When services are covered 1 2 We cover insulin pumps and insulin pump supplies, in accordance with the Massachusetts Mandate, Chapter 175.

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1 MEDICAL POLICY Policy #: 332 Original policy date: 4/96 Page: 1 of 8 Revised date: 6/27/2014 Title Insulin Delivery Devices Pumps, Pens, and Jet Injectors Related policies: Diabetic Supplies, #202 CGMS, #107 When services are covered 1 2 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. We cover portable insulin infusion pumps. The following guidelines may be used: Inclusion Patient has insulin dependent diabetes (IDDM, Type 1) The pump is prescribed by a diabetologist familiar with insulin pump management Patient is capable of and committed to intensive insulin therapy, and has demonstrated substantial improvement in diabetic control while on multiple daily insulin injections. Patients must be willing to monitor blood sugar at least four times a day, and follow prescribed eating and activity patterns Patient has undergone a successful trial period with a loaned pump of at least three months, demonstrating that the patient is capable of managing the pump and that the desired improvement in metabolic control can be achieved The patient is at high risk for preventable complications of diabetes, early signs of diabetic complications including micro albuminuria or is found to have persistent difficulty in achieving optimal control despite good compliance with an intensive multiple injection regimen. Exclusion Patients with non-insulin-dependent diabetes (NIDDM or IR-NIDDM, Type 2), even if they take insulin Patients with end-stage complications (such as renal failure) Patients who are pregnant. If a woman is attempting to conceive, this may not be the best time to begin pump therapy. If a patient is already on the pump and doing well, pumps may be continued during pregnancy. However, because of the small risk for increased diabetic ketoacidosis episodes with pump therapy, starting the pump at these times results in possible increased risk for miscarriage. Patients who are unable, because of, behavioral, psychological problems, or functional ability, to technically operate the pump and perform frequent blood glucose monitoring Our subscriber contracts do not permit coverage of items used for convenience purposes. Insulin pumps are covered for patients who are committed to achieving possibly tighter blood sugar control, to improve

2 health outcomes. When excellent control is achieved with multiple daily injections, pump therapy is not covered merely because some may find it more convenient. We cover insulin infusion pumps for patients with Type 1, juvenile-onset diabetes for Medicare HMO Blue and Medicare PPO Blue members, in accordance with Centers for Medicare and Medicaid. We cover insulin injection pens, in accordance with the Massachusetts Mandate, Chapter 175. We cover OmniPod: Insulin delivery/management device. (Covered for all plans, effective 4/1/08) See footnote 3 for covered diagnoses for commercial products and for Medicare HMO Blue and Medicare PPO Blue 3 When services are not covered We do not cover jet pressure Infusion devices. We pay for the least expensive delivery system that will result in appropriate health outcome. We do not cover surgically implanted insulin infusion systems. We do not cover chronic intermittent intravenous insulin therapy (CIIIT) or pulsatile IV insulin therapy (PIVIT), because its effectiveness in improving glucose control has not been proven in the medical literature. 4 In December 2009, CMS issued a national coverage decision on outpatient intravenous (IV) insulin therapy (OIVIT) which they define as an outpatient regimen that integrates pulsatile or continuous intravenous infusion of insulin via any means, guided by the results of measurement of: respiratory quotient; and/or urine urea nitrogen (UUN); and/or arterial, venous, or capillary glucose; and/or potassium concentration; and performed in scheduled recurring periodic intermittent episodes. According to the decision memo, Services comprising an Outpatient Intravenous Insulin Therapy regimen are nationally non-covered under Medicare when furnished pursuant to an OIVIT regimen. Coverage of the components of the therapy in conventional treatment regimens would be determined by other national and local Medicare coverage decisions. We do not cover MiniMed530G by Medtronics artificial pancreas system, including but not limited to closed-loop monitoring devices with low glucose suspend (LGS) features. Individual consideration All our medical policies are written for the majority of people with a given condition. Each policy is based on medical science. For many of our medical policies, each individual s unique clinical circumstances may be considered in light of current scientific literature. For consideration of an individual patient, physicians may send relevant clinical information to: For services already billed Blue Cross Blue Shield of Massachusetts Provider Appeals PO Box Boston, MA Prior to performance of service Blue Cross Blue Shield of Massachusetts Case Creation/Medical Policy One Enterprise Drive Quincy, MA Tel: Fax: Managed care guidelines Authorizations are not required for portable insulin infusion pumps. Any specialist visit requires a referral for Medicare HMO Blue

3 For all other Managed Care plans, any specialist visit requires a referral, except for visits performed by OB/GYN specialists. Indemnity and PPO guidelines All authorization requirements are determined by the individual s subscriber certificate, however: Authorizations are required for all inpatient services. Authorizations are not required for most outpatient services as determined by the individual s subscriber certificate. Referrals to a specialist are not required. Coding information Procedure codes are from current CPT, HCPCS Level II, Revenue Code, and/or ICD-9-CM manuals, as recommended by the American Medical Association, Centers for Medicare and Medicaid Services and American Hospital Associations. Blue Cross Blue Shield Association national codes may be developed when appropriate. 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. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Insulin Pump HCPCS Level II code E0784: External ambulatory infusion pump, insulin Insulin Pump Supplies HCPCS Level II codes: A4230: Infusion set for external insulin pump, non-needle, cannula type A4231: Infusion set for external insulin pump, needle type A4232: Syringe with needle for external insulin pump, sterile, 3cc National code S9145: Insulin pump initiation, instruction in initial use of pump (pump not included). Insulin Delivery Device HCPCS Level II code: A9274: (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) Insulin Pump Dressing Supplies HCPCS Level II code: A6257: Transparent film, 16 sq. in. or less, each dressing A6258: Transparent film, more than 16 sq. in., but less than or equal to 48 sq. in., each dressing A6259: Transparent film, more than 48 sq. in., each dressing Modifier: NU (purchase) 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

4 CLARIFICATION: In 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.) Insulin Delivery Device/Pen National codes: S5560: Insulin delivery device, reusable pen; 1.5 ml size S5561: Insulin delivery device, reusable pen; 3 ml size S5570: Insulin delivery, disposable pen (including insulin): 1.5 ml size S5571: Insulin delivery device, disposable pen (including insulin); 3 ml size 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. Needle-Free injection Device HCPCS Level II code: A4210: Needle-free injection device, each NOTE: This code is not specific for needle-free insulin administration and it may be used for other drug(s) administration. This code is processed through a member s DME benefit. ICD-9 Diagnosis Codes ICD-9-CM diagnosis codes: Code Description Diabetes mellitus without mention of complication, type I [juvenile type], uncontrolled Diabetes mellitus with ketoacidosis, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with ketoacidosis, type I [juvenile type], uncontrolled Diabetes mellitus with hyperosmolarity, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with hyperosmolarity, type I [juvenile type], uncontrolled Diabetes mellitus with other coma, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with renal manifestations, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with renal manifestations, type I [juvenile type], uncontrolled Diabetes mellitus with ophthalmic manifestations, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with ophthalmic manifestations, type I [juvenile type], uncontrolled Diabetes mellitus with neurological manifestations, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with neurological manifestations, type I [juvenile type], uncontrolled Diabetes mellitus with peripheral circulatory disorders, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with peripheral circulatory disorders, type I [juvenile type], uncontrolled Diabetes mellitus with other specified manifestations, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with other specified manifestations, type I [juvenile type], - 4 -

5 uncontrolled Diabetes mellitus with unspecified complication, type I [juvenile type], not stated as uncontrolled Diabetes mellitus with unspecified complication, type I [juvenile type], uncontrolled ICD-10-CM Diagnosis Codes ICD-10-CM diagnosis codes: Code Description E10.65 Type 1 diabetes mellitus with hyperglycemia E10.10 Type 1 diabetes mellitus with ketoacidosis without coma E10.69 Type 1 diabetes mellitus with other specified complication E10.11 Type 1 diabetes mellitus with ketoacidosis with coma E Type 1 diabetes mellitus with hypoglycemia 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 E Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema E Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E edema Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without E macular edema Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with E macular edema Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without E macular edema Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E edema Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema E E Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema E 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 E Type 1 diabetes mellitus with diabetic neuropathic arthropathy 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 E Type 1 diabetes mellitus with other diabetic arthropathy E Type 1 diabetes mellitus with diabetic dermatitis E Type 1 diabetes mellitus with foot ulcer E Type 1 diabetes mellitus with other skin ulcer E Type 1 diabetes mellitus with other skin complications E Type 1 diabetes mellitus with periodontal disease - 5 -

6 E Type 1 diabetes mellitus with other oral complications E Type 1 diabetes mellitus with hypoglycemia without coma E10.8 Type 1 diabetes mellitus with unspecified complications Other information Effective 7/1/00, we allow the purchase of one insulin pump once in 5 years. Updated 3/1/10, to allow the purchase of one insulin pump once in 4 years. Policy update history Issued 4/96. Reviewed 3/97; no change in coverage. Updated 5/97 to revise medical necessity criteria for coverage, including demonstration of reasonable control with multiple daily injections, successful trial period; exclusions were added for those with tendency for hypoglycemia, pre-conception or pregnant, brittle diabetes, and those using the pump for convenience. Reviewed 2/98; no changes in coverage were made. Reviewed 2/99; no changes in coverage were made. Updated 2/00 to revise portable insulin infusion pump guidelines; include coverage for patients with Type 1 juvenile onset diabetes for Medicare HMO Blue in accordance with CMS guidelines; include coverage for insulin injection pens; and change insulin infusion pumps billing guideline into a clinical recommendation. Updated 7/00 to include the Massachusetts State Mandate Chapter 175 on insulin pumps and insulin pump supplies. Updated 1/02 to exclude coverage for chronic intermittent intravenous insulin therapy. Updated 2/02 to change insulin delivery devices from clinical recommendation into medical policy. Reviewed 2/03 MPG Endocrinology, no changes in coverage were made. Reviewed 2/04 MPG Psychiatry, Ophthalmology and Endocrinology, no changes in coverage were made. Reviewed 2/05 MPG - ophthalmology, psychiatry and endocrinology, no changes in coverage were made. Updated 4/05 to include the 2005 BCBSA policy references on chronic intermittent intravenous insulin therapy. Updated 3/06 to update billing information and clarify benefit coverage of insulin delivery devices/pens. Reviewed 2/06 MPG- Psychiatry, Ophthalmology and Endocrinology, no changes in coverage were made. Updated 6/06 billing information to clarify benefit coverage for insulin pump and pump supplies. Updated 1/07 to clarify benefit coverage of insulin pump and pump supplies with the addition of footnote 9 and updated Billing now Coding Information section. Reviewed 2/07 MPG- Psychiatry, Ophthalmology and Endocrinology, no changes in coverage were made. Updated 6/07 based upon BCBSA national policy issued 4/07, with no change in coverage exclusion of CIIIT. Updated to include coverage for Omnipod, External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories, for all plans, as DME, effective April 1, Reviewed 2/08 MPG- Psychiatry, Ophthalmology and Endocrinology, no changes in coverage were made. Reviewed 2/09 MPG Psychiatry, Ophthalmology and Endocrinology, no changes in coverage were made. 3/10, Policy updated to reflect decision to allow the purchase of one insulin pump once in 4 years. Reviewed 2/2010 MPG Psychiatry, Ophthalmology, and Endocrinology, no changes in coverage were made. Updated 6/2010 to add Medicare language regarding non-coverage of services comprising an Outpatient Intravenous Insulin Therapy regimen when furnished pursuant to an OIVIT regimen. References added. Updated 12/2010 to apply new policy format, endnotes for references, procedure to diagnoses editing. Reviewed 5/2011 MPG Pediatrics and Endocrinology, no changes in coverage were made. Updated 11/29/2011 to reference a limit of insulin pump reservoirs (HCPCS level II code A9274) of 15 units per 30 days, effective 2/1/2012. Updated 4/2012 with additional references based on BCBSA national policy, reviewed 8/2011. Updated 10/2013 to include new references from BCBSA. Updated/1/7/2014 to clarify noncoverage of artificial pancreas. Updated 2/10/2014 to clarify noncoverage of MiniMed530G by Medtronics artificial pancreas system. 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. References References for footnote 4: 1. Aoki TT, Benbarka MM, Okimura MC et al. Long-term intermittent intravenous insulin therapy and type 1 diabetes mellitus. Lancet 1993; 342(8870): Aoki TT, Grecu EO, Arcangeli MA. Chronic intermittent intravenous insulin therapy corrects orthostatic hypotension of diabetes. Am J Med 1995; 99(6):

7 3. Aoki TT, Grecu EO, Prendergast JJ et al. Effect of chronic intermittent intravenous insulin therapy on antihypertensive medication requirements in IDDM subjects with hypertension and nephropathy. Diabetes Care 1995; 18(9): Dailey GE, Boden GH, Creech RH et al. Effects of pulsatile intravenous insulin therapy on the progression of diabetic nephropathy. Metabolism 2000; 49(11): Weinrauch LA, Sun J, Gleason RE et al. Pulsatile intermittent intravenous insulin therapy for attenuation of retinopathy and nephropathy in type 1 diabetes mellitus. Metabolism 2010; 59(10): Handelsman Y, Mechanick JI, Blonde L et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011; 17 Suppl 2: Rodbard HW, Blonde L, Braithwaite SS et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007; 13 Suppl 1: American Diabetes Association. Clinical Practice Recommendations Diabetes Care 2009; 32(suppl 1). Available online at: Last accessed June 26, Qaseem A, Humphrey LL, Chou R et al. Use of intensive insulin therapy for the management of glycemic control in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2011; 154(4): Kansagara D, Fu R, Freeman M et al. Intensive insulin therapy in hospitalized patients: a systematic review. Ann Intern Med 2011; 154(4): This document is designed for informational purposes only and is not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically Blue Cross and Blue Shield of Massachusetts, Inc. All rights reserved. Blue Cross and Blue Shield of Massachusetts, Inc. is an Independent Licensee of the Blue Cross and Blue Shield Association. Footnotes 1 Based on The General Laws of Massachusetts Chapter 175, 2 Based on Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Outpatient Intravenous Insulin Treatment (40.7) 3 ICD-9 CM diagnoses codes that are covered for the codes listed below: , Diabetes mellitus without mention of complication, type I [juvenile type], uncontrolled , Diabetes with ketoacidosis, type I [juvenile type], not stated as uncontrolled , Diabetes with ketoacidosis, type I [juvenile type], uncontrolled , Diabetes with hyperosmolarity, type I [juvenile type], not stated as uncontrolled , Diabetes with hyperosmolarity, type I [juvenile type], uncontrolled , Diabetes with other coma, type I [juvenile type], not stated as uncontrolled , Diabetes with renal manifestations, type I [juvenile type], not stated as uncontrolled , Diabetes with renal manifestations, type I [juvenile type], uncontrolled , Diabetes with ophthalmic manifestations, type I [juvenile type], not stated as uncontrolled , Diabetes with ophthalmic manifestations, type I [juvenile type], uncontrolled - 7 -

8 250.61, Diabetes with neurological manifestations, type I [juvenile type], not stated as uncontrolled , Diabetes with neurological manifestations, type I [juvenile type], uncontrolled , Diabetes with peripheral circulatory disorders, type I [juvenile type], not stated as uncontrolled , Diabetes with peripheral circulatory disorders, type I [juvenile type], uncontrolled , Diabetes with other specified manifestations, type I [juvenile type], not stated as uncontrolled , Diabetes with other specified manifestations, type I [juvenile type], uncontrolled , Diabetes with unspecified complication, type I [juvenile type], not stated as uncontrolled , Diabetes with unspecified complication, type I [juvenile type], uncontrolled 4 Based on BCBSA national policy Chronic Intermittent Intravenous Insulin Therapy (CIIIT) reviewed 8/