policy defines medical necessity for reconstructive breast surgery and explantation of breast implants, and establishes site-of-service rules and documentation expectations for elective breast procedures. Reconstructive breast surgery is considered medically necessary when performed to restore the breast after a prior mastectomy/partial mastectomy for breast disease (including breast cancer or severe fibrocystic disease unresponsive to therapy), injury/trauma, prophylactic mastectomy, or congenital conditions such as Poland syndrome, or when reconstruction is needed to restore symmetry to the affected breast. Explantation (removal) of silicone or saline implants placed for medically necessary reconstructive purposes is considered medically necessary when the original implant was placed for reconstructive (not cosmetic) reasons and one or more specified conditions are present (e.g., Baker Class III/IV contracture, documented rupture after reconstructive mastectomy, extrusion, infection, treatment of breast malignancy, or BIA-ALCL).

Site-of-service determinations prioritize the Ambulatory Surgical Center (ASC) as the preferred medically necessary location for certain elective procedures; hospital outpatient or inpatient use is allowed only when ASC access is unavailable within 30 miles, the ASC lacks necessary equipment or physician privileges, specific ASC guidelines prohibit use for the individual’s condition or weight, the individual is ≤18 years old, an additional concurrent service requires a hospital outpatient department, or the individual has specified clinical risk factors (e.g., ASA III or higher, prolonged surgery > 3 hours, MELD > 8, FEV1 < 50% for COPD, FEV1 < 80% for poorly controlled asthma, or BMI ≥ 50).

Documentation requirements include clinical records that support the indication for reconstruction (prior mastectomy/partial mastectomy with specific diagnoses, Poland syndrome criteria, injury/trauma, or prophylactic mastectomy), and for explantation that the original implant was placed for medically necessary reasons and that at least one listed condition is present; imaging confirmation (mammography, MRI, or ultrasound) is required to document implant rupture when claimed. Site-of-service review does not apply to Indian Health Services (IHS) facilities.

Key facts — reconstruction, BIA-ALCL, revisions

Mandated reconstruction benefitMandated benefit for reconstructive breast surgery after mastectomy (federal and many state mandates)

Reported global BIA-ALCL cases1380 (as of 2024-06-30)

Reported US cases to PROFILE458 (suspected/confirmed, as of 2025-05-30)

Policy revision span1997-2026 (history span)

Recent material additionsPoland syndrome added (effective July 2, 2026 after 90-day notification)

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 (including 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)
Poland syndrome, as determined by clinical exam or imaging, with ALL of the following present:

Coding (grouped)

Relevant CPT codes (reconstructive / explantation / related procedures)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.
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; 50 cc or less injectate.
15772	Grafting of autologous fat; each additional 50 cc injectate.
19316	Mastopexy.
19318	Breast reduction.

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Relevant HCPCS / prosthesis codesHCPCSCovered

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

Added CPT codes (per history entries)CPT

15771	Added 06/10/20 (no description in part)
15772	Added 06/10/20 (no description in part)
11921	Added 08/18/17 (no description in part)
11922	Added 09/07/18 (no description in part)
11970	Added 09/07/18 (no description in part)
11971	Added 09/07/18 (no description in part)
19324	Added 09/07/18; later removed/termed 1/1/2021 (see history)
19325	Added 09/07/18 (no description in part)
19366	Coding update terminated 1/1/2021 (see history)
19380	Description updated 03/01/23

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Added HCPCS / Other codesHCPCS|mixed

S2067	Added 06/01/18; later removed 04/01/23
S2068	Added 06/01/18; later removed 04/01/23
C1789	Added 04/01/26

Removed CPT codes (per history entries)CPT

19303	Removed 10/01/19
19304	Removed 10/01/19
11960	Removed 01/03/20

Provider actions & authorization requirements

Documentation Required

Document indication for reconstructive surgery

Submit clinical documentation supporting the indication for reconstructive surgery. Acceptable indications include prior mastectomy or partial mastectomy for breast cancer, severe fibrocystic breast disease unresponsive to medical therapy, Poland syndrome (per clinical exam or imaging with required anatomic findings), prior mastectomy/partial mastectomy for injury or trauma, or prophylactic mastectomy. When applicable, document that the reconstruction is performed to restore symmetry between the affected and unaffected breast.

Prior mastectomy/partial mastectomy for breast cancer
Severe fibrocystic disease unresponsive to medical therapy
Poland syndrome (congenital pectoralis muscle absence/hypoplasia, breast hypoplasia, partial absence of upper costal cartilages) documented by exam or imaging
Prior mastectomy/partial mastectomy for injury or trauma
Prophylactic mastectomy
Document restoration of symmetry when relevant

Background, definitions & evidence

Background: Reconstructive surgery is performed to restore breast appearance after surgery, injury, or trauma and is distinguished from cosmetic procedures by the presence of a medical condition; benefits for reconstruction after mastectomy are mandated by federal law and in many states. Cosmetic surgery is intended primarily to improve appearance and is not covered under this policy.

Implant complications: Local complications are common and may necessitate explantation. Capsular contracture is the most frequent local complication and is graded by the Baker classification (Grade I–IV, with III = firm/palpable and visible distortion; IV = hard, painful, distorted). Documented implant rupture requires imaging confirmation by mammography, MRI, or ultrasonography.

BIA-ALCL: Breast implant–associated anaplastic large cell lymphoma is a rare T-cell lymphoma linked primarily to textured implants; it presents most often with a seroma/effusion and can occur with saline or silicone implants placed for cosmetic or reconstructive purposes. As of June 30, 2024 there were 1,380 confirmed global cases (64 deaths) and as of May 30, 2025 there were 458 suspected/confirmed US cases reported to the PROFILE registry. Diagnosis and management recommendations (including total capsulectomy and implant removal) are described in specialty guidance.

Federal/state mandates: The Women’s Health and Cancer Rights Act (1998) requires coverage for reconstruction following mastectomy (reconstruction of the affected breast, surgery on the contralateral breast for symmetry, and prostheses/complications). Select state mandates (e.g., Alaska, Washington) also require coverage for reconstructive surgery following mastectomy.

Term	Definition
Reconstructive surgery
Surgery to restore normal appearance of the breast after surgery, accidental injury, or trauma; distinguished from cosmetic procedures by presence of a medical condition.
Cosmetic
Services primarily intended to preserve or improve appearance; not medically necessary under this policy.
Baker Classification
Scale for capsular contracture: Grade I (soft) to Grade IV (hard, painful, distorted).
ASA Physical Status Classification
ASA I-VI definitions provided; ASA III or higher indicates increased anesthesia risk relevant to site-of-service determinations.
Poland syndrome
Congenital disorder with pectoralis muscle absence/hypoplasia, breast hypoplasia, and costal cartilage absence; may warrant reconstructive surgery.
BIA-ALCL
Breast Implant-Associated Anaplastic Large Cell Lymphoma.

Evidence summary and conclusions:

• Evidence supports that reconstructive breast surgery after breast surgery or trauma improves psychosocial outcomes (anxiety, social functioning, body image) and is sufficient to demonstrate net health benefit.

Medicare determinations

Determination name/number	Effective / Notes
National coverage determination — No national coverage determination
No national coverage determination
NCD #140.2 — Breast reconstruction following mastectomy
Effective 1997-01-01; Medicare national coverage determination for breast reconstruction following mastectomy.

Clinical thresholds & site‑of‑service risk criteria

Numeric site-of-service thresholds

Prolonged surgery> 3 hours

ASA classification requirementASA III or higher

MELD score threshold> 8

COPD pulmonary functionFEV1 < 50%

Poorly controlled asthmaFEV1 < 80% despite treatment

Morbid obesity (BMI)BMI >= 50

Note: The numeric clinical thresholds listed in the policy (for example, prolonged surgery > 3 hours, ASA classification III or higher, MELD > 8, FEV1 < 50% for COPD, FEV1 < 80% for poorly controlled asthma, and BMI ≥ 50) are applied specifically within the Site-of-Service criteria to justify use of a hospital outpatient or inpatient setting instead of the preferred Ambulatory Surgical Center (ASC). These thresholds are intended to identify individuals with increased perioperative risk or procedural complexity that warrant a higher-acuity site of service.

Revision history & material changes

04/01/26 (effective July 2, 2026 after 90-day notification)material_addition

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

04/01/26coding_addition

CPT 15769 and HCPCS C1789 added to the policy code list.

06/01/26 (interim update)material_revisionLatest

Site-of-service update: removed hospital medical center from the medically necessary sites of service for elective surgical procedures so that Ambulatory Surgical Center is the preferred/only listed site; header added clarifying site-of-service review does not apply to Indian Health Services (IHS) facilities.

Policy update changes (document-level)

Document changes (short-form):

• Added 04/01/26; Poland syndrome added to list of breast diseases for which reconstructive surgery may be medically necessary when criteria are met. (Material)

• Added 04/01/26: CPT 15769 and HCPCS C1789 added to the policy code list. (Non-material)

• Interim update 06/01/26: Header added clarifying site-of-service review does not apply to IHS facilities; removed hospital medical center from medically necessary sites of service for elective procedures so that Ambulatory Surgical Center is the preferred site. (Material)

• 09/01/24 annual review clarification: Clarified Baker Class III contractures and rupture of a saline implant placed for cosmetic purposes are considered not medically necessary. (Material)

• Added 06/10/20: BIA-ALCL added as an indication for removal of implants placed for cosmetic purposes. (Material)

• Coding history: removed HCPCS codes S2067 and S2068 (04/01/23); other coding additions/removals documented in history.