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April 2020 policy update bulletin Medical & Administrative 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

Access a policy listed below for complete details on the latest updates. A comprehensive summary of changes is provided at the bottom of every policy document for your reference.

To view a detailed version of this bulletin, click here.

Policy Title Status Effective Date CLINICAL POLICY Abnormal Uterine Bleeding and Uterine Fibroids Revised Jun. 1, 2020 Actemra® (Tocilizumab) Injection for Intravenous Infusion Revised May 1, 2020 Adakveo® (Crizanlizumab-Tmca) Updated Apr. 1, 2020 Adakveo® (Crizanlizumab-Tmca) Revised Jul. 1, 2020 Cell-Free Fetal DNA Testing Revised Jun. 1, 2020 Cimzia® (Certolizumab Pegol) New Jul. 1, 2020 Collagen Crosslinks and Biochemical Markers of Bone Turnover Revised May 1, 2020 Drug Coverage Criteria – New and Therapeutic Equivalent Medications Revised May 1, 2020 Drug Coverage Guidelines Revised Apr. 1, 2020  Adakveo (Crizanlizumab-Tmca)  Givlaari (Givosiran)  Ziextenzo (Pegfilgrastim-Bmez) Drug Coverage Guidelines Revised May 1, 2020  Adlyxin (Lixisenatide)  Arnuity Ellipta (Fluticasone Furoate)  Arikayce (Amikacin)  Avsola (Infliximab-Axxq)  Ayvakit (Avapritinib)  Azesco (13 Mg Iron-1 Tablet Multivitamins)  Basaglar (Insulin Glargine)  Bethkis (Tobramycin)  Bosulif (Bosutinib)  Bydureon (Exenatide)  Bydureon Bcise (Exenatide)

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Policy Title Status Effective Date  Byetta (Exenatide)  Cayston (Aztreonam for Inhalation Solution)  Cinqair (Reslizumab)  Clobex 0.05% Spray (Brand Only) (Clobetasol Propionate)  Cuvitru [Immune Globulin Subcutaneous (Human)]  Divigel 1.25g (Estradiol Gel)  Drizalma (Duloxetine)  Egrifta (Tesamorelin)  Ezallor Sprinkle (Rosuvastatin)  Farxiga (Depagliflozin)  Fasenra (Benralizumab)  Feraheme (Ferumoxytol)  Firdapse (Amifampridine)  Flebogamma (Immune Globulin Non-Lyophilized)  Flovent Diskus, Flovent HFA (Fluticasone)  Gammagard® Liquid (Immunoglobulin, Non-Lyophilized)  Gammaplex (Immunoglobulin, Non-Lyophilized)  Gamunex-C, Gammaked (Immune Globulin, Non-Lyophilized)  Gloperba (Colchicine)  Glyxambi (Empagliflozin/ Linagliptin)  Hizentra (Immune Globulin)  Immune Globulin (IVIG and SCIG)  Injectafer (Ferric Carboxymaltose)  Invokana (Canagliflozin)  Janumet (Sitagliptin and Metformin Hydrochloride)  Janumet XR (Sitagliptin and Metformin Hydrochloride, Extended Release)  Januvia (Sitagliptin)  Jardiance (Empagliflozin)  Kitabis Pak (Tobramycin)  Lantus (Insulin Glargine)  Lantus Solostar (Insulin Glargine)  Levemir (Insulin Detemir)  Lovaza (Brand Only) (Omega-3-Acid Ethyl Esters)  Lovaza (Generic) (Omega-3-Acid Ethyl Esters)  Lynparza (Olaparib)  Monoferric (Ferric Derisomaltose)  Nexletol (Bempedoic Acid)  Noxafil (Brand Only) (Posaconazole)  Nucala (Mepolizumab)  Nurtec ODT (Rimegepant)  Octagam (Immune Globulin, Non-Lyophilized)  Oxervate (Cenegermin)  Ozempic (Semaglutide)  Ozobax (Baclofen)  Qtern (Dapagliflozin/ Saxagliptin)  Panzyga (Immunoglobulin Intravenous, Human)  Praluent (Alirocumab)  Prenatal Vitamins  Privigen (Immune Globulin)  Prograf Granules for Suspension (Tacrolimus)  Pulmicort Flexhaler (Budesonide)  Pulmozyme® (Dornase Alfa)  Rapaflo (Brand Only) (Silodosin)  Repatha (Evolocumab)  Rybelsus (Semaglutide)  Segluromet (Ertugliflozin/ Metformin Hcl)  Slynd (Drospirenone)  Spravato (Esketamine)  Steglatro (Ertugliflozin)

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Policy Title Status Effective Date  Steglujan (Ertugliflozin/ Sitagliptin)  Tepezza (Teprotumumab-Trbw)  Tirosint-Sol Oral Solution (Levothyroxine Sodium)  Tobi™ Nebulizer Solution (Tobramycin Inhalation Solution)  Tobi® Podhaler™ (Tobramycin Inhalation Powder)  Tobramycin Nebulized Solution (Generic Tobi)  Toujeo Solostar (Insulin Glargine)  Tresiba Flex Touch (Insulin Degludec)  Trijardy XR (Empagliflozin/ Linagliptin/Metformin Hydrochloride)  Trinaz (Prenatal Vitamin)  Trulicity (Dulaglutide)  Vascepa (Omega-3-Acid Ethyl Esters)  Vascepa 0.5 Gram Only (Omega-3-Acid Ethyl Esters)  Vectical (Calcitriol)(Generic)  Vectical Ointment (Brand Only)  Victoza (Liraglutide)  Vyepti (Eptinezumab-JJMR)  Vyndamax (Tafamidis)  Vyndaqel (Tafamidis Meglumine)  Xalkori (Crizotinib)  Xeljanz (Tofacitinib)  Xeljanz XR  Xembify (Immune Globulin Subcutaneous, Human- Klhw)  Xigduo XR (Dapagliflozin and Metformin Hcl)  Xospata (Gilteritinib)  Yonsa (Abiraterone Acetate)  Zerviate (Cetirizine Ophthalmic Solution)  Ziextenzo (Pegfilgrastim-Bmez)  Zomig and Zomig-ZMT (Zolmitriptan)  Zomig (Zolmitriptan)

Entyvio® (Vedolizumab) Revised May 1, 2020 Epidural Steroid and Facet Injections for Spinal Pain Revised May 1, 2020 Fetal Aneuploidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood Updated Apr. 1, 2020 Givlaari™ (Givosiran) Updated Apr. 1, 2020 Givlaari™ (Givosiran) Revised Jul. 1, 2020 Glaucoma Surgical Treatments Revised Jun. 1, 2020 Gonadotropin Releasing Hormone Analogs Revised May 1, 2020 Home Health Care Updated Apr. 1, 2020 Infertility Diagnosis and Treatment Revised Jun. 1, 2020 Intravenous Iron Replacement Therapy (Feraheme® & Injectafer®, & Revised May 1, 2020 Monoferric®) Knee Replacement Surgery (Arthroplasty), Total and Partial Updated May 1, 2020 Lemtrada (Alemtuzumab) Revised May 1, 2020 Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) Scan – New Jun. 1, 2020 Site of Service Manipulation Under Anesthesia Revised May 1, 2020 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Updated Apr. 1, 2020 Decisions Radicava® (Edaravone) Revised May 1, 2020 Reblozyl® (Luspatercept-Aamt) Revised Jul. 1, 2020 Respiratory Interleukins (Cinqair®, Fasenra®, & Nucala®) Revised May 1, 2020 Simponi Aria® (Golimumab) Injection for Intravenous Infusion Revised May 1, 2020

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Policy Title Status Effective Date Stelara® (Ustekinumab) Revised May 1, 2020 Tepezza™ (Teprotumumab-Trbw) New May 1, 2020 Trogarzo® (Ibalizumab-Uiyk) Revised May 1, 2020 Vyepti™ (Eptinezumab-Jjmr) New May 1, 2020 Vyondys 53™ (Golodirsen) New Apr. 1, 2020 Vyondys 53™ (Golodirsen) Revised Jul. 1, 2020 White Blood Cell Colony Stimulating Factors Updated Apr. 1, 2020 ADMINISTRATIVE POLICY Orthopedic Services Revised May 1, 2020 Participating Gastroenterologists Using Non-Participating Anesthesiologists: In- Updated May 1, 2020 Office and Ambulatory Surgery Centers Protocol Participating Providers Using Non-Participating Laboratory and Pathology Updated May 1, 2020 Providers Protocol Participating Providers Using Non-Participating Providers Protocol Revised May 1, 2020 Participating Surgeons Using Non-Participating Assistant Surgeons and Co- Updated May 1, 2020 Surgeons Protocol Participating Surgeons Using Non-Participating Providers for Intraoperative Updated May 1, 2020 Neuro-Monitoring (IONM) Protocol Precertification Exemptions for Outpatient Services Revised Apr. 1, 2020 Speech Therapy and Early Intervention Programs/Birth to Three Revised May 1, 2020 Timeframe Standards for Utilization Management (UM) Initial Decisions Revised May 1, 2020 REIMBURSEMENT POLICY Drug Testing Updated Apr. 1, 2020 Increased Procedural Services Revised May 1, 2020 Increased Procedural Services (CES) Revised May 1, 2020 Injection and Infusion Services Revised May 1, 2020 Injection and Infusion Services (CES) Revised May 1, 2020 Observation and Discharge Revised May 1, 2020 Outpatient Hospital Add-On Codes (CES) New Jul. 1, 2020 Outpatient Hospital Maximum Frequency Per Day (CES) New Jul. 1, 2020 Prolonged Services Updated Apr. 1, 2020 Telehealth and Telemedicine Revised May 1, 2020 Telehealth and Telemedicine (CES) Revised May 1, 2020 Time Span Codes Revised May 1, 2020

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General Information

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

documentation review requirements Note: The absence of a policy does not automatically indicate or imply coverage. As always, coverage for a Replaced health service must be determined in accordance with An existing policy has been replaced with a new or the member’s benefit plan and any applicable federal different policy or state regulatory requirements. Additionally, Retired UnitedHealthcare Oxford® reserves the right to review the clinical evidence supporting the safety and The health service(s) addressed in the policy are no effectiveness of a medical technology prior to longer being managed or are considered to be rendering a coverage determination. proven/medically necessary and are therefore not excluded as unproven/not medically necessary UnitedHealthcare respects the expertise of the services, unless coverage guidelines or criteria are physicians, health care professionals, and their staff otherwise documented in another policy who participate in our network. Our goal is to support you and your patients in making the most informed decisions regarding the choice of quality and cost- effective care, and to support practice staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share important information regarding UnitedHealthcare Oxford® Medical and Administrative Policy updates. When information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law.

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.

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