IV-05-008

Medical Policy:

IV-05-008

Topic:

Cryoablation of Solid Tumors

Section:

Surgery

Effective Date:

August 31, 2020

Issued Date:

May 31, 2021

Last Revision Date:

June 2020

Annual Review:

May 2021

This policy version was replaced June 27, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Cryoablation uses extreme cold to destroy cancer cells by circulating liquid nitrogen or argon through a probe which is placed in contact with the tumor. The procedure involves a cycle of treatments in which the tumor is frozen, allowed to thaw, and then refrozen. Cryoablation may be performed as an open, laparoscopic, or percutaneous technique, and has been used to treat several types of solid tumors

Proposed advantages of cryoablation include improved local control and benefits common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization). Potential complications of the procedure include those caused by hypothermic damage to normal tissue adjacent to the tumor, structural damage along the probe track, and secondary tumors, if cancerous cells are seeded during probe removal.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Cryoablation may be considered MEDICALLY NECESSARY AND APPROPRIATE for the following indications:

Treatment of primary or metastatic liver tumors when both of the following criteria are met:
- Tumor is unresectable due to location of lesion[s] and/or comorbid conditions; AND
- ONE of the following:
  - A single tumor of ≤5 cm; OR
  - Up to 3 lesions ≤3 cm each.
Treatment of lung cancer under the following circumstances:
- Patient with early-stage non-small cell lung cancer who is a poor candidate for surgical resection; OR
- Palliation of a central airway obstruction lesion.
Treatment of prostate cancer under the following circumstances:
- Primary treatment for clinically localized prostate cancer; OR
- Salvage treatment for recurrent prostate cancer following failed radiation therapy.
Treatment of localized renal cell carcinoma when tumor size is ≤ 4 cm and either of the following criteria are met:
- Preservation of kidney function is necessary (i.e., the patient has one kidney or renal insufficiency, defined as a glomerular filtration rate [GFR] of < 60 mL/min/m²) and standard surgical approaches would compromise kidney function; OR
- Patient is not considered a surgical candidate due to co-morbid disease.

II. Cryoablation is considered EXPERIMENTAL/INVESTIGATIVE for treatment of all other solid tumors or metastases including, but not limited to, the following due to lack of clinical evidence demonstrating an impact on improved health outcomes:

Benign breast tumors (e.g., fibroadenomas);
Malignant breast tumors;
Renal cell carcinoma in patients who are surgical candidates;
Pancreatic cancer;
Subtotal prostate ablation.

0581T 19105 32994 47371 47381 47383 50250 50542 50593 55873

Denial Statements

No additional statements.

Links

Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

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Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

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