This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. It provides the criteria used to determine the medical necessity of hospital outpatient administration as the site of service for identified specialty medications.

This policy applies to the following therapies administered by health care professionals:

Actemra IV formulation - effective 1/1/2019
Adakveo-effective 2/1/2020
Aldurazyme-effective 1/1/2020
Alpha 1 proteinase inhibitors (Glassia, Prolastin C, Aralast NP, Zemaira)-effective 1/1/2020
Avsola (infliximab-axxq) – effective 9/1/2020
Bavencio-effective 7/1/2020
Benlysta IV formulation - effective 7/1/2019  
Cerezyme-effective 1/1/2020
Cinqair – effective 9/1/2020
Cinryze-effective 1/1/2020
Crysvita - effective 7/13/2018   
Elaprase-effective 1/1/2020
Elelyso-effective 1/1/2020
Entyvio - effective 1/1/2019   
Exondys 51 - effective 1/11/2017
Fabrazyme-effective 1/1/2020
Fasenra (provider-administered) – effective 9/1/2020
Givlaari-effective 2/1/2020
Imfinzi-effective 7/1/2020
Immune Globulins - effective 1/1/2017
Inflectra (infliximab-dyyb) - effective 7/1/2017
Inflectra - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators - effective 7/1/2017
Kanuma-effective 1/1/2020
Keytruda-effective 7/1/2020
Lemtrada - effective 7/1/2017
Libtayo-effective 7/1/2020
Lumizyme-effective 1/1/2020
Luxturna* - effective 3/9/2018
Mepsevii-effective 1/1/2020
Naglazyme-effective 1/1/2020
Nucala (provider-administered) – effective 9/1/2020
Ocrevus - effective 05/23/2017
Onpattro - effective 08/23/2018
Opdivo - effective 7/1/2020
Orencia IV formulation - effective 1/1/2019
Radicava (edaravone) - effective 7/20/2017
Remicade (infliximab) - effective 7/1/2017
Remicade - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators - effective 7/1/2017
Renflexis (infliximab-abda) - effective 9/1/2017
Renflexis - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators - effective 9/1/2017
Simponi Aria - effective 1/1/2019
Soliris - effective 1/1/2017
Tecentriq - effective 7/1/2020
Tepezza – effective 7/1/2020
Tysabri - effective 7/1/2017
Ultomiris- effective 3/15/2019
Uplizna- effective 9/1/20
Viltepso-effective 11/10/20
Vimizim -effective 1/1/2020
Vpriv - effective 1/1/2020
Vyepti – effective 7/1/2020
Vyondys 53 - effective 3/1/2019
Xolair – effective 9/1/2020
Yervoy - effective 7/1/2020
Zolgensma^ – effective 7/1/2019

*Product is available for administration at Aetna Gene Therapy Designated Centers identified below:

• Bascom Palmer Eye Institute – Miami, FL
• Baylor Eye Center – Houston, TX
• Casey Eye Institute (Oregon Health Sciences) – Portland, OR
• Massachusetts Eye and Ear – Boston, MA
• Penn Medicine, Scheie Eye Institute – Philadelphia, PA
• The Vision Center at Children's Hospital – Los Angeles, CA
   

^Product is available for administration at Aetna Gene Therapy Designated Centers identified below:

• Akron Children's Hospital (Children's Hospital Medical Center of Akron) – Akron, OH
• Children's Hospital of Colorado – Aurora, CO
• Children's Hospital of Dallas – Dallas, TX
• Children's Hospital Los Angeles – Los Angeles, CA
• Children’s Hospital of Michigan – Detroit, MI
• Children's Hospital of Philadelphia – Philadelphia, PA
• Children's Mercy Hospital – Kansas City, MO
• Cincinnati Children’s Hospital and Medical Center – Cincinnati, OH
• Columbia University Medical Center – New York, NY
• Cook Children’s Medical Center – Fort Worth, TX
• Doernbecher Children’s Hospital – Portland, OR
• Hershey Medical Center Pennsylvania State University Pediatric – Hershey, PA
• Integris Southwest Medical Center – Oklahoma City, OK
• Massachusetts General Hospital – Boston, MA
• Nationwide Children’s Hospital – Columbus, OH
• Rady Children’s Hospital San Diego – San Diego, CA
• Ronald Reagan UCLA Medical Center – Los Angeles, CA
• Texas Children Clinic – Houston, TX
• University of Kentucky – Lexington, KY
• University of Rochester Medical Center Health System, Strong Memorial Hospital – Rochester, NY

Site of Care

The starting dose(s) of the medications subject to this policy may be given at the physician’s facility of choice only when multiple administrations are required and provided that the medication is available and not subject to limited distribution. For identified gene and cellular therapies, Aetna Gene Therapy Designated Centers listed in the policy apply.

This includes hospital outpatient facilities, non-hospital outpatient facilities and home care. In the event the therapy is represented by a single administration, the policy applies to the first administration.

All subsequent doses will be subject to the Aetna Site of Care for Drug Administration policy, which requires the use of non-hospital outpatient facilities or home care.

Clinical rationale and documentation must be provided for review of Medical Necessity exceptions.  

Criteria for Medical Necessity

  I.        CRITERIA FOR APPROVAL FOR ADMINISTRATION IN OUTPATIENT-HOSPITAL SETTING

This policy provides coverage for administration of therapy in an outpatient hospital setting for up to 45 days^^ when ANY of the following criteria are met:
A.    The member is new to therapy or reinitiating therapy after not being on therapy for at least 6 months. For Xolair only, the member is new to therapy or reinitiating therapy after not being on therapy for at least 3 months.
B.    The member is switching to a product that he/she has not received before.**
C.    The member has experienced a gap in therapy.^†

This policy provides coverage for provider administered therapies in an outpatient hospital setting when ANY of the following criteria are met:
A.    The member has experienced an adverse reaction that did not respond to conventional interventions (eg, acetaminophen, steroids, diphenhydramine, fluids or other pre-medications) or a severe adverse event (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures) during or immediately after administration.
B.    The member either has immunoglobulin A (IgA) deficiency with anti-IgA antibodies^†† or has developed anti-drug antibodies^§ which increases the risk for infusion related reactions.
C.    The member is medically unstable (eg respiratory, cardiovascular, or renal conditions).
D.    The member has severe venous access issues that require the use of a special intervention.^†††
E.    The member has significant behavioral issues and/or physical or cognitive impairment that would impact the safety of the administration AND the patient does not have access to a caregiver.
F.    For members receiving an immune checkpoint inhibitor (Bavencio, Imfinzi, Keytruda, Libtayo, Opdivo, Tecentriq, and Yervoy), ANY of the following additional criteria also apply:
       1.     The member is within the initial 6 months of starting therapy.
       2.     The member is continuing on a maintenance regimen that includes provider administered combination chemotherapy including but not limited to:
               a. Tecentriq used in combination with bevacizumab for non-small cell lung cancer (NSCLC)
               b. Tecentriq used in combination with paclitaxel protein-bound for breast cancer
               c. Keytruda in combination with pemetrexed for NSCLC
       3.     The member is experiencing severe toxicity requiring continuous monitoring (e.g. Grade 2-4 bullous dermatitis, transaminitis, pneumonitis, Stevens-Johnson syndrome, acute pancreatitis, primary adrenal insufficiency aseptic meningitis, encephalitis, transverse myelitis, myocarditis, pericarditis, arrhythmias, impaired ventricular function, conduction abnormalities)

 II.        REQUIRED DOCUMENTATION

The following information is necessary to initiate the site of care prior authorization review (where applicable): 
A.    Medical records supporting the member has experienced an adverse reaction that did not respond to conventional interventions or a severe adverse event during or immediately after administration
B.    Medical records supporting the member has IgA antibodies or has developed anti-drug antibodies
C.    Medical records supporting the member is medically unstable
D.    Medical records supporting the member has severe venous access issues that require specialized interventions only available in the outpatient hospital setting
E.    Medical records supporting the member has behavioral issues and/or physical or cognitive impairment and no access to a caregiver
F.    Medical records supporting the member is receiving provider administered combination chemotherapy.    

For situations where administration of the medication does not meet the criteria for outpatient hospital administration, coverage for the medication is provided when administered in alternative sites such as; physician office, home infusion or ambulatory care.

^^A duration greater than 45 days will be allowed for members initiating therapy for any of the following drugs and corresponding indications:

**Applies only to IVIG, infliximab and alpha-1-anti-trypsin products

† Applies only to IVIG, Tysabri, and infliximab products

†† Applies only to IVIG, HyQvia, Alpha 1 proteinase inhibitors

††† Does not apply to drugs administered by subcutaneous injection

§ Applies only to Tysabri, Infliximab, Elaprase, Kanuma, Aldurazyme, Cerezyme, Fabrazyme and Lumizyme

Applicable codes

• J0517
• J0585
• J3490, J3590, C9399 NDC 00078-0883-61 Adakveo (crizanlizumab)
• J3490, J3590, C9399 NDC 71336-1001-01 Givlaari (givosiran)
• J3490, J3590, C9399 NDC 60923-0465-02 Vyondys 53 (golodirsen)
• J1300
• J1301
• J1428
• J1459
• J1460
• J1555
• J1556
• J1557
• J1559
• J1560
• J1561
• J1566
• J1568
• J1569
• J1572
• J1575
• J1599
• J2182
• J2350
• J2786
• J3262
• J3380
• Q5103
• J0202
• J3398
• J0490
• J3490, C9399 NDC 71336-1000-1 Onpattro (patisiran)
• J0129
• J1745
• Q5104
• J1602
• J2323
• J2357
• J3490, J3590, C9399 NDC 25682-022-01 (Ultomiris)
• J0598
• J0256
• S9346
• J0180
• J0220
• J0221
• J1322
• J1458
• J1743
• J1786
• J1931
• J2840
• J3060
• J3385
• J3397
• J9228
• J9023
• J9173
• J9271
• J9119
• J9299
• J9022
• J3490, J3590, C9399, NDC 75987-0130-15 (Tepezza)
• J3490, J3590, C9399, NDC 67386-0130-51 (Vyepti)
• J3490, J3590, C9399, NDC 72677-0551-01 (Uplinza)
• J3490, J3590, C9399 NDC 73292-0011-01 (Viltepso)