|
Medical Policy: 06.01.23
Original Effective Date: October 2006
Reviewed: August 2011
Revised: August 2010
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Hepatic tumors can arise either as primary liver cancer or by metastasis to the liver from other tissues or organs. Local therapy for hepatic metastasis is indicated only when there is no extrahepatic disease, which rarely occurs for patients with primary cancers other than colorectal carcinoma (CRC) or certain neuroendocrine malignancies. At present, surgical resection with tumor-free margins and liver transplantation are the only potentially curative treatments. For liver metastases from CRC, randomized trials have reported that post-surgical adjuvant chemotherapy administered systemically or via the hepatic artery decreases recurrence rates and increases time to recurrence.
Unfortunately, most hepatic tumors are unresectable at diagnosis, due either to their anatomic location, size, number of lesions, concurrent nonmalignant liver disease, or insufficient hepatic reserve. Palliative chemotherapy by combined systemic and hepatic artery infusion (HAI) may increase disease-free intervals for patients with unresectable hepatic metastases from CRC. However, durable responses to chemotherapy are less likely for patients with unresectable primary hepatocellular cancer (HCC).
Radioembolization (sometimes referred to as SIRT [selective internal radiation therapy]) is the intra-arterial delivery of small beads (microspheres) impregnated with yttrium-90 (90Y) via the hepatic artery. The microspheres, which become permanently embedded, are delivered to the tumor preferentially to normal liver tissue, as the hepatic circulation is uniquely organized, whereby tumors greater than 0.5cm rely on the hepatic artery for blood supply while normal liver is primarily perfused cia the portal vein. 90Y is a pure beta-emitter with a relatively limited effective range and short half-life that helps focus the radiation and minimize its spread.
Candidates for radioembolization are initially examined with liver angiography and technetium lung scan to rule out aberrant hepatic vasculature or significant lung shunting that would permit diffusion of injected microspheres.
There are currently two commercial forms of 90Y microspheres available. The U.S. Food and Drug Administration (FDA) granted premarket approval of SIR-Spheres® for use in combination with 5-floxuridine chemotherapy by hepatic artery infusion to treat unresectable hepatic metastases from colorectal cancer. TheraSpheres® has an FDA humanitarian device exemption for use as monotherapy to treat unresectable HCC.
 Top
Prior Approval:
Not applicable
Top
Policy:
Radioembolization may be considered medically necessary to treat unresectable primary hepatocellular carcinoma that is limited to the liver.
Radioembolization may be considered medically necessary to treat unresectable hepatic metastases from colorectal cancer.
Radioembolization may be considered medically necessary to treat hepatic metastases from neuroendocrine tumors (carcinoid and non carcinoid) with diffuse and symptomatic disease when systemic therapy has failed to control symptoms.
Radioembolization may be considered medically necessary in primary hepatocellular carcinoma as a bridge to liver transplantation.
Radioembolization may be considered medically necessary in primary hepatocellular carcinoma as a bridge to liver transplantation.
Top
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- S2095 Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using ytrrium-90 microspheres.
- 37204 Transcatheter occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, non-central nervous system, non-head or neck
- 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation
Top
Selected References:
- Dancey JE, Shepherd FA, et al. Treatment of nonresectable hepatocellular carcinoma with intrahepatic 90Y-microspheres. J Nucl Med. 2000 Oct;41(10):1673-81.
- Moroz P, Anderson JE, et al. Effect of selective internal radiation therapy and hepatic arterial chemotherapy on normal liver volume and spleen volume. J Surg Oncol. 2001 Dec;78(4):248-52.
- Lim L, Gibbs P, et al. A prospective evaluation of treatment with Selective Internal Radiation Therapy (SIR-spheres) in patients with unresectable liver metastases from colorectal cancer previously treated with 5-FU based chemotherapy. BMC Cancer. 2005 Oct 15;5:132.
- Steel J, Baum A, Carr B. Quality of life in patients diagnosed with primary hepatocellular carcinoma: hepatic arterial infusion of Cisplatin versus 90-Yttrium microspheres (Therasphere). Psycho-Oncology. 2004 Feb;13(2):73-9.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; June 2006; Target Report 828. Intrahepatic yttrium-90 microsphere therapy for primary liver cancer. Available: http://www.ecri.org.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; June 2006; Target Report 828. Intrahepatic yttrium-90 microsphere therapy for primary liver cancer. Available: http://www.ecri.org.
- Vente MA, Wondergem M, van der Tweel I et al. Yttrium-90 microsphere radioembolization for the treatment of liver malignancies: a structured meta-analysis. Eur Radiol. 2009 Apr;19(4):951-9. Epub 2008 Nov 7.
- Stuart JE, Tan B, Myerson RJ et al. Salvage radioembolization of liver-dominant metastases with a resin-based microsphere: initial outcomes. J Vasc Interv Radiol. 2008 Oct; 19(10):1427-33. Epub 2008 Aug 27.
- King J, Quinn R, Glenn DM et al. Radioembolization with selective internal radiation microspheres for neuroendocrine liver metastases. Cancer. 2008 Sep 1; 113(5):921-9.
- Jakobs TF, Hoffmann RT, Dehm K et al. Hepatic yttrium-90 radioembolization of chemotherapy-refractory colorectal cancer liver metastases. J Vasc Interv Radiol. 2008 Aug; 19(8):1187-95. Epub 2008 Jun 27.
- Sato KT, Lewandowski RJ, Mulcahy MF et al. Unresectable chemorefractory liver metastases: radioembolization with 90 Y microspheres—safety, efficacy, and survival. Radiology. 2008 May; 247(2):507-15. Epub 2008 Mar 18.
- Kulik LM, Carr BI, Mucahy MF et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology. 2008 Jan; 47(1):71-81.
- Carr BI, Kondragunta V, Buch SC et al. Therapeutic equivalence in survival for hepatic arterial chemoembolization and yttrium 90 microspheres treatments in unresectable hepatocellular carcinoma. A two cohort study. Cancer 2010; 116(5):1305-14.
- 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.
- 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.
- 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.
- 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. J Clin Oncol Aug 10, 2010; 28(23): 3687-94.
Top
Policy History:
Date Reason Action
August 2010 New literature Policy revised
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
|
 |
