Clinical UM Guideline

Subject:External (Portable) Continuous Insulin Infusion Pumps
Guideline #:  CG-DME-01Current Effective Date:  07/07/2015
Status:ReviewedLast Review Date:  05/07/2015


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: Please see the following document for information regarding implantable infusion pumps:

Clinical Indications

Medically Necessary: 

External insulin pumps (with or without wireless communication capability) are considered medically necessary for individuals with diabetes in any of the following groups:

  1. Individuals with documented diabetes mellitus meeting all the following criteria (a-e):
    1. Completed a comprehensive diabetes education program within the past 2 years; AND
    2. Follows a program of multiple daily injections of insulin; AND
    3. Has frequent self-adjustments of insulin doses for the past 6 months; AND
    4. Has documented frequency of glucose self-testing an average of at least 4 times per day during the past month; AND
    5. Has documentation of any of the following while on a multiple daily injection regimen:
      • Glycosylated hemoglobin level (HbAlc) greater than 7.0 percent; OR
      • "Brittle" diabetes mellitus with recurrent episodes of diabetic ketoacidosis, hypoglycemia or both, resulting in recurrent and/or prolonged hospitalization; OR
      • History of recurring hypoglycemia or severe glycemic excursions; OR
      • Wide fluctuations in blood glucose before mealtime; OR
      • "Dawn phenomenon" with fasting blood sugars frequently exceeding 200 mg/dl; OR
  2. Pre-conception or pregnancy to reduce the incidence of fetal mortality or anomaly; OR
  3. Individuals with diabetes mellitus successfully using a continuous insulin infusion pump prior to enrollment, and have documented frequency of glucose self-testing on average of at least 4 times per day during the month prior to enrollment.

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. 

Replacement pumps:

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:

  1. Current insulin pump reservoir volume; and
  2. Current insulin needs; and
  3. Current insulin change out frequency required to meet individual needs. 

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. 

A9274External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories
E0784External ambulatory infusion pump, insulin
S1034Artificial 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
S1035Sensor; invasive (eg, subcutaneous), disposable, for use with artificial pancreas device system
S1036Transmitter; external, for use with artificial pancreas device system
S1037Receiver (monitor); external, for use with artificial pancreas device system
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
 All diagnoses
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
 All diagnoses
Discussion/General Information

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).

A moderately size, 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.

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:

  1. Berghaeuser MA, Kapellen T, Heidtmann B, et al. Continuous subcutaneous insulin infusion in toddlers starting at diagnosis of type 1 diabetes mellitus. A multicenter analysis of 104 patients from 63 centres in Germany and Austria. Pediatric Diabetes. 2008; 9(6):590-595.
  2. Berthe E, Lireux B, Coffin C, et al. Effectiveness of intensive insulin therapy by multiple daily injections and continuous subcutaneous infusion: a comparison study in type 2 diabetes with conventional insulin regimen failure. Horm Metab Res. 2007; 39(3):224-229.
  3. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes. Diabetes Care. 1996; 19(4):324-327.
  4. Bruttomesso D, Pianta A, Crassolara D, et al. Continuous subcutaneous insulin infusion (CSII) in the Veneto region: efficacy, acceptability, and quality of life. Diabet Med. 2002; 19(8):628-634.
  5. Carlsson BM, Attvall S, Clements M, et al. Insulin pump-long-term effects on glycemic control: an observational study at 10 diabetes clinics in Sweden. Diabetes Technol Ther. 2013; 15(4):302-307.
  6. Danne T, Battelino T, Jarosz-Chobot P, et al.; PedPump Study Group. Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries. Diabetologia. 2008; 51(9):1594-1601.
  7. DeVries JH, Snoek FJ, Kostense PJ, et al. A randomized trial of continuous subcutaneous insulin infusion and
    intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control. Diabetes
    Care. 2002; 25(11):2074-2080.
  8. Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329(14):977-986.
  9. Fatourechi MM, Kudva YC, Murad MH, et al. Clinical review: Hypoglycemia with intensive insulin therapy: a systematic review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus multiple daily injections. J Clin Endocrinol Metab. 2009; 94(3):729-740.
  10. Halvorson M, Carpenter S, Kaiserman K, Kaufman FR. A pilot trial in pediatrics with the sensor-augmented pump: combining real-time continuous glucose monitoring with the insulin pump. J Pediatr. 2007; 150(1):103-105. e1.
  11. Hanaire-Broutin H, Melki V, Bessieres-Lacombe S, Tauber JP. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. The Study Group for the Development of Pump Therapy in Diabetes. Diabetes Care. 2000; 23(9):1232-1235.
  12. Hirsch IB, Farkas-Hirsch R, Skyler JS. Intensive insulin therapy for treatment of Type 1 diabetes. Diabetes Care. 1990; 13(12):1265-1283.
  13. Jakisch BI, Wagner VM, Heidtmann B, et al. Comparison of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) in paediatric Type 1 diabetes: a multicentre matched-pair cohort analysis over 3 years. Diabet Med. 2008; 25(1):80-85.
  14. Jeitler K, Horvath K, Berghold A, et al. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis. Diabetologia. 2008; 51(6):941-951.
  15. Kitzmiller JL, Gavin LA, Gin GD, et al. Preconception care of diabetes. Glycemic control prevents congenital anomalies. JAMA. 1991; 265(6):731-736.
  16. Mastrototaro JJ, Cooper KW, Soundararajan G, et al. Clinical experience with an integrated continuous glucose sensor/insulin pump platform: a feasibility study. Adv Ther. 2006; 23(5):725-732.
  17. Nathan DM, Zinman B, Cleary PA, et al.; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009; 169(14):1307-1316.
  18. Nuboer R, Borsboom GJ, Zoethout JA, et al. Effects of insulin pump vs. injection treatment on quality of life and impact of disease in children with type 1 diabetes mellitus in a randomized, prospective comparison. Pediatr Diabetes. 2008; 9(4 Pt 1):291-296.
  19. Pańkowska E, Błazik M, Dziechciarz P, et al. Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials. Pediatr Diabetes. 2009; 10(1):52-58. 
  20. Pickup J, Keen H. Continuous subcutaneous insulin infusion at 25 years: evidence base for expanding use of insulin pump therapy in type 1 diabetes. Diabetes Care. 2002; 25(3):593-598.
  21. Pohar SL. Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm Real-Time System. Issues Emerg Health Technol. 2007; (105):1-6.
  22. Raskin P, Bode BW, Marks JB, et al. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized, parallel-group, 24-week study. Diabetes Care.  2003; 26(9):2598-2603.
  23. Reznik Y, Cohen O, Aronson R, et al.; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014; 384(9950):1265-1272.
  24. Sanfield, JA, Hegstad M, Hanna RS. Protocol for outpatient screening and initiation of continuous subcutaneous insulin infusion therapy: impact on cost and quality. Diabetes Educ. 2002; 28(4):599-607.
  25. Selam JL, Charles MA, Devices for insulin administration. Diabetes Care. 1990; 13(9):955-979.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Diabetes Association. Standards of Medical Care in Diabetes—2015. Diabetes Care. 2014; 38(Suppl 1):S1-S93.  Available at:  Accessed on February 16, 2015.
  2. American Association of Clinical Endocrinologists (AACE). American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011; 17(2):287-302.
  3. American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care. 2014; 37(Suppl 1):S14-S80.
  4. Centers for Medicare and Medicaid Services. National Coverage Determination for Infusion Pumps. NCD #280.14. Effective February 4, 2005. Available at: Accessed on February 16, 2015.
  5. Fullerton B, Jeitler K, Seitz M, et al. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2014;(2):CD00912.
  6. Misso ML, Egberts KJ, Page M, et al. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010;(1):CD005103.
  7. Silverstein J, Klingensmith G, Copeland K, et al. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care. 2005; 28(1):186-212.
Websites for Additional Information
  1. American Diabetes Association. Insulin Pumps. Available at:  Accessed on March 16, 2015.

Insulin Infusion Systems
JewelPUMP™ 2
Paradigm REAL-Time System
Portable External Insulin Pump
Solo™ MicroPump
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.

Reviewed05/07/2015Medical Policy & Technology Assessment Committee (MPTAC) review.  Added "s" to the end of "Pump" in the title.  Updated Rationale, Reference, and Index sections.
Revised05/15/2014MPTAC 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.
Reviewed05/09/2013MPTAC review.
Revised05/10/2012MPTAC 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.
Reviewed05/19/2011MPTAC 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.
Revised05/13/2010MPTAC 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.
 02/25/2010Updated Coding section; removed HCPCS codes A4230, A4231, A4232, J1817, S9145.
Reviewed05/21/2009MPTAC review. Updated Reference section.
Revised05/15/2008MPTAC 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.
Reviewed02/21/2008MPTAC review. Updated Reference section.
 01/01/2008Updated coding section with 01/01/2008 HCPCS changes.
Revised03/08/2007MPTAC 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.
Revised03/23/2006MPTAC review.
 11/18/2005Added reference for Centers for Medicare & Medicaid Services (CMS) -National Coverage Determination (NCD).
New04/28/2005MPTAC initial guideline development.