UnitedHealthcare Value & Balance Exchange

Medical Policy Update Bulletin: June 2021

In This Issue

Medical Policy Updates Page Updated • Implanted Electrical Stimulator for Spinal Cord – Effective Jun. 1, 2021 ...... 3 • Macular Degeneration Treatment Procedures – Effective Jul. 1, 2021 ...... 3 Revised • Cochlear Implants – Effective Jul. 1, 2021 ...... 4 • Cognitive Rehabilitation – Effective Jul. 1, 2021 ...... 5 • Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation – Effective Jul. 1, 2021 ...... 6 • Electroencephalographic (EEG) Monitoring and Video Recording – Effective Jul. 1, 2021 ...... 7 • Gastrointestinal Motility Disorders, Diagnosis and Treatment – Effective Jul. 1, 2021 ...... 9 • Genetic Testing for Cardiac Disease – Effective Jul. 1, 2021 ...... 10 • Glaucoma Surgical Treatments – Effective Jul. 1, 2021 ...... 11 • Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors – Effective Jul. 1, 2021 ...... 13 • Infertility Diagnosis and Treatment – Effective Jul. 1, 2021 ...... 14 • Lower Extremity Invasive Diagnostic and Endovascular Procedures – Effective Jul. 1, 2021 ...... 15 • Obstructive Sleep Apnea Treatment – Effective Jul. 1, 2021 ...... 18 • Surgery of the Foot – Effective Jul. 1, 2021 ...... 22 • Surgery of the Knee – Effective Jul. 1, 2021 ...... 22 Replaced • Femoroacetabular Impingement Syndrome – Effective Jun. 1, 2021 ...... 23

Page 1 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

In This Issue

Medical Benefit Drug Policy Updates New • Long-Acting Injectable Antiretroviral Agents – Effective Jul. 1, 2021 ...... 24 Updated • Boniva® (Ibandronate) – Effective Jul. 1, 2021 ...... 25 Revised • Antiemetics for Oncology – Effective Jul. 1, 2021 ...... 25 • Complement Inhibitors (Soliris® & Ultomiris™) – Effective Jul. 1, 2021 ...... 33 • Simulect® (Basiliximab) – Effective Jul. 1, 2021 ...... 39 • Spinraza® (Nusinersen) – Effective Jul. 1, 2021 ...... 40 • Thyrogen® (Thyrotropin Alfa) – Effective Jul. 1, 2021 ...... 44 • Vibativ ® (Telavancin) – Effective Jul. 1, 2021 ...... 44 • Xiaflex® (Collagenase Clostridium Histolyticum) – Effective Jul. 1, 2021 ...... 45 • Zolgensma® (Onasemnogene Abeparvovec-Xioi) – Effective Jul. 1, 2021 ...... 48

Coverage Determination Guideline Updates Updated • Breast Reconstruction Post Mastectomy and Poland Syndrome – Effective Jul. 1, 2021 ...... 53 • Cosmetic and Reconstructive Procedures – Effective Jul. 1, 2021 ...... 53 • Enteral Nutrition – Effective Jul. 1, 2021 ...... 53 • Rhinoplasty and Other Nasal Surgeries – Effective Jun. 1, 2021 ...... 54 Revised • Ambulance Services – Effective Jul. 1, 2021 ...... 58 • Emergency Health Care Services and Urgent Care Center Services – Effective Jul. 1, 2021 ...... 62 • Preventive Care Services – Effective Jul. 1, 2021 ...... 66

Page 2 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Updated Policy Title Effective Date Summary of Changes Implanted Electrical Jun. 1, 2021 Notice of Revision: The following summary of changes has been modified. Revisions to the previous policy update Stimulator for Spinal announcement are outlined in red below. Please take note of the amended updates to be applied on Jun. 1, 2021. Cord Template Update Removed CMS section Coverage Rationale Replaced references to “implanted electrical stimulators for spinal cord” with “implanted electrical spinal cord stimulators” Replaced language indicating “implanted electrical stimulators for spinal cord, including high-frequency dorsal column stimulators (also known as BurstDR spinal cord stimulators), are proven and medically necessary” with “implanted electrical spinal cord stimulators, including high-frequency spinal cord stimulators and burst spinal cord stimulators, are proven and medically necessary for treating the [listed] indications” Added list of proven and medically indications: o Complex regional pain syndrome (CRPS) o Failed back surgery syndrome Removed list of services addressed in the referenced InterQual® criteria Added language to indicate implanted electrical stimulators for spinal cord are unproven and not medically necessary for treating the following indications: o Diabetic neuropathy o Refractory angina pectoris Applicable Codes Removed CPT/HCPCS codes 95972 and L8683 Macular Degeneration Jul. 1, 2021 Template Update Treatment Procedures Removed CMS section Coverage Rationale Revised list of unproven and not medically necessary indications; replaced “epiretinal radiation therapy for treating ocular disorders including age-related macular degeneration” with “radiation therapy for age-related macular degeneration (i.e., epimacular and/or epiretinal brachytherapy and stereotactic radiotherapy and/or radiosurgery)” Supporting Information Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information

Page 3 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Cochlear Implants Jul. 1, 2021 Template Update The following are proven and medically necessary when used according to Removed CMS section U.S. Food and Drug Administration (FDA) labeled indications, Coverage Rationale contraindications, warnings and precautions: Non-hybrid cochlear implantation (unilateral or bilateral) for treating Revised coverage criteria for individuals who meet all of the following criteria: hybrid cochlear implantation; Diagnosis of bilateral prelingual or postlingual moderate-to-profound replaced criterion requiring o “diagnosis of bilateral severe to Sensorineural Hearing Loss; and

profound Sensorineural Hearing o Limited benefit (refer to the FDA section of the policy) from Loss in the mid to high appropriate hearing (or vibrotactile) aids (a hearing aid trial is not frequencies with residual low- required in an individual with a concern for meningitis-related cochlear frequency hearing sensitivity” with ossification); and “diagnosis of bilateral severe to o Ability to follow or participate in a program of aural rehabilitation; and Freedom from middle ear infection, an accessible cochlear lumen that profound or moderate sloping to o is structurally suited to implantation, and freedom from lesions in the profound Sensorineural Hearing auditory nerve and acoustic areas of the central nervous system Loss in the mid to high frequencies with residual low- • Hybrid cochlear implantation for treating individuals who meet all of the

frequency hearing sensitivity” following criteria:

Added language to indicate the o Diagnosis of bilateral severe to profound or moderate sloping to cochlear implant’s external profound Sensorineural Hearing Loss in the mid to high frequencies components (i.e., speech with residual low-frequency hearing sensitivity; and processor, microphone, and o Ability to follow or participate in a program of aural rehabilitation; and transmitter coil) are considered o Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the under the DME benefit, and the implantable components are auditory nerve and acoustic areas of the central nervous system

considered under the medical- surgical benefit Hybrid and non-hybrid cochlear implantation are unproven and not medically necessary for treating the following due to insufficient evidence o The member specific benefit plan document must be of efficacy: referenced to determine if • Single sided deafness or unilateral Sensorineural Hearing Loss there are DME benefits for All other conditions that do not meet the above criteria repair or replacement of Note: The cochlear implant’s external components (i.e., speech processor, external components microphone, and transmitter coil) are considered under the DME benefit, and

Page 4 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Cochlear Implants Jul. 1, 2021 o Refer to the Coverage the implantable components are considered under the medical-surgical (continued) Determination Guideline titled benefit. The member specific benefit plan document must be referenced to Durable Medical Equipment, determine if there are DME benefits for repair or replacement of external Orthotics, Ostomy Supplies, components. Refer to the Coverage Determination Guideline titled Durable Medical Supplies and Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements Repairs/Replacements. Applicable Codes Removed HCPCS codes L8622 and L8629 Supporting Information Updated Clinical Evidence, and References sections to reflect the most current information Cognitive Rehabilitation Jul. 1, 2021 Coverage Rationale Cognitive Rehabilitation (CR) is proven and medically necessary when Revised language pertaining to treating individuals following a traumatic brain injury (TBI) or stroke. For ® medical necessity clinical medical necessity clinical coverage criteria, refer to the InterQual 2021, Apr. 2021 Release, LOC: Outpatient Rehabilitation & Chiropractic: coverage criteria: Added reference to the Cerebrovascular Accident (CVA): Rehabilitation (Adult) o InterQual® 2021, Apr. 2021 Traumatic Brain Injury (TBI): Rehabilitation (Adult) Release, LOC: Outpatient Rehabilitation & Chiropractic: Click here to view the InterQual® criteria. . Cerebrovascular Accident (CVA): Rehabilitation The following are unproven and not medically necessary due to insufficient (Adult) evidence of efficacy: . Traumatic Brain Injury Cognitive Rehabilitation for any other condition or diagnosis Coma Stimulation (also known as Coma arousal, Coma responsiveness, (TBI): Rehabilitation (Adult) multisensory stimulation, and Coma care therapy/programs) for any

Removed reference to the indication, including individuals who are Comatose, in a Vegetative, or o InterQual® Client Defined Minimally Conscious State 2021, LOC: Outpatient Rehabilitation & Chiropractic:

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Cognitive Rehabilitation Jul. 1, 2021 . Cerebrovascular Accident (continued) (CVA): Rehabilitation (Adult) (Custom) - UHG . Traumatic Brain Injury (TBI): Rehabilitation (Adult) (Custom) - UHG Supporting Information o Updated Clinical Evidence and References sections to reflect the most current information Electrical Stimulation for Jul. 1, 2021 Template Update Functional electrical stimulation (FES) is proven and medically necessary as the Treatment of Pain Removed CMS section a component of a comprehensive rehabilitation program in members with and Muscle Coverage Rationale lower limb paralysis due to spinal cord injury (SCI) when all of the following criteria are met: Rehabilitation Added language to indicate Demonstration of intact lower motor units (L1 and below) (both muscle and percutaneous peripheral nerve peripheral nerves) stimulation (PNS) is unproven and Muscle and joint stability for weight bearing at upper and lower extremities not medically necessary due to that can demonstrate balance and control to maintain an upright support insufficient evidence of efficacy; posture independently for information regarding Demonstration of brisk muscle contraction percutaneous peripheral nerve Demonstration of sensory perception sufficient for muscle contraction stimulation for occipital neuralgia Demonstration of a high level of motivation, commitment, and cognitive and headache, refer to Medical ability for device use Policy titled Occipital Neuralgia Ability to transfer independently and Headache Treatment Demonstration of independent standing tolerance for at least three Applicable Codes minutes Added CPT code 64555 Demonstration of hand and finger function to manipulate controls Supporting Information Post-recovery from SCI and restorative surgery of at least six months Updated Description of Services, Absence of hip and knee degenerative disease Clinical Evidence, FDA, and Absence of history of long bone fracture secondary to osteoporosis References sections to reflect the

most current information Neuromuscular electrical stimulation (NMES) is proven and medically necessary for treating the following indications:

Page 6 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Electrical Stimulation for Jul. 1, 2021 Disuse muscle atrophy if: the Treatment of Pain o The nerve supply to the muscle is intact; and and Muscle o The disuse muscle atrophy is not of neurological origin, but results Rehabilitation from other conditions including but not limited to casting, splinting, or (continued) contractures To improve wrist and finger function and prevent or correct shoulder subluxation in persons with partial paralysis following stroke

The following are unproven and not medically necessary due to insufficient evidence of efficacy: Dorsal root ganglion (DRG) stimulation FES for treating any other indication not listed above Interferential therapy (IFT) for treating musculoskeletal disorders/injuries, or to facilitate healing of nonsurgical soft tissue injuries or bone fractures Microcurrent electrical nerve stimulation (MENS) NMES for treating any other indication not listed above Percutaneous electrical nerve stimulation (PENS), percutaneous electrical nerve field stimulation (PENFS) or percutaneous neuromodulation therapy (PNT) Percutaneous peripheral nerve stimulation (PNS)* Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS) Pulsed electrical stimulation (PES) Scrambler Therapy (ST)

* For information regarding percutaneous peripheral nerve stimulation for occipital neuralgia and headache, refer to medical policy for Occipital Neuralgia and Headache Treatment. Electroencephalographic Jul. 1, 2021 Template Update Electroencephalographic (EEG) monitoring and video recording is proven (EEG) Monitoring and Removed CMS section and medically necessary in certain circumstances. For medical necessity Video Recording Coverage Rationale clinical coverage criteria, refer to the InterQual® 2021, Apr. 2021 Release, CP: Procedures

Video Electroencephalographic (EEG) Monitoring

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Electroencephalographic Jul. 1, 2021 Revised language pertaining to Video Electroencephalographic (EEG) Monitoring (Pediatric) (EEG) Monitoring and medical necessity clinical ® Video Recording coverage criteria: Click here to view the InterQual criteria. (continued) o Added reference to the InterQual® 2021, Apr. 2021 Documentation Requirements Release, CP: Procedures: Benefit coverage for health services is determined by the member specific . Video benefit plan document and applicable laws that may require coverage for a Electroencephalographic specific service. The documentation requirements outlined below are used to (EEG) Monitoring assess whether the member meets the clinical criteria for coverage, but do not . Video guarantee coverage of the service requested.

Electroencephalographic (EEG) Monitoring Provide medical notes documenting all of the following: (Pediatric) Current prescription Removed reference to the o Name and tax ID number of the servicing provider (facility to facilitate claim InterQual® Client Defined processing) 2020, CP: Procedures: Physician office notes that include: . Video Member diagnosis Electroencephalographic o History/physical with results of resting EEG (EEG) Monitoring o Prior seizure treatments, neuro imaging, and medications (Custom) - UHG o Hospitalizations Video Electroencephalographic (EEG) o o Seizure frequency and intensity Monitoring (Pediatric) (Custom) - UHG o All medications the member is taking

o All medications tried, failed, and contraindicated, including names of the medicines and dates tried

o Dose, frequency, and the physician treatment plan Location where the service will be administered o If the location is in a facility, provide office notes for at least one of the following:

. Medically unstable based upon submitted clinical history

. Previous experience of a severe adverse event

. Continuing experience of adverse events that cannot be mitigated by pre-medications

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Electroencephalographic Jul. 1, 2021 . Physically and/or cognitively impaired and no home caregiver (EEG) Monitoring and available Video Recording . Homecare provider has deemed that the member, home (continued) caregiver, or home environment is not suitable for monitoring Gastrointestinal Motility Jul. 1, 2021 Template Update The following procedures are proven and medically necessary: Disorders, Diagnosis and • Removed CMS section Gastric electrical stimulation (GES) therapy for treating refractory Treatment Applicable Codes gastroparesis that has failed other therapies, or chronic intractable (drug- refractory) nausea and vomiting secondary to gastroparesis of diabetic or • Added CPT codes 72195, 72196, idiopathic etiology and 72197 Rectal manometry, rectal sensation, tone and compliance test, and • Removed CPT code 76498 anorectal manometry Supporting Information Conventional defecography for evaluating intractable constipation or • Updated Clinical Evidence, FDA, constipation in members who have one or more of the following conditions and References sections to reflect that are suspected to be the cause of impaired defecation: the most current information o Pelvic floor dyssynergia (inappropriate contraction of the puborectalis muscle); or o Enterocele (e.g., after hysterectomy); or o Anterior rectocele

Refer to the U.S. Food and Drug Administration (FDA) section of the policy for information regarding FDA labeling and Humanitarian Device Exemption (HDE) for GES.

The following procedures are unproven and not medically necessary due to insufficient evidence of efficacy: Colonic manometry for evaluating colon motility Conventional defecography for evaluating all other conditions not included above Magnetic resonance imaging (MRI) defecography for evaluating constipation and anorectal or pelvic floor disorders Cutaneous, mucous, or serosal electrogastrography or electroenterography for diagnosing intestinal or gastric disorders including gastroparesis

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jul. 1, 2021 Template Update Multi-Gene Panel testing for the diagnosis of a hereditary cardiomyopathy Cardiac Disease Removed CMS section or arrhythmia syndrome is proven and medically necessary in individuals Coverage Rationale with a confirmed or suspected diagnosis of the following conditions: Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C); or Replaced language indicating Brugada syndrome (BrS); or “Multi-Gene Panel testing in individuals with inherited thoracic Catecholaminergic polymorphic ventricular tachycardia (CPVT); or

aortic disease is proven and Dilated cardiomyopathy (DCM), without an identifiable cause, when one of

medically necessary” with “Multi- the following criteria are met:

Gene Panel testing in individuals o Individual has cardiac conduction disease (first-, second-, or third- with a confirmed or suspected degree block); or diagnosis of heritable thoracic o Sudden cardiac death in a first- or second-degree relative at age 45 or aortic disease is proven and younger Familial long QT syndrome (LQTS) when acquired causes have been ruled medically necessary” out and one of the following criteria are met: Supporting Information Prolonged QTc [>460ms] on exercise or ambulatory electrocardiogram Updated Clinical Evidence and o (ECG), Holter monitoring or during pharmacologic provocation testing; References section to reflect the or most current information

o T wave abnormalities on ECG suggestive of LQTS (i.e., Torsade de pointes, T wave alternans, or notched T wave in 3 leads); or o Profound congenital bilateral sensorineural hearing loss and prolonged QTc; or o Schwartz score ≥1.5 points Hypertrophic cardiomyopathy (HCM) without an identifiable cause (e.g.,

valvular disease, hypertension, infiltrative, or neuromuscular disorder); or

Short QT syndrome (SQTS)

Multi-Gene Panel testing in individuals with a confirmed or suspected diagnosis of heritable thoracic aortic disease is proven and medically necessary. Multi-Gene Panel testing for the diagnosis of inherited arrhythmic disorders or cardiomyopathy is proven and medically necessary in asymptomatic individuals with a close blood relative with one of the following conditions:

Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C); or

Page 10 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jul. 1, 2021 Brugada syndrome (BrS); or Cardiac Disease Catecholaminergic polymorphic ventricular tachycardia (CPVT); or (continued) Congenital long QT syndrome (LQTS); or Familial dilated cardiomyopathy (DCM); or Hypertrophic cardiomyopathy (HCM); or Short QT syndrome (SQTS); or A first-degree relative experienced sudden cardiac death or near sudden death at age 45 or younger

Genetic testing for cardiomyopathies, arrhythmias or aortic vascular disease is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy.

Genetic testing for coronary artery disease (CAD) is unproven and not medically necessary due to insufficient evidence of efficacy. This includes, but is not limited to, the following tests: Gene expression tests Microarray or other genetic profiles for cardiac disease risk (e.g., Cardiac DNA Insight®, Cardiac Healthy Weight DNA Insight®, Cardio IQ® gene tests and panels) Glaucoma Surgical Jul. 1, 2021 Template Update The following are proven and medically necessary: Treatments Removed CMS section Canaloplasty (ab externo) for treating primary open-angle glaucoma Coverage Rationale • Some glaucoma drainage devices (specifically: EX-PRESS, Molteno Revised list of proven and Implant, Baerveldt Tube Shunt, Ahmed Glaucoma Valve Implant, and Krupin-Denver Valve Implant) for treating refractory glaucoma when medically necessary indications: medical or surgical treatments have failed or are inappropriate o Replaced “glaucoma drainage • iStent®, iStent Inject®, and the Hydrus® Microstent when used in devices for treating refractory glaucoma when medical or combination with cataract surgery for treating mild to moderate open-angle

surgical treatments have failed glaucoma and a cataract in adults currently being treated with ocular

or are inappropriate” with hypotensive medication “some glaucoma drainage • Gonioscopy-assisted transluminal trabeculotomy for pediatric glaucoma devices (specifically: EX- (age 18 years or less PRESS, Molteno Implant,

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Glaucoma Surgical Jul. 1, 2021 Baerveldt Tube Shunt, Ahmed The following are unproven and not medically necessary for treating any Treatments Glaucoma Valve Implant and type of glaucoma due to insufficient evidence of efficacy and/or safety: (continued) Krupin-Denver Valve Implant) Canaloplasty (ab interno) for treating refractory Glaucoma drainage devices that are not FDA approved glaucoma when medical or Gonioscopy-Assisted Transluminal Trabeculotomy (for all other conditions

surgical treatments have failed not included above)

or are inappropriate” Viscocanalostomy

o Added “gonioscopy-assisted Viscocanalostomy and goniscopy-assisted transluminal trabeculotomy transluminal trabeculotomy for (e.g., OMNI® Surgical System) pediatric glaucoma (age 18 XEN® Glaucoma Treatment System years or less)” Revised list of unproven and not medically necessary services/devices: Replaced “gonioscopy- o assisted transluminal

trabeculotomy” with “gonioscopy-assisted transluminal trabeculotomy (for all other conditions not [listed as proven and medically necessary]” o Added “viscocanalostomy and gonioscopy-assisted

transluminal trabeculotomy

(e.g., OMNI® Surgical System)”

Applicable Codes

Added CPT/HCPCS codes 65820

and C1889

Supporting Information

Updated Description of Services, Clinical Evidence, FDA, and

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Glaucoma Surgical Jul. 1, 2021 References sections to reflect the Treatments most current information (continued) Implantable Beta- Jul. 1, 2021 Template Update Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres Emitting Microspheres • Removed CMS section is proven and medically necessary for the following: for Treatment of Coverage Rationale When used for the following indications: Malignant Tumors Added language to indicate o Unresectable metastatic liver tumors from primary colorectal cancer transarterial radioembolization (CRC) (TARE) using yttrium-90 (90Y) o Unresectable metastatic liver tumors from neuroendocrine tumors microspheres is proven and o Unresectable primary hepatocellular carcinoma (HCC) medically necessary when the o Unresectable intrahepatic cholangiocarcinoma following criteria are met: and When the following criteria are met: o Eastern Cooperative Oncology Group (ECOG) performance o Eastern Cooperative Oncology Group (ECOG) performance status of status of 0,1, or 2; and 0,1, or 2; and Malignancy is confined to the liver or with Limited Extra-Hepatic o Malignancy is confined to the o liver or with Limited Extra- Disease; and Hepatic Disease; and o Refractory to or relapsed following systemic chemotherapy Refractory to or relapsed o 90 following systemic Transarterial radioembolization (TARE) using yttrium-90 ( Y) microspheres chemotherapy is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy. Definitions Added definition of: o Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status o Limited Extra-Hepatic Disease o Refractory Supporting Information Updated Clinical Evidence and References sections to reflect the most current information

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Infertility Diagnosis and Jul. 1, 2021 Template Update For medical necessity reviews, refer to the Clinical Guideline titled Fertility Treatment Removed CMS section Solutions Medical Necessity Clinical Guideline: Infertility. Coverage Rationale The following tests or procedures are proven and medically necessary for Revised list of proven and diagnosing or treating Infertility: medically necessary tests or Antisperm antibodies procedures for diagnosing or treating Infertility; removed Antral follicle count

“clomiphene citrate challenge Cryopreservation of sperm, semen, or embryos for individuals who are

test” undergoing treatment with assisted reproductive technologies or are planning to undergo therapies that threaten their reproductive health, such Supporting Information as cancer chemotherapy Updated Clinical Evidence and Cryopreservation of mature oocytes (eggs) for women under the age of 42 References section to reflect the who are undergoing treatment with assisted reproductive technologies or most current information are planning to undergo therapies that threaten their reproductive health,

such as cancer chemotherapy

Genetic screening tests:

o Cystic fibrosis gene mutations

o Karyotyping for chromosomal abnormalities

o Y-chromosome microdeletion testing Hormone level tests: o Antimüllerian hormone (AMH) o Estradiol Follicle-stimulating hormone (FSH) o Luteinizing hormone (LH) o Progesterone o o Prolactin

o Testosterone (total and free)

o Thyroid-stimulating hormone (TSH) Hysterosalpingogram (HSG) Diagnostic hysteroscopy Diagnostic laparoscopy with or without chromotubation Leukocyte count in semen Pelvic ultrasound (transabdominal or transvaginal)

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Infertility Diagnosis and Jul. 1, 2021 Post-ejaculatory urinalysis Treatment Scrotal, testicular or transrectal ultrasound (continued) Semen analysis Sonohysterogram or saline infusion ultrasound Testicular biopsy Vasography

Due to insufficient evidence of efficacy, the following are unproven and not medically necessary for diagnosing or treating Infertility: Co-culture of embryos Computer-assisted sperm analysis (CASA) Cryopreservation of immature oocytes (eggs), ovarian tissue, or testicular tissue EmbryoGlue® Hyaluronan binding assay (HBA) In vitro maturation (IVM) of oocytes Inhibin B Postcoital cervical mucus penetration test Reactive oxygen species (ROS) test Sperm acrosome reaction test Sperm DNA integrity/fragmentation tests [e.g., sperm chromatin structure assay (SCSA), single-cell gel electrophoresis assay (Comet), deoxynucleotidyl transferase-mediated dUTP nick end labeling assay (TUNEL), sperm chromatin dispersion (SCD) or Sperm DNA Decondensation™ Test (SDD)] Sperm penetration assays Uterine/endometrial receptivity testing Treatments to improve uterine/endometrial receptivity (e.g., immunotherapy, endometrial scratching, uterine artery vasodilation) Lower Extremity Invasive Jul. 1, 2021 Template Update Note: This policy does not apply to upper extremities. Diagnostic and Removed CMS section Endovascular Coverage Rationale Procedures Diagnosis

Page 15 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Lower Extremity Invasive Jul. 1, 2021 Replaced language indicating: Diagnosis Diagnostic and o “Lower extremity vascular Lower extremity vascular angiography is proven and medically necessary Endovascular angiography is proven and for evaluating arterial disease, aneurysms, pervascular masses and trauma Procedures medically necessary for related injuries of the lower extremity under certain circumstances. evaluating arterial disease, (continued) aneurysms, and trauma Angiography for known chronic lower extremity arterial disease (peripheral related injuries of the lower vascular disease [PVD], occlusion or stenosis of arteries of the leg, extremity” with “lower claudication, and limb ischemia) requires all of the following: extremity vascular Abnormal ankle brachial index (ABI) or an abnormal CT, MRI angiography, angiography is proven and or duplex ultrasound; and medically necessary for One of the following: evaluating arterial disease, Claudication – as evidenced with an ankle-brackial index ≤ .90; or perivascular o aneurysms, Limb Ischemia – as evidenced with an ankle-brackial index < .40 masses, and trauma related o

injuries of the lower extremity For additional medical necessity clinical coverage criteria, refer to the under certain circumstances” ® InterQual 2021, April 2021 Release, CP: Imaging, Imaging, Peripheral Vascular o “Angiography for known lower for: extremity arterial disease Angiogram, X-ray, Extremity, Bilateral (peripheral vascular disease, Angiogram, X-ray, Extremity, Unilateral occlusion or stenosis of

arteries of the leg, claudication Click here to view the InterQual® criteria.

and limb ischemia) requires all of the [listed criteria]” with Treatment “angiography for known Endovascular revascularization procedures (e.g., stents, angioplasty and/or chronic lower extremity arterial atherectomy) for treating lower extremity ischemia are proven and disease (peripheral vascular disease, occlusion or stenosis medically necessary in individuals who meet the following indication-

of arteries of the leg, specific criteria:

claudication and limb Claudication due to atherosclerotic disease of the aortoiliac and/or femoropopliteal arteries when all of the following criteria are met: ischemia) requires all of the Impaired ability to work and/or perform activities of daily living (ADL) [listed criteria]” o Removed language indicating o All of the following conservative therapies have been tried and failed: . At least twelve (12) weeks of a Supervised or Structured Exercise angiography [is proven and Program

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Lower Extremity Invasive Jul. 1, 2021 medically necessary] for trauma . Pharmacologic therapy Diagnostic and related injuries including, but not . Smoking cessation, if applicable Endovascular limited to, one of the following o Moderate to severe ischemic peripheral artery disease with ankle- Procedures findings: brachial index (ABI) ≤ 0.69 Clinically significant Imaging results show anatomic location and severity of occlusion (continued) o o hematoma (stenosis ≥ 50%) (e.g., duplex ultrasound, CTA, MRA or invasive

o Knee dislocation (confirmed angiography). If duplex ultrasound does not demonstrate a stenosis ≥ by x-ray) 50%, another imaging modality will be necessary to demonstrate the

Need for localization of the extent of stenosis. o source of bleeding and Chronic limb-threatening ischemia (CLTI) when all of the following criteria vascular injury found on are met:

duplex ultrasound o One or more of the following: Updated language pertaining to . Pain at rest additional medical necessity . Nonhealing wound or ulcer due to ischemia

coverage criteria; replaced . Gangrene ® reference to “InterQual 2020” with o Moderate to severe ischemic peripheral artery disease and any of the “InterQual® 2021” following:

. Ankle-Brachial Index (ABI) ≤ 0.69 or Treatment Revised coverage criteria; added . Ankle pressure < 50 mmHg or

criterion requiring “if duplex . Toe-Brachial Index ≤ 0.70 or

ultrasound does not demonstrate . Toe pressure < 30 mmHg or a stenosis ≥ 50%, another imaging . Transcutaneous Oxygen Pressure (TcPO2) < 25 mmHg modality will be necessary to o Imaging results show anatomic location and severity of occlusion (stenosis ≥ 50%) (e.g., duplex ultrasound, CTA, MRA or invasive demonstrate the extent of angiography). If duplex ultrasound does not demonstrate a stenosis ≥ stenosis” Definitions 50%, another imaging modality will be necessary to demonstrate the extent of stenosis. Updated definition of “Ankle-

Brachial Index (ABI)” Due to insufficient evidence of efficacy, endovascular revascularization Supporting Information procedures (e.g., stents, angioplasty and/or atherectomy) for treating lower Updated Description of Services, extremity ischemia are unproven and not medically necessary in the Clinical Evidence, and References following circumstances: sections to reflect the most current information

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Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Lower Extremity Invasive Jul. 1, 2021 Claudication due to isolated infrapopliteal (e.g., anterior tibial, posterior Diagnostic and tibial, or peroneal) artery disease Endovascular To prevent the progression of claudication to CLTI Procedures Individual is asymptomatic (continued) Treatment of a nonviable limb Obstructive Sleep Apnea Jul. 1, 2021 Coverage Rationale Nonsurgical Treatment Treatment Nonsurgical Treatment Removable, custom oral appliances are proven and medically necessary for Revised language pertaining to treating Obstructive Sleep Apnea (OSA) as documented by a sleep study medical necessity clinical (e.g., polysomnography or Home Sleep Apnea Testing). coverage criteria for removable Refer to the Medical Policy titled Attended Polysomnography for Evaluation of oral appliances: Sleep Disorders for further information. Added reference to the o InterQual® 2021, Apr. 2021 For many individuals, oral appliance therapy (OAT) may be an effective

Release, CP: Durable Medical alternative to failed continuous positive airway pressure (CPAP) therapy.

Equipment, Noninvasive Documentation of the following is required: Airway Assistive Devices A patient presenting with symptoms of OSA be seen in a face-to-face o Removed reference to the evaluation with a qualified physician (MD or DO) trained in sleep medicine ® InterQual 2021, Apr. 2021 prior to beginning treatment for OAT (AASM and AADSM, December 2012, Release, Medicare: Durable AAO-HNS, November 2019) Medical Equipment, Oral A treating physician (MD or DO) must diagnose OSA and recommend Appliances for Obstructive course of treatment (AAO-HNS, November 2019)

Sleep Apnea If the patient refuses CPAP therapy, documentation of the refusal from the

Applicable Codes patient’s treating physician (MD or DO) must be supplied

Removed HCPCS codes A4556, A4557, E0470, and E0601 For information on snoring and oral appliances, refer to the Coverage Determination Guideline titled Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements.

For medical necessity clinical coverage criteria for removable oral appliances, refer to the InterQual® 2021, Apr. 2021 Release, CP: Durable Medical Equipment Noninvasive Airway Assistive Devices.

Click here to view the InterQual® criteria.

Page 18 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Apnea Jul. 1, 2021 Documentation Requirements for Oral Appliance Therapy for Treatment OSA (continued) For members with Obstructive Sleep Apnea, oral appliance therapy (OAT) may be an effective alternative to failed CPAP therapy. Documentation of all of the following is required: A patient presenting with symptoms of OSA be seen in a face-to-face evaluation with a qualified physician (MD or DO) trained in sleep medicine prior to beginning treatment for OAT (AASM and AADSM, December 2012) and A treating physician (MD or DO) must diagnose OSA and recommend

course of treatment and

Confirmation the treating physician diagnosed the member with OSA, including documentation of the member’s intolerance, failure of, or refusal of CPAP; and Results of sleep study including severity of the OSA (AHI or RDI values, etc.); and If the oral appliance is being prescribed for reasons other than OSA, an explanation of why appliance is needed.

The following are unproven and not medically necessary due to insufficient

evidence of efficacy:

Devices for treating positional OSA Nasal dilator devices for treating OSA Removable oral appliances for treating Central Sleep Apnea Prefabricated Oral Appliance/Device

Surgical Treatment The following surgical procedures are proven and medically necessary for treating Obstructive Sleep Apnea as documented by polysomnography. For medical necessity clinical coverage criteria, refer to Client Defined 2020, CP: Procedures: Mandibular Osteotomy (Custom) – UHG

Page 19 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Apnea Jul. 1, 2021 Maxillomandibular Osteotomy and Advancement (Custom) – UHG Treatment Uvulopalatopharyngoplasty (UPPP) (Custom) – UHG (continued) ® Click here to view the InterQual criteria.

Implantable hypoglossal nerve stimulation is proven and medically

necessary in an adult patient with moderate to severe OSA when all the

following criteria are met: Body mass index of (BMI) less than or equal to 32kg/m2; and Apnea Hypopnea Index (AHI) of 15 or greater and less than or equal to 65 as determined with polysomnography; and Absence of complete concentric collapse at the soft palate level; and Failure or intolerance of Positive Airway Pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway

pressure [BPAP] machines)

PAP failure is defined as an inability to eliminate OSA (AHI of greater o than 20 despite PAP usage) and PAP intolerance is defined as:

. Inability to use PAP (greater than five nights per week of usage; usage defined as greater than four hours of use per night); or . Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it)

Documentation Requirements for Surgical Treatment for OSA Medical notes documenting all of the following: History of condition Sleep study confirming diagnosis of sleep apnea Excessive daytime sleepiness documented by:

Epworth Sleepiness Scale or other validated scale o Interference with daily activity or work (e.g., causes safety issues) o Failed response or intolerance to CPAP usage or other non-invasive treatment with involvement of qualified sleep specialist Oral appliance therapy unsuccessful due to failure to improve symptoms, intolerance, or inappropriate for patient anatomy

Page 20 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Apnea Jul. 1, 2021 Counseling about the benefits and risks of surgery by Physician trained in Treatment sleep disorders (continued) Weight not a concern or weight loss was tried and failed

In addition to the requirements above, medical notes documenting all of the

following for:

Uvulopalatopharyngoplasty (UPPP)

Isolated oropharyngeal narrowing demonstrated as source of airway o obstruction as the cause of OSA or failure of previous uvulopalatopharyngoplasty to correct the OSA Mandibular Osteotomy

o Sleep study confirming diagnosis of sleep apnea must show moderate to severe OSA o Functional obstruction mostly retrolingual or lower pharyngeal o Being performed as part of cleft palate repair or complex repair of craniofacial anomaly

Maxillomandibular Osteotomy And Advancement

Sleep study confirming diagnosis of sleep apnea must show moderate o to severe OSA

o Craniofacial disproportion or deformities, with evidence of maxillomandibular deficiency

o Surgery is being performed as part of cleft palate repair or complex repair of craniofacial anomaly

The following surgical procedures are unproven and not medically necessary for treating Obstructive Sleep Apnea due to insufficient evidence of efficacy: Laser-assisted uvulopalatoplasty (LAUP) Lingual suspension – Also referred to as tongue stabilization, tongue

stitch, or tongue fixation

Palatal implants Radiofrequency ablation of the soft palate and/or tongue base Transoral robotic surgery (TORS)

Page 21 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Surgery of the Foot Jul. 1, 2021 Coverage Rationale Surgery of the foot is proven and medically necessary in certain Revised language pertaining circumstances. For medical necessity clinical coverage criteria, refer to the medical necessity clinical InterQual® 2021, Apr. 2021 Release, CP: Procedures: coverage criteria; replaced Arthrodesis or Arthroplasty, Interphalangeal Joint, Second-Fifth Toes reference to: Exostectomy, First Metatarsophalangeal (MTP) Joint (Bunionectomy) ® Osteotomy, Distal Transpositional, First Metatarsal (MT) (Bunionectomy) o “InterQual 2020, Apr. 2020 Release, CP: Procedures” with Osteotomy, Proximal, First Metatarsal (MT) (Bunionectomy) “InterQual® 2021, Apr. 2021 Plantar Fascial Release Release, CP: Procedures” ® Click here to view the InterQual® criteria. o “InterQual 2020, Oct. 2020 Release, CP: Procedures” with “InterQual® 2021, Apr. 2021 Release, CP: Procedures” Surgery of the Knee Jul. 1, 2021 Coverage Rationale Surgery of the knee is proven and medically necessary in certain Revised language pertaining to circumstances. For medical necessity clinical coverage criteria, refer to the ® medical necessity clinical InterQual 2021, Apr. 2021 Release, CP: Procedures: Arthroscopy or Arthroscopically Assisted Surgery, Knee coverage criteria; replaced reference to: Arthroscopy, Diagnostic, +/- Synovial Biopsy, Knee

® Arthrotomy, Knee o “InterQual 2020, Apr. 2020 Release, CP: Procedures” with Removal and Replacement, Total Joint Replacement (TJR), Knee “InterQual® 2021, Apr. 2021 Total Joint Replacement (TJR), Knee Release, CP: Procedures” Unicondylar or Patellofemoral Knee Replacement ® o “InterQual 2020, Dec. 2020 Release, CP: Procedures” with Click here to view the InterQual® criteria. “InterQual® 2021, Apr. 2021 Release, CP: Procedures” ® o “InterQual 2020, Jan. 2021 Release, CP: Procedures” with

“InterQual® 2021, Apr. 2021 Release, CP: Procedures”

Page 22 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Surgery of the Knee Jul. 1, 2021 Supporting Information (continued) Updated References section to reflect the most current information

Replaced Policy Title Effective Date Summary of Changes Femoroacetabular Jun. 1, 2021 Policy replaced; refer to the Medical Policy titled Surgery of the Hip Impingement Syndrome

Page 23 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

New Policy Title Effective Date Coverage Rationale Long-Acting Injectable Jul. 1, 2021 Cabenuva (cabotegravir/rilpivirine) has been added to the Review at Launch program. Some members may not be Antiretroviral Agents eligible for coverage of this medication at this time. Refer to the policy titled Review at Launch for New to Market Medications for additional details.

This policy refers to the following long-acting injectable antiretroviral products:

Cabenuva (cabotegravir/rilpivirine)

Cabenuva (cabotegravir/rilpivirine) is proven for the treatment of a human immunodeficiency virus type-1 (HIV-1) in patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL). Cabenuva is medically necessary when the following additional criteria are met: For initial therapy, all of the following: o Diagnosis of HIV-1 infection; and Patient has no prior virologic failures or baseline resistance to either cabotegravir or rilpivirine; and o Patient is currently on a stable antiretroviral regimen; and o Submission of medical records (e.g., chart notes, laboratory results) showing viral suppression (HIV-1 RNA less o than 50 copies per mL) for at least six months prior to initiation of Cabenuva; and

o Provider attests that patient demonstrates treatment readiness by both of the following: . Patient understands the risks of missed doses of Cabenuva . Patient has the ability to adhere to the required monthly injection appointments; and o Provider confirms that tolerability will be assessed using a 28-day oral lead-in of Vocabria (cabotegravir) and ® Edurant (rilpivirine) tablets prior to the first injection of Cabenuva; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Initial authorization is for no more than 12 months. o For continuation therapy, all of the following:

o Patient has previously received treatment with Cabenuva; and

o Physician confirms that the patient has achieved and maintained viral suppresion (HIV-1 RNA less than 50 copies per mL) while on Cabenuva therapy; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Authorization is for no more than 12 months.

Cabenuva is unproven and not medically necessary for the treatment of:

Page 24 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

New Policy Title Effective Date Coverage Rationale Long-Acting Injectable Jul. 1, 2021 Human immunodeficiency virus type-1 (HIV-1) in patients who are not currently virally suppressed (HIV-1 RNA less than Antiretroviral Agents 50 copies per mL) (continued)

Updated Policy Title Effective Date Summary of Changes

Boniva® (Ibandronate) Jul. 1, 2021 Template Update Removed CMS section Coverage Rationale Revised coverage criteria for initial therapy: o Removed criterion requiring documentation of closed epiphyses on x-ray o Replaced criterion requiring “authorization is for no more than 6 months” with “authorization is for no more than 12 months” Supporting Information Updated References section to reflect the most current information

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 Notice of Revision: The following This policy refers to the following products used as antiemetics for oncology Oncology summary of changes has been use: ® modified. Revisions to the previous Akynzeo (palonosetron/fosnetupitant) injection policy update announcement are Akynzeo® (palonosetron/netupitant) capsule

outlined in red below. Please take note Aloxi® (palonosetron) injection

of the amended updates to be applied Cinvanti™ (aprepitant) injectable emulsion

on Jul. 1, 2021. Emend® (fosaprepitant) injection, capsule Sustol® (granisetron extended release) injection Title Change Kytril® (granisetron) injection, tablets Previously titled Intravenous Anti- Varubi® (rolapitant) tablet Emetics Zofran® (ondansetron) injection, tablets Coverage Rationale Revised list of antiemetic products Inclusion of oral antiemetics in this policy and application of the preferred product criteria to them is limited to when these are administered prior to the for oncology use to reflect/include:

Page 25 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale ® Antiemetics for Jul. 1, 2021 o Akynzeo chemotherapy infusion and not when they are self-administered by the patient Oncology (palonosetron/fosnetupitant) outside of the infusion. (continued) injection ® o Akynzeo Neurokinin 1 Receptor Antagonist (NK1 RA) (palonosetron/netupitant) Preferred Product Non-Preferred Product capsule ® Emend injection Cinvanti injectable emulsion o Aloxi (palonosetron) injection ™ Emend capsule Varubi tablet o Cinvanti (aprepitant) injectable emulsion ® o Emend (fosaprepitant) 5-Hydroxytryptamine Receptor Antagonist (5HT3 RA) injection, capsule Preferred Product Non-Preferred Product ® o Sustol (granisetron extended Kytril injection Aloxi injection release) injection Kytril tablet Sustol injection Kytril® (granisetron) injection, o Zofran injection tablets ® Zofran tablet o Varubi (rolapitant) tablet ® o Zofran (ondansetron) injection, tablets NK1 RA/5HT3 RA combination

Added language to indicate: Preferred Product Non-Preferred Product Inclusion of oral antiemetics in o Akynzeo injection this policy and application of Akynzeo capsule the preferred product criteria

to them is limited to when these are administered prior to Coverage for antiemetics will be provided contingent on the coverage criteria in

the chemotherapy infusion and the Diagnosis-Specific Criteria section.

not when they are self- administered by the patient Preferred Product outside of the infusion Coverage for Cinvanti and Varubi will be provided contingent on the criteria in

o Coverage for antiemetics will this section and the coverage criteria in the Diagnosis-Specific Criteria section. be provided contingent on the coverage criteria in the Coverage of Aloxi and Sustol will be provided contingent on the criteria in this Diagnosis-Specific Criteria section and the coverage criteria in the Diagnosis-Specific Criteria section. section of the policy

Page 26 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 Added list of preferred and non- NK1 RA/5HT3 RA combination (Akynzeo): Coverage of Akynzeo will be provided Oncology preferred antiemetic products for contingent on the criteria in this section and the coverage criteria in the (continued) oncology use Diagnosis-Specific Criteria section. Preferred Product Revised language to indicate Preferred Product Criteria coverage for Cinvanti, Varubi, Aloxi, Treatment with non-preferred NK1 RA, 5HT3 RA, or NK1 RA/5HT3 RA Sustol, and NK1 RA/5HT3 RA combination product is medically necessary for the indications specified in combination (Akynzeo) will be the policy when one of the following is met:

provided contingent on the criteria Both of the following:

in the Preferred Product and History of a trial of adequate dose and duration of preferred NK1 RA or o Diagnosis-Specific Criteria section 5HT3 RA product, resulting in minimal clinical response; and of the policy o Physician attests that, in their clinical opinion, the clinical response Preferred Product Criteria would be expected to be superior with non-preferred NK1 RA, 5HT3 RA, Added language to indicate or NK1 RA/5HT3 RA combination product, than experienced with treatment with non-preferred NK1 preferred NK1 RA or 5HT3 RA; RA, 5HT3 RA, or NK1 RA/5HT3 RA or Both of the following: combination product is medically necessary for the indications History of intolerance, contraindication, or adverse event to preferred o specified in the policy when one of NK1 RA or 5HT3 RA; and

the following is met: o Physician attests that, in their clinical opinion, the same intolerance,

Both of the following: contraindication, or adverse event would not be expected to occur with o . History of a trial of non-preferred NK1 RA, 5HT3 RA, or NK1 RA/5HT3 RA combination adequate dose and product duration of preferred NK1 RA or 5HT3 RA product, Diagnosis-Specific Criteria resulting in minimal clinical For the coverage criteria below, in absence of specified drug products, the term response; and “antiemetics” will be used in this policy where the coverage criteria apply to all . Physician attests that, in products listed above. their clinical opinion, the

clinical response would be Antiemetics are proven and medically necessary for the following indications:

expected to be superior

with non-preferred NK1 NK1 RA (Emend, Cinvanti, Varubi) may be indicated when one of following RA, 5HT3 RA, or NK1 are present:

Page 27 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 RA/5HT3 RA combination Both of the following: Oncology product, than experienced o Prevention of chemotherapy-induced nausea and vomiting due to high (continued) with preferred NK1 RA or emetic risk parenteral anticancer agents; and 5HT3 RA o In combination with dexamethasone and a 5HT3 RA; or or

Both of the following: All of the following: o . History of intolerance, Prevention of chemotherapy-induced nausea and vomiting due to o contraindication, or moderate emetic risk parenteral anticancer agents; and

adverse event to preferred o In combination with dexamethasone and a 5HT3 RA; and

NK1 RA or 5HT3 RA; and o One of the risk factors for anticancer-agent induced nausea/vomiting: . Physician attests that, in . Younger age (< 55 years) their clinical opinion, the . Female sex same intolerance, . Previous history of chemotherapy induced nausea or vomiting contraindication, or . Little or no previous alcohol use

adverse event would not . History of motion sickness or morning sickness during pregnancy

be expected to occur with . High anxiety

non-preferred NK1 RA, 5HT3 RA, or NK1 5HT3 RA (Aloxi, Kytril, Sustol, Zofran) may be indicated when one of the RA/5HT3 RA combination following are present: product Both of the following: Diagnosis-Specific Criteria o Prevention of chemotherapy-induced nausea and vomiting due to high Added language to indicate, in emetic risk parenteral anticancer agents; and absence of specified drug o In combination with dexamethasone and a NK1 RA; or products, the term “antiemetics” Both of the following: will be used in this policy where the coverage criteria apply to all Prevention of chemotherapy-induced nausea and vomiting due to o products listed [in this policy] moderate emetic risk parenteral anticancer agents; and

Revised coverage criteria to o In combination with dexamethasone; indicate antiemetics are proven or and medically necessary for the All of the following: following indications: o Prevention of chemotherapy-induced nausea and vomiting due to moderate emetic risk parenteral anticancer agents; and In combination with dexamethasone and NK1 RA; and o

Page 28 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 o NK1 RA (Emend, Cinvanti, . One of the risk factors for anticancer-agent induced Oncology Varubi) may be indicated when nausea/vomiting: (continued) one of following are present: . Younger age (< 55 years) . Both of the following: . Female sex Prevention of . Previous history of chemotherapy induced nausea or vomiting

chemotherapy- . Little or no previous alcohol use

induced nausea and . History of motion sickness or morning sickness during pregnancy

vomiting due to high . High anxiety emetic risk parenteral or

anticancer agents; and o Treatment of breakthrough nausea and/or vomiting due to anticancer In combination with agent(s) dexamethasone and a 5HT3 RA or

. All of the following:

Prevention of

chemotherapy- induced nausea and vomiting due to moderate emetic risk parenteral anticancer

agents; and In combination with dexamethasone and a

5HT3 RA; and

One of the risk factors for anticancer-agent induced nausea/vomiting: • Younger age (< 55 years) • Female sex

Page 29 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 • Previous history of Oncology chemotherapy (continued) induced nausea or vomiting • Little or no

previous alcohol

use

• History of motion sickness or morning sickness during pregnancy • High anxiety o 5HT3 RA (Aloxi, Kytril, Sustol, Zofran) may be indicated when

one of the following are

present:

. Both of the following: Prevention of chemotherapy- induced nausea and vomiting due to high emetic risk parenteral anticancer agents; and In combination with

dexamethasone and a

NK1 RA or . Both of the following: . Prevention of chemotherapy-induced nausea and vomiting due to moderate emetic risk

Page 30 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 parenteral anticancer Oncology agents; and (continued) In combination with dexamethasone or

. All of the following:

Prevention of chemotherapy- induced nausea and vomiting due to moderate emetic risk parenteral anticancer agents; and In combination with

dexamethasone and

NK1 RA; and

One of the risk factors for anticancer-agent induced nausea/vomiting: Younger age (< 55 years) Female sex Previous history of

chemotherapy

induced nausea or vomiting Little or no previous alcohol use History of motion sickness or

Page 31 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 morning sickness Oncology during pregnancy (continued) High anxiety or . Treatment of breakthrough

nausea and/or vomiting

due to anticancer agent(s)

o NK1 RA/5HT3 RA combination product (Akynzeo) may be indicated when one of the following are present: . Prevention of chemotherapy-induced

nausea and vomiting due

to high emetic risk

parenteral anticancer agents12; or . Both of the following: Prevention of chemotherapy- induced nausea and vomiting due to moderate emetic risk

parenteral anticancer

agents11; and

One of the risk factors

for anticancer-agent induced nausea/vomiting: • Younger age ( < 55 years) • Female sex

Page 32 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Antiemetics for Jul. 1, 2021 • Previous history of Oncology chemotherapy (continued) induced nausea or vomiting • Little or no previous alcohol use • History of motion sickness or morning sickness during pregnancy • High anxiety Definitions Added definition of: o Low Emetic Risk o Minimal Emetic Risk Applicable Codes Added HCPCS codes J2405, J8501, J8655, J8670, Q0162, and Q0166 Added ICD-10 diagnosis code V58.11 Z51.11 Removed ICD-10 diagnosis codes R11.11, R11.12, R11.13, and R11.14 Supporting Information Removed CMS section Updated Background, Clinical Evidence, FDA, and References sections Complement Inhibitors Jul. 1, 2021 Template Update This policy refers to the following complement inhibitor drug products: (Soliris® & Ultomiris™) Removed CMS section Soliris (eculizumab) Ultomiris (ravulizumab-cwvz)

Page 33 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 Applicable Codes Soliris and Ultomiris are proven for the treatment of atypical Hemolytic (Soliris® & Ultomiris™) Maximum Allowed Quantities by Uremic Syndrome (aHUS). (continued) National Drug Code (NDC) Units Soliris and Ultomiris are medically necessary when all of the following criteria are met: Revised list of applicable NDCs for Initial Therapy: Ultomiris; added: Documentation supporting the diagnosis of aHUS by ruling out both of 25682-0025-01 o o the following: . How supplied: 300 mg/3 . Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); mL solution in vials . Thrombotic thrombocytopenia purpura (TTP) (e.g., rule out . Maximum allowed: 36 mL ADAMTS13 deficiency) 25682-0028-01 o and . How supplied: 1,100 Laboratory results, signs, and/or symptoms attributed to aHUS (e.g., mg/11 mL solution in vials o thrombocytopenia, microangiopathic hemolysis, thrombotic . Maximum allowed: 36 mL microangiopathy, acute renal failure, etc.); and

Supporting Information Patient is treatment naïve with both Soliris and Ultomiris; and o Updated References section to Soliris or Ultomiris are dosed according to the US FDA labeled dosing o reflect the most current information for aHUS; and

o Prescribed by, or in consultation with, a hematologist or nephrologist; and

o Initial authorization will be for no more than six months. Continuation of Therapy: o Patient has previously been treated with Soliris or Ultomiris; and o Documentation demonstrating a positive clinical response from baseline (e.g., reduction of plasma exchanges, reduction of dialysis, increased

platelet count, reduction of hemolysis); and

o Soliris or Ultomiris are dosed according to the US FDA labeled dosing for aHUS; and

o Prescribed by, or in consultation with, a hematologist or nephrologist; and o Reauthorization will be for no more than 12 months.

Soliris and Ultomiris are unproven and not medically necessary for treatment of Shiga Toxin E. Coli related Hemolytic Uremic Syndrome (STEC-HUS).

Page 34 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 Soliris and Ultomiris are proven for the treatment of paroxysmal Nocturnal (Soliris® & Ultomiris™) Hemoglobinuria (PNH). (continued) Soliris and Ultomiris are medically necessary when all of the following criteria are met: Initial Therapy:

Documentation supporting the diagnosis of PNH that includes both of o the following:

. Flow cytometry analysis confirming presence of PNH clones. . Laboratory results, signs, and/or symptoms attributed to PNH (e.g., abdominal pain, anemia, dyspnea, extreme fatigue, smooth muscle dystonia, unexplained/unusual thrombosis, hemolysis/hemoglobinuria, kidney disease, pulmonary hypertension, etc.) and

Patient is treatment naïve with both Soliris and Ultomiris; and o Soliris or Ultomiris are dosed according to the US FDA labeled dosing o for PNH; and

o Prescribed by, or in consultation with, a hematologist or oncologist; and

o Initial authorization will be for no more than six months. Continuation of Therapy: o Patient has previously been treated with Soliris or Ultomiris; and o Documentation demonstrating a positive clinical response from baseline (e.g., increased or stabilization of hemoglobin levels, reduction in transfusions, improvement in hemolysis, decrease in LDH, increased

reticulocyte count, etc.); and

o Soliris or Ultomiris are dosed according to the US FDA labeled dosing for PNH; and

o Prescribed by, or in consultation with, a hematologist or oncologist; and

o Reauthorization will be for no more than 12 months.

Soliris is proven for the treatment of generalized Myasthenia Gravis. Soliris is medically necessary when all of the following criteria are met: Initial Therapy:

Page 35 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 o Submission of medical records (e.g., chart notes, laboratory values, etc.) (Soliris® & Ultomiris™) to support the diagnosis of generalized myasthenia gravis (gMG) by a (continued) neurologist or in consultation with a neurologist confirming all of the following: . Patient has not failed a previous course of Soliris therapy; and

. Positive serologic test for anti-AChR antibodies; and

. One of the following:

History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation History of positive anticholinesterase test, e.g., edrophonium chloride test Patient has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating

neurologist

and

. Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy; and . Patient has a Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL) total score ≥ 6 at initiation of therapy and o Both of the following: . History of failure of at least two immunosuppressive agent over the course of at least 12 months [e.g., azathioprine, methotrexate,

cyclosporine, mycophenylate, etc.]; and

. Patient has required two or more courses of plasmapheresis/plasma exchanges and/or intravenous immune globulin for at least 12 months without symptom control and o Patient is currently on a stable dose (at least two months) of immunosuppressive therapy; and o Soliris is initiated and titrated according to the US FDA labeled dosing for gMG, up to a maximum of 1,200 mg every two weeks; and

Page 36 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 o Prescribed by, or in consultation with, a neurologist; and (Soliris® & Ultomiris™) o Initial authorization will be for no more than six months. (continued) Continuation of Therapy: o Patient has previously been treated with Soliris; and Submission of medical records (e.g., chart notes, laboratory tests) to o demonstrate a positive clinical response from baseline as demonstrated

by at least all of the following:

. Improvement and/or maintenance of at least a three point improvement (reduction in score) in the MG-ADL score from pre- treatment baseline. . Reduction in signs and symptoms of myasthenia gravis . Maintenance, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy (IST) prior to starting 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

o Soliris is dosed according to the US FDA labeled dosing for gMG: up to a maximum of 1,200 mg every two weeks; and

o Prescribed by, or in consultation with, a neurologist; and o Reauthorization will be for no more than 12 months.

Soliris is proven for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Soliris is medically necessary when all of the following criteria are met:

Initial Therapy:

o Submission of medical records (e.g., chart notes, laboratory values, etc.) to support the diagnosis of neuromyelitis optica spectrum disorder (NMOSD) by a neurologist confirming all of the following: . Past medical history of one of the following: Optic neuritis Acute myelitis

Page 37 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 Area postrema syndrome: episode of otherwise unexplained (Soliris® & Ultomiris™) hiccups or nausea and vomiting (continued) Acute brainstem syndrome Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions

Symptomatic cerebral syndrome with NMOSD-typical brain

lesions and . Positive serologic test for anti-aquaporin-4 immunoglobulin G (AQP4-IgG)/NMO-IgG antibodies; and . Diagnosis of multiple sclerosis or other diagnoses have been ruled out and Patient has not failed a previous course of Soliris therapy; and o History of failure of, contraindication, or intolerance to rituximab o therapy; and

o One of the following: . History of at least two relapses during the previous 12 months prior to initiating Soliris . History of at least three relapses during the previous 24 months, at least one relapse occurring within the past 12 months prior to initiating Soliris and Soliris is initiated and titrated according to the US FDA labeled dosing o for NMOSD, up to a maximum of 1,200 mg every two weeks; and

o Prescribed by, or in consultation with, a neurologist; and

o Patient is not receiving Soliris in combination with any of the following: . Disease modifying therapies for the treatment of multiple sclerosis [e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.] . Anti-IL6 therapy [e.g., Actemra (tocilizumab), Enspryng (satralizumab)] . Rituximab

Page 38 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 and (Soliris® & Ultomiris™) o Initial authorization will be for no more than six months. (continued) Continuation of Therapy: o Patient has previously been treated with Soliris; and o Submission of medical records (e.g., chart notes, laboratory tests) to demonstrate a positive clinical response from baseline as demonstrated by at least both of the following: . Reduction in the number and/or severity of relapses or signs and symptoms of NMOSD . Maintenance, reduction, or discontinuation of dose(s) of any baseline immunosuppressive therapy (IST) prior to starting Soliris. Note: Add on, dose escalation of IST, or additional rescue therapy from baseline to treat NMOSD or exacerbation of symptoms while on Soliris therapy will be considered as treatment failure. and o Soliris is dosed according to the US FDA labeled dosing for NMOSD: up to a maximum of 1,200 mg every two weeks; and o Prescribed by, or in consultation with, a neurologist; and o Patient is not receiving Soliris in combination with any of the following: . Disease modifying therapies for the treatment of multiple sclerosis [e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.] . Anti-IL6 therapy [e.g., Actemra (tocilizumab), Enspryng (satralizumab] . Rituximab and o Reauthorization will be for no more than 12 months. Simulect® Jul. 1, 2021 Template Update Simulect is proven and medically necessary for the treatment of Prophylaxis (Basiliximab) • Removed CMS section of acute organ rejection when all of the following criteria are met: Coverage Rationale Patient has received a kidney transplant; and Physician provided documentation that patient’s prophylaxis therapy Revised coverage criteria; removed includes cyclosporine modified and corticosteroids; and criterion requiring:

Page 39 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Simulect® Jul. 1, 2021 o Simulect is prescribed by or in Simulect dosing is in accordance with the U.S. Food and Drug (Basiliximab) consultation with a transplant Administration (FDA) approved labeling: 20 mg as an intravenous infusion (continued) specialist or nephrologist within two hours prior to transplant surgery, followed by a second 20 mg experienced in intravenous infusion dose four days after transplantation; and immunosuppression therapy Authorization is for no more than one month and management of organ transplantation patients o Physician provided documentation that patient’s prophylaxis therapy includes least one of the following: . Cyclosporine modified and corticosteroids; or . Everolimus and cyclosporine modified (reduced dose) and corticosteroid o Patient is considered low risk for kidney rejection Supporting Information • Updated Background and References section to reflect the most current information Spinraza® Jul. 1, 2021 Template Update Spinraza® (nusinersen) is proven and medically necessary for the treatment of (Nusinersen) Removed CMS section spinal muscular atrophy (SMA) in patients who meet all of the following

Coverage Rationale criteria:

Revised coverage criteria; replaced Initial Therapy criterion requiring “diagnosis of spinal muscular atrophy type I, II, or Diagnosis of spinal muscular atrophy by, or in consultation with, a III by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; and

neurologist with expertise in the Submission of medical records (e.g., chart notes, laboratory values)

diagnosis of SMA” with “diagnosis confirming the mutation or deletion of genes in chromosome 5q resulting in

of spinal muscular atrophy by, or in one of the following:

Page 40 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 consultation with, a neurologist o Homozygous gene deletion or mutation (e.g., homozygous deletion of (Nusinersen) with expertise in the diagnosis of exon 7 at locus 5q13); or (continued) SMA” o Compound heterozygous mutation (e.g., deletion of SMN1 exon 7 [allele Removed specific dosage 1] and mutation of SMN1 [allele 2]) requirements for Spinraza; refer to and

the applicable US FDA approved Patient is not dependent on either of the following:

labeling Invasive ventilation or tracheostomy o Supporting Information o Use of non-invasive ventilation beyond use for naps and nighttime sleep

Updated Clinical Evidence and and

References sections to reflect the Submission of medical records (e.g., chart notes, laboratory values) of the most current information baseline exam of at least one of the following exams (based on patient age and motor ability) to establish baseline motor ability:* * Baseline assessments for patients less than 2 months of age are not necessary in order to not delay access to initial therapy in recently

diagnosed infants. Initial assessments shortly post-therapy can serve as

baseline with respect to efficacy reauthorization assessment

o Hammersmith Infant Neurological Exam Part 2 (HINE-2) (infant to early childhood)

o Hammersmith Functional Motor Scale Expanded (HFMSE)

o Upper Limb Module (ULM) Test (Non ambulatory) o Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND); and Spinraza is prescribed by, or in consultation with, a neurologist with

expertise in the treatment of SMA; and

Patient has not previously received gene replacement therapy for the

treatment of SMA; and Patient is not receiving concomitant chronic survival motor neuron (SMN) modifying therapy [e.g., Evrysdi (risdiplam)]; and Spinraza is to be administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures; and Spinraza dosing for SMA is within accordance with the United States Food and Drug Administration approved labeling:and

Page 41 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 Initial authorization will be for no more than four loading doses. (Nusinersen) (continued) Continuation Therapy Diagnosis of spinal muscular atrophy by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; and Patient has previously received Spinraza therapy; and Patient is not dependent on either of the following: Invasive ventilation or tracheostomy o Use of non-invasive ventilation beyond use for naps and nighttime sleep o and

Patient has not previously received gene replacement therapy for the treatment of SMA; and Patient is not receiving concomitant chronic survival motor neuron (SMN) modifying therapy [e.g., Evrysdi (risdiplam)]; and Submission of medical records (e.g., chart notes, laboratory values) with the most recent results (< one month prior to request) documenting a positive clinical response from pretreatment baseline status to Spinraza therapy as

demonstrated by at least one of the following exams:

HINE-2 milestones : o . One of the following: Improvement or maintenance of previous improvement of at least two point (or maximal score) increase in ability to kick Improvement or maintenance of previous improvement of at least one point increase in any other HINE-2 milestone (e.g., head control, rolling, sitting, crawling, etc.), excluding voluntary grasp; and

. One of the following:

The patient exhibited improvement, or maintenance of previous improvement in more HINE motor milestones than worsening, from pretreatment baseline (net positive improvement)

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Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 Achieved and maintained any new motor milestones when they (Nusinersen) would otherwise be unexpected to do so (e.g., sit unassisted, (continued) stand, walk) or HFMSE: One of the following: o . Improvement or maintenance of previous improvement of at least a

three point increase in score from pretreatment baseline

. Patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so or o ULM: One of the following: . Improvement or maintenance of previous improvement of at least a two point increase in score from pretreatment baseline

. Patient has achieved and maintained any new motor milestone from

pretreatment baseline when they would otherwise be unexpected to

do so or

o CHOP INTEND: One of the following: . Improvement or maintenance of previous improvement of at least a four point increase in score from pretreatment baseline . Patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so

and

Spinraza is prescribed by, or in consultation with, a neurologist with expertise in the treatment of SMA; and Spinraza is to be administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures; and Spinraza dosing for SMA is within accordance with the United States Food and Drug Administration approved labeling; and Reauthorization will be for no more than three maintenance doses (12 months)

Page 43 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 Unproven (Nusinersen) Spinraza is not proven or medically necessary for: (continued) Spinal muscular atrophy without chromosome 5q mutations or deletions Concomitant treatment of SMA in patients who have previously received gene replacement therapy Concomitant treatment of SMA in patients receiving Evrysdi (risdiplam) Thyrogen® Jul. 1, 2021 Template Update Thyrogen is proven and medically necessary for the treatment of Thyroid (Thyrotropin Alfa) • Removed CMS section cancer when all of the following criteria are met: Coverage Rationale Diagnosis of one of the following: Well-differentiated thyroid cancer for use as an adjunctive diagnostic Revised coverage criteria; replaced o tool for serum thyroglobulin (Tg) testing with or without radioiodine criterion requiring: imaging; or “Diagnosis of [well- o Well-differentiated thyroid cancer for use as an adjunctive treatment for differentiated thyroid cancer] o radioiodine ablation of thyroid tissue remnants in patients who have by or in consultation with an undergone a near-total or total thyroidectomy oncologist or endocrinologist and with expertise in the treatment Thyrogen dosing is in accordance with the U.S. Food and Drug of thyroid cancer” with Administration (FDA) approved labeling: 0.9 mg administered “diagnosis of [well- intramuscularly, followed by a second 0.9 mg dose 24 hours later; and differentiated thyroid cancer]” Authorization is for no more than one month o “Authorization is for no more than two doses” with “authorization is for no more than one month” Supporting Information • Updated References section to reflect the most current information Vibativ ® (Telavancin) Jul. 1, 2021 Template Update Vibativ is proven and medically necessary for the treatment of: Removed CMS section Complicated skin and skin structure infections (cSSSI) caused by Coverage Rationale susceptible gram-positive bacteria or hospital-acquired and ventilator- associated bacterial pneumonia (HABP/VABP) caused by Revised coverage criteria: Staphylococcus aureus when all of the following criteria are met: Replaced criterion requiring o Diagnosis of cSSSI or HABP/VABP; and “patient has reported trial and o

Page 44 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Vibativ ® (Telavancin) Jul. 1, 2021 failure with intravenous o Patient is 18 years of age or older; and (continued) vancomycin for the current o One of the following: active infection” with “trial and . Trial and failure with intravenous vancomycin for the current active failure with intravenous infection; or vancomycin for the current . A culture and sensitivity report indicates the cultured organism is active infection” resistant to vancomycin o Updated criterion for the and treatment of bacteremia due to o Vibativ dosing is in accordance with the U.S. Food and Drug Staphylococcus aureus (S. Administration (FDA) approved labeling: aureus) to clarify Vibativ dosing . For cSSSI dosage of 10 mg/kg every 24 hours for 7 to 14 days is in accordance with . For HABP/VABP dosage of 10 mg/kg every 24 hours for 7 to 21 Infectious Diseases Society of days America (IDSA) guidelines . Patients with renal impairment dosing: used in clinical evidence: 10 CrCl 30—50 ml/min: 7.5 mg/kg every 24 hours. mg/kg every 24 hours CrCl 10—29 ml/min: 10 mg/kg every 48 hours Supporting Information and Updated References section to o Authorization is for no longer than one month reflect the most current information Bacteremia due to Staphylococcus aureus (S. aureus) when all of the following criteria are met: o Diagnosis of bacteremia due to S. aureus; and o One of the following: . Trial and failure with intravenous vancomycin for the current active infection; or . A culture and sensitivity report indicates the cultured organism is resistant to vancomycin and o Vibativ dosing is in accordance with Infectious Diseases Society of America (IDSA) guidelines used in clinical evidence: 10 mg/kg every 24 hours; and o Authorization is for no longer than one month Xiaflex® (Collagenase Jul. 1, 2021 Template Update Xiaflex is proven and medically necessary for the treatment of: Clostridium Removed CMS section Dupuytren’s contracture when all of the following criteria are met: Histolyticum) Coverage Rationale o For initial therapy all of the following:

Page 45 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Xiaflex® (Collagenase Jul. 1, 2021 Revised coverage criteria for . Patient has diagnosis of Dupuytren’s contracture with a palpable Clostridium Dupuytren’s contracture: cord; and Histolyticum) Initial Therapy . Patient is 18 years of age or older; and (continued) . Xiaflex is prescribed and administered by a healthcare provider o Replaced criterion requiring: experienced in injection procedures of the hand and in the . “Documented contracture treatment of Dupuytren’s contracture; and of at least 40 degrees flexion for a . Documented contracture of at least 20 degrees flexion for a

metacarpophalangeal metacarpophalangeal (MP) joint contracture or proximal

(MP) joint contracture or at interphalangeal (PIP) joint contracture; and

least 20 degrees flexion for . Documentation that the flexion deformity meets one of the

a proximal interphalangeal following: (PIP) joint contracture” – Function is impaired; or with “documented – Contracture is progressing; or – Severe disabling deformity contracture of at least 20 and degrees flexion for a . If two injections (two vials) are requested, they are for one of the metacarpophalangeal following: (MP) joint contracture or – One cord affecting two joints in the same finger; or proximal interphalangeal (PIP) joint contracture” – Two cords affecting two joints in the same hand

. “Documentation that the and flexion deformity results in . Xiaflex dosing is in accordance with the U.S. Food and Drug functional limitations” with Administration (FDA) approved labeling: 0.58 mg per injection into a “documentation that the palpable cord; and . The total number of injections does not exceed three injections per flexion deformity meets cord at approximately four-week intervals; and one of the following: function is impaired or . Authorization is for no more than two injections in the same hand

contracture is progressing o For continuation of therapy, all of the following:

or severe disabling . Patient has previously received Xiaflex; and

deformity” . Documentation of positive clinical response to Xiaflex; and . Treatment request is for at least one of the following: o Removed criterion requiring patient has not received – Metacarpophalangeal (MP) or proximal interphalangeal (PIP) surgical treatment on the contracture remains in affected cord since previous injection and the contracture is > 5 degrees

Page 46 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Xiaflex® (Collagenase Jul. 1, 2021 selected primary joint within – A different MP or PIP contracture will be injected Clostridium the last 90 days and Histolyticum) Continuation of Therapy . If two injections (two vials) are requested, use is for one of the (continued) following: o Removed criterion requiring – One cord affecting two joints in the same finger; or patient has not received – Two cords affecting two joints in the same hand surgical treatment (e.g., and fasciectomy, fasciotomy) on . The previous treatment was at least four weeks ago; and the selected primary joint within the last 90 days . Xiaflex dosing is in accordance with the U.S. Food and Drug

Supporting Information Administration (FDA) approved labeling: 0.58 mg per injection into a palpable cord; and Updated Clinical Evidence, FDA, . The total number of injections does not exceed three injections per and References sections to reflect cord at approximately four-week intervals; and the most current information . Authorization is for no more than two injections in the same hand

Peyronie’s disease when all of the following criteria are met:

For initial therapy all of the following: o . Patient has diagnosis of Peyronie’s disease with both of the

following: – Palpable plaque; and – Curvature deformity of greater than or equal to 30 degrees at the start of therapy and . Patient is 18 years of age or older; and . Xiaflex is prescribed and administered by a healthcare provider

experienced in the treatment of male urological diseases; and

. Xiaflex dosing is in accordance with the U.S. Food and Drug

Administration (FDA) approved labeling: 0.58 mg per injection into a Peyronie’s plaque; and . Authorization is for no more than two injections

o For continuation of therapy, all of the following: . Patient has previously received Xiaflex; and . Documentation of positive clinical response to Xiaflex; and . Last treatment was at least six weeks ago; and

Page 47 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Xiaflex® (Collagenase Jul. 1, 2021 . Documented curvature deformity of ≥ 15 degrees remaining since Clostridium last treatment cycle; and Histolyticum) . Patient has received less than four treatment cycles (i.e., less than (continued) eight injections [two injections per cycle]); and . Xiaflex dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling: 0.58 mg per injection into a Peyronie’s plaque; and

. Authorization is for no more than two injections

Xiaflex is considered unproven and not medically necessary for any other uses. Zolgensma® Jul. 1, 2021 Coverage Rationale Zolgensma is proven and medically necessary for one treatment per lifetime (Onasemnogene Revised coverage criteria: for the treatment of spinal muscular atrophy (SMA) in patients who meet all of the following criteria: Abeparvovec-Xioi) o Added criterion requiring 1. Submission of medical records (e.g., chart notes, laboratory values) patient is less than 2 years of age confirming the mutation or deletion of genes in chromosome 5q resulting in

one of the following: o Removed criterion requiring one of the following: a. Homozygous gene deletion or mutation of SMN1 gene (e.g.,

. Both of the following: homozygous deletion of exon 7 at locus 5q13); or

Patient is less than or b. Compound heterozygous mutation of SMN1 gene (e.g., deletion of equal to 6 months of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2]) age and Patient does not have 2. One of the following: a. Diagnosis of symptomatic SMA by a neurologist with expertise in the advanced SMA at baseline (e.g., diagnosis of SMA; or

complete paralysis of b. Both of the following:

limbs) (1) Diagnosis of SMA based on the results of SMA newborn screening;

. All of the following: and

Patient is greater than (2) Submission of medical records (e.g., chart notes, laboratory values) 6 months of age, but confirming that patient has four copies or less of SMN2 gene less than 2 years of and age; and 3. For use in a neonatal patient born prematurely, the full-term gestational age One of the following: has been reached; and

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Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 • Both of the 4. Patient is less than 2 years of age; and (Onasemnogene following: 5. Patient is not dependent on either of the following: Abeparvovec-Xioi) o Patient has a. Invasive ventilation or tracheostomy (continued) previously b. Use of non-invasive ventilation beyond use for naps and nighttime sleep received SMN and

modifying 6. Zolgensma is prescribed by a neurologist with expertise in the treatment of

therapy [e.g., SMA; and

Spinraza 7. Patient is not to receive routine concomitant SMN modifying therapy [e.g.,

(nusinersen), Spinraza (nusinersen), Evrysdi (risdiplam)] (patient’s medical record will be Evrysdi reviewed and any current authorizations for SMN modifying therapy will be (risdiplam)] terminated upon Zolgensma approval); and for the 8. Patient does not have an elevated anti-AAV9 antibody titer above 1:50*; and treatment of 9. Patient is less than 13.5 kg; and SMA before 6 10. Patient will receive prophylactic prednisolone (or glucocorticoid equivalent)

months of age prior to and following receipt of Zolgensma in accordance with the United

with positive States Food and Drug Administration (FDA) approved Zolgensma labeling;

clinical and

response; and 11. Patient will receive Zolgensma intravenously in accordance with the FDA

o Submission of approved labeling; and medical 12. Patient has never received Zolgensma treatment in their lifetime; and records (e.g., 13. Authorization will be for no longer than 14 days from approval or until 2 chart notes, years of age, whichever is first laboratory values) Additional Information Relevant to the Review Process but Not confirming Impacting the Determination of Medical Necessity patient does 1. Physician attests that the patient, while under the care of the physician, will not have be assessed by one of the following exam scales during subsequent office advanced visits† SMA as a. Children’s Hospital of Philadelphia Infant Test of Neuromuscular defined by the Disorders (CHOP INTEND) scale during subsequent office visits while fact that the the patient is 2 to 3 years of age or younger; or patient has b. Hammersmith Functional Motor Scale Expanded (HFMSE) during not shown subsequent office visits while the patient is 2 to 3 years of age or older;

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Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 evidence of and (Onasemnogene clinical 2. Physician attests that the patient will be assessed via the CHOP INTEND Abeparvovec-Xioi) decline while scale to establish a baseline functional assessment within the following † (continued) receiving timelines ; SMN a. For patients greater than 2 months of age at the time of Zolgensma

modifying administration, a baseline CHOP INTEND score will be assessed within

therapy [e.g., the two weeks prior to Zolgensma administration; or

Spinraza b. For patients less than or equal to 2 months of age at the time of

(nusinersen, Zolgensma administration, a baseline CHOP INTEND score will be Evrysdi assessed within the two weeks prior to, or the two weeks following (risdiplam)] Zolgensma administration; • Both of the † following: For quality purposes only, this information will not be considered as part of the Patient has individual coverage decision. o previously

received SMN Zolgensma is not proven or medically necessary for:

modifying • The treatment of pre-symptomatic patients diagnosed by newborn screening

therapy [e.g., who have more than four copies of the SMN2 gene; or

Spinraza • The treatment of symptomatic later-onset SMA older than 2 years of age; or (nusinersen), • SMA without chromosome 5q mutations or deletions; or Evrysdi • The routine combination treatment of SMA with concomitant SMN modifying (risdiplam)] therapy for the treatment of

later-onset SMA before 2

years of age with positive clinical response; and o Submission of medical records (e.g.,

Page 50 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 chart notes, (Onasemnogene laboratory Abeparvovec-Xioi) values) (continued) confirming patient does

not have advanced

SMA as

defined by the fact that the patient has not shown evidence of clinical

decline while

receiving

SMN

modifying therapy [e.g., Spinraza (nusinersen), Evrysdi (risdiplam)] . Patient has recently been

diagnosed with symptomatic later-onset

SMA within the previous 6 months Removed specific dosage requirements for Zolgensma; refer to the applicable US FDA approved labeling

Page 51 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Medical Benefit Drug Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 Revised additional information (Onasemnogene relevant to the review process but Abeparvovec-Xioi) not impacting the determination of (continued) medical necessity; removed language indicating: o The physician acknowledges that UnitedHealthcare may request documentation, not more frequently than biannually, and not for a period to exceed 3 years, of follow-up patient assessment(s) including, but not necessarily limited to, serial CHOP INTEND or HFMSE assessments while the patient is under the care of the physician o UnitedHealthcare has established an internal registry where this is a potential outcome measure; this registry has been established to prioritize early access to an SMA therapy with promising early clinical evidence, yet with unique commercialization characteristics, while ensuring appropriate management as clinical data matures Supporting Information Updated Clinical Evidence and References sections to reflect the most current information

Page 52 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Updated Policy Title Effective Date Summary of Changes Breast Reconstruction Jul. 1, 2021 Applicable Codes Post Mastectomy and Added CPT codes 15771 and 15772

Poland Syndrome Cosmetic and Jul. 1, 2021 Applicable Codes Reconstructive Replaced language indicating “CPT codes 15769, 15771, and 15772 are considered cosmetic; the codes do not Procedures improve a functional, physical, or physiological impairment” with “CPT codes 15769, 15771, and 15772 may be cosmetic; review is required to determine if considered cosmetic or reconstructive” Supporting Information Updated References section to reflect the most current information Enteral Nutrition Jul. 1, 2021 Indications for Coverage Certain plans may include benefit plan specific coverage for enteral nutrition. Please refer to the member specific benefit plan document to determine if this coverage applies.

For Plans with Language that Cover Enteral Nutrition For plans that cover enteral nutrition, if there is a difference between a member specific benefit plan document and the information below, the member specific benefit plan document should be used for making benefit determinations.

Note: Check state mandate applicability before proceeding with the following.

Benefits are provided for enteral formulas and low protein modified food products, administered either orally or by tube

feeding as the primary source of nutrition, for certain conditions which require specialized nutrients or formulas. Examples of conditions include: Metabolic Diseases such as phenylketonuria (PKU) and maple syrup urine disease Severe food allergies Impaired absorption of nutrients caused by disorders affecting the gastrointestinal tract

Benefits for prescription or over-the-counter formula are available when a Physician issues a prescription or written order stating the formula or product is Medically Necessary for the therapeutic treatment of a condition requiring specialized

nutrients and specifying the quantity and the duration of the prescription or order. The formula or product must be

administered under the direction of a Physician or registered dietitian.

For the purpose of this Benefit:

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Coverage Determination Guideline Updates

Updated Policy Title Effective Date Summary of Changes Enteral Nutrition Jul. 1, 2021 Enteral formulas include: (continued) o Amino acid-based elemental formulas o Extensively hydrolyzed protein formulas o Modified nutrient content formulas Severe food allergies mean allergies which if left untreated will result in: o Malnourishment o Chronic physical disability o Intellectual disability o Loss of life

Enteral Pumps Enteral pumps and supplies are addressed in the Coverage Determination Guideline titled Durable Medical Equipment, Orthotics, Medical Supplies and Repairs/Replacements.

Coverage Limitations and Exclusions Certain plans may exclude coverage for specific types of enteral nutrition. Refer to the member specific benefit plan document to determine if this exclusion applies. Food of any kind, infant formula, standard milk-based formula, and donor breast milk. This exclusion does not apply to enteral formula and other modified food products for which Benefits are provided in the members benefit plan document. This exclusion includes but is not limited to: o Blenderized food o Clear liquids o Food additives o Food thickeners Nutritional or cosmetic therapy using high dose or mega quantities of vitamins, minerals or elements and other nutrition-based therapy. Examples include supplements and electrolytes. Rhinoplasty and Other Jun. 1, 2021 Indications for Coverage Nasal Surgeries Some states require benefit coverage for services that UnitedHealthcare considers Cosmetic Procedures, such as repair of external Congenital Anomalies in the absence of a Functional Impairment. Refer to the member specific benefit plan document.

Lysis Intranasal Synechia (CPT code 30560) is considered reconstructive when:

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Coverage Determination Guideline Updates

Updated Policy Title Effective Date Summary of Changes Rhinoplasty and Other Jun. 1, 2021 There is a documented Functional Impairment (e.g., obstruction, pain, or bleeding) due to intranasal Synechia Nasal Surgeries (adhesions/scar bands); and (continued) The Functional Impairment will be eliminated by lysis of the Synechia

Repair of Nasal Vestibular Stenosis or Alar Collapse (CPT code 30465) is considered reconstructive and medically

necessary when all of the following criteria are present:

Prolonged, persistent obstructed nasal breathing due to internal and/or External Nasal Valve compromise (see

Definitions section of the policy); and Internal valve compromise due to collapse of the upper lateral cartilage and/or External Nasal Valve compromise due to collapse of the alar (lower lateral) cartilage resulting in an anatomic Mechanical Nasal Airway Obstruction that is a primary contributing factor for obstructed nasal breathing; and Photos clearly document internal and/or external valve collapse as the primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam; and Other causes have been ruled out as the primary cause of nasal obstruction (e.g., sinusitis, allergic rhinitis, vasomotor

rhinitis, nasal polyposis, adenoid hypertrophy, nasopharyngeal masses, nasal septal deviation, turbinate hypertrophy,

and choanal atresia)

Note: For placement of absorbable nasal implants (e.g., Latera), refer to the Medical Policy titled Omnibus Codes.

Rhinophyma Excision (CPT code 30120) is considered reconstructive and medically necessary when all of the following criteria are present: One of the following:

Prolonged, persistent obstructed nasal breathing due to rhinophyma; or o o Chronic infection or bleeding unresponsive to medical management due to rhinophyma and Photos clearly document rhinophyma as the primary cause of an anatomic Mechanical Nasal Airway Obstruction or chronic infection and are consistent with the clinical exam; and The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the nasal airway obstruction by correcting the deformity or the proposed procedure is designed to address the chronic infection

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Coverage Determination Guideline Updates

Updated Policy Title Effective Date Summary of Changes Rhinoplasty and Other Jun. 1, 2021 Rhinoplasty for Congenital Anomalies (CPT codes 30460, 30462) is considered reconstructive and medically Nasal Surgeries necessary when the following are present: (continued) Rhinoplasty is considered reconstructive when performed for a nasal deformity associated with congenital craniofacial anomalies including, but not limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal Cleft (most commonly #1), or associated with a cleft lip or cleft palate

Rhinoplasty-Primary (CPT codes 30410, 30420) is considered reconstructive and medically necessary when all of the

following criteria are present: Prolonged, persistent obstructed nasal breathing due to nasal bone and septal deviation that are the primary causes of an anatomic Mechanical Nasal Airway Obstruction; and The nasal airway obstruction cannot be corrected by septoplasty alone as documented in the medical record; and Photos clearly document the nasal bone/septal deviation as the primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam; and The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the

nasal airway obstruction by centralizing the nasal bony pyramid (30410) and also straightening the septum (30420);

and

One of the following is present:

o Nasal fracture with nasal bone displacement severe enough to cause nasal airway obstruction; or

o Residual large cutaneous defect following resection of a malignancy or nasal trauma and Nasal airway obstruction is causing significant symptoms (e.g., chronic rhinosinusitis, difficulty breathing); and Obstructive symptoms persist despite conservative management for four weeks or greater, which includes, where appropriate, nasal steroids or immunotherapy

Rhinoplasty-Secondary (CPT codes 30430, 30435, 30450) is primarily cosmetic. However, it is considered

reconstructive and medically necessary when all of the following criteria are present:

Required as treatment of a complication/residual deformity from primary surgery performed to address a Functional Impairment when a documented Functional Impairment persists due to the complication/deformity (these codes are usually cosmetic); and Photos clearly document the secondary deformity/complication as the primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam; and

Page 56 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Updated Policy Title Effective Date Summary of Changes Rhinoplasty and Other Jun. 1, 2021 The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the Nasal Surgeries nasal airway obstruction by correcting the deformity or treating the complication (these codes are usually cosmetic); (continued) and Nasal airway obstruction is causing significant symptoms (e.g., chronic rhinosinusitis, difficulty breathing); and Obstructive symptoms persist despite conservative management for four weeks or greater, which includes, where

appropriate, nasal steroids or immunotherapy

Rhinoplasty-Tip (CPT code 30400) is primarily cosmetic. However, it is considered reconstructive and medically necessary when all of the following criteria are present: Prolonged, persistent obstructed nasal breathing due to tip drop that is the primary cause of an anatomic Mechanical Nasal Airway Obstruction (this code is usually cosmetic); and Photos clearly document tip drop as the primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam (acute columellar-labial angle); and The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the

nasal airway obstruction by lifting the nasal tip; and

Nasal airway obstruction is causing significant symptoms (e.g., chronic rhinosinusitis, difficulty breathing); and

Obstructive symptoms persist despite conservative management for four weeks or greater, which includes, where appropriate, nasal steroids or immunotherapy

Septal Dermatoplasty (CPT code 30620) is considered reconstructive when: There is a documented Functional Impairment (e.g., obstruction, pain, or bleeding) due to diseased nasal mucosa; and The Functional Impairment will be eliminated by a skin graft

Nasal Polypectomy (CPT code 31237) is considered reconstructive and medically necessary in certain circumstances.

For medical necessity clinical coverage criteria, refer to the InterQual® 2020, Apr. 2020 Release, CP: Procedures,

Polypectomy, Nasal.

Click here to view the InterQual® criteria.

Coverage Limitations and Exclusions UnitedHealthcare excludes Cosmetic Procedures from coverage including but not limited to the following: Procedures that correct an anatomical Congenital Anomaly without improving or restoring Physiologic Function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially

Page 57 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Updated Policy Title Effective Date Summary of Changes Rhinoplasty and Other Jun. 1, 2021 avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other Nasal Surgeries procedures done to relieve such consequences or behavior) as a Reconstructive Procedure. (continued) Rhinoplasty, unless rhinoplasty criteria above are met Any procedure that does not meet the reconstructive criteria Rhinoplasty procedures performed to improve appearance (check member specific benefit plan document)

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Jul. 1, 2021 Coverage Rationale When deciding coverage, the member specific benefit plan document must be Emergency Air Ambulance referenced to determine available coverage for Ambulance Services, if any, as Added language to indicate: the terms of the member specific benefit plan vary by state.

Emergency air ambulance o Indications for Coverage services may be deployed when the member’s condition Emergency Air Ambulance requires immediate Emergency air ambulance services may be deployed when the member’s transportation that cannot be condition requires immediate transportation that cannot be provided by ground provided by ground ambulance. Examples may include situations when a member’s medical ambulance; examples may condition is unstable and transportation by ground ambulance poses a threat to

include situations when a the member’s survival or seriously endangers the member’s health and the

member’s medical condition is member’s care cannot be provided/stabilized at the current location. unstable and transportation by

ground ambulance poses a Emergency air ambulance transportation may also be considered when ground threat to the member’s survival transport times exceed 30-60 minutes and the lengthy transport times may or seriously endangers the endanger the member’s life or seriously endanger the member’s health. member’s health and the

member’s care cannot be In addition, emergency air ambulance may be considered when the pickup point provided/stabilized at the is inaccessible by ground ambulance or is in a remote or sparsely populated

current location area. Emergency air ambulance o transportation may also be Emergency air ambulance transportation should meet the following criteria: considered when ground The member’s destination is an acute care hospital; and transport times exceed 30-60 Services requested by police or medical authorities at the site of an minutes and the lengthy emergency; and transport times may endanger

Page 58 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Jul. 1, 2021 the member’s life or seriously Emergency Air ambulance transportation requiring advanced life support; or (continued) endanger the member’s health Weather or traffic conditions make ground ambulance transportation o In addition, emergency air impractical, impossible, or overly time consuming ambulance may be considered when the pickup point is Emergency Ambulance (Ground, Water, or Air) inaccessible by ground Coverage includes Emergency ambulance transportation (including wait time ambulance or is in a remote or and treatment at the scene) by a licensed ambulance service from the location of sparsely populated area the sudden illness or injury, to the nearest hospital where Emergency Health

Removed language indicating as a Care Services can be performed.

general guideline, when it would take a ground ambulance 30-60 The following Emergency ambulance services are covered: minutes or more to transport a Transportation to the nearest hospital that can provide services appropriate member whose medical condition to the covered person’s illness or injury. at the time of pick-up required Transportation to the nearest neonatal special care unit for newborn infants immediate and rapid transport due treatment of illness, injuries, congenital birth defects, or complications of to the nature and/or severity of the premature birth that require that level of care. member’s illness/injury, air Ground ambulance transportation or air ambulance transportation requiring transportation may be appropriate basic life support or advanced life support Revised coverage criteria; removed Supplies that are needed for advanced life support or basic life support to criterion requiring: stabilize a member’s medical condition The member’s condition is o Treatment at the scene (paramedic services) without ambulance such that the ground transportation ambulance (basic or advanced Wait time associated with covered ambulance transportation life support) would endanger Transportation to a hospital that provides a required higher level of care that the member’s life or health was not available at the original hospital Inaccessibility to ground o ambulance transport or extended length of time Non-Emergency Ambulance (Ground or Air) Between Facilities required to transport the Coverage includes non-Emergency ambulance transportation by a licensed member via ground ambulance ambulance service (either ground or air ambulance, as UnitedHealthcare determines appropriate) between facilities only when the transport meets one of transportation could endanger the following: the member From an out-of-Network Hospital to the closest Network Hospital when Covered Health Care Services are required.

Page 59 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Jul. 1, 2021 Non-Emergency Ambulance To the closest Network Hospital or facility that provides the required (continued) (Ground or Air) Between Facilities Covered Health Care Services that were not available at the original Hospital or facility Removed language indicating coverage includes non-Emergency From a Short-Term Acute Care Facility to the closest Network Long-Term Acute Care Facility (LTAC), Network Inpatient Rehabilitation Facility, or other ambulance transportation by a Network Sub-Acute Care facility where the required services can be licensed ambulance service (either delivered ground or air ambulance, as UnitedHealthcare determines

appropriate) between facilities only The applicable benefit level for eligible non-Emergency ambulance when the member’s condition transportation depends on the member pick-up location (origin) as follows: requires treatment at another If the member is inpatient and is transported from a hospital to another facility and another mode of hospital or inpatient facility, coverage levels for these ambulance services transportation would endanger the may vary. If the member is in a sub-acute care setting and is transported to an member’s medical condition outpatient facility and back (outpatient hospital, outpatient facility, or Prior Authorization Requirements physician’s office), these ambulance services are covered under the benefits for Non-Emergency Ambulance that apply to that Sub-Acute Care setting. For example, if the member is at a Added language to indicate Skilled Nursing Facility, the ambulance transport to an outpatient facility physicians and other health care (dialysis facility or radiation whether or not it is attached to a hospital) and professionals who participate in a back is covered under the Skilled Nursing Facility/Inpatient Rehabilitation network are responsible for Facility Services section of the Certificate of Coverage (COC). obtaining prior authorization;

however, if the member chooses to Prior Authorization Requirements for Non-Emergency Ambulance receive Covered Health Care Services from an out-of-network Physicians and other health care professionals who participate in a Network are provider, the member is responsible for obtaining prior authorization. However, if the member chooses to responsible for obtaining prior receive Covered Health Care Services from an out-of-Network provider, the member is responsible for obtaining prior authorization before receiving the authorization before receiving the services. services Removed language indicating: If UnitedHealthcare initiates the non-Emergency ambulance transportation,

If UnitedHealthcare does not member prior authorization is not required. o initiate the non-Emergency ambulance transportation, certain plans may require the

Page 60 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Jul. 1, 2021 member or the provider to call Out-of-Network Ambulance (Emergency) (continued) in for notification If the ambulance transportation is covered, the benefit level for out-of-Network o Provider notification Emergency ambulance (ground, water, or air) is covered at the Network level of requirements are not deductible and coinsurance. addressed by this document

Applicable Codes Coverage Limitations and Exclusions Revised description for ambulance The following services are not eligible for coverage: modifiers D, I, J, and X Ambulance services from providers that are not properly licensed to be Revised description for revenue performing the ambulance services rendered. codes 0545, 0546, 0548, and 0549 Air ambulance transportation that does not meet the covered indications in the Air Ambulance criteria listed above.

Non-ambulance transportation. Non-ambulance transportation is not covered even if rendered in an Emergency situation. Examples include but are not limited to:

o Commercial or private airline or helicopter o A police car ride to a hospital o Medi-van or wheel-chair van transportation o Taxi ride, bus ride, rideshare services such as Lyft and Uber, etc. Ambulance transportation when other mode of transportation is appropriate. Except as indicated under the Indications for Coverage section above,

ambulance services when transportation by other means would not

endanger the member’s health are not covered. Ambulance transportation to a home, residential, domiciliary or custodial facility is not covered. Ambulance transportation that violates the notification criteria listed in the Indications for Coverage section above. Ambulance transportation for member convenience or other miscellaneous reasons for member and/or family. Examples include but are not limited to: Member wants to be at a certain hospital or facility for o personal/preference reasons

Page 61 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Jul. 1, 2021 o Member is in foreign country, or out of state, and wants to come home for a surgical procedure or treatment (this includes those recently (continued) discharged from inpatient care) o Member is going for a routine service and is medically able to use another mode of transportation o Member is deceased and family wants transportation to the coroner’s office or mortuary Ambulance transportation deemed not appropriate. Examples include but are not limited to: o Hospital to home o Home to physician’s office o Home (e.g., residence, nursing home, domiciliary or custodial facility) to a hospital for a scheduled service If the member is at a Skilled Nursing Facility/Inpatient Rehabilitation Facility and has met the annual day/visit limit on Skilled Nursing Facility/Inpatient Rehabilitation Facility Services, ambulance transports (during the non- covered days) are not eligible. Emergency Health Jul. 1, 2021 Coverage Rationale Indications for Coverage Care Services and Emergency Health Care Services - Emergency Health Care Services - Outpatient Urgent Care Center Outpatient Emergency Health Care Services are services that are required to stabilize or Services Replaced language indicating begin treatment in an Emergency. Emergency Health Care Services must be “benefits include the facility received on an outpatient basis at a Hospital or Alternate Facility. charge, supplies, diagnostic tests, and all professional services Benefits include the facility charge, supplies, and all professional services required to stabilize the member’s required to stabilize the member’s condition and/or begin treatment. This condition and/or begin treatment” includes placement in an observation bed to monitor the member’s condition with “benefits include the facility (rather than being admitted to a Hospital for an Inpatient Stay).

charge, supplies, and all professional services required to For services that are determined to be an Emergency, Emergency Health Care stabilize the member’s condition Services are always covered at the Network level of cost-sharing; even if an out-

and/or begin treatment” of-Network provider renders services.

Added language to indicate:

Page 62 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Emergency Health Jul. 1, 2021 o To determine if a visit is To determine if a visit is emergent or non-emergent, UnitedHealthcare will Care Services and emergent or non-emergent, consider the following factors (list is not all inclusive): Urgent Care Center UnitedHealthcare will consider • Reason for visit Services the following factors (list is not • External cause of injury all inclusive): • Patient work-up and treatment received (continued) . Reason for visit • Patient comorbidities

. External cause of injury • Principle final diagnosis . Patient work-up and • Location of discharge (community versus facility)

treatment received

. Patient comorbidities Use of emergency room for routine medical care and/or for convenience is not . Principle final diagnosis considered emergent. . Location of discharge (community versus facility) Certain plans may have no coverage or limited coverage for Non-Emergent ER Use of emergency room for o Services. Refer to the member specific benefit plan document. routine medical care and/or for

convenience is not considered Physician-Ordered Emergency Department Visit emergent Emergency Department (ED) visits that are ordered by a physician (i.e., physician Certain plans may have no o directs the member to the ED) for evaluation of a potential Emergency condition coverage or limited coverage are covered services. These are covered even if the member’s condition does for Non-Emergent ER Services; not meet the definition of Emergency or Emergency Medical Condition. refer to the member specific

benefit plan document Emergency Medical Treatment and Labor Act (EMTALA) (Federal Coverage Limitations and Labor Law) Exclusions Emergency Medical Condition means: Replaced language indicating “the use of the Emergency Department A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms to treat a non-Emergency situation of substance abuse) such that the absence of immediate medical attention other than services necessary to could reasonably be expected to result in: conduct a medical screening examination and Stabilization o Placing the health of the individual (or, with respect to a pregnant

services (revenue code 0451) is woman, the health of the woman or her unborn child) in serious

excluded” with “the use of the jeopardy; Serious impairment to bodily functions; or Emergency Department to treat a o

Page 63 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Emergency Health Jul. 1, 2021 non-Emergency situation other than o Serious dysfunction of any bodily organ or part; or Care Services and services necessary to conduct a With respect to a pregnant woman who is having contractions: Urgent Care Center medical screening examination and o That there is inadequate time to effect a safe transfer to another hospital Services Stabilization services (revenue code before delivery; or 0451) is excluded” That transfer may pose a threat to the health or safety of the woman (continued) o Definitions

Added definition of: Additional Information

o Alternate Facility Emergency Hospital o If the member leaves the ED for services in another department (for example Network o radiology or surgical suite) and then returns to the ED for discharge, all such Non-Emergent ER Services o services are considered part of the Emergency Health Care Services benefit.

For example, if the member has a broken arm and is brought from the o ED to the operating room to reduce the fracture, and is then returned to the ED for discharge, all services in this encounter would be considered

under the Emergency Health Care Services benefit (i.e., the services in

the operating room are not considered under the outpatient surgery benefit). If the member is admitted to the hospital through the ED, the entire encounter is considered an inpatient admission (i.e., including the services rendered in the ED), and therefore only the inpatient benefits/copay apply.

The fact that the member entered the hospital for admission through the o ED (versus the admissions door) does not change the benefit for the inpatient admission (i.e., only the inpatient benefit applies).

If the Emergency admission is at an out-of-Network facility, Network o benefits will be applied.

. UnitedHealthcare may elect to transfer the member to a Network facility as soon as medically appropriate. . If the member chooses to stay at the out-of-Network facility after the date that it is determined a transfer is medically appropriate, out-of- Network benefits will be applied for the remainder of the inpatient

stay.

State mandates for Emergency care impact the benefits for Emergency Health Care Services.

Page 64 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Emergency Health Jul. 1, 2021 These benefits, when eligible and offered during an ED visit, are covered as Care Services and follows: Urgent Care Center o Dental services are covered under the accidental dental benefit, not Services under the Emergency Health Care Services benefit. Durable Medical Equipment (DME) given for take-home use is not (continued) o covered under the Emergency Health Care Services benefit. It is

covered under the DME section of the COC. Pharmaceutical products are covered under the Emergency Health Care o Services benefit.

The Emergency Health Care Services copayment or benefit level will apply if the member has been placed in an observation bed for the purpose of monitoring the member’s condition, rather than being admitted as an inpatient in the hospital.

Urgent Care Center Services Benefits are applied as Urgent Care Center whether it is a free standing Urgent Care or part of a hospital facility (i.e., Urgent Care benefits, not outpatient diagnostic and/or therapeutic benefits, apply if the Urgent Care

Center is part of a hospital facility).

When the Urgent Care Center is a free-standing facility or a part of a larger facility (e.g., hospital), if the member has additional services, such as

diagnostic, therapeutic, or pharmaceuticals administered during the Urgent Care visit, a separate cost share may be applied to those services.

o For example, a member is sent to the radiology department of that same facility for an X-ray, and is then returned to the Urgent Care Center for discharge. In this situation, a separate cost share may be applied. Refer to the member specific benefit plan document for cost sharing o details.

These benefits, when eligible and offered during an Urgent Care visit, are covered as follows:

Accidental dental services are covered under the accidental dental o benefit, not under the Urgent Care Center Services benefit.

Page 65 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Emergency Health Jul. 1, 2021 o Durable Medical Equipment (DME) given for take-home use is not Care Services and covered under the Urgent Care Center Services benefit. It is covered Urgent Care Center under the DME section of the COC. Services Network vs. out-of-Network coverage: Refer to member specific benefit plan (continued) document for coverage.

Coverage Limitations and Exclusions Check the member specific benefit plan document for possible coverage. Otherwise, the following are excluded: Use of Emergency Department to treat a non-Emergency situation (refer to definition of Emergency). Use of Urgent Care Center Services to treat non-urgent conditions (refer to definition of Urgent Care Center). Non-Emergency Health Care Services received outside of the United States. Preventive Care Jul. 1, 2021 Frequently Asked Questions (FAQ) Refer to the policy for complete details. Services Added FAQ #14 pertaining to maternal depression screening as a preventive care services benefit Applicable Codes Preventive Care Services Hepatitis C Virus Infection Screening Updated service description;

added March 2021 Bright Futures

recommendation for screening all

individuals ages 18 to 79 years at least once for hepatitis C virus infection (HCV) Genetic Counseling and Evaluation for BRCA Testing; and BRCA Lab Screening and Breast Cancer: Medication Use to Reduce Risk

Page 66 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jul. 1, 2021 Updated list of CPT codes for Services Evaluation and Management (continued) (Office Visits); added 99417 Colorectal Cancer Screening Updated list of Code Group 5 CPT codes for Pre-op/Consultation; added 99417

Weight Loss to Prevent Obesity- Related Morbidity and Mortality in Adults: Behavioral Interventions and Screening for Obesity in Children

and Adolescents

Updated list of CPT/HCPCS codes

for:

o Medical Nutrition Therapy: Added G0270, G0271, and S9470

o Behavioral Counseling or Therapy: Added 0403T Updated preventive benefit instructions; added language to indicate CPT/HCPCS codes

0403T, G0270, G0271, and S9470

requires one of the diagnosis

codes listed in this [policy]

Interventions for Tobacco Smoking

Cessation in Adults, including Pregnant Persons (previously titled Smoking Cessation in Adults, including Pregnant Women: Behavioral and Pharmacotherapy Interventions)

Page 67 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jul. 1, 2021 Updated service description: Services o Removed September 2015 (continued) USPSTF rating “A” o Added January 2021 USPSTF rating “A” to indicate:

. For pregnant persons, the

USPSTF recommends that

clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who

use tobacco

. For nonpregnant adults,

the USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and US Food and Drug Administration (FDA)-

approved

pharmacotherapy for cessation to nonpregnant adults who use tobacco

o Added instruction to refer to the plan’s pharmacy benefit plan administrator for details on prescription medications

Page 68 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

Coverage Determination Guideline Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jul. 1, 2021 available under the plan’s Services preventive benefit (continued) Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis Updated list of CPT codes for Office Visits; added 99417 Preventive Vaccines (Immunizations) Immunization Administration Updated list of applicable CPT codes to reflect COVID-19 related edits; added 0031A Expanded Women’s Preventive Health Well-Woman Visits Updated list of CPT codes for Prenatal Office Visits; added 99417 Supporting Information Updated References section to reflect the most current information

Page 69 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021

General Information

The inclusion of a health service (e.g., test, drug, device or procedure) in this updates. When information in this bulletin conflicts with applicable state and/or bulletin indicates only that UnitedHealthcare is adopting a new policy and/or federal law, UnitedHealthcare follows such applicable federal and/or state law. updated, revised, replaced or retired an existing policy; it does not imply that Policy Update Classifications UnitedHealthcare provides coverage for the health service. Note that most New benefit plan documents exclude from benefit coverage health services identified as investigational or unproven/not medically necessary. Physicians and other New clinical coverage criteria have been adopted for a health service (e.g., test, health care professionals may not seek or collect payment from a member for drug, device or procedure) services not covered by the applicable benefit plan unless first obtaining the member’s written consent, acknowledging that the service is not covered by the Updated benefit plan and that they will be billed directly for the service. An existing policy has been reviewed and changes have not been made to the clinical coverage criteria; however, items such as the clinical evidence, FDA Note: The absence of a policy does not automatically indicate or imply coverage. information, and/or list(s) of applicable codes may have been updated As always, coverage for a health service must be determined in accordance with the member’s benefit plan and any applicable federal or state regulatory Revised requirements. Additionally, UnitedHealthcare reserves the right to review the An existing policy has been reviewed and revisions have been made to the clinical evidence supporting the safety and effectiveness of a medical clinical coverage criteria technology prior to rendering a coverage determination.

Replaced UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to An existing policy has been replaced with a new or different policy support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice staff with a Retired simple and predictable administrative experience. The Medical Policy Update The health service(s) addressed in the policy are no longer being managed or Bulletin was developed to share important information regarding are considered to be proven/medically necessary and are therefore not UnitedHealthcare Value & Balance Exchange Medical Policy, Medical Benefit excluded as unproven/not medically necessary services, unless coverage Drug Policy, Coverage Determination Guideline, and Utilization Review Guideline guidelines or criteria are otherwise documented in another policy

The complete library of UnitedHealthcare Value & Balance Exchange Medical Policies, Medical Benefit Drug Policies, Coverage Determination Guidelines, and Utilization Review Guidelines is available at UHCprovider.com > Policies and Protocols > Exchange Plans Policies > Medical & Drug Policies and Coverage Determination Guidelines for UnitedHealthcare® Value & Balance Exchange Plans.

Page 70 of 70 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: June 2021