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Medical Policy

Policy Num:       01.001.005
Policy Name:     External Infusion Pumps
Policy ID:          [01.001.005]    [Ar / B / M + / P ]        [1.01.08]  

Archived

Last Review:      December 27, 2019
Next Review:     N/A
Issue:                   12:2019

Related Policies BCBSA: 1.01.30 Artificial Pancreas

External Infusion Pumps

Summary

An external infusion pump (EIP) is a portable device intended to provide continuous ambulatory drug infusion therapy over an extended time period. The EIP is also known as an external pump, ambulatory pump, or a mini-infuser. The EIP is usually the size of a portable cassette player and can be worn on a belt around the patient’s waist or from a shoulder harness. It is a battery driven device.

Proposed drug delivery routes using the EIP include the intravenous, intra-arterial, sub-cutaneous, intraperitoneal, epidural, intrathecal, and intraventricular routes. A heparinized saline solution may be used during an interruption of drug therapy to maintain catheter patency. The EIP is battery powered, and drug reservoir refilling is non-invasive. A catheter from the pump is attached to the desired access route for drug delivery.

Objective

The objective of this evidence review is to evaluate the use of an external infusion pump (EIP) as an alternative to provide medically necessary prolonged delivery of parenteral medication in the ambulatory setting.

Policy Statements

Use of the EIP for the administration of the following drugs is considered medically necessary for selected patients on:

• morphine and other parenteral analgesics for treatment of severe, chronic cancer pain  that is resistant to conventional therapy. Acceptable routes are subcutaneous (SC) andintravenous (IV);
• insulin for treatment of insulin-dependent diabetes mellitus in patients who cannot be controlled by intermittent dosing. Acceptable routes are SC and IV;
• heparin for treatment of severe thromboembolic disease that cannot be managed conventionally(e.g., complicated pregnancy). Acceptable routes are SC and IV;
• chemotherapeutics for treatment of cancer. Acceptable routes are stipulated in the drug labelingand might include either IV or intra-arterial (IA).

Policy Guidelines

Patient selection is key to appropriate utilization of the EIP. Factors relevant to the selection of EIP candidates may include several of the following conditions:

• Patient is ambulatory and treatment can be appropriately delivered on an outpatient basis, with an expected improvement in the quality of life;
• Drug therapy is ongoing and a therapeutic advantage is expected by using continuous (or pulsatile) infusion rather than intermittent injections;
• Patient is otherwise treatable only by conventional infusion pump in an institutional setting, or compliance difficulties make intermittent injection ineffective;
• Patient education protocols are documented and emergency support is available when unexpected adverse events occur; and
• Presence of favorable technical factors, such as a convenient, safe, and reliable EIP delivery system along with correct placement of the needle and catheter exist.

Benefit Application

BlueCard/National Account Issues

Portable external infusion pumps are adjudicated under Durable Medical Equipment. There are over 600 different models of pumps, most of which have been received clearance for marketing by the Food and Drug Administration (FDA) through a pre-notification application (510 (K)).

Background

An external infusion pump is a medical device used to deliver fluids into a patient’s body in a controlled manner. There are many different types of infusion pumps, which are used for a variety of purposes and in a variety of environments.

Infusion pumps may be capable of delivering fluids in large or small amounts, and may be used to deliver nutrients or medications – such as insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers.

Some infusion pumps are designed mainly for stationary use at a patient’s bedside. Others, called ambulatory infusion pumps, are designed to be portable or wearable.

A number of commonly used infusion pumps are designed for specialized purposes. These include:

• Enteral pump - A pump used to deliver liquid nutrients and medications to a patient’s digestive tract.
• Patient-controlled analgesia (PCA) pump - A pump used to deliver pain medication, which is equipped with a feature that allows patients to self-administer a controlled amount of medication, as needed.
• Insulin pump - A pump typically used to deliver insulin to patients with diabetes. Insulin pumps are frequently used in the home.

Infusion pumps may be powered electrically or mechanically. Different pumps operate in different ways. For example:

• In a syringe pump, fluid is held in the reservoir of a syringe, and a moveable piston controls fluid delivery.
• In an elastomeric pump, fluid is held in a stretchable balloon reservoir, and pressure from the elastic walls of the balloon drives fluid delivery.
• In a peristaltic pump, a set of rollers pinches down on a length of flexible tubing, pushing fluid forward.
• In a multi-channel pump, fluids can be delivered from multiple reservoirs at multiple rates.
• A "smart pump" is equipped with safety features, such as user-alerts that activate when there is a risk of an adverse drug interaction, or when the user sets the pump's parameters outside of specified safety limits.

Regulatory Status

Text

Rationale

A search of the literature was completed through the MEDLINE database for the period of January 1992 through May 1995. The search strategy focused on references containing the following Medical Subject Headings:
- Infusion Pumps
- Portable or External or Ambulatory
Research was limited to English-language journals on humans.
See also:
TEC Evaluations 1989: p. 59

Population Reference No. 1 Policy Statement

morphine and other parenteral analgesics for treatment of severe, chronic cancer pain that is resistant to conventional therapy. Acceptable routes are subcutaneous (SC) and intravenous (IV);

Population Reference No. 2 Policy Statement

insulin for treatment of insulin-dependent diabetes mellitus in patients who cannot be controlled by intermittent dosing. Acceptable routes are SC and IV;

Population Reference No. 3 Policy Statement

heparin for treatment of severe thromboembolic disease that cannot be managed conventionally (e.g., complicated pregnancy). Acceptable routes are SC and IV;

Population Reference No. 4 Policy Statement

chemotherapeutics for treatment of cancer. Acceptable routes are stipulated in the drug labeling and might include either IV or intra-arterial (IA).

Supplemental Information

Practice Guidelines and Position Statements

Medicare National Coverage

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist and compliance with these policies is required where applicable. See the DME MAC LCDs for External Infusion Pump (L33794). (Accessed August 26, 2019)                                                                                       

References

1 MEDICARE NATIONAL COVERAGE DETERMINATION FOR INFUSION PUMPS (ID #280.14); EFFECTIVE DATE, 12/17/2004, ACCESSED VIA INTERNET SITE WWW.CMS.GOV/MEDICARE-COVERAGE-DATABASE ON 12/18/2012, 1/2/19.

2. MEDICARE LOCAL COVERAGE DETERMINATION FOR EXTERNAL INFUSION PUMPS – CGS ADMINISTRATORS (L11555); EFFECTIVE DATE, 1/1/2015, ACCESSED VIA WWW.CMS.GOV/MCD/VIEWLCD 2/13/15. (NOTE: THIS LCD HAS BEEN RETIRED, KEEPING AS A REFERENCE FOR STAFF TO USE WHEN NEEDING TO REFER TO PRIOR CRITERIA OF PARENTERAL INTROPIC THERAPY FOR CLINICAL STATUS).

3. MEDICARE LOCAL COVERAGE DETERMINATION FOR EXTERNAL INFUSION PUMPS – CGS ADMINISTRATORS (L33794); EFFECTIVE DATE 3/29/18, ACCESSED VIA WWW.CMS.GOV/ ON 1/2/1

Codes

Appplicable Modifiers

Policy History