Approved by: Integrated Health Quality Management Subcommittee Effective Date: Department of Origin: Integrated Healthcare Services.

Transcription

1 Reference #: MC/L008 Page: 1 of 8 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 one of the following: I - III I. Initial System Request must have Type 1 diabetes and any of the following: A-C A. Adults greater than or equal to 18 years of age - must satisfy both of the following: 1 and 2 1. Ordered by a physician-coordinated team expert both in the management of and support of members 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 [CGMS]); and 2. Adequate glucose control has not been achieved despite compliance with frequent self monitoring and insulin adjustments (4 or more finger sticks a day) - as evidenced by one or more of the following: a-c a. Hypoglycemic unawareness (includes nocturnal hypoglycemia); or b. HbA1c over target; or c. Excess glycemic variability (eg, hypoglycemia judged to be very excessive, potentially disabling, or life-threatening) B. Youth under 18 years of age must be ordered by a physician-coordinated team expert both in the management of and support of members 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) C. Pre-conception or pregnancy.

2 Reference #: MC/L008 Page: 2 of 8 II. Request for combination CGMS and insulin infusion pump must satisfy all of the following: A-E A. One of the following devices: CGMS (sensor/transmitter) with wireless communication to a compatible external insulin pump eg, MiniMed Paradigm REAL-Time Revel System and Animas Vibe System; or 2. CGMS (sensor/transmitter) with wireless communication to a compatible external insulin pump with low glucose suspend feature (open loop) (eg, MiniMed 530G and 630G); or 3. Hybrid closed loop system, (eg, MiniMed 670G). B. The criteria for a continuous glucose monitoring system has been met (see I., above); and C. The criteria for an insulin pump has been met (see MC/L011); and D. The device is FDA approved for its requested use (see Background); and E. The member does not have existing devices that are fully functional and would duplicate the same purpose that is served by a CGMS with wireless communication capability to an insulin infusion pump. III. Request for a replacement system - must meet both of the following: A and B A. The device is out of warranty; and B. The device is malfunctioning. EXCLUSIONS: Devices, such as, but not limited to, Dexcom SHARE, MiniMed Connect or mysentry, are considered convenience items and are ineligible for coverage. DEFINITIONS: Adjunctive/Non-Therapeutic continuous glucose monitor (CGM): Adjunctive/non-therapeutic CGM are devices used as an adjunct to blood glucose monitor (BGM) testing (i.e., primary therapeutic decisions regarding diabetes treatment must be made with a standard home BGM, not the CGM). Non-adjunctive/Therapeutic continuous glucose monitor (CGM): Non-adjunctive/therapeutic CGM are defined as CGM used as a replacement for fingerstick blood glucose testing for diabetes treatment decisions i.e., non-adjunctive use. Type 1 Diabetes: Type 1 diabetes is usually diagnosed in children and young adults and was previously known as juvenile diabetes. Only 5% of people with diabetes have this form of the disease. In type 1 diabetes, the body does not produce insulin. The body breaks down the sugars and starches you eat into a simple sugar called glucose, which it uses for energy. Insulin is a hormone that the body needs to get glucose from the bloodstream into the cells of the body.

3 Reference #: MC/L008 Page: 3 of 8 BACKGROUND: This criteria document is based on expert consensus opinion and/or available reliable evidence. Continuous Glucose Monitoring Systems Continuous glucose monitoring systems (CGMS) are devices that measure glucose levels in interstitial fluid at programmable intervals. These readings help detect any patterns or trends with an individual s glucose levels to help improve diabetes management. The majority of the FDA approved CGMS are intended to assist in calculating the insulin dosage needed to manage glycemic control. CGMS readings may also be used as adjunctive devices to complement, not replace, information obtained from standard home glucose monitoring and to supplement, not replace, a fingerstick (non-therapeutic continuous glucose monitor) CGMS use sensors that are inserted under the skin in the abdomen and work by extracting glucose from the interstitial fluid, measuring and recording the glucose level and converting these measurements into equivalent blood glucose readings. Sensors are designed to be worn three days to two weeks, depending on the product. Calibration is required whenever a new glucose sensor is inserted, which in most devices, requires obtaining blood glucose from a traditional fingerstick sample. Examples of US Food and Drug Administration (FDA) approved CGMS include, but are not limited to: Abbott FreeStyle Libre Flash: CGM device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The system detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. (HCPCS K0553, K0554) Non-adjunctive/therapeutic continuous glucose monitor Dexcom G5 Mobile: Complete, mobile CGMS with wireless technology that is built into the transmitter. Glucose information is sent wirelessly from the device transmitter to a compatible smart device or Dexcom G5 receiver. The Dexcom G5 is FDA approved for use in adults and children ages two years and older and is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. However, the system must be calibrated by using a fingerstick blood sample at least once every 12 hours. Interpretation of the Dexcom G5 results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. (HCPCS K0553, K0554) Non-adjunctive/therapeutic continuous glucose monitor Dexcom G6 System: A real time, continuous glucose monitoring device indicated for the management of diabetes in persons age two years and older. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. (HCPCS K0553, K0554) Non-adjunctive/therapeutic continuous glucose monitor

4 Reference #: MC/L008 Page: 4 of 8 Guardian REAL-Time: CGMS device that uses a glucose sensor connected to a transmitter that sends glucose readings every five minutes to a monitor. The glucose sensor is typically discarded and replaced after three days. Unique features include predictive and rate of change alarms and expanded trend graphs. Graphs can show the effect of exercise, diet and lifestyle, as well as medication on glucose values using 3, 6, 12 and 24- hour increments. Alarms that signal high and low glucose alerts warn individuals of any significant glucose changes. Data is downloaded using the Medtronic Carelink Therapy Management Software. FDA approved for use in adults and children ages seven years and older. (HCPCS A9277, A9278) Adjunctive continuous glucose monitor Insulin Pumps Insulin pumps are devices used to deliver insulin in a programmed and controlled manner to diabetic individuals. These devices work with a separate glucometer through manual or remote functions. The goal of insulin pump therapy is to achieve near-normal control of blood glucose levels. Insulin pumps are categorized as follows: External insulin pumps: Deliver insulin via subcutaneous or intraperitoneal routes. External insulin pumps may be either disposable or have disposable components. Examples of FDA approved external insulin pumps include, but are not limited to: ACCU-CHEK Spirit Combo Insulin Pump: Nondisposable insulin pump with programmable reminders for basal and bolus delivery of insulin. Bluetooth capable for two-way wireless communication with the Aviva combo meter to deliver insulin and adjust pump settings remotely. ADI Insulin Pump: For persons with diabetes requiring insulin Amigo Insulin Pump: For subcutaneous infusion of insulin. Animas Vibe Insulin Pump: For continuous subcutaneous infusion of insulin for the management of insulinrequiring diabetes. Asante Snap: For adult patients requiring insulin Dana Diabecare II Insulin Pump: For subcutaneous delivery of insulin OmniPod System: Disposable device that consolidates the pump, tubing and subcutaneous needle into one compact unit and can be remotely controlled by a hand-held device that has a built-in glucose meter. The unit is worn up to three days before requiring replacement. One-Touch Ping*: Nondisposable insulin pump with programmable basal and bolus insulin delivery that uses a glucose meter with remote capability. Solo MicroPump Delivery System: For the management of diabetes mellitus in persons requiring insulin Tandem t:flex Insulin Pump: A battery operated infusion pump capable of basal and bolus subcutaneous delivery of insulin at set and variable rates in persons requiring insulin, for individuals 12 years of age and greater

5 Reference #: MC/L008 Page: 5 of 8 Tandem t:slim Micro-Delivery Insulin Pump: For the subcutaneous delivery of insulin for the management of diabetes mellitus in persons requiring insulin, for individuals twelve years of age and greater Tandem t:slim X2: A t:slim predicate device approved for the subcutaneous deliver of insulin for individuals age six years. The device is indicated for use with NovoLog or Humalog U-100 insulin. V-Go Disposable Insulin Delivery Device: A fully disposable, nonelectronic device for the delivery of basalbolus insulin therapy for adults with diabetes. It provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes. It is applied to the skin daily for one 24-hour period. Combined External Insulin Pumps with CGMS A device that integrates an insulin pump with real-time continuous glucose monitoring and in most cases, is not intended to replace finger sticks. These systems incorporate features including predictive alerts that give early warnings so action can be taken to prevent dangerous high or low blood glucose events. Examples of FDA approved combined external insulin pumps with CGMS include: Animas Vibe System*: Combines a Dexcom G4 Platinum sensor and transmitter with the Animas Vibe insulin pump. FDA approved for use in adults and children, ages two years and older. MiniMed Paradigm REAL-Time Revel System: Approved for use in adults and children ages seven years and older and works with the mysentry remote monitoring system: o The mysentry remote monitoring system is an optional monitoring device for the MiniMed Paradigm REAL-Time Revel System. The mysentry consists of a remote outpost and monitor. Blood glucose levels collected by the CGM are sent to the remote (wireless) monitor, which also has alarms to alert the user of high or low blood glucose levels. (See Exclusions) t:slim X2 Insulin Pump: Intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, six years of age and older. The t:slim X2 insulin pump can be used solely for continuous insulin delivery or in addition with the Dexcom G5 mobile sensor or Dexcom G6 System and transmitter ( t:slim X2 system ). This pump features a Bluetooth radio and is designed to receive remote software updates. *[NOTE: The One-Touch Ping insulin pump and the Animas Vibe System are no longer being manufactured or sold.] Combined External Insulin Pumps and CGMS with Suspend on Low Feature (open loop) Suspend on low is the first step towards an artificial pancreas device system (APDS). This technology combines CGMS with an insulin pump which allows the user to set a low blood sugar threshold value. When the CGM sensor detects the preset low glucose threshold, insulin delivery is suspended. Examples of this type of device include: MiniMed 530G System: Intended for automatic, continuous delivery of basal insulin (at user selectable rates) and manual administration of insulin boluses (in user selectable amounts) in persons seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. This device has SmartGuard technology which automatically stops insulin delivery (for up to two hours) when sensor glucose values reach a preset level and when the individual does not respond to the suspend on low alarm.

6 Reference #: MC/L008 Page: 6 of 8 o MiniMed Connect (compatible with MiniMed 530G with Enlite and MiniMed Paradigm Revel insulin pump): An optional wireless device used to access continuous glucose monitor sensor data. Information can be viewed using an internet application through a smart device or via a browser accessible website and can be shared as needed (See Exclusions) MiniMed 630G: Intended for automatic, continuous delivery of basal insulin (at user selectable rates) and manual administration of insulin boluses (in user selectable amounts) for persons seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 630G system includes SmartGuard which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed 630G system with SmartGuard consists of the following devices: MiniMed 630G insulin pump, Enlite sensor, One-Press Serter, Guardian Link transmitter system, CareLink USB and Contour NEXT Link 2.4 wireless glucose meter. Hybrid Closed Loop System Along with the suspend on low feature, this newly FDA approved system has a suspend before low feature that purportedly stops insulin delivery when the sensor is predicted to reach a low limit and resumes after sensor glucose levels recover. An example of this type of device: MiniMed 670G: Intended for automatic, continuous delivery of basal insulin (at user selectable rates) and manual administration of insulin boluses (in user selectable amounts) for Type 1 diabetes mellitus (T1DM) in persons seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G System includes advanced SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on CGM sensor glucose values and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The MiniMed 670G system consists of the following devices: MiniMed 670G insulin pump, the Guardian Link 3 transmitter, the Guardian Sensor 3, One-Press serter and the Contour NEXT Link 2.4 wireless glucose meter. Automated Insulin Delivery (Closed Loop) Fully automated, closed-loop glucose management systems with a continuous glucose monitor and an insulin pump programmed with a computer algorithm that calculates insulin and glucagon doses from the CGM readings and tells the pump to deliver or temporarily suspend or reduce insulin based upon specified thresholds of measured glucose levels. Currently there are no fully closed loop systems on the market

7 Reference #: MC/L008 Page: 7 of 8 FOR INTERNAL USE COVERAGE: Prior Authorization: Yes Coverage is subject to the member s contract benefits. SETTING/LOS: Outpatient CODING: HCPCS A4225 Supplies for external insulin infusion pump, syringe type cartridge, sterile, each 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 A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories (OmniPod, V-Go) prior authorization is required for initial request only A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system A9278 Receiver (monitor), external, for use with interstitial continuous glucose monitoring system E0784 External ambulatory infusion pump, insulin J1817 Insulin for administration through DME (i.e., insulin pump) per 50 units K0553 Supply allowance for therapeutic glucose monitor (CGM), includes all supplies and accessories, 1 month supply =1 unit of service K0554 Receiver (monitor), dedicated, for use with therapeutic glucose monitor system S1030 Continuous noninvasive glucose monitoring device, purchase S1031 Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor S1034 Artificial pancreas device system (e.g., low glucose suspend (LGS) feature including continuous glucose monitor; blood glucose device, insulin pump and computer algorithm that communicates with all of the devices RELATED CRITERIA/POLICIES: Process Manual: UR015 of Medical Policy and Criteria Medical Criteria: MC/L011 Insulin Infusion Pump Medical Policy: MP/C009 Coverage Determination Guidelines Medical Policy: MP/D004 Durable Medical Equipment, Prosthetics, Orthotics and Supplies REFERENCES: 1. The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type I Diabetes. N Engl J Med 2008;359: Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocrine Practice, 2015;21(Suppl1). Retrieved from 3. Danne T, Nimri R, Bettelino T. International Consensus on of Continuous Glucose Monitoring. American Diabetes Association. Retrieved from Diabetes Care 2017 Dec; 40(12): Accessed 05/14/2018

8 Reference #: MC/L008 Page: 8 of 8 4. American Diabetes Association. Standards of Medical Care in Diabetes The Journal of Clinical and Applied Research and Education. January ;41(1). Retrieved from Accessed 04/09/ AACE Consensus Statement. Continuous Glucose Monitoring: A Consensus Conference of the American Association of Clinical Endocrinologists and American College of Endocrinology Aug;22(8). Retrieved from Accessed 04/09/ American Association of Clinical Endocrinologists (AACE). Clinical Practice Guideline. Diabetes technology continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults. Accessed 04/09/ American Association of Clinical Endocrinologists (AACE). Consensus statement by the American Association of Clinical Endocrinologists/American College of Endocrinology insulin pump task force. Published May Accessed 04/09/ AACE/ACE Consensus Statement. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm 2018 Executive Summary Jan;24(1). Retrieved from Accessed 04/09/ McGill JB, Ahmann A. Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies. Diabetes Technol/ Ther Jun 1;19(Suppl 3):S-3-S US Food and Drug Administration (FDA). Summary of safety and effectiveness data: Dexcom G6 mobile continuous glucose monitoring system. Published March 27, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: Dexcom G5 mobile continuous glucose monitoring system. Published July 21, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: FreeStyle Libre Flash glucose monitoring system. Published September 27, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: MiniMed 530G System. Published December 17, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: MiniMed 630G System with SmartGuard. Published August 10, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: MiniMed 670G System. Published September 28, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: Paradigm REAL-Time Revel insulin pump. Published December 7, US Food and Drug Administration (FDA). Summary of safety and effectiveness data: t:slim X2 insulin pump with Dexcom G5 mobile CGM. Published August 25, U.S. Food and Drug Administration. 510(k) data base. Product code LZG. 19. Agency for Healthcare Research and Quality (AHRQ). Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness Retrieved from Accessed 04/09/ Agency for Healthcare Research and Quality (AHRQ). Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness. AHRQ Systematic Review Surveillance Program. Number Retrieved from Accessed 04/09/2018. DOCUMENT HISTORY: Created Date: 03/25/08 Reviewed Date: 11/10/09, 11/02/10, 03/13/12, 03/13/13, 03/13/14, 03/13/15, 03/11/16, 03/13/17, 03/13/18 Revised Date: 1/22/09, re-adopted 03/09/11, 10/05/11, 12/22/11, 01/31/12, 03/14/14, 05/05/16, 09/27/17, 05/18/18 Retired Date: 11/12/10

9 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)

10 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)