Cigna percutaneous breast ablation Coverage Update

Coverage Criteria for Ablative Treatments

Not Medically Necessary

The following ablative treatments for malignant breast tumors are considered not medically necessary:

Not medically necessary ablative procedures: Cryoablation, percutaneous laser ablation, microwave ablation, and radiofrequency ablation for malignant breast tumors

These modalities are listed as not medically necessary in this policy.

Percutaneous ablation (policy addition)

Policy updated to include percutaneous ablation; supporting evidence, guideline references, and the focused-review coding change are summarized below.

Policy update summary: Focused review added percutaneous ablation to the policy and a new code (0971T) on 10/15/2025.

See Revision Details and Coding changes.

Evidence summary: Literature and systematic reviews (e.g., Mauri et al. 2017; Xia et al. 2021) and multiple single-center and prospective studies report limited, low-to-moderate quality evidence evaluating percutaneous ablation modalities for small breast tumors; outcomes and complications vary by modality.

Supporting citations include systematic reviews and clinical series listed in Professional Societies/Organizations references.

Guidelines and compendia: NCCN and NCI PDQ do not currently include percutaneous ablation techniques as standard guideline-recommended therapies for breast cancer; referenced professional literature is provided for context.

See NCCN (2025) and NCI PDQ citations in the policy.

Regulatory context: The ProSense Cryoablation System received FDA De Novo authorization for a limited indication (patients ≥70 years with biologically low-risk tumors ≤1.5 cm treated with adjuvant endocrine therapy); however, device-level FDA authorization does not by itself establish broad clinical coverage for all percutaneous ablation approaches.

Refer to FDA De Novo language and stated limitations in the policy.

Operational implication: Although the policy recognizes percutaneous ablation and added code 0971T, clinical use remains supported primarily in investigational or highly selected contexts with required documentation; providers should reference the policy literature and coding guidance when submitting claims.

See Revision Details and documentation/prior authorization notes.

The FDA De Novo decision for the ProSense Cryoablation System includes explicit device-specific limitations that affect appropriate use. The ProSense system is not intended for recurrent breast cancer, for patients who require neoadjuvant chemotherapy, biologic, or other targeted neoadjuvant therapies apart from endocrine therapy, or for breast cancers with inflammatory features. The FDA decision also notes patient selection constraints: only patients with adequate breast size are candidates, and for patients with breast implants providers must document adequate distance between the lesion and implant to ensure safe margins and avoid implant compromise. The FDA further states long-term outcomes (recurrence, disease-free survival, overall survival) are unknown beyond 5 years, and that cryoablation relies on imaging rather than a surgical specimen to assess completeness of tumor destruction.

Published literature reviews and primary studies for percutaneous laser ablation, microwave ablation, and radiofrequency ablation consistently describe an insufficient high-quality evidence base to support routine clinical use for malignant breast tumors. Systematic reviews note small sample sizes, heterogeneous methods, inconsistent protocols, limited long-term follow-up, and absence of randomized comparative data. For laser ablation, pooled complete ablation rates reported in included studies were approximately 74.4% but reviewers concluded the technique remains restricted to research contexts and selected cases. Similar limitations — technical feasibility demonstrated in preliminary studies but lacking controlled, long-term effectiveness data — are described for microwave ablation and RFA.

While the policy text and cited professional literature summarize limitations and research-only recommendations for multiple percutaneous techniques, the document does not list additional explicit procedural exclusions specific to percutaneous ablation beyond the device-specific constraints described for ProSense. Guideline and literature citations emphasize investigational status or restriction to research protocols rather than enumerating discrete exclusions for all percutaneous ablation modalities.

Cigna's policy designates the following ablative procedures for malignant breast tumors as not medically necessary: cryoablation, percutaneous laser ablation, microwave ablation, and radiofrequency ablation. Example procedure codes associated with this stance include 19499, 0581T, and 0971T. This coverage position reflects the policy’s assessment of the current evidence and guides reimbursement determinations accordingly.

Across modalities, the policy summarizes that percutaneous laser ablation, microwave ablation, and radiofrequency ablation are described in the literature as investigational or insufficiently supported and therefore are considered not medically necessary for treatment of malignant breast tumors outside of clinical trials or highly selected research contexts. Cryoablation is also listed as not medically necessary in the policy’s coverage statement.

The policy and cited reviews consistently describe percutaneous laser ablation, microwave ablation, and radiofrequency ablation as investigational or having insufficient evidence to support routine clinical use for malignant breast tumors. Systematic reviews and small prospective or retrospective series report variable technical success and incomplete ablation in some patients, and consequently these modalities are recommended for use primarily in research protocols or carefully selected investigational circumstances.

Codes and Billing

Considered Not Medically Necessary / Example CPT codesCPTNot Covered

19499	Unlisted procedure, breast
0581T	Ablation, malignant breast tumor(s), percutaneous, cryotherapy, including imaging guidance when performed, unilateral
0971T	Ablation, malignant breast tumor(s), percutaneous, laser, including imaging guidance when performed, unilateral

Added Procedure CodesHCPCS

0971T

Percutaneous ablation (new code added per focused review)

ProSense device tumor size — key/value (≤ 1.5 cm)

ProSense tumor size threshold≤ 1.5 cm (FDA De Novo indication for ProSense Cryoablation System)

Document contextReferenced in FDA indication as size limit for biologically low‑risk tumors

Related study size rangePolicy literature and cited studies frequently evaluate tumors ≤ 2 cm (contextual)

ProSense patient age — key/value (≥ 70 years)

ProSense patient age threshold≥ 70 years (FDA De Novo indication for ProSense Cryoablation System)

Population describedPatients ≥70 years with biologically low‑risk tumors and treated with adjuvant endocrine therapy

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for percutaneous ablation procedures for malignant breast tumors. This includes procedures billed with newly added code 0971T and other percutaneous ablation codes listed as not medically necessary when prior authorization is requested for coverage consideration.

Affected code: 0971T (Ablation, malignant breast tumor(s), percutaneous, laser, including imaging guidance when performed, unilateral).
Also applicable: 0581T (percutaneous cryotherapy) and 19499 (unlisted procedure, breast) where used to bill percutaneous ablation services.

Denial Risk

Claims Coding and Denial Risk

Services billed for ablative procedures that are not accompanied by covered codes under this policy will be denied as not covered. Failure to use the appropriate, currently effective codes (including the newly added 0971T) or billing percutaneous ablation under non-covered/unlisted codes increases the likelihood of claim denial.

Background and Context

Breast cancer management is individualized by tumor type, stage, and patient factors; standard of care commonly includes surgical resection (e.g., lumpectomy) with appropriate adjuvant therapy when indicated. Percutaneous ablative techniques (cryoablation, laser, microwave, radiofrequency) are emerging minimally invasive options evaluated primarily for small, early-stage tumors and in patients who may be unfit for surgery. However, these techniques are not established as standard therapy because evidence consists largely of small prospective series, nonrandomized studies, and systematic reviews with limited long-term outcomes; professional guidelines cited in the policy do not endorse routine use of percutaneous ablation for breast cancer outside of research settings.

Definitions

Definition — Cryoablation (procedure description)

Procedure descriptionCryoablation is a percutaneous technique in which one or more cryoprobes are inserted under image guidance into the tumor and deliver alternating cycles of freezing and thawing using liquid nitrogen or argon gas to induce localized tumor destruction via dehydration, swelling, and rupture of cancer cells.

Guidance modalitiesOften performed under ultrasound guidance

Intended effectLocalized tumor destruction while sparing surrounding tissue

Definition — Percutaneous laser ablation (procedure description)

Procedure descriptionPercutaneous laser ablation involves percutaneous insertion of a cooled laser fiber to the tumor under image guidance (mammography, ultrasound, or MRI) with delivery of laser energy to cause irreversible thermal damage to tumor cells while minimizing effects on surrounding healthy tissue.

Line of Therapy Considerations

first-line

First-line therapy considerations (top-level):

Device-indicated population (ProSense): Patients ≥70 years with biologically low-risk, unifocal invasive ductal carcinoma ≤1.5 cm who are treated with adjuvant endocrine therapy or are not suitable for surgery (FDA De Novo ProSense indication).Age ≥ 70 years; tumor size ≤ 1.5 cm; Ki-67 <15% / ER+/PR+/HER2-; clinically N0

FDA De Novo indication described in the policy; trial cohorts often included additional selection criteria (e.g., ECOG 0–1).

first-line

Additional first-line considerations and context:

Evidence and guideline context: Guideline sources (NCCN, NCI PDQ) do not include percutaneous ablation techniques as standard first-line options; percutaneous approaches have been evaluated in trials and series for select early-stage patients but are generally considered investigational outside of defined indications or research protocols.

Biomarker and Testing Requirements

ER, PR, HER2, Ki-67, genomic testing — biomarker profile expectations for select patients

Biomarker profile (FDA ProSense definition)ER‑positive, PR‑positive, HER2‑negative, Ki‑67 <15% and/or genomic testing indicative of low‑risk (defines biologically low‑risk tumors for ProSense use)

Clinical implicationsBiologically low‑risk designation tied to ProSense indication and patient selection criteria in studies

Histologic restriction notedProSense indication specifies infiltrating ductal carcinoma (IDC) and excludes lobular carcinoma, extensive intraductal component, or lymphovascular invasion

Regimens and Investigational Uses

Regimen	Key study / evidence	Patient selection / adjunctive therapy	Coverage status
Percutaneous cryoablation	Fine et al. (prospective, multi-center single-arm trial; interim and 5‑year results reported) showing low ipsilateral breast tumor recurrence at median follow-up and Z1072 phase II results reporting 75.9% complete ablation on central pathology	Eligible patients in Fine et al.: unifocal IDC ≤1.5 cm, older adults (mean age 75), ER/PR positive, HER2 negative; many participants received adjuvant whole-breast radiation and endocrine therapy	Experimental

Regimen	Key study / evidence	Patient selection / safety margins	Coverage status
MR‑guided percutaneous microwave coagulation (MR‑guided PMC)	Ji et al. (2024) prospective, non-randomized study of 26 patients reported complete response on histopathology after MR‑guided PMC	Study inclusion: core‑needle biopsy‑proven unifocal breast cancer <2.0 cm on MRI, ≥1 cm distance from skin and pectoralis muscle, no enlarged nodes or distant mets; intra-procedural MRI used to extend ablation when margins insufficient	Experimental

Regimen	Key trials	Notes on trial context	Coverage status
Image‑guided cryoablation (clinical trial context)	ACOSOG (Alliance) Z1072 phase II trial (Simmons et al.) and Fine et al. prospective trial with 5‑year results	Z1072 used cryoablation followed by surgical resection to assess complete ablation (central pathology showed 75.9% success); Fine et al. reported low IBTR with many patients receiving adjuvant radiation and endocrine therapy	Experimental

Regimen	Evidence summary	Patient selection / outcomes	Coverage status
Percutaneous laser ablation	Systematic reviews and single‑arm studies (e.g., Matsumoto & Facina 2025) report ~74.4% complete ablation in included studies; MRI recommended for evaluation	Suggested selection for future studies: tumors <2 cm, ≥0.5 cm from skin/chest wall, pure IDC without associated DCIS or ILC; complications include skin burns (~6%)	Experimental
Radiofrequency ablation (RFA)	Systematic reviews and trials (e.g., Xia et al. 2021; Garcia‑Tejedor 2018) show variable complete ablation rates, small heterogeneous studies, and insufficient evidence to support routine use	Studies often include tumors <2 cm; technical success high but technique efficacy and long‑term outcomes limited; some randomized and comparative data are small and underpowered	Experimental

Regimen	Evidence synthesis	Population / clinical context	Coverage status
Percutaneous radiofrequency ablation	Mauri et al. (systematic review/meta‑analysis) and other reviews report pooled technique efficacy (RFA ~82%) but overall evidence is from small, noncomparative studies with complication rates 6–8%	Considered in select early‑stage small tumors and in patients unfit for surgery; studies commonly restricted to lesions ≤2 cm with variable follow‑up	Experimental
Cryoablation, microwave ablation, laser ablation	Pooled analyses and multiple single‑arm studies show variable technique efficacy (cryoablation ~75%, laser ~59%, microwave data from pilot and small series) and limited long‑term comparative data	Used in select populations (e.g., elderly or those unsuitable for surgery) and often combined with adjuvant therapies in study cohorts	Experimental

OpenPayer

Ablative Treatments for Malignant Breast Tumors