05/01/2019 – UnitedHealthcare Commercial Medical Policy Update Bulletin: May 2019

Transcript

1 May 2019 medical policy update bulletin Medical Benefit Drug Policy & Coverage Determination Guideline Updates Medical Policy, UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to effective care, and to support practice - most informed decisions regarding the choice of quality and cost making the support you and your patients in rtant information staff with a simple and predictable administrative experience. The Medical Policy Update Bulletin was developed to share impo e, and Quality of g UnitedHealthcare Medical Policy, Medical Benefit Drug Policy, Coverage Determination Guideline, Utilization Review Guidelin regardin Care Guideline updates.* *Where UnitedHealthcare follows such applicable federal and/or state law. information in this bulletin conflicts with applicable state and/or federal law,

2 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates Overview Policy Update Classifications This bulletin provides complete details on UnitedHealthcare Medical Policy, Medical Benefit Drug Policy, Coverage Determination New Guideline (CDG), Utiliza tion Review Guideline (URG), and/or New clinical coverage criteria and/or documentation review The inclusion of a Quality of Care Guideline (QOCG) updates. a requirements have been adopted for health service (e.g., test, drug, health service (e.g., test, drug, device or procedure) in this bulletin device or procedure) indicates only that UnitedHealthcare has recently adopted a new Updated policy and/or updated, revised, replaced or retired an existing ot been made An existing policy has been reviewed and changes have n policy; it does not imply that UnitedHealthcare provides coverage to the clinical coverage criteria or documentation review requirements; health for the In the event of an inconsistency or conflict service. however, items such as the clinical evidence, FDA information, and/or between the information provided in this bulletin and the posted list(s) of applicable codes may have been updated Note that visions of the posted policy will prevail. policy, the pro most benefit plan documents exclude from benefit coverage health Revised or unproven/not medically services identified as investigational An existing policy has been reviewed and re visions have been made to necessary. Physicians and other health care professionals may not the clinical coverage criteria and/or documentation review requirements member collect payment from a seek or for services not covered by Replaced member’s the applicable benefit plan unless first obtaining the An existing policy has been replaced with a new or different policy written consent, acknowledging that the service is not covered by billed directly for the serv the benefit plan and that they will be ice. Retired in the policy are no longer being health service(s) addressed The ical The complete library of UnitedHealthcare Med be proven/medically necessary and are or are considered to managed Policies, Medical Benefit Drug Policies, CDGs, URGs, and therefore not excluded as unproven/not medically necessary services, > Policies and QOCGs is available at UHCprovider.com are otherwise documented in unless coverage guidelines or criteria ial Policies > Medical & Drug Protocols > Commerc another policy Policies and Coverage Determination Guidelines . Note: The absence of a policy does not autom atically indicate or imply coverage. As always, coverage for a health service must be determined Bulletin: Tips for using the Medical Policy Update in accordance with the member’s benefit plan and any applicable  , click the policy title to be table of contents From the federal or state regulatory requirements. Additionally, UnitedHealthcare directed to the corresponding policy update summary. review the clinical evidence supporting the safety reserves the right to , click the policy title to view a From the polic y updates table  and effectiveness of a medical technology prior to rend ering a coverage complete copy of a new, updated, or revised policy. determination. 2 M ay 2019 Medical Policy Update Bulletin:

3 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue Page Medical Policy Updates UPDATED – Effective Jun. 1, 2019  ... ... ... . 5 Negative Pressure Wound Therapy ... REVISED Omnibus Codes –  Effective May 1, 2019 ... ... ... ... ... 5 pharmaceuticals – Effective Jul. 1, 2019 Therapeutic Radio ... ... ... .. 5  ... Transpupillary Thermotherapy – Effective Jun. 1, 2019  ... ... ... ... ... 6 Medical Benefit Drug Policy Updates NEW ... Evenity™ (Romosozumab Aqqg) – Effective May 1, 2019 ...  ... - ... 8 ... UPDATED ® Mifeprex – (Mifepristone)  ... ... ... ... ... 9 Effective May 1, 2019 REVISED ... m Toxins A and B – Effective May 1, 2019  ... Botulinu ... ... ... 9 ® ... ... Effective May 1, 2019 9  Complement Inhibitors (Soliris ... & Ultomiris™) ... – ...  erapy – Effective May 1, 2019 Enzyme Replacement Th ... ... ... ... 12  Ketamine – Effective May 1, 2019 ... ... ... ... ... .. 13 ...  – Effective May 1, 2019 ... Lemtrada (Alemtuzumab) ... ... ... 16  Maximum Dosage – Effective May 1, 2019 ... ... ... ... ... 18  Spinraza™ (Nusinersen) ... – Effective May 1, 2019 ... ... ... ... 20 ...  accines – Effective May 1, 2019 ... ... ... V ... ... 25 Coverage Determination Guideline (CDG) Updates UPDATED  Habilitative Services and Outpatient Rehabilitation Therapy – Effective M ay 1, 2019 ... ... ... 28 REVISED  Ambulance Services – Effective Jun. 1, 2019 ... ... ... ... ... 28 31 tive Jul. 1, 2019 ... ... ... ... ...  Orthognathic (Jaw) Surgery – Effec 2019 3 Medical Policy Update Bulletin: M ay

4 Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue Utilization Review Guideline (URG) Updates UPDATED  Site of Care 34 ... ... ... ... ... Immune Globulin – – Effective May 1, 2019 2019 4 Medical Policy Update Bulletin: M ay

5 Medical Po licy Updates olicy Title Effective Date Summary of Changes P UPDATED Negative Pressure Jun. 1, 2019  Simplifie d coverage rationale (no change to guidelines)  Relocated the following terms/descriptions from the Coverage Rationale section to the Definitions section : Wound Therapy o Gustilo Grade III Fracture o National Pressure Ulcer Advisory Panel (NPUAP) Staging System Updated list  of applicable HCPCS codes; removed A7000 Effective Date Summary of Changes Coverage Rationale Policy Title REVISED Omnibus Codes May 1, 2019  Removed coverage guidelines for details on the coverage guidelines for Refer to the policy for complete Omnibus Codes percutaneous cryoablative . therapy of pulmonary tumors, including the pleura or chest wall when involved by tumor extension (CPT code 32994) (no longer requires clinical review) ® Azedra Revised coverage rationale:  (iobenguane I 131) injection for intravenous use is proven Jul. 1, 2019 Therapeutic Radio - and medically necessary when ALL the following criteria are met p : harmaceuticals Simplified content o o Added language to indicate  and Individual with positive iobenguane scan; ® Azedra (iobenguane I 131)  Individual has unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer injection for intravenous use therapy is: Proven and me dically  ® necessary when all the (iobenguane I 131) injection for intravenous use is Azedra unproven and not medically necessary for ALL other indications due following criteria are . to insufficient evidence of efficacy met: - Individual with ® (lut Lutathera etium Lu 177 dotatate) injection for intravenous use positive iobenguane is proven and medically necessary for the treatment of somatostatin scan; and - receptor positive metastatic or unresectable locally advanced Individual has - - unresectable, locally gastroenteropancreatic neuroendocrine tumors (GEP NETs), including foregu advanced or t, midgut, and hindgut neuroendocrine tumors in metastatic adults, who have progressed on a high dose somatostatin analog pheochromocytoma (e.g., long acting octreotide, lanreotide) . or paraganglioma ® Lutathera who require systemic (lutetium Lu 177 dotatate) injection for intravenous use is unproven and not medically ne cessary for ALL other indications anticancer therapy Unproven and not due to insufficient evidence of efficacy .  M 2019 5 Medical Policy Update Bulletin: ay

6 Medical Po licy Updates Policy Title Effective Date Summary of Changes Coverage Rationale REVISED ® Jul. 1, 2019 o 223 (Xofig - Radium ) is proven and medically necessary when ALL medically necessary for Therapeutic Radio - pharmaceuticals all other indications due of the following criteria are met : Individual has metastatic, castration resistant prostate cancer (mCRCP); (continued)  to insufficient evidence - of efficacy and   Indi vidual has bone metastases documented on imaging; and Added definition of: ® o Individual is not/will not be receiving concurrent chemotherapy, biologic  Azedra (iobenguane I 131) o therapy, or immunotherapy (concurrent use of hormonal therapy is Pheochromocytoma Updated list of applicable codes;  permitted); and  added notation to clarify HCPCS Individual has no curr ent visceral metastatic disease codes A4641 and A9508 are ® Radium 223 (Xofigo - ) is unproven and not medically necessary for intended to be reported for diagnostic use and are not ALL other indications due to insufficient evidence of efficacy . appropriate for reporting therapeutic use of the radiopharmaceuticals addressed in this policy Updated supporting information  to reflect the most current description of services, clinical evidence, FDA information , and references Transpupillary thermotherapy is proven and medically necessary for Jun . 1, 2019 Transpupillary  Revised coverage rationale; replaced language indicating treating Thermotherapy : the following  “transpupillary thermotherapy is R etinoblastoma Choroidal melanomas unproven and not medically  necessary for treating choroidal Transpupillary thermotherapy is unproven and not medically neovascularization and macular degeneration due to insufficient due to insufficient all other indications necessary for treating evidence of efficacy with dence of efficacy” evi . These include but are not limited to: “transpupillary thermotherapy is C horoidal neovascularization  unproven and not medically necessary for treating  Macular degeneration all other indications [not listed as proven due to and medically necessary] insufficient evidence of efficacy; these include but are not limited to horoidal neovascularization c and macular degeneration” 6 Medical Policy Update Bulletin: M ay 2019

7 Updates Medical Po licy Effective Date Policy Title Coverage Rationale Summary of Changes REVISED Jun. 1, 2019  Transpupillary Updated supporting information to reflect the most current Thermotherapy clinical evidence, CMS (continued) information, and references 2019 7 Medical Policy Update Bulletin: M ay

8 Medical Benefit Drug Policy Updates Effective Date Coverage Rationale Policy Title NEW Evenity™ aqqg) has been added to the Review at Launch program. Some members may not be eligible - May 1, 2019 Evenity ( romosozumab - for coverage of this medication at this time. Refer to the policy titled Review at Launch for New to Market (Romosozumab Aqqg) Medications for additional details. Evenity is proven for the treatment of osteoporosis in postmenopausal patients at high risk for fracture. Evenity is : medically necessary when ALL of the following criteria are met Diagnosis of osteoporosis ; and I. II. One of the following: BMD T score ≤ 2.5 based on BMD measurements from lumbar spine (at least two vertebral bodies), hip - A. - - third radius site); or (femoral neck, total hip), or radius (one History of one of the following resulting from minimal trauma: B. 1. Vertebral compression fractur e Fracture of the hip 2. 3. Fracture of the distal radius Fracture of the pelvis 4. 5. Fracture of the proximal humerus or C. Both of the following: - 1. BMD T - score between - 1 and - 2.5 (BMD T - score greater than 2.5 and less than or equal to - 1) based on BMD measurements from lumber spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one - third radius site) 2. One of the following: a. year fracture probabilities: major osteoporotic fracture at 20% or more FRAX 10 - b. racture at 3% or more year fracture probabilities: hip f - FRAX 10 and III. History of failure, contraindication, or intolerance to oral or intravenous bisphosphonate therapy; and any of the following: Patient is not receiving Evenity in combination with IV. A. Parathyroid hormone analogs (e.g., Forteo, Tymlos) B. RANK ligand inhibitors (e.g., Prolia, Xgeva) and V. Evenity dosing is in accordance with the United States Food and Drug Administration approved labeling: 210mg and ; once monthly VI. Authorization is for no more than 12 months. re Criteria Reauthorization/Continuation of Ca The clinical benefit of Evenity has not been demonstrated beyond 12 months in phase 3 clinical trials. The continued use of Evenity beyond 12 months is unproven and not medically necessary. 2019 8 Medical Policy Update Bulletin: M ay

9 Medical Benefit Drug Policy Updates Policy Title Summary of Changes Effective Date ATED UPD ® Mifeprex May 1, 2019  Updated coverage rationale; added language to clarify Mifeprex (mifepristo ne), in combination with misoprostol, (Mifepristone) intrauterine pregnancy through 70 days is proven and medically necessary for the medical termination of gestation when administered under the supervision of a qualified physician  Updated supporting information to refle ct the most current clinical evidence, CMS information, and references Policy Title Summary of Changes Coverage Rationale Effective Date REVISED Botulinum Toxins A May 1, 2019  Revised coverage rationale; This policy refers to the following drug products: added criterion for chronic Botulinum toxin types A and B: and B ® (abobotulinumtoxinA) migraine headache requiring  Dysport ® botox is not used in combination  (incobotulinumtoxinA) Xeomin ®  Botox with CGRP antagonists [i.e., (onabotulinumtoxinA) ® Myobloc Aimovig (erenumab), Ajovy  (rimabotulinumtoxinB) (fremanezumab), Em gality ete details on the coverage guidelines for Refer to the policy for compl (galcanezumab)] Botulinum Toxins A and B .  cwvz) has been added to the Review at Launch - May 1, 2019 Revised coverage rationale; Ultomiris (ravulizumab Complement ® Inhibitors (Soliris updated coverage criteria for program. Some members may not be eligible for coverage of this medication paroxysmal nocturnal & Ultomiris™) a t this time. Refer to the policy titled Review at Launch for New to Market ils. for additional deta Medications : NH) hemoglobinuria (P Initial Therapy This policy refers to the following complement inhibitor drug products: Added criteria requiring: o Soliris (eculizumab)   Documentation - cwvz)  Ultomiris (ravulizumab supporting the diagnosis I. typical Hemolytic Uremic Soliris is proven for the treatment of a of PNH that includes Syndrome (aHUS) . both of the following: Soliris is medically necessary when all of th e following criteria Flow cytometry - are met : analysis confirming Initial Therapy: A. presence of PNH 1. Documentation supporting the diagnosis of aHUS by ruling out clones both of the following: Laboratory results, - a. - Shiga toxin E. coli related hemolytic uremic syndrome signs, and/or (STEC HUS); - symptoms attributed b. Thrombotic thrombocytopenia purpura (TTP) (e.g., rule out to PNH (e.g., DAMTS13 deficiency); A abdominal pain, and anemia, dyspnea, Soliris is initiated and titrated according to the US FDA labeled 2. extreme fatigue, dosing for aHUS, up to a maximum of 1200 mg every 2 weeks; smooth muscle 9 Medical Policy Update Bulletin: M ay 2019

10 Drug Policy Updates Medical Benefit Effective Date Policy Title Coverage Rationale Summary of Changes REVISED dystonia, Complement May 1, 2019 and ® unexplained/unusual 3. Prescribed by or in consultation with a hematologist; Inhibitors (Soliris and 4. thrombosis, & Ultomiris™) Initial authorization will be for no more th an 6 months. hemolysis/hemoglobi (continued) : Continuation Therapy B. 1. and nuria, kidney Patient has previously been treated with Soliris; Documentation demonstrating a positive clinical response from 2. disease, pulmonary baseline (e.g., reduction of plasma exchanges, reduction of hypertension, etc.) of hemolysis); dialysis, increased platelet count, reduction and  Patient is treatment Soliris is dosed according to the US FDA labeled dosing for aHUS: naïve with both Soliris 3. and Ultomiris and 1200 mg every 2 weeks; quiring: and Prescribed by or in consultation with a hematologist; Removed criteria re o 4. Reauthorization will be for no more than 12 months. Documentation 5.  supporting the diagnosis II. Soliris is unproven and not medi cally ne cessary for treatment of of PNH that includes one related Hemolytic U yndrome (STEC - Shiga Toxin E. Coli S - remic of the following: HUS). - At least 10% PNH type III red cells aroxysmal III. Soliris and Ultomiris are proven for the treatment of p - Greater than 50 % of Nocturnal Hemoglobinuria (PNH) . glycosylphosphatidyli Soliris and Ultomiris are medically necessary when all of t he - anchored nositol following criteria are met : proteins (GPI - AP) - Initial Therapy: A. - deficient poly 1. Documentation supporting the diagnosis of PNH that includes morphonuclear cells of the following: both (PMNs) a. Flow cytometry analysis confirming presence of PNH clones. One of the following:  Laboratory results, signs, and/or symptoms attributed to PNH b. - Patient is transfusion (e. g., abdominal pain, anemia, dyspnea, extreme fatigue, dependent as smooth muscle dystonia, unexplained/unusual thrombosis, defined as hemolysis/hemoglobinuria, kidney disease, pulmonary hemoglobin ≤ 7 g/dL hypertension, etc.) or both of the and following: Patient is treatment naïve with both Soliris and Ultomiris; 2. and  Hemoglobin ≤ 9 Soliri s according to the US FDA labeled 3. or Ultomiris are dosed g/dL ; and dosing for PNH Patient is  Prescribed by or in c or 4. onsultation with a hematologist experiencing oncologist and ; symptoms of Initial authorization will be for no more than 6 months. 5. anemia B. : Continuation Therapy Patient has a - or Ultomiris 1. and Patient has previously been treated with Soliris ; documented history Documentation demonstrating a positive clinical response from 2. M 10 2019 Medical Policy Update Bulletin: ay

11 Medical Benefit Drug Policy Updates Coverage Rationale Policy Title Effective Date Summary of Changes REVISED baseline (e.g., increased or stabilization of hemoglobin levels, May 1, 2019 Complement of major adverse ® reduction in transfusions, vascular events from hibitors (Soliris improvement in hemolysis, decrease in In etc.); & Ultomiris™) te count, thromboembolism LDH, increased reticulocy and or Ultomiris are dosed according to the US FDA labeled (continued) o R eplaced criterion requiring 3. Soliris dosing for PNH; “[drug is] prescribed by or in and or 4. Prescribed by or in consultation with a hematologist consultation with a ; hematologist” with “[drug is] oncologist and 5. prescribed by or in Reauthorization will be for no more than 12 months. consultation with a hematologist or oncologist ” IV. yasthenia M eneralized reatment of g Soliris is proven for the t G . ravis Continuation Therapy Soliris is medically necessary when all of the following criteria Modified list of examples of o are met: documentation A. : nitial therapy I demonstrating a positive Submission of medical records (e.g., chart notes, laboratory 1. clinical response from values, etc.) to support the diagnosis of generalized myasth enia : baseline; added gravis (gMG) by a neurologist or in consultation with a ecrease in LDH  D neurologist confirming all of the following: I mprovement in  a. Patient has not failed a previous course of Soliris therapy; hemolysis and ncreased reticulocyte I  b. Positive serologic test for anti - AChR antibodies; and count One c. of the following: o Replaced criterion requiring i. f abnormal neuromuscular transmission test History o “[drug is] prescribed by or in fiber electromyography (SFEMG) - demonstrated by single consultation with a or repetitive nerve stimulation hematologist” with “[drug is] History of positive anticholinesterase test, e.g., ii. prescribed by or in edrophonium chloride test tation with a consul n Patient has demonstrated improvement in MG signs o iii. hematologist or oncologist ” oral cholinesterase inhibitors, as assessed by the treating Updated supporting information  neurologist to reflect the most current and references d. Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation and of therapy; e. Patient has a Myasthenia Gravis - specifi c Activities of Daily - Living scale (MG ADL) total score ≥ 6 at initiation of therapy; and 2. Both of the following: immunosuppressive agent two History of failure of at least a. 11 Medical Policy Update Bulletin: M ay 2019

12 Medical Benefit Drug Policy Updates Summary of Changes Coverage Rationale Policy Title Effective Date REVISED over the course of at least 12 months [e.g., azathioprine, Complement May 1, 2019 ® Inhibitors (Soliris methotrexate, cyclosporine, mycophenylate, etc.]; and & Ultomiris™) b. Patient has required 2 or more courses of plasmapheresis/ (continued) plasma exchanges and/or intravenous immune globulin for at least 12 months without symptom control and 3. Patient is currently on a stable dose (at least 2 months) of and immunosuppressive therapy; 4. So liris is initiated and titrated according to the US FDA labeled dosing for gMG, up to a maximum of 1200 mg every 2 weeks; and Prescribed by or in consultation with a Neurologist; and 5. Initial authorization will be for no more than 6 months. 6. rapy B. C ontinuation the : 1. Patient has previously been treated with Soliris; and Submission of medical records (e.g., chart notes, laboratory 2. tests) to demonstrate a positive clinical response from baseline of the following: as demonstrated by at least all aintenance of at least a 3 point Improvement and/or m a. improvement (reduction in score) in the MG ADL score from - pre treatment baseline. - b. Reduction in signs and symptoms of myasthenia gravis Maintenance, reduction, or discontinuation of dose(s) of c. apy (IST) prior to starting baseline immunosuppressive ther Soliris.* * Note: Add on, dose escalation of IST, or additional rescue therapy from baseline to treat myasthenia gravis or exacerbation of symptoms while on Soliris therapy will be considered as treatment failure. and 3. Soliris is dosed according to the US FDA labeled dosing for gMG: up to a maximum of 1200 mg every 2 weeks; and 4. Prescribed by or in consultation with a Neurologist; and 5. Reauthorization will be for no more than 12 months. May 1, 2019 Enzyme This policy refers to the following enzyme replacement therapy products:  Revised coverage rationale: ® Replacement Updated list of applicable (laronidase)  Aldurazyme o ®  idursulfase) Therapy ( enzyme replacement therapy Elaprase ® ® products; removed Adagen Fabrazyme (agalsidase beta )   (pegademase bovine) Kanuma™ (sebelipase alfa) 2019 12 Medical Policy Update Bulletin: M ay

13 Medical Benefit Drug Policy Updates Coverage Rationale Policy Title Effective Date Summary of Changes REVISED ® Lumizyme E nzyme (alglucosidase alfa)  May 1, 2019 o Removed coverage criteria ® Mepsevii™ (vestronidase alfa  Replacement vjbk) for Adagen - (pegademase ® bovine) moved from (galsulfase) (re Naglazyme  Therapy (continued) lvlr) - Revcovi™ (elapegademase market)  ®  Updated coverage criteria for (elosulfase alfa) o Vimizim Revcovi:  Removed specific dosage Refer to the policy for complete details on the coverage guidelines for Enzyme Replacement Therapy . quantities Replaced references to  pegademase “ therapy” with “ elapegademase therapy”  Updated list of applicable HCPCS codes; removed J2504 Updated supporting information  to re flect the most current background information, clinical evidence, FDA and CMS information, and references Revised coverage rationale:  This policy refers to the following ketamine products: Ketamine May 1, 2019 o  Ketalar (ketamine) Added language to indicate:   ine) Spravato (esketam This policy refers to the follo wing ketamine Spravato (esketamine) Nasal Spray products: Spravato is proven and/or medically necessary for the treatment of - Ketalar (ketamine) - treatment resistant depression (TRD) when ALL of the following - Spravato criteria are met: (esketamine)  Spravato (esketamine) Initial Therapy nasal spray is proven ding to the current Diagnosis for major depressive disorder (MDD) accor I. and/or medically DSM (i.e., DSM - 5), by a mental health professional; and necessary for the Patient has not experienced a clinically meaningful improvement after II. treatment of treatment - treatment with at least different antidepressants of adequate dose, two resistant depression duration (at least 6 weeks), and adher ence in the current depressive all of the (TRD) when ; episode (Must document medications, doses, and durations) and following criteria are III. Patient is to receive Spravato therapy in conjunction with another oral met: and antidepressant; Initial Therapy IV. Provider and/or the provider’s healthcare setting is certified in the Di - agnosis for major and Spravato REMS program; 13 Medical Policy Update Bulletin: M 2019 ay

14 Medical Benefit Drug Policy Updates Coverage Rationale Policy Title Summary of Changes Effective Date REVISED depressive disorder V. Spravato dosing is in accordance with the United States Food and Drug Ketamine May 1, 2019 and Administration approved labeling; (continued) (MDD) according to VI. Initial authorization will be for no longer than 12 weeks. the current DSM - 5), by a (i.e., DSM Continuation Therapy mental health and Spravato; Patient has previously been treated with I. professional; and II. Documentation demonstrating a positive clinical response from baseline Patient has not - - Asberg Depression Rating Scale [MADRS], (e.g., improved Montgomery experienced a clinical remission, response, etc.), as defined by the provider; and clinically meaningful III. rapy in conjunction with another oral Patient is to receive Spravato the improvement after antidepressant; and treatment with at IV. Provider and/or the provider’s healthcare setting is certified in the least two different Spravato REMS program; and antidepressants of Spravato dosing is in accordance with the United States Food and Drug V. adeq uate dose, Administration approved labelin g; and duration (at least 6 Authorization will be for no longer than 6 months. VI. weeks), and adherence in the Spravato is unproven and not medically necessary for the following: current depressive Anesthetic agent  episode (must  Chronic pain (including but not limited to nonmalignant pain, document Fibromyalgia, neuropathic pain, Complex Regional P ain Syndrome, Reflex medications, doses, Sympathetic Dystrophy) and durations); and Migraine headaches  - Patient is to receive Ketalar (ketamine) Injection Spravato therapy in conjunction with Ketamine injection is considered medically necessary and may be another oral covered for the following: antidepressant; and  Anesthesia for diagnostic and surgical procedures that do not require - Provider and/or the eletal muscle relaxation, OR sk p rovider’s healthcare  The induction of anesthesia prior to administration of other anesthesia setting is certified in agents, OR the Spravato REMS  As supplemental anesthesia for low - potency agents, such as nitrous program; and oxide Spravato dosing is in - Ketamine injection is investigational, and therefore not proven or accordance with the ically necessary for the following: med United States Food Psychiatric disorders (including, but not limited to depression, bipolar  and Drug disorder, & posttraumatic stress disorder) Administration Chronic pain (including but not limited to nonmalignant pain,  approved labeling; Fibromyalgia, neuropathic pain, Complex Re gional Pain Syndrome, Reflex and Sympathetic Dystrophy) Medical Policy Update Bulletin: M 14 2019 ay

15 Medical Benefit Drug Policy Updates Effective Date Policy Title Coverage Rationale Summary of Changes REVISED  Migraine headaches - Initial authorization Ketamine May 1, 2019 (continued) will be for no longer than 12 weeks Continuation T herapy Patient has - previously been treated with Spravato; and Documentation - demonstrating a positive clinical response from baseline (e.g., improved Asberg Montgomery - Depression Rating Scale [MADRS], clinical remission, response, etc.), as defined by the p rovider; and - Patient is to receive Spravato therapy in conjunction with another oral antidepressant; and - Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and - Spravato dosing is in accordance with the s Food United State and Drug Administration approved labeling; and Authorization will be - M 2019 ay Medical Policy Update Bulletin: 15

16 Drug Policy Updates Medical Benefit Coverage Rationale Summary of Changes Policy Title Effective Date REVISED for no longer than 6 Ketamine May 1, 2019 (continued) months Spravato is unproven  and not medically necessary for the following: - Anesthetic agent Chronic pain - (including but not limited to nonmalignant pain, myalgia, Fibro neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy) - Migraine headaches Replaced references to o “ketamine” with “ketamine ” injection - Added list of applicable ICD  10 diagnosis codes: F33.0, F33.1, F33.2, F33.3, F33.40, F33 .41, F33.42, F33.8, and F33.9 Updated supporting information  to reflect the most current background information, clinical evidence, FDA information, and references Lemtrada for medically necessary Lemtrada (alemtuzumab) is proven and May 1, 2019 Revised coverage rationale:  ALL (Alemtuzumab) of the Updated coverage criteria for o treatment of relapsing forms of multiple sclerosis when patients who are: following criteri : a are met I. Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing - N - Treatment aïve to remitting MS, secondary - progressive MS with relapses, progressive - Alemtuzumab relapsing MS with relapses); and  Modified list of products of the following: II. One to which the patient naïve to alemtuzumab: Treatment - A. must have a history of history Patient has 1. of failure following a trial for at least 4 weeks 2019 16 Medical Policy Update Bulletin: M ay

17 Medical Benefit Drug Policy Updates Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Lemtrada of the following: May 1, 2019 two history of intolerance to at least or failure following a trial ® ® 1a (Avonex - interferon β ) a. or Rebif for at least 4 weeks or (Alemtuzumab) ® ® (continued) b. interferon β - 1b (Betaseron or Extavia ) history of intolerance; ® ® glatiramer acetate (Copaxone or Glatopa c. ) removed “daclizumab ® dimethyl fumarate (Tecfid era d. ) (Zinbryta™)” ® teriflunomide (Aubagio e. ) Treatment - Experienced ® fingolimod (Gilenya ) f. with Alemtuzumab - g. 1a (Plegridy™) peginterferon beta  Added criterion req uiring ® h. ) natalizumab (Tysabri documentation of ® ) ocrelizumab (Ocrevus i. positive clinical response and to alemtuzumab therapy Patient has and not been previously treated with alemtuzumab; 2. Modified list of examples of o receiving alemtuzumab in combination with 3. Patient is not disease modifying agents for another disease modifying agent for multiple sclerosis (e.g., multiple sclerosis the patient interferon beta preparations, glatiramer acetate, natalizumab, must not receive in fingolimod, teriflunomide, ocrelizumab, etc.); and combination with Initial dosing is administered: 12 mg intravenously daily for 5 4. alemtuzumab; added and consecutive days ; “ocrelizumab” 5. and Regimen is administered only once within 12 months; Added language to indic o ate 6. Initial authorization is for no more than 12 months authorization is for no more or than 12 months experienced with alemtuzumab: - Treatment B. o Removed language Patient has previously received treatment with alemtuzumab; 1. indicating coverage for and Lemtrada is limited to up to response to alemtuzumab Documentation of positive clinical 2. two treatment courses (5 and therapy; day initial and 3 day end receiving alemtuzumab in combination with not 3. Patient is course); requests for another disease modifying agent for multiple sclerosis (e.g., additional doses/courses interferon beta preparations, glatiramer acetate, natalizumab, beyond two courses will not fingolimod, teriflunomide, ocrelizum ab etc.); and be approved 4. Retreatment dosing is administered: 12 mg intravenously daily Updated supporting information  and for 3 consecutive days; to reflect the most current and Regimen is administered only once within 12 months; 5. clinical evidence, CMS Authorization is for no more than 12 months 6. information, and references for the Alemtuzumab is unproven and not medically necessary treatment of:  Rheumatoid arthritis Autoimmune neutropenia   Autoimmune hemolytic anemia 2019 ay M Medical Policy Update Bulletin: 17

18 Drug Policy Updates Medical Benefit Effective Date Policy Title Coverage Rationale Summary of Changes REVISED Lemtrada May 1, 2019  Pure red cell aplasia (Alemtuzumab)  Immune thrombocytopenic purpura (continued)  Evans syndrome  Autoimmune pancytopenia Updated list of related policies;  the maximum dosage per May 1, 2019 Maximum Dosage This policy provides information about added reference link to the administration for certain medications administered by a medical professional. policy titled: ® & o Denosumab (Prolia ® Drug Products: Xgeva ) ® )  bevacizumab (Avastin Oncology Medication Clinical o ® ® ) denosumab (Prolia  & Xgeva Coverage ®  eculizumab (Soliris )  Revised coverage rationale: ® )  infliximab (Remicade applicable o Updated list of -  dyyb (Inflectra™) infliximab drug products; added: ®  bda (Renflexis™) a - infliximab & Denosumab (Prolia  ® ® )  nivolumab (Opdivo ) Xgeva ® ®  omalizumab (Xolair ) Nivolumab (Opdivo  ) ® )  pegfilgrastim (Neulasta  cbqv - Pegfilgrastim - pegfilgrastim  cbqv (Udenyca™) (Udenyca™) jmdb (Fulphila™) -  pegfilgrastim o Added HCPCS code based ® ) rituximab (Rituxan  maximum dosage ® )  trastuzumab (Herceptin information for: ® )  ustekinumab (Stelara Opdivo (nivolumab) ®  ) vedolizumab (Entyvio Maximum Dosage per  ® ® and Zometa ledronic acid, Reclast )  zoledronic acid (zo Administration: 480 mg HCPCS Code: J9299  Most medications have a maximum dosage based upon body surface llowed: 480  Maximum A area or patient weight or a set maximal dosage independent of HCPCS units (1 mg per patient body size, and are proven when used according to labeled unit) indications or when otherwis e supported by published clinical Prolia (denosumab) evidence. Diagnosis: Osteoporosis  Maximum Dosage per  The medications included in this policy when given beyond maximum Administration: 60 mg dosages based upon body surface area or patient weight or a set  HCPCS Code: J0897 maximal dosage independent of patient body size are not supported Maximum Allowed: 60  by package lab eling or published clinical evidence and are unproven. HCPCS units (1 mg per unit) This policy creates an upper dose limit based on the clinical evidence and the th Udenyca (pegfilgrastim - percentile for adult body weight (128 kg) and body surface area (2.59 95 2019 18 M Medical Policy Update Bulletin: ay

19 Medical Benefit Drug Policy Updates Summary of Changes Effective Date Coverage Rationale Policy Title REVISED 2 meters cbqv) May 1, 2019 ) in the U.S. (adult male, 30 to 39 yea Maximum Dos age rs, Fryar, 2016). In some  cases, the maximum allowed units and/or vials may exceed the upper level Maximum Dosage per (continued) limit as defined within this policy due to an individual patient body weight > Administration: 6 mg 2 . total dose 128 kg or body surface area > 2.59 meters HCPCS Code: Q5111  details on the coverage guidelines for Refer to the policy for complete  Maximum Allowed: 12 . Maximum Dosage HCPCS units (0.5mg per unit) Xgeva (denosumab)  Diagnosis: Oncology  Maximum Dosage per Administration: 120 mg  HCPCS Code: J0897 Maximum Allowed: 120  HCPCS units (1 mg per unit) o Added maximum allowed quanti ties for National Drug Code (NDC) billing for: Opdivo (nivolumab) NDC: 00003  13 - 3734 - How Supplied: 240 - mg/24 mL solution in vials Maximum Allowed: - 48 mL  NDC: 00003 3772 - 11 - How Supplied: 40 - mg/4 mL solution in vials - Maximum Allowed: 8 mL - 12 - 3774  NDC: 00003 How Supplied: 100 - mg/10 mL solution in vials Maximum Allowed: - 40 mL Prolia (denosumab) 19 2019 ay M Medical Policy Update Bulletin:

20 Medical Benefit Drug Policy Updates Summary of Changes Coverage Rationale Policy Title Effective Date REVISED Maximum Dosage May 1, 2019  Diagnosis: Osteoporosis - NDC: 55513  01 0710 (continued) -  How Supplied: 60 mg/1 mL prefilled syringe  Maximum Allowed: 1 mL Udenyca (pegfilgrastim - cbqv) 01  NDC: 70114 - 0101 -  6 How Supplied: mg/0.6mL prefilled syringe Maximum Allowed:  0.6mL Xgeva (denosumab)  Diagnosis: Oncology - 01 - NDC: 55513  0730  How Supplied: 120 mg/1.7 mL solution in vials  Maximum Allowed: 1.7 mL  Updated list of applicable HCPCS codes; added J0897, J9173, and Q5111  Update d list of applicable NDCs; - 3734 - 13, 00003 - added 00003 - 11, 00003 - 3774 - 12, 3772 - 0730 0710 - 01, 55513 - 55513 - 01, and 70114 0101 - 01 -  Updated supporting information to reflect the most current CMS information and references ™ Spinraza™ is proven and medically necessary for: (nusinersen) May 1, 2019 Spinraza  Revised coverage rationale: The treatment of I. (Nusinersen) in patients who Spinal Muscular Atrophy (SMA) o Added coverage criteria for spinal muscular atrophy of the following criteria: all meet initial therapy For all (SMA) A. of the following: , requiring: Diagnosi s of spinal muscular atrophy type I, II, or III by, or in 1. Initial Therapy consultation with, a neurologist with expertise in the diagnosis of Patient has not  20 2019 Medical Policy Update Bulletin: M ay

21 Medical Benefit Drug Policy Updates Effective Date Policy Title Summary of Changes Coverage Rationale REVISED SMA; Spinraza™ previously received gene May 1, 2019 and (Nusinersen) replacement therapy for Submission of medical records (e.g., chart notes, laboratory 2. of the following: both values) confirming the treatment of SMA; or (continued) a. The mutation or de letion of genes in chromosome 5q  One of the following: - Bot h resulting in one of the following: of the Homozygous gene deletion or mutation (e.g., following: i. homozygous deletion of exon 7 at locus 5q13); or Patient recently  received gene ii. Compound heterozygous mutation (e.g., deletion of replacement SMN1 exon 7[allele 1] and mutation of SMN1 [a llele 2]) and therapy within b. the previous 6 Patient has at least 2 copies of SMN2 and months; and either Patient is of the following: 3. dependent on  Patient has not experienced a a. Invasive ventilation or tracheostomy - b. declination in Use of non invasive ventilation beyond use for naps and clinical status nightime sleep and since receipt of 4. gene Submission of medical records (e.g ., chart notes, laboratory one values) of the baseline exam of at least of the following replacement exams (based on patient age and motor ability) to establish therapy baseline motor ability: or Hammersmith Infant Neurological Exam Part 2 ( Both - a. of the HINE 2 ) - (infant to early childhood) following: b. HFMSE Patient has  ) Ha mmersmith Functional Motor Scale Expanded ( c. Upper Limb Module ( ULM ) Test (Non ambulatory) previously Children’s Hospital of Philadelphia Infant Test of d. rec eived gene ) replacement Neuromuscular Disorders ( CHOP INTEND and therapy; and  Spinraza is prescribed by, or in consultation with, a neurologist Patient has 5. experienced a and ; ith expertise in the treatment of SMA w declination in One 6. of the following: clinical status Patient has not previously received gene replacement a. that represents a or therapy for the treatment of SMA; b. One potential of the following: Both of the following: abatement of i. Patient recently received gene replacement therapy gene therapy 1) withi and n the previous 6 months; efficacy 2) Patient has experienced a declination in clinical status Continuation Therapy since receipt of gene replacement therapy One of the following:  21 Medical Policy Update Bulletin: M ay 2019

22 Medical Benefit Drug Policy Updates Coverage Rationale Policy Title Effective Date Summary of Changes REVISED Patient has not - Spinraza™ or May 1, 2019 ii. previously received Both of the following: (Nusinersen) Patient has previously received gene replacement gene replacement 1) (continued) therapy; and ther apy for the clinical status treatment of SMA; or Patient has experienced a declination in 2) that represents a potential aba - tement of gene Both of the following: therapy efficacy  Patient has and previously 7. Spinraza is to be administered intrathecally by, or under the received gene direction of, healthcare professionals experienced in performing and lumbar punctures; replacement is within accordance with the United Spinraza dosing for SMA 8. therapy; and  Patient has States Food and Drug Administration approved labeling: and maximum dosing of 12mg for each loading dose; experienced a declination in 9. . Initial authorization will be for no more than 4 loading doses For continuation therapy , B. clinical status all of the following: Diagnosis of spinal muscular atrophy type I, II, or III by, or in 1. that represented pertise in the diagnosis of a potential consultation with, a neurologist with ex failure or SMA; and 2. Submission of medical records (e.g., chart notes, laboratory abatement of both gene therapy values) confirming of the following: ion or deletion of genes in chromosome 5q The mutat a. efficacy of the following: resulting in one  Submis sion of medical records (e.g., chart i. Homozygous gene deletion or mutation (e.g., or notes, laboratory values) homozygous deletion of exon 7 at locus 5q13); with the most recent Compound heterozygous mutation (e.g., deletion of ii. f SMN1 [allele 2]) SMN1 exon 7[allele 1] and mutation o results (< 1 month prior to request) documenting and a positive clinical Patient has at least 2 copies of SMN2 b. response from and either dependent on not Patient is 3. pretreatment baseline of the following: a. Invasive ventilation or tracheostomy status to Spinraza therapy as demonstrated b. Use of non - invasive ventilation beyond use for naps and by both of the following nighttime sleep : Patient was - and prescribed Spinraza 4. One of the following: due to clinical ient has not previously received gene replacement Pat a. or declination after therapy for the treatment of SMA; receipt of gene b. of the following: Both 22 M ay 2019 Medical Policy Update Bulletin:

23 Medical Benefit Drug Policy Updates Effective Date Policy Title Coverage Rationale Summary of Changes REVISED Spinraza™ i. May 1, 2019 Patient has previously received gene replacement therapy; and Patients clinical (Nusinersen) - therapy; and Patient has experienced a declination in clinical status ii. (continued) status has stabilized after receipt of tement of gene l failure or aba that represented a potentia therapy efficacy Spinraza therapy and o Added language to indicate Submission of medical records (e.g., chart notes, laboratory 5. Spinraza is not proven or medically necessary for: values) with the most recent results (< 1 month prior to request) Spinal documenting a positive clinical response  muscular atrophy from pretreatment without chromosome 5q Spinraza therapy as demonstrated by at to baseline status mutations or deletions one of the following exams: least milestones:  2 - HINE a. Routine concomitant i. of the following: One treatment of SMA in 1) Improvement or maintenance of previous patients who have improvement of at least 2 point (or maximal score) previously received gene replacement therapy increase in ability to kick  2) Updated supporting information nce of previous Improvement or maintena improvement of at least 1 point increase in any other to reflect the most current 2 milestone (e.g., head control, rolling, sitting, HINE background information, clinical - evidence, CMS information, and crawling, etc.), excluding voluntary grasp and references ii. of the following: One 1) The patient exhibited improvement, or maintenance of previous improvement in more HINE motor milestones than worsening, from pretreatment baseline (net positive improvement) Achieved and maintained any new motor milestones 2) when they would otherwise be unexpected to do so (e.g., sit unassisted, stand, walk) or b. HFMSE: One of the following: Improvement or maintenance of previous improvement i. of at least a 3 point increase in score from pretreatment baseline Patient has achieved and maintained any new motor ii. milestone from pretreatment baseline when they would unexpected to do so otherwise be or c. of the following: One ULM: 23 Medical Policy Update Bulletin: M ay 2019

24 Medical Benefit Drug Policy Updates Summary of Changes Coverage Rationale Policy Title Effective Date REVISED i. Improvement or maintenance of previous improvement Spinraza™ , 2019 May 1 of at least a 2 point increase in score from pretreatment (Nusinersen) (continued) baseline ii. Patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so or of the following: d. CHOP INTEND: One i. Improvement or maintenance of previous improvement of at least a 4 point increase in score from pretreatment baseline Patient has achieved and maintained any new motor ii. m ilestone from pretreatment baseline when they would otherwise be unexpected to do so or of the following: Both e. i. Patient was prescribed Spinraza due to clinical declination and ; after receipt of gene therapy ii. receipt of Patients clinical status has stabilized after Spinraza therapy and Spinraza is prescribed by, or in consultation with, a neurologist 6. and in the treatment of SMA; with expertise 7. Spinraza is to be administered intrathecally by, or under the direction of, healthcare professionals experienced i n performing and lumbar punctures; 8. Spinraza dosing for SMA is within accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 12mg every 4 months, starting 4 months after the last loading dose; and 9. will be for no more than 3 maintenance doses Reauthorization (12 months). is not proven or medically necessary for spinal muscular Spinraza is atrophy without chromosome 5q mutations or deletions. Spinraza not proven or medically necessary for routine concomitant trea tment of SMA in patients who have previously received gene replacement therapy . 24 2019 ay M Medical Policy Update Bulletin:

25 Medical Benefit Drug Policy Updates Coverage Rationale Policy Title Effective Date Summary of Changes REVISED Conditions: May 1, 2019 Vaccines  Revised coverage rationale: o Removed language The following conditions apply to all covered vaccines. A vaccine is of the following conditions are satisfied: both considered covered after indicating:  The standard 1. US Food and Dru g Administration (FDA) approval; and Explicit ACIP recommendations (e.g., should, shall, is) rather than a 2. re UnitedHealthca permissive ("may") recommendation, published in the Morbidity & Certificate of Coverage Mortality Weekly Report (MMWR) of the Centers for Disease Control and covers preventive health Prevention (CDC ). services, including immunizations, Coverage Clarifications: administered in a Preventive  : For a list of vaccines that are covered under the preventive physician office; some care benefit, see the Coverage Determination Guideline titled Preventive immunizations are . Care Services excluded, e.g., Therapeutic : Certain vaccines are used as a medical treatment. For  immunizations that are example, therapeutic treatment of an animal bite using the rabies required for travel, vaccine. These vaccines are under the plan’s treatment b enefits, not employment, education, under preventive care benefits. insurance, marriage, Excluded  : Vaccines that that fall under one of the exclusions in the on, military adopti specific benefit plan document. For example, most plans - member service, or other specific vaccines. - exclude travel administrative reasons  Implementation of covered vaccines will typically occur within 60 days after publication in the MMWR o Updated conditions of coverage to clarify th e following conditions apply to all covered vaccines; a v is considered accine covered after both of the following conditions are satisfied:  US Food and Drug Administration (FDA) approval; and ACIP Explicit  recommendations (e.g., should, shall, is) rather 25 2019 M ay Medical Policy Update Bulletin:

26 Drug Policy Updates Medical Benefit Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Vaccines May 1, 2019 than a permissive ("may") (continued) recommendation, e published in th Morbidity & Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC) Updated coverage o clarification notations: Modified instruction to  clarify the Coverage Determination Guideline Preventive Care titled should be Services a for list of ferenced re vaccines that are covered under the preventive care benefit  Added language to indicate: - Certain vaccines are used as a medical treatment  For example, therapeutic treatment of an animal bite using the rabies vaccine These vaccines  are under the plan’s treatment benefits, not under preventive care benefits Vaccines that that - fall under one of the 26 Medical Policy Update Bulletin: M 2019 ay

27 Medical Benefit Drug Policy Updates Summary of Changes Coverage Rationale Policy Title Effective Date REVISED May 1, 2019 exclusions in the Vaccines - member (continued) specific benefit plan document are excluded; for example, most plans - exclude travel specific vaccines Updated support  ing information to reflect the most current and references; removed CMS information 2019 27 Medical Policy Update Bulletin: M ay

28 Coverage Determination Guideline (CDG) Updates nges Summary of Cha Policy Title Effective Date UPDATED Habilitative  May 1, 2019 Upd ated coverage rationale: Services and o Simplified content o Outpatient Modified list of coverage limitations and exclusions for both habilitative services and rehabilitation therapy to clarify coverage is excluded for Rehabilitation once the treatment plan goals are met services that continue Therapy Effective Date Summary of Changes Coverage Rationale P olicy Title REVISED Jun. 1, 2019 Reorganized policy template: Coverage Indications for Ambulance  Services d Simplified and relocate o Air Ambulance Instructions for Use 60 As a general guideline, when it would take a ground ambulance 30 - Removed Benefit o minutes or more to transport a member whose medical condition at the time section Considerations of pick - up required immediate and rapid transport due to the nature and/or  Revised coverage rationale: severity of the nsportation may be member’s illness/injury, air tra o Simplified content appropriate. o Removed language pertaining to: Air ambulance transportation should meet the following criteria: Cost  ffective e - ; The member’s destination is an acute care hospital  and a lternatives [UHIC 2007 The member’s condition is such that the ground ambulance (basic or  Certificate of Coverage adv or anced life support) would endanger the member’s life or health ; (COC) and 2009 COC  Inaccessibility to ground ambulance transport or extended length of time Amendment] member via ground ambulance transportation required to transport the Negotiated rates for -  out or ; could endanger the member of - network coverage  c conditions make ground ambulance transportation Weather or traffi Updated list of examples of o impractical, impossible, or overly time consuming - non ambulance transportation services that Emergency Ambulance (Ground, Water, or Air) are not eligible for coverage; Coverage includes Emergency ambulance transportation (including wait time added “rideshare services and treatment at the scene) by a lice nsed ambulance service from the such as Lyft and Uber” location of the sudden illness or injury, to the nearest hospital where Removed definition of “Medically  Emergency he alth services can be performed. Necessary (2011 Generic COC)” The following Emergency ambulance services are covered:  Ground ambulance or air ambulance transportation re quiring basic life port or advanced life support sup upplies that are needed for advanced life support or basic life support to S  member’s medical condition stabilize a hout ambulance Treatment at the scene (paramedic services) wit  M ay 28 2019 Medical Policy Update Bulletin:

29 (CDG) Updates Coverage Determination Guideline Effective Date P olicy Title Coverage Rationale Summary of Changes REVISED transportation Jun. 1, 2019 Ambulance Services  Wait time a ssociated with c overed ambulance transportation (continued) ransportation t  hospital that provides a required higher level of care o a T ilable at the original hospital that was not ava Emergency Ambulance (Ground or Air) Between Facilities - Non Coverage includes non - E me rgency ambulance transportation by a licensed ambulance service (either ground or air ambulance, as we determine of the appropriate) between facilities only when the transport meets one following:  Network Hospital to the closest Network Hosp - ital when of - From an out Covered Health Care Services are required  To the closest Network Hospital or facility that provides the required Care Covered Health Services that were not available at the original Hospital or facility - Term Acute Care Facility to th e closest Network Long - Term  From a Short Acute Care Facility (LTAC), Network Inpatient Rehabilitation Facility, or acility other Network S ub - A cu te F where the required Covered Health Care Services can be delivered condition requires treatm member’s hen the  W ent at anothe r facility and medical another mode of transportation would endanger the member’s condition Emergency ambulance - for eligible non level The applicable benefit transportation depends on the member up location (origin) as follows: pick -  If the member is inpat ient and is transported from a hospital to another e ambulance hospital or inpatient facility, coverage levels for thes services may vary. acute setting and is transported to an -  is in a sub If the member tpatient facility, or outpatient facility and back (outpatient hospital, ou physician’s office), these ambulance services are covered under the member benefits that apply to that sub setting. acute - For example, if the is at a Skilled Nursing Facility, the ambulance transport to an outpatient facility (dialysi s facility or radiation whether or not it is attached to a hospital) and back is covered under the Skilled Nursing Facility/Inpatient Services section of the COC. Rehabilitation Facility - - Pre Service Notification Requirements for Non Emergency Ambulance 29 2019 ay M Medical Policy Update Bulletin:

30 Coverage Determination (CDG) Updates Guideline olicy Title P Summary of Changes Coverage Rationale Effective Date REVISED Ambulance If UnitedHealthcare Jun. 1, 2019 initiates the non - Emergency ambulance  transportation, member notification is not required. Services does not initiate the  Emergency ambulance - non (continued) UnitedHealthcare If transportation , certain plans may require the member or the provide r to call in f or notification. Provider notification requirements are not addressed by this document.  Network - of - ut O Ambulance (Emergency) If the ambulance transportation is covered, the benefit level for out - of - Emergency am is c overed at the Network bulance (ground, water, or air) N etwork level of deductib le and coinsurance. Coverage Limitations and Exclusions services are not eligible for coverage: The following  Ambulance services from providers that are not properly licensed to be performing the ambulance services r endered. transportation Air ambulance  that does not meet the covered indications in the Air Ambulance criteria listed above. ambulance transportation is not  Non - ambulance transportation. Non - covered even if rende red in an Emergency situation. Examples include : but are not limited to o C ommercial or private airline or helicopter o police car ride to a hospital A edi chair van o M transportation - van or wheel - , etc. o Taxi ride, bus ride, rideshare services such as Lyft and Uber  Ambulance transportation when other mode of transportation is appropriate. Except as indicated under the Indications for Coverage , ambulance services when transportation by other means section above are not covered. d not endanger the member’s health woul Ambulance transportation to a home, residential, domiciliary or custodial  facility is not covered. Ambulance transportation that violates the notification criteria listed in  the section above. Indications for Coverage convenience or other member transportation for Ambulance  miscellaneous reas and/or family. member ons for include but are not limited to: Examples ty for o Member wants to be at a certain hospital or facili personal/preference reasons o wants to come and is in foreign country, or out of state, Member 2019 30 Medical Policy Update Bulletin: M ay

31 Coverage Determination Guideline (CDG) Updates P olicy Title Effective Date Summary of Changes Coverage Rationale REVISED Ambulance Jun. 1, 2019 home for a surgical procedure or treatment (this includes those Services recently discharged from inpatient care) for is going (continued) Member lly able to use a routine service and is medica o another mode of transportation Member and family wants is deceased o transportation to the coroner’s office or mortuary Examples include but  Ambulance transpor tation deemed not appropriate. are not limited to: o Hospital to home ian’s office o Home to physic residence, nursing home, domiciliary or custodial o Home (e . g. , facility) to a hospital for a scheduled service If the member is at a Skilled Nursing Facility/Inpatient Rehabilitation  rsing Facility and has met the annual day/visit limit on Skilled Nu Facility/Inpatient Rehabilitation Facility Services, ambulance transports (during the non - covered days) are not eligible. Orthognathic (jaw) surgery is a standard exclusion from coverage in most Jul. 1, 2019  Revised coverage rationale: Orthognathic (Jaw) Surgery insured plans. The following represents exceptions o fully - Simplified content to the orthognathic ion Replaced language indicating and may be eligible for coverage as reconstructive (jaw) surgery exclus o “[the listed services] are and medically necessary :  eligible for coverage as Acute traumatic injury reconstructive and medically  cancerous tumors and cysts - Cancerous or non bstructive sleep apnea  O necessary” with “[the listed Congenital anomalies  services] may be eligible for age as reconstructive cover and medically necessary” Criteria Modified list of services that o Orthognathic (jaw) surgery may be eligible for cove rage as may be eligible for coverage reconstructive and medically necessary for the conditions cited as reconstructive and : criteria below are met following when the above ; medically necessary one or more The presence of  of the following facial skeletal deformities removed: associated with masticatory malocclusion: Surgical Sequela - Post  o Anteroposterior Disc repancies ( established norm=2mm):  Cleft lip/palate (for cleft  Maxillary/Mandibular Incisor Relationship: O verjet of 5mm or lip/palate related Jaw more or a 0 to a negative value Surgery)  Maxillary/Mandibular Anteroposterior Molar Relationship: Modified list o of coverage iscrepancy of 4mm or more D limitations and exclusions;  eviation from These values represent two or more standard d removed: published norm 31 Medical Policy Update Bulletin: M 2019 ay

32 Guideline (CDG) Updates Coverage Determination Effective Date P Coverage Rationale olicy Title Summary of Changes REVISED Orthognathic (Jaw)  Surgery for torus Jul. 1, 2019 o Vertical Discrepancies: Presence of a vertical facial skeletal deformity mandibularis and torus which is two or more standard deviations from published norms Surgery for accepted skeletal landmarks palatinus for fabrication (continued)  Open bite: of dentures Removed language o - No vertical overlap of anterior teeth indicating some states may or bilateral posterior open bite greater than 2mm Unilateral - Deep overbite with impingement or irritation of buccal or lingual require orthognathic (jaw)  surgery for cleft lip and cleft soft tissues of the opposing arch Supraeruption of a dentoalveolar segment due to lack of palate, or for services that  UnitedHealthcare considers occlusion o Cosmetic Procedures, such Transverse Discrepancies: as repair of external transverse skeletal discrepancy which is two or Presence of a  congenital anomalies in the more standard deviations from published norms absence of a Functional  Total bilateral maxillary palatal cusp to mandibular fossa discrepancy of 4mm or greater, or a unilateral discrepancy of Impairment 3mm or greater, given normal axial inclin ation of the posterior Updated definitions:  Added definition of o teeth o Asymmetries: Anteroposterior, transverse or lateral asymmetries “Obstructive Sleep Apnea” o Removed definition of: greater than 3mm with concomitant occlusal asymmetry Cancer Sequela  AND of the following one or more he individual must also have  Post - Su T  rgical Sequela Functional Updated supporting information  Impairments : nd swallowing dysfunction due to skeletal Masticatory (chewing) a to reflect the most current o references malocclusion (e.g., inability to incise/and or chew solid foods, choking on incompletely masticated solid foods, damage to soft tissue during mastication, malnutrition) o xistence of speech Documentation of speech deficits to support e impairment due to skeletal malocclusion o Moderate to Severe Obstructive Sleep Apnea (OSA) with O ropharyngeal narrowing secondary to maxillomandibular deficiency  also refer for OSA, clinical coverage criteria For medical necessity ollowing: to the f Maxillomandibular A urgery (MMA) S dvancement - For : , see MCG™ Care criteria clinical coverage medical necessity rd , Maxillomandibular Osteotomy 9 edition, 201 Guidelines, 2 3 0248 (ACG). - and Advancement, A Multilevel Procedures Whether Done i n a Single - r Phased Multiple Surgeries Surgery o There are a : variety of procedure combinations, including mandibular ay M Medical Policy Update Bulletin: 32 2019

33 (CDG) Updates Guideline Coverage Determination Summary of Changes Coverage Rationale Effective Date P olicy Title REVISED osteotomy and genioglossal advancement with hyoid Jul. 1, 2019 Orthognathic (Jaw) Surgery myotomy (GAHM). For medical necessity clinical coverage rd 9 , ed (continued) criteria , see MCG™ Care Guidelines, 2 3 ition, 201 0247 (ACG). - Mandibular Osteotomy, A Coverage Limitations and Exclusions Orthognathic surgery for the following is not covered: reconstructive Jaw Surgery and jaw alignment - Cosmetic and non  procedures t  surgical orthodontic treatmen - Pre and post 2019 33 Medical Policy Update Bulletin: M ay

34 Utilization Review Guideline (URG) Updates Policy Title Effective Date Summary of Changes UPDATED Changed policy title; previously titled  May 1, 2019 – Globulin Immune Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion Site of Care  Simplified coverage rationale (no change to guidelines) M Medical Policy Update Bulletin: 2019 ay 34

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