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

March 2020 medical policy update bulletin Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

In This Issue Medical Policy Updates Page UPDATED  Cardiac Event Monitoring – Effective Apr. 1, 2020 ...... 3  Cytological Examination of Breast Fluids for Cancer Screening or Diagnosis – Effective Apr. 1, 2020 ...... 3  Elbow Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2020 ...... 3  Electrical and Ultrasound Bone Growth Stimulators – Effective Apr. 1, 2020 ...... 3  Implanted Electrical Stimulator for Spinal Cord – Effective Apr. 1, 2020 ...... 3  Obstructive Sleep Apnea Treatment – Effective Apr. 1, 2020 ...... 3  Pneumatic Compression Devices – Effective Apr. 1, 2020 ...... 3  Prolotherapy and Platelet Rich Plasma Therapies – Effective Apr. 1, 2020 ...... 3  Shoulder Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2020 ...... 3  Temporomandibular Joint Disorders – Effective Apr. 1, 2020 ...... 4 REVISED  Abnormal Uterine Bleeding and Uterine Fibroids – Effective Apr. 1, 2020 ...... 4  Attended Polysomnography for Evaluation of Sleep Disorders – Effective Apr. 1, 2020 ...... 4  Bariatric Surgery – Effective May 1, 2020 ...... 7  Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Effective Apr. 1, 2020 ...... 10  Electroencephalographic (EEG) Monitoring and Video Recording – Effective Apr. 1, 2020 ...... 12  Hip Resurfacing and Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2020 ...... 13  Hysterectomy for Benign Conditions – Effective Apr. 1, 2020 ...... 13  Knee Replacement Surgery (Arthroplasty), Total and Partial – Effective Apr. 1, 2020 ...... 13  Lower Extremity Vascular Angiography – Effective Apr. 1, 2020 ...... 14  Surgical Treatment for Spine Pain – Effective Apr. 1, 2020 ...... 14 Medical Benefit Drug Policy Updates NEW  Intravenous Iron Replacement Therapy (Feraheme® & Injectafer®) – Effective Apr. 1, 2020 ...... 16

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 Vyondys 53™ (Golodirsen) – Effective Apr. 1, 2020 ...... 18 UPDATED  Denosumab (Prolia® & Xgeva®) – Effective Mar. 1, 2020 ...... 20 REVISED  Botulinum Toxins A and B – Effective Apr. 1, 2020 ...... 20  Exondys 51® (Eteplirsen) – Effective Apr. 1, 2020 ...... 20  Ketalar (Ketamine) and Spravato™ (Esketamine) – Effective Apr. 1, 2020 ...... 21  Oncology Medication Clinical Coverage – Effective Apr. 1, 2020 ...... 26  Rituximab (Rituxan®, Ruxience™, & Truxima®) – Effective Apr. 1, 2020 ...... 27 Coverage Determination Guideline (CDG) Updates UPDATED  Blepharoplasty, Blepharoptosis, and Brow Ptosis Repair – Effective Apr. 1, 2020...... 30  Gynecomastia Treatment – Effective Apr. 1, 2020 ...... 30  Habilitative Services and Outpatient Rehabilitation Therapy – Effective Apr. 1, 2020 ...... 30  Orthognathic (Jaw) Surgery – Effective Apr. 1, 2020 ...... 30  Panniculectomy and Body Contouring Procedures – Effective Apr. 1, 2020 ...... 30  Rhinoplasty and Other Nasal Surgeries – Effective Apr. 1, 2020 ...... 30 Utilization Review Guideline (URG) Updates REVISED  Chemotherapy Observation or Inpatient Hospitalization – Effective Apr. 1, 2020 ...... 31  Provider Administered Drugs – Site of Care – Effective May 1, 2020 ...... 32

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Medical Policy Updates

Policy Title Effective Date Coverage Rationale UPDATED Cardiac Event Apr. 1, 2020 Coverage Rationale Monitoring  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, 2020” Cytological Apr. 1, 2020 References Examination of  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Breast Fluids for 2020” Cancer Screening or Diagnosis Elbow Replacement Apr. 1, 2020 Coverage Rationale Surgery  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, (Arthroplasty) 2020” Documentation Requirements  Updated required clinical information for elbow replacement surgery (arthroplasty) Electrical and Apr. 1, 2020 Coverage Rationale Ultrasound Bone  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Growth Stimulators 2020” Implanted Electrical Apr. 1, 2020 Coverage Rationale Stimulator for  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Spinal Cord 2020” Obstructive Sleep Apr. 1, 2020 Coverage Rationale Apnea Treatment  Replaced references to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, 2020” Pneumatic Apr. 1, 2020 Coverage Rationale Compression  Replaced references to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Devices 2020” Prolotherapy and Apr. 1, 2020 Coverage Rationale Platelet Rich  Replaced references to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Plasma Therapies 2020” Shoulder Apr. 1, 2020 Coverage Rationale Replacement  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Surgery 2020” (Arthroplasty) Documentation Requirements  Updated required clinical information for shoulder replacement surgery (arthroplasty) Supporting Information  Removed Professional Societies section

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Medical Policy Updates

Policy Title Effective Date Coverage Rationale UPDATED Temporomandibular Apr. 1, 2020 Coverage Rationale Joint Disorders  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, 2020” Documentation Requirements  Updated required clinical information for temporomandibular joint disorders

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Abnormal Uterine Apr. 1, 2020 Coverage Rationale Levonorgestrel-Releasing Intrauterine Device Bleeding and  Replaced reference to “MCG™ Levonorgestrel-releasing intrauterine devices (LNG-IUD) (e.g., rd Uterine Fibroids Care Guidelines, 23 edition, Mirena®, Skyla®, Liletta® or Kyleena™) are proven and medically 2019” with “MCG™ Care necessary for treating menorrhagia. th Guidelines, 24 edition, 2020”; Refer to the U.S. Food and Drug Administration (FDA) section of the policy th refer to the 24 edition for for additional information. complete details on applicable updates to the MCG™ Care Uterine Fibroids Guidelines Uterine artery embolization (UAE) is proven and medically necessary for treating symptomatic uterine fibroids. For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, 24th edition, 2020, Uterine Artery Embolization, ACG: A-0287 (AC).

Click here to view the MCG™ Care Guidelines.

UAE is unproven and not medically necessary for the purpose of preserving childbearing potential for women with symptomatic 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®) Attended Apr. 1, 2020 Coverage Rationale Home Sleep Apnea Testing Polysomnography Attended Full-Channel Nocturnal Home Sleep Apnea Testing (HSAT), using a portable monitor, is for Evaluation of Polysomnography, Performed in medically necessary for evaluating adults with suspected OSA. Sleep Disorders a Healthcare Facility or Where HSAT is indicated, an autotitrating Positive Airway Pressure (APAP) Laboratory Setting device is an option to determine a fixed PAP pressure.  Revised list of indicators of moderate to severe heart Attended Full-Channel Nocturnal Polysomnography, Performed in a

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Attended Apr. 1, 2020 failure; added “left ventricular Healthcare Facility or Laboratory Setting Polysomnography ejection fraction ≤ 40” Attended full-channel nocturnal polysomnography is medically for Evaluation of  Updated language pertaining to necessary for evaluating individuals with suspected OSA when: Sleep Disorders sleep disorders other than OSA  Results of previous HSAT are negative, indeterminate or technically (continued) to clarify attended full-channel inadequate to make a diagnosis of OSA; or nocturnal polysomnography is  Individual is a child or adolescent (i.e., less than 18 years of age); or medically necessary following an  Individual is known to have one or more of the following comorbid appropriate clinical assessment medical conditions that prohibits the use of a HSAT: either because OSA has been o Significant Chronic Pulmonary Disease as defined by a forced excluded, OSA has been expiratory volume (FEV1) % predicted of <60 (Pellegrino et al., adequately treated, or 2005) documented symptoms suggest o Progressive neuromuscular disease/neurodegenerative disorder one of the [listed] conditions (examples include, but are not limited to, Parkinson’s disease, Daytime Sleep Studies myotonic dystrophy, amyotrophic lateral sclerosis, multiple sclerosis  Replaced reference to “MCG™ with associated pulmonary disease, history of stroke with persistent Care Guidelines, 23rd edition, neurological sequelae) 2019” with “MCG™ Care o Moderate to severe heart failure (New York Heart Association class Guidelines, 24th edition, 2020” III or IV [NYHA, 1994] or left ventricular ejection fraction ≤40 Attended Repeat Testing [Yancy et al., 2013; Yancy et al., 2017])  Updated list of examples of o Body mass index (BMI) >50 (DeMaria et al., 2007; Blackstone and complications with current Cortés, 2010) treatment or PAP therapy that o Obesity Hypoventilation Syndrome have been addressed and o Documented ongoing epileptic seizures in the presence of symptoms appropriately managed; added of sleep disorder “unsuccessful titration” Documentation Requirements Also, see Repeat Testing section below.

 Updated required clinical information for attended Attended full-channel nocturnal polysomnography is medically polysomnography for evaluation necessary following an appropriate clinical assessment either of sleep disorders because OSA has been excluded, OSA has been adequately treated,

Definitions or documented symptoms suggest ONE of the following conditions:

 Added definition of “New York  Periodic Limb Movement Disorder (PLMD) (not leg movements associated

Heart Association (NYHA) Heart with another disorder such as sleep disordered breathing)

Failure Classification”  Restless Legs Syndrome (RLS)/Willis-Ekbom Disease that has not responded to treatment Applicable Codes  Parasomnia with documented disruptive, violent or potentially injurious  Revised description for CPT code sleep behavior suspicious of rapid eye movement sleep behavior disorder 95811 (RBD) Supporting Information  Narcolepsy, once other causes of excessive sleepiness have been ruled

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Attended Apr. 1, 2020  Updated Clinical Evidence, CMS, out by appropriate clinical assessment (also see MSLT section below) Polysomnography and References sections to  Central Sleep Apnea for Evaluation of reflect the most current Sleep Disorders information The following studies are not medically necessary due to insufficient (continued) evidence of efficacy:  Attended full-channel nocturnal polysomnography for evaluating any of the following conditions: o Circadian Rhythm Disorders o Depression o Insomnia  Actigraphy for any sleep disorders

Daytime Sleep Studies Multiple Sleep Latency Testing (MSLT) is medically necessary when it is indicated by all of the following:  Suspected narcolepsy; and  Other causes of Excessive Sleepiness have been excluded by appropriate clinical assessment

For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, 24th edition, 2020, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).

Click here to view the MCG™ Care Guidelines.

Maintenance of Wakefulness Testing (MWT) is medically necessary for evaluating the following:  An individual who is unable to stay awake, resulting in a safety issue; or  Assessing response to treatment in individuals with Narcolepsy or idiopathic Hypersomnia

For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, 24th edition, 2020, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).

Click here to view the MCG™ Care Guidelines.

The following studies are not medically necessary due to insufficient evidence of efficacy:

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Attended Apr. 1, 2020  Multiple Sleep Latency Testing (MSLT) for evaluating OSA, Insomnia or Polysomnography circadian rhythm disorders for Evaluation of  Maintenance of Wakefulness Testing (MWT) for evaluating OSA, Sleep Disorders Insomnia or circadian rhythm disorders (continued)  PAP-Nap

Attended PAP Titration When an individual meets the above criteria for an attended full- channel nocturnal polysomnography sleep study, the following are medically necessary:  A split-night sleep study, performed in a healthcare facility or laboratory setting, for diagnosis and PAP titration  A full night study for PAP titration, when a split-night sleep study is inadequate or not feasible and the individual has a confirmed diagnosis of OSA

Also, see Repeat Testing section below.

Attended Repeat Testing Repeat attended full-channel nocturnal polysomnography, performed in a health care facility or laboratory setting, as well as repeat PAP titration, is medically necessary for certain individuals who have persistent or new symptoms, despite documented appropriate current treatment or PAP therapy (e.g., equipment failure, improper mask fit, pressure leaks, unsuccessful titration, inadequate pressure and medical problems including nasal congestion have been addressed and appropriately managed).

Repeat testing and repositioning/adjustments for oral sleep appliances can be done in the home unless the individual meets criteria for an attended sleep study. Bariatric Surgery May 1, 2020 Coverage Rationale The following bariatric surgical procedures are proven and medically  Revised coverage criteria for necessary for treating obesity: bariatric surgery using one of  Gastric bypass (includes robotic-assisted gastric bypass) the procedures [listed in the  Laparoscopic adjustable gastric banding for individuals > 18 years of policy] for treating obesity in age. Refer to the U.S. Food and Drug Administration (FDA) section of the adults; replaced criterion policy for additional information requiring “the individual to have  Gastric sleeve procedure

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Bariatric Surgery May 1, 2020 a psychosocial-behavioral  Vertical banded gastroplasty (continued) evaluation to provide screening  Biliopancreatic bypass and identification of risk factors  Biliopancreatic diversion with duodenal switch or potential postoperative challenges that may contribute In adults, bariatric surgery using one of the procedures identified to a poor postoperative above for treating obesity is proven and medically necessary when outcome” with “the individual to ALL of the following criteria are met: have a psychosocial-behavioral  Class III obesity; or evaluation by an individual who  Class II obesity in the presence of one or more of the following co- is professionally recognized as morbidities: part of a behavioral health o Type 2 diabetes; or discipline to provide screening o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly and identification of risk factors controlled hypertension (systolic blood pressure greater than 140 or potential postoperative mm Hg or diastolic blood pressure 90 mm Hg or greater, despite challenges that may contribute pharmacotherapy)]; or to a poor postoperative o History of coronary artery disease with a surgical intervention such outcome” as coronary artery bypass or percutaneous transluminal coronary Documentation Requirements angioplasty; or  Updated required clinical o History of cardiomyopathy; or information for bariatric surgery o Obstructive Sleep Apnea (OSA) confirmed on polysomnography with Definitions an AHI or RDI of >30  Added definition of and “Multidisciplinary”  The individual must also meet the following criteria: o Supporting Information Both of the following: . Completion of a preoperative evaluation that includes a detailed  Updated References section to reflect the most current weight history along with dietary and physical activity patterns; information and . Psychosocial-behavioral evaluation by an individual who is professionally recognized as part of a behavioral health discipline to provide screening and identification of risk factors or potential postoperative challenges that may contribute to a poor postoperative outcome or o Participation in a multi-disciplinary surgical preparatory regimen

In Adolescents, the bariatric surgical procedures identified above are proven and medically necessary for treating obesity when ALL of the following criteria are met:  Class III obesity; or

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Bariatric Surgery May 1, 2020  Class II obesity in the presence of one or more of the following co- (continued) morbidities: o Type 2 diabetes; or o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or o History of coronary artery disease with a surgical intervention such as coronary artery bypass or percutaneous transluminal coronary angioplasty; or o History of cardiomyopathy; or o Obstructive Sleep Apnea confirmed on polysomnography with an AHI or RDI of >30 and  The individual must also receive an evaluation at, or in consultation with, a multidisciplinary center focused on the surgical treatment of severe childhood obesity. This may include adolescent centers that have received accreditation by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) or can demonstrate similar programmatic components.

Revisional Bariatric Surgery using one of the procedures identified above is proven and medically necessary when due to a Technical Failure or Major Complication from the initial bariatric procedure.

The following procedures are unproven and not medically necessary for treating obesity due to insufficient evidence of efficacy:  Revisional Bariatric Surgery for any other indication than those listed above  Bariatric surgery as the primary treatment for any condition other than obesity  Bariatric surgical interventions for the treatment of obesity including but not limited to: o Transoral endoscopic surgery o Mini-gastric bypass (MGB) or laparoscopic mini-gastric bypass (LMGBP) o Gastric electrical stimulation with an implantable gastric stimulator (IGS) o VBLOC® vagal blocking therapy

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Bariatric Surgery May 1, 2020 o Intragastric balloon (continued) o Laparoscopic greater curvature plication, also known as total gastric vertical plication o Stomach aspiration therapy (AspireAssist®) o Bariatric artery embolization (BAE) o Single-Anastomosis Duodenal Switch (also known as duodenal switch with single anastomosis, or stomach intestinal pylorus sparing surgery [SIPS]) o TransPyloric Shuttle (TPS) Device

Gastrointestinal liners (EndoBarrier®) are investigational, unproven and not medically necessary for treating obesity due to lack of U.S. Food and Drug Administration (FDA) approval, and insufficient evidence of efficacy. Continuous Glucose Apr. 1, 2020 Notice of Revision: The following Insulin Delivery Monitoring and summary of changes has been External insulin pumps that deliver insulin by continuous Insulin Delivery for modified. Revisions to the previous subcutaneous infusion are proven and medically necessary for Managing Diabetes policy update announcement are managing individuals with type 1 or insulin-requiring type 2 outlined in red below. Please take diabetes. note of the amended guidelines to For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, be applied on Apr. 1, 2020. 24th edition, 2020, Insulin Infusion Pump ACG:A-0339 (AC).

Coverage Rationale Click here to view the MCG™ Care Guidelines. Insulin Delivery  Replaced reference to “MCG™ Note: Programmable disposable external insulin pumps (e.g., OmniPod) are Care Guidelines, 23rd edition, considered clinically equivalent to standard insulin pumps. 2019” with “MCG™ Care Guidelines, 24th edition, 2020”; Due to insufficient evidence of efficacy, the following devices are refer to the 24th edition for unproven and not medically necessary for managing individuals with complete details on applicable diabetes: updates to the MCG™ Care  Implantable insulin pumps Guidelines  Insulin infuser ports Continuous Glucose Monitoring  Nonprogrammable transdermal insulin delivery systems (e.g., V-Go) (CGM)  Revised list of proven and Continuous Glucose Monitoring (CGM) medically necessary indications; CGM is proven and medically necessary for managing individuals replaced: with diabetes in the following circumstances:

ο “Short-term use (3-7 days)  Short-term use (3-14 days) by a healthcare provider for diagnostic

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Continuous Glucose Apr. 1, 2020 by a healthcare provider for purposes. Monitoring and diagnostic purposes” with  Long-term use for personal use at home for managing individuals with Insulin Delivery for “short-term use (3-14 days) diabetes during pregnancy who meet all of the following criteria: Managing Diabetes by a healthcare provider for o Have demonstrated adherence to a physician ordered diabetic (continued) diagnostic purposes” treatment plan; and o “Long-term personal use at o Are on an intensive insulin regimen (3 or more insulin injections per home for managing day or insulin pump therapy); and individuals with type 1 o Regularly monitor blood glucose 3 or more times per day. diabetes who meet all of the  Long-term use for personal use at home for managing individuals with [listed] criteria” with “long- type 1 or type 2 diabetes when certain criteria are met. For medical term personal use at home necessity clinical coverage criteria, see MCG™ Care Guidelines, 24th for managing individuals edition, 2020, Continuous Glucose Monitoring ACG:A-0126 (AC). with diabetes who meet all of the [listed] criteria: Click here to view the MCG™ Care Guidelines. . Diabetes during pregnancy who meet all Due to insufficient evidence of efficacy, the following services and/or of the following criteria: devices are unproven and not medically necessary for managing - Have demonstrated individuals with diabetes: adherence to a  CGM using an implantable glucose sensor (e.g., Eversense) physician ordered  CGM using a noninvasive device diabetic treatment plan; and - Are on an intensive insulin regimen (3 or more insulin injections per day or insulin pump therapy); and - Regularly monitor blood glucose 3 or more times per day . Type 1 or type 2 diabetes when certain criteria are met; for medical necessity clinical coverage criteria, see MCG™ Care Guidelines, 24th edition, 2020, Continuous Glucose

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Continuous Glucose Apr. 1, 2020 Monitoring ACG:A-0126 Monitoring and (AC)” Insulin Delivery for  Removed language indicating Managing Diabetes long-term CGM for managing (continued) individuals with type 2 or gestational diabetes is unproven and not medically necessary Documentation Requirements  Updated list of HCPCS codes with associated documentation requirements; added A4226 and E0787 Applicable Codes  Removed notation indicating procedure codes for continuous glucose monitoring (CGM) are unproven and not medically necessary when reported with diagnosis codes for type 2 diabetes or gestational diabetes  Removed ICD-10 diagnosis codes O24.410, O24.415, O24.419, O24.430, O24.435, and O24.439 O24.414 and O24.434 Supporting Information  Updated Clinical Evidence and References sections to reflect the most current information Electroencephalo- Apr. 1, 2020 Coverage Rationale Electroencephalographic (EEG) monitoring and video recording is graphic (EEG)  Replaced reference to “MCG™ proven and medically necessary in certain circumstances. Monitoring and Care Guidelines, 23rd edition, For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, Video Recording 2019” with “MCG™ Care 24th edition, 2020, EEG, Video Monitoring, M-580 (ISC). Guidelines, 24th edition, 2020”; refer to the 24th edition for Click here to view the MCG™ Care Guidelines. complete details on applicable updates to the MCG™ Care Guidelines

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Electroencephalo- Apr. 1, 2020 Supporting Information graphic (EEG)  Updated CMS section to reflect Monitoring and the most current information Video Recording (continued) Hip Resurfacing Apr. 1, 2020 Coverage Rationale Hip Replacement Surgery (Arthroplasty) and Replacement  Replaced references to “MCG™ Hip replacement surgery (arthroplasty) is proven and medically rd Surgery Care Guidelines, 23 edition, necessary in certain circumstances. (Arthroplasty) 2019” with “MCG™ Care For medical necessity clinical coverage criteria, see the following MCG™ Care th Guidelines, 24 edition, 2020”; Guidelines, 24th edition, 2020: th refer to the 24 edition for  Hip Arthroplasty, S-560 (ISC) complete details on applicable  Hip: Displaced Fracture of Femoral Neck, Hemiarthroplasty, S-600 (ISC) updates to the MCG™ Care Guidelines Click here to view the MCG™ Care Guidelines. Documentation Requirements  Updated required clinical Hip Resurfacing Arthroplasty information for hip resurfacing Hip resurfacing is proven and medically necessary in certain and replacement surgery circumstances. (arthroplasty) For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, 24th edition, 2020, Hip Resurfacing, S-565 (ISC).

Click here to view the MCG™ Care Guidelines. Hysterectomy for Apr. 1, 2020 Coverage Rationale Hysterectomy is proven and medically necessary in certain Benign Conditions  Replaced reference to “MCG™ circumstances. Care Guidelines, 23rd edition, For medical necessity clinical coverage criteria, see the following MCG™ Care 2019” with “MCG™ Care Guidelines, 24th edition, 2020: Guidelines, 24th edition, 2020”;  Hysterectomy, Abdominal, ORG: S-650 (ISC) refer to the 24th edition for  Hysterectomy, Vaginal, ORG: S-660 (ISC) complete details on applicable  Hysterectomy, Laparoscopic, ORG: S-665 (ISC) updates to the MCG™ Care Guidelines Click here to view the MCG™ Care Guidelines. Supporting Information  Updated CMS section to reflect the most current information Knee Replacement Apr. 1, 2020 Coverage Rationale Knee replacement surgery (arthroplasty) is proven and medically Surgery  Replaced reference to “MCG™ necessary in certain circumstances. (Arthroplasty), Care Guidelines, 23rd edition, For medical necessity clinical coverage criteria, see the following MCG™ Care Total and Partial 2019” with “MCG™ Care Guidelines, 24th edition, 2020:

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Knee Replacement Apr. 1, 2020 Guidelines, 24th edition, 2020”;  For total knee arthroplasty: Knee Arthroplasty, Total, S-700 (ISC) Surgery refer to the 24th edition for  For unicompartmental knee arthroplasty: Musculoskeletal Surgery or (Arthroplasty), complete details on applicable Procedure GRG: SG-MS (ISC GRG) Total and Partial updates to the MCG™ Care (continued) Guidelines Click here to view the MCG™ Care Guidelines. Documentation Requirements  Updated required clinical information for knee arthroplasty or arthroplasty revision Supporting Information  Updated CMS section to reflect the most current information Lower Extremity Apr. 1, 2020 Coverage Rationale Lower extremity vascular angiography is proven and medically Vascular  Replaced reference to “MCG™ necessary for evaluating arterial disease of the lower extremity. Angiography Care Guidelines, 23rd edition, For medical necessity clinical coverage criteria, see MCG™ Care Guidelines, 2019” with “MCG™ Care 24th edition, 2020, Lower Extremity Angiography, ACG: A-0002 (AC). Guidelines, 24th edition, 2020”; refer to the 24th edition for Click here to view the MCG™ Care Guidelines. complete details on applicable updates to the MCG™ Care Note: This policy does not apply to upper extremities. Guidelines Surgical Treatment Apr. 1, 2020 Coverage Rationale and Spinal procedures for the treatment of spine pain are proven and for Spine Pain References medically necessary in certain circumstances.  Replaced references to “MCG™ For medical necessity clinical coverage criteria, see the following MCG™ Care Care Guidelines, 23rd edition, Guidelines, 24th edition, 2020: 2019” with “MCG™ Care  Cervical Diskectomy or Microdiskectomy, Foraminotomy, Laminotomy, S- Guidelines, 24th edition, 2020”; 310 (ISC) refer to the 24th edition for  Lumbar Diskectomy, Foraminotomy, or Laminotomy S-810 (ISC) complete details on applicable  Cervical Laminectomy S-340 (ISC) updates to the MCG™ Care  Lumbar Laminectomy S-830 (ISC) Guidelines  Cervical Fusion, Anterior S-320 (ISC) Documentation Requirements  Cervical Fusion, Posterior S-330 (ISC)  Updated required clinical  Lumbar Fusion S-820 (ISC) information for surgical treatment for spine pain Click here to view the MCG™ Care Guidelines. Definitions  Added definition of: The following techniques for lumbar interbody fusion (LIF) are

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Surgical Treatment Apr. 1, 2020 o Conservative Therapy proven and medically necessary: for Spine Pain o Disabling Symptoms  Anterior LIF(ALIF) including lateral approaches e.g., extreme lateral (continued) o Neurogenic Claudication interbody fusion (XLIF®), Direct lateral interbody fusion (DLIF) (also known as  Posterior LIF (PLIF), including transforaminal lumbar interbody fusion pseudoclaudication) (TLIF) o Progressive o Radicular Pain The following spinal procedures are unproven and not medically o Spinal Instability necessary due to insufficient evidence of efficacy (this includes o Unremitting procedures that utilize interbody cages, screws, and pedicle screw  Updated definition of fixation devices*): “Spondylolisthesis”  Laparoscopic anterior lumbar interbody fusion (LALIF)* Supporting Information  Transforaminal lumbar interbody fusion (TLIF) which utilizes only  Updated References section to endoscopy visualization (such as a percutaneous incision with video reflect the most current visualization)* ® information  Axial lumbar interbody fusion (AxiaLIF )*  Interlaminar lumbar instrumented fusion (ILIF) (e.g., Coflex-F®)*  Spinal decompression and interspinous process decompression systems for the treatment of lumbar spinal stenosis (e.g., Interspinous process decompression (IPD), Minimally invasive lumbar decompression ( mild ®)  Spinal stabilization systems o Stabilization systems for the treatment of degenerative spondylolisthesis o Total facet joint arthroplasty, including facetectomy, laminectomy, foraminotomy, vertebral column fixation o Percutaneous sacral augmentation (sacroplasty) with or without a balloon or bone cement for the treatment of back pain  Stand-alone facet fusion without an accompanying decompressive procedure: o This includes procedures performed with or without bone grafting and/or the use of posterior intrafacet implants such as fixation systems, facet screw systems or anti-migration dowels

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Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Intravenous Iron Apr. 1, 2020 This policy refers to the following intravenous iron replacements: Replacement  Feraheme® (ferumoxytol) Therapy  Injectafer® (ferric carboxymaltose) (Feraheme® & Injectafer®) The following intravenous iron replacements are not subject to the coverage criteria in this section:  Ferrlecit (sodium ferric gluconate complex)  Infed® (iron dextran)  Venofer® (iron sucrose)

Feraheme (ferumoxytol) and Injectafer (ferric carboxymaltose) are proven for the following indications:

Iron Deficiency Anemia (IDA) Without Chronic Kidney Disease (CKD) Feraheme and Injectafer are medically necessary when the following criteria are met:  For initial therapy, all of the following: o Submission of medical records (e.g., lab values, chart notes, etc.) supporting the diagnosis of IDA; and o Patient does not have CKD; and o History of failure, contraindication, or intolerance, to oral iron therapy; and o One of the following: . Both of the following: - Submission of laboratory values demonstrating treatment failure after at least 3 weeks of therapy, to at least two of the following intravenous iron therapies each (Note: Laboratory values should be obtained within 1 to 3 weeks following the last dose of 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 . 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

16 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Intravenous Iron Apr. 1, 2020 and Replacement o One of the following: Therapy . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; (Feraheme® & or Injectafer®) . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course (continued) and o Initial authorization will be for no longer than 3 months.

 For continuation of therapy, all of the following: o Coverage has previously been provided by UnitedHealthcare for Feraheme or Injectafer for the treatment of IDA; and o Submission of recent laboratory results (within the past 4 weeks) since the last Feraheme or Injectafer administration to demonstrate need for additional therapy; and o Patient does not have CKD; and o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Continuation authorization will be for no longer than 3 months.

Iron Deficiency Anemia (IDA) Associated With Chronic Kidney Disease (CKD), Without End Stage Renal Disease (ESRD) Feraheme and Injectafer are medically necessary when the following criteria are met:  For initial therapy, all of the following: o Diagnosis of IDA and CKD; and o Submission of medical records (e.g., lab values, chart notes, etc.) supporting the diagnosis of IDA; and o Patient does not have ESRD; and o One of the following: . Patient’s CKD requires hemodialysis or peritoneal dialysis treatment; or . 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 o One of the following: . Both of the following: - Submission of laboratory values demonstrating treatment failure after at least 3 weeks of therapy, to at least two of the following intravenous iron therapies each (Note: Laboratory values should be obtained within 1 to 3 weeks following the last dose of intravenous iron in a treatment course):

17 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Intravenous Iron Apr. 1, 2020  Infed® (iron dextran) Replacement  Ferrlecit (sodium ferric gluconate complex) Therapy  Venofer® (iron sucrose) (Feraheme® & and Injectafer®) - Physician attests that in their clinical opinion, the clinical response would be expected to be superior (continued) with Feraheme or Injectafer, than experienced with the other products or . 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 o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Initial authorization will be for no longer than 3 months.

 For continuation of therapy, all of the following: o Coverage has previously been provided by UnitedHealthcare for Feraheme or Injectafer for the treatment of IDA with CKD; and o Patient does not have ESRD; and o Submission of recent laboratory results (within the past 4 weeks) since the last Feraheme or Injectafer administration to demonstrate need for additional therapy; and o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Continuation authorization will be for no longer than 3 months. 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 the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications for additional details.

18 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Vyondys 53™ Apr. 1, 2020 Vyondys 53 (golodirsen) may be covered for the treatment of Duchenne muscular dystrophy (DMD) in (Golodirsen) patients who meet all of the following criteria: (continued)  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 of 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 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 Reauthorization will be for no more than 12 months.

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

19 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Denosumab Mar. 1, 2020 Template Update (Prolia® & Xgeva®)  Relocated Background and FDA sections Coverage Rationale  Updated language to clarify denosumab is unproven and not medically necessary for the [listed] indications Xgeva (denosumab)  Updated list of examples of metastatic diseases secondary to a solid tumor; added “breast” Supporting Information  Updated Clinical Evidence, CMS, and References sections to reflect the most current information

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Botulinum Toxins A Apr. 1, 2020 Coverage Rationale This policy refers to the following botulinum toxin types A and B: and B  Revised medical necessity  Dysport® (abobotulinumtoxinA) criteria for Xeomin  Xeomin® (incobotulinumtoxinA) (incobotulinumtoxinA) for the  Botox® (onabotulinumtoxinA) treatment of blepharospasm  Myobloc® (rimabotulinumtoxinB) associated with dystonia; removed criterion requiring: Refer to the policy for complete details on the coverage guidelines for o Diagnosis of blepharospasm Botulinum Toxins A and B. associated with dystonia; and o History of failure, contraindication, or intolerance to Botox (onabotulinumtoxinA) Supporting Information  Updated References section to reflect the most current information Exondys 51® Apr. 1, 2020 Coverage Rationale Exondys 51® (eteplirsen) may be covered for the treatment of (Eteplirsen)  Revised coverage criteria; added Duchenne muscular dystrophy (DMD) in patients who meet all of the criterion requiring Exondys 51 is following criteria: not used concomitantly with other exon skipping therapies for  For initial therapy, all of the following: DMD (e.g., Vyondys 53) 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 51

20 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Exondys 51® Apr. 1, 2020 skipping; and (Eteplirsen) o Submission of medical records (e.g., chart notes, laboratory values) (continued) 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 Exondys 51 therapy; and o Exondys 51 is prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD; and o Exondys 51 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 Exondys 51 is not used concomitantly with other exon skipping therapies for DMD (e.g., Vyondys 53); and o Initial authorization will be for no more than 8 weeks.

 For continuation of therapy, all of the following: o Exondys 51 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, laboratory values) demonstrating that the patient continues to have a 6-Minute Walk Time (6MWT) ≥ 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.). This must be measured no earlier than 4 weeks prior to a continuation request; and o Exondys 51 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 Exondys 51 is not used concomitantly with other exon skipping therapies for DMD (e.g., Vyondys 53); and o Reauthorization will be for no more than 6 months.

Exondys 51 will not be covered for other forms of muscular dystrophy. Ketalar (Ketamine) Apr. 1, 2020 Coverage Rationale This policy refers to the following ketamine products: and Spravato™  Revised medical necessity  Ketalar (ketamine) (Esketamine) criteria for Spravato:  Spravato (esketamine) Initial Therapy o Replaced criterion requiring Spravato (Esketamine) Nasal Spray “attestation of baseline Spravato is proven for the treatment of treatment-resistant

21 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar (Ketamine) Apr. 1, 2020 scoring (prior to starting depression (TRD) when ALL of the following criteria are met: and Spravato™ Spravato) on at least one of (Esketamine) the [listed] clinical Initial Therapy (continued) assessments has been  Diagnosis for major depressive disorder (treatment-resistant) according completed” with “submission to the current DSM (i.e., DSM-5), by a mental health professional; and of baseline scoring (prior to  Patient has not experienced a clinically meaningful improvement after starting Spravato) on at treatment with at least two different antidepressants of adequate dose, least one of the [listed] duration (at least 6 weeks), and adherence in the current depressive clinical assessments has episode (must document medications, doses, and durations); and been completed”  Patient is to receive Spravato therapy in conjunction with another oral Continuation of Therapy antidepressant; and o Replaced criterion requiring  Provider and/or the provider’s healthcare setting is certified in the “Spravato dosing is in Spravato REMS program; and accordance with the United  Spravato dosing is in accordance with the United States Food and Drug States FDA approved Administration approved labeling; and labeling” with “Spravato  Initial authorization will be for no longer than 12 weeks. dosing is in accordance with the United States FDA Continuation of Therapy approved labeling, not to  Patient has previously been treated with Spravato; and exceed 84 mg (3 devices)  Documentation demonstrating a positive clinical response from baseline per week” (e.g., improved Montgomery-Asberg Depression Rating Scale [MADRS], Supporting Information clinical remission, response, etc.), as defined by the provider; and  Updated Clinical Evidence, CMS,  Patient is to receive Spravato therapy in conjunction with another oral and References sections to antidepressant; and reflect the most current  Provider and/or the provider’s healthcare setting is certified in the information Spravato REMS program; and  Spravato dosing is in accordance with the United States Food and Drug Administration approved labeling; and  Authorization will be for no longer than 6 months.

Spravato is medically necessary for the treatment of treatment- resistant depression (TRD) when ALL of the following criteria are met:

Initial Therapy

 Diagnosis of major depressive disorder (treatment-resistant), according

to the current DSM (i.e., DSM-5), by a mental health professional; and

 Prescribed by or in consultation with a psychiatrist; and

 Submission of baseline scoring (prior to starting Spravato) on at least

22 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar (Ketamine) Apr. 1, 2020 one of the following clinical assessments has been completed: and Spravato™ o Baseline score on the 17-item Hamilton Rating Scale for Depression (Esketamine) (HAMD17) (continued) o Baseline score on the 16-item Quick Inventory of Depressive Symptomatology (QIDS-C16) o Baseline score on the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) and  Patient has not experienced a clinically meaningful improvement after treatment with at least three different antidepressants or treatment regimens of adequate dose (maximally tolerated), duration (at least 8 weeks), and adherence in the current depressive episode o An antidepressant or treatment regimen would include any of the following classes or combinations (document medication, dose, and duration): . Selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline) . Serotonin norepinephrine reuptake inhibitors (e.g., duloxetine, venlafaxine, etc.) . Bupropion . Tricyclic antidepressants (e.g., amitriptyline, clomipramine, nortriptyline, etc.) . Mirtazapine . Monoamine oxidase inhibitors (e.g., selegiline, tranylcypromine, etc.) . Serotonin modulators (e.g., nefazodone, trazodone, etc.) . Augmentation with lithium, Cytomel (liothyronine), antipsychotics, or anticonvulsants and  Spravato will be initiated at the same time the member starts a new daily oral antidepressant (one that has not previously been tried); and  Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and  Spravato dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling; and  Initial authorization will be for no longer than 12 weeks.

Continuation of Therapy  Patient has previously been treated with Spravato; and

23 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar (Ketamine) Apr. 1, 2020  Documentation of remission or a positive clinical response to Spravato; and Spravato™ and (Esketamine)  Submission of baseline and recent (within the last month) scoring on at (continued) least one of the following assessments demonstrating remission or clinical response (e.g., score reduction from baseline) as defined by the: o Hamilton Rating Scale for Depression (HAMD17; remission defined as a score of ≤7) o Quick Inventory of Depressive Symptomatology (QIDS-C16; remission defined as a score of ≤5) o Montgomery-Asberg Depression Rating Scale (MADRS; remission defined as a score of ≤12) and  Patient is to receive Spravato therapy in conjunction with an oral antidepressant; and  Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and  Prescribed by or in consultation with a psychiatrist; and  Spravato dosing is in accordance with the United States FDA approved labeling, not to exceed 84 mg (3 devices) per week; and  Authorization will be for no longer than 6 months.

Spravato is unproven and not medically necessary for the following:  Anesthetic agent  Chronic pain (including but not limited to nonmalignant pain, fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy)  Migraine headaches

Ketalar (Ketamine) Injection Ketamine injection is considered medically necessary and may be covered for the following:  Anesthesia for diagnostic and surgical procedures that do not require skeletal muscle relaxation  The induction of anesthesia prior to administration of other anesthesia agents  As supplemental anesthesia for low-potency agents, such as nitrous oxide

Ketamine injection is investigational, and therefore not proven or medically necessary for the following:

24 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar (Ketamine) Apr. 1, 2020  Psychiatric disorders (including, but not limited to depression, bipolar and Spravato™ disorder, & posttraumatic stress disorder) (Esketamine)  Chronic pain (including but not limited to nonmalignant pain, (continued) fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy)  Migraine headaches Oncology Apr. 1, 2020 Coverage Rationale Description Medication Clinical  Updated list of preferred This policy provides parameters for coverage of injectable oncology Coverage oncology products with medications (including, but not limited to octreotide acetate, leuprolide therapeutically equivalent and/or acetate, leucovorin and levoleucovorin), including therapeutic biosimilar non-preferred radiopharmaceuticals, covered under the medical benefit based upon the products; added: National Comprehensive Cancer Network (NCCN) Drugs & Biologics Preferred Non-Preferred Compendium® (NCCN Compendium®). The Compendium lists the appropriate Oncology Oncology drugs and biologics for specific cancers using US Food and Drug Product Product Administration (FDA)-approved disease indications and specific NCCN panel Rituxan recommendations. Each recommendation is supported by a level of evidence (rituximab) Truxima category. Coverage of White Blood Cell Colony Stimulating Factors and Ruxience (rituximab- Erythropoiesis-Stimulating Agents are addressed in separate policies. This (rituximab- abbs) policy does not provide coverage criteria for Chimeric Antigen Receptor pvvr) (CAR)-T Cell products. Coverage determinations are based on the member’s benefits and the OptumHealth Transplant Solutions criteria for covered Infugem transplants; refer to the Clinical Guideline titled Transplant Review (gemcitabine in Gemcitabine Guidelines: Hematopoietic Stem Cell Transplantation. sodium chloride injection) Coverage Rationale Applicable Codes Medical Necessity Plans  Added list of denied drug codes The Oncology Products table below lists the UnitedHealthcare preferred [HCPCS code J9219 (product oncology products and respective non-preferred products. Coverage will be discontinued)] provided for the UnitedHealthcare preferred oncology product contingent on  Added language to indicate the coverage criteria in the Diagnosis-Specific Criteria section. denied drug codes apply to all outpatient places of service Coverage for any respective non-preferred oncology product will be provided (including office, hospital, etc.) contingent on the criteria in the Preferred Product Criteria and the Diagnosis- Specific Criteria sections. Members new to therapy will be required to utilize the UnitedHealthcare preferred oncology product unless they meet the criteria in this section.

25 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Oncology Apr. 1, 2020 Preferred Product Criteria Medication Clinical Treatment with the respective non-preferred product specified in the Coverage Oncology Products table below is medically necessary for oncology (continued) indications when BOTH of the following are met:  History of intolerance or contraindication to the UnitedHealthcare preferred oncology product; and  Physician attests that, in their clinical opinion, the same intolerance, contraindication, or adverse event would not be expected to occur with the respective non-preferred product.

Oncology Products Below are UnitedHealthcare preferred oncology products with therapeutically equivalent and/or biosimilar* non-preferred products as determined by the UnitedHealthcare P&T Committee:

UnitedHealthcare Preferred UnitedHealthcare Non-Preferred Oncology Product Oncology Product Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr)

Herceptin (trastuzumab)

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) Kanjinti (trastuzumab-anns) Herzuma (trastuzumab-pkrb) Ogivri (trastuzumab-dkst) Ontruzant (trastuzumab-dttb) Trazimera (trastuzumab-qyyp)

Rituxan (rituximab) Truxima (rituximab-abbs) Ruxience (rituximab-pvvr) Infugem (gemcitabine in sodium Gemcitabine chloride injection) Leucovorin Levoleucovorin

*Biosimilar means that the biological product is FDA-approved based on data demonstrating that it is highly similar to an already FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

26 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Oncology Apr. 1, 2020 Diagnosis-Specific Criteria Medication Clinical Injectable Oncology Medications Coverage UnitedHealthcare recognizes indications and uses of injectable oncology (continued) medications, including therapeutic radiopharmaceuticals, listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus of 1, 2A, and 2B as proven and medically necessary, and Categories of Evidence and Consensus of 3 as unproven and not medically necessary.

UnitedHealthcare will cover all chemotherapy agents for individuals under the age of 19 years for oncology indications. The majority of pediatric patients receive treatments on national pediatric protocols that are quite similar in concept to the NCCN patient care guidelines.

Refer to Preferred Product Criteria for the UnitedHealthcare preferred oncology products that have therapeutically equivalent and/or biosimilar products available. Rituximab Apr. 1, 2020 Coverage Rationale This policy refers only to the following drug products, rituximab injections for ® (Rituxan ,  Added language pertaining to intravenous infusion for non-oncology conditions: ® Ruxience™, & Preferred Products to indicate:  Rituxan (rituximab) ® ® Truxima ) Medical Necessity Plans  Rituxan Hycela (rituximab and hyaluronidase human)* ® o Rituxan (rituximab) and  Ruxience (rituximab-pvvr) ® Ruxience (rituximab-pvvr)  Truxima (rituximab-abbs) are the preferred rituximab products; coverage will be “Rituximab” will be used to refer to all rituximab products without provided for Rituxan or hyaluronidase. Ruxience contingent on the coverage criteria in the *Rituxan Hycela is unproven and not medically necessary for the treatment Diagnosis-Specific Criteria of non-oncology indications. For oncology indications and for Rituxan Hycela section (rituximab/hyaluronidase human), refer to the Oncology Medication Clinical o Coverage for Truxima Coverage Policy for updated information based upon the National ® (rituximab-abbs) will be Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium ® provided contingent on the (NCCN Compendium ). criteria in the Preferred Product Criteria section and Refer to the policy for complete details on the coverage guidelines for ® ® the coverage criteria in the Rituximab (Rituxan , Ruxience™, & Truxima ). Diagnosis-Specific Criteria section; in order to continue coverage, members already

27 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Rituximab Apr. 1, 2020 on Truxima will be required (Rituxan®, to change therapy to Rituxan Ruxience™, & or Ruxience unless they Truxima®) meet the criteria in the (continued) Preferred Product Criteria section o Treatment with Truxima, or other rituximab product, is medically necessary for the indications specified in this policy when both the following criteria are met: . History of intolerance, contraindication, or serious adverse event to both Rituxan and Ruxience; and . Physician attests that, in their clinical opinion, the same intolerance, contraindication, or serious adverse event would not be expected to occur with the respective non-preferred product Non-Medical Necessity Plans o Any rituximab product is to be approved contingent on the coverage criteria in the Diagnosis-Specific Criteria section  Revised medical necessity criteria for treatment of neuromyelitis optica: o Removed initial therapy criterion requiring history of failure, contraindication, or intolerance to at least two of

28 Medical Policy Update Bulletin: March 2020

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Rituximab Apr. 1, 2020 the following: (Rituxan®, . Azathioprine Ruxience™, & . Corticosteroids Truxima®) . Mycophenolate mofetil (continued) o Updated list of examples of: . Anti-IL6 therapy; added Kevzara (sarilumab) . Complement inhibitors; added Ultomiris (ravulizumab)

29 Medical Policy Update Bulletin: March 2020

Coverage Determination Guideline (CDG) Updates

Policy Title Effective Date Summary of Changes UPDATED Blepharoplasty, Apr. 1, 2020 References Blepharoptosis,  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, and Brow Ptosis 2020” Repair Gynecomastia Apr. 1, 2020 References Treatment  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, 2020” Habilitative Apr. 1, 2020 Coverage Rationale Services and  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Outpatient 2020” Rehabilitation Therapy Orthognathic (Jaw) Apr. 1, 2020 Coverage Rationale Surgery  Replaced references to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, 2020” Documentation Requirements  Updated required clinical information for Orthognathic (Jaw) Surgery Supporting Information  Updated References section to reflect the most current information Panniculectomy Apr. 1, 2020 References and Body  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Contouring 2020” Procedures Rhinoplasty and Apr. 1, 2020 References Other Nasal  Replaced reference to “MCG™ Care Guidelines, 23rd edition, 2019” with “MCG™ Care Guidelines, 24th edition, Surgeries 2020” Documentation Requirements  Updated required clinical information for rhinoplasty and other nasal surgeries

30 Medical Policy Update Bulletin: March 2020

Utilization Review Guideline (URG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Chemotherapy Apr. 1, 2020 Coverage Rationale Most cancer chemotherapies can be administered safely and effectively in a Observation or  Replaced reference to “MCG™ physician office or through home healthcare services. However, because of Inpatient Care Guidelines, 23rd edition, the risk of certain toxicities or individual comorbidities, some cancer Hospitalization 2019” with “MCG™ Care chemotherapy may be administered either in a facility observation or Guidelines, 24th edition, 2020”; inpatient unit. refer to the 24th edition for complete details on applicable The following drugs may require observation or inpatient hospital updates to the MCG™ Care stay: Guidelines  Campath® (alemtuzumab)  Cisplatin (high-dose) > 75 mg/m2  Interleukin 2 infusion  Ifosphamide infusion > 1g/m2/day (usually given consecutive days)  Methotrexate > 500 mg/m2  Other complex multiple-drug or multiple-day regimens such as Hyper- CVAD, ESHAP or EPOCH, Einhorn regimen

The following are clinical conditions or complications of cancer chemotherapy which, when present, may require an observation stay:  Known hypersensitivity reactions from previous infusion  Congestive heart failure or chronic renal failure requiring high volume fluid infusions  Transcatheter arterial chemoembolization (TACE) or intra-arterial chemotherapy infusion  Comorbidities that require an observation or overnight stay  Cancer chemotherapy administered during a hospitalization for an unrelated problem

The following are clinical conditions which require an inpatient hospital stay:  Acute leukemia induction therapy or consolidation therapy  Intra-arterial infusion of chemotherapy  Prophylaxis of tumor lysis syndrome in cases of high grade lymphoma with large masses  Comorbidities that require an inpatient stay

Conditions requiring observation or inpatient hospital treatment other than those noted above will be reviewed on a case-by-case basis.

31 Medical Policy Update Bulletin: March 2020

Utilization Review Guideline (URG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Chemotherapy Apr. 1, 2020 For medical necessity clinical coverage criteria, see MCG™ Care Observation or Guidelines, 24th edition, 2020, for the following: Inpatient  Observation care criteria for chemotherapy: Chemotherapy: Observation Hospitalization Care OCG: OC-008 (ISC) (continued)  Inpatient admission criteria for administration of chemotherapy: Chemotherapy: ORG: M-87 (ISC) and Neutropenia after Chemotherapy ORG: P-300 (ISC)  Admission to home health services for all the above drugs or therapeutic agents: Chemotherapy: ORG: M-2087 (HC) and Neutropenia after Chemotherapy ORG: P-2300 (HC)  Use of infusion pump for delivery of chemotherapy and therapeutic agents: Infusion Pump: ACG: A-0618(AC)

Click here to view the MCG™ Care Guidelines.

Additional Review Points  A written protocol will be expected to be followed by the provider administering the chemotherapy drug.  Any requests for an extension of the inpatient stay beyond the recommended day(s) must be clinically reviewed. Provider May 1, 2020 Related Policies This guideline addresses the criteria for consideration of allowing hospital Administered  Added reference link to the outpatient facility specialty medication infusion services. This includes claim Drugs – Site of Medical Benefit Drug Policy titled submission for hospital based services with the following CMS/AMA Place of Care Respiratory Interleukins Service codes: (Cinqair®, Fasenra®, and  19 Off Campus-Outpatient Hospital; and Nucala®)  22 On Campus-Outpatient Hospital Coverage Rationale  Revised list of specialty Alternative sites of care, such as non-hospital outpatient infusion, physician medications that require office, ambulatory infusion or home infusion services are well accepted healthcare provider places of service for medication infusion therapy. If an individual does not administration; added Cinqair® meet criteria for outpatient hospital facility infusion, alternative sites of care (reslizumab), Fasenra® may be used. (benralizumab), and Nucala® (mepolizumab) Outpatient hospital facility-based intravenous medication infusion is Applicable Codes medically necessary for individuals who meet at least ONE of the  Added HCPCS codes J0517, following criteria (submission of medical records is required): J2182, and J2786 1. Documentation that the individual is medically unstable for administration of the prescribed medication at the alternative sites of

32 Medical Policy Update Bulletin: March 2020

Utilization Review Guideline (URG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Provider May 1, 2020 care as determined by any of the following: Administered a. The individual’s complex medical status or therapy requires Drugs – Site of enhanced monitoring and potential intervention above and beyond Care the capabilities of the office or home infusion setting; or (continued) b. The individual’s documented history of a significant comorbidity (e.g., cardiopulmonary disorder) or fluid overload status that precludes treatment at an alternative site of care; or c. Outpatient treatment in the home or office setting presents a health risk due to a clinically significant physical or cognitive impairment; or d. Difficulty establishing and maintaining patent vascular access; or e. To initiate, re-initiate products for a short duration (e.g., 4 weeks); or 2. Documentation (e.g., infusion records, medical records) of episodes of severe or potentially life-threatening adverse events (e.g., anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) that have not been responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other pre-medications, thereby increasing risk to the individual when administration is in the home or office setting; or 3. Initial infusion or re-initiation of therapy after more than 6 months; or 4. Homecare or infusion provider has deemed that the individual, home caregiver, or home environment is not suitable for home infusion therapy (if the prescriber cannot infuse in the office setting).

Ongoing outpatient hospital facility-based infusion duration of therapy will be no more than 6 months to allow for reassessment of the individual’s ability to receive therapy at an alternative site of care.

This policy applies to these specialty medications that require healthcare provider administration:  Actemra® (tocilizumab)  Aldurazyme® (laronidase)  Aralast NP™ (A1-PI)  Benlysta® (belimumab)  Cerezyme® (imiglucerase)  Cinqair® (reslizumab)

33 Medical Policy Update Bulletin: March 2020

Utilization Review Guideline (URG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Provider May 1, 2020  Crysvita® (burosumab-twza) Administered  Elaprase® (idursulfase) Drugs – Site of  Elelyso® (taliglucerase) Care  Entyvio® (vedolizumab) (continued)  Exondys 51™ (eteplirsen)  Fabrazyme® (agalsidase beta)  Fasenra® (benralizumab)  Glassia™ (A1-PI)  Ilaris® (canakinumab)  Ilumya™ (tildrakizumab-asmn)  Inflectra™ (infliximab-dyyb)  Kanuma® (sebelipase alfa)  Lumizyme® (alglucosidase alfa)  Mepsevii™ (vestronidase alfa-vjbk)  Naglazyme® (galsulfase)  Nucala® (mepolizumab)  Ocrevus™ (ocrelizumab)  Onpattro™ (patisiran)  Orencia® (abatacept)  Prolastin®-C™ (A1-PI)  Radicava™ (edaravone)  Reblozyl® (luspatercept-aamt)  Remicade® (infliximab)  Renflexis™ (infliximab-abda)  Revcovi™ (elapegademase-lvlr)  Simponi Aria® (golimumab)  Soliris® (eculizumab)  Trogarzo™ (ibalizumab-uiyk)  Ultomiris™ (ravulizumab-cwvz)  Vimizim® (elosulfase alfa)  VPRIV® (velaglucerase)  Zemaira® (A1-PI)

34 Medical Policy Update Bulletin: March 2020

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

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

The complete library of UnitedHealthcare Medical Policies, Medical Benefit Drug Policies, CDGs, URGs, and QOCGs is available at UHCprovider.com > Policies and Protocols > Commercial Policies > Medical & Drug Policies and Coverage Determination Guidelines.

35 Medical Policy Update Bulletin: March 2020