Clinical UM Guideline

This document addresses the use of external infusion pumps for the administration of parenteral or enteral drugs in the home or other residential care settings for diagnoses other than diabetes mellitus or pulmonary hypertension. The administration of oral or enteral nutrition is not addressed in this document.

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

• CG-DME-09 Continuous Local Delivery of Analgesia to Operative Sites using an Elastomeric Infusion Pump during the Post-Operative Period
• CG-DME-50 Automated Insulin Delivery Systems
• CG-DME-51 External Insulin Pumps
• CG-DME-42 Continuous Glucose Monitoring Devices
• CG-MED-23 Home Health

Note: Please see the following document for information regarding the administration of oral or enteral nutrition:

• CG-MED-08 Home Enteral Nutrition

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) is met:

Criteria set 1

• Parenteral administration of the drug in the home is reasonable and necessary; and
• An infusion pump is necessary to safely administer the drug; and
• The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy; and

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; and
• An infusion pump is necessary to safely administer the drug; and
• 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; and
• Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Prescribers’ Digital Reference.

An external infusion pump is considered medically necessary for the administration of enteral medications when all of the following criteria have been met:

• The infusion pump is necessary to safely administer the drug; and
• The drug is administered in a time and rate limited infusion in accordance with its U.S. Food & Drug Administration (FDA) prescribing information label.

Not Medically Necessary:

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

An external infusion pump is considered not medically necessary for the administration of enteral medications when the criteria above have not been 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.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

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

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 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 individual being treated. It must be capable of a single infusion cycle of at least 8 hours.

Enteral: Route of administration through the gastrointestinal tract.

Parenteral: Route of administration other than the gastrointestinal tract (for example, intravenous, intramuscular, intraperitoneal).

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services. National Coverage Determinations. Available at: https://www.cms.gov/medicare-coverage-database/search.aspx. Accessed on September 8, 2023.
   • Durable Medical Equipment Reference List. NCD #280.1. Effective May 16, 2023.
   • Infusion Pumps. NCD #280.14. Effective December 17, 2004.
2. Carbidopa and levodopa (Duopa) [Product Information], North Chicago, IL. AbbieVie Inc. January 31, 2015. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203952s000lbl.pdf. Accessed on September 8, 2023.

External Infusion Pumps

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.