Effective 4/15/2026, Cigna clarified medical necessity criteria for removal and replacement of silicone and saline breast implants, emphasizing plan-specific coverage and that the member’s benefit document controls. Removal is considered medically necessary for implant rupture confirmed on imaging (silicone), infection not responsive to medical therapy, implant exposure, Baker Grade IV capsular contracture, tissue necrosis, confirmed BIA‑ALCL or BIA‑SCC, interference with breast cancer diagnosis or treatment, and current use of Allergan BIOCELL textured devices. Replacement is covered only when meeting reconstructive criteria (post‑mastectomy/lumpectomy reconstruction or symmetry of the contralateral breast) with referenced CPTs; many procedures are excluded as cosmetic or not medically necessary, including removal of intact silicone implants for suspected systemic illness and routine removal of ruptured saline implants absent other indications. Providers should verify member plan terms and applicable state/federal mandates before proceeding.
April 2026 Revision: Clarified Medical Necessity Criteria for Implant Removal/Replacement
This revision, effective 4/15/2026, clarifies and consolidates medical necessity criteria specific to removal and replacement of both silicone gel-filled and saline-filled breast implants under Cigna's Coverage Policy 0048. The policy reiterates that coverage varies by plan and may be subject to federal or state mandates, and emphasizes that the customer's specific benefit plan document supersedes this Coverage Policy when conflicts exist.
The update highlights specific scenarios considered medically necessary (e.g., implant rupture confirmed on imaging for silicone gel implants, interference with breast cancer diagnosis or treatment, infection unresponsive to medical management, implant exposure, Baker Grade IV capsular contracture, tissue necrosis, confirmed BIA-ALCL or BIA-SCC, and current use of Allergan BIOCELL textured implants). It also enumerates circumstances considered not medically necessary, including removal of intact silicone implants solely for suspected autoimmune/connective tissue disease or breast implant illness, and removal/replacement when performed solely for cosmetic reasons or psychological complaints.
Medically Necessary Indications for Implant Removal
The policy defines explicit medically necessary indications for removal of either silicone gel-filled or saline-filled breast implants. Removal with or without capsular revision (partial or complete capsulectomy) is considered medically necessary when the implant interferes with diagnostic evaluation of suspected breast cancer or interferes with adequate treatment of known breast cancer, such as obstructing radiation therapy. Additional listed indications include acute, persistent, or recurrent local or systemic infection secondary to an implant when medical management has failed or is contraindicated, current implant exposure, Baker Grade IV capsular contracture, tissue necrosis secondary to the implant, confirmed diagnoses of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) or breast implant-associated squamous cell carcinoma (BIA-SCC), and current use of Allergan BIOCELL textured implants and tissue expanders.
For silicone gel-filled implants specifically, removal (with or without capsular revision) is considered medically necessary when rupture and/or extrusion of implant contents have been confirmed on imaging (mammography, ultrasound, or MRI). The policy distinguishes silicone rupture from saline rupture in terms of the medical necessity of removal.
Criteria for Implant Replacement and Associated CPT Codes
The policy specifies when replacement (implantation of a new FDA-approved implant) after removal is medically necessary. Replacement is covered when performed for breast reconstruction of a diseased or affected breast following mastectomy or lumpectomy, or to create symmetry in the contralateral/nondiseased breast following mastectomy or lumpectomy in the opposite breast. The document cross-references reconstructive coverage under Medical Coverage Policy 0178 for postmastectomy or lumpectomy reconstruction.
When reconstruction criteria are met, the policy lists relevant procedure codes considered medically necessary, including 19325 (breast augmentation with implant) and 19342 (insertion or replacement of breast implant on separate day from mastectomy).
Not Medically Necessary and Cosmetic Exclusions
The policy delineates several not medically necessary or cosmetic scenarios. Removal of an intact silicone gel-filled implant solely for suspected autoimmune disease, connective tissue disease, or breast implant illness is considered not medically necessary. Similarly, removal of a ruptured saline-filled implant is considered not medically necessary in the absence of other listed indications (e.g., significant capsular contracture or persistent infection), because saline rupture generally does not produce medical complications requiring intervention.
Other exclusions include removals performed solely to treat psychological symptomatology or psychosocial complaints, solely to improve appearance, solely because of implant shifting or migration (unless accompanied by other covered indications), removal of a contralateral implant unless that implant individually meets criteria, replacement of an implant following removal (unless reconstruction criteria are met), and mastopexy following implant removal. The policy maps several CPT codes as not medically necessary/cosmetic in these contexts, including 19316, 19328, 19330, and 19342 when not associated with reconstruction.
Clinical Background and Distinctions Between Silicone and Saline Implants
The policy provides clinical rationale and background that informs these coverage determinations. It explains typical implant characteristics (shell surface, shape, profile, filler) and common surgical approaches. The document notes that while both reconstructive and cosmetic indications exist for implants, clinically significant complications — for example, capsular contracture, infection, extrusion, tissue necrosis, and rupture — are the circumstances that may necessitate removal.
Specific distinctions are made between saline and silicone implant complications: saline implant deflation or rupture often alters appearance but, absent other complications, does not require removal; implant shifting similarly does not constitute a medical necessity absent accompanying clinical problems. The policy emphasizes use of imaging confirmation (mammography, ultrasound, MRI) for diagnosing silicone rupture when removal is being considered.
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