ADMINISTRATIVE POLICY AND PROCEDURES MedStar Family Choice

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1 ADMINISTRATIVE POLICY AND PROCEDURES MedStar Family Choice Policy #: 1405 Subject: Continuous Glucose Effective Date: 12/01/2012 Monitoring Devices Revision Dates: 10/13, 10/14 Section: Care Management Page Number: 1 of 5 Submitted by: Patryce Toye, MD Responsible Department(s): Case Management Carol Attia, RN AVP, Care Management Patryce A. Toye, MD Senior Medical Director Sheryl-Anne Murray AVP, District Operations Kim Collins, LPN Sr. Director, Clinical Support Services Theresa Bittle, RN Sr. Director, Case Management Cyd Campbell, MD Medical Director, District of Columbia Marlise Skinner, RN Manager, Case Management, District of Columbia Purpose: Scope: Policy: It is the purpose of this policy to define the conditions under which MedStar Family Choice utilization staff may authorize continuous glucose monitoring devices. MedStar Family Choice, MD; MedStar Family Choice, District of Columbia Healthy Families and Alliance. It is the policy of MSFC to authorize continuous glucose monitoring devices by nurse utilization management staff as outlined in the criteria below. Requests that do not specifically meet the criteria may be submitted with Page 1 of 5

2 supporting medical records, articles from the literature, etc. and will be reviewed by a Physician Advisor for a medical exception. For the sake of this policy inadequate glycemic control is defined as a persistent hyperglycemia (>180mg/dl) and/or recurring episodes of hypoglycemia (<50mg/dl) in spite of compliance with multiple alterations in self-monitoring and insulin administration regimens to optimize care as directed by a physician who specializes in the treatment of diabetics. I. Professional CGM for short-term use: MSFC considers this a short term, diagnostic use of this device and provides it as a rental. This device supplies retrospective information to the prescribing practitioner or realtime data to the patient. MSFC utilization staff may authorize for up to 3-7 days use of Continuous Glucose Monitoring System Devices (CGMS) for members with diabetes who have the following problems in controlling blood glucose level unresponsive to conventional insulin dose adjustment and meet criteria in sections A, B and C below: A. MSFC will authorize Professional short-term CGMS devices as an adjunct to standard care for Type I diabetics age 8 years and over, who meet at least two of the following criteria: 1. The patient exhibits inadequate glycemic control despite multiple daily injections of insulin (3 or more injections) or use of the insulin pump and frequent monitoring of blood glucose with a home glucometer (4 or more times a day). 2. The patient has had at least one recent episode of significant ketoacidosis, acute hypoglycemia, or hospitalization for uncontrolled hyperglycemia. 3. The patient has signs and symptoms of undocumented hypoglycemia. 4. The patient has unexplained large fluctuations in blood glucose values. 5. The patient has early morning fasting hyperglycemia, or dawn phenomenon. 6. The patient has hypoglycemic unawareness that required assistance from another person to administer oral carbohydrate, glucagon, or other resuscitative actions. 7. The patient is experimenting with important changes to their diabetes regimen (requires consultative review with a Physician Advisor.) B. Professional CGMS are to be prescribed by a physician who specializes in the treatment of diabetes and who is familiar with how to manage treatment of the person with diabetes based on the data obtained from the monitor. Page 2 of 5

3 C. The device is generally worn for periods of consecutive 3-7 days (short term). It is anticipated that the device would be used only two times in a given year to give an opportunity for treatment modification. Any additional requests will require review and approval of a Physician Advisor. II. Personal CGM for long-term use: MSFC considers this long term monitoring and a therapeutic use of this device. In this situation, the device is purchased for the member and is used as an adjunct to self-glucose monitoring. It reports data to the member in real time. MSFC utilization staff may authorize long-term use of a Personal Continuous Glucose Monitoring System Devices (CGMS) for members with diabetes who have the following problems in controlling blood glucose level unresponsive to conventional insulin dose adjustment and meet criteria in sections A and B below A. MSFC utilization staff may authorize long-term use of a Personal continuous glucose monitoring device (CGM) when one of the following criteria is met: 1. Patients with Type 1 diabetes who are pregnant 2. For Adults: Members with Type 1 diabetes on insulin therapy who have consistent problems with inadequate glycemic control in spite of aggressive management by an Endocrinologist including multiple doses of insulin (3 or more insulin injections a day or proper use of an insulin pump) and frequent finger stick self monitoring (4 or more per day) over weeks to months. OR The member has documented recurring episodes of severe hypoglycemia (50mg/dl). The poor control is in spite of multiple alterations in selfmonitoring and insulin administration regimens to optimize care (3 or more insulin injections a day or proper use of the insulin pump.) OR Members with Type I diabetes who has hypoglycemic unawareness that required assistance from another person to administer oral carbohydrate, glucagon, or other resuscitative actions 3. For children and young adults (< 18 yo) with Type 1 diabetes: For children under the age of 18 years old, a CGMS may be considered on an individual basis. Requests will require review by a Physician Advisor. Page 3 of 5

4 B. And all of the following criteria are also met: 1. The member must also be able to demonstrate adherence to physicianordered treatment regimen. 2. It is prescribed by the treating physician to supplement, and not replace, the traditional finger stick self-monitoring of glucose levels. 3. Compliance with frequent self-monitoring of blood glucose as evidenced by a blood glucose log. 4. Professional CGM trial is encouraged prior to request for long-term CGM for personal use. 5. The patient is in an appropriate Case Management Program. III. MFSC will not authorize the following: A. Use of CGMS is not recommended for the treatment of people with Type 2 diabetes, except on a case-by-case basis. B. The use of continuous interstitial glucose monitoring devices and supplies that do not meet the policy criteria above. BACKGROUND: Professional CGM for short-term use: Continuous Glucose Monitoring System (CGMS) is an externally- worn monitoring device which continuously samples and measures glucose levels in the interstitial fluid of the subcutaneous tissues. A glucose sensor is inserted into the subcutaneous tissue using a needlelike introducer. The system records the glucose level every 5 minutes and displays data for review by the provider and the patient. The CGMS is not intended to take the place of the patient s regular treatment regimen of checking blood sugar levels by sampling of blood using a finger stick. Rather, the CGMS is designed to measure fluctuations as well as trends in the overall glucose levels during the entire period usually for up to 3-7 days, including times of sleep, activity, mealtimes, and so forth. The rationale for doing this study is that some persons with diabetes present special challenges in controlling the blood glucose levels. Although the standard for fingerstick blood glucose levels may be within the accepted range and although the patient s HbA1C level may be 7% (6.5%) or below, the patient may experience nighttime hypoglycemic episodes or they may have daytime hyperglycemic periods. The data obtained from shortterm Professional CGMS can be used by the specialist to modify the patient s insulin dosage, the time it should be given, and the optimum times for the test blood sugar levels. The goal for optimum control is to maintain a level of glycosylated hemoglobin (HbA1C) at 7 % or lower (6.5%). In some circumstances, a higher HbA1C maybe be set as the goal. Improved metabolic control, then, leads to reduction in the onset of complications of diabetes. Personal CGM for long-term use: Continuous Glucose Monitoring for long-term use is used as a supplement to self-monitoring of blood glucose (when it is medically necessary to detect trends and patterns in glucose levels over time in order to optimize glycemic control and reduce incidences of hyperglycemia and hypoglycemia in patients with type 1 diabetes Page 4 of 5

5 The overall goal for the use of CGMS is improving overall glycemic control, and reducing the incidence of hyperglycemic and hypoglycemic events. ******* Page 5 of 5

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