CurrentHighmark Blue Cross Blue Shield WnyPolicy N/A

Management and Coverage Criteria for Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

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Clinical guidance on diagnosis, evaluation, and surgical management (implant removal and capsulectomy) for suspected or confirmed BIA-ALCL affecting patients with breast implants; intended for clinicians and payers involved in care decisions.

Policy Summary

PayerHighmark Blue Cross Blue Shield Wny

PolicyManagement and Coverage Criteria for Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJun 1, 2020

Next Review DateN/A

Key ActionObtain pathology confirmation (cytology with CD30 immunohistochemistry or biopsy) and document preoperative imaging and oncology consultation before implant removal and total capsulectomy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentHighmark Blue Cross Blue Shield WnyPolicy N/A

Management and Coverage Criteria for Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Customize your policy alerts

Sign up for all Highmark Blue Cross Blue Shield Wny policy alerts

Know when Highmark Blue Cross Blue Shield Wny releases new policies or updates existing guidance.

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Policy Summary

PayerHighmark Blue Cross Blue Shield Wny

PolicyManagement and Coverage Criteria for Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJun 1, 2020

Next Review DateN/A

Key ActionObtain pathology confirmation (cytology with CD30 immunohistochemistry or biopsy) and document preoperative imaging and oncology consultation before implant removal and total capsulectomy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

estimated incidence among women with textured breast implants

4.6%incidental bilateral disease found at surgery

NCCN v1.2020referenced guideline version

surgery + capsulectomyprimary recommended treatment for localized BIA-ALCL

Coverage Criteria for BIA-ALCL and Implant Removal

Treatment of confirmed or strongly suspected BIA-ALCL

Covered when ALL of the following are met

Diagnosis and workup: Clinical suspicion or histologic confirmation of BIA-ALCL based on imaging (breast ultrasound ± MRI as indicated), aspiration cytology, CD30 immunohistochemistry, and flow cytometry or biopsy

If results are indeterminate, obtain a second pathology consultation at a tertiary cancer center; obtain adequate fluid volume for testing per institutional/NCCN guidance (ensure specimen submission for cytology, CD30 IHC, and flow cytometry)

Preoperative evaluation: Complete history and physical exam, pregnancy testing when applicable, appropriate staging imaging (PET-CT or CT as indicated), and oncology and/or surgical oncology consultation prior to definitive surgery

Referral to oncology recommended before surgery for staging and treatment planning

Treatment: Complete surgical excision including removal of the implant(s) and total capsulectomy with excision/biopsy of any mass or suspicious regional nodes

Consider removal of the contralateral implant given ~4.6% incidental bilateral disease; residual or advanced disease may require adjuvant therapy per oncology

Routine prophylactic removal of breast implants in asymptomatic patients without clinical suspicion of BIA-ALCL is not recommended by the FDA. The policy aligns with this guidance and does not support implant removal purely for prophylaxis in patients who have no symptoms or clinical findings suggestive of BIA-ALCL.

When symptoms or clinical concern for BIA-ALCL exist (see diagnostic and treatment criteria), management should follow established evaluation and treatment pathways rather than prophylactic explantation in asymptomatic individuals.

Removal of intact silicone gel–filled breast implants solely for suspected autoimmune or connective tissue disease, or solely for cancer prevention, is described in referenced payer policies as experimental, investigational, or unproven and is not routinely considered medically necessary.

Coverage for explantation in these scenarios is not supported by the clinical evidence cited in payer policies; surgical removal should be reserved for clearly documented medical indications or when other coverage criteria for BIA-ALCL evaluation and treatment are met.

Diagnosis and Procedure Coding

Diagnosis (ICD-10)ICD-10

C84.70-84.79	Anaplastic large cell lymphoma, ALK-negative, extranodal, solid organ sites
N63	Unspecified lump in breast, nodule, mass, or swelling of the breast
64.4	Mastodynia
R52	Pain
T85.49XA	Other mechanical complication of breast prosthesis and implant, initial encounter
T85.79XA	Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts
T85.848A	Pain due to internal prosthetic devices, implants and grafts
T85.44XA	Contracture of Breast Prosthesis
T85.43XA	Rupture of Breast Prosthesis
R59.9	Enlarged lymph node

1–10 of 11

1/2

Procedure (CPT)CPT

10022	Fine needle aspiration with imaging guidance
19101	Breast biopsy, open, incisional
19260	Excision of chest wall tumor
19328	Removal intact mammary implant
19330	Removal of mammary implant material
19340	Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction
19371	Breast periprosthetic capsulectomy
38525	Biopsy/excisions, lymph node; open or deep axillary node

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior authorization required for implant removal and capsulectomy

Prior authorization is required for surgical removal of implant and total capsulectomy (CPT 19328, 19330, 19371). Requests should be supported by diagnostic confirmation or reasonable clinical suspicion of BIA‑ALCL and appropriate preoperative imaging and pathology workup (e.g., ultrasound ± MRI, aspiration cytology with CD30 immunohistochemistry, flow cytometry, or biopsy).

Include relevant CPT codes: 19328, 19330, 19371.
Provide imaging results (ultrasound or MRI) showing effusion or mass when available.
Provide pathology results from aspiration cytology, CD30 IHC, flow cytometry, or tissue biopsy.

Step Therapy

Step therapy — not applicable; proceed to definitive surgery

Step therapy does not apply; definitive surgical management (complete surgical excision including implant removal and total capsulectomy) is recommended for localized BIA‑ALCL. Advanced disease may require adjuvant therapy per oncology guidance.

Background on BIA-ALCL

Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare T‑cell lymphoma that arises in the fluid or fibrous capsule around breast implants and is most commonly associated with textured implants. The World Health Organization recognizes BIA-ALCL as a distinct entity that is often noninvasive and has an excellent prognosis when identified and treated early.

Clinically, BIA-ALCL typically presents years after implantation with a late seroma and sudden breast swelling; patients may also report pain, a palpable mass, regional lymphadenopathy, or breast asymmetry. Early-stage disease is frequently curable with complete surgical excision including removal of the implant(s) and total capsulectomy, while more advanced cases may require systemic chemotherapy or radiation per oncology guidance.

Because delays in diagnosis or treatment can lead to disease progression (including lymphadenopathy and distant spread), evaluation should include appropriate imaging and pathology workup and oncology consultation before definitive management. Routine screening or prophylactic removal in asymptomatic patients is not recommended.

Definitions

BIA-ALCL — definition and concise description

DefinitionBreast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare T-cell lymphoma that can develop following breast implantation; it is not a breast cancer.

Cell markerTumor cells express CD30 on immunohistochemistry.

ClassificationA form of Anaplastic Large Cell Lymphoma (ALCL), a T‑cell type non‑Hodgkin lymphoma.

Typical sitesMay involve peri-implant fluid or capsule and can appear in lymph nodes, skin, bone, soft tissue, lungs, or liver.

Clinical contextOften presents years after implantation with late seroma, swelling, pain, mass, or regional lymphadenopathy; early-stage disease may be cured with complete surgical excision.

Capsulectomy — procedure definition and common indications

Policy Summary

PayerHighmark Blue Cross Blue Shield Wny

PolicyManagement and Coverage Criteria for Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJun 1, 2020

Next Review DateN/A

Key ActionObtain pathology confirmation (cytology with CD30 immunohistochemistry or biopsy) and document preoperative imaging and oncology consultation before implant removal and total capsulectomy.

SourceLink

On This Page

Do not delay definitive surgery in favor of stepwise nonoperative measures when localized disease is suspected or confirmed.
Refer to oncology for consideration of adjuvant chemotherapy or radiation if surgery reveals advanced disease.

Documentation Required

Required clinical documentation for authorization

Document pathology confirmation and operative pathology for the implant and capsule, plus preoperative workup and consultations. Pathologic documentation should include cytology, CD30 immunohistochemistry, and T‑cell clonality/flow cytometry when applicable; operative pathology of implant and capsule and biopsy of any mass or suspicious nodes should be included.

Cytology report and CD30 immunohistochemistry results.
Flow cytometry or T‑cell clonality testing reports when performed.
Operative pathology reports for the implant, capsule, any mass, and sampled lymph nodes.
Preoperative imaging reports (ultrasound ± MRI, PET‑CT/CT if performed) and oncology/surgical oncology consultation notes.

Denial Risk

Delay risks and coverage note

Delaying diagnosis or treatment can lead to disease progression with advanced features; evaluation and treatment of confirmed BIA‑ALCL (including implant removal and total capsulectomy) are covered benefits and should not be deferred for concerns about out‑of‑pocket costs.

Timely diagnostic aspiration and pathology review are recommended when effusion or mass is identified.
If results are indeterminate, obtain a second pathology consultation at a tertiary cancer center and proceed with recommended preoperative staging and oncology referral.

DefinitionCapsulectomy is the surgical removal of the surrounding reactive fibrous tissue (capsule) that develops around a breast implant, often performed when removing the implant.

Indication — symptomatic implantPerformed when the capsule contracts (capsular contracture) causing deformation, pain, or implant dysfunction.

Indication — oncologicPerformed as part of definitive surgical management for confirmed or strongly suspected BIA-ALCL to remove the capsule and any associated peri-implant disease.

Relation to implant removalCapsulectomy is usually done concurrently with implant removal to excise the reactive tissue surrounding the prosthesis.

Pathophysiologic rationaleRemoves contracted, fibrotic capsule tissue that can exert pressure on the implant and may harbor disease or effusion.