medical policy update bulletin

Transcription

1 January 2019 medical policy update bulletin Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates 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.

2 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates Overview 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. Tips for using the Medical Policy Update Bulletin: 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. 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. 2 Medical Policy Update Bulletin: January 2019

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

4 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue Radicava (Edaravone) Effective Jan. 1, Respiratory Interleukins (Cinqair, Fasenra, and Nucala ) Effective Jan. 1, Rituxan (Rituximab) Effective Jan. 1, 2019 Effective Jan. 1, Self-Administered Medications List Effective Jan. 1, Skin and Soft Tissue Substitutes Effective Jan. 1, Sodium Hyaluronate Effective Jan. 1, Surgical Treatment for Spine Pain Effective Jan. 1, Therapeutic Radiopharmaceuticals Effective Jan. 1, Trogarzo (Ibalizumab-Uiyk) Effective Jan. 1, White Blood Cell Colony Stimulating Factors Effective Jan. 1, Medical Policy Updates UPDATED Ablative Treatment for Spinal Pain Effective Jan. 1, Autologous Chondrocyte Transplantation in the Knee Effective Jan. 1, Bone or Soft Tissue Healing and Fusion Enhancement Products Effective Jan. 1, Breast Imaging for Screening and Diagnosing Cancer Effective Jan. 1, Cardiovascular Disease Risk Tests Effective Jan. 1, Cochlear Implants Effective Jan. 1, Deep Brain and Cortical Stimulation Effective Jan. 1, Electric Tumor Treatment Field Therapy Effective Jan. 1, Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable Effective Jan. 1, Hepatitis Screening Effective Jan. 1, Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors Effective Jan. 1, Infertility Diagnosis and Treatment Effective Jan. 1, Intensity-Modulated Radiation Therapy Effective Jan. 1, Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Effective Jan. 1, Macular Degeneration Treatment Procedures Effective Jan. 1, Magnetic Resonance Spectroscopy (MRS) Effective Jan. 1, Mechanical Stretching Devices Effective Jan. 1, Meniscus Implant and Allograft Effective Jan. 1, Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions Effective Jan. 1, Osteochondral Grafting Effective Jan. 1, Percutaneous Vertebroplasty and Kyphoplasty Effective Jan. 1, Medical Policy Update Bulletin: January 2019

5 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue Spinal Ultrasonography Effective Jan. 1, Surgical Treatment for Spine Pain Effective Jan. 1, Surgical Treatment for Spine Pain Effective Feb. 1, Total Artificial Heart Effective Jan. 1, Transpupillary Thermotherapy Effective Jan. 1, Umbilical Cord Blood Harvesting and Storage for Future Use Effective Jan. 1, Unicondylar Spacer Devices for Treatment of Pain or Disability Effective Jan. 1, Vagus Nerve Stimulation Effective Jan. 1, Electrical Stimulation and Electromagnetic Therapy for Wounds Effective Feb. 1, Fetal Aneuploidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood Effective Mar. 1, Omnibus Codes Effective Feb. 1, Proton Beam Radiation Therapy Effective Jan. 1, Skin and Soft Tissue Substitutes Effective Feb. 1, Temporomandibular Joint Disorders Effective Feb. 1, Medical Benefit Drug Policy Updates Botulinum Toxins A and B Effective Jan. 1, Clotting Factors, Coagulant Blood Products & Other Hemostatics Effective Jan. 1, Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease Effective Jan. 1, Maximum Dosage Effective Jan. 1, Respiratory Interleukins (Cinqair, Fasenra, and Nucala ) Effective Jan. 1, Xolair (Omalizumab) Effective Jan. 1, Coverage Determination Guideline (CDG) Updates UPDATED Ambulance Services Effective Jan. 1, Breast Repair/Reconstruction Not Following Mastectomy Effective Jan. 1, Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements Effective Jan. 1, Home Health Care Effective Jan. 1, Infertility Services Effective Jan. 1, Private Duty Nursing Services (PDN) Effective Jan. 1, Skilled Care and Custodial Care Services Effective Jan. 1, Medical Policy Update Bulletin: January 2019

6 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue Speech Language Pathology Services Effective Feb. 1, Utilization Review Guideline (URG) Updates NEW Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) Scan Site of Care Effective Feb. 1, Medical Policy Update Bulletin: January 2019

7 Take Note ANNUAL CPT AND HCPCS CODE UPDATES 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 Medical Policy Added 20932, 20933, 20934, Q4186, and Q4187 Healing and Fusion Enhancement Products Removed Q4131 Breast Imaging for Screening and Diagnosing Cancer Brineura (Cerliponase Alfa) Cardiovascular Disease Risk Tests Carrier Testing for Genetic Diseases Chemosensitivity and Chemoresistance Assays in Cancer Clotting Factors, Coagulant Blood Products & Other Hemostatics Crysvita (Burosumab-Twza) Deep Brain and Cortical Stimulation Enzyme Replacement Therapy Medical Policy Added 76391, 77046, 77047, 77048, and Removed 0159T, 0346T, 77058, and Medical Benefit Drug Policy Added J0567 Removed C9014 Medical Policy Removed 0337T Medical Policy Added Medical Policy Added 0083U Medical Benefit Drug Policy Medical Benefit Drug Policy Added J7170, J7177, and J7203 Removed Q9995 Revised description for J7178 Added J0584 Medical Policy Removed and Medical Benefit Drug Policy Added J Medical Policy Update Bulletin: January 2019

8 Take Note ANNUAL CPT AND HCPCS CODE UPDATES Policy Title Policy Type Summary of Changes Extracorporeal Shock Wave Therapy (ESWT) Medical Policy Added 0512T and 0513T Genetic Testing for Hereditary Cancer Gonadotropin Releasing Hormone Analogs Habilitative Services and Outpatient Rehabilitation Therapy Hearing Aids and Devices Including Wearable, Bone- Anchored and Semi- Implantable Medical Policy Added 81163, 81164, 81165, 81166, and Removed 81211, 81213, and Revised description for 81162, 81212, 81215, 81216, and Medical Benefit Drug Policy Coverage Determination Guideline Added J3316 Removed 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 Revised description for G0499 High Frequency Chest Wall Compression Devices Home Health Care Ilumya (Tildrakizumab-Asmn) Infliximab (Remicade, Inflectra, Renflexis ) Intensity-Modulated Radiation Therapy Medical Policy Revised description for E0483 Coverage Determination Guideline Medical Benefit Drug Policy Medical Benefit Drug Policy Added G0068, G0069, and G0070 Added J3245 Added Q5109 Medical Policy Revised description for Medical Policy Update Bulletin: January 2019

9 Take Note ANNUAL CPT AND HCPCS CODE UPDATES Policy Title Policy Type Summary of Changes Luxturna Medical Benefit Added J3398 (Voretigene Neparvovec-Rzyl) Drug Policy Removed C9032 Macular Degeneration Treatment Procedures Maximum Dosage Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions Neurophysiologic Testing and Monitoring Neuropsychological Testing Under the Medical Benefit Medical Policy Removed 0190T Medical Benefit Drug Policy Added J9312 Removed J9310 Medical Policy Added Medical Policy Added 0533T, 0534T, 0535T, and 0536T Medical Policy Added 96121, 96132, 96133, 96136, 96137, 96138, 96139, and Removed 96118, 96119, and Revised description for 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 and Removed 0387T, 0388T, 0389T, 0390T, and 0391T Ultrasound elastography Added 76981, 76982, and Medical Policy Update Bulletin: January 2019

10 Take Note ANNUAL CPT AND HCPCS CODE UPDATES Policy Title Policy Type Summary of Changes Omnibus Codes Medical Policy Removed 0346T 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) Preventive Care Services Proton Beam Radiation Therapy Radicava (Edaravone) Respiratory Interleukins (Cinqair, Fasenra, and Nucala ) Rituxan (Rituximab) Self-Administered Medications List Medical Benefit Drug Policy Coverage Determination Guideline Added C9036 Preventive Care Services Genetic Counseling and Evaluation for BRCA Testing; and BRCA Lab Screening Added 81163, 81164, 81165, 81166, and Removed 81211, 81213, and Cholesterol Screening (Lipid Disorders Screening) Added Dyslipidemia Screening (Bright Futures) Added Preventive Immunizations Seasonal Influenza ( flu ) Added Medical Policy Revsied description for Medical Benefit Drug Policy Medical Benefit Drug Policy Medical Benefit Drug Policy Medical Benefit Drug List Added J1301 Added J0517 Added J9312 Removed J9310 Removed C9015 and C Medical Policy Update Bulletin: January 2019

11 Take Note ANNUAL CPT AND HCPCS CODE UPDATES Policy Title Policy Type Summary of Changes Skin and Soft Tissue Medical Policy Added Q4186, Q4187, Q4195, and Q4196 Substitutes Removed Q4131 and Q4172 Sodium Hyaluronate Medical Policy Added J7318 and J7329 Surgical Treatment for Spine Pain Therapeutic Radiopharmaceuticals Trogarzo (Ibalizumab-Uiyk) White Blood Cell Colony Stimulating Factors Medical Policy Removed 0195T and 0196T Medical Policy Added A9513 Removed C9031 Medical Benefit Drug Policy Medical Benefit Drug Policy Added J1746 Added Q Medical Policy Update Bulletin: January 2019

12 Medical Policy Updates 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 Bone or Soft Tissue Healing and Fusion Enhancement Products Breast Imaging for Screening and Diagnosing Cancer Cardiovascular Disease Risk Tests Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) 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 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 o Removed 0159T, 0346T, 77058, and 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 o Removed 0337T (annual code edit) Updated supporting information to reflect the most current clinical evidence, CMS information, and references 12 Medical Policy Update Bulletin: January 2019

13 Medical Policy Updates Policy Title Effective Date Summary of Changes UPDATED Cochlear Implants 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 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 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 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 and Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) 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 Medical Policy Update Bulletin: January 2019

14 Medical Policy Updates Policy Title Effective Date Summary of Changes UPDATED Hepatitis Screening Jan. 1, 2019 o Revised description for G0499 Implantable Beta- Emitting Microspheres for Treatment of Malignant Tumors Infertility Diagnosis and Treatment Intensity- Modulated Radiation Therapy 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 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 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 14 Medical Policy Update Bulletin: January 2019

15 Medical Policy Updates Policy Title Effective Date Summary of Changes UPDATED Intensity- Modulated Radiation Therapy Jan. 1, 2019 demonstrated on a comparison of treatment plans for the IMRT and non-imrt technique (e.g., threedimensional 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., threedimensional conformal treatment plan) Updated list of applicable CPT codes to reflect annual code edits; revised description for Updated supporting information to reflect the most current clinical evidence, CMS information, and references Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Macular Degeneration Treatment Procedures Magnetic Resonance Spectroscopy (MRS) Mechanical Stretching Devices Meniscus Implant and Allograft Jan. 1, 2019 Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section Simplified coverage rationale (no change to guidelines) Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) Updated list of applicable CPT codes to reflect annual code edits; removed 0190T Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) 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, FDA information, and references Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) Added definition of Functional or Physical Impairment 15 Medical Policy Update Bulletin: January 2019

16 Medical Policy Updates Policy Title Effective Date Summary of Changes 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, Reorganized policy template: o Simplified and relocated Instructions for Use o Removed Benefit Considerations section 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 Percutaneous Vertebroplasty and Kyphoplasty Spinal Ultrasonography Surgical Treatment for Spine Pain Surgical Treatment for Spine Pain 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 Replaced criterion requiring willingness to comply with an extensive period of rehabilitation following surgery with willingness to comply with rehabilitation following surgery 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 Replaced reference to severe debilitating pain with pain causing Functional or Physical Impairment Added definition of Functional or Physical Impairment Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) Jan. 1, 2019 Reorganized policy template: o Simplified and relocated Instructions for Use o Removed Benefit Considerations section Updated list of applicable CPT codes to reflect annual code edits; removed 0195T and 0196T Feb. 1, 2019 Simplified coverage rationale (no change to guidelines) Updated list of applicable CPT codes: 16 Medical Policy Update Bulletin: January 2019

17 Medical Policy Updates Policy Title Effective Date Summary of Changes UPDATED Surgical Treatment for Spine Pain Feb. 1, 2019 o Added 62380, 63051, 63275, 63277, 63280, 63282, 63285, 63287, and o Revised description for 0202T Updated supporting information to reflect the most current description of services, clinical evidence, CMS information, and references Total Artificial Heart Transpupillary Thermotherapy Umbilical Cord Blood Harvesting and Storage for Future Use Unicondylar Spacer Devices for Treatment of Pain or Disability Vagus Nerve Stimulation Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) Jan. 1, 2019 Simplified coverage rationale (no change to guidelines) 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 supporting information to reflect the most current references 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) 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) 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 17 Medical Policy Update Bulletin: January 2019

18 Medical Policy Updates Electrical Stimulation and Electromagnetic Therapy for Wounds 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 pressurereducing 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 o Measurable Signs of Healing 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 18 Medical Policy Update Bulletin: January 2019

19 Medical Policy Updates Electrical Stimulation and Electromagnetic Therapy for Wounds Feb. 1, 2019 G0295 Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS information, and references Fetal Aneuploidy Testing Using Cell- Free Fetal Nucleic Acids in Maternal Blood Mar. 1, 2019 Reorganized policy template: o Simplified and relocated Instructions for Use o Removed Benefit Considerations section 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. 19 Medical Policy Update Bulletin: January 2019

20 Medical Policy Updates Fetal Aneuploidy Testing Using Cell- Free Fetal Nucleic Acids in Maternal Blood Mar. 1, 2019 o strongly recommended prior to this test with genetic counseling is strongly recommended prior to fetal screening or prenatal diagnosis Revised list of unproven/not medically necessary DNAbased 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 20 Medical Policy Update Bulletin: January 2019

21 Medical Policy Updates Fetal Aneuploidy Testing Using Cell- Free Fetal Nucleic Acids in Maternal Blood 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 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, periprostatic (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. 21 Medical Policy Update Bulletin: January 2019

22 Medical Policy Updates Omnibus Codes 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, periprostatic (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 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 Reorganized policy template: o Simplified and relocated Instructions for Use o Removed Benefit Considerations section 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: 22 Medical Policy Update Bulletin: January 2019

23 Medical Policy Updates Proton Beam Radiation Therapy 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 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 23 Medical Policy Update Bulletin: January 2019

24 Medical Policy Updates Proton Beam Radiation Therapy 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 24 Medical Policy Update Bulletin: January 2019

25 Medical Policy Updates Skin and Soft Tissue Substitutes 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 information, and references 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 25 Medical Policy Update Bulletin: January 2019

26 Medical Policy Updates Skin and Soft Tissue Substitutes 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. Temporomandibular Joint Disorders Feb. 1, 2019 Reorganized policy template; simplified and relocated Instructions for Use and Benefit Considerations section Revised and reformatted coverage rationale: o o Simplified content 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 26 Medical Policy Update Bulletin: January 2019

27 Medical Policy Updates Temporomandibular Joint Disorders 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 o repositioning splints) Updated reference to applicable MCG Care Guidelines, 22 nd 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 27 Medical Policy Update Bulletin: January 2019

28 Medical Policy Updates Temporomandibular Joint Disorders 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 28 Medical Policy Update Bulletin: January 2019

29 Medical Benefit Drug Policy Updates 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. 29 Medical Policy Update Bulletin: January 2019

30 Medical Benefit Drug Policy Updates Clotting Factors, Coagulant Blood Products & Other Hemostatics 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 30 Medical Policy Update Bulletin: January 2019

31 Medical Benefit Drug Policy Updates Clotting Factors, Coagulant Blood Products & Other Hemostatics 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: 31 Medical Policy Update Bulletin: January 2019

32 Medical Benefit Drug Policy Updates Clotting Factors, Coagulant Blood Products & Other Hemostatics 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 information, and references 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 3. Dose does not exceed 60 units/kg every 2 weeks. *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: 32 Medical Policy Update Bulletin: January 2019