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Intensity-Modulated Radiation Therapy (Imrt) Hs-094

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Intensity-Modulated Radiation Therapy (Imrt) Hs-094 INTENSITY-MODULATED RADIATION THERAPY (IMRT) HS-094 Easy Choice Health Plan, Inc. Exactus Pharmacy Solutions, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Incorporated WellCare Health Insurance of Arizona, Inc., operating in Hawai‘i as ‘Ohana Health Plan, Inc. WellCare of Kentucky, Inc. WellCare Health Plans of Kentucky, Inc. WellCare Health Plans of New Jersey, Inc. WellCare of Connecticut, Inc. WellCare of Florida, Inc., operating in Florida as Staywell Intensity-Modulated WellCare of Georgia, Inc. Radiation Therapy WellCare of Louisiana, Inc. Policy Number: HS-094 WellCare of New York, Inc. WellCare of South Carolina, Inc. Original Effective Date: 4/2/2009 WellCare of Texas, Inc. Revised Date(s): 4/30/2010; 4/30/2011; WellCare Prescription Insurance, Inc. 4/5/2012; 4/11/2013; 3/6/2014; 3/5/2015; Windsor Health Plan, Inc. 3/3/2016 APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Clinical Coverage Guideline page 1 Original Effective Date: 4/2/2009 - Revised: 4/30/2010, 4/30/2011, 4/5/2012, 4/11/2013, 3/6/2014, 3/5/2015, 3/3/2016 INTENSITY-MODULATED RADIATION THERAPY (IMRT) HS-094 DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com – select the Provider tab, then “Tools” and “Clinical Guidelines”. BACKGROUND Intensity-modulated radiation therapy (IMRT) is a specialized form of external beam radiation treatment that allows clinicians to shape radiation doses to more closely match the contours of a tumor. By precisely targeting only the cancerous tissue, clinicians may be able to apply much higher radiation doses to tumors while minimizing unnecessary radiation of surrounding normal tissues. Larger, precisely targeted radiation doses may result in better local control with fewer side effects. IMRT should be distinguished from conformal radiotherapy. Conformal radiotherapy uses computed tomography (CT)-based treatment planning to construct a precise target and more focused (conformal) delivery of radiation dose. Three-dimensional conformal radiation therapy (3D-CRT) systems are intended to permit higher radiation dosing of tumor tissue, limit dosing of normal tissue, and ultimately improve local control of radiation exposure. IMRT involves adjusting the beam-intensity to permit even more conformal dose distributions. In IMRT, the intensity of the radiation exposure in one portion of the field is modified depending on whether tumor or normal tissue is present in the beam pathway. To do this IMRT divides the beam into multiple beamlets. When the beamlet hits normal tissues, the intensity is lowered, and when the beamlet hits tumor, the intensity is higher. The changing of beam intensity is computer controlled. Conformal radiotherapy does not allow for this type of beam adjustment. The first step in IMRT is treatment planning using computed tomography and magnetic resonance imaging to produce a model of the tumor. The patient is immobilized during scanning and treatment, often with a custom-fitted plastic mask. Using computer software, the radiation oncologist and medical physicist develop a plan to deliver the desired amount of radiation to the tumor. The treatment step involves the delivery of a radiation beam produced by a linear accelerator and modified by the computerized MLC as the whole unit is moved around the patient’s head. The total dose is delivered in small daily amounts (fractions) over 15 to 30 minutes, 5 days a week, for 2 to 6 weeks. Treatment is given in a hospital radiation oncology outpatient unit. The oncology team includes the radiation oncologist, medical physicist, dosimetrist, radiation therapist, and oncology nurses. The decision process for using IMRT requires an understanding of accepted practices that take into account the risks and benefits of such therapy compared to conventional treatment techniques. While IMRT technology may empirically offer advances over conventional or three-dimensional conformal radiation, a comprehensive understanding of all consequences is required before applying this technology. IMRT is not a replacement therapy for conventional radiation therapy methods. Medicare will consider IMRT reasonable and necessary in 1,2,3,4,5 instances where sparing the surrounding normal tissue is essential. Accelerated Partial Breast Irradiation (APBI) Accelerated partial breast irradiation (APBI) is a type of radiation therapy used in patients with early-stage breast cancer who have undergone breast-conserving surgery. With APBI, only the lumpectomy bed plus a 1- to 2- centimeter (cm) margin receives irradiation, generally consisting of daily doses > 2 grays (GY) delivered in < 5 weeks. The goal of APBI is to allow treatment to be accomplished in a shorter period of time through greater radiation fraction size and reduced target volume. 3D-CRT is the most recently developed technique for delivery of APBI. In the most widely used 3D-CRT approach, first described by investigators at the William Beaumont Hospital, patients lie in the supine position with the ipsilateral arm elevated and undergo scanning by computed tomography (CT). Some researchers have used prone positioning of the patient to minimize target tissue movement during breathing and to enable greater sparing of heart and lung tissue; however, the prone position requires the use of a special immobilization device and is uncomfortable for some patients.6,7 Clinical Coverage Guideline page 2 Original Effective Date: 4/2/2009 - Revised: 4/30/2010, 4/30/2011, 4/5/2012, 4/11/2013, 3/6/2014, 3/5/2015, 3/3/2016 INTENSITY-MODULATED RADIATION THERAPY (IMRT) HS-094 The American Society of Breast Surgeons (ASBS) issued a revised consensus statement regarding APBI in August 2011. Patients should undergo careful selection for APBI and be properly informed of the risks and benefits of this type of radiation treatment. The ASBS recommends the following selection criteria for patients being 1 considered for treatment with APBI as a sole form of radiation therapy instead of (WBI): Age ≥ 45 years Invasive ductal carcinoma or ductal carcinoma in situ (DCIS) Total tumor size (invasive and DCIS) ≤ 3 cm in size Negative microscopic surgical margins of excision Negative sentinel lymph nodes Surgeons, radiation oncologists, and physicists utilizing APBI techniques should be adequately trained to permit optimum radiation therapy planning and delivery. Multi-lumen catheter devices or multi-catheter interstitial approaches may allow for greater flexibility in treatment planning for thin skin-to-lumpectomy cavity distances or devices that abut the pectoralis muscle to avoid high skin and chest wall doses. All patients should undergo regular monitoring to identify adverse events and local recurrences. Continuous, long-term, outcomes-based monitoring of APBI is required. The American Society for Radiation Oncology (ASTRO) assembled a task force in 2008 consisting of experts in breast cancer to review all available prospective data on the use of APBI. Patients who select APBI should be informed that WBI is considered an established treatment due to a much longer track record with documented long- term effectiveness and safety. The selection criteria and best practices for use of APBI outside of the clinical trial setting were stated; recommendations arising from this statement proposed three patient groups:2 A “suitable” group for whom APBI is acceptable outside of a clinical trial. A “cautionary” group for whom concern and caution should be used when APBI outside of a clinical trial is considered as a treatment approach. An “unsuitable” group for whom APBI outside of a clinical trial is not usually considered warranted. Whole Breast Irradiation (WBI) Three-dimensional conformal radiation therapy (3D-CRT) uses advanced computer technology to tailor the radiotherapy beam to the exact size and shape of a tumor, while minimizing incidental irradiation of surrounding normal tissues. Conformal radiation therapy allows the delivery of higher doses of radiation than would be possible with conventional external beam radiation therapy, with the objective of improving local control and, ultimately, survival. Intensity-modulated radiation therapy (IMRT), a refinement of conformal radiation therapy, combines two advanced concepts to deliver 3D-CRT to tumors at the higher dosages with
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