CG-DME-21 External Infusion Pumps for the Administration of Drugs in the Home or Residential Care Settings

Clinical UM Guideline

Subject: External Infusion Pumps for the Administration of Drugs in the Home or Residential Care Settings
Guideline #: CG-DME-21	Publish Date: 01/03/2024
Status: Reviewed	Last Review Date: 11/09/2023

Description

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:

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

CG-MED-08 Home Enteral Nutrition

Clinical Indications

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.

Coding

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:

HCPCS
	Equipment
E0776	IV pole
E0779	Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater
E0780	Ambulatory infusion pump, mechanical, reusable, for infusion less than 8 hours
E0781	Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient
E0791	Parenteral infusion pump, stationary, single or multi-channel

	Supplies
A4221	Supplies for maintenance of drug infusion catheter, per week (list drug separately)
A4222	Supplies for external drug infusion pump, per cassette or bag (list drug separately)
K0552	Supplies for external drug infusion pump, syringe type cartridge, sterile, each

ICD-10 Diagnosis
	All diagnoses

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.

Discussion/General Information

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.

Definitions

Enteral: Route of administration through the gastrointestinal tract.

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

References

Government Agency, Medical Society, and Other Authoritative Publications:

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.
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.

Index

External Infusion Pumps

History

Status	Date	Action
Reviewed	11/09/2023	Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Description and References sections.
Reviewed	11/10/2022	MPTAC review. Updated References section.
Reviewed	11/11/2021	MPTAC review. Updated References section.
Reviewed	11/05/2020	MPTAC review. Updated Clinical Indications section and changed “Physicians’ Desk Reference” to “Prescribers’ Digital Reference”. Updated References section. Reformatted Coding section; removed codes K0601-K0605.
Reviewed	11/07/2019	MPTAC review. Updated References section.
Reviewed	11/08/2018	MPTAC review. Updated Description, Definitions, and References sections.
Reviewed	01/27/2017	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.”
Revised	02/02/2017	MPTAC review. Made minor typographical revision to Clinical Indications. Updated References section.
Revised	02/04/2016	MPTAC review. Minor language clarification made in Medically Necessary Section. Removed ICD-9 codes from Coding section.
Revised	02/05/2015	MPTAC review. Revised Title and Description sections to clarify scope of document. Added new medically necessary and not medically necessary statements for continuous administration of enteral drugs. Added Definitions section. Updated Rationale and References sections.
Reviewed	08/14/2014	MPTAC review.
Reviewed	11/14/2013	MPTAC review.
Reviewed	11/08/2012	MPTAC review. Updated References section.
Reviewed	11/17/2011	MPTAC review. Updated References section.
Reviewed	11/17/2010	MPTAC review. Updated References section.
Reviewed	11/19/2009	MPTAC review. Updated References section.
Reviewed	11/20/2008	MPTAC review.
Reviewed	11/29/2007	MPTAC review. References updated. Minor formatting changes.
Reviewed	12/07/2006	MPTAC review. References updated.
New	12/01/2005	MPTAC initial guideline development.

Pre-Merger Organizations	Last Review Date	Document Number	Title
Anthem, Inc.			No document
Anthem CO/NV	10/29/2004	DME.217	External Infusion Pumps

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.

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