Oxford Policy Update Bulletin: April 2020

Oxford

April 2020 policy update bulletin Medical & Administrative Policy Updates

In This Issue Clinical Policy Updates Page TAKE NOTE • Policy Implementation Delayed ...... 6 NEW • Cimzia® (Certolizumab Pegol) – Effective Jul. 1, 2020 ...... 6 • Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) Scan – Site of Service – Effective Jun. 1, 2020 ...... 9 • Tepezza™ (Teprotumumab-Trbw) – Effective May 1, 2020 ...... 10 • Vyepti™ (Eptinezumab-Jjmr) – Effective May 1, 2020 ...... 10 • Vyondys 53™ (Golodirsen) – Effective Apr. 1, 2020 ...... 14 UPDATED • Adakveo® (Crizanlizumab-Tmca) – Effective Apr. 1, 2020 ...... 15 • Fetal Aneuploidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood – Effective Apr. 1, 2020 ...... 15 • Givlaari™ (Givosiran) – Effective Apr. 1, 2020 ...... 15 • Home Health Care – Effective Apr. 1, 2020 ...... 15 • Knee Replacement Surgery (Arthroplasty), Total and Partial – Effective May 1, 2020 ...... 15 • Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Apr. 1, 2020 ...... 15 • White Blood Cell Colony Stimulating Factors – Effective Apr. 1, 2020 ...... 15 REVISED • Abnormal Uterine Bleeding and Uterine Fibroids – Effective Jun. 1, 2020 ...... 16 • Actemra® (Tocilizumab) Injection for Intravenous Infusion – Effective May 1, 2020 ...... 16 • Adakveo® (Crizanlizumab-Tmca) – Effective Jul. 1, 2020 ...... 20 • Cell-Free Fetal DNA Testing – Effective Jun. 1, 2020 ...... 21 • Collagen Crosslinks and Biochemical Markers of Bone Turnover – Effective May 1, 2020 ...... 22 • Drug Coverage Criteria – New and Therapeutic Equivalent Medications – Effective May 1, 2020 ...... 23 • Drug Coverage Guidelines – Effective Apr. 1, 2020 ...... 24 o Adakveo (Crizanlizumab-Tmca) ...... 24

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o Givlaari (Givosiran) ...... 24 o Ziextenzo (Pegfilgrastim-Bmez) ...... 24 • Drug Coverage Guidelines – Effective May 1, 2020 ...... 24 o Adlyxin (Lixisenatide) ...... 24 o Arnuity Ellipta (Fluticasone Furoate) ...... 24 o Arikayce (Amikacin) ...... 24 o Avsola (Infliximab-Axxq) ...... 24 o Ayvakit (Avapritinib) ...... 24 o Azesco (13 Mg Iron-1 Tablet Multivitamins) ...... 25 o Basaglar (Insulin Glargine) ...... 25 o Bethkis (Tobramycin) ...... 25 o Bosulif (Bosutinib) ...... 25 o Bydureon (Exenatide) ...... 25 o Bydureon Bcise (Exenatide) ...... 25 o Byetta (Exenatide) ...... 25 o Cayston (Aztreonam for Inhalation Solution) ...... 25 o Cinqair (Reslizumab) ...... 26 o Clobex 0.05% Spray (Brand Only) (Clobetasol Propionate) ...... 26 o Cuvitru [Immune Globulin Subcutaneous (Human)] ...... 26 o Divigel 1.25g (Estradiol Gel) ...... 26 o Drizalma (Duloxetine)...... 26 o Egrifta (Tesamorelin) ...... 26 o Ezallor Sprinkle (Rosuvastatin) ...... 26 o Farxiga (Depagliflozin) ...... 26 o Fasenra (Benralizumab) ...... 27 o Feraheme (Ferumoxytol)...... 27 o Firdapse (Amifampridine) ...... 27 o Flebogamma (Immune Globulin Non-Lyophilized)...... 27 o Flovent Diskus, Flovent HFA (Fluticasone) ...... 27 o Gammagard® Liquid (Immunoglobulin, Non-Lyophilized) ...... 27 o Gammaplex (Immunoglobulin, Non-Lyophilized) ...... 27 o Gamunex-C, Gammaked (Immune Globulin, Non-Lyophilized) ...... 27 o Gloperba (Colchicine) ...... 27 o Glyxambi (Empagliflozin/ Linagliptin) ...... 27 o Hizentra (Immune Globulin) ...... 28 o Immune Globulin (IVIG and SCIG) ...... 28 o Injectafer (Ferric Carboxymaltose) ...... 28 o Invokana (Canagliflozin) ...... 28 o Janumet (Sitagliptin and Metformin Hydrochloride) ...... 28 o Janumet XR (Sitagliptin and Metformin Hydrochloride, Extended Release) ...... 28 o Januvia (Sitagliptin) ...... 28 o Jardiance (Empagliflozin) ...... 28 o Kitabis Pak (Tobramycin) ...... 28 o Lantus (Insulin Glargine) ...... 28

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o Lantus Solostar (Insulin Glargine) ...... 28 o Levemir (Insulin Detemir) ...... 28 o Lovaza (Brand Only) (Omega-3-Acid Ethyl Esters) ...... 29 o Lovaza (Generic) (Omega-3-Acid Ethyl Esters) ...... 29 o Lynparza (Olaparib) ...... 29 o Monoferric (Ferric Derisomaltose) ...... 29 o Nexletol (Bempedoic Acid) ...... 29 o Noxafil (Brand Only) (Posaconazole) ...... 29 o Nucala (Mepolizumab) ...... 30 o Nurtec ODT (Rimegepant) ...... 30 o Octagam (Immune Globulin, Non-Lyophilized) ...... 30 o Oxervate (Cenegermin) ...... 30 o Ozempic (Semaglutide) ...... 30 o Ozobax (Baclofen) ...... 30 o Qtern (Dapagliflozin/ Saxagliptin) ...... 30 o Panzyga (Immunoglobulin Intravenous, Human) ...... 30 o Praluent (Alirocumab) ...... 30 o Prenatal Vitamins ...... 31 o Privigen (Immune Globulin)...... 31 o Prograf Granules for Suspension (Tacrolimus) ...... 31 o Pulmicort Flexhaler (Budesonide) ...... 31 o Pulmozyme® (Dornase Alfa) ...... 31 o Rapaflo (Brand Only) (Silodosin) ...... 31 o Repatha (Evolocumab) ...... 31 o Rybelsus (Semaglutide) ...... 31 o Segluromet (Ertugliflozin/ Metformin Hcl)...... 31 o Slynd (Drospirenone) ...... 32 o Spravato (Esketamine) ...... 32 o Steglatro (Ertugliflozin) ...... 32 o Steglujan (Ertugliflozin/ Sitagliptin) ...... 32 o Tepezza (Teprotumumab-Trbw) ...... 32 o Tirosint-Sol Oral Solution (Levothyroxine Sodium) ...... 32 o Tobi™ Nebulizer Solution (Tobramycin Inhalation Solution) ...... 32 o Tobi® Podhaler™ (Tobramycin Inhalation Powder) ...... 33 o Tobramycin Nebulized Solution (Generic Tobi) ...... 33 o Toujeo Solostar (Insulin Glargine) ...... 33 o Tresiba Flex Touch (Insulin Degludec) ...... 33 o Trijardy XR (Empagliflozin/Linagliptin/Metformin Hydrochloride) ...... 33 o Trinaz (Prenatal Vitamin) ...... 33 o Trulicity (Dulaglutide) ...... 33 o Vascepa (Omega-3-Acid Ethyl Esters) ...... 33 o Vascepa 0.5 Gram Only (Omega-3-Acid Ethyl Esters) ...... 33 o Vectical (Calcitriol)(Generic) ...... 34 o Vectical Ointment (Brand Only) ...... 34

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o Victoza (Liraglutide) ...... 34 o Vyepti (Eptinezumab-JJMR) ...... 34 o Vyndamax (Tafamidis) ...... 34 o Vyndaqel (Tafamidis Meglumine) ...... 35 o Xalkori (Crizotinib) ...... 35 o Xeljanz (Tofacitinib) ...... 35 o Xeljanz XR ...... 35 o Xembify (Immune Globulin Subcutaneous, Human- Klhw) ...... 35 o Xigduo XR (Dapagliflozin and Metformin Hcl) ...... 35 o Xospata (Gilteritinib) ...... 35 o Yonsa (Abiraterone Acetate) ...... 35 o Zerviate (Cetirizine Ophthalmic Solution) ...... 35 o Ziextenzo (Pegfilgrastim-Bmez) ...... 35 o Zomig and Zomig-ZMT (Zolmitriptan) ...... 35 o Zomig (Zolmitriptan) ...... 36 • Entyvio® (Vedolizumab) – Effective May 1, 2020 ...... 36 • Epidural Steroid and Facet Injections for Spinal Pain – Effective May 1, 2020 ...... 38 • Givlaari™ (Givosiran) – Effective Jul. 1, 2020 ...... 39 • Glaucoma Surgical Treatments – Effective Jun. 1, 2020 ...... 40 • Gonadotropin Releasing Hormone Analogs – Effective May 1, 2020 ...... 41 • Infertility Diagnosis and Treatment – Effective Jun. 1, 2020 ...... 42 • Intravenous Iron Replacement Therapy (Feraheme® & Injectafer®, & Monoferric®) – Effective May 1, 2020 ...... 44 • Lemtrada (Alemtuzumab) – Effective May 1, 2020 ...... 48 • Manipulation Under Anesthesia – Effective May 1, 2020...... 49 • Radicava® (Edaravone) – Effective May 1, 2020 ...... 50 • Reblozyl® (Luspatercept-Aamt) – Effective Jul. 1, 2020 ...... 51 • Respiratory Interleukins (Cinqair®, Fasenra®, & Nucala®) – Effective May 1, 2020 ...... 52 • Simponi Aria® (Golimumab) Injection for Intravenous Infusion – Effective May 1, 2020 ...... 57 • Stelara® (Ustekinumab) – Effective May 1, 2020 ...... 60 • Trogarzo® (Ibalizumab-Uiyk) – Effective May 1, 2020 ...... 64 • Vyondys 53™ (Golodirsen) – Effective Jul. 1, 2020 ...... 65 Administrative Policy Updates UPDATED • Participating Gastroenterologists Using Non-Participating Anesthesiologists: In-Office and Ambulatory Surgery Centers Protocol – Effective May 1, 2020 67 • Participating Providers Using Non-Participating Laboratory and Pathology Providers Protocol – Effective May 1, 2020 ...... 67 • Participating Surgeons Using Non-Participating Assistant Surgeons and Co-Surgeons Protocol – Effective May 1, 2020 ...... 67 • Participating Surgeons Using Non-Participating Providers for Intraoperative Neuro-Monitoring (IONM) Protocol – Effective May 1, 2020 ...... 67

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REVISED • Orthopedic Services – Effective May 1, 2020 ...... 67 • Participating Providers Using Non-Participating Providers Protocol – Effective May 1, 2020 ...... 69 • Precertification Exemptions for Outpatient Services – Effective Apr. 1, 2020 ...... 70 • Speech Therapy and Early Intervention Programs/Birth to Three – Effective May 1, 2020 ...... 70 • Timeframe Standards for Utilization Management (UM) Initial Decisions – Effective May 1, 2020 ...... 75 Reimbursement Policy Updates NEW • Outpatient Hospital Add-On Codes (CES) – Effective Jul. 1, 2020 ...... 77 • Outpatient Hospital Maximum Frequency Per Day (CES) – Effective Jul. 1, 2020 ...... 77 UPDATED • Drug Testing – Effective Apr. 1, 2020 ...... 78 • Prolonged Services – Effective Apr. 1, 2020 ...... 78 REVISED • Increased Procedural Services – Effective May 1, 2020 ...... 78 • Increased Procedural Services (CES) – Effective May 1, 2020 ...... 80 • Injection and Infusion Services – Effective May 1, 2020 ...... 81 • Injection and Infusion Services (CES) – Effective May 1, 2020 ...... 83 • Observation and Discharge – Effective May 1, 2020 ...... 85 • Telehealth and Telemedicine – Effective May 1, 2020 ...... 90 • Telehealth and Telemedicine (CES) – Effective May 1, 2020 ...... 93 • Time Span Codes – Effective May 1, 2020 ...... 96

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Clinical Policy Updates

Take Note POLICY IMPLEMENTATION DELAYED

Implementation of the changes associated with the following Clinical Policies, previously announced for an effective date on or after Apr. 1, 2020, has been delayed as noted below:

Policy Title Status Effective Date Genitourinary Pathogen Nucleic Acid Detection Panel Testing New May 1, 2020 Jun. 1, 2020 Outpatient Surgical Procedures - Site of Service Revised Apr. 6, 2020 TBD Tysabri® (Natalizumab) New Apr. 1, 2020 Jul. 1, 2020

Policy Title Effective Date Coverage Rationale NEW Cimzia® Jul. 1, 2020 This policy refers to Cimzia (certolizumab pegol) injection. Cimzia (certolizumab pegol) for self-administered (Certolizumab subcutaneous injection is obtained under the pharmacy benefit. Pegol) Cimzia is proven and/or medically necessary for the treatment of:

Crohn’s disease (CD) when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of moderately to severely active Crohn’s disease; and o Patient has had an inadequate response to conventional therapies (examples include anti-inflammatory drugs, corticosteroids, or oral immunosuppressive agents); and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for CD; and o Patient is not receiving Cimzia in combination with either of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and o Initial authorization will be issued for 12 months. • For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for CD; and o Patient is not receiving Cimzia in combination with either of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib, Olumiant (baricitinib)] and o Authorization will be issued for 12 months.

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Policy Title Effective Date Coverage Rationale NEW Cimzia® Jul. 1, 2020 Rheumatoid arthritis (RA) when all of the following criteria are met: (Certolizumab • For initial therapy, all of the following: Pegol) o Diagnosis of moderately to severely active rheumatoid arthritis; and (continued) o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for RA; and o Patient is not receiving Cimzia in combination with either of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and o Initial authorization will be issued for 12 months. • For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for RA; and o Patient is not receiving Cimzia in combination with either of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and o Authorization will be issued for 12 months.

Psoriatic arthritis (PsA) when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of active psoriatic arthritis; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PsA; and o Patient is not receiving Cimzia in combination with any of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Initial authorization will be issued for 12 months. • For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PsA; and o Patient is not receiving Cimzia in combination with any of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

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Policy Title Effective Date Coverage Rationale NEW Cimzia® Jul. 1, 2020 ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast); Olumiant (baricitinib)] (Certolizumab and Pegol) o Authorization will be issued for 12 months. (continued) Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for AS or nr- axSpA; and o Patient is not receiving Cimzia in combination with any of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] and o Initial authorization will be issued for 12 months. • For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for AS or nr- axSpA; and o Patient is not receiving Cimzia in combination with any of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Authorization will be issued for 12 months.

Plaque Psoriasis (PS) when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of moderate to severe plaque psoriasis; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PS; and o Patient is not receiving Cimzia in combination with any of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

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Policy Title Effective Date Coverage Rationale NEW Cimzia® Jul. 1, 2020 and (Certolizumab o Initial authorization will be issued for 12 months. Pegol) • For continuation of therapy, all of the following: (continued) o Documentation of positive clinical response; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PS; and o Patient is not receiving Cimzia in combination with any of the following: ▪ Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Authorization will be issued for 12 months. Magnetic Jun. 1, 2020 An advanced radiologic imaging procedure in the hospital outpatient department is considered medically Resonance Imaging necessary for individuals who meet ANY of the following criteria: (MRI) and • Less than 19 years of age Computed • Require obstetrical observation Tomography (CT) • Require perinatology services Scan – Site of • Have a known contrast allergy Service • Have a known chronic disease undergoing active treatment or surveillance for which direct comparison to prior hospital based imaging is required for care planning • Pre-procedure imaging which is done within 24 hours of the interventional or surgical procedure and is an integral part of the planned procedure

An advanced radiologic imaging procedure in the hospital outpatient department is considered medically necessary when there are no geographically accessible appropriate alternative sites for the individual to undergo the procedure, including but not limited to the following: • Moderate or deep sedation or general anesthesia is required for the procedure; or • The equipment for the size of the individual is not available; or • Open magnetic resonance imaging is required because the member has a documented diagnosis of claustrophobia and/or severe anxiety

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

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

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Clinical Policy Updates

Policy Title Effective Date Coverage Rationale NEW Tepezza™ May 1, 2020 Tepezza has been added to the Review at Launch program. Some members may not be eligible for coverage of this (Teprotumumab- medication at this time. Refer to the Clinical Policy titled Review at Launch for New to Market Medications for Trbw) additional details.

Thyroid Eye Disease Tepezza is proven for the treatment of thyroid eye disease. Tepezza is medically necessary when all of the following criteria are met: • Diagnosis of Graves’ disease associated with active thyroid eye disease (TED); and • Presence of moderately to severely active TED, associated with at least one of the following: o Lid retraction ≥ 2 mm o Moderate or severe soft tissue involvement o Exophthalmos ≥ 3 mm above normal for race and gender o Diplopia and • One of the following: o Patient must be euthyroid with thyroid function under control o Mild hypothyroidism or hyperthyroidism undergoing treatment to correct and/or maintain euthyroid and • Tepezza is prescribed by, or in consultation with, an endocrinologist or specialist with expertise in the treatment of Graves’ disease associated with TED; and • Tepezza will not be used in combination with another biologic immunomodulator [e.g., rituximab (Rituxan, Ruxience, Truxima), Actemra (tocilizumab), Kevzara (sarilumab)]; and • Dosing is in accordance with the United States Food and Drug Administration approved labeling: Initial dose 10mg/kg followed by 20mg/kg every 3 weeks for 7 additional infusions; and • Authorization will be issued for a maximum of 8 doses per lifetime.

Reauthorization/Continuation of Care Criteria The clinical benefit of Tepezza has not been demonstrated beyond 8 infusions in phase 3 clinical trials. The continued use of Tepezza beyond 8 infusions in the patient’s lifetime is unproven and not medically necessary. Vyepti™ May 1, 2020 Vyepti has been added to the Review at Launch program. Some members may not be eligible for coverage of this (Eptinezumab- medication at this time. Refer to the Clinical Policy titled Review at Launch for New to Market Medications for Jjmr) additional details.

Chronic Migraine Vyepti is proven for the preventive treatment of chronic migraines when all of the following criteria are met: • For initial therapy, all of the following:

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Policy Title Effective Date Coverage Rationale NEW Vyepti™ May 1, 2020 o Diagnosis of chronic migraines with both of the following: (Eptinezumab- ▪ Greater than or equal to 15 headache days per month Jjmr) ▪ Greater than or equal to 8 migraine days per month (continued) and o Medication will not be used in combination with another CGRP antagonist or inhibitor [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Nurtec ODT (rimegepant), and Ubrelvy (ubrogepant)]; and o Dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling; and o Authorization will be issued for no more than 3 months.

• For continuation of therapy, all of the following: o Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and o Medication will not be used in combination with another CGRP antagonist or inhibitor [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Nurtec ODT (rimegepant), and Ubrelvy (ubrogepant)]; and o Dosing is in accordance with the FDA approved labeling; and o Authorization will be issued for no more than 12 months.

Vyepti is medically necessary for the preventive treatment of chronic migraines when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of chronic migraines with both of the following: ▪ Greater than or equal to 15 headache days per month ▪ Greater than or equal to 8 migraine days per month and o Trial and failure (after a trial of at least two months) to two of the following, or contraindication or intolerance to all of the following prophylactic therapies from the list below: ▪ Amitriptyline (Elavil) ▪ One of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol ▪ Divalproex sodium (Depakote/Depakote ER) ▪ OnabotulinumtoxinA (Botox) [trial of at least 2 quarterly injections (6 months)] ▪ Topiramate (Topamax) ▪ Venlafaxine (Effexor/Effexor XR) and o Trial and failure (after a trial of at least three months), contraindication, or intolerance to both of the following: ▪ Aimovig (erenumab)

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Clinical Policy Updates

Policy Title Effective Date Coverage Rationale NEW Vyepti™ May 1, 2020 ▪ Emgality (galcanezumab) (Eptinezumab- and Jjmr) o Medication will not be used in combination with another CGRP antagonist or inhibitor [e.g., Aimovig (continued) (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Nurtec ODT (rimegepant), and Ubrelvy (ubrogepant)]; and o Dosing is in accordance with the FDA approved labeling; and o Authorization will be issued for no more than 3 months.

Episodic Migraine Vyepti is proven for the preventive treatment of episodic migraines when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of episodic migraines with both of the following: ▪ Less than 15 headache days per month ▪ Patient has 4 to 14 migraine days per month and o Medication will not be used in combination with another CGRP antagonist or inhibitor [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Nurtec ODT (rimegepant), and Ubrelvy (ubrogepant)]; and o Dosing is in accordance with the FDA approved labeling; and o Authorization will be issued for no more than 3 months.

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Clinical Policy Updates

Policy Title Effective Date Coverage Rationale NEW Vyepti™ May 1, 2020 o Authorization will be issued for no more than 12 months. (Eptinezumab- Jjmr) Vyepti is medically necessary for the preventive treatment of episodic migraines when all of the (continued) following criteria are met: • For initial therapy, all of the following: o Diagnosis of episodic migraines with both of the following: ▪ Less than 15 headache days per month ▪ Patient has 4 to 14 migraine days per month and o Trial and failure (after a trial of at least two months) to two of the following, or contraindication or intolerance to all of the following prophylactic therapies from the list below: ▪ Amitriptyline (Elavil) ▪ One of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol ▪ Divalproex sodium (Depakote/Depakote ER) ▪ Topiramate (Topamax) ▪ Venlafaxine (Effexor/Effexor XR) and o Trial and failure (after a trial of at least three months), contraindication, or intolerance to both of the following: ▪ Aimovig (erenumab) ▪ Emgality (galcanezumab) and o Medication will not be used in combination with another CGRP antagonist or inhibitor [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Nurtec ODT (rimegepant), and Ubrelvy (ubrogepant)]; and o Dosing is in accordance with the FDA approved labeling; and o Authorization will be issued for no more than 3 months.

Vyepti is unproven and not medically necessary for:

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Clinical Policy Updates

Policy Title Effective Date Coverage Rationale NEW Vyepti™ May 1, 2020 • Acute attack of migraine (Eptinezumab- • Episodic cluster headache Jjmr) (continued) Vyondys 53™ Apr. 1, 2020 Vyondys 53 has been added to the Review at Launch program. Some members may not be eligible for coverage of (Golodirsen) this medication at this time. Refer to Clinical Policy titled Review at Launch for New to Market Medications for additional details.

Vyondys 53 (golodirsen) may be covered for the treatment of Duchenne muscular dystrophy (DMD) in patients who meet all of the following criteria: • For initial therapy, all of the following: o Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a neurologist with expertise in the diagnosis of DMD; and o Submission of medical records (e.g., chart notes, laboratory values) confirming the mutation of the DMD gene is amenable to exon 53 skipping; and o One of the following: ▪ Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a 6- Minute Walk Time (6MWT) ≥ 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.) prior to beginning Vyondys 53 therapy; or ▪ Both of the following: - Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.); and - One of the following: • Patient has achieved a score of greater than 17 on the North Star Ambulatory Assessment (NSAA);or • Patient has achieved a time to rise from the floor (Gower’s test) of less than 7 seconds; and o Vyondys 53 is prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD; and o Vyondys 53 dosing for DMD is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 30 mg/kg infused once weekly; and o Vyondys 53 is not used concomitantly with other exon skipping therapies for DMD; and o Initial authorization will be for no more than 6 months.

• For continuation therapy, all of the following: o Vyondy 53 is prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD; and o Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.); and

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Policy Title Effective Date Coverage Rationale NEW Vyondys 53™ Apr. 1, 2020 o Vyondys 53 dosing for DMD is in accordance with the United States Food and Drug Administration approved (Golodirsen) labeling: maximum dosing of 30 mg/kg infused once weekly; and (continued) o Vyondys 53 is not used concomitantly with other exon skipping therapies for DMD; and o Reauthorization will be for no more than 12 months.

Vyondys 53 will not be covered for other forms of muscular dystrophy.

Policy Title Effective Date Summary of Changes UPDATED Adakveo® Apr. 1, 2020 Applicable Codes (Crizanlizumab- • Updated list of applicable HCPCS codes to reflect quarterly code edits; replaced C9399 with C9053 Tmca) Fetal Aneuploidy Apr. 1, 2020 Applicable Codes Testing Using Cell- • Updated list of applicable CPT codes to reflect quarterly code edits; added 0168U Free Fetal Nucleic Acids in Maternal Blood Givlaari™ Apr. 1, 2020 Applicable Codes (Givosiran) • Updated list of applicable HCPCS codes to reflect quarterly code edits; replaced C9399 with C9056 Home Health Care Apr. 1, 2020 Applicable Codes • Updated list of applicable HCPCS codes to reflect quarterly code edits; added G2168 and G2169 Knee Replacement May 1, 2020 Definitions Surgery • Added definition of “Significant Radiographic Findings” (Arthroplasty), Supporting Information Total and Partial • Updated References section to reflect the most current information Molecular Oncology Apr. 1, 2020 Applicable Codes Testing for Cancer • Updated list of applicable CPT codes to reflect quarterly code edits; added 0171U Diagnosis, Prognosis, and Treatment Decisions White Blood Cell Apr. 1, 2020 Applicable Codes Colony Stimulating • Updated list of applicable HCPCS codes to reflect quarterly code edits; added C9058 Factors

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Abnormal Uterine Jun. 1, 2020 Coverage Rationale Levonorgestrel-Releasing Intrauterine Device Bleeding and • Revised language pertaining to Levonorgestrel-releasing intrauterine devices (LNG-IUD) (e.g., ® ® ® Uterine Fibroids proven and medically necessary Mirena , Skyla , Liletta or Kyleena™) are proven and medically treatment of uterine fibroids to necessary for treating menorrhagia. indicate uterine artery Refer to the U.S. Food and Drug Administration (FDA) section of the policy embolization (UAE) is proven for additional information. and medically necessary for treating symptomatic uterine Uterine Fibroids fibroids when there is Uterine artery embolization (UAE) is proven and medically necessary documentation of evaluation of for treating symptomatic uterine fibroids when there is abnormal uterine bleeding (UAB) documentation of evaluation of abnormal uterine bleeding (UAB) including endometrial biopsy for including endometrial biopsy for individuals >40 years of age and a individuals >40 years of age and pap smear screening consistent with current guidelines. a pap smear screening For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, consistent with current 24th edition, 2020, Uterine Artery Embolization, ACG: A-0287 (AC). guidelines Supporting Information Click here to view the MCG™ Care Guidelines. • Updated Description of Services, Clinical Evidence, and UAE is unproven and not medically necessary for the purpose of References sections to reflect preserving childbearing potential for women with symptomatic the most current information uterine fibroids due to insufficient evidence of efficacy.

The following procedures are unproven and not medically necessary for treating uterine fibroids due to insufficient evidence of efficacy: • Magnetic resonance-guided focused ultrasound ablation (MRgFUS) • Ultrasound-guided radiofrequency ablation (e.g., Acessa™, Sonata®) Actemra® May 1, 2020 Coverage Rationale Refer to the Clinical Policy titled Injectable Chemotherapy Drugs: Application (Tocilizumab) Polyarticular Juvenile Idiopathic of NCCN Clinical Practice Guidelines for updated information based upon the Injection for Arthritis, Rheumatoid Arthritis, National Comprehensive Cancer Network (NCCN) Drugs & Biologics Intravenous and Systemic Juvenile Idiopathic Compendium® (NCCN Compendium®) for oncology indications. Infusion Arthritis • Added language to indicate This policy refers only to Actemra (tocilizumab) injection for authorization for initial therapy intravenous infusion. Actemra (tocilizumab) for self-administered or continuation of therapy will subcutaneous injection is obtained under the pharmacy benefit. be issued for no more than 12 months Actemra is proven and medically necessary for the treatment of: • Revised coverage criteria for • Polyarticular juvenile idiopathic arthritis when ALL of the

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® May 1, 2020 continuation of therapy; following criteria are met: (Tocilizumab) added criterion requiring For initial therapy, all of the following: Injection for “patient has previously received o Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA); and Intravenous Actemra injection for o Actemra is dosed according to US Food and Drug Administration Infusion intravenous infusion” labeled dosing for polyarticular juvenile idiopathic arthritis up to a (continued) Supporting Information maximum of (or equivalent dose and interval schedule): • Updated Clinical Evidence and ▪ 10mg/kg every 4 weeks for patients weighing < 30kg References sections to reflect ▪ 8mg/kg every 4 weeks for patients weighing ≥ 30kg the most current information and o Patient is not receiving Actemra in combination with either of the following: ▪ Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib, Olumiant (baricitinib)] and o Initial authorization is for no more than 12 months

For continuation of therapy, all of the following: o Patient has previously received Actemra injection for intravenous infusion; and o Documentation of positive clinical response to Actemra; and o Actemra is dosed according to US Food and Drug Administration labeled dosing for polyarticular juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule): ▪ 10mg/kg every 4 weeks for patients weighing < 30kg ▪ 8mg/kg every 4 weeks for patients weighing ≥ 30kg and o Patient is not receiving Actemra in combination with either of the following: ▪ Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and o Authorization is for no more than 12 months

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® May 1, 2020 • Rheumatoid arthritis when ALL of the following criteria are met: (Tocilizumab) For initial therapy, all of the following: Injection for o Diagnosis of moderate to severely active rheumatoid arthritis (RA); Intravenous and Infusion o History of failure, contraindication, or intolerance to at least one (continued) non-biologic DMARD [e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, minocycline, etc.]; and o Actemra is dosed according to FDA 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) Olumiant (baricitinib)] and o Initial authorization is for no more than 12 months

For continuation of therapy, all of the following: o Patient has previously received Actemra injection for intravenous infusion; and o Documentation of positive clinical response; and o Actemra is dosed according to FDA 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), Olumiant (baricitinib)] and o Authorization is for no more than 12 months

• Systemic juvenile idiopathic arthritis when ALL of the following criteria are met: For initial therapy, all of the following:

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® May 1, 2020 o Diagnosis of systemic juvenile idiopathic arthritis (SJIA); and (Tocilizumab) o Actemra is dosed according to FDA labeled dosing for systemic Injection for juvenile idiopathic arthritis up to a maximum of (or equivalent dose Intravenous and interval schedule): Infusion ▪ 12mg/kg every 2 weeks for patients weighing < 30kg (continued) ▪ 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)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and o Initial authorization is for no more than 12 months

For continuation of therapy, all of the following: o Patient has previously received Actemra injection for intravenous infusion; and o Documentation of positive clinical response; and o Actemra is dosed according to FDA 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)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and o Authorization is for no more than 12 months

• Cytokine release syndrome when ALL of the following criteria are met: For initial therapy, all of the following:

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® May 1, 2020 o Diagnosis of chimeric antigen receptor (CAR) T cell-induced cytokine (Tocilizumab) release syndrome (CRS); and Injection for o Actemra is dosed according to FDA labeled dosing for CRS: Intravenous ▪ 12mg/kg for patients weighing < 30kg Infusion ▪ 8mg/kg for patients weighing ≥ 30kg; up to a maximum of (continued) 800mg per infusion and o Actemra is prescribed for a maximum of 4 doses

For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Actemra is dosed according to FDA 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 Adakveo® Jul. 1, 2020 Conditions of Coverage Adakveo is proven and/or medically necessary to reduce the (Crizanlizumab- • Revised precertification frequency of vasoocclusive crises in patients with sickle cell disease Tmca) guidelines to indicate who meet ALL of the following criteria: precertification with Medical Director review is required Initial Therapy Coverage Rationale • Patient is 16 years of age or older; and • Removed reference link to the • Diagnosis of a sickle cell disease, including, but not limited to, Clinical Policy titled Review at homozygous hemoglobin S [HbSS], sickle hemoglobin C disease [HbSC], Launch for New to Market sickle beta0 thalassemia, and sickle beta+ thalassemia; and Medications for Adakveo (prior • Patient has previously experienced 2 or more sickle cell-related authorization requirements apply vasoocclusive crises within the previous 12 months; and Jul. 1, 2020) • One of the following: o Patient is currently receiving hydroxyurea therapy o Patient has a history of treatment failure, intolerance, or contraindication to hydroxyurea therapy; and • Patient is not receiving concomitant chronic, prophylactic blood transfusion therapy; and • Patient is not receiving concomitant Oxbryta (voxelotor) therapy; and • Adakveo is prescribed by, or in consultation with, a hematologist, or other specialist with expertise in the diagnosis and management of sickle

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Adakveo® Jul. 1, 2020 cell disease; and (Crizanlizumab- • Adakveo initial dosing is in accordance with the United States Food and Tmca) Drug Administration approved labeling: 5 mg/kg by intravenous infusion (continued) on week 0, week 2, and every 4 weeks thereafter; and • Initial authorization will be for no more than 6 months

Continuation Therapy • Diagnosis of a sickle cell disease, including, but not limited to, homozygous hemoglobin S [HbSS], sickle hemoglobin C disease [HbSC], sickle beta0 thalassemia, and sickle beta+ thalassemia; and • Patient has experienced a reduction in sickle cell-related vasoocclusive crises and/or a decrease in severity of sickle cell-related vasoocclusive crises from pretreatment baseline while on Adakveo; and • Patient is not receiving concomitant chronic, prophylactic blood transfusion therapy; and • Patient is not receiving concomitant Oxbryta (voxelotor) therapy; and • Adakveo is prescribed by, or in consultation with, a hematologist, or other specialist with expertise in the diagnosis and management of sickle cell disease; and • Adakveo maintenance dosing is in accordance with the United States Food and Drug Administration approved labeling: 5 mg/kg by intravenous infusion every 4 weeks; and • Reauthorization will be for no more than 12 months

Adakveo is not proven or medically necessary for the treatment of: • Pediatric patients less than 16 years of age with sickle cell disease • Treatment of myelofibrosis Cell-Free Fetal DNA Jun. 1, 2020 Title Change DNA-based noninvasive prenatal tests of fetal Aneuploidy are proven Testing • Previously titled Fetal Aneuploidy and medically necessary as screening tools for Trisomy 21 (Down Testing Using Cell-Free Fetal syndrome), Trisomy 18 (Edwards syndrome), or Trisomy 13 (Patau Nucleic Acids in Maternal Blood syndrome) in ANY ONE of the following circumstances: Coverage Rationale • Maternal age or oocyte age of 35 years or older at delivery • Revised list of proven and • Fetal ultrasound findings indicating an increased risk of Aneuploidy medically necessary indications • History of a prior pregnancy with a Trisomy for DNA-based noninvasive • Positive first- or second-trimester screening test results for Aneuploidy prenatal tests of fetal aneuploidy • Parental balanced Robertsonian translocation with an increased risk of as screening tools for trisomy 21 fetal Trisomy 13 or Trisomy 21 (Down syndrome), trisomy 18

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Cell-Free Fetal DNA Jun. 1, 2020 (Edwards syndrome) or trisomy Due to insufficient evidence of efficacy, DNA-based noninvasive Testing 13 (Patau syndrome); replaced prenatal tests are unproven and not medically necessary for all other (continued) “maternal age of 35 years or fetal conditions including, but not limited to, the following: older at delivery” with “maternal • Multiple gestation pregnancies age or oocyte age of 35 years or • Twin zygosity older at delivery” • Repeat testing due to low fetal fraction • Added language to indicate DNA- • Screening for the following: based noninvasive prenatal tests o Aneuploidy other than trisomies 21, 18, or 13 of fetal aneuploidy in o Microdeletions conjunction with biochemical o Single gene disorders marker testing of maternal blood o Fetal RhD status for maternal conditions, such as pre-eclampsia, is unproven and Due to insufficient evidence of efficacy, DNA-based noninvasive not medically necessary due to prenatal tests of fetal Aneuploidy in conjunction with biochemical insufficient evidence of efficacy marker testing of maternal blood for maternal conditions, such as Applicable Codes pre-eclampsia, is unproven and not medically necessary. • Added CPT codes 0126U and 0128U Genetic Counseling Supporting Information Genetic counseling is strongly recommended prior to fetal screening or • Updated Description of Services, prenatal diagnosis in order to inform persons being tested about the Clinical Evidence, FDA, and advantages and limitations of the test as applied to a unique person. References sections to reflect the most current information Collagen Crosslinks May 1, 2020 Template Update Serum or urine collagen crosslinks or biochemical markers are and Biochemical • Removed Applicable Lines of unproven and not medically necessary to assess risk of fracture, Markers of Bone Business/Products section predict bone loss or assess response to antiresorptive therapy. Turnover (policy applies to all Commercial plan membership; no exceptions apply) Coverage Rationale

• Replaced language indicating “serum or urine collagen crosslinks or biochemical

markers are unproven and not medically necessary for any indication due to insufficient evidence of efficacy” with

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Collagen Crosslinks May 1, 2020 “serum or urine collagen and Biochemical crosslinks or biochemical Markers of Bone markers are unproven and not Turnover medically necessary to assess (continued) risk of fracture, predict bone loss, or assess response to antiresorptive therapy” Supporting Information • Updated Clinical Evidence and References sections to reflect the most current information Drug Coverage May 1, 2020 Coverage Rationale Refer to the policy for complete details on Drug Coverage Criteria – New and Criteria – New and • Revised list of medications Therapeutic Equivalent Medications. Therapeutic requiring precertification through Equivalent the pharmacy benefit manager Medications (PBM): o Added Arnuity Ellipta, Azeschew, Clobex 0.05% Spray (brand only), Firdapse, Flovent Diskus, Flovent HFA, Nexletol, Noxafil Tablets (brand only), Nurtec ODT, Pulmicort Flexhaler, Qmiiz ODT, Rapaflo (brand only), Trijardy XR, Vectical Ointment (brand only), Zalvit (prenatal vitamin), and Zerviate o Removed Divigel 1.25g, Ezallor Sprinkle, Ozempic, Slynd, Steglujan, and Toujeo Solostar o Revised formulary alternatives for Adhansia XR, ArmonAir RespiClick, Evekeo ODT, Jornay PM, and Tosymra

23 Oxford® Policy Update Bulletin: April 2020

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Apr. 1, 2020 Adakveo (Crizanlizumab- Updated • Updated list of applicable HCPCS codes to reflect quarterly code edits; Guidelines Tmca) replaced C9399 with C9053 Givlaari (Givosiran) Updated • Updated list of applicable HCPCS codes to reflect quarterly code edits; replaced C9399 with C9056 Ziextenzo (Pegfilgrastim- Updated • Updated list of applicable HCPCS codes to reflect quarterly code edits; Bmez) added C9058 Drug Coverage May 1, 2020 Adlyxin (Lixisenatide) Revised • Added language to indicate precertification is required through the Guidelines Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Arnuity Ellipta Revised • Added language to indicate precertification is required through the (Fluticasone Furoate) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Arikayce (Amikacin) Revised • Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Arikayce for complete details Avsola (Infliximab-Axxq) Revised • Revised precertification guidelines: o Added language to indicate: ▪ Precertification is required through Oxford’s Medical Management for all sites of service ▪ Administration of Avsola in a hospital outpatient facility (including any ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee; refer to Precertification Guidelines: Provider Administered Drugs - Site of Care for complete details o Removed reference link to the policy titled Precertification Guidelines: Review at Launch for New to Market Medications Ayvakit (Avapritinib) New • Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Ayvakit for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Azesco (13 Mg Iron-1 Removed • Removed coverage guidelines Guidelines Tablet Multivitamins) (continued) Basaglar (Insulin New • Added language to indicate precertification is required through the Glargine) Pharmacy Benefit Manager (PBM) • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: New and Therapeutic Equivalent Medications for complete details Bethkis (Tobramycin) Updated • Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Bethkis for complete details Bosulif (Bosutinib) Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Bosulif (Bosutinib) for complete details Bydureon (Exenatide) New • Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Bydureon Bcise New • Added language to indicate precertification is required through the (Exenatide) Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Byetta (Exenatide) New • Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Cayston (Aztreonam for Updated • Updated prior authorization/notification guidelines; refer to Prior Inhalation Solution) Authorization/Notification Guidelines: Cayston for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Cinqair (Reslizumab) Revised • Revised precertification guidelines; added language to indicate: Guidelines o The administration of Cinqair in a hospital outpatient facility (continued) (including any ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee; refer to Precertification Guidelines: Provider Administered Drugs - Site of Care for complete details Clobex 0.05% Spray New • Added language to indicate precertification is required through the (Brand Only) (Clobetasol Pharmacy Benefit Manager (PBM) Propionate) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Cuvitru [Immune Removed • Removed coverage guidelines Globulin Subcutaneous (Human)] Divigel 1.25g (Estradiol Revised • Revised coverage guidelines to indicate precertification is not required Gel) • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Drizalma (Duloxetine) Revised • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms for complete details Egrifta (Tesamorelin) Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Egrifta (Tesamorelin) for complete details Ezallor Sprinkle Revised • Added prior authorization/medical necessity guidelines; refer to Prior (Rosuvastatin) Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms for complete details • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications • Updated medication/drug name; added “Sprinkle” • Updated list applicable dosage of forms; replaced “tablet” with “capsule” Farxiga (Depagliflozin) Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Diabetes Medications SGLT2 Inhibitors (NJ) for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Fasenra (Benralizumab) Revised • Revised precertification guidelines; added language to indicate: Guidelines o The administration of Fasenra in a hospital outpatient facility (continued) (including any ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee; refer to Precertification Guidelines: Provider Administered Drugs - Site of Care for complete details Feraheme (Ferumoxytol) Updated • Updated reference link to reflect title change for Precertification Guidelines: Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & MonoferricTM) Firdapse Revised • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent (Amifampridine) Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Flebogamma (Immune Removed • Removed coverage guidelines Globulin Non- Lyophilized) Flovent Diskus, Flovent New • Added language to indicate precertification is required through the HFA (Fluticasone) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Gammagard® Liquid Removed • Removed coverage guidelines (Immunoglobulin, Non- Lyophilized) Gammaplex Removed • Removed coverage guidelines (Immunoglobulin, Non- Lyophilized) Gamunex-C, Gammaked Removed • Removed coverage guidelines (Immune Globulin, Non- Lyophilized) Gloperba (Colchicine) Revised • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms for complete details Glyxambi (Empagliflozin/ Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Linagliptin) Diabetes Medications SGLT2 Inhibitors (NJ) for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Hizentra (Immune Removed • Removed coverage guidelines Guidelines Globulin) (continued) Immune Globulin (IVIG Revised • Updated list of applicable codes; added CPT codes 90283 and 90284 and SCIG) Injectafer (Ferric Updated • Updated reference link to reflect title change for Precertification Carboxymaltose) Guidelines: Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & MonoferricTM) Invokana (Canagliflozin) Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Diabetes Medications SGLT2 Inhibitors (NJ) for complete details Janumet (Sitagliptin and Revised • Added prior authorization/medical necessity guidelines; refer to Prior Metformin Authorization/Medical Necessity Guidelines: New and Therapeutic Hydrochloride) Equivalent Medications for complete details Janumet XR (Sitagliptin Revised • Added prior authorization/medical necessity guidelines; refer to Prior and Metformin Authorization/Medical Necessity Guidelines: New and Therapeutic Hydrochloride, Extended Equivalent Medications for complete details Release) Januvia (Sitagliptin) Revised • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: New and Therapeutic Equivalent Medications for complete details Jardiance (Empagliflozin) Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Diabetes Medications SGLT2 Inhibitors (NJ) for complete details Kitabis Pak (Tobramycin) Updated • Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Kitabis Pak for complete details Lantus (Insulin Glargine) Revised • Revised coverage guidelines to indicate precertification is not required • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Prior Authorization/Medical Necessity Guidelines: New and Therapeutic Equivalent Medications Lantus Solostar (Insulin Revised • Revised coverage guidelines to indicate precertification is not required Glargine) • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Prior Authorization/Medical Necessity Guidelines: New and Therapeutic Equivalent Medications Levemir (Insulin Revised • Added language to indicate: Detemir) o Precertification is required through the Pharmacy Benefit Manager o Levemir may be excluded from coverage; refer to the member

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Levemir (Insulin Revised specific benefit plan document as applicable Guidelines Detemir) • Added prior authorization/notification guidelines; refer to Prior (continued) (continued) Authorization/Notification Guidelines: Levemir for complete details Lovaza (Brand Only) Revised • Removed therapeutic equivalent guidelines and corresponding reference (Omega-3-Acid Ethyl link to the policy titled Prior Authorization/Notification Guidelines: Lovaza Esters) Lovaza (Generic) Revised • Revised coverage guidelines to indicate precertification is not required (Omega-3-Acid Ethyl • Removed therapeutic equivalent guidelines and corresponding reference Esters) link to the policy titled Prior Authorization/Notification Guidelines: Lovaza Lynparza (Olaparib) Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Lynparza for complete details Monoferric (Ferric New • Added language to indicate coverage is provided under the medical Derisomaltose) benefit o Precertification is not required however it is strongly recommended o While no penalty will be imposed for failure to request a pre-service review, if one is not requested, a medical necessity review will be conducted post-service to determine coverage o It is the referring physician’s responsibility to provide medical documentation to demonstrate clinical necessity for the medication o Beginning Oct. 1, 2020, precertification will be required • Added precertification guidelines; refer to the following policies for complete details: o Precertification Guidelines: Intravenous Iron Replacement Therapy (Feraheme® & Injectafer®, & Monoferric®) o Precertification Guidelines: Review at Launch for New to Market Medications Nexletol (Bempedoic New • Added language to indicate precertification is required through the Acid) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Noxafil (Brand Only) Revised • Added language to indicate precertification is required through the (Posaconazole) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details • Updated medication/drug name; added “(Brand Only)”

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Nucala (Mepolizumab) Revised • Revised precertification guidelines; added language to indicate: Guidelines o The administration of Nucala in a hospital outpatient facility (continued) (including any ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee; refer to Precertification Guidelines: Provider Administered Drugs - Site of Care for complete details Nurtec ODT New • Added language to indicate precertification is required through the (Rimegepant) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Octagam (Immune Removed • Removed coverage guidelines Globulin, Non- Lyophilized) Oxervate (Cenegermin) Updated • Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Oxervate for complete details Ozempic (Semaglutide) Revised • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Ozobax (Baclofen) Revised • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms for complete details Qtern (Dapagliflozin/ Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Saxagliptin) Diabetes Medications SGLT2 Inhibitors (NJ) for complete details Panzyga Removed • Removed coverage guidelines (Immunoglobulin Intravenous, Human) Praluent (Alirocumab) Revised • Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Praluent (Alirocumab) for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Prenatal Vitamins Revised • Revised list of applicable drugs; added coverage guidelines for Guidelines Azeschew, Azesco, Trinaz, and Zalvit to indicate: (continued) o Precertification is required through the Pharmacy Benefit Manager (PBM); refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Privigen (Immune Removed • Removed coverage guidelines Globulin) Prograf Granules for Revised • Added language to indicate precertification is required through the Suspension (Tacrolimus) Pharmacy Benefit Manager (PBM) • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms for complete details Pulmicort Flexhaler Revised • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent (Budesonide) Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Pulmozyme® (Dornase Updated • Updated prior authorization/notification guidelines; refer to Prior Alfa) Authorization/Notification Guidelines: Pulmozyme (Dornase Alfa) for complete details Rapaflo (Brand Only) New • Added language to indicate precertification is required through the (Silodosin) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Repatha (Evolocumab) Revised • Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Repatha for complete details Rybelsus (Semaglutide) Revised • Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Segluromet (Ertugliflozin/ Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Metformin Hcl) Diabetes Medications SGLT2 Inhibitors (NJ) for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Slynd (Drospirenone) Revised • Added prior authorization/medical necessity guidelines; refer to Prior Guidelines Authorization/Medical Necessity Guidelines: Slynd for complete details (continued) • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Spravato (Esketamine) Updated • Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Spravato for complete details Steglatro (Ertugliflozin) Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Diabetes Medications SGLT2 Inhibitors (NJ) for complete details Steglujan (Ertugliflozin/ Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: Sitagliptin) Diabetes Medications SGLT2 Inhibitors (NJ) for complete details Tepezza New • Added language to indicate coverage is provided under the medical (Teprotumumab-Trbw) benefit o Precertification is not required however it is strongly recommended o While no penalty will be imposed for failure to request a pre-service review, if one is not requested, a medical necessity review will be conducted post-service to determine coverage o It is the referring physician’s responsibility to provide medical documentation to demonstrate clinical necessity for the medication o Beginning Oct. 1, 2020, precertification will be required • Added precertification guidelines; refer to the following policies for complete details: o Precertification Guidelines: Tepezza® (Teprotumumab-trbw) o Precertification Guidelines: Review at Launch for New to Market Medications Tirosint-Sol Oral Solution Revised • Added prior authorization/medical necessity guidelines; refer to Prior (Levothyroxine Sodium) Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms • Removed prior authorization/medical necessity guidelines and corresponding reference link to the policy titled Prior Authorization/Medical Necessity Guidelines: Tirosint Oral Solution • Updated medication/drug name; replaced “Tirosint Oral Solution” with “Tirosint-Sol Oral Solution” Tobi™ Nebulizer Solution Updated • Updated prior authorization/notification guidelines; refer to Prior (Tobramycin Inhalation Authorization/Notification Guidelines: TOBI for complete details Solution)

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Tobi® Podhaler™ Updated • Updated prior authorization/notification guidelines; refer to Prior Guidelines (Tobramycin Inhalation Authorization/Notification Guidelines: TOBI for complete details (continued) Powder) Tobramycin Nebulized Updated • Updated prior authorization/notification guidelines; refer to Prior Solution (Generic Tobi) Authorization/Notification Guidelines: Tobramycin Nebulized Solution for complete details Toujeo Solostar (Insulin Revised • Revised coverage guidelines to indicate precertification is not required Glargine) • Removed therapeutic equivalent guidelines and corresponding reference link to the policy titled Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Tresiba Flex Touch Revised • Added language to indicate precertification is required through the (Insulin Degludec) Pharmacy Benefit Manager (PBM) • Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: New and Therapeutic Equivalent Medications for complete details Trijardy XR New • Added language to indicate precertification is required through the (Empagliflozin/ Pharmacy Benefit Manager (PBM) Linagliptin/Metformin • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Hydrochloride) Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Trinaz (Prenatal Vitamin) Removed • Removed coverage guidelines Trulicity (Dulaglutide) Revised • Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Vascepa (Omega-3-Acid Revised • Added prior authorization/medical necessity guidelines; refer to Prior Ethyl Esters) Authorization/Medical Necessity Guidelines: Vascepa • Removed prior authorization/notification guidelines and corresponding reference link to the policy titled Prior Authorization/Notification Guidelines: Vascepa Vascepa 0.5 Gram Only Revised • Added prior authorization/medical necessity guidelines; refer to Prior (Omega-3-Acid Ethyl Authorization/Medical Necessity Guidelines: Vascepa Esters) • Removed prior authorization/notification guidelines and corresponding

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Vascepa 0.5 Gram Only Revised reference link to the policy titled Prior Authorization/Notification Guidelines (Omega-3-Acid Ethyl Guidelines: Vascepa (continued) Esters) (continued) Vectical Updated • Updated medication/drug name; added “(Generic)” (Calcitriol)(Generic) • Updated list of applicable dosage forms; replaced “topical” with “topical ointment” Vectical Ointment (Brand New • Added language to indicate precertification is required through the Only) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Victoza (Liraglutide) New • Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: GLP-1 Receptor Agonists (CT and NY) for complete details • Added step therapy guidelines; refer to Step Therapy Guidelines: GLP-1 Receptor Agonists (NJ) for complete details Vyepti (Eptinezumab- New • Added language to indicate coverage is provided under the medical JJMR) benefit o Precertification is not required however it is strongly recommended o While no penalty will be imposed for failure to request a pre-service review, if one is not requested, a medical necessity review will be conducted post-service to determine coverage o It is the referring physician’s responsibility to provide medical documentation to demonstrate clinical necessity for the medication o Beginning Oct. 1, 2020, precertification will be required • Added precertification guidelines; refer to the following policies for complete details: o Precertification Guidelines: VyeptiTM (Eptinezumab-JJMR) o Precertification Guidelines: Review at Launch for New to Market Medications Vyndamax (Tafamidis) Revised • Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Vyndamax for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Vyndaqel (Tafamidis Revised • Revised prior authorization/medical necessity guidelines; refer to Prior Guidelines Meglumine) Authorization/Medical Necessity Guidelines: Vyndaqel for complete (continued) details Xalkori (Crizotinib) Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xalkori for complete details Xeljanz (Tofacitinib) Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xeljanz for complete details • Revised step therapy guidelines; refer to Step Therapy Guidelines: Xeljanz for complete details Xeljanz XR Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xeljanz XR for complete details • Revised step therapy guidelines; refer to Step Therapy Guidelines: Xeljanz XR for complete details Xembify (Immune Removed • Removed coverage guidelines Globulin Subcutaneous, Human- Klhw) Xigduo XR (Dapagliflozin Updated • Updated step therapy guidelines; refer to Step Therapy Guidelines: and Metformin Hcl) Diabetes Medications SGLT2 Inhibitors (NJ) for complete details Xospata (Gilteritinib) Revised • Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xospata for complete details Yonsa (Abiraterone Revised • Revised prior authorization/notification guidelines; refer to Prior Acetate) Authorization/Notification Guidelines: Yonsa for complete details Zerviate (Cetirizine New • Added language to indicate precertification is required through the Ophthalmic Solution) Pharmacy Benefit Manager (PBM) • Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Ziextenzo (Pegfilgrastim- Revised • Revised coverage guidelines for provider administration; added notation Bmez) to indicate: o Precertification is required through Oxford’s Medical Management o Coverage is provided under the medical benefit Zomig and Zomig-ZMT Revised • Split entry from Zomig (Zolmitriptan) (Zolmitriptan) o Updated list of applicable dosage forms; removed “nasal spray” o Updated list of applicable HCPCS codes; removed J3590

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage May 1, 2020 Zomig (Zolmitriptan) Revised • Split entry from Zomig and Zomig-ZMT (Zolmitriptan) Guidelines o Updated list of applicable dosage forms; removed “tablet” (continued) o Updated list of applicable HCPCS codes; replaced J8499 and J3590 with J3490 • Added step therapy guidelines; refer to Step Therapy Guidelines: Zomig for complete details

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Entyvio® May 1, 2020 Coverage Rationale Entyvio (vedolizumab) is proven and medically necessary for the (Vedolizumab) • Revised coverage criteria for: treatment of: Crohn’s Disease – Initial Therapy Crohn's disease when all of the following criteria are met: o Updated list of medications • For initial therapy, all of the following: not to be received in o Diagnosis of moderately to severely active Crohn’s disease (CD); combination with Entyvio: and ▪ Replaced “tumor o One of the following: necrosis factor (TNF) ▪ History of failure, contraindication, or intolerance to at least one blocker [e.g., Humira of the following conventional therapies: (adalimumab), Cimzia - Tumor necrosis factor (TNF) blocker [e.g., Humira (certolizumab)]” with (adalimumab), Cimzia (certolizumab)] “biologic DMARD [e.g., - Immunomodulator (e.g., azathioprine, 6-mercaptopurine) infliximab, Humira - Corticosteroid (adalimumab), Cimzia ▪ Corticosteroid dependent (e.g., unable to successfully taper (certolizumab), Stelara corticosteroids without a return of the symptoms of CD) (ustekinumab)]” and ▪ Added “Janus kinase o Entyvio is initiated and titrated according to US Food and Drug inhibitor [e.g., Administration (FDA) labeled dosing for Crohn’s disease up to a Xeljanz/Xeljanz XR maximum of 300mg every 8 weeks (or equivalent dose and interval (tofacitinib)]” schedule); and Ulcerative Colitis – Initial o Patient is not receiving Entyvio in combination with any of the Therapy following: o Updated list of medications ▪ Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia not to be received in (certolizumab), Stelara (ustekinumab)] combination with Entyvio: ▪ Janus kinase inhibitor [e.g., Xeljanz/Xeljanz XR (tofacitinib)] ▪ Replaced “tumor ▪ Tysabri (natalizumab); and necrosis factor (TNF) o Initial authorization will be for no more than 14 weeks. blocker [e.g., Humira • For continuation of therapy, all of the following:

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Entyvio® May 1, 2020 (adalimumab), Simponi o Documentation of positive clinical response to Entyvio; and (Vedolizumab) (golimumab)]” with o Entyvio dosing for Crohn’s disease is in accordance with the FDA (continued) “biologic DMARD [e.g., labeled dosing up to a maximum of 300mg every 8 weeks (or infliximab, Humira equivalent dose and interval schedule); and (adalimumab), Simponi o Reauthorization will be for no more than 12 months. (golimumab), Stelara (ustekinumab)]” Ulcerative colitis when all of the following criteria are met: ▪ Added “Janus kinase • For initial therapy, all of the following: inhibitor [e.g., o Diagnosis of moderately to severely active ulcerative colitis (UC); Xeljanz/Xeljanz XR and (tofacitinib)]” o One of the following: Immune Checkpoint ▪ History of failure, contraindication, or intolerance to at least one Inhibitor-Related Toxicities of the following conventional therapies: o Replaced criterion requiring - Tumor necrosis factor (TNF) blocker [e.g., Humira “history of failure, (adalimumab), Simponi (golimumab)] contraindication, or - Immunomodulator (e.g., azathioprine, 6-mercaptopurine) intolerance to infliximab” - Corticosteroid with “one of the following: ▪ Corticosteroid dependent (e.g., unable to successfully taper history of failure, corticosteroids without a return of the symptoms of UC) contraindication, or and intolerance to infliximab, or o Entyvio is initiated and titrated according to US Food and Drug patient has immune-related Administration labeled dosing for ulcerative colitis up to a maximum hepatitis” of 300mg every 8 weeks (or equivalent dose and interval schedule); Supporting Information and • Updated Clinical Evidence and o Patient is not receiving Entyvio in combination with any of the References sections to reflect following: the most current information ▪ Biologic DMARD [e.g., infliximab, Humira (adalimumab), Simponi (golimumab), Stelara (ustekinumab)] ▪ Janus kinase inhibitor [e.g., Xeljanz/Xeljanz XR (tofacitinib)] ▪ Tysabri (natalizumab); and o Initial authorization will be for no more than 14 weeks. • For continuation of 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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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Entyvio® May 1, 2020 Immune checkpoint inhibitor-related toxicities when all of the (Vedolizumab) following criteria are met for initial and continuation of therapy: (continued) • Diagnosis of severe (G3-4) immunotherapy-related diarrhea or colitis; and • Patient is receiving a checkpoint inhibitor [e.g., Keytruda (pembrolizumab), Opdivo (nivolumab)]; and • One of the following: o History of failure, contraindication, or intolerance to infliximab o Patient has immune-related hepatitis and • Authorization will be for no more than 3 doses of Entyvio. Epidural Steroid May 1, 2020 Coverage Rationale Note: This policy addresses Epidural Steroid Injections (ESI) of the lumbar and Facet • Replaced language indicating spine only. The policy does not address Epidural Steroid Injections of the Injections for “Diagnostic Facet Joint Injection cervical or thoracic spine, nor does it address injections for obstetrical or Spinal Pain (FJI) and/or facet nerve block surgical anesthetic. The policy addresses Facet Joint Injections of multiple (i.e., medial branch block) to sites and is not limited to Facet Joint Injections of the lumbar spine. localize the source of pain to the facet joint in persons with spinal The following are proven and medically necessary: pain” with “Diagnostic Facet • Epidural Steroid Injections (ESI) for treating lumbar radicular pain Joint Injection (FJI) and/or facet caused by spinal stenosis, disc herniation, degenerative changes in the nerve block (i.e., medical branch vertebrae or for the short-term management of low back pain when the block) to localize the level of following criteria are met: facet joint pain in persons with o The pain is associated with symptoms of nerve root irritation and/or pain suspected to originate from low back pain due to disc extrusions and/or contained herniations; a facet joint as based on clinical and exam” • The pain is unresponsive to Conservative Treatment, including but not • Updated list of Epidural Steroid limited to pharmacotherapy, exercise or physical therapy. Injection Limitations; simplified • Diagnostic Facet Joint Injection (FJI) and/or Facet Nerve Block (i.e., language pertaining to injection medical branch block) to localize the level of facet joint pain in persons maximums (no change to intent) with pain suspected to originate from a facet joint as based on clinical Applicable Codes exam. • Updated list of applicable ICD-10 diagnosis codes for Epidural; The following are unproven and not medically necessary due to added G57.03, G57.73, G57.83, insufficient evidence of efficacy: and G57.93 • The use of ultrasound guidance for ESIs and FJIs Supporting Information • ESI for ALL other indications of the lumbar spine not included above • Updated Clinical Evidence and • Therapeutic Facet Joint Injection (FJI) and/or Facet Nerve Block (i.e. Medial Branch Block) for treating chronic spinal pain References sections to reflect

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Epidural Steroid May 1, 2020 the most current information Epidural Steroid Injection Limitations: and Facet • A maximum of three (3) ESI (regardless of level, location, or side) in a Injections for year when criteria (indications for coverage) are met for each injection. Spinal Pain • A session is defined as one date of service in which ESI injections are (continued) performed. • A year is defined as the 12-month period starting from the date of service of the first approved injection. Givlaari® Jul. 1, 2020 Conditions of Coverage Givlaari is proven and/or medically necessary for the treatment of (Givosiran) • Revised precertification acute hepatic porphyrias: guidelines to indicate precertification with Medical Initial Therapy Director review is required • Diagnosis of an acute hepatic porphyria (AHP) [i.e., acute intermittent Coverage Rationale porphyria, hereditary coproporphyria, variegate porphyria, ALA • Removed reference link to the dehydratase deficient porphyria]; and Clinical Policy titled Review at • One of the following: Launch for New to Market o Patient has active disease as defined in the clinical trial by having at Medications for Givlaari (prior least 2 documented porphyria attacks within the past 6 months; or authorization requirements apply o Patient is currently receiving treatment with prophylactic hemin to Jul. 1, 2020) prevent porphyria attacks and • Provider attestation that the patient’s baseline (before givosiran is initiated) hemin administration requirements (prophylactic or treatment) and rate and/or number of porphyria attacks has been documented; and • Patient has not had a liver transplant; and • Patient will not receive concomitant prophylactic hemin treatment while on Givlaari; and • Prescribed by, or in consultation with, a hematologist, or a specialist with expertise in the diagnosis and management of AHPs; and • Givlaari dosing is in accordance with the United States Food and Drug Administration approved labeling: up to a maximum of 2.5 mg/kg (body weight) subcutaneously once monthly; and • Initial authorization will be for no more than 6 months

Continuation Therapy • Patient has previously received Givlaari for the treatment of AHP; and • Documentation that the patient has experienced a positive clinical response while on Givlaari by demonstrating all of the following from pre-treatment baseline:

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Givlaari® Jul. 1, 2020 o Reduction in hemin administration requirements (if previously (Givosiran) required, including prophylactic and/or treatment doses) (continued) o Reduction in the rate and/or number of porphyria attacks o Improvement of signs and symptoms of AHPs (e.g., pain, neurological, gastrointestinal, renal, quality of life, etc.) and • Patient has not had a liver transplant; and • Patient will not receive concomitant prophylactic hemin treatment while on Givlaari; and • Prescribed by, or in consultation with, a hematologist, or a specialist with expertise in the diagnosis and management of AHPs; and • Givlaari dosing is in accordance with the United States Food and Drug Administration approved labeling: up to a maximum of 2.5 mg/kg (body weight) subcutaneously once monthly; and • Reauthorization will be for no more than 12 months Glaucoma Surgical Jun. 1, 2020 Coverage Rationale The following are proven and medically necessary: Treatments • Revised list of proven and • Canaloplasty (ab externo) for treating primary open-angle glaucoma medically necessary indications; • Glaucoma drainage devices for treating refractory glaucoma when replaced “canaloplasty for medical or surgical treatments have failed or are inappropriate treating primary open-angle • iStent®, iStent inject®, and the Hydrus® Microstent when used in glaucoma” with “canaloplasty combination with cataract surgery for treating mild to moderate open- (ab externo) for treating primary angle glaucoma and a cataract in adults currently being treated with open-angle glaucoma” ocular hypotensive medication • Revised list of unproven and not medically necessary indications: The following are unproven and not medically necessary for treating o Added: any type of glaucoma due to insufficient evidence of efficacy and/or ▪ Canaloplasty (ab safety: interno) • Canaloplasty (ab interno) ▪ Gonioscopy-Assisted • Glaucoma drainage devices that are not FDA approved Transluminal • Gonioscopy-Assisted Transluminal Trabeculotomy Trabeculotomy • Viscocanalostomy o Removed: • XEN® Glaucoma Treatment System ▪ CyPass® Micro-Stent System Applicable Codes • Added CPT code 66185 • Removed CPT code 66170 Supporting Information

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Glaucoma Surgical Jun. 1, 2020 • Updated Description of Services, Treatments Clinical Evidence, and (continued) References sections to reflect the most current information Gonadotropin May 1, 2020 Coverage Rationale Refer to the Clinical Policy titled Injectable Chemotherapy Drugs: Application Releasing Hormone • Added language to indicate: of NCCN Clinical Practice Guidelines for updated information based on the Analogs o Vantas is proven for the National Comprehensive Cancer Network (NCCN) Drugs & Biologics treatment of central Compendium® (NCCN Compendium®) for oncology indications. precocious puberty o Vantas is medically This policy refers to the following gonadotropin releasing hormone analog necessary for the treatment (GnRH analog) drug products: of central precocious puberty • Firmagon (degarelix) when all of the [listed] • Lupaneta Pack (leuprolide acetate injection & norethindrone acetate criteria are met tablets) o Vantas treatment should be • Lupron Depot (leuprolide acetate) discontinued at the • Lupron Depot-Ped (leuprolide acetate) appropriate age of onset of • Supprelin LA (histrelin acetate) puberty at the discretion of • Trelstar (triptorelin pamoate) the physician; give • Triptodur (triptorelin) consideration to • Vantas (histrelin acetate) discontinuing treatment • Zoladex (goserelin acetate) before 11 years of age in girls and 12 years of age in For the coverage criteria below, in absence of specified drug products, the boys term “GnRH analogs” will be used in this policy where the coverage criteria Supporting Information apply to all products listed above. • Updated References section to reflect the most current Covered Indications information Central Precocious Puberty (Lupron Depot-Ped, Supprelin LA, Triptodur, Vantas) Lupron Depot-Ped, Supprelin LA, Triptodur, and Vantas are proven for the treatment of central precocious puberty.

Lupron Depot-Ped, Supprelin LA, Triptodur, and Vantas are medically necessary for the treatment of central precocious puberty when ALL of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of central precocious puberty (idiopathic or neurogenic); and

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Gonadotropin May 1, 2020 o Onset of secondary sexual characteristics in one of the following: Releasing Hormone ▪ Females ≤ 8 years of age Analogs ▪ Males ≤9 years of age (continued) and o Confirmation of diagnosis as defined by one of the following: ▪ Pubertal basal level of luteinizing hormone (based on laboratory reference ranges) ▪ Pubertal luteinizing hormone response to a GnRH stimulation test ▪ Bone age advanced one year beyond the chronological age o Initial authorization will be for no more than 12 months. • For continuation of therapy, all of the following: o Patient is currently receiving therapy for central precocious puberty; and o Documentation of positive clinical response to therapy; and o Patient is currently younger than the appropriate time point for the onset of puberty, for example: ▪ Females younger than 11 years of age ▪ Males younger than 12 years of age o Reauthorization will be for no more than 12 months.

Lupron Depot-Ped, Supprelin LA, Triptodur, or Vantas treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.1 Give consideration to discontinuing treatment before 11 years of age in girls and 12 years of age in boys.

Refer to the policy for complete details on the coverage guidelines for Gonadotropin Releasing Hormone Analogs. Infertility Diagnosis Jun. 1, 2020 Coverage Rationale For medical necessity reviews, refer to the Clinical Guideline titled and Treatment • Added language to indicate Fertility Solutions Medical Necessity Clinical Guideline: Infertility. treatments to improve uterine/endometrial receptivity The following tests or procedures are proven and medically (e.g., immunotherapy, necessary for diagnosing or treating Infertility: endometrial scratching, uterine • Antisperm antibodies artery vasodilation) are • Antral follicle count unproven and not medically • Clomiphene citrate challenge test necessary • Cryopreservation of sperm, semen, or embryos for individuals who are Supporting Information undergoing treatment with assisted reproductive technologies or are • Updated Clinical Evidence and planning to undergo therapies that threaten their reproductive health,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infertility Diagnosis Jun. 1, 2020 References sections to reflect such as cancer chemotherapy and Treatment the most current information • Cryopreservation of mature oocytes (eggs) for women under the age of (continued) 42 who are undergoing treatment with assisted reproductive technologies or are planning to undergo therapies that threaten their reproductive health, such as cancer chemotherapy • Genetic screening tests o Cystic fibrosis gene mutations o Karyotyping for chromosomal abnormalities o Y-chromosome microdeletion testing • Hormone level tests: o Antimüllerian hormone (AMH) o Estradiol o Follicle-stimulating hormone (FSH) o Luteinizing hormone (LH) o Progesterone o Prolactin o Testosterone (total and free) o Thyroid-stimulating hormone (TSH) • Hysterosalpingogram (HSG) • Diagnostic hysteroscopy • Diagnostic laparoscopy with or without chromotubation • Leukocyte count in semen • Pelvic ultrasound (transabdominal or transvaginal) • Post-ejaculatory urinalysis • Scrotal, testicular or transrectal ultrasound • Semen analysis • Sonohysterogram or saline infusion ultrasound • Testicular biopsy • Vasography

Due to insufficient evidence of efficacy, the following are unproven and not medically necessary for diagnosing or treating Infertility: • Co-culture of embryos • Computer-assisted sperm analysis (CASA) • Cryopreservation of immature oocytes (eggs), ovarian tissue, or testicular tissue • EmbryoGlue® • Hyaluronan binding assay (HBA)

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Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infertility Diagnosis Jun. 1, 2020 • In vitro maturation (IVM) of oocytes and Treatment • Inhibin B (continued) • Postcoital cervical mucus penetration test • Reactive oxygen species (ROS) test • Sperm acrosome reaction test • Sperm DNA integrity/fragmentation tests (e.g., sperm chromatin structure assay (SCSA), single-cell gel electrophoresis assay (Comet), deoxynucleotidyl transferase-mediated dUTP nick end labeling assay (TUNEL), sperm chromatin dispersion (SCD) or Sperm DNA Decondensation™ Test (SDD)) • Sperm penetration assays • Uterine/endometrial receptivity testing • Treatments to improve uterine/endometrial receptivity (e.g., immunotherapy, endometrial scratching, uterine artery vasodilation Intravenous Iron May 1, 2020 Title Change Monoferric has been added to the Review at Launch program. Some Replacement • Previously titled Intravenous members may not be eligible for coverage of this medication at this time. Therapy Iron Replacement Therapy Refer to the Clinical Policy titled Review at Launch for New to Market (Feraheme®, (Feraheme® & Injectafer®) Medications for additional details. Injectafer®, & Conditions of Coverage Monoferric®) • Replaced language indicating This policy refers to the following intravenous iron replacements: “home infusion of Feraheme and • Feraheme® (ferumoxytol) Injectafer requires additional • Injectafer® (ferric carboxymaltose) precertification for the home • Monoferric® (ferric derisomaltose) care services” with “home infusion of intravenous iron The following intravenous iron replacements are not subject to the replacement therapy requires coverage criteria in this section: additional precertification for the • Ferrlecit® (sodium ferric gluconate complex) home care services” • Infed® (iron dextran) • Added language to indicate: • Venofer® (iron sucrose). o New Jersey Small group plan members should refer to Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and their Certificate of Coverage Monoferric (ferric derisomaltose) are proven for the following for precertification and indications: quantity limit guidelines o Precertification is not Iron Deficiency Anemia (IDA) Without Chronic Kidney Disease (CKD) required, however it is Feraheme, Injectafer, and Monoferric are medically necessary when strongly recommended for the following criteria are met: Monoferric

44 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Iron May 1, 2020 ▪ While no penalty will be Initial Therapy Replacement imposed for failure to • Submission of medical records (e.g., lab values, chart notes, etc.) Therapy request a pre-service supporting the diagnosis of IDA; and ® (Feraheme , review, if one is not • Patient does not have CKD; and ® Injectafer , & requested, a medical • History of failure, contraindication, or intolerance, to oral iron therapy; ® Monoferric ) necessity review will be and (continued) conducted post-service • One of the following: to determine coverage o Both of the following: ▪ It is the referring ▪ Submission of laboratory values demonstrating treatment failure physician’s responsibility after at least 3 weeks of therapy, to at least two of the following to provide medical intravenous iron therapies each (Note: Laboratory values should documentation to be obtained within 1 to 3 weeks following the last dose of demonstrate clinical intravenous iron in a treatment course): necessity for the - Infed® (iron dextran) medication - Ferrlecit® (sodium ferric gluconate complex) ▪ As of Oct. 1, 2020, - Venofer® (iron sucrose) precertification will be and required ▪ Physician attests that in their clinical opinion, the clinical Coverage Rationale response would be expected to be superior with Feraheme or • Revised list of applicable Injectafer, than experienced with the other products intravenous iron replacements; or ® added “Monoferric (ferric o Both of the following: derisomaltose)” ▪ History of intolerance, contraindication, or severe adverse event, • Added language to indicate: to all of the following intravenous iron therapies not previously o Monoferric has been added tried and experienced treatment failure: to the Review at Launch - Infed® (iron dextran) program - Ferrlecit® (sodium ferric gluconate complex) ▪ Some members may not - Venofer® (iron sucrose) be eligible for coverage and of this medication at this ▪ Physician attests that in their clinical opinion, the same time intolerance, contraindication, or severe adverse event would not ▪ Refer to the Clinical be expected to occur with Feraheme or Injectafer, than Policy titled Review at experienced with the other products Launch for New to and Market Medications for • One of the following: additional details o Feraheme dose does not exceed 510 mg elemental iron per dose and o Monoferric (ferric 2.04g elemental iron per course; or derisomaltose) is proven for: o Injectafer dose does not exceed 750 mg elemental iron per dose and

45 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Iron May 1, 2020 ▪ Iron Deficiency Anemia 1500mg elemental iron per course Replacement (IDA) without Chronic and Therapy Kidney Disease (CKD) • Initial authorization will be for no longer than 3 months. (Feraheme®, ▪ Iron Deficiency Anemia Injectafer®, & (IDA) associated with Continuation of Therapy Monoferric®) Chronic Kidney Disease • Coverage has previously been provided by United Healthcare Oxford for (continued) (CKD), without end Feraheme or Injectafer for the treatment of IDA; and stage renal disease • Submission of recent laboratory results (within the past 4 weeks) since (ESRD) the last Feraheme or Injectafer administration to demonstrate need for o Monoferric is medically additional therapy; and necessary when the [listed] • Patient does not have CKD; and criteria are met • One of the following: Applicable Codes o Feraheme dose does not exceed 510 mg elemental iron per dose and • Added HCPCS codes C9399 and 2.04g elemental iron per course; or J3490 o Injectafer dose does not exceed 750 mg elemental iron per dose and Supporting Information 1500mg elemental iron per course • Updated FDA and References and sections to reflect the most • Continuation authorization will be for no longer than 3 months. current information Iron Deficiency Anemia (IDA) Associated With Chronic Kidney Disease (CKD), without End Stage Renal Disease (ESRD) Feraheme, Injectafer, and Monoferric are medically necessary when the following criteria are met:

Initial Therapy

• Diagnosis of IDA and CKD; and • Submission of medical records (e.g., lab values, chart notes, etc.) supporting the diagnosis of IDA; and • Patient does not have ESRD; and • One of the following: o Patient’s CKD requires hemodialysis or peritoneal dialysis treatment; or o Both of the following: ▪ Patient’s CKD does not require hemodialysis or peritoneal dialysis treatment; and ▪ History of failure, contraindication, or intolerance, to oral iron therapy and

46 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Iron May 1, 2020 • One of the following: Replacement o Both of the following: Therapy ▪ Submission of laboratory values demonstrating treatment failure (Feraheme®, after at least 3 weeks of therapy, to at least two of the following Injectafer®, & intravenous iron therapies each (Note: Laboratory values should Monoferric®) be obtained within 1 to 3 weeks following the last dose of (continued) intravenous iron in a treatment course): - Infed® (iron dextran) - Ferrlecit® (sodium ferric gluconate complex) - Venofer® (iron sucrose) and ▪ Physician attests that in their clinical opinion, the clinical response would be expected to be superior with Feraheme or Injectafer, than experienced with the other products or o Both of the following: ▪ History of intolerance, contraindication, or severe adverse event, to all of the following intravenous iron therapies not previously tried and experienced treatment failure: - Infed® (iron dextran) - Ferrlecit® (sodium ferric gluconate complex) - Venofer® (iron sucrose) and ▪ Physician attests that in their clinical opinion, the same intolerance, contraindication, or severe adverse event would not be expected to occur with Feraheme or Injectafer, than experienced with the other products and • One of the following: o Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or o Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and • Initial authorization will be for no longer than 3 months.

Continuation of Therapy

• Coverage has previously been provided by UnitedHealthcare Oxford for

47 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Iron May 1, 2020 Feraheme or Injectafer for the treatment of IDA with CKD; and Replacement • Patient does not have ESRD; and Therapy • Submission of recent laboratory results (within the past 4 weeks) since (Feraheme®, the last Feraheme or Injectafer administration to demonstrate need for Injectafer®, & additional therapy; and Monoferric®) • One of the following: (continued) o Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or o Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and • Continuation authorization will be for no longer than 3 months. Lemtrada May 1, 2020 Template Update Lemtrada (alemtuzumab) is proven and medically necessary for (Alemtuzumab) • Relocated Background and FDA treatment of relapsing forms of multiple sclerosis when ALL of the sections following criteria are met: Conditions of Coverage • Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing- • Added language to indicate: remitting MS, secondary-progressive MS with relapses, progressive- o New Jersey Small group relapsing MS with relapses); and plan members should refer • One of the following: to their Certificate of o Treatment-naïve to alemtuzumab: Coverage for precertification ▪ Member has history of failure following a trial for at least 4 and quantity limit guidelines weeks or history of intolerance to at least two of the following: o Participating providers in - interferon β-1a (Avonex® or Rebif®)) the office setting: - interferon β-1b (Betaseron® or Extavia®) Precertification is required - glatiramer acetate (Copaxone® or Glatopa®) for services performed in the - dimethyl fumarate (Tecfidera®) office of a participating - teriflunomide (Aubagio®) provider - fingolimod (Gilenya®) o Non-participating/out-of- - peginterferon beta-1a (Plegridy™) network providers in the - natalizumab (Tysabri®) office setting: - ocrelizumab (Ocrevus®) Precertification is not - rituximab (Ruxience™, Rituxan®) required, but encouraged for and out-of-network services ▪ Member has not been previously treated with alemtuzumab; performed in the office; if and precertification is not ▪ Member is not receiving alemtuzumab in combination with obtained, Oxford will review another disease modifying agent for multiple sclerosis (e.g., for out-of-network benefits interferon beta preparations, glatiramer acetate, natalizumab,

48 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Lemtrada May 1, 2020 and medical necessity after fingolimod, teriflunomide, ocrelizumab, etc.); and (Alemtuzumab) the service is rendered ▪ Initial dosing is administered: 12 mg intravenously daily for 5 (continued) o Home infusion of Lemtrada consecutive days; and requires precertification for ▪ Regimen is administered only once within 12 months; and the home care services ▪ Initial authorization is for no more than 12 months Coverage Rationale or • Revised coverage criteria for o Treatment-experienced with alemtuzumab: patients who are treatment- ▪ Member has previously received treatment with alemtuzumab; naïve to alemtuzumab; and updated list of medications ▪ Documentation of positive clinical response to alemtuzumab requiring history of trial and therapy; and failure or intolerance to include ▪ Member is not receiving alemtuzumab in combination with “rituximab (Ruxience™, another disease modifying agent for multiple sclerosis (e.g., Rituxan®)” interferon beta preparations, glatiramer acetate, natalizumab, Supporting Information fingolimod, teriflunomide, ocrelizumab, etc.); and • Updated References section to ▪ Retreatment dosing is administered: 12 mg intravenously daily reflect the most current for 3 consecutive days; and information ▪ Regimen is administered only once within 12 months; and ▪ Authorization is for no more than 12 months

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 Manipulation Under May 1, 2020 Coverage Rationale Manipulation under anesthesia (MUA) is proven and medically Anesthesia • Removed language indicating necessary for: manipulation under anesthesia • Knee joint for arthrofibrosis following total knee arthroplasty, knee (MUA) is proven and medically surgery, or fracture necessary for: • Shoulder joint for adhesive capsulitis (frozen shoulder) o Elbow joint for arthrofibrosis following elbow surgery or MUA is unproven and not medically necessary for all other conditions fracture (whether for single or serial manipulations) including but not limited o Pelvis for acute traumatic to the following, due to insufficient evidence of efficacy:

49 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Manipulation Under May 1, 2020 fracture or dislocation • Ankle Anesthesia • Revised list of conditions for • Finger (continued) which MUA is unproven and not • Hip joint or adhesive capsulitis of the hip medically necessary; replaced • Knee joint - any condition other than for arthrofibrosis following total “pelvis for diastasis or knee arthroplasty, knee surgery, or fracture subluxation” with “pelvis” • Pelvis • Added language to indicate this • Shoulder - any condition other than adhesive capsulitis (frozen shoulder) policy does not apply to MUA for • Spine elbow joint for arthrofibrosis • Temporomandibular joint (TMJ) following elbow surgery or • Toe fracture • Wrist Definitions • Added definition of This policy does not apply to the following: “Arthrofibrosis” • Manipulation of the finger on the day following the injection of ® Applicable Codes collagenase clostridium histolyticum (Xiaflex ) to treat Dupuytren's • Removed CPT code 24300 contracture. • Removed ICD-10 diagnosis • Closed reduction of a fracture or joint dislocation unless specified codes M24.621, M24.622, and • Elbow joint for arthrofibrosis following elbow surgery or fracture M24.629 Supporting Information • Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information Radicava® May 1, 2020 Template Update Radicava (edaravone) is proven and medically necessary for1 the (Edaravone) • Removed Documentation treatment of amyotrophic lateral sclerosis (ALS) in patients who Requirements section meet all of the following criteria: Conditions of Coverage • For initial therapy, all of the following: • Revised applicable sites of o Submission of medical records (e.g., chart notes, previous medical service; replaced “all” with history, diagnostic testing including: imaging, nerve conduction “office, outpatient, and home” studies, laboratory values) to support 14 the diagnosis of “definite” or • Added language to indicate: “probable” ALS per the El Escorial/revised Airlie House diagnostic o New Jersey Small group plan criteria, and prescribed by, or in consultation with, a neurologist with members should refer to expertise in the diagnosis of ALS; and their Certificate of Coverage o Submission of the most recent ALS Functional Rating Scale-Revised for precertification and (ALSFRS-R) score confirming that the patient has scores ≥ 2 in all quantity limit guidelines items of the ALSFRS-R criteria at the start of treatment13; and

50 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Radicava® May 1, 2020 o Home infusion of Radicava o Submission of medical records (e.g., chart notes, laboratory values) (Edaravone) requires precertification for confirming that the patient has a % forced vital capacity (%FVC) ≥ (continued) the home care services 80% at the start of treatment13; and Supporting Information o Radicava dosing for ALS is in accordance with the United States Food • Updated References section to and Drug Administration approved labeling; and reflect the most current o Initial authorization will be for no more than 6 cycles (64 doses over information 168 days). • For continuation therapy, all of the following: o Diagnosis of “definite” or “probable” ALS per the El Escorial/revised Airlie House diagnostic criteria, and prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; and o Patient is currently receiving Radicava therapy; and o Patient is not dependent on invasive ventilation or tracheostomy; and o Radicava dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling; and o Authorization will be for no more than 6 cycles (60 doses over 168 days). Reblozyl® Jul. 1, 2020 Conditions of Coverage Reblozyl is proven and/or medically necessary for the treatment of (Luspatercept- • Revised precertification anemia in adult patients with beta thalassemia who meet ALL of the Aamt) guidelines to indicate following criteria: precertification with Medical Director review is required Initial Therapy Coverage Rationale • Diagnosis of beta thalassemia including beta+ thalassemia, beta0 • Removed reference link to the thalassemia, and hemoglobin E/beta thalassemia; and Clinical Policy titled Review at • Patient is 18 years of age or older; and Launch for New to Market • Patient is transfusion dependent as evidenced by both of the following in Medications for Reblozyl (prior the previous 24 weeks: authorization requirements apply o Has required regular transfusion of at least six units of packed red Jul. 1, 2020) blood cells (PRBC); and o No transfusion free period greater than 35 days and • Reblozyl is prescribed by, or in consultation with, a hematologist, or other specialist with expertise in the diagnosis and management of beta thalassemia; and Reblozyl dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling: starting dose of 1 mg/kg every 3 weeks by subcutaneous injection, with maximum dose of 1.25 mg/kg

51 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Reblozyl® Jul. 1, 2020 every 3 weeks; and (Luspatercept- • Initial authorization will be for no more than 6 months Aamt) (continued) Continuation Therapy • Diagnosis of beta thalassemia including beta+ thalassemia, beta0 thalassemia, and hemoglobin E/beta thalassemia; and • Reblozyl is prescribed by, or in consultation with, a hematologist, or other specialist with expertise in the diagnosis and management of beta thalassemia;and • Patient has experienced a reduction in transfusion requirements from pretreatment baseline of at least 2 units PRBC while receiving Reblozyl; and • Reblozyl dosing is in accordance with the FDA approved labeling: starting dose of 1 mg/kg every 3 weeks by subcutaneous injection, with maximum dose of 1.25 mg/kg every 3 weeks; and • Reauthorization will be for no more than 12 months

Reblozyl is not proven or medically necessary for the treatment of: • Alpha thalassemia • Beta thalassemia in pediatric patients • Myelodisplastic syndromes with or without ring siderobalsts • Myeloproliferative neoplasm (mpn)-associated myelofibrosis • Non-transfusion dependent beta thalassemia • Sickle beta thalassemia (hemoglobin s [hbs]/beta thalassemia) Respiratory May 1, 2020 Template Update This policy provides information about the use of certain specialty pharmacy Interleukins • Relocated Background and FDA medications administered by either the subcutaneous (SC) or intravenous (Cinqair®, sections (IV) route. Fasenra®, & Conditions of Coverage Nucala®) • Added language to indicate This policy refers to the following drug products: administration of Cinqair, • Cinqair® (reslizumab) Fasenra, and Nucala in a • Fasenra® (benralizumab) hospital outpatient facility • Nucala® (mepolizumab) (including any ambulatory infusion suite associated with Refer to the policy for complete details on the coverage guidelines for the hospital) requires Respiratory Interleukins (Cinqair®, Fasenra®, & Nucala®). precertification with review by a Medical Director or their designee; refer to the Clinical

52 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Respiratory May 1, 2020 Policy titled Provider Interleukins Administered Drugs – Site of (Cinqair®, Care Fasenra®, & Coverage Rationale Nucala®) • Replaced references to (continued) “Fasenra/Nucala for subcutaneous use” with “Fasenra/Nucala for provider administration” • Added language to clarify Fasenra/Nucala for provider administration is medically necessary when criteria are met • Revised coverage criteria for: Eosinophilic Granulomatosis with Polyangiitis (EGPA) Nucala o Removed criterion for initial

therapy requiring one of the

following values at

diagnosis: ▪ Blood eosinophil level of at least 10% of leucocytes

▪ Absolute eosinophil

count > 1,000 cells/µL

o Updated list of

characteristics typical of EGPA; replaced “alveolar hemorrhage (by bronchoalveolar lavage)”

with “alveolar hemorrhage”

o Added criterion requiring

documentation to support one of the following: ▪ For initial therapy: Patient is new to therapy with Nucala and requires

53 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Respiratory May 1, 2020 initial dose to be directly Interleukins monitored by a (Cinqair®, healthcare professional Fasenra®, & before continued self- Nucala®) administration (note: (continued) authorization will be for 1 dose) ▪ For initial and continuation of therapy: - Physician attestation that the patient or caregiver is not competent or is physically unable to administer the Nucala product FDA labeled for self- administration - Patient has experienced severe hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, or hypotension) to Nucala within the past 6 months and requires administration and direct monitoring by a healthcare professional Severe Asthma All Respiratory Interleukins (Cinqair, Fasenra, and Nucala) o Added criterion for initial

54 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Respiratory May 1, 2020 therapy requiring patient is Interleukins currently dependent on (Cinqair®, maintenance therapy with Fasenra®, & oral corticosteroids for the Nucala®) treatment of asthma (continued) o Updated list of combination inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) products: ▪ Replaced “Advair” with “Advair/AirDue Respiclick” ▪ Added “Breo Ellipta (fluticasone furoate/vilanterol)” Cinqair o Added criterion for initial and continuation of therapy requiring one of the following: ▪ History of failure to a 4 month trial of Fasenra or Nucala ▪ Contraindication or intolerance to Fasenra or Nucala Fasenra and Nucala o Added criterion requiring documentation to support one of the following: ▪ For initial therapy: Patient is new to therapy with Fasenra/Nucala and requires initial dose to be directly monitored by a healthcare professional before continued self- administration (note:

55 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Respiratory May 1, 2020 authorization will be for Interleukins 1 dose) (Cinqair®, ▪ For initial and Fasenra®, & continuation of Nucala®) therapy: (continued) - Physician attestation that the patient or caregiver is not competent or is physically unable to administer the Fasenra/Nucala product FDA labeled for self- administration - Patient has experienced severe hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, or hypotension) to Fasenra/Nucala within the past 6 months and requires administration and direct monitoring by a healthcare professional Applicable Codes • Added list of national drug codes (NDCs) associated with HCPCS code: o J0517: Added NDCs 00310- 1730-30 and 00310-1830- 30 o J2182: Added NDCs 00173-

56 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Respiratory May 1, 2020 0881-01, 00173-0892-01, Interleukins and 00173-0892-42 (Cinqair®, o J2786: Added NDC 59310- Fasenra®, & 0610-31 Nucala®) Supporting Information (continued) • Updated Clinical Evidence, FDA, and References sections to reflect the most current information Simponi Aria® May 1, 2020 Template Update This policy refers only to Simponi Aria (golimumab) injection for intravenous (Golimumab) • Relocated Background and FDA infusion. Simponi for self-administered subcutaneous injection is obtained Injection for sections under the pharmacy benefit. Intravenous Conditions of Coverage Infusion • Added language to indicate: Simponi Aria is proven and/or medically necessary for the treatment o New Jersey Small group plan of: members should refer to their Certificate of Coverage • Ankylosing spondylitis when all of the following criteria are met: for precertification and For initial therapy, all of the following: quantity limit guidelines o Diagnosis of active ankylosing spondylitis (AS); and o Home infusion of Simponi o Simponi Aria is initiated and titrated according to US Food and Drug Aria requires precertification Administration labeled dosing for ankylosing spondylitis, up to a for the home care services maximum of 2mg/kg at weeks 0 and 4 upon initiation of therapy, Coverage Rationale then 2 mg/kg every 8 weeks (or equivalent dose and interval schedule); and Ankylosing Spondylitis, Psoriatic o Arthritis, and Rheumatoid Patient is not receiving Simponi Aria in combination with either of Arthritis the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g., • Added language to indicate ▪ Enbrel (etanercept), Humira (adalimumab), Cimzia authorization for initial therapy (certolizumab), Orencia (abatacept)] or continuation of therapy will ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] be issued for no more than 12 and months o Initial authorization is for no more than 12 months • Revised coverage criteria for continuation of therapy; added criterion requiring For continuation therapy, all of the following: o Patient has previously received Simponi Aria injection for intravenous “patient has previously received infusion; and Simponi Aria injection for o Documentation of positive clinical response to Simponi Aria; and intravenous infusion” o Simponi Aria dosing for ankylosing spondylitis is in accordance with

57 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Simponi Aria® May 1, 2020 Supporting Information the FDA labeled dosing up to a maximum of 2 mg/kg every 8 weeks (Golimumab) • Updated Clinical Evidence and (or equivalent dose and interval schedule); and Injection for References sections to reflect o Patient is not receiving Simponi Aria in combination with either of Intravenous the most current information the following: Infusion ▪ Biologic disease-modifying antirheumatic drug (DMARD) [e.g., (continued) Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Orencia (abatacept)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and o Authorization is for no more than 12 months

• Psoriatic arthritis when all of the following criteria are met: For initial therapy, all of the following: o Diagnosis of active psoriatic arthritis (PsA); and o Simponi Aria is initiated and titrated according to US Food and Drug Administration (FDA) labeled dosing for psoriatic arthritis up to a maximum of 2mg/kg at weeks 0 and 4 upon initiation of therapy, then 2 mg/kg every 8 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Simponi Aria in combination with any 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)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Initial authorization is for no more than 12 months

For continuation therapy, all of the following: o Patient has previously received Simponi Aria injection for intravenous infusion; and o Documentation of positive clinical response to Simponi Aria; and o Simponi Aria dosing for psoriatic arthritis is in accordance with the FDA labeled dosing up to a maximum of 2 mg/kg every 8 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Simponi Aria in combination with any of the following:

58 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Simponi Aria® May 1, 2020 ▪ Biologic disease-modifying antirheumatic drug (DMARD) [e.g., (Golimumab) Enbrel (etanercept), Humira (adalimumab), Cimzia Injection for (certolizumab), Orencia (abatacept)] Intravenous ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Infusion ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] (continued) and o Authorization is for no more than 12 months

• Rheumatoid arthritis when all of the following criteria are met: For initial therapy, all of the following: o Diagnosis of moderately to severely active rheumatoid arthritis (RA); and o One of the following: ▪ 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 (FDA) labeled dosing for rheumatoid arthritis up to a maximum of 2 mg/kg at weeks 0 and 4 upon initiation of therapy, then 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), Olumiant (baricitinib)]5,6and o Initial authorization is for no more than 12 months

For continuation therapy, all of the following: o Patient has previously received Simponi Aria injection for intravenous infusion; and o Documentation of positive clinical response to Simponi Aria; and o Simponi Aria dosing for rheumatoid arthritis is in accordance with the FDA labeled dosing up to a maximum of 2 mg/kg every 8 weeks (or equivalent dose and interval schedule); and o Patient is not receiving Simponi Aria in combination with either of

59 Oxford® Policy Update Bulletin: April 2020

Oxford

Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Simponi Aria® May 1, 2020 the following: (Golimumab) ▪ Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Injection for Enbrel (etanercept), Humira (adalimumab), Cimzia Intravenous (certolizumab), Orencia (abatacept)] Infusion ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (continued) (baricitinib)] and o Initial authorization is for no more than 12 months Stelara® May 1, 2020 Coverage Rationale This policy refers to Stelara (ustekinumab) injection. Stelara (Ustekinumab) • Revised coverage criteria for (ustekinumab) for self-administered subcutaneous injection is obtained proven and medically under the pharmacy benefit. necessary indications: All Indications – Stelara is proven and/or medically necessary for the treatment of: Initial/Continuation of Therapy Crohn’s disease when all of the following criteria are met: o Replaced criterion requiring • Diagnosis of moderately to severely active Crohn’s disease; and “physician attestation that • One of the following: the patient or caregiver is o For initial therapy, all of the following: not competent to administer ▪ Stelara is to be administered as a single intravenous induction Stelara FDA labeled for self- dose; and administration; physician ▪ Stelara induction dosing is in accordance with the United States must submit explanation” Food and Drug Administration (FDA) approved labeled dosing for with “prescriber attestation Crohn’s disease: that the patient or caregiver - 260mg for patients weighing ≤55kg is not able to be trained or is - 390mg for patients weighing >55kg to ≤85kg physically unable to - 520mg for patients weighing >85kg administer Stelara FDA and labeled for self- ▪ Patient is not receiving Stelara in combination with either of the administration; prescriber following: must submit explanation” - Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] Plaque Psoriasis – Initial - Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant Therapy (baricitinib)] o Replaced criterion requiring and “patient is a candidate for systemic therapy” with ▪ Authorization will be for one induction dose. o “patient is a candidate for For continuation of therapy, all of the following: phototherapy or systemic ▪ Documentation of positive clinical response; and ▪ Prescriber attestation that the patient or caregiver are not able

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® May 1, 2020 therapy” to be trained or are physically unable to administer Stelara FDA (Ustekinumab) • Revised list of unproven and labeled for self-administration; prescriber must submit (continued) not medically necessary explanation; and indications; added “treatment of ▪ Stelara is to be subcutaneously administered 8 weeks after the ankylosing spondylitis” initial intravenous dose; and Supporting Information ▪ Stelara continuation dosing is in accordance with the FDA • Updated Clinical Evidence and approved labeled dosing for Crohn’s disease: 90mg every 8 References sections to reflect weeks subcutaneously; and the most current information ▪ Patient is not receiving Stelara in combination with either of the following: - Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] - Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and ▪ Authorization is for no more than 12 months.

Plaque psoriasis when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of moderate to severe plaque psoriasis; and o Patient is a candidate for phototherapy or systemic therapy; and o Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer Stelara FDA labeled for self-administration; prescriber must submit explanation; and o Stelara is initiated and titrated according to FDA 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, Olumiant (baricitinib)]

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® May 1, 2020 ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] (Ustekinumab) o Initial authorization is for no more than 12 months. (continued) • For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer Stelara FDA labeled for self-administration; prescriber must submit explanation; and o Stelara is initiated and titrated according to FDA 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., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] o Authorization is for no more than 12 months.

Psoriatic arthritis when all of the following criteria are met: • For initial therapy, all of the following: o Diagnosis of psoriatic arthritis; and o Stelara is initiated and titrated according to FDA labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and interval schedule); and o Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer Stelara FDA labeled for self-administration; prescriber must submit explanation; 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), Olumiant

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® May 1, 2020 (baricitinib)] (Ustekinumab) ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] (continued) o Initial authorization is for no more than 12 months. • For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer Stelara FDA labeled for self-administration; prescriber must submit explanation; and o Stelara is initiated and titrated according to FDA labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and interval schedule); and o Patient is not receiving Stelara in combination with any of the following: ▪ Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] ▪ Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)]16 ▪ Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] o Authorization is for no more than 12 months.

Ulcerative colitis when ALL of the following criteria are met: • Diagnosis of moderately to severely active ulcerative colitis; and • One of the following: o For initial therapy, all of the following: ▪ Stelara is to be administered as a single intravenous induction dose; and ▪ Stelara induction dosing is in accordance with the FDA approved labeled dosing for ulcerative colitis: - 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 either of the following: - Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] - Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)]

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® May 1, 2020 and (Ustekinumab) ▪ Authorization will be for one induction dose. (continued) o For continuation of therapy, all of the following: ▪ Documentation of positive clinical response; and ▪ Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer Stelara FDA labeled for self-administration; prescriber must submit explanation; and ▪ Stelara is to be subcutaneously administered 8 weeks after the initial intravenous dose; and ▪ Stelara continuation dosing is in accordance with the FDA approved labeled dosing for ulcerative colitis: 90mg every 8 weeks subcutaneously; and ▪ Patient is not receiving Stelara in combination with either of the following: - Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] - Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] and ▪ Authorization is for no more than 12 months.

Stelara is unproven and not medically necessary for the treatment of: • Ankylosing spondylitis • Multiple sclerosis Trogarzo® May 1, 2020 Template Update Trogarzo (ibalizumab-uiyk) is proven and/or medically necessary for (Ibalizumab-Uiyk) • Relocated Background and FDA the treatment of multi-drug resistant human immunodeficiency virus sections (HIV) in patients who meet ALL of the following criteria: Conditions of Coverage • Revised applicable sites of • For initial therapy, all of the following: service; replaced “all” with o Both of the following: “office, outpatient, and home” ▪ Diagnosis of HIV-1 infection • Added language to indicate: ▪ Physician attestation that the patient has multi-drug resistant o New Jersey Small group plan HIV-1 infection members should refer to and their Certificate of Coverage o Physician confirms that the patient has been prescribed an optimized for precertification and backround antiretroviral regimen, containing at least one

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Trogarzo® May 1, 2020 quantity limit guidelines antiretroviral agent that demonstrates full viral (Ibalizumab-Uiyk) o Participating providers in sensitivity/susceptibility; and (continued) the office setting: o Ibalizumab initial and maintenance dosing is in accordance with the Precertification is required US Food and Drug Administration prescribing information: A single for services performed in the loading dose of 2,000mg intravenously (IV) followed by a office of a participating maintenance dose of 800mg IV every two weeks thereafter; and provider o Initial authorization is for no more than 6 months. o Non-participating/out-of- network providers in the • For continuation therapy, all of the following: office setting: o Patient has previously received treatment with ibalizumab; and Precertification is not o Physician confirms that the patient has achieved a clinically required, but encouraged for significant viral response to ibalizumab therapy; and out-of-network services o Physician confirms that the patient will continue to take an optimized performed in the office; if backround antiretroviral regimen, in combination with ibalizumab; precertification is not and obtained, Oxford will review o Ibalizumab maintenance dosing is in accordance with the US Food for out-of-network benefits and Drug Administration prescribing information; and and medical necessity after o Authorization is for no more than 12 months. the service is rendered o Home infusion of Trogarzo requires precertification for the home care services Supporting Information • Updated Clinical Evidence and References sections to reflect the most current information Vyondys 53™ Jul. 1, 2020 Conditions of Coverage Vyondys 53 (golodirsen) may be covered for the treatment of (Golodirsen) • Revised precertification Duchenne muscular dystrophy (DMD) in patients who meet all of the guidelines to indicate: following criteria: o Precertification with Medical Director review is required • For initial therapy, all of the following: o New Jersey Small group plan o Diagnosis of Duchenne muscular dystrophy by, or in consultation members should refer to with, a neurologist with expertise in the diagnosis of DMD; and their Certificate of Coverage o Submission of medical records (e.g., chart notes, laboratory values) for precertification and confirming the mutation of the DMD gene is amenable to exon 53 quantity limit guidelines skipping; and o Home infusion of Vyondys o One of the following: 53 requires additional ▪ Submission of medical records (e.g., chart notes, laboratory

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Vyondys 53™ Jul. 1, 2020 precertification for the home values) confirming that the patient has a 6-Minute Walk Time (Golodirsen) care services (6MWT) ≥ 300 meters while walking independently (e.g., without (continued) o Participating providers in side-by-side assist, cane, walker, wheelchair, etc.) prior to the office setting: beginning Vyondys 53 therapy; or Precertification is required ▪ Both of the following: for services performed in the - Submission of medical records (e.g., chart notes) confirming office of a participating that the patient is ambulatory without needing an assistive provider device (e.g., without side-by-side assist, cane, walker, o Non-participating/out-of- wheelchair, etc.); and network providers in the - One of the following: office setting: • Patient has achieved a score of greater than 17 on the Precertification is not North Star Ambulatory Assessment (NSAA);or required, but encouraged for • Patient has achieved a time to rise from the floor out-of-network services (Gower’s test) of less than 7 seconds; and performed in the office; if o Vyondys 53 is prescribed by, or in consultation with, a neurologist precertification is not with expertise in the treatment of DMD; and obtained, Oxford will review o Vyondys 53 dosing for DMD is in accordance with the United States for out-of-network benefits Food and Drug Administration approved labeling: maximum dosing and medical necessity after of 30 mg/kg infused once weekly; and the service is rendered o Vyondys 53 is not used concomitantly with other exon skipping o Hospital outpatient therapies for DMD; and facility: Additional o Initial authorization will be for no more than 6 months. precertification requirements apply to requests for • For continuation therapy, all of the following: hospital outpatient facility o Vyondy 53 is prescribed by, or in consultation with, a neurologist infusion of Vyondys 53™ with expertise in the treatment of DMD; and (golodirsen); refer to the o Submission of medical records (e.g., chart notes) confirming that the Clinical Policy titled Provider patient is ambulatory without needing an assistive device (e.g., Administered Drugs - Site of without side-by-side assist, cane, walker, wheelchair, etc.); and Care o Vyondys 53 dosing for DMD is in accordance with the United States Coverage Rationale Food and Drug Administration approved labeling: maximum dosing • Removed reference link to the of 30 mg/kg infused once weekly; and Clinical Policy titled Review at o Vyondys 53 is not used concomitantly with other exon skipping Launch for New to Market therapies for DMD; and Medications for Vyondys 53 o Reauthorization will be for no more than 12 months. (prior authorization requirements apply Jul. 1, 2020) Vyondys 53 will not be covered for other forms of muscular dystrophy.

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Participating May 1, 2020 Title Change Gastroenterologists • Previously titled Par Gastroenterologists Using Non-Par Anesthesiologists: In-Office & Ambulatory Surgery Using Non- Centers Participating Related Policies Anesthesiologists: • Added reference link to the Administrative Policy titled Participating Providers Using Non-Participating Providers In-Office and Protocol Ambulatory Surgery Centers Protocol Participating May 1, 2020 Title Change Providers Using • Previously titled Participating Provider Laboratory and Pathology Protocol Non-Participating Related Policies Laboratory and • Added reference link to the Administrative Policy titled Participating Providers Using Non-Participating Providers Pathology Protocol Providers Protocol Participating May 1, 2020 Title Change Surgeons Using • Previously titled Par Surgeons Using Non-Par Assistant Surgeons and Co-Surgeons Non-Participating Related Policies Assistant Surgeons • Removed reference link to the Administrative Policy titled: and Co-Surgeons o New York & Connecticut Participating Surgeons Using Non-Participating Providers for Intraoperative Neuro- Protocol Monitoring (IONM) o Par Gastroenterologists Using Non-Par Anesthesiologists: In-Office & Ambulatory Surgery Centers Applicable Lines of Business/Products • Added language to clarify this policy applies to Oxford New York Commercial plan membership

Participating May 1, 2020 Title Change Surgeons Using • Previously titled New York & Connecticut Participating Surgeons Using Non-Participating Providers for Non-Participating Intraoperative Neuro-Monitoring (IONM) Providers for Applicable Lines of Business/Products (previously titled Benefit Considerations) Intraoperative • Updated language to clarify this policy applies to Oxford New York and Connecticut Commercial plan Neuro-Monitoring membership (IONM) Protocol

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Orthopedic May 1, 2020 Applicable Codes Oxford covers medically necessary acute care services and post-acute Services • Revised list of CPT codes services delivered at the most appropriate level of care. OrthoNet's

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Orthopedic May 1, 2020 requiring medical necessity Orthopedic division will perform utilization management to review requested Services review; added 28295 services that should meet approved clinical guidelines for medical necessity. (continued) Review is conducted by determining medical necessity and medical appropriateness, and to initiate discharge planning as appropriate. The review will be based on the obtained clinical information and some or all of the following criteria/tools: • MCG™ Care Guidelines, 24th edition, 2020 (Inpatient Care) • Member benefits • Oxford medical and reimbursement policies

Medical Director Review Requirements If a request is submitted which: • Meets the applicable guideline(s)/medical criteria, an OrthoNet Case Manager may make a utilization review decision (with oversight by a Medical Director). • Does not meet the applicable guideline(s)/criteria, and/or there is a question regarding whether the request is a covered benefit, the request will be referred to an OrthoNet Medical Director for review and decision-making.

Additional information as well as input from a consultant may be requested and reviewed as part of this process.

In the case of non-certification decisions, where the OrthoNet Case Manager did not make an attempt to discuss the matter with the member’s provider, a reconsideration procedure will be offered and activated according to current regulatory requirements and Oxford policy.

A Medical Director must make all adverse utilization review decisions including those for benefit non-certifications (with the exception of non- certification due to the member's enrollment status with Oxford and approval determinations).

Note: Payment for requested services will be based on Oxford’s medical and reimbursement policies.

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Participating May 1, 2020 Title Change In Advance of Any Services Being Rendered Providers Using • Previously titled Non- If a Participating provider intends to utilize a non-participating physician, Non-Participating Participating Provider Consent facility or other healthcare provider in a member’s care, the provider is Providers Protocol Form Protocol required to: Application (previously titled Applicable Lines of • Verbally discuss Provider options and financial impacts with the Business/Products) member: • Updated list of applicable o The Participating Provider must review this policy and the Member providers/services (relocated Advance Notice Form with the member. from the Procedures and • The discussion must provide participating alternatives and Responsibilities section): explain the reason for the non-participating physician, facility or o Added: other healthcare provider. ▪ Gastroenterology • The discussion must include a conversation explaining the procedures in-office or at financial impact of utilizing a non-participating physician, facility an ambulatory surgery or other healthcare provider. center • A copy of the Member Advance Notice Form must be providerd to ▪ Intraoperative neuro- the Member. monitoring (IONM) o If the member has out-of-network benefits, they may utilize those o Replaced “assistant surgeon” benefits to receive services from a non-participating physician, with “assistant and/or co- facility or other healthcare provider, however; they may have higher surgeon” out-of-pocket costs when using a non-participating provider. o Removed definition of o Members that do not have out-of-network benefits may be assistant surgeon responsible for the entire cost of the service(s) provided by the non- • Added reference link to the participating physician, facility or other healthcare provider. Administrative Policy titled: o Participating • Obtain a completed Member Advance Notice Form Gastroenterologists Using o The member will ned to agree or disagree to use a non-participating Non-Participating physician, facility or other healthcare provider. If the member: Anesthesiologists: In-Office • Does not agree to the use of a non-participating physician, and Ambulatory Surgery facility or other healthcare provider: Following the Centers Protocol discussion, if the Participating Provider: o Participating Surgeons Using • Is unable to locate a participating physician, facility or other Non-Participating Assistant healthcare provider, they must contact the health plan for Surgeons and Co-Surgeons assistance in locating a participating provider. Protocol • Still wants to recommend the non-participating physician, facility o Participating Surgeons Using or other healthcare provider, they must contact Oxford to Non-Participating Providers request and initiate an In-Network Exception request. for Intraoperative Neuro- • Does agree to the use of a non-participating physician, Monitoring (IONM) Protocol facility or other healthcare provider: The Participating

Procedures and Responsibilities Provider must ensure that the Member understands the financial • Added language to indicate a obligations of using a Non-Participating physician, facility or 69 participating provider is required other healthcareOxford provider.® Policy Update Bulletin: April 2020 to follow the steps in this ▪ For Members with out-of-network benefits: Non- protocol when intending to Participating physician, facility or other healthcare providers will

Oxford

Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Precertification Apr. 1, 2020 Notice of Revision: The following Refer to the policy for complete details on Precertification Exemptions for Exemptions for summary of changes has been Outpatient Services. Outpatient Services modified. Revisions to the previous policy update announcement are outlined in red below. Please take note of the additional updates to be implemented on Apr. 1, 2020.

Procedures and Responsibilities • Revised list of services that do not require Precertification in the Outpatient Setting: Cardiac Monitoring (previously titled Holter Monitoring) o Added CPT codes 93268, 93270, 93271 and 93272 o Added reference link to the Clinical Policy titled Cardiac Event Monitoring Pathology and Laboratory o Updated list of applicable CPT codes to reflect quarterly code edits: ▪ Added 0014M, 0164U, 0165U, 0166U, 0167U, 0169U, and 0170U ▪ Removed 0006U Speech Therapy May 1, 2020 Conditions of Coverage Speech Therapy and Early • Revised language pertaining to Notes: Intervention applicable sites of service to • The following providers can refer for speech therapy: orthopedist, Programs/Birth to clarify: neurologist, neurosurgeon, physiatrist, ENT, pediatrician, or PCP. Three o This policy applies to all • For speech therapy related to the diagnosis and treatment for Autism, sites of service refer to the Administrative Policy titled Autism for additional information. o Speech therapy services do • Refer to the member specific benefit plan document for specific details not require authorization in regarding benefit coverage for speech therapy (ST). the outpatient and office sites of service State Speech Therapy Coverage o Authorization is required for CT Small & Speech therapy (ST) is covered when:

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy May 1, 2020 all Early Intervention (EI) Large Plans • It is necessary to correct a condition that is the and Early services in all sites of result of a disease, injury or congenital physical Intervention service deformity that inhibits normal function. Programs/Birth to • Removed language indicating • Used to help a person keep, learn or improve skills Three precertification with Medical and functioning for daily living. (continued) Director review is required in the ST is covered for the correction of a speech impairment home site of service resulting from illness, surgery, injury, congenital

Applicable Codes NJ Small anomaly, or previous therapeutic processes.

• Revised list of diagnosis codes Plans Exception: For a covered person who has been

for Speech Therapy benefit diagnosed with a behavioral health condition, ST means

exclusions (not covered): treatment of a speech impairment. o Added R27.0, R48.1, and R48.2 ST is covered when it is necessary to correct a/an: o Removed F70, F71, F72, • Condition that is the result of a disease • Mental illness including autism spectrum disorder F73, F80.1, F81.0, F82, and NJ Large • Injury R48.0 Plans Supporting Information • Congenital physical deformity that inhibits normal • Updated References section to function reflect the most current • Developmental disability information ST is covered to:

• Assist a member in keeping, getting back or

improving skills and functioning for daily living that

have been lost or impaired because a person was

NY Small & sick, hurt, or disabled.

Large Plans • Keep, learn or improve skills and functioning for

daily living. This includes the management of

limitations and disabilities, including services or

programs that help maintain or prevent

deterioration.

Early Intervention (EI) Program/Birth to Three State Early Intervention Program/Birth to Three Coverage

CT Residents 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.

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy May 1, 2020 CT Residents Coverage Guidelines and Early (continued) • The reimbursement of EI services will not be applied Intervention against any visit maximums or any maximum Programs/Birth to lifetime or annual monetary limits and in and out of Three network cost shares (i.e., copayment, coinsurance (continued) and deductibles) may not be applied. Exception: Deductibles may be applied on high deductible plans, such as an HSA. • Precertification is required for all services related to EI; however, Oxford may not apply medical necessity or any other Oxford policy to EI services. • CT EI services may include: o Evaluation o Assistive technology o Audiology o Family training, counseling, and home visits o Health services (those services necessary to enable a child to benefit from the other EI services during the time the child is receiving other EI services) o Medical services only for diagnostic or evaluation purposes o Nursing services o Nutrition services o Occupational therapy (OT) o Physical therapy (PT) o Psychological services o Service coordination o Sign language and cued language services o Social work services o Special instruction o Speech-language pathology o Transportation and related costs (as documented in the IFSP) o Vision services

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy May 1, 2020 Oxford will provide coverage for EI services for any and Early Eligible Child who is a Massachusetts (MA) resident for Intervention services that are part of an IFSP under the MA Early Programs/Birth to Intervention (EI) Program. Three (continued) Coverage Guidelines • The reimbursement of EI services will not be applied against visit maximums or any maximum lifetime or 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. MA Residents • Providers of EI services documented in the IFSP are (who have a considered to be participating providers for EI CT, NJ or NY services. Line of • MA EI services may include: Business) o Assistive technology o Audiology o Family counseling and home visits o Medical services for diagnostic or evaluation purposes o Nursing care o Nutrition services o OT o PT o Psychological services o Service coordination o Sign language and cued speech o Social work services o Special instruction o Speech and language therapy services o Transportation services o Vision services

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy May 1, 2020 Oxford will provide coverage for any Eligible Child who and Early is a NY resident for EI services provided as part of the Intervention EI program and covered under the member specific

Programs/Birth to benefit plan document. This reimbursement will not be Three applied against maximum annual or lifetime monetary (continued) limits and copayments and coinsurance cannot be applied. Note: The deductible may be applied.

Coverage Guidelines

• Precertification is required for all services related to

an EI Program. • EI services may be reviewed for medical necessity; however, EI 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 NY Residents coverage may vary based on the member specific

benefit plan documents. The EI provider: o Must send a subrogation notice indicating the provider’s assignment as the EI provider for the child. o Must send a copy of the IFSP either with the subrogation notice or separately to medical management for the medical necessity review. o Submit claims through the NY state fiscal

agent.

Note: The provider or the municipality has a right to subrogation. • NY EI Services may include: o Assistive technology devices and services o Family education and counseling, home visits and parent support groups o Nursing services

o Nutrition services o OT

o PT o Psychological services

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Speech Therapy May 1, 2020 NY Residents o Service coordination and Early (continued) o Social work services Intervention o Special instruction Programs/Birth to o Speech pathology and audiology Three o Vision services (continued) Subrogation Oxford must reimburse municipalities or the provider where the municipality has paid for and/or the provider has rendered EI services for an Eligible Child that are medically necessary and covered under a fully insured NY plan member's Certificate of Coverage (subject to the member specific benefit plan documents). • Upon notice of a child's eligibility for benefits under a health insurance plan, a municipality or the provider must promptly notify the commercial insurer of its intent to exercise subrogation rights. • Notice to the insurer must include specific information using the state mandated subrogation form. • When the notice of subrogation is sent to Oxford by the municipality or the provider, Oxford will request the IFSP in order to determine medical necessity. • Any written claim for EI program services must be submitted by the NY state fiscal agent, the municipality as the approved provider or the provider.

Timeframe May 1, 2020 Procedures and Responsibilities Refer to the policy for complete details on Timeframe Standards for Standards for • Revised guidelines for Pre- Utilization Management (UM) Initial Decisions. Utilization Service Requests: Management (UM) Initial Decision Timeframe Initial Decisions o For New Jersey (NJ): Updated language to indicate the determination will be made within 15 days after receiving the request Strictest Timeframe/Oxford Goal

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Timeframe May 1, 2020 o For Connecticut (CT), New Standards for Jersey (NJ), New York Utilization (NY), and Department of Management (UM) Labor (DOL): Updated Initial Decisions language to indicate initial (continued) determinations will be made no later than 15 calendar days from receipt of all necessary information o For New York (NY): Added language (relocated from Notification requirements) to indicate determinations for any request for court ordered mental health and/or substance use disorder services must be made by telephone within 72 hours of receipt of the request; written notice of the determination to the member or member's designee shall follow within 3 business days

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Reimbursement Policy Updates

Policy Title Effective Date Reimbursement Guidelines NEW Outpatient Hospital Jul. 1, 2020 The basis for Add-On Codes is to enable physicians or other qualified health care professionals to separately identify Add-On Codes a service that is performed in certain situations as an additional service or a commonly performed supplemental (CES) service complimentary to the primary service/procedure.

Oxford follows the American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS) with respect to the reporting of "Add-On" CPT and HCPCS codes. Per CPT Add-On Codes describe additional intra- service work associated with a primary procedure/service, are always reported in addition to the primary service/procedure, and must be performed by the same outpatient hospital reporting the primary service/procedure. Many Add-On Codes are designated by the AMA with a “+” symbol and are also listed in Appendix D of the CPT book. CMS assigns Add-On Codes a Global Days indicator of “ZZZ” on the CMS National Physician Fee Schedule (NPFS).

CMS further defines the code pair relationships in the CMS National Correct Coding Initiative (NCCI) package. CMS NCCI designates Add-On Code relationships as Type I, II, or III. Type I Add-On Codes have a limited number of identifiable primary procedures that they must be reported with and Type II and III do not have an all-inclusive list of primary procedures.

Oxford follows the CMS ‘Integrated’ Outpatient Code Editor (I/OCE) specific edits for Type I Add-On Code and primary code relationships. If the Add-on code is not submitted on the claim as the same day of service or the day before, the Add-On Code will not be reimbursed. In addition, Add-On Codes are never reimbursed unless a primary procedure codes is also reimbursed.

Infusion Services Hospitals should report only one initial drug administration service, including infusion services, per encounter for each distinct vascular access site, with other services through the same vascular access site being reported via the sequential, concurrent or additional hour codes. Therefore, for infusion services, the Add-On Code is not required to be billed for the same date of service as the initial drug service. However, both the initial drug service and the corresponding Add-On Code must be reported on the same claim. Outpatient Hospital Jul. 1, 2020 MFD Determination Maximum The following criteria are used to determine the MFD values for codes to which these criteria are applicable: Frequency Per Day • The Centers for Medicare and Medicaid Services (CMS) Medically Unlikely Edit (MUE) value, specifically the MUE (CES) table for Facility Outpatient Hospital Services. • Codes assigned a CMS MUE value of zero will have MFD values established using the same criteria as CMS, including but not limited to anatomic considerations, CPT/HCPCS code descriptors, CPT coding instructions, nature of service/procedure, nature of an analyte, nature of equipment, and unlikely clinical treatment. • If a MFD value is not listed, it’s the responsibility of the outpatient hospital to bill the appropriate number of units for each service.

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Policy Title Effective Date Reimbursement Guidelines NEW Outpatient Hospital Jul. 1, 2020 Reimbursement Maximum The MFD values apply whether a hospital submits one CPT or HCPCS code with multiple units on a single claim line Frequency Per Day or multiple claim lines with one or more unit(s) on each line. Services provided are reimbursable services up to and (CES) including the MFD value for an individual CPT or HCPCS code. (continued) There may be situations where a facility reports units accurately and those units exceed the established MFD value. In such cases, Oxford will consider additional reimbursement if reported with an appropriate modifier such as modifier 59, 76, 91, XE, XP, XS, or XU. Medical records are not required to be submitted with the claim when modifiers 59, 76, 91, XE, XP, XS, or XU are appropriately reported. Documentation within the medical record should reflect the number of units being reported and should support the use of the modifier.

Medically Unlikely Edit (MUE) Adjudication Indicator (MAI) 2 CMS has identified CPT/HCPCS codes where the units of service (UOS) on the same date of service in excess of the MUE value would be considered impossible because it is contrary to statute, regulation or sub-regulatory guidance. Therefore, Oxford will not allow units in excess of the MFD value to be reimbursed for CPT/HCPCS codes assigned an MAI indicator of “2”. Per CMS guidelines, no modifier override will be allowed, however, anatomic modifiers may be considered when appropriate.

Policy Title Effective Date Summary of Changes UPDATED Drug Testing Apr. 1, 2020 Applicable Codes • Updated list of applicable HCPCS codes to reflect quarterly code edits for definitive drug testing; removed 0006U Prolonged Services Apr. 1, 2020 Overview and Reimbursement Guidelines • Replaced references to “other health care professional” with “other qualified health care professional”

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Increased May 1, 2020 Reimbursement Guidelines and Oxford's standard for additional reimbursement of Modifier 22 (increased Procedural Services Definitions procedural services) and/or Modifier 63 (procedures performed on infants • Added language to indicate less than 4 kg) is 20% of the Allowable Amount for the unmodified Modifier 63 may be appended to procedure, not to exceed the billed charges. Claims submitted with these codes 92920, 92928, 92953, modifiers must include medical record documentation which supports the use 92960, 92986, 92987, 92990, of the modifiers and which will be reviewed by Oxford in accordance with this 92997, 92998, 93312, 93313, policy. 93314, 93315, 93316, 93317, 93318, 93452, 93505, 93530, Note: When both Modifier 22 and Modifier 63 are appended to the same CPT

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Increased May 1, 2020 93531, 93532, 93533, 93561, code, reimbursement will be a total of an additional 20% of the Allowable Procedural Services 93562, 93563, 93564, 93568, Amount of the unmodified procedure, not to exceed the billed charges, (continued) 93580, 93582, 93590, 93591, provided the documentation supports use of either Modifier 22 or Modifier 93592, 93615, and 93616 from 63. the Medicine/Cardiovascular section of the Current Procedural Modifier 22 - Increased Procedural Services Terminology (CPT®) book In order to be considered for additional reimbursement when reporting Modifier 22, thorough medical records or reports and a separate document containing a concise statement about how the service differed from the usual service or procedure is required. The documents must indicate the substantial additional work performed and the reason for the additional work which may include, but not be limited to, increased intensity or time, technical difficulty of procedure that is not described by a more comprehensive procedure code, severity of the patient’s condition, or increased physical and mental effort required.

Additional reimbursement will only be considered for services appended with Modifier 22 that are assigned a global period of 0, 10, 42 or 90 days. Modifier 22 should not be appended to an evaluation and management service.

Modifier 63 - Procedure Performed on Infants Less Than 4 kg

In order to be considered for additional reimbursement when reporting

Modifier 63, thorough medical record(s) or report(s) that support the use of

the modifier is required. The document(s) must indicate the substantial

additional work performed and the reason for the additional work which may

include, but not be limited to, increased intensity or time, technical difficulty

of procedure that is not described by a more comprehensive procedure code,

severity of the patient’s condition, or increased physical and mental effort

required.

Unless otherwise designated, this modifier may only be appended to

procedures/services listed in the 20100-69990 code series and 92920,

92928, 92953, 92960, 92986, 92987, 92990, 92997, 92998, 93312, 93313,

93314, 93315, 93316, 93317, 93318, 93452, 93505, 93530, 93531, 93532,

93533, 93561, 93562, 93563, 93564, 93568, 93580, 93582, 93590, 93591,

93592, 93615, and 93616 from the Medicine/Cardiovascular section of the

CPT book. Modifier 63 should not be appended to any CPT code listed in the

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Increased May 1, 2020 Evaluation and Management Services, Anesthesia, Radiology, Procedural Services Pathology/Laboratory, or Medicine sections (other than those identified (continued) above from the Medicine/Cardiovascular section) of the CPT cook. Increased May 1, 2020 Reimbursement Guidelines and Oxford's standard for additional reimbursement of Modifier 22 (increased Procedural Services Definitions procedural services) and/or Modifier 63 (procedures performed on infants (CES) • Added language to indicate less than 4 kg) is 20% of the Allowable Amount for the unmodified Modifier 63 may be appended to procedure, not to exceed the billed charges. Claims submitted with these codes 92920, 92928, 92953, modifiers must include medical record documentation which supports the use 92960, 92986, 92987, 92990, of the modifiers and which will be reviewed by Oxford in accordance with this 92997, 92998, 93312, 93313, policy. 93314, 93315, 93316, 93317, 93318, 93452, 93505, 93530, Note: When both Modifier 22 and Modifier 63 are appended to the same CPT 93531, 93532, 93533, 93561, code, reimbursement will be a total of an additional 20% of the Allowable 93562, 93563, 93564, 93568, Amount of the unmodified procedure, not to exceed the billed charges, 93580, 93582, 93590, 93591, provided the documentation supports use of either Modifier 22 or Modifier 93592, 93615, and 93616 from 63. the Medicine/Cardiovascular section of the Current Procedural Modifier 22 - Increased Procedural Services Terminology (CPT®) book In order to be considered for additional reimbursement when reporting Modifier 22, thorough medical records or reports and a separate document containing a concise statement about how the service differed from the usual service or procedure is required. The documents must indicate the substantial additional work performed and the reason for the additional work which may include, but not be limited to, increased intensity or time, technical difficulty of procedure that is not described by a more comprehensive procedure code, severity of the patient’s condition, or increased physical and mental effort required.

Modifier 63 - Procedure Performed on Infants Less Than 4 kg

In order to be considered for additional reimbursement when reporting

Modifier 63, thorough medical record(s) or report(s) that support the use of

the modifier is required. The document(s) must indicate the substantial

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Increased May 1, 2020 additional work performed and the reason for the additional work which may Procedural Services include, but not be limited to, increased intensity or time, technical difficulty (CES) of procedure that is not described by a more comprehensive procedure code, (continued) severity of the patient’s condition, or increased physical and mental effort required.

Unless otherwise designated, this modifier may only be appended to procedures/services listed in the 20100-69990 code series and 92920, 92928, 92953, 92960, 92986, 92987, 92990, 92997, 92998, 93312, 93313, 93314, 93315, 93316, 93317, 93318, 93452, 93505, 93530, 93531, 93532, 93533, 93561, 93562, 93563, 93564, 93568, 93580, 93582, 93590, 93591, 93592, 93615, and 93616 from the Medicine/Cardiovascular section of the CPT book. Modifier 63 should not be appended to any CPT code listed in the Evaluation and Management Services, Anesthesia, Radiology, Pathology/Laboratory, or Medicine sections (other than those identified above from the Medicine/Cardiovascular section) of the CPT cook. Injection and May 1, 2020 Applicable Codes Injections (96372-96379) and Evaluation and Management Services Infusion Services • Reformatted list of applicable by Place of Service CPT/HCPCS codes Facility, Emergency Room, and Ambulatory Surgical Center Services • Revised list of E&M Codes Per CPT and the CMS National Correct Coding Initiative (NCCI) Policy Manual, Applicable When Reported CPT codes 96372-96379 are not intended to be reported by the physician in Injection Codes 96372-96379: the facility setting. Thus, when an E/M service and a therapeutic and o Added HCPCS code G0463 diagnostic Injection service are submitted with CMS Place of Service (POS) o Removed CPT code 99488 codes 19, 21, 22, 23, 24, 26, 51, 52, and 61 for the same patient by the and HCPCS code G0402 Same Individual Physician or Other Qualified Health Care Professional on the • Revised list of HCPCS codes for same date of service, only the E/M service will be reimbursed and the Injection and Infusion Inclusive therapeutic and diagnostic Injection(s) are not separately reimbursed, Supplies; added E0776 regardless of whether a modifier is reported with the Injection(s).

For additional information, refer to the Questions and Answers section of the policy, Q&A #1.

Non-Facility Injection Services

E/M services provided in a non-facility setting are considered an inherent

component for providing an Injection service. CPT indicates these services

typically require direct supervision for any or all purposes of patient

assessment, provision of consent, safety oversight, and intra-service

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Injection and May 1, 2020 supervision of staff. When a diagnostic and therapeutic Injection procedure is Infusion Services performed in a POS other than 19, 21, 22, 23, 24, 26, 51, 52, and 61 and an (continued) E/M service is provided on the same date of service, by the Same Individual Physician or Other Qualified Health Care Professional only the appropriate therapeutic and diagnostic Injection(s) will be reimbursed and the EM service is not separately reimbursed.

If a significant, separately identifiable EM service is performed unrelated to the physician work (Injection preparation and disposal, patient assessment, provision of consent, safety oversight, supervision of staff, etc.) required for the Injection service, Modifier 25 may be reported for the E/M service in addition to 96372-96379. If the E/M service does not meet the requirement for a significant separately identifiable service, then Modifier 25 would not be reported and a separate E/M service would not be reimbursed.

Exceptions CPT 99211: E/M service code 99211 will not be reimbursed when submitted with a diagnostic or therapeutic Injection code, with or without Modifier 25. This very low service level code does not meet the requirement for "significant" as defined by CPT, and therefore should not be submitted in addition to the procedure code for the Injection.

CPT 99381-99429: The Preventive Medicine codes (99381-99429) do not need Modifier 25 to indicate a significant, separately identifiable service when reported in addition to the diagnostic and therapeutic Injection service. The Preventive Medicine codes include routine services such as the ordering of immunizations or diagnostic procedures. The performance of these services is to be reported in addition to the Preventive Medicine E/M code. Therefore, diagnostic and therapeutic Injections can be reported at the same time as a Preventive Medicine code without appending Modifier 25.

For additional information, refer to the Questions and Answers section of the policy, Q&A#2, Q&A #3 and Q&A #6. • CMS POS Database • E/M Codes for Injection Codes 96372-96379

Injection and Infusion Services (96360-96549 and G0498) and HCPCS Supplies

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Injection and May 1, 2020 Consistent with CPT guidelines, HCPCS codes identified by code description Infusion Services as standard tubing, syringes, and supplies are considered included when (continued) reported with Injection and Infusion services (CPT codes 96360-96549 and HCPCS code G0498) and will not be separately reimbursed. Refer to the Injection and Infusion Inclusive Supplies List.

Drug Codes Oxford reimbursement policy is aligned with CMS and will separately reimburse for the HCPCS drug code when submitted with Injection or Infusion codes (CPT codes 96360-96549 and HCPCS code G0498) by the Same Individual Physician or Other Qualified Health Care Professional on the same date of service under the guidelines of this policy.

For additional information, refer to the Questions and Answers section of the policy, Q&A #4. Injection and May 1, 2020 Related Policies Injections (96372-96379) and Evaluation and Management Services Infusion Services • Added reference link to the by Place of Service (CES) Reimbursement Policy titled Facility, Emergency Room, and Ambulatory Surgical Center Services Procedure/Technical Component Per CPT and the CMS National Correct Coding Initiative (NCCI) Policy Manual, (CES) CPT codes 96372-96379 are not intended to be reported by the physician in Reimbursement Guidelines and the facility setting. Thus, when an E/M service and a therapeutic and Q&A #1 diagnostic Injection service are submitted with CMS Place of Service (POS) • Added instruction to refer to the codes 19, 21, 22, 23, 24, 26, 51, 52, and 61 for the same patient by the “incident to” guidelines within Same Individual Physician or Other Qualified Health Care Professional on the the Reimbursement Policy titled same date of service, only the E/M service will be reimbursed and the Professional/Technical therapeutic and diagnostic Injection(s) are not separately reimbursed, Component (CES) for additional regardless of whether a modifier is reported with the Injection(s). guidelines pertaining to CPT codes 96360-96549 performed Also refer to the “incident to” guidelines within the Reimbursement Policy in a facility setting titled Professional/Technical Component (CES) for additional guidelines Applicable Codes pertaining to CPT codes 96360-96549 performed in a facility setting. • Reformatted list of applicable CPT/HCPCS codes For additional information, refer to the Questions and Answers section of the • Revised list of E&M Codes policy, Q&A1. Applicable When Reported Injection Codes 96372-96379: Non-Facility Injection Services

o Added HCPCS code G0463 E/M services provided in a non-facility setting are considered an inherent o Removed CPT code 99488

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Injection and May 1, 2020 and HCPCS code G0402 component for providing an Injection service. CPT indicates these services Infusion Services • Revised list of HCPCS codes for typically require direct supervision for any or all purposes of patient (CES) Injection and Infusion Inclusive assessment, provision of consent, safety oversight, and intra-service (continued) Supplies; added E0776 supervision of staff. When a diagnostic and therapeutic Injection procedure is Questions and Answers (Q&A) performed in a POS other than 19, 21, 22, 23, 24, 26, 51, 52, and 61 and an • Updated Q&A #1; added E/M service is provided on the same date of service, by the Same Individual instruction to refer to the Physician or Other Qualified Health Care Professional only the appropriate “incident to” guidelines within therapeutic and diagnostic Injection(s) will be reimbursed and the EM service the Reimbursement Policy titled is not separately reimbursed. Professional/Technical Component (CES) for additional If a significant, separately identifiable E/M service is performed unrelated to guidelines pertaining to CPT the physician work (Injection preparation and disposal, patient assessment, codes 96360-96549 and G0498 provision of consent, safety oversight, supervision of staff, etc.) required for performed in a facility setting the Injection service, Modifier 25 may be reported for the E/M service in addition to 96372-96379. If the E/M service does not meet the requirement for a significant separately identifiable service, then Modifier 25 would not be reported and a separate E/M service would not be reimbursed.

For additional information, refer to the Questions and Answers section of the policy, Q&A2, Q&A3 and Q&A6. • CMS POS Database • E/M Codes for Injection Codes 96372-96379

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Injection and May 1, 2020 Injection and Infusion Services (96360-96549 and G0498) and Infusion Services HCPCS Supplies (CES) Consistent with CPT guidelines, HCPCS codes identified by code description (continued) as standard tubing, syringes, and supplies are considered included when reported with Injection and Infusion services (CPT codes 96360-96549 and HCPCS code G0498) and will not be separately reimbursed. Refer to the Injection and Infusion Inclusive Supplies List.

For additional information, refer to the Questions and Answers section of the policy, Q&A4. Observation and May 1, 2020 Overview Duplicate or Repeat Services Discharge • Added language to indicate: When duplicate or repeat initial Observation Care, subsequent Observation o Observation Care discharge Care, Observation Care discharge day management, Observation or inpatient day management CPT code hospital Care (including admission and discharge), or inpatient hospital 99217 is used to report all discharge day management CPT codes are reported by the same or different services provided to a Physician or Other Qualified Health Care Professional, only one Physician or patient discharged from Other Qualified Health Care Professional will be reimbursed. outpatient hospital “observation status” if the For the purposes of this policy, duplicate or repeat services are defined as discharge is on a date other initial or subsequent Observation Care, Observation Care discharge day than the initial date of management, Observation or inpatient hospital Care (including admission “observation status” and discharge), or inpatient hospital discharge day management CPT codes o Inpatient hospital discharge submitted for the same patient, within the same stay, by any other Physician day management CPT codes or Qualified Health Care Professional, other than the Admitting/Supervising 99238 and 99239 are used Physician or Other Qualified Health Care Professional. to report all discharge day management services for Initial Observation Care the hospital inpatient when Initial hospital Observation Care CPT codes 99218-99220 describe the first discharge is on a date other visit of the patient's admission for outpatient hospital Observation Care by than the initial date of the Admitting/Supervising Physician or Other Qualified Health Care admission

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Observation and May 1, 2020 • Revised language pertaining to Professional. Hospital outpatient observation services include the supervision Discharge CPT codes 99234-99236 to of the care plan for observation, as well as, periodic reassessments. (continued) indicate Observation or inpatient hospital Care (including The patient is not required to be physically located in a designated admission and discharge) CPT observation area, within a hospital. The designation of “observation status” codes 99234-99236 are used to refers to the initiation of Observation Care and not to a specific area of a report observation or initial facility. CPT and CMS guidelines indicate that initial observation services are hospital services for a patient reported only by the Admitting/Supervising Physician or Other Qualified that is admitted and discharged Health Care Professional. on the same date of service • Removed definition of Same When a patient is admitted to “observation status”, during the course of Specialty Physician or Other another encounter from a different site of service, such as the physician's Qualified Health Care office or the emergency department, all of the E/M services rendered are Professional (refer to the considered part of the initial Observation Care services, when they are Definitions section of the policy) performed on the same day; the level of the initial Observation Care CPT Reimbursement Guidelines code reported should incorporate the other services related to the hospital • Added guidelines for Duplicate outpatient observation admission that were provided in any other site of or Repeat Services to indicate: service, as well as, those provided in the actual observation setting. o When duplicate or repeat Initial Observation Care, In order to report initial Observation Care CPT codes, the subsequent Observation Admitting/Supervising Physician or Other Qualified Health Care Professional Care, Observation Care must include: discharge day management, • Documentation within the patient’s medical record that the patient is Observation or inpatient designated as or admitted to observation status. The medical record hospital Care (including should include the Admitting/Supervising Physician or Other Qualified admission and discharge), or Health Care Professional’s dated and timed orders that detail the inpatient hospital discharge observation services the patient is to receive. day management CPT codes • Documentation that the Admitting/Supervising Physician or Other are reported by the same or Qualified Health Care Professional explicitly assessed patient risk to different Physician or Other determine that the patient would benefit from Observation Care. This Qualified Health Care documentation must be in addition to any other documentation Professional, only one prepared, as a result of an emergency department or outpatient Physician or Other Qualified clinic/other site of service encounter. Health Care Professional will • Nursing notes and progress notes that are timed, written and signed by be reimbursed the Admitting/Supervising Physician or Other Qualified Health Care o For the purposes of this Professional, during the time the patient received Observation Care. policy, duplicate or repeat services are defined as initial UnitedHealthcare follows the Centers for Medicare and Medicaid Services

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Observation and May 1, 2020 or subsequent Observation (CMS) Claims Processing Manual and will consider reimbursement for initial Discharge Care, Observation Care Observation Care CPT codes when billed only by the Admitting/Supervising (continued) discharge day management, Physician or Other Qualified Health Care Professional who ordered the Observation or inpatient hospital outpatient Observation Care services and who was responsible for hospital Care (including the patient, during his/her Observation Care stay. admission and discharge), or inpatient hospital discharge A Physician or Other Qualified Health Care Professional who does not have day management CPT codes inpatient admitting privileges, but is authorized to furnish hospital outpatient submitted for the same observation services, may bill initial Observation Care CPT codes. Consistent patient, within the same with CMS guidelines, UnitedHealthcare requires that an Initial Observation stay, by any other Physician Care CPT code 99218-99220 be reported for a patient admitted to or Qualified Health Care “observation status” for less than 8 hours on a calendar date. Professional, other than the Admitting/Supervising Subsequent Observation Care Physician or Other Qualified Similar to initial Observation Care CPT codes, payment for subsequent Health Care Professional Observation Care CPT codes includes all of the care rendered by only the • Revised guidelines for: Admitting/Supervising Physician or Other Qualified Health Care Professional o Initial Observation Care on the day(s) other than the initial or discharge date. In the instance that a o Subsequent Observation patient is held in observation status for more than two calendar dates, the Care Admitting/Supervising Physician or Other Qualified Health Care Professional o Observation Care Discharge should utilize subsequent Observation Care CPT codes 99224-99226. Day Management Services o Observation Care Admission According to the CPT codebook: “All levels of subsequent Observation Care and Discharge Services on include reviewing the medical record and reviewing the results of diagnostic Same Date studies and changes in the patient's status (i.e., changes in history, physical o Observation Care Services conditions, and response to management) since the last assessment.” During a Global Period o Inpatient Hospital Discharge All other Physicians or Other Qualified Health Care Professionals, who furnish Day Management Services consultations or additional evaluations or services, while the patient is Definitions receiving outpatient hospital observation services, must bill the appropriate • Added definition of: outpatient service codes. o Admitting/Supervising Physician or Other Qualified Observation Care Discharge Day Management Services Health Care Professional Per CPT, Observation Care discharge day management services (CPT code o Duplicate or Repeat Services 99217) includes final examination of the patient, discussion of the hospital • Revised definition of “Physician stay, instructions for continuing care to all relevant caregivers and or Other Qualified Health Care preparation of discharge records, prescriptions and referral forms, performed Professional” by the Admitting/Supervising Physician or other Qualified Health Care

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Observation and May 1, 2020 Applicable Codes Professional. Discharge • Reformatted list of applicable (continued) CPT codes Observation Care discharge services include all E/M services on the date of Questions and Answers (Q&A) discharge from observation status and should only be reported if the • Updated Q&A #2, #3, and #4 to discharge from observation status is on a date other than the date of initial reflect Overview and Observation Care. Reimbursement Guidelines Observation Care Admission and Discharge Services on Same Date Supporting Information

• Updated References section to Admitting/Supervising Physicians or Other Qualified Health Care reflect the most current Professionals, who admit a patient to observation status for a minimum of 8 information hours, but less than 24 hours with discharge from observation status on the

same calendar date, should report Observation or inpatient hospital Care (including admission and discharge services) CPT codes 99234-99236, as appropriate.

In accordance with CMS Claims Processing Manual, when reporting an Observation or inpatient hospital Care (including admission and discharge) CPT code, the medical record must include: • Documentation meeting the E/M requirements for history, examination and medical decision making. • Documentation stating the stay for hospital treatment or Observation Care status involves 8 hours but less than 24 hours. • Documentation identifying the Admitting/Supervising Physician or Other Qualified Health Care Professional was present and personally performed the services; and • Documentation identifying that the admission and discharge notes were written by the Admitting/Supervising Physician or Other Qualified Health Care Professional.

Observation or inpatient hospital Care (including admission and discharge), includes the final examination of the patient and discussion of the hospital stay, even if the time spent by the Admitting/Supervising Physician or other Qualified Health Care Professional on that date is not continuous, instructions for continuing care to all relevant caregivers, and preparation of discharge records, prescriptions and referral forms.

Observation Care Services During a Global Period Observation Care codes are not separately reimbursable services when

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Observation and May 1, 2020 performed within the assigned global of a procedure or service. Observation Discharge Care services, during a global period, are included in the global package. (continued) Refer to the Reimbursment Policy titled Global Days for guidelines on reporting services during a global period.

Inpatient Hospital Discharge Day Management Services Per CPT, the hospital discharge day management codes 99238 and 99239 are to be used to report the total duration of time spent by the Admitting/Supervising Physician or Other Qualified Health Care Professional for final hospital discharge of a patient. The codes include the final examination of the patient, discussion of the hospital stay, even if the time spent by the Admitting/Supervising Physician or other Qualified Health Care Professional on that date is not continuous, instructions for continuing care to all relevant caregivers, and preparation of discharge records, prescriptions and referral forms.

In accordance with CMS' Claims Processing Manual, hospital discharge day management services (CPT code 99238 or 99239) are face-to-face evaluation and management (E/M) services between the Admitting/Supervising Physician or Other Qualified Health Care Professional and the patient. The hospital discharge day management services should be reported for the date of the actual visit by the Admitting/Supervising Physician or Other Qualified Health Care Professional, even if the patient is discharged from the facility on a different calendar date. Only one hospital discharge day management service is payable per patient per hospital stay.

Only the Admitting/Supervising Physician or Other Qualified Health Care Professional of record reports the discharge day management service. Physicians or Other Qualified Health Care Professionals, other than the Admitting/ Supervising Physician or Other Qualified Health Care Professional, who have been managing concurrent health care problems, not primarily managed by the Admitting/Supervising Physician or Other Qualified Health Care Professional, who are not acting on behalf of the Admitting/Supervising Physician or Other Qualified Health Care Professional, should use subsequent hospital care CPT codes 99231-99233 for their final visit.

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 Reimbursement Guidelines Oxford will consider for reimbursement Telehealth services which are Telemedicine • Added language to indicate: recognized by The Centers for Medicare and Medicaid Services (CMS) and o Oxford will consider for appended with modifiers GT, GQ , or G0 (numeric zero, not alpha O) for reimbursement Telehealth telehealth services related to acute stroke, as well as services recognized by services which are the AMA included in Appendix P of CPT and appended with modifier 95. recognized by The Centers for Medicare and Medicaid In addition, Oxford recognizes certain additional services which can be Services (CMS) and effectively performed via Telehealth/Telemedicine. These codes will be appended with modifier G0 considered for reimbursement when reported with modifier GT or GQ: (numeric zero, not alpha O) • Medical genetics and genetic counseling services (CPT code 96040) for telehealth services • Education and training for patient self-management by a qualified, related to acute stroke nonphysician health care professional using a standardized curriculum o Oxford recognizes but does (codes 98960-98962) not require Place of Service • Alcohol and/or substance abuse screening and brief intervention services (POS) code 02 for reporting (codes 99408-99409) Telehealth services rendered • Remote real-time interactive video-conferenced critical care evaluation by a physician or practitioner and management of the critically ill or critically injured patient (CPT code from a Distant Site; 99499) modifiers G0 are required instead to identify Telehealth Oxford requires one of the telehealth-associated modifiers (GT, GQ, G0 or services 95) to be reported when performing a service via Telehealth to indicate the • Replaced language indicating type of technology used and to identify the service as Telehealth. Oxford will “Oxford requires one of the consider reimbursement for a procedure code/modifier combination using [listed] modifiers to be reported these modifiers only when the modifier has been used appropriately. when performing a service via Telehealth to indicate the type of Oxford recognizes the CMS designated Originating Sites which are technology used and to identify considered eligible for furnishing a Telehealth service to a patient located in the service as Telehealth” with an Originating Site. “Oxford requires one of the telehealth-associated modifiers Examples of Originating Sites are listed below: (GT, GQ, G0 or 95) to be • The office of a physician or practitioner reported when performing a • A hospital (inpatient or outpatient) service via Telehealth to indicate • A critical access hospital (CAH) the type of technology used and • A rural health clinic (RHC) to identify the service as • A federally qualified health center (FQHC) Telehealth” • A hospital-based or critical access hospital-based renal dialysis center • Removed list of modifier (including satellites) descriptions Note: Independent renal dialysis facilities are not eligible Originating

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 Telehealth Transmission Sites Telemedicine • Added language to indicate • A skilled nursing facility (SNF) (continued) Oxford follows CMS guidelines • A community mental health center (CMHC) which do not allow • Mobile Stroke Unit reimbursement for telehealth • Patient home - only for monthly end stage renal, ESRD-related clinical transmission, per minute, assessments, and for purposes of treatment of a substance use disorder professional services bill or a co-occurring mental health disorder separately reported with HCPCS code T1014; they are non- Oxford recognizes the CMS-designated practitioners eligible to be reimbursed reimbursable codes according to for Telehealth services. Examples of practitioners are listed below: the CMS Physician Fee Schedule • Physician (PFS) and are considered • Nurse practitioner included in Telehealth services • Physician assistant Online Digital Evaluation and • Nurse-midwife Medical Evaluation • Clinical nurse specialist • Revised language to indicate: • Clinical psychologist o Oxford aligns with CMS • Clinical social worker Physician Fee Schedule • Certified Registered Nurse Anesthetists (PFS) guidelines and • Registered dietitian or nutrition professional considers online digital evaluation and management Oxford recognizes but does not require Place of Service (POS) code 02 for services (99421-99423 and reporting Telehealth services rendered by a physician or practitioner from a G2061-G2063) eligible for Distant Site. Modifiers GT, GQ, G0 or 95 are required instead to identify reimbursement; these codes Telehealth services. must be reported according to the guidelines as outlined Oxford recognizes federal and state mandates regarding Telehealth and by the AMA in CPT Telemedicine. o Codes 98970-98972 are not eligible for reimbursement, Telehealth Transmission according to the CMS PFS Oxford follows CMS guidelines which do not allow reimbursement for

Remote Evaluation of Recorded Telehealth transmission, per minute, professional services bill separately

Video and/or Images (new to reported with HCPCS code T1014. They are non-reimbursable codes

policy) according to the CMS Physician Fee Schedule (PFS) and are considered

• Added language to indicate included in Telehealth services. Oxford follows CMS guidelines and considers remote evaluation Telephone Services of recorded video and/or images Oxford follows CMS guidelines which we do not allow reimbursement for submitted by an established telephone services which are non-face-to face evaluation and management

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 patient (e.g., store and forward), services by a Physician or Other Qualified Health Care Professional reported Telemedicine including interpretation with with CPT codes 98966-98968 or 99441-99443. They are non-reimbursable (continued) follow-up with the patient within codes according to the CMS Physician Fee Schedule (PFS) and are considered 24 business hours, not originating an integral part of other services provided. from a related E/M service provided within the previous 7 On-Line Digital Evaluation and Medical Evaluation days reported with HCPCS codes Oxford aligns with follows CMS Physician Fee Schedule (PFS) guidelines and G2010 eligible for reimbursement considers online digital evaluation and management services (99421-99423 according to the CMS Physician and G2061-G2063) eligible for reimbursement. These codes must be Fee Schedule (PFS) reported according to the guidelines as outlined by the AMA in CPT. Opioid Use Disorder Treatment Note: Codes 98970-98972 are not eligible for reimbursement, according to (new to policy) the CMS PFS. • Added language to indicate Oxford follows CMS guidelines Interprofessional Telephone/Internet/Electronic Health Record effective for services rendered Consultations

on or after January 1, 2020, and Oxford follows CMS guidelines and considers interprofessional

considers office-based treatment telephone/Internet assessment and management services reported with CPT

for opioid use disorders (HCPCS codes 99446-99449 and 99451-99452 eligible for reimbursement according to

codes G2086-G2088) eligible for the CMS Physician Fee Schedule (PFS).

reimbursement according to the

CMS Physician Fee Schedule Digitally Stored Data Services/Remote Physiologic

(PFS) Monitoring/Remote Physiologic Treatment Management

Applicable Codes Oxford follows CMS guidelines and considers digitally stored data services or Reformatted list of Non- • remote physiologic monitoring services reported with CPT codes 99453, Reimbursable CPT/HCPCS Codes 99454, 99457, and 99091 eligible for reimbursement according to the CMS (regardless of appended Physician Fee Schedule (PFS). modifier)

Questions and Answers (Q&A) Remote Evaluation of Recorded Video and/or Images • Removed Q&A #3 pertaining to Oxford follows CMS guidelines and considers remote evaluation of recorded reimbursement of website video and/or images submitted by an established patient (e.g., store and charges for physician groups forward), including interpretation with follow-up with the patient within 24

business hours, not originating from a related E/M service provided within the previous 7 days reported with HCPCS codes G2010 eligible for reimbursement according to the CMS Physician Fee Schedule (PFS).

Brief Communication Technology-Based Service Oxford follows CMS guidelines and considers brief communication technology-

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 based service, e.g., virtual check-in, by a Physician or Other Qualified Health Telemedicine Care Professional who can report evaluation and management services, (continued) provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion reported with HCPCS code G2012 eligible for reimbursement according to the CMS qualified Fee Schedule (PFS).

Opioid Use Disorder Treatment Oxford follows CMS guidelines effective for services rendered on or after January 1, 2020, and considers office-based treatment for opioid use disorders (HCPCS codes G2086-G2088) eligible for reimbursement according to the CMS Physician Fee Schedule (PFS). Telehealth and May 1, 2020 Reimbursement Guidelines Oxford will consider for reimbursement Telehealth services which are Telemedicine (CES) • Added language to indicate: recognized by The Centers for Medicare and Medicaid Services (CMS) and o Oxford will consider for appended with modifiers GT, GQ, or G0 (numeric zero, not alpha O) for reimbursement Telehealth telehealth services related to acute stroke, as well as services recognized by services which are the AMA included in Appendix P of CPT and appended with modifier 95. recognized by The Centers for Medicare and Medicaid In addition, Oxford recognizes certain additional services which can be Services (CMS) and effectively performed via Telehealth/Telemedicine .These codes will be appended with modifier G0 considered for reimbursement when reported with modifier GTor GQ: (numeric zero, not alpha O) • Medical genetics and genetic counseling services (CPT code 96040) for telehealth services • Education and training for patient self-management by a qualified, related to acute stroke nonphysician health care professional using a standardized curriculum o Oxford recognizes but does (CPT codes 98960-98962) not require Place of Service • Alcohol and/or substance abuse screening and brief intervention services (POS) code 02 for reporting (CPT codes 99408-99409) Telehealth services rendered • Remote real-time interactive video-conferenced critical care evaluation by a physician or practitioner and management of the critically ill or critically injured patient (CPT code from a Distant Site; 99499) modifiers G0 are required instead to identify Telehealth Oxford requires one of the telehealth-associated modifiers (GT, GQ, G0, or services 95) to be reported when performing a service via Telehealth to indicate the • Replaced language indicating type of technology used and to identify the service as Telehealth. Oxford will “Oxford requires one of the consider reimbursement for a procedure code/modifier combination using [listed] modifiers to be reported these modifiers only when the modifier has been used appropriately. Coding when performing a service via relationships for modifier GQ and modifier 95 are administered through the

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 Telehealth to indicate the type of Reimbursement Policy titled Procedure to Modifier (CES). Telemedicine (CES) technology used and to identify (continued) the service as Telehealth” with Oxford recognizes the CMS designated Originating Sites which are “Oxford requires one of the considered eligible for furnishing a Telehealth service to a patient located in telehealth-associated modifiers an Originating Site. (GT, GQ, G0 or 95) to be reported when performing a Examples of Originating Sites are listed below: service via Telehealth to indicate • The office of a physician or practitioner the type of technology used and • A hospital (inpatient or outpatient) to identify the service as • A critical access hospital (CAH) Telehealth” • A rural health clinic (RHC) • Removed list of modifier • A federally qualified health center (FQHC) descriptions • A hospital-based or critical access hospital-based renal dialysis center Online Digital Evaluation and (including satellites) Medical Evaluation Note: Independent renal dialysis facilities are not eligible Originating • Revised language to indicate: Sites o Oxford aligns with CMS • A skilled nursing facility (SNF) Physician Fee Schedule • A community mental health center (CMHC) (PFS) guidelines and • Mobile Stroke Unit considers online digital • Patient home - only for monthly end stage renal, ESRD-related clinical evaluation and management assessments, and for purposes of treatment of a substance use disorder services (99421-99423 and or a co-occurring mental health disorder G2061-G2063) eligible for reimbursement; these codes Oxford recognizes the CMS-designated practitioners eligible to be reimbursed must be reported according for Telehealth services. Examples of practitioners are listed below: to the guidelines as outlined • Physician by the AMA in CPT • Nurse practitioner o Codes 98970-98972 are not • Physician assistant eligible for reimbursement, • Nurse-midwife according to the CMS PFS • Clinical nurse specialist Remote Evaluation of Recorded • Clinical psychologist Video and/or Images (new to • Clinical social worker policy) • Certified Registered Nurse Anesthetists • Added language to indicate • Registered dietitian or nutrition professional Oxford follows CMS guidelines and considers remote evaluation Oxford recognizes but does not require Place of Service (POS) code 02 for of recorded video and/or images reporting Telehealth services rendered by a physician or practitioner from a submitted by an established Distant Site. Modifiers GT, GQ, G0, or 95 are required instead to identify

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 patient (e.g., store and forward), Telehealth services. Telemedicine (CES) including interpretation with (continued) follow-up with the patient within Oxford recognizes federal and state mandates regarding Telehealth and 24 business hours, not originating Telemedicine. from a related E/M service provided within the previous 7 Telehealth Transmission days reported with HCPCS codes Oxford follows CMS guidelines which do not allow reimbursement for G2010 eligible for reimbursement Telehealth transmission, per minute, professional services bill separately according to the CMS Physician reported with HCPCS code T1014. They are non-reimbursable codes Fee Schedule (PFS) according to the CMS Physician Fee Schedule (PFS) and are considered Opioid Use Disorder Treatment included in Telehealth services. (new to policy) • Added language to indicate Telephone Services

Oxford follows CMS guidelines Oxford follows CMS guidelines which we do not allow reimbursement for

effective for services rendered telephone services which are non-face-to face evaluation and management

on or after January 1, 2020, and services by a Physician or Other Qualified Health Care Professional reported

considers office-based treatment with CPT codes 98966-98968 or 99441-99443. They are non-reimbursable

for opioid use disorders (HCPCS codes according to the CMS Physician Fee Schedule (PFS) and are considered

codes G2086-G2088) eligible for an integral part of other services provided.

reimbursement according to the

CMS Physician Fee Schedule Online Digital Evaluation and Medical Evaluation (PFS) Oxford aligns with CMS Physician Fee Schedule (PFS) guidelines and Applicable Codes considers online digital evaluation and management services (99421-99423 Reformatted list of Non- • and G2061-G2063) eligible for reimbursement. These codes must be Reimbursable CPT/HCPCS Codes reported according to the guidelines as outlined by the AMA in CPT. (regardless of appended Note: Codes 98970-98972 are not eligible for reimbursement, according to modifier) the CMS PFS. Questions and Answers (Q&A)

• Removed Q&A #3 pertaining to Interprofessional Telephone/Internet/Electronic Health Record reimbursement of website Consultations charges for physician groups Oxford follows CMS guidelines and considers interprofessional telephone/Internet assessment and management services reported with CPT codes 99446-99449 and 99451-99452 eligible for reimbursement according to the CMS Physician Fee Schedule (PFS).

Digitally Stored Data Services/Remote Physiologic Monitoring/Remote Physiologic Treatment Management

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Telehealth and May 1, 2020 Oxford follows CMS guidelines and considers digitally stored data services or Telemedicine (CES) remote physiologic monitoring services reported with CPT codes 99453, (continued) 99454, 99457, and 99091 eligible for reimbursement according to the CMS Physician Fee Schedule (PFS).

Remote Evaluation of Recorded Video and/or Images Oxford follows CMS guidelines and considers remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days reported with HCPCS codes G2010 eligible for reimbursement according to the CMS Physician Fee Schedule (PFS).

Brief Communication Technology-Based Service Oxford follows CMS guidelines and considers brief communication technology-based service, e.g., virtual check-in, by a Physician or Other Qualified Health Care Professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion reported with HCPCS code G2012 eligible for reimbursement according to the CMS qualified Fee Schedule (PFS).

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Time Span Codes May 1, 2020 corresponding time span For example: Within the CPT book, the code description for CPT code 95250 (continued) designations: states, “Ambulatory continuous glucose monitoring of interstitial tissue fluid o Added HCPCS code G2066 via subcutaneous sensor for a minimum of 72 hours; sensor placement, (30 days) hook-up, calibration of monitor, patient training, removal of sensor, and o Revised time span printout of recording”. In addition to that code description, there is also a designation for HCPCS code parenthetical that provides further instructions with regard to the frequency A4226; replaced “7 days” the code can be reported. The parenthetical states, “Do not report 95250 with “weekly” more than once per month”. Oxford will reimburse CPT Code 95250 only o Removed CPT/HCPCS codes once per month for the same member, for services provided by the Same 0533T, 0534T, 0535T, Group Physician and/or Other Qualified Health Care Professional. 0536T, G0502, G0503 and G0507 CPT coding guidelines specify for physicians or other qualified health care • Revised list of applicable professionals to select the name of the procedure or service that accurately comprehensive/component CPT identifies the services performed. codes; added comprehensive code 0533T with corresponding Refer to Q&A #2 of the Questions and Answers section of the policy for component codes 0534T, 0535T, information on Time Span Code values and modifier usage. and 0536T External Electrocardiographic Recording Services - CPT codes 93224, 93225, 93226, and 93227 Reported with Modifier 52 CPT codes 93224-93227 are reported for external electrocardiographic recording services up to 48 hours by continuous rhythm recording and storage. CPT coding guidelines for codes 93224-93227 specify that when there are less than 12 hours of continuous recording modifier 52 (Reduced Services) should be used.

When modifier 52 is appended to CPT code 93224, 93225, 93226, or 93227, Oxford does not apply the Time Span Codes Policy for reimbursement of these codes. Instead, Oxford applies the Reduced Services policy which addresses reimbursement for codes appended with modifier 52.

End-Stage Renal Disease Services (ESRD) 90951-90962

CPT codes 90951-90962 are grouped by age of the patient and the number

of face-to-face physician or other qualified health care professional visits

provided per month (i.e., 1, 2-3, or 4 or more). Oxford will reimburse the

single most comprehensive outpatient ESRD code submitted per age

category (i.e., under 2 years of age, 2-11 years of age, 11-19 years of age,

and 20 years of age and older) once per month. This aligns with CPT coding

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Oxford

Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Time Span Codes May 1, 2020 guidance which states to report the age-specific ESRD codes should be (continued) reported once per month for all physician or other qualified health care professional face-to-face outpatient services.

Time Span Comprehensive and Component Codes When related Time Span Codes which share a common portion of a code description are both reported during the same time span period by the Same Group Physicians and/or Other Qualified Health Care Professional for the same patient, the code with the most comprehensive description is the reimbursable service. The other code is considered inclusive and is not a separately reimbursable service. No modifiers will override this denial.

The following example illustrates how the CPT book lists code 93268 first as it is the comprehensive code. CPT codes 93270, 93271, and 93272 are indented and each share a common component of their code description with CPT code 93268.

CPT Code Description External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote 93268 download capability up to 30 days, 24-hour attended monitoring; includes transmission, physician review and interpretation Recording (includes connection, recording, and 93270 disconnection)

93271 Transmission and analysis

Review and interpretation by a physician or other 93272 qualified health care professional

When CPT code 93270, 93271, or 93272 are reported with CPT 93268 during the same 30 day period by the Same Group Physician and/or Other Qualified Health Care Professional for the same patient, only CPT code 93268 is the reimbursable service.

The Time Span Comprehensive and Component Codes list includes applicable comprehensive and related component Time Span Codes.

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Oxford

General Information

The inclusion of a health service (e.g., test, drug, device or procedure) Policy Update Classifications in this bulletin indicates only that UnitedHealthcare is adopting a new New policy and/or updated, revised, replaced or retired an existing policy; New clinical coverage criteria and/or documentation review ® it does not imply that Oxford provides coverage for the health service. requirements have been adopted for a health service (e.g., test, drug, Note that most benefit plan documents exclude from benefit coverage device or procedure) health services identified as investigational or unproven/not medically necessary. Physicians and other health care professionals may not seek Updated or collect payment from a member for services not covered by the An existing policy has been reviewed and changes have not been made applicable benefit plan unless first obtaining the member’s written to the clinical coverage criteria or documentation review requirements; consent, acknowledging that the service is not covered by the benefit however, items such as the clinical evidence, FDA information, and/or plan and that they will be billed directly for the service. list(s) of applicable codes may have been updated Revised Note: The absence of a policy does not automatically indicate or imply An existing policy has been reviewed and revisions have been made to coverage. As always, coverage for a health service must be determined the clinical coverage criteria and/or documentation review requirements in accordance with the member’s benefit plan and any applicable federal or state regulatory requirements. Additionally, Oxford® reserves Replaced the right to review the clinical evidence supporting the safety and An existing policy has been replaced with a new or different policy effectiveness of a medical technology prior to rendering a coverage Retired determination. The health service(s) addressed in the policy are no longer being Oxford® respects the expertise of the physicians, health care managed or are considered to be proven/medically necessary and are professionals, and their staff who participate in our network. Our goal is therefore not excluded as unproven/not medically necessary services, to support you and your patients in making the most informed unless coverage guidelines or criteria are otherwise documented in decisions regarding the choice of quality and cost-effective care, and to another policy support practice staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share Tips for using the Policy Update Bulletin ® important information regarding Oxford Medical and Administrative • From the table of contents, click the policy title to be directed to the Policy updates. When information in this bulletin conflicts with corresponding policy update summary. ® applicable state and/or federal law, Oxford follows such applicable • From the policy updates table, click the policy title to view a federal and/or state law. complete copy of a new, updated, or revised policy.

A complete library of Oxford Medical and Administrative Policies is available at OxfordHealth.com > Providers > Tools & Resources > Medical Information > Medical and Administrative Policies or at UHCprovider.com > Policies and Protocols > Commercial Policies > UnitedHealthcare Oxford Clinical, Administrative and Reimbursement Policies. Refer to the back of the member's health care ID card for the applicable website.

99 Oxford® Policy Update Bulletin: April 2020