DESCRIPTION
Cryosurgical ablation (cryoablation, cryotherapy or cryosurgery) involves exposing tissue to extreme cold to produce well-demarcated areas of cell injury and destruction. Cryosurgical ablation may be performed as an open surgical technique, laparoscopically, or percutaneously with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.
Potential complications of cryosurgery 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.
Note: This policy does not address cryosurgical ablation for Barrett’s esophagus or uterine fibroids. Please refer to MCG Guideline Esophagogastroduodenoscopy (EGD), UGI Endoscopy ACG: A-0203 (AC) for Barrett’s esophagus and for uterine fibroids use medical policy Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids.
POLICY
Cryosurgical ablation of solid tumors may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cryosurgical ablation of other benign or malignant solid tumors, including but not limited to subtotal prostate, uterine, cutaneous melanoma, neuroendocrine, pancreatic, cervical, and breast are considered investigational.
MEDICAL APPROPRIATENESS
Cryosurgical ablation of solid tumors is considered medically appropriate if ALL of the following are met:
Treatment is indicated if ANY ONE of the following are met:
Bone Cancer (i.e., chondrosarcoma) with ALL of the following:
Grade I intracompartmental lesion(s)
As an adjuvant to intralesional curettage
Colon cancer with ALL of the following:
Metastasis to the lungs or liver
Oligometastases (one or limited number of metastases)
Hepatocellular Carcinoma
Non-small cell lung cancer and ANY ONE of the following:
Palliation of airway obstruction
Early-stage non-small cell lung cancer
Prostate tumor (whole gland) if ANY ONE of the following criteria are met:
Performed as initial treatment
Salvage treatment for recurrent tumors following radiation therapy with ANY ONE of the following met:
Stage T2b or below
Gleason score less than 9
PSA less than 8 ng/ml
Renal tumors if ALL of the following criteria are met:
Tumors are 4 cm or less in size
Documentation of ANY ONE of the following:
Documentation of ALL of the following:
To preserve kidney function (i.e., individual has one kidney or renal sufficiency defined by a glomerular filtration rate [GRF] of less than 60 mL/min per m2)
Standard surgical approach (i.e., resection of renal tissue) is likely to substantially worsen kidney function
Individual is not considered a surgical candidate
Uveal Melanoma if ANY ONE of the following criteria are met:
Treatment of ocular tumor if inadequate response was achieved from initial radiation and ANY ONE of the following:
Diameter of less than or equal to 19 millimeters and a thickness of 2.5 to 10 millimeters
Diameter greater than 19 millimeters
Thickness of greater than 10 millimeters
Thickness of greater than 8 millimeters with optic nerve involvement
Intraoperative treatment of extraocular extension at the time of enucleation (removal of the eye) when ANY ONE of the following are met:
Visible extraocular tumor
Suspicion of gross disease in the orbit
Treatment of orbital tumor if there is ocular recurrence with ALL of the following:
Extraocular involvement
Surgical resection is needed (e.g., partial orbital tumor resection, enucleation, or exenteration)
Treatment of orbital tumor if there is ocular recurrence with orbital involvement in individuals with prior enucleation (removal of the eye)
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The available literature does not support the safety and efficacy of cryosurgical ablation for the treatment of those diagnoses listed in the investigational statement.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (10:2022). Cryosurgical ablation of primary or metastatic liver tumors (7.01.75). Retrieved June 23, 2023 from www.ebcbsaoca.com/eps. (33 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (10:2022). Focal treatments for prostate cancer (8.01.61). Retrieved June 23, 2023 from www.ebcbsaoca.com/eps. (64 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (8:2022). Cryoablation of tumors located in the kidney, lung, breast, pancreas, or bone (7.01.92). Retrieved June 23, 2023 from www.ebcbsaoca.com/eps. (46 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (9:2022). Whole gland cryoablation of prostate cancer (7.01.79). Retrieved June 23, 2023 from www.ebcbsaoca.com/eps. (44 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for cryosurgery of prostate (230.9). Retrieved October 3, 2019 from http://www.cms.gov.
National Comprehensive Cancer Network. (2022, December). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Neuroendocrine and adrenal tumors V.2.2022. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Bone cancer V.3.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Cervical cancer V.1.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer V.2.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-small cell lung cancer V.3.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Uterine neoplasm V.2.2023. Retrieved June 27, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, June). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Kidney cancer V.1.2024. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Hepatocellular carcinoma V.1.2023. Retrieved June 27, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Melanoma: Cutaneous V.2.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, May). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Melanoma: Uveal V.1.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate cancer V.1.2023. Retrieved June 26, 2023 from the National Comprehensive Cancer Network.
Winifred S. Hayes, Inc. Evolving Analysis Research Brief. (2022, April). Cryoablation for treatment of non-small cell lung cancer. Retrieved June 14, 2022 from www.Hayesinc.com/subscribers. (3 articles and/or guidelines reviewed)
Winifred S. Hayes. Inc. Comparative Effectiveness Review. (2017, July; last update search September 2021). Comparative effectiveness review of cryoablation for primary treatment of localized prostate cancer. Retrieved June 14, 2022 from www.Hayesinc.com/subscriberes. (61 articles and/or guidelines reviewed)
Winifred S. Hayes. Inc. Comparative Effectiveness Review. (2017, July; last update search September 2021). Comparative effectiveness review of cryoablation for salvage treatment of recurrent prostate cancer following radiotherapy. Retrieved June 14, 2022 from www.Hayesinc.com/subscriberes. (91 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1/2000
MOST RECENT REVIEW DATE: 8/10/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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