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Date Printed: August 23, 2017: 01:24 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative 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.

04-77260-21

Original Effective Date: 11/15/10

Reviewed: 10/19/16

Revised: 11/15/16

Subject: Selective Internal Radiation Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Selective internal radiation therapy (SIRT) also referred to as intrahepatic radioembolization is the intra-arterial delivery of small beads (microspheres) impregnated with yttrium-90 via the hepatic artery. SIRT is performed by threading a catheter from the groin into the hepatic artery. Radioactive isotopes containing yttrium-90 are delivered to the liver tumor through a catheter placed into the hepatic artery emitting localized radiation therapy. This therapy is proposed as a treatment for both primary and metastatic liver tumors.

The Food and Drug Administration (FDA) has approved two commercial forms of 90Y microspheres; TheraSphere® (MDS Nordion) and SIR-Spheres® (Sirtex Medical). TheraSphere® are glass microspheres, indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. TheraSphere® was approved by the FDA under Humanitarian Device Exemption. SIR-Spheres® are resin microspheres, indicated for the treatment of unresectable metastatic liver tumors from primary colorectal with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).

POSITION STATEMENT:

Selective internal radiation therapy (SIRT) with an FDA approved microsphere meets the definition of medical necessity for the following:

Selective internal radiation therapy is considered experimental or investigational for all other indications, due to insufficient evidence to support conclusions regarding the effect of selective internal radiation therapy on health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT code which specifically describes selective internal radiation therapy.

The following HCPCS code may be used to describe selective internal radiation therapy.

HCPCS Code:

S2095

Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C18.0 – C18.9

Malignant neoplasm of colon

C22.0

Liver cell carcinoma

C22.2

Hepatoblastoma

C22.3

Angiosarcoma of liver

C22.4

Other sarcomas of liver

C22.7

Other specified carcinomas of liver

C22.8

Malignant neoplasm of liver, primary, unspecified as to type

C7B.02

Secondary carcinoid tumors of liver

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, plan of treatment and reason for selective internal radiation therapy.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Plan of treatment

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Humanitarian Device Exemption (HDE) a Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. An approved HDE authorizes marketing of the HUD. An HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of the HUD and after the IRB has approved the use of the device to treat or diagnose the specific disease (FDA , 2010).

RELATED GUIDELINES:

Brachytherapy-Oncologic Applications, 04-777260-20
Intravascular Brachytherapy for Prevention and Management of Restenosis after Percutaneous Transluminal Angioplasty (PTA), 04-77260-14

OTHER:

Other names used to report selective internal radiation therapy:

Intra-arterial brachytherapy
Radioembolization (RE)
Selective Internal Radiation
Transarterial embolization (TARE)

REFERENCES:

  1. ACR-SIR Practice Guideline for Radioembolization with Microsphere Brachytherapy Device (RMBD) for Treatment of Liver Malignancies, 2014.
  2. Al-Adra DP, Gill RS, Axford SJ et al. Treatment of unresectable intrahepatic cholangiocarcinoma with yttrium-90 radioembolization: a systematic review and pooled analysis. European Journal of surgical Oncology 2015; 41(1): 120-7.
  3. Atassi B, Bangash AK, Bahrani A et al. Multimodality imaging following 90Y radioembolization: a comprehensive review and pictorial essay. Radiographics 2008; 28(1): 81-99.
  4. Bangash AK, Atassi B, Kaklamani V et al. 90 Y radioembolization of metastatic breast cancer to the liver: toxicity, imaging response, survival. Journal of Vascular Interventional Radiology 2007; 18(5):621-628.
  5. Blue Cross Blue Shield Association Medical Policy Reference Manual Radioembolization for Primary and Metastatic Tumors of the Liver (8.01.43), 07/16.
  6. Cao CQ, Yan TD, Bester L et al. Radioembolization with yttrium microspheres for neuroendocrine tumour liver metastases. British Journal of Surgery 2010; 97(4): 537-543.
  7. Coldwell DM, Kennedy AS, Nutting CW. Use of yttrium-90 microspheres in the treatment of unresectable hepatic metastases from breast cancer. International Journal of Radiation Oncology, Biology, Physics 2007; 69(3): 800-804.
  8. Coldwell D, Kennedy A, Sangro et al. Integrating radioembolisation into current treatment options for liver tumors: an international working group report. American Journal of Clinical Oncology 2012; 35(1): 81-90.
  9. Dancey JE, Shepard FA, Paul K et al. Treatment of nonresectable hepatocellular carcinoma with intrahepatic 90Y-microspheres. Journal of Nuclear Medicine 2000; 41(10): 1673-1681.
  10. Devicic Z, Rosenberg J, Braat AJ et al. The efficacy of hepatic 90Y resin radioembolization for metastatic neuroendocrine tumors: a meta-analysis. Journal of Nuclear Medicine 2014; 55(9): 1404-1410.
  11. Duke E, Deng J, Ibrahim SM et al. Agreement between competing imaging measures of response of hepatocellular carcinoma to yttrium-90 radioembolization. Journal of Vascular Interventional Radiology 2010; 21(4): 515-512.
  12. ECRI Emerging Technology Evidence Report: Intrahepatic Yttrium-90 Microsphere Therapy for Primary Unresectable Liver Cancer, 02/06/12.
  13. Engelman ES, Leon-Ferre R, Naraev BG et al. Comparison of transarterial liver-directed therapies for low-grade metastatic neuroendocrine tumors in a single institution. Pancreas 2014; 43(2): 219-25.
  14. Gonsalves CF, Eschelman DJ, Sullivan KL et al. Radioembolization as Salvage therapy for hepatic metastasis of uveal melanoma: a single-institution experience. Vascular and Interventional radiology 2011; 196(2): 468-473.
  15. Gray B, Van Hazel G, Hope M et al. Randomised trial of SIR-Spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer. Annals of Oncology 2001; 12(12): 1711-1720.
  16. Herba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Seminars in Oncology 2002; 29(2): 152-159.
  17. Hendlisz A, Van den Eynde M, Peeters M et al. Phase III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. Journal of Clinical Oncology 2010; 28(32): 3687-3694.
  18. Hoffmann RT, Jakobs TF, Kubisch CH et al. Radiofrequency ablation after selective internal radiation therapy with Yttrium90 microspheres in metastatic liver disease-is it feasible? European Journal of Radiology 2010; 94(1): 199-205.
  19. Ibrahim SM, Lewandowski RJ, Sato KT et al. Radioembolization for the treatment of unresectable hepatocellular carcinoma: a clinical review. Worl Journal of Gastroenterology 2008; 14(11): 1664-1669.
  20. Ibrahim SM, Mulcahy MF, Lewandowski RJ et al. Treatment of unresectable cholangiocarcinoma using yttrium-90 microspheres: results from a pilot study. Cancer 2008; 113(8): 2119-2128.
  21. Jakobs TF, Hoffmann RT, Fischer T et al. Radioembolization in patients with hepatic metastases from breast cancer. Journal of Vascular and interventional Radiology 2008; 19(5): 683-690.
  22. Kennedy AS, Dezarn WA, McNeillie P et al. Radioembolization for unresectable neuroendocrine hepatic metastases using resin 90Y-microspheres: early results in 148 patients. American Journal of Clinical Oncology 2008; 31(3):271-279.
  23. Kennedy A, Nag S, Salem R et al. Recommendations for radioembolization of hepatic malignancies using yttrium-90 microsphere brachytherapy: a consensus panel report from the radioembolization brachytherapy oncology consortium. International Journal of Radiation Oncology, Biology, Physics 2007; 68(1): 13-23.
  24. Kennedy AS, Salem R. Radioembolization (yttrium-90 microspheres) for primary and metastatic hepatic malignancies. Cancer Journal 2010; 16(2): 163-175.
  25. King J, Quinn R, Glenn DM et al. Radioembolization with selective internal radiation microspheres for neuroendocrine liver metastases. Cancer 2008; 113(5): 921-929.
  26. Kulik LM, Carr BI, Mulcahy MF et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology 2008; 47(1): 71-81.
  27. Lewandowski RJ, Kulik LM, Riaz A et al. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. American Journal of Transplantation 2009; 9(8): 1920-1928.
  28. Lim L, Gibbs P, Yip D et al. Prospective study of treatment with selective internal radiation therapy spheres in patients with unresectable primary or secondary hepatic malignancies. Internal Medicine Journal 2005; 35(4); 222-227.
  29. Mulcahy MF, Lewandowski RJ, Ibrahim SM et al. Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres. Cancer 2009; 115(8): 1849-1858.
  30. Murthy R, Kamat P, Nunez R et al. Radioembolization of yttrium-90 microspheres for hepatic malignancy. Seminars in Interventional Radiology 2008; 25(1): 48-57.
  31. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. Version 2.2016.
  32. National Institute for Health and Care Excellence (NICE) Selective Internal Radiation Therapy for Primary Hepatocellular Carcinoma (IPG460), July 2013.
  33. Oladeru OT, Miccio JA, Yang J, et al. Conformal external beam radiation or selective internal radiation therapy-a comparison of treatment outcomes for hepatocellular carcinoma. Journal of Gastrointestinal Oncology 2016; 7(3):433-440.
  34. Pitton MB, Kloeckner R, Ruckes C et al. Randomized comparison of selective internal radiotherapy (SIRT) versus drug-eluting bead transarterial chemoembolization (DEB-TACE) for the treatment of hepatocellular carcinoma. Cardiovascular and Interventional Radiology 2015; 38(2): 352-360.
  35. Popperl G, Helmberger T, Munzing W et al. Selective internal radiation therapy with SIR-Spheres® in patients with nonresectable liver tumors. Cancer Biotherapy & Radiopharmaceuticals 2005; 20(2): 200-208.
  36. Rhee TK, Lewandowski RJ, Liu DM et al. 90Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Annals of Surgery 2008; 247(6): 1029-1035.
  37. Rubin D, Nutting C, Jones B. Radioembolization with yttrium microspheres for neuroendocrine tumour liver metastases. British Journal of Surgery 2004; 97(4): 537-543.
  38. Salem R, Lewandowski RJ, Mulcahy MF et al. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology 2010; 138(1): 52-64.
  39. Sato KT, Lewandowski RJ, Mulcahy MF et al. Unresectable chemorefractory liver metastases: radioembolization with 90Y microspheres—safety, efficacy, and survival. Radiology 2008; 247(2): 507-515.
  40. Shah RP, Brown KT, Sofocleous CT. Arterially directed therapies for hepatocellular carcinoma. American Journal of Roentgenology 2011; 197(4): W590-W602.
  41. Sharma RA, Van Hazel GA Morgan B et al. Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy. Journal of Clinical Oncology 2007; 25(9): 1099-1106.
  42. Society of Interventional Radiology Fact Sheet: Interventional Radiology Treatments for Liver Cancer Minimally Invasive Treatments Help Cancer Patients Extend Life and Improve Quality, 11/04.
  43. Stuart, Tan B, Myerson RJ et al. Salvage radioembolization of liver-dominant metastases with a resin-based microsphere: initial outcomes 2008; 19(10): 1427-1433.
  44. Stubbs RS, Cannan RJ, Mitchell AW. Selective internal radiation therapy with 90yttrium microspheres for extensive colorectal liver metastases. Journal of Gastrointestinal Surgery 2001; 5(3): 294-302.
  45. Stubbs RS, Wickremesekera SK. Selective internal radiation therapy (SIRT): a new modality for treating patients with colorectal liver metastases. Journal of the International Hepto Pancreato Biliary Association 2004; 6(3): 133-139.
  46. Tice JA. Selective internal radiation therapy or radioembolization for inoperable liver metastases from colorectal cancer. California Technology Assessment Forum. 02/17/10.
  47. Townsend A, Price T, Karapetis C. Selective internal radiation therapy for liver metastases from colorectal cancer. Cochrane Database Systematic Reviews 2009 Oct 7; (4): CD007045.
  48. van Hazel GA, Heinemann V, Sharma NK, et al. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. May 20 2016;34(15):1723-1731.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/19/16.

GUIDELINE UPDATE INFORMATION:

11/15/10

New Medical Coverage Guideline.

10/01/11

Revision; formatting changes.

12/15/11

Updated position statement; add “In primary hepatocellular carcinoma as a bridge to liver transplantation”, “To treat hepatic metastases from neuroendocrine tumors (carcinoid and noncarcinoid) with diffuse and symptomatic disease when systemic therapy (e.g., chemotherapy) has failed to control symptoms”. Revised experimental or investigational statement; remove “including but not limited to when used as a bridge to transplantation”. Added ICD-9 diagnosis code 209.72 and ICD-10 diagnosis code C7b.02 and C78.7. Updated references.

09/15/12

Scheduled review; position statements maintained and references updated.

05/15/14

Scheduled review; position statements maintained and references updated.

09/15/15

Annual review; added position statement for primary intrahepatic cholangiocarcinoma, unresectable hepatic metastases from liver predominant melanoma (ocular or cutaneous) and unresectable hepatic metastases from liver predominant breast cancer. Added ICD-9 code 197.7. Updated references.

10/01/15

Revision; updated ICD9 and ICD10 coding section.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/16

Revision; no change to position statement. Updated references.

Date Printed: August 23, 2017: 01:24 PM