January 2019 medical policy update bulletin...complete copy of a new, updated, or revised policy....

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice

staff with a simple and predictable administrative experience. The Medical Policy Update Bulletin was developed to share important information regarding UnitedHealthcare Medical Policy, Medical Benefit Drug Policy, Coverage Determination Guideline, Utilization Review Guideline, and Quality of Care Guideline updates.* *Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law.

January 2019

medical policy update bulletin Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

2 Medical Policy Update Bulletin: January 2019

Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

Overview

Tips for using the Medical Policy Update Bulletin:

From the table of contents, click the policy title to be

directed to the corresponding policy update summary.

From the policy updates table, click the policy title to view a

complete copy of a new, updated, or revised policy.

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

requirements have been adopted for a health service (e.g., test, drug,

device or procedure)

Updated

An existing policy has been reviewed and changes have not been made

to the clinical coverage criteria or documentation review requirements;

however, items such as the clinical evidence, FDA information, and/or

list(s) of applicable codes may have been updated

Revised

An existing policy has been reviewed and revisions have been made to

the clinical coverage criteria and/or documentation review requirements

Replaced

An existing policy has been replaced with a new or different policy

Retired

The health service(s) addressed in the policy are no longer being

managed or are considered to be proven/medically necessary and are

therefore not excluded as unproven/not medically necessary services,

unless coverage guidelines or criteria are otherwise documented in

another policy

Note: The absence of a policy does not automatically indicate or imply

coverage. As always, coverage for a health service must be determined

in accordance with the member’s benefit plan and any applicable

federal or state regulatory requirements. Additionally, UnitedHealthcare

reserves the right to review the clinical evidence supporting the safety

and effectiveness of a medical technology prior to rendering a coverage

determination.

This bulletin provides complete details on UnitedHealthcare Medical

Policy, Medical Benefit Drug Policy, Coverage Determination

Guideline (CDG), Utilization Review Guideline (URG), and/or

Quality of Care Guideline (QOCG) updates. The inclusion of a

health service (e.g., test, drug, device or procedure) in this bulletin

indicates only that UnitedHealthcare has recently adopted a new

policy and/or updated, revised, replaced or retired an existing

policy; it does not imply that UnitedHealthcare provides coverage

for the health service. In the event of an inconsistency or conflict

between the information provided in this bulletin and the posted

policy, the provisions of the posted policy will prevail. Note that

most benefit plan documents exclude from benefit coverage health

services identified as investigational or unproven/not medically

necessary. Physicians and other health care professionals may not

seek or collect payment from a member for services not covered by

the applicable benefit plan unless first obtaining the member’s

written consent, acknowledging that the service is not covered by

the benefit plan and that they will be billed directly for the service.

The complete library of UnitedHealthcare Medical

Policies, Medical Benefit Drug Policies, CDGs, URGs, and

QOCGs is available at UHCprovider.com > Policies and

Protocols > Commercial Policies > Medical & Drug

Policies and Coverage Determination Guidelines.

https://www.uhcprovider.com/en/policies-protocols/commercial-policies/commercial-medical-drug-policies.html





In This Issue

Take Note Page

ANNUAL CPT® AND HCPCS CODE UPDATES

Bone or Soft Tissue Healing and Fusion Enhancement Products – Effective Jan. 1, 2019 .......................................................................................... 7 Breast Imaging for Screening and Diagnosing Cancer – Effective Jan. 1, 2019 ........................................................................................................ 7 Brineura™ (Cerliponase Alfa) – Effective Jan. 1, 2019 ......................................................................................................................................... 7 Cardiovascular Disease Risk Tests – Effective Jan. 1, 2019 .................................................................................................................................. 7 Carrier Testing for Genetic Diseases – Effective Jan. 1, 2019 ............................................................................................................................... 7 Chemosensitivity and Chemoresistance Assays in Cancer – Effective Jan. 1, 2019 ................................................................................................... 7 Clotting Factors, Coagulant Blood Products & Other Hemostatics – Effective Jan. 1, 2019 ......................................................................................... 7 Crysvita® (Burosumab-Twza) – Effective Jan. 1, 2019 ........................................................................................................................................ 7 Deep Brain and Cortical Stimulation – Effective Jan. 1, 2019................................................................................................................................ 7 Enzyme Replacement Therapy – Effective Jan. 1, 2019 ....................................................................................................................................... 7 Extracorporeal Shock Wave Therapy (ESWT) – Effective Jan. 1, 2019 ...................................................................................................................... 8 Genetic Testing for Hereditary Cancer – Effective Jan. 1, 2019 ............................................................................................................................. 8 Gonadotropin Releasing Hormone Analogs – Effective Jan. 1, 2019 ....................................................................................................................... 8 Habilitative Services and Outpatient Rehabilitation Therapy – Effective Jan. 1, 2019 ............................................................................................... 8 Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable – Effective Jan. 1, 2019 ............................................................ 8 Hepatitis Screening – Effective Jan. 1, 2019 ...................................................................................................................................................... 8 High Frequency Chest Wall Compression Devices – Effective Jan. 1, 2019 .............................................................................................................. 8 Home Health Care – Effective Jan. 1, 2019........................................................................................................................................................ 8 Ilumya™ (Tildrakizumab-Asmn) – Effective Jan. 1, 2019 ..................................................................................................................................... 8 Infliximab (Remicade®, Inflectra™, Renflexis™) – Effective Jan. 1, 2019 ............................................................................................................... 8 Intensity-Modulated Radiation Therapy – Effective Jan. 1, 2019 ........................................................................................................................... 8 Luxturna™ (Voretigene Neparvovec-Rzyl) – Effective Jan. 1, 2019 ........................................................................................................................ 9 Macular Degeneration Treatment Procedures – Effective Jan. 1, 2019 ................................................................................................................... 9 Maximum Dosage – Effective Jan. 1, 2019 ........................................................................................................................................................ 9 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Jan. 1, 2019 ........................................................... 9 Neurophysiologic Testing and Monitoring – Effective Jan. 1, 2019 ......................................................................................................................... 9 Neuropsychological Testing Under the Medical Benefit – Effective Jan. 1, 2019 ....................................................................................................... 9 Omnibus Codes – Effective Jan. 1, 2019 ........................................................................................................................................................... 9 Onpattro™ (Patisiran) – Effective Jan. 1, 2019 ................................................................................................................................................. 10 Preventive Care Services – Effective Jan. 1, 2019 ............................................................................................................................................ 10 Proton Beam Radiation Therapy – Effective Jan. 1, 2019 ................................................................................................................................... 10



In This Issue

Radicava™ (Edaravone) – Effective Jan. 1, 2019 .............................................................................................................................................. 10 Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®) – Effective Jan. 1, 2019 ............................................................................................. 10 Rituxan® (Rituximab) – Effective Jan. 1, 2019 – Effective Jan. 1, 2019 ................................................................................................................ 10 Self-Administered Medications List – Effective Jan. 1, 2019 ............................................................................................................................... 10 Skin and Soft Tissue Substitutes – Effective Jan. 1, 2019 .................................................................................................................................. 11 Sodium Hyaluronate – Effective Jan. 1, 2019 ................................................................................................................................................... 11 Surgical Treatment for Spine Pain – Effective Jan. 1, 2019 ................................................................................................................................ 11 Therapeutic Radiopharmaceuticals – Effective Jan. 1, 2019 ................................................................................................................................ 11 Trogarzo™ (Ibalizumab-Uiyk) – Effective Jan. 1, 2019 ...................................................................................................................................... 11 White Blood Cell Colony Stimulating Factors – Effective Jan. 1, 2019 .................................................................................................................. 11

Medical Policy Updates

UPDATED

Ablative Treatment for Spinal Pain – Effective Jan. 1, 2019 ................................................................................................................................ 12 Autologous Chondrocyte Transplantation in the Knee – Effective Jan. 1, 2019 ...................................................................................................... 12 Bone or Soft Tissue Healing and Fusion Enhancement Products – Effective Jan. 1, 2019 ........................................................................................ 12 Breast Imaging for Screening and Diagnosing Cancer – Effective Jan. 1, 2019 ...................................................................................................... 12 Cardiovascular Disease Risk Tests – Effective Jan. 1, 2019 ................................................................................................................................ 12 Cochlear Implants – Effective Jan. 1, 2019 ...................................................................................................................................................... 13 Deep Brain and Cortical Stimulation – Effective Jan. 1, 2019.............................................................................................................................. 13 Electric Tumor Treatment Field Therapy – Effective Jan. 1, 2019 ........................................................................................................................ 13 Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable – Effective Jan. 1, 2019 .......................................................... 13 Hepatitis Screening – Effective Jan. 1, 2019 .................................................................................................................................................... 13 Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors – Effective Jan. 1, 2019 ...................................................................... 14 Infertility Diagnosis and Treatment – Effective Jan. 1, 2019 ............................................................................................................................... 14 Intensity-Modulated Radiation Therapy – Effective Jan. 1, 2019 ......................................................................................................................... 14 Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) – Effective Jan. 1, 2019 ................................................................................. 15 Macular Degeneration Treatment Procedures – Effective Jan. 1, 2019 ................................................................................................................. 15 Magnetic Resonance Spectroscopy (MRS) – Effective Jan. 1, 2019 ...................................................................................................................... 15 Mechanical Stretching Devices – Effective Jan. 1, 2019 ..................................................................................................................................... 15 Meniscus Implant and Allograft – Effective Jan. 1, 2019 .................................................................................................................................... 15 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Jan. 1, 2019 ......................................................... 16 Osteochondral Grafting – Effective Jan. 1, 2019 ............................................................................................................................................... 16 Percutaneous Vertebroplasty and Kyphoplasty – Effective Jan. 1, 2019 ............................................................................................................... 16



In This Issue

Spinal Ultrasonography – Effective Jan. 1, 2019 ............................................................................................................................................... 16 Surgical Treatment for Spine Pain – Effective Jan. 1, 2019 ................................................................................................................................ 16 Surgical Treatment for Spine Pain – Effective Feb. 1, 2019 ................................................................................................................................ 16 Total Artificial Heart – Effective Jan. 1, 2019 ................................................................................................................................................... 17 Transpupillary Thermotherapy – Effective Jan. 1, 2019 ..................................................................................................................................... 17 Umbilical Cord Blood Harvesting and Storage for Future Use – Effective Jan. 1, 2019 ............................................................................................ 17 Unicondylar Spacer Devices for Treatment of Pain or Disability – Effective Jan. 1, 2019 ......................................................................................... 17 Vagus Nerve Stimulation – Effective Jan. 1, 2019 ............................................................................................................................................. 17

REVISED

Electrical Stimulation and Electromagnetic Therapy for Wounds – Effective Feb. 1, 2019 ........................................................................................ 17 Fetal Aneuploidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood – Effective Mar. 1, 2019 ................................................................... 19 Omnibus Codes – Effective Feb. 1, 2019 ......................................................................................................................................................... 21 Proton Beam Radiation Therapy – Effective Jan. 1, 2019 ................................................................................................................................... 22 Skin and Soft Tissue Substitutes – Effective Feb. 1, 2019 .................................................................................................................................. 24 Temporomandibular Joint Disorders – Effective Feb. 1, 2019 ............................................................................................................................ 26

Medical Benefit Drug Policy Updates

REVISED

Botulinum Toxins A and B – Effective Jan. 1, 2019 ........................................................................................................................................... 29 Clotting Factors, Coagulant Blood Products & Other Hemostatics – Effective Jan. 1, 2019 ....................................................................................... 29 Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease – Effective Jan. 1, 2019 ............................................................................... 32 Maximum Dosage – Effective Jan. 1, 2019 ...................................................................................................................................................... 34 Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®) – Effective Jan. 1, 2019 ............................................................................................. 37 Xolair® (Omalizumab) – Effective Jan. 1, 2019 ................................................................................................................................................... 38

Coverage Determination Guideline (CDG) Updates

UPDATED

Ambulance Services – Effective Jan. 1, 2019 ................................................................................................................................................... 42 Breast Repair/Reconstruction Not Following Mastectomy – Effective Jan. 1, 2019 .................................................................................................. 42 Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements – Effective Jan. 1, 2019 .................................... 42 Home Health Care – Effective Jan. 1, 2019...................................................................................................................................................... 42 Infertility Services – Effective Jan. 1, 2019 ...................................................................................................................................................... 43 Private Duty Nursing Services (PDN) – Effective Jan. 1, 2019 ............................................................................................................................ 43 Skilled Care and Custodial Care Services – Effective Jan. 1, 2019 ....................................................................................................................... 43



In This Issue

REVISED

Speech Language Pathology Services – Effective Feb. 1, 2019 ........................................................................................................................... 43

Utilization Review Guideline (URG) Updates

NEW

Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) Scan – Site of Care – Effective Feb. 1, 2019 .................................................... 47


Take Note


Effective Jan. 1, 2019, the following Medical Policies, Medical Benefit Drug Policies, Coverage Determination Guidelines, and Utilization Review Guidelines have been modified to reflect the 2019 Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) code additions, revisions, and deletions. Refer to the following sources for information on the 2019 code updates:

American Medical Association. Current Procedural Terminology: CPT®

Centers for Medicare & Medicaid Services. Healthcare Common Procedure Coding System: HCPCS Level II

Policy Title Policy Type Summary of Changes

Bone or Soft Tissue Healing and Fusion Enhancement

Products

Medical Policy Added 20932, 20933, 20934, Q4186, and Q4187 Removed Q4131

Breast Imaging for Screening and Diagnosing Cancer

Medical Policy Added 76391, 77046, 77047, 77048, and 77049 Removed 0159T, 0346T, 77058, and 77059

Brineura™ (Cerliponase Alfa)

Medical Benefit Drug Policy

Added J0567 Removed C9014

Cardiovascular

Disease Risk Tests

Medical Policy Removed 0337T

Carrier Testing for Genetic Diseases

Medical Policy Added 81443

Chemosensitivity and Chemoresistance

Assays in Cancer

Medical Policy Added 0083U

Clotting Factors, Coagulant Blood Products & Other Hemostatics


Added J7170, J7177, and J7203 Removed Q9995 Revised description for J7178

Crysvita®

(Burosumab-Twza)

Medical Benefit

Drug Policy

Added J0584

Deep Brain and Cortical Stimulation

Medical Policy Removed 95978 and 95979

Enzyme Replacement Therapy


Added J3397

https://www.ama-assn.org/practice-management/cpt

https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html


Take Note



Extracorporeal Shock

Wave Therapy (ESWT)

Medical Policy Added 0512T and 0513T

Genetic Testing for Hereditary Cancer

Medical Policy Added 81163, 81164, 81165, 81166, and 81167 Removed 81211, 81213, and 81214 Revised description for 81162, 81212, 81215, 81216, and 81217

Gonadotropin Releasing Hormone

Analogs


Added J3316

Habilitative Services and Outpatient Rehabilitation Therapy

Coverage Determination Guideline

Removed 64550

Hearing Aids and

Devices Including Wearable, Bone-Anchored and Semi-

Implantable

Medical Policy Added V5171, V5172, V5181, V5211, V5212, V5213, V5214, V5215, and V5221

Removed V5170, V5180, V5210, and V5220 Revised description for V5190 and V5230

Hepatitis Screening Medical Policy Added 81596

Revised description for G0499

High Frequency Chest Wall Compression Devices

Medical Policy Revised description for E0483

Home Health Care Coverage

Determination Guideline

Added G0068, G0069, and G0070

Ilumya™ (Tildrakizumab-Asmn)


Added J3245

Infliximab (Remicade®,

Inflectra™, Renflexis™)


Added Q5109

Intensity-Modulated Radiation Therapy

Medical Policy Revised description for 77387


Take Note



Luxturna™

(Voretigene Neparvovec-Rzyl)

Medical Benefit

Drug Policy

Added J3398

Removed C9032

Macular Degeneration Treatment Procedures


Maximum Dosage Medical Benefit Drug Policy

Added J9312 Removed J9310

Molecular Oncology

Testing for Cancer Diagnosis, Prognosis, and Treatment

Decisions

Medical Policy Added 81518

Neurophysiologic Testing and Monitoring

Medical Policy Added 0533T, 0534T, 0535T, and 0536T

Neuropsychological Testing Under the

Medical Benefit

Medical Policy Added 96121, 96132, 96133, 96136, 96137, 96138, 96139, and 96146 Removed 96118, 96119, and 96120

Revised description for 96116

Omnibus Codes Medical Policy Multifocal electroretinogram (mfERG) and pattern electroretinogram (PERG) or pattern electroretinogram optimized for glaucoma screening (PERGLA) Added 0509T

Intracardiac ischemia monitoring systems Added 0525T, 0526T, 0527T, 0528T, 0529T, 0530T, 0531T, and 0532T

Sinus tarsi implant Revised description for 0335T

Leadless pacemakers for treating cardiac arrhythmias Added 33274 and 33275 Removed 0387T, 0388T, 0389T, 0390T, and 0391T

Ultrasound elastography Added 76981, 76982, and 76983


Take Note



Omnibus Codes

(continued)


Digestive enzyme cartridges (e.g., Relizorb™) for use with enteral tube feeding Added B4105 Removed Q9994

Retinal prosthetic devices

Added L8608

Upper limb orthotic known as the MyoPro™ Added L8701 and L8702

Onpattro™ (Patisiran) Medical Benefit

Drug Policy

Added C9036

Preventive Care Services

Coverage Determination Guideline

Preventive Care Services

Genetic Counseling and Evaluation for BRCA Testing; and BRCA Lab Screening Added 81163, 81164, 81165, 81166, and 81167 Removed 81211, 81213, and 81214

Cholesterol Screening (Lipid Disorders Screening)

Added 83722

Dyslipidemia Screening (Bright Futures)

Added 83722

Preventive Immunizations

Seasonal Influenza (‘flu’)

Added 90689

Proton Beam Radiation Therapy

Medical Policy Revsied description for 77387

Radicava™ (Edaravone)


Added J1301

Respiratory Interleukins

(Cinqair®, Fasenra®, and Nucala®)


Added J0517

Rituxan® (Rituximab) Medical Benefit Drug Policy

Added J9312 Removed J9310

Self-Administered

Medications List

Medical Benefit

Drug List

Removed C9015 and C9029


Take Note



Skin and Soft Tissue

Substitutes

Medical Policy Added Q4186, Q4187, Q4195, and Q4196

Removed Q4131 and Q4172

Sodium Hyaluronate Medical Policy Added J7318 and J7329

Surgical Treatment

for Spine Pain

Medical Policy Removed 0195T and 0196T

Therapeutic Radiopharmaceuticals

Medical Policy Added A9513 Removed C9031

Trogarzo™ (Ibalizumab-Uiyk)


Added J1746

White Blood Cell

Colony Stimulating Factors

Medical Benefit

Drug Policy

Added Q5111



Policy Title Effective Date Summary of Changes

UPDATED

Ablative Treatment

for Spinal Pain

Jan. 1, 2019 Updated and reformatted coverage rationale:

o Simplified content o Replaced reference to "regional pain disorders and syndromes” with “Complex Regional Pain Syndrome” o Modified list of examples of unproven and not medically necessary pain indications; removed “diabetic

neuropathy” Added definition of:

o Complex Regional Pain Syndrome (CRPS) o Facet Nerve Block

o Pulsed Radiofrequency Ablation Updated supporting information to reflect the most current references

Autologous Chondrocyte

Transplantation in the Knee

Jan. 1, 2019 Simplified coverage rationale (no change to guidelines)

Bone or Soft Tissue

Healing and Fusion Enhancement

Products

Jan. 1, 2019 Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section

Simplified coverage rationale (no change to guidelines) Updated list of applicable CPT/HCPCS codes to reflect annual code edits:

o Added 20932, 20933, 20934, Q4186, and Q4187 o Removed Q4131

Breast Imaging for Screening and

Diagnosing Cancer

Jan. 1, 2019 Reorganized policy template: o Simplified and relocated Instructions for Use

o Removed Benefit Considerations section Simplified coverage rationale (no change to guidelines) Updated list of applicable CPT codes to reflect annual code edits:

o Added 76391, 77046, 77047, 77048, and 77049

o Removed 0159T, 0346T, 77058, and 77059

Cardiovascular Disease Risk Tests

Jan. 1, 2019 Reorganized policy template: o Simplified and relocated Instructions for Use o Removed Benefit Considerations section

Simplified coverage rationale (no change to guidelines) Updated list of applicable CPT codes:

o Added 93998

o Removed 0337T (annual code edit)

Updated supporting information to reflect the most current clinical evidence, CMS information, and references




UPDATED

Cochlear Implants


Updated and reformatted coverage rationale: o Simplified content o Removed criterion requiring “no contraindications to surgery"

Added definition of “Sensorineural Hearing Loss (SNHL)”

Updated list of applicable HCPCS codes; revised description for V5273 Updated supporting information to reflect the most current CMS information and references

Deep Brain and Cortical Stimulation

Jan. 1, 2019 Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section Updated and reformatted coverage rationale:

o Simplified content o Modified language to clarify the listed services are:

Proven and medically necessary (as described) Unproven and not medically necessary (as described)

Added definition of: o Primary Dystonia o Secondary Dystonia

o Secondary Parkinsonism Updated list of applicable CPT codes to reflect annual code edits; removed 95978 and 95979 Updated supporting information to reflect the most current description of services, clinical evidence, FDA

information, and references

Electric Tumor Treatment Field Therapy


Hearing Aids and Devices Including

Wearable, Bone-Anchored and Semi-Implantable

Jan. 1, 2019 Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section Simplified coverage rationale (no change to guidelines)

Added definition of “Hearing Impairment” Updated list of applicable HCPCS codes for wearable hearing aids to reflect annual code edits:

o Added V5171, V5172, V5181, V5211, V5212, V5213, V5214, V5215, and V5221

o Removed V5170, V5180, V5210, and V5220 o Revised description for V5190 and V5230

Hepatitis Screening

Jan. 1, 2019

Reorganized policy template: o Simplified and relocated Instructions for Use o Removed Benefit Considerations section

Updated list of applicable CPT/HCPCS codes to reflect annual code edits: o Added 81596




UPDATED

Hepatitis Screening

(continued)

Jan. 1, 2019 o Revised description for G0499

Implantable Beta-

Emitting Microspheres for Treatment of

Malignant Tumors

Jan. 1, 2019 Reorganized policy template:

o Simplified and relocated Instructions for Use o Removed Benefit Considerations section

Updated and reformatted coverage rationale:

o Simplified content o Modified language to clarify the listed services are:

Proven and medically necessary (as described)

Unproven and not medically necessary (as described) Updated supporting information to reflect the most current description of services, clinical evidence, and

references

Infertility Diagnosis and Treatment

Jan. 1, 2019 Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section Updated and reformatted coverage rationale:

o Simplified content

o Modified language to clarify the listed services are: Proven and medically necessary (as described)

Unproven and not medically necessary (as described) Updated definitions:

o Added definition of “Preimplantation Genetic Testing (PGT)”

o Removed definition of: Preimplantation Genetic Diagnosis (PGD) Preimplantation Genetic Screening (PGS)

Updated supporting information to reflect the most current clinical evidence, CMS information, and references

Intensity-

Modulated Radiation Therapy

Jan. 1, 2019

Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section

Updated and reformatted coverage rationale: o Simplified content o Modified language to clarify the listed services are:

Proven and medically necessary (as described) Unproven and not medically necessary (as described)

o Replaced references to: “Diagnoses” with “conditions”

“Patient(s)” with “individual(s)” o Replaced language indicating “intensity-modulated radiation therapy (IMRT) may be covered for a condition

that is not listed as proven, including recurrences or metastases in selected cases, when a non-IMRT

technique would substantially increase the probability of clinically meaningful normal tissue toxicity, as




UPDATED

Intensity-

Modulated Radiation Therapy (continued)

Jan. 1, 2019 demonstrated on a comparison of treatment plans for the IMRT and non-IMRT technique (e.g., three-

dimensional conformal treatment plan)” with “IMRT may be covered for a condition that is not listed as proven, including recurrences or metastases in selected cases, when a non-IMRT technique would increase the probability of clinically meaningful normal tissue toxicity (e.g., as specified by the QUANTEC guidelines) and demonstrated on a comparison of treatment plans for the IMRT and non-IMRT technique (e.g., three-

dimensional conformal treatment plan)” Updated list of applicable CPT codes to reflect annual code edits; revised description for 77387 Updated supporting information to reflect the most current clinical evidence, CMS information, and references

Intraoperative

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)


Simplified coverage rationale (no change to guidelines)

Macular

Degeneration

Treatment Procedures


Updated list of applicable CPT codes to reflect annual code edits; removed 0190T

Magnetic

Resonance Spectroscopy (MRS)


Mechanical Stretching Devices


o Removed Benefit Considerations section Updated and reformatted coverage rationale:


o Modified language to clarify the listed services are: Proven and medically necessary (as described) Unproven and not medically necessary (as described)

Updated supporting information to reflect the most current description of services, clinical evidence, FDA


Meniscus Implant

and Allograft


Added definition of “Functional or Physical Impairment”




UPDATED

Molecular Oncology

Testing for Cancer Diagnosis, Prognosis, and Treatment

Decisions

Jan. 1, 2019 Notice of Revision: The following summary of changes has been modified. Revisions to the previous policy update

announcement are outlined in red below. Please take note of the amended updates to be implemented on Jan. 1, 2019. Reorganized policy template:


Updated coverage rationale; modified language to clarify the listed services are:

o Proven and medically necessary (as described) o Unproven and not medically necessary (as described)

Updated list of applicable CPT codes; added 81425, 81426, 81427, 81443*, 81479, and 81518* (*annual code

edit)

Osteochondral

Grafting



Updated and reformatted coverage rationale:

o Simplified content o Replaced criterion requiring “willingness to comply with an extensive period of rehabilitation following

surgery” with “willingness to comply with rehabilitation following surgery”

Percutaneous

Vertebroplasty and Kyphoplasty



Updated and reformatted coverage rationale: o Simplified content

o Replaced reference to “severe debilitating pain” with “pain causing Functional or Physical Impairment” Added definition of “Functional or Physical Impairment”

Spinal Ultrasonography


Surgical Treatment for Spine Pain


o Removed Benefit Considerations section Updated list of applicable CPT codes to reflect annual code edits; removed 0195T and 0196T

Surgical Treatment for Spine Pain

Feb. 1, 2019

Simplified coverage rationale (no change to guidelines) Updated list of applicable CPT codes:




UPDATED

Surgical Treatment

for Spine Pain (continued)

Feb. 1, 2019 o Added 62380, 63051, 63275, 63277, 63280, 63282, 63285, 63287, and 63290

o Revised description for 0202T Updated supporting information to reflect the most current description of services, clinical evidence, CMS


Total Artificial Heart


Transpupillary

Thermotherapy


Umbilical Cord Blood Harvesting and Storage for Future Use



Updated supporting information to reflect the most current references

Unicondylar Spacer Devices for Treatment of Pain

or Disability



Vagus Nerve Stimulation



Policy Title Effective Date Summary of Changes Coverage Rationale

REVISED

Electrical Stimulation and Electromagnetic

Therapy for Wounds

Feb. 1, 2019

Reorganized policy template: o Simplified and relocated

Instructions for Use

o Removed Benefit Considerations section

Revised and reformatted

coverage rationale:

o Simplified content o Added language to indicate

Electrical stimulation is proven and medically necessary for treating Stage III or IV pressure ulcers that have failed to demonstrate Measurable Signs of Healing with 30 days of conventional treatment

which includes ALL of the following: Application of dressings to maintain a moist wound environment; and Debridement of necrotic tissue, if present; and

Evaluation of and provision for adequate nutritional status; and

Appropriate turning and positioning; and Use of a pressure-reducing support surface; and




REVISED

Electrical

Stimulation and Electromagnetic Therapy for Wounds

(continued)

Feb. 1, 2019

electrical stimulation is

proven and medically necessary for treating Stage III or IV pressure ulcers that have failed to demonstrate

Measurable Signs of Healing with 30 days of conventional treatment, which includes all

of the following: Application of dressings

to maintain a moist

wound environment; and Debridement of necrotic

tissue, if present; and Evaluation of and

provision for adequate nutritional status; and

Appropriate turning and

positioning; and Use of a pressure-

reducing support

surface; and Moisture and

incontinence management

o Removed language indicating electrical stimulation is unproven and

not medically necessary for treating arterial ulcers and chronic pressure sores

Added definition of: o Measurable Signs of Healing o Pressure Ulcer Staging

[National Pressure Ulcer

Advisory Panel (NPUAP) Staging System]

Updated list of applicable HCPCS

codes; revised description for

Moisture and incontinence management.

The following are unproven and not medically necessary due to insufficient evidence of efficacy: Electrical stimulation for treating all other wounds or ulcers, including

but not limited to: o Diabetic ulcers o Venous stasis ulcers

Electromagnetic therapy for treating wounds or ulcers including but not limited to: o Venous stasis ulcers

o Arterial ulcers o Diabetic foot ulcers o Chronic pressure sores o Soft tissue injuries




REVISED

Electrical

Stimulation and Electromagnetic Therapy for Wounds

(continued)

Feb. 1, 2019 G0295

Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS


Fetal Aneuploidy Testing Using Cell-Free Fetal Nucleic

Acids in Maternal Blood

Mar. 1, 2019




Revised coverage rationale: o Modified language to clarify

the listed services are: Proven and medically

necessary (as described)

Unproven and not medically necessary (as described)

o Replaced language indicating: “DNA-based noninvasive

prenatal tests of fetal

aneuploidy are unproven and/or not medically necessary for all other

indications including, but not limited to, [those listed in the policy]” with

“DNA-based noninvasive prenatal tests are unproven and not medically necessary for

all other fetal conditions including, but not limited to, [those listed in the

policy]” “Genetic counseling is

DNA-based noninvasive prenatal tests of fetal aneuploidy are proven and medically necessary as screening tools for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) or trisomy 13 (Patau

syndrome) in ANY ONE of the following circumstances: Maternal age of 35 years or older at delivery Fetal ultrasound findings indicating an increased risk of aneuploidy History of a prior pregnancy with a trisomy

Positive first- or second-trimester screening test results for aneuploidy Parental balanced Robertsonian translocation with an increased risk of

fetal trisomy 13 or trisomy 21

DNA-based noninvasive prenatal tests are unproven and not medically necessary for all other fetal conditions including, but not

limited to, the following: Multiple gestation pregnancies Twin zygosity Repeat testing due to low fetal fraction

Screening for the following: o Aneuploidy other than trisomies 21, 18, or 13 o Microdeletions

o Single gene disorders o Fetal RhD status

Genetic Counseling

Genetic counseling is strongly recommended prior to fetal screening or

prenatal diagnosis in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.




REVISED

Fetal Aneuploidy

Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood

(continued)

Mar. 1, 2019

strongly recommended

prior to this test” with “genetic counseling is strongly recommended prior to fetal screening

or prenatal diagnosis” o Revised list of unproven/not

medically necessary DNA-

based noninvasive prenatal tests: Added:

- Twin zygosity - Repeat testing due

to low fetal fraction - Screening for:

Aneuploidy other than trisomies

21, 18, or 13

Single gene disorders

Fetal RhD status

Removed: - Screening for sex

chromosome aneuploidies

Removed language indicating further studies are needed to evaluate

the use of these tests in other populations

Added definition of:

o Aneuploidy o Cell Free Fetal DNA (cffDNA

or cfDNA) o Comparative Genomic

Hybridization (CGH) o Massively Parallel

Sequencing (MPS)

o Mosaicism




REVISED

Fetal Aneuploidy

Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood

(continued)

Mar. 1, 2019 o Next Generation Sequencing

(NGS) o Non-Invasive Prenatal

Testing/Screening (NIPT/NIPS)

o Single Nucleotide Polymorphisms (SNPs)

o Trisomy 13 (Patau

Syndrome) o Trisomy 18 (Edwards

Syndrome)

o Trisomy 21 (Down Syndrome)

o Whole Genome Sequencing (WGS)

Updated list of applicable CPT codes; added 0060U and 81479

Updated supporting information

to reflect the most current description of services, clinical evidence, FDA information, and

references

Omnibus Codes

Feb. 1, 2019

Revised coverage guidelines for

transperineal placement of biodegradable material, peri-prostatic (via needle) (CPT

code 55874): o Added language to indicate

the transperineal placement

of biodegradable material, peri-prostatic (via needle) is proven and medically necessary for use with

radiotherapy for treating prostate cancer

o Replaced language indicating

“the transperineal placement of biodegradable material,

Refer to the policy for complete details on the coverage guidelines for

Omnibus Codes.




REVISED

Omnibus Codes

(continued)

Feb. 1, 2019 peri-prostatic (via needle) is

unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in the

published peer-reviewed medical literature” with “the transperineal placement of

biodegradable material, peri-prostatic (via needle) is unproven and not medically

necessary for all other indications [not listed as proven and medically necessary] due to

insufficient evidence of efficacy”

Added coverage guidelines to

indicate laboratory measurement of antibodies and serum levels related to

biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab) for treating inflammatory

bowel disease (CPT codes 80299 and 84999) is unproven and not medically necessary due

to insufficient evidence of efficacy

Updated supporting information

to reflect the most current clinical evidence and references

Proton Beam Radiation Therapy

Jan. 1, 2019




Note: This policy applies to persons 19 years of age and older. Proton beam radiation therapy (PBT) is covered without further review for persons younger than 19 years of age.

The following are proven and medically necessary:




REVISED

Proton Beam

Radiation Therapy (continued)

Jan. 1, 2019

Revised and reformatted

coverage rationale: o Simplified content o Added notation (previously

located in the Benefit

Considerations section) to indicate this policy applies to persons 19 years of age and

older; proton beam radiation therapy (PBT) is covered without further review for

persons younger than 19 years of age

o Modified language to clarify the listed services are:

Proven and medically necessary (as described)

Unproven and not

medically necessary (as described)

o Added language to indicate

PBT and intensity-modulated radiation therapy (IMRT) are proven and considered clinically equivalent for

treating prostate cancer; medical necessity will be determined based on the

terms of the member’s benefit plan

o Removed language

indicating PBT is unproven and not medically necessary for treating prostate cancer

Updated list of applicable CPT

codes to reflect annual code edits; revised description for

77387

Updated list of applicable ICD-10

PBT for Definitive Therapy of the following indications:

o Intracranial arteriovenous malformations (AVMs) o Ocular tumors, including intraocular/uveal melanoma (includes the

iris, ciliary body and choroid) o Skull-based tumors (e.g., chordomas, chondrosarcomas or paranasal

sinus tumors) o Localized, unresectable hepatocellular carcinoma (HCC) in the

curative setting when documentation is provided that sparing of the

surrounding normal tissue cannot be achieved with standard radiation therapy techniques, including intensity-modulated radiation therapy (IMRT), and stereotactic body radiation therapy (SBRT), and

selective internal radiation spheres, and transarterial therapy (for example, chemoembolization) is contraindicated or not technically feasible

PBT may be covered for a diagnosis that is not listed above as proven,

including recurrences or metastases in selected cases. Requests for exceptions will be evaluated on a case-by-case basis when both of the

following criteria are met:

o Documentation is provided that sparing of the surrounding normal tissue cannot be achieved with standard radiation therapy techniques; and

o Evaluation includes a comparison of treatment plans for PBT, IMRT and SBRT

PBT and IMRT are proven and considered clinically equivalent for

treating prostate cancer. Medical necessity will be determined based on the terms of the member’s benefit plan.

PBT is unproven and not medically necessary due to insufficient evidence of efficacy for treating ALL other indications not listed above as proven, including but not limited to:

Age related macular degeneration (AMD) Bladder cancer Brain and spinal cord tumors Breast cancer

Choroidal hemangioma Esophageal cancer

Gynecologic cancers

Lung cancer




REVISED

Proton Beam

Radiation Therapy (continued)

Jan. 1, 2019 diagnosis codes; added C61.0

Updated supporting information to reflect the most current clinical evidence and references

Lymphomas

Pancreatic cancer Vestibular tumors (e.g., acoustic neuroma or vestibular schwannoma) PBT used in conjunction with IMRT

Skin and Soft Tissue Substitutes

Feb. 1, 2019

Revised and reformatted coverage rationale:

o Simplified content o Added language to indicate

the following skin and soft

tissue substitutes are unproven and not medically necessary for any indication due to insufficient evidence

of efficacy: AmnioArmor™ AmnioExcel Plus™

Artacent AC Cellesta™ or Cellesta

Flowable Amnion

Coll-e-Derm™ Derma-Gide™ Genesis Amniotic

Membrane

Grafix PRIME® GrafixPL PRIME® Keroxx™

Matrion™ Novachor™ PuraPly XT

Restorigin™ SkinTE™ Stravix™ or StravixPL™ Surgigraft™

XWRAP™ o Replaced reference to:

“Artacent®” with

“Artacent® Wound” “PuraPly™ Antimicrobial”

TransCyte™

TransCyte is proven and medically necessary for treating surgically excised Full-Thickness Thermal Burn wounds and deep Partial-Thickness Thermal Burn wounds before autograft placement.

TransCyte is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy.

Other Skin and Soft Tissue Substitutes

The following skin and soft tissue substitutes are unproven and not

medically necessary for any indication* due to insufficient evidence of efficacy:

Affinity®

Alloskin® Allowrap® Amnio Wound™

AmnioArmor™ Amnioband® AmnioExcel™, AmnioExcel Plus™,or BioDExcel™ AmnioFix®

Amniomatrix™ or Biodmatrix™ Architect Extracellular Matrix® Artacent® Wound or Artacent AC

ArthroFLEX® Bio-ConneKt® Biodfence™ or Biodfence Dryflex™

BioSkin™ BioSkin Flow Biovance® Cellesta™ or Cellesta Flowable Amnion

Clarix® Clarix Flo

Coll-e-Derm™

Conexa™ Reconstructive Matrix




REVISED

Skin and Soft

Tissue Substitutes (continued)

Feb. 1, 2019

with “PuraPly AM”

Updated list of applicable HCPCS codes to reflect annual code edits: o Added Q4183, Q4184,

Q4185, Q4188, Q4189, Q4190, Q4191, Q4192, Q4193, Q4194, Q4197,

Q4198, Q4200, Q4201, Q4202, Q4203, and Q4204

o Revised description for

Q4133 and Q4137 Updated supporting information

to reflect the most current clinical evidence, CMS


CorMatrix®

Cygnus™ Cymetra™ Cytal™ DermACELL®* (see asterisked note below when DermACELL is used

during breast reconstruction) Derma-Gide™ Dermapure™

DermaSpan™ Dermavest® or Plurivest® Epicord™

Epifix® Excellagen® Ez-derm® Floweramnioflo™ or FlowerFlo™

Floweramniopatch™ or FlowerPatch™ FlowerDerm™

GammaGraft™

Genesis Amniotic Membrane Grafix® GrafixPL®

Grafix PRIME® GrafixPL PRIME® Guardian Helicoll™

Hmatrix® HYALOMATRIX® Integra® Flowable Wound Matrix

InteguPly® Interfyl™ Keramatrix®

Kerecis™ Omega3 Keroxx™ Matrion™ MatriStem®

Mediskin™ MemoDerm™

Miroderm™

NeoPatch™




REVISED

Skin and Soft

Tissue Substitutes (continued)

Feb. 1, 2019 Neox®

Neox Flo® Novachor™ Nushield® PalinGen® Amniotic Tissue Allograft and PalinGen Flow products

PriMatrix® ProMatrX™ PuraPly™, PuraPly AM, or PuraPly XT

Repriza® Restorigin™ Revita™

Revitalon® SkinTE™ Strattice™ Stravix™ or StravixPL™

Surgigraft™ Talymed®

Tensix® TheraSkin® TranZgraft®

Truskin™ WoundEx™ WoundEx™ Flow Xcm Biologic Tissue Matrix®

XWRAP™ *Refer to the policy titled Breast Reconstruction Post Mastectomy for

information about coverage for skin and soft tissue substitutes used during post mastectomy breast reconstruction procedures.

Temporo-mandibular Joint Disorders

Feb. 1, 2019

Reorganized policy template; simplified and relocated Instructions for Use and Benefit

Considerations section Revised and reformatted

coverage rationale:


o Modified language to clarify the listed services are:

The following services are proven and medically necessary for treating disorders of the temporomandibular joint (TMJ): Arthrocentesis

Injections of corticosteroids for rheumatoid arthritis related disorders Trigger point injections Physical therapy

Occlusal splints (stabilization and repositioning splints)

Sodium Hyaluronate for disc displacement and osteoarthritis Partial or total joint replacement when other treatments have failed




REVISED

Temporo-

mandibular Joint Disorders (continued)

Feb. 1, 2019

Proven and medically

necessary (as described) Unproven and not

medically necessary (as described)

o Updated list of proven and medically necessary indications:

Added: - Trigger point

injections

- Sodium hyaluronate for disc displacement and osteoarthritis

Replaced:

- “Stabilization and repositioning splint

therapy (does not

include low-load prolonged-duration stretch (LLPS) devices

discussed [in the policy])” with “occlusal splints (stabilization and

repositioning splints)” o Updated reference to

applicable MCG™ Care

Guidelines, 22nd edition, 2018; added: Arthroscopy:

- Temporomandibular Joint Arthroscopy, ACG: A-0492 (AC)

Arthrotomy:

- Temporomandibular Joint Arthrotomy,

ACG: A-0522 (AC)

- Temporomandibular

For medical necessity clinical coverage criteria for the following

services, refer to MCG™ Care Guidelines, 22nd edition, 2018 Arthroplasty-Temporomandibular Joint Arthroplasty, ACG: A-0523 (AC) Arthroscopy-Temporomandibular Joint Arthroscopy, ACG: A-0492 (AC) Arthrotomy- Temporomandibular Joint Arthrotomy, ACG: A-0522

(AC);Temporomandibular Joint Modified Condylotomy, ACG: A-0521 (AC) The following services are unproven and not medically necessary for

treating disorders of the temporomandibular joint (TMJ) due to insufficient evidence of efficacy: Biofeedback

Craniosacral manipulation Passive rehabilitation therapy Low-load prolonged-duration stretch (LLPS) devices




REVISED

Temporo-

mandibular Joint Disorders (continued)

Feb. 1, 2019 Joint Modified

Condylotomy, ACG: A-0521 (AC)

Updated supporting information to reflect the most current

description of services, clinical evidence, CMS information, and references




REVISED

Botulinum Toxins A

and B

Jan. 1, 2019 Revised coverage

rationale/diagnosis-specific requirements for the use of Botox (onabotulinumtoxinA): o Replaced references to

“onabotulinumtoxinA” with “Botox”

Migraine headache, chronic

o Updated criteria defining chronic migraine headache: Replaced criterion

requiring “greater than or equal to 15 headache days per month, of which at least 50% are

migraine or probable migraine” with “greater

than or equal to 15

headache days per month”

Added criterion requiring

diagnosis greater than or equal to 8 migraine days per month

o Added medical necessity

criterion requiring Botox will not be used in combination with CGRP antagonists [i.e.,

Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab)]

This policy refers to the following Botulinum toxin types A and B drug

products: Dysport® (abobotulinumtoxinA) Xeomin® (incobotulinumtoxinA) Botox® (onabotulinumtoxinA)

Myobloc® (rimabotulinumtoxinB) Refer to the policy for complete details on the coverage guidelines for

Botulinum Toxins A and B.

Clotting Factors, Coagulant Blood

Products & Other Hemostatics

Jan. 1, 2019

Changed policy title; previously titled Clotting Factors and

Coagulant Blood Products Revised coverage rationale for

Hemophilia A (i.e., Factor

VIII Deficiency, Classical Hemophilia):

Refer to the policy for complete details on the coverage guidelines for Clotting Factors, Coagulant Blood Products & Other Hemostatics.




REVISED

Clotting Factors,

Coagulant Blood Products & Other Hemostatics (continued)

Jan. 1, 2019

Antihemophilic Factor

(recombinant), FC Fusion Protein [Eloctate] o Updated medical necessity

criteria:

Replaced criterion requiring “diagnosis of severe hemophilia A”

with “diagnosis of severe hemophilia A”

Removed criterion

requiring one of the following: - Routine prophylactic

treatment; or

- Peri-operative management of

surgical bleeding; or

- Treatment of bleeding episodes

Added criterion requiring

both of the following: - Patient is less than 6

years of age; and - One of the following:

PK testing results suggest that dosing more

intensive than 50 IU/kg is required; or

PK testing results suggest that dosing more frequently than

every 3.5 days is required; or

PK testing results

suggest that




REVISED

Clotting Factors,


Jan. 1, 2019

dosing more

intensive that 14.5 IU/kg/day is required

Removed criteria

pertaining to mild and moderate hemophilia A

Emicizumab-kxwh [Hemlibra]

o Replaced language indicating “emicizumab-kxwh [Hemlibra] is proven and

medically necessary when all of the following criteria are met” with “emicizumab-kxwh [Hemlibra] is proven for

routine prophylaxis to prevent or reduce the

frequency of bleeding

episodes in patients with hemophilia A when all of the [listed] criteria are met”

o Updated coverage criteria for: Initial therapy; removed

criterion requiring

patient has developed high-titer factor VIII inhibitors (> 5 Bethesda

units [BU]) Continuation of therapy;

added criterion requiring

documentation of positive clinical response to Hemlibra therapy

o Added medical necessity

criteria Updated list of applicable HCPCS

codes to reflect annual code

edits:




REVISED

Clotting Factors,


Jan. 1, 2019 o Added J7170, J7177, and

J7203 o Removed Q9995 o Revised description for

J7178

Updated supporting information to reflect the most current clinical evidence, FDA


Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

Jan. 1, 2019

Updated list of related policies; added reference link to the policy titled Specialty Medication Administration – Site of Care

Review Guidelines Reformatted and revised

coverage rationale:

Treatment of Type 1 Gaucher disease

Initial Therapy

o Added medical necessity criterion requiring the dose does not exceed 60 units/kg every 2 weeks

Continuation of Therapy o Added coverage/medical

necessity criteria requiring:

Diagnosis of Type 1 Gaucher disease; and

Documentation of

positive clinical response to therapy (e.g., reduced severity or resolution of anemia,

thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and

Dose does not exceed 60 units/kg every 2 weeks

This policy refers to the following drug products, all of which are intravenous enzyme replacement therapies used in the treatment of Gaucher disease: Cerezyme® (imiglucerase) Elelyso® (taliglucerase)

VPRIV® (velaglucerase) I. Cerezyme, Elelyso and VPRIV* are proven for the treatment of

Type 1 Gaucher disease when all of the following criteria are met: A. For initial therapy, all of the following:

1. Diagnosis of Type 1 Gaucher disease; and

2. Symptomatic disease (e.g., moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and

3. Dose does not exceed 60 units/kg every 2 weeks.

B. For continuation of therapy, all of the following: 1. Diagnosis of Type 1 Gaucher disease; and 2. Documentation of positive clinical response to therapy (e.g.,

reduced severity or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and


*VPRIV is the preferred enzyme replacement therapy. II. Enzyme replacement therapy with Elelyso is medically necessary

for the treatment of Type 1 Gaucher disease when all of the following criteria are met: A. For initial therapy, all of the following:

1. Diagnosis of Type 1 Gaucher disease; and 2. One of the following:




REVISED

Intravenous Enzyme

Replacement Therapy (ERT) for Gaucher Disease (continued)

Jan. 1, 2019

Treatment of Type 3 Gaucher

disease

Initial Therapy o Replaced language indicating

“Cerezyme is proven and

medically necessary for the treatment of Type 3 Gaucher disease when all of the

[listed] criteria are met” with “enzyme replacement therapy with Cerezyme is

proven and medically necessary for the treatment of Type 3 Gaucher disease when all of the [listed]

criteria are met”

Continuation of Therapy

o Added criteria requiring:

Diagnosis of Type 3 Gaucher disease; and

Documentation of

positive clinical response to therapy (e.g., reduced severity or resolution of anemia,


Dose does not exceed 60 units/kg every 2 weeks

a. History of failure of VPRIV due to failure to meet clinical goals

(e.g., persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly) despite VPRIV therapy; or

b. History of failure of VPRIV due to hypersensitivity to VPRIV therapy;

and 3. Dose does not exceed 60 units/kg every 2 weeks.

B. For continuation of therapy, all of the following:

1. Diagnosis of Type 1 Gaucher disease; and 2. Documentation of positive clinical response to therapy (e.g.,

reduced severity or resolution of anemia, thrombocytopenia,

bone disease, hepatomegaly, splenomegaly); and 3. Dose does not exceed 60 units/kg every 2 weeks.

III. Enzyme replacement therapy with Cerezyme is medically

necessary for the treatment of Type 1 Gaucher disease when all of the following criteria are met:

A. For initial therapy, all of the following:

1. Diagnosis of Type 1 Gaucher disease; and 2. One of the following:

a. History of failure of VPRIV due to failure to meet clinical goals

(e.g., persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly) despite VPRIV therapy; or

b. History of failure of VPRIV due to hypersensitivity to VPRIV therapy; or

c. Patient is pregnant or breastfeeding; or d. Patient is attempting to become pregnant; and

3. Dose does not exceed 60 units/kg every 2 weeks. B. For continuation of therapy, all of the following:


2. Documentation of positive clinical response to therapy (e.g., reduced severity or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and


IV. Enzyme replacement therapy with Cerezyme is proven and

medically necessary for the treatment of Type 3 Gaucher disease

when all of the following criteria are met:




REVISED

Intravenous Enzyme

Replacement Therapy (ERT) for Gaucher Disease (continued)

Jan. 1, 2019 A. For initial therapy, all of the following

1. Diagnosis of Type 3 Gaucher disease; and 2. Symptomatic disease (e.g., moderate to severe anemia,


3. Dose does not exceed 60 units/kg every 2 weeks. B. For continuation of therapy, all of the following:


2. Documentation of positive clinical response to therapy (e.g., reduced severity or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and


Maximum Dosage

Jan. 1, 2019

Revised coverage rationale:

o Updated language defining upper dose limit level for: Adult body weight;

replaced “119 kg” with “128 kg”

Adult body surface;

replaced “2.45 meters2” with “2.59 meters2”

o Updated HCPCS code based maximum dosage

information for:

Avastin (bevacizumab) Changed maximum

allowed amount from “179 HCPCS units” to “192 HCPCS units”

Herceptin (trastuzumab) Changed maximum

allowed amount from “95 HCPCS units” to “103

HCPCS units”

Remicade (infliximab) Changed maximum

allowed amount from “119 HCPCS units” to

This policy provides information about the maximum dosage per

administration for certain medications administered by a medical professional.

Drug Products:

bevacizumab (Avastin®) eculizumab (Soliris®) infliximab (Remicade®)

infliximab-dyyb (Inflectra™) infliximab-abda (Renflexis™) omalizumab (Xolair®)

pegfilgrastim (Neulasta®) pegfilgrastim-jmdb (Fulphila™) rituximab (Rituxan®) trastuzumab (Herceptin®)

ustekinumab (Stelara®) vedolizumab (Entyvio®) zoledronic acid (zoledronic acid, Reclast® and Zometa®)

Most medications have a maximum dosage based upon body surface area or patient weight or a set maximal dosage independent of

patient body size, and are proven when used according to labeled indications or when otherwise supported by published clinical evidence.

The medications included in this policy when given beyond maximum

dosages based upon body surface area or patient weight or a set




REVISED

Maximum Dosage

(continued)

Jan. 1, 2019

“128 HCPCS units”

Inflectra (infliximab-dyyb) Changed maximum

allowed amount from

“119 HCPCS units” to “128 HCPCS units”

Renflexis (infliximab-

abda) Changed maximum

allowed amount from

“119 HCPCS units” to “128 HCPCS units”

Rituxan (rituximab) Updated list of applicable

HCPCS codes to reflect annual code edits;

replaced “J9310” with

“J9312” Changed maximum

allowed amount from “13

HCPCS units (100 mg per unit)” to “123 HCPCS units (10 mg per unit)”

Soliris (eculizumab)

Updated list of applicable diagnoses for HCPCS code J1300; added

myasthenia gravis (MG) o Updated maximum allowed

quantities for National Drug

Code (NDC) billing for:

Avastin (bevacizumab): NDC 50242-0060-01 and 50242-0061-01

Changed maximum allowed amount from “72

mL” to “77 mL”

maximal dosage independent of patient body size are not supported

by package labeling or published clinical evidence and are unproven. This policy creates an upper dose limit based on the clinical evidence and the 95th percentile for adult body weight (128 kg) and body surface area (2.59

meters2) in the U.S. (adult male, 30 to 39 years, Fryar, 2016). In some cases, the maximum allowed units and/or vials may exceed the upper level limit as defined within this policy due to an individual patient body weight >

128 kg or body surface area > 2.59 meters2. Refer to the policy for complete details on Maximum Dosage guidelines.




REVISED

Maximum Dosage

(continued)

Jan. 1, 2019

Inflectra (infliximab-

dyyb): NDC 32228-0001-01 Changed maximum

allowed amount from “12

vials” to “13 vials”

Remicade (infliximab): NDC 57894-0030-01

Changed maximum allowed amount from “12 vials” to “13 vials”

Renflexis (infliximab-abda): NDC 00006-4305-02 Changed maximum

allowed amount from “12 vials” to “13 vials”

Soliris (eculizumab): NDC

25682-0001-01 Updated list of applicable

diagnoses; added

myasthenia gravis (MG) with maximum allowed amount of 120 mL

Changed maximum

allowed amount for: - Diagnosis of

paroxysmal

nocturnal hemoglobinuria (PNH) from “3 vials”

to “90 mL” - Diagnosis of atypical

hemolytic uremic syndrome (aHUS)

from “4 vials” to “120 mL”

Updated list of applicable HCPCS

codes to reflect annual code




REVISED

Maximum Dosage

(continued)

Jan. 1, 2019 edits:

o Added J9312 o Removed J9310

Updated supporting information to reflect the most current

clinical evidence, CMS information, and references

Respiratory Interleukins

(Cinqair®, Fasenra®, and Nucala®)

Jan. 1, 2019 Revised coverage rationale; modified list of agents the

patient must not receive in combination with Cinqair, Fasenra, or Nucala: o Added anti-interleukin 4

therapy [e.g. Dupixent (dupilumab)]

o Replaced:

“Nucala (mepolizumab), Cinqair (reslizumab), and/or Fasenra

(benralizumab)” with “anti-interleukin 5 therapy [e.g., Nucala (mepolizumab), Cinqair

(resilizumab), Fasenra (benralizumab)]”

“Xolair (omalizumab)”

with “anti-IgE therapy [e.g., Xolair (omalizumab)]”

Updated list of applicable HCPCS codes to reflect annual code edits: o Added J0517

o Removed C9466

This policy provides information about the use of certain specialty pharmacy medications administered by either the subcutaneous (SC) or intravenous

(IV) route. This policy refers to the following drug products: Cinqair® (reslizumab)

Fasenra® (benralizumab) Nucala® (mepolizumab)

Refer to the policy for complete details on the coverage guidelines for Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®).




REVISED

Xolair®

(Omalizumab)

Jan. 1, 2019

Revised coverage rationale for

the use of Xolair for patients with moderate to severe persistent asthma; modified list of agents the patient must

not receive in combination with Xolair: o Added anti-interleukin 4

therapy [e.g., Dupixent (dupilumab)]

o Replaced “Nucala

(mepolizumab), Cinqair (reslizumab), or Fasenra (benralizumab)” with “anti-interleukin 5 therapy [e.g.,

Nucala (mepolizumab), Cinqair (resilizumab),

Fasenra (benralizumab)]”

Xolair (omalizumab) for subcutaneous use is proven for:

I. Patients with moderate to severe persistent asthma who meet all

of the following criteria: A. Have a positive skin test or in vitro reactivity to a perennial

aeroallergen. B. Symptoms inadequately controlled with inhaled corticosteroids. C. Have a baseline plasma immunoglobulin E (IgE) level greater than or

equal to 30 IU/mL and less than or equal to 1500 IU/mL.

Xolair is medically necessary when all of the following criteria are

met: A. Diagnosis of moderate or severe asthma; and B. Classification of asthma as uncontrolled or inadequately controlled as

defined by at least one of the following:

1. Poor symptom control (e.g., Asthma Control Questionnaire [ACQ] score consistently greater than 1.5 or Asthma Control Test [ACT]

score consistently less than 20); or

2. Two or more bursts of systemic corticosteroids for at least 3 days each in the previous 12 months; or

3. Asthma-related emergency treatment (e.g., emergency room

visit, hospital admission, or unscheduled physician’s office visit for nebulizer or other urgent treatment); or

4. Airflow limitation (e.g., after appropriate bronchodilator withhold forced expiratory volume in 1 second [FEV1] less than 80%

predicted [in the face of reduced FEV1/forced vital capacity [FVC] defined as less than the lower limit of normal]);

and

C. Baseline (pre-omalizumab treatment) serum total IgE level greater than or equal to 30 IU/mL and less than or equal to 1500 IU/mL; and

D. Positive skin test or in vitro reactivity to a perennial aeroallergen;

and E. Used in combination with one of the following:

1. One maximally-dosed (appropriately adjusted for age) combination inhaled corticosteroid (ICS)/long-acting beta2-

agonist (LABA) product [e.g., fluticasone propionate/salmeterol (Advair®), budesonide/formoterol (Symbicort®)]; or

2. Combination therapy including both of the following:

a. One high-dose (appropriately adjusted for age) ICS product




REVISED

Xolair®

(Omalizumab) (continued)

Jan. 1, 2019

[e.g., ciclesonide (Alvesco®), mometasone furoate

(Asmanex®), beclomethasone dipropionate (QVAR®)]; and b. One additional asthma controller medication [e.g., LABA -

olodaterol (Striverdi®) or indacaterol (Arcapta®); leukotriene receptor antagonist – montelukast (Singulair®); theophylline]

and F. Patient is not receiving Xolair in combination with any of the

following:

1. Anti-interleukin 4 therapy [e.g. Dupixent (dupilumab)] 2. Anti-interleukin 5 therapy [e.g. Nucala (mepolizumab), Cinqair

(resilizumab), Fasenra (benralizumab)]

and G. Xolair dosing for moderate to severe persistent asthma is in

accordance with the United States Food and Drug Administration approved labeling; and

H. Prescribed by or in consultation with an allergist/immunologist or pulmonologist; and

I. Initial authorization will be for no more than 6 months.

Reauthorization/Continuation of Care Criteria For patients currently on Xolair for the treatment of moderate to severe

persistent asthma, authorization for continued use will be approved based on all of the following criteria: A. Documentation of positive clinical response as demonstrated by at

least one of the following:

1. Reduction in the frequency of exacerbations 2. Decreased utilization of rescue medications 3. Increase in percent predicted FEV1 from pretreatment baseline

4. Reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, shortness of breath, coughing, etc.)

and

B. Used in combination with an ICS-containing controller medication; and

C. Patient is not receiving Xolair in combination with any of the following:

1. Anti-interleukin 4 therapy [e.g. Dupixent (dupilumab)] 2. Anti-interleukin 5 therapy [e.g. Nucala (mepolizumab), Cinqair

(resilizumab), Fasenra (benralizumab)]

and




REVISED

Xolair®


Jan. 1, 2019

D. Xolair dosing for moderate to severe persistent asthma is in

accordance with the United States Food and Drug Administration approved labeling; and

E. Prescribed by or in consultation with allergist/immunologist or pulmonologist; and

F. Reauthorization will be for no more than 12 months. II. Patients with chronic urticaria who continue to remain

symptomatic despite H1 antihistamine [e.g., cetirizine (Zyrtec), fexofenadine (Allegra)] treatment. Xolair is medically necessary when all of the following criteria are

met: A. Diagnosis of chronic urticaria; and B. One of the following:

1. Patient remains symptomatic despite at least a 2-week trial of, or

history of contraindication or intolerance to, two H1-antihistamines [e.g., Allegra (fexofenadine), Benadryl

(diphenhydramine), Claritin (loratadine)]*; or

2. Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to both of the following taken in combination:

a. A second generation H1-antihistamine [e.g., Allegra (fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]; and

b. One of the following: i. Different second generation H1-antihistamine [e.g.,

Allegra (fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]

ii. First generation H1-antihistamine [e.g., Benadryl

(diphenhydramine), Chlor-Trimeton (chlorpheniramine), Vistaril (hydroxyzine)]*

iii. H2-antihistamine [e.g., Pepcid (famotidine), Tagamet HB

(cimetidine), Zantac (ranitidine)] iv. Leukotriene modifier [e.g., Singulair (montelukast),]

and C. Xolair dosing for chronic urticaria is in accordance with the United

States Food and Drug Administration approved labeling; and D. Prescribed by or in consultation with an allergist/immunologist or

dermatologist; and

E. Initial authorization will be for no more than 6 months.




REVISED

Xolair®


Jan. 1, 2019 Reauthorization/Continuation of Care Criteria

For patients currently on Xolair for the treatment of chronic urticaria, authorization for continued use will be approved based on all of the following criteria: A. Documentation of positive clinical response (e.g., reduction in

exacerbations, itch severity, hives); and B. Xolair dosing for chronic urticaria is in accordance with the United

States Food and Drug Administration approved labeling; and

C. Prescribed by or in consultation with allergist/immunologist or dermatologist; and

D. Reauthorization will be for no more than 12 months.

*Note: Patients 65 years of age and older in whom first generation H1-antihistamines are considered high risk medications to be avoided (e.g., Beers criteria, HEDIS) should be directed to try alternatives that are not

considered high risk.

Xolair is unproven and not medically necessary in the following:

Seasonal allergic rhinitis Perennial allergic rhinitis Atopic dermatitis

Peanut allergy Acute bronchospasm or status asthmaticus




UPDATED

Ambulance

Services

Jan. 1, 2019 Updated definition of “Medically Necessary (2018 Generic COC)”

Breast Repair/

Reconstruction Not Following Mastectomy

Jan. 1, 2019 Updated coverage rationale; removed duplicative language pertaining to the diagnosis of anaplastic lymphoma

(no change to guidelines)

Durable Medical

Equipment, Orthotics, Ostomy Supplies, Medical

Supplies and Repairs/ Replacements

Jan. 1, 2019 Notice of Revision: The following summary of changes has been modified. Revisions to the previous policy update

announcement are outlined in red below. Please take note of the additional updates to be implemented on Jan. 1, 2019.

Updated coverage rationale:

Indications for Coverage o Replaced language indicating:

“Breast pumps may be covered as DME” with “breast pumps may be covered under the preventive care services benefit”

“Mobility Devices (manual wheelchair, electric wheelchairs, transfer chair or scooters) are a Covered

Health Care Service” with “Mobility Devices (manual wheelchair, electric wheelchairs, transfer chair or scooters/power-operated vehicles) are a Covered Health Care Service when Medically Necessary”

o Added language to clarify:

Cranial molding helmets (cranial remolding orthosis, billed with S1040) used to facilitate a successful post-surgical outcome are covered as DME and are not subject to the orthotic device exclusion

For Mobility Devices, proof of the home evaluation is not required at the time of prior authorization - The on-site home evaluation can be performed prior to, or at the time of, delivery of a Power

Mobility Device - The written report of the home evaluation must be available on request post-delivery

Coverage Limitations and Exclusions

o Replaced language indicating “cranial helmets used for other indications other than those in the Indications for Coverage [of the policy] are excluded from coverage under the orthotics exclusion” with “cranial molding

helmets and cranial banding are excluded from coverage except when used to avoid the need for surgery and/or to facilitate a successful surgical outcome”

o Added language to clarify powered and non-powered exoskeleton devices are excluded from coverage Updated definition of:

o Covered Health Care Service(s) o Medically Necessary

Home Health Care

Jan. 1, 2019

Updated definition of “Skilled Care” Updated list of applicable HCPCS codes to reflect annual code edits; added G0068, G0069, and G0070




UPDATED

Home Health Care

(continued)

Jan. 1, 2019 Updated supporting information to reflect the most current references

Infertility Services

Jan. 1, 2019 Updated coverage rationale/benefit limitations and exclusions; replaced reference(s) to:

o “Preimplantation Genetic Diagnosis (PGD)” with “Preimplantation Genetic Testing – Monogenic/Single Gene Defects (PGT-M) and Preimplantation Genetic Testing – Chromosomal Structure Rearrangements (PGT – SR)”

o “Preimplantation Genetic Screening (PGS)” with “Preimplantation Genetic Testing – Aneuploidy (PGT-A)” Updated definitions:

o Added definition of “Preimplantation Genetic Testing (PGT)”

o Removed definition of: Preimplantation Genetic Diagnosis (PGD) Preimplantation Genetic Screening (PGS)

Updated supporting information to reflect the most current references

Private Duty

Nursing Services

(PDN)

Jan. 1, 2019 Updated definition of “Skilled Care”

Skilled Care and Custodial Care

Services

Jan. 1, 2019 Updated definition of “Skilled Care” Updated supporting information to reflect the most current references


REVISED

Speech Language Pathology Services

Feb. 1, 2019

Updated list of related policies: o Added reference link to the

policy titled Habilitative Services and Outpatient Rehabilitation Therapy

o Removed reference link to the policy titled: Habilitative Services for

Essential Health Groups

(replaced) Rehabilitation Services

(Outpatient) (replaced)

Revised coverage rationale:

Indications for Coverage

Benefit Interpretation

Speech therapy (speech–language pathology services) for the treatment of

disorders of speech, language, voice, communication and auditory processing are covered when the disorder results from: Autism spectrum disorders Cancer

Congenital Anomaly (including but not limited to the following) o Downs syndrome o Cleft palate

o Tongue tie

Injury (including but not limited to the following) o Otitis media resulting in hearing loss documented by testing (such as




REVISED

Speech Language

Pathology Services (continued)

Feb. 1, 2019

o Replaced references to

“patient” with “individual”

Indications for Coverage o Updated and reformatted

benefit interpretation

guidelines for speech therapy: Clarified language

pertaining to: - Otitis media - Services of a speech-

language pathologist or other licensed healthcare professional

Removed duplicative language pertaining to

autism spectrum

disorders o Updated medical necessity

clinical coverage criteria;

removed reference to specific MCG™ Care Guidelines titled: Acquired Apraxia of

Speech Rehabilitation ACG: A-0555 (AC)

Dysarthria Rehabilitation

ACG: A-0556 (AC) Voice Disorders

Rehabilitation ACG: A-

0559 (AC) Developmental Speech

Disorders Rehabilitation ACG: A-0560 (AC)

Developmental Language Disorders Rehabilitation

ACG: A-0561 (AC)

Discharge Criteria (new to

audiogram or notes of such testing).

o Vocal cord injuries (e.g., edema, nodules, polyps) o Stroke/CVA o Trauma o Cerebral palsy

o Static encephalopathy Stroke

Services of a speech-language pathologist or other licensed healthcare professional (within the scope of his/her licensure) to treat the above disorders may be covered when:

There is a need for the supervision of a licensed therapist for speech–language therapy, swallowing or feeding rehabilitative or Restorative Therapy Services.

The services are part of a treatment plan with documented goals for

functional improvement of the individual’s condition, e.g., speech, articulation, swallowing or communication with or without alternative

methods.

The teaching of an individual and or caregiver is required to strengthen muscles, improve feeding techniques or improve speech–language skills to progress toward the documented treatment plan goals. Once the

individual and/or caregiver are trained the services are no longer skilled, therefore custodial, and not a covered health service. Refer to the Coverage Determination Guideline titled Skilled Care and Custodial Care Services.

Mandated benefits (federal and state) for speech therapy. Examples may include Developmental Delay, autism, cleft palate and/or lip, aphasia.

Rehabilitation Services for feeding and or swallowing rehabilitative or Restorative Therapy Services: Swallowing Disorders (dysphagia)

Feeding disorders including problems with gathering food and sucking, chewing, or swallowing food. For example, a child who cannot pick up food and get it to his/her mouth or cannot completely close his/her lips to keep food from falling out of his/her mouth may have a feeding

disorder Auditory (Aural) rehabilitation which includes speech–language therapy,

e.g., when a auditory implant or cochlear implant is a covered healthcare

service




REVISED

Speech Language


Feb. 1, 2019

policy)

o Added language to indicate discharge criteria includes: Treatment goals and

objectives have been

met Speech, language,

communication, or

feeding and swallowing disorder are within normal limits or is

consistent with the individual's baseline

Communication abilities have become

comparable to those of others of the same

chronological age,

gender, ethnicity, or cultural and linguistic background

The desired level of enhanced communication skills has been reached

The speech, language, communication, and/or feeding and swallowing

skills no longer affect the individual’s health status

The individual is

unwilling to participate in treatment, requests discharge, or exhibits behavior that interferes

with improvement or participation in

treatment (e.g.,

noncompliance, non-

Outpatient rehabilitation can occur in the following settings:

Physician’s office Therapist’s office Member’s place of residence Separate part of a clinic or hospital where speech therapy is performed

Discharge Criteria Includes the following: Treatment goals and objectives have been met

Speech, language, communication, or feeding and swallowing disorder are within normal limits or is consistent with the individual's baseline

Communication abilities have become comparable to those of others of

the same chronological age, gender, ethnicity, or cultural and linguistic background

The desired level of enhanced communication skills has been reached The speech, language, communication, and/or feeding and swallowing

skills no longer affect the individual’s health status The individual is unwilling to participate in treatment, requests discharge,

or exhibits behavior that interferes with improvement or participation in

treatment (e.g., noncompliance, non attendance) The level of services do not require a Speech-Language Pathologist or

other licensed healthcare professional (within the scope of his/her

licensure) The individual is unable to tolerate treatment because of a serious

medical, psychological, or other condition. The individual will get services from a different provider

Note: State mandates always take precedence over plan language.

Additional Information

Eligible speech therapy received in the home from a Home Health Agency

is covered under Home Health Care. The Home Health Care section only applies to services that are rendered by a Home Health Agency.

Eligible speech therapy received in the home from an independent speech therapist (a speech therapist that is not affiliated with a Home

Health Agency) is covered under Rehabilitation Services-Outpatient Therapy.

Swallowing and feeding rehabilitation therapy may be done with speech

Rehabilitation Services; when performed together both should be billed and only the speech therapy will count toward the speech therapy benefit




REVISED

Speech Language


Feb. 1, 2019 attendance)

The level of services do not require a Speech-Language Pathologist or other licensed healthcare

professional (within the scope of his/her licensure)

The individual is unable to tolerate treatment because of a serious

medical, psychological, or other condition

The individual will get services from a different

provider

Coverage Limitations and

Exclusions

o Added language to indicate: Benefits for cognitive

rehabilitation therapy are

covered only when Medically Necessary following a post-traumatic brain Injury or

cerebral vascular accident

Benefits are not available

for maintenance/preventive treatment

Updated list of applicable CPT codes; removed 70371

limit, if applicable.

Swallowing therapy (92526) when billed alone will count toward the speech therapy benefit limit, if applicable.

Cochlear implant monitoring (remapping and reprogramming of implant) and rehabilitation following the cochlear implant surgery is usually billed

as aural rehabilitation. This is not covered as a speech therapy benefit. The member specific benefit plan document must be referenced for any applicable limits that may apply to aural rehabilitation.

For Medical Necessity Clinical Coverage Criteria

Refer to MCG™ Care Guidelines, 22nd edition, 2018. Coverage Limitations and Exclusions

Benefits for cognitive rehabilitation therapy are covered only when Medically Necessary following a post-traumatic brain Injury or cerebral vascular accident

Devices and computers to assist in communication and speech (refer to

the Coverage Determination Guideline titled Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements)

Speech therapy if the provider is school based (check benefit language and state mandates)

Idiopathic Developmental Delay (no Illness to explain the cause of

Developmental Delay in speech–language) Sign language (does not require the services of a licensed or certified

healthcare professional) Speech therapy beyond the benefit maximum (visits limits) Benefits are not available for maintenance/preventive treatment. Please

refer to the member specific benefit plan document

A child being bilingual is not considered a developmental speech or Developmental Delay and speech therapy is usually not a covered health service, except when other criteria for speech therapy are met (see the

Definitions section of the policy for Speech Delay – Bilingualism) Home Speech Therapy for the convenience of a provider or member


Utilization Review Guideline (URG) Updates

Policy Title Effective Date Coverage Rationale

NEW

Magnetic

Resonance Imaging (MRI) and Computed Tomography (CT)

Scan – Site of Care

Jan. 1, 2019

Feb. 1, 2019

Notice of Implementation Delay: This Utilization Review Guideline will not be effective on Jan. 1, 2019 as

previously announced; implementation has been postponed until Feb. 1, 2019. An advanced radiologic imaging procedure in the hospital outpatient department is considered medically necessary for individuals who meet ANY of the following criteria:

Less than 10 years of age Require obstetrical observation Require perinatology services

Have a known contrast allergy Have a known chronic disease with prior radiology imaging procedures for the diagnosis, management or

surveillance of the disease at the hospital outpatient department

Have pre-procedure imaging where the surgery or procedure is being performed at the hospital An advanced radiologic imaging procedure in the hospital outpatient department is considered medically necessary when there are no geographically accessible appropriate alternative sites for the individual to

undergo the procedure, including but not limited to the following: Moderate or deep sedation or general anesthesia is required for the procedure; or

The equipment for the size of the individual is not available; or

Open magnetic resonance imaging is required because the member has a documented diagnosis of claustrophobia and/or severe anxiety

An advanced radiologic imaging procedure in the hospital outpatient department is considered medically necessary when imaging in a physician’s office or freestanding imaging center would reasonably be expected to delay care and adversely impact health outcome.

All other advanced radiologic imaging procedures in the hospital outpatient department are considered not medically necessary when the above criteria are not met.

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