Medical Policy and Clinical Guideline updates

Material Adverse Change (MAC)

 

These updates list the new and/or revised Empire BlueCross BlueShield (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 https://www.empireblue.com.

 

Note: These updates may not apply to all ASO Accounts, as some accounts may have nonstandard benefits that apply.

 

To view Medical Policies and Clinical Utilization Management (UM) Guidelines applicable to members enrolled in the Blue Cross and Blue Shield Service Benefit Plan (commonly referred to as the Federal Employee Program (FEP^®), please visit www.fepblue.org > Policies & Guidelines.

 

Medical Policy updates

 

Revised medical policy effective August 18, 2022

The following policy was revised to expand medical necessity indications or criteria:

• MED.00129 Gene Therapy for Spinal Muscular Atrophy

 

Revised medical policy effective September 7, 2022

The following policy was reviewed and may have word changes or clarifications but had no significant changes to the policy position or criteria:

• MED.00129 Gene Therapy for Spinal Muscular Atrophy

 

New medical policy effective September 28, 2022

The following policy is new:

• MED.00142 Gene Therapy for Cerebral Adrenoleukodystrophy

 

Revised medical policy effective September 28, 2022

The following policy was reviewed and may have word changes or clarifications but had no significant changes to the policy position or criteria:

• LAB.00019 Proprietary Algorithms for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease

 

Revised medical policies effective September 28, 2022

The following policies were updated with new CPT^®/HCPCS/ICD-10-PCS procedure code and/or ICD-10-CM diagnosis code updates:

• DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices
• GENE.00009 Gene Expression Profiling and Genomic Biomarker Tests for Prostate Cancer
• GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status
• GENE.00039 Genetic Testing for Frontotemporal Dementia (FTD)
• GENE.00049 Circulating Tumor DNA Panel Testing (Liquid Biopsy)
• GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling
• LAB.00015 Detection of Circulating Tumor Cells
• LAB.00046 Testing for Biochemical Markers for Alzheimer's Disease
• MED.00098 Hyperoxemic Reperfusion Therapy
• SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting
• SURG.00120 Internal Rib Fixation Systems

 

Archived medical policy effective October 5, 2022

The following policy has been archived:

• GENE.00034 SensiGene^® Fetal RhD Genotyping Test

 

Revised medical policy effective October 5, 2022

The following policy was revised to expand medical necessity indications or criteria:

• SURG.00119 Endobronchial Valve Devices

 

Revised medical policies effective October 5, 2022

The following policies were reviewed and may have word changes or clarifications but had no significant changes to the policy position or criteria:

• ADMIN.00006 Review of Services for Benefit Determinations in the Absence of a Company Applicable Medical Policy or Clinical Utilization Management (UM) Guideline
• DME.00025 Self-Operated Spinal Unloading Devices
• DME.00041 Ultrasonic Diathermy Devices
• DME.00043 Neuromuscular Electrical Training for the Treatment of Obstructive Sleep Apnea or Snoring
• GENE.00018 Gene Expression Profiling for Cancers of Unknown Primary Site
• GENE.00020 Gene Expression Profile Tests for Multiple Myeloma
• GENE.00033 Genetic Testing for Inherited Peripheral Neuropathies
• GENE.00058 TruGraf Blood Gene Expression Test for Transplant Monitoring
• LAB.00003 In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays
• LAB.00028 Serum Biomarker Tests for Multiple Sclerosis
• LAB.00029 Rupture of Membranes Testing in Pregnancy
• LAB.00030 Measurement of Serum Concentrations of Monoclonal Antibody Drugs and Antibodies to Monoclonal Antibody Drugs
• LAB.00036 Multiplex Autoantigen Microarray Testing for Systemic Lupus Erythematosus
• LAB.00040 Serum Biomarker Tests for Risk of Preeclampsia
• LAB.00042 Molecular Signature Test for Predicting Response to Tumor Necrosis Factor Inhibitor Therapy
• MED.00055 Wearable Cardioverter Defibrillators
• MED.00082 Quantitative Sensory Testing
• MED.00089 Quantitative Muscle Testing Devices
• MED.00096 Low-Frequency Ultrasound Therapy for Wound Management
• MED.00103 Automated Evacuation of Meibomian Gland
• MED.00134 Non-invasive Heart Failure and Arrhythmia Management and Monitoring System.
• OR-PR.00007 Microprocessor Controlled Knee-Ankle-Foot Orthosis
• RAD.00057 Near-Infrared Coronary Imaging and Near-Infrared Intravascular Ultrasound Coronary Imaging
• RAD.00061 PET/MRI
• RAD.00064 Myocardial Sympathetic Innervation Imaging with or without Single-Photon Emission Computed Tomography (SPECT)
• SURG.00008 Mechanized Spinal Distraction Therapy
• SURG.00052 Percutaneous Vertebral Disc and Vertebral Endplate Procedures
• SURG.00077 Uterine Fibroid Ablation: Laparoscopic, Percutaneous or Transcervical Image Guided Techniques
• SURG.00082 Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures of the Appendicular System
• SURG.00088 Coblation® Therapies for Musculoskeletal Conditions
• SURG.00092 Implanted Devices for Spinal Stenosis
• SURG.00104 Extraosseous Subtalar Joint Implantation and Subtalar Arthroereisis
• SURG.00107 Prostate Saturation Biopsy
• SURG.00114 Facet Joint Allograft Implants for Facet Disease
• SURG.00128 Implantable Left Atrial Hemodynamic Monitor
• SURG.00131 Lower Esophageal Sphincter Augmentation Devices for the Treatment of Gastroesophageal Reflux Disease (GERD)
• SURG.00135 Radiofrequency Ablation of the Renal Sympathetic Nerves
• SURG.00144 Occipital Nerve Block Therapy for the Treatment of Headache and Occipital Neuralgia
• SURG.00153 Cardiac Contractility Modulation Therapy
• SURG.00156 Implanted Artificial Iris Devices
• SURG.00157 Minimally Invasive Treatment of the Posterior Nasal Nerve to Treat Rhinitis

 

New medical policy effective October 15, 2022

The following policy is new:

• MED.00140 Gene Therapy for Beta Thalassemia

 

Revised medical policies effective October 15, 2022

The following policies were revised to expand medical necessity indications or criteria:

• MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications
• SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea or Snoring

 

Revised medical policies effective October 15, 2022

The following policies were reviewed and may have word changes or clarifications but had no significant changes to the policy position or criteria:

• LAB.00011 Selected Protein Biomarker Algorithmic Assays
• SURG.00032 Patent Foramen Ovale and Left Atrial Appendage Closure Devices for Stroke Prevention

 

Revised medical policies effective October 15, 2022

The following policies were updated with new CPT/HCPCS/ICD-10-PCS procedure code and/or ICD-10-CM diagnosis code updates:

• RAD.00038 Use of 3-D, 4-D or 5-D Ultrasound in Maternity Care
• TRANS.00038 Thymus Tissue Transplantation

 

Archived medical policy effective November 6, 2022

The following policy has been archived and has been replaced by AIM guidelines:

• SURG.00143 Perirectal Spacers for Use During Prostate Radiotherapy

 

New medical policies effective February 1, 2023

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

• DME.00050 Remote Devices for Intermittent Monitoring of Intraocular Pressure
• LAB.00049 Artificial Intelligence-Based Software for Prostate Cancer Detection

 

Revised medical policy effective February 1, 2023

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:

• DME.00044 Robotic Arm Assistive Devices

 

New medical policies effective February 4, 2023

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

• DME.00049 External Upper Limb Stimulation for the Treatment of Tremors
• MED.00141 High-volume Colonic Irrigation
• TRANS.00040 Hand Transplantation

 

Revised medical policy effective February 4, 2023

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:

• SURG.00079 Nasal Valve Repair

 

Revised medical policy effective February 11, 2023

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:

• SURG.00121 Transcatheter Heart Valve Procedures

 

Clinical Guideline updates

 

Revised clinical guideline effective August 24, 2022

The following adopted guideline was reviewed and may have word changes or clarifications but had no significant changes to the policy position or criteria:

• CG-MED-68 Therapeutic Apheresis

 

Revised clinical guidelines effective September 28, 2022

The following adopted guidelines were updated with new CPT/HCPCS/ICD-10-PCS procedure code and/or ICD-10-CM diagnosis code updates:

• CG-GENE-10 Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability and Congenital Anomalies
• CG-MED-68 Therapeutic Apheresis
• CG-SURG-97 Cardioverter Defibrillators

 

Unadopted clinical guideline effective October 1, 2022

The criteria in the following guideline will no longer be applied:

• CG-SURG-96 Intraocular Telescope

 

Revised clinical guideline effective October 5, 2022

The following adopted guideline was revised to expand medical necessity indications or criteria:

• CG-GENE-22 Gene Expression Profiling for Managing Breast Cancer Treatment

 

Revised clinical guidelines effective October 5, 2022

The following adopted guidelines were reviewed and may have word changes or clarifications but had no significant changes to the policy position or criteria:

• CG-DME-10 Durable Medical Equipment
• CG-DME-41 Ultraviolet Light Therapy Delivery Devices for Home Use
• CG-DME-44 Electric Tumor Treatment Field (TTF)
• CG-MED-55 Site of Care: Advanced Radiologic Imaging
• CG-MED-64 Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins
• CG-MED-66 Cryopreservation of Oocytes or Ovarian Tissue
• CG-MED-69 Inhaled Nitric Oxide
• CG-MED-83 Site of Care: Specialty Pharmaceuticals
• CG-REHAB-07 Skilled Nursing and Skilled Rehabilitation Services (Outpatient)
• CG-REHAB-08 Private Duty Nursing in the Home Setting
• CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities
• CG-SURG-52 Site of Care: Hospital-Based Ambulatory Surgical Procedures and Endoscopic Services
• CG-SURG-63 Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure
• CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity

 

Revised clinical guidelines effective February 1, 2023

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-GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status
• CG-GENE-13 Genetic Testing for Inherited Diseases

 

Revised clinical guidelines effective February 11, 2023

The following adopted guideline was revised and might result in services that were previously covered but may now be found to be not medically necessary:

• CG-DME-31 Powered Wheeled Mobility Devices

 

NYBCBS-CM-009373-22