Drug infusion/Injection 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 (See Site of Care for Specialty Drug Infusion/Injection applicable drug therapy below.)

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, all doses (including the starting dose(s)) must be administered at an Aetna Institutes® Gene Based, Cellular and Other Innovative Therapy (GCIT®) Network listed in the policy apply. (See Aetna Institutes® GCIT Designated Centers below)

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. (See Criteria for Medical Necessity below)

For identified gene and cellular therapies, Aetna Institutes® program GCIT Designated Network applies in place of medical necessity exception criteria. (See Aetna Institutes® GCIT Designated Centers below)

Site of care for specialty drug infusion/Injection applicable drug therapy

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
Amvuttra – effective 9/22/2022
Avsola (infliximab-axxq) – effective 9/1/2020
Bavencio – effective 7/1/2020
Benlysta IV formulation – effective 7/1/2019
Briumvi – effective 4/11/2023
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
Elevidys^GCIT effective 09/14/2023
Elfabrio – effective 8/1/2023

Enjaymo – effective 4/29/2022

Entyvio – effective 1/1/2019
Evkeeza – effective 5/7/2021
Exondys 51 – effective 1/11/2017
Fabrazyme – effective 1/1/2020
Fasenra (provider-administered) – effective 9/1/2020
Givlaari – effective 2/13/2020
Hemgenix^GCIT effective 3/17/2023
Imfinzi – effective 7/1/2020
Immune Globulins – effective 1/1/2017
Inflectra (infliximab-dyyb) – effective 7/1/2017
Jemperli – effective 7/1/2021
Kanuma – effective 1/1/2020
Keytruda – effective 7/1/2020
Lamzede – effective 7/1/2023
Lemtrada – effective 7/1/2017
Leqembi – effective 04/5/2023
Libtayo – effective 7/1/2020
Lumizyme – effective 1/1/2020
LuxturnaGCIT – 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

Opdualag – effective 6/1/2022

^GCITProduct available for administration at Aetna Institutes^® Gene Based, Cellular and Other Innovative Therapy (GCIT^®) Designated Centers.

Aetna Institutes® GCIT Designated Centers

Elevidys	Skysona
Hemgenix	Spinraza
Luxturna	Zolgensma
Qalsody	Zynteglo
Roctavian

For more information on Aetna Institutes® Gene Based, Cellular and Other Innovative Therapy (GCIT®) Designated Centers refer to our Aetna Institutes page.

For the GCIT network facility listing, refer to:

GCIT network facility listing (PDF)

GCIT network facility listing - Spanish (PDF)

Criteria for medical necessity

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.
The member is switching to a product that he/she has not received before.*
The member has experienced a gap in therapy.**

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

**Applies only to IVIG, Tysabri, and infliximab products.

The member has experienced an adverse reaction that did not respond to conventional interventions (e.g., 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.
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.
The member is medically unstable (e.g., respiratory, cardiovascular, or renal conditions).
The member has severe venous access issues that require the use of a special intervention.††
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.
For members receiving an immune checkpoint inhibitor (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Opdivo, Opdualag, Tecentriq, Yervoy and Zynyz), 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: i. Tecentriq used in combination with bevacizumab for non-small cell lung cancer (NSCLC); ii. Tecentriq used in combination with paclitaxel protein-bound for breast cancer; iii. 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).

***Applies only to IVIG, HyQvia, Alpha 1 proteinase inhibitors.

†Applies only to Tysabri, Infliximab, Elaprase, Kanuma, Aldurazyme, Cerezyme, Elfabrio, Fabrazyme, Lamzede, Lumizyme, Nexviazyme, and Xenpozyme.

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

The following information is necessary to initiate the site of care prior authorization review (where applicable): 

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
Medical records supporting the member has IgA antibodies or has developed anti-drug antibodies
Medical records supporting the member is medically unstable
Medical records supporting the member has severe venous access issues that require specialized interventions only available in the outpatient hospital setting
Medical records supporting the member has behavioral issues and/or physical or cognitive impairment and no access to a caregiver
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.

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
Elfabrio	Fabry disease	106 days
Fabrazyme	Fabry disease	106 days
Infliximab	Takayasu only	85 days
Kanuma	LAL deficiency	50 days
Lamzede	Alpha-mannosidosis	54 days
Lumizyme	Pompe disease	106 days
Mepsevii	Mucopolysacaridosis VII	50 days
Naglazyme	Mucopolysacaridosis VI	54 days
Nexviazyme	Pompe disease	106 days
Oxlumo	Primary hyperoxaluria type I	60 days
Vimizim	Mucopolysacaridosis IVA	82 days
Vpriv	Gaucher disease type I	50 days
Vyepti	Migraine prevention	50 days
Xolair	Asthma, chronic idiopathic urticaria	60 days
Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Opdivo, Opdualag, Tecentriq, Yervoy, and Zynyz)	All indications	6-month initial authorization, then up to 45 day renewal

Drug	Actemra
Indication	Rheumatoid arthritis (RA) only
Days allowed	99 days
Drug	Actemra
Indication	Polyarticular Juvenile Idiopathic Arthritis(PJIA) only
Days allowed	99 days
Drug	Actemra
Indication	Systemic Juvenile Idiopathic Arthirits (SJIA) only
Days allowed	50 days
Drug	Actemra
Indication	Castleman's disease
Days allowed	50 days
Drug	Actemra
Indication	Immunotherapy-related inflammatory arthritis only
Days allowed	99 days
Drug	Aldurazyme
Indication	Mucopolysaccharidosis I
Days allowed	54 days
Drug	Elaprase
Indication	Hunter syndrome
Days allowed	54 days
Drug	Elfabrio
Indication	Fabry disease
Days allowed	106 days
Drug	Fabrazyme
Indication	Fabry disease
Days allowed	106 days
Drug	Infliximab
Indication	Takayasu only
Days allowed	85 days
Drug	Kanuma
Indication	LAL deficiency
Days allowed	50 days
Drug	Lamzede
Indication	Alpha-mannosidosis
Days allowed	54 days
Drug	Lumizyme
Indication	Pompe disease
Days allowed	106 days
Drug	Mepsevii
Indication	Mucopolysacaridosis VII
Days allowed	50 days
Drug	Naglazyme
Indication	Mucopolysacaridosis VI
Days allowed	54 days
Drug	Nexviazyme
Indication	Pompe disease
Days allowed	106 days
Drug	Oxlumo
Indication	Primary hyperoxaluria type I
Days allowed	60 days
Drug	Vimizim
Indication	Mucopolysacaridosis IVA
Days allowed	82 days
Drug	Vpriv
Indication	Gaucher disease type I
Days allowed	50 days
Drug	Vyepti
Indication	Migraine prevention
Days allowed	50 days
Drug	Xolair
Indication	Asthma, chronic idiopathic urticaria
Days allowed	60 days
Drug	Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Opdivo, Opdualag, Tecentriq, Yervoy, and Zynyz)
Indication	All indications
Days allowed	6-month initial authorization, then up to 45 day renewal

Medication billing procedure codes

References

Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; December 2022.

Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2021.

Aduhelm [prescribing information]. Cambridge, MA: Biogen; February 2023.

Aldurazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc.; December 2019.

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

Amondys 45 [package insert]. Cambridge, MA: Sarepta Therapeutics; February 2021.

Amvuttra [package insert]. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; February 2023.

Aralast NP [package insert]. Lexington, MA: Baxalta US Inc.; December 2018.

Asceniv [prescribing information.] Kankakee, IL: CSL Behring LLC; April 2019.

Avsola [prescribing information]. Thousand Oaks, CA: Amgen Inc.; September 2021.

Bavencio [prescribing information]. Rockland, MA: EMD Serono, Inc; July 2022.

Benlysta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; July 2022.

Bivigam [prescribing information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; December 2022.

Bonilla FA. Intravenous immunoglobulin: adverse reactions and management. J Allergy Clin Immunol. 2008;122(6):1238-1239.

Briumvi [prescribing information]. Morrisville, NC: TG Therapeutics, Inc.; December 2022.

Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; December 2021.

Cinqair [prescribing information]. Frazer, PA: Teva Respiratory, LLC; February 2020.

Cinryze [prescribing information]. Lexington, MA: Shire ViroPharma Biologics Inc.; February 2023.

Crysvita [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc; June 2020.

Cutaquig [package insert]. Hoboken, NJ: Octapharma USA Inc; November 2021.

Cuvitru [package insert]. Lexington, MA: Baxalta USA Inc.; March 2023.

Elaprase [prescribing information]. Lexington, MA: Shire Human Genetic Therapies, Inc.; September 2021.

Elelyso [prescribing information]. NY, NY: Pfizer Inc.; August 2022.

Elfabrio [prescribing information]. Cary, NC: Chiesi USA, Inc.; May 2022.

Enjaymo [package insert]. Waltham, MA: Bioverativ USA Inc Inc.; March 2023.

Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; June 2022.

Evkeeza [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals Inc; February 2021.

Exondys 51 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc.; January 2022.

Fabrazyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; March 2021.

Fasenra [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.

Flebogamma 10% DIF [prescribing information]. Barcelona, Spain: Instituto Grifols, SA; November 2019.

Flebogamma 5% DIF [prescribing information]. Barcelona, Spain: Instituto Grifols, SA; November 2019.

Gammagard Liquid [prescribing information]. Lexington, MA: Baxalta US Inc; March 2021.

Gammagard S/D IgA less than 1 mcg/mL [package insert]. Lexington, MA: Baxalta US Inc; March 2021.

Gammaked [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; January 2020.

Gammaplex 5% [package insert]. Durham, NC: Bio Products Laboratory Inc; November 2021.

Gammaplex 10% [package insert]. Durham, NC: Bio Products Laboratory Inc; November 2021.

Gamunex-C [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; January 2020.

Givlaari [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals.; January 2022.

Glassia [package insert]. Lexington, MA: Baxter US Inc.; March 2022.

Hemgenix [package insert]. King of Prussia, PA: CSL Behring LLC; November 2022.

Hizentra [package insert]. Kankakee, IL: CSL Behring LLC; April 2023.

HyQvia [package insert]. Lexington, MA: Baxalta USA Inc.; March 2021.

Imfinzi [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2022.

Inflectra [prescribing information]. Lake Forest, IL: Celltrion, Inc.; April 2023.

Jemperli [prescribing information]. Philadelphia, PA: GlaxoSmithKline LLC; February 2023.

Kanuma [prescribing information]. Cheshire, CT: Alexion Pharmaceuticals Inc.; November 2021.

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

Keytruda [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; April 2023.

Lamzede [prescribing information]. Cary, NC: Chiesi USA, Inc.; February 2022.

Lemtrada [prescribing information]. Cambridge, MA: Genzyme Corp.; January 2023.

Leqembi [prescribing information]. Nutley, NJ: Eisai Inc.; January 2023.

Libtayo [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; April 2023.

Lumizyme [prescribing information]. Cambridge, MA: Genzyme Corporation; May 2022.

Luxturna [prescribing information]. Philadelphia, PA: Spark Therapeutics, Inc.; December 2019.

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

Mepsevii [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc.; December 2020.

Naglazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; December 2019.

Nexviazyme [prescribing information]. Cambridge, MA: Genzyme Corporation; August 2021.

Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline, Inc.; January 2022.

Ocrevus [prescribing information]. Genentech, Inc. South San Francisco, CA.; March 2023.

Octagam 10% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; March 2022.

Octagam 5% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; April 2022.

Onpattro (patisiran) [prescribing Information]. Alnylam Pharmaceuticals, Inc. January 2023.

Opdivo [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; February 2023.

Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; March 2022.

Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; December 2021.

Oxlumo [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals, Inc; October 2022.

Panzyga [package insert]. Lingolsheim, France : Octapharma SAS, Inc; February 2021.

Privigen [package insert]. Bern, Switzerland: CSL Behring AG; March 2022.

Prolastin-C [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; May 2020.

Qalsody [package insert]. Cambridge, MA: Biogen Inc.; April 2023.

Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; May 2022.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; October 2021.

Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; January 2022.

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

Saphnelo [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2022.

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.; February 2021.

Skysona [package insert]. Somerville, MA: Bluebird bio.; September 2022.

Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals Inc; November 2020.

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

Spinraza [package insert]. Cambridge, MA: Biogen Inc.; February 2023.

Stiehm ER. Adverse effects of human immunoglobulin therapy. Transfus Med Rev. 2013;27(3):171-178.

Tecentriq [prescribing information]. South San Francisco, CA: Genentech, Inc.; May 2023.

Tepezza [package insert]. Dublin, Ireland: Horizon Therapeutics Ireland DAC; December 2022.

Tezspire [package insert]. Thousand Oaks, CA: Amgen; February 2023.

Tysabri [prescribing information]. Cambridge, MA: Biogen Idec Inc.; April 2023.

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.

Ultomiris [prescribing information]. Boston, MA: Alexion Pharmaceuticals. Inc. July 2022.

Uplizna [prescribing information]. Gaithersburg, MD: Viela Bio, Inc.; July 2021.

Viltepso [prescribing information]. Paramus, NJ: NS Pharma, Inc.; March 2021.

Vimizim [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; December 2019.

Vpriv [prescribing information]. Lexington, MA: Shire Human Genetic Therapies Inc; September 2021.

Vyondys 53 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc. February 2021.

Vyepti [package insert]. Bothell, WA: Lundbeck Seattle Bio Pharmaceuticals, Inc; October 2022.

Xembify [package insert]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2020.

Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; July 2021.

Yervoy [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company. February 2023.

Zemaira [package insert]. Kankakee, IL: CSL Behring LLC.; September 2022.

Zolgensma [prescribing information]. Bannockburn, IL: AveXis, Inc.; February 2023.

Zynteglo [package insert]. Somerville, MA: Bluebird bio; August 2022.

Zynyz [package insert]. Wilmington, DE: Incyte Corporation; March 2023.

Legal notices

Aetna is the brand name used for products and services provided by one or more of the Aetna group of companies, including Aetna Life Insurance Company and its affiliates (Aetna).

Health benefits and health insurance plans contain exclusions and limitations.

See all legal notices