Medically Necessary: 

External insulin pumps are considered medically necessary for diabetic patients in any of the following groups:

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

Outpatient

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 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 patient. Implementation of this approach requires the patient 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 patients 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 patients 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 patients using continuous insulin pump therapy.

The use of external insulin infusion pumps requires careful selection of patients, meticulous patient monitoring, and thorough patient 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 patients on insulin pump treatment. 

Definitive, agreed upon patient 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 patient group (Kitzmiller, 1991).  There also is 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 patients 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; Selam, 1990; Pickup, 2002).

An external insulin infusion pump is an 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 patient 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 patients 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 patient 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 (e.g., Guardian® REAL-Time Continuous Glucose Monitoring System).  (See DME.00005 Glucose Monitoring and Related Supplies)

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, a patient can and should revert to daily multiple injections until the pump is repaired or replaced.

Some pediatric patients 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 member 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 US 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:

1. 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.
2. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes. Diabetes Care. 1996; 19:324-327.
3. Bruttomesso D, Pianta A, Crassolara D, et al. Continuous subcutaneous insulin infusion (CSII) in the Veneto region: efficacy, acceptability, and quality of life. Diabetic Medicine. 2002; 19:628-634.
4. 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; 329:997-986.
5. 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.
6. 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.
7. 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.
8. Hirsch IB, Farkas-Hirsch R, Skyler JS. Intensive insulin therapy for treatment of Type 1 diabetes. Diabetes Care. 1990; 12:1265-1283.
9. Kitzmiller JL, Gavin LA, Gin GD, et al. Preconception care of diabetes; glycemic control prevents congenital anomalies. JAMA. 1991; 265:731-736.
10. 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.
11. 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.
12. Pohar SL.  Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm Real-Time System. Issues Emerg Health Technol. 2007; (105):1-6.
13. Raskin P, Bode B, Marks J, et al. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes.  Diabetes Care.  2003; 26:2598-2603.
14. Sanfield, JA, Hegstad M, Hanna RS. Protocol for outpatient screening and initiation of continuous subcutaneous insulin infusion therapy: impact on cost and quality. The Diabetes Educator. 2002; 28(4):599- 607.
15. Selam JL, Charles MA, Devices for insulin administration. Diabetes Care. 1990; 12:955-979.

 Government Agency, Medical Society, and Other Authoritative Publications:

1. American Association of Clinical Endocrinologists (AACE). Diabetes Guidelines. Endocr Pract. 2007; 13(Suppl 1). Available at: http://www.aace.com/pub/guidelines/.  Accessed on March 7, 2008.
2. American Diabetes Association. Position Statement: Standards of medical care in diabetes. 2007. Diabetes Care. 2007; 30:S4-S41. Available at: http://care.diabetesjournals.org/cgi/content/full/30/suppl_1/S4  Accessed on March 7, 2008.
3. Pohar SL. Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm® Real-Time system [Issues in emerging health technologies issue 105]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.Available at: http://www.cadth.ca/index.php/en/hta/reports-publications/search?keywords=Paradigm  Accessed on April 15, 2008.
4. Centers for Medicare and 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 April 15, 2008.
5. Hayes Medical Technology Directory. Insulin Pumps, External. Lansdale, PA: Hayes, Inc.; February 2003. Search updated March 24, 2007.
6. Silverstein J, Klingensmith G, Copeland K, et al. Care of Children and Adolescents With Type 1 Diabetes A statement of the American Diabetes Association. 2005; Diabetes Care. 28:186-212.