This document addresses the use of external infusion pumps in the home or residence setting for diagnoses other than diabetes or pulmonary hypertension.

Note: Please see the following documents for further information regarding other types or uses for infusion pumps:

• CG-DME-01 External (Portable) Continuous Insulin Infusion Pump
• CG-DME-09 Continuous Local Delivery of Analgesia to Operative Sites Using an Elastomeric Infusion Pump
• CG-MED-23 Home Health
• DRUG.00004 Prostacyclin Infusion Therapy and Inhalation Therapy for Treatment of Pulmonary Arterial Hypertension (epoprostenol [Flolan®], treprostinil [TYVASO™, Remodulin®], iloprost [Ventavis®])

Medically Necessary:

An external infusion pump is considered medically necessary for the administration of intravenous medications if either of the following sets of criteria (Criteria set 1 or Criteria set 2) are met:

Criteria set 1

• Parenteral administration of the drug in the home is reasonable and necessary
• An infusion pump is necessary to safely administer the drug
• The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy
• The therapeutic regimen is proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hours

 Criteria set 2

• Parenteral administration of the drug in the home is reasonable and necessary
• An infusion pump is necessary to safely administer the drug
• The drug is administered by intermittent infusion (each episode of infusion lasting less than 8 hours) that does not require the individual to return to the physician's office prior to the beginning of each infusion
• Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Physicians Desk Reference.

Not Medically Necessary:  

External infusion pumps and related supplies are considered not medically necessary when the criteria described above are not met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. 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.

An ambulatory infusion pump is an electrical or battery operated device that is used to deliver solutions containing a parenteral drug under pressure at a regulated flow rate. It is small, portable, and designed to be carried by the patient.

A stationary infusion pump is an electrical device that serves the same purpose as an ambulatory pump but is larger and typically mounted on a pole.

A reusable mechanical infusion pump is a device used to deliver solutions containing parenteral drugs under pressure at a constant flow rate determined by the tubing with which it is used. It is small, portable, and designed to be carried by the patient. It must be capable of a single infusion cycle of at least 8 hours.

This Clinical UM Guideline is based on Medicare criteria.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services. National Coverage Determination: Durable Medical Equipment Reference List.  NCD #280.1. Effective May 5, 2005. Available at:  http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd.  Accessed on September 14, 2009.
2. Centers for Medicare and Medicaid Services. National Coverage Determination: Infusion Pumps. NCD #280.14. Effective December 17, 2004. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on September 14, 2009.

External Infusion Pumps