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

Coverage Criteria Revised for Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer

Effective April 25, 2016, Highmark Blue Shield has revised the clinical criteria for coverage of Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer (i.e. Oncotype DX).

The following statement is added to the clinical criteria:

Multi-gene expression testing, that is, Oncotype DX for Stage II colon cancer, is covered on a one-time basis only. Repeat testing is considered not medically necessary. The only exception is in the uncommon occurrence of a second primary Stage II colon cancer.

Please see Medical Policy L-91 for additional information.

New Clinical Criteria Established for Subcutaneous Implantable Cardioverter- Defibrillators (S-ICD)

Highmark Blue Shield has established new clinical criteria for coverage of Implantable Automatic Cardioverter-Defibrillators/Subcutaneous Implantable Defibrillator (S-ICD), Medical Policy S-59. This new criterion applies to both professional provider and facility claims. The effective date was February 1, 2016.

S-ICDs may be considered medically necessary when an approved FDA S-ICD is used and patients have met the clinical criteria.

Please refer to Medical Policy S-59 for a more comprehensive view of the policy.

Place of Service: Outpatient

Surgical Treatment of Lymphedema Added to Medical Policy Y-11, Treatments for Lymphedema

Highmark Blue Shield considers the surgical treatment of lymphedema experimental/investigational. Original notification published in the December 2015 Medical Policy Update. This statement has been added to Medical Policy Y-11 and will apply to both professional provider and facility claims. The effective date remains February 29, 2016.

For further information, refer to Medical Policy Y-11 which will be renamed Treatments for Lymphedema.

Place of Service: Inpatient/Outpatient

6 Medical Policy Update February 2016

Talimogene Laherparepvec (Imlygic) – New Coverage Criteria

Highmark Blue Shield has established new clinical criteria for coverage of Talimogene laherparepvec (Imlygic™). This new policy will apply to both professional provider and facility claims. The effective date is April 25, 2016.

Imlygic is genetically modified viral therapy, from the Herpes Simplex Virus Type 1; and is used to treat melanoma.

Please refer to Medical Policy I-147 for coverage criteria and additional information.

Place of Service: Outpatient

Medical Policy S-69 Cancelled

Highmark Medical Policy S-69, Surgical Treatment of Lymphedema, which was scheduled to issue on February 29, 2016, has been cancelled.

For further information, refer to Medical Policy Y-11, Treatments for Lymphedema.

Coverage Criteria Revised for Lung and Lobar Lung Transplantation

Effective April 25, 2016, Highmark Blue Shield has revised the clinical criteria for coverage of lung transplantation.

The following absolute contraindication has been added:

 Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Please see Medical Policy S-123 for additional information.

7 Medical Policy Update February 2016

Updated Criteria for Cardiac Rehabilitation Program, Phase II Outpatient

Highmark Blue Shield has updated clinical criteria regarding coverage for Cardiac Rehabilitation Program, Phase II Outpatient. These updated criteria will apply to both professional provider and facility claims. The effective date is April 25, 2016.

The following are considered not medically necessary:

 Phase III cardiac rehabilitation programs, or self-directed, self-controlled or monitored exercise programs;  Phase IV cardiac rehabilitation programs or maintenance therapy that may be safely carried out without medical supervision;  Cardiac rehabilitation when used in a preventive or prophylactic way, such as for angina, hypertension, or diabetes. Repeat participation in an outpatient cardiac rehabilitation program in the absence of another qualifying cardiac event is considered experimental/investigational. Scientific evidence does not support the need for repeat cardiac rehabilitation in the absence of cardiac events.

Place of Service: Outpatient

For further information, refer to Medical Policy V-1, Cardiac Rehabilitation Program, Phase II Outpatient.

New Criteria Established for Coverage of Magnetic Resonance Imaging (MRI) of the Breast

Highmark Blue Shield has established new clinical criteria for coverage of Magnetic Resonance Imaging (MRI) of the Breast. This new criteria will apply to professional provider claims. The effective date is March 7, 2016.

For more information, please refer to Medical Policy X-44.

Place of Service: Outpatient

8 Medical Policy Update February 2016

Complexity of the Procedure Codes Added to Emergency Department/ Emergency Medical Care/Urgent Care/ and Emergency Accident Care

Highmark Blue Shield has established new clinical criteria for coverage regarding Emergency Department/ Emergency Medical Care/Urgent Care/ and Emergency Accident Care. The revised criteria will apply to both professional provider and facility claims. The effective date is April 25, 2016.

Emergency Department/ Emergency Medical Care/Urgent Care/ and Emergency Accident Care level of service is determined by the intervention(s) that are performed in relationship to the intensity of medical care required by the presenting symptoms and resulting diagnosis of the patient:

Straight Forward Complexity (Level 1): The presenting problem(s) are self-limited or minor conditions with no medications or home treatment required, signs and symptoms are explained to the patient, return to emergency department if problems develop or persist.

Low Complexity (Level 2): The presenting problem(s) are of low severity. Over the counter (OTC) medications or treatment provided. Patient demonstrates understanding quickly and easily.

Moderate Complexity (Level 3): The presenting problem(s) are of moderate severity. OTC and/or prescription or treatments provided. Prescription medication reviewed of possible side effects and potential adverse reactions. Patient may have questions, but otherwise demonstrates adequate understanding of instructions either verbally or by demonstration. Patient requires teaching and skill demonstration. Patient to follow up as required.

Moderate- High Complexity (Level 4): The presenting problem(s) are of moderate- high severity, and require urgent evaluation by the physician but do not pose an immediate significant threat to life or physiologic function. Prescription medication with review of side effects and potential adverse reactions. Patient may have questions, but otherwise demonstrates adequate understanding of instructions either verbally or by demonstration. Patient to follow up as required.

High Complexity (Level 5): The presenting problem(s) are of high severity and pose an immediate significant threat to life or physiologic function. Multiple prescription medications and/or home therapies with review of side effects and/or potential adverse reactions. Patient/caregiver may demonstrate difficulty understanding instructions and may require additional directions to support compliance with prescribed treatment compliance with prescribed treatment.

Place of Service: Outpatient

For further information please see Medical Policy Z-13, Emergency Department/ Emergency Medical Care/Urgent Care/ and Emergency Accident Care.

9 Medical Policy Update February 2016

Medicare Advantage Policy

Revised Policy Guidelines for Azacitidine (Vidaza)

Highmark Senior Health Company’s Medicare Advantage products have 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.

 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 see Medicare Advantage Medical Policy I-124 for a more comprehensive view of the policy.

Talimogene Laherparepvec (Imlygic) – New Coverage Criteria

Highmark Senior Health Company’s Medicare Advantage products have established new clinical criteria for coverage of Talimogene laherparepvec (Imlygic™). This new policy will apply to both professional provider and facility claims. The effective date is April 25, 2016.

Imlygic is genetically modified viral therapy, from the Herpes Simplex Virus Type 1; and is used to treat melanoma.

Please refer to Medicare Advantage Policy I-147 for coverage criteria and additional information.

10 Medical Policy Update February 2016

Criteria Revised for Velcade (bortezomib)

Highmark Senior Health Company's Medicare Advantage products have revised clinical criteria for Velcade® (bortezomib). This new criteria applies to both professional provider and facility claims. The effective date was February 1, 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).

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 Medicare Advantage Policy I-83, Velcade (bortezomib).

Place of Service: Outpatient

11 Medical Policy Update February 2016

Criteria Established for Mepolizumab (NUCALA)

Highmark Senior Health Company’s Medicare Advantage products have established new clinical criteria for coverage of Mepolizumab (NUCALA®). The effective date is April 25, 2016.

 Symptoms are inadequately controlled with use of either combination therapy:

 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

 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.

All other indications for Mepolizumab not stated above will be denied as experimental/investigational and therefore, not medically necessary.

For further information, refer to Medicare Advantage Policy I-146, Mepolizumab (NUCALA).

12 Medical Policy Update February 2016

New Policy for Diagnostic Abdominal Aortography and Renal Angiography

Highmark Senior Health Company’s Medicare Advantage products have established new policy guidelines for coverage of Diagnostic Abdominal Aortography and Renal Angiography. This new policy will apply to both professional provider and facility claims. The effective date is March 7, 2016.

For further information, refer to Medicare Advantage Policy X-12, Diagnostic Abdominal Aortography and Renal Angiography.

Medicare Advantage Will No Longer Cover Injectable Medication, Firazyr (Icatibant)

Effective April 25, 2016, Highmark Senior Health Company's Medicare Advantage products will no longer provide coverage for the Hereditary Angioedema Drug, Firazyr (icatibant). This non-coverage position is applicable to both professional and facility claims.

Medicare Advantage Self-Administered Drug Exclusion List Revised

Effective April 25, 2016 Highmark Senior Health Company's Medicare Advantage products have revised the self-administered drug exclusion list.

Please see Medicare Advantage Policy I-51 for additional information.

13 Medical Policy Update February 2016

Coverage Criteria Revised for Oxaliplatin (Eloxatin)

Effective April 25, 2016, Highmark Senior Health Company’s Medicare Advantage Products have revised clinical criteria for coverage of Oxaliplatin (Eloxatin®).

Oxaliplatin (Eloxatin) may be considered medically necessary in the treatment of extranodal NK/T-cell lymphoma (nasal type) when criteria are met.

Oxaliplatin (Eloxitan) will be considered medically necessary for neuroendocrine tumors of the pancreas only; treatment for all other neuroendocrine tumors will be considered not medically necessary.

For additional information see Medicare Advantage Policy I-48, Oxaliplatin (Eloxatin).

Comments on these new medical policies? We want to know what you think about our new medical policy changes. Send us an email with any questions or comments that you may have on the new medical policies in this edition of Medical Policy Update.

Write to us at [email protected].

14 Medical Policy Update February 2016 Contents Revised Policy Guidelines for Azacitidine (Vidaza)...... 1 Criteria Revised for Outpatient Pneumatic Compression Devices...... 2 Criteria Revised for Wearable Cardioverter-Defibrillators...... 3 Additional Criteria for Palonosetron Hydrochloride (Aloxi) ...... 3 Facility Applied to Paclitaxel (Taxol)...... 3 Criteria Revised for Velcade (bortezomib) ...... 4 Criteria Established for Mepolizumab (NUCALA)...... 5 Coverage Criteria Revised for Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer...... 6 New Clinical Criteria Established for Subcutaneous Implantable Cardioverter-Defibrillators (S-ICD)...... 6 Surgical Treatment of Lymphedema Added to Medical Policy Y-11, Treatments for Lymphedema...... 6 Medical Policy S-69 Cancelled...... 7 Coverage Criteria Revised for Lung and Lobar Lung Transplantation ...... 7 Updated Criteria for Cardiac Rehabilitation Program, Phase II Outpatient ...... 8 New Criteria Established for Coverage of Magnetic Resonance Imaging (MRI) of the Breast ...... 8 Complexity of the Procedure Codes Added to Emergency Department/ Emergency Medical Care/Urgent Care/ and Emergency Accident Care...... 9 Revised Policy Guidelines for Azacitidine (Vidaza)...... 10 Criteria Revised for Velcade (bortezomib) ...... 11 Criteria Established for Mepolizumab (NUCALA)...... 12 New Policy for Diagnostic Abdominal Aortography and Renal Angiography...... 13 Medicare Advantage Will No Longer Cover Injectable Medication, Firazyr (Icatibant)...... 13 Medicare Advantage Self-Administered Drug Exclusion List Revised ...... 13 Coverage Criteria Revised for Oxaliplatin (Eloxatin) ...... 14 Comments on these new medical policies?...... 14 Contents...... 15

15 Medical Policy Update February 2016

Save yourself valuable time with e-Subscribe! Sign up today and you’ll begin receiving email notifications with a direct link to the latest issue of Medical Policy Update.

About this newsletter

Medical Policy Update is the monthly newsletter for most health care professionals (and office staff) and facilities who participate in our networks and submit claims to Highmark using the 837P HIPAA transaction or the CMS 1500 form, or the 837I HIPAA transaction. Medical Policy Update focuses only on medical policy and claims administration updates, including coding guidelines and procedure code revisions, and is the sole source for this information. For all other news, information and updates, be sure to read Provider News, available on the Provider Resource Center at www.highmarkblueshield.com.

Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Shield encourages providers to use the electronic resources available to them - NaviNet® and the applicable HIPAA transactions – prior to placing a telephone call to the Provider Service Center at 1-866-803-3708.

Acknowledgement The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2016, Copyright 2015, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and procedures.