MEDICAL COVERAGE POLICY. SERVICE: Insulin Pump and Continuous Glucose Monitoring. PRIOR AUTHORIZATION: Required. POLICY:

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1 Important note Even though this policy may indicate that a particular service or supply may be considered covered, this conclusion is not based upon the terms of your particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary will be covered benefits under the terms of your benefit plan. You need to consult the Evidence of Coverage to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and your plan of benefits, the provisions of your benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and self-funded non-erisa (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. With respect to Senior Care members, this policy will apply unless Medicare policies extend coverage beyond this Medical Policy & Criteria Statement. Senior Care policies will only apply to benefits paid for under Medicare rules, and not to any other health benefit plan benefits. CMS's Coverage Issues Manual can be found on the CMS website. SERVICE: PRIOR AUTHORIZATION: Required. POLICY: Continuous subcutaneous insulin infusion and related drugs/supplies are covered as medically reasonable and necessary for the treatment of diabetic patients who meet ALL of the criteria (1-4) below. (Insulin for insulin pumps requires a prescription and must be obtained at a plan pharmacy): (Adapted from CMS NCD ) 1. Patients must meet EITHER Criterion A or B as follows: Criterion A: The patient must meet ALL of the following: a. Completed a comprehensive diabetes education program, AND b. Has been on a program of multiple daily injections of insulin (i.e., at least 3 injections per day), with frequent self-adjustments of insulin doses for at least 6 months prior to initiation of the insulin pump, AND c. 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 d. Meets ONE or MORE of the following criteria while on the multiple daily injection regimen: Glycosylated hemoglobin level (HbAlc) > 7.0 percent; 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. For pediatric patients: member requiring very low insulin doses that cannot be safely delivered with insulin injection therapy Criterion B: The patient with diabetes is already on a pump on effective date of SWHP coverage, and has documented frequency of glucose self-testing an average of at least 4 times per day. Page 1 of 5

2 2. The patient must be insulinopenic as evidenced by the updated fasting C-peptide testing requirement, a positive beta cell autoantibody test (Islet Cell Cytoplasmic Autoantibodies), OR, for lines of business other than SeniorCare, a history of diabetic ketoacidosis. Fasting C-peptide testing requirement: Has 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, weight, and serum creatinine) 50 ml/minute, insulinopenia is defined as a fasting C-peptide level that is less than or equal to 200% of the lower limit of normal of the laboratory's measurement method. Fasting C-peptide levels will only be considered valid with a concurrently obtained fasting glucose 225 mg/dl. Levels only need to be documented once in the medical records. 3. Continued coverage of the insulin pump would require that the patient be seen and evaluated by the treating physician at least every 3 months. 4. The pump must be ordered by and follow-up care of the patient must be managed by an endocrinologist 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. An implantable insulin pump therapy may be medically necessary for patients with type 1 or type 2 diabetes mellitus who have not achieved adequate glycemic control with intensive SC insulin therapy or an external insulin pump. (See first exclusion below.) Replacement of an insulin pump is covered once every 4 years, or when the insulin pump malfunctions, is no longer under warranty, and cannot be repaired. An implanted infusion pump for the infusion of insulin to treat diabetes is NOT covered by Medicare because the data do not demonstrate that the pump provides effective administration of insulin. Chronic intermittent intravenous insulin therapy (CIIIT) also referred to as metabolic activation therapy (MAT), or pulsatile intravenous insulin therapy (PIIT) is NOT covered because it is considered experimental/investigational or unproven. Supplies or accessories not required for the functioning of the insulin pump, such as alcohol, alcohol wipes, carrying cases, clips, pouches, shower packs, etc., are NOT covered. Combined or integrated continuous subcutaneous insulin infusion pump and standard fingerstick blood glucose monitoring (CSII-BGM) system (e.g., Omnipod Starter Kit [pods and Personal Diabetes Manager]) are covered as medically necessary for the management of type 1 diabetes mellitus if the member meets criteria for CSII, or member was already on a CSII device on the effective date of SWHP coverage. Page 2 of 5

3 Replacement of an insulin pump is covered once every 4 years, or when the insulin pump malfunctions, is no longer under warranty, and cannot be repaired. Supplies or accessories not required for the functioning of the insulin pump, such as alcohol, alcohol wipes, carrying cases, clips, pouches, shower packs, etc., are NOT covered. Continuous glucose monitoring systems (CGMS) may be medically necessary when such monitoring is needed to detect trends and patterns in glucose levels over time in order to optimize glycemic control and reduce incidences of hyperglycemia and hypoglycemia in insulin-dependent diabetics. The following criteria must be met: 1. Member requires insulin injections 3 or more times per day or use of an insulin pump for maintenance of blood sugar control; AND 2. Member is capable of using a long-term continuous glucose monitoring system; AND 3. Member meets at least one of the following criteria despite adherence to a physician ordered diabetic treatment plan and compliance with at least four times per day self-monitoring and multiple alterations in insulin administration regimens: Member has been unable to achieve optimum glycemic control as defined by the current version of the American Diabetes Association Standards of Medical Care in Diabetes 1; OR Member has experienced hypoglycemia unawareness; OR Member has experienced recurring episodes of severe hypoglycemia (<50 mg/dl). Coverage for members already on a CGMS device on the effective date of SWHP coverage may be continued after medical review. Short-term use (less than 7 days) of continuous glucose monitoring devices may be considered medically necessary when there is inadequate glycemic control despite compliance with frequent (at least 4x/day) self-monitoring, and: 1. Poor control is in spite of compliance with multiple alterations in self-monitoring and insulin administration regimens, as evidenced by fasting hyperglycemia (>150 mg/dl) or recurring episodes of severe hypoglycemia (<50 mg/dl); and 2. Insulin injections are required 3 or more times per day, or use of an insulin pump is required for maintenance of blood sugar control; and 3. Results are monitored and interpreted under supervision of a physician. Authorizations for short-term use are limited to 3 times during the calendar year. NOT considered medically necessary for individuals with type 2 diabetes as there is limited evidence that the use of such monitoring leads to improved glycemic control. NOT considered medically necessary for pregnant women with gestational diabetes (not known to be diabetic prior to pregnancy) as there is limited evidence to suggest that the use Page 3 of 5

4 of CGMS in these patients results in a reduction in undetected hyperglycemia and nocturnal hypoglycemic events. Combined or integrated continuous subcutaneous insulin infusion and blood glucose monitoring system that includes a continuous blood glucose monitor (CBGM) are covered as medically necessary for long-term use in the treatment of ANY of the following: Type 1 diabetic age 25 years or older Type 1 diabetic age 24 years or younger with recurrent, severe hypoglycemic events (i.e., blood glucose 50mg/dL) despite appropriate modifications in insulin therapy and compliance with frequent self-monitoring of blood glucose (i.e., at least four times daily) Type 2 diabetic with recurrent, severe hypoglycemic events (i.e., blood glucose < 50mg/dL) despite appropriate modifications in insulin therapy, and compliance with frequent selfmonitoring of blood glucose (i.e., at least four times daily) and EITHER of the following: Fasting C-peptide level 110% of the lower limit of normal of the laboratory s measurement method AND a concurrently obtained fasting glucose 225 mg/dl Renal insufficiency with a creatinine clearance (actual or calculated from age, gender, weight and serum creatinine) 50 ml/minute AND a fasting C-peptide level 200% of the lower limit of normal of the laboratory s measurement method This coverage is NOT available for Senior Care line of business General information: SWHP covers as medically necessary DME, the supplies required for the proper use of a medically necessary insulin pump including custom-designed batteries and power supplies. However, off-theshelf batteries that can also be used to power non-medical equipment are not considered DME and are therefore not covered. SWHP does not cover additional software or hardware required for downloading data to a personal computer to aid in self-management of diabetes mellitus because it is considered a convenience item and not medically necessary. SWHP does not cover a transdermal insulin delivery system (e.g., V-Go Disposable Insulin Delivery Device) because it is considered experimental, investigational or unproven. OVERVIEW: An external insulin pump is a device that delivers insulin subcutaneously. The insulin is delivered in a programmed and controlled manner and eliminates the need for the patient to selfinject insulin. The main goal in using an insulin pump is to achieve near normal blood glucose levels in order to prevent both acute and chronic complications of diabetes and prevent dangerous episodes of low blood sugar. MANDATES: N/A CODES: HCPCS 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 Page 4 of 5

5 CPT Not Covered: ICD9 codes: ICD9 Not covered: A9274 External ambulatory delivery system, disposable, each, includes all supplies and accessories E0784 External ambulatory infusion pump, insulin E1399 Durable medical equipment, miscellaneous K0552 Supplies for external drug infusion pump, syringe type cartridge, sterile, each S9145 Insulin pump initiation, instruction in initial use of pump (pump not included) 250.xx CMS: See NCD effective 2/18/2005 POLICY HISTORY: Status Date Action New 8/1/2010 New policy Reviewed 12/2/2011 Reviewed. Reviewed 12/6/2012 Reviewed. Extensively revised. Reviewed 2/28/2013 Reviewed and revised pediatric section. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Centers for Medicare & Medicaid Services Medicare Coverage Database LCD for External Infusion Pumps (L5044). Revision 01 /01/ Eugster EA, Francis G and the Lawson-Wilkins Drug and Therapeutics Committee. Position Statement: Continuous Subcutaneous Insulin Infusion in Very Young Children with Type 1 Diabetes. Pediatrics 2006 Oct:1 1 8(4): Weinzimer SA, Ahern JH, Doyle EA, Vincent MR, Dziura J, Steffen AT, Tamborlane WV. Persistence of Benefits of Continuous Subcutaneous Insulin Infusion in Very Young Children with Type 1 Diabetes: A Follow-up Report. Pediatrics 2004 Dec;1 14(6): Kaufman FR, Halvorson M, Carpenter S, Devoe D, Pitukcheewanont P. Insulin Pump Therapy in Young Children with Diabetes. Diabetes Spectrum 2001;14(2): Cummins E, Royle P, Snaith A, et al.(2010) Clinical effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation. Health Technol Asses, 2010; 14: Pickup JC.(2012) Insulin-Pump Therapy for Type 1 Diabetes-Mellitus. New Engl J Med, 2012; 266: Page 5 of 5