Clinical UM Guideline

This document addresses the use of external insulin pumps, which provide subcutaneous insulin infusion to treat diabetes mellitus.

Note: External insulin pump devices come equipped with the capacity to be combined with continuous interstitial glucose monitor (CGM) devices to create automated insulin delivery systems. Devices with such features may be used as stand-alone insulin pumps or as combined systems, depending upon an individual’s need. This document addresses use of insulin pumps alone (continuous glucose monitor not requested or in use).

Note: For additional information regarding diabetes care, please see:

• CG-DME-42 Continuous Glucose Monitoring Devices
• CG-DME-50 Automated Insulin Delivery Systems
• CG-SURG-79 Implantable Infusion Pumps

Medically Necessary:

External insulin pumps (either disposable or durable) are considered medically necessary when the following criteria are met:

1. The individual has documented diabetes mellitus (any type); and
2. The individual or caregiver(s) has completed a comprehensive diabetes education program; and
3. Both of the following criteria are met:
   1. Insulin injections are required multiple times daily; and
   2. Multiple blood glucose tests are required daily or a continuous glucose monitor is being used.

Refills for medically necessary disposable external insulin pumps are considered medically necessary.

Continued use of an external insulin pump (including for individuals who used a continuous insulin infusion pump prior to enrollment with this plan) is considered medically necessary when the device has resulted in clinical benefit (for example, improved or stabilized HbA1c control or fewer episodes of symptomatic hypoglycemia or hyperglycemia).

Replacement pumps:

The replacement of external insulin pumps is considered medically necessary when the following criteria have been met:

1. The device is out of warranty; and
2. The device is malfunctioning; and
3. The device cannot be refurbished.

Note: The medical necessity of the replacement of an external insulin pump for pediatric individuals (under 18 years of age) 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.

Not Medically Necessary:

The use of an external insulin pump is considered not medically necessary when the criteria above have not been met.

Continued use of an external insulin pump is considered not medically necessary when continued use criteria above have not been met.

Replacement of currently functional and warranted external insulin pumps is considered not medically necessary when the criteria above have not been met, including when the request is to upgrade to a newer pump with additional features.

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.

When services may be Medically Necessary when criteria are met:
For the following codes or when the code describes an external insulin pump:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure, device or situation designated in the Clinical Indications section as not medically necessary.

Diabetes is one of the most common chronic diseases in the United States (U.S.), with approximately 37 million Americans with diagnosed disease and the fourth leading cause of death in the U.S. (American Diabetes Association, 2023).

Individuals with diabetes mellitus have impaired metabolism of carbohydrate, protein and fat as a result of abnormal production or utilization of insulin, the hormone secreted by the pancreas that controls blood sugar. When poorly controlled, diabetes leads to cardiovascular disease, retinal damage that could lead to blindness, peripheral nerve damage, and kidney damage.

There are several types of diabetes. Type 1 can occur at any age but is most commonly diagnosed from infancy to late 30s. In type 1 the pancreas produces little to no insulin, and the body’s immune system destroys the insulin-producing cells in the pancreas. Type 2 diabetes typically develops after age 40, but has recently begun to appear with more frequency in children. Individuals with type 2 diabetes still produce insulin, but the body does not produce enough or is not able to use it effectively.

Type 1 diabetes is treated with insulin. Insulin administration may be done in several ways. The most common method is multiple daily injections (MDI) via a syringe and subcutaneous injection. For some individuals with diabetes, the use of multiple daily insulin injection therapy is insufficient to provide adequate control of blood sugar levels. In such cases, an external insulin pump may be recommended. These devices are worn externally and are attached to a temporary subcutaneous insulin catheter placed into the skin of the abdomen. The pump can be set to administer the insulin at a set (basal) rate or provide injections (bolus) 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 glucose control.

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 (Hirsch, 1990; Kitzmiller, 1991; Pickup, 2002; Selam, 1990; Grunberger, 2014).

The benefit of insulin pump use for individuals with type 2 diabetes was established by the results of the OpT2mise Study (Aronson, 2016; Conget, 2016; Reznik, 2014). This well designed and conducted randomized controlled trial (RCT) concluded that for individuals with poorly controlled type 2 diabetes despite MDI, use of an insulin pump can be a valuable treatment option.

While standard insulin pumps operate on electricity, mechanical disposable insulin pumps (for example, the V-Go) have been proposed as an alternative. The existing evidence addressing this device is mainly in the form of short-term, retrospective studies (Boonin, 2017; Johns, 2014; Lajara, 2016a and 2016b; Meade, 2021; Rosenfeld, 2012; Sutton, 2016; Winter, 2015). A comparative trial reported by Lajara (2015) involved 204 subjects using the V-Go device vs. MDI. As with the above-described study, significant improvements in HbA1c concentration and decreases in required insulin volume were reported (-1.58% at 27 weeks and, p<0.001 for both).

Raval and colleagues (2019) reported the results of a retrospective cohort study involving data derived from the HealthCore Integrated Research Database. The study looked at 118 matched pairs of individuals with type 2 diabetes undergoing treatment with either the V-Go wearable insulin pump or MDI with 12 months of data available. At the end of 12 months of treatment both cohorts were reported to have improvements in percent HbA1c ≤ 9%, but no differences between groups were noted (p<0.001 for V-Go group and p=0.046 for the MDI group; p=0.263 between groups). Insulin prescription fills were reported to be lower in the V-Go group (mean change: -0.8 vs. +1.8 fills, p<0.001). A decrease in insulin total daily dose during the last 6 months of follow-up was also reported in the V-Go group (mean change in insulin units per day: -29.2 vs. +5.8, p<0.001).

Grunberger (2020) reported the results of a prospective open label case series study initially involving 188 subjects with type 2 diabetes and suboptimal glycemic control (HbA1c ≥ 7%) treated with the V-Go device. At 12 months, 112 subjects (60%) remained in the study, with 66 still on V-Go device. The authors reported a mean decrease in HbA1c from baseline of - 0.64%; (p=0.003) and total daily dose of insulin of 12 units/day (p<0.0001) at 12 months. However, due to the high dropout rate and lack of blinding, the value of this data is uncertain.

At this time, the available data comparing addressing the V-Go device appears to demonstrate equivalent outcomes to standard battery-operated insulin pump devices.

Back-up Insulin Infusion Pumps

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.

Insulin Infusion Pump Reservoir Issues

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.

Major Specialty Medical Society Recommendations

The ADA Standards of Medical Care in Diabetes-2023 has recommendations regarding the use of continuous glucose monitoring. These recommendations state:

6.5a An A1C goal for many nonpregnant adults of <7% (<53 mmol/mol) without significant hypoglycemia is appropriate. A
6.5b If using an ambulatory glucose profile/glucose management indicator to assess glycemia, a parallel goal for many nonpregnant adults is TIR >70% with time below range <4% and time <54 mg/dL (<3 mmol/L) <1%. For those with frailty or at high risk of hypoglycemia, a goal of >50% TIR with <1% time below range is recommended (Fig. 6.1  and Table 6.2 ). B
6.6 On the basis of health care professional judgment and the preference of the person with diabetes, achievement of lower A1C levels than the goal of 7% (53 mmol/mol) may be acceptable and even beneficial if it can be achieved safely without significant hypoglycemia or other adverse effects of treatment. B
6.7 Less stringent glycemic goals may be appropriate for individuals with limited life expectancy or where the harms of treatment are greater than the benefits. B
7.1 Diabetes devices should be offered to people with diabetes. A
7.4 The type(s) and selection of devices should be individualized based on a person’s specific needs, preferences, and skill level. In the setting of an individual whose diabetes is partially or wholly managed by someone else (e.g., a young child or a person with cognitive impairment or dexterity, psychosocial, and/or physical limitations), the caregiver’s skills and preferences are integral to the decision-making process. E
7.5 When prescribing a device, ensure that people with diabetes and caregivers receive initial and ongoing education and training, either in person or remotely, and ongoing evaluation of technique, results, and the ability to utilize data, including uploading/sharing data (if applicable), to monitor and adjust therapy. C
7.6 People with diabetes who have been using CGM, continuous subcutaneous insulin infusion (CSII), and/or automated insulin delivery (AID) for diabetes management should have continued access across third-party payers, regardless of age or A1C levels. E
7.8 Initiation of CSII and/or AID early, even at diagnosis, in the treatment of diabetes can be beneficial depending on a person’s or caregiver’s needs and preferences. C
7.18 In people with diabetes on MDI or CSII, rtCGM devices should be used as close to daily as possible for maximal benefit. A isCGM devices should be scanned frequently, at a minimum once every 8 h to avoid gaps in data. A People with diabetes should have uninterrupted access to their supplies to minimize gaps in CGM. A
7.28 Insulin pump therapy alone with or without a sensor-augmented pump low-glucose suspend feature should be offered for diabetes management to youth and adults on MDI with type 1 diabetes A or other types of insulin-deficient diabetes E who are capable of using the device safely (either by themselves or with a caregiver) and are not able to use or do not choose an AID system. The choice of device should be made based on the individual’s circumstances, preferences, and needs. A
7.29 Insulin pump therapy can be offered for diabetes management to youth and adults on MDI with type 2 diabetes who are capable of using the device safely (either by themselves or with a caregiver). The choice of device should be made based on the individual’s circumstances, preferences, and needs. A
7.30 I Individuals with diabetes who have been using CSII should have continued access across third-party payers. E
7.31 Individuals with diabetes may be using systems not approved by the FDA, such as do-it-yourself closed-loop systems and others; health care professionals cannot prescribe these systems but should assist in diabetes management to ensure the safety of people with diabetes. E
14.20 Insulin pump therapy alone should be offered for diabetes management to youth on multiple daily injections with type 1 diabetes who are capable of using the device safely (either by themselves or with caregivers) if unable to use AID systems. The choice of device should be made based on the individual’s and family’s circumstances, desires, and needs. A
14.22 A1C goals must be individualized and reassessed over time. An A1C of <7% (<53 mmol/mol) is appropriate for many children and adolescents. B
14.23 Less stringent A1C goals (such as <7.5% [<58 mmol/mol]) may be appropriate for youth who cannot articulate symptoms of hypoglycemia; have hypoglycemia unawareness; lack access to analog insulins, advanced insulin delivery technology, and/or CGM; cannot check blood glucose regularly; or have nonglycemic factors that increase A1C (e.g., high glycators). B
14.24 Even less stringent A1C goals (such as <8% [<64 mmol/mol]) may be appropriate for individuals with a history of severe hypoglycemia, limited life expectancy, or where the harms of treatment are greater than the benefits. B
14.25 Health care professionals may reasonably suggest more stringent A1C goals (such as <6.5% [<48 mmol/mol]) for selected individuals if they can be achieved without significant hypoglycemia, negative impacts on well-being, or undue burden of care or in those who have nonglycemic factors that decrease A1C (e.g., lower erythrocyte life span). Lower goals may also be appropriate during the honeymoon phase. B
14.60 A reasonable A1C goal for most children and adolescents with type 2 diabetes is <7% (<53 mmol/mol). More stringent A1C goals (such as <6.5% [<48 mmol/mol]) may be appropriate for selected individuals if they can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate individuals might include those with a short duration of diabetes and lesser degrees of β-cell dysfunction and individuals treated with lifestyle or metformin only who achieve significant weight improvement. E
14.61 Less stringent A1C goals (such as 7.5% [58 mmol/mol]) may be appropriate if there is an increased risk of hypoglycemia. E
14.62 A1C goals for individuals on insulin should be individualized, taking into account the relatively low rates of hypoglycemia in youth-onset type 2 diabetes. E
15.8 Due to increased red blood cell turnover, A1C is slightly lower during pregnancy in people with and without diabetes. Ideally, the A1C goal in pregnancy is <6% (<42 mmol/mol) if this can be achieved without significant hypoglycemia, but the goal may be relaxed to <7% (<53 mmol/mol) if necessary to prevent hypoglycemia. B

The AACE and American College of Endocrinology (ACE) published a position statement on the integration of insulin pumps and continuous glucose monitoring in patients with diabetes mellitus (Grunberger, 2018). This document states the following:

R2.7.1 The use of an insulin pump without CGM could be used to manage persons with diabetes who are achieving glycemic targets with minimal TBR, who report infrequent episodes of symptomatic hypoglycemia, and who are using SMBG on a regular basis (at least 4 times per day for persons with T1D). Grade B; Intermediate-High Strength of Evidence; BEL
R3.5.1 Clinicians should strongly consider the discontinuation of insulin pump therapy based on an individual’s ability to use it effectively and safely or based on the personal preference of a person with diabetes to discontinue this insulin delivery modality. Grade A; Intermediate Strength of Evidence; BEL 1

Additionally, in 2023 the Endocrine Society published Management of individuals with diabetes at high risk for hypoglycemia (McCall, 2023). In this document they make the following recommendations:

Recommendation 2: We suggest using real-time continuous glucose monitoring (CGM) and algorithm-driven insulin pumps (ADIPs) rather than multiple daily injections (MDIs) with self-monitoring of blood glucose (SMBG) three or more times daily for adults and children with type 1 diabetes (T1D). (2⊕⊕OO)

FDA Authorized/Approved Devices*

* This may not be an all-inclusive-list. Additional CGM devices may be FDA approved and available in the US.

External insulin infusion pumps: A device that is worn externally and attached to a temporary subcutaneous insulin catheter. An integrated computer controls a pump mechanism that administers insulin at a set rate or provide bolus injections as needed.

Glycemic: Having to do with blood sugar (glucose) levels.

Glycemic control: The ability of an individual’s body to control blood glucose concentrations within a specific physiologic range, either on its own or with the assistance of medical therapy.

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.

Interstitial glucose: Glucose present in the fluid present in spaces between the tissue cells of the body.

Type 1 diabetes: A condition characterized by the impaired or inability of the pancreas to produce insulin. Sometimes known as ‘juvenile diabetes.’

Type 2 diabetes: A condition characterized by a person’s body losing the ability to use insulin properly, a problem referred to as insulin resistance.

Peer Reviewed Publications:

1. Aronson R, Reznik Y, Conget I, et al.; OpT2mise Study Group. Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12-month data from the OpT2mise randomized trial. Diabetes Obes Metab. 2016; 18(5):500-507.
2. 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.
3. 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.
4. 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.
5. Boonin A, Balinski B, Sauter J, et al. A retrospective chart review of two different insulin administration systems on glycemic control in older adults in long-term care. J Gerontol Nurs. 2017; 43(1):10-16.
6. 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.
7. 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.
8. Conget I, Castaneda J, Petrovski G, et al.; OpT2mise Study Group. The impact of insulin pump therapy on glycemic profiles in patients with type 2 diabetes: data from the OpT2mise study. Diabetes Technol Ther. 2016; 18(1):22-28.
9. 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.
10. 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.
11. 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.
12. 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.
13. Grunberger G, Rosenfeld CR, Bode BW, et al. Effectiveness of V-Go® for patients with type 2 diabetes in a real-world setting: a prospective observational study. Drugs Real World Outcomes. 2020; 7(1):31-40.
14. 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.
15. 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.
16. Hirsch IB, Farkas-Hirsch R, Skyler JS. Intensive insulin therapy for treatment of Type 1 diabetes. Diabetes Care. 1990; 13(12):1265-1283.
17. 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.
18. 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.
19. Johns BR, Jones TC1 Sink JH 2nd, Cooke CE. Real-world assessment of glycemic control after V-Go® initiation in an endocrine practice in the southeastern United States. J Diabetes Sci Technol. 2014; 8(5):1060-1061.
20. Kitzmiller JL, Gavin LA, Gin GD, et al. Preconception care of diabetes. Glycemic control prevents congenital anomalies. JAMA. 1991; 265(6):731-736.
21. Lajara R, Davidson JA, Nikkel CC, Morris TL. Clinical and cost-effectiveness of insulin delivery with V-Go(®) disposable insulin delivery device versus multiple daily injections in patients with type 2 diabetes inadequately controlled on basal insulin. Endocr Pract. 2016; 22(6):726-735.
22. Lajara R, Fetchick DA, Morris TL, Nikkel C. Use of V-Go^® insulin delivery device in patients with sub-optimally controlled diabetes mellitus: a retrospective analysis from a large specialized diabetes system. Diabetes Ther. 2015; 6(4):531-545
23. Lajara R, Nikkel C, Abbott S. The clinical and economic impact of the V-Go^® disposable insulin delivery device for insulin delivery in patients with poorly controlled diabetes at high risk. Drugs Real World Outcomes. 2016; 3(2):191-199
24. Layne JE, Parkin CG, Zisser H. Efficacy of the omnipod insulin management system on glycemic control in patients with type 1 diabetes previously treated with multiple daily injections or continuous subcutaneous insulin infusion. J Diabetes Sci Technol. 2016; 10(5):1130-1135.
25. 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.
26. Meade LT, Battise D. Evaluation of clinical outcomes with the V-Go wearable insulin delivery device in patients with type 2 diabetes. Clin Diabetes. 2021; 39(3):297-303.
27. 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.
28. 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.
29. 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.
30. 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.
31. Pohar SL. Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm Real-Time System. Issues Emerg Health Technol. 2007; (105):1-6.
32. 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.
33. Raval AD, Nguyen MH, Zhou S, et al. Effect of V-Go versus multiple daily injections on glycemic control, insulin use, and diabetes medication costs among individuals with type 2 diabetes mellitus. J Manag Care Spec Pharm. 2019; Jul 5:1-14.
34. 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.
35. Rosenfeld CR, Bohannon NJ, Bode B, et al. The V-Go insulin delivery device used in clinical practice: patient perception and retrospective analysis of glycemic control. Endocr Pract. 2012; 18(5):660-667.
36. 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.
37. Selam JL, Charles MA, Devices for insulin administration. Diabetes Care. 1990; 13(9):955-979.
38. Sutton D, Higdon C, Carmon M, Abbott S. Regular insulin administered with the V-Go disposable insulin delivery device in a clinical diabetes setting: a retrospective analysis of efficacy and cost. Clin Diabetes. 2016; 34(4):201-205.
39. Winter A, Lintner M, Knezevich E. V-Go insulin delivery system versus multiple daily insulin injections for patients with uncontrolled type 2 diabetes mellitus. J Diabetes Sci Technol. 2015; 9(5):1111-1116.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Diabetes Association. Standards of Care in Diabetes-2024. Diabetes Care. 2023; 47(Suppl 1):S1-S321.
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Infusion Pumps. NCD #280.14. Effective February 4, 2005. Available at: https://www.cms.gov/medicare-coverage-database/search.aspx?redirect=Y&from=Overview&list_type=ncd. Accessed on Accessed on January 15, 2024.
3. 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.
4. Grunberger G, Abelseth J, Bailey T, et al. Consensus statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force. Endocr Pract. 2014; 20(5):463-489.
5. McCall AL, Lieb DC, Gianchandani R, et al. Management of individuals with diabetes at high risk for hypoglycemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2023; 108(3):529-562.

1. American Diabetes Association. 2020 Consumer guides. Available at: https://consumerguide.diabetes.org/. Accessed on January 15, 2024.
2. American Diabetes Association. Type 1 diabetes. Available at: http://www.diabetes.org/diabetes-basics/type-1/. Accessed on January 15, 2024.
3. American Diabetes Association. Type 2 diabetes. Available at: http://www.diabetes.org/diabetes-basics/type-2/?loc=db-slabnav/. Accessed on January 15, 2024.

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.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.

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