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 2/13/2020
Aduhelm – effective 8/3/2021
Aldurazyme-effective 1/1/2020
Alpha 1 proteinase inhibitors (Glassia, Prolastin C, Aralast NP, Zemaira)-effective 1/1/2020
Amondys 45 – effective 6/1/2021
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   
Evkeeza – effective 5/7/21  
Exondys 51 - effective 1/11/2017
Fabrazyme-effective 1/1/2020
Fasenra (provider-administered) – effective 9/1/2020
Givlaari-effective 2/13/2020
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
Jemperli – effective 7/1/2021
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
Nexviazyme – effective 10/7/2021
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
Oxlumo – effective date 3/17/2021
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
Saphnelo – effective 10/7/2021
Simponi Aria - effective 1/1/2019
Soliris - effective 1/1/2017
Spinraza^#- effective 7/1/2021
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:

• Baylor Eye Center – Houston, TX
• Cincinnati Children’s Hospital – Cincinnati, OH
• Massachusetts Eye and Ear – Boston, MA
• The Vision Center at Children's Hospital – Los Angeles, CA
• Children’s Hospital of Philadelphia – Philadelphia, PA
• Oregon Health & Science University Hospital - Casey Eye Institute – Portland, OR
• University of Iowa Hospital and Clinics – Iowa City, IA
• University Of Michigan Medical Center – Kellogg Eye Center – Ann Arbor, MI

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

• Akron Children's Hospital – Akron, OH
• Boston Children's Hospital – Boston, MA
• Children's Healthcare of Atlanta - Scottish Rite Hospital/Egleston Children's Hospital – Atlanta, GA
• Children's Hospital and Medical Center – Omaha, NE
• Children's Hospital of Colorado – Aurora, CO
• Children's Hospital of Dallas – Dallas, TX
• Children’s Hospital of the Kings Daughters – Norfolk, VA
• Children's Hospital Los Angeles – Los Angeles, CA
• Children’s Hospital of Michigan – Detroit and Grand Blanc, MI
• Children’s Hospital of New Orleans – New Orleans, LA
• 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
• Gillette Children’s Specialty Healthcare – Saint Paul, MN
• Goryeb Children’s Hospital at Morristown Medical Center – Morristown, NJ
• Integris Southwest Medical Center – Oklahoma City, OK
• Jackson Memorial Hospital – Miami, FL
• Joe DiMaggio Children's Hospital – Hollywood, FL
• Lucile Packard Children's Hospital – Palo Alto, CA
• Massachusetts General Hospital – Boston, MA
• Memorial Hospital Regional – Hollywood, FL
• Milton Hershey Medical Center Pennsylvania State University – Hershey, PA
• Nemours Children’s Hospital Delaware – Wilmington, DE
• Nemours Children’s Hospital – Orlando, FL
• Nicklaus Children's Hospital – Miami, FL
• Oregon Health & Science University Hospital – Doernbecher Children's Hospital – Portland, OR
• OU Medicine – Children’s Hospital – Oklahoma City, OK
• Rady Children’s Hospital San Diego – San Diego, CA
• Ronald Reagan UCLA Medical Center – Los Angeles, CA
• Seattle Children’s Hospital – Seattle, WA
• Stanford Medical Center – Standford, CA
• Texas Children’s Clinic – Houston, TX
• University of Iowa Hospital and Clinics – Iowa City, IA
• University of Kansas, Kansas City, KS
• University of Kentucky – Lexington, KY
• University Of Michigan Medical Center – C S Mott Children's Hospital – Ann Arbor, MI
• University of Rochester Medical Center Health System – Strong Memorial Hospital – Rochester, NY
• University of Wisconsin Hospital and Clinics – Madison, WI

#Product is available for administration at Aetna Gene Therapy Designated Centers

• Banner University Medical Center Tucson Campus – Tucson, AZ
• Banner University Medical Center Phoenix Campus – Phoenix, AZ
• Boston Children's Hospital – Boston, MA
• Diamond Children’s Hospital, part of Banner University Tucson Campus – Tucson, AZ
• Children's Healthcare of Atlanta – Scottish Rite Hospital/Egleston Children's Hospital – Atlanta, GA
• Children's Hospital and Medical Center – Omaha, NE
• Children’s Hospital Colorado – Aurora, CO
• Children’s Hospital Los Angeles (The Vision Center) – Los Angeles, CA
• Children’s Hospital of the Kings Daughters – Norfolk, VA
• Children’s Hospital of Michigan – Grand Blanc, MI
• Children’s Hospital of Michigan – Detroit, MI
• Children’s Hospital of Philadelphia – Philadelphia, PA
• Children’s Medical Center of Dallas – Dallas, TX
• Children’s Mercy Hospital – Kansas City, MO
• Children's National Medical Center – Washington, DC
• Cincinnati Children’s Hospital – Cincinnati, OH
• Cook Children’s Medical Center – Fort Worth, TX
• Gillette Children’s Specialty Hospital – St. Paul, MN
• Goryeb Children's Hospital at Morristown Medical Center – Morristown, NJ
• Joe DiMaggio Children's Hospital – Hollywood, FL
• Memorial Hospital Regional – Hollywood, FL
• Milton Hershey Medical Center Pennsylvania State University – Hershey, PA
• Lucile Packard Children's Hospital – Palo Alto, CA
• Nemours Children’s Hospital Delaware – Wilmington, DE
• Nemours Children’s Hospital – Orlando, FL
• Nicklaus Children's Hospital – Miami, FL
• Ohio State University Hospital – Columbus, OH
• Oregon Health & Science University Hospital - Doernbecher Children's Hospital – Portland, OR
• OU Medicine – Children’s Hospital – Oklahoma City, OK
• Rady Children’s Hospital San Diego – San Diego, CA
• Seattle Children’s Hospital – Seattle, WA
• Stanford Medical Center – Standford, CA
• University of Iowa Hospital and Clinics – Iowa City, IA
• University of Kansas – Kansas City, KS
• University Of Michigan Medical Center – C S Mott Children's Hospital – Ann Arbor, MI
• University of Wisconsin Hospital and Clinics – Madison, WI

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, Jemperli, 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,  Lumizyme, and Nexviazyme

Applicable codes

• J0517
• J0585
• J0791
• J0223
• J1429
• J1300
• J1301
• J1428
• J3590, C9399, NDC 61755-0010-01, 61755-0013-01 (Evkeeza)
• J1459
• J1460
• J1555
• J1556
• J1557
• J1559
• J1560
• J1561
• J1566
• J1568
• J1569
• J1572
• J1575
• J1599
• J2182
• J2326
• J2350
• J2786
• J3262
• J3380
• Q5103
• J0202
• J3398
• J0490
• J0222
• J0129
• J3490, C9399, NDC 71336-1002-01 (Oxlumo)
• J1745
• Q5104
• J1602
• J2323
• J2357
• J1303
• J0598
• J0256
• S9346
• J0180
• J0220
• J0221
• J1322
• J1458
• J1743
• J1786
• J1931
• J2840
• J3060
• J3385
• J3397
• Q5121
• J9228
• J9023
• J9173
• J9271
• J9119
• J9299
• J9022
• J3241
• J3032
• J1823
• J1427
• J3490, C9399, NDC 60923-0227-02 (Amondys 45)
• J3490, J3590, C9399, J9999, NDC 00173-0898-03 (Jemperli)
• J3590, NDC 64406-0102-02, 64406-0101-01 (Aduhelm)
• J3590, NDC 00310-3040-00 (Saphnelo)
• J3590, NDC 58468-0426-01 (Nexviazyme)