06/13/17. A. Completed a comprehensive diabetes education program within the past two years; and

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1 Reference #: MC/L011 Page 1 of 4 PRODUCT APPLICATION: PreferredOne Community Health Plan (PCHP) PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group Please refer to the member s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member s benefit plan or certificate of coverage, the terms of the member s benefit plan document will govern. Benefits must be available for health care services. Health care services must be ordered by a physician, physician assistant, or nurse practitioner. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration. PURPOSE: The intent of this criteria document is to ensure services are medically necessary. GUIDELINES: Medical Necessity Criteria - Must satisfy: I, and any of II-IV I. Must be ordered by a physician-coordinated team expert both in the management of and support of patients with complex diabetic conditions (such as, but not limited to, experience in management of diabetes requiring insulin pumps as well as continuous glucose monitoring systems); and II. Members with documented diabetes mellitus all of the following: 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. If greater than 18 years of age, has required frequent self-adjustments of insulin doses for the past 6 months (not required for members aged 18 years or younger); 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: Glycated hemoglobin (HbAlc) level greater than 7.0%; or 2. "Brittle" diabetes mellitus with recurrent episodes of diabetic ketoacidosis, hypoglycemia or both, resulting in recurrent and/or prolonged hospitalization; or 3. History of recurring hypoglycemia or severe glycemic excursions; or

2 Reference #: MC/L011 Page 2 of 4 4. Wide fluctuations in blood glucose before mealtime; or 5. "Dawn phenomenon" with fasting blood sugars frequently exceeding 200 mg/dl. III. Pre-conception or pregnancy; or IV. Replacement Pumps one of the following: A or B A. For children who require a larger insulin reservoir; or B. Request for a replacement pump - must meet all of the following: The device is out of warranty; and 2. The device is malfunctioning; and 3. The device cannot be refurbished. EXCLUSIONS: I. Replacement of a functioning insulin pump with an insulin pump with wireless communication to a glucose monitor is not considered medically necessary as such wireless communication has not been shown to improve clinical outcomes II. Additional software or hardware required for downloading data to a device such as personal computer, smart phone, or tablet to aid in self-management of diabetes mellitus BACKGROUND: This criteria set is based on expert consensus opinion and/or available reliable evidence. See Attachment A for examples of FDA-approved devices. Table 1 on pages of the 2014 Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force found at contains a comparison of features of major insulin pump models currently available.

3 Reference #: MC/L011 Page 3 of 4 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes Coverage is subject to the member s contract benefits. SETTING/LOS: Outpatient CODING: HCPCS A4230 Infusion set for external insulin pump, non-needle cannula type A4231 Infusion set for external insulin pump, needle type A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories (OmniPod) prior auth required for initial request only E0784 External ambulatory infusion pump, insulin RELATED CRITERIA/POLICIES: Process Manual: UR015 Use of Medical Policy and Criteria Medical Criteria: MC/L008 Continuous Glucose Monitoring Systems for Long-term Use Medical Policy: MP/C009 Coverage Determination Guidelines Medical Policy: MP/D004 Durable Medical Equipment, Supplies, Orthotics and Prosthetics REFERENCES: 1. Cigna Medical Coverage Policy. External Insulin Pumps. Effective Date 4/15/2016. Coverage Policy Number Retrieved from _external_insulin_pumps.pdf 2. Agency for Healthcare Research and Quality (AHRQ). Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness. Number Retrieved from 3. Bergenstal, et al. The Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. N Engl J Med 2010;363 4: AACE/ACE Consensus Statement. Consensus Statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force. Endocrine Practice 2014;20(5): Retrieved from 5. Agency for Healthcare Research and Quality (AHRQ). Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness. AHRQ Systematic Review Surveillance Program. Number Retrieved from DOCUMENT HISTORY: Created Date: 03/04/11 Reviewed Date: 02/27/12, 02/27/13, 02/27/14, 02/27/15, 02/26/16, 02/24/17 Revised Date:

4 Reference #: MC/L011 Page 4 of 4 Attachment A Examples of FDA-approved Devices 1 Accu-Chek Combo System or Spirit Insulin Pump Systems (Roche Diagnostics, Indianapolis, IN) combined insulin pump with finger stick blood glucose meter for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger ADI Insulin Pump (NiliMedix Ltd., Haifa, Israel) for persons with diabetes requiring insulin Amigo Insulin Pump (Nipro Diabetes Systems, Inc., Miramar, FLA) for subcutaneous infusion of insulin. Animas OneTouch Ping (Animas Corp., Frazer, PA) insulin pump with a OneTouch Ping Meter Remote for diabetics requiring continuous subcutaneous insulin delivery and measurement of glucose Asante Snap (Asante Solutions, Sunnyvale, CA) for adult patients requiring insulin Dana Diabecare II Insulin Pump (Sooil Development Co., Ltd., North Attleboro, MA) for subcutaneous delivery of insulin MiniMed Paradigm Revel Insulin Pump (Medtronic MiniMed, Northridge, CA) for the management of diabetes mellitus in persons requiring continuous delivery of insulin (MMT-523/723 for adults and MMT-523K/723K for ages 7 17 years) MiniMed Paradigm Revel Insulin Pump (Medtronic MiniMed, Inc. Northridge, CA) used in conjunction with the Contour Next Link glucose meter (Bayer HealthCare, Tarrytown, NY) for the continuous delivery of insulin in persons requiring insulin and the quantitative measurement of glucose in fresh capillary whole blood OmniPod Insulin Management System (Insulet Corporation, Boston, MA) is a wireless insulin pump that consists of a disposable insulin pod and Personal Diabetes Manager that includes a built-in FreeStyle glucose meter. The pod is filled with insulin by the patient and replaced every 72 hours. Solo MicroPump Delivery System (Medingo, Ltd., Yoqneam, Israel) for the management of diabetes mellitus in persons requiring insulin t:slim micro-delivery insulin pump (Tandem Diabetes Care, Inc., San Diego CA) for the subcutaneous delivery of insulin for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater t:flex Insulin Delivery System (Tandem Diabetes Care, Inc., San Diego CA) is a t:slim predicate device intended for the subcutaneous delivery of insulin for individuals 12 years of age and greater. The t:flex includes a 4.8 ml cartridge vs. 3.0 ml cartridge in the t:slim. Retrieved from: Cigna Medical Coverage Policy, External Insulin Pumps 1

5 PreferredOne Community Health Plan Nondiscrimination Notice PreferredOne Community Health Plan ( PCHP ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PCHP: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Community Health Plan PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PCHP LV (10/16)

6 PreferredOne Insurance Company Nondiscrimination Notice PreferredOne Insurance Company ( PIC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PIC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Insurance Company PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PIC LV (10/16)