![]() | Clinical UM Guideline |
Subject: Site of Care: Specialty Pharmaceuticals | |
Guideline #: CG-MED-83 | Publish Date: 09/27/2023 |
Status: Revised | Last Review Date: 08/10/2023 |
Description |
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:
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 there are no other geographically accessible appropriate alternative sites for the individual to undergo the IV infusion or injectable therapy service.
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 |
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.
The potential for severe infusion reactions poses a significant safety risk to certain individuals with a history of previous severe infusion reactions, including anaphylaxis to prior infusion therapy with a related pharmacologic or biologic agent and should be considered when identifying the appropriate site of care for the administration an IV infusion or injectable therapy service. The risk assessment should include consideration whether immediate access to specific services of a medical center/hospital setting, including emergency resuscitation equipment and personnel are needed, as well as the need for inpatient admission or intensive care services.
Definitions |
Geographically accessible: Refers to the ease of reaching a destination; the concept takes into account multiple factors, including, but not limited to: distance to and time required to get to a specific location and the logistical complexity of transport.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Websites for Additional Information |
Index |
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.
History |
Status | Date | Action |
Revised | 08/10/2023 | Medical Policy & Technology Assessment Committee (MPTAC) review. Revised formatting in Clinical Indications section. Added new MN statement addressing geographic accessibility. Added Definitions section. Revised Discussion, References, and Websites sections. |
Reviewed | 08/11/2022 | MPTAC review. Updated References and Websites sections. |
Reviewed | 08/12/2021 | MPTAC review. Updated reference and Websites sections. |
Revised | 08/13/2020 | 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. |
Reviewed | 05/14/2020 | MPTAC review. Updated References and Websites sections. |
Reviewed | 06/06/2019 | MPTAC review. Updated Discussion, References and Websites sections. |
| 03/21/2019 | Changed the document number from CG-DRUG-47 to CG-MED-83 with same title. |
Reviewed | 07/26/2018 | MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date”. Updated References and Websites sections. |
Reviewed | 08/03/2017 | MPTAC review. Formatting updated in clinical indications section. Updated References section. |
Reviewed | 08/04/2016 | MPTAC review. Updated formatting in clinical indications section. Updated Discussion, References and Index sections. |
Revised | 11/05/2015 | MPTAC review. Clarified medically necessary and not medically necessary statement. Updated Description and References sections. |
New | 08/06/2015 | MPTAC review. Initial document development. |
Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not 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 back of the member's card.
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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