Medical Policy Insulin Delivery Devices

Medical Policy Insulin Delivery Devices Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History Endnotes Policy Number: 332 BCBSA Reference Number: N/A Related Policies Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid, #107 Policy 1 Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity We cover insulin pumps and insulin pump supplies, in accordance with the Massachusetts Mandate, Chapter 175. In accordance with the Massachusetts State Mandate, we cover the proper use of insulin delivery devices. Insulin delivery devices are covered to the extent that devices are generally covered by each member s benefit design. External insulin pumps (with or without wireless communication capability) are considered MEDICALLY NECESSARY for individuals with diabetes, when prescribed by a diabetologist familiar with insulin pump management, in any of the following groups: 1. Individuals with documented diabetes mellitus meeting all the following criteria (a-e): a. Completed a comprehensive diabetes education program within the past two years; AND b. Follows a program of multiple daily injections of insulin; AND c. Has frequent self-adjustments of insulin doses for the past 6 months; AND d. Has documented frequency of glucose self-testing an average of at least 4 times per day during the past month; and e. 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. 2. 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 1

Use of a disposable external insulin pump with wireless communication capability to a hand-held control unit (e.g., 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. Note: The purchase of one insulin pump is allowed every 4 years. The use of external insulin pumps for any indication other than those listed above is considered NOT MEDICALLY NECESSARY. 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. Insulin injection pens are considered MEDICALLY NECESSARY as determined by a licensed health care professional, in accordance with the Massachusetts Mandate, Chapter 175. Jet pressure Infusion devices are considered NOT MEDICALLY NECESSARY. Surgically implanted insulin infusion systems are considered INVESTIGATIONAL. Chronic intermittent intravenous insulin therapy (CIIIT) and pulsatile IV insulin therapy (PIVIT) are considered INVESTIGATIONAL. Medicare HMO Blue SM and Medicare PPO Blue SM Members We cover external insulin pumps for Medicare members in accordance with the CMS NCD. Continuous subcutaneous insulin infusion (CSII) and related drugs/supplies are covered as medically reasonable and necessary in the home setting for the treatment of diabetic patients who: (1) either meet the updated fasting C-Peptide testing requirement, or, are beta cell autoantibody positive; and, (2) satisfy the remaining criteria for insulin pump therapy as described below. Patients must meet either Criterion A or B as follows: 2

Criterion A: The patient has completed a comprehensive diabetes education program, and has been on a program of multiple daily injections of insulin (i.e., at least 3 injections per day), with frequent selfadjustments of insulin doses for at least 6 months prior to initiation of the insulin pump, and has documented frequency of glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump, and meets one or more of the following criteria while on the multiple daily injection regimen: Glycosylated hemoglobin level (HbAlc) > 7.0%; History of recurring hypoglycemia; Wide fluctuations in blood glucose before mealtime; Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl; or, History of severe glycemic excursions. Criterion B: The patient with diabetes has been on a pump prior to enrollment in Medicare and has documented frequency of glucose self-testing an average of at least 4 times per day during the month prior to Medicare enrollment. General CSII Criteria In addition to meeting Criterion A or B above, the following general requirements must be met: The patient with diabetes must be insulinopenic per the updated fasting C-peptide testing requirement, or, as an alternative, must be beta cell autoantibody positive. Updated fasting C-peptide testing requirement: Insulinopenia is defined as a fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method. For patients with renal insufficiency and creatinine clearance (actual or calculated from age, gender, that is less than or equal to 200% of the lower limit of normal of the laboratory's measurement method. 225 mg/dl. Levels only need to be documented once in the medical records. Continued coverage of the insulin pump would require that the patient be seen and evaluated by the treating physician at least every 3 months. The pump must be ordered by and follow-up care of the patient must be managed by a physician who manages multiple patients with CSII and who works closely with a team including nurses, diabetes educators, and dietitians who are knowledgeable in the use of CSII. Other Uses of CSII The Centers for Medicare & Medicaid Services will continue to allow coverage of all other uses of CSII in accordance with the Category B investigational device exemption clinical trials regulation (42 CFR 405.201) or as a routine cost under the clinical trials policy (Medicare National Coverage Determinations Manual 310.1). An implanted infusion pump for the infusion of insulin to treat diabetes is not covered. The data does not demonstrate that the pump provides effective administration of insulin. National Coverage Determination (NCD) for Infusion Pumps (280.14) http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=223&ncdver=2&bc=agaagaaaaaaaaa%3d%3d& Prior Authorization Information Pre-service approval is required for all inpatient services for all products. 3

See below for situations where prior authorization may be required or may not be required for outpatient services. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Outpatient Commercial Managed Care (HMO and POS) No Commercial PPO and Indemnity No Medicare HMO Blue SM No Medicare PPO Blue SM No CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. The following codes are included below for informational purposes only; this is not an all-inclusive list. The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS) PPO and Indemnity: HCPCS Codes HCPCS codes: A4210 A4230 A4231 A4232 A9274 E0784 S9145 S5560 S5561 S5570 S5571 Code Description Needle-free injection device, each Infusion set for external insulin pump, non-needle, cannula type Infusion set for external insulin pump, needle type Syringe with needle for external insulin pump, sterile, 3cc (Omnipod), External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories. (There is a limit of insulin pump reservoirs of 15 units per 30 days. Effective 2/1/2012) External ambulatory infusion pump, insulin Insulin pump initiation, instruction in initial use of pump (pump not included) Insulin delivery device, reusable pen; 1.5 ml size Insulin delivery device, reusable pen; 3 ml size Insulin delivery, disposable pen (including insulin): 1.5 ml size Insulin delivery device, disposable pen (including insulin); 3 ml size The following ICD Diagnosis Codes are considered medically necessary when submitted with the HCPCS codes above if medical necessity criteria are met: ICD-9 Diagnosis Codes ICD-9-CM diagnosis codes: Code Description Diabetes mellitus without mention of complication, type II or unspecified type, not stated 250.00 as uncontrolled Diabetes mellitus without mention of complication, type I [juvenile type], not stated as 250.01 uncontrolled 250.02 Diabetes mellitus without mention of complication, type II or unspecified type, 4

uncontrolled 250.03 Diabetes mellitus without mention of complication, type I [juvenile type], uncontrolled 250.10 Diabetes with ketoacidosis, type II or unspecified type, not stated as uncontrolled 250.11 Diabetes mellitus with ketoacidosis, type I [juvenile type], not stated as uncontrolled 250.12 Diabetes with ketoacidosis, type II or unspecified type, uncontrolled 250.13 Diabetes mellitus with ketoacidosis, type I [juvenile type], uncontrolled 250.20 Diabetes with hyperosmolarity, type II or unspecified type, not stated as uncontrolled 250.21 Diabetes mellitus with hyperosmolarity, type I [juvenile type], not stated as uncontrolled 250.22 Diabetes with hyperosmolarity, type II or unspecified type, uncontrolled 250.23 Diabetes mellitus with hyperosmolarity, type I [juvenile type], uncontrolled 250.30 Diabetes with other coma, type II or unspecified type, not stated as uncontrolled 250.31 Diabetes mellitus with other coma, type I [juvenile type], not stated as uncontrolled 250.32 Diabetes with other coma, type II or unspecified type, uncontrolled 250.33 Diabetes with hyperosmolarity, type I [juvenile type], uncontrolled Diabetes with renal manifestations, type II or unspecified type, not stated as 250.40 uncontrolled Diabetes mellitus with renal manifestations, type I [juvenile type], not stated as 250.41 uncontrolled 250.42 Diabetes with renal manifestations, type II or unspecified type, uncontrolled 250.43 Diabetes mellitus with renal manifestations, type I [juvenile type], uncontrolled Diabetes with ophthalmic manifestations, type II or unspecified type, not stated as 250.50 uncontrolled Diabetes mellitus with ophthalmic manifestations, type I [juvenile type], not stated as 250.51 uncontrolled 250.52 Diabetes with ophthalmic manifestations, type II or unspecified type, uncontrolled 250.53 Diabetes mellitus with ophthalmic manifestations, type I [juvenile type], uncontrolled Diabetes with neurological manifestations, type II or unspecified type, not stated as 250.60 uncontrolled Diabetes mellitus with neurological manifestations, type I [juvenile type], not stated as 250.61 uncontrolled 250.62 Diabetes with neurological manifestations, type II or unspecified type, uncontrolled 250.63 Diabetes mellitus with neurological manifestations, type I [juvenile type], uncontrolled Diabetes with peripheral circulatory disorders, type II or unspecified type, not stated as 250.70 uncontrolled Diabetes mellitus with peripheral circulatory disorders, type I [juvenile type], not stated 250.71 as uncontrolled 250.72 Diabetes with peripheral circulatory disorders, type II or unspecified type, uncontrolled Diabetes mellitus with peripheral circulatory disorders, type I [juvenile type], 250.73 uncontrolled Diabetes with other specified manifestations, type II or unspecified type, not stated as 250.80 uncontrolled Diabetes mellitus with other specified manifestations, type I [juvenile type], not stated 250.81 as uncontrolled 250.82 Diabetes with other specified manifestations, type II or unspecified type, uncontrolled 250.83 Diabetes mellitus with other specified manifestations, type I [juvenile type], uncontrolled Diabetes with unspecified complication, type II or unspecified type, not stated as 250.90 uncontrolled Diabetes mellitus with unspecified complication, type I [juvenile type], not stated as 250.91 uncontrolled 250.92 Diabetes with unspecified complication, type II or unspecified type, uncontrolled 250.93 Diabetes mellitus with unspecified complication, type I [juvenile type], uncontrolled 5

ICD-10-CM Diagnosis Codes ICD-10-CM diagnosis codes: Code Description E10.10 Type 1 diabetes mellitus with ketoacidosis without coma E10.11 Type 1 diabetes mellitus with ketoacidosis with coma E10.21 Type 1 diabetes mellitus with diabetic nephropathy E10.22 Type 1 diabetes mellitus with diabetic chronic kidney disease E10.29 Type 1 diabetes mellitus with other diabetic kidney complication E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema E10.319 Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema E10.321 E10.329 E10.331 E10.339 E10.341 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema E10.349 E10.351 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema E10.359 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema E10.36 Type 1 diabetes mellitus with diabetic cataract E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy E10.44 Type 1 diabetes mellitus with diabetic amyotrophy E10.49 Type 1 diabetes mellitus with other diabetic neurological complication E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene E10.52 Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene E10.59 Type 1 diabetes mellitus with other circulatory complications E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy E10.618 Type 1 diabetes mellitus with other diabetic arthropathy E10.620 Type 1 diabetes mellitus with diabetic dermatitis E10.621 Type 1 diabetes mellitus with foot ulcer E10.622 Type 1 diabetes mellitus with other skin ulcer E10.628 Type 1 diabetes mellitus with other skin complications E10.630 Type 1 diabetes mellitus with periodontal disease E10.638 Type 1 diabetes mellitus with other oral complications E10.641 Type 1 diabetes mellitus with hypoglycemia with coma E10.649 Type 1 diabetes mellitus with hypoglycemia without coma E10.65 Type 1 diabetes mellitus with hyperglycemia E10.69 Type 1 diabetes mellitus with other specified complication E10.8 Type 1 diabetes mellitus with unspecified complications E10.9 Type 1 Diabetes Mellitus Without Complications E11.00 Type 2 Diabetes Mellitus With Hyperosmolarity Without Nonketotic Hyperglycemic- Hyperosmolar Coma (Nkhhc) 6

E11.01 Type 2 Diabetes Mellitus With Hyperosmolarity With Coma E11.21 Type 2 Diabetes Mellitus With Diabetic Nephropathy E11.29 Type 2 Diabetes Mellitus With Other Diabetic Kidney Complication E11.311 Type 2 Diabetes Mellitus With Unspecified Diabetic Retinopathy With Macular Edema Type 2 Diabetes Mellitus With Unspecified Diabetic Retinopathy Without Macular E11.319 Edema E11.36 Type 2 Diabetes Mellitus With Diabetic Cataract E11.39 Type 2 Diabetes Mellitus With Other Diabetic Ophthalmic Complication E11.40 Type 2 Diabetes Mellitus With Diabetic Neuropathy, Unspecified E11.51 Type 2 Diabetes Mellitus With Diabetic Peripheral Angiopathy Without Gangrene E11.618 Type 2 Diabetes Mellitus With Other Diabetic Arthropathy E11.620 Type 2 Diabetes Mellitus With Diabetic Dermatitis E11.622 Type 2 Diabetes Mellitus With Other Skin Ulcer E11.628 Type 2 Diabetes Mellitus With Other Skin Complications E11.630 Type 2 Diabetes Mellitus With Periodontal Disease E11.638 Type 2 Diabetes Mellitus With Other Oral Complications E11.641 Type 2 Diabetes Mellitus With Hypoglycemia With Coma E11.649 Type 2 Diabetes Mellitus With Hypoglycemia Without Coma E11.65 Type 2 Diabetes Mellitus With Hyperglycemia E11.69 Type 2 Diabetes Mellitus With Other Specified Complication E11.8 Type 2 Diabetes Mellitus With Unspecified Complications E11.9 Type 2 Diabetes Mellitus Without Complications NOTE: Insulin pumps and insulin pump supplies are processed through a member s pharmacy benefit. When a member does not have pharmacy benefits, the insulin pump and insulin pump supplies would be processed as a prosthetic benefit according to the member s certificate language. Please refer to the specific member s certificate for determination of benefit design. CLARIFICATION: I n reviewing member certificate language, under Prescription Drugs header and sub header titled Covered Drugs and Supplies, it notes coverage of insulin infusion pumps and related pump supplies with this notation (You will obtain the insulin infusion pump from an appliance company instead of a pharmacy. For the insulin infusion pump itself, the cost you would normally pay for covered drugs and supplies will be waived.) NOTE: Reusable insulin delivery devices/pens are processed through a member s pharmacy benefit. When a member does not have pharmacy benefits, the insulin delivery devices/pens would be processed as a DME benefit according to the member s certificate language. Description An external insulin infusion pump is a programmable, battery-powered mechanical syringe/reservoir device controlled by a micro-computer to provide continuous subcutaneous insulin infusion (CSII) in individuals with diabetes mellitus. Typically, the syringe has a two to three day insulin capacity and is connected to an infusion set attached to a small needle or cannula which is inserted into the subcutaneous tissue. The syringe and pump devices are battery operated and controlled by a small computer that is programmed to deliver a steady "basal" amount of insulin. Pumps may also release a "bolus" dose at meals and at programmed intervals. 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. This document addresses the medically necessary uses of these devices. 7

Summary 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 selfmeasurement 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). Policy History Date Action 11//2014 New covered indications for type 2 diabetes described. Language on artificial pancreas transferred to medical policy 107, Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid. Coding information clarified. Effective 11/1/2014. 12/2014 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements. 2/2014 Clarified non-coverage of 530G artificial pancreas system. Effective 2/10/2014. 1/2014 Clarified non-coverage of artificial pancreas system. Effective 1/1/2014. 11/2011 Added limit of insulin pump reservoirs (HCPCS level II code A9274) of 15 units per 30 days. Effective 2/1/2012. 5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology, no change in coverage statement. 6/2010 Added Medicare language regarding non-coverage of services comprising an Outpatient Intravenous Insulin Therapy regimen when furnished pursuant to an OIVIT regimen. 2/2010 Reviewed - Medical Policy Group - Psychiatry, Ophthalmology, and Endocrinology, no change in coverage statement. 3/2010 Policy updated to reflect decision to allow the purchase of one insulin pump once in 4 years. Effective 3/10/2010 7/2000 Policy updated to allow the purchase of one insulin pump once in 5 years. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines 8

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. DiabetesCare. 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 sensoraugmented 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. 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. 9

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. 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. 24. Selam JL, Charles MA, Devices for insulin administration. Diabetes Care. 1990; 13(9):955-979. 25. 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. 26. American Diabetes Association. Standards of medical care in diabetes 2014. Diabetes Care. 2014; 37(Suppl 1):S14-S80. 27. 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 March 03, 2014. 28. 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. 29. National Institute for Health and Clinical Excellence. NICE technology appraisal guidance 151: Continuous subcutaneous insulin infusion for the treatment of diabetes (review). July 2008. Available at: http://www.nice.org.uk/guidance/ta151. Accessed on March 03, 2014. 30. 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. Endnotes 1 Massachusetts State Mandate, Chapter 175. 10