Medical Policy and Clinical Guideline Updates

These updates list the new and/or revised Empire medical policies, clinical guidelines and reimbursement policies*.  The implementation date for each policy or guideline is noted for each section.  Implementation of the new or revised medical policy, clinical guideline or reimbursement policy is effective for all claims processed on and after the specified implementation date, regardless of date of service.  Previously processed claims will not be reprocessed as a result of the changes.  If there is any inconsistency or conflict between the brief description provided below and the actual policy or guideline, the policy or guideline will govern.

 

Federal and state law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over medical policy and clinical guidelines (and medical policy takes precedence over clinical guidelines) and must be considered first in determining eligibility for coverage.  The member’s contract benefits in effect on the date that the services are rendered must be used. This document supplements any previous medical policy and clinical guideline updates that may have been issued by Empire.  Please include this update with your Provider Manual for future reference. 

 

Please note that medical policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication.  Empire’s medical policies and clinical guidelines can be found at empireblue.com.

 

*Note: These updates may not apply to all ASO Accounts as some accounts may have non-standard benefits that apply.

 

Medical Policy Updates

 

Revised Medical Policies Effective 03-28-2019

(The following policies were revised to expand medical necessity indications or criteria.)

• DRUG.00053 - Carfilzomib (Kyprolis®)
• DRUG.00082 - Daratumumab (DARZALEX®)
• DRUG.00088 - Atezolizumab (Tecentriq®)

 

Revised Medical Policies Effective 04-24-2019

(The following policies were revised to expand medical necessity indications or criteria.)

• GENE.00010 - Genotype Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status
• GENE.00045 - Detection and Quantification of Tumor DNA Using Next Generation Sequencing in Lymphoid Cancers
• SURG.00121 - Transcatheter Heart Valve Procedures

 

Archived Medical Policy Numbers Effective 04-24-2019

(The following policy numbers have been archived.)

• DRUG.00003 - Chelation Therapy (NOTE: This policy has been renumbered to MED.00127 - Chelation Therapy.)
• DRUG.00034 - Insulin Potentiation Therapy (NOTE: This policy has been renumbered to MED.00128 - Insulin Potentiation Therapy.)

 

Recategorized Medical Policies Effective 04-24-2019

(The following policies were renumbered and had no changes to the policy position or criteria.)

• MED.00127 - Chelation Therapy (NOTE: This policy has been renumbered, formerly DRUG.00003.)
• MED.00128 - Insulin Potentiation Therapy (NOTE: This policy has been renumbered, formerly DRUG.00034.)

 

Revised Medical Policies Effective 04-24-2019

(The following policies were reviewed and had no significant changes to the policy position or criteria.)

• ANC.00008 - Cosmetic and Reconstructive Services of the Head and Neck
• DME.00009 - Vacuum Assisted Wound Therapy in the Outpatient Setting
• DME.00022 - Functional Electrical Stimulation (FES); Threshold Electrical Stimulation (TES)
• DME.00032 - Automated External Defibrillators for Home Use
• DRUG.00076 - Blinatumomab (Blincyto®)
• DRUG.00107 - Avelumab (Bavencio®)
• DRUG.00109 - Durvalumab (Imfinzi®)
• GENE.00001 - Genetic Testing for Cancer Susceptibility
• GENE.00003 - Genetic Testing and Biochemical Markers for the Diagnosis of Alzheimer's Disease
• GENE.00009 - Gene-Based Tests for Screening, Detection and Management of Prostate Cancer
• GENE.00017 - Genetic Testing for Diagnosis and Management of Hereditary Cardiomyopathies (including arrhythmogenic right ventricular dysplasia/cardiomyopathy)
• GENE.00023 - Gene Expression Profiling of Melanomas
• GENE.00026 - Cell-Free Fetal DNA-Based Prenatal Testing
• GENE.00038 - Genetic Testing for Statin-Induced Myopathy
• LAB.00003 - In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays
• LAB.00011 - Analysis of Proteomic Patterns
• LAB.00015 - Detection of Circulating Tumor Cells in the Blood as a Prognostic Factor for Cancer
• LAB.00025 - Topographic Genotyping
• MED.00004 - Technologies for the Evaluation of Skin Lesions (including Dermatoscopy, Epiluminescence Microscopy, Videomicroscopy, Ultrasonography)
• MED.00011 - Sensory Stimulation for Brain-Injured Individuals in Coma or Vegetative State
• MED.00024 - Adoptive Immunotherapy and Cellular Therapy
• MED.00053 - Noninvasive Measurement of Left Ventricular End Diastolic Pressure in the Outpatient Setting
• MED.00057 - MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications
• MED.00059 - Idiopathic Environmental Illness (IEI)
• MED.00077 - In-Vivo Analysis of Gastrointestinal Lesions
• MED.00087 - Imaging Techniques for Screening and Identification of Cervical Cancer
• MED.00102 - Ultrafiltration in Decompensated Heart Failure
• MED.00104 - Non-invasive Measurement of Advanced Glycation Endproducts (AGEs) in the Skin
• MED.00105 - Bioimpedance Spectroscopy Devices for the Detection and Management of Lymphedema
• MED.00111 - Intracardiac Ischemia Monitoring
• MED.00112 - Autonomic Testing
• MED.00118 - Continuous Monitoring of Intraocular Pressure
• MED.00120 - Voretigene neparvovec-rzyl (Luxturna®)
• MED.00125 - Biofeedback and Neurofeedback
• OR-PR.00004 - Partial-Hand Myoelectric Prosthesis
• RAD.00001 - Computed Tomography to Detect Coronary Artery Calcification
• RAD.00038 - Use of 3-D, 4-D or 5-D Ultrasound in Maternity Care
• RAD.00040 - PET Scanning Using Gamma Cameras
• RAD.00044 - Magnetic Resonance Neurography
• RAD.00052 - Positional MRI
• RAD.00054 - MRI of the Bone Marrow
• RAD.00059 - Transcatheter Arterial Chemoembolization (TACE) and  Transcatheter Arterial Embolization (TAE) for Malignant Lesions Outside the Liver except Central Nervous System (CNS) and Spinal Cord
• SURG.00016 - Stereotactic Radiofrequency Pallidotomy
• SURG.00022 - Lung Volume Reduction Surgery
• SURG.00026 - Deep Brain, Cortical, and Cerebellar Stimulation
• SURG.00043 - Electrothermal Shrinkage of Joint Capsules, Ligaments and Tendons
• SURG.00045 - Extracorporeal Shock Wave Therapy for Orthopedic Conditions
• SURG.00053 - Unicondylar Interpositional Spacer
• SURG.00056 - Transanal Radiofrequency Treatment of Fecal Incontinence
• SURG.00061 - Presbyopia and Astigmatism-Correcting Intraocular Lenses
• SURG.00062 - Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome
• SURG.00070 - Photocoagulation of Macular Drusen
• SURG.00072 - Lysis of Epidural Adhesions
• SURG.00075 - Intervertebral Stabilization Devices
• SURG.00089 - Self-Expanding Absorptive Sinus Ostial Dilation
• SURG.00096 - Surgical and Ablative Treatments for Chronic Headaches
• SURG.00107 - Prostate Saturation Biopsy
• SURG.00113 - Artificial Retinal Devices
• SURG.00124 - Carotid Sinus Baroreceptor Stimulation Devices
• SURG.00132 - Drug-Eluting Devices for Maintaining Sinus Ostial Patency
• SURG.00137 - Focused Microwave Thermotherapy for Breast Cancer
• SURG.00139 - Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery with Radiofrequency Spectroscopy or Optical Coherence Tomography
• SURG.00148 - Spectral Analysis of Prostate Tissue by Fluorescence Spectroscopy
• SURG.00149 - Percutaneous Ultrasonic Ablation of Soft Tissue
• SURG.00150 - Leadless Pacemaker
• SURG.00151 - Balloon Dilation of Eustachian Tubes
• TRANS.00011 - Pancreas Transplantation and Pancreas Kidney Transplantation
• TRANS.00013 - Small Bowel, Small Bowel/Liver, and Multivisceral Transplantation
• TRANS.00016 - Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation
• TRANS.00025 - Laboratory Testing as an Aid in the Diagnosis of Heart Transplant Rejection
• TRANS.00028 - Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma
• TRANS.00031 - Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors

 

Archived Medical Policies Effective 05-09-2019

(The following policies have been archived and their content has been transferred to new Clinical UM Guidelines.)

• DRUG.00110 - Inotuzumab ozogamicin (Besponsa®) [Note: Content transferred to CG-DRUG-113 Inotuzumab ozogamicin (Besponsa®)]
• GENE.00002 - Preimplantation Genetic Diagnosis Testing [Note: Content transferred to CG-GENE-06 Preimplantation Genetic Diagnosis Testing]
• GENE.00005 BCR-ABL Mutation Analysis [Note: Content transferred to CG-GENE-07 BCR-ABL Mutation Analysis]
• GENE.00031 - Genetic Testing for PTEN Hamartoma Tumor Syndrome [Note: Content transferred to CG-GENE-08 Genetic Testing for PTEN Hamartoma Tumor Syndrome]
• GENE.00040 - Genetic Testing for CHARGE Syndrome [Note: Content transferred to CG-GENE-09 Genetic Testing for CHARGE Syndrome]
• MED.00119 - High Intensity Focused Ultrasound (HIFU) for Oncologic Indications [Note: Content transferred to CG-MED-81 High Intensity Focused Ultrasound (HIFU) for Oncologic Indications]
• RAD.00066 - Multiparametric Magnetic Resonance Fusion Imaging Targeted Prostate Biopsy [Note: Content transferred to CG-SURG-98 Prostate Multiparametric Magnetic Resonance Imaging]
• SURG.00048 - Panniculectomy and Abdominoplasty [Note: Content transferred to CG-SURG-99 Panniculectomy and Abdominoplasty]

 

Archived Medical Policy Effective 06-24-2019

(The following policy has been archived and its content has been transferred to a new Clinical UM Guideline.)

• SURG.00033 - Cardioverter Defibrillators [Note: Content transferred to CG-SURG-97 Cardioverter Defibrillators]

 

New Medical Policy Effective 05-11-2019

(The following policy is new and determined to not have significant changes.)

• SURG.00152 - Wireless Cardiac Resynchronization Therapy for Left Ventricular Pacing

 

New Medical Policy Effective 08-01-2019

(The following policy is new and determined to not have significant changes.)

• GENE.00050 - Gene Expression Profiling for Coronary Artery Disease [Note: Content transferred from GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases]

 

Revised Medical Policies Effective 08-01-2019

(The policies below were revised and might result in services that were previously covered but may now be found to be either not medically necessary and/or investigational.)

• GENE.00007 - Cardiac Ion Channel Genetic Testing
• GENE.00010 - Genotype Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status
• GENE.00012 - Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent
• GENE.00043 - Genetic Testing of an Individual’s Genome for Inherited Diseases [Note: Content for gene expression profiling for coronary disease moved to new medial policy GENE.00050 Gene Expression Profiling for Coronary Artery Disease]

 

Revised Medical Policy Effective 08-17-2019

(The policy below was revised and might result in services that were previously covered but may now be found to be either not medically necessary and/or investigational.)

• MED.00101 - Physiologic Recording of Tremor using Accelerometer(s) and Gyroscope(s)

 

Clinical Guideline Updates

 

Revised Clinical Guideline Effective 03-19-2019

(The following adopted guideline was updated with new HCPCS procedure codes.)

• CG-MED-79 – Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing Systems

 

Revised Clinical Guidelines Effective 03-28-2019

(The following adopted guidelines were revised to expand medical necessity indications or criteria.)

• CG-DRUG-50 - Paclitaxel, protein-bound (Abraxane®)
• CG-DRUG-96 - Ado-trastuzumab emtansine (Kadcyla®)
• CG-GENE-04 - Molecular Marker Evaluation of Thyroid Nodules

 

Revised Clinical Guidelines Effective 03-28-2019

(The following adopted guidelines were updated with new HCPCS procedure codes.)

• CG-DRUG-63 – Levoleucovorin Products
• CG-DRUG-78 – Antihemophilic Factor and Clotting Factors
• CG-DRUG-98 - Bendamustine Hydrochloride

 

Archived Clinical Guideline Numbers Effective 04-24-2019

(The following clinical guideline numbers have been archived.)

• CG-DRUG-25 - Intravenous versus Oral Drug Administration in the Outpatient and Home Setting (NOTE: This guideline has been renumbered to CG-MED-82.)
• CG-DRUG-47 - Level of Care: Specialty Pharmaceuticals (NOTE: This guideline has been renumbered to CG-MED-83.)

 

Recategorized Clinical Guidelines Effective 04-24-2019

(The following adopted guidelines were renumbered and had no changes to the policy position or criteria.)

• CG-MED-82 - Intravenous versus Oral Drug Administration in the Outpatient and Home Setting (NOTE: This guideline has been renumbered, formerly CG-DRUG-25.)
• CG-MED-83 - Level of Care: Specialty Pharmaceuticals (NOTE: This guideline has been renumbered, formerly CG-DRUG-47.)

 

Revised Clinical Guidelines Effective 04-24-2019

(The following adopted guidelines were revised to expand medical necessity indications or criteria.)

• CG-DRUG-68 - Bevacizumab (Avastin®) for Non-Ophthalmologic Indications
• CG-GENE-01 - Janus Kinase 2, CALR and MPL Gene Mutation Assays
• CG-SURG-09 - Temporomandibular Disorders

 

Revised Clinical Guidelines Effective 04-24-2019

(The following adopted guidelines were reviewed and had no significant changes to the policy position or criteria.)

• CG-BEH-02 - Adaptive Behavioral Treatment for Autism Spectrum Disorder
• CG-DME-06 - Pneumatic Compression Devices for Lymphedema
• CG-DRUG-49 - Doxorubicin Hydrochloride Liposome Injection
• CG-DRUG-51 - Romidepsin (Istodax®)
• CG-DRUG-53 - Drug Dosage, Frequency, and Route of Administration
• CG-DRUG-62 - Fulvestrant (FASLODEX®)
• CG-DRUG-67 - Cetuximab (Erbitux®)
• CG-DRUG-100 - Interferon gamma-1b (Actimmune®)
• CG-DRUG-101 - Ixabepilone (Ixempra®)
• CG-DRUG-102 - Olaratumab (Lartruvo™)
• CG-GENE-02 - Analysis of KRAS Status
• CG-MED-37 - Intensive Programs for Pediatric Feeding Disorders
• CG-MED-55 - Level of Care: Advanced Radiologic Imaging
• CG-MED-69 - Inhaled Nitric Oxide
• CG-MED-70 - Wireless Capsule Endoscopy for Gastrointestinal Imaging and the Patency Capsule
• CG-REHAB-08 - Private Duty Nursing in the Home Setting
• CG-SURG-74 - Total Ankle Replacement
• CG-SURG-76 - Carotid, Vertebral and Intracranial Artery Stent Placement with or without Angioplasty
• CG-SURG-78 - Locally Ablative Techniques for Treating Primary and Metastatic Liver Malignancies
• CG-SURG-80 - Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Embolization (TAE) for Treating Primary or Metastatic Liver Tumors
• CG-TRANS-02 - Kidney Transplantation

 

Adopted Clinical Guidelines Effective 05-09-2019

(The following guidelines were previously medical policies and have been adopted and have no significant changes.)

• CG-DRUG-113 - Inotuzumab ozogamicin (Besponsa®) [Note: Content moved from DRUG.00110 Inotuzumab ozogamicin (Besponsa®)]
• CG-GENE-06 - Preimplantation Genetic Diagnosis Testing [Note: Content moved from GENE.00002 Preimplantation Genetic Diagnosis Testing]
• CG-GENE-07 - BCR-ABL Mutation Analysis [Note: Content moved from GENE.00005 BCR-ABL Mutation Analysis]
• CG-GENE-08 - Genetic Testing for PTEN Hamartoma Tumor Syndrome [Note: Content moved from GENE.00031 Genetic Testing for PTEN Hamartoma Tumor Syndrome]
• CG-GENE-09 - Genetic Testing for CHARGE Syndrome [Note: Content moved from GENE.00040 Genetic Testing for CHARGE Syndrome]
• CG-MED-81 - High Intensity Focused Ultrasound (HIFU) for Oncologic Indications [Note: Content moved from MED.00119 High Intensity Focused Ultrasound (HIFU) for Oncologic Indications]
• CG-SURG-98 - Prostate Multiparametric Magnetic Resonance Imaging [Note: Content moved from RAD.00066 Multiparametric Magnetic Resonance Fusion Imaging Targeted Prostate Biopsy]
• CG-SURG-99 - Panniculectomy and Abdominoplasty [Note: Content moved from SURG.00048 Panniculectomy and Abdominoplasty]

 

Adopted Clinical Guideline Effective 06-24-2019

(The following guideline was previously a medical policy and has been adopted and has no significant changes.)

• CG-SURG-97 - Cardioverter Defibrillators [Note: Content moved from SURG.00033 Cardioverter Defibrillators]

 

Revised Clinical Guidelines Effective 08-01-2019

(The following adopted guidelines were revised and might result in services that were previously covered but may now be found to be not medically necessary.)

• CG-DME-44 - Electric Tumor Treatment Field (TTF)
• CG-GENE-01 - Janus Kinase 2, CALR and MPL Gene Mutation Assays
• CG-MED-72 - Hyperthermia for Cancer Therapy

 

Revised Clinical Guideline Effective 08-17-2019

(The following adopted guidelines were revised and might result in services that were previously covered but may now be found to be not medically necessary.)

• CG-SURG-09 - Temporomandibular Disorders