UnitedHealthcare Value & Balance Exchange
Medical Policy Update Bulletin: May 2021
In This Issue
Medical Policy Updates Page Updated • Attended Polysomnography for Evaluation of Sleep Disorders – Effective Jun. 1, 2021 ...... 3 • Chromosome Microarray Testing – Effective Jun. 1, 2021...... 4 • Computerized Dynamic Posturography – Effective May 1, 2021 ...... 4 • Epidural Steroid Injections for Spinal Pain – Effective Jun. 1, 2021 ...... 4 • Implanted Electrical Stimulator for Spinal Cord – Effective Jun. 1, 2021 ...... 5 Revised • Airway Clearance Devices – Effective May 1, 2021 ...... 5 • Articular Cartilage Defect Repairs – Effective Jun. 1, 2021 ...... 7 • Cell-Free Fetal DNA Testing – Effective Jul. 1, 2021 ...... 10 • Cognitive Rehabilitation – Effective May 1, 2021 ...... 11 • Deep Brain and Cortical Stimulation – Effective May 1, 2021 ...... 11 • Hearing Aids and Devices Including Wearable, Bone Anchored and Semi-Implantable – Effective Jun. 1, 2021 ...... 13 • Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Jun. 1, 2021 ...... 14 • Obstructive Sleep Apnea Treatment – Effective Jun. 1, 2021 ...... 18 • Otoacoustic Emissions Testing – Effective Jul. 1, 2021 ...... 22 • Surgery of the Elbow – Effective Jul. 1, 2021 ...... 24 • Total Artificial Disc Replacement for the Spine – Effective May 1, 2021 ...... 24 Retired • Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) Scans – Effective May 1, 2021 ...... 28
Page 1 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
In This Issue
Medical Benefit Drug Policy Updates New • Evkeeza™ (Evinacumab-Dgnb) – Effective Jun. 1, 2021 ...... 29 Updated • Alpha1-Proteinase Inhibitors – Effective May 1, 2021 ...... 30 • Buprenorphine (Probuphine® & Sublocade®) – Effective May 1, 2021 ...... 31 • Cimzia® (Certolizumab Pegol) – Effective Jun. 1, 2021 ...... 31 • Evenity® (Romosozumab-Aqqg) – Effective May 1, 2021 ...... 31 • Krystexxa® (Pegloticase) – Effective May 1, 2021 – May 1, 2021 ...... 31 Revised • Ketalar® (Ketamine) and Spravato® (Esketamine) – Effective Jun. 1, 2021 ...... 31 • Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors – Effective Jun. 1, 2021 ...... 35 • Simponi Aria® (Golimumab) Injection for Intravenous Infusion – Effective Jun. 1, 2021 ...... 38 • Vyepti™ (Eptinezumab-Jjmr) – Effective Jun. 1, 2021 ...... 40 • Zilretta® (Triamcinolone Acetonide Extended Release) – Effective Jun. 1, 2021 ...... 43 • Zolgensma® (Onasemnogene Abeparvovec-Xioi) – Effective Jun. 1, 2021 ...... 44 Coverage Determination Guideline Updates Updated • Clinical Trials – Effective May 1, 2021 ...... 49 Revised • Pectus Deformity Repair – Effective May 1, 2021 ...... 49
Page 2 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Updated Policy Title Effective Date Summary of Changes Attended Jun. 1, 2021 Template Update Polysomnography for Replaced content sub-heading titled “Professional Societies” with “Clinical Practice Guidelines” in Clinical Evidence Evaluation of Sleep section Disorders Coverage Rationale Added language to indicate Home Sleep Apnea Testing (HSAT), using a portable monitor, is medically necessary for evaluating adults with suspected OSA; where HSAT is indicated, an autotitrating Positive Airway Pressure (APAP)
device is an option to determine a fixed PAP pressure
Removed language indicating: Diagnostic testing for Obstructive Sleep Apnea (OSA) should be performed in conjunction with a comprehensive o sleep evaluation
o Home Sleep Apnea Testing (HSAT), using a technically adequate device is to be used for the diagnosis of OSA in uncomplicated members is medically necessary for evaluating adults with suspected OSA
o Home Sleep Apnea testing (HSAT) must be administered by an accredited sleep center under the supervision of a board-certified sleep medicine physician, or board-eligible provider and of acceptable quality: . The single HSAT recording is over at least one (1) night; and
. Includes a minimum of four (4) hours of technically adequate oximetry and flow data; and
. RDI or REI greater than or equal to 5 is typically seen in OSA A technically adequate HSAT device incorporates use of the following sensors: nasal pressure, chest and o abdominal respiratory inductance plethysmography, and oximetry or PAT with oximetry and actigraphy
o Polysomnography is the standard diagnostic test for the diagnosis of OSA in adult patients when there is a concern for OSA based on a comprehensive sleep evaluation
o Attended full-channel nocturnal polysomnography is medically necessary for evaluating individuals with suspected OSA for chronic opioid medication use [the use of opioids (20-50 morphine milligram equivalents (MME) per day)] when:
. Used in treating chronic pain (pain lasting longer than 3 months or past the time of normal tissue healing)
. Used outside of active cancer treatment, palliative care, and end-of-life care . A diagnostic PSG or PAP-titration must be performed prior to an Multiple Sleep Latency Testing (MSLT); HSAT
and Split-night Polysomnography should not be performed in conjunction with the MSLT
. A diagnostic PSG or PAP-titration may be performed prior to the Maintenance of Wakefulness Testing (MWT) at the discretion of the ordering physician; however, the MWT may also be performed as a stand-alone test Definitions Removed definition of “Chronic Opioid Medication Use” Updated definition of:
Page 3 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Updated Policy Title Effective Date Summary of Changes Attended Jun. 1, 2021 o Apnea Hypopnea Index (AHI) Polysomnography for o Home Sleep Apnea Testing (HSAT) Evaluation of Sleep o Medically Necessary Disorders o Periodic Limb Movement Arousal Index (PLMAI) Periodic Limb Movement Index (PLMI) (continued) o o Respiratory Disturbance Index (RDI) o Respiratory Event Index (REI) Applicable Codes Added CPT/HCPCS codes 95782, 95783, 95800, 95801, 95803, 95806, G0398, G0399, and G0400 Supporting Information Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information Chromosome Jun. 1, 2021 Template Update Microarray Testing Replaced content sub-heading titled “Professional Societies” with “Clinical Practice Guidelines” in Clinical Evidence section Removed CMS section Applicable Codes Added ICD-10 diagnosis code O02.89 Supporting Information Updated Clinical Evidence and References sections to reflect the most current information Computerized May 1, 2021 Template Update Dynamic Replaced content sub-heading titled “Professional Societies” with “Clinical Practice Guidelines” in Clinical Evidence Posturography section Removed CMS section Supporting Information Updated Clinical Evidence and References section to reflect the most current information Epidural Steroid May 1, 2021 Notice of Revision: The following summary of changes has been modified and implementation has been delayed. Injections for Spinal Jun. 1, 2021 Revisions to the previous policy update announcement are outlined in red below. Please take note of the additional Pain updates to be applied on Jun. 1, 2021.
Template Update Replaced content sub-heading titled “Professional Societies/Technology Assessments” with “Clinical Practice Guidelines” in Clinical Evidence section
Page 4 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Updated Policy Title Effective Date Summary of Changes Epidural Steroid Jun. 1, 2021 Removed CMS section Injections for Spinal Applicable Codes Pain Added CPT codes 62324, 62325, 62326, and 62327 (continued) Added ICD-10 diagnosis codes G90.50 and G90.59 Supporting Information Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information Implanted Electrical Jun. 1, 2021 Template Update Stimulator for Spinal Removed CMS section Cord Coverage Rationale 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
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Airway Clearance May 1, 2021 Template Update A two-month rental trial of a high-frequency chest wall oscillation system is Devices • Removed CMS section proven and Medically Necessary in the management of bronchiectasis, cystic Coverage Rationale fibrosis, and neuromuscular diseases characterized by the production of excessive airway secretions, infection and inadequate airway clearance when Replaced language indicating: criteria have been met. For medical necessity clinical coverage criteria, refer to “A two-month rental trial of a o the InterQual® Client Defined 2020, CP: Durable Medical Equipment, Secretion high-frequency chest wall oscillation system is proven Clearance Devices (Custom) – UHG.
and medically necessary in the ® management of pulmonary Click here to view the InterQual criteria.
conditions characterized by the production of excessive airway
Page 5 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Airway Clearance May 1, 2021 secretions, infection and An initial two-month rental trial must confirm individual tolerance and efficacy in Devices inadequate airway clearance using the device.
(continued) when criteria have been met” An acoustical or mechanical percussor, positive expiratory pressure and with “a two-month rental trial of aerosol drug delivery system combination device (e.g., Vibralung®) is a high-frequency chest wall considered Medically Necessary in the management of airway clearance for oscillation system is proven bronchiectasis, cystic fibrosis, and neuromuscular diseases. For medical
and medically necessary in the necessity clinical coverage criteria, refer to the InterQual® Client Defined 2020,
management of CP: Durable Medical Equipment, Secretion Clearance Devices (Custom) – UHG.
bronchiectasis, cystic fibrosis, and neuromuscular diseases Click here to view the InterQual® criteria. characterized by the production of excessive airway An intrapulmonary percussive ventilation (IPV) device for home use is secretions, infection and considered unproven and not Medically Necessary. An IPV (E0481) is a inadequate airway clearance mechanized form of chest physical therapy, which delivers mini-bursts (more when criteria have been met” than 200 per minute) of respiratory gases to the lungs via a mouthpiece. Its “An acoustical or mechanical purpose is to mobilize endobronchial secretions and diffuse patchy atelectasis. o percussor, positive expiratory The patient controls variables such as inspiratory time, delivery rates and peak
pressure and aerosol drug pressure. Alternatively a therapist will do a slapping or clapping of the patient’s
delivery system combination chest wall. device (e.g., Vibralung®) is considered medically necessary in the management of airway clearance” with “an acoustical or mechanical
percussor, positive expiratory
pressure and aerosol drug delivery system combination device (e.g., Vibralung®) is considered medically necessary in the management of airway clearance for bronchiectasis, cystic fibrosis, and neuromuscular diseases”
Page 6 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Articular Cartilage Jun. 1, 2021 Template Update Autologous chondrocyte transplantation (ACT) is proven and medically Defect Repairs Replaced content sub-heading necessary for treating individuals with a symptomatic full-thickness articular titled “Professional Societies” with cartilage defect.
“Clinical Practice Guidelines” in Clinical Evidence section Microfracture repair is proven and medically necessary to treat full and
Coverage Rationale partial thickness chondral defects of the knee.
Revised language to indicate: ACT is unproven and not medically necessary for treating individuals with the o Autologous chondrocyte transplantation (ACT) is proven following indications due to insufficient evidence of efficacy: and medically necessary for Treatment of joints other than the knee treating individuals with a Growth plates have not closed symptomatic full-thickness History of partial-thickness defects Osteochondritis dissecans (OCD) articular cartilage defect Microfracture repair is proven Malignancy in the bone, cartilage, fat, or muscle of the treated limb o and medically necessary to Active infection in the affected knee
treat full and partial thickness Instability of the knee
chondral defects of the knee. History of total meniscectomy Repeat ACT o ACT is unproven and not medically necessary for Active inflammatory degenerative, rheumatoid or osteoarthritis treating individuals with the As initial or first line of surgical therapy following indications due to insufficient evidence of For medical necessity clinical coverage criteria for ACT and microfracture repair, refer to the InterQual® Client Defined 2020, CP: Procedures, Articular Cartilage efficacy: . Treatment of joints other Defect Repairs (Custom) - UHG.
than the knee ® . Growth plates have not Click here to view the InterQual criteria. closed . History of partial-thickness Osteochondral Autograft and Allograft transplantation is proven and defects medically necessary for treating individuals with cartilage defects of the . Osteochondritis dissecans knee. (OCD) For medical necessity clinical coverage criteria for Osteochondral Autograft and Allograft transplantation, refer to the InterQual® 2020, CP: Procedures:
Arthrotomy, Knee
Page 7 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Articular Cartilage Jun. 1, 2021 . Malignancy in the bone, Arthroscopy or Arthroscopically Assisted Surgery, Knee Defect Repairs cartilage, fat or muscle of Arthroscopy or Arthroscopically Assisted Surgery, Knee (Pediatric) (continued) the treated limb ® . Active infection in the Click here to view the InterQual criteria. affected knee
. Instability of the knee Focal articular cartilage repair is unproven and not medically necessary for
. History of total treating individuals with any of the following due to insufficient evidence of
meniscectomy efficacy: . Repeat ACT Osteochondral Autograft and Allograft transplantation for all other . Active inflammatory indications than those listed above degenerative, rheumatoid Use of minced articular cartilage repair (whether synthetic, allograft or or osteoarthritis autograft) for treating osteochondral defects of the knee . As initial or first line of Use of cryopreserved viable Osteochondral Allograft products (e.g., surgical therapy Cartiform)
For medical necessity clinical Microfracture repair of the knee with any of the following indications: o coverage criteria for ACT and Misalignment of the knee o microfracture repair, refer to o Osteoarthritis ® the InterQual Client Defined o Systemic immune-mediated disease, disease-induced arthritis, or 2020, CP: Procedures, cartilage disease
Articular Cartilage Defect o Unwilling or unable to participate in post-operative physical Repairs (Custom) - UHG rehabilitation program o Osteochondral Autograft and ® Allograft transplantation is Click here to view the InterQual criteria. proven and medically
necessary for treating
individuals with cartilage defects of the knee; for medical necessity clinical coverage criteria, refer to the InterQual® 2020, Apr. 2020 Releaqse, CP: Procedures: . Arthrotomy, Knee
Page 8 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Articular Cartilage Jun. 1, 2021 . Arthroscopy or Defect Repairs Arthroscopically Assisted (continued) Surgery, Knee . Arthroscopy or Arthroscopically Assisted
Surgery, Knee (Pediatric)
o Focal articular cartilage repair is unproven and not medically necessary for treating individuals with any of the following due to insufficient evidence of efficacy: . Osteochondral Autograft and Allograft
transplantation for all other
indications than those
listed above . Use of minced articular cartilage repair (whether synthetic, allograft or autograft) for treating osteochondral defects of the knee . Use of cryopreserved
viable Osteochondral
Allograft products (e.g., Cartiform) . Microfracture repair of the knee with any of the following indications: Misalignment of the knee Osteoarthritis
Page 9 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Articular Cartilage Jun. 1, 2021 Systemic immune- Defect Repairs mediated disease, (continued) disease-induced arthritis, or cartilage disease Unwilling or unable to participate in post- operative physical rehabilitation program Cell-Free Fetal DNA Jul. 1, 2021 Template Update DNA-based noninvasive prenatal tests of fetal aneuploidy are proven and Testing Replaced content sub-heading medically necessary as screening tools for trisomy 21 (Down syndrome), titled “Professional Societies” with trisomy 18 (Edwards syndrome), or trisomy 13 (Patau syndrome) for individuals with a singleton pregnancy in any one of the following “Clinical Practice Guidelines” in Clinical Evidence section circumstances:
Removed CMS section Maternal age or oocyte age of 35 years or older at delivery; or
Coverage Rationale Fetal ultrasound findings indicating an increased risk of aneuploidy; or
Added language to indicate non- History of a prior pregnancy with a trisomy; or amplified or sequenced cell-free Positive first- or second-trimester screening test results for aneuploidy; or DNA-based noninvasive prenatal Parental balanced Robertsonian translocation with an increased risk of fetal tests (e.g., Vanadis) are unproven trisomy 13 or trisomy 21; or and not medically necessary Screening after pre-test counseling from a board-certified genetic counselor or from the prenatal care physician or healthcare professional using Shared Supporting Information Decision-Making (SDM) Updated Clinical Evidence and
References sections to reflect the most current information Due to insufficient evidence of efficacy, DNA-based noninvasive prenatal tests are unproven and not medically necessary for any of the following Conditions including, but not limited to, the following:
o Multiple gestation pregnancies o Twin zygosity o Repeat testing due to low fetal fraction o Screening for the following: . Aneuploidy other than trisomies 21, 18, or 13
. Microdeletions
Page 10 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Cell-Free Fetal DNA Jul. 1, 2021 . Single gene disorders Testing Fetal RhD statusNon-amplified or sequenced cell-free DNA-based (continued) noninvasive prenatal tests (e.g., Vanadis)
Genetic Counseling Genetic counseling is strongly recommended prior to fetal screening or prenatal diagnosis in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person. Cognitive May 1, 2021 Template Update Cognitive Rehabilitation (CR) is proven and medically necessary when Rehabilitation Removed CMS section treating individuals following a traumatic brain injury (TBI) or stroke. For Supporting Information medical necessity clinical coverage criteria, refer to the InterQual® Client Defined Updated Description of Services, 2021, LOC: Outpatient Rehabilitation & Chiropractic: Clinical Evidence, and References Cerebrovascular Accident (CVA): Rehabilitation (Adult) (Custom) - UHG sections to reflect the most current Traumatic Brain Injury (TBI): Rehabilitation (Adult) (Custom) - UHG information Click here to view the InterQual® criteria.
The following are unproven and not medically necessary due to insufficient evidence of efficacy: Cognitive Rehabilitation for any other condition or diagnosis Coma Stimulation (also known as Coma arousal, Coma responsiveness, multisensory stimulation, and Coma care therapy/programs) for any indication, including individuals who are Comatose, in a Vegetative or Minimally Conscious State Deep Brain and May 1, 2021 Coverage Rationale Conventional deep brain stimulation is proven and medically necessary for Cortical Stimulation Proven and Medically Necessary treating the following indications (this does not apply to directional deep Revised language to indicate: brain stimulation): Dystonia o Conventional deep brain Essential Tremor stimulation is proven and medically necessary for Parkinson’s disease
treating the following Refractory Epilepsy
indications (this does not apply
Page 11 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Deep Brain and May 1, 2021 to directional deep brain Responsive cortical stimulation is proven and medically necessary for Cortical Stimulation stimulation): treating partial or focal seizure disorder. (continued) . Dystonia ® . Essential tremor For medical necessity clinical coverage criteria, refer to the InterQual 2020, Apr. . Parkinson’s disease 2020 Release, CP: Procedures, Stereotactic Introduction, Subcortical or Cortical
. Refractory epilepsy Electrodes.
o Responsive cortical stimulation is proven and medically Click here to view the InterQual® criteria. necessary for treating partial or focal seizure disorder The following are unproven and not medically necessary due to insufficient o For medical necessity clinical evidence of efficacy: coverage criteria, refer to the Conventional deep brain stimulation and cortical stimulation for treating ® InterQual 2020, Apr. 2020 obsessive-compulsive disorder (OCD) and for all other indications not listed Release, CP: Procedures, above.
Stereotactic Introduction, Directional deep brain stimulation that enables specific steering of current
Subcortical or Cortical towards targeted lesions for treating any condition including but not limited
Electrodes to:
Unproven and Not Medically o Dystonia
Necessary o Parkinson’s disease
Revised list of unproven and not o Tremor medically necessary indications: Responsive cortical stimulation for treating all other indications not listed above. o Replaced “deep brain stimulation for treating conditions other than those listed [in the policy] as proven” with “conventional deep brain stimulation and cortical
stimulation for treating
obsessive-compulsive disorder
(OCD) and for all other indications not listed [in the policy as proven]”
Page 12 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Deep Brain and May 1, 2021 o Added “responsive cortical Cortical Stimulation stimulation for treating all other (continued) indications not listed [in the policy as proven]” Supporting Information Added Description of Services, Clinical Evidence, and References sections Updated FDA section to reflect the most current information Hearing Aids and Jun. 1, 2021 Template Update Wearable air-conduction Hearing Aids required for the correction of a Devices Including Replaced content sub-heading Hearing Impairment are proven and medically necessary.
Wearable, Bone titled “Professional Societies” with When used according to U.S. Food and Drug Administration (FDA) labeled Anchored and Semi- “Clinical Practice Guidelines” in Implantable Clinical Evidence section indications, contraindications, warnings, and precautions, the following are
Removed CMS section proven and Medically Necessary for hearing loss in an individual who is not a candidate for an air-conduction Hearing Aid: Coverage Rationale Bilateral fully or partially implantable bone-anchored Hearing Aids for Added language to indicate Conductive or Mixed Hearing Loss in both ears wearable air-conduction Hearing Aids required for the correction of a Bilateral or unilateral bone-anchored Hearing Aids utilizing a headband
Hearing Impairment are proven and (without osseointegration) Semi-implantable electromagnetic Hearing Aid for Sensorineural Hearing medically necessary Loss Removed coverage criteria Unilateral fully or partially implantable bone-anchored Hearing Aids for pertaining to individuals 21 years of age or older requiring air Conductive or Mixed Hearing Loss in one or both ears Unilateral fully or partially implantable bone-anchored Hearing Aids for conduction devices Sensorineural Hearing Loss in one ear Removed language indicating air conduction hearing aid devices are The following are unproven and not Medically Necessary for treating hearing considered proven and Medically loss due to insufficient evidence of efficacy: Necessary for the correction of a Intraoral bone conduction Hearing Aids Hearing Impairment when the Laser or light-based Hearing Aids [listed] criteria are met Totally implanted middle ear hearing systems
Page 13 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Hearing Aids and Jun. 1, 2021 Definitions Repair/Replacement Devices Including Removed definition of “Medically The original hearing aid shall be replaced by a provider only under the Wearable, Bone Necessary Services” following conditions: Anchored and Semi- Applicable Codes • Routine wear on the equipment renders it non-functional and the member Implantable Removed HCPCS codes V5266 still requires the equipment. (continued) and V5299 o Vendors/manufacturers are responsible for repairs, and replacements covered by warranty • Replacement of Hearing Aid is for the same or similar type of equipment • Unless otherwise stated, Hearing Aids have a Reasonable Useful Lifetime (RUL) of 3 years Note: For state specific information on mandated coverage of Hearing Aids, check the member specific benefit plan. • The physician provides documentation that the condition of the member changes (e.g., impaired function necessitates an upgrade)
Repair or replacement is not covered for the following: Malicious damage, neglect or abuse Reconditioned hearing aids
Equipment Upgrades • A change in the member’s medical condition and equipment needs requires the same documentation as a new request • Equipment upgrades are equivalent to a new service Molecular Oncology Jun. 1, 2021 Template Update Breast Cancer Testing for Cancer Replaced content sub-heading The use of one of the following Gene Expression Tests: Mammaprint, Diagnosis, Prognosis, titled “Professional Societies” with Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene and Treatment “Clinical Practice Guidelines” in Signature Assay, Breast Cancer Index (BCI) and EndoPredict is proven and Decisions Clinical Evidence section medically necessary to make a treatment decision regarding adjuvant Applicable Codes chemotherapy in females or males with breast cancer in the following Added CPT Codes 0017M, 0120U, situations:
and 0239U Newly diagnosed (within the last 6 months) when all of the following criteria
are met:
o Lymph node negative or 1-3 positive axillary lymph nodes; and
Page 14 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Molecular Oncology Jun. 1, 2021 o No distant metastases; and Testing for Cancer o Hormone receptor-positive (estrogen receptor positive, progesterone Diagnosis, Prognosis, receptor positive or both); and and Treatment o HER2 receptor negative; and Decisions Adjuvant chemotherapy is not precluded due to any other factor (e.g., o (continued) advanced age and/or significant co-morbidities); and
Currently receiving adjuvant hormonal therapy (e.g., Tamoxifen or an
aromatase inhibitor) for a breast cancer diagnosed within the prior six years when all of the following criteria are met:
Individual has not had prior Gene Expression Testing; and o Hormone receptor-positive (estrogen receptor positive, progesterone o receptor positive or both); and
o HER2 receptor negative; and Individual and treating physician have had a discussion prior to testing o regarding the potential results of the test and determined to use the
results to guide a decision regarding extended adjuvant hormonal
therapy Use of more than one Gene Expression Test for the same tumor in an
individual with breast cancer is unproven and not medically necessary due to
insufficient evidence of efficacy.
Gene Expression Tests for breast cancer are unproven and not medically
necessary for all other indications, including ductal carcinoma in situ (DCIS), due to insufficient evidence of efficacy.
Due to insufficient evidence of efficacy, gene expression profiling assays for
breast cancer treatment other than those previously described as covered are unproven and not medically necessary, including but not limited to:
BluePrint (also referred to as “80-gene profile”)
Breast Cancer Gene Expression Ratio (also known as Theros H/I)
Oncotype DX DCIS
The 41-gene signature assay The 76-gene “Rotterdam signature” assay
Page 15 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Molecular Oncology Jun. 1, 2021 Thyroid Cancer Testing for Cancer Molecular profiling of thyroid nodules (e.g., Afirma GSC, ThyroSeq V3, Diagnosis, Prognosis, ThyGeNEXT/ThyraMIR, or the gene and gene fusion panel BRAF, RAS, and Treatment HRAS, NRAS, RET/PTC1, RET/PTC3, PAX8/PPAR ) is proven and medically Decisions γ necessary when all of the following criteria are met: (continued) Follicular pathology on fine needle aspiration is indeterminate
The results of the test will be used for making decisions about further surgery
Molecular profiling of thyroid nodules or thyroid cancers is unproven and not
medically necessary for all other indications due to insufficient evidence of efficacy.
Use of more than one molecular profile test in an individual with a thyroid
nodule is unproven and not medically necessary due to insufficient evidence
of efficacy.
Hematological Cancer
Molecular profiling using chromosomal microarray analysis (e.g., Oncoscan, Reveal SNP-Oncology, CGH or SNP array) is proven and medically necessary
for individuals with acute leukemia.
Use of a Next Generation Sequencing profile test to assess minimal residual disease (e.g., ClonoSeq) is proven and medically necessary when the
following criteria are met:
Individual has acute myeloid leukemia (AML) or acute lymphoblastic
leukemia (ALL) and testing is being performed within 3 months of
completing a course of therapy and there is no clinical evidence of disease;
or Individual has multiple myeloma and testing is being performed within three
months of an allogenic or autologous bone marrow transplant; and there is
no clinical evidence of disease
Page 16 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Molecular Oncology Jun. 1, 2021 All other multigene, gene expression or microarray molecular profiling for Testing for Cancer hematological malignancies is unproven and not medically necessary due to Diagnosis, Prognosis, insufficient evidence of efficacy. This includes, but is not limited to the and Treatment following: Decisions Assessment of minimal residual disease by Next Generation Sequencing for
(continued) acute myeloid leukemia
Use of multi-gene Next Generation Sequencing gene panels for predicting
prognosis
Lung Cancer
Multigene molecular profiling of non-small cell lung cancer is proven and medically necessary when all of the following criteria are met:
The panel selected has no more than 50 genes; and
No prior molecular profiling has been performed on the same tumor
Liquid biopsy (circulating tumor cell free DNA) molecular profiling tests of non-small cell lung cancer are proven and medically necessary when the
following criteria is met:
The test selected has no more than 50 genes; and
No prior molecular profiling has been performed on the same tumor; and The individual is not medically fit for invasive biopsy; or
Non-small cell lung cancer has been pathologically confirmed, but there is
insufficient material available for molecular testing; and
Individual and treating physician have had a discussion prior to testing
regarding the potential results of the test and determined to use the results
to guide therapy
Liquid biopsy (circulating tumor cell free DNA or circulating tumor cells) for
any other tumor genetic analysis or tumor screening (e.g., Guardant,
Colosentry, epi ProColon, OncoCEE CTC) is unproven and not medically necessary due to insufficient evidence of efficacy.
Page 17 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Molecular Oncology Jun. 1, 2021 Due to insufficient evidence of efficacy, molecular profiling using gene Testing for Cancer expression profiling, Chromosome Microarray multi-gene cancer panels are Diagnosis, Prognosis, unproven and not medically necessary for all other indications, including but and Treatment not limited to: Decisions Bladder Cancer (e.g., Decipher Bladder) (NCCN, Bladder 2020)
(continued) Cancers of unknown primary site (e.g., Response Dx, CancerTYPE ID,
Rosetta Cancer Origin, ProOnc, SourceDX, PancraGen )
Colorectal Cancer (e.g., Oncotype DX Colon Cancer Assay, Colorectal Cancer DSA, GeneFx Colon, OncoDefender CRC)
Gene panels of >50 genes
Leukemia other than chromosome microarray (e.g., FoundationOne® Heme)
Melanoma (e.g., Decision Dx – Melanoma, Decision Dx-UM, DermTech PLA)
Multiple myeloma (e.g., MyPRS/MyPRS Plus) Prostate cancer (e.g., Oncotype DX Prostate Cancer Assay, TMPRSS2
fusion gene, Prolaris Prostate Cancer Test, Decipher Prostate Cancer
Classifier, ExoDX Prostate IntelliScore (EPI))
Uveal melanoma (e.g., Decision Dx-UM) Whole Exome Sequencing (WES) and whole genomic sequencing (WGS) of tumors Obstructive Sleep Jun. 1, 2021 Notice of Revision: The following Nonsurgical Treatment Apnea Treatment summary of changes has been Removable, custom oral appliances are proven and medically necessary for modified. Revisions to the previous treating Obstructive Sleep Apnea (OSA) as documented by a sleep study policy update announcement are (e.g., polysomnography or Home Sleep Apnea Testing). outlined in red below. Please take note Refer to the Medical Policy titled Attended Polysomnography for Evaluation of of the additional updates to be applied Sleep Disorders for further information. on Jun. 1, 2021.
For many individuals, oral appliance therapy (OAT) may be an effective
Template Update alternative to failed continuous positive airway pressure (CPAP) therapy.
Replaced content sub-heading Documentation of the following is required: titled “Professional Societies” with A patient presenting with symptoms of OSA be seen in a face-to-face “Clinical Practice Guidelines” in evaluation with a qualified physician (MD or DO) trained in sleep medicine Clinical Evidence section prior to beginning treatment for OAT (AASM and AADSM, December 2012, Removed CMS section AAO-HNS, November 2019)
Page 18 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Jun. 1, 2021 Coverage Rationale A treating physician (MD or DO) must diagnose OSA and recommend Apnea Treatment Nonsurgical Treatment course of treatment (AAO-HNS, November 2019) (continued) Added language to indicate for If the patient refuses CPAP therapy, documentation of the refusal from the many individuals, oral appliance patient’s treating physician (MD or DO) must be supplied
therapy (OAT) may be an effective For information on snoring and oral appliances, refer to the Coverage alternative to failed continuous Determination Guideline titled Durable Medical Equipment, Orthotics, Ostomy positive airway pressure (CPAP) therapy; documentation of the Supplies, Medical Supplies and Repairs/Replacements.
following is required: For medical necessity clinical coverage criteria, refer to the InterQual® 2020, Sep. o A patient presenting with symptoms of OSA be seen in a 2020 Release, Medicare: Durable Medical Equipment, Oral Appliances for face-to-face evaluation with a Obstructive Sleep Apnea. qualified physician (MD or DO) Click here to view the InterQual® criteria. trained in sleep medicine prior
to beginning treatment for OAT Documentation Requirements for Oral Appliance Therapy for OSA o A treating physician (MD or DO) must diagnose OSA and For members with Obstructive Sleep Apnea, oral appliance therapy (OAT) may
recommend course of be an effective alternative to failed continuous positive airway pressure (CPAP)
treatment therapy. Documentation of all of the following is required:
o If the patient refuses CPAP A patient presenting with symptoms of OSA be seen in a face-to-face therapy, documentation of the evaluation with a qualified physician (MD or DO) trained in sleep medicine refusal from the patient’s prior to beginning treatment for OAT (AASM and AADSM, December 2012) treating physician (MD or DO) and must be supplied A treating physician (MD or DO) must diagnose OSA and recommend Added reference link to the course of treatment and Coverage Determination Guideline Confirmation the treating physician diagnosed the member with OSA, titled Durable Medical Equipment, including documentation of the member’s intolerance, failure of, or refusal
Orthotics, Ostomy Supplies, of CPAP; and
Medical Supplies and Results of sleep study including severity of the OSA (AHI or RDI values,
Repairs/Replacements etc.); and Revised list of unproven and not If the oral appliance is being prescribed for reasons other than OSA, an medically necessary devices; explanation of why appliance is needed. added:
Page 19 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Jun. 1, 2021 o Devices for treating positional The following are unproven and not medically necessary due to insufficient Apnea Treatment OSA evidence of efficacy: (continued) o Nasal dilator devices for Devices for treating positional OSA treating OSA Nasal dilator devices for treating Obstructive Sleep Apnea (OSA) Prefabricated oral Removable oral appliances for treating Central Sleep Apnea o appliance/device Prefabricated Oral Appliance/Device
Surgical Treatment Surgical Treatment Obstructive Sleep Apnea as Documented by Polysomnography The following surgical procedures are proven and medically necessary for
Revised list of proven and treating Obstructive Sleep Apnea as documented by polysomnography.
medically necessary surgical For medical necessity clinical coverage criteria, refer to Client Defined 2020, CP:
procedures; removed “multilevel Procedures: procedures whether done in a Mandibular Osteotomy (Custom) – UHG single surgery or phased multiple Maxillomandibular Osteotomy and Advancement (Custom) – UHG surgeries from surgical treatment” Uvulopalatopharyngoplasty (UPPP) (Custom) – UHG Removed reference link to the ® Coverage Determination Guideline Click here to view the InterQual criteria.
titled Orthognathic (Jaw) Surgery Added language to refer to the Implantable hypoglossal nerve stimulation is proven and medically necessary
following InterQual® criteria for in an adult patient with moderate to severe OSA when all the following
medical necessity clinical coverage criteria are met: 2 criteria: Body mass index of (BMI) less than or equal to 32kg/m ; and ® Apnea Hypopnea Index (AHI) of 15 or greater and less than or equal to 65 as o InterQual Client Defined 2020, CP: Procedures, Mandiblular determined with polysomnography; and Osteotomy (Custom) - UHG Absence of complete concentric collapse at the soft palate level; and ® Failure or intolerance of Positive Airway Pressure (PAP) treatments (such as o InterQual Client Defined 2020, continuous positive airway pressure [CPAP] or bi-level positive airway CP: Procedures, Maxillomandibular Osteotomy pressure [BPAP] machines)
and Advancement (Custom) - PAP failure is defined as an inability to eliminate OSA (AHI of greater o UHG than 20 despite PAP usage) and PAP intolerance is defined as:
® . Inability to use PAP (greater than 5 nights per week of usage; usage o InterQual Client Defined 2020, CP: Procedures, Uvulopalato- defined as greater than 4 hours of use per night); or
Page 20 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Jun. 1, 2021 pharyngoplasty (UPPP) . Unwillingness to use PAP (for example, a patient returns the PAP Apnea Treatment (Custom) - UHG system after attempting to use it) (continued) Implantable Hypoglossal Nerve Stimulation Documentation Requirements for Surgical Treatment for OSA Removed language indicating Medical notes documenting all of the following: implantable hypoglossal nerve History of condition stimulation is proven and medically Sleep study confirming diagnosis of sleep apnea necessary in an adult patient with Excessive daytime sleepiness documented by:
moderate to severe OSA [the Epworth Sleepiness Scale or other validated scale o individual is] 22 years of age or Interference with daily activity or work (e.g., causes safety issues) o older Failed response or intolerance to CPAP usage or other non-invasive Definitions treatment with involvement of qualified sleep specialist
Added definition of: Oral appliance therapy unsuccessful due to failure to improve symptoms, intolerance, or inappropriate for patient anatomy o Home Sleep Apnea Testing (HSAT) Counseling about the benefits and risks of surgery by Physician trained in sleep disorders o Hypopnea Weight not a concern or weight loss was tried and failed o Oral Appliance
o Positional Obstructive Sleep Apnea In addition to the requirements above, medical notes documenting all of the
Updated definition of: following for:
Apnea Hypopnea Index (AHI) Uvulopalatopharyngoplasty (UPPP) o o Physician or Practitioner o Isolated oropharyngeal narrowing demonstrated as source of airway
o Respiratory Disturbance Index obstruction as the cause of OSA or failure of previous (RDI) uvulopalatopharyngoplasty to correct the OSA o Respiratory Event Index (REI) Mandibular Osteotomy Applicable Codes o Sleep study confirming diagnosis of sleep apnea must show moderate Added CPT/HCPCS codes 0466T, to severe OSA 0467T, 0468T, 41512, 41530, o Functional obstruction mostly retrolingual or lower pharyngeal Being performed as part of cleft palate repair or complex repair of 41599, 42299, 64569, E0485, o K1001, L8679, L8680, L8686, craniofacial anomaly
S2080, and S2900 Maxillomandibular Osteotomy And Advancement
Sleep study confirming diagnosis of sleep apnea must show moderate Supporting Information o to severe OSA
Page 21 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Jun. 1, 2021 Updated Description of Services, o Craniofacial disproportion or deformities, with evidence of Apnea Treatment Clinical Evidence, FDA, and maxillomandibular deficiency References sections to reflect the (continued) o Surgery is being performed as part of cleft palate repair or complex most current information 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) Otoacoustic Emissions Jul. 1, 2021 Template Update Neonatal hearing screening as a preventive service using otoacoustic Testing Replaced content sub-heading emissions (OAEs) is proven and medically necessary for infants who are 90 titled “Professional Societies and days or younger.
Guidelines” with “Clinical Practice Guidelines” in Clinical Evidence For hearing screening as a preventive service using OAEs for individuals who are
section 91 days to 21 years of age, refer to the policy titled Preventive Care Services.
Coverage Rationale
Added language to indicate: Otoacoustic emissions (OAEs) testing as a diagnostic service is proven and
o For hearing screening as a medically necessary for the evaluation of hearing loss in one or more of the preventive service using following: otoacoustic emissions (OAEs) Infants over 90 days old and children up to 4 years of age who did not pass for individuals who are 91 days or receive an initial hearing screening to 21 years of age, refer to the Children and adults who are unable to cooperate with other methods of Clinical Policy titled Preventive hearing testing (e.g., individuals with autism or stroke) Care Services Children with developmental or delayed speech or language disorders
Otoacoustic emissions tests Individuals with acoustic trauma, noise induced hearing loss, or sudden o should not be offered as part hearing loss
of an investigation of tinnitus Individuals with Auditory Neuropathy or auditory processing disorder (APD), unless the tinnitus is also known as central auditory processing disorder (CAPD) Individuals with Sensorineural Hearing Loss confirmed by audiometry
Page 22 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Otoacoustic Emissions Jul. 1, 2021 accompanied by other Individuals with abnormal auditory function studies or failed hearing exam Testing symptoms and signs Individuals who may be feigning a hearing loss (continued) Replaced language indicating Monitoring of ototoxicity in individuals before, during, and after “OAEs testing as a diagnostic administration of agents known to be ototoxic (e.g., aminoglycosides, service is proven and medically chemotherapy agents) necessary for the evaluation of hearing loss in infants over 90 days Note: Otoacoustic emissions tests should not be offered as part of an old and children up to 4 years of investigation of tinnitus unless the tinnitus is accompanied by other age” with “OAEs testing as a symptoms and signs. (NICE guideline NG155, 2020) diagnostic service is proven and medically necessary for the Auditory screening or diagnostic testing using otoacoustic emissions (OAEs) evaluation of hearing loss in infants is unproven and not medically necessary for all other populations and over 90 days old and children up to conditions due to insufficient evidence of efficacy. 4 years of age who did not pass or receive an initial hearing screening” Removed language indicating OAEs testing as a diagnostic service is proven and medically necessary for the evaluation of hearing loss in individuals with tinnitus Applicable Codes Removed ICD-10 diagnosis codes H93.11, H93.12, H93.13, H93.19, H93.A1, H93.A2, H93.A3, and H93.A9 Supporting Information Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information
Page 23 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Surgery of the Elbow Jul. 1, 2021 Coverage Rationale Surgery of the Elbow is proven and medically necessary in certain Revised language pertaining to circumstances. For medical necessity clinical coverage criteria, refer to the: ® medical necessity clinical coverage InterQual 2021, Apr. 2021 Release, CP: Procedures: criteria: o Arthroscopy, Diagnostic, +/- Synovial Biopsy, Elbow ® Arthroplasty, Removal or Revision, Elbow o Added reference to InterQual o 2021, Apr. 2021 Release, CP: o Arthroscopy, Surgical, Elbow Procedures: o Joint Replacement, Elbow . Arthroplasty, Removal or Revision, Elbow Click here to view the InterQual® criteria. . Arthroscopy, Diagnostic, +/- Synovial Biopsy, Elbow . Arthroscopy, Surgical, Elbow . Joint Replacement, Elbow o Removed reference to: . InterQual® 2020, Apr. 2020 Release, CP: Procedures, Arthroscopy, Surgical, Elbow . InterQual® Client Defined 2020, CP: Procedures: Joint Replacement, Elbow (Custom) - UHG Arthroplasty, Removal or Revision, Elbow (Custom) - UHG Applicable Codes Added CPT code 29830 Total Artificial Disc May 1, 2021 Template Update Cervical artificial total disc replacement with an FDA-approved prosthetic Replacement for the Replaced content sub-heading intervertebral disc is proven and medically necessary for treating one-level or Spine titled “Professional Societies” with two contiguous levels of cervical Degenerative Disc Disease (C3 to C7), in a Skeletally Mature individual with symptomatic radiculopathy and/or “Clinical Practice Guidelines” in Clinical Evidence section myelopathy. For medical necessity clinical coverage criteria, refer to the
Page 24 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Total Artificial Disc May 1, 2021 Coverage Rationale InterQual® 2020, Apr. 2020 Release, CP: Procedures, Artificial Disc Replacement for the Replaced language indicating: Replacement, Cervical. Spine “Cervical artificial total disc o ® (continued) replacement with an FDA- Click here to view the InterQual criteria.
approved prosthetic Cervical artificial disc replacement at one level combined with cervical spinal intervertebral disc is proven and medically necessary in fusion surgery at another level (adjacent or non-adjacent) is unproven and
certain circumstances” with not medically necessary due to insufficient evidence of efficacy.
“cervical artificial total disc
replacement with an FDA- Lumbar artificial total disc replacement with an FDA-approved prosthetic
approved prosthetic intervertebral disc is proven and medically necessary for treating single level intervertebral disc is proven lumbar Degenerative Disc Disease with symptomatic intractable discogenic and medically necessary for low back pain in a Skeletally Mature individual when there are no contraindications. treating one-level or two
contiguous levels of cervical Contraindications to lumbar artificial total disc replacement include but are Degenerative Disc Disease (C3 to C7), in a Skeletally Mature not limited to the following:
individual with symptomatic Moderate or severe facet arthropathy or pars defect at the operative level on
radiculopathy and/or a preoperative MRI scan, CT scan or plain radiograph
myelopathy” Lumbosacral spinal fracture Scoliosis of the lumbosacral spine o “Lumbar artificial total disc replacement with an FDA- Active systemic infection or infection localized to the site of implantation approved prosthetic Tumor in the peritoneum, retroperitoneum or site of implantation Osteoporosis or osteopenia as defined by recent (within one year) DEXA intervertebral disc is proven scan and medically necessary in Isolated radicular compression syndromes, especially due to disc herniation certain circumstances” with Spinal stenosis or radiculopathy “lumbar artificial total disc Previous lumbar spine surgery where the previous surgery destabilized the replacement with an FDA- approved prosthetic spine or where the spine at the level of the previous surgery is an alternate
intervertebral disc is proven source of pain and medically necessary for Vascular, urological, or other peritoneal or retroperitoneal pathology that treating single level lumbar may preclude safe and adequate anterior spine exposure as required for the surgery Degenerative Disc Disease with
Page 25 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Total Artificial Disc May 1, 2021 symptomatic intractable For medical necessity clinical coverage criteria, refer to the InterQual® Client Replacement for the discogenic low back pain in a Defined 2020, CP: Procedures, Artificial Disc Replacement, Lumbar (Custom) - Spine Skeletally Mature individual UHG. (continued) when there are no contraindications” Click here to view the InterQual® criteria.
Added language to indicate:
Contraindications to lumbar Lumbar artificial total disc replacement is unproven and not medically o artificial total disc replacement necessary in the following situations due to insufficient evidence of efficacy:
include but are not limited to More than one spinal level the following: Prior history of lumbar fusion or when combined with a lumbar fusion at any . Moderate or severe facet level arthropathy or pars defect Treating any other indications not listed above at the operative level on a preoperative MRI scan, CT scan or plain radiograph
. Lumbosacral spinal fracture
. Scoliosis of the lumbosacral spine . Active systemic infection or infection localized to the site of implantation . Tumor in the peritoneum, retroperitoneum, or site of
implantation
. Osteoporosis or
osteopenia as defined by
recent (within one year) DEXA scan . Isolated radicular compression syndromes, especially due to disc herniation
Page 26 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Total Artificial Disc May 1, 2021 . Spinal stenosis or Replacement for the radiculopathy Spine . Previous lumbar spine (continued) surgery where the previous surgery destabilized the spine or where the spine at the level of the previous surgery is an alternate source of pain . Vascular, urological, or other peritoneal or retroperitoneal pathology that may preclude safe and adequate anterior spine exposure as required for the surgery o Lumbar artificial total disc replacement is unproven and not medically necessary in the following situations due to insufficient evidence of efficacy: . More than one spinal level . Prior history of lumbar fusion or when combined with a lumbar fusion at any level . Treating any other indications not listed [in the policy as proven and medically necessary]
Page 27 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Policy Updates
Retired Policy Title Effective Date Summary of Changes Single-Photon May 1, 2021 Policy retired; single-photon emission computed tomography (SPECT) and positive emission tomography (PET) scans Emission Computed are managed by eviCore healthcare on behalf of UnitedHealthcare Tomography (SPECT) and Positron Emission Tomography (PET) Scans
Page 28 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
New Policy Title Effective Date Coverage Rationale Evkeeza™ Jun. 1, 2021 Evkeeza (evinacumab-dgnb) has been added to the Review at Launch program. Some members may not be eligible for (Evinacumab-Dgnb) coverage of this medication at this time. Refer to the policy titled Review at Launch for New to Market Medications for additional details.
Evkeeza (evinacumab-dgnb) is proven and medically necessary for the treatment of homozygous familial
hypercholesterolemia (HoFH) patients who meet all of the following criteria:
For initial therapy, all of the following:
o Diagnosis of HoFH by, or in consultation with, a lipid specialtist (e.g., cardiologist, endocrinologist, lipid specialist/lipidologist) experienced in the management of HoFH; and o Confirmation of the HoFH diagnosis based on one of the following: . Submission of medical records (e.g., chart notes, laboratory values) confirming genetic confirmation of two
mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus; or
. Submission of medical records (e.g., chart notes, laboratory values) confirming both of the following:
One of the following:
• Pre-treatment LDL-C greater than 500 mg/dL • Treated LDL-C greater than 300 mg/dL or history of treatment with Juxtapid (lomitapide) and One of the following: • Xanthoma before 10 years of age; or • Heterozygous familial hypercholesterolemia (HeFH) in both parents; and
Patient has failed to achieve an LDL-C goal of <100 mg/dL despite use of both of the following: o . One of the following:
Patient is currently treated with maximally tolerated statin therapy plus ezetimibe; or Patient is unable to tolerate statin therapy as evidenced by one of the following intolerable and persistent (i.e., more than 2 weeks) symptoms: • Myalgia (muscle symptoms without CK elevations) • Myositis (muscle symptoms with CK elevations < 10 times upper limit of normal [ULN]); or • Patient has a labeled contraindication to all statins as documented in medical records; or
Page 29 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
New Policy Title Effective Date Coverage Rationale Evkeeza™ Jun. 1, 2021 • Patient has experienced rhabdomyolysis or muscle symptoms with statin treatment with CK elevations (Evinacumab-Dgnb) > 10 times ULN (continued) and . One of the following: Patient has been treated with PCSK9 therapy or did not respond to PCSK9 therapy; or Physician attests that the patient is known to have two LDL-receptor negative alleles (little to no residual function) and therefore would not respond to PCSK9 therapy; or Patient has a history of intolerance or contraindication to PCSK9 therapy; or Patient has previously been treated with Juxtapid (lomitapide); or Patient has previously been treated with lipoprotein apheresis; or and o Patient will continue other traditional low-density lipoprotein-cholesterol (LDL-C) lowering therapies (e.g., maximally tolerated statins, ezetimibe) in combination with Evkeeza; and o Evkeeza will not be used in combination with Juxtapid (lomitapide); and o Evkeeza dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Initial authorization will be for no more than 6 months.
For continuation of therapy, all of the following: o Documentation of a positive clinical response to therapy from pre-treatment baseline; and o Patient continues treatment with other traditional low-density lipoprotein-cholesterol (LDL-C) lowering therapies (e.g., statin, ezetimibe) in combination with Evkeeza; and o Evkeeza will not be used in combination with Juxtapid (lomitapide); and o Evkeeza dosing is in accordance with the United States Food and Drug Administration approved labeling; and Reauthorization will be for no more than 12 months. o Updated Policy Title Effective Date Summary of Changes Alpha1-Proteinase May 1, 2021 Template Update Inhibitors Removed CMS section Coverage Rationale Removed specific dosage requirements for Alpha1-proteinase inhibitor; refer to the applicable U.S. FDA approved labeling. Supporting Information Updated References section to reflect the most current information
Page 30 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Updated Policy Title Effective Date Summary of Changes Buprenorphine May 1, 2021 Template Update (Probuphine® & Removed CMS section Sublocade®) Coverage Rationale Removed specific dosage requirements for buprenorphine extended-release injection (e.g., Sublocade®); refer to the applicable US FDA approved labeling Supporting Information Updated References section to reflect the most current information Cimzia® (Certolizumab Jun. 1, 2021 Template Update Pegol) Removed CMS section Applicable Codes Added ICD-10 diagnosis codes M46.80, M46.81, M46.82, M46.83, M46.84, M46.85, M46.86, M46.87, M46.88, and M46.89 Supporting Information Updated References section to reflect the most current information Evenity® May 1, 2021 Template Update (Romosozumab-Aqqg) Removed CMS section Coverage Rationale Removed specific dosage requirements for Evenity; refer to the applicable U.S. FDA approved labeling Supporting Information Updated References section to reflect the most current information Krystexxa® May 1, 2021 Template Update (Pegloticase) Removed CMS section Coverage Rationale Removed specific dosage requirements for Krystexxa; refer to the applicable U.S. FDA approved labeling Supporting Information Updated Clinical Evidence and References section to reflect the most current information
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ketalar® (Ketamine) Jun. 1, 2021 Template Update This policy refers to the following ketamine products: and Spravato® Removed CMS section Ketalar (ketamine) (Esketamine) Coverage Rationale Spravato (esketamine)
Page 31 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ketalar® (Ketamine) Jun. 1, 2021 Revised medical necessity criteria Spravato (Esketamine) Nasal Spray ® and Spravato for the treatment of treatment- Spravato is proven for the treatment of treatment-resistant depression (TRD) (Esketamine) resistant depression (TRD); when all of the following criteria are met: (continued) replaced criterion requiring “submission of baseline scoring on Initial Therapy at least one of the [listed] clinical
assessments has been completed” Diagnosis for major depressive disorder (treatment-resistant) according to
with “submission of medical the current DSM (i.e., DSM-5), by a mental health professional; and
records (e.g., chart notes, Patient has not experienced a clinically meaningful improvement after laboratory values) documenting treatment with at least two different antidepressants of adequate dose, baseline scoring on at least one of duration (at least 6 weeks), and adherence in the current depressive episode (must document medications, doses, and durations); and the [listed] clinical assessments Patient is to receive Spravato therapy in conjunction with another oral has been completed” antidepressant; and Supporting Information Provider and/or the provider’s healthcare setting is certified in the Spravato Updated Clinical Evidence and REMS program; and References sections to reflect the Spravato dosing is in accordance with the United States Food and Drug most current information Administration approved labeling; and Initial authorization will be for no longer than 12 weeks.
Continuation of Therapy Patient has previously been treated with Spravato; and Documentation demonstrating a positive clinical response from baseline (e.g., improved Montgomery-Asberg Depression Rating Scale [MADRS], clinical remission, response, etc.), as defined by the provider; and
Patient is to receive Spravato therapy in conjunction with another oral
antidepressant; and
Provider and/or the provider’s healthcare setting is certified in the Spravato
REMS program; and Spravato dosing is in accordance with the United States Food and Drug Administration approved labeling; and Authorization will be for no longer than 6 months.
Page 32 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ketalar® (Ketamine) Jun. 1, 2021 Spravato is medically necessary for the treatment of treatment-resistant and Spravato® depression (TRD) when all of the following criteria are met: (Esketamine) (continued) Initial Therapy Diagnosis of major depressive disorder (treatment-resistant), according to the current DSM (i.e., DSM-5), by a mental health professional; and Prescribed by or in consultation with a psychiatrist; and Submission of medical records (e.g., chart notes, laboratory values)
documenting baseline scoring (prior to starting Spravato) on at least one of
the following clinical assessments has been completed:
Baseline score on the 17-item Hamilton Rating Scale for Depression o (HAMD17)
o Baseline score on the 16-item Quick Inventory of Depressive Symptomatology (QIDS-C16)
o Baseline score on the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) and Patient has not experienced a clinically meaningful improvement after
treatment with at least three different antidepressants or treatment regimens
of adequate dose (maximally tolerated), duration (at least 8 weeks), and
adherence in the current depressive episode
o An antidepressant or treatment regimen would include any of the following classes or combinations (document medication, dose, and duration): . Selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline) . Serotonin norepinephrine reuptake inhibitors (e.g., duloxetine, venlafaxine, etc.)
. Bupropion
. Tricyclic antidepressants (e.g., amitriptyline, clomipramine,
nortriptyline, etc.)
. Mirtazapine
Page 33 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ketalar® (Ketamine) Jun. 1, 2021 . Monoamine oxidase inhibitors (e.g., selegiline, tranylcypromine, and Spravato® etc.) (Esketamine) . Serotonin modulators (e.g., nefazodone, trazodone, etc.) (continued) . Augmentation with lithium, Cytomel (liothyronine), antipsychotics, or anticonvulsants
and
Spravato will be initiated at the same time the member starts a new daily oral
antidepressant (one that has not previously been tried); and
Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and Spravato dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling; and Initial authorization will be for no longer than 12 weeks.
Continuation of Therapy Patient has previously been treated with Spravato; and Documentation of remission or a positive clinical response to Spravato; and Submission of medical records (e.g., chart notes, laboratory values)
documenting baseline and recent (within the last month) scoring on at least one of the following assessments demonstrating remission or clinical
response (e.g., score reduction from baseline) as defined by the:
o Hamilton Rating Scale for Depression (HAMD17; remission defined as a score of ≤7)
o Quick Inventory of Depressive Symptomatology (QIDS-C16; remission defined as a score of ≤5) o Montgomery-Asberg Depression Rating Scale (MADRS; remission defined as a score of ≤12)
and
Patient is to receive Spravato therapy in conjunction with an oral
antidepressant; and
Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and Prescribed by or in consultation with a psychiatrist; and
Page 34 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ketalar® (Ketamine) Jun. 1, 2021 Spravato dosing is in accordance with the United States FDA approved and Spravato® labeling, not to exceed 84 mg (3 devices) per week; and (Esketamine) Authorization will be for no longer than 6 months. (continued) Spravato is unproven and not medically necessary for the following: Anesthetic agent Chronic pain (including but not limited to nonmalignant pain, Fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy) Migraine headaches
Ketalar (Ketamine) Injection Ketamine injection is considered medically necessary and may be covered for the following: Anesthesia for diagnostic and surgical procedures that do not require skeletal muscle relaxation The induction of anesthesia prior to administration of other anesthesia agents As supplemental anesthesia for low-potency agents, such as nitrous oxide
Ketamine injection is investigational, and therefore not proven or medically necessary for the following: Psychiatric disorders (including, but not limited to depression, bipolar disorder, and posttraumatic stress disorder) Chronic pain (including, but not limited to nonmalignant pain, Fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy) Migraine headaches Ophthalmologic Jun. 1, 2021 Template Update This policy provides information about the use of certain specialty pharmacy Policy: Vascular Removed CMS section medications administered by the intravitreal route for ophthalmologic conditions. Endothelial Growth Supporting Information Factor (VEGF) Updated References section to This policy refers to the following drug products, all of which are vascular Inhibitors reflect the most current information endothelial growth factor (VEGF) inhibitors:
Page 35 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ophthalmologic Jun. 1, 2021 Avastin® (bevacizumab) Policy: Vascular Beovu® (brolucizumab-dbll) ® Endothelial Growth Eylea (aflibercept) ® Factor (VEGF) Lucentis (ranibizumab) Inhibitors Macugen® (pegaptanib)
(continued) Mvasi™ (bevacizumab-awwb) ™ Zirabev (bevacizumab-bvzr)
“Bevacizumab” will be used to refer to Avastin, Mvasi, and Zirabev.
Proven
Beovu (brolucizumab) is proven and medically necessary for the treatment
of:
Neovascular age-related macular degeneration (AMD)
Bevacizumab is proven and medically necessary for the treatment of: Choroidal neovascularization secondary to pathologic myopia, angioid
streaks/pseudoxanthoma elasticum, or ocular histoplasmosis syndrome
(OHS)
Diabetic macular edema (DME) Macular edema secondary to branch retinal vein occlusion (BRVO) or
central retinal vein occlusion (CRVO)
Neovascular age-related macular degeneration (AMD)
Neovascular glaucoma
Neovascularization of the iris (NVI) (rubeosis iridis)
Proliferative diabetic retinopathy Type I retinopathy of prematurity
Eylea (aflibercept) is proven and medically necessary for the treatment of:
Diabetic macular edema (DME) Diabetic retinopathy
Macular edema secondary to branch retinal vein occlusion (BRVO) or
central retinal vein occlusion (CRVO)
Page 36 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ophthalmologic Jun. 1, 2021 Neovascular age-related macular degeneration (AMD) Policy: Vascular Endothelial Growth Lucentis (ranibizumab) is proven and medically necessary for the treatment Factor (VEGF) of: Inhibitors Choroidal neovascularization secondary to pathologic myopia, angioid
(continued) streaks/pseudoxanthoma elasticum, or ocular histoplasmosis syndrome
(OHS)
Diabetic macular edema (DME) Diabetic retinopathy
Macular edema secondary to branch retinal vein occlusion (BRVO) or
central retinal vein occlusion (CRVO)
Neovascular age-related macular degeneration (AMD)
Macugen (pegaptanib) is proven and medically necessary for the treatment
of:
Diabetic macular edema
Neovascular age-related macular degeneration (AMD)
Additional Information
Avastin (bevacizumab) is supplied in sterile vials containing a solution of 25
mg/mL. Doses utilized in ophthalmic conditions generally range from 6.2 mcg to
2.5 mg. Therefore, bevacizumab in vials is often divided into single-dose,
prefilled syringes for intravitreal use by compounding pharmacies.
Compounding pharmacies must comply with United States Pharmacopeia (USP)
Chapter 797, which sets standards for the compounding, transportation, and storage of compounded sterile products (CSP). The Pharmacy Compounding
Accreditation Board can verify that the pharmacy is adhering to these standards.
The American Society of Retinal Specialists (ASRS) is committed to ensuring that retina specialists have access to compounded drugs (such as Avastin) that
are prepared with high-quality material following good quality controls and
sound engineering design by appropriately trained personnel. Refer to their
information page at https://www.asrs.org/advocacy-practice/access-to-safe-
Page 37 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ophthalmologic Jun. 1, 2021 compounded-agents for resources pertaining to access of safe compounded Policy: Vascular agents. Endothelial Growth Factor (VEGF) Refer to the US Food and Drug Administration (FDA) section of the policy for Inhibitors information related to contamination of compounded bevacizumab. In an effort (continued) to guard against contamination during the compounding process, the United States Veterans Health Administration (USVHA) requires that only USVHA pharmacies may dispense bevacizumab for intravitreal administration to Veterans Administration beneficiaries. The medication must be dispensed directly to the VA ophthalmologist, who will then be responsible for preparing and administering the bevacizumab dose for each patient. In addition to strict labeling and storage requirements, the ophthalmologist is required to prepare only one dose of medication from each vial; if both eyes are to be treated, a separate vial and syringe must be utilized. Simponi Aria® Jun. 1, 2021 Template Update Refer to the policy for complete details. (Golimumab) Injection Removed CMS section for Intravenous Coverage Rationale Infusion Removed specific dosage requirements for Simponi Aria; refer to the applicable U.S. FDA
approved labeling
Added language to indicate Simponi Aria is proven and
medically necessary for the treatment of polyarticular juvenile idiopathic arthritis when all of the [listed] criteria are met Applicable Codes Added ICD-10 diagnosis codes M08.00, M08.011, M08.012,
M08.019, M08.021, M08.022,
M08.029, M08.031, M08.032, M08.039, M08.041, M08.042,
Page 38 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Simponi Aria® Jun. 1, 2021 M08.049, M08.051, M08.052, (Golimumab) Injection M08.059, M08.061, M08.062, for Intravenous M08.069, M08.071, M08.072, Infusion M08.079, M08.08, M08.09, M08.0A, M08.20, M08.211, (continued) M08.212, M08.219, M08.221,
M08.222, M08.229, M08.231, M08.232, M08.239, M08.241,
M08.242, M08.249, M08.251,
M08.252, M08.259, M08.261, M08.262, M08.269, M08.271, M08.272, M08.279, M08.28, M08.29, M08.2A, M08.3, M08.80, M08.811, M08.812, M08.819,
M08.821, M08.822, M08.829,
M08.831, M08.832, M08.839, M08.841, M08.842, M08.849,
M08.851, M08.852, M08.859,
M08.861, M08.862, M08.869, M08.871, M08.872, M08.879, M08.88, M08.89, M08.90, M08.911, M08.912, M08.919, M08.921, M08.922, M08.929, M08.931, M08.932, M08.939, M08.941,
M08.942, M08.949, M08.951,
M08.952, M08.959, M08.961, M08.962, M08.969, M08.971,
M08.972, M08.979, M08.98, M08.99, and M08.9A Supporting Information Updated Clinical Evidence, FDA, and References sections to reflect the most current information
Page 39 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Vyepti™ (Eptinezumab- Jun. 1, 2021 Template Update Chronic Migraine Jjmr) Removed CMS section Vyepti is proven for the preventive treatment of chronic migraines when all of Coverage Rationale the following criteria are met: Removed reference link to the For initial therapy, all of the following: Medical Benefit Drug Policy titled o Diagnosis of chronic migraines with both of the following: Review at Launch for New to . Greater than or equal to 15 headache days per month Market Medications . Greater than or equal to 8 migraine days per month
Updated list of biologic CGRP and
antagonists or inhibitors the o Medication will not be used in combination with another biologic CGRP individual must not be using in antagonist or inhibitor (e.g., Aimovig, Emgality); and combination with Vyepti; removed o Dosing is in accordance with the United States Food and Drug Ajovy (fremanezumab), Nurtec ODT Administration (FDA) approved labeling; and (rimegepant), and Ubrelvy o Authorization will be issued for no more than 3 months (ubrogepant) Added language to clarify For continuation of therapy, all of the following: reauthorization will be issued for no Patient has experienced a positive response to therapy, demonstrated o more than 12 months by a reduction in headache frequency and/or intensity; and
Revised medical necessity criteria Medication will not be used in combination with another biologic CGRP o for the initial therapy for preventive antagonist or inhibitor (e.g., Aimovig, Emgality); and treatment of chronic migraines; o Dosing is in accordance with the FDA approved labeling; and replaced criterion requiring “trial o Reauthorization will be issued for no more than 12 months and failure (after a trial of at least three months), contraindication, or Vyepti is medically necessary for the preventive treatment of chronic intolerance to both of the following: migraines when all of the following criteria are met: Aimovig (erenumab) and Emgality For initial therapy, all of the following: (galcanezumab)” with “trial and Diagnosis of chronic migraines with both of the following: o failure (after a trial of at least three . Greater than or equal to 15 headache days per month
months), contraindication, or . Greater than or equal to 8 migraine days per month intolerance to one of the following: and Aimovig (erenumab), Emgality o Trial and failure (after a trial of at least two months) to two of the (galcanezumab), or Ajovy following, or contraindication or intolerance to all of the following (fremanezumab)” prophylactic therapies from the list below: . Amitriptyline (Elavil)
Page 40 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Vyepti™ (Eptinezumab- Jun. 1, 2021 . One of the following beta-blockers: atenolol, metoprolol, nadolol, Jjmr) propranolol, or timolol (continued) . Divalproex sodium (Depakote/Depakote ER) . OnabotulinumtoxinA (Botox) [trial of at least 2 quarterly injections (6 months)]
. Topiramate (Topamax)
. Venlafaxine (Effexor/Effexor XR) and
o Trial and failure (after a trial of at least three months), contraindication, or intolerance to one of the following: . Aimovig (erenumab) . Emgality (galcanezumab) . Ajovy (fremanezumab) and
Medication will not be used in combination with another biologic CGRP o antagonist or inhibitor (e.g., Aimovig, Emgality); and
o Dosing is in accordance with the FDA approved labeling; and
o Authorization will be issued for no more than 3 months
For continuation of therapy, all of the following: o Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and o Medication will not be used in combination with another biologic CGRP antagonist or inhibitor (e.g., Aimovig, Emgality); and
Dosing is in accordance with the FDA approved labeling; and o o Reauthorization will be issued for no more than 12 months
Episodic Migraine
Vyepti is proven for the preventive treatment of episodic migraines when all of the following criteria are met: For initial therapy, all of the following:
o Diagnosis of episodic migraines with both of the following: . Less than 15 headache days per month
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Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Vyepti™ (Eptinezumab- Jun. 1, 2021 . Patient has 4 to 14 migraine days per month Jjmr) and (continued) o Medication will not be used in combination with another biologic CGRP antagonist or inhibitor (e.g., Aimovig, Emgality); and Dosing is in accordance with the FDA approved labeling; and o Authorization will be issued for no more than 3 months o
For continuation of therapy, all of the following:
o Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and o Medication will not be used in combination with another biologic CGRP antagonist or inhibitor (e.g., Aimovig, Emgality); and o Dosing is in accordance with the FDA approved labeling; and Reauthorization will be issued for no more than 12 months o
Vyepti is medically necessary for the preventive treatment of episodic
migraines when all of the following criteria are met: For initial therapy, all of the following:
o Diagnosis of episodic migraines with both of the following: . Less than 15 headache days per month . Patient has 4 to 14 migraine days per month and o Trial and failure (after a trial of at least two months) to two of the following, or contraindication or intolerance to all of the following
prophylactic therapies from the list below:
. Amitriptyline (Elavil)
. One of the following beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol . Divalproex sodium (Depakote/Depakote ER) . Topiramate (Topamax) . Venlafaxine (Effexor/Effexor XR) and
Page 42 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale ™ Vyepti (Eptinezumab- Jun. 1, 2021 o Trial and failure (after a trial of at least three months), contraindication, Jjmr) or intolerance to both of the following: (continued) . Aimovig (erenumab) . Emgality (galcanezumab) and o Medication will not be used in combination with another biologic CGRP antagonist or inhibitor (e.g., Aimovig, Emgality); and o Dosing is in accordance with the FDA approved labeling; and o Authorization will be issued for no more than 3 months
For continuation of therapy, all of the following: o Patient has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity; and o Medication will not be used in combination with another biologic CGRP antagonist or inhibitor (e.g., Aimovig, Emgality); and o Dosing is in accordance with the FDA approved labeling; and o Reauthorization will be issued for no more than 12 months
Vyepti is unproven and not medically necessary for: Acute attack of migraine Episodic cluster headache Zilretta® Jun. 1, 2021 Template Update Zilretta is proven and medically necessary for the treatment of Osteoarthritis (Triamcinolone Removed CMS section pain of the knee when all of the following criteria are met: Acetonide Extended Coverage Rationale Diagnosis of osteoarthritis pain of the knee; and Documentation that the member has not responded adequately to Release) Revised coverage criteria; replaced conservative non-pharmacological therapy (such as physical therapy) for at criterion requiring “documentation that the member has not least 12 weeks; and Documentation that the member has not adequately responded to, or is responded adequately to unable to tolerate, or has contraindications to at least a 12 week trial of conservative non-pharmacological therapy (e.g., strengthening, topical or oral non-steroidal anti-inflammatory drugs (NSAIDs); and
cardiovascular, balance training, One of the following:
neuromuscular exercise, Tai Chi, o Documentation of treatment failure or inadequate response to at least Yoga, dietary weight two of the following intra-articular corticosteroid injections for the knee:
Page 43 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zilretta® Jun. 1, 2021 management)” with . Triamcinolone Acetonide Injection Suspension (Triamcinolone “documentation that the member . Methylprednisolone Acetate Injection Suspension Acetonide Extended has not responded adequately to . Betamethasone Acetate-Betamethasone Sodium Phosphate Release) conservative non-pharmacological Injection Suspension (continued) therapy (such as physical therapy) . Dexamethasone Sodium Phosphate Injection for at least 12 weeks” or o Both of the following: . History of intolerance, contraindication, or severe adverse event, to at least two of the following intra-articular corticosteroid injections for the knee Triamcinolone Acetonide Injection Suspension Methylprednisolone Acetate Injection Suspension Betamethasone Acetate-Betamethasone Sodium Phosphate Injection Suspension Dexamethasone Sodium Phosphate Injection and . Physician attests that in their clinical opinion, the same intolerance, contraindication, or severe adverse event would not be expected to occur with Zilretta than experienced with the other products; and Member is 18 years of age or older; and Member has not previously been treated with Zilretta; and Dose does not exceed 32 mg as a single intra-articular injection to the knee; and Authorization is for no more than 30 days Zolgensma® Jun. 1, 2021 Template Update Zolgensma is proven and medically necessary for one treatment per lifetime (Onasemnogene Removed CMS section for the treatment of spinal muscular atrophy (SMA) in patients who meet all Abeparvovec-Xioi) Coverage Rationale of the following criteria: 1. Submission of medical records (e.g., chart notes, laboratory values) Revised list of Additional confirming the mutation or deletion of genes in chromosome 5q resulting in Information Relevant to the Review Process but Not Impacting the one of the following:
Determination of Medical Necessity a. Homozygous gene deletion or mutation of SMN1 gene (e.g.,
Removed/replaced: homozygous deletion of exon 7 at locus 5q13); or o
Page 44 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jun. 1, 2021 . Physician attests that the b. Compound heterozygous mutation of SMN1 gene (e.g., deletion of (Onasemnogene patient will be assessed via SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2]) Abeparvovec-Xioi) an age appropriate and (continued) validated exam scale 2. One of the following: within two weeks of a. Diagnosis of symptomatic SMA by a neurologist with expertise in the
Zolgensma administration diagnosis of SMA; or
to establish a baseline b. Both of the following:
functional assessment (1) Diagnosis of SMA based on the results of SMA newborn screening;
o Added: and . Physician attests that the (2) Submission of medical records (e.g., chart notes, laboratory values) patient will be assessed via confirming that patient has 4 copies or less of SMN2 gene the CHOP INTEND scale to and establish a baseline 3. For use in a neonatal patient born prematurely, the full-term gestational age functional assessment has been reached; and
within the following 4. One of the following:
timelines: a. Both of the following:
For patients greater (1) Patient is less than or equal to 6 months of age
than 2 months of age (2) Patient does not have advanced SMA at baseline (e.g., complete at the time of paralysis of limbs) Zolgensma or administration, a b. All of the following: baseline CHOP (1) Patient is greater than 6 months of age, but less than 2 years of age; INTEND score will be and assessed within the 2 (2) One of the following:
weeks prior to A. Both of the following:
Zolgensma i. Patient has previously received SMN modifying therapy
administration [e.g., Spinraza (nusinersen), Evrysdi (risdiplam)] for the
For patients less than treatment of SMA before 6 months of age with positive or equal to 2 months clinical response; and of age at the time of ii. Submission of medical records (e.g., chart notes, Zolgensma laboratory values) confirming patient does not have administration, a advanced SMA as defined by the fact that the patient has baseline CHOP not shown evidence of clinical decline while receiving SMN
Page 45 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jun. 1, 2021 INTEND score will be modifying therapy [e.g., Spinraza (nusinersen, Evrysdi (Onasemnogene assessed within the 2 (risdiplam)] Abeparvovec-Xioi) weeks prior to or the or (continued) 2 weeks following B. Both of the following: Zolgensma i. Patient has previously received SMN modifying therapy
administration [e.g., Spinraza (nusinersen), Evrysdi (risdiplam)] for the treatment of later-onset SMA before 2 years of age with
positive clinical response; and
ii. Submission of medical records (e.g., chart notes, laboratory values) 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)]
or
C. Patient has recently been diagnosed with symptomatic later-
onset SMA within the previous 6 months
and 5. Patient is not dependent on either of the following: a. Invasive ventilation or tracheostomy b. Use of non-invasive ventilation beyond use for naps and nighttime sleep and 6. Zolgensma is prescribed by a neurologist with expertise in the treatment of SMA; and
7. Patient is not to receive routine concomitant SMN modifying therapy [e.g., Spinraza (nusinersen), Evrysdi (risdiplam)] (patient’s medical record will be
reviewed and any current authorizations for SMN modifying therapy will be terminated upon Zolgensma approval); and 8. Patient does not have an elevated anti-AAV9 antibody titer above 1:50*; and 9. Patient is less than 13.5 kg; and 10. Patient will receive prophylactic prednisolone (or glucocorticoid equivalent) prior to and following receipt of Zolgensma in accordance with the U.S. Food and Drug Administration (FDA) approved Zolgensma labeling; and
Page 46 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jun. 1, 2021 11. Patient will receive Zolgensma intravenously in accordance with the FDA (Onasemnogene approved labeling, 1.1 x 1014 vector genomes (vg) per kg of body weight; Abeparvovec-Xioi) and (continued) 12. Patient has never received Zolgensma treatment in their lifetime; and 13. Authorization will be for no longer than 14 days from approval or until 2
years of age, whichever is first
Additional Information Relevant to the Review Process but Not
Impacting the Determination of Medical Necessity
1. Physician attests that the patient, while under the care of the physician, will
be assessed by one of the following exam scales during subsequent office
visits
a. Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) scale during subsequent office visits while the patient is 2 to 3 years of age or younger; or b. Hammersmith Functional Motor Scale Expanded (HFMSE) during subsequent office visits while the patient is 2 to 3 years of age or older; and 2. Physician attests that the patient will be assessed via the CHOP INTEND
scale to establish a baseline functional assessment within the following timelines*†:
a. For patients greater than 2 months of age at the time of Zolgensma administration, a baseline CHOP INTEND score will be assessed within the 2 weeks prior to Zolgensma administration; or b. For patients less than or equal to 2 months of age at the time of Zolgensma administration, a baseline CHOP INTEND score will be assessed within the 2 weeks prior to, or the 2 weeks following Zolgensma administration;
and
3. 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,
Page 47 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Medical Benefit Drug Policy Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jun. 1, 2021 serial CHOP INTEND or HFMSE assessments while the patient is under the (Onasemnogene care of the physician*† Abeparvovec-Xioi) (continued) *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.
†For quality purposes only, this information will not be considered as part of the individual coverage decision.
Zolgensma is not proven or medically necessary for: • The treatment of pre-symptomatic patients diagnosed by newborn screening who have more than 4 copies of the SMN2 gene; or • The treatment of symptomatic later-onset SMA older than 2 years of age; or • SMA without chromosome 5q mutations or deletions; or • The routine combination treatment of SMA with concomitant SMN modifying therapy
Page 48 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Coverage Determination Guideline Updates
Updated Policy Title Effective Date Summary of Changes Clinical Trials May 1, 2021 Definitions Updated definition of “Clinical Trials/Studies Involving Investigational New Drugs” Supporting Information Updated References section to reflect the most current information
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Pectus Deformity May 1, 2021 Coverage Rationale Indications for Coverage Repair Added coverage criteria for Surgical repair of Pectus Excavatum is considered reconstructive and surgical repair of Pectus medically necessary when the following criteria has been met: Excavatum requiring: Imaging studies confirm Haller Index greater than 3.25; and Imaging studies confirm Haller o A Functional Impairment defined in physician office notes; and Index greater than 3.25; and o For restrictive lung capacity the total lung capacity is documented in the A Functional Impairment physician office notes as <80% of the predicted value; or o defined in physician office There is cardiac compromise as demonstrated by decreased cardiac o notes: output on the echocardiogram; or . For restrictive lung o There is objective evidence of exercise intolerance as documented by capacity the total lung cardiopulmonary exercise testing that is below the predicted values capacity is documented in the physician office notes Surgical repair of Pectus Carinatum may be considered reconstructive and as < 80% of the predicted medically necessary. Requests for coverage of repair of Pectus Carinatum will value; or be reviewed by a UnitedHealthcare Medical Director on a case-by-case basis. . There is cardiac
compromise as Coverage Limitations and Exclusions demonstrated by UnitedHealthcare excludes Cosmetic Procedures from coverage including but decreased cardiac output not limited to the following: on the echocardiogram; or Procedures that correct an anatomical Congenital Anomaly without . There is objective improving or restoring physiologic function are considered Cosmetic evidence of exercise Procedures. The fact that a Covered Person may suffer psychological intolerance as consequences or socially avoidant behavior as a result of an Injury, Sickness documented by
cardiopulmonary exercise or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a Reconstructive Procedure.
Page 49 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
Coverage Determination Guideline Updates
Revised Policy Title Effective Date Summary of Changes Coverage Rationale Pectus Deformity May 1, 2021 testing that is below the Procedures that do not meet the reconstructive criteria in the Indications for Repair predicted values Coverage section. (continued) Removed reference link to InterQual® Client Defined 2020, CP: Documentation Requirements Procedures, Pectus Deformity Benefit coverage for health services is determined by the member specific Repair (Custom) - UHG for medical benefit plan document and applicable laws that may require coverage for a necessity clinical coverage criteria specific service. The documentation requirements outlined below are used to assess whether the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested.
Pectus Excavatum Medical notes documenting all of the following: Results of imaging studies (CT scan confirming Haller Index greater than 3.25) Documentation of functional limitation/impairment Results of: o Pulmonary function test (confirming restrictive lung capacity) the total lung capacity is documented as <80% of the predicted value; or o One of the following: . An echocardiogram (Ejection Fraction) confirming by decreased cardiac output . Stress test demonstrating cardiopulmonary function that is below the predicted values Physician treatment plan
Pectus Carinatum Medical notes documenting all of the following: Documentation of functional limitation/impairment Physician treatment plan
Page 50 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021
General Information
The inclusion of a health service (e.g., test, drug, device or procedure) in this Policy Update Classifications bulletin indicates only that UnitedHealthcare is adopting a new policy and/or New updated, revised, replaced or retired an existing policy; it does not imply that UnitedHealthcare provides coverage for the health service. Note that most New clinical coverage criteria have been adopted for a health service (e.g., test, benefit plan documents exclude from benefit coverage health services identified drug, device or procedure) as investigational or unproven/not medically necessary. Physicians and other health care professionals may not seek or collect payment from a member for Updated services not covered by the applicable benefit plan unless first obtaining the An existing policy has been reviewed and changes have not been made to the member’s written consent, acknowledging that the service is not covered by the clinical coverage criteria; however, items such as the clinical evidence, FDA benefit plan and that they will be billed directly for the service. information, and/or list(s) of applicable codes may have been updated
Note: The absence of a policy does not automatically indicate or imply coverage. Revised As always, coverage for a health service must be determined in accordance with An existing policy has been reviewed and revisions have been made to the the member’s benefit plan and any applicable federal or state regulatory clinical coverage criteria requirements. Additionally, UnitedHealthcare reserves the right to review the clinical evidence supporting the safety and effectiveness of a medical Replaced technology prior to rendering a coverage determination. An existing policy has been replaced with a new or different policy UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to Retired support you and your patients in making the most informed decisions regarding The health service(s) addressed in the policy are no longer being managed or the choice of quality and cost-effective care, and to support practice staff with a are considered to be proven/medically necessary and are therefore not simple and predictable administrative experience. The Medical Policy Update excluded as unproven/not medically necessary services, unless coverage Bulletin was developed to share important information regarding guidelines or criteria are otherwise documented in another policy UnitedHealthcare Value & Balance Exchange Medical Policy, Medical Benefit Drug Policy, Coverage Determination Guideline, and Utilization Review Guideline updates. When information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law.
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 51 of 51 UnitedHealthcare Value & Balance Exchange Medical Policy Update Bulletin: May 2021