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Drug Infusion Site of Care Policy

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

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

Exondys 51  
IVIG  
Inflectra (infliximab-dyyb)  
Inflectra - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators   
Lemtrada  
Ocrevus  
Radicava (edaravone)  
Remicade (infliximab)  
Remicade - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators  
Renflexis (infliximab-abda)  
Renflexis - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators  
Soliris
Tysabri

Site of Care

The first dose of the medications subject to this policy may be given at the physician’s facility of choice. This includes hospital outpatient facilities, non-hospital outpatient facilities and home care.

All subsequent doses will be subject to the Aetna Site of Care for Drug Infusion Management policy, which requires the use of non-hospital outpatient facilities or home infusion when clinically appropriate.

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 six criteria below:

  • Member is medically unstable for infusions 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.

For IVIG:

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

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
  • J1745 NDC 57894-030-01 (Remicade (infliximab)
  • J0202 NDC 58468-0200-01 (Lemtrada)
  • J2323 NDC 64406-008-01 (Tysabri)
  • 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)
  • J3490 NDC 50242-0150-01 (Ocrevus specific J code currently unassigned)
  • J3590 NDC 50242-0150-01 (Ocrevus specific J code currently unassigned)
  • C9399 NDC 50242-0150-01 (Ocrevus specific J code currently unassigned)
  • Q5102 NDC 32228-001-01 (Inflectra - infliximab-dyyb)
  • J3490, C9399 NDC 70510-2171-1; 70510-2171-2 (Radicava (edaravone))
  • Q5102 NDC: 0006-4305-02 Renflexis (infliximab-abda)

References

American Academy of Allergy, Asthma and Immunology.  Guidelines for the Site of Care for Administration of IGIV Therapy.  December 2011.

Inflectra [prescribing information]. Lake Forest, IL: Celltrion, Inc.; Nov. 2016.

Lemtrada [prescribing information]. Cambridge, MA: Genzyme Corp.; Nov. 2014.

MCG Care Guidelines, 19th Edition, 2015, Home Infusion Therapy:  CMT:  CMT-0009

Ocrevus (ocrelizumab) [prescribing information]. Genentech, Inc.  South San Francisco, CA.  March 2017.  Available online at:https://www.gene.com/download/pdf/ocrevus_prescribing.pdf. Accessed on May 16, 2017.

Katzberg H, Rasutis V, Bril V  Home iVIG for CIDP:  A Focus on Patient Centred Care  Can J Neurol Sci.  2013; 40: 384-388.

Kelly R, Hill A, Arnold L, et. al.  Long-term treatment with eculizumab in paryoxysmal nocturnal hemoglobinuria:  sustained efficacy and improved survival.  Blood 2011; 117(25):6786-6792.

Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; May 2017.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; Oct. 2015.

Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; April 2017.

Rigas M, Tandan R, Sterling R.  Safety of Liquid Intravenous Immunoglobulin for Neuroimmunologic Disorders in the Home Setting:  A Retrospective Analysis of 1085 Infusions.  J Clin Neuromusc Dis 2008; 10:52-55

Sarepta Therapeutics, Inc. Exondys 51 (eteplirsen) injection, for intravenous use. Prescribing Information. Reference ID: 3987286. Cambridge, MA: Sarepta; revised September 2016.

Souayah N, Hasan A, Khan H, et. al.  The Safety Profile of Home Infusion of Intravenous Immunoglobulin in Patients with Neuroimmunologic Disorders.  J Clin Neuromusc Dis 2011; 12:S1-S10

Tysabri [prescribing information]. Cambridge, MA: Biogen Idec Inc.; May 2016.

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