Clinical UM Guideline
|Subject:||External (Portable) Continuous Insulin Infusion Pump|
|Guideline #:||CG-DME-01||Current Effective Date:||07/01/2014|
|Status:||Revised||Last Review Date:||05/15/2014|
An external insulin infusion pump is a programmable, battery-powered mechanical syringe/reservoir device controlled by a micro-computer to provide continuous subcutaneous insulin infusion (CSII) in individuals with diabetes mellitus. Typically, the syringe has a two to three day insulin capacity and is connected to an infusion set attached to a small needle or cannula which is inserted into the subcutaneous tissue. The syringe and pump devices are battery operated and controlled by a small computer that is programmed to deliver a steady "basal" amount of insulin. Pumps may also release a "bolus" dose at meals and at programmed intervals. The purpose of the insulin pump is to provide an accurate, continuous, controlled delivery of insulin which can be regulated by the user to achieve intensive glucose control objectives and to prevent the metabolic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis. Other more recently developed devices are not battery powered and rely on mechanical instillation of programmed basal and bolus insulin. This document addresses the medically necessary uses of these devices.
Note: Please see the following document for information regarding implantable infusion pumps:
Note: Please note that there are differences between the MiniMed® Paradigm 522 and 722 model insulin pumps, the Guardian® REAL-Time Continuous Glucose Monitoring System, MiniMed® 530G, the MiniMed® Paradigm® REAL-Time System, and the MiniMed Paradigm Revel™ Insulin Pump, which incorporate both an insulin pump and continuous interstitial glucose monitoring devices. See the information below for more complete descriptions of these devices.
External insulin pumps (with or without wireless communication capability) are considered medically necessary for individuals with diabetes in any of the following groups:
Use of a disposable external insulin pump with wireless communication capability to a hand-held control unit (for example, OmniPod®) is an acceptable alternative to a standard insulin infusion pump and considered medically necessary when the criteria above have been met.
Refills for medically necessary disposable external insulin pumps are considered medically necessary.
The medical necessity of replacement external insulin pumps for pediatric individuals who require a larger insulin reservoir will be considered on a case-by-case basis. The following information is required when submitting requests:
The replacement of external insulin pumps that are out of warranty, are malfunctioning, and cannot be refurbished is considered medically necessary.
Not Medically Necessary:
The use of external insulin pumps for any indication other than those listed above is considered not medically necessary.
Use of a disposable external insulin pump with no wireless communication capability (for example, V-Go®) is considered not medically necessary under all circumstances.
Replacement of currently functional and warranted insulin pumps for the sole purpose of receiving the most recent insulin pump technology (commonly referred to as an "upgrade") is considered not medically necessary as such upgrades have not been shown to make a clinically significant difference.
Equipment upgrades or accessories whose sole purpose is to integrate (with wireless communication technology) an insulin pump and interstitial glucose monitor are considered not medically necessary.
Note: Intensive diabetic management in any form, including the use of external insulin infusion pumps, is CONTRAINDICATED for individuals (or for children, their caregivers) who for any reason are unwilling or unable to participate actively in intensive glucose management and to acquire the cognitive and technical skills required by their regimen.
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.
|A9274||External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories|
|E0784||External ambulatory infusion pump, insulin|
|S1034||Artificial pancreas device system (eg, low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices|
|S1035||Sensor; invasive (eg, subcutaneous), disposable, for use with artificial pancreas device system|
|S1036||Transmitter; external, for use with artificial pancreas device system|
|S1037||Receiver (monitor); external, for use with artificial pancreas device system|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
Diabetes mellitus, the fourth leading cause of death in the U.S., is a chronic condition marked by impaired metabolism of carbohydrate, protein and fat affecting nearly 21 million Americans. The underlying problem in diabetes is in the production or utilization of insulin, the hormone secreted by the pancreas that controls the level of blood sugar by regulating the transfer of glucose from the blood into the cells. Diabetes mellitus, if poorly controlled, can cause cardiovascular disease, retinal damage that could lead to blindness, damage to the peripheral nerves, and injury to the kidneys. Management of diabetes mellitus involves attempting to keep the blood sugar in normal ranges without causing potentially dangerous hypoglycemia, or low blood sugar. In type 1 diabetes, insulin usually has to be injected several times a day under the skin to maintain blood sugar control. In type 2 diabetes, control is typically achieved through diet, exercise, and/or various medications; although in some instances administration of insulin may be required as well.
Since the publication of the Diabetes Control and Complication Trial (1993), there has been a growing body of evidence to suggest that improved blood glucose control in diabetics leads to improved clinical outcomes, especially with regard to long-term diabetic complications. This has led to an approach of intensive diabetic management to maintain blood glucose to as near normal as possible over all hours of the day and over the life span of the individual. Implementation of this approach requires the individual to be capable of, and committed to, a day-to-day medical program of some complexity. It requires ongoing compliance with multiple daily glucose measurements and insulin injections accompanied by appropriate adjustments in insulin dose. Additionally, successful intensive diabetic management requires response to a variety of external factors including changes in diet, exercise and the presence of infection. Despite this complexity, many motivated individuals can, with adequate training and support, achieve significant improvements in glucose control using this approach. Both multiple daily insulin injections and continuous subcutaneous insulin infusion via an external pump are effective means of providing intensive diabetic management (DCCT Research Group, 1993). Controlled trials comparing these insulin delivery methods show that in most individuals overall blood glucose control is the same or slightly improved with insulin pump treatment. However, in diabetics treated with insulin pumps, hypoglycemia is less frequent and nocturnal glucose control is improved.
The evidence supports the efficacy of the external insulin infusion pump for properly trained diabetics who are not well controlled on intensive, multi-dose insulin therapy. Benefits are seen in long-term control as shown by lowered glycosylated hemoglobin A1c levels. In addition, stability of blood glucose self-measurement values as well as surveyed functional status and quality of life outcomes have been shown to improve in individuals using continuous insulin pump therapy.
The use of external insulin infusion pumps requires careful selection of individuals, meticulous monitoring, and thorough education and long-term ongoing follow-up. This care is generally provided by a multidisciplinary team of health professionals with specific expertise and experience in the management of individuals on insulin pump treatment.
Definitive, agreed upon selection criteria for continuous insulin infusion have not been established. Intensive insulin therapy has been shown to reduce complications and improve outcome in pregnant women with type 1 diabetes, and external insulin pump therapy is considered an appropriate alternative to multiple daily injections for this group (Kitzmiller, 1991). There is also evidence to support the use of external insulin pump therapy for type 1 diabetics who have not achieved adequate glucose control despite multiple daily injections. There is evidence to suggest that insulin pumps may benefit individuals with various types of glycemic excursions such as the "dawn phenomenon" (early morning rise in blood glucose), nocturnal hypoglycemic episodes, hypoglycemic unawareness, and severe hypoglycemia (Hirsch, 1990; Pickup, 2002; Selam, 1990).
An external insulin infusion pump is a U.S. Food and Drug Administration (FDA) approved mechanical device used to deliver insulin to manage diabetes mellitus. The pump is about the size of a deck of cards, weighs about 3 ounces, and can be worn on a belt or in a pocket. It contains a cartridge reservoir filled with fast acting insulin. The pump connects to narrow flexible plastic tubing that ends with a needle inserted just under the skin near the abdomen. Users set the pump to give a steady trickle or "basal" amount of insulin continuously throughout the day. Pumps also release additional ("bolus") doses of insulin at meals and at times when blood sugar is too high based on user input. Frequent blood glucose monitoring is essential to determine insulin dosages and to ensure that insulin is delivered appropriately. Most modern pumps tend to be quite reliable, with premature malfunction or failure rarely occurring.
External insulin pump technology has evolved in the past several years beyond the simple battery powered pump. Several models currently available provide various forms of wireless connectivity to separate parts of the pump device or to other types of devices.
One such pump, the Insulet OmniPod®, involves two separate devices with wireless radiofrequency connection. The first part of this device, referred to as the "Pod," is a disposable self-adhesive unit that incorporates an insulin reservoir, a microcomputer controlled insulin pump, and a cannulation device. The "Pod" portion of the device is filled with insulin by the individual and then adhered to the skin with an automated cannula inserter. The "Pod" is worn for up to 72 hours and then replaced. The second portion of the device, referred to as the "PDM," or "Personal Diabetes Manager," is a hand-held control unit which communicates wirelessly with the "Pod" to control basal-rate and bolus insulin administration. This PDM also contains a blood glucose monitor (not a continuous interstitial monitor) which is integrated into the control system of the "Pod," allowing individuals to use this data in dosage calculations. The PDM incorporates a FreeStyle™ blood glucose meter which works similarly to a stand-alone blood glucose monitor, requiring the traditional finger-stick method of blood sample acquisition. Once the "Pod" is activated and programmed, it is not necessary for the PDM to remain with the individual until it is used again to check blood glucose levels, give bolus dosages or adjust the basal infusion rate.
Another type of wireless insulin pump device involves the connection between an external insulin pump and a continuous glucose sensor/transmitter. One such device is the Medtronic MiniMed Paradigm REAL-Time System, which incorporates the MiniMed paradigm model insulin pump (models 522, 722 and newer) with the MiniMed continuous glucose sensor and MiniLink™ REAL-Time Transmitter. With this system, the continuous glucose sensor-transmitter wirelessly transmits interstitial glucose concentration data (288 readings in a 24-hour period) to the pump unit, which displays it in "real time." However, the data transmitted via the wireless feed cannot be seamlessly used for dosage calculations. Such calculations require blood glucose measurements. A glucose sensor/transmitter device may also be wirelessly integrated with an externally worn continuous glucose receiver/monitor (for example, Guardian® REAL-Time Continuous Glucose Monitoring System).
A newer type of mechanical disposable insulin pump (V-Go®) has been proposed as an alternative to standard pump therapy. At this time, there is no clinical trial data comparing this type of device to a standard battery operated pump devices. The safety and efficacy has not been sufficiently evaluated to demonstrate equivalent clinical outcomes.
Modern external infusion pumps appear safe and reliable, and studies reviewed did not indicate a need for a "back-up" pump. If an insulin pump fails, an individual can and should revert to daily multiple injections until the pump is repaired or replaced.
Some pediatric individuals experience increased insulin requirements which exceed the capabilities of the insulin reservoir of their current external insulin pump. In such cases, it may be reasonable to replace their existing pump with a model that has a reservoir that meets their insulin requirements. Requests for this type of equipment upgrade would be reviewed individually taking into account the unique needs of the individual and capacity of existing equipment.
Glycemic: Having to do with blood sugar (glucose) levels.
Glycosylated hemoglobin (HbA1c) test: A laboratory test that provides the percentage of a specific type of modified hemoglobin in the blood. This test ascertains the level of diabetic blood glucose control over the past three to four months.
Medtronic Guardian® REAL-Time Continuous Glucose Monitoring System: A continuous glucose monitoring system for either periodic or continuous monitoring of interstitial glucose levels. This system is comprised of three separate components, a glucose sensor, a MiniLink transmitter and a receiver/monitor device attached to the belt. The sensor and transmitter are attached to each other and affixed to the skin of the abdomen. Data collected by sensor is then wirelessly transmitted to the receiver/monitor device which then displays it in real-time. The receiver/monitor can also display trend information and sound alerts when glucose measurements are out of a pre-set range.
Medtronic MiniMed Paradigm® Model Insulin Pump: An external insulin pump model. Some Paradigm model pumps (models 522, 722 and newer) have the capability of wireless communication with the MiniMed continuous interstitial glucose sensor/transmitter devices, which are available separately from the Paradigm pump, or may be purchased as a combined system that is marketed under the name MiniMed Paradigm REAL-Time System (see below). All Medtronic MiniMed Paradigm® insulin pumps currently marketed in the U.S. are compatible with MiniMed interstitial glucose sensor/transmitter devices.
Medtronic MiniMed Paradigm® REAL-Time System: A device that integrates a Medtronic MiniMed Paradigm model external insulin pump (models 522, 722 and newer) with a Medtronic MiniMed continuous interstitial glucose sensor and transmitter via wireless communication technology. This system has all the functionality of the Paradigm external insulin pumps, as well as those described above for the Guardian REAL-Time Continuous Glucose Monitoring System. The system is comprised of three components, a glucose sensor, a MiniLink transmitter and the Paradigm pump, which acts as the receiver/monitor device for the continuous glucose monitoring data.
OmniPod®: An external insulin pump sold by Insulet Corp. This device has two separate units, a disposable "Pod" portion affixed to the skin that acts as the insulin pump and reservoir and a hand-held control unit referred to as a Personal Diabetes Manager or "PDM." The PDM also incorporates a FreeStyle blood glucose (not continuous) monitor. The OmniPod is not a continuous interstitial glucose monitoring device.
Peer Reviewed Publications:
|Websites for Additional Information|
Insulin Infusion Systems
Paradigm® REAL-Time System
Portable External Insulin Pump
Subcutaneous External Insulin Pump
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Revised||05/15/2014||Medical Policy & Technology Assessment Committee (MPTAC) review. Added Not Medically Necessary statement addressing disposable, non-wireless pump devices. Updated Reference section. Updated Coding section; added S1034, S1035, S1036 and S1037 HCPCS updates effective 07/01/2014.|
|Reviewed||05/09/2013||MPTAC review. No change to position statement.|
|Revised||05/10/2012||MPTAC review. Deleted position statement regarding pumps with wireless communications capability. Revised first medically necessary statement to address wireless pump devices. Added new medically necessary statement regarding pump refills. Updated Reference section.|
|Reviewed||05/19/2011||MPTAC review. Deleted criteria # 2 in the position section addressing external insulin pumps with wireless communication to a compatible continuous glucose monitoring sensor/transmitter This criteria required meeting criteria in DME.00005 Glucose Monitoring and Related Supplies. Updated Coding and Reference sections.|
|Revised||05/13/2010||MPTAC review. Deleted medically necessary criteria for external insulin pump requiring individuals to be seen by their medical provider four times within the last year. Updated Reference section and Appendix.|
|02/25/2010||Updated Coding section; removed HCPCS codes A4230, A4231, A4232, J1817, S9145.|
|Reviewed||05/21/2009||MPTAC review. No change to position statement. Updated Reference section.|
|Revised||05/15/2008||MPTAC review. Added medically necessary statement regarding disposable external insulin pump with wireless communication capability to a hand-held control unit. Added medically necessary statement regarding replacement of external insulin pumps for pediatric individuals. Added not medically necessary statement regarding equipment upgrades or accessories whose sole purpose is to integrate an insulin pump and interstitial glucose monitor. Updated Rationale, Discussion, Definitions and Reference sections.|
|Reviewed||02/21/2008||MPTAC review. Updated Reference section.|
|01/01/2008||Updated coding section with 01/01/2008 HCPCS changes.|
|Revised||03/08/2007||MPTAC review. Added "Continuous" to title. Revised medically necessary criteria to allow for individuals with Dawn phenomenon. Added medically necessary criteria requiring documentation of frequent adjustments in dose over a period of 6 months. Added medically necessary criteria for individuals who have had successful use of an insulin pump prior to enrollment. Updated Discussion, Reference, Coding, and Index sections.|
|11/18/2005||Added reference for Centers for Medicare & Medicaid Services (CMS) -National Coverage Determination (NCD).|
|New||04/28/2005||MPTAC initial guideline development.|