Subject:

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:

• CG-MED-23 Home Health
• CG-SURG-10 Ambulatory or Outpatient Surgery Center Procedures
• CG-SURG-52 Site of Care: Hospital-Based Ambulatory Surgical Procedures and Endoscopic Services

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.

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