Clinical UM Guideline
Subject: Site of Care: Specialty Pharmaceuticals
Guideline #: CG-MED-83 Publish Date: 10/06/2021
Status: Reviewed Last Review Date: 08/12/2021

This document provides clinical criteria for use of outpatient infusion therapy service in the hospital outpatient department or hospital outpatient clinic site of care for intravenous (IV) infusion and injectable therapy.

Note: In some plans, “level of care,” “site of service” or another term such as “setting” or “place of service” may be the term used in benefit plans, provider contracts, or other materials instead of or in addition to “site of care” and, in some plans, these terms may be used interchangeably.

Note: Please see the following related documents for additional information:

Clinical Indications

Note: The medical necessity of the infused pharmacologic or biologic agent may be separately reviewed against the appropriate criteria. This guideline is for determination of the medical necessity of hospital outpatient site of care for the IV infusion and injectable therapy.

Medically Necessary:

An outpatient IV infusion or injectable therapy service in the hospital outpatient department or hospital outpatient clinic site of care for the use of an infused pharmacologic or biologic agent is considered medically necessary when all of the following are present:

  1. The inherent complexity or risk of the infusion required by an individual is such that it can be performed safely and effectively only by or under the general supervision of skilled nursing personnel; and
  2. The individual's medical status or therapy is such that it requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; and
  3. The potential changes in the individual’s clinical condition are such that immediate access to specific services of a medical center/hospital setting, having emergency resuscitation equipment and personnel, and inpatient admission or intensive care is necessary, for example, the individual is at significant risk of sudden life-threatening changes in medical status based on clinical conditions including but not limited to:
    1. concerns regarding fluid overload status; or
    2. history of anaphylaxis to prior infusion therapy with a related pharmacologic or biologic agent; or
    3. acute mental status changes.

Not Medically Necessary:

All other uses of outpatient IV infusion and injectable therapy services in the hospital outpatient department or hospital outpatient clinic site of care for the infusion of pharmacologic and biologic agents are considered not medically necessary.


Coding edits for medical necessity review are not implemented for this guideline. Where a more specific policy or guideline exists, that document will take precedence and may include specific coding edits and/or instructions. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Discussion/General Information

Infusion therapy (pharmacologic or biologic agents) has been proven to be safely and effectively administered in an office-based setting, infusion center or the home setting. Home-based infusion, when appropriate and available, may in some cases be supported by member preference (Chataway, 2006; Milligan, 2006; Riazi, 2011). Hospital outpatient administration of IV medications may be appropriate for complex infusions requiring direct observation or the minimization of certain treatment risks that require hospital based therapy when criteria are met.

The hospital outpatient department or hospital outpatient clinic is part of a hospital, but is designed for the treatment of outpatients; that is, individuals who do not require hospital admission.


Peer Reviewed Publications:

  1. Chataway J, Porter B, Riazi A, et al. Home versus outpatient administration of intravenous steroids for multiple-sclerosis relapses: a randomized controlled trial. Lancet Neurol. 2006; 5(7):565-571.
  2. Gutierrez-Aguirre CH, Ruiz-Arguelles G, Cantu-Rodriguez OG, et al. Outpatient reduced-intensity allogeneic stem cell transplantation for patients with refractory or relapsed lymphomas compared with autologous stem cell transplantation using a simplified method. Ann Hematol. 2010; 89(10):1045-1052.
  3. Mank A, van der Lelie J, de Vos R, Kersten MJ. Safe early discharge for patients undergoing high dose chemotherapy with or without stem cell transplantation: a prospective analysis of clinical variables predictive for complications after treatment. J Clin Nurs. 2011; 20(3-4):388-395.
  4. Milligan A, Hughes D, Goodwin S, et al. Intravenous enzyme replacement therapy: better in home or hospital? Br J Nurs. 2006; 15(6):330-333.
  5. Riazi A, Porter B, Chataway J, et al. A tool to measure the attributes of receiving IV therapy in a home versus hospital setting: the Multiple Sclerosis Relapse management Scale (MSRMS). Health Qual Life Outcomes. 2011; 9:80.
  6. Teuffel O, Ethier MC, Alibhai SM, et al. Outpatient management of cancer patients with febrile neutropenia: a systematic review and meta-analysis. Ann Oncol. 2011; 22(11):2358-2365.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Allergy Asthma and Immunology. Guidelines for the site of care for administration of IGIV therapy. December 2011. Available at: Accessed on June 9, 2021.
  2. Basch E, Hesketh PJ, Kris MG, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Onc. 2011; 29(31):4189-4198.
  3. Broyles AD, Banerji A, Barmettler S, et al. Practical guidance for the evaluation and management of drug hypersensitivity: Specific drugs. J Allergy Clin Immunol Pract. 2020; 8(95):S16-S116.
  4. NCCN Clinical Practice Guidelines in Oncology®. © 2021 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: Accessed on June 9, 2021.
Websites for Additional Information
  1. National Home Infusion Association. About home and specialty infusion. Available at: Accessed on. June 9, 2021.
  2. National Home Infusion Association. Infusion FAQs. Available at: Accessed on June 9, 2021.

Infusion therapy
Injectable therapy
Site of care
Specialty pharmaceuticals

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.







Medical Policy & Technology Assessment Committee (MPTAC) review. Updated reference and Websites sections.



MPTAC. Updated MN and NMN clinical indications to address “site of care” removing reference to level of care. Revised title to: Site of Care: Specialty Pharmaceuticals. Updated Description, References and Websites sections.



MPTAC review. Updated References and Websites sections.



MPTAC review. Updated Discussion, References and Websites sections.



Changed the document number from CG-DRUG-47 to CG-MED-83 with same title.



MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date”. Updated References and Websites sections.



MPTAC review. Formatting updated in clinical indications section. Updated References section.



MPTAC review. Updated formatting in clinical indications section. Updated Discussion, References and Index sections.



MPTAC review. Clarified medically necessary and not medically necessary statement. Updated Description and References sections.



MPTAC review. Initial document development.


Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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