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 infusions administered by health care professionals:

Actemra IV formulation - effective 1/1/2019   
Crysvita - effective 7/13/2018   
Entyvio - effective 1/1/2019   
Exondys 51 - effective 1/11/2017  
IVIG - effective 1/1/2017  
Inflectra (infliximab-dyyb) - effective 7/1/2017  
Inflectra - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators - effective 7/1/2017  
Lemtrada - effective 7/1/2017  
Luxturna* - effective 3/9/2018  
Ocrevus - effective 05/23/2017  
Onpattro - effective 08/23/2018  
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
Tysabri - effective 7/1/2017

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

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

Site of Care

The first dose 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 Luxturna gene therapy, 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

Aetna considers hospital outpatient facility medication infusion medically necessary for members that have been documented as meeting one or more of the criteria below:

• Member is medically unstable for administration of medication at alternate levels of care as noted by any of the following:
  • Documented clinical history of cardiopulmonary conditions that may cause an increased risk of severe adverse reactions
  • An inability to safely tolerate intravenous volume loads, including from unstable renal function
  • Unstable vascular access
  • Physical or cognitive impairments such that home infusion, where appropriate, would present an unnecessary health risk
• Member is initiating therapy.
• Member is reinitiating therapy after not being on therapy for at least 6 months.
• Member has a previously documented severe or potentially life-threatening adverse event during or following infusion of the prescribed drug, and the adverse event cannot be managed through pre-medication in the home or office setting.
• The drug requested is subject to limited distribution and is not available for administration at non-hospital outpatient facilities or for home infusion.

• Member is changing to a different immune globulin product. (Applicable to IVIG only)
• Member has immunoglobulin A (IgA) deficiency with anti-IgA antibodies. (Applicable to IVIG only)

If the member does not meet any of the above criteria, and the proposed hospital outpatient facility is considered a least costly site of care, hospital outpatient infusion would be approved.

Applicable codes

• J1300
• J1459
• J1460
• J1557
• J1559
• J1561
• J1566
• J1567
• J1568
• J1569
• J1571
• J1572
• J1573
• J3262 NDC 50242-135-01; 50242-136-01; 50242-137-01 (Actemra IV formulation)
• J3490 NDC 69794010201 or 69794020301 or 69794030401 (Crysvita specific J Code is currently unassigned)
• J3590 NDC 69794010201 or 69794020301 or 69794030401 (Crysvita specific J Code is currently unassigned)
• C9399 NDC 69794010201 or 69794020301 or 69794030401 (Crysvita specific J Code is currently unassigned)
• J3380 NDC 64764-300-20 (Entyvio)
• J3490 NDC 60923-0284-10 or 60923-0363-02 (Exondys 51 specific J code currently unassigned)
• C9399 NDC 60923-0284-10 or 60923-0363-02 (Exondys 51 specific J code currently unassigned)

• J1602 NDC 57894-350-01 (Simponi Aria)
• J2323 NDC 64406-008-01 (Tysabri)