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Revised Policy Guidelines for Azacitidine (Vidaza) in This Issue

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Revised Policy Guidelines for Azacitidine (Vidaza) in This Issue February 2016 In This Issue Coverage Criteria Revised for Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer . 6 Surgical Treatment of Lymphedema Added to Medical Policy Y-11, Treatments for Lymphedema........... 6 Updated Criteria for Cardiac Rehabilitation Program, Phase II Outpatient ................................................ 8 New Criteria Established for Coverage of Magnetic Resonance Imaging (MRI) of the Breast ................... 8 Contents......................................................................................................................................................... 15 Policy Revised Policy Guidelines for Azacitidine (Vidaza) Highmark Blue Shield has revised clinical criteria for coverage of Azacitidine (Vidaza). These revised clinical criteria will apply to both professional provider and facility claims. The effective date is April 25, 2016. Intravenous or Subcutaneous use of azacitidine (Vidaza) may be considered medically necessary for treatment of higher risk disease in Myelodysplastic Syndromes (MDS) subtypes (i.e. refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) in ANY ONE of the following indications: In nontransplant candidates (preferred); or In transplant candidates (preferred if awaiting donor availability); or As maintenance therapy for nontransplant candidates or for transplant candidates awaiting donor availability that have clinical benefit to treatment in the first-line setting. Please refer to Medical Policy I-124 for a more comprehensive view of the policy. Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. Note: This publication may contain certain administrative requirements, policies, procedures, or other similar requirements of Highmark Inc. (or changes thereto) which are binding upon Highmark Inc. and its contracted providers. Pursuant to their contract, Highmark Inc. and such providers must comply with any requirements included herein unless and until such item(s) are subsequently modified in whole or in part. Medical Policy Update February 2016 Criteria Revised for Outpatient Pneumatic Compression Devices Highmark Blue Shield has revised the clinical criteria for coverage of outpatient pneumatic compression devices. This new criteria will apply to both professional provider and facility claims. The effective date is April 25, 2016. Changes to the criteria include the following: Outpatient use of limb compression devices for the following indications may be considered medically necessary: venous thromboembolism (VTE) prophylaxis after major orthopedic surgery in patients with a contraindication to pharmacological agents, i.e., at high risk for bleeding; or VTE prophylaxis after major non-orthopedic surgery or non-major orthopedic surgery in patients who are at moderate or high risk of VTE (see Professional Statements and Societal Positions) with a contraindication to pharmacological agents, i.e., at high risk for bleeding. Outpatient use of limb compression devices for VTE prophylaxis, after major orthopedic surgery, is considered experimental/investigational and, therefore, non-covered for patients without a contraindication to pharmacological prophylaxis. Outpatient use of limb compression devices for VTE prophylaxis, after major non-orthopedic surgery or non-major orthopedic surgery, is considered experimental/investigational and, therefore, non-covered for patients who are at moderate or high risk of VTE without a contraindication to pharmacological prophylaxis and in patients who are at low risk of VTE. Outpatient use of limb compression devices for VTE prophylaxis after all other surgeries is considered experimental/investigational and, therefore, non-covered. A portable, intermittent, pneumatic compression device (i.e. Vena Pro) is considered experimental/investigational and, therefore, non-covered. There is a lack of evidence based literature to confirm the efficacy and safety of these devices. Outpatient use of limb compression devices for VTE prophylaxis for periods longer than 30 days post-surgery is not medically necessary. For more information, please refer to Medical Policy E-7, Pneumatic Compression Devices. 2 Medical Policy Update February 2016 Criteria Revised for Wearable Cardioverter-Defibrillators Highmark Blue Shield has established new clinical criteria for coverage of Wearable Cardioverter-Defibrillators. This new criteria will apply to both professional provider and facility claims. The effective date is March 21, 2016. Wearable Cardioverter-Defibrillators will be eligible for patients age 8 and over who meet medical policy criteria. Please refer to Medical Policy E-58 for more information. Additional Criteria for Palonosetron Hydrochloride (Aloxi) Highmark Blue Shield has established updated clinical criteria for coverage of Palonosetron Hydrochloride (Aloxi®). These updated criteria apply to both professional provider and facility claims. The effective date was February 8, 2016. Palonosetron Hydrochloride may be considered medically necessary for an infant, child, or adolescent (age 1 month to less than 17 years) for: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Place of Service: Outpatient For additional information please see Medical Policy I-36. Facility Applied to Paclitaxel (Taxol) Effective March 28, 2016, Highmark Blue Shield’s Medical Policy I-75, Paclitaxel (Taxol®), will apply to facility claims. For additional information refer to Medical Policy I-75, Paclitaxel (Taxol). 3 Medical Policy Update February 2016 Criteria Revised for Velcade (bortezomib) Highmark Blue Shield has revised clinical criteria for coverage of Velcade® (bortezomib).This new and revised criterion will apply to both professional provider and facility claims. The effective date is March 28, 2016. Velcade (bortezomib) may be considered medically necessary for the following: Multiple myeloma Primary chemotherapy for progressive solitary plasmacytoma or smoldering myeloma (asymptomatic) that has progressed to active (symptomatic) myeloma in combination with dexamethasone with or without cyclophosphamide doxorubicin, lenalidomide, or thalidomide for transplant candidates (all preferred regimens) combination with dexamethasone with or without cyclophosphamide or lenalidomide or in MPB (melphalan, prednisone, and bortezomib) regimen for non-transplant candidates (all preferred regimens). Maintenance therapy as a single agent (preferred) or in combination with prednisone or thalidomide for active (symptomatic) myeloma responding to primary myeloma therapy for stable or responsive disease following stem cell transplant with second tandem transplant for stable or responsive disease following autologous stem cell transplant. Per NCCN criteria guidelines the following will no longer apply to Medical Policy I-83, Velcade (bortezomib): NHL - Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders Single-agent therapy for relapsed or refractory primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions cutaneous ALCL with regional nodes (excludes systemic ALCL). For more information refer to Medical Policy I-83, Velcade (bortezomib). Place of Service: Outpatient 4 Medical Policy Update February 2016 Criteria Established for Mepolizumab (NUCALA) Highmark Blue Shield has established new clinical criteria for coverage of Mepolizumab (NUCALA®). This new criteria will apply to both professional provider and facility claims. The effective date is April 25, 2016. Mepolizumab may be considered medically necessary for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype when the following criteria are met: Symptoms are inadequately controlled with use of either combination therapy: 12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of controller medication (either a long-acting beta2- agonist [LABA], or leukotriene receptor antagonist [LTRA], or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; or 6 months of ICS with daily oral glucocorticoids given in combination with a minimum of 3 months of controller medication (either a LABA, or LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; and Has one of the following blood eosinophil counts (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection): Greater than or equal to 150 cells/microliter* at initiation of therapy; or Greater than or equal to 300 cells/microliter* in the prior 12 months; and *Note: 1 microliter (ul) is equal to 1 cubic millimeter (mm3) Evidence of asthma as demonstrated by both of the following: A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; and FEV1 reversibility of at least 12% and 200 milliliters (ml) after albuterol (salbutamol) administration. Place of Service: Outpatient For further information, refer to Medical Policy I-146, Mepolizumab (NUCALA). 5 Medical Policy Update February 2016
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