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Cryoablation of Tumors (Excluding Liver or Prostate Tumors)

Policy Number: MP-429

Latest Review Date: July 2024

Category: Surgery                                                                  

POLICY:

Cryosurgical ablation of localized renal cell carcinoma that is no more than 4 cm in size may be considered medically necessary when performed open, laparoscopically, or percutaneously when either of the following criteria is met:

  • Preservation of kidney function is necessary (i.e., the individual has 1 kidney or renal insufficiency defined by a glomerular filtration rate [GFR] of less than 60 mL/min/m2) and standard surgical approach (i.e., resection of renal tissue) is likely to substantially worsen kidney function; OR
  • The individual is not considered a surgical candidate.

Cryosurgical ablation may be considered medically necessary for the treatment of individuals with osteolytic bone metastases that have failed or are poor candidates for standard treatments such as radiation and opioids.

Cryosurgical ablation may be considered medically necessary to treat lung cancer when either of the following criteria is met:

  • The individual has early-stage non-small cell lung cancer and is a poor surgical candidate; OR
  • The individual requires palliation for a central airway obstructing lesion.

Cryosurgical ablation is considered investigational when used to treat any of the following (including but not limited to):

  • Benign or malignant tumors of the breast, lung (other than defined above), pancreas, or bone (other than defined above)
  • Other solid tumors or metastases outside the liver and prostate, including desmoid tumors
  • Renal cell carcinomas in individuals who are surgical candidates

***Refer also to medical policy 733: Cryosurgical Ablation of Primary or Metastatic Liver Tumors

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Cryosurgical ablation (hereafter referred to as cryosurgery or cryoablation) involves freezing of target tissues; this is most often performed by inserting a coolant-carrying probe into the tumor. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.

Breast Tumors

Early-stage primary breast cancers are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach is balanced against the patient’s desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient’s age, hormone receptor status, and other factors. Adjuvant radiotherapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on presence and number of involved nodes, hormone receptor status, and other factors. Treatment of metastatic disease includes surgery to remove the lesion and combination chemotherapy.

Fibroadenomas are common benign tumors of the breast that can present as a palpable mass or a mammographic abnormality. These benign tumors are frequently surgically excised to rule out a malignancy.

Lung Tumors and Lung Metastases

Early-stage lung tumors are typically treated surgically. Patients with early-stage lung cancer who are not surgical candidates may be candidates for radiotherapy with curative intent. Cryoablation is being investigated in patients who are medically inoperable, with small primary lung cancers or lung metastases from extrapulmonary primaries. Patients with a more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment is rarely curative; rather, it seeks to retard tumor growth or palliate symptoms.

Pancreatic Cancer

Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults, and it is largely considered incurable. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However, the nature of the cancer is such that few tumors are found at such an early and potentially curable stage. Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment focuses on slowing tumor growth and palliation of symptoms.

Renal Tumors

Localized renal cell carcinoma is treated with radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule because chemotherapy is relatively ineffective against metastatic renal cell carcinoma.

Bone Cancer and Bone Metastases

Primary bone cancers are extremely rare, accounting for less than 0.2% of all cancers. Bone metastases are more common, with clinical complications including debilitating bone pain. Treatment for bone metastases is performed to relieve local bone pain, provide stabilization, and prevent impending fracture or spinal cord compression.

KEY POINTS:

The most recent literature search was performed through June 3, 2024.

Summary of Evidence

For individuals with early stage kidney cancer who are surgical candidates treated with cryoablation, the evidence includes comparative observational studies and systematic reviews. Relevant outcomes are overall survival (OS), disease-specific survival, quality of life, and treatment-related morbidity. Multiple comparative observational studies and systematic reviews of these studies have compared cryoablation to partial nephrectomy for early stage renal cancer. These studies have consistently found that partial nephrectomy is associated with better oncological outcomes than cryosurgery, but cryosurgery was associated with better perioperative outcomes, lower incidence of complications, and less decline in kidney function. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with early stage kidney cancer who are not surgical candidates and who are treated with cryoablation, the evidence includes comparative observational studies of cryoablation compared to partial nephrectomy or other ablative techniques, systematic reviews of these studies, and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Although oncological outcomes were better with surgery, in comparative observational studies, cryoablation was associated with less decline in kidney function. Recent case series totaling more than 400 patients showed cryoablation was associated with good oncological outcomes and preservation of renal function. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with non-small cell lung cancer (NSCLC) who are not surgical candidates, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Medically inoperable patients with early stage primary lung tumors were treated with cryoablation in a consecutive series of 45 patients. Five year survival was 68%; the main complications were hemoptypsis in 40% of patients and pneumothorax in 51%. A prospective single arm Phase 2 study of 128 patients reported on cryoablation for treatment of metastases to the lung. Cryoablation for metastatic lung cancer was studied in a single arm trial in 40 patients. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with NSCLC who require palliation for a central airway obstructing lesion who are treated with cryoablation, the evidence includes case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. There are no comparative studies. A series of 521 consecutive patients reported improvement in symptoms in 86% of patients, but multiple study design, conduct, and relevance limitations preclude drawing conclusions about efficacy or safety of cryoablation in this population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with solid tumors located in the breast, pancreas, or bone who are treated with cryoablation, the evidence includes uncontrolled observational studies and case series. Relevant outcomes are OS, disease-specific survival, quality of life, and treatment-related morbidity. Due to the lack of prospective controlled trials, it is not possible to conclude that cryoablation improves outcomes for any indication better than alternative treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Radiology

The American College of Radiology Appropriateness Criteria (2009, updated 2021) for post-treatment follow-up and active surveillance of renal cell carcinoma [RCC] indicated that "Ablative therapies, such as radiofrequency ablation, microwave ablation, and cryoablation, have been shown to be effective and safe alternatives [to surgical resection] for the treatment of small, localized RCCs." These recommendations are based on a review of the data and expert consensus.

American Urological Association

In 2021, the American Urological Association updated its guidelines on evaluation and management of clinically localized sporadic renal masses suspicious for renal cell carcinoma. The guideline statements on thermal ablation (radiofrequency ablation and cryoablation) are listed in Table 7.

Table 7. Guidelines on Localized Masses Suspicious for Renal Cell Carcinoma

Recommendations

LOR

LOE

Guideline statement 25

 

 

Clinicians should consider thermal ablation (TA) as an alternate approach for the management of cT1a renal masses <3 cm in size. For patients who elect TA, a percutaneous technique is preferred over a surgical approach whenever feasible to minimize morbidity.

Moderate

C

Guideline statement 26

 

 

Both radiofrequency ablation (RFA) and cryoablation may be offered as options for patients who elect thermal ablation

Conditional

C

Guideline statement 28

 

 

Counseling about thermal ablation should include information regarding an increased likelihood of tumor persistence or local recurrence after primary thermal ablation relative to surgical excision, which may be addressed with repeat ablation if further intervention is elected

Strong

B

LOE: level of evidence; LOR: level of recommendation.

National Comprehensive Cancer Network

Kidney Cancer

The National Comprehensive Network (NCCN) ( v.4.2024) guidelines on kidney cancer state that "thermal ablation (cryosurgery, radiofrequency ablation) is an option for the management of clinical stage T1 renal lesions. Thermal ablation is an option for clinical T1b masses in select patients not eligible for surgery. Biopsy of lesions is recommended to be done prior to or at time of ablation. Ablative techniques may require multiple treatments to achieve the same local oncologic outcomes as conventional surgery. The NCCN guidelines also note that "ablative techniques such as cryotherapy, microwave ablation, or radiofrequency ablation are alternative strategies for selected patients, particularly for those who are older, those with competing health risks and those with T1b masses not eligible for surgery." NCCN guidelines also note that "Randomized phase III comparison of ablative techniques with surgical resection (ie, radical or partial nephrectomy by open or laparoscopic techniques) has not been performed.

Non-Small Cell Lung Cancer

The NCCN (v. 5.2024) guidelines for NSCLC made the following relevant recommendations:

  • Resection is the preferred local treatment modality for medically operable disease.
  • Image-guided thermal ablation (IGTA) techniques include radiofrequency ablation, microwave ablation, and cryoablation.
  • IGTA may be an option for select patients not receiving stereotactic ablative radiotherapy or definitive radiotherapy.
  • IGTA may be considered for those patients who are deemed "high risk"- those with tumors that are for the most part surgically resectable but rendered medically inoperable due to comorbidities. In cases where IGTA is considered for high-risk or borderline operable patients, a multidisciplinary evaluation is recommended.
  • IGTA is an option for the management of NSCLC lesions <3 cm. Ablation for NSCLC lesions >3 cm may be associated with higher rates of local recurrence and complications.
  • The guidelines do not separate out recommendations by ablation technique and note that "each energy modality has advantages and disadvantages. Determination of energy modality to be used for ablation should take into consideration the size and location of the target tumor, risk of complication, as well as local expertise and/or operator familiarity."

Cancer Pain

The NCCN Guidelines on Adult Cancer Pain (v.2.2024) do not address cryoablation specifically for pain due to bone metastases, but note that "ablation techniques may...be helpful for pain management in patients who receive inadequate relief from pharmacological therapy.

U.S. Preventive Services Task Force Recommendations

Cryoablation/cryosurgery is not a preventive service.

KEY WORDS:

Renal cell carcinoma, RCC, cryoablation, cryosurgery, cryosurgical ablation, cryotherapy, breast cancer, pancreatic cancer, breast fibroadenoma, lung cancer, bone cancer, metastatic bone cancer, Cryocare Surgical System, CryoGen Cryosurgical System, CryoHit, SeedNet System, Visica, IceSense2, IceSense3, ablation, fibroadenoma, breast ablation, breast cryoablation, pulmonary tumors, lung cancer, cryoablation of pulmonary tumor, cryoablation of lung tumor, desmoid tumors

APPROVED BY GOVERNING BODIES:

Several cryoablation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use in open, minimally invasive or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, thoracic surgery and ear; nose; and throat. Examples include:

  • Cryocare® Surgical System by Endocare; 
  • CryoGen Cryosurgical System by Cryosurgical, Inc.;
  • CryoHit® by Galil Medical for the treatment of breast fibroadenoma;
  • IceSense3™, ProSense™, and MultiSense Systems (IceCure Medical);
  • SeedNet™ System by Galil Medical; and
  • Visica® System by Sanarus Medical.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT codes:

19105

Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma

19499

Unlisted procedure, breast

20983

Ablation therapy for reduction or eradication of 1 or more bone tumors (e.g., metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation

32994

Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; cryoablation

48999

Unlisted procedure, pancreas

50250

Ablation, open, one or more renal mass lesion(s), cryosurgical, including intra-operative ultrasound guidance and monitoring, if performed

50542

Laparoscopy, surgical; ablation of renal mass lesion(s), including intra-operative ultrasound guidance and monitoring, when performed

50593

Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy

0581T

Ablation, malignant breast tumor(s), percutaneous, cryotherapy, including imaging guidance when performed,  unilateral

 

REFERENCES:

  1. American College of Radiology (ACR). ACR Appropriateness Criteria: Post-treatment follow-up and active surveillance of clinically localized renal cell carcinoma. Updated 2021. https://acsearch.acr.org/docs/69365/Narrative/.
  2. American Society of Breast Surgeons.  Official Statements:  Position Statement on Ablative and Percutaneous Treatment of Breast Cancer. www.breastsurgeons.org. 
  3. American Society of Breast Surgeons. Consensus Statement: Management of Fibroadenomas of the Breast. Revised, April 29, 2008. Available online at: www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/Fibroadenoma.pdf
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  5. Atkins Michael B and Richie Jerome P.  Surgical management of renal cell carcinoma. www.uptodate.com.
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  7. Callstrom MR and Kurup AN. Percutaneous ablation for bone and soft tissue metastases-why cryoablation? Skeletal Radiology 2009; 38: 835-839.
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  17. Golatta M, Harcos A, Pavlista D et al. Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial. Arch Gynecol Obstet, June 2015, 291(6): 1355-1360.
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  19. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  20. Jennings JW, Prologo JD, Garnon J, et al. Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study. Radiol Imaging Cancer. Mar 2021; 3(2): e200101.
  21. Keane MG, Bramis K, Pereira SP et al. Systematic review of novel ablative methods in locally advanced pancreatic cancer. World J Gastroenterol Mar 07 2014; 20(9):2267-78.
  22. Klatte T, Grubmuller B, Waldert M et al. Laparoscopic cryoablation versus partial nephrectomy for the treatment of small renal masses: systematic review and cumulative analysis of observational studies. Eur Urol 2011; 60(3):435-43.
  23. Klatte T, Shariat SF, Remzi M. Systematic review and meta-analysis of perioperative and oncologic outcomes of laparoscopic cryoablation versus laparoscopic partial nephrectomy for the treatment of small renal tumors. J Urol May 2014; 191(5):1209-17.
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  26. Li J, Chen X, Yang H et al. Tumour cryoablation combined with palliative bypass surgery in the treatment of unresectable pancreatic cancer: a retrospective study of 142 patients. Postgrad Med J Feb 2011; 87(1024):89-95.
  27. Lim E, Kumar S, Seager M, et al. Outcomes of Renal Tumors Treated by Image-Guided Percutaneous Cryoablation: Immediate and 3- and 5-Year Outcomes at a Regional Center. AJR Am J Roentgenol. Apr 14 2020: 1-6.
  28. Long CJ, Kutikov A, Canter DJ et al. Percutaneous vs surgical cryoablation of the small renal mass: is efficacy compromised? BJU Int 2011; 107(9):1376-80.
  29. Manenti G, Perretta T, Gaspari E et al. Percutaneous local ablation of unifocal subclinical breast cancer: clinical experience and preliminary results of cryotherapy. Eur Radiol Nov 2011; 21(11):2344-53.
  30. Martin J, Athreya S. Meta-analysis of cryoablation versus microwave ablation for small renal masses: is there a difference in outcome? Diagn Interv Radiol 2013; 19(6):501-7.
  31. Moore W, Talati R, Bhattacharji P, et al. Five-year survival after cryoablation of stage I non-small cell lung cancer in medically inoperable patients. J Vasc Interv Radiol. Mar 2015; 26(3):312-319.
  32. Morkos J, Porosnicu Rodriguez KA, Zhou A, 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. Aug 2020; 296(2): 452-459.
  33. Murray CA, Welch BT, Schmit GD, et al. Safety and Efficacy of Percutaneous Image-guided Cryoablation of Completely Endophytic Renal Masses. Urology. Nov 2019; 133: 151-156.
  34. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 4.2024. www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. 
  35. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 5.2024. www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. 
  36. National Comprehensive Cancer Network. Adult Cancer Pain. Version 2. 2024. www.nccn.org/professionals/physician_gls/pdf/pain.pdf. 
  37. National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma (V2.2018). Available online at: www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. 
  38. National Comprehensive Cancer Network® (NCCN). NCCN Clinical Practice Guidelines in Oncology. Breast Cancer (V.2.2019). Available online at: www.nccn.org/professionals/physician_gls/pdf/breast.pdf. 
  39. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology: Bone Cancer. (V.2.2019). Available online at: www.nccn.org/professionals/physician_gls/pdf/bone.pdf. 
  40. Niu L, Mu F, Zhang C et al. Cryotherapy protocols for metastatic breast cancer after failure of radical surgery. Cryobiology Aug 2013; 67(1): 17-22.
  41. Niu L, Xu K, Mu F. Cryosurgery for lung cancer. J Thorac Dis Aug 2012; 4(4):408-19.
  42. Pecoraro A, Palumbo C, Knipper S, et al. Cryoablation Predisposes to Higher Cancer Specific Mortality Relative to Partial Nephrectomy in Patients with Nonmetastatic pT1b Kidney Cancer. J Urol. Dec 2019; 202(6): 1120-1126.
  43. Pessoa RR, Autorino R, Laguna MP, et al. Laparoscopic versus percutaneous cryoablation of small renal mass: systematic review and cumulative analysis of comparative studies. Clin Genitourin Cancer. Oct 2017; 15(5):513-519 e515.
  44. Purysko AS, Nikolaidis P, Khatri G, et al. ACR Appropriateness Criteria® Post-Treatment Follow-up and Active Surveillance of Clinically Localized Renal Cell Carcinoma: 2021 Update. J Am Coll Radiol. May 2022; 19(5S): S156-S174.
  45. Purysko AS, Nikolaidis P, Dogra VS, et al. ACR Appropriateness Criteria(R) Post-Treatment Follow-up and Active Surveillance of Clinically Localized Renal Cell Cancer. J Am Coll Radiol. Nov 2019; 16(11S): S399-S416.
  46. Ratko TA, Vats V, Brock J et al. Local Nonsurgical Therapies for Stage I and Symptomatic Obstructive Non-Small-Cell Lung Cancer. Rockville, MD: Agency for Healthcare Research and Quality, 2013.
  47. Rembeyo G, Correas JM, Jantzen R, et al. Percutaneous Ablation Versus Robotic Partial Nephrectomy in the Treatment of cT1b Renal Tumors: Oncologic and Functional Outcomes of a Propensity Score-weighted Analysis. Clin Genitourin Cancer. Apr 2020; 18(2): 138-147.
  48. Rodriguez R, Cizman Z, Hong K. Prospective analysis of the safety and efficacy of percutaneous cryoablation for pT1NxMx biopsy-proven renal cell carcinoma. Cardiovasc Intervent Radiol 2011; 34(3):573-8.
  49. Sewell Patrick E and Shingleton W Bruce. Percutaneous renal tumor cryoablation with magnetic resonance imaging guidance. GE Healthcare-Clinical Case Studies.  www.gehealthcare.com.
  50. Simmons RM, Ballman KV, Cox C, et al. A phase II trial exploring the success of cryoablation therapy in the treatment of invasive breast carcinoma: results from ACOSOG (Alliance) Z1072. Ann Surg Oncol. Aug 2016; 23(8): 2438-45.
  51. Stacul F, Sachs C, Giudici F, et al. Cryoablation of renal tumors: long-term follow-up from a multicenter experience. Abdom Radiol (NY). Sep 2021; 46(9): 4476-4488.
  52. Strom KH, Derweesh I, Stroup SP et al. Second prize: recurrence rates after percutaneous and laparoscopic renal cryoablation of small renal masses: does the approach make a difference? J Endourol 2011; 25(3):371-5.
  53. Tang K, Yao W, Li H et al. Laparoscopic Renal Cryoablation versus Laparoscopic Partial Nephrectomy for the Treatment of Small Renal Masses: A Systematic Review and Meta-analysis of Comparative Studies. J Laparoendosc Adv Surg Tech A Jun 2014; 24(6):403-10.
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  57. Wu J, Chang J, Bai HX, et al. A Comparison of Cryoablation with Heat-Based Thermal Ablation for Treatment of Clinical T1a Renal Cell Carcinoma: A National Cancer Database Study. J Vasc Interv Radiol. Jul 2019; 30(7): 1027-1033.e3.
  58. Yanagisawa T, Mori K, Kawada T, et al. Differential efficacy of ablation therapy versus partial nephrectomy between clinical T1a and T1b renal tumors: A systematic review and meta-analysis. Urol Oncol. Jul 2022; 40(7): 315-330.
  59. Yan S, Yang W, Zhu CM, 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). May 2019; 98(21): e15610.
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POLICY HISTORY:

Medical Policy Group, January 2004 (from MP# 149)

Medical Policy Administration Committee, February 2004 (from MP# 149)

Available for comment February 7-March 22, 2004 (from MP# 149)

Medical Policy Group, January 2006 (1): (from MP# 149)

Medical Policy Group, October 2007 (3): (from MP# 149)

Medical Policy Administration Committee, November 2007 (from MP# 149)

Available for comment November 17-December 31, 2007 (from MP# 149)

Medical Policy Group, March 2009 (1): (from MP# 149)

Medical Policy Administration Committee, April 2009 (from MP# 149)

Medical Policy Group, October 2009 (3): (from MP# 149)

Medical Policy Administration Committee, November 2009 (from MP# 149)

Available for comment November 6-December 21, 2009 (from MP# 149)

Medical Policy Group, June 2010 (1)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medical Policy Group, November 2010 CPT Code update

Medical Policy Group, March 2011; Reference added to Policy section (from MP# 149)

Medical Policy Administration Committee, March 2011 (from MP# 149)

Available for comment April 4 – May 18, 2011 (from MP# 149)

Medical Policy Group, July 2011 (1): Update to Key Points, Approved by Governing Bodies and References; Key Points reformatted

Medical Policy Panel, July 2012

Medical Policy Group, April 2013 (1): Update to policy with addition of lung cancer to non-covered/investigational indications; update to Key Points and References; policies #236 and #294 removed due to duplicate information that is contained and maintained on this policy

Medical Policy Administration Committee, April 2013

Available for comment April 18 through June 5, 2013

Medical Policy Panel, July 2013

Medical Policy Group, September 2013 (1): Update to Policy statement with addition of “other metastases” to investigational section, other policy statements unchanged; update to Key Points and References

Medical Policy Administration Committee, October 2013

Available for comment September 24 through November 7, 2013

Medical Policy Group, December 2013 (1): 2014 Coding Update: added new code 0340T, effective 01/01/2014

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (1): Policy statement criteria consolidated in more current concise verbiage; update to Key Points and References; no change in intent or coverage of policy statement

Medical Policy Group, November 2014: 2015 Annual Coding update; added CPT 20983(from MP# 149)

Medical Policy Group, February 2015 (4):  Information was taken from MP# 149- Ablation of Bone Tumors and added to Description, Policy, Key Points, Key Words, Coding and References.  Policy statement from MP# 149 (CSA bone mets) struck through and updated statement added, however intent of statement unchanged from MP# 149; MP# 149 archived.

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (4): Updates to Description, Key Points, Key Words and References.  No change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4): Updates to Key points, Key Words, and References.  No change to policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, November 2017 (4): Updates to Key Points, Coding, Policy section and References.  Policy statement updated to add Coverage for pulmonary tumors with criteria. All other policy statements unchanged. Created Previous Coding section and moved 0340T from current coding to previous coding; added code 32994 to current coding section effective 1/1/18.

Medical Policy Administration Committee, December 2017

Available for comment November 30, 2017 through January 13, 2018

Medical Policy Panel, July 2018

Medical Policy Group, August 2018 (4): Updates to Description, Key Points, and References.  No change to policy statement.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (4): Updates to Description, Key Points, and References. No change to policy statement.

Medical Policy Group, December 2019: 2020 Annual Coding Update.  Added new CPT code 0581T to Current Coding.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (5): Updates to Approved by Governing Bodies, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, July 2021

Medical Policy Group, July 2021 (5): Updates to Title, Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to align with the separation of indications by tumor location, no change to policy intent. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, September 2021 (5): Minor update to Key Words. Policy statement updated for clarification of investigational statement with no change to policy intent. Desmoid tumors were previously non-covered per Investigational Criteria Policy #495.

Medical Policy Group, January 2022 (5): Policy Title changed from “Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone,” to “Cryoablation of Tumors (Excluding Liver or Prostate Tumors) for clarity.” No change in policy statement, or intent.

Medical Policy Panel, July 2022

Medical Policy Group, July 2022 (5): Updates to Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to replace the word “patients” with the word “individuals.” No change to policy intent.

Medical Policy Panel, July 2023

Medical Policy Group, July 2023 (11): Updates to Key Points, Approved by Governing Bodies, Benefit Application, and References. No change in policy statement.

Medical Policy Panel, July 2024

Medical Policy Group, July 2024 (11): Updates to Key Points, and References. No change in policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.