Clinical UM Guideline
This document addresses the use of external insulin infusion pumps. Such devices are programmable, battery-powered mechanical syringe/reservoir devices controlled by a micro-computer to provide continuous subcutaneous insulin infusion (CSII) in individuals with diabetes mellitus.
Note: For additional information regarding diabetes treatment please see:
Note: Please see the following document for information regarding implantable infusion pumps:
Note: Some external insulin infusion pumps have the capability to be paired with a continuous interstitial glucose monitoring devices to create a diabetes management systems. Some such devices may be used independently as external insulin infusion pumps without an accompanying continuous interstitial glucose monitoring devices. Such devices may be considered medically necessary when the medically necessary criteria below have been met.
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 is considered medically necessary when the following criteria have been met:
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 guideline 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|
Note: Please be aware that the Medtronic MiniMed 530G, 630G, and 670G insulin pumps are not addressed in this document. Please see DME.00040 Automated Insulin Delivery Devices for information regarding the medical necessity of those devices.
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.
Insulin administration may be done in several ways. The most common method is multiple daily injections via a syringe and subcutaneous injection. Dosing of these injections is timed by the individual to coincide with expected changes in blood sugar concentrations such as occur following meals. Another common method is via external insulin infusion pump. These devices are worn externally and are attached to a temporary subcutaneous insulin catheter placed into the skin of the abdomen. The pump is controlled by a computer controlled pump mechanism that can be set to administer the insulin at a set rate or provide bolus injections as needed. The pump typically has a syringe reservoir that has a 2- to 3-day insulin capacity. 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.
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 HbA1c 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).
In 2014, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) published a consensus statement addressing insulin pump use (Grunberger, 2014). This document provided proposed clinical characteristics of individuals with both type 1 and type 2 diabetes who may be suitable insulin pump candidates. Among the proposed characteristics were labile diabetes, frequent hypoglycemia, significant 'dawn phenomenon,' and microvascular and macrovascular complications. Additionally, candidates should be undergoing self-testing for blood glucose ≥4 per day, ≥4 insulin injections daily, and have elevated HbA1c. Recommendations are also provided for the treatment of diabetes during pregnancy. Finally, they specify special characteristics for individuals who are not good candidates for insulin pump therapy, including those who are unable or unwilling to perform multiple daily injections, self-monitoring of blood glucose levels, and carbohydrate counting; those who are not motivated to achieve better blood glucose control, and individuals with serious psychological or psychiatric conditions.
The OpT2mise Study, a moderately sized, randomized, non-blinded, controlled trial involving 311 subjects with poorly controlled type 2 diabetes (HbA1c between 8.0 and 12.0%) despite multiple daily injection therapy was reported by Reznik and colleagues (2014). Following a 2 month optimization period with multiple daily injections (MDI), subjects were randomized to receive treatment with either insulin pump therapy (n=168) or continued MDI therapy (n=163). There were 16 drop-outs in the pump group and 7 in the MDI group. Once a 6 month randomization phase was completed, all subjects were treated with pump therapy for an additional 6 months. At the 6 month follow-up period, the authors reported that an intent-to-treat analysis showed that there was a significant difference in the decrease in mean HbA1c in the pump group vs. the MDI group (1.1% vs 0.4%; p<0.001). Masked 6 day continuous glucose monitoring data from baseline and at 6 months revealed significantly greater decrease in glucose concentrations in the pump group vs. the MDI group (p=0.0062), as well as significantly shorter duration of hypoglycemic events in the pump group vs. the MDI group (p=0.0007). Additionally, at the end of the study period, the total daily dose of insulin was significantly lower in the pump group vs. the MDI group (97 units vs. 122 units; p<0.0001). The authors conclude that in individuals with poorly controlled type 2 diabetes despite multiple daily injections, use of an insulin pump can be a valuable treatment option. Additional papers reporting on data from the OpT2mise Study were published in 2016 by Conget et al. and Aronson et al. The Conget paper reported that after 6 months, reductions in HbA1c levels were significantly greater with insulin pump therapy vs. MDI (1.1 ± 1.2% vs. -0.4 ± 1.1%; p<0.001). Similarly, compared with subjects receiving MDI, those receiving insulin pump therapy demonstrated significantly greater reductions in 24-hour mean sensor glucose (p=0.0023), less exposure to sensor glucose (p=0.0004) and sensor glucose > 250 mg/dL (p=0.0153), and more time in the sensor glucose range of 70-180 mg/dL (p=0.0002). No differences in exposure to sensor glucose < 70 mg/dL or in glucose variability were reported. Furthermore, changes in postprandial (4-hour) glucose area under the curve > 180 mg/dL were significantly greater with insulin pump therapy than with MDI after breakfast (p=0.0015) and after dinner (p=0.0014). The Aronson paper reported that in the randomization phase, the reduction in HbA1c was significantly greater with pump therapy than with MDI (p<0.001). The pump therapy group maintained this improvement to 12 months while the MDI group, which was switched to pump therapy, showed a 0.8% reduction. Final HbA1c levels were identical in both groups. In the randomization phase, total daily insulin dose was 20.4% lower with pump therapy than with MDI and remained stable in the continuation phase. The MDI-pump group showed a 19% decline in total daily insulin dose, such that by 12 months it was equivalent in both groups. There were no differences in weight gain or ketoacidosis between groups. One subject in each group experienced severe hypoglycemia. These results demonstrate that pump therapy has a sustained durable effect on glycemic control in uncontrolled type 2 diabetes.
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.
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:
Government Agency, Medical Society, and Other Authoritative 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.
|02/28/2018||Added note to Description section addressing external insulin infusion pumps with the capability of pairing with continuous interstitial glucose monitoring devices. The document header wording updated from “Current Effective Date” to “Publish Date.”|
|Revised||05/04/2017||Medical Policy & Technology Assessment Committee (MPTAC) review. Clarified MN criteria for replacement pumps. Updated formatting in Clinical Indications section. Updated coding section; removed S1034.|
|Revised||05/05/2016||MPTAC review. Added microvascular or macrovascular complications to MN criteria. Updated Rationale and Reference sections. Updated Coding section; removed S1035, S1036, and S1037 and ICD-9 codes.|
|Reviewed||05/07/2015||MPTAC review. Added "s" to the end of "Pump" in the title. Updated Rationale, Reference, and Index sections.|
|Revised||05/15/2014||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.|
|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. 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.|