may 2018 policy update bulletin - oxhp.com · 3 oxford ® policy update ... o test strips and...

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to

support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice

staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share important information regarding

Oxford® Medical and Administrative Policy.*

*Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law

May 2018

policy update bulletin Medical & Administrative Policy Updates

2 Oxford® Policy Update Bulletin: May 2018

Oxford® Medical and Administrative Policy Updates

Overview

Oxford

Tips for using the Policy Update Bulletin:

From the table of contents, click the policy title to be

directed to the corresponding policy update summary.

From the policy updates table, click the policy title to view a

complete copy of a new, updated, or revised policy.

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

requirements have been adopted for a health service (e.g., test, drug,

device or procedure)

Updated

An existing policy has been reviewed and changes have not been made

to the clinical coverage criteria or documentation review requirements;

however, items such as the clinical evidence, FDA information, and/or

list(s) of applicable codes may have been updated

Revised

An existing policy has been reviewed and revisions have been made to

the clinical coverage criteria and/or documentation review requirements

Replaced

An existing policy has been replaced with a new or different policy

Retired

The health service(s) addressed in the policy are no longer being

managed or are considered to be proven/medically necessary and are

therefore not excluded as unproven/not medically necessary services,

unless coverage guidelines or criteria are otherwise documented in

another policy

Note: The absence of a policy does not automatically indicate or imply

coverage. As always, coverage for a health service must be determined

in accordance with the member’s benefit plan and any applicable

federal or state regulatory requirements. Additionally, UnitedHealthcare

reserves the right to review the clinical evidence supporting the safety

and effectiveness of a medical technology prior to rendering a coverage

determination.

This bulletin provides complete details on Oxford® Clinical,

Administrative and Reimbursement Policy updates. The inclusion of

a health service (e.g., test, drug, device or procedure) in this

bulletin indicates only that UnitedHealthcare has recently adopted a

new policy and/or updated, revised, replaced or retired an existing

policy; it does not imply that Oxford® provides coverage for the

health service. In the event of an inconsistency or conflict between

the information provided in this bulletin and the posted policy, the

provisions of the posted policy will prevail. Note that most benefit

plan documents exclude from benefit coverage health services

identified as investigational or unproven/not medically necessary.

Physicians and other health care professionals may not seek or

collect payment from a member for services not covered by the

applicable benefit plan unless first obtaining the member’s written

consent, acknowledging that the service is not covered by the

benefit plan and that they will be billed directly for the service.

A complete library of Oxford® Medical and

Administrative Policies is available at

OxfordHealth.com > Providers > Tools & Resources >

Medical Information > Medical and Administrative Policies.

https://www.oxhp.com/secure/policy/medical_administrative_policy_index.html

https://www.oxhp.com/secure/policy/medical_administrative_policy_index.html



In This Issue

Oxford

Clinical Policy Updates Page

NEW

Benlysta® (Belimumab) - Effective May 1, 2018 ................................................................................................................................................... 7 Crysvita® (Burosumab-Twza) - Effective May 1, 2018 ........................................................................................................................................... 7 Enzyme Replacement Therapy - Effective May 1, 2018 .......................................................................................................................................... 8

UPDATED

Chelation Therapy for Non-Overload Conditions - Effective May 1, 2018 ................................................................................................................ 14 Cochlear Implants - Effective Jun. 1, 2018 ......................................................................................................................................................... 14 Computerized Dynamic Posturography - Effective May 1, 2018 ............................................................................................................................. 15 Deep Brain and Cortical Stimulation - Effective May 1, 2018 ................................................................................................................................ 15 Embolization of the Ovarian and Iliac Veins for Pelvic Congestion Syndrome - Effective May 1, 2018 ......................................................................... 15 Infertility Diagnosis and Treatment - Effective Jun. 1, 2018 ................................................................................................................................. 15 Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines - Effective Jun. 1, 2018 ................................................................. 15 Otoacoustic Emissions Testing - Effective Jun. 1, 2018 ........................................................................................................................................ 15 Site of Service Guidelines for Certain Outpatient Surgical Procedures - Effective May 1, 2018 .................................................................................. 16 Thermography - Effective May 1, 2018 .............................................................................................................................................................. 16 Vaccines - Effective May 1, 2018 ...................................................................................................................................................................... 16

REVISED

Ablative Treatment for Spinal Pain - Effective Jun. 1, 2018 .................................................................................................................................. 16 Actemra® (Tocilizumab) Injection for Intravenous Infusion - Effective Jun. 1, 2018 ................................................................................................ 18 Benlysta® (Belimumab) - Effective Aug. 1, 2018 ................................................................................................................................................. 20 Chromosome Microarray Testing (Non-Oncology Conditions) - Effective Jun. 1, 2018 .............................................................................................. 21 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Jun. 1, 2018 ................................................................................ 24 Drug Coverage Guidelines - Effective May 1, 2018 .............................................................................................................................................. 24

o Adagen (Pegademase Bovine) .................................................................................................................................................................... 24 o Aldurazyme® (Laronidase) ......................................................................................................................................................................... 24 o Benlysta (Belimumab) ............................................................................................................................................................................... 24 o Crysvita (Burosumab-Twza) ....................................................................................................................................................................... 25 o Elaprase (Idursulfase) ............................................................................................................................................................................... 25 o Fabrazyme® (Agalsidase Beta) .................................................................................................................................................................... 25 o Kanuma (Sebelipase Alfa) .......................................................................................................................................................................... 26 o Lumizyme (Alglucosidase Alfa) .................................................................................................................................................................... 26 o Mepsevii (Vestronidase Alfa-Vjbk) ............................................................................................................................................................... 26 o Naglazyme (Galsulfase) ............................................................................................................................................................................. 26



In This Issue

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o Vimizim (Elosulfase Alfa) ............................................................................................................................................................................ 26 Drug Coverage Guidelines - Effective Jun. 1, 2018 .............................................................................................................................................. 26

o Actemra (Tocilizumab) ............................................................................................................................................................................... 26 o Actiq (Brand Only) (Fentanyl Citrate) .......................................................................................................................................................... 26 o Afstyla (Antihemophilic Factor [Recombinant] Single Chain) ........................................................................................................................... 26 o Atorvastatin (Generic Lipitor) 10mg, 20mg................................................................................................................................................... 26 o Belsomra (Suvorexant) .............................................................................................................................................................................. 26 o Benznidazole ............................................................................................................................................................................................ 26 o Bupropion (SR) (Generic Zyban) ................................................................................................................................................................. 27 o Carospir Suspension (Spironolactone).......................................................................................................................................................... 27 o Chantix (Varenicline Tartrate) ..................................................................................................................................................................... 27 o Cimduo (Lamivudine/Tenofovir DF) ............................................................................................................................................................. 27 o Cimzia (Certolizumab Pegol) ....................................................................................................................................................................... 27 o Cosentyx (Secukinumab) ........................................................................................................................................................................... 27 o Daraprim (Pyrimethamine) ......................................................................................................................................................................... 27 o Enbrel (Etanercept) ................................................................................................................................................................................... 27 o Ergomar (Ergotamine Tartrate) ................................................................................................................................................................... 27 o Farydak (Panobinostat) .............................................................................................................................................................................. 27 o Fentanyl Citrate (Generic Actiq) .................................................................................................................................................................. 27 o Grastek (Timothy Grass Pollen Allergen Extract) ........................................................................................................................................... 28 o Jakafi (Ruxolitinib) .................................................................................................................................................................................... 28 o Kineret (Anakinra) .................................................................................................................................................................................... 28 o Korlym (Mifepristone) ................................................................................................................................................................................ 28 o Lidocaine Patch ......................................................................................................................................................................................... 28 o Lemtrada (Alemtuzumab) .......................................................................................................................................................................... 28 o Linzess (Linaclotide) .................................................................................................................................................................................. 28 o Lynparza (Olaparib) .................................................................................................................................................................................. 28 o Lyrica CR (Pregabalin) ............................................................................................................................................................................... 28 o Mekinist (Trametinib) ................................................................................................................................................................................ 28 o Migranal (Dihydro-Ergotamine) (Brand) ....................................................................................................................................................... 28 o Migranal (Dihydro-Ergotamine) (Generic) ..................................................................................................................................................... 28 o Movantik (Naloxegol)................................................................................................................................................................................. 28 o Nicotine OTC Products ............................................................................................................................................................................... 28 o Ninlaro (Ixazomib) .................................................................................................................................................................................... 28 o Odactra (House Dust Mite Allergen Extract) .................................................................................................................................................. 29 o Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass, Mixed Pollens Allergen Extract) ............................................... 29 o Prolia, Xgeva (Denosumab) ........................................................................................................................................................................ 29 o Radicava (Edaravone)................................................................................................................................................................................ 29 o Ragwitek (Short Ragweed Pollen Allergen Extract) ........................................................................................................................................ 29 o Rexulti (Brexpiprazole) .............................................................................................................................................................................. 29



In This Issue

Oxford

o Rhopressa (Netarsudil) .............................................................................................................................................................................. 29 o Rozerem (Ramelteon) ................................................................................................................................................................................ 29 o Simponi (Golimumab) ................................................................................................................................................................................ 29 o Simponi Aria (Golimumab) ......................................................................................................................................................................... 29 o Simvastatin (Generic Zocor) 5mg, 10mg, 20mg, 40mg .................................................................................................................................. 29 o Sutent (Sunitinib) ..................................................................................................................................................................................... 30 o Symfi (Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate) ......................................................................................................................... 30 o Smyfi Lo (Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate) ..................................................................................................................... 30 o Symproic (Naldemedine) ............................................................................................................................................................................ 30 o Tafinlar (Dabrafenib) ................................................................................................................................................................................. 30 o Tamiflu Capsules (Brand Only) (Oseltamivir Phosphate) ................................................................................................................................. 30 o Test Strips and Meters (Diabetic) ................................................................................................................................................................ 30 o Trulance (Plecanatide) ............................................................................................................................................................................... 30 o Viberzi (Eluxadoline) ................................................................................................................................................................................. 30 o Vyzulta (Latanoprostene Bunod) ................................................................................................................................................................. 30 o Zelboraf (Vemurafenib) ............................................................................................................................................................................. 30 o Zolpimist (Zolpidem Tartrate) ..................................................................................................................................................................... 30 o Zypitamag (Pitavastatin) ............................................................................................................................................................................ 30

Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Effective Jun. 1, 2018 ............................................................................ 31 Entyvio® (Vedolizumab) - Effective Jun. 1, 2018 ................................................................................................................................................. 34 Enzyme Replacement Therapy - Effective Aug. 1, 2018 ....................................................................................................................................... 35 Exondys 51™ (Eteplirsen) - Effective Jun. 1, 2018 .............................................................................................................................................. 43 Ilaris® (Canakinumab) - Effective Jun. 1, 2018 ................................................................................................................................................... 44 Infliximab (Remicade®, Inflectra™, Renflexis™) - Effective Jun. 1, 2018 ................................................................................................................ 47 Ocrevus™ (Ocrelizumab) - Effective Jun. 1, 2018 ............................................................................................................................................... 50 Orencia® (Abatacept) Injection for Intravenous Infusion - Effective Jun. 1, 2018 .................................................................................................... 53 Preventive Care Services - Effective Jun. 1, 2018 ............................................................................................................................................... 55 Radicava™ (Edaravone) - Effective Jun. 1, 2018 ................................................................................................................................................. 59 Radiology Procedures Requiring Precertification for eviCore healthcare Arrangement - Effective Jun. 1, 2018 ............................................................. 59 Simponi Aria® (Golimumab) Injection for Intravenous Infusion - Effective Jun. 1, 2018 ........................................................................................... 60

Administrative Policy Updates

NEW

New York & Connecticut Participating Surgeons Using Non- Participating Providers for Intraoperative Neuro-Monitoring (IONM) - Effective Jun. 1, 2018 62

UPDATED

Accreditation Requirements for Radiology Services - Effective May 1, 2018 ............................................................................................................ 64



In This Issue

Oxford

REVISED

Ambulance Services - Effective Jun. 1, 2018 ...................................................................................................................................................... 65

Reimbursement Policy Updates

UPDATED

Maximum Frequency Per Day - Effective May 7, 2018 ......................................................................................................................................... 69 Services and Modifiers Not Reimbursable to Healthcare Professionals - Effective May 7, 2018 .................................................................................. 69


Clinical Policy Updates

Oxford

Policy Title Effective Date Coverage Rationale

NEW

Benlysta® (Belimumab)

May 1, 2018 This policy refers only to Benlysta (belimumab) injection for intravenous infusion for the treatment of systemic lupus erythematosus (SLE). Benlysta (belimumab) for self-administered subcutaneous injection is obtained under the pharmacy benefit and is indicated systemic lupus erythematosus.

Benlysta (belimumab) is proven and medically necessary for the treatment of systemic lupus erythematosus when all of the following criteria are met:

Diagnosis of active systemic lupus erythematosis; and One of the following:

o Anti-nuclear antibody (ANA) titer ≥ 1:80 o Anti-double-stranded DNA (anti-dsDNA) level ≥ 30 IU/mL]

and Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g.,

antimalarials, corticosteroids, or immunosuppressants); and Benlysta is initiated and titrated according to US Food and Drug Administration labeled dosing for SLE up to a

maximum of 10mg/kg every 4 weeks.

Benlysta is unproven and not medically necessary for: Severe active lupus nephritis

Severe active central nervous system (CNS) lupus Use in combination with other biologics or intravenous cyclophosphamide Waldenström macroglobulinemia Sjögren's syndrome Rheumatoid arthritis

Crysvita® (Burosumab-Twza)

May 1, 2018

Crysvita (burosumab) is proven for the treatment of X-linked hypophosphatemia (XLH).

Crysvita (burosumab) is medically necessary for the treatment of XLH when the following criteria are met:

For initial therapy, all of the following: o Diagnosis of XLH, confirmed by one of the following:

Genetic testing

Elevated Serum fibroblast growth factor 23 (FGF23) level > 30 pg/mL and

o Prescribed by, or in consultation with, a specialist experienced in the treatment of metabolic bone disorders;

and o Serum phosphorus is below the normal range for age; and o Presence of clinical signs and symptoms of the disease (e.g rickets, growth retardation, musculoskeletal

pain, bone fractures ); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Initial authorization will be for no more than 12 months.

For continuation therapy, all of the following:



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NEW

Crysvita® (Burosumab-Twza) (continued)

May 1, 2018 o Patient has previously received treatment with burosumab; and o Prescribed by, or in consultation with, a specialist experienced in the treatment of metabolic bone disorders;

and

o Patient has experienced normalization of serum phosphate while on therapy; and o Patient has experienced a positive clinical response to burosumab (e.g., enhanced height velocity,

improvement in skeletal deformities, reduction of fractures, reduction of generalized bone pain); and

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

Enzyme Replacement Therapy

May 1, 2018

This policy refers to the following enzyme replacement therapy products: Adagen (pegademase bovine) Aldurazyme (laronidase) Elaprase (idursulfase)

Fabrazyme (agalsidase beta) Kanuma (sebelipase alfa) Lumizyme (alglucosidase alfa) Mepsevii (vestronidase alfa-vjbk) Naglazyme (galsulfase)

Vimizim (elosulfase alfa)

Adagen (pegademase bovine) is medically necessary for the treatment of severe combined immunodeficiency disease (SCID) associated with a deficiency of adenosine deaminase (ADA) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of SCID; and o Deficiency of adenosine deaminase is confirmed by any of the following:

Deficiency or absence of ADA in plasma, lysed erythrocytes, fibroblasts (cultured from amniotic fluid), or chorionic villus

Increase in deoxyadenosine triphosphate (dATP) levels in erythrocyte lysates compared to laboratory standard

Decrease in ATP concentration in erythrocytes Molecular genetic confirmation of mutations in both alleles of the ADA1 gene Positive screening by T cell receptor excision circles (TRECs);

and o One of the following:

Patient is not a suitable candidate for hematopoietic cell transplantation (HCT) Patient has failed HCT; and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: dosing is

started at 10 U/kg for the first dose, and titrated up to a maximum dose of 30 U/kg per week; and



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(continued)

May 1, 2018

o Initial authorization will be for no more than 12 months. For continuation therapy, all of the following:

o Patient has previously received treatment with pegademase therapy; and

o Patient has experienced a positive clinical response to pegademase therapy (e.g., normalization of plasma ADA activity, erythrocyte dATP levels, improvement of disease symptoms, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: appropriate

maintenance dosing, up to a maximum dose of 30 U/kg per week; and o Reauthorization will be for no more than 12 months.

Aldurazyme (laronidase) is medically necessary for the treatment of Mucopolysaccharidosis I (MPS I)

when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of any of the MPS I syndromes confirmed by one the following: Hurler variant (severe mucopolysaccharidosis I; also MPS IH) Hurler-Scheie variant (attenuated mucopolysaccharidosis I; also MPS IHS) Scheie variant (attenuated mucopolysaccharidosis I; also MPS IS);

and o Diagnosis of MPS I is confirmed by either of the following:

Deficiency or absence of fibroblast or leukocyte enzyme activity of alpha-L-iduronidase enzyme activity Molecular genetic confirmation of mutations in the alpha-L-iduronidase gene; and

o Presence of clinical signs and symptoms of the disease (e.g., asymptomatic with affected older sibling, cardiac abnormalities, corneal clouding, dysostosis multiplex, hepatomegaly, restrictive lung disease, etc.);

and o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

Administered dose does not exceed 0.58 mg/kg intravenously once every week; and o Initial authorization will be for no more than 12 months.

For continuation therapy, all of the following: o Patient has previously received treatment with laronidase therapy; and

o Patient has experienced a positive clinical response to laronidase therapy (e.g., improved endurance,

improved functional capacity, reduced urine dermatan sulfate/heparan sulfate excretion, etc.); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

administered dose does not exceed 0.58 mg/kg intravenously once every week; and o Reauthorization will be for no more than 12 months.

Elaprase (idursulfase) is medically necessary for the treatment of Mucopolysaccharidosis II (MPS II,

Hunter Syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of MPS II confirmed by one the following:



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(continued)

May 1, 2018

Deficiency in iduronate 2-sulfatase enzyme activity as measured in fibroblasts or leukocytes combined with normal enzyme activity level of another sulfatase

Molecular genetic testing for deletion or mutations in the iduronate 2-sulfatase gene;

and o Presence of clinical signs and symptoms of the disease (e.g., hepatosplenomegaly, skeletal deformities,

dysostosis, neurocognitive decline, cardiovascular disorders, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 0.5 mg/kg intravenously once every week; and


o Patient has previously received treatment with idursulfase therapy; and o Patient has experienced a positive clinical response to idursulfase therapy (e.g., improved endurance,

improved functional capacity, reduced spleen volume, reduced urine GAG excretion, etc.); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

administered dose does not exceed 0.5 mg/kg intravenously once every week; and o Reauthorization will be for no more than 12 months.

Fabrazyme (agalsidase beta) is medically necessary for the treatment of Fabry disease when the

following criteria are met: For initial therapy, all of the following:

o Diagnosis of Fabry disease as confirmed by one the following: Absence or deficiency (< 5% of mean) of normal alpha-galactosidase A (α-Gal A) enzyme activity) in

leukocytes, dried blood spots, or serum analysis

Molecular genetic testing for deletion or mutations in the galactosidase alpha gene; and

o Presence of clinical signs and symptoms of the disease (e.g., Acroparesthesias, angiokeratomas, whorls, anhidrosis/hypohidrosis, renal disease, exercise/heat/cold intolerance, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 1 mg/kg intravenously every two weeks; and

o Initial authorization will be for no more than 12 months.

For continuation therapy, all of the following: o Patient has previously received treatment with agalsidase therapy; and o Patient has experienced a positive clinical response to agalsidase therapy (e.g., improved renal function,

reduction in mean plasma GL-3 levels, decreased GL-3 inclusions, etc.); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

administered dose does not exceed 1 mg/kg intravenously every two weeks; and

o Reauthorization will be for no more than 12 months.

Kanuma (sebelipase alfa) is medically necessary for the treatment of Lysosomal acid lipase deficiency



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(continued)

May 1, 2018

[LAL-D, Wolman disease (WD), cholesteryl ester disease (CESD)] when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of lysosomal acid lipase deficiency [LAL-D, Wolman disease (WD), cholesteryl ester disease

(CESD)] as confirmed by one the following: Absence or deficiency lysosomal acid lipase activity by dried blood spot test Molecular genetic testing for deletion or mutations in the lipase A, lysosomal acid type (LIPA) gene;

and o Presence of clinical signs and symptoms of the disease (e.g., abdominal distention, hepatosplenomegaly,

liver fibrosis, ascities, etc.); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling by one of

the following: For rapidly progressive disease presenting within the first 6 months of life: administered initial starting

dose is 1 mg/kg intravenously once weekly, up to a maximum of 3 mg/kg once weekly Pediatric and adult patients with disease: administered dose does not exceed 1 mg/kg intravenously

every other week; and


o Patient has previously received treatment with sebelipase therapy; and o Patient has experienced a positive clinical response to sebelipase therapy [e.g., improved disease symptoms,

improvement of laboratory values (LFTs, cholesterol, triglycerides), etc.]; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling by one of

the following:

For rapidly progressive disease presenting within the first 6 months of life: administered dose is 1 mg/kg intravenously once weekly, up to a maximum of 3 mg/kg once weekly

Pediatric and adult patients with disease: administered dose does not exceed 1 mg/kg intravenously every other week;

and o Reauthorization will be for no more than 12 months.

Lumizyme (alglucosidase alfa) is medically necessary for the treatment of Pompe disease when the following criteria are met: For initial therapy, one of the following:

o All of the following for infantile-onset Pompe disease: Diagnosis of infantile-onset Pompe disease as confirmed by one the following:

- Absence or deficiency (<1% of the lab specific normal mean) acid alpha-glucosidase deficiency

(GAA) activity in skin fibroblasts - Molecular genetic testing for deletion or mutations in the GAA gene; and



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(continued)

May 1, 2018

Presence of clinical signs and symptoms of the disease (e.g., cardiac hypertrophy, respiratory distress, skeletal muscle weakness, etc.); and

Dosing is in accordance with the United States Food and Drug Administration approved labeling:

administered dose does not exceed 20 mg/kg intravenously every two weeks; and Initial authorization will be for no more than 12 months; or

o All of the following for late-onset (non-infantile) Pompe disease: Diagnosis of late-onset Pompe disease as confirmed by one the following:

- Absence or deficiency (<40% of the lab specific normal mean) acid alpha-glucosidase deficiency (GAA) activity in lymphocytes, fibroblasts or muscle

- Molecular genetic testing for deletion or mutations in the GAA gene; and

Presence of clinical signs and symptoms of the disease (e.g., cardiac hypertrophy, respiratory distress, skeletal muscle weakness, etc.); and

Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 20 mg/kg intravenously every two weeks; and

Initial authorization will be for no more than 12 months. For continuation therapy, all of the following:

o Patient has previously received treatment with alglucosidase therapy; and o Patient has experienced a positive clinical response to alglucosidase therapy (e.g., improved

respiratory/cardiac function, improved endurance, etc.); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

administered dose does not exceed 20 mg/kg intravenously every two weeks; and

o Reauthorization will be for no more than 12 months. Mepsevii (vestronidase alfa-vjbk) is proven and medically necessary for the treatment of Mucopolysaccharidosis VII (Sly syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of Mucopolysaccharidosis VII confirmed by either of the following:

Absence or deficiency of fibroblast or leukocyte enzyme activity of beta glucuronidase

Molecular genetic confirmation of mutations in the GUSB gene. and

o Presence of clinical signs and symptoms of the disease (e.g., enlarged liver and spleen, joint limitations, airway obstruction or pulmonary problems, limitation of mobility while still ambulatory, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: Administered dose does not exceed 4 mg/kg intravenously once every two weeks; and


o Patient has previously received treatment with vestronidase therapy; and



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(continued)

May 1, 2018

o Patient has experienced a positive clinical response to vestronidase therapy (e.g., improved endurance, improved functional capacity, improved pulmonary function, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

Administered dose does not exceed 4 mg/kg intravenously once every two weeks; and o Reauthorization will be for no more than 12 months.

Naglazyme (galsulfase) is medically necessary for the treatment of Mucopolysaccharidosis VI (Maroteaux-Lamy syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of Mucopolysaccharidosis VI confirmed by either of the following:

Absence or deficiency of fibroblast or leukocyte enzyme activity of N-acetylgalactosamine 4-sulfatase (arylsulfatase)

Molecular genetic confirmation of mutations in the ASB gene (5q13-q14); and

o Presence of clinical signs and symptoms of the disease (e.g., kyphoscoliosis, genu valgum, pectus carinatum, gait disturbance, growth deficiency, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 1 mg/kg intravenously once every week; and


o Patient has previously received treatment with galsulfase therapy; and o Patient has experienced a positive clinical response to galsulfase therapy (e.g., improved endurance,

improved functional capacity, reduced urine dermatan sulfate excretion, etc.); and


o Reauthorization will be for no more than 12 months. Vimizim (elosulfase alfa) is medically necessary for the treatment of Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) when the following criteria are met:

For initial therapy, all of the following:

o Diagnosis of Morquio A syndrome confirmed by either of the following: Absence or deficiency of fibroblast or leukocyte GALNS enzyme activity Molecular genetic testing for mutations in the GALNS gene (16q24.3); and


o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 2 mg/kg IV once every week; and




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(continued)

May 1, 2018 For continuation therapy, all of the following: o Patient has previously received treatment with elosulfase alfa therapy; and o Patient has experienced a positive clinical response to elosulfase alfa therapy (e.g., improved endurance,

improved functional capacity, reduced urine keratan sulfate excretion); and o Dosing is in accordance with the United States Food and Drug Administration approved labeling:

administered dose does not exceed 2 mg/kg IV once every week; and


Policy Title Effective Date Summary of Changes

UPDATED

Chelation Therapy

for Non-Overload Conditions

May 1, 2018 Updated coverage rationale; replaced language indicating:

o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically necessary”

o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary”

Updated supporting information to reflect the most current description of services, clinical evidence, and references

Cochlear Implants Jun. 1, 2018 Replaced references to “patient” with “individual” Updated benefit considerations:

o Replaced reference to “Covered Health Service” with “Covered Health Care Service”

o Replaced language indicating “cochlear implant monitoring (remapping and reprogramming of implant) and rehabilitation following the cochlear implant surgery is usually billed as aural rehabilitation and is not covered as a speech therapy benefit” with “cochlear implant monitoring (remapping and reprogramming of implant) and rehabilitation following the cochlear implant surgery is usually billed as aural rehabilitation and is covered as an outpatient rehabilitation therapy benefit”

Updated coverage rationale; replaced language indicating: o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically

necessary”

o “[The listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or not medically necessary”

o “There is insufficient high quality evidence in the published clinical literature demonstrating the safety and efficacy of cochlear hybrid implants in the management of individuals with severe hearing loss” with “there is insufficient high quality evidence in the published clinical literature demonstrating the efficacy of cochlear

hybrid implants in the management of individuals with severe hearing loss” Updated list of applicable HCPCS codes:

o Added V5273 o Removed L8621, L8622, L8623, L8624, and L8629

Updated supporting information to reflect the most current clinical evidence and references



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UPDATED

Computerized Dynamic Posturography

May 1, 2018 Updated non-coverage rationale; replaced language indicating “[the listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or not medically necessary”

Updated supporting information to reflect the most current clinical evidence and references

Deep Brain and Cortical Stimulation

May 1, 2018 Updated coverage rationale: o Replaced references to:

“Patients” with “individuals” “Patient population” with “population” or “study population” “Patient selection criteria” with “selection criteria”

o Replaced language indicating: “[The listed services] are proven and medically necessary” with “[the listed services] are proven and/or

medically necessary” “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven

and/or not medically necessary” o Removed reference to specific directional deep brain stimulation device/product name (Infinity™ DBS

System) o Added reference link to the U.S. Food and Drug Administration (FDA) section of the policy for information

regarding directional deep brain stimulation devices

Updated supporting information to reflect the most current clinical evidence and FDA information

Embolization of the Ovarian and Iliac Veins for Pelvic Congestion Syndrome

May 1, 2018 Updated non-coverage rationale; replaced language indicating “[the listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or not medically necessary”


Infertility Diagnosis and Treatment

Jun. 1, 2018 Added definition of: o Preimplantation Genetic Diagnosis (PGD) o Preimplantation Genetic Screening (PGS)

Updated supporting information to reflect the most current references

Injectable Chemotherapy Drugs: Application

of NCCN Clinical Practice Guidelines

Jun. 1, 2018 Updated list of applicable HCPCS codes: o Added J0202 o Removed J9010

Otoacoustic Emissions Testing

Jun. 1, 2018

Updated list of related policies; added reference link to the policy titled Preventive Care Services Updated coverage rationale

o Replaced language indicating:

“[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or



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UPDATED

Otoacoustic Emissions Testing (continued)

Jun. 1, 2018 medically necessary” “[The listed services] are not proven and medically necessary” with “[the listed services] are unproven

and/or not medically necessary”

o Replaced reference(s)to: “Patients” with “individuals” “Patient populations” with “populations”

Updated list of applicable ICD-10 diagnosis codes; added F44.6, F68.10, F68.12, F68.13, H91.01, H91.02, H91.03, and H91.09


Site of Service Guidelines for Certain Outpatient Surgical Procedures

May 1, 2018 Updated supporting information to reflect the most current references; no change to coverage rationale or list of applicable codes

Thermography May 1, 2018 Updated non-coverage rationale; replaced language indicating “[the listed service] is unproven or not medically necessary” with “[the listed service] is unproven and/or not medically necessary”

Updated list of applicable CPT codes: o Modified table heading; removed descriptor classifying codes as “non-reimbursable”

Updated supporting information to reflect the most current clinical evidence, FDA information, and references

Vaccines May 1, 2018 Updated coverage rationale; replaced reference to “ACIP definitive (‘shall’) recommendation” with “ACIP definitive (e.g., should, shall, is) recommendation”


Policy Title Effective Date Summary of Changes Coverage Rationale

REVISED

Ablative Treatment for Spinal Pain

Jun. 1, 2018

Updated list of related policies; added reference link to the

policy titled Office Based Program

Revised conditions of coverage/precertification

requirements; replaced language indicating “pulsed radiofrequency ablation (unlisted CPT code 64999) requires Medical Director review in all sites of service” with “CPT codes 64633, 64635,

Thermal radiofrequency ablation of facet joint nerves is proven and medically necessary for chronic cervical, (C3-4 and below), thoracic

and lumbar pain when confirmed by: Positive response to medial branch block at the side and level of the

proposed ablation Confirmation of needle placement by fluoroscopic guided imaging

Operative notes document: o Temperature 60 degrees celsius or more o Duration of ablation at least 40 seconds

A repeat thermal radiofrequency ablation of the same facet joint nerves is proven and medically necessary when:



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REVISED

Ablative Treatment for Spinal Pain (continued)

Jun. 1, 2018

and 64999 (when used for pulsed radiofrequency ablation) require precertification with

Medical Director review in all sites of service”

Performed at a frequency of six months or longer (maximum of 2 times over a 12 month period), and

There has been a 50% or greater documented reduction in pain for 10 to

12 weeks following the previous ablation. Thermal radiofrequency ablation of facet joint nerves is unproven

and not medically necessary: When there has been no positive response to medial branch block

injection; or When performed more frequently than every six months

For additional information regarding frequency guidelines, refer to the Clinical Evidence section of the policy.

Documentation requirements for the aforementioned procedures must include: Temperature of procedure Duration of ablation

Specific identification of side and level of medial branch blocks Specific identification of side and level of ablation

Percentage of pain relief with prior ablation if applicable Duration of improvement from previous ablation if applicable. Thermal radiofrequency ablation is unproven and not medically necessary for treating ALL other pain indications including but not limited to:

Diabetic neuropathy Sacroiliac pain Complex regional pain syndrome or regional pain disorders and

syndromes in the absence of spinal pain

Definitive clinical and/or imaging findings identifying a condition requiring surgical treatment

Identified specific causes of spinal pain (e.g., disc herniation) requiring

definitive treatment

Studies of radiofrequency ablation for other conditions were limited,

uncontrolled, and insufficient to support conclusions regarding efficacy or duration of effect. Additional well-designed, longer-term randomized controlled trials are required to evaluate the safety and efficacy of radiofrequency ablation and to compare this technique with other medical or



Oxford


REVISED

Ablative Treatment for Spinal Pain (continued)

Jun. 1, 2018

surgical therapies for pain. The following ablation procedures are unproven and not medically

necessary for treating spinal pain: Pulsed radiofrequency therapy of the facet nerves of the cervical,

thoracic, or lumbar region, sacral nerve root or dorsal root ganglion

Endoscopic radiofrequency ablation (rhizotomy) Cryoablation (cryodenervation, cryoneurolysis, cryosurgery, or

cryoanesthesia) Chemical ablation (including but not limited to alcohol, phenol or sodium

morrhuate Laser ablation (including pulsed, continuous, or low level) There is insufficient evidence to establish the efficacy of the ablation therapies bulleted immediately above to reduce or relieve spinal pain. Studies are limited by small sample size retrospective and case series

studies. The clinical value needs to be examined in well-designed, randomized controlled trials with large sample size and long term follow-up.

Actemra® (Tocilizumab) Injection for Intravenous Infusion

Jun. 1, 2018

Revised conditions of coverage/precertification requirements; added language to indicate: o Requests for hospital

outpatient facility infusion of Actemra require additional precertification with review by a Medical Director or their designee; refer to the policy titled Specialty Medication

Administration - Site of Care

Review Guidelines

Please refer to Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines for updated information based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium®

(NCCN Compendium®) for oncology indications.

This policy refers only to Actemra (tocilizumab) injection for intravenous infusion for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Actemra for self-administered subcutaneous injection is obtained under the pharmacy benefit and is indicated in the treatment of rheumatoid arthritis and giant cell arteritis.

Actemra is proven and medically necessary for the treatment of: Polyarticular juvenile idiopathic arthritis when ALL of the

following criteria are met: o Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA); and o Actemra is initiated and titrated according to US Food and Drug

Administration labeled dosing for polyarticular juvenile idiopathic

arthritis up to a maximum of (or equivalent dose and interval schedule):



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REVISED

Actemra® (Tocilizumab) Injection for

Intravenous Infusion (continued)

Jun. 1, 2018

10mg/kg every 4 weeks for patients weighing < 30kg 8mg/kg every 4 weeks for patients weighing ≥ 30kg; and

o Patient is not receiving Actemra in combination with either of the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,

Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Rheumatoid arthritis when ALL of the following criteria are met: o Diagnosis of moderate to severely active rheumatoid arthritis (RA);

and o History of failure, contraindication, or intolerance to at least one

non-biologic DMARD [e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, minocycline, etc.]; and

o Actemra is initiated and titrated according to US Food and Drug Administration labeled dosing for rheumatoid arthritis up to a

maximum of 800mg every 4 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Actemra in combination with either of the following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Systemic juvenile idiopathic arthritis when ALL of the following

criteria are met: o Diagnosis of systemic juvenile idiopathic arthritis (SJIA); and

o Actemra is initiated and titrated according to US Food and Drug

Administration labeled dosing for systemic juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule): 12mg/kg every 2 weeks for patients weighing < 30kg 8mg/kg every 2 weeks for patients weighing ≥ 30kg; and

o Patient is not receiving Actemra in combination with either of the

following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]



Oxford


REVISED

Actemra® (Tocilizumab) Injection for


Jun. 1, 2018 Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Cytokine release syndrome when ALL of the following criteria are

met: o Diagnosis of chimeric antigen receptor (CAR) T cell-induced cytokine

release syndrome (CRS); and

o Actemra is prescribed according to US Food and Drug Administration labeled dosing for CRS: 12mg/kg for patients weighing < 30kg 8mg/kg for patients weighing ≥ 30kg; up to a maximum of

800mg per infusion and

o Actemra is prescribed for a maximum of 4 doses

Benlysta® (Belimumab)

Aug. 1, 2018

Updated list of related policies; added reference link to the policy titled Specialty Medication Administration – Site of Care

Review Guidelines Revised conditions of

coverage/precertification requirements to indicate: o Precertification with review

by a Medical Director or their

designee through Oxford’s Medical Management is required

o New Jersey Small Group members should refer to their certificate of coverage

for precertification guidelines

and quantity limit guidelines o Requests for hospital

outpatient facility infusion of Benlysta require additional precertification with review by a Medical Director or their designee; refer to the policy

titled Specialty Medication Administration - Site of Care

This policy refers only to Benlysta (belimumab) injection for intravenous infusion for the treatment of systemic lupus erythematosus (SLE). Benlysta

(belimumab) for self-administered subcutaneous injection is obtained under the pharmacy benefit and is indicated systemic lupus erythematosus.

Benlysta (belimumab) is proven and medically necessary for the treatment of systemic lupus erythematosus when all of the following criteria are met: Diagnosis of active systemic lupus erythematosis; and One of the following:

o Anti-nuclear antibody (ANA) titer ≥ 1:80 o Anti-double-stranded DNA (anti-dsDNA) level ≥ 30 IU/mL] and

Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants); and

Benlysta is initiated and titrated according to US Food and Drug

Administration labeled dosing for SLE up to a maximum of 10mg/kg every 4 weeks.

Benlysta is unproven and not medically necessary for: Severe active lupus nephritis Severe active central nervous system (CNS) lupus Use in combination with other biologics or intravenous cyclophosphamide

Waldenström macroglobulinemia Sjögren's syndrome



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REVISED

Benlysta® (Belimumab) (continued)

Aug. 1, 2018 Review Guidelines

Rheumatoid arthritis

Chromosome Microarray Testing

(Non-Oncology Conditions)

Jun. 1, 2018

Changed policy title; previously titled Chromosome Microarray

Testing Updated list of related policies:

o Added reference link to the policy titled Molecular

Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions

o Removed reference link to the policy titled Gene Expression Tests for Cardiac

Indications Revised coverage rationale:

o Replaced reference to “patients” with “individuals”

o Replaced language indicating: “[The listed services] are

proven and medically necessary” with “[the listed services] are proven and/or medically necessary”

“Genome-wide comparative genomic

hybridization microarray testing and single nucleotide polymorphism (SNP) chromosomal microarray analysis are unproven and not

medically necessary for all other patient populations and conditions [not listed as

Genome-wide comparative genomic hybridization microarray testing or single nucleotide polymorphism (SNP) chromosomal microarray

analysis is proven and/or medically necessary for evaluating an embryo/fetus in the following cases: Women undergoing invasive prenatal testing (i.e., amniocentesis,

chorionic villus sampling or fetal tissue sampling)

Intrauterine Fetal Demise or Stillbirth Genome-wide comparative genomic hybridization microarray testing or SNP chromosomal microarray analysis is proven and/or medically necessary for evaluating individuals with one or more of the following:

Multiple anomalies not specific to a well-delineated genetic syndrome and cannot be identified by a clinical evaluation alone

Non-syndromic Developmental Delay/Intellectual Disability Autism spectrum disorders Genome-wide comparative genomic hybridization microarray testing or SNP chromosomal microarray analysis are unproven and/or not

medically necessary for all other populations and conditions including but not limited to the following: For evaluating an embryo/fetus in the following cases:

o Preimplantation Genetic Diagnosis (PGD) in embryos o Preimplantation Genetic Screening (PGS) in embryos

Epilepsy

There is insufficient evidence in the clinical literature demonstrating that genome-wide comparative genomic hybridization microarray testing or SNP chromosomal microarray analysis has a role in clinical decision-making or has a beneficial effect on health outcomes for other indications such as PGD in embryos, PGS in embryos, or epilepsy. Further studies are needed to determine the analytic validity, clinical validity and clinical utility of this test

for indications other than those listed above as proven/medically necessary. Note: Genome-wide comparative genomic hybridization microarray testing or SNP chromosomal microarray analysis for the evaluation of cancer is



Oxford


REVISED

Chromosome Microarray Testing (Non-Oncology

Conditions) (continued)

Jun. 1, 2018

proven and/or medically necessary]” with “genome-wide

comparative genomic hybridization microarray testing or SNP

chromosomal microarray analysis are unproven and/or not medically necessary for all other

populations and conditions [not listed as proven and/or medically necessary]”

o Updated list of populations and conditions for which

genome-wide comparative genomic hybridization

microarray testing or SNP chromosomal microarray analysis is unproven and/or not medically necessary: Added epilepsy

Removed diagnosis, management, and prognosis of cancer

Replaced “preimplantation genetic diagnosis or screening in

embryos” with

“Preimplantation Genetic Diagnosis (PGD) and Preimplantation Genetic Screening (PGS) in embryos”

o Modified language pertaining

to clinical evidence/study findings to indicate there is insufficient evidence in the

addressed in the policy titled Molecular Oncology Testing for Cancer Diagnosis Prognosis, and Treatment Decisions. Genetic Counseling

Genetic counseling is strongly recommended prior to this test in order to

inform persons being tested about the advantages and limitations of the test as applied to a unique person.



Oxford


REVISED



Jun. 1, 2018

clinical literature demonstrating that genome-wide comparative genomic

hybridization microarray testing or SNP chromosomal microarray analysis has a

role in clinical decision-making or has a beneficial effect on health outcomes for other indications such as

PGD in embryos, PGS in embryos, or epilepsy

o Added language to indicate genome-wide comparative genomic hybridization microarray testing or SNP

chromosomal microarray analysis for the evaluation of

cancer is addressed in the policy titled Molecular Oncology Testing for Cancer Diagnosis Prognosis, and Treatment Decisions

Added definition of: o Preimplantation Genetic

Diagnosis (PGD) o Preimplantation Genetic

Screening (PGS) o Prenatal Diagnosis

Updated list of applicable CPT

codes: o Added 81479 o Removed 0004M

Reformatted list of applicable ICD-10 diagnosis codes; transferred content to embedded

Excel file format Updated supporting information

to reflect the most current



Oxford


REVISED



Jun. 1, 2018 description of services, clinical evidence, and references

Drug Coverage Criteria - New and Therapeutic Equivalent

Medications

Jun. 1, 2018 Revised list of medications requiring precertification through the pharmacy benefit manager (PBM):

o Added Cimduo, Rhopressa, Symfi, Symfi Lo, Tamiflu Capsules (brand only), and Zypitamag

o Removed Actiq, Carospir Suspension, and Lyrica CR

Refer to the policy for complete details on Drug Coverage Criteria - New and Therapeutic Equivalent Medications.

Policy Title Effective Date Drug/Medication Status Summary of Changes

REVISED

Drug Coverage Guidelines

May 1, 2018 Adagen (Pegademase Bovine)

New Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)

Added precertification guidelines; refer to Precertification Guidelines: Enzyme Replacement Therapy for complete details

Aldurazyme®

(Laronidase)

Revised Added language to indicate precertification is not required however it is

strongly recommended o While no penalty will be imposed for failure to request a pre-service

review, if you do not request one, 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 Aug. 1, 2018, precertification will be required


Benlysta (Belimumab)

Revised

Added language to indicate precertification is not required however it is strongly recommended o While no penalty will be imposed for failure to request a pre-service

review, if you do not request one, a medical necessity review will be conducted post-service to determine coverage




Oxford


REVISED

Drug Coverage Guidelines (continued)

May 1, 2018 Benlysta (Belimumab) (continued)

Revised documentation to demonstrate clinical necessity for the medication o Beginning Aug. 1, 2018, precertification will be required

Added precertification guidelines; refer to Precertification Guidelines:

Enzyme Replacement Therapy for complete details

Crysvita (Burosumab-Twza)

New Added language to indicate precertification is not required however it is strongly recommended

o While no penalty will be imposed for failure to request a pre-service review, if you do not request one, 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 Aug. 1, 2018, precertification will be required o Added precertification guidelines; refer to the following policies for

complete details: o Precertification Guidelines: Crysvita (Burosumab-Twza)

o Precertification Guidelines: Review at Launch for New to Market Medications

Elaprase (Idursulfase) Revised Added language to indicate precertification is not required however it is strongly recommended o While no penalty will be imposed for failure to request a pre-service

review, if you do not request one, a medical necessity review will be

conducted post-service to determine coverage o It is the referring physician’s responsibility to provide medical



Fabrazyme® (Agalsidase Beta)

Revised Added language to indicate precertification is not required however it is strongly recommended

o While no penalty will be imposed for failure to request a pre-service review, if you do not request one, a medical necessity review will be conducted post-service to determine coverage






Oxford


REVISED


May 1, 2018 Kanuma (Sebelipase Alfa)

New

Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)

Added precertification guidelines; refer to Precertification Guidelines:


Lumizyme (Alglucosidase Alfa)



Mepsevii (Vestronidase Alfa-Vjbk)



Naglazyme (Galsulfase) New Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) Added precertification guidelines; refer to Precertification Guidelines:


Vimizim (Elosulfase Alfa) New Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) Added precertification guidelines; refer to Precertification Guidelines:


Drug Coverage Guidelines

Jun. 1, 2018 Revised conditions of coverage; added instruction to refer to the policy titled Supply Limits: New Jersey Benefit Maximum Limits for details on applicable benefit guidelines for Jersey (NJ) plan members

Actemra (Tocilizumab) Updated Updated step therapy guidelines; refer to Step Therapy Guidelines:

Actemra (Tocilizumab) for complete details

Actiq (Brand Only) (Fentanyl Citrate)

Revised Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Updated medication/drug name to include “Brand Only”

Afstyla (Antihemophilic

Factor [Recombinant] Single Chain)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Afstyla for complete details

Atorvastatin (Generic Lipitor) 10mg, 20mg

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Cardiovascular Disease Prevention

Zero Cost Share for complete details

Belsomra (Suvorexant) Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Belsomra for complete details

Benznidazole

New

Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) Added prior authorization/notification guidelines; refer to Prior



Oxford


REVISED


Jun. 1, 2018 Benznidazole (continued)

New Authorization/Notification Guidelines: Benznidazole for complete details

Bupropion (SR) (Generic Zyban)

Revised Updated medication/drug name to include “SR” Added supply limit guidelines; refer to Supply Limit Guidelines: HCR

Tobacco Cessation - Supply Limits Override - NJ Fully Insured for complete details

Carospir Suspension

(Spironolactone)

Revised Added prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Carospir for complete details Removed therapeutic equivalent guidelines and corresponding reference

link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Chantix (Varenicline Tartrate)

Revised Added supply limit guidelines; refer to Supply Limit Guidelines: HCR Tobacco Cessation - Supply Limits Override - NJ Fully Insured for

complete details

Cimduo (Lamivudine/ Tenofovir DF)


Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent

Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Cimzia (Certolizumab Pegol)

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Cimzia (Certolizumab Pegol) for complete details

Cosentyx (Secukinumab) Updated Updated prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Cosentyx for complete details

Daraprim (Pyrimethamine)

Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Daraprim for complete details

Enbrel (Etanercept) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Enbrel (Etanercept) for complete

details

Ergomar (Ergotamine Tartrate)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Migranal for complete details

Farydak (Panobinostat) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Farydak for complete details

Fentanyl Citrate (Generic Actiq)


Added prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Actiq (Fentanyl Citrate) for complete details



Oxford


REVISED


Jun. 1, 2018 Grastek (Timothy Grass Pollen Allergen Extract)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Grastek (Timothy Grass Pollen Allergen Extract) for complete details

Jakafi (Ruxolitinib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Jakafi for complete details

Kineret (Anakinra) Updated Updated prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Kineret (Anakinra) for complete

details

Korlym (Mifepristone) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Korlym for complete details

Lidocaine Patch Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Lidocaine Patch for complete

details

Lemtrada (Alemtuzumab)

Updated Updated list of applicable HCPCS codes; replaced J9010 with J0202

Linzess (Linaclotide) Updated Updated prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Linzess (Linaclotide) for complete

details

Lynparza (Olaparib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Lynparza for complete details

Lyrica CR (Pregabalin) Revised Added step therapy guidelines; refer to Step Therapy Guidelines: Lyrica

CR for complete details Removed therapeutic equivalent guidelines and corresponding reference

link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Mekinist (Trametinib) Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Mekinist (Trametinib) for complete details

Migranal (Dihydro-

Ergotamine) (Brand)


Authorization/Medical Necessity Guidelines: Migranal for complete details

Migranal (Dihydro-

Ergotamine) (Generic)


Authorization/Medical Necessity Guidelines: Migranal for complete details

Movantik (Naloxegol) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Movantik for complete details

Nicotine OTC Products Revised Added supply limit guidelines; refer to Supply Limit Guidelines: HCR

Tobacco Cessation - Supply Limits Override - NJ Fully Insured for complete details

Ninlaro (Ixazomib) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Ninlaro for complete details



Oxford


REVISED


Jun. 1, 2018 Odactra (House Dust Mite Allergen Extract)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Odactra for complete details

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass, Mixed

Pollens Allergen Extract)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass, Mixed Pollens Allergen Extract) for complete details

Prolia, Xgeva (Denosumab)

Revised Revised coverage guidelines to indicate precertification is required through Oxford’s Medical Management

Radicava (Edaravone) Revised Added notation to indicate administration of Radicava in a hospital outpatient facility (including any ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee; refer to Specialty Medication Administration –

Site of Care Review Guidelines

Ragwitek (Short Ragweed Pollen Allergen Extract)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Ragwitek (Short Ragweed Pollen Allergen Extract) for complete details

Rexulti (Brexpiprazole) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Rexulti for complete details

Rhopressa (Netarsudil) New Added language to indicate precertification 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

Rozerem (Ramelteon) Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Rozerem (Ramelteon) for complete details

Simponi (Golimumab) Updated Updated prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Simponi (Golimumab) for complete details

Simponi Aria (Golimumab)

Updated Updated list of related policies: o Modified reference link Precertification Guidelines: Simponi Aria®

(Golimumab) Injection for Intravenous Infusion to reflect title change o Added reference link to Precertification Guidelines: Specialty

Medication Administration – Site of Care Review Guidelines (previously listed under Notes section only)

Simvastatin (Generic Zocor) 5mg, 10mg, 20mg, 40mg

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Cardiovascular Disease Prevention Zero Cost Share for complete details



Oxford


REVISED


Jun. 1, 2018 Sutent (Sunitinib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Sutent for complete details

Symfi (Efavirenz/ Lamivudine/Tenofovir Disoproxil Fumarate)


Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent

Medications for complete details

Smyfi Lo (Efavirenz/Lamivudine/ Tenofovir Disoproxil Fumarate)


Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Symproic (Naldemedine) New Added prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Symproic for complete details

Tafinlar (Dabrafenib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tafinlar for complete details

Tamiflu Capsules (Brand

Only) (Oseltamivir Phosphate)

Revised Added language to indicate precertification 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

Test Strips and Meters (Diabetic)

Revised Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Test Strips for complete details

Added notation to indicate Contour Next test strips do not require precertification

Trulance (Plecanatide) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Trulance for complete details

Viberzi (Eluxadoline) Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Viberzi for complete details

Vyzulta (Latanoprostene Bunod)

Revised Added step therapy guidelines; refer to Step Therapy Guidelines: Vyzulta for complete details

Zelboraf (Vemurafenib) Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Zelboraf for complete details

Zolpimist (Zolpidem Tartrate)

Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Zolpimist (Zolpidem Tartrate) for complete details

Zypitamag (Pitavastatin) New Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent

Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent



Oxford


REVISED


Jun. 1, 2018 Medications for complete details


REVISED

Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation

Jun. 1, 2018

Replaced references to “patients” with “individuals”

Revised coverage rationale; replaced language indicating: o “[The listed services] are

proven and medically necessary” with “[the listed

services] are proven and/or medically necessary”

o “[The listed services] are unproven and not medically

necessary” with “[the listed services] are unproven

and/or not medically necessary”

o “Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS) is unproven and not medically

necessary for treating pain” with “peripheral subcutaneous field

stimulation (PSFS) or peripheral nerve field stimulation (PNFS) is unproven and/or not

medically necessary for all indications, including but not limited to pain and opioid management”

o “Evidence for the effectiveness of PSFS or

When used for walking, functional electrical stimulation (FES), a form of neuromuscular electrical stimulation (NMES) is proven and/or medically necessary when used as one component of a comprehensive rehabilitation program in persons with paralyzed lower limbs due to spinal cord injury (SCI) with ALL of the following characteristics: Intact lower motor units (L1 and below) (both muscle and peripheral

nerves); Muscle and joint stability for weight bearing at upper and lower

extremities that can demonstrate balance and control to maintain an upright support posture independently;

Demonstrate brisk muscle contraction to NMES and have sensory perception of electrical stimulation (ES) sufficient for muscle contraction;

Possess high motivation, commitment and cognitive ability to use such devices for walking;

Able to transfer independently and can demonstrate independent standing tolerance for at least 3 minutes;

Demonstrate hand and finger function to manipulate controls; Post recovery from SCI and restorative surgery of at least 6 months; No hip and knee degenerative disease and no history of long bone

fracture secondary to osteoporosis. FES is unproven and/or not medically necessary for treating ANY

other indication not listed above as proven and medically necessary, including but not limited to: Disuse muscle atrophy in persons with SCI. Disuse muscle atrophy in persons with multiple sclerosis (MS).

Gait disorders (e.g., foot drop) of central neurologic origin, including but not limited to stroke or MS.

Further studies are needed to confirm that FES promotes bone remineralization and prevents or reverses muscle atrophy. Only a few studies have looked at FES as a modality of treatment of MS, and the results are



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Electrical Stimulation for the Treatment of Pain

and Muscle Rehabilitation (continued)

Jun. 1, 2018

PNFS based on controlled studies is lacking; randomized controlled trials

(RCTs) are needed to evaluate the efficacy of this treatment” with “evidence

for the effectiveness of PSFS or PNFS based on controlled studies is limited; additional studies are needed to

evaluate the efficacy of this treatment”

Updated supporting information to reflect the most current clinical evidence, FDA information, and references

limited and conflicting regarding whether FES improves treatment outcomes in MS when offered in addition to other rehabilitative treatment modalities. There is insufficient evidence in the peer reviewed literature that use of FES

will improve health outcomes in individuals with gait disorders. Published studies have included small heterogeneous patient populations, short-term follow-ups, and various treatment protocols, outcome measures, and FES

devices. NMES is proven and/or medically necessary for treating Disuse muscle atrophy if:

The nerve supply to the muscle is intact; and The disuse muscle atrophy is not of neurological origin but originates

from conditions such as casting, splinting or contractures; or To improve wrist and finger function and prevent or correct shoulder

subluxation in persons with partial paralysis following stroke.

NMES is unproven and/or not medically necessary for treating ANY other indication not listed above as proven and medically necessary.

There is insufficient evidence in the peer reviewed literature that use of ES will improve health outcomes for the treatment of multiple conditions other than those identified above as proven. Overall, studies in the form of RCTs and case series included small, heterogeneous patient populations and short-term follow-ups. Some systematic reviews have reported that no

improvement was seen with NMES, outcomes were conflicting and/or in some cases, when improvement was noted, the effects did not last. Heterogeneity of treatment regimens and outcome measures make it difficult to establish that NMES resulted in meaningful clinical outcomes (e.g., decrease pain, functional improvement, improvement in quality of life (QOL) and ability to carry out activities of daily living (ADLs) for these other

conditions and indications.

Interferential therapy (IFT) is unproven and/or not medically necessary for treating the following indications: For the treatment of musculoskeletal disorders or injuries. For stimulating healing of nonsurgical soft tissue injuries. To facilitate the healing of bone fractures.

There is limited evidence from the available studies to conclude that IFT reduces the pain or promotes healing of bone fractures, musculoskeletal or



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Electrical Stimulation for the Treatment of Pain

and Muscle Rehabilitation (continued)

Jun. 1, 2018 nonsurgical soft tissue injuries. Although a few studies reported some improvement in pain or disability following IFT for these conditions, none of the double-blind, randomized, placebo-controlled studies reported a positive

treatment effect of IFT for nonsurgical soft tissue injuries or bone fractures. Pulsed electrical stimulation (PES) is unproven and/or not medically

necessary for treating osteoarthritis (OA). There is insufficient evidence to conclude that PES provides health benefits to individuals with OA. RTCs are necessary to assess the durability of this procedure in comparison to other types of treatment.

Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve

field stimulation (PNFS) is unproven and/or not medically necessary for all indications, including but not limited to pain and opioid management. Evidence for the effectiveness of PSFS or PNFS based on controlled studies is limited. Additional studies are needed to evaluate the efficacy of this

treatment.

Microcurrent electrical nerve stimulation (MENS) therapy is unproven and/or not medically necessary. There is insufficient evidence to conclude that MENS is safe and effective. Robust clinical trials are needed to evaluate this therapy in comparison to other types of treatment.

Percutaneous electrical nerve stimulation (PENS) or percutaneous neuromodulation therapy (PNT) is unproven and/or not medically necessary for treating pain. There is limited evidence in the peer reviewed literature to support that PENS

or PNT will improve health outcomes in individuals with pain. RCTs assessing larger patient groups and long-term follow up are needed to further clarify its role.

Dorsal root ganglion (DRG) stimulation is unproven and/or not medically necessary. There is limited evidence in the peer reviewed literature to support that DRG stimulation will improve health outcomes in individuals with pain. RCTs assessing larger patient groups and long-term follow up are needed to further clarify its role.



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Entyvio® (Vedolizumab)

Jun. 1, 2018

Updated list of related policies; added reference link to the policy titled Acquired Rare

Disease Drug Therapy Exception Process

Revised conditions of

coverage/precertification requirements; added language to indicate: o Requests for hospital

outpatient facility infusion of Entyvio require additional precertification with review by a Medical Director or their designee; refer to the policy titled Specialty Medication

Administration - Site of Care Review Guidelines


Entyvio (vedolizumab) is proven and medically necessary for the treatment of:

Crohn's disease when all of the following criteria are met:

For initial therapy, all of the following: o Diagnosis of moderately to severely active Crohn’s disease (CD);

and o One of the following:

History of failure, contraindication, or intolerance to at least one of the following conventional therapies:

- Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)]

- Immunomodulator (e.g., azathioprine, 6-mercaptopurine) - Corticosteroid

Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of CD)

and o Entyvio is initiated and titrated according to US Food and Drug

Administration (FDA) labeled dosing for Crohn’s disease up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Entyvio in combination with either of the following:

Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)]

Tysabri (natalizumab); and o Initial authorization will be for no more than 14 weeks

For continuation therapy, all of the following: o Documentation of positive clinical response to Entyvio; and

o Entyvio dosing for Crohn’s disease is in accordance with the FDA

labeled dosing up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Reauthorization will be for no more than 12 months. Ulcerative colitis when all of the following criteria are met:


o Diagnosis of moderately to severely active ulcerative colitis (UC); and

o One of the following:



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Entyvio® (Vedolizumab) (continued)

Jun. 1, 2018 History of failure, contraindication, or intolerance to at least one of the following conventional therapies: - Tumor necrosis factor (TNF) blocker [e.g., Humira

(adalimumab), Simponi (golimumab)] - Immunomodulator (e.g., azathioprine, 6-mercaptopurine) - Corticosteroid

Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of UC)

and o Entyvio is initiated and titrated according to US Food and Drug

Administration labeled dosing for ulcerative colitis up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Entyvio in combination with either of the following: Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab),

Simponi (golimumab)] Tysabri (natalizumab); and

o Initial authorization will be for no more than 14 weeks. For continuation therapy, all of the following:

o Documentation of positive clinical response to Entyvio; and o Entyvio dosing for ulcerative colitis is in accordance with the FDA

labeled dosing up to a maximum of 300mg every 8 weeks (or

equivalent dose and interval schedule); and o Reauthorization will be for no more than 12 months.


Aug. 1, 2018

Updated list of related policies; added reference link to the policy titled Specialty Medication Administration – Site of Care

Review Guidelines

Revised conditions of coverage/precertification requirements to indicate: o Precertification with review

by a Medical Director or their designee through Oxford’s Medical Management is

required o New Jersey Small Group

This policy refers to the following enzyme replacement therapy products: Adagen (pegademase bovine) Aldurazyme (laronidase) Elaprase (idursulfase)

Fabrazyme (agalsidase beta)

Kanuma (sebelipase alfa) Lumizyme (alglucosidase alfa) Mepsevii (vestronidase alfa-vjbk) Naglazyme (galsulfase) Vimizim (elosulfase alfa) Adagen (pegademase bovine) is medically necessary for the

treatment of severe combined immunodeficiency disease (SCID) associated with a deficiency of adenosine deaminase (ADA) when the

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/entyvio-ohp.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/entyvio-ohp.pdf



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(continued)

Aug. 1, 2018

members should refer to their certificate of coverage for precertification guidelines

and quantity limit guidelines o Requests for hospital

outpatient facility infusion of

enzyme replacement therapy products addressed in this policy require additional precertification with review

by a Medical Director or their designee; refer to the policy titled Specialty Medication Administration - Site of Care Review Guidelines

following criteria are met: For initial therapy, all of the following:

o Diagnosis of SCID; and

o Deficiency of adenosine deaminase is confirmed by any of the following: Deficiency or absence of ADA in plasma, lysed erythrocytes,

fibroblasts (cultured from amniotic fluid), or chorionic villus Increase in deoxyadenosine triphosphate (dATP) levels in

erythrocyte lysates compared to laboratory standard Decrease in ATP concentration in erythrocytes

Molecular genetic confirmation of mutations in both alleles of the ADA1 gene

Positive screening by T cell receptor excision circles (TRECs); and

o One of the following: Patient is not a suitable candidate for hematopoietic cell

transplantation (HCT) Patient has failed HCT;

and o Dosing is in accordance with the United States Food and Drug

Administration approved labeling: dosing is started at 10 U/kg for the first dose, and titrated up to a maximum dose of 30 U/kg per week; and


o Patient has previously received treatment with pegademase therapy; and

o Patient has experienced a positive clinical response to pegademase therapy (e.g., normalization of plasma ADA activity, erythrocyte

dATP levels, improvement of disease symptoms, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: appropriate maintenance dosing, up to a maximum dose of 30 U/kg per week; and

o Reauthorization will be for no more than 12 months. Aldurazyme (laronidase) is medically necessary for the treatment of

Mucopolysaccharidosis I (MPS I) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of any of the MPS I syndromes confirmed by one the



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(continued)

Aug. 1, 2018

following: Hurler variant (severe mucopolysaccharidosis I; also MPS IH) Hurler-Scheie variant (attenuated mucopolysaccharidosis I; also

MPS IHS) Scheie variant (attenuated mucopolysaccharidosis I; also MPS

IS);

and o Diagnosis of MPS I is confirmed by either of the following:

Deficiency or absence of fibroblast or leukocyte enzyme activity of alpha-L-iduronidase enzyme activity

Molecular genetic confirmation of mutations in the alpha-L-iduronidase gene;

and o Presence of clinical signs and symptoms of the disease (e.g.,

asymptomatic with affected older sibling, cardiac abnormalities, corneal clouding, dysostosis multiplex, hepatomegaly, restrictive lung

disease, etc.); and o Dosing is in accordance with the United States Food and Drug

Administration approved labeling: Administered dose does not exceed 0.58 mg/kg intravenously once every week; and


o Patient has previously received treatment with laronidase therapy;

and o Patient has experienced a positive clinical response to laronidase

therapy (e.g., improved endurance, improved functional capacity, reduced urine dermatan sulfate/heparan sulfate excretion, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not

exceed 0.58 mg/kg intravenously once every week; and

o Reauthorization will be for no more than 12 months. Elaprase (idursulfase) is medically necessary for the treatment of Mucopolysaccharidosis II (MPS II, Hunter Syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of MPS II confirmed by one the following: Deficiency in iduronate 2-sulfatase enzyme activity as measured

in fibroblasts or leukocytes combined with normal enzyme



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(continued)

Aug. 1, 2018

activity level of another sulfatase Molecular genetic testing for deletion or mutations in the

iduronate 2-sulfatase gene;


hepatosplenomegaly, skeletal deformities, dysostosis, neurocognitive

decline, cardiovascular disorders, etc.); and o Dosing is in accordance with the United States Food and Drug

Administration approved labeling: administered dose does not exceed 0.5 mg/kg intravenously once every week; and


o Patient has previously received treatment with idursulfase therapy; and

o Patient has experienced a positive clinical response to idursulfase therapy (e.g., improved endurance, improved functional capacity,

reduced spleen volume, reduced urine GAG excretion, etc.); and o Dosing is in accordance with the United States Food and Drug

Administration approved labeling: administered dose does not exceed 0.5 mg/kg intravenously once every week; and

o Reauthorization will be for no more than 12 months. Fabrazyme (agalsidase beta) is medically necessary for the

treatment of Fabry disease when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of Fabry disease as confirmed by one the following: Absence or deficiency (< 5% of mean) of normal alpha-

galactosidase A (α-Gal A) enzyme activity) in leukocytes, dried blood spots, or serum analysis

Molecular genetic testing for deletion or mutations in the

galactosidase alpha gene; and

o Presence of clinical signs and symptoms of the disease (e.g., Acroparesthesias, angiokeratomas, whorls, anhidrosis/hypohidrosis, renal disease, exercise/heat/cold intolerance, etc.); and

o Dosing is in accordance with the United States Food and Drug

Administration approved labeling: administered dose does not exceed 1 mg/kg intravenously every two weeks; and




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(continued)

Aug. 1, 2018

For continuation therapy, all of the following: o Patient has previously received treatment with agalsidase therapy;

and

o Patient has experienced a positive clinical response to agalsidase therapy (e.g., improved renal function, reduction in mean plasma GL-3 levels, decreased GL-3 inclusions, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 1 mg/kg intravenously every two weeks; and


Kanuma (sebelipase alfa) is medically necessary for the treatment of Lysosomal acid lipase deficiency [LAL-D, Wolman disease (WD), cholesteryl ester disease (CESD)] when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of lysosomal acid lipase deficiency [LAL-D, Wolman disease (WD), cholesteryl ester disease (CESD)] as confirmed by one the

following: Absence or deficiency lysosomal acid lipase activity by dried

blood spot test Molecular genetic testing for deletion or mutations in the lipase

A, lysosomal acid type (LIPA) gene;


abdominal distention, hepatosplenomegaly, liver fibrosis, ascities, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling by one of the following:

For rapidly progressive disease presenting within the first 6

months of life: administered initial starting dose is 1 mg/kg intravenously once weekly, up to a maximum of 3 mg/kg once weekly

Pediatric and adult patients with disease: administered dose does not exceed 1 mg/kg intravenously every other week;

and


o Patient has previously received treatment with sebelipase therapy;



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(continued)

Aug. 1, 2018

and o Patient has experienced a positive clinical response to sebelipase

therapy [e.g., improved disease symptoms, improvement of

laboratory values (LFTs, cholesterol, triglycerides), etc.]; and o Dosing is in accordance with the United States Food and Drug

Administration approved labeling by one of the following:

For rapidly progressive disease presenting within the first 6 months of life: administered dose is 1 mg/kg intravenously once weekly, up to a maximum of 3 mg/kg once weekly

Pediatric and adult patients with disease: administered dose does

not exceed 1 mg/kg intravenously every other week; and


Lumizyme (alglucosidase alfa) is medically necessary for the treatment of Pompe disease when the following criteria are met:

For initial therapy, one of the following: o All of the following for infantile-onset Pompe disease:

Diagnosis of infantile-onset Pompe disease as confirmed by one the following: - Absence or deficiency (<1% of the lab specific normal mean)

acid alpha-glucosidase deficiency (GAA) activity in skin fibroblasts

- Molecular genetic testing for deletion or mutations in the GAA gene;

and Presence of clinical signs and symptoms of the disease (e.g.,

cardiac hypertrophy, respiratory distress, skeletal muscle weakness, etc.); and

Dosing is in accordance with the United States Food and Drug


Initial authorization will be for no more than 12 months; or

o All of the following for late-onset (non-infantile) Pompe disease: Diagnosis of late-onset Pompe disease as confirmed by one the

following: - Absence or deficiency (<40% of the lab specific normal

mean) acid alpha-glucosidase deficiency (GAA) activity in



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REVISED


(continued)

Aug. 1, 2018

lymphocytes, fibroblasts or muscle - Molecular genetic testing for deletion or mutations in the GAA

gene;

and Presence of clinical signs and symptoms of the disease (e.g.,

cardiac hypertrophy, respiratory distress, skeletal muscle

weakness, etc.); and Dosing is in accordance with the United States Food and Drug


Initial authorization will be for no more than 12 months. For continuation therapy, all of the following:

o Patient has previously received treatment with alglucosidase therapy; and

o Patient has experienced a positive clinical response to alglucosidase therapy (e.g., improved respiratory/cardiac function, improved

endurance, etc.); and o Dosing is in accordance with the United States Food and Drug


o Reauthorization will be for no more than 12 months. Mepsevii (vestronidase alfa-vjbk) is proven and medically necessary

for the treatment of Mucopolysaccharidosis VII (Sly syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of Mucopolysaccharidosis VII confirmed by either of the following: Absence or deficiency of fibroblast or leukocyte enzyme activity

of beta glucuronidase

Molecular genetic confirmation of mutations in the GUSB gene. and

o Presence of clinical signs and symptoms of the disease (e.g., enlarged liver and spleen, joint limitations, airway obstruction or pulmonary problems, limitation of mobility while still ambulatory, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: Administered dose does not exceed 4 mg/kg intravenously once every two weeks; and



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(continued)

Aug. 1, 2018


o Patient has previously received treatment with vestronidase therapy;

and o Patient has experienced a positive clinical response to vestronidase

therapy (e.g., improved endurance, improved functional capacity,

improved pulmonary function, etc.); and o Dosing is in accordance with the United States Food and Drug

Administration approved labeling: Administered dose does not exceed 4 mg/kg intravenously once every two weeks; and

o Reauthorization will be for no more than 12 months. Naglazyme (galsulfase) is medically necessary for the treatment of Mucopolysaccharidosis VI (Maroteaux-Lamy syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of Mucopolysaccharidosis VI confirmed by either of the following:

Absence or deficiency of fibroblast or leukocyte enzyme activity of N-acetylgalactosamine 4-sulfatase (arylsulfatase)

Molecular genetic confirmation of mutations in the ASB gene (5q13-q14);

and




For continuation therapy, all of the following: o Patient has previously received treatment with galsulfase therapy;

and o Patient has experienced a positive clinical response to galsulfase

therapy (e.g., improved endurance, improved functional capacity, reduced urine dermatan sulfate excretion, etc.); and




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REVISED


(continued)

Aug. 1, 2018 o Reauthorization will be for no more than 12 months. Vimizim (elosulfase alfa) is medically necessary for the treatment of

Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) when the following criteria are met: For initial therapy, all of the following:

o Diagnosis of Morquio A syndrome confirmed by either of the following: Absence or deficiency of fibroblast or leukocyte GALNS enzyme

activity

Molecular genetic testing for mutations in the GALNS gene (16q24.3);


kyphoscoliosis, genu valgum, pectus carinatum, gait disturbance, growth deficiency, etc.); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not

exceed 2 mg/kg IV once every week; and o Initial authorization will be for no more than 12 months.

For continuation therapy, all of the following: o Patient has previously received treatment with elosulfase alfa

therapy; and

o Patient has experienced a positive clinical response to elosulfase alfa therapy (e.g., improved endurance, improved functional capacity, reduced urine keratan sulfate excretion); and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling: administered dose does not exceed 2 mg/kg IV once every week; and


Exondys 51™ (Eteplirsen)

Jun. 1, 2018


outpatient facility infusion of Exondys 51 require

additional precertification with review by a Medical

Exondys 51™ (eteplirsen) may be covered for the treatment of Duchenne muscular dystrophy (DMD) in patients who meet ALL of the following criteria:

For initial therapy, all of the following: o Diagnosis of Duchenne muscular dystrophy by, or in consultation

with, a neurologist with expertise in the diagnosis of DMD; and o Submission of medical records (e.g., chart notes, laboratory values)

confirming the mutation of the DMD gene is amenable to exon 51 skipping; and



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REVISED

Exondys 51™ (Eteplirsen) (continued)

Jun. 1, 2018 Director or their designee; refer to the policy titled Specialty Medication


o Submission of medical records (e.g., chart notes, laboratory values) confirming patient has a 6-Minute Walk Time (6MWT) ≥ 300 meters while walking independently (e.g., without side-by-side assist, cane,

walker, wheelchair, etc.) prior to beginning Exondys 51 therapy;and o Exondys 51 is prescribed by, or in consultation with, a neurologist

with expertise in the treatment of DMD; and

o Exondys 51 dosing for DMD is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 30 mg/kg infused once weekly; and

o Initial authorization will be for no more than 8 weeks.

For continuation therapy, all of the following: o Exondys 51 is prescribed by, or in consultation with, a neurologist

with expertise in the treatment of DMD; and o Submission of medical records (e.g., chart notes, laboratory values)

demonstrating that the patient continues to have a 6-Minute Walk Time (6MWT) ≥ 300 meters while walking independently (e.g.,

without side-by-side assist, cane, walker, wheelchair, etc.). This must be measured no earlier than 4 weeks prior to a continuation

request; and o Exondys 51 dosing for DMD is in accordance with the United States

Food and Drug Administration approved labeling: maximum dosing of 30 mg/kg infused once weekly; and


Exondys 51 will not be covered for other forms of muscular dystrophy.

Ilaris® (Canakinumab)

Jun. 1, 2018

Revised conditions of coverage/precertification requirements; added language

to indicate:

o Requests for hospital outpatient facility infusion of Ilaris require additional precertification with review by a Medical Director or their designee; refer to the policy titled Specialty Medication


Ilaris® (canakinumab) is proven and medically necessary for: The treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in

patients who meet ALL of the following criteria:

For initial therapy, all of the following: o One of the following, as diagnosed by, or in consultation with, a

rheumatologist or immunologist with expertise in the diagnosis of the following: Familial Cold Autoinflammatory Syndrome (FCAS) Muckle-Wells syndrome (MWS)

and o Ilaris dosing for FCAS/MWS is in accordance with the United States



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REVISED

Ilaris® (Canakinumab) (continued)

Jun. 1, 2018

Food and Drug Administration approved labeling: maximum dosing of 3mg/kg up to 150 mg every 8 weeks; and


For continuation therapy, all of the following: o Patient is currently on Ilaris therapy for one of the following:

FCAS

MWS

and o Ilaris dosing for FCAS/MWS is in accordance with the United States

Food and Drug Administration approved labeling: maximum dosing of 3mg/kg up to 150 mg every 8 weeks; and

o Documentation of positive clinical response to Ilaris therapy; and o Reauthorization will be for no more than 12 months.

The treatment of Tumor Necrosis Factor (TNF) Receptor-Associated Periodic Syndrome (TRAPS) in patients who meet ALL of the following criteria:


o Diagnosis of TRAPS by, or in consultation with, a rheumatologist or immunologist with expertise in the diagnosis of TRAPS. and

o Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and


For continuation of therapy, all of the following: o Patient is currently receiving Ilaris therapy for TRAPS; and o Documentation of a positive clinical response to therapy, defined as a

decrease in frequency or severity of attacks; and

o Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 4

mg/kg up to 300mg every 4 weeks; and o Reauthorization will be for no more than 12 months.

The treatment of Hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in patients who meet ALL of the following criteria: For initial therapy, all of the following:

o One of the following, as diagnosed by, or in consultation with, a



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REVISED


Jun. 1, 2018

rheumatologist or immunologist with expertise in the diagnosis of the following: HIDS

MKD and

o Ilaris dosing for HIDS/MKD is in accordance with the United States

Food and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and

o Initial authorization will be for no more than 12 months. For continuation of therapy, all of the following:

o Patient is currently receiving Ilaris for one of the following: HIDS MKD and

o Documentation of a positive clinical response to therapy, defined by a decrease in frequency or severity of attacks; and

o Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of

4 mg/kg up to 300mg every 4 weeks; and o Reauthorization will be for no more than 12 months.

The treatment of Familial Mediterranean Fever (FMF) in patients who meet ALL of the following criteria:

For initial therapy, all of the following: o Diagnosis of FMF by, or in consultation with, a rheumatologist or

immunologist with expertise in the diagnosis of FMF; and o History of failure, contraindication, or intolerance to colchicine; and o Ilaris dosing for FMF is in accordance with the United States Food and

Drug Administration approved labeling: maximum dosing of 4 mg/kg

up to 300mg every 4 weeks; and


o Patient is currently receiving Ilaris for FMF; and o Documentation of a positive clinical response to therapy, defined by

a decrease in index disease flare or normalization of CRP; and o Ilaris dosing for FMF is in accordance with the United States Food and

Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and




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REVISED


Jun. 1, 2018 The treatment of Systemic Juvenile Idiopathic Arthritis (SJIA) in patients who meet ALL of the following criteria: For initial therapy, all of the following:

o Diagnosis of SJIA by, or in consultation with, a rheumatologist or immunologist with expertise in the diagnosis of SJIA; and

o Ilaris dosing for SJIA is in accordance with the United States Food

and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and

o Patient is not receiving Ilaris in combination with another biologic [e.g., Actemra]; and


o Patient is currently receiving Ilaris for SJIA; and o Documentation of a positive clinical response to therapy; and o Ilaris dosing for SJIA is in accordance with the United States Food

and Drug Administration approved labeling: maximum dosing of 4

mg/kg up to 300mg every 4 weeks; and o Patient is not receiving Iliaris in combination with another biologic

[e.g., Actemra]; and o Reauthorization will be for no more than 12 months.

Ilaris is not proven or medically necessary for the management or treatment of cardiovascular disease.

Infliximab (Remicade®, Inflectra™, Renflexis™)

Jun. 1, 2018



Remicade, Inflectra, and

Renflexis require additional precertification with review by a Medical Director or their designee; refer to the policy titled Specialty Medication Administration - Site of Care Review Guidelines

This policy refers to the following infliximab products: Inflectra™ (infliximab-dyyb) Remicade® (infliximab) Renflexis™ (infliximab-abda) A. Preferred Product

Remicade® (infliximab) is the preferred infliximab product. Coverage will be provided for Remicade® contingent on the coverage criteria in the Diagnosis-Specific Criteria section.

Coverage for Inflectra™ (infliximab-dyyb) or Renflexis™ (infliximab-abda) will be provided contingent on the criteria in this section and the coverage criteria in the Diagnosis-Specific Criteria section. In order to continue coverage, members already on Inflectra™ or Renflexis™ will be required to change therapy to Remicade® unless they meet the criteria in



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REVISED

Infliximab (Remicade®, Inflectra™,

Renflexis™) (continued)

Jun. 1, 2018

this section.

Preferred Product Criteria

Treatment with Inflectra™ (infliximab-dyyb), Renflexis™ (infliximab-abda) or other infliximab biosimilar is medically

necessary for the indications specified in this policy when the following criteria are met: o Both of the following:

One of the following: - Both of the following:

o History of a trial of at least 14 weeks of Remicade resulting in minimal clinical response to therapy and

residual disease activity. o Physician attests that in their clinical opinion the clinical

response would be expected to be superior with Inflectra or other infliximab biosimilar product, than experienced with Remicade.

or - Both of the following:

o History of intolerance or adverse event to Remicade. o Physician attests that in their clinical opinion the same

intolerance or adverse event would not be expected to occur with Inflectra or other infliximab biosimilar product.

and Both of the following:

- Patient has NOT had a loss of a favorable response after established maintenance therapy with Remicade or other infliximab product.

- Patient has NOT developed neutralizing antibodies to any

infliximab product that has led to an attenuation of efficacy of therapy.

B. Diagnosis-Specific Criteria

“Infliximab” will be used to refer to all infliximab products.

Infliximab is proven and medically necessary for the treatment of: o Ankylosing spondylitis when the following criterion is met:

Diagnosis of ankylosing spondylitis (AS).



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Jun. 1, 2018

o Crohn’s disease when the following criterion is met: One of the following:

- Diagnosis of fistulizing Crohn’s disease (Crohn’s Disease

Activity Index (CDAI) ≥ 220 and ≤ 400); or - Both of the following:

o Diagnosis of moderately to severely active Crohn’s

disease; and o History of failure, contraindication, or intolerance to at

least one conventional therapy (e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.).

o Noninfectious uveitis when BOTH of the following criteria are met: Diagnosis of refractory noninfectious uveitis that is causing or

threatening vision loss (e.g., noninfectious uveitis associated with Behçet’s or Reiter’s syndromes); and

History of failure, contraindication, or intolerance to ALL of the

following: - Topical corticosteroids;

- Systemic corticosteroids; - Immunosuppressive drugs (e.g., azathioprine, cyclosporine,

or methotrexate). o Plaque psoriasis when BOTH of the following criteria are met:

Diagnosis of chronic severe plaque psoriasis i.e., extensive

and/or disabling); and Patient is a candidate for systemic therapy.

o Psoriatic arthritis when the following criterion is met: Diagnosis of psoriatic arthritis (PsA).

o Rheumatoid arthritis when BOTH of the following criteria are met:

Diagnosis of moderately to severely active rheumatoid arthritis

(RA); and One of the following:

- Member is receiving concurrent therapy with methotrexate; - History of contraindication or intolerance to methotrexate.

o Sarcoidosis when ALL of the following criteria are met: Diagnosis of sarcoidosis; and

History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); and

History of failure, contraindication, or intolerance to one



Oxford


REVISED



Jun. 1, 2018 immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine).

o Ulcerative colitis when BOTH of the following criteria are met:

Diagnosis of moderately to severely active ulcerative colitis (UC); and

History of failure, contraindication, or intolerance to at least one

conventional therapy e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids.

There may be other conditions that qualify as serious, rare diseases for

which the use of infliximab may be appropriate. Please refer to the Benefit Considerations section of the policy for additional information.

Infliximab is unproven and not medically necessary in the treatment of: o Still’s disease

o Sjogren’s syndrome o Graft-vs-host disease

o Myelodysplastic syndromes o Undifferentiated spondyloarthropathy o Reiter’s syndrome o Hidradenitis suppurativa o Wegener’s granulomatosis

o Juvenile idiopathic arthritis (juvenile rheumatoid arthritis)

Infliximab is unproven and not medically necessary for the treatment of the above conditions because statistically robust randomized controlled trials are needed to address the issue of whether Infliximab has sufficient superiority in clinical efficacy compared to other available treatments to

justify the inherent clinical risk in the use of a monoclonal antibody anti-

tumor necrosis factor agent.

Ocrevus™ (Ocrelizumab)

Jun. 1, 2018

Updated list of related policies; added reference link to the policy titled Specialty Medication Administration - Site of Care Review Guidelines


coverage/precertification requirements; added language

Please refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines for updated information based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®) for oncology indications. Ocrevus (ocrelizumab) is proven and medically necessary for:

Primary Progressive Multiple Sclerosis Ocrevus is medically necessary for the treatment of primary



Oxford


REVISED

Ocrevus™ (Ocrelizumab) (continued)

Jun. 1, 2018

to indicate: o Requests for hospital


Ocrevus require additional precertification with review by a Medical Director or their

designee; refer to the policy titled Specialty Medication Administration - Site of Care Review Guidelines

progressive multiple sclerosis (PPMS) when ALL of the following criteria are met: o Diagnosis of primary progressive multiple sclerosis (PPMS); and

o One of the following: Initial therapy for ocrelizumab when meeting both of the

following:

- Patient is not receiving ocrelizumab in combination with any of the following: Disease modifying therapy (e.g., interferon beta

preparations, daclizumab, dimethyl fumarate, glatiramer

acetate, natalizumab, fingolimod, or teriflunomide) B cell targeted therapy (e.g., rituximab, belimumab,

ofatumumab) Lymphocyte trafficking blockers (e.g., alemtuzumab,

mitoxantrone) and

- Initial dosing: One time 300 mg intravenous course of doses on days 1 and 15.

or Continuation therapy for ocrelizumab when meeting all of the

following: - Patient has previously received treatment with ocrelizumab;

and

- Documentation of positive clinical response to ocrelizumab therapy; and


preparations, daclizumab, dimethyl fumarate, glatiramer

acetate, natalizumab, fingolimod, or teriflunomide)

B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)

Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)

and Continued dosing: One 600 mg intravenous dose every 6

months. Relapsing Forms of Multiple Sclerosis

Ocrevus is medically necessary for the treatment of relapsing



Oxford


REVISED


Jun. 1, 2018

forms of multiple sclerosis (MS) when BOTH of the following criteria are met: o Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g.,

relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses); and


Initial therapy for ocrelizumab meeting all of the following: - Patient has history of failure following a trial for at least 4

weeks or history of intolerance or contraindication to one of the following:

interferon β-1a (Avonex®, Rebif®, Plegridy™) interferon β-1b (Betaseron® or Extavia®) glatiramer acetate (Copaxone®) dimethyl fumarate (Tecfidera®) teriflunomide (Aubagio®) fingolimod (Gilenya®)

alemtuzumab (Lemtrada®) natalizumab (Tysabri®)

daclizumab (Zinbryta™) and


preparations, daclizumab, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)

B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)

Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)

and

- Initial dosing: One time 300 mg intravenous course of doses on days 1 and 15.

or Continuation therapy for ocrelizumab when meeting all of the

following: - Patient has previously received treatment with ocrelizumab;

and - Documentation of positive clinical response to ocrelizumab

therapy; and



Oxford


REVISED


Jun. 1, 2018 - Patient is not receiving ocrelizumab in combination with any of the following: Disease modifying therapy (e.g., interferon beta

preparations, daclizumab, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)

B cell targeted therapy (e.g., rituximab, belimumab,

ofatumumab) Lymphocyte trafficking blockers (e.g., alemtuzumab,

mitoxantrone) and

- Continued dosing: One 600 mg intravenous dose every 6 months.

Ocrevus is unproven and not medically necessary for the treatment of: Lupus nephritis

Rheumatoid arthritis Systemic lupus erythematosus

Orencia® (Abatacept) Injection for Intravenous Infusion

Jun. 1, 2018


outpatient facility infusion of Orencia require additional precertification with review by a Medical Director or their designee; refer to the policy titled Specialty Medication

Administration - Site of Care

Review Guidelines

This policy refers to Orencia (abatacept) injection for intravenous infusion. Orencia is proven and medically necessary for the treatment of: Polyarticular juvenile idiopathic arthritis when all of the following

criteria are met:

o Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA); and

o Orencia is initiated and titrated according to US Food and Drug Administration labeled dosing for polyarticular juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule):

10mg/kg every 4 weeks for patients weighing <75kg

1,000mg every 4 weeks for patients weighing ≥75kg and

o Member is not receiving Orencia in combination with either of the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,

Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Rheumatoid arthritis when all of the following criteria are met:



Oxford


REVISED

Orencia® (Abatacept) Injection for


Jun. 1, 2018

o Diagnosis of moderately to severely active rheumatoid arthritis; and o Orencia is initiated and titrated according to US Food and Drug

Administration labeled dosing for rheumatoid arthritis up to a

maximum of (or equivalent dose and interval schedule): 500mg every 4 weeks for patients weighing <60kg 750mg every 4 weeks for patients weighing 60kg to 100kg

1,000mg every 4 weeks for patients weighing >100kg and

o Member is not receiving Orencia in combination with either of the following:

Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Psoriatic arthritis when all of the following criteria are met:

o Diagnosis of active psoriatic arthritis (PsA); and o Orencia is initiated and titrated according to US Food and Drug

Administration labeled dosing for psoriatic arthritis up to a maximum of (or equivalent dose and interval schedule):

500mg every 4 weeks for patients weighing <60kg 750mg every 4 weeks for patients weighing 60kg to 100kg 1,000mg every 4 weeks for patients weighing >100kg and

o Patient is not receiving Orencia in combination with any of the

following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]


Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

Orencia is unproven and not medically necessary for the treatment

of: Multiple sclerosis Systemic lupus erythematosus Graft versus host disease (GVHD) Uveitis associated with Behçet's disease



Oxford


REVISED

Preventive Care Services

Jun. 1, 2018

Revised coverage rationale for Women’s Health; added language to indicate the

following services are covered under the Preventive Care Services benefit effective Jun. 1,

2018: o Screening for diabetes

mellitus for those with a history of gestational

diabetes o Screening for urinary

continence, annually Revised list of applicable

procedure and diagnosis codes for:

Preventive Care Services

Diabetes Screening

o Updated service description; added instruction to refer to the Screening for Diabetes Mellitus After Pregnancy section of policy for

information on additional diabetes screening benefits

Gestational Diabetes Mellitus

Screening o Updated service description;

added instruction to refer to

the Screening for Gestational Diabetes Mellitus and Screening for Diabetes Mellitus After Pregnancy

sections of policy for information on additional diabetes screening benefits

Wellness Examinations

o Updated service description/language

Refer to the policy for complete details on the coverage guidelines for Preventive Care Services.



Oxford


REVISED

Preventive Care Services (continued)

Jun. 1, 2018

pertaining to Health Resources and Services Administration (HRSA)

coverage requirements; added “screening for urinary incontinence” to list of

services included in codes for wellness examinations

Expanded Women’s

Preventive Health

Screening for Gestational

Diabetes Mellitus o Updated service description;

added instruction to refer to the Screening for Diabetes Mellitus After Pregnancy

section of policy for

additional information

Screening for Diabetes Mellitus After Pregnancy (new to policy)

o Added service description to indicate: The Women’s Preventive

Services Initiative [HRSA Requirement (Dec. 2017)] recommends:

Women with a history of gestational diabetes mellitus

(GDM) who are not currently pregnant and who have not previously been

diagnosed with type 2 diabetes mellitus should be screened for diabetes mellitus

Initial testing should ideally occur within



Oxford


REVISED


Jun. 1, 2018

the first year postpartum and can be conducted as

early as 4-6 weeks postpartum

Women with a

negative initial postpartum screening test result should be rescreened

at least every 3 years for a minimum of 10 years after pregnancy

See the Gestational Diabetes Mellitus

Screening, Diabetes Screening, and

Screening for Gestational Diabetes Mellitus sections of policy for additional information

o Added list of applicable CPT

codes: 36415, 36416, 82947, 82948, 82950, 82951, 82952, and 83036

o Added list of applicable ICD-10 diagnosis codes: Z00.00, Z00.01, or

Z13.1; and

Z86.32 o Added preventive benefit

instructions to indicate: The service is payable

when the listed diagnosis code requirements are

met No benefit age limit

applies



Oxford


REVISED


Jun. 1, 2018

CPT codes 36415 and 36416 are payable when billed with all of the

following: One of the

[listed/required]

diabetes screening procedure codes; and

The [listed/required]

diagnosis codes If a diabetes diagnosis

code is present in any position, the preventive benefit will not be applied; see the list of

applicable diabetes diagnosis codes

Screening for Urinary Incontinence (new to policy)

o Added service description to indicate the Women’s Preventive Services Initiative recommends screening women for urinary incontinence annually

o Added instruction to see the Wellness Examinations section of the policy for

applicable codes and preventive benefit instructions

Updated supporting information

to reflect the most current references



Oxford


REVISED

Radicava™ (Edaravone)

Jun. 1, 2018 Updated list of related policies; added reference link to the policy titled Specialty Medication



coverage/precertification requirements; added language to indicate: o Requests for hospital

outpatient facility infusion of Radicava require additional precertification with review by a Medical Director or their designee; refer to the policy titled Specialty Medication


Updated coverage rationale; reformatted/clarified coverage criterion addressing applicable diagnosis and treating physician

Radicava (edaravone) is proven and medically necessary for the treatment of amyotrophic lateral sclerosis (ALS) in patients who meet all of the following criteria:

For initial therapy, all of the following: o Submission of medical records (e.g., chart notes, previous medical

history, diagnostic testing including: imaging, nerve conduction

studies, laboratory values) to support the following: Diagnosis of “definite” or “probable” ALS per the EL Escorial / revised Airlie House diagnostic criteria, and prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS; and

o Submission of the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score confirming that the patient has scores ≥ 2 in all items of the ALSFRS-R criteria at the start of treatment; and

o Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a % forced vital capacity (%FVC) ≥ 80% at the start of treatment; and

o Radicava dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling; and

o Initial authorization will be for no more than 6 cycles (64 doses over 168 days).

For continuation therapy, all of the following: o Diagnosis of “definite” or “probable” ALS per the revised EL Escorial

and Airlie House diagnostic criteria, and prescribed by, or in

consultation with, a neurologist with expertise in the diagnosis of ALS; and

o Patient is currently receiving Radicava therapy; and o Patient is not dependent on invasive ventilation or tracheostomy;

and o Radicava dosing for ALS is in accordance with the United States Food

and Drug Administration approved labeling; and

o Authorization will be for no more than 6 cycles (60 doses over 168 days).

Radiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

Jun. 1, 2018

Reformatted and revised the Oxford Radiology Prior Notification/Authorization Crosswalk Table: o Transferred content to

embedded Excel file format o Added language to indicate

Refer to the policy for complete details on Radiology Procedures Requiring Precertification for eviCore healthcare Arrangement.

http://www.outcomes-umassmed.org/als/alsscale.aspx

http://www.outcomes-umassmed.org/als/alsscale.aspx



Oxford


REVISED

Radiology Procedures Requiring

Precertification for eviCore healthcare Arrangement

(continued)

Jun. 1, 2018 precertification given with CPT code 74177 will be allowed for claims submitted

with CPT codes 72194 and 74170

Simponi Aria® (Golimumab) Injection for

Intravenous Infusion

Jun. 1, 2018

Revised conditions of coverage/precertification requirements; added language

to indicate: o Requests for hospital

outpatient facility infusion of Simponi-Aria require additional precertification with review by a Medical Director or their designee;

refer to the policy titled Specialty Medication Administration - Site of Care Review Guidelines

This policy refers only to Simponi Aria (golimumab) injection for intravenous infusion for the treatment of ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis. Simponi, for self-administered subcutaneous injection,

is obtained under the pharmacy benefit and is indicated in the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. Simponi Aria is proven and/or medically necessary for the treatment of: Ankylosing spondylitis when all of the following criteria are met:

o Diagnosis of active ankylosing spondylitis (AS); and o Simponi Aria is initiated and titrated according to US Food and Drug

Administration labeled dosing for ankylosing spondylitis, up to a maximum of 2mg/kg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Simponi Aria in combination with either of

the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,

Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Orencia (abatacept)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Psoriatic arthritis when all of the following criteria are met:

o Diagnosis of active psoriatic arthritis (PsA); and

o Simponi Aria is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of 2mg/kg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Simponi Aria in combination with either of the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,




Oxford


REVISED

Simponi Aria® (Golimumab) Injection for


Jun. 1, 2018 Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

Rheumatoid arthritis when all of the following criteria are met:

o Diagnosis of moderately to severely active rheumatoid arthritis (RA); and


Patient is receiving concurrent therapy with methotrexate History of contraindication or intolerance to methotrexate and

o Simponi Aria is initiated and titrated according to US Food and Drug

Administration labeled dosing for rheumatoid arthritis up to a maximum of 2mg/kg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Simponi Aria in combination with either of the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,





Oxford

Policy Title Effective Date Administrative Guidelines

NEW

New York & Connecticut Participating

Surgeons Using Non- Participating Providers for

Intraoperative Neuro-Monitoring (IONM)

Jun. 1, 2018

Notice of Revision: The following Administrative Policy has been modified; revisions to the original policy update announcement are outlined in red below. Please take note of the amended guidelines to be applied beginning Jun. 1, 2018.

NY and CT Participating Providers Using Non-Participating IONM Providers

The following procedures and responsibilities apply to Participating Providers located in NY and CT when providing services to members enrolled on NY and/or CT products in an outpatient or inpatient facility setting that involve

intraoperative neuro-monitoring (IONM). Services performed by a Participating Provider located in NY or CT and meeting the following criteria must ensure that the IONM provider utlized is participating with the Oxford network. Member is enrolled on a NY or CT product; and Service is being provided in an outpatient or inpatient facility setting; and Involve intraoperative neuro-monitoring (IONM).

Outpatient and Inpatient Facility Place Codes

Place Code Description

15 Mobile diagnostic unit

19 Off campus - outpatient hospital

21 Inpatient Hospital

22 On campus - outpatient hospital

24 Ambulatory surgical center

99 Other unlisted factilty

If the Participating Provider intends to utilize an IONM provider that does not participate in the Oxford network, the provider is required to: Verbally discuss options and financial impact with the Member

o The Participating Provider must review this policy and the Non-Participating Provider Consent Form with the Member. The discussion must explain Participating and Non-Participating IONM Provider alternatives and provide

the Member with an understanding of all the providers involved in the Member’s care. The discussion must include a conversation explaining the financial impact of using a Non-Participating

IONM Provider. A copy of the Non-Participating Provider Consent Form must be provided to the Member.

o The discussion must occur no more than 90 days, and no less than 14 days before, the scheduled date of the procedure.

o If the Member does not sign the form at the end of the discussion, explain that it needs to be completed and



Oxford


NEW



Intraoperative Neuro-Monitoring (IONM) (continued)

Jun. 1, 2018

returned no less than 14 days before the scheduled date of the procedure. o The discussion must then be noted in the Member’s medical record.

Obtain a completed Non-Participating Provider Consent Form

o The member will need to agree or disagree to receive IONM services from a Non-Participating Provider by marking the appropriate box on the Non-Participating Provider Consent Form. The member must then sign and date the form and return the form to the Participating Provider no less than 14 days before the

scheduled date of the procedure. If the Member: Does not agree to the use of a Non-Participating IONM Provider: Following the discussion, if the

Participating Provider: - Is unable to locate a Participating IONM Provider, they must contact the health plan for assistance in

locating a Participating IONM Provider. - Still wants to recommend the Non-Participating IONM Provider, they must contact Oxford to request

and initiate an In-Network Exception request. Does agree to the use of a Non-Participating IONM Provider: The Participating Provider must

ensure that the Member understands the financial obligations of using a Non-Participating IONM Provider.

- For Members with out-of-network benefits: Non-Participating IONM Providers will be paid at the out-of-network benefit level. Out-of-network cost shares and deductibles will apply. In addition,

Members may be responsible to the Non-Participating IONM Provider for any amount above the amount paid by the health plan, as determined by the Member’s out-of-network benefit; or

- For Members with only in-network benefits: Non-Participating IONM Provider claims will be denied because the Member has no coverage for services provided by Non-Participating Providers. Members will therefore be responsible for the entire cost of the service(s).

o The Participating Provider must then sign and date the form to acknowledge the Member’s decision. o The Non-Participating Provider Consent Form must be kept on file by the Participating Provider. o A separate Non-Participating Provider Consent Form is required for every service when the Participating

Provider wants to refer to or involve a Non-Participating IONM Provider in a member’s care. o The Non-Participating Provider Consent Form will only be valid for 90 days from the date of member

signature.

o Oxford may request a copy of the completed Non-Participating Provider Consent Form from the Participating

Provider (who is required to keep the form on file) in order to conduct standard business. When requested, the Participating Provider must provide a copy of the Non-Participating Provider

Consent Form within 15 days of the request. If a copy of the completed Non-Participating Provider Consent Form is not received within 15 days of the

request, the Participating Provider’s claim will be denied administratively for failure to comply with this protocol.

In these instances, the Participating Provider is prohibited from balance billing the Member. Any payment previously made for the surgical service will be subject to recovery. The Participating

provider cannot balance bill the member for claims denied for administrative reasons.

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/nonpar-provider-consent-form-protocol-ohp.pdf



Oxford


NEW



Intraoperative Neuro-Monitoring (IONM) (continued)

Jun. 1, 2018 Participating IONM Providers

When a Participating Provider performs services in an outpatient or inpatient facility setting using a Participating IONM Provider, there will be no additional requirements to fulfill. A Non-Participating Provider Consent Form is not required.

Non-Compliance With This Policy

Oxford may request a copy of the completed Non-Participating Provider Consent Form from the Participating Provider

(who is required to keep the form on file) in order to conduct standard business. When requested: The Participating Provider must provide a copy of the Non-Participating Provider Consent Form within 15 days of

the request. If a copy of the completed Non-Participating Provider Consent Form is not received within 15 days of the

request, as proof that they discussed the member’s options for selecting a Participating or Non-Participating IONM Provider, in advance of the service, the Participating Provider’s claim will be denied administratively for failure to comply with the protocol.

In these instances, the Participating Provider is prohibited from balance billing the member. Any payment previously made for the service will be subject to recovery. The Participating Provider cannot balance bill the member for claims denied for administrative reasons.

In-Network Exception Requests

If requesting an In-Network Exception to have a Non-Participating IONM Provider covered as if they were participating with the Oxford network, the Participating Provider must make the exception request. The exception request will not be accepted from the Non-Participating IONM Provider. The In-Network Exception request must be made no less than 14 days in advance of the scheduled procedure in

order to avoid delays in care and alleviate potential complications with the patient’s required preparations for the procedure.

If the Participating Provider requests an In-Network Exception less than 14 days in advance of the scheduled procedure, the In-Network Exception request will be processed per Oxford’s standard guidelines, however the Participating Provider will receive an administrative denial for their claim for failure to follow protocol.


UPDATED

Accreditation Requirements for Radiology Services

May 1, 2018 Updated policy guidelines: o Modified list of modalities/procedures for AIUM accreditation; removed echocardiography (previously listed in

error; no change to accreditation guidelines) o Updated reference link to eviCore healthcare Accreditation Fax Cover Sheet; redirected from “Prior

Authorization and Notification App” to “eviCore healthcare website”



Oxford

Policy Title Effective Date Summary of Changes Administrative Guidelines

REVISED

Ambulance Services

Jun. 1, 2018

Changed policy title; previously titled Transportation Services


coverage/precertification guidelines; added language to indicate:

o Precertification with review by a Medical Director or their designee is required for all requests for out-of-the-

country transportation o In the event precertification

for air or water transportation is not feasible due to time constraints related to medical

emergencies, Oxford will require review of clinical

notes post-service and prior to payment

Revised coverage rationale:

o Replaced references to: “Patient” with “member”

“Transportation” with “ambulance”

Emergency Ambulance (Ground, Water, or Air) o Added language to indicate

the following Emergency

ambulance services are covered: Ground ambulance

transportation requiring basic life support or advanced life support

Treatment at the scene

(paramedic services) without ambulance transportation

Note: Refer to Oxford’s Ambulance policy for additional information regarding the reimbursement of ambulance transportation services. Indications for Coverage

Emergency Ambulance (Ground, Water, or Air)

Coverage includes Emergency ambulance transportation (including wait time and treatment at the scene) by a licensed ambulance service from the

location of the sudden illness or injury, to the nearest hospital where services can be performed.

Emergency transportation to an acute care hospital and/or hospital Emergency facility does not require notification, precertification or certification.

The following Emergency ambulance services are covered: Ground ambulance transportation requiring basic life support or

advanced life support

Treatment at the scene (paramedic services) without ambulance transportation

Wait time associated with covered ambulance transportation To a hospital that provides a required higher level of care that was not

available at the original hospital Air Ambulance

As a general guideline, when it would take a ground ambulance 30-60 minutes or more to transport a member whose medical condition at the time of pick-up required immediate and rapid transport due to the nature and/or severity of the member’s illness/injury, air transportation may be appropriate.

Air Ambulance transportation should meet the following criteria: The member’s destination is an acute care hospital, and The member’s condition is such that the ground ambulance (basic or

advanced life support) would endanger the member’s life or health, or Inaccessibility to ground ambulance transport or extended length of time

required to transport the member via ground ambulance transportation

could endanger the member, or Weather or traffic conditions make ground ambulance transportation

impractical, impossible, or overly time consuming.



Oxford


REVISED

Ambulance Services (continued)

Jun. 1, 2018

Wait time associated with covered ambulance transportation

To a hospital that provides a required higher level of care that

was not available at the original hospital

o Removed duplicative language pertaining to

precertification requirements (see the Conditions of Coverage section of the policy)

Non-Emergency Ambulance (Ground or Air)

o Modified language to indicate coverage includes non-

Emergency ambulance transportation by a licensed ambulance service (either ground or air ambulance, as we determine appropriate)

between facilities only when the transport meets one of the following: From an out-of-Network

Hospital to the closest Network Hospital when

Covered Health Care

Services are required To the closest Network

Hospital or facility that provides the required Covered Health Care Services that were not

available at the original Hospital or facility

From a Short-Term

Additional Information

Emergency ambulance coverage includes supplies that are needed for advanced life support or basic life support to stabilize a member’s medical

condition. Non-Emergency Ambulance (Ground or Air)

Coverage includes Non-Emergency ambulance transportation by a licensed ambulance service (either ground or Air Ambulance), between health care facilities only when the transport meets one of the following: From an out-of-network hospital or facility to the closest Network

hospital when Covered Health Care Services are required. To the closest Network hospital or facility that provides the required

Covered Health Care Services that were not available at the original hospital

From a Short-Term Acute Care Facility to the closest Network Long-Term Acute Care Facility (LTAC), Network Inpatient Rehabilitation Facility, or other Network Sub-Acute facility where the required Covered Health Care

Services can be delivered.

Additional Information

Non-emergent transportation and is covered only when the member’s specific benefit document includes coverage for non-emergent ambulance/transportation and/or coverage is required due to federal or state mandates.

Ambulance transportation that is done for convenience of the patient is not covered. Please see the Coverage Limitations and Exclusions section of the policy for more information on non-covered ambulance

transportation. Coverage Limitations and Exclusions

The following services are not eligible for coverage: Ambulance services from providers that are not properly licensed to be

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 not

covered even if rendered in an Emergency situation. Examples include but are not limited to:



Oxford


REVISED


Jun. 1, 2018

Acute Care Facility to the closest Network Long-Term Acute Care Facility

(LTAC), Network Inpatient Rehabilitation Facility, or other Network

Sub-Acute Facility where the required Covered Health Care Services can be delivered

o Added reference link to the Coverage Limitations and Exclusions section of the policy for additional information on non-covered ambulance transportation

Coverage Limitations and Exclusions

o Replaced reference to “air ambulance” with “air ambulance transportation”

o Removed language indicating ambulance

transportation that violates the notification criteria listed in the Indications for Coverage section of the policy is not covered

o Modified list of examples of

excluded ambulance

transportation for member convenience or other miscellaneous reasons to reflect/include: Member wants to be at a

certain hospital or facility

for personal/ preference reasons

Member is in foreign

o Commercial or private airline or helicopter o A police car ride to a hospital o Medi-van or wheel chair van transportation

o Taxi ride, bus ride, 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 not covered.

Ambulance transportation to a home, residential, domiciliary or custodial facility is not covered.

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 o Home (e.g., residence, nursing home, domiciliary or custodial

facility) to a hospital for a scheduled service 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, precertification 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 policy titled Emergency Room Visits (Including Coverage for Members Outside of the United States for additional information on coverage



Oxford


REVISED


Jun. 1, 2018 country, or out of state, and wants to come home for a surgical procedure

or treatment (this includes those recently discharged from

inpatient care) Member is going for a

routine service and is medically able to use

another mode of transportation

Member is deceased and family wants transportation to the coroner’s office or

mortuary Out-of-Country

Transportation o Removed duplicative

language pertaining to precertification requirements (see the Conditions of

Coverage section of the policy)

Updated definitions: o Added definition of

“Emergency” o Removed definition of:

Air Ambulance

Fixed Wing Aircraft Rotary Wing Aircraft

Updated list of applicable HCPCS

codes; revised description for

A0427

for services received outside of the United States, Mexico, Canada, and the U.S. Territories.


Reimbursement Policy Updates

Oxford


UPDATED

Maximum Frequency Per Day

May 7, 2018 Updated Maximum Frequency Per Day Code List (attachment file designating the maximum frequency per day value assignments for CDT, CPT, and HCPCS codes) to reflect quarterly code edits:

o Added 0012M, 0013M, 0035U, 0036U, 0037U, 0038U, 0039U, 0040U, 0041U, 0042U, 0043U, 0044U, 0492T, 34711, 64913, 86008, 99494, A4225, A9515, A9587, E0953, E0954, J1428, J1555, J1726, J2182, J2326, J2350, J2786, K0903, Q2041, Q5103, and Q5104

o Revised value assignments for 0394T, 0395T, 0398T, 0450T, 22854, 22859, 23101, 64636, 74713, 93592,

95886, A0384, A0392, A0396, A0422, A4224, A4337, A5200, A9575, B4081, B4082, B4083, B4164, B4172, B4176, B4178, B4180, H0003, J0638, J1575, and J3060

Updated list of Codes Restricting Modifiers LT and RT (attachment file listing codes that allow up to the MFD limit

with "bilateral" or "unilateral or bilateral" in the description or where the concept of laterality does not apply) to reflect quarterly code edits; added 0012M, 0013M, 0035U, 0036U, 0037U, 0038U, 0039U, 0040U, 0041U, 0042U, 0043U, 0044U, Q2041, Q5103, and Q5104

Services and Modifiers Not Reimbursable to Healthcare

Professionals

May 7, 2018

Updated list of Status E and X Codes to reflect quarterly code edits; added G9873, G9874, G9875, G9876, G9877, G9878, G9879, G9880, G9881, G9882, G9883, G9884, G9885, G9890, and G9891

may 2018 policy update bulletin - oxhp.com · 3 oxford ® policy update ... o test strips and...

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