Description:
An external insulin infusion pump is a battery-operated device worn about the waist and attached to a subcutaneous needle or catheter that provides continuous infusion of insulin. The purpose of the insulin pump is to provide an accurate, continuous, controlled delivery of insulin that can be regulated by the user to achieve intensive glucose control objectives. This document addresses the medically necessary uses of these devices.

Policy:
External insulin infusion pumps are considered MEDICALLY NECESSARY durable medical equipment for persons with diabetes who meet the criteria listed below:

A. Members must meet ALL of these criteria:

OR

B. The member has been on a pump prior to enrollment with the current plan and has documented frequency of glucose self-testing an average of at least four times per day during the month prior to enrollment with the current plan.

OR

Preconception or pregnancy to reduce the incidence of fetal mortality or anomaly

Notes on external insulin infusion pumps:

• External subcutaneous insulin infusion pumps are only considered medically necessary for persons who have demonstrated ability and commitment to comply with a regimen of pump care, frequent self-monitoring of blood glucose and careful attention to exercise and diet.
• The pump must be ordered by and follow-up care of the member must be managed by a physician with experience managing persons with insulin infusion pumps and who works closely with a team including nurses, diabetic educators and dieticians who are knowledgeable in the use of insulin infusion pumps.
• Documentation of continued medical necessity of the external insulin infusion pump requires that the member be seen and evaluated by the treating physician at least once every six months.
• Some external insulin infusion pumps are able to take results of the blood glucose reading, wirelessly transmit the results from the blood glucose monitor to the pump and automatically adjust the insulin infusion rate. Wireless transmission from the blood glucose monitor to the pump and automated insulin infusion rate adjustment are considered integral features of the external insulin infusion pump and blood glucose monitor.

Notes on repair or replacement of external insulin infusion pumps:

• An individualized letter of medical necessity is needed from the ordering physician indicating the technical or mechanical problem that makes the current pump unstable in its use.
• Any M.D. office notes that document the member has been seen by physician for pump therapy management, including problems related to the pump.
• And documentation that the pump is no longer under warranty. (If the pump is under warranty, the pump should be replaced at no charge to the member/health plan.)

Replacement or repair of an item that has been misused or abused by the member or member's caregiver/family will be the responsibility of the member.

**Note** For Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid, please see policy CAM 10120. 

Rationale
Diabetes mellitus, the fourth leading cause of death in the United States, 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 that 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 lifespan 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 that 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 that 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 that 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.

References:

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.
26. American Diabetes Association. Standards of Medical Care in Diabetes—2015. Diabetes Care. 2014; 38(Suppl 1):S1-S93. Available at: http://professional.diabetes.org/admin/UserFiles/0%20-%20Sean/Documents/January%20Supplement%20Combined_Final.pdf. Accessed on February 16, 2015.
27. 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.
28. American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care. 2014; 37(Suppl 1):S14-S80.
29. Centers for Medicare & Medicaid Services. National Coverage Determination for Infusion Pumps. NCD #280.14. Effective February 4, 2005. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on February 16, 2015.
30. 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.
31. 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.
32. 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.
33. U. S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Infusion pumps. Medicare Coverage Issues Manual §60-14. HCFA Pub. 6. Baltimore, MD: HCFA; 2000.
34. No authors listed. American Diabetes Association: Clinical practice recommendations 1995. Diabetes Care. 1995;18(Supp 1):1-96.
35. No authors listed. Implementation of treatment protocols in the Diabetes Control and Complications Trial. Diabetes Care. 1995;18(3):361-376.
36. American Diabetes Association. Continuous subcutaneous insulin infusion. Diabetes Care. 2003;26 Suppl 1:S125.
37. Medtronic MiniMed. The Paradigm Wireless Diabetes Management System. Northridge, CA: Medtronic MiniMed; 2004.CMS; December 17, 2004.
38. Colquitt JL, Green C, Sidhu MK, et al. Clinical and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes. Health Technol Assess. 2004;8(43):iii, 1-171.
39. Misso ML, O'Connor DA, Egberts KJ, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus (Protocol for Cochrane Review). Cochrane Database Syst Rev. 2005;(1):CD005103.
40. Tuffnell DJ, West J, Farrar D. Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes (Protocol for Cochrane Review). Cochrane Database Syst. Rev. 2005;(4):CD005542. 

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines. 

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