UnitedHealthcare Oxford

Policy Update Bulletin: June 2021

In This Issue

Clinical Policy Updates Page New • Long-Acting Injectable Antiretroviral Agents for HIV – Effective Jun. 1, 2021 ...... 5 • Surgery of the Foot – Effective Jul. 1, 2021 ...... 6 Updated • Breast Reconstruction Post Mastectomy and Poland Syndrome – Effective Jul. 1, 2021 ...... 6 • Cosmetic and Reconstructive Procedures – Effective Jul. 1, 2021 ...... 6 • Gastrointestinal Motility Disorders, Diagnosis and Treatment – Effective Jul. 1, 2021 ...... 6 • Rhinoplasty and Other Nasal Surgeries – Effective Jun. 1, 2021 ...... 7 • Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins – Effective Jun. 1, 2021 ...... 7 Revised • Cochlear Implants – Effective Jul. 1, 2021...... 7 • Complement Inhibitors (Soliris® & Ultomiris®) – Effective Jul. 1, 2021 ...... 8 • Drug Coverage Criteria: New and Therapeutic Equivalent Medications – Effective Jul. 1, 2021 ...... 9 • Drug Coverage Guidelines – Effective Jun. 1, 2021 ...... 9 o Cabenuva (Cabotegravir; Rilpivirine) ...... 9 • Drug Coverage Guidelines – Effective Jul. 1, 2021 ...... 10 o Actemra (Tocilizumab): Sq Injection ...... 10 o Aklief 0.005% Cream (Trifarotene) ...... 10 o Altreno (Tretinoin) ...... 10 o Amondys 45™ (Casimersen) ...... 10 o Amzeeq (Minocycline 4% Topical Foam) ...... 10 o Arazlo (Tazarotene) ...... 10 o Atralin (Tretinoin) (Brand and Generic) ...... 10 o Berinert (C1 Esterase Inhibitor Human) ...... 10 o Bronchitol (Mannitol) ...... 10 Page 1 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

In This Issue

o Cablivi (Caplacizumab-Yhdp) ...... 11 o Cataflam (Diclofenac Potassium Immediate-Release) ...... 11 o Digital Applications: Endeavorrx, Reset, Reset-O, Somrys ...... 11 o Elepsia XR (Levetiracetam Extended-Release) ...... 11 o Entresto (Valsartan – Sacubitril) ...... 11 o Fasenra Pen (Benralizumab) ...... 11 o Firazyr (Icatibant) ...... 11 o Fotivda (Tivozanib) ...... 12 o Gemtesa (Vibegron) ...... 12 o Hetlioz LQ (Tasimelteon)...... 12 o Inrebic (Fedratinib) ...... 12 o Jublia (Efinaconazole) ...... 12 o Kerydin (Tavaborole) ...... 12 o Kisqali (Ribociclib) ...... 12 o Lonsurf (Trifluridine/Tipiracil) ...... 12 o Nextstellis (Estetrol/Drospirenone) ...... 12 o Northera (Droxidopa) ...... 12 o Oxlumo (Lumasiran) ...... 13 o Ponvory (Ponesimod) ...... 13 o Prudoxin (Doxepin) ...... 13 o Quelbree (Viloxazine Extended-Release) ...... 13 o Reltone (Ursodiol) ...... 13 o Retin-A Micro (Tretinoin Microspheres) ...... 13 o Roszet (Rosuvastatin and Ezetimibe) ...... 14 o Ruconest (C1 Esterase Inhibitor [Recombinant]) ...... 14 o Slynd (Drospirenone) ...... 14 Spravato (Esketamine) ...... 14 o o Tepmetko (Tepotinib) ...... 14 o Ukoniq (Umbralisib) ...... 14 o Venclexta (Venetoclax) ...... 14 o Vocabria (Cabotegravir) ...... 14 o Weight Loss ...... 15 o Xifaxan (Rifaximin) ...... 15 o Xiidra (Lifitegrast 5% Ophthalmic Solution) ...... 15 o Zegalogue (Dasiglucagon)...... 15 o Zonalon (Doxepin) ...... 15

Page 2 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

In This Issue

• Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation – Effective Aug. 1, 2021 ...... 15 • Electroencephalographic (EEG) Monitoring and Video Recording – Effective Jul. 1, 2021 ...... 17 • Genetic Testing for Cardiac Disease – Effective Jul. 1, 2021 ...... 18 • Glaucoma Surgical Treatments – Effective Aug. 1, 2021 ...... 19 • Implantable Beta Emitting Microspheres for Treatment of Malignant Tumors – Effective Aug. 1, 2021 ...... 21 • Implanted Electrical Stimulator for Spinal Cord – Effective Jul. 1, 2021 ...... 22 • Infertility Diagnosis and Treatment – Effective Jul. 1, 2021 ...... 22 • Lower Extremity Invasive Diagnostic and Endovascular Procedures – Effective Jul. 1, 2021 ...... 24 • Macular Degeneration Treatment Procedures – Effective Jul. 1, 2021 ...... 27 • Obstructive Sleep Apnea Treatment – Effective Jul. 1, 2021 ...... 27 • Office Based Procedures – Site of Service – Effective Aug. 1, 2021 ...... 29 • Outpatient Surgical Procedures – Site of Service – Effective Aug. 1, 2021 ...... 30 • Preventive Care Services – Effective Jul. 1, 2021 ...... 32 • Spinraza® (Nusinersen) – Effective Jul. 1, 2021 ...... 35 • Surgery of the Elbow – Effective Jul. 1, 2021 ...... 39 • Surgery of the Knee – Effective Jul. 1, 2021 ...... 40 • Zolgensma® (Onasemnogene Abeparvovec-Xioi) – Effective Jul. 1, 2021 ...... 42 Administrative Policy Updates Revised • Ambulance Services – Effective Aug. 1, 2021 ...... 48 Reimbursement Policy Updates New • Outpatient Hospital Inappropriate Primary Diagnosis (CES) – Effective Jun. 1, 2021 ...... 53 Updated • Increased Procedural Services – Effective Jun. 1, 2021 ...... 55 • Increased Procedural Services (CES) – Effective Jun. 1, 2021 ...... 56 Revised • B Bundle Codes – Effective Jul. 1, 2021 ...... 56 • B Bundle Codes (CES) – Effective Jul. 1, 2021 ...... 56 • Injection and Infusion Services – Effective Jul. 1, 2021 ...... 57

Page 3 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

In This Issue

• Injection and Infusion Services (CES) – Effective Jul. 1, 2021 ...... 59 • Modifier Reference – Effective Jul. 1, 2021 ...... 61 • Modifier Reference (CES) – Effective Jul. 1, 2021 ...... 63 • Obstetrical Policy – Effective Jul. 1, 2021 ...... 65 • Professional/Technical Component (CES) – Effective Jul. 1, 2021 ...... 65 • Prolonged Services – Effective Jul. 1, 2021 ...... 66

Page 4 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

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

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

Cabenuva (cabotegravir/rilpivirine)

Cabenuva (cabotegravir/rilpivirine) is proven for the treatment of a human immunodeficiency virus type-1 (HIV-1) in patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL). Cabenuva is medically necessary when the following additional criteria are met: For initial therapy, all of the following: o Diagnosis of HIV-1 infection; and Patient has no prior virologic failures or baseline resistance to either cabotegravir or rilpivirine; and o Patient is currently on a stable antiretroviral regimen; and o Submission of medical records (e.g., chart notes, laboratory results) showing viral suppression (HIV-1 RNA less o than 50 copies per mL) for at least 6 months prior to initiation of Cabenuva; and

o Provider attests that patient demonstrates treatment readiness by both of the following: . Patient understands the risks of missed doses of Cabenuva . Patient has the ability to adhere to the required monthly injection appointments; and o Provider confirms that tolerability will be assessed using a 28-day oral lead-in of Vocabria (cabotegravir) and Edurant® (rilpivirine) tablets prior to the first injection of Cabenuva; and

Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Initial authorization is for no more than 12 months. o For continuation therapy, all of the following:

o Patient has previously received treatment with Cabenuva; and

o Physician confirms that the patient has achieved and maintained viral suppression (HIV-1 RNA less than 50 copies per mL) while on Cabenuva therapy; and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Authorization is for no more than 12 months.

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

Page 5 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

New Policy Title Effective Date Coverage Rationale Long-Acting Injectable Jun. 1, 2021 Human immunodeficiency virus type-1 (HIV-1) in patients who are not currently virally suppressed (HIV-1 RNA less than Antiretroviral Agents 50 copies per mL) for HIV (continued) Surgery of the Foot Jul. 1, 2021 Surgery of the foot is proven and medically necessary in certain circumstances. For medical necessity clinical coverage criteria, refer to the InterQual® 2021, Apr. 2021 Release, CP: Procedures: Exostectomy, First Metatarsophalangeal (MTP) Joint (Bunionectomy) Osteotomy, Distal Transpositional, First Metatarsal (MT) (Bunionectomy) Plantar Fascial Release Arthrodesis or Arthroplasty, Interphalangeal Joint, Second-Fifth Toes Osteotomy, Proximal, First Metatarsal (MT) (Bunionectomy)

Click here to view the InterQual® criteria

Updated Policy Title Effective Date Summary of Changes Breast Reconstruction Jul. 1, 2021 Applicable Codes Post Mastectomy and Added CPT codes 15771 and 15772 Poland Syndrome Cosmetic and Jul. 1, 2021 Applicable Codes Reconstructive Replaced language indicating “CPT codes 15769, 15771, and 15772 are considered cosmetic; the codes do not Procedures improve a functional, physical, or physiological impairment” with “CPT codes 15769, 15771, and 15772 may be cosmetic; review is required to determine if considered cosmetic or reconstructive” Gastrointestinal Jul. 1, 2021 Prior Authorization Motility Disorders, Revised list of CPT codes requiring prior authorization for all sites of service: Diagnosis and o Added 72195, 72196, and 72197 Treatment o Removed 76498 Applicable Codes Added CPT codes 72195, 72196, and 72197 Removed CPT code 76498 Supporting Information Updated Clinical Evidence and References sections to reflect the most current information

Page 6 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Updated Policy Title Effective Date Summary of Changes Rhinoplasty and Other Jun. 1, 2021 Coverage Rationale Nasal Surgeries Added language to clarify Rhinophyma Excision (CPT Code 30120) is considered reconstructive and medically necessary when all of the [listed] criteria are present Surgical and Ablative Jun. 1, 2021 Documentation Requirements Procedures for Updated list of Required Clinical Information Venous Insufficiency and Varicose Veins

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

Sensorineural Hearing Loss in the o Diagnosis of bilateral prelingual or postlingual moderate-to-profound mid to high frequencies with Sensorineural Hearing Loss; and

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

sensitivity” auditory nerve and acoustic areas of the central nervous system

Added language to indicate the • Hybrid cochlear implantation for treating individuals who meet all of the cochlear implant’s external following criteria:

components (i.e., speech o Diagnosis of bilateral severe to profound or moderate sloping to processor, microphone, and profound Sensorineural Hearing Loss in the mid to high frequencies transmitter coil) are considered with residual low-frequency hearing sensitivity; and under the DME benefit, and the o Ability to follow or participate in a program of aural rehabilitation; and implantable components are

Page 7 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Cochlear Implants Jul. 1, 2021 considered under the medical- o Freedom from middle ear infection, an accessible cochlear lumen that is (continued) surgical benefit structurally suited to implantation, and freedom from lesions in the o The member specific benefit auditory nerve and acoustic areas of the central nervous system plan document must be referenced to determine if Hybrid and non-hybrid cochlear implantation are unproven and not medically there are DME benefits for necessary for treating the following due to insufficient evidence of efficacy: repair or replacement of • Single sided deafness or unilateral Sensorineural Hearing Loss external components • All other conditions that do not meet the above criteria o Refer to the Coverage Determination Guideline titled Note: The Cochlear implant’s external components (i.e., speech processor, Durable Medical Equipment, microphone, and transmitter coil) are considered under the DME benefit, and Orthotics, Ostomy Supplies, the implantable components are considered under the medical-surgical benefit. Medical Supplies and The member specific benefit plan document must be referenced to determine if Repairs/Replacements there are DME benefits for repair or replacement of external components. Refer Supporting Information to the Administrative Policy titled Durable Medical Equipment, Orthotics, Medical Updated Clinical Evidence and Supplies and Repairs/ Replacements. References sections to reflect the most current information Complement Inhibitors Jul. 1, 2021 Applicable Codes Refer to the policy for complete details. (Soliris® & Ultomiris®) Maximum Allowed Quantities by National Drug Code (NDC) Units Revised list of applicable NDCs for Ultomiris; added: o 25682-0025-01 . How supplied: 300 mg/3

mL solution in vials

. Maximum allowed: 36 mL

o 25682-0028-01 . How supplied: 1,100 mg/11 mL solution in vials . Maximum allowed: 36 mL Supporting Information

Page 8 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Complement Inhibitors Jul. 1, 2021 Updated References section to (Soliris® & Ultomiris®) reflect the most current information (continued) Drug Coverage Jul. 1, 2021 Coverage Rationale Refer to the policy for complete details. Criteria: New and Revised list of medications Therapeutic requiring prior authorization Equivalent through the pharmacy benefit Medications manager (PBM); added Bronchitol, Cataflam, Elepsia XR, Fotivda, Gemtesa, Hetlioz LQ, Nextstellis, Ponvory, Quelbree, Reltone, Roszet, Tepmetko, Ukoniq, Vocabria, and Zegalogue

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jun. 1, 2021 Updated reference link to reflect title change for Pharmacy Benefit/Prior Authorization Guidelines: New and Guidelines Therapeutic Equivalent Medications (no content changes) Cabenuva New Added language to indicate coverage is provided under the medical benefit (Cabotegravir; o Prior authorization is not required however it is strongly recommended Rilpivirine) o While no penalty will be imposed for failure to request a pre-service review, if one is not requested, a medical necessity review will be conducted post-service to determine coverage o It is the referring physician’s responsibility to provide medical documentation to demonstrate clinical necessity for the medication o Beginning Oct. 1, 2021, prior authorization will be required Added prior authorization guidelines; refer to the following policies for complete details: o Prior Authorization Guidelines: Long-Acting Injectable Antiretroviral Agents for HIV o Prior Authorization Guidelines: Review at Launch for New to Market Medications

Page 9 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jul. 1, 2021 Revised opioid overutilization guidelines; refer to Short-Acting Opioid Review Criteria for Opioid Naïve Members for Guidelines complete details Actemra (Tocilizumab): Revised Revised prior authorization/medical necessity guidelines; refer to Prior Sq Injection Authorization/Medical Necessity Guidelines: Actemra for complete details Aklief 0.005% Cream Revised Revised prior authorization/notification guidelines; refer to Prior (Trifarotene) Authorization/Notification Guidelines: Aklief for complete details Altreno (Tretinoin) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Altreno for complete details Amondys 45™ Revised Revised coverage guidelines to indicate: (Casimersen) o Prior authorization is required through Oxford’s Medical Management o The administration of Amondys 45 in a hospital outpatient facility (including any ambulatory infusion suite associated with the hospital) requires prior authorization with review by a Medical Director or their designee Added Prior Authorization/Notification Guidelines: Provider Administered Drugs – Site of Care; refer to the policy for complete details Removed Prior Authorization/Notification Guidelines: Review at Launch for New to Market Medications Amzeeq (Minocycline Updated Updated medication/drug name; replaced “(Minocycline Topical)” with 4% Topical Foam) “(Minocycline 4% Topical Foam)” Arazlo (Tazarotene) Revised • Updated list of applicable dosage forms; added “Topical” Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Arazlo for complete details Atralin (Tretinoin) Revised Updated medication/drug name; added “(Brand and Generic)” (Brand and Generic) Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Atralin (Tretinoin) for complete details Berinert (C1 Esterase Revised Revised prior authorization/medical necessity guidelines; refer to Prior Inhibitor Human) Authorization/Medical Necessity Guidelines: Berinert for complete details Bronchitol (Mannitol) Revised Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Page 10 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jul. 1, 2021 Cablivi (Caplacizumab- Revised Revised prior authorization/notification guidelines; refer to Prior Guidelines Yhdp) Authorization/Notification Guidelines: Cablivi for complete details (continued) Cataflam (Diclofenac New • Added language to indicate prior authorization is required through the Potassium Immediate- Pharmacy Benefit Manager (PBM) Release) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Digital Applications: New Added language to indicate prior authorization is required through the Endeavorrx, Reset, Pharmacy Benefit Manager (PBM) Reset-O, Somrys o This program is for prescription digital applications (computer-based treatment for cognitive behavioral therapy) including, but not limited to, EndeavorRx, reSET, reSET-O and Somryst o Digital Application devices are typically excluded from coverage Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Digital Applications: EndeavorRx, reSET, reSET-O, Somryst for complete details Elepsia XR New • Added language to indicate prior authorization is required through the (Levetiracetam Pharmacy Benefit Manager (PBM) Extended-Release) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Entresto (Valsartan – Revised Revised prior authorization/medical necessity guidelines; refer to Prior Sacubitril) Authorization/Medical Necessity Guidelines: Entresto (Valsartan-Sacubitril) for complete details Fasenra Pen Updated Updated prior authorization/medical necessity guidelines; refer to Prior (Benralizumab) Authorization/Medical Necessity Guidelines: Fasenra for complete details Firazyr (Icatibant) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Firazyr for complete details

Page 11 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jul. 1, 2021 Fotivda (Tivozanib) New • Added language to indicate prior authorization is required through the Guidelines Pharmacy Benefit Manager (PBM) (continued) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Gemtesa (Vibegron) New • Added language to indicate prior authorization is required through the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Hetlioz LQ New • Added language to indicate prior authorization is required through the (Tasimelteon) Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Inrebic (Fedratinib) Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Inrebic for complete details Jublia (Efinaconazole) Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Jublia for complete details Kerydin (Tavaborole) Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Kerydin for complete details Kisqali (Ribociclib) Revised Revised step therapy guidelines; refer to Step Therapy Guidelines: Kisqali for complete details Lonsurf (Trifluridine/ Updated Updated prior authorization/notification guidelines; refer to Prior Tipiracil) Authorization/Notification Guidelines: Lonsurf for complete details Nextstellis (Estetrol/ New • Added language to indicate prior authorization is required through the Drospirenone) Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Northera (Droxidopa) Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Northera for complete details

Page 12 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jul. 1, 2021 Oxlumo (Lumasiran) Revised Revised coverage guidelines to indicate: Guidelines o Prior authorization is required through Oxford’s Medical Management (continued) o The administration of Oxlumo (lumasiran) in a hospital outpatient facility (including any ambulatory infusion suite associated with the hospital) requires prior authorization with review by a Medical Director or their designee Added Prior Authorization/Notification Guidelines: Provider Administered Drugs – Site of Care; refer to the policy for complete details Removed Prior Authorization/Notification Guidelines: Review at Launch for New to Market Medications Ponvory (Ponesimod) New • Added language to indicate prior authorization is required through the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Prudoxin (Doxepin) Revised Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Prudoxin for complete details Removed prior authorization/notification guidelines and corresponding reference link to the policy titled Prior Authorization/Notification Guidelines: Prudoxin Quelbree (Viloxazine New • Added language to indicate prior authorization is required through the Extended-Release) Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Reltone (Ursodiol) New • Added language to indicate prior authorization is required through the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Retin-A Micro Updated Updated medication/drug name; added “Microspheres” (Tretinoin Microspheres)

Page 13 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jul. 1, 2021 Roszet (Rosuvastatin New • Added language to indicate prior authorization is required through the Guidelines and Ezetimibe) Pharmacy Benefit Manager (PBM) (continued) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Ruconest (C1 Esterase Revised Revised prior authorization/medical necessity guidelines; refer to Prior Inhibitor Authorization/Medical Necessity Guidelines: Ruconest for complete details [Recombinant]) Slynd (Drospirenone) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Slynd for complete details Spravato (Esketamine) Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Spravato for complete details Tepmetko (Tepotinib) New • Added language to indicate prior authorization is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tepmetko for complete details Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Ukoniq (Umbralisib) New • Added language to indicate prior authorization is required through the Pharmacy Benefit Manager (PBM) • Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Ukoniq for complete details Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Venclexta (Venetoclax) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Venclexta for complete details Vocabria New • Added language to indicate prior authorization is required through the (Cabotegravir) Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Page 14 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jul. 1, 2021 Weight Loss Revised Updated list of applicable versions/formulations requiring prior authorization Guidelines through the Pharmacy Benefit Manager (PBM); added “Imcivree (continued) (setmelanotide)” Revised prior authorization/regulatory guidelines; refer to Prior Authorization/Regulatory Guidelines: Weight Loss for complete details Xifaxan (Rifaximin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Xifaxan for complete details Xiidra (Lifitegrast 5% Updated Updated medication/drug name; added “5% Ophthalmic Solution” Ophthalmic Solution) Zegalogue New • Added language to indicate prior authorization is required through the (Dasiglucagon) Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Zonalon (Doxepin) Revised Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Zonalon for complete details Removed prior authorization/notification guidelines and corresponding reference link to the policy titled Prior Authorization/Notification Guidelines: Zonalon

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Electrical Stimulation Aug. 1, 2021 Related Policies Functional electrical stimulation (FES) is proven and medically necessary as a for the Treatment of • Added reference link to the Clinical component of a comprehensive rehabilitation program in members with lower Pain and Muscle Policy titled Occipital Neuralgia limb paralysis due to spinal cord injury (SCI) when all of the following criteria are met: Rehabilitation and Headache Treatment Demonstration of intact lower motor units (L1 and below) (both muscle and Coverage Rationale peripheral nerves); • Added language to indicate Muscle and joint stability for weight bearing at upper and lower extremities percutaneous peripheral nerve that can demonstrate balance and control to maintain an upright support stimulation (PNS) is unproven and posture independently; not medically necessary due to insufficient evidence of efficacy; for Demonstration of brisk muscle contraction; information regarding Demonstration of sensory perception sufficient for muscle contraction;

Page 15 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Electrical Stimulation Aug. 1, 2021 percutaneous peripheral nerve Demonstration of a high level of motivation, commitment and cognitive for the Treatment of stimulation for occipital neuralgia ability for device use; Pain and Muscle and headache, refer to the Clinical Ability to transfer independently; Rehabilitation Policy titled Occipital Neuralgia Demonstration of independent standing tolerance for at least 3 minutes; and Headache Treatment Demonstration of hand and finger function to manipulate controls; (continued) Post-recovery from SCI and restorative surgery of at least 6 months; Applicable Codes • Added CPT code 64555 Absence of hip and knee degenerative disease; Absence of history of long bone fracture secondary to osteoporosis Supporting Information

• Updated Description of Services, Neuromuscular electrical stimulation (NMES) is proven and medically Clinical Evidence, FDA, and necessary for treating the following indications: References sections to reflect the • Disuse muscle atrophy if: most current information The nerve supply to the muscle is intact; and o The disuse muscle atrophy is not of neurological origin but results from o other conditions including but not limited to casting, splinting or

contractures. • To improve wrist and finger function and prevent or correct shoulder

subluxation in persons with partial paralysis following stroke

The following are unproven and not medically necessary due to insufficient evidence of efficacy: Dorsal root ganglion (DRG) stimulation FES for treating any other indication not listed above Interferential therapy (IFT) for treating musculoskeletal disorders/injuries, or

to facilitate healing of nonsurgical soft tissue injuries or bone fractures

Microcurrent electrical nerve stimulation (MENS) NMES for treating any other indication not listed above

Percutaneous electrical nerve stimulation (PENS), percutaneous electrical

nerve field stimulation (PENFS) or percutaneous neuromodulation therapy (PNT) Percutaneous peripheral nerve stimulation (PNS)* Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS)

Page 16 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Electrical Stimulation Aug. 1, 2021 Pulsed electrical stimulation (PES) for the Treatment of Scrambler Therapy (ST) Pain and Muscle Rehabilitation *For information regarding percutaneous peripheral nerve stimulation for (continued) occipital neuralgia and headache, refer to the Clinical Policy titled Occipital Neuralgia and Headache Treatment. Electroencephalo- Jul. 1, 2021 Coverage Rationale Electroencephalographic (EEG) monitoring and video recording is proven graphic (EEG) Revised language pertaining to and medically necessary in certain circumstances. For medical necessity Monitoring and Video medical necessity clinical coverage clinical coverage criteria, refer to the InterQual® 2021, Apr. 2021 Release, CP: Recording criteria: Procedures: Video Electroencephalographic (EEG) Monitoring o Added reference to the InterQual® 2021, Apr. 2021 Video Electroencephalographic (EEG) Monitoring (Pediatric) Release, CP: Procedures: . Video Click here to view the InterQual® criteria. Electroencephalographic (EEG) Monitoring . Video Electroencephalographic (EEG) Monitoring (Pediatric) o Removed reference to the InterQual® Client Defined 2020, CP: Procedures: . Video Electroencephalographic (EEG) Monitoring (Custom) - UHG . Video Electroencephalographic (EEG) Monitoring (Pediatric) (Custom) - UHG

Page 17 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

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

medically necessary” with “Multi- Catecholaminergic polymorphic ventricular tachycardia (CPVT); or

Gene Panel testing in individuals Dilated cardiomyopathy (DCM), without an identifiable cause, when one of

with a confirmed or suspected the following criteria are met:

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

or

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

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

Short QT syndrome (SQTS)

Multi-Gene Panel testing in individuals with a confirmed or suspected diagnosis of heritable thoracic aortic disease is proven and medically necessary.

Multi-Gene Panel testing for the diagnosis of inherited arrhythmic disorders or cardiomyopathy is proven and medically necessary in asymptomatic

individuals with a close blood relative with one of the following conditions:

Page 18 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

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

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

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

glaucoma when medical or treatments have failed or are inappropriate

surgical treatments have failed iStent®, iStent inject®, and the Hydrus® Microstent when used in combination or are inappropriate” with with cataract surgery for treating mild to moderate open-angle glaucoma and “some glaucoma drainage a cataract in adults currently being treated with ocular hypotensive devices (specifically: EX- medication PRESS, Molteno Implant, Gonioscopy-assisted transluminal trabeculotomy for pediatric glaucoma (age Baerveldt Tube Shunt, Ahmed 18 years or less)

Page 19 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

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

or are inappropriate” not included above)

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

trabeculotomy” with

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

(e.g., OMNI® Surgical System)”

Applicable Codes

Added CPT/HCPCS codes 65820

and C1889

Supporting Information

Removed Documentation

Requirements section Updated Description of Services, Clinical Evidence, FDA, and

Page 20 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Glaucoma Surgical Aug. 1, 2021 References sections to reflect the Treatments most current information (continued) Implantable Beta Aug. 1, 2021 Related Policies Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is Emitting Microspheres Added reference link to the Clinical proven and medically necessary for the following: for Treatment of Policy titled Abnormal Uterine When used for the following indications: Unresectable metastatic liver tumors from primary colorectal cancer Malignant Tumors Bleeding and Uterine Fibroids Coverage Rationale (CRC); or Unresectable metastatic liver tumors from neuroendocrine tumors; or Added language to indicate Unresectable primary hepatocellular carcinoma (HCC); or transarterial radioembolization 90 Unresectable intrahepatic cholangiocarcinoma (TARE) using yttrium-90 ( Y) and microspheres is proven and medically necessary when the When the following criteria are met:

following criteria are met: Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2; and Eastern Cooperative Oncology o Malignancy is confined to the liver or with Limited Extra-Hepatic Disease; Group (ECOG) performance and status of 0,1, or 2; and Refractory to or relapsed following systemic chemotherapy Malignancy is confined to the o liver or with Limited Extra- Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is Hepatic Disease; and unproven and not medically necessary for all other indications due to o Refractory to or relapsed following systemic insufficient evidence of efficacy.

chemotherapy

Documentation Requirements

Added list of Required Clinical

Information

Definitions

Added definition of:

o Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status Limited Extra-Hepatic Disease o

Page 21 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Implantable Beta Aug. 1, 2021 o Refractory Emitting Microspheres Supporting Information for Treatment of Updated Clinical Evidence and Malignant Tumors References sections to reflect the (continued) most current information Implanted Electrical Jul. 1, 2021 Coverage Rationale Implanted electrical spinal cord stimulators, including high-frequency spinal Stimulator for Spinal • Replaced references to “implanted cord stimulators and burst spinal cord stimulators are proven and medically Cord electrical stimulators for spinal necessary for treating the following indications: cord” with “implanted electrical Complex regional pain syndrome (CRPS) spinal cord stimulators” Failed back surgery syndrome • Replaced language indicating “implanted electrical stimulators for For medical necessity clinical coverage criteria, refer to the InterQual® 2020, Apr. spinal cord, including high- 2020 Release, CP: Procedures, Spinal Cord Stimulator (SCS) Insertion. frequency dorsal column stimulators (also known as BurstDR Click here to view the InterQual® criteria. spinal cord stimulators), are proven and medically necessary for Implanted electrical spinal cord stimulators are unproven and not medically treating the [listed] indications” necessary for treating the following indications: with “implanted electrical spinal Diabetic Neuropathy cord stimulators, including high- Refractory angina pectoris frequency spinal cord stimulators and burst spinal cord stimulators, Notes: are proven and medically Coverage of a replacement battery/generator for a previously implanted necessary for treating the [listed] electrical stimulator is appropriate when the individual’s existing indications” battery/generator is malfunctioning, cannot be repaired, and is no longer under warranty. For Dorsal Root Ganglion (DRG) stimulation, refer to the Clinical Policy titled Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation. Infertility Diagnosis Jul. 1, 2021 Coverage Rationale For medical necessity reviews, refer to the Clinical Guideline titled Fertility and Treatment Revised list of proven and Solutions Medical Necessity Clinical Guideline: Infertility. medically necessary tests or The following tests or procedures are proven and medically necessary for procedures for diagnosing or diagnosing or treating Infertility:

Page 22 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Infertility Diagnosis Jul. 1, 2021 treating Infertility; removed Antisperm antibodies and Treatment “clomiphene citrate challenge test” Antral follicle count (continued) Supporting Information Cryopreservation of sperm, semen, or embryos for individuals who are Updated Clinical Evidence and undergoing treatment with assisted reproductive technologies or are planning to undergo therapies that threaten their reproductive health, such References sections to reflect the as cancer chemotherapy most current information Cryopreservation of mature oocytes (eggs) for women under the age of 42

who are undergoing treatment with assisted reproductive technologies or are planning to undergo therapies that threaten their reproductive health, such as cancer chemotherapy Genetic screening tests o Cystic fibrosis gene mutations o Karyotyping for chromosomal abnormalities Y-chromosome microdeletion testing o Hormone level tests:

Antimüllerian hormone (AMH) o o Estradiol

o Follicle-stimulating hormone (FSH)

o Luteinizing hormone (LH)

o Progesterone o Prolactin o Testosterone (total and free) o Thyroid-stimulating hormone (TSH) Hysterosalpingogram (HSG)

Diagnostic hysteroscopy

Diagnostic laparoscopy with or without chromotubation

Leukocyte count in semen Pelvic ultrasound (transabdominal or transvaginal) Post-ejaculatory urinalysis Scrotal, testicular or transrectal ultrasound Semen analysis Sonohysterogram or saline infusion ultrasound Testicular biopsy

Page 23 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Infertility Diagnosis Jul. 1, 2021 Vasography and Treatment (continued) Due to insufficient evidence of efficacy, the following are unproven and not medically necessary for diagnosing or treating Infertility: Co-culture of embryos Computer-assisted sperm analysis (CASA) Cryopreservation of immature oocytes (eggs), ovarian tissue, or testicular tissue EmbryoGlue® Hyaluronan binding assay (HBA) In vitro maturation (IVM) of oocytes Inhibin B Postcoital cervical mucus penetration test Reactive oxygen species (ROS) test Sperm acrosome reaction test Sperm DNA integrity/fragmentation tests (e.g., sperm chromatin structure assay (SCSA), single-cell gel electrophoresis assay (Comet), deoxynucleotidyl transferase-mediated dUTP nick end labeling assay (TUNEL), sperm chromatin dispersion (SCD) or Sperm DNA Decondensation™ Test (SDD)) Sperm penetration assays Uterine/endometrial receptivity testing Treatments to improve uterine/endometrial receptivity (e.g., immunotherapy, endometrial scratching, uterine artery vasodilation Lower Extremity Jul. 1, 2021 Coverage Rationale Note: This policy does not apply to upper extremities. Invasive Diagnostic Diagnosis and Endovascular Replaced language indicating: Diagnosis Procedures o “Lower extremity vascular Lower extremity vascular angiography is proven and medically necessary for angiography is proven and evaluating arterial disease, aneurysms, perivascular masses and trauma medically necessary for related injuries of the lower extremity under certain circumstances. evaluating arterial disease,

aneurysms, and trauma related injuries of the lower extremity”

Page 24 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Lower Extremity Jul. 1, 2021 with “lower extremity vascular Angiography for known chronic lower extremity arterial disease (peripheral Invasive Diagnostic angiography is proven and vascular disease, occlusion or stenosis of arteries of the leg, Claudication and and Endovascular medically necessary for limb ischemia) requires all of the following: Procedures evaluating arterial disease, Abnormal Ankle-Brachial Index (ABI) or an abnormal computed tomography aneurysms, perivascular angiography (CTA), magnetic resonance angiography (MRA) or duplex (continued) masses, and trauma related ultrasound; and

injuries of the lower extremity One of the following: under certain circumstances” Claudication – as evidenced with an ABI ≤ 0.90; or o “Angiography for known lower Limb Ischemia – as evidenced with an ABI < 0.40 o o extremity arterial disease (peripheral vascular disease, For additional medical necessity clinical coverage criteria, refer to the InterQual® occlusion or stenosis of 2021, April 2021 Release, CP: Imaging, Imaging, Peripheral Vascular for: arteries of the leg, claudication Angiogram, X-ray Extremity, Unilateral Angiogram, X-ray Extremity, Bilateral and limb ischemia) requires all of the [listed criteria]” with ® “angiography for known Click here to view the InterQual criteria.

chronic lower extremity arterial disease (peripheral vascular Treatment disease, occlusion or stenosis Endovascular revascularization procedures (e.g., stents, angioplasty and/or of arteries of the leg, atherectomy) for treating lower extremity ischemia are proven and medically

claudication and limb necessary in individuals who meet the following indication-specific criteria:

ischemia) requires all of the Claudication due to atherosclerotic disease of the aortoiliac and/or [listed criteria]” femoropopliteal arteries when all of the following criteria are met: Removed language indicating o Impaired ability to work and/or perform activities of daily living (ADL) angiography [is proven and o All of the following conservative therapies have been tried and failed: medically necessary] for trauma . At least twelve (12) weeks of a Supervised or Structured Exercise related injuries including, but not Program limited to, one of the following . Pharmacologic therapy findings: . Smoking cessation, if applicable

o Clinically significant hematoma Moderate to severe ischemic peripheral artery disease with Ankle- o o Knee dislocation (confirmed by Brachial Index (ABI) ≤ 0.69 x-ray) o Imaging results show anatomic location and severity of occlusion (stenosis ≥ 50%) (e.g., duplex ultrasound, CTA, MRA or invasive

Page 25 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Lower Extremity Jul. 1, 2021 o Need for localization of the angiography). If duplex ultrasound does not demonstrate a stenosis ≥ Invasive Diagnostic source of bleeding and 50%, another imaging modality will be necessary to demonstrate the and Endovascular vascular injury found on duplex extent of stenosis. Procedures ultrasound Chronic Limb-Threatening Ischemia (CLTI) when all of the following criteria (continued) Updated language pertaining to are met: additional medical necessity o One or more of the following: coverage criteria; replaced . Pain at rest reference to “InterQual® 2020” with . Nonhealing wound or ulcer due to ischemia “InterQual® 2021” . Gangrene Treatment o Moderate to severe ischemic peripheral artery disease and any of the Revised coverage criteria; added following: criterion requiring “if duplex . Ankle-Brachial Index (ABI) ≤ 0.69 or ultrasound does not demonstrate a . Ankle pressure < 50 mmHg or stenosis ≥ 50%, another imaging . Toe-Brachial Index ≤ 0.70 or modality will be necessary to . Toe pressure < 30 mmHg or demonstrate the extent of stenosis” . Transcutaneous Oxygen Pressure (TcPO2) < 25 mmHg Documentation Requirements o Imaging results show anatomic location and severity of occlusion (stenosis ≥ 50%) (e.g., duplex ultrasound, CTA, MRA] or invasive Updated list of Required Clinical angiography). If duplex ultrasound does not demonstrate a stenosis ≥ Information for lower extremity 50%, another imaging modality will be necessary to demonstrate the vascular angiography extent of stenosis. Definitions Updated definition of “Ankle- Due to insufficient evidence of efficacy, endovascular revascularization Brachial Index (ABI)” procedures (e.g., stents, angioplasty and/or atherectomy) for treating lower Supporting Information extremity ischemia are unproven and not medically necessary in the following Updated Description of Services, circumstances: Clinical Evidence, and References Claudication due to isolated infrapopliteal (e.g., anterior tibial, posterior tibial sections to reflect the most current or peroneal) artery disease information To prevent the progression of Claudication to critical limb ischemia Individual is asymptomatic Treatment of a nonviable limb

Page 26 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Macular Degeneration Jul. 1, 2021 Coverage Rationale The following is proven and medically necessary: Treatment Procedures Revised list of unproven and not • The Implantable Miniature Telescope (IMT) when used according to U.S. medically necessary indications; Food and Drug Administration (FDA) labeled indications, contraindications, replaced “epiretinal radiation warnings and precautions for treating individuals with end-stage, age-related therapy for treating ocular macular degeneration. disorders including age-related macular degeneration” with The following are unproven and not medically necessary due to insufficient “radiation therapy for age-related evidence of efficacy: macular degeneration (i.e., • Conjunctival incision with posterior extrascleral placement of a epimacular and/or epiretinal pharmacologic agent for treating ocular disorders including age-related brachytherapy and stereotactic macular degeneration. radiotherapy and/or radiosurgery)” • Laser photocoagulation for treating macular drusen. Supporting Information • Radiation therapy for age-related macular degeneration (i.e., epimacular Updated Description of Services, and/or epiretinal brachytherapy and stereotactic radiotherapy and/or Clinical Evidence, and References radiosurgery sections to reflect the most current information Obstructive Sleep Jul. 1, 2021 Coverage Rationale Nonsurgical Treatment Apnea Treatment Nonsurgical Treatment Removable Oral Appliances are proven and medically necessary for treating Revised language pertaining to Obstructive Sleep Apnea (OSA) as documented by a sleep study (e.g., medical necessity clinical coverage polysomnography or Home Sleep Apnea Testing). criteria for removable oral Refer to the Clinical Policy titled Attended Polysomnography for Evaluation of appliances: Sleep Disorders for further information. Added reference to the o InterQual® 2021, Apr. 2021 For many individuals, Oral Appliance therapy (OAT) may be an effective

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

Page 27 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Jul. 1, 2021 Appliances for Obstructive • If the patient refuses CPAP therapy, documentation of the refusal from the Apnea Treatment Sleep Apnea patient’s treating Physician (MD or DO) must be supplied. (continued) For information on snoring and Oral Appliances, see the Administrative Policy titled Durable Medical Equipment, Orthotics, Medical Supplies and Repairs/ Replacements.

For medical necessity clinical coverage criteria for removable oral appliances,

refer to the InterQual® 2021, Apr. 2021 Release, CP: Durable Medical Equipment

Noninvasive Airway Assistive Devices.

Click here to view the InterQual® criteria.

The following are unproven and not medically necessary due to insufficient evidence of efficacy: • Devices for treating Positional OSA

• Nasal dilator devices for treating Obstructive Sleep Apnea (OSA)

• Removable Oral Appliances for treating central sleep Apnea

• Prefabricated Oral Appliance/device

Surgical Treatment

The following surgical procedures are proven and medically necessary for treating Obstructive Sleep Apnea as documented by polysomnography. For medical necessity clinical coverage criteria, refer to the InterQual® Client Defined 2020, CP: Procedures: Mandibular Osteotomy (Custom) - UHG Maxillomandibular Osteotomy and Advancement (Custom) - UHG Uvulopalatopharyngoplasty (UPPP) (Custom) - UHG

Click here to view the InterQual® criteria.

Page 28 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Obstructive Sleep Jul. 1, 2021 Implantable hypoglossal nerve stimulation is proven and medically necessary Apnea Treatment in an adult patient with moderate to severe OSA when all of the following (continued) criteria are met: Body Mass Index of (BMI) less than or equal to 32kg/m2; and Apnea Hypopnea Index (AHI) of 15 or greater and less than or equal to 65 as determined with polysomnography; and Absence of complete concentric collapse at the soft palate level, and Failure or intolerance of Positive Airway Pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) o PAP failure is defined as an inability to eliminate OSA (AHI of greater than 20 despite PAP usage) and PAP intolerance is defined as: . Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or . Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it)

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) Office Based Aug. 1, 2021 Documentation Requirements Oxford members may choose to receive surgical procedures in an office setting Procedures – Site of Updated list of Required Clinical or other locations. We are conducting site of service medical necessity reviews, Service Information however, to determine whether the ambulatory surgical center (ASC) is medically necessary, in accordance with the terms of the member’s benefit plan. If the Prior Authorization Requirements ambulatory surgical center is not considered medically necessary, this location Added language to indicate: will not be covered under the member’s plan. o Prior authorization is required in all sites of service for CPT codes

20552 and 20553, except in an

Page 29 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Office Based Aug. 1, 2021 office setting when the services Certain elective procedures performed in an ambulatory surgical center are Procedures – Site of are unrelated to considered medically necessary for an individual who meets any of the Service temporomandibular joint following criteria: (continued) disorders • Allergy to local anesthetic o For CPT codes 20552 and • Bleeding disorder that would cause a significant risk of morbidity 20553, refer to the Clinical • Developmental stage or cognitive status warranting use of an ambulatory Policy titled Temporomandibular surgical center Joint Disorders for additional • Failed office-based procedure attempt due to body habitus, abnormal information anatomy, or technical difficulties o For CPT codes 64633 and • Presence of complications and comorbid disease that would cause office 64635, refer to the Clinical based procedure to be unsafe or unsuitable Policy titled Ablative Treatment for Spinal Pain for additional An elective surgical procedure performed in an ambulatory surgical center is information considered medically necessary if there is an inability to access an office Applicable Codes setting for the procedure due to the following: Revised list of CPT codes requiring • There is no geographically accessible office that has the necessary site of service medical necessity equipment for the procedure review; added 11404, 11420, 11421, • There is no geographically accessible in-network provider 11423, 11424, 20552, and 20553 Supporting Information Elective Procedures List Updated References section to Prior authorization is required for procedures listed in the Applicable Codes reflect the most current information section of the policy if not performed in an office setting. Outpatient Surgical Aug. 1, 2021 Coverage Rationale UnitedHealthcare® Oxford members may choose to receive surgical procedures Procedures – Site of Revised medically necessary in an ambulatory surgical center (ASC) or other locations. We are conducting site Service criteria for certain planned surgical of service medical necessity reviews, however, to determine whether the outpatient hospital department is medically necessary, in accordance with the procedures performed in a hospital outpatient department; replaced terms of the member’s benefit plan. If the outpatient hospital department is not

considered medically necessary, this location will not be covered under the criterion requiring “significant severe valvular heart disease” with member’s plan.

“severe valvular heart disease”

Documentation Requirements Certain planned surgical procedures performed in a hospital outpatient

Updated list of Required Clinical department are considered medically necessary for an individual who meets Information any of the following criteria:

Page 30 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Outpatient Surgical Aug. 1, 2021 Applicable Codes Advanced liver disease (MELD Score > 8) Procedures – Site of Revised list of CPT codes requiring Advance surgical planning determines an individual requires overnight Service site of service medical necessity recovery and care following a surgical procedure (continued) review: Anticipated need for transfusion Bleeding disorder requiring replacement factor or blood products or special o Added 19020, 23120, 23440, infusion products to correct a coagulation defect 24341, 24342, 24343, 25115, Brittle Diabetes 26350, 27606, 27659, 27680, Cardiac arrhythmia (symptomatic arrhythmia despite medication) 27690, 27696, 28122, 28200, 28232, 28238, 28322, 28810, Chronic obstructive pulmonary disease (COPD) (FEV1 <50%)

29900, 29901, 29902, 49520, Coronary artery disease (CAD)/peripheral vascular disease (PVD) (ongoing 52317, 54065, 64425, 64435, cardiac ischemia requiring medical management or recently placed [within 1 64530, 64581, 64910, 67010, year] drug eluting stent) and 69205 Developmental stage or cognitive status warranting use of a hospital outpatient department o Removed 20552, 20553, and End stage renal disease ([hyperkalemia above reference range] receiving 65820 peritoneal or hemodialysis) Supporting Information History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) Updated References section to (recent event [< 3 months]) reflect the most current information History of myocardial infarction (MI) (recent event [< 3 months])

Individuals with drug eluting stents (DES) placed within one year or bare metal stents (BMS) or plain angioplasty within 90 days unless acetylsalicylic acid and antiplatelet drugs will be continued by agreement of surgeon, cardiologist and anesthesia Ongoing evidence of myocardial ischemia

Poorly Controlled asthma (FEV1 < 80% despite medical management)

Pregnancy

Prolonged surgery (> 3 hours)

Resistant hypertension (Poorly Controlled) Severe valvular heart disease Sleep apnea (moderate to severe Obstructive Sleep Apnea (OSA) Uncompensated chronic heart failure (CHF) (NYHA class III or IV) Under 18 years of age

Page 31 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Outpatient Surgical Aug. 1, 2021 A planned surgical procedure performed in a hospital outpatient department Procedures – Site of is considered medically necessary if there is an inability to access an Service ambulatory surgical center for the procedure due to any one of the following: (continued) There is no geographically accessible ambulatory surgical center that has the necessary equipment for the procedure; or There is no geographically accessible ambulatory surgical center available at which the individual’s physician has privileges; or An ASC’s specific guideline regarding the individual’s weight or health conditions that prevents the use of an ASC

Planned Surgical Procedures List Site of service medical necessity reviews will be conducted for surgical procedures on the Applicable Codes list of this policy only when performed in an outpatient hospital setting. Preventive Care Jul. 1, 2021 Frequently Asked Questions Refer to the policy for complete details. Services (FAQ) Added FAQ #14 pertaining to maternal depression screening as a preventive care services benefit

Applicable Codes Preventive Care Services Hepatitis C Virus Infection Screening Updated service description;

added March 2021 Bright Futures

recommendation for screening all

individuals ages 18 to 79 years at least once for hepatitis C virus infection (HCV) Genetic Counseling and Evaluation for BRCA Testing; and BRCA Lab

Page 32 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

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

Weight Loss to Prevent Obesity- Related Morbidity and Mortality in

Adults: Behavioral Interventions and

Screening for Obesity in Children

and Adolescents

Updated list of CPT/HCPCS codes

for:

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

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

0403T, G0270, G0271, and S9470

requires one of the diagnosis codes listed in this [policy] Interventions for Tobacco Smoking Cessation in Adults, including Pregnant Persons (previously titled Smoking Cessation in Adults, including Pregnant Women:

Page 33 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

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

. For pregnant persons, the

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

use tobacco

. For nonpregnant adults,

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

Administration (FDA)-

approved

pharmacotherapy for cessation to nonpregnant adults who use tobacco

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

Page 34 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jul. 1, 2021 on prescription medications Services available under the plan’s (continued) preventive benefit Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis Updated list of CPT codes for Office Visits; added 99417 Preventive Vaccines (Immunizations) Immunization Administration Updated list of applicable CPT codes to reflect COVID-19 related edits; added 0031A Expanded Women’s Preventive Health Well-Woman Visits Updated list of CPT codes for Prenatal Office Visits; added 99417 Supporting Information Updated References section to reflect the most current information Spinraza® Jul. 1, 2021 Coverage Rationale Spinraza® (nusinersen) is proven and medically necessary for the treatment of (Nusinersen) Revised coverage criteria; replaced Spinal Muscular Atrophy (SMA) in patients who meet all of the following criterion requiring “diagnosis of criteria:

spinal muscular atrophy type I, II, or III by, or in consultation with, a Initial Therapy

neurologist with expertise in the • Diagnosis of spinal muscular atrophy type by, or in consultation with, a diagnosis of SMA” with “diagnosis neurologist with expertise in the diagnosis of SMA; and of spinal muscular atrophy by, or in consultation with, a neurologist

Page 35 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 with expertise in the diagnosis of • Submission of medical records (e.g., chart notes, laboratory values) (Nusinersen) SMA” confirming the mutation or deletion of genes in chromosome 5q resulting in (continued) Removed specific dosage one of the following: requirements for Spinraza; refer to o Homozygous gene deletion or mutation (e.g., homozygous deletion of the applicable US FDA approved exon 7 at locus 5q13), or

labeling Compound heterozygous mutation (e.g., deletion of SMN1 exon 7 [allele o Supporting Information 1] and mutation of SMN1 [allele 2])

Updated Clinical Evidence and and

References sections to reflect the • Patient is not dependent on either of the following:

most current information o Invasive ventilation or tracheostomy

o Use of non-invasive ventilation beyond use for naps and nighttime sleep and • Submission of medical records (e.g., chart notes, laboratory values) of the baseline exam of at least one of the following exams (based on patient age

and motor ability) to establish baseline motor ability:*

*Baseline assessments for patients less than 2 months of age are not

necessary in order to not delay access to initial therapy in recently diagnosed infants. Initial assessments shortly post-therapy can serve as baseline with respect to efficacy reauthorization assessment

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

o Hammersmith Functional Motor Scale Expanded (HFMSE) Upper Limb Module (ULM) Test (Non ambulatory) o Children’s Hospital of Philadelphia Infant Test of Neuromuscular o Disorders (CHOP INTEND)

and

• Spinraza is prescribed by, or in consultation with, a neurologist with expertise in the treatment of SMA; and • Patient has not previously received gene replacement therapy for the treatment of SMA; and • Patient is not receiving concomitant chronic survival motor neuron (SMN) modifying therapy [e.g., Evrysdi (risdiplam)]; and

Page 36 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 • Spinraza is to be administered intrathecally by, or under the direction of, (Nusinersen) healthcare professionals experienced in performing lumbar punctures; and (continued) • Spinraza dosing for SMA is within accordance with the United States Food and Drug Administration approved labeling: and • Initial authorization will be for no more than 4 loading doses.

Continuation Therapy

• Diagnosis of spinal muscular atrophy by, or in consultation with, a

neurologist with expertise in the diagnosis of SMA; and

• Patient has previously received Spinraza therapy; and

• Patient is not dependent on either of the following:

o Invasive ventilation or tracheostomy

o Use of non-invasive ventilation beyond use for naps and nighttime sleep and • Patient has not previously received gene replacement therapy for the treatment of SMA; and • Patient is not receiving concomitant chronic survival motor neuron (SMN)

modifying therapy [e.g., Evrysdi (risdiplam)]; and

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

most recent results (< 1 month prior to request) documenting a positive clinical response from pretreatment baseline status to Spinraza therapy as demonstrated by at least one of the following exams:

o HINE-2 milestones: . One of the following: Improvement or maintenance of previous improvement of at least 2 point (or maximal score) increase in ability to kick, or Improvement or maintenance of previous improvement of at

least 1 point increase in any other HINE-2 milestone (e.g., head

control, rolling, sitting, crawling, etc.), excluding voluntary grasp and One of the following:

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Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 The patient exhibited improvement or maintenance of previous (Nusinersen) improvement in more HINE motor milestones than worsening, (continued) from pretreatment baseline (net positive improvement) Achieved and maintained any new motor milestones when they would otherwise be unexpected to do so (e.g., sit unassisted,

stand, walk)

or

o HFMSE: One of the following: . Improvement or maintenance of previous improvement of at least a 3 point increase in score from pretreatment baseline . Patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so or

ULM: One of the following: o . Improvement or maintenance of previous improvement of at least a

2 point increase in score from pretreatment baseline

. Patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so or o CHOP INTEND: One of the following: . Improvement or maintenance of previous improvement of at least a 4 point increase in score from pretreatment baseline

. Patient has achieved and maintained any new motor milestone from

pretreatment baseline when they would otherwise be unexpected to do so and • Spinraza is prescribed by, or in consultation with, a neurologist with expertise in the treatment of SMA; and • Spinraza is to be administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures; and

Page 38 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Spinraza® Jul. 1, 2021 • Spinraza dosing for SMA is within accordance with the United States Food (Nusinersen) and Drug Administration approved labeling; and (continued) • Reauthorization will be for no more than 3 maintenance doses (12 months)

Unproven Spinraza is not proven or medically necessary for: Spinal muscular atrophy without chromosome 5q mutations or deletions Concomitant treatment of SMA in patients who have previously received gene replacement therapy Concomitant treatment of SMA in patients receiving Evrysdi (risdiplam) Surgery of the Elbow Jul. 1, 2021 Title Change Surgery of the elbow is proven and medically necessary in certain Previously titled Elbow circumstances. ® Replacement Surgery For medical necessity clinical coverage criteria, refer to the InterQual 2021, Apr. 2021 Release, CP: Procedures: (Arthroplasty) Arthroscopy, Diagnostic, +/- Synovial Biopsy, Elbow Coverage Rationale Arthroplasty, Removal or Revision, Elbow Replaced language indicating “elbow replacement surgery is Arthroscopy, Surgical, Elbow

proven and medically necessary in Joint Replacement, Elbow

certain circumstances” with ® “surgery of the elbow is proven and Click here to view the InterQual criteria. medically necessary in certain circumstances” Revised language pertaining to medical necessity clinical coverage criteria: Added InterQual® 2021, Apr. o 2021 Release, CP:

Procedures:

. Arthroscopy, Diagnostic, +/- Synovial Biopsy, Elbow . Arthroplasty, Removal or Revision, Elbow

Page 39 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Surgery of the Elbow Jul. 1, 2021 . Arthroscopy, Surgical, (continued) Elbow . Joint Replacement, Elbow ® o Removed InterQual Client Defined 2020, CP: Procedures: . Joint Replacement, Elbow (Custom) - UHG . Arthroplasty, Removal or Revision, Elbow (Custom) – UHG Documentation Requirements Updated list of Required Clinical Information Applicable Codes Added CPT codes 24365, 24366, 29830, 29834, 29837, and 29838 Supporting Information Updated FDA section to reflect the most current information Surgery of the Knee Jul. 1, 2021 Title Change Surgery of the knee is proven and medically necessary in certain Previously titled Knee Replacement circumstances. For medical necessity clinical coverage criteria, refer to the ® Surgery (Arthroplasty), Total and InterQual 2021, Apr. 2021 Release, CP: Procedures: Arthroscopy, Diagnostic, +/- Synovial Biopsy, Knee Partial Arthroscopy or Arthroscopically Assisted Surgery, Knee Coverage Rationale Arthrotomy, Knee Replaced language indicating “knee replacement surgery Total Joint Replacement (TJR), Knee

(arthroplasty) is proven and Removal and Replacement, Total Joint Replacement (TJR), Knee

medically necessary in certain Unicondylar or Patellofemoral Knee Replacement circumstances” with “surgery of ® the knee is proven and medically Click here to view the InterQual criteria. necessary in certain circumstances”

Page 40 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Surgery of the Knee Jul. 1, 2021 Revised language pertaining to (continued) medical necessity clinical coverage criteria: ® o Added InterQual 2021, Apr. 2021 Release, CP:

Procedures:

. Arthroscopy, Diagnostic, +/- Synovial Biopsy, Knee . Arthroscopy or Arthroscopically Assisted Surgery, Knee . Arthrotomy, Knee . Total Joint Replacement (TJR), Knee

Replaced: o . “InterQual® 2020, Apr. 2020 Release, CP: Procedures, Unicondylar or Patellofemoral Knee Replacement” with “InterQual® 2021, Apr. 2021 Release, CP: Procedures, Unicondylar or Patellofemoral Knee

Replacement”

. “InterQual® 2020, Dec. 2020 Release, CP: Procedures, Removal and Replacement, Total Joint Replacement (TJR), Knee” with “InterQual® 2021, Apr. 2021 Release, CP: Procedures, Removal and

Page 41 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Surgery of the Knee Jul. 1, 2021 Replacement, Total Joint (continued) Replacement (TJR), Knee” ® o Removed InterQual Client Defined 2020, CP: Procedures, Total Joint Replacement (TJR), Knee (Custom) - UHG Documentation Requirements Updated list of Required Clinical Information Applicable Codes Added CPT codes 27437, 27438, 27440, 27441, 27442, 27443, 29850, 29851, 29855, 29856, 29870, 29871, 29873, 29874, 29875, 29876, 29877, 29880, 29881, 29882, 29883, 29884, 29885, 29886, 29887, 29888, and 29889 Supporting Information Updated FDA section to reflect the most current information Zolgensma® Jul. 1, 2021 Coverage Rationale Zolgensma is proven and medically necessary for one treatment per lifetime (Onasemnogene Revised coverage criteria: for the treatment of spinal muscular atrophy (SMA) in patients who meet all of the following criteria: Abeparvovec-Xioi) o Added criterion requiring 1. Submission of medical records (e.g., chart notes, laboratory values) patient is less than 2 years of age confirming the mutation or deletion of genes in chromosome 5q resulting in

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

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

Patient is less than or b. Compound heterozygous mutation of SMN1 gene (e.g., deletion of equal to 6 months of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2]) age and 2. One of the following:

Page 42 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 Patient does not have a. Diagnosis of symptomatic SMA by a neurologist with expertise in the (Onasemnogene advanced SMA at diagnosis of SMA; or Abeparvovec-Xioi) baseline (e.g., b. Both of the following: (continued) complete paralysis of (1) Diagnosis of SMA based on the results of SMA newborn screening; limbs) and

. All of the following: (2) Submission of medical records (e.g., chart notes, laboratory values)

Patient is greater than confirming that patient has 4 copies or less of SMN2 gene;

6 months of age, but and

less than 2 years of 3. For use in a neonatal patient born prematurely, the full-term gestational age age; and has been reached; and One of the following: 4. Patient is less than 2 years of age; and • Both of the 5. Patient is not dependent on either of the following: following: a. Invasive ventilation or tracheostomy Patient has b. Use of non-invasive ventilation beyond use for naps and nighttime sleep o previously and

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

modifying SMA; and

therapy [e.g., 7. Patient is not to receive routine concomitant SMN modifying therapy [e.g. Spinraza Spinraza (nusinersen), Evrysdi (risdiplam)] (patient’s medical record will be (nusinersen), reviewed and any current authorizations for SMN modifying therapy will be Evrysdi terminated upon Zolgensma approval); and (risdiplam)] 8. Patient does not have an elevated anti-AAV9 antibody titer above 1:50*; and for the 9. Patient is less than 13.5 kg; and

treatment of 10. Patient will receive prophylactic prednisolone (or glucocorticoid equivalent)

SMA before 6 prior to and following receipt of Zolgensma in accordance with the United

months of States Food and Drug Administration (FDA) approved Zolgensma labeling;

age with and

positive 11. Patient will receive Zolgensma intravenously in accordance with the FDA clinical approved labeling; and response; 12. Patient has never received Zolgensma treatment in their lifetime; and and 13. Authorization will be for no longer than 14 days from approval or until 2 years o Submission of of age, whichever is first. medical

Page 43 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 records (e.g., Additional Information Relevant to the Review Process but Not (Onasemnogene chart notes, Impacting the Determination of Medical Necessity Abeparvovec-Xioi) laboratory 1. Physician attests that the patient, while under the care of the physician, will (continued) values) be assessed by one of the following exam scales during subsequent office confirming visits*† patient does a. Children’s Hospital of Philadelphia Infant Test of Neuromuscular not have Disorders (CHOP INTEND) scale during subsequent office visits while advanced the patient is 2 to 3 years of age or younger; or SMA as b. Hammersmith Functional Motor Scale Expanded (HFMSE) during defined by subsequent office visits while the patient is 2 to 3 years of age or older; the fact that and the patient 2. Physician attests that the patient will be assessed via the CHOP INTEND has not scale to establish a baseline functional assessment within the following shown timelines:*† evidence of For patients greater than 2 months of age at the time of Zolgensma clinical o administration, a baseline CHOP INTEND score will be assessed within decline while the 2 weeks prior to Zolgensma administration; or receiving For patients less than or equal to 2 months of age at the time of SMN o Zolgensma administration, a baseline CHOP INTEND score will be modifying assessed within the 2 weeks prior to, or the 2 weeks following therapy [e.g., Zolgensma administration; Spinraza

(nusinersen, †For quality purposes only, this information will not be considered as part of the Evrysdi individual coverage decision. (risdiplam)]

• Both of the Zolgensma is not proven or medically necessary for: following: The treatment of pre-symptomatic patients diagnosed by newborn screening Patient has o who have more than 4 copies of the SMN2 gene; or previously The treatment of symptomatic later-onset SMA older than 2 years of age; or received SMN SMA without chromosome 5q mutations or deletions; or modifying The routine combination treatment of SMA with concomitant SMN modifying therapy [e.g., therapy Spinraza

Page 44 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 (nusinersen), (Onasemnogene Evrysdi Abeparvovec-Xioi) (risdiplam)] (continued) for the treatment of

later-onset SMA before 2

years of age

with positive clinical response; and o 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

Page 45 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 modifying (Onasemnogene therapy [e.g., Abeparvovec-Xioi) Spinraza (continued) (nusinersen), Evrysdi

(risdiplam)]

. Patient has recently been

diagnosed with

symptomatic later-onset SMA within the previous 6 months Removed specific dosage requirements for Zolgensma; refer to the applicable US FDA approved

labeling

Revised additional information

relevant to the review process but

not impacting the determination of medical necessity; removed language indicating:

o The physician acknowledges that Oxford may request documentation, not more

frequently than biannually, and

not for a period to exceed 3

years, of follow-up patient

assessment(s) including, but not necessarily limited to, serial CHOP INTEND or HFMSE assessments while the patient is under the care of the physician

Page 46 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Clinical Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Zolgensma® Jul. 1, 2021 o Oxford has established an (Onasemnogene internal registry where this is a Abeparvovec-Xioi) potential outcome measure; (continued) this registry has been established to prioritize early access to an SMA therapy with promising early clinical evidence, yet with unique commercialization characteristics, while ensuring appropriate management as clinical data matures Supporting Information Updated Clinical Evidence and References sections to reflect the most current information

Page 47 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Administrative Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Aug. 1, 2021 Coverage Rationale Note: Refer to the Reimbursement Policy titled Ambulance for additional Emergency Air Ambulance information regarding the reimbursement of ambulance transportation services. Added language to indicate: o Emergency air ambulance Indications for Coverage services may be deployed Emergency Air Ambulance when the member’s condition Emergency air ambulance services may be deployed when the member’s requires immediate condition requires immediate transportation that cannot be provided by ground transportation that cannot be ambulance. Examples may include situations when a member’s medical provided by ground condition is unstable and transportation by ground ambulance poses a threat to ambulance; examples may the member’s survival or seriously endangers the member’s health and the include situations when a member’s care cannot be provided/stabilized at the current location. member’s medical condition is

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

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

Emergency air ambulance o Emergency air ambulance transportation should meet the following criteria: transportation may also be The member’s destination is an acute care hospital; and considered when ground Services requested by police or medical authorities at the site of an transport times exceed 30-60 emergency; or minutes and the lengthy Emergency Air ambulance transportation requiring advanced life support; or transport times may endanger Weather or traffic conditions make ground ambulance transportation the member’s life or seriously impractical, impossible, or overly time consuming. endanger the member’s health

o In addition, emergency air ambulance may be considered Emergency Ambulance (Ground, Water, or Air) when the pickup point is Coverage includes Emergency ambulance transportation (including wait time inaccessible by ground and treatment at the scene) by a licensed ambulance service from the location of

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Administrative Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Aug. 1, 2021 ambulance or is in a remote or the sudden illness or injury, to the nearest hospital where services can be (continued) sparsely populated area performed. Removed language indicating as a general guideline, when it would Emergency transportation to an acute care hospital and/or hospital Emergency take a ground ambulance 30-60 facility does not require notification, prior authorization or certification.

minutes or more to transport a

member whose medical condition The following Emergency ambulance services are covered: at the time of pick-up required Transportation to the nearest hospital that can provide services appropriate immediate and rapid transport due to the covered person's illness or injury. to the nature and/or severity of the Transportation to the nearest neonatal special care unit for newborn infants member’s illness/injury, air treatment of illness, injuries, congenital birth defects, or complications of transportation may be appropriate premature birth that require that level of care. Revised coverage criteria; removed Ground ambulance transportation requiring basic life support or advanced criterion requiring: life support

The member’s condition is Supplies that are needed for advanced life support or basic life support to o such that the ground stabilize a member’s medical condition

ambulance (basic or advanced Treatment at the scene (paramedic services) without ambulance life support) would endanger transportation the member’s life or health Wait time associated with covered ambulance transportation o Inaccessibility to ground Transportation to a hospital that provides a required higher level of care that ambulance transport or was not available at the original hospital extended length of time required to transport the Non-Emergency Ambulance (Ground or Air) Between Facilities member via ground ambulance Coverage includes non-Emergency ambulance transportation by a licensed transportation could endanger ambulance service (either ground or air ambulance, as Oxford determines the member appropriate) between facilities only when the transport meets one of the Non-Emergency Ambulance following:

(Ground or Air) Between Facilities From an out-of-Network Hospital to the closest Network Hospital when

Removed language indicating Covered Health Care Services are required. coverage includes non-Emergency To the closest Network Hospital or facility that provides the required ambulance transportation by a Covered Health Care Services that were not available at the original Hospital licensed ambulance service (either or facility. ground or air ambulance, as Oxford

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Administrative Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Aug. 1, 2021 determines appropriate) between From a Short-Term Acute Care Facility to the closest Network Long-Term (continued) facilities only when the member’s Acute Care Facility (LTAC), Network Inpatient Rehabilitation Facility, or other condition requires treatment at Network Sub-Acute Facility where the required Covered Health Care another facility and another mode Services can be delivered. of transportation would endanger

the member’s medical condition The applicable benefit level for eligible non-Emergency ambulance

Prior Authorization Requirements transportation depends on the member pick-up location (origin) as follows:

for Non-Emergency Ambulance If the member is inpatient and is transported from a hospital to another hospital or inpatient facility, coverage levels for these ambulance services Removed language indicating: may vary. o If Oxford does not initiate the non-Emergency ambulance If the member is in a sub-acute setting and is transported to an outpatient transportation, certain plans facility and back (outpatient hospital, outpatient facility, or physician’s may require the member or the office), these ambulance services are covered under the benefits that apply to that sub-acute setting. For example, if the member is at a Skilled Nursing provider to call in for Facility, the ambulance transport to an outpatient facility (dialysis facility or notification radiation whether or not it is attached to a hospital) and back is covered o Provider notification requirements are not under the Skilled Nursing Facility/Inpatient Rehabilitation Facility Services

addressed by this document section of the COC.

Applicable Codes

Revised description for ambulance Prior Authorization Requirements for Non-Emergency

modifiers D, I, J, and X Ambulance Revised description for revenue If Oxford initiates the non-Emergency ambulance transportation, member codes 0545, 0546, 0548, and 0549 notification is not required.

Out-of-Network Ambulance (Emergency) If the ambulance transportation is covered, the benefit level for out-of-Network Emergency ambulance (ground, water, or air) is covered at the Network level of deductible and coinsurance.

Coverage Limitations and Exclusions The following services are not eligible for coverage:

Page 50 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Administrative Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Aug. 1, 2021 Ambulance services from providers that are not properly licensed to be (continued) performing the ambulance services rendered. Air Ambulance transportation that does not meet the covered indications in the Air Ambulance criteria listed above. Non-ambulance transportation. Non-ambulance transportation is excluded

even if rendered in an Emergency situation. Examples include but are not

limited to:

o Commercial or private airline or helicopter

o A police car ride to a hospital o Medi-van or wheelchair van transportation o Taxi ride, bus ride, rideshare services such as Lyft and Uber, etc. Ambulance transportation when other mode of transportation is appropriate. Except as indicated under the Indications for Coverage section of the policy, ambulance services when transportation by other means would not

endanger the member’s health are excluded.

Ambulance transportation to a home, residential, domiciliary or custodial facility is excluded. Ambulance transportation for member convenience or other miscellaneous reasons for member and/or family. Examples include but are not limited to: o Member wants to be at a certain hospital or facility for personal/preference reasons o Member is in foreign country, or out of state, and wants to come home for a surgical procedure or treatment (this includes those recently discharged from inpatient care)

o Member is going for routine service and is medically able to use another mode of transportation

o Member is deceased and family wants transportation to the coroner’s office or mortuary Ambulance transportation deemed not appropriate. Examples include but are not limited to: o Hospital to home o Home to physician’s office

Page 51 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Administrative Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Ambulance Services Aug. 1, 2021 o Home (e.g., residence, nursing home, domiciliary or custodial facility) to a hospital for a scheduled service (continued) • If the member is at a Skilled Nursing Facility/Inpatient Rehabilitation Facility and has met the annual day/visit limit on Skilled Nursing Facility/Inpatient Rehabilitation Facility Services, ambulance transports (during the non-

covered days) are not eligible for coverage.

Out-of-Country Transportation

When a member has traveled outside of the United States, Mexico, Canada and the U.S. Territories, Emergency transportation to the nearest hospital and/or hospital Emergency facility does not require notification, prior authorization or certification. However, Oxford should be notified of an admission within 48 hours or as soon as possible, consistent with the member's certificate.

Refer to the Administrative Policy titled Emergency Room Visits (Including Coverage for Members Outside of the United States for additional information on coverage for services received outside of the United States, Mexico, Canada, and the U.S. Territories.

Page 52 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Reimbursement Policy Updates

New Policy Title Effective Date Coverage Rationale Outpatient Hospital Jun. 1, 2021 Oxford will deny claims where an inappropriate diagnosis is in box 67 on a UB-04 claim form or its electronic equivalent. Inappropriate Primary When a code on the Inappropriate Primary Diagnosis List is listed as the primary diagnosis on the claim form, the claim will Diagnosis (CES) be denied.

Inappropriate Primary Diagnosis Codes Determination

The following criteria, used to determine codes that are added to the Inappropriate Primary Diagnosis Code List, are sourced to the Official ICD-10-CM Guidelines for Coding and Reporting, which govern the use of specific codes.

Manifestation Codes

Manifestation codes cannot be reported as first-listed or principal diagnoses. In most cases the manifestation codes will

include the verbiage, “in diseases classified elsewhere.”

“Code First” Notes When Not a Manifestation Code

“Code first” notes occur with certain codes that are not specifically manifestation codes but may be due to an underlying

cause. When a “code first” note is present which is caused by an underlying condition, the underlying condition is to be sequenced first if known.

Sequela Codes Coding of sequela generally requires two codes sequenced with the condition or nature of the sequela first and the sequela code second. Exceptions to this guideline are those instances where the code for the sequela is followed by a manifestation code identified in the tabular list and title, or the sequela code has been expanded at the fourth, fifth or sixth characters to include the manifestation(s).

Malignant Neoplasm Associated with Transplanted Organ

A malignant neoplasm of a transplanted organ should be coded as a transplant complication. Assign first the appropriate

code for complications of transplanted organs and tissue (category T86), followed by code C80.2 (malignant neoplasm associated with transplanted organ).

Conditions Due to External or Toxic Agents

For any conditions which have been caused by external or toxic agents, assign first the appropriate code for the external or toxic agent (category T51-T65), followed by the condition.

Page 53 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Reimbursement Policy Updates

New Policy Title Effective Date Coverage Rationale Outpatient Hospital Jun. 1, 2021 Gout (Category M1A - M10) Inappropriate Primary For lead-induced gout and lead-induced chronic gout, code first toxic effects of lead and its compounds (Category Diagnosis (CES) T56.0). (continued) For gout and chronic gout due to renal impairment, code first associated renal disease. For other secondary gout and other secondary chronic gout, code first associated condition.

Symptoms and Signs Specifically Associated with Systemic Inflammation and Infection (Category R65) When systemic inflammatory response syndrome (SIRS) is present with a noninfectious condition and no subsequent infection is present, assign first the appropriate code for the underlying condition, followed by a code from Category R65.1 (SIRS of non-infectious origin). Severe sepsis requires a code for the underlying systemic infection be sequenced first, followed by a code from

category R65.2 (severe sepsis).

Burns and Corrosions of External Body Surfaces Specified by Site, or Those Confined to Eye

and Internal Organs (Category T20-T28)

For corrosion burns of external body surfaces specified by site or those confined to eye and internal organs, assign first the

appropriate code for the chemical and intent (Category T51-T65), followed by the corrosion burn code. Non-corrosion burns may be sequenced first.

Poisoning by, Adverse Effects of and Underdosing of Drugs, Medicaments and Biological

Substances (Category T36-T50)

For adverse effects of drugs, medicaments and biological substances, assign first the appropriate code for the nature

of the adverse effect, followed by the appropriate code for the adverse effect of the drug (Category T36-T50).

Codes for underdosing (Category T36-T50) should never be assigned as principal or first-listed diagnosis codes. Codes for poisoning (Category T36-T50) may be sequenced first.

External Causes of Morbidity (Category V00-Y99) The external cause of morbidity codes should never be sequenced as the first-listed or principal diagnosis, as they are intended only to provide data for injury research and evaluation of injury prevention strategies.

Page 54 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Reimbursement Policy Updates

New Policy Title Effective Date Coverage Rationale Outpatient Hospital Jun. 1, 2021 Factors Influencing Health Status (Category of Codes Beginning with Z) Inappropriate Primary Codes Z15.03-Z15.09, Z15.81, Z15.89 Genetic susceptibility to malignant neoplasms and other disease. These codes Diagnosis (CES) should only be reported as secondary diagnoses. (continued) Category Z16, Resistance to antimicrobial drugs. Sequence the infection code first. Category Z17, Estrogen receptor status. Sequence the malignant neoplasm of breast code first. Category Z19, Hormone sensitivity malignancy status. Sequence the malignant neoplasm code first. Code Z33.1, Pregnant state. This code is a secondary code only for use when the pregnancy is in no way complicating the reason for visit. Otherwise, a code from the obstetric chapter is required. Category Z37, Outcome of Delivery. The outcome of delivery (Category Z37) should be included on all maternal delivery records and it is always sequenced as a secondary code. Category Z3A, Weeks of gestation. Sequence first complications of pregnancy, childbirth, and the puerperium (O00- O9A), followed by a code from Category Z3A to identify the specific week of the pregnancy. Z55-Z65, Persons with potential health hazards related to socioeconomic and psychosocial circumstances. These codes should only be reported as secondary diagnoses. Category Z68, Body Mass Index (BMI). The BMI codes should only be reported as secondary diagnoses. Category Z91.12, Patient’s intentional underdosing of medication regimen. Sequence the underdosing of medication (T36-T50) first. Category Z91.13, Patient’s unintentional underdosing of medication regimen. Sequence the underdosing of medication (T36-T50) first. Code Z91.83, Wandering in diseases classified elsewhere. Sequence the underlying disorder first. Code Z92.82, Status post administration of tPA in a different facility within the last 24 hours prior to admission to current facility. Sequence the condition requiring tPA first.

Refer to the Inappropriate Primary Diagnosis Code List for all codes applicable to this policy.

Updated Policy Title Effective Date Summary of Changes Increased Procedural Jun. 1, 2021 Template Update Services Reformatted and reorganized policy; transferred content to new template Definitions Updated definition of “Allowed Amount”

Page 55 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Reimbursement Policy Updates

Updated Policy Title Effective Date Summary of Changes Increased Procedural Jun. 1, 2021 Template Update Services (CES) Reformatted and reorganized policy; transferred content to new template Definitions Updated definition of “Allowed Amount”

Revised Policy Title Effective Date Summary of Changes Coverage Rationale B Bundle Codes Jul. 1, 2021 Applicable Codes All codes published on the NPFS Relative Value File are assigned a status code. Added CPT code 99070 (COVID-19 The status code indicates whether the code is separately payable if the service is related edit) covered. Per the public use file that accompanies the NPFS Relative Value File, Added HCPCS code G2211 the following is stated for the status code B: "Payment for covered services is Supporting Information always bundled into payment for other services not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, Updated References section to reflect the most current information payment for them is subsumed by the payment for the services to which they are incident. (An example is a telephone call from a hospital nurse regarding care of

a patient)."

Consistent with CMS, Oxford will not separately reimburse for specific Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes assigned a status code “B” on the NPFS Relative Value File indicating a bundled procedure. B Bundle Codes are not reimbursable services regardless of whether they are billed alone or in conjunction with other services. The codes which Oxford has included in this policy (for which separate reimbursement is not made) can be found in the Attachments section of the policy. B Bundle Codes (CES) Jul. 1, 2021 Applicable Codes All codes published on the NPFS Relative Value File are assigned a status code. Added CPT code 99070 (COVID-19 The status code indicates whether the code is separately payable if the service is related edit) covered. Per the public use file that accompanies the NPFS Relative Value File, the following is stated for the status code B: Added HCPCS code G2211

Supporting Information "Payment for covered services is always bundled into payment for other services Updated References section to reflect the most current information not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for

Page 56 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale B Bundle Codes (CES) Jul. 1, 2021 the services to which they are incident. (An example is a telephone call from a (continued) hospital nurse regarding care of a patient)."

Consistent with CMS, Oxford will not separately reimburse for specific Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes assigned a status code “B” on the NPFS Relative Value File indicating a bundled procedure. B Bundle Codes are not reimbursable services regardless of whether they are billed alone or in conjunction with other services. The codes which Oxford has included in this policy (for which separate reimbursement is not made) can be found in the Attachments section of the policy. Injection and Infusion Jul. 1, 2021 Applicable Codes Injections (96372-96379) and Evaluation and Management Services Removed HCPCS code G0498 Services by Place of Service Facility, Emergency Room, and Ambulatory Surgical Center

Services

Per CPT and the CMS National Correct Coding Initiative (NCCI) Policy Manual,

CPT codes 96372-96379 are not intended to be reported by the physician in the

facility setting. Thus, when an E/M service and a therapeutic and diagnostic Injection service are submitted with CMS Place of Service (POS) codes 19, 21, 22, 23, 24, 26, 51, 52, and 61 for the same patient by the Same Individual Physician or Other Qualified Health Care Professional on the same date of service, only the E/M service will be reimbursed and the therapeutic and diagnostic Injection(s) are not separately reimbursed, regardless of whether a modifier is reported with the Injection(s).

For additional information, refer to the Questions and Answers section of the

policy, Q&A #1.

Non-Facility Injection Services

E/M services provided in a non-facility setting are considered an inherent component for providing an Injection service. CPT indicates these services typically require direct supervision for any or all purposes of patient assessment,

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Injection and Infusion Jul. 1, 2021 provision of consent, safety oversight, and intra-service supervision of staff. Services When a diagnostic and therapeutic Injection procedure is performed in a POS (continued) other than 19, 21, 22, 23, 24, 26, 51, 52, and 61 and an E/M service is provided on the same date of service, by the Same Individual Physician or Other Qualified Health Care Professional only the appropriate therapeutic and diagnostic

Injection(s) will be reimbursed and the EM service is not separately reimbursed.

If a significant, separately identifiable EM service is performed unrelated to the physician work (Injection preparation and disposal, patient assessment, provision of consent, safety oversight, supervision of staff, etc.) required for the Injection service, Modifier 25 may be reported for the E/M service in addition to 96372-96379. If the E/M service does not meet the requirement for a significant separately identifiable service, then Modifier 25 would not be reported and a separate E/M service would not be reimbursed.

Exceptions

CPT code 99211: E/M service code 99211 will not be reimbursed when

submitted with a diagnostic or therapeutic Injection code, with or without

Modifier 25. This very low service level code does not meet the requirement for

"significant" as defined by CPT, and therefore should not be submitted in addition to the procedure code for the Injection.

CPT codes 99381-99412, 99429: The Preventive Medicine codes (99381- 99412, 99429) do not need Modifier 25 to indicate a significant, separately identifiable service when reported in addition to the diagnostic and therapeutic Injection service. The Preventive Medicine codes include routine services such as the ordering of immunizations or diagnostic procedures. The performance of

these services is to be reported in addition to the Preventive Medicine E/M

code. Therefore, diagnostic and therapeutic Injections can be reported at the same time as a Preventive Medicine code without appending Modifier 25.

For additional information, refer to the Questions and Answers section of this policy, Q&A #2, Q&A #3 and Q&A #6.

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Injection and Infusion Jul. 1, 2021 CMS POS Database Services (continued) Injection and Infusion Services (96360-96549) and HCPCS Supplies Consistent with CPT guidelines, HCPCS codes identified by code description as standard tubing, syringes, and supplies are considered included when reported with Injection and Infusion services (CPT codes 96360-96549) and will not be separately reimbursed.

Drug Codes Oxford reimbursement policy is aligned with CMS and will separately reimburse for the HCPCS drug code when submitted with Injection or Infusion codes (CPT codes 96360-96549) by the Same Individual Physician or Other Qualified Health Care Professional on the same date of service under the guidelines of this policy.

For additional information, refer to the Questions and Answers section of the policy, Q&A #4. Injection and Infusion Jul. 1, 2021 Related Policies Injections (96372-96379) and Evaluation and Management Services (CES) Removed reference link to the Services by Place of Service Reimbursement Policy titled Facility, Emergency Room, and Ambulatory Surgical Center Procedure/Technical Component Services (CES) Per CPT and the CMS National Correct Coding Initiative (NCCI) Policy Manual, Applicable Codes CPT codes 96372-96379 are not intended to be reported by the physician in the Removed HCPCS code G0498 facility setting. Thus, when an E/M service and a therapeutic and diagnostic

Injection service are submitted with CMS Place of Service (POS) codes 19, 21, 22, 23, 24, 26, 51, 52, and 61 for the same patient by the Same Individual Physician or Other Qualified Health Care Professional on the same date of service, only the E/M service will be reimbursed and the therapeutic and diagnostic Injection(s) are not separately reimbursed, regardless of whether a modifier is reported with the Injection(s).

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Injection and Infusion Jul. 1, 2021 For additional information, refer to the Questions and Answers section of this Services (CES) policy, Q&A #1. (continued) Non-Facility Injection Services E/M services provided in a non-facility setting are considered an inherent component for providing an Injection service. CPT indicates these services typically require direct supervision for any or all purposes of patient assessment, provision of consent, safety oversight, and intra-service supervision of staff.

When a diagnostic and therapeutic Injection procedure is performed in a POS

other than 19, 21, 22, 23, 24, 26, 51, 52, and 61 and an E/M service is provided

on the same date of service, by the Same Individual Physician or Other Qualified Health Care Professional only the appropriate therapeutic and diagnostic Injection(s) will be reimbursed and the EM service is not separately reimbursed.

If a significant, separately identifiable E/M service is performed unrelated to the physician work (Injection preparation and disposal, patient assessment, provision of consent, safety oversight, supervision of staff, etc.) required for the

Injection service, Modifier 25 may be reported for the E/M service in addition to

96372-96379. If the E/M service does not meet the requirement for a significant

separately identifiable service, then Modifier 25 would not be reported and a separate E/M service would not be reimbursed.

Exceptions CPT code 99211: E/M service code 99211 will not be reimbursed when submitted with a diagnostic or therapeutic Injection code, with or without Modifier 25. This very low service level code does not meet the requirement for "significant" as defined by CPT, and therefore should not be submitted in addition to the procedure code for the Injection.

CPT codes 99381-99412, 99429: The Preventive Medicine codes (99381-

99412, 99429) do not need Modifier 25 to indicate a significant, separately

identifiable service when reported in addition to the diagnostic and therapeutic Injection service. The Preventive Medicine codes include routine services such

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Injection and Infusion Jul. 1, 2021 as the ordering of immunizations or diagnostic procedures. The performance of Services (CES) these services is to be reported in addition to the Preventive Medicine E/M (continued) code. Therefore, diagnostic and therapeutic Injections can be reported at the same time as a Preventive Medicine code without appending Modifier 25.

For additional information, refer to the Questions and Answers section of the policy, Q&A #2, Q&A #3 and Q&A #6.

CMS POS Database

Injection and Infusion Services (96360-96549) and HCPCS Supplies Consistent with CPT guidelines, HCPCS codes identified by code description as standard tubing, syringes, and supplies are considered included when reported with Injection and Infusion services (CPT codes 96360-96549) and will not be separately reimbursed.

Drug Codes Oxford reimbursement policy is aligned with CMS and will separately reimburse for the HCPCS drug code when submitted with Injection or Infusion codes (CPT codes 96360-96549) by the Same Individual Physician or Other Qualified Health Care Professional on the same date of service under the guidelines of this policy.

For additional information, refer to the Questions and Answers section of the policy, Q&A #4. Modifier Reference Jul. 1, 2021 Reimbursement Guidelines Refer to the policy for complete details. Revised list of modifiers [with industry standards for usage and corresponding Reimbursement Policy reference(s)]:

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Modifier Reference Jul. 1, 2021 o Added reference to the (continued) Reimbursement Policy titled: . Intraoperative Neuromonitoring for modifiers 26 and TC

. Multiple Procedure

Payment Reduction (MPPR) for Cardiovascular and Ophthalmology for modifiers 26 and TC . Physical Medicine & Rehabilitation: PT, OT and Evaluation & Management for modifiers GO and GP . Physical Medicine &

Rehabilitation: Speech

Therapy for modifier GN

o Removed reference to the Reimbursement Policy titled Supply Policy for modifiers KH, KI, KJ, KM, KN, KR, MS, NR, NU, RR, TW, and UE Revised list of Reimbursement Policies [with corresponding modifier reference(s)]:

Intraoperative

Neuromonitoring

Added modifiers 26 and TC o Multiple Procedure Payment

Reduction (MPPR) for

Cardiovascular and

Ophthalmology

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Modifier Reference Jul. 1, 2021 o Added modifiers 26 and TC (continued) Physical Medicine & Rehabilitation: PT, OT and Evaluation & Management o Added modifiers GO and GP Physical Medicine & Rehabilitation: Speech Therapy o Added modifier GN Supply Policy o Removed modifiers KH, KI, KJ, KM, KN, KR, MS, NR, NU, RR, TW, and UE Modifier Reference Jul. 1, 2021 Reimbursement Guidelines Refer to the policy for complete details. (CES) Revised list of modifiers [with industry standards for usage and corresponding Reimbursement Policy reference(s)]:

Added reference to the o Reimbursement Policy titled:

. Intraoperative Neuromonitoring for modifiers 26 and TC . Laboratory Services for modifiers 59, 76, 77, 90, 91, 92, XE, XP, XS, and XU . Multiple Procedure

Payment Reduction

(MPPR) for Cardiovascular

and Ophthalmology for modifiers 26 and TC

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Modifier Reference Jul. 1, 2021 . Physical Medicine & (CES) Rehabilitation: PT, OT and (continued) Evaluation & Management for modifiers GO and GP . Physical Medicine &

Rehabilitation: Speech

Therapy for modifier GN

o Removed reference to the Reimbursement Policy titled Supply Policy for modifiers KH, KI, KJ, KM, KN, KR, MS, NR, NU, RR, TW, and UE Revised list of Reimbursement Policies [with corresponding modifier reference(s)]:

Intraoperative

Neuromonitoring

Added modifiers 26 and TC o Laboratory Services

Added modifiers 59, 76, 77, o 90, 91, 92, XE, XP, XS, and XU

Multiple Procedure Payment

Reduction (MPPR) for

Cardiovascular and

Ophthalmology

o Added modifiers 26 and TC

Physical Medicine &

Rehabilitation: PT, OT and

Evaluation & Management

o Added modifiers GO and GP

Page 64 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021

Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Modifier Reference Jul. 1, 2021 Physical Medicine & (CES) Rehabilitation: Speech (continued) Therapy o Added modifier GN Supply Policy o Removed modifiers KH, KI, KJ, KM, KN, KR, MS, NR, NU, RR, TW, and UE Obstetrical Policy Jul. 1, 2021 Reimbursement Guidelines Refer to the policy for complete details. Prolonged Physician Services Updated list of applicable CPT/HCPCS codes for prolonged physician services; added 99417 and G2212 Applicable Codes Obstetrical Evaluation & Management (E/M) Removed CPT/HCPCS codes 99417 and G2212 Professional/Technical Jul. 1, 2021 Reimbursement Guidelines Refer to the policy for complete details. Component (CES) For Services Furnished in a Mobile Unit Replaced language indicating “a mobile unit may be sent to a physician’s office; since the mobile unit is serving an entity for which an office POS already exists, the

POS code 11 (office) for that

location should be reported” with

“a mobile unit may be sent to a facility; since the mobile unit is

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Professional/Technical Jul. 1, 2021 serving an entity for which a facility Component (CES) POS already exists, the POS code (continued) 21 (inpatient hospital) for that location should be reported” Duplicate or Repeat Services for Professional/Technical Eligible Codes Added reference link to the Reimbursement Policy titled Laboratory Services for additional information on duplicate charges for laboratory services Definitions Updated definition of “Reference Laboratory” Applicable Codes Laboratory Codes (CMS NPFS PC/TC Indicator 3 or 9) Added CPT code 86413 Codes Subject to the PC/TC Concept Without RVU Splits Updated relative value units (RVUs) for CPT/HCPCS codes 0633T, 0634T, 0635T, 0636T, 75956, 75957, 75958, 75959, 78609, 96020, and G0252 Prolonged Services Jul. 1, 2021 Reimbursement Guidelines Oxford reimburses Prolonged Services when reported with E/M codes in which Revised list of CPT/HCPCS codes time is a factor in determining level of service in accordance with CPT and/or for: HCPCS guidelines.Physicians or other qualified health care professionals should report only Prolonged Services beyond the typical duration of the service on a o Prolonged Services: Removed given date, even if the time spent by the physician or other qualifed health care 99417 and G2211 professional is not continuous. Providers should not include the time devoted to

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Reimbursement Policy Updates

Revised Policy Title Effective Date Summary of Changes Coverage Rationale Prolonged Services Jul. 1, 2021 o Care Management (CM): performing separately reportable services when determining the amount of (continued) Added 99417 and G2058 prolonged services time. For example, the time devoted to performing cardiopulmonary resuscitation (CPT code 92950) should not be included in prolonged services time. A prolonged service of less than 30 minutes total duration on a given date is not separately reported because the work involved is included in the total work of the evaluation and management codes.

According to CPT and HCPCS, Prolonged Service codes 99354-99357,99359, 99415, 99416, G0513, G0514, and G2212 are considered add-on codes and should not be reported without the appropriate primary code.

Prolonged Services for labor and delivery are not separately reimbursable services. As described in American Congress of Obstetricians and Gynecologists (ACOG) coding guidelines, prolonged services are not reported for services that do not have a time component such as labor and delivery management.

In accordance with CMS and the AMA, Prolonged Services without Direct Patient Contact (CPT codes 99358-99359) will not be separately reimbursed when reported with CM CPT/HCPCS codes 99417, 99484, 99487, 99489, 99490, 99491, 99492, 99493, 99494, and G2058 and TCM CPT codes 99495 and 99496.

Page 67 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 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 Oxford® is adopting a new policy New and/or updated, revised, replaced or retired an existing policy; it does not imply that UnitedHealthcare Oxford® provides coverage for the health service. Note New clinical coverage criteria have been adopted for a health service (e.g., test, that most benefit plan documents exclude from benefit coverage health services drug, device or procedure) identified as investigational or unproven/not medically necessary. Physicians and other health care professionals may not seek or collect payment from a Updated member for services not covered by the applicable benefit plan unless first An existing policy has been reviewed and changes have not been made to the obtaining the member’s written consent, acknowledging that the service is not clinical coverage criteria; however, items such as the clinical evidence, FDA covered by the 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 Oxford® reserves the right to review the clinical evidence supporting the safety and effectiveness of a medical technology prior to rendering a coverage determination. Replaced An existing policy has been replaced with a new or different policy UnitedHealthcare Oxford® 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 Policy Update Bulletin excluded as unproven/not medically necessary services, unless coverage was developed to share important information regarding UnitedHealthcare guidelines or criteria are otherwise documented in another policy ® Oxford Clinical, Administrative, and Reimbursement Policy updates. When information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare Oxford® follows such applicable federal and/or state law.

The complete library of UnitedHealthcare Oxford® Medical and Administrative Policies is available at OxfordHealth.com > Providers > Tools & Resources > Medical Information > Medical and Administrative Policies or at UHCprovider.com > Policies and Protocols > Commercial Policies > UnitedHealthcare Oxford Clinical, Administrative and Reimbursement Policies. Refer to the back of the member's health care ID card for the applicable website.

Page 68 of 68 UnitedHealthcare Oxford Policy Update Bulletin: June 2021