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Oxford

September 2018 policy update bulletin

Medical & Administrative Policy 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 Policy Update Bulletin was developed to share important information regarding Oxford® Medical and Administrative Policy.*

*Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law

Oxford ® Oxford Medical and Administrative Policy Updates Overview

This bulletin provides complete details on Oxford® Clinical, Policy Update Classifications Administrative and Reimbursement Policy updates. The inclusion of New a health service (e.g., test, drug, device or procedure) in this New clinical coverage criteria and/or documentation review bulletin indicates only that UnitedHealthcare has recently adopted a requirements have been adopted for a health service (e.g., test, drug, new policy and/or updated, revised, replaced or retired an existing device or procedure) policy; it does not imply that Oxford® provides coverage for the Updated health service. In the event of an inconsistency or conflict between An existing policy has been reviewed and changes have not been made the information provided in this bulletin and the posted policy, the to the clinical coverage criteria or documentation review requirements; provisions of the posted policy will prevail. Note that most benefit however, items such as the clinical evidence, FDA information, and/or plan documents exclude from benefit coverage health services list(s) of applicable codes may have been updated identified as investigational or unproven/not medically necessary. Physicians and other health care professionals may not seek or Revised collect payment from a member for services not covered by the An existing policy has been reviewed and revisions have been made to applicable benefit plan unless first obtaining the member’s written the clinical coverage criteria and/or documentation review requirements consent, acknowledging that the service is not covered by the Replaced benefit plan and that they will be billed directly for the service. An existing policy has been replaced with a new or different policy

A complete library of Oxford® Medical and Retired Administrative Policies is available at The health service(s) addressed in the policy are no longer being OxfordHealth.com > Providers > Tools & Resources > managed or are considered to be proven/medically necessary and are Medical Information > Medical and Administrative Policies. therefore not excluded as unproven/not medically necessary services, unless coverage guidelines or criteria are otherwise documented in

another policy Tips for using the Policy Update Bulletin:  From the table of contents, click the policy title to be Note: The absence of a policy does not automatically indicate or imply directed to the corresponding policy update summary. coverage. As always, coverage for a health service must be determined in accordance with the member’s benefit plan and any applicable  From the policy updates table, click the policy title to view a federal or state regulatory requirements. Additionally, UnitedHealthcare complete copy of a new, updated, or revised policy. reserves the right to review the clinical evidence supporting the safety and effectiveness of a medical technology prior to rendering a coverage determination.

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Oxford ® Oxford Medical and Administrative Policy Updates In This Issue

Clinical Policy Updates Page NEW  Onpattro™ (Patisiran) - Effective Sep. 1, 2018 ...... 7 UPDATED  Abnormal Uterine Bleeding and Uterine Fibroids - Effective Sep. 1, 2018 ...... 8  Carrier Testing for Genetic Diseases - Effective Oct. 1, 2018 ...... 8  Chemosensitivity and Chemoresistance Assays in Cancer - Effective Sep. 1, 2018 ...... 8  Chromosome Microarray Testing (Non-Oncology Conditions) - Effective Oct. 1, 2018 ...... 8  Discogenic Pain Treatment - Effective Oct. 1, 2018 ...... 9  Electrical Bioimpedance for Cardiac Output Measurement - Effective Sep. 1, 2018 ...... 9  Exondys 51™ (Eteplirsen) - Effective Oct. 1, 2018 ...... 9  Gender Dysphoria Treatment - Effective Sep. 1, 2018 ...... 9  Home Health Care - Effective Sep. 1, 2018 ...... 9  Occipital Neuralgia and Headache Treatment - Effective Oct. 1, 2018 ...... 9  Otoacoustic Emissions Testing - Effective Oct. 1, 2018 ...... 10  Pharmacogenetic Testing - Effective Oct. 1, 2018 ...... 10  Whole Exome and Whole Genome Sequencing - Effective Oct. 1, 2018 ...... 10 REVISED  Actemra® () Injection for Intravenous Infusion - Effective Oct. 1, 2018 ...... 10  Botulinum Toxins A and B - Effective Oct. 1, 2018 ...... 12  Crysvita® (Burosumab-Twza) - Effective Oct. 1, 2018 ...... 12  Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Oct. 1, 2018 ...... 15  Drug Coverage Guidelines - Effective Oct. 1, 2018 ...... 15 o Absorica (Isotretinoin) ...... 15 o Actemra (Tocilizumab): SQ Injection ...... 15 o Actemra (Tocilizumab): Injection ...... 16 o Amnesteem (Isotretinoin) ...... 16 o Berinert (C1 Esterase Inhibitor Human) ...... 16 o Bonjesta (Doxylamine/Pyridoxine) ...... 16 o Briviact (Brivaracetam) ...... 16 o Butal/Apap 50/300 mg (Butalbital-Acetaminophen) ...... 16 o Caprelsa (Vandetanib) ...... 16 o Carbaglu (Carglumic Acid) ...... 16 o Cimzia () ...... 16

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o Cinryze (C1 Esterase Inhibitor (Human)) ...... 16 o Claravis (Isotretinoin) ...... 16 o Crysvita (Burosumab-Twza) ...... 16 o Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride) ...... 17 o Dupixent () ...... 17 o Eligard (Leuprolide Acetate) ...... 17 o Entyvio () ...... 17 o Epanova (Omega-3-Carboxylic Acids) ...... 17 o Eucrisa (Crisaborole) ...... 17 o Firazyr (Icatibant) ...... 17 o Haegarda [C1 Esterase Inhibitor Subcutaneous (Human)] ...... 17 o Ilumya (-Asmn) ...... 17 o Inflectra () ...... 17 o Inlyta (Axitinib) ...... 18 o Kevzara () ...... 18 o Kuvan (Sapropterin Dihydrochloride) ...... 18 o Lemtrada () ...... 18 o Lenvima (Lenvatinib) ...... 18 o Leuprolide Acetate (Subcutaneous) (Eligard), 1mg/0.2ml ...... 18 o Lokelma (Sodium Zirconium Cyclosilicate) ...... 18 o Lupron, Lupron-3, Lupron-4, Lupron Depot, Lupron Depot Pediatric, Lupron Implant (Leuprolide Acetate) ...... 18 o Myorisan (Isotretinoin) ...... 18 o Nexavar (Sorafenib Tosylate) ...... 18 o Noctiva (Desmopressin Acetate) ...... 18 o Ocrevus () ...... 18 o Olumiant () ...... 19 o Omtryg (Omega-3-Acid Ethyl Esters A) ...... 19 o Orencia () ...... 19 o Orilissa (Elagolix) ...... 19 o Palynziq (Pegvaliase-Pqpz) ...... 19 o Pancreaze (Pancrelipase) ...... 19 o Parsabiv (Etelcalcetide)...... 19 o Pertzye (Pancrelipase) ...... 19 o Ravicti (Glycerol Phenylbutyrate Oral Liquid) ...... 19 o Remicade (Infliximab) ...... 19 o Renflexis (Infliximab) ...... 19 o Ruconest (C1 Esterase Inhibitor [Recombinant]) ...... 20 o Simponi Aria () ...... 20 o Solaraze (Diclofenac)...... 20 o Somavert (Pegvisomant) ...... 20

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o Soolantra (Ivermectin) ...... 20 o Stelara (): Sub-Cutaneous Injection ...... 20 o Stelara (Ustekinumab): Intravenous Infusion ...... 20 o Symtuza (Darunavir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide ...... 20 o Tysabri () ...... 20 o Uloric (Febuxostat) ...... 21 o Ultresa (Pancrelipase)...... 21 o Viokace (Pancrelipase) ...... 21 o Xyrem (Sodium Oxybate) ...... 21 o Zenatane ...... 21  Entyvio® (Vedolizumab) - Effective Oct. 1, 2018 ...... 21  Genetic Testing for Hereditary Cancer - Effective Oct. 1, 2018 ...... 23  Infliximab (Remicade®, Inflectra™, Renflexis™) - Effective Oct. 1, 2018 ...... 33  Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease - Effective Oct. 1, 2018 ...... 36  Lemtrada (Alemtuzumab) - Effective Oct. 1, 2018 ...... 38  Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions - Effective Oct. 1, 2018 ...... 39  Obstetrical Ultrasonography - Effective Oct. 1, 2018 ...... 42  Ocrevus™ (Ocrelizumab) - Effective Oct. 1, 2018 ...... 44  Omnibus Codes - Effective Oct. 1, 2018 ...... 47  Orencia® (Abatacept) Injection for Intravenous Infusion - Effective Oct. 1, 2018 ...... 57  Preventive Care Services - Effective Oct. 1, 2018 ...... 58  Respiratory (Cinqair®, Fasenra®, and Nucala®) - Effective Oct. 1, 2018 ...... 62  Sandostatin LAR® Depot (Octreotide Acetate) - Effective Oct. 1, 2018 ...... 63  Simponi Aria® (Golimumab) Injection for Intravenous Infusion - Effective Oct. 1, 2018 ...... 65  Skin and Soft Tissue Substitutes - Effective Oct. 1, 2018 ...... 66  Specialty Medication Administration - Site of Care Review Guidelines - Effective Oct. 1, 2018 ...... 69  Stelara® (Ustekinumab) - Effective Oct. 1, 2018 ...... 70  Xolair® () - Effective Oct. 1, 2018 ...... 73 Administrative Policy Updates UPDATED  Autism - Effective Oct. 1, 2018 ...... 78  Behavioral Health Services - Effective Oct. 1, 2018 ...... 78  Follow-Up Care Rendered in an Emergency Room Site of Service - Effective Oct. 1, 2018 ...... 78  Orthopedic Services - Effective Oct. 1, 2018 ...... 78  Skilled Care and Custodial Care Services - Effective Sep. 1, 2018 ...... 78

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REVISED  Abortions (Therapeutic and Elective) - Effective Oct. 1, 2018 ...... 78  Precertification Exemptions for Outpatient Services - Effective Oct. 1, 2018 ...... 79  Speech Therapy and Early Intervention Programs/Birth to Three - Effective Oct. 1, 2018 ...... 80 Reimbursement Policy Updates NEW  Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting - Effective Oct. 1, 2018 ...... 91 UPDATED  Add-On Policy - Effective Oct. 1, 2018 ...... 91  Ambulance - Effective Sep. 1, 2018 ...... 91  Care Plan Oversight - Effective Oct. 1, 2018 ...... 91  Co-Surgeon/Team Surgeon - Effective Oct. 1, 2018 ...... 92  New Patient Visit - Effective Oct. 1, 2018 ...... 92  Services and Modifiers Not Reimbursable to Healthcare Professionals - Effective Sep. 1, 2018 ...... 92 REVISED  After Hours and Weekend Care - Effective Oct. 1, 2018 ...... 92  Co-Surgeon/Team Surgeon (CES) - Effective Oct. 1, 2018 ...... 93  Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency (CES) - Effective Oct. 1, 2018 ...... 95  From - To Date Policy - Effective Oct. 1, 2018 ...... 100

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Clinical Policy Updates

Policy Title Effective Date Coverage Rationale NEW Onpattro™ Sep. 1, 2018 Onpattro (patisiran) is proven for the treatment of the polyneuropathy of hereditary transthyretin- (Patisiran) mediated (hATTR) amyloidosis.

Onpattro (patisiran) is medically necessary for the treatment of the polyneuropathy of hATTR amyloidosis with polyneuropathy in patients who meet ALL of the following criteria:

 For initial therapy, all of the following: o Both of the following: . Diagnosis of hATTR amyloidosis with polyneuropathy . Documentation that the patient has a pathogenic TTR mutation (e.g., V30M) and o Documentation of one of the following: . Patient has a baseline polyneuropathy disability (PND) score ≤ IIIb . Patient has a baseline FAP Stage 1 or 2 and o Presence of clinical signs and symptoms of the disease (e.g., peripheral/autonomic neuropathy, motor disability, cardiovascular dysfunction, renal dysfunction); and o Patient is not receiving patisiran in combination with either of the following: . Oligonucleotide agents (e.g., inotersen) . Tafamidis meglumine and o Patisiran dosing is in accordance with the US Food and Drug Administration prescribing information (0.3 mg/kg up to a maximum of 30mg, every 3 weeks); and o Initial authorization is for no more than 12 months.

 For continuation therapy, all of the following: o Patient has previously received treatment with patisiran; and o Documentation of one of the following: . Patient continues to have a polyneuropathy disability (PND) score ≤ IIIb . Patient continues to have a FAP Stage 1 or 2 and o Documentation that the patient has experienced a positive clinical response to patisiran (e.g., improved neurologic impairment, motor function, cardiac function, quality of life assessment, serum TTR levels, etc.); and o Patient is not receiving patisiran in combination with either of the following: . Oligonucleotide agents (e.g., inotersen) . Tafamidis meglumine and o Patisiran dosing is in accordance with the US Food and Drug Administration prescribing information (0.3

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Clinical Policy Updates

Policy Title Effective Date Coverage Rationale NEW Onpattro™ Sep. 1, 2018 mg/kg up to a maximum of 30mg, every 3 weeks); and (Patisiran) o Authorization is for no more than 12 months. (continued) Onpattro (patisiran) is unproven and not medically necessary for the treatment of:  Sensorimotor or autonomic neuropathy not related to hATTR amyloidosis  Primary or leptomeningeal amyloidosis

Policy Title Effective Date Summary of Changes UPDATED Abnormal Uterine Sep. 1, 2018  Updated coverage rationale; modified language pertaining to clinical evidence/ study findings for treatment of Bleeding and uterine fibroids: Uterine Fibroids o Replaced language indicating “the effects of uterine artery embolization (UAE) on ovarian and uterine function and on fertility are relatively unknown [and] further studies of safety and/or efficacy in published, peer- reviewed medical literature are necessary” with “the effects of UAE on ovarian and uterine function and on fertility require further studies of safety and/or efficacy in published, peer-reviewed medical literature” o Replaced language indicating “further studies are needed to determine the long-term efficacy of laparoscopic ultrasound-guided radiofrequency ablation for treating uterine fibroids” with “further well-designed randomized controlled trials are needed to determine the long-term efficacy of laparoscopic ultrasound- guided radiofrequency ablation for treating uterine fibroids”  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references

Carrier Testing for Oct. 1, 2018  Updated list of applicable CPT codes; added 81479 Genetic Diseases  Updated supporting information to reflect the most current description of services, clinical evidence, and references

Chemosensitivity Sep. 1, 2018  Updated non-coverage rationale: and o Replaced language indicating “[the listed service] is unproven and not medically necessary” with “[the listed Chemoresistance service] is unproven and/or not medically necessary” Assays in Cancer o Replaced references to “patients” with “individuals”  Updated supporting information to reflect the most current description of services, clinical evidence, and references

Chromosome Oct. 1, 2018  Updated coverage rationale; modified language to clarify: Microarray Testing o [The listed services are] proven and medically necessary (Non-Oncology o [The listed service is] unproven and not medically necessary Conditions)  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: o Added Q93.51, Q93.59, and Q93.82 o Removed Q93.5

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Policy Title Effective Date Summary of Changes UPDATED Discogenic Pain Oct. 1, 2018  Updated non-coverage rationale: Treatment o Replaced language indicating “[the listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary” o Modified language pertaining to clinical evidence/study findings for percutaneous discectomy and decompression procedures: . Removed language indicating available clinical studies are weakened by the lack of randomization, lack comparator groups, and lack of long-term follow-up . Replaced language indicating “well-designed studies with larger patient populations are needed” with “well-designed studies with larger populations and long term follow-up are needed” o Replaced reference to “patients” with “members”  Updated list of applicable CPT codes; added 22899  Updated supporting information to reflect the most current description of services, clinical evidence, and references

Electrical Sep. 1, 2018  Updated non-coverage rationale: Bioimpedance for o Replaced language indicating “[the listed service] is unproven and not medically necessary” with “[the listed Cardiac Output service] is unproven and/or not medically necessary” Measurement o Replaced reference to: . “Patient selection criteria” with “selection criteria” . “Patient” with “individual”  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references

Exondys 51™ Oct. 1, 2018  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: (Eteplirsen) o Added G71.01 o Removed G71.0

Gender Dysphoria Sep. 1, 2018  Updated coverage rationale; replaced language indicating “[the listed services] are considered cosmetic and not Treatment medically necessary” with “[the listed services] are considered cosmetic and/or not medically necessary”  Updated supporting information to reflect the most current clinical evidence and references

Home Health Care Sep. 1, 2018  Updated list of applicable CPT codes; revised description for 99602  Updated list of applicable HCPCS codes; revised description for S5523, S9211, S9212, S9348, S9494, S9503, S9504, S9542, and S9559

Occipital Neuralgia Oct. 1, 2018  Updated coverage rationale and clinical evidence; replaced references to “greater occipital nerve blocks” with and Headache “occipital nerve blocks” Treatment

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Otoacoustic Oct. 1, 2018  Updated coverage rationale; modified language to clarify: Emissions Testing o [The listed services are] proven and medically necessary o [The listed service is] unproven and not medically necessary  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: o Added I67.850, Z13.40, Z13.41, Z13.42, and Z13.49 o Removed Z13.4 o Revised description for F68.10, F68.12, and F68.13

Pharmacogenetic Oct. 1, 2018  Updated coverage rationale: Testing o Replaced language indicating “[the listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or not medically necessary” o Replaced reference to “pharmacogenetic testing panels” with “pharmacogenetic multigene testing panels”  Updated list of applicable CPT codes; added 0029U  Updated supporting information to reflect the most current clinical evidence and references

Whole Exome and Oct. 1, 2018  Updated list of applicable CPT codes; added 0036U Whole Genome  Updated supporting information to reflect the most current description of services, clinical evidence, and Sequencing references

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® Oct. 1, 2018  Updated list of related policies; Please refer to Injectable Chemotherapy Drugs: Application of NCCN Clinical (Tocilizumab) added reference link to the Practice Guidelines for updated information based upon the National Injection for policy titled Specialty Pharmacy Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® Intravenous for Certain Specialty Medications (NCCN Compendium®) for oncology indications. Infusion Administered in an Outpatient Hospital Setting This policy refers only to Actemra (tocilizumab) injection for intravenous  Revised conditions of infusion for the treatment of , polyarticular juvenile coverage/special considerations; idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release added language to indicate: syndrome. Actemra for self-administered subcutaneous injection is obtained o Participating hospitals are under the pharmacy benefit and is indicated in the treatment of rheumatoid required to purchase arthritis and giant cell arteritis. Actemra® (tocilizumab) from the BriovaRx Specialty Actemra is proven and medically necessary for the treatment of: Pharmacy when the  Polyarticular juvenile idiopathic arthritis when ALL of the medication is administered in following criteria are met: an outpatient hospital o Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA); and setting; refer to the policy o Actemra is initiated and titrated according to US Food and Drug titled Specialty Pharmacy for Administration labeled dosing for polyarticular juvenile idiopathic

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® Oct. 1, 2018 Certain Specialty Medications arthritis up to a maximum of (or equivalent dose and interval (Tocilizumab) Administered in an schedule): Injection for Outpatient Hospital Setting . 10mg/kg every 4 weeks for patients weighing < 30kg Intravenous for additional information . 8mg/kg every 4 weeks for patients weighing ≥ 30kg; Infusion and (continued) o Patient is not receiving Actemra in combination with either of the following: . Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (), Humira (), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz ()]  Rheumatoid arthritis when ALL of the following criteria are met: o Diagnosis of moderate to severely active rheumatoid arthritis (RA); and o History of failure, contraindication, or intolerance to at least one non-biologic DMARD [e.g., , , sulfasalazine, hydroxychloroquine, minocycline, etc.]; and o Actemra is initiated and titrated according to US Food and Drug Administration labeled dosing for rheumatoid arthritis up to a maximum of 800mg every 4 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Actemra in combination with either of the following: . Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]  Systemic juvenile idiopathic arthritis when ALL of the following criteria are met: o Diagnosis of systemic juvenile idiopathic arthritis (SJIA); and o Actemra is initiated and titrated according to US Food and Drug Administration labeled dosing for systemic juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule): . 12mg/kg every 2 weeks for patients weighing < 30kg . 8mg/kg every 2 weeks for patients weighing ≥ 30kg; and o Patient is not receiving Actemra in combination with either of the following: . Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® Oct. 1, 2018 . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] (Tocilizumab)  Cytokine release syndrome when ALL of the following criteria are Injection for met: Intravenous o Diagnosis of chimeric receptor (CAR) -induced cytokine Infusion release syndrome (CRS); and (continued) o Actemra is prescribed according to US Food and Drug Administration labeled dosing for CRS: . 12mg/kg for patients weighing < 30kg . 8mg/kg for patients weighing ≥ 30kg; up to a maximum of 800mg per infusion and o Actemra is prescribed for a maximum of 4 doses

Botulinum Toxins A Oct. 1, 2018  Revised coverage rationale; Refer to the policy for complete details on the coverage guidelines for and B added language to indicate Botulinum Toxins A and B. Xeomin (incobotulinumtoxinA) is proven and medically necessary for the treatment of sialorrhea  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: o Added G51.31, G51.32, G51.33, and G51.39 o Removed G51.3  Updated supporting information to reflect the most current FDA information and references

Crysvita® Oct. 1, 2018 Notice of Revision: The following Crysvita (burosumab) is proven for the treatment of X-linked (Burosumab-Twza) summary of changes has been hypophosphatemia (XLH). modified. Revisions to the original policy update announcement are Crysvita (burosumab) is medically necessary for the treatment of outlined in red below. Please take XLH when the following criteria are met: note of the additional updates to be  For initial therapy, all of the following: implemented on Oct. 1, 2018. o Diagnosis of XLH, confirmed by one of the following: . Genetic testing (e.g., confirmed PHEX gene mutation in patient  Updated list of related policies: or first-degree relative) o Added reference link to the . Elevated Serum fibroblast growth factor 23 (FGF23) level > 30 policy titled Specialty pg/mL Medication Administration – and

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Crysvita® Oct. 1, 2018 Site of Care Review o Patient is greater than 1 year of age; and (Burosumab-Twza) Guidelines o One of the following: (continued) o Removed reference link to . Patient epiphyseal plate has not fused; or the policy titled Review at . All of the following: Launch for New to Market - Patients’ epiphyseal plate has fused; and Medications - Patient is experiencing clinical signs and symptoms of the  Revised conditions of coverage/ disease (e.g., limited mobility, musculoskeletal pain, bone precertification requirements to fractures); and indicate: - Failure, contraindication, or intolerance to therapy with o Precertification with review calcitriol in combination with an oral phosphate agent (e.g., by a Medical Director or their K-Phos®, K-Phos Neutra®) designee is required and o New Jersey small group plan o Prescribed by, or in consultation with, an endocrinologist or specialist members should refer to experienced in the treatment of metabolic bone disorders; and their Certificate of Coverage o Fasting serum phosphorus is below the normal range for age; and for precertification and o Dosing is in accordance with the United States Food and Drug quantity limit guidelines Administration approved labeling; and o Additional precertification o Initial authorization will be for no more than 12 months. requirements apply to  For continuation therapy, all of the following: requests for hospital o Patient has previously received treatment with burosumab; and outpatient facility infusion of o Prescribed by, or in consultation with, an endocrinologist or specialist Crysvita; refer to the policy experienced in the treatment of metabolic bone disorders; and titled Specialty Medication o Patient has experienced normalization of serum phosphate while on Administration - Site of Care therapy; and Review Guidelines o Patient has experienced a positive clinical response to burosumab  Revised coverage (e.g., enhanced height velocity, improvement in skeletal deformities, rationale/medical necessity reduction of fractures, reduction of generalized bone pain); and criteria: o Dosing is in accordance with the United States Food and Drug o Updated criterion requiring Administration approved labeling; and diagnosis of X-linked o Reauthorization will be for no more than 12 months. hypophosphatemia (XLH) confirmed by genetic testing; added example of “confirmed PHEX gene mutation in patient or first- degree relative” o Added criterion requiring: . Patient is greater than 1 year of age

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Crysvita® Oct. 1, 2018 . One of the following: (Burosumab-Twza) - Patient epiphyseal (continued) plate has not fused; or - All of the following:  Patients’ epiphyseal plate has fused  Patient is experiencing clinical signs and symptoms of the disease  Failure, contraindication, or intolerance to therapy with calcitriol in combination with an oral phosphate agent (e.g., K-Phos®, K-Phos Neutra®) o Updated list of examples of clinical signs and symptoms of XLH: . Added “limited mobility” . Removed “rickets” and “growth retardation” o Replaced criterion requiring “[drug is] prescribed by, or in consultation with, a specialist experienced in the treatment of metabolic bone disorders” with “[drug is] prescribed by, or in consultation with, an endocrinologist or specialist experienced in the treatment

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Crysvita® Oct. 1, 2018 of metabolic bone disorders” (Burosumab-Twza) o Replaced reference to (continued) “serum phosphorus” with “fasting serum phosphorus”  Updated list of applicable HCPCS codes; added C9399  Updated supporting information to reflect the most current background information, clinical evidence, and references

Drug Coverage Oct. 1, 2018  Revised list of medications Refer to the policy for complete details on Drug Coverage Criteria - New and Criteria - New and requiring precertification through Therapeutic Equivalent Medications. Therapeutic the pharmacy benefit manager Equivalent (PBM): Medications o Added Butal/APAP 50/300 mg, Lokelma, Orilissa, and Symtuza o Removed Bonjesta

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018  Updated opioid utilization guidelines; added reference link to the policy titled Short-Acting Opioid Review Criteria Guidelines for Opioid Naïve Members for details on applicable coverage criteria  Added language to indicate participating hospitals in New York, New Jersey and Connecticut will be required to purchase certain multiple sclerosis and anti-inflammatory specialty medications from the BriovaRx Specialty Pharmacy; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for complete details Absorica (Isotretinoin) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Absorica (Isotretinoin) for complete details Actemra (Tocilizumab): Revised  Revised prior authorization/notification guidelines; refer to Prior SQ Injection Authorization/Notification Guidelines: Actemra (Tocilizumab) for complete details

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Oxford

Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018 Actemra (Tocilizumab): Revised  Added language to indicate participating hospitals are required to Guidelines Injection purchase Actemra (tocilizumab) injection for intravenous infusion from (continued) the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Amnesteem Updated  Updated prior authorization/notification guidelines; refer to Prior (Isotretinoin) Authorization/Notification Guidelines: Amnesteem for complete details Berinert (C1 Esterase Updated  Updated prior authorization/notification guidelines; refer to Prior Inhibitor Human) Authorization/Notification Guidelines: Berinert for complete details Bonjesta Revised  Added prior authorization/medical necessity guidelines; refer to Prior (Doxylamine/Pyridoxine) Authorization/Medical Necessity Guidelines: Bonjesta for complete details  Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Briviact (Brivaracetam) Revised  Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Briviact for complete details Butal/Apap 50/300 mg New  Added language to indicate precertification is required through the (Butalbital- Pharmacy Benefit Manager (PBM) Acetaminophen)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Caprelsa (Vandetanib) Revised  Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Caprelsa for complete details Carbaglu (Carglumic Updated  Updated prior authorization/notification guidelines; refer to Prior Acid) Authorization/Notification Guidelines: Carbaglu for complete details Cimzia (Certolizumab Revised  Added language to indicate participating hospitals are required to Pegol) purchase Cimzia (certolizumab pegol) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Cinryze (C1 Esterase Revised  Revised prior authorization/medical necessity guidelines; refer to Prior Inhibitor (Human)) Authorization/Medical Necessity Guidelines: Cinryze for complete details Claravis (Isotretinoin) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Claravis for complete details Crysvita (Burosumab- Revised  Revised coverage guidelines: Twza) o Added language to indicate: . Precertification is required through Oxford’s Medical Management . Administration of Crysvita in a hospital outpatient facility

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Oxford

Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018 Crysvita (Burosumab- Revised (including any ambulatory infusion suite associated with the Guidelines Twza) hospital) requires precertification with review by a Medical (continued) (continued) Director or their designee; refer Specialty Medication Administration – Site of Care Review Guidelines for complete details o Removed reference link to the policy titled Precertification Guidelines: Review at Launch for New to Market Medications Diclegis (Doxylamine Updated  Updated prior authorization/medical necessity guidelines; refer to Prior Succinate and Pyridoxine Authorization/Medical Necessity Guidelines: Diclegis for complete details Hydrochloride) Dupixent (Dupilumab) Updated  Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Dupixent for complete details Eligard (Leuprolide Revised  Revised prior authorization/notification guidelines; refer to Prior Acetate) Authorization/Notification Guidelines: Eligard (Leuprolide Acetate) for complete details Entyvio (Vedolizumab) Revised  Added language to indicate participating hospitals are required to purchase Entyvio (vedolizumab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Epanova (Omega-3- Removed  Removed coverage guidelines Carboxylic Acids) Eucrisa (Crisaborole) Updated  Updated step therapy guidelines; refer to Step Therapy Guidelines: Eucrisa for complete details Firazyr (Icatibant) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Firazyr for complete details Haegarda [C1 Esterase Revised  Added prior authorization/medical necessity guidelines; refer to Prior Inhibitor Subcutaneous Authorization/Medical Necessity Guidelines: Haegarda for complete (Human)] details  Removed prior authorization/notification guidelines and corresponding reference link to the policy titled Prior Authorization/Notification Guidelines: Haegarda Ilumya (Tildrakizumab- Updated  Added notation to indicate precertification will be required effective Jan. Asmn) 1, 2019 Inflectra (Infliximab) Revised  Added language to indicate participating hospitals are required to purchase Inflectra (infliximab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered

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Oxford

Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018 Inflectra (Infliximab) Revised in an Outpatient Hospital Setting for additional information Guidelines (continued) (continued) Inlyta (Axitinib) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Inlyta for complete details Kevzara (Sarilumab) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Kevzara for complete details Kuvan (Sapropterin Revised  Revised prior authorization/notification guidelines; refer to Prior Dihydrochloride) Authorization/Notification Guidelines: Kuvan (Sapropterin Dihydrochloride) for complete details Lemtrada Revised  Added language to indicate participating hospitals are required to (Alemtuzumab) purchase Lemtrada (alemtuzumab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Lenvima (Lenvatinib) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Lenvima for complete details Leuprolide Acetate Revised  Revised prior authorization/notification guidelines; refer to Prior (Subcutaneous) Authorization/Notification Guidelines: Leuprolide Acetate for complete (Eligard), 1mg/0.2ml details Lokelma (Sodium New  Added language to indicate precertification is required through the Zirconium Cyclosilicate) Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Lupron, Revised  Revised precertification guidelines for oncology use; added notation to Lupron-3, indicate precertification is not required for J9217 (Lupron Depot 7.5mg, Lupron-4, 22.5mg, and 30mg) for the diagnosis of prostate cancer Lupron Depot, Lupron Depot Pediatric Lupron Implant (Leuprolide Acetate) Myorisan (Isotretinoin) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Myorisan for complete details Nexavar (Sorafenib Revised  Revised prior authorization/notification guidelines; refer to Prior Tosylate) Authorization/Notification Guidelines: Nexavar for complete details Noctiva (Desmopressin Revised  Revised prior authorization/medical necessity guidelines; refer to Prior Acetate) Authorization/Medical Necessity Guidelines: Noctiva for complete details Ocrevus (Ocrelizumab) Revised  Added language to indicate participating hospitals are required to purchase Ocrevus (Ocrelizumab) from the BriovaRx Specialty Pharmacy

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Oxford

Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018 Ocrevus (Ocrelizumab) Revised when administered in an outpatient hospital setting; refer to the policy Guidelines (continued) titled Specialty Pharmacy for Certain Specialty Medications Administered (continued) in an Outpatient Hospital Setting for additional information Olumiant (Baricitinib) Revised  Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Olumiant for complete details Omtryg (Omega-3-Acid Removed  Removed coverage guidelines Ethyl Esters A) Orencia (Abatacept) Revised  Added language to indicate participating hospitals are required to purchase Orencia (abatacept) injection for intravenous infusion from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Orilissa (Elagolix) New  Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Palynziq (Pegvaliase- Revised  Added prior authorization/notification guidelines; refer to Prior Pqpz) Authorization/Notification Guidelines: Palynziq for complete details Pancreaze (Pancrelipase) Updated  Updated step therapy guidelines; refer to Step Therapy Guidelines: Pancreaze for complete details Parsabiv (Etelcalcetide) Revised  Revised coverage guidelines to indicate precertification is required through Oxford’s Medical Management Pertzye (Pancrelipase) Updated  Updated step therapy guidelines; refer to Step Therapy Guidelines: Pertzye for complete details Ravicti (Glycerol Updated  Updated prior authorization/medical necessity guidelines; refer to Prior Phenylbutyrate Oral Authorization/Medical Necessity Guidelines: Ravicti for complete details Liquid) Remicade (Infliximab) Revised  Added language to indicate participating hospitals are required to purchase Remicade (infliximab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Renflexis (Infliximab) Revised  Added language to indicate participating hospitals are required to purchase Renflexis (infliximab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information

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Oxford

Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018 Ruconest (C1 Esterase Updated  Updated prior authorization/notification guidelines; refer to Prior Guidelines Inhibitor [Recombinant]) Authorization/Notification Guidelines: Ruconest for complete details (continued) Simponi Aria Revised  Added language to indicate participating hospitals are required to (Golimumab) purchase Simponi Aria (golimumab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Solaraze (Diclofenac) Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Solaraze for complete details Somavert (Pegvisomant) Updated  Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Somavert for complete details Soolantra (Ivermectin) Updated  Updated step therapy guidelines; refer to Step Therapy Guidelines: Soolantra for complete details Stelara (Ustekinumab): Revised  Added language to indicate participating hospitals are required to Sub-Cutaneous Injection purchase Stelara (ustekinumab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information Stelara (Ustekinumab): Revised  Added language to indicate: Intravenous Infusion o Participating hospitals are required to purchase Stelara (ustekinumab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information o Precertification is not required if provided in an office or outpatient setting Symtuza New  Added language to indicate precertification is required through the (Darunavir/Cobicistat/ Pharmacy Benefit Manager (PBM) Emtricitabine/Tenofovir  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Alafenamide Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Tysabri (Natalizumab) Revised  Added language to indicate participating hospitals are required to purchase Tysabri (natalizumab) from the BriovaRx Specialty Pharmacy when administered in an outpatient hospital setting; refer to the policy titled Specialty Pharmacy for Certain Specialty Medications Administered in an Outpatient Hospital Setting for additional information

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Oxford

Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Oct. 1, 2018 Uloric (Febuxostat) Updated  Updated step therapy guidelines; refer to Step Therapy Guidelines: Guidelines Uloric for complete details (continued) Ultresa (Pancrelipase) Removed  Removed coverage guidelines Viokace (Pancrelipase) Updated  Updated step therapy guidelines; refer to Step Therapy Guidelines: Viokace for complete details Xyrem (Sodium Updated  Updated prior authorization/medical necessity guidelines; refer to Prior Oxybate) Authorization/Medical Necessity Guidelines: Xyrem (Sodium Oxybate) for complete details Zenatane Updated  Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Zenatane for complete details

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Entyvio® Oct. 1, 2018  Updated list of related policies; Entyvio (vedolizumab) is proven and medically necessary for the (Vedolizumab) added reference link to the treatment of: policy titled Specialty Pharmacy for Certain Specialty Medications Crohn's disease when all of the following criteria are met: Administered in an Outpatient  For initial therapy, all of the following: Hospital Setting o Diagnosis of moderately to severely active Crohn’s disease (CD);  Revised conditions of and coverage/special considerations; o One of the following: added language to indicate: . History of failure, contraindication, or intolerance to at least one o Participating hospitals are of the following conventional therapies: required to purchase - (TNF) blocker [e.g., Humira Entyvio® (vedolizumab) from (adalimumab), Cimzia (certolizumab)] the BriovaRx Specialty - Immunomodulator (e.g., , 6-mercaptopurine) Pharmacy when the - Corticosteroid medication is administered in . Corticosteroid dependent (e.g., unable to successfully taper an outpatient hospital corticosteroids without a return of the symptoms of CD) setting; refer to the policy and titled Specialty Pharmacy for o Entyvio is initiated and titrated according to US Food and Drug Certain Specialty Medications Administration (FDA) labeled dosing for Crohn’s disease up to a Administered in an maximum of 300mg every 8 weeks (or equivalent dose and interval Outpatient Hospital Setting schedule); and for additional information o Patient is not receiving Entyvio in combination with either of the following: . Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)] . Tysabri (natalizumab); and

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Entyvio® Oct. 1, 2018 o Initial authorization will be for no more than 14 weeks (Vedolizumab)  For continuation therapy, all of the following: (continued) o Documentation of positive clinical response to Entyvio; and o Entyvio dosing for Crohn’s disease is in accordance with the FDA labeled dosing up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and o Reauthorization will be for no more than 12 months.

Ulcerative colitis when all of the following criteria are met:  For initial therapy, all of the following: o Diagnosis of moderately to severely active (UC); and o One of the following: . History of failure, contraindication, or intolerance to at least one of the following conventional therapies: - Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Simponi (golimumab)] - Immunomodulator (e.g., azathioprine, 6-mercaptopurine) - Corticosteroid . Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of UC) and o Entyvio is initiated and titrated according to US Food and Drug Administration labeled dosing for ulcerative colitis up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Entyvio in combination with either of the following: . Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Simponi (golimumab)] . Tysabri (natalizumab); and o Initial authorization will be for no more than 14 weeks.  For continuation therapy, all of the following: o Documentation of positive clinical response to Entyvio; and o Entyvio dosing for ulcerative colitis is in accordance with the FDA labeled dosing up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and o Reauthorization will be for no more than 12 months.

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018  Reorganized and revised Refer to the policy for complete details on the coverage guidelines for Hereditary Cancer coverage rationale: Genetic Testing for Hereditary Cancer. o Replaced language indicating: . “[The listed services] are proven and medically necessary” with “[the listed services] are proven and/or medically necessary” . “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary” o Replaced references to “patient” with “individual” Hereditary Breast and Ovarian Cancer (BRCA1/BRCA2)  Modified list of proven and/or medically necessary indications for genetic testing for BRCA1 and BRCA2 for individuals with a personal history of a related cancer: o Added “individuals with a BRCA 1/2 pathogenic mutation detected in tumor tissue” o Revised coverage criteria for women with a personal history of Breast Cancer diagnosed at any age: . Removed language indicating testing should be targeted to the known BRCA1/BRCA2 mutation

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 in the family; further Hereditary Cancer BRCA1/BRCA2 testing (continued) should only be pursued if the results are negative and the patient otherwise meets testing criteria . Added language to indicate genetic testing for BRCA1 and BRCA2 is proven and/or medically necessary when there is an unknown or Limited Family History o Revised coverage criteria for individuals with a personal history of pancreatic cancer diagnosed at any age: . Added criterion requiring “at least one Close Blood Relative who has a known BRCA1 or BRCA2 mutation” . Added language to indicate genetic testing for BRCA1 and BRCA2 is proven and/or medically necessary when there is an unknown or Limited Family History o Revised coverage criteria for men with a personal history of prostate cancer diagnosed at any age: . Added criterion requiring “metastatic prostate cancer (radiographic evidence of metastases

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 or biopsy-proven Hereditary Cancer disease)” (continued) . Modified criteria pertaining to men with a personal history of high risk prostate cancer: - Replaced criterion requiring:  “Gleason Score > 7” with “Gleason Score at least 7”  “At least one Close Blood Relative with Breast Cancer (< age 50 years)” with “at least one Close Blood Relative with Breast Cancer diagnosed at age 50 or younger” - Added language to indicate genetic testing for BRCA1 and BRCA2 is proven and/or medically necessary for men with a personal history of high risk prostate cancer when there is an unknown or Limited Family History  Modified list of proven and/or medically necessary indications for genetic testing for BRCA1 and BRCA2 for individuals

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 without a personal history of a Hereditary Cancer related cancer: (continued) o Removed language indicating testing should be targeted to the known BRCA1/BRCA2 mutation in the family; further BRCA1/BRCA2 testing should only be pursued if the results are negative and the patient otherwise meets testing criteria  Added language to indicate genetic testing for BRCA1 and/or BRCA2 testing is unproven and/or not medically necessary for confirmation of direct to consumer genetic testing without meeting any of the proven indications [listed in the policy] Multi-Gene Hereditary Cancer Panel Testing Criteria  Revised coverage criteria for proven and/or medically necessary genetic testing with a multi-gene hereditary cancer panel in individuals with an indication for testing for hereditary breast and ovarian cancer: o Expanded criterion pertaining to individuals with a family or personal history that is strongly suggestive of more than one hereditary cancer syndrome to indicate at least one of the following is required: . A personal history of at

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 least two different Hereditary Cancer cancers (e.g., Breast (continued) Cancer and Ovarian Cancer) . A personal history of cancer diagnosed at age 40 or younger . A personal history of cancer and at least one relative with a cancer associated with Lynch Syndrome (i.e., brain, colorectal, endometrial, gastric, ovarian, pancreatic, renal pelvis, small intestine, or ureter cancers, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas) . At least one Close Blood Relative diagnosed with Breast Cancer, Ovarian Cancer, prostate cancer, or pancreatic cancer at age 40 or younger . At least three Close Blood Relatives on the same side of the family diagnosed with any cancer  Revised coverage criteria for hereditary colorectal cancer to indicate genetic testing with a multi-gene cancer panel in individuals with an indication for testing for hereditary colorectal cancer is proven and/or medically necessary in the

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 following situations: Hereditary Cancer o The suspected hereditary (continued) cancer syndromes can be diagnosed by testing of one or more genes included in the specific hereditary cancer panel; and o The results of testing will directly impact this individual’s medical management; and o The individual has a personal or family history with at least one of the following criteria for Hereditary Colorectal Cancer/Lynch Syndrome Cancer or colorectal polyposis syndrome: . Men with a personal history of colorectal cancer or women with a personal history of colorectal or endometrial cancer diagnosed at age 50 or younger . Men with a personal history of colorectal cancer or women with a personal history of colorectal or endometrial cancer diagnosed at age 51 or later with at least one of the following criteria: - A personal history of another cancer associated with Lynch Syndrome

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 (i.e., brain, gastric, Hereditary Cancer ovarian, pancreatic, (continued) renal pelvis, small intestine, or ureter cancers, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas); or - Tumor testing results showing that their colorectal or endometrial cancer was MSI-high or had immunohistochem- ical (IHC) staining showing the absence of one or more mismatch repair proteins (MLH1, MSH2, MSH6 or PMS2) . A personal history of colorectal polyposis with at least 10 adenomatous polyps, at least 2 hamartomatous polyps, or at least 5 serrated polyps . At least one close blood relative with a diagnosis of colorectal cancer or endometrial cancer at age 50 or younger . At least one close blood relative with at least two cancers associated with Lynch Syndrome (i.e.,

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 brain, colorectal, Hereditary Cancer endometrial, gastric, (continued) ovarian, pancreatic, renal pelvis, small intestine, or ureter cancers, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas) . Two or more close blood relatives with a cancer associated with Lynch Syndrome (i.e., brain, colorectal, endometrial, gastric, ovarian, pancreatic, renal pelvis, small intestine, or ureter cancers, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas), with at least one diagnosed at age 50 or younger . Three or more close blood relatives with a cancer associated with Lynch Syndrome (i.e., brain, colorectal, endometrial, gastric, ovarian, pancreatic, renal pelvis, small intestine, or ureter cancers, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas) diagnosed at any age . At least one close blood relative with a clinical

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 diagnosis of Familial Hereditary Cancer Adenomatous Polyposis, (continued) Attenuated Familial Adenomatous Polyposis, Juvenile Polyposis Syndrome, or Peutz- Jeghers Syndrome . A PREMM5, PREMM1,2,6, MMRpro, or MMRpredict Score of 5% or greater for having a Lynch syndrome gene mutation  Added language to indicate genetic testing with a multi-gene hereditary cancer panel in individuals diagnosed with cancer at age 18 or younger is proven and/or medically necessary  Revised coverage criteria for proven and/or medically necessary genetic testing with a multi-gene cancer panel in an individual who has previously tested negative (indeterminate) for the high Penetrance genes that are most likely to explain the personal or family history of cancer (e.g., BRCA1/2 for Breast Cancer and Ovarian Cancer): o Added criterion requiring “the suspected hereditary cancer syndromes can be diagnosed by testing of one or more genes included in the specific hereditary cancer panel” o Expanded criterion pertaining to individuals with

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 a personal and family history Hereditary Cancer remains strongly suggestive (continued) of an inherited susceptibility that can be diagnosed by testing of one or more genes included in the specific hereditary cancer panel to indicate at least one of the following is required: . A personal history of at least two different cancers (e.g., Breast Cancer and Ovarian Cancer) . A personal history of cancer diagnosed at age 40 or younger . A personal history of cancer and at least one relative with a cancer associated with Lynch Syndrome (i.e., brain, colorectal, endometrial, gastric, ovarian, pancreatic, renal pelvis, small intestine, or ureter cancers, sebaceous adenomas, sebaceous carcinomas, and keratoacanthomas) . At least one Close Blood Relative diagnosed with Breast Cancer, Ovarian Cancer, prostate cancer or pancreatic cancer at age 40 or younger . At least three Close Blood Relatives on the same side of the family

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2018 diagnosed with any Hereditary Cancer cancer (continued) Definitions  Added definition of: o Age Guidelines o Breast Cancer o Close Blood Relatives o Founder Mutation o Gleason Scoring o Limited Family History o Lynch Syndrome Cancers o Ovarian Cancer o Penetrance o Personal and Family History Documentation o Triple-Negative Breast Cancer  Removed definition of “1st, 2nd, and 3rd Degree Relatives” Applicable Codes  Updated and reorganized list of applicable CPT codes; added 81435, 81436, 81437, and 81438 Supporting Information  Updated supporting information to reflect the most current description of services, clinical evidence, and references

Infliximab Oct. 1, 2018  Updated list of related policies; This policy refers to the following infliximab products: (Remicade®, added reference link to the  Inflectra™ (infliximab-dyyb) Inflectra™, policy titled Specialty Pharmacy  Remicade® (infliximab) Renflexis™) for Certain Specialty Medications  Renflexis™ (infliximab-abda) Administered in an Outpatient Hospital Setting Preferred Product  Revised conditions of Remicade® (infliximab) is the preferred infliximab product. Coverage will be coverage/special considerations; provided for Remicade® contingent on the coverage criteria in the Diagnosis- added language to indicate: Specific Criteria section of the policy.

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2018 o Participating hospitals are Coverage for Inflectra™ (infliximab-dyyb) or Renflexis™ (infliximab-abda) (Remicade®, required to purchase will be provided contingent on the criteria in this section and the coverage Inflectra™, Inflectra™ (infliximab-dyyb), criteria in the Diagnosis-Specific Criteria section of the policy. In order to Renflexis™) Remicade® (infliximab), and continue coverage, members already on Inflectra™ or Renflexis™ will be (continued) Renflexis™ (infliximab-abda) required to change therapy to Remicade® unless they meet the criteria in from the BriovaRx Specialty this section. Pharmacy when the medication is administered in Preferred Product Criteria an outpatient hospital Treatment with Inflectra™ (infliximab-dyyb), Renflexis™ (infliximab- setting; refer to the policy abda) or other infliximab biosimilar is medically necessary for the titled Specialty Pharmacy for indications specified in this policy when the following criteria are Certain Specialty Medications met: Administered in an  Both of the following: Outpatient Hospital Setting o One of the following: for additional information . Both of the following: - History of a trial of at least 14 weeks of Remicade resulting in minimal clinical response to therapy and residual disease activity. - Physician attests that in their clinical opinion the clinical response would be expected to be superior with Inflectra or other infliximab biosimilar product, than experienced with Remicade. or . Both of the following: - History of intolerance or adverse event to Remicade. - Physician attests that in their clinical opinion the same intolerance or adverse event would not be expected to occur with Inflectra or other infliximab biosimilar product. and o Both of the following: . Patient has NOT had a loss of a favorable response after established maintenance therapy with Remicade or other infliximab product. . Patient has NOT developed neutralizing to any infliximab product that has led to an attenuation of efficacy of therapy.

Diagnosis-Specific Criteria “Infliximab” will be used to refer to all infliximab products.

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2018 Infliximab is proven and medically necessary for the treatment of: (Remicade®,  when the following criterion is met: Inflectra™, o Diagnosis of ankylosing spondylitis (AS). Renflexis™)  Crohn’s disease when the following criterion is met: (continued) o One of the following: . Diagnosis of fistulizing Crohn’s disease (Crohn’s Disease Activity Index (CDAI) ≥ 220 and ≤ 400); or . Both of the following: - Diagnosis of moderately to severely active Crohn’s disease; and - History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., corticosteroids, 6- mercaptopurine, azathioprine, methotrexate, etc.).  Noninfectious when BOTH of the following criteria are met: o Diagnosis of refractory noninfectious uveitis that is causing or threatening vision loss (e.g., noninfectious uveitis associated with Behçet’s or Reiter’s syndromes); and o History of failure, contraindication, or intolerance to ALL of the following: . Topical corticosteroids; . Systemic corticosteroids; . Immunosuppressive drugs (e.g., azathioprine, cyclosporine, or methotrexate).  Plaque when BOTH of the following criteria are met: o Diagnosis of chronic severe plaque psoriasis i.e., extensive and/or disabling); and o Patient is a candidate for systemic therapy.  when the following criterion is met: o Diagnosis of psoriatic arthritis (PsA).  Rheumatoid arthritis when BOTH of the following criteria are met: o Diagnosis of moderately to severely active rheumatoid arthritis (RA); and o One of the following: . Member is receiving concurrent therapy with methotrexate; . History of contraindication or intolerance to methotrexate.  when ALL of the following criteria are met: o Diagnosis of sarcoidosis; and o History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); and

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2018 o History of failure, contraindication, or intolerance to one (Remicade®, immunosuppressant (e.g., methotrexate, cyclophosphamide, Inflectra™, azathioprine). Renflexis™)  Ulcerative colitis when BOTH of the following criteria are met: (continued) o Diagnosis of moderately to severely active ulcerative colitis (UC); and o History of failure, contraindication, or intolerance to at least one conventional therapy e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids.

There may be other conditions that qualify as serious, rare diseases for which the use of infliximab may be appropriate. Please refer to the Benefit Considerations section of the policy for additional information.

Infliximab is unproven and not medically necessary in the treatment of:  Still’s disease  Sjogren’s syndrome  Graft-vs-host disease  Myelodysplastic syndromes  Undifferentiated spondyloarthropathy  Reiter’s syndrome  Hidradenitis suppurativa  Wegener’s granulomatosis  Juvenile idiopathic arthritis (juvenile rheumatoid arthritis)

Infliximab is unproven and not medically necessary for the treatment of the above conditions because statistically robust randomized controlled trials are needed to address the issue of whether Infliximab has sufficient superiority in clinical efficacy compared to other available treatments to justify the inherent clinical risk in the use of a monoclonal anti-tumor necrosis factor agent.

Intravenous Oct. 1, 2018  Revised coverage rationale: This policy refers to the following drug products, all of which are intravenous Enzyme o Replaced language indicating enzyme replacement therapies used in the treatment of Gaucher disease: Replacement “Cerezyme, Elelyso and  Cerezyme® (imiglucerase) Therapy (ERT) for VPRIV are proven and  Elelyso® (taliglucerase) Gaucher Disease medically necessary for the  VPRIV®* (velaglucerase) treatment of Type 1 Gaucher disease when all of the Cerezyme, Elelyso, and VPRIV* are proven for the treatment of

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Oct. 1, 2018 [listed] criteria are met” with Type 1 Gaucher disease when ALL of the following criteria are met: Enzyme “Cerezyme, Elelyso and  Diagnosis of Type 1 Gaucher disease; and Replacement VPRIV are proven for the  Symptomatic disease (e.g., moderate to severe anemia, Therapy (ERT) for treatment of Type 1 Gaucher thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and Gaucher Disease disease when all of the  Dose does not exceed 60 units/kg every 2 weeks. (continued) [listed] criteria are met; enzyme replacement therapy *VPRIV is the preferred enzyme replacement therapy and does not require with Elelyso or Cerezyme is precertification. medically necessary for the treatment of Gaucher Enzyme replacement therapy with Elelyso is medically necessary for disease when [the listed] the treatment of Gaucher disease when BOTH of the following criteria are met” criteria are met:  Updated supporting information  Diagnosis of Type 1 Gaucher Disease; and to reflect the most current  One of the following: references; replaced references o History of failure of VPRIV due to failure to meet clinical goals (e.g., to “MCG™ Care Guidelines, persistent anemia, thrombocytopenia, bone disease, hepatomegaly, Ambulatory Care 21st Edition” or splenomegaly) despite VPRIV therapy with “MCG™ Care Guidelines, o History of failure of VPRIV due to hypersensitivity to VPRIV therapy Ambulatory Care 22nd Edition” Enzyme replacement therapy with Cerezyme is medically necessary for the treatment of Gaucher disease when ONE of the following criteria is met:  Both of the following: o Diagnosis of Type 1 Gaucher Disease; and o One of the following: . 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 . History of failure of VPRIV due to hypersensitivity to VPRIV therapy . Patient is pregnant or breastfeeding . Patient is attempting to become pregnant or  Diagnosis of Type 3 Gaucher disease

Cerezyme is proven and medically necessary for the treatment of Type 3 Gaucher disease when ALL of the following criteria are met:  Diagnosis of Type 3 Gaucher disease; and  Symptomatic disease (e.g., moderate to severe anemia,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Oct. 1, 2018 thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and Enzyme  Dose does not exceed 60 units/kg every 2 weeks. Replacement Therapy (ERT) for Gaucher Disease (continued) Lemtrada Oct. 1, 2018  Updated list of related policies; Lemtrada (alemtuzumab) is proven and medically necessary for (Alemtuzumab) added reference link to the treatment of relapsing forms of multiple sclerosis when ALL of the policy titled Specialty Pharmacy following criteria are met: for Certain Specialty Medications  Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing- Administered in an Outpatient remitting MS, secondary-progressive MS with relapses, progressive- Hospital Setting relapsing MS with relapses); and  Revised conditions of  One of the following: coverage/special considerations; o Treatment-naïve to alemtuzumab: added language to indicate: . Member has history of failure following a trial for at least 4 weeks o Participating hospitals are or history of intolerance to at least two of the following: required to purchase - β-1a (Avonex® or Rebif®)) Lemtrada (alemtuzumab) - interferon β-1b (Betaseron® or Extavia®) from the BriovaRx Specialty - glatiramer acetate (Copaxone® or Glatopa®) Pharmacy when the - (Tecfidera®) medication is administered in - (Aubagio®) an outpatient hospital - (Gilenya®) setting; refer to the policy - peginterferon beta-1a (Plegridy™) titled Specialty Pharmacy for - natalizumab (Tysabri®) Certain Specialty Medications - (Zinbryta™) Administered in an - ocrelizumab (Ocrevus®) Outpatient Hospital Setting and for additional information . Member has not been previously treated with alemtuzumab; and . Member is not receiving alemtuzumab in combination with another disease modifying agent for multiple sclerosis (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, teriflunomide, etc.); and . Initial dosing is administered: 12 mg intravenously daily for 5 consecutive days; and . Regimen is administered only once within 12 months or o Treatment-experienced with alemtuzumab: . Member has previously received treatment with alemtuzumab; and

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Lemtrada Oct. 1, 2018 . Member is not receiving alemtuzumab in combination with (Alemtuzumab) another disease modifying agent for multiple sclerosis (e.g., (continued) interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, teriflunomide, etc.); and . Retreatment dosing is administered: 12 mg intravenously daily for 3 consecutive days; and . Regimen is administered only once within 12 months

Coverage of Lemtrada is limited up to two treatment courses (5 day initial and 3 day end course). Requests for additional doses/courses beyond two courses will not be approved.

Alemtuzumab is unproven and not medically necessary for the treatment of:  Rheumatoid arthritis  Autoimmune neutropenia  Autoimmune hemolytic anemia  Pure red cell aplasia  Immune thrombocytopenic purpura  Evan's syndrome  Autoimmune pancytopenia

Molecular Oncology Oct. 1, 2018  Reorganized and revised Breast Cancer Testing for Cancer coverage rationale: The use of one of the following gene expression tests listed below is Diagnosis, o Added language to indicate: considered proven and/or medically necessary to make a treatment Prognosis, and . Molecular profiling of decision regarding adjuvant chemotherapy in females or males with Treatment thyroid nodules (e.g., non-metastatic breast cancer when all of the following criteria are Decisions Afirma, ThyraMIR, met. Thyroseq) is proven and/or medically Use of more than one gene expression test for the same tumor in an necessary when all of individual with breast cancer is unproven and/or not medically the following criteria are necessary. met: - Follicular pathology MammaPrint (also referred to as the "Amsterdam Signature" or "70- on fine needle Gene Signature"), is considered proven and/or medically necessary aspiration is to assess distant recurrence of disease in individuals with recently indeterminate diagnosed non-metastatic breast cancer when ALL the following - The results of the criteria are met: test will be used for  High clinical risk of recurrence based on at least one of the following making decisions

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Molecular Oncology Oct. 1, 2018 about further criteria: Testing for Cancer surgery o Lymph node positive (pN1-2); or Diagnosis, . Use of more than one o Tumor size greater than 2 cm; or Prognosis, and molecular profile test in o Poorly differentiated or undifferentiated histology (grade 3) AND Treatment an individual with a tumor size greater than 1 cm; and Decisions thyroid nodule is  Hormone receptor-positive (estrogen receptor positive, progesterone (continued) unproven and/or not receptor positive or both); and medically necessary  HER2 receptor negative; and . Molecular profiling using  Adjuvant chemotherapy is not precluded due to any other factor (e.g., chromosomal microarray advanced age and/or significant co-morbidities); and analysis is considered  Individual and treating physician have had a discussion prior to testing proven and/or medically regarding the potential results of the test and determined to use the necessary for individuals results to guide therapy. with acute leukemia . Whole Exome MammaPrint is considered unproven and/or not medically necessary Sequencing (WES) and for all other indications. Whole Genome Sequencing (WGS) of Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene tumors is considered Signature Assay, EndoPredict and the Breast Cancer Index gene unproven and/or not expression tests for intermediate and low risk breast cancer are medically necessary for considered proven and/or medically necessary to assess use of all indications adjuvant chemotherapy in individuals with recently diagnosed non- o Updated list of unproven metastatic breast cancer when all of the following criteria are met: and/or not medically  Lymph node negative (pN0) or axillary lymph node micrometastasis less necessary indications for than 2mm (pN1mi); and molecularly profiling using  Hormone receptor positive (estrogen receptor positive, progesterone gene expression profiling or receptor positive or both); and multi-gene cancer panels:  HER2 receptor negative; and . Added:  Adjuvant chemotherapy is not precluded due to any other factor (e.g., • Bladder Cancer (e.g., advanced age and/or significant co-morbidities); and CytoScan® DX  Individual and treating physician have had a discussion prior to testing Assay) regarding the potential results of the test and determined to use the • Breast cancer other results to guide therapy. than those previously described Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene as covered Signature Assay, EndoPredict, and the Breast Cancer Index are • Leukemia other than considered unproven and/or not medically necessary for all other those described as indications. covered (e.g.,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Molecular Oncology Oct. 1, 2018 FoundationOne® Gene expression profiling assays for breast cancer treatment other Testing for Cancer Heme) than those previously described as covered are considered unproven Diagnosis, • Plasma detection of and/or not medically necessary, including but not limited to: Prognosis, and cell-free DNA (e.g.,  BluePrint (also referred to as "80-gene profile") Treatment Guardant,  Breast Cancer Gene Expression Ratio (also known as Theros H/I) Decisions Colonsentry)  BreastNext (continued) . Updated list of examples  BreastOncPX of tests associated with  BreastPRS cancers of unknown  Insight DX Breast Cancer Profile primary site; added  Mammostrat “Pathfinder TG”  NexCourse Breast IHC4 . Replaced “cutaneous  NuvoSelect eRx 200-Gene Assay melanoma” with  Oncotype DX DCIS “melanoma”  SYMPHONY Genomic Breast Cancer Profile o Removed language  TargetPrint pertaining to clinical  TheraPrint evidence/study findings for  The 41-gene signature assay the following unproven  The 76-gene "Rotterdam signature" assay and/or not medically necessary indications: Thyroid Cancer . Breast cancer treatment Molecular profiling of thyroid nodules (e.g., Afirma, ThyraMIR, other than those Thyroseq) is proven and/or medically necessary when all of the described [in the policy] following criteria are met: as covered  Follicular pathology on fine needle aspiration is indeterminate . Identification of the  The results of the test will be used for making decisions about tissue of origin for further surgery cancers of unknown primary site Use of more than one molecular profile test in an individual with a . Cutaneous and uveal thyroid nodule is unproven and/or not medically necessary. melanoma . Colorectal cancer (CRC) Leukemia risk assessment or Molecular profiling using chromosomal microarray analysis is management considered proven and/or medically necessary for individuals with . Evaluation or acute leukemia. management of multiple

myeloma Lung Cancer . Screening, detection and Molecular profiling of tumors using a multi-gene cancer panel of up management of prostate to 50 genes is considered proven and/or medically necessary for cancer individuals with metastatic non-small cell lung cancer (NSCLC).

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED

Molecular Oncology Oct. 1, 2018 o Removed language Use of more than one gene multi-gene cancer panel for the same Testing for Cancer indicating topographic individual with non-small cell lung cancer is unproven and/or not Diagnosis, genotyping is unproven medically necessary. Prognosis, and and/or not medically Treatment necessary Molecular Profiling Tests for for Other Indications or Cancers Decisions  Added definition of: Whole Exome Sequencing (WES) and whole genomic sequencing (continued) o Comparative Genome (WGS) of tumors is considered unproven and/or not medically Hybridization (CGH) necessary for all indications. o Gene Expression Testing o Next Generation Sequencing Multi-gene cancer panels of greater than 50 genes are considered (NGS) unproven and/or not medically necessary for all indications. o Variant of Unknown Significance (VUS) Molecularly profiling using gene expression profiling or multi-gene o Whole Exome Sequencing cancer panels is considered unproven and/or not medically (WES) necessary for all other indications, including but not limited to: o Whole Genome Sequencing  Bladder Cancer (e.g. CytoScan® DX Assay) (WGS)  Breast cancer other than those previously described as covered  Updated list of applicable CPT  Cancers of Unknown Primary Site (e.g. Response Dx, CancerTYPE ID, codes; added 0018U, 0026U, Rosetta Cancer Origin, ProOnc, SourceDX, Pathfinder TG) 0036U, 0037U, 0045U, 0047U,  Colorectal Cancer (e.g. Oncotype DX Colon Cancer Assay, Colorectal 0048U, 0050U, 0056U, and Cancer DSA, GeneFx Colon, OncoDefender-CRC) 0057U  Leukemia other than those previously described as covered (e.g.  Updated supporting information FoundationOne® Heme) to reflect the most current  Melanoma (e.g. Decision Dx – Melanoma, Decision Dx-UM) description of services, clinical  Multiple myeloma (e.g. MyPRS/MyPRS Plus) evidence, FDA information, and  Plasma detection of cell free DNA (e.g. Guardant, Colonsentry) references  Prostate cancer (e.g. Oncotype DX Prostate Cancer Assay, TMPRSS2 fusion gene, Prolaris Prostate Cancer Test, Decipher Prostate Cancer Classifer)  Uveal melanoma (e.g. Decision Dx-UM)

Obstetrical Oct. 1, 2018  Updated coverage rationale: This policy has three components: Ultrasonography o Redirected reference link to eviCore healthcare radiology 1. Utilization Management evidence-based guidelines Participating Providers will be reimbursed in accordance to their contract, for and management criteria up to three ultrasounds per pregnancy, based upon their specialty and from applicable payment rules, without precertification as outlined in Section II “http://www.carecorenationa and III of the policy. l.com/page/criteria.aspx” to

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Obstetrical Oct. 1, 2018 “Prior Authorization and The fourth and subsequent obstetrical ultrasound procedure per Member per Ultrasonography Notification App” pregnancy performed by a participating provider as outlined are subject to (continued)  Revised list of applicable CPT utilization review (pre-certification) by eviCore healthcare. codes; added payment guidelines to indicate: Oxford has engaged eviCore healthcare to perform initial reviews of requests o 76815 will be reimbursed for pre-certification and Medical necessity reviews. To pre-certify a radiology one time per date of service procedure, please call eviCore healthcare at 1-877-PRE-AUTH (1-877-773- o 76816 will be reimbursed 2884) or log on to the eviCore healthcare web site using the Prior when reported with modifier Authorization and Notification App. 59 for each additional fetus o Profile assessments will be eviCore healthcare has established an infrastructure to support the review, reimbursed for the second development, and implementation of comprehensive outpatient imaging and any additional fetuses criteria. The radiology evidence-based guidelines and management criteria and should be reported are available on the eviCore healthcare web site using the Prior separately by code 76818 or Authorization and Notification App. 76819 with the modifier 59 appended 2 & 3. Payment by Specialty & Accreditation/Certification o 76826 and 76828 will be Requirements reimbursed when reported Specialists will be reimbursed for radiology services rendered in the office, with modifier 59 for follow- outpatient or home setting. Services are payable to participating physicians up or repeat studies for the based on their specialty. In addition, certain ultrasounds may not be second and any additional reimbursed unless the providers hold a particular accreditation. fetuses  Reproductive Endocrinologists may perform the following ultrasound CPT codes; precertification for the fourth and subsequent procedures per Member per pregnancy is required: o 76815, 76816, 76817 *In addition to the codes listed above a Reproductive Endocrinologist, with an AIUM/ACR accreditation may perform the following studies; precertification for the fourth and subsequent procedure per Member per pregnancy is required: o 76801, 76802, 76805, 76810, 76811, 76812, 76813, 76814, 76818, 76819, 76820, 76821, 76825, 76826, 76827, 76828  Obstetricians/Gynecologists may perform the following ultrasound CPT codes; precertification for the fourth and subsequent procedure per Member per pregnancy is required: o 76815, 76816, 76817 *In addition to the codes listed above an Obstetrician/Gynecologist, with an AIUM or ACR accreditation may perform the following studies; precertification for the fourth and subsequent procedure per

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Obstetrical Oct. 1, 2018 Member per pregnancy is required: Ultrasonography o 76801, 76802, 76805, 76810, 76811, 76812, 76813, 76814, 76818, (continued) 76819, 76820, 76821, 76825, 76826, 76827, 76828  Maternal Fetal Medicine and Perinatal Neonatal Medicine specialists may perform the following ultrasound CPT codes; precertification for the fourth and subsequent procedure per Member per pregnancy is required: o 76815, 76816, 76817 *In addition to the codes listed above a Maternal Fetal Medicine and Perinatal Neonatal Medicine specialist, with an AIUM or ACR accreditation may perform the following studies, precertification for the fourth and subsequent procedure per Member per pregnancy is required: o 76801, 76802, 76805, 76810, 76811, 76812, 76813, 76814, 76818, 76819, 76820, 76821, 76825, 76826, 76827, 76828  Board Certified Pediatric Cardiologists with the American Board of Pediatrics and Cardiology Laboratories accredited by the Intersocietal Accreditation Commission for Echocardiography may perform the following ultrasound CPT codes; precertification for the fourth and subsequent procedure per Member per pregnancy is required: o 76825-76828

Ocrevus™ Oct. 1, 2018  Updated list of related policies; Please refer to the policy titled Injectable Chemotherapy Drugs: Application (Ocrelizumab) added reference link to the of NCCN Clinical Practice Guidelines for updated information based upon the policy titled Specialty Pharmacy National Comprehensive Cancer Network (NCCN) Drugs & Biologics for Certain Specialty Medications Compendium® (NCCN Compendium®) for oncology indications. Administered in an Outpatient Hospital Setting Ocrevus (ocrelizumab) is proven and medically necessary for:  Revised conditions of  Primary Progressive Multiple Sclerosis coverage/special considerations; Ocrevus is medically necessary for the treatment of primary added language to indicate: progressive multiple sclerosis (PPMS) when ALL of the following o Participating hospitals are criteria are met: required to purchase o Diagnosis of primary progressive multiple sclerosis (PPMS); and Ocrevus™ (ocrelizumab) o One of the following: from the BriovaRx Specialty . Initial therapy for ocrelizumab when meeting both of the Pharmacy when the following: medication is administered in - Patient is not receiving ocrelizumab in combination with any an outpatient hospital of the following: setting; refer to the policy  Disease modifying therapy (e.g., interferon beta titled Specialty Pharmacy for preparations, daclizumab, dimethyl fumarate, glatiramer Certain Specialty Medications acetate, natalizumab, fingolimod, or teriflunomide)

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ocrevus™ Oct. 1, 2018 Administered in an  B cell targeted therapy (e.g., , , (Ocrelizumab) Outpatient Hospital Setting ofatumumab) (continued) for additional information  Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone) and - Initial dosing: One time 300 mg intravenous course of doses on days 1 and 15. or . Continuation therapy for ocrelizumab when meeting all of the following: - Patient has previously received treatment with ocrelizumab; and - Documentation of positive clinical response to ocrelizumab therapy; and - Patient is not receiving ocrelizumab in combination with any of the following:  Disease modifying therapy (e.g., interferon beta preparations, daclizumab, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)  B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)  Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone) and - Continued dosing: One 600 mg intravenous dose every 6 months.  Relapsing Forms of Multiple Sclerosis Ocrevus is medically necessary for the treatment of relapsing forms of multiple sclerosis (MS) when BOTH of the following criteria are met: o Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses); and o One of the following: . Initial therapy for ocrelizumab meeting all of the following: - Patient has history of failure following a trial for at least 4 weeks or history of intolerance or contraindication to one of the following:  interferon β-1a (Avonex®, Rebif®, Plegridy™)

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ocrevus™ Oct. 1, 2018  interferon β-1b (Betaseron® or Extavia®) (Ocrelizumab)  glatiramer acetate (Copaxone®) (continued)  dimethyl fumarate (Tecfidera®)  teriflunomide (Aubagio®)  fingolimod (Gilenya®)  alemtuzumab (Lemtrada®)  natalizumab (Tysabri®)  daclizumab (Zinbryta™) and - Patient is not receiving ocrelizumab in combination with any of the following:  Disease modifying therapy (e.g., interferon beta preparations, daclizumab, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)  B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)  Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone) and - Initial dosing: One time 300 mg intravenous course of doses on days 1 and 15. or . Continuation therapy for ocrelizumab when meeting all of the following: - Patient has previously received treatment with ocrelizumab; and - Documentation of positive clinical response to ocrelizumab therapy; and - Patient is not receiving ocrelizumab in combination with any of the following:  Disease modifying therapy (e.g., interferon beta preparations, daclizumab, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)  B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)  Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone) and - Continued dosing: One 600 mg intravenous dose every 6

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ocrevus™ Oct. 1, 2018 months. (Ocrelizumab) (continued) Ocrevus is unproven and not medically necessary for the treatment of:  Lupus nephritis  Rheumatoid arthritis  Systemic lupus erythematosus

Omnibus Codes Oct. 1, 2018  Added coverage guidelines for: Refer to the policy for complete details on the coverage guidelines for Pulse-Echo Ultrasound Bone Omnibus Codes. Density Measurement (CPT code 0508T) o Added language to indicate the use of pulse-echo ultrasound bone density measurement is unproven and/or not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical literature Refined Autologous Adipose Cell Transfer for the Treatment of Meniscal Tears (CPT code 27599) o Added language to indicate refined autologous adipose cell transfer is unproven and/or not medically necessary for the treatment of meniscal tears due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical literature Absorbable Nasal Implants

(CPT codes 30999 and L8699)

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 o Added language to indicate (continued) absorbable nasal implants [e.g., Latera Absorbable Nasal Implant (Spirox®)] are unproven and/or not medically necessary for supporting nasal upper and lower lateral cartilage due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical literature Multi-Biomarker Disease Activity (MBDA) Test (CPT code 81490) o Added language to indicate the use of a multi-biomarker disease activity (MBDA) test is unproven and/or not medically necessary for managing individuals with rheumatoid arthritis (RA) due to insufficient evidence of safety and/or efficacy in the published peer-reviewed medical literature  Revised coverage guidelines for: All Services o Replaced language indicating: . “[The listed services] are proven and medically necessary” with “[the listed services] are proven and/or medically necessary” . “[The listed services] are unproven and not medically necessary”

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 with “[the listed (continued) services] are unproven and/or not medically necessary” Computer-Assisted Musculoskeletal Surgical Navigational for Orthopedic Procedures (CAOS) (CPT codes 0054T, 0055T, 0396T, and 20985) o Updated list of applicable CPT codes; revised description for 20985 Pillcam Colon2 Capsule Endoscopy System (CPT code 0355T) o Replaced reference to “Pillcam Colon 2” with “Pillcam Colon2 capsule endoscopy system” Transurethral Waterjet

Ablation of the Prostate, also

known as Aquablation (CPT code 0421T) o Modified language pertaining to clinical evidence/study

findings to indicate there is a

lack of high quality evidence

demonstrating the beneficial

impact of transurethral waterjet ablation in patients with benign prostatic hyperplasia (BPH);

therefore, it is not possible

to conclude whether this new

technology has a beneficial effect on health outcomes

Implantable

Neurostimulation Devices for

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 the Treatment of Central (continued) Sleep Apnea (CPT codes 0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, and 0436T) o Replaced language indicating “implantable neurostimulation devices for the treatment of central sleep apnea are investigational, unproven and/or not medically necessary due to lack of U.S. Food and Drug Administration (FDA) approval and insufficient clinical evidence” with “implantable neurostimulation devices for the treatment of central sleep apnea are investigational, unproven and/or not medically necessary due to insufficient clinical evidence” o Removed language indicating: . Coverage may be available through participation in an eligible depending on the member specific benefit plan document . Implantable neurostimulation devices have not yet received FDA approval and are

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 limited to investigational (continued) use o Added instruction to refer to the policy titled Obstructive Sleep Apnea Treatment for additional information on treatment of central sleep apnea Cooled Radiofrequency Ablation (RFA) (CPT codes 22899, 27299, 27599, and 64999) o Updated list of applicable CPT codes; revised description for 22899, 27299, 27599, and 64999 Percutaneous Cryoablative Therapy of Pulmonary Tumors (CPT code 32994) o Replaced language indicating “percutaneous cryoablative therapy of pulmonary tumors, including the pleura or chest wall when involved by tumor extension, is unproven” with “percutaneous cryoablative therapy of pulmonary tumors, including the pleura or chest wall when involved by tumor extension, is unproven and/or not medically necessary”

Optical Endomicroscopy (CPT codes 0397T, 43206, 43252, and 88375) o Updated list of applicable CPT codes; added 0397T and

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 88375 (continued) Surgical Treatment of a Tarlov Cyst from the Sacrum (CPT code 64999) o Removed information pertaining to medical necessity review Intraoperative Radiation Therapy Using Low-Energy X- Rays or Electrons (CPT codes 19294, 77424, 77425, and 77469) o Updated list of applicable CPT codes; added 19294 Multifocal Electroretinogram

(mfERG) and Pattern Electroretinogram (PERG) or Pattern Electroretinogram Optimized for Glaucoma Screening (PERGLA) (CPT

code 92499)

o Updated list of applicable

CPT codes; revised description for 92499

Microscopic Examination of

Hair to Determine Telogen

and Anagen Counts or

Structural Hair Shaft

Abnormality (CPT code

96902)

o Replaced language indicating

“microscopic analysis of hair

is unproven and not

medically necessary” with

“microscopic examination of

hair to determine telogen

and anagen counts or

structural hair shaft

abnormality is unproven

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 and/or not medically (continued) necessary” Kinesio Taping (CPT codes 29799, 97139, and 97799) o Updated list of applicable CPT codes; added 97799 Instrument-Based Ocular Screening Using Photoscreening (CPT codes 99174 and 99177) o Replaced reference to “children” with “individuals” o Updated and reformatted list of applicable ICD-10 diagnosis codes: . Transferred content to embedded Excel file format . Added I69.010, I69.011, I69.012, I69.013, I69.014, I69.015, I69.018, I69.019, I69.110, I69.111, I69.112, I69.113, I69.114, I69.115, I69.118, I69.119, I69.210, I69.211, I69.212, I69.213, I69.214, I69.215, I69.218, I69.219, I69.310, I69.311, I69.312, I69.313, I69.314, I69.315, I69.318, I69.319, I69.810, I69.811, I69.812, I69.813, I69.814, I69.815, I69.818, I69.819, I69.910, I69.911,

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 I69.912, I69.913, (continued) I69.914, I69.915, I69.918, I69.919, and R41.840 . Removed H54.0, I69.1, I69.11, I69.21, I69.31, I69.81, and I69.91 Digestive Enzyme Cartridges for Use with Enteral Tube Feeding (HCPCS codes B4104, B9998, and Q9994) o Updated list of applicable CPT codes; added Q9994 Upper Limb Orthotic Known As MyoPro™ (HCPCS codes E1399 and L3999) o Updated list of applicable CPT codes; added E1399 Three-Dimensional (3-D) Printed Cranial Implants

(HCPCS code L8699)

o Removed reference to

specific product names (OssDsign® Cranial Patient- Specific Implant and OsteoFab™ Patient Specific

Cranial Device)

o Added language to indicate

3D printing of implants may

be performed with other procedures such as 3D rendering with interpretation and reporting of imaging; for

additional information

regarding these imaging

procedures, refer to the Imaging: Evidence-Based Clinical Guidelines

Prolaryn, Prolaryn Plus,

54 Oxford® Policy Update Bulletin: September 2018

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 Radiesse, and Sculptra (continued) (HCPCS codes L8607, Q2026, and Q2028) o Added language to indicate uses of Radiesse other than for treating facial defects due to facial lipidatrophy in persons with human immunodeficiency virus (HIV) may be cosmetic  Removed coverage guidelines for: o Breath testing for a measure of heart transplant rejection (CPT code 0085T) (no longer requires clinical review) o Intravascular catheter-based spectroscopy to assess coronary artery plaque vulnerability (CPT code 0205T) (no longer requires clinical review) o Two-lead, computerized, resting electrocardiography (ECG) analysis to diagnose heart disease (CPT code 0206T) (no longer requires clinical review) o Nocturnal epilepsy monitoring systems that record external heart rate and accelerometer motion data (CPT/HCPCS codes 0381T, 0382T, 0383T, 0384T, 0385T, and 0386T) (no longer requires clinical review) o Cardiac contractility modulation using an

55 Oxford® Policy Update Bulletin: September 2018

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 implantable device (CPT (continued) codes 0408T, 0409T, 0410T, 0411T, 0412T, 0413T, 0414T, 0415T, 0416T, 0417T, and 0418T) (no longer requires clinical review) o Inert gas rebreathing for measuring cardiac output (CPT codes 93799 and 94799) (no longer requires clinical review) o Testing for Thymol turbidity (HCPCS code P2033) (no longer requires clinical review) o Testing for blood mucoprotein (HCPCS code P2038) (no longer requires clinical review) o Skin and soft tissue substitutes (HCPCS codes Q4100, Q4115, Q4123, Q4131, Q4132, Q4133, Q4134, Q4135, Q4136, Q4137, Q4138, Q4139, Q4140, Q4141, Q4142, Q4143, Q4145, Q4146, Q4147, Q4148, Q4149, Q4150, Q4151, Q4152, Q4153, Q4154, Q4155, Q4156, Q4157, Q4158, Q4159, Q4160, Q4161, Q4162, Q4163, Q4164, Q4165, Q4166, Q4167, Q4168, Q4169, Q4170, Q4171, Q4172, Q4173, Q4174, Q4175, Q4176, Q4177, Q4178, Q4179,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Oct. 1, 2018 Q4180, Q4181, and Q4182); (continued) refer to the policy titled Skin and Soft Tissue Substitutes for applicable coverage guidelines  Updated supporting information to reflect the most current clinical evidence and references

Orencia® Oct. 1, 2018  Updated list of related policies; This policy refers to Orencia (abatacept) injection for intravenous infusion. (Abatacept) added reference link to the Injection for policy titled Specialty Pharmacy Orencia is proven and medically necessary for the treatment of: Intravenous for Certain Specialty Medications  Polyarticular juvenile idiopathic arthritis when all of the following Infusion Administered in an Outpatient criteria are met: Hospital Setting o Diagnosis of moderately to severely active polyarticular juvenile  Revised conditions of idiopathic arthritis (PJIA); and coverage/special considerations; o Orencia is initiated and titrated according to US Food and Drug added language to indicate: Administration labeled dosing for polyarticular juvenile idiopathic o Participating hospitals are arthritis up to a maximum of (or equivalent dose and interval required to purchase schedule): Orencia® (abatacept) from . 10mg/kg every 4 weeks for patients weighing <75kg the BriovaRx Specialty . 1,000mg every 4 weeks for patients weighing ≥75kg Pharmacy when the and medication is administered in o Member is not receiving Orencia in combination with either of the an outpatient hospital following: setting; refer to the policy . Biologic disease-modifying antirheumatic drug (DMARD) [e.g., titled Specialty Pharmacy for Enbrel (etanercept), Humira (adalimumab), Cimzia Certain Specialty Medications (certolizumab), Simponi (golimumab)] Administered in an . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Outpatient Hospital Setting  Rheumatoid arthritis when all of the following criteria are met: for additional information o Diagnosis of moderately to severely active rheumatoid arthritis; and o Orencia is initiated and titrated according to US Food and Drug Administration labeled dosing for rheumatoid arthritis up to a maximum of (or equivalent dose and interval schedule): . 500mg every 4 weeks for patients weighing <60kg . 750mg every 4 weeks for patients weighing 60kg to 100kg . 1,000mg every 4 weeks for patients weighing >100kg and o Member is not receiving Orencia in combination with either of the following:

57 Oxford® Policy Update Bulletin: September 2018

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Orencia® Oct. 1, 2018 . Biologic DMARD [e.g., Enbrel (etanercept), Humira (Abatacept) (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] Injection for . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Intravenous  Psoriatic arthritis when all of the following criteria are met: Infusion o Diagnosis of active psoriatic arthritis (PsA); and (continued) o Orencia is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of (or equivalent dose and interval schedule): . 500mg every 4 weeks for patients weighing <60kg . 750mg every 4 weeks for patients weighing 60kg to 100kg . 1,000mg every 4 weeks for patients weighing >100kg and o Patient is not receiving Orencia in combination with any of the following: . Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla ()]

Orencia is unproven and not medically necessary for the treatment of:  Multiple sclerosis  Systemic lupus erythematosus  Graft versus host disease (GVHD)  Uveitis associated with Behçet's disease

Preventive Care Oct. 1, 2018  Reformatted and revised lists of Refer to the policy for complete details on the coverage guidelines for Services applicable procedure and Preventive Care Services. diagnosis codes: o Replaced references to “ICD- 10 diagnosis codes” with “diagnosis codes” o Clarified preventive benefit instructions; replaced language indicating “[service is] payable or preventive [when listed guidelines are met]” with “[service] requires [listed guidelines to be met]”

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Oct. 1, 2018 Preventive Care Services Services Cervical Cancer Screening, Pap (continued) Smear o Updated preventive benefit instructions; added language to clarify Code Group 2 Procedure Codes require one of the Code Group 2 Diagnosis Codes Cholesterol Screening (Lipid Disorders Screening) o Updated preventive benefit instructions; modified list of

diagnosis codes for lipid

disorders to which the

preventive benefit does not apply to reflect annual code edits: . Added E78.41 and E78.49

. Removed E78.4

Osteoporosis Screening

o Removed January 2011

USPSTF ‘B’ rating

o Added June 2018 USPSTF ‘B’

rating to indicate:

. The USPSTF

recommends screening

for osteoporosis with

bone measurement

testing to prevent

osteoporotic fractures in

women 65 years and

older

. The USPSTF

recommends screening

for osteoporosis with

bone measurement

testing to prevent

59 Oxford® Policy Update Bulletin: September 2018

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Oct. 1, 2018 osteoporotic fractures in Services postmenopausal women (continued) younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool Screening for Depression in Adults and Depression in Children and Adolescents (Screening) o Updated list of applicable ICD-10 diagnosis codes required for 96127 only: . Added Z13.31* and Z13.32* . Removed Z13.89 (*annual code edit) Behavioral Counseling in Primary Care to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors o Updated list of diagnosis codes for hyperlipidemia/dyslipidemia to reflect annual code edits: . Added E78.41 and E78.49 . Removed E78.4 Prevention of Falls in

Community-Dwelling Older

Adults

o Removed May 2012 USPSTF ‘B’ rating o Added April 2018 USPSTF ‘B’ rating to indicate the USPSTF

60 Oxford® Policy Update Bulletin: September 2018

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Oct. 1, 2018 recommends exercise Services interventions to prevent falls (continued) in community-dwelling adults 65 years or older who are at increased risk for falls Formal Developmental/Autism Screening (Bright Futures) o Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: . Added Z13.40, Z13.41, Z13.42, and Z13.49 . Removed Z13.4 Preventive Immunizations o Removed age range descriptions from “Age Group” column heading (duplicative to language provided in notation above code table) Rotavirus (RV1, RV5)

o Added benefit limit/age

guideline of 0-8 months for CPT codes 90680 and 90681

Expanded Women’s

Preventive Health

Well-Woman Visits o Updated preventive benefit instructions; modified language to clarify prenatal care visits and global obstetrical codes do not have diagnosis code requirements for the preventive benefit to apply Screening for Diabetes Mellitus After Pregnancy o Modified preventive benefit

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Oct. 1, 2018 instructions for diabetes Services screening and blood draw; (continued) added language to clarify Z86.32 is required in addition to one of the Required Screening diagnosis codes Diagnosis Codes Hepatitis C Virus Infection Screening Diagnosis Code List o Updated attachment file to reflect annual code edits; added F12.23, F12.93, Z04.81, and Z62.813 Pregnancy Diagnosis Code List o Updated attachment file to reflect annual code edits; added O30.131, O30.132, O30.133, O30.139, O30.231, O30.232, O30.233, O30.239, O30.831, O30.832, O30.833, O30.839, O86.00, O86.01, O86.02, O86.03, O86.04, and O86.09  Updated supporting information to reflect the most current references

Respiratory Oct. 1, 2018  Revised coverage rationale: Refer to the policy for complete details on the coverage guidelines for Interleukins o Reformatted coverage Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®). (Cinqair®, statements; separated Fasenra®, and content addressing “proven” Nucala®) and “medically necessary” guidelines/criteria o Removed language indicating Cinqair for intravenous use, Fasenra for subcutaneous use, and Nucala for subcutaneous use

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Respiratory Oct. 1, 2018 are medically necessary for Interleukins add-on therapy for patients (Cinqair®, who meet both of the Fasenra®, and following criteria: Nucala®) . Have an eosinophilic (continued) phenotype . Will be used as add-on maintenance therapy in the treatment of severe asthma  Updated supporting information to reflect the most current clinical evidence

Sandostatin LAR® Oct. 1, 2018  Revised coverage rationale; Please refer to the policy titled Injectable Chemotherapy Drugs: Application Depot (Octreotide replaced language indicating: of NCCN Clinical Practice Guidelines for updated information based on the Acetate) o “Sandostatin LAR (octreotide National Comprehensive Cancer Network (NCCN) Drugs & Biologics acetate LAR) is proven and Compendium for oncology indications. medically necessary for the treatment of one of the Note: For information regarding coverage for Sandostatin® subcutaneous [listed conditions]” with formulation, refer to the policy titled Drug Coverage Guidelines. “Sandostatin LAR (octreotide acetate LAR) is proven for Sandostatin LAR (octreotide acetate LAR) is proven for the treatment the treatment of one of the of one of the following: [listed conditions]” o “Sandostatin LAR is proven  Bleeding gastroesophageal varices associated with liver disease and medically necessary for Octreotide acetate is medically necessary for the treatment of the treatment of acromegaly bleeding esophageal varices when both of the following criteria when all of the [listed] are met: criteria are met” with o Diagnosis of bleeding esophageal varices associated with liver “Sandostatin LAR is proven disease; and for the treatment of o Octreotide acetate will be used as an adjunct to endoscopic therapy acromegaly; Sandostatin LAR is medically necessary  Diarrhea, chemotherapy and/or radiation-induced for the treatment of acromegaly when all of the  Diarrhea, refractory HIV/AIDS-related [listed] criteria are met” Octreotide acetate is medically necessary for the treatment of  Updated list of applicable ICD-10 refractory HIV/AIDS-related diarrhea when both of the following diagnosis codes; added E34.0 criteria are met:  Updated supporting information

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Sandostatin LAR® Oct. 1, 2018 to reflect the most current o Diagnosis of HIV/AIDS-related diarrhea; and Depot (Octreotide references o History of failure, contraindication, or intolerance to standard therapy Acetate) (e.g., loperamide, diphenoxylate/atropine) (continued)  Malignant bowel disease

Sandostatin LAR is proven for the treatment of acromegaly. Sandostatin LAR is medically necessary for the treatment of acromegaly when all of the following criteria are met:  Diagnosis of acromegaly by one of the following: o Serum GH level > 1 ng/mL after a 2 hour oral glucose tolerance test (OGTT) at time of diagnosis o Elevated serum IGF-1 levels (above the age and gender adjusted normal range as provided by the physician’s lab) at time of diagnosis and  One of the following: o Inadequate response to one of the following: . Surgery . Radiotherapy . Dopamine agonist (e.g., bromocriptine, cabergoline) therapy o Not a candidate for any of the following: . Surgery . Radiotherapy . Dopamine agonist (e.g., bromocriptine, cabergoline) therapy and  Initial treatment with octreotide immediate release (IR) has been shown to be effective and tolerated

Sandostatin LAR is unproven and not medically necessary for treating the following conditions:  Chylothorax  Dumping syndrome  Pancreatitis  Persistent hyperinsulinemic hypoglycemia of infancy  Prevention of postoperative complications following pancreatic surgery  Short bowel syndrome

Sandostatin LAR is unproven and not medically necessary for

treating other conditions not listed above as proven and medically

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Sandostatin LAR® Oct. 1, 2018 necessary due to the lack of published clinical evidence of safety Depot (Octreotide and/or efficacy in published peer reviewed medical literature. Acetate) (continued) Documentation required for Medical Director Review: Letter of medical necessity and/or office notes.

Simponi Aria® Oct. 1, 2018  Updated list of related policies; This policy refers only to Simponi Aria (golimumab) injection for intravenous (Golimumab) added reference link to the infusion for the treatment of ankylosing spondylitis, psoriatic arthritis, and Injection for policy titled Specialty Pharmacy rheumatoid arthritis. Simponi, for self-administered subcutaneous injection, Intravenous for Certain Specialty Medications is obtained under the pharmacy benefit and is indicated in the treatment of Infusion Administered in an Outpatient rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative Hospital Setting colitis.  Revised conditions of coverage/special considerations; Simponi Aria is proven and/or medically necessary for the treatment added language to indicate: of: o Participating hospitals are  Ankylosing spondylitis when all of the following criteria are met: required to purchase o Diagnosis of active ankylosing spondylitis (AS); and Simponi® Aria™(golimumab) o Simponi Aria is initiated and titrated according to US Food and Drug from the BriovaRx Specialty Administration labeled dosing for ankylosing spondylitis, up to a Pharmacy when the maximum of 2mg/kg every 8 weeks (or equivalent dose and interval medication is administered in schedule); and an outpatient hospital o Patient is not receiving Simponi Aria in combination with either of setting; refer to the policy the following: titled Specialty Pharmacy for . Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Certain Specialty Medications Enbrel (etanercept), Humira (adalimumab), Cimzia Administered in an (certolizumab), Orencia (abatacept)] Outpatient Hospital Setting . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

for additional information  Psoriatic arthritis when all of the following criteria are met: o Diagnosis of active psoriatic arthritis (PsA); and o Simponi Aria is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of 2mg/kg every 8 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Simponi Aria in combination with either of the following: . Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

65 Oxford® Policy Update Bulletin: September 2018

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Simponi Aria® Oct. 1, 2018 . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

(Golimumab)  Rheumatoid arthritis when all of the following criteria are met: Injection for o Diagnosis of moderately to severely active rheumatoid arthritis (RA); Intravenous and Infusion o One of the following: (continued) . Patient is receiving concurrent therapy with methotrexate . History of contraindication or intolerance to methotrexate and o Simponi Aria is initiated and titrated according to US Food and Drug Administration labeled dosing for rheumatoid arthritis up to a maximum of 2mg/kg every 8 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Simponi Aria in combination with either of the following: . Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Skin and Soft Oct. 1, 2018  Reformatted policy; content TransCyte™ Tissue Substitutes previously located in the policy TransCyte is proven and/or medically necessary for treating titled Omnibus Codes surgically excised Full-Thickness Thermal Burn wounds and deep  Added reference links to related Partial-Thickness Thermal Burn wounds in individuals who require policies such a covering before autograft placement.  Revised coverage rationale: o Replaced language TransCyte is unproven and/or not medically necessary for all other indicating: indications. . “[The listed service] is Additional studies are needed to evaluate the safety and effectiveness of proven and medically TransCyte for other indications. necessary” with “[the listed service] is proven Other Skin and Soft Tissue Substitutes and/or medically The following skin and soft tissue substitutes are unproven and/or necessary” not medically necessary for any indication: . “[The listed services] are  Affinity® unproven and not  Alloskin® medically necessary due  Allowrap® to insufficient clinical  Amnio Wound™ evidence of safety  Amnioband® and/or efficacy in  Amnioexcel™ or Biodexcel™

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Skin and Soft Oct. 1, 2018 published peer-reviewed  AmnioFix® Tissue Substitutes medical literature” with  Amniomatrix™ or Biodmatrix™ (continued) “[the listed services] are  Architect Extracellular Matrix® unproven and/or not  Artacent® medically necessary”  ArthroFLEX® o Added language to indicate:  Bio-ConneKt® . The following skin and  Biodfence™ or Biodfence Dryflex™ soft tissue substitutes  BioSkin™ are unproven and/or not  BioSkin™ Flow medically necessary for  Biovance® any indication:  Clarix® ArthroFLEX®, Cymetra™,  Clarix® Flo DermACELL®,  Conexa™ Reconstructive Matrix DermaSpan™,  CorMatrix® GammaGraft™,  Cygnus™ HYALOMATRIX®,  Cymetra™ Integra® Flowable  Cytal™ Wound Matrix,  DermACELL® InteguPly®, MatriStem®,  Dermapure™ MemoDerm™,  DermaSpan™ PriMatrix®, Strattice™,  Dermavest® or Plurivest® Talymed®, TheraSkin®,  Epicord™ and TranZgraft®  Epifix® . Additional studies are  Excellagen® needed to evaluate the  Ez-derm® safety and effectiveness  Floweramnioflo™ or FlowerFlo™ of TransCyte for other  Floweramniopatch™ or FlowerPatch™ indications  FlowerDerm™ . Due to limited studies,  GammaGraft™ small sample sizes, and  Grafix® weak study designs,  GrafixPL® there is insufficient  Guardian clinical evidence to  Helicoll™ conclude that these skin  Hmatrix® substitutes have an  HYALOMATRIX® improved health  Integra® Flowable Wound Matrix outcome over standard  InteguPly® therapies; well-designed,  Interfyl™ randomized comparative  Keramatrix®

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Skin and Soft Oct. 1, 2018 clinical trials are needed  Kerecis™ Omega3 Tissue Substitutes to demonstrate the  MatriStem® (continued) efficacy and safety of  Mediskin™ these products  MemoDerm™ o Removed language  Miroderm™ indicating:  NeoPatch™ . AmnioGen-A™,  Neox® AmnioGen-C™,  Neox Flo® AmnioGen-45™, or  Nushield® AmnioGen-200™ are  PalinGen® Amniotic Tissue Allograft and PalinGen® Flow products unproven and/or not  PriMatrix® medically necessary for  ProMatrX™ any indication  PuraPly™ or PuraPly™ Antimicrobial o Replaced reference to:  Repriza® . “Persons” with  Revita™ “individuals”  Revitalon® . “Kerecis™ or Marigen™”  Strattice™ with “Kerecis™ Omega3”  Talymed®  Added definition of:  Tensix® o Acellular Matrix  TheraSkin® o Allogeneic Matrix  TranZgraft® o Composite Matrix  Truskin™ o Full-Thickness Thermal Burn  WoundEx™ (Third Degree Burn)  WoundEx™ Flow o Human Skin Allograft  Xcm Biologic Tissue Matrix® o Partial-Thickness Thermal Burn (Second Degree Burn) Due to limited studies, small sample sizes, and weak study designs, there is  Updated list of applicable HCPCS insufficient clinical evidence to conclude that these skin substitutes have an codes; added Q4110, Q4111, improved health outcome over standard therapies. Well-designed, Q4112, Q4114, Q4117, Q4118, randomized comparative clinical trials are needed to demonstrate the Q4121, Q4122, Q4125, Q4126, efficacy and safety of these products. Q4127, and Q4130  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Specialty Oct. 1, 2018  Updated list of related policies; This policy addresses the criteria for consideration of allowing hospital Medication added reference link to the outpatient facility specialty medication infusion services. This includes claim Administration - policy titled: submission for hospital based services with the following CMS/AMA Place of Site of Care Review o Crysvita® (Burosumab-Twza) Service codes: Guidelines o Specialty Pharmacy for  19 Off-Campus - Outpatient Hospital; and Certain Specialty Medications  22 On-Campus - Outpatient Hospital Administered in an Outpatient Hospital Setting Alternative sites of care, such as non-hospital outpatient infusion, physician  Revised conditions of office, ambulatory infusion or home infusion services are well accepted coverage/special considerations; places of service for medication infusion therapy. If a patient does not meet added language to indicate: criteria for outpatient hospital facility infusion, alternative sites of care may o Participating hospitals are be used. required to purchase Actemra® (tocilizumab), Outpatient hospital facility-based intravenous medication infusion is Entyvio® (vedolizumab), medically necessary for members who meet any of the following Infliximab (Remicade®, criteria (submission of medical records detailing at least one of the Inflectra™, Renflexis™), following criteria is required): Ocrevus™ (ocrelizumab),  Medically unstable based upon submitted clinical history; or Orencia® (abatacept), and  Initial medication infusion of or re-initiation after more than 6 months Simponi Aria® (golimumab) following discontinuation of therapy; or from the BriovaRx Specialty  Previous experience of a severe adverse event following infusion. Pharmacy when the Examples include but are not limited to anaphylaxis, seizure, medication is administered in thromboembolism, myocardial infarction, renal failure; or an outpatient hospital  Continuing experience of adverse events that cannot be mitigated by pre- setting; refer to the policy medications or infusion rate adjustments; or titled Specialty Pharmacy for  Physically and/or cognitively impaired and no home caregiver available; Certain Specialty Medications or Administered in an  Difficulty establishing and maintaining patent vascular access; or Outpatient Hospital Setting  Homecare or infusion provider has deemed that the patient, home for additional information caregiver, or home environment is not suitable for home infusion  Revised coverage rationale; therapy. added Crysvita® (burosumab- twza) to the list of applicable This policy applies to these specialty medications that require healthcare specialty medications that provider administration: require healthcare provider  Actemra® (tocilizumab) administration  Adagen® (pegademase bovine)  Aldurazyme® (laronidase)  Aralast NP™ (A1-PI)  Benlysta® (belimumab)

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Specialty Oct. 1, 2018  Cerezyme® (imiglucerase) Medication  Crysvita® (burosumab-twza) Administration -  Elaprase® (idursulfase) Site of Care Review  Elelyso® (taliglucerase) Guidelines  Entyvio® (vedolizumab) (continued)  Exondys 51™ (eteplirsen)  Fabrazyme® (agalsidase beta)  Glassia™ (A1-PI)  Ilaris® ()  Inflectra™ (infliximab-dyyb)  Kanuma® (sebelipase alfa)  Lumizyme® (alglucosidase alfa)  Mepsevii™ (vestronidase alfa-vjbk)  Naglazyme® (galsulfase)  Ocrevus™ (ocrelizumab)  Orencia® (abatacept) ®  Prolastin -C™ (A1-PI)  Radicava™ (edaravone)  Remicade® (infliximab)  Renflexis™ (infliximab-abda)  Simponi Aria® (golimumab)  Soliris® ()  Trogarzo™ ()  Vimizim® (elosulfase alfa)  VPRIV® (velaglucerase) ®  Zemaira (A1-PI)

Medical necessity criteria for administration of intravenous infusion therapy at home are addressed in MCG™ Care Guidelines, 22nd edition, 2018, Home Infusion Therapy, CMT: CMT-0009(SR).

Stelara® Oct. 1, 2018  Updated list of related policies; This policy refers to Stelara (ustekinumab) injection. (Ustekinumab) added reference link to the policy titled Specialty Pharmacy Stelara is proven and medically necessary for the treatment of: for Certain Specialty Medications Administered in an Outpatient  Crohn’s disease when all of the following criteria are met: Hospital Setting o Diagnosis of moderately to severely active Crohn’s disease; and  Revised conditions of o One of the following: coverage/special considerations; . History of failure, contraindication, or intolerance to at least one added language to indicate: tumor necrosis factor (TNF) blocker [e.g., Remicade/Inflectra

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2018 o Participating hospitals are (infliximab), Humira (adalimumab), Cimzia (certolizumab)]; or (Ustekinumab) required to purchase . Both of the following: (continued) Stelara® (ustekinumab) from - History of failure, contraindication, or intolerance to at least the BriovaRx Specialty one immunomodulator or corticosteroid (e.g., Pharmacy when the corticosteroids, 6-mercaptopurine, azathioprine, medication is administered in methotrexate, etc.) an outpatient hospital - Patient has never failed a TNF blocker [e.g., setting; refer to the policy Remicade/Inflectra (infliximab), Humira (adalimumab), titled Specialty Pharmacy for Cimzia (certolizumab)] Certain Specialty Medications and Administered in an o One of the following: Outpatient Hospital Setting . Initial Therapy for additional information - Stelara is to be administered as an intravenous induction dose; and - Stelara induction dosing is accordance with the United States Food and Drug Administration approved labeled dosing for Crohn’s disease:  260mg for patients weighing ≤55kg  390mg for patients weighing >55kg to ≤85kg  520mg for patients weighing >85kg and - Patient is not receiving Stelara in combination with any of the following:  Biologic DMARD [e.g., Remicade/Inflectra (infliximab), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]  Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]  Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and - Authorization will be for one induction dose or . Continuation Therapy - Patient is unable to self-administer subcutaneous doses; and - Stelara is to be subcutaneously administered 8 weeks after the initial intravenous dose; and - Stelara continuation dosing is in accordance with the United States Food and Drug Administration approved labeled dosing for Crohn’s disease:

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2018  90mg every 8 weeks subcutaneously (Ustekinumab) and (continued) - Patient is not receiving Stelara in combination with any of the following:  Biologic DMARD [e.g., Remicade/Inflectra (infliximab), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]  Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]  Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

 Plaque psoriasis when all of the following criteria are met: o Diagnosis of moderate to severe plaque psoriasis; and o One of the following: . Patient is a candidate for phototherapy . Patient is a candidate for systemic therapy and o Patient is unable to self-administer subcutaneous doses; and o Stelara is initiated and titrated according to US Food and Drug Administration labeled dosing for plaque psoriasis up to a maximum of (or equivalent dose and interval schedule): . 45mg every 12 weeks for patients weighing ≤100kg subcutaneously . 90mg every 12 weeks for patients weighing >100kg subcutaneously and o Patient is not receiving Stelara in combination with any of the following: . Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

 Psoriatic arthritis when all of the following criteria are met: o Diagnosis of psoriatic arthritis; and o Stelara is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and interval schedule); and

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2018 o Patient is unable to self-administer subcutaneous doses; and (Ustekinumab) o Patient is not receiving Stelara in combination with any of the (continued) following: . Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

Stelara is unproven and not medically necessary for the treatment of:  Multiple sclerosis

In available studies, ustekinumab does not demonstrate efficacy in the treatment of multiple sclerosis.

Xolair® Oct. 1, 2018  Revised coverage rationale: Xolair (omalizumab) for subcutaneous use is proven for: (Omalizumab) o Replaced language indicating “Xolair (omalizumab) for  Patients with moderate to severe persistent asthma who meet all subcutaneous use is proven of the following criteria: and medically necessary for o Have a positive skin test or in vitro reactivity to a perennial [the listed conditions]” with aeroallergen; “Xolair (omalizumab) for o Symptoms inadequately controlled with inhaled corticosteroids; subcutaneous use is proven o Have a baseline plasma (IgE) level greater than or for [the listed conditions]; equal to 30 IU/mL and less than or equal to 1500 IU/mL. Xolair is medically necessary when all of the [listed] Xolair is medically necessary when all of the following criteria are criteria are met” met: o Modified medical necessity o Diagnosis of moderate or severe asthma; and criteria for patients with o Classification of asthma as uncontrolled or inadequately controlled as moderate to severe defined by at least one of the following: persistent asthma; added . Poor symptom control (e.g., Asthma Control Questionnaire [ACQ] “Fasenra ()” to score consistently greater than 1.5 or Asthma Control Test [ACT] the list of drug products the score consistently less than 20); or patient cannot receive in . Two or more bursts of systemic corticosteroids for at least 3 days combination with Xolair each in the previous 12 months; or  Updated list of applicable ICD-10 . Asthma-related emergency treatment (e.g., emergency room diagnosis codes; removed visit, hospital admission, or unscheduled physician’s office visit J45.20, J45.21, J45.30, and for nebulizer or other urgent treatment); or J45.31 . Airflow limitation [e.g., after appropriate bronchodilator withhold  Updated supporting information forced expiratory volume in 1 second (FEV1) less than 80%

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Xolair® Oct. 1, 2018 to reflect the most current predicted [in the face of reduced FEV1/forced vital capacity (FVC) (Omalizumab) clinical evidence and references defined as less than the lower limit of normal)]; (continued) and o 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 o Positive skin test or in vitro reactivity to a perennial aeroallergen; and o Used in combination with one of the following: . 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 . Combination therapy including both of the following: - One high-dose (appropriately adjusted for age) ICS product [e.g., ciclesonide (Alvesco®), mometasone furoate (Asmanex®), beclomethasone dipropionate (QVAR®)]; and - One additional asthma controller medication [e.g., LABA - olodaterol (Striverdi®) or indacaterol (Arcapta®); leukotriene receptor antagonist – montelukast (Singulair®); theophylline]; and o Patient is not receiving Xolair in combination with any of the following: . Nucala () . Cinqair () . Fasenra (benralizumab) and o Xolair dosing for moderate to severe persistent asthma is in accordance with the United States Food and Drug Administration approved labeling; and o Prescribed by or in consultation with an allergist/immunologist or pulmonologist; and o 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:

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Xolair® Oct. 1, 2018 o Documentation of positive clinical response as demonstrated by at (Omalizumab) least one of the following: (continued) . Reduction in the frequency of exacerbations) . Decreased utilization of rescue medications . Increase in percent predicted FEV1 from pretreatment baseline . Reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, shortness of breath, coughing, etc.) and o Used in combination with an ICS-containing controller medication; and o Patient is not receiving Xolair in combination with any of the following: . Nucala (mepolizumab) . Cinqair (reslizumab) . Fasenra (benralizumab) and o Xolair dosing for moderate to severe persistent asthma is in accordance with the United States Food and Drug Administration approved labeling; and o Prescribed by or in consultation with allergist/immunologist or pulmonologist; and o Reauthorization will be for no more than 12 months.

 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: o Diagnosis of chronic urticaria; and o One of the following: . 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), (diphenhydramine), Claritin (loratadine)]*; or . 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 second generation H1-antihistamine [e.g., Allegra

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Xolair® Oct. 1, 2018 (fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]; and (Omalizumab) - One of the following: (continued)  Different second generation H1-antihistamine [e.g., Allegra (fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]  First generation H1-antihistamine [e.g., Benadryl (diphenhydramine), Chlor-Trimeton (chlorpheniramine), Vistaril (hydroxyzine)]*  H2-antihistamine [e.g., Pepcid (famotidine), Tagamet HB (cimetidine), Zantac (ranitidine)]  Leukotriene modifier [e.g., Singulair (montelukast)] and o Xolair dosing for chronic urticaria is in accordance with the United States Food and Drug Administration approved labeling; and o Prescribed by or in consultation with an allergist/immunologist or dermatologist; and o Initial authorization will be for no more than 6 months.

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: o Documentation of positive clinical response (e.g., reduction in exacerbations, itch severity, hives); and o Xolair dosing for chronic urticaria is in accordance with the United States Food and Drug Administration approved labeling; and o Prescribed by or in consultation with allergist/immunologist or dermatologist; and o 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

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Xolair® Oct. 1, 2018  Peanut allergy (Omalizumab)  Acute bronchospasm or status asthmaticus (continued)

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Autism Oct. 1, 2018  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: o Added G71.00, G71.01, G71.02, and G71.09 o Removed G71.0

Behavioral Health Oct. 1, 2018  Updated list of applicable ICD-10 diagnosis codes for Connecticut (CT) - Parity Exclusions to reflect annual code Services edits; added F12.23 and F12.93 Follow-Up Care Oct. 1, 2018  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits; revised description for S62.626D, Rendered in an S62.626G, S62.627D, S62.627G, S62.628D, S62.628G, S62.629D, S62.629G, S62.654D, S62.654G, S62.655D, Emergency Room S62.655G, S62.656D, S62.656G, S62.657D, S62.657G, S62.658D, S62.658G, S62.659D, and S62.659G Site of Service Orthopedic Oct. 1, 2018  Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits: Services o Added M79.10, M79.11, M79.12, and M79.18 o Removed M79.1

Skilled Care and Sep. 1, 2018  Updated list of applicable CPT codes; added notation to clarify 99509 may or may not be considered custodial Custodial Care care depending on whether care is provided as part of a skilled service or not Services  Updated supporting information to reflect the most current references

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Abortions Oct. 1, 2018  Revised list of applicable Therapeutic Abortions (Therapeutic and (therapeutic) ICD-10 diagnosis Oxford covers Therapeutic Abortions that may include the following Elective) codes: indications: o Added O36.20X0, O36.20X1,  Medical conditions which cause pregnancy to pose substantial risk to O36.20X2, O36.20X3, maternal health such as cardiac or cardiovascular anomalies, O36.20X4, O36.20X5, cardiovascular disease, renal disease, malignancy, and severe diabetes O36.20X9, O36.21X0, mellitus O36.21X1, O36.21X2,  The certain diagnosis of: O36.21X3, O36.21X4, o Chromosomal abnormalities inconsistent with normal life in the fetus O36.21X5, O36.21X9, o Major structural defects such as severe neural tube defects, severe O36.22X0, O36.22X1, cardiac abnormalities, severe ventral wall defects, or other severe O36.22X2, O36.22X3, structural defects O36.22X4, O36.22X5, o Major metabolic abnormalities such as sickle cell disease, Tay Sachs O36.22X9, O36.23X0, disease, cystic fibrosis, or major biochemical abnormalities O36.23X1, O36.23X2,  Pregnancy which is the result of rape or incest O36.23X3, O36.23X4,  Exposure to known teratogenic agents, which pose significant risk of fetal O36.23X5, O36.23X9, developmental abnormalities O9A.111, O9A.112,

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Abortions Oct. 1, 2018 O9A.113, O9A.119, Elective Abortions (Therapeutic and Q93.51*, Q93.59*, Q93.82*, Elective Abortions may be performed surgically [e.g., by dilation and Elective) T74.51XA*, T74.51XD*, curettage (D&C)] or medically [e.g., by administration of medications such (continued) T74.51XS*, T74.52XA*, as mifepristone (also known as RU486 or mifeprex) and misoprostol]. Refer T74.52XD*, T74.52XS*, and to the policy titled Mifeprex® (Mifepristone). Z14.8 o Removed Q93.5* Note: o Revised description for  Treatment of complications of elective and Therapeutic Abortions is O00.212 considered medically necessary and therefore not subject to annual and (*annual code edit) dollar limits.  Updated supporting information  If an abortion CPT code is billed, then it is reimbursed according to the to reflect the most current Elective Abortion benefit unless the diagnosis code is considered references therapeutic (please see the list of Therapeutic ICD-10 Diagnosis Codes in the policy).

Precertification Oct. 1, 2018  Revised list of applicable CPT Refer to the policy for complete details on Precertification Exemptions for Exemptions for codes for Pathology and Outpatient Services. Outpatient Services Laboratory services that do not require precertification in the office or outpatient setting: o Added 0085T, P2033, and P2038 o Removed: . 0018U, 0026U, 0037U, 0045U, 0047U, and 0048U (refer to the policy titled Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions for applicable coverage guidelines) . 0036U (refer to the policies titled Whole Exome and Whole Genome Sequencing and Molecular Oncology Testing for Cancer

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Precertification Oct. 1, 2018 Diagnosis, Prognosis, Exemptions for and Treatment Decisions Outpatient Services for applicable coverage (continued) guidelines) . 0029U (refer to the policy titled Pharmacogenetic Testing for applicable coverage guidelines) . 81435, 81436, 81437, and 81438 (refer to the policy titled Genetic Testing for Hereditary Cancer for applicable coverage guidelines) . 81535 and 81536 (refer to the policy titled Chemosensitivity and Chemoresistance Assays in Cancer for applicable coverage guidelines) . 81490 (refer to the policy titled Omnibus Codes for applicable coverage guidelines)

Speech Therapy Oct. 1, 2018  Updated list of related policies; Refer to the policy for complete details on the coverage guidelines for Speech and Early added reference link to the Therapy and Early Intervention Programs/Birth to Three. Intervention policy titled Home Health Care Programs/Birth to  Revised conditions of Three coverage/special considerations; added language to indicate authorization is required for all early intervention (EI) services regardless of the site of service  Revised benefit considerations/product specific information to indicate: Connecticut (CT) & New

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 Jersey (NJ) and Early o Refer to the policy titled Intervention Autism for additional Programs/Birth to information on speech Three therapy services related to (continued) the diagnosis and treatment of autism spectrum disorders NJ Small Plans o Refer to the policy titled Physical, Occupational (OptumHealth Care Solutions Arrangement) and Speech Therapy including Cognitive/ Neuropsychological Rehabilitation for New Jersey Small Group Members for information regarding coverage for the: . Retraining of the brain to perform intellectual skills which it was able to perform prior to disease, trauma, surgery, or previous therapeutic process, or . Training of the brain to perform intellectual skills it should have been able to perform if there were not a congenital anomaly NJ Large Plans o Oxford must provide coverage for speech therapy for members who have been diagnosed with a biologically based mental illness; this includes treatment of any speech impairment New York (NY) Plans

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 o Coverage must be provided and Early for the screening and Intervention diagnosis of autism or Programs/Birth to another developmental Three disability (continued) o Coverage must also be provided for medically necessary occupational, physical and speech therapies, as prescribed through a treatment plan, when the diagnosis is autism or another developmental disability o Refer to the policy titled Autism for additional information  Revised coverage rationale for: Speech Therapy (ST) CT Small & Large Plans o Added language to indicate ST is covered when used to help a person keep, learn or improve skills and functioning for daily living o Removed language indicating ST is covered to develop a function not currently present as a result of a congenital, genetic or early acquired disorder (hereditary disorders, disorder resulting from sickness, injury, trauma or some other event or condition suffered by a member prior to that member developing functional life skills such as

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 talking) and Early NJ Small Plans Intervention o Added exception language Programs/Birth to for a covered person who Three has been diagnosed with a (continued) biologically-based mental illness to indicate ST means treatment of a speech impairment o Removed language indicating speech therapy is covered when it is provided to help develop rather than restore function (habilitative) if a member’s primary diagnosis is autism or another developmental disability NJ Large Plans o Added language to indicate ST is covered when it is necessary to correct a/an: . Condition that is the result of a disease . Mental illness including autism spectrum disorder . Injury . Congenital physical deformity that inhibits normal function . Developmental disability NY Small & Large Plans

o Replaced language

indicating:

. “ST is covered to assist a member in retaining, recovering or improving skills and functioning for

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 daily living” with “ST is and Early covered to assist a Intervention member in keeping, Programs/Birth to getting back or Three improving skills and (continued) functioning for daily living” . “ST is covered to retain, learn or improve skills and functioning for daily living” with “ST is covered to keep, learn or improve skills and functioning for daily living” Early Intervention Program/Birth to Three CT Residents o Modified coverage guidelines to indicate: . Oxford will reimburse services for any eligible child, who is a CT resident, for services that are part of a prescribed Individualized Family Service Plan (IFSP) for children up to age 3 . The reimbursement of EI services will not be applied against any visit maximums or any maximum lifetime or annual monetary limits and in and out of network cost shares (i.e., copayment, coinsurance and

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 deductibles) may not be and Early applied Intervention . Precertification is Programs/Birth to required for all services Three related to EI; however, (continued) Oxford may not apply medical necessity or any other Oxford policy to EI services o Updated list of applicable EI services: . Added: - Assistive technology - Sign language and cued language services - Transportation and related costs (as documented in the IFSP) . Replaced: - “Audiology or hearing services” with “audiology” - “Initial evaluation” with “evaluation” Massachusetts (MA) Residents (who have a CT, NJ, or NY Line of Business) o Modified coverage guidelines to indicate: . Oxford will provide coverage for EI services for any eligible child, who is a MA resident, for services that are part of an IFSP, under the MA Early Intervention (EI) Program

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 . The reimbursement of EI and Early services will not be Intervention applied against visit Programs/Birth to maximums or any Three maximum lifetime or (continued) annual monetary limit and cost shares (i.e., copayment, coinsurance and deductible) cannot be applied; the prohibition on cost sharing applies to both in and out of network services (when non- network services are otherwise covered under the policy) . Precertification is required for all services related to EI; however, Oxford may not apply medical necessity or any other Oxford policy to EI services . Providers of EI services documented in the IFSP are considered to be participating providers for EI services o Updated list of applicable EI services: . Added: - Medical services for diagnostic or evaluation purposes - Service coordination - Sign language and cued speech - Special instruction

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 - Speech and language and Early therapy services Intervention - Transportation Programs/Birth to services Three - Vision services (continued) . Removed: - Behavior modification - Educational services - Other specialty services . Replaced: - “Nutritional counseling” with “nutrition services” - “Social services” with “social work services” NY Residents o Modified coverage guidelines to indicate: . Oxford will provide coverage for any eligible child who is a NY resident for EI services provided as part of the EI program and covered under the member specific benefit plan document . Reimbursement will not be applied against maximum annual or lifetime monetary limits and copayments and coinsurance cannot be applied (the deductible may be applied) . Precertification is

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 required for all services and Early related to an EI program Intervention . EI services may be Programs/Birth to reviewed for medical Three necessity; however, EI (continued) services may not be denied solely because they are EI related . Coverage for EI services is focused primarily on hospital, medical or therapeutic services as opposed to educational or instructional services, and coverage may vary based on the member specific benefit plan document; the EI provider: - Must send a subrogation notice indicating the provider’s assignment as the EI provider for the child - Must send a copy of the IFSP either with the subrogation notice or separately to medical management for the medical necessity review - Submit claims through the NY state fiscal agent Note: The provider or the municipality has a right to

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 subrogation (no and Early change to NY Intervention subrogation Programs/Birth to guidelines) Three o Removed language (continued) pertaining to maximums or lifetime limits  Updated definitions for CT: o Added definition of: . Individualized Family Service Plan (IFSP) . Interim IFSP o Modified definition of “Eligible Child/Children (Birth to Three)”  Updated lists of applicable codes for: Speech Therapy CPT Codes o Added 92521, 92522, 92523, and 92524 o Removed 92506 HCPCS Codes o Added G0153 and S9128

ICD-10 Diagnosis Codes (Benefit

Exclusions/Not Covered)

o Removed F07.89, R27.0,

R48.1, and R48.2

o Removed notation pertaining

to exceptions for members

participating in an Early

Intervention/Birth to Three

program (refer to the

Coverage Rationale section

of the policy for applicable

guidelines)

Early Intervention Program/Birth to Three

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Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy Oct. 1, 2018 HCPCS Codes and Early o MA: Added T1025 and Intervention T1026 Programs/Birth to o CT: Three . Removed H2015, T1015, (continued) and T1024 . Modified notation pertaining to the fee schedule for early intervention services; replaced reference to “Department of Mental Retardation (DMR)” with “Department of Developmental Services (DDS)”  Updated supporting information to reflect the most current references

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Reimbursement Policy Updates

Policy Title Effective Date Reimbursement Guidelines NEW Specialty Pharmacy Oct. 1, 2018 For Oxford members, participating hospitals in Connecticut (CT), New Jersey (NJ) and New York (NY) will be required for Certain to purchase certain multiple sclerosis and anti-inflammatory specialty medications from the BriovaRx Specialty Specialty Pharmacy. The multiple sclerosis and anti-inflammatory specialty medications included in this protocol are: Medications  Actemra® (tocilizumab) injection for intravenous infusion Administered in an  Cimzia (certolizumab pegol) Outpatient Hospital  Entyvio® (vedolizumab) Setting  Infliximab (Remicade®, Inflectra™, Renflexis™)  Lemtrada (alemtuzumab)  Ocrevus™ (ocrelizumab)  Orencia® (abatacept) injection for intravenous infusion  Simponi Aria® (golimumab) injection for intravenous infusion  Stelara® (ustekinumab)  Tysabri (natalizumab)

All hospitals must procure the specialty medications to be administered in an outpatient hospital setting from BriovaRx. BriovaRx will bill Oxford directly for these medications.

Participating hospitals:  Will bill Oxford for the administration of the medication only.  May not bill members for these medications.

Financial Consequence for Non-Compliance Oxford will issue an administrative denial of payment for failure to comply with this protocol.

Policy Title Effective Date Summary of Changes UPDATED Add-On Policy Oct. 1, 2018  Updated list of related policies; added reference link to the policy titled B Bundle Codes  Updated policy application guidelines; added language to clarify this policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form  Updated reimbursement guidelines; modified notation to clarify all services described in this policy may be subject to other reimbursement policies including but not limited to the policy titled B Bundle Codes  Updated supporting information to reflect the most current references

Ambulance Sep. 1, 2018  Routine review; no content changes

Care Plan Oversight Oct. 1, 2018  Updated policy application guidelines; added language to clarify this policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Co-Surgeon/Team Oct. 1, 2018  Updated/clarified definition of “Allowable Amount”; no change to reimbursement guidelines Surgeon New Patient Visit Oct. 1, 2018  Updated policy application guidelines; added language to clarify this policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form

Services and Sep. 1, 2018  Routine review; no content changes Modifiers Not Reimbursable to Healthcare Professionals

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED After Hours and Oct. 1, 2018  Revised reimbursement The Centers for Medicare and Medicaid Services (CMS) considers Weekend Care guidelines: reimbursement for Current Procedural Terminology (CPT®) codes 99050, o Removed language 99051, 99053, 99056, 99058, and 99060 to be bundled into payment for indicating Oxford will not other services provided on the same day. separately reimburse CPT code 99051 CPT Codes 99053, 99056, 99058, or 99060 o Added language to indicate: Consistent with CMS and with the intent of this policy, Oxford will not . Although CMS considers separately reimburse CPT codes 99053, 99056, 99058, or 99060. CPT code 99051 to be bundled into the CPT Code 99050 and 99051 payment for other Although CMS considers CPT codes 99050 and 99051 to be bundled into the services provided on the payment for other services provided on the same day, Oxford will provide same day, Oxford will additional compensation to participating primary care providers for seeing provide additional patients in situations that would otherwise require more costly urgent care or compensation to emergency room settings by reimbursing CPT code 99050 in addition to basic participating primary service codes and CPT code 99051 in addition to acute care services (not care providers for seeing preventive medicine codes). patients in situations

that would otherwise Oxford will reimburse after hours CPT codes 99050 and 99051 to require more costly participating primary care providers when reported with basic services in one urgent care or of the following CMS non-facility place of service (POS) designations only: emergency room settings by reimbursing POS Code Description CPT code 99051 in 03 School addition to acute care 05 Indian health service free-standing facility

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED After Hours and Oct. 1, 2018 services (not preventive 07 Tribal 638 free-standing facility Weekend Care medicine codes) 11 Office (continued) . Oxford will reimburse after hours CPT code 49 Independent clinic 99051 to participating 50 Federally qualified health center primary care providers 71 State or local public health clinic when reported with basic services in one of the 72 Rural health clinic [listed] CMS non-facility place of service (POS) Oxford will reimburse the following participating primary care providers for designations CPT codes 99050 and 99051: . Oxford will reimburse the  Adolescent medicine, pediatric-adolescent, pediatrics [listed] participating  Family nurse practitioner, nurse practitioner, pediatric nurse practitioner, primary care providers advanced registered nurse practitioner for CPT code 99051  Family practice  Revised list of reimbursable CPT  General practice codes; added 99051  Geriatric medicine  Updated Questions and Answers  Gynecology, obstetrics & gynecology, obstetrics (Q&A):  Internal medicine o Modified Q&A#1 pertaining  Certified nurse midwife to non-reimbursable CPT codes; removed reference to CPT code 99051 o Added Q&A#2 pertaining to reimbursement of CPT code 99050 o Added Q&A#3 pertaining to reimbursement of CPT code 99051

Co-Surgeon/Team Oct. 1, 2018  Revised policy application Co-Surgeon Services Surgeon (CES) guidelines; removed language Modifier 62 identifies a Co-Surgeon involved in the care of a patient at indicating this policy applies to: surgery. Each Co-Surgeon should submit the same Current Procedural o Services reported using the Terminology (CPT) code with modifier 62. UB-04 Claim Form o Hospitals and ambulatory For services included on the Co-Surgeon Eligible List, Oxford will reimburse surgical centers Co-Surgeon services at 63% of the Allowable Amount to each surgeon  Updated definition of “Allowable subject to additional multiple procedure reductions if applicable (see Multiple Amount” Procedure Reductions section below). The Allowable Amount is determined

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Co-Surgeon/Team Oct. 1, 2018 independently for each surgeon and is calculated from the Allowable Amount Surgeon (CES) that would be given to that surgeon performing the surgery without a Co- (continued) Surgeon. The reimbursable percentage amount (63%) of allowable is based on the rate adopted by the Centers for Medicare and Medicaid Services (CMS), which allows 62.5% of allowable to each Co-Surgeon.

Exception: For New Jersey small group plans, standard reimbursement is based on the 80th percentile of Prevailing Healthcare Charges System (PHCS).

Team Surgeon Services Modifier 66 identifies Team Surgeons involved in the care of a patient during surgery. Each Team Surgeon should submit the same CPT code with modifier 66.

Each Team Surgeon is required to submit written medical documentation describing the specific surgeon's involvement in the total procedure. For services included on the Team Surgeon Eligible List, Oxford will review each submission with its appropriate medical documentation and will make reimbursement decisions on a case-by-case basis.

Co-Surgeon and Team Surgeon Eligible Lists The Co-Surgeon Eligible List and Team Surgeon Eligible List are developed based on the Centers for Medicare and Medicaid Services (CMS) National Physician Fee Schedule (NPFS) Relative Value File status indicators.

All codes in the NPFS with status code indicators "1" or "2" for "Co-Surgeons" are considered by Oxford to be eligible for Co-Surgeon services as indicated by the Co-Surgeon modifier 62.

Oxford applies the payment indicators for HCPCS codes G0412-G0415 when adjudicating CPT codes 27215-27218 for the purposes of this policy.

All codes in the NPFS with the status code indicators "1" or "2" for "Team Surgeons" are considered by Oxford to be eligible for Team Surgeon services as indicated by the Team Surgeon modifier 66.

Please refer to the Attachments section of the policy for the listing of eligible codes for both Co-Surgeon and Team Surgeon.

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Co-Surgeon/Team Oct. 1, 2018 CMS Files for Download Surgeon (CES) (continued) Multiple Procedure Reductions Multiple procedure reductions apply to Co-Surgeon and Team Surgeon claim submissions when one or more physicians are billing multiple CPT codes that are eligible for reductions. Refer to the policy titled Multiple Procedures for application of multiple procedure reductions.

Assistant Surgeon and Co-Surgeon Services During the Same Encounter Oxford follows CMS guidelines and does not reimburse for Assistant Surgeon services, as indicated by modifiers 80, 81, 82, or AS, for procedures where reimbursement has been provided for eligible Co-Surgeon services, using the same surgical procedure code, during the same encounter.

If a Co-Surgeon acts as an Assistant Surgeon in the performance of additional procedure(s) during the same surgical session, the procedures are reimbursable services (if eligible per the Assistant Surgeon Eligible List, refer to the policy titled Assistant Surgeon) when indicated by separate procedure code(s) with modifier 80 or modifier 82 added, as appropriate.

Simultaneous Bilateral Services Simultaneous bilateral services are those procedures in which each surgeon performs the same procedure on opposite sides. Each surgeon should report the simultaneous bilateral procedures with modifiers 50 and 62. Assistant Surgeon services will not be reimbursed services in addition to the simultaneous bilateral submission as described in the Assistant Surgeon and Co-Surgeon Services During Same Encounter section of the policy.

Durable Medical Oct. 1, 2018  Revised policy application Rental and Purchase Modifiers Equipment, guidelines; removed language Some DME items are eligible for rental as well as for purchase. The codes Orthotics and indicating this policy applies to: representing these items are listed in Items Eligible for Rental or Purchase in Prosthetics Multiple o Services reported using the the Attachments section of the policy and must be reported with the Frequency (CES) UB-04 Claim Form appropriate rental or purchase modifier in order to be considered for o Hospitals and ambulatory reimbursement. surgical centers  Replaced references to “Same Some DME items are eligible for rental only. The codes representing these Specialty Physician, Hospital, items are listed in Items Eligible for Rental Only in the Attachments section Ambulatory Surgical Center, or of the policy and must be reported with the appropriate rental modifier in

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Durable Medical Oct. 1, 2018 Other Health Care Professional” order to be considered for reimbursement. Equipment, with “Same Specialty Physician Orthotics and or Other Health Care Total reimbursement of fees reported for a single code (modified with RR Prosthetics Multiple Professional” and/or NU) from a single vendor is limited to either the purchase price of an Frequency (CES)  Removed “year” from date item or a maximum number of rental months, whichever is less. These rental (continued) format in example illustrations limits do not apply to oxygen equipment or to ventilators.

Rental guidelines are explained further in the sections titled Monthly Rental and Daily Rental.

Rental Modifiers The following modifiers indicate that an item has been rented:  RR - Rental  KH - Initial claim, purchase or first month rental  KI - Second or third monthly rental  KJ - Capped rental months four to fourteen  KR - Partial month

Purchase Modifiers The following modifiers indicate that an item has been purchased:  NU - New equipment (use the NR modifier when DME which was new at the time of rental is subsequently purchased)  UE - Used equipment  NR - New when rented  KM - Replacement of facial prosthesis including new impression/moulage  KN - Replacement of facial prosthesis using previous master model

Monthly Rental

Monthly rental of DME, Orthotics, or Prosthetics identified by the applicable

code with a rental modifier RR and/or modifiers KH, KI, KJ, KR appended will

be reimbursed once per Calendar Month to the Same Specialty Physician or

Other Health Care Professional. A Calendar Month is the period of duration

from a day of one month to the corresponding day of the next month (see

Definitions section of the policy) and is determined based on the “From” date

reported on the claim.

If a code is submitted with modifier RR and/or modifiers KH, KI, KJ, KR with

units greater than 1, or multiple times during the same Calendar Month,

Oxford will only reimburse one monthly rate per Calendar Month to the Same

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Durable Medical Oct. 1, 2018 Specialty Physician or Other Health Care Professional except where noted Equipment, below. Orthotics and Prosthetics Multiple Modifiers RT and LT Frequency (CES) An additional rental rate will be allowed in the same Calendar Month for (continued) codes with a rental modifier when both modifiers RT and LT are submitted for the same HCPCS code on separate lines. Modifiers RT and LT may be used to report an item for the right or left side of the body. Use of these modifiers may convey that multiples of that item are being utilized.

Second Ventilator It may be necessary for a patient to rent two ventilators in the same month. Examples of situations where a second ventilator may be necessary include:  A patient requires one type of ventilator (e.g., a negative pressure ventilator with a chest shell) for part of the day and needs a different type of ventilator (e.g., a positive pressure ventilator with a nasal mask) during the rest of the day.  A patient who is confined to a wheelchair requires a ventilator mounted on the wheelchair for use during the day and needs another ventilator of the same type for use while in bed. Without both pieces of equipment the patient may be prone to certain medical complications, may not be able to achieve certain appropriate medical outcomes, or may not be able to use the medical equipment effectively.  One additional rental rate will be allowed in the same Calendar Month for a second ventilator reported with a rental modifier plus modifier KX (Requirements specified in the medical policy have been met), appended to HCPCS codes E0465 and E0466.

Codes with “Extension/Flexion,” “Supination/Pronation,” or “Each” in the Description

Up to two rental rates will be allowed in the same Calendar Month for codes

with "extension/flexion," "supination/pronation" or "each" in the description.

These codes describe services where multiple devices may be reported. If

these codes are reported with modifiers RT and LT and multiple units, Oxford

will consider for separate reimbursement up to two units for each side for a

total of up to four rental rates in the same Calendar Month.

For additional information, refer to the Questions & Answers and

Attachments sections of the policy.

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED

Durable Medical Oct. 1, 2018 Reporting Monthly Rental Equipment, Monthly rental of DME, Orthotics, or Prosthetics should be reported on a Orthotics and 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic Prosthetics Multiple equivalent or its successor form according to the National Uniform Billing Frequency (CES) Committee (NUBC) and the National Uniform Claim Committee (NUCC) (continued) guidelines.

The appropriate HCPCS code and rental modifier are submitted with one unit for each Calendar Month time span. The rental initiation date is entered in the "From" field, and the end date in the "To" field.

In the following example, the rental for HCPCS code E1130 (Standard wheelchair, fixed full-length arms, fixed or swing-away detachable footrests), is initiated on 1/10, and the item is rented for 3 months, ending on 4/9. The claim should be submitted as follows:

Code Modifier Units From Date To Date E1130 RR 1 1/10 2/9 E1130 RR 1 2/10 3/9

E1130 RR 1 3/10 4/9

E1130-RR reported with 3 units, a From Date of 1/10 and a To Date of 4/9 on one line will result in reimbursement of only 1 unit.

Daily Rental Oxford will allow a daily rental for the following items to the Same Specialty Physician or Other Health Care Professional.

HCPCS codes E0935 (Continuous passive motion exercise device for use on knee only), and E0936 (Continuous passive motion exercise device for use other than knee) are reimbursed on a daily basis consistent with CMS guidelines.

The following HCPCS codes are also reimbursed on a daily basis:  E0193 - Powered air flotation bed (low air loss therapy)  E0194 - Air fluidized bed  E0277 - Powered pressure-reducing air mattress  E0304 - Hospital bed, heavy duty, extra wide, with weight capacity

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Durable Medical Oct. 1, 2018 greater than 600 pounds, with any type side rails, with mattress Equipment,  E0371 - Nonpowered advanced pressure reducing overlay for mattress, Orthotics and standard mattress length and width Prosthetics Multiple  E0372 - Powered air overlay for mattress, standard mattress length and Frequency (CES) width (continued)  E0373 - Nonpowered advanced pressure reducing mattress  E1639 - Scale, each  E2402 - Negative pressure wound therapy electrical pump, stationary or portable

Maintenance and Service Fees Oxford allows for reimbursement of maintenance and service once every six months to the Same Specialty Physician or Other Health Care Professional. The appropriate HCPCS code appended with modifier MS (maintenance/service fee) is required to identify such services. The Maintenance and Service modifier (MS), must be reported on a separate line in order to be considered for separate reimbursement from the rental or purchase of the equipment.

Maintenance and Service agreements include the following:  Regular routine maintenance and performance checks as required to maintain the warranty or performance standards  Re-education  Compliance with alerts and recalls  necessary supplies in accordance with the applicable agreement  Back-up equipment  Emergency availability and replacement equipment when out-of-service for repair

For the purposes of this policy, maintenance and servicing does not apply to Orthotics or Prosthetics.

HCPCS Codes A9900, A9901 and L9900 Delivery, set-up and supplies are included in the payment rates associated with a DME, Orthotic, or Prosthetic item. They are not reimbursable services when submitted alone or with another service.

Therefore, Oxford will not separately reimburse the following codes:  A9900 - Miscellaneous DME supply, accessory, and/or service component

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Durable Medical Oct. 1, 2018 of another HCPCS code Equipment,  A9901 - DME delivery, set up, and/or dispensing service component of Orthotics and another HCPCS code Prosthetics Multiple  L9900 - Orthotic and Prosthetic supply, accessory, and/or service Frequency (CES) component of another HCPCS "L" code (continued)

From - To Date Oct. 1, 2018  Updated reimbursement The National Uniform Claim Committee (NUCC) develops and oversees the Policy guidelines; added language to NUCC Data Set (NUCC-DS), which is a standardized data set for use in an clarify: electronic environment, but applicable to and consistent with evolving paper o As stated in the Application claim form standards. The NUCC 1500 Health Insurance Claim Form section of the policy, home Reference Instruction Manual for Form Version 02/12 provides instruction for health care, home infusion, the completion of the 1500 Health Insurance Claim form. This manual durable medical equipment, includes the following instruction for entering the dates of service: orthotics, and prosthetics  "If there is only one date of service, enter that date under 'From'. Leave suppliers are excluded from 'To' blank or re-enter 'From' date." this policy unless they report  "If Grouping services, the place of service, procedure code, charges, and a code that by description individual provider for each line must be identical for that service line. indicates it should be Grouping is allowed only for services on consecutive days. The number of reported only once daily days must correspond to the number of units in 24G. . For example, HCPCS code S9328 describes The Centers for Medicare and Medicaid Services (CMS) Medicare Claims services that would be Processing Manual Chapter 26, also states: "When 'from' and 'to' dates are reported once per day shown for a series of identical services, enter the number of days or units in (per diem); therefore, column G." CMS returns a claim as unprocessable if a date of service extends units billed should more than 1 day and a valid "to" date is not present. correspond to ‘from’ and ‘to’ dates. Consistent with NUCC and CMS, Oxford will only consider reimbursement for o Refer to the Attachments claim lines, with a 'from' and 'to' date span greater than one day, when the section of the policy for a list units entered correspond or are equally divisible to the number of days of codes that describe ‘per indicated. Claim lines for which the 'from' and 'to' dates and units do not diem’ or ‘per day’ services correspond, or are not equally divisible by the number of days indicated, will that are not excluded from not be processed. The services will need to be resubmitted on separate claim this policy when billed by form lines with the units matching the corresponding from and to dates. home health care, home infusion, durable medical An example of a claim form submission where the service dates cannot be equipment, orthotics, and determined and therefore the claim cannot be processed: prosthetics suppliers Code Modifier Units From Date To Date  Revised From - To Policy 99213 - 3 02/10/2009 03/19/2009 Exceptions List (attachment file

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED From - To Date Oct. 1, 2018 listing codes for services exempt The claim should be submitted as follows: Policy from this policy): Code Modifier Units From Date To Date (continued) o Added CPT code 83840 and 99213 - 1 02/10/2009 02/10/2009 HCPCS code H0020 o Removed HCPCS codes 99213 - 1 02/25/2009 02/25/2009 H0001, H0002, H0005, 99213 - 1 03/19/2009 03/19/2009 H2020, and S9480  Added From-To Date Policy Per Oxford recognizes there are exceptions to this policy based on the Diem Per Day List (attachment uniqueness of some CPT and HCPCS codes reported for services rendered. The following types of services are exempt from this policy: file listing services and supplies ® to be reported only once daily)  Certain CPT and HCPCS codes, based on their description, are not intended to be reported on consecutive dates of service, but may be appropriate to report with a 'from' and 'to' date. For example, codes whose descriptions say per week, per month, per course of treatment would be considered exceptions to this policy. Refer to the policy titled Time Span Codes for additional information.  Codes that represent drugs or contrast and radiopharmaceutical imaging materials  Global maternity codes. Refer to the Obstetrical Policy.  Time based anesthesia codes  Unlisted codes

For a complete list of codes exempt from this policy, please see the Attachments section of the policy.

As stated in the Application section of the policy, home health care, home infusion, durable medical equipment, orthotics and prosthetics suppliers are excluded from this policy unless they report a code that by description indicates it should be reported only once daily. For example, HCPCS code S9328 (Home infusion therapy, implanted pump pain management infusion; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem) describes services that would be reported once per day, therefore, units billed should correspond to ‘from’ and ‘to’ dates.

Refer to the Attachments section of the policy for a listing of codes that describe ‘per diem’ or ‘per day’ services that are not excluded from this policy when billed by home health care, home infusion, durable medical equipment, orthotics and prosthetics suppliers.

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