THIS IS NO LONGER AN ACTIVE POLICY. POLICY WAS ARCHIVED ON 06/16/2025.
THIS IS NO LONGER AN ACTIVE POLICY. POLICY WAS ARCHIVED ON 06/16/2025.
Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.
This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.
The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations.
This medical policy outlines Highmark Health Options services for Ablation of Miscellaneous Solid Tumors.
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
Radiofrequency Ablation (RFA) – Heat is projected into a tumor by a high-frequency, alternating current that flows from electrodes. The cells killed by RFA are gradually replaced by fibrosis and scar tissue. RFA can be performed percutaneously, laparoscopically, or as an open procedure.
Cryosurgical Ablation – Also called cryosurgery, cryotherapy, or cryodestruction, is the use of extreme cold to destroy cancer cells while preserving the surrounding healthy tissue.
Prior Authorization
Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup
Procedures
OSTEOLYTIC BONE PAIN
RFA may be considered medically necessary to palliate pain in individuals with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids.
RFA as initial treatment for painful bony metastases is considered experimental/investigational, and therefore, noncovered. The evidence is insufficient to determine the impact of technology on health outcomes.
OSTEOID OSTEOMAS
RFA may be considered medically necessary to treat osteoid osteomas that cannot be managed successfully with medical treatment.
RFA for osteoid osteomas that can be managed with medical treatment is considered experimental/investigational, and therefore, non-covered. The evidence is insufficient to determine the impact of technology on health outcomes.
ISOLATED PERIPHERAL NON-SMALL CELL LUNG CANCER
RFA may be considered medically necessary to treat an isolated peripheral non-small-cell lung cancer lesion that is no more than three (3) cm in size when ALL the following criteria are met:
RFA for any other isolated peripheral non-small cell lung cancer is considered experimental/investigational, and is therefore, non-covered due to the evidence is insufficient to determine the impact of the technology on health outcomes.
MALIGNANT NONPULMONARY TUMOR(S) METASTATIC TO THE LUNG
RFA may be considered medically necessary to treat malignant nonpulmonary tumor(s) metastatic to the lung that are no more than three (3) cm in size when the following criteria are met:
RFA for any other malignant non-pulmonary tumors metastatic to the lung is considered experimental/investigational, and is therefore, noncovered due to the evidence is insufficient to determine the impact of the technology on health outcomes.
RENAL CELL CARCINOMA
RFA of renal cell carcinoma may be considered medically necessary to treat localized small renal cell carcinoma that is no more than four (4) cm in size when EITHER of the following criteria is met:
Radiofrequency ablation for renal cell carcinoma not meeting the criteria as indicated in this policy is considered not medically necessary.
RFA as a technique for ablation for ANY of the following is considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
RENAL CELL CARCINOMA CRYOSURGICAL ABLATION
Cryosurgical ablation may be considered medically necessary to treat localized renal cell carcinoma that is no more than four (4) cm in size when EITHER of the following criteria is met:
Cryosurgical ablation for renal cell carcinoma not meeting the criteria as indicated in this policy is considered not medically necessary.
LUNG CANCER CRYOSURGICAL ABLATION
Cryosurgical ablation may be considered medically necessary to treat lung cancer when EITHER of the following criteria is met:
Cryosurgical ablation for lung cancer not meeting the criteria as indicated in this policy is considered experimental/investigational, and is therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
OSTEOLYTIC BONE PAIN CRYOSURGICAL ABLATION
Cryosurgical ablation may be considered medically necessary to palliate pain in individuals with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids.
Cryosurgical ablation for osteolytic bone pain not meeting the criteria as indicated in this policy is considered experimental/investigational, and is therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature
Cryosurgical ablation as a technique for ablation for ANY of the following is considered experimental/investigational, and therefore, noncovered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
POST-PAYMENT AUDIT STATEMENT
The medical record must include documentation that reflects the medical necessity criteria and is
subject to audit by Highmark Health Options at any time pursuant to the terms of your provider
agreement.
PLACE OF SERVICE: INPATIENT/OUTPATIENT
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in exceptional circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting
National Comprehensive Cancer Network (NCCN) – 2022
The NCCN guidelines (v.2.2020) for renal cancer indicate that “[t]hermal ablation (e.g., cryosurgery, radiofrequency ablation) is an option for the management of patients with clinical stage T1 renal lesions. Thermal ablation is an option for masses <3 cm, but it may also be an option for larger masses in select patients. Ablation in masses >3 cm is associated with higher rates of local recurrence/persistence and complications."
Participating facilities will be reimbursed per their Highmark Health Options contract.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Nonsmall cell lung cancer. Version 4.2022.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Thyroid Carcinoma. Version 2.022.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma. Version 1.2022.
Oc Y, Kilinc BE, Cennet S, et. al. Complications of computer tomography assisted radiofrequency ablation in the treatment of osteoid osteoma. BioMed Res Int. 2019:1-6.
National Institute for Health and Care Excellence (NICE). Percutaneous radiofrequency ablation of renal cancer. 2010.
Rosian K, Hawlik K, Piso B. Efficacy assessment of radiofrequency ablation as a palliative pain treatment in patients with painful metastatic spinal lesions: A systematic review. Pain Physician. 2018;21(5): E467-E476.
Albisinni U, Facchini G, Spinnato P, et al. Spinal osteoid osteoma: Efficacy and safety of radiofrequency ablation. Skeletal Radiol. 2017;46(8):1087-1094.
Lassalle L, Campagna R, Corcos G, et al. Therapeutic outcome of CT-guided radiofrequency ablation in patients with osteoid osteoma. Skeletal Radiol. 2017;46(7):949-956.
Tordjman M, Perronne L, Madelin G, Mali RD, et al. CT-guided radiofrequency ablation for osteoid osteomas: A systematic review. Eur Radiol. 2020;30(11):5952-5963.
Sahin C, Oc Y, Ediz N, Altınay M, et al. The safety and the efficacy of computed tomography guided percutaneous radiofrequency ablation of osteoid osteoma. Acta Orthop Traumatol Turc. 2019;53(5):360-365.
Hasegawa T, Takaki H, Kodama H, Yamanaka T, et al. Three-year survival rate after radiofrequency ablation for surgically resectable colorectal lung metastases: A prospective
multicenter study. Radiology. 2020;294(3):686-695.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancer. Version 2.2022.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer. Version 4.2022.
Barthet M, Giovannini M, Lesavre N, Boustiere C, et al. Endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors and pancreatic cystic neoplasms: A prospective multicenter study. Endoscopy. 2019;51(9):836-842.
Hlavsa J, Procházka V, Andrasina T, Pavlík T, et al. Radiofrequency ablation in pancreatic cancer. Rozhl Chir. 2019;98(11):441-449.
Oh D, Ko SW, Seo DW, Hong SM, et al. Endoscopic ultrasound-guided radiofrequency ablation of pancreatic microcystic serous cystic neoplasms: A retrospective study. Endoscopy. 2021;53(7):739-743.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Kidney Cancer. Version 2.2023.
InterQual® Level of Care Criteria 2021. Acute Care Adult. McKesson Health Solutions, LLC.
Dai Y, Covarrubias D, Uppot R, Arelleno RS. Image-guided percutaneous radiofrequency ablation of central renal cell carcinoma: Assessment of clinical efficacy and safety in 31 tumors. J Vasc Interv Radiol. 2017;28(12):1643-1650.
Dvorak P, Hoffmann P, Brodak M, Kosina J, Pacovsky J, et al. Percutaneous radiofrequency and microwave ablation in the treatment of renal tumors - 10 years of experience. Wideochir Inne Tech Maloinwazyjne. 2017;12(4):394-402.
Park BK, Gong IH, Kang MY, Sung HH, Jeon HG, et al. RFA versus robotic partial nephrectomy for T1a renal cell carcinoma: A propensity score-matched comparison of mid-term outcome. Eur Radiol. 2018;28(7):2979-2985.
Uhlig J, Strauss A, Rucker G, Seif Amir Hosseini A, et al. Partial nephrectomy versus ablative techniques for small renal masses: A systematic review and network meta-analysis. Eur Radiol. 2019;29(3):1293-1307.
Pessoa RR, Autorino R, Laguna MP, et al. Laparoscopic verses percutaneous cryoablation of small renal mass: Systematic review and cumulative analysis of comparative studies. Clin Genitourin Cancer. 2017;15(5):513-519.e5.
Campbell S, Uzzo RG, Allaf ME, et al. Renal mass and localized renal cancer: AUA Guideline. J Urol. 2017;198(3):520-529.
Marshall HR, Shakeri S, Hosseiny M, Sisk A, et al. Long-term survival after percutaneous radiofrequency ablation of pathologically proven renal cell carcinoma in 100 patients. J Vasc Interv Radiol. 2020;31(1):15-24.
Andrews JR, Atwell T, Schmit G, Lohse CM, et al. Oncologic outcomes following partial nephrectomy and percutaneous ablation for cT1 renal masses. Eur Urol. 2019;76(2):244-251.
Miyazaki M, Saito K, Yanagawa T, Chikuda H, et al. Phase I clinical trial of percutaneous cryoablation for osteoid osteoma. Jpn J Radiol. 2018;36(11):669-675.
Ierardi AM, Carnevale A, Angileri SA, Pellegrino F, et al Outcomes following minimally invasive imagine-guided percutaneous ablation of adrenal glands. Gland Surg. 2020;9(3):859-866.
Coupal TM, Pennycooke K, Mallinson PI, Ouellette HA, et al. The hopeless case? Palliative cryoablation and cementoplasty procedures for palliation of large pelvic bone metastases. Pain Physician. 2017;20(7): E1053-E1061.
Colangeli S, Parchi P, Andreani L, Beltrami G, et al. Cryotherapy efficacy and safety as local therapy in surgical treatment of musculoskeletal tumours. A retrospective case series of 143 patients. J Biol Regul Homeost Agents. 2018;32(6 Suppl. 1):65-70.
Yan S, Yang W, Zhu CM, Yan PM, et al. Comparison among cryoablation, radiofrequency ablation, and partial nephrectomy for renal cell carcinomas sized smaller than 2 cm or sized 2- 4 cm: A population-based study. Medicine (Baltimore). 2019;98(21): e15610.
Morkos J, Porosnicu Rodriguez KA, Zhou A, Kolarich AR, et al. Percutaneous cryoablation for stage 1 renal cell carcinoma: Outcomes from a 10-year prospective study and comparison with matched cohorts from the National Cancer database. Radiology. 2020;296(2):452-459.
Stacul F, Sachs C, Giudici F, Bertolotto M, et al. Cryoablation of renal tumors: Long-term followup from a multicenter experience. Abdom Radiol (NY). 2021;46(9):4476-4488.
Callstrom MR, Woodrum DA, Nichols FC, Palussiere J, et al. Multicenter study of metastatic lung tumors targeted by interventional cryoablation evaluation (SOLSTICE). J Thorac Oncol. 2020;15(7):1200-1209.
Takada M, Toi M. Cryosurgery for primary breast cancers, its biological impact, and clinical outcomes. Int J Clin Oncol. 2019;24(6):608-613.
Fine RE, Gilmore RC, Dietz JR, Boolbol SK, et al. Cryoablation without excision for low-risk earlystage breast cancer: 3-Year interim analysis of ipsilateral breast tumor recurrence in the ICE3 trial. Ann Surg Oncol. 2021.
Wu Y, Gu Y, Zhang B, Zhou X, et al. Laparoscopic ultrasonography-guided cryoablation of locally advanced pancreatic cancer: A preliminary report. Jpn J Radiol. 2021.
He L, Niu L, Korpan NN, Sumida S, et al. Clinical practice guidelines for cryosurgery of pancreatic cancer: A consensus statement from the China Cooperative Group of Cryosurgery on Pancreatic Cancer, International Society of Cryosurgery, and Asian Society of Cryosurgery. Pancreas.
2017;46(8):967-972.
Jennings JW, Prologo JD, Garnon J, Gangi A, et al. Cryoablation for palliation of painful bone metastases: The MOTION multicenter study. Radiol Imaging Cancer. 2021;3(2):e200101.
Ferrer-Mileo L, Luque Blanco AI, González-Barboteo J. Efficacy of cryoablation to control cancer pain: A systematic review. Pain Pract. 2018;18(8):1083-1098.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Bone Cancer. Version 1.2023.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 4.2022.
Hayes, Inc. Hayes Health Technology Assessment. Radiofrequency Ablation for Benign Thyroid Nodules. Lansdale, PA: Hayes, Inc.; 06/29/2021.
Gray RE, Harris GT. Renal cell carcinoma: Diagnosis and management. Am Fam Physician. 2019;99(12):732.
Tanigawa N, Arai Y, Yamakado K, et al. Phase I/II Study of radiofrequency ablation for painful bone metastases: Japan Interventional Radiology in Oncology Study Group 0208. Cardiovasc Intervent Radiol. 2018;41(7):1043-1048.
Sebek J, Taeprasartsit P, Wibowo H, Beard WL, Bortel R, Prakash P. Microwave ablation of lung tumors: A probabilistic approach for simulation-based treatment planning. Med Phys. 2021;48(7):3991-4003.
Qi H, Fan W. Value of ablation therapy in the treatment of lung metastases. Thorac Cancer. 2018;9(2):199-207.