Blue Cross Blue Shield MA Cryoablation Coverage Update

Coverage Criteria — Medically Necessary and Investigational Indications

Medically Necessary Indications

Cryosurgical ablation is considered MEDICALLY NECESSARY when ALL of the following grouped criteria are met as specified per indication:

Renal cell carcinoma - general

Patient suitability: Either the individual is not a surgical candidate OR preservation of kidney function is necessary (GFR < 60 mL/min per m2) and standard surgical approach is likely to worsen kidney function substantiallyGFR < 60 mL/min per m2
See policy definition of renal insufficiency and rationale; cryoablation appropriate when nephron-sparing required or surgery contraindicated.

Lung cancer - covered scenarios: Cryoablation may be considered medically necessary for lung cancer when either the individual requires palliation for a central airway obstructing lesion OR has early-stage non-small cell lung cancer and is a poor surgical candidate

Policy supports cryoablation for palliation of central airway obstruction or for early-stage NSCLC in poor surgical candidates.

Investigational / Not Medically Necessary

Cryosurgical ablation is considered investigational (not supported by sufficient evidence) for the following indications:

Breast tumors: Benign or malignant tumors of the breast, including fibroadenomas and primary breast cancers

Breast cryoablation (including CPT codes 0581T and 19105) is listed as investigational in the policy.

Lung tumors - other: Lung tumors other than palliation for central airway obstruction or early-stage NSCLC in poor surgical candidates

Cryoablation for lung indications outside the defined palliation or early-stage NSCLC poor-surgical-candidate scenarios is investigational due to insufficient comparative evidence.

Pancreas, bone, and other solid tumors: Pancreatic tumors, bone tumors/metastases, and other solid tumors or metastases outside the liver and prostate

Policy states evidence is insufficient to conclude benefit for cryoablation of breast, pancreas, bone, and other solid tumors; CPT code 20983 for bone cryoablation is listed investigational.

Cryosurgical ablation is considered investigational (not medically necessary) for tumors of the breast, pancreatic tumors, bone tumors or metastases, and other solid tumors or metastases outside the liver and prostate. The policy does not support cryoablation for benign or malignant breast lesions (including fibroadenomas and primary breast cancers) or for pancreatic and bone lesions because the evidence is insufficient to establish safety and effectiveness for these indications.

For renal disease, cryoablation is not supported when used to treat renal cell carcinomas in individuals who are surgical candidates; in other words, cryoablation is investigational for treatment of surgically resectable kidney cancers when surgery is a viable option.

Cryosurgical ablation is considered investigational for lung tumors except in the limited, specifically defined situations where cryoablation may be medically necessary: palliation of a central airway–obstructing lesion, or treatment of early-stage non–small cell lung cancer in patients who are poor surgical candidates. All other lung tumor indications remain investigational.

Specific CPT codes for breast and bone cryoablation are listed as investigational in the coding section; when considering coverage for any patient, providers should confirm whether the indication falls within the policy’s defined medically necessary scenarios for lung or renal disease or otherwise is considered investigational and therefore not covered.

Coding and Clinical Thresholds

Covered CPT Codes (when criteria met)CPTCovered

32994	Ablation therapy for reduction or eradication of one or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation
50250	Ablation, open, 1 or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring if performed
50542	Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring when performed
50593	Ablation, renal tumor(s) unilateral, percutaneous, cryotherapy
76940	Ultrasound guidance and monitoring of parenchymal tissue ablation
77013
77022	Magnetic resonance guidance for and monitoring of parenchymal tissue ablation

Investigational CPT CodesCPTNot Covered

0581T	Ablation, malignant breast tumor(s), percutaneous, cryotherapy, including imaging guidance when performed; unilateral
19105	Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma
20983	Ablation therapy for reduction or eradication of one or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation

inv-07: Maximum renal tumor size — key clinical threshold value for coverage decisions

Maximum tumor size for medically necessary renal cryoablationLocalized renal cell carcinoma no more than 4 cm in size

Context of thresholdApplies to localized renal cell carcinoma when patient is not a surgical candidate or when kidney function preservation is required

Policy populationCommercial and Medicare members (Managed Care, PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue)

inv-08: Renal insufficiency threshold (GFR) — clinical threshold for nephron-sparing consideration

Renal insufficiency definition for nephron-sparing considerationGlomerular filtration rate (GFR) less than 60 mL/min per m2

Use in coverage decision

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Inpatient Precertification Required

Prior authorization is required for all products when the procedure is performed inpatient. Providers must obtain precertification/preauthorization prior to inpatient admissions for services described in this policy.

Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.

Prior Authorization

Outpatient Prior Authorization Guidance

Outpatient prior authorization requirements vary by product. For Commercial Managed Care (HMO and POS) and Commercial PPO/Indemnity, prior authorization is not required for outpatient procedures per the source text; confirm member-specific benefits and product rules before proceeding.

Commercial Managed Care (HMO and POS), Outpatient = Prior authorization is not required.
Commercial PPO and Indemnity, Outpatient = Prior authorization is not required.
Confirm product-specific outpatient rules for Medicare HMO and Medicare PPO members in the member contract.

Background and Rationale

Cryosurgical ablation (cryoablation) is a technique that destroys target tissue by freezing. The procedure uses one or more probes that circulate a coolant to create an ice ball at the probe tip, producing tissue necrosis in the targeted area. Cryoablation can be performed via an open surgical approach, laparoscopically, or percutaneously.

Image guidance (for example, ultrasound, computed tomography, or magnetic resonance imaging) is commonly used to place probes and to monitor the ablation zone in real time during the procedure. Choice of approach and imaging modality depends on tumor location, size, and surrounding structures, and is selected to maximize treatment accuracy while minimizing injury to adjacent tissues.

Definitions

inv-18: Cryoablation — Definition of cryosurgical ablation and procedural approaches

DefinitionCryosurgical ablation (cryoablation) involves freezing of target tissues using a coolant-carrying probe

Procedural approachesMay be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound (percutaneous) guidance

Typical deliveryProbe insertion into the tumor with imaging guidance to freeze target tissue

inv-19: Nephron-sparing surgery — Definition and context as standard treatment for localized kidney tumors

DefinitionNephron-sparing surgery is surgical resection of a renal tumor aimed at preserving kidney tissue and function

Role in treatmentStandard treatment option for localized kidney cancer, alongside radical nephrectomy

OpenPayer

Cryosurgical Ablation of Tumors

Coverage Criteria — Medically Necessary and Investigational Indications

Coding and Clinical Thresholds

Provider Actions, Prior Authorization, and Documentation

Background and Rationale

Definitions