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Drug Infusion Site of Care Policy

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
Aldurazyme-effective 1/1/2020 Alpha 1 proteinase inhibitors (Glassia, Prolastin C, Aralast NP, Zemaira)-effective 1/1/2020
Benlysta IV formulation - effective 7/1/2019  
Cerezyme-effective 1/1/2020
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
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
Lemtrada - effective 7/1/2017  
Lumizyme-effective 1/1/2020
Luxturna* - effective 3/9/2018  
Mepsevii-effective 1/1/2020
Naglazyme-effective 1/1/2020
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
Ultomiris- effective 3/15/2019
Vimizim-effective 1/1/2020
Vpriv-effective 1/1/2020
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
  • 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 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
  • Gillette Children’s Specialty Healthcare – Saint Paul, MN
  • 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
  • Seattle Children’s Hospital – Seattle, WA
  • Texas Children Clinic – Houston, TX
  • University of Kentucky – Lexington, KY

 

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.
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 administration of intravenous medication infusion 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 an infusion.
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 infusion therapy AND the patient does not have access to a caregiver.

 

 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 an infusion
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

For situations where administration of the medication does not meet the criteria for outpatient hospital infusion, 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:

Drug

Indication

Days Allowed

Actemra

Rheumatoid arthritis (RA) only

99 days

Actemra

Polyarticular Juvenile Idiopathic Arthritis(PJIA) only

99 days

Actemra

Systemic Juvenile Idiopathic Arthirits (SJIA) only

50 days

Actemra

Castleman's disease

50 days

Actemra

Immunotherapy-related inflammatory arthritis only

99 days

Aldurazyme

Mucopolysaccharidosis I

54 days

Elaprase

Hunter syndrome

54 days

Fabrazyme

Fabry disease

106 days

Infliximab

Takayasu only

85 days

Kanuma

LAL deficiency

50 days

Lumizyme

Pompe disease

106 days

Mepsveii

Mucopolysacaridosis VII

50 days

Naglazyme

Mucopolysacaridosis VI

54 days

Vimizim

Mucopolysacaridosis IVA

82 days

Vpriv

Gaucher disease type I

50 days

*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

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

Applicable codes

  • J0585
  • J1300
  • J1301
  • J1428
  • J1459
  • J1460
  • J1555
  • J1556
  • J1557
  • J1559
  • J1560
  • J1561
  • J1566
  • J1568
  • J1569
  • J1572
  • J1575
  • J1599
  • J2350
  • J3262
  • J3380
  • Q5103
  • J0202
  • J3398
  • J0490
  • J3490, C9399 NDC 71336-1000-1 Onpattro (patisiran)
  • J0129
  • J1745
  • Q5104
  • J1602
  • J2323
  • J3490, J3590, C9399 NDC 25682-022-01 (Ultomiris)
  • J0598
  • J0256
  • S9346
  • J0180
  • J0220
  • J0221
  • J1322
  • J1458
  • J1743
  • J1786
  • J1931
  • J2840
  • J3060
  • J3385
  • J3397

References

Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; May 2018.

Alexion Pharmaceuticals. Inc. Ultomiris (ravulizumab-cwvz) injection, for intravenous use. Prescribing Information. Reference ID: 4367173. Boston, MA: Alexion Pharma; revised December 2018b

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

Benlysta [prescribing information]. Rockville, MA: GlaxoSmithKline; April 2019.

Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; April 2014.

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

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

Luxturna [prescribing information]. Philadelphia, PA: Spark Therapeutics, Inc.; December 2017.

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.

Onpattro (patisiran) [prescribing Information]. Alnylam Pharmaceuticals, Inc. 8/2018.

Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June 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.

Scheinman SJ and Drezner MK. Hereditary hypophosphatemic rickets and tumor-induced osteomalacia. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed September 2017.

Simponi Aria [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; Oct. 2017.

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.

Ultragenyx Pharmaceutical Inc. CRYSVITA (burosumab-twza) injection, for subcutaneous use. Prescribing Information. Novato, CA: Ultragenyx Pharmaceutical Inc; revised April 2018.

U.S. Food and Drug Administration (FDA). FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia. Silver Spring, MD: FDA; April 21, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604810.htm. Accessed April 24, 2018.

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