Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.    Requests for Continuous Glucose Monitors and their supplies other than Freestyle LIbre and Dexcom systems require prior authorization. All PA requests for CGM are reviewed by QualChoice.

2.    Dexcom and Freestyle Libre systems/supplies are preferred products covered under the pharmacy benefit at Tier 2 (only for members using the QualChoice contracted PBM). All other CGM system/supplies (including Minimed) are non-preferred products, requiring PA, and are not covered under the pharmacy benefit.

3.    The Pre-authorization requests for continuous glucose monitoring require submission by the ordering provider (information on vendor request forms is not acceptable).

4.    The GlucoWatch, non-invasive glucose monitoring system, is not covered.

Requests for Continuous Glucose Monitors and their supplies other than Freestyle Libre and Dexcom systems require prior authorization. All PA requests for CGM are reviewed by QualChoice.

1. Dexcom and Freestyle Libre systems/supplies are preferred products and are covered under the pharmacy benefit (for members using the QualChoice contracted PBM).  All other CGM system/supplies (including Minimed) are non-preferred and not covered under the pharmacy benefit. Long term continuous therapeutic glucose monitoring is considered medically necessary DME for members meeting all the following criteria: Diagnosis of diabetes (either Type 1 or Type 2)

a.    Use a home blood glucose monitor (BGM) and conduct four or more daily BGM tests

b.    Currently treated with insulin with multiple daily injections (at least 3) or a constant subcutaneous insulin pump

c.    Require frequent adjustments of the insulin treatment regimen, based on CGM test results

Codes Used In This BI:

A9276            Sensor, for CGMS

A9277            Transmitter, external, for CGMS

A9278            Receiver, external, for adjunctive, short-term CGMS

K0554            Receiver (monitor), dedicated for use with therapeutic glucose continuing monitor (new code 7/1/17)

S1030            Gluc monitor purchase

S1031            Gluc monitor rental

1. GlucoWatch Biographer (Cygnus Inc., Redwood City, CA.), a glucose meter that is worn on the wrist, is considered experimental and investigational.

2.    Additional software or hardware required for downloading data from blood glucose monitors to computers for the management of diabetes mellitus is considered convenience and is not covered.

3.    Transmitters for Continuous Glucose Monitors are limited to two every 12 months. Any additional transmitter requests will require documentation of transmitter malfunction by the ordering provider.

1.    The Continuous Glucose Monitoring System (CGMS) (MiniMed) and the upgraded version, the Guardian CGMS, consists of a subcutaneously implanted sensor that is attached to a small plastic disk the size of a dime and is taped to the skin to hold the sensor in place. A thin wire connects the sensor to a pager-sized glucose monitor, which records and stores glucose values in memory. An electrical signal is continuously relayed to the glucose sensor, which records glucose levels every 5 minutes, some 288 values per day. For calibration purposes, the manufacturer recommends that the patient enter the results of four finger stick blood glucose measurements per day into the monitor. For the Guardian CGMS, it is recommended that the device be calibrated with finger stick blood glucose levels every 12 hours at a minimum. The CGMS sensors are capable of transmitting values for up to three days, after which time the sensor must be removed and replaced with another by the patient, if additional monitoring is needed. The Guardian CGMS can store up to 21 days of data. The data captured in the monitor can be downloaded to a personal computer for review and used by a physician or the patient. Unlike the GlucoWatch, the glucose values are not displayed on these systems. However, the Guardian CGMS features an audible alarm that sounds when glucose levels become too high or too low per parameters set by the patient and the physician. The alarm is intended to prompt the patient to perform a finger stick blood glucose measurement since a level is not provided with the sounding of the alarm.

2.    The FDA approved labeling for the Continuous Glucose Monitoring System (CGMS) states in part: The CGMS is currently intended for occasional rather than everyday use, and is to be used only as a supplement to, and not a replacement for, standard invasive measurement. The CGMS is not intended to change patient management based on the numbers generated, but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take the fingerstick glucose measurements to better manage the patients.

3.    Additional devices now have FDA approval. The iPro Professional CGM (Medtronic). The FreeStyle Navigator CGM System (Abbott) was approved in March 2008. The sensor for this device can be worn on the back of the upper arm or on the abdomen. As with other CGM devices, information for this device also notes ”Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.” The FreeStyle Navigator system is no longer being offered or supported in the United States.  The Paradigm REAL-Time System and Guardian REAL-Time System (Pediatric Versions) (Medtronic, Mini Med) were approved by the FDA in March 2007. These are pediatric versions of previously approved devices. The approval of these devices includes the wording “All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings ….” This approval was based on the concordance of glucose results between those obtained with the sensor and with a glucose meter. The Paradigm system consists of an insulin infusion pump, the glucose sensor, and a transmitter.

1. Goldstein DE, Little RR, Lorenz RA, et al. American Diabetes Association. Position statement: Tests of glycemia in diabetes. ADA Clinical Practice Recommendations 2003. Diabetes Care. 2003; 26 (suppl. 1): S106-S108. Available at: http://care.diabetesjournals.org/cgi/content/full/26/suppl_1/s106
2. MiniMed, Inc. MiniMed Web: The MiniMed Continuous Glucose Monitoring System (CGMS). Sylmar, CA: MiniMed Inc.; 2000. Available at: http://www.minimed.com/files/cgms_web.htm.
3. Gerritsen M, Jansen JA, Kros A, et al. Performance of subcutaneously implanted glucose sensors: A review. J Invest Surg. 1998; 11(3):163-174.
4. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 1999; 22(suppl. 1):S32-S41.
5. Gin H, Catargi B, Rigalleau V, et al. Experience with the Biostator for diagnosis and assisted surgery of 21 insulinomas. Eur J Endocrinol. 1998; 139(4):371-377.
6. Tamada JA, Garg S, Jovanovic L, et al. Noninvasive glucose monitoring: Comprehensive clinical results. Cygnus Research Team. JAMA. 1999; 282(19):1839-1844.
7. Garg SK, Potts RO, Ackerman NR, et al. Correlation of fingerstick blood glucose measurements with GlucoWatch biographer glucose results in young subjects with type 1 diabetes. Diabetes Care. 1999; 22(10):1708-1714.
8. Cygnus, Inc. GlucoWatch® Biographer. Redwood City, CA: Cygnus; 2000. Available at: http://www.cygn.com/glucowatch.html.
9. American Diabetes Association. Statement from the American Diabetes Association Regarding the FDA Advisory Committee`s Recommendations on GlucoWatch. Alexandria, VA: American Diabetes Association; December 7, 1999.
10. Taking charge of diabetes. Self-care is crucial -- and widely neglected. Consumer Reports. 2001; 66(10):34-38.
11. Jungheim K, Koschinsky T. Risk delay of hypoglycemia testing by glucose monitoring at the arm. Diabetes Care. 2001; 24(7):1303-1306.
12. Fineberg SE, Bergenstal RM, Bernstein RM, et al. Use of automated device for alternative site blood glucose monitoring. Diabetes Care. 2001; 24(7):1217-1220.
13. The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes; NEJM; Oct 2, 2008
14. Beck RW, et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017;167:365–374.

Addendum:

1)    Effective 07/01/2017:  Added new code and language distinguishing between adjunctive, short-term CGM and therapeutic, long-term CGM. Added clarifying verbiage that Continuous Glucose Monitor requests will need to be submitted by ordering provider office along with provider’s clinic progress notes. Requests from Vendors or on vendor request forms will not be accepted.

2)      Effective 01/01/2018:  Transmitters for Continuous Glucose Monitors are limited to two every 12 months. Any additional transmitter requests require documentation of transmitter malfunction by the ordering provider and prior authorization.

3)      Effective 1/1/2018: 2018 Code Updates. Updated Claim Statement section & Codes Used in This BI section to reflect revised CPT/HCPCS codes. The following codes were revised 1/1/18: 95250 & 95251.

4)    Effective 4/18/2018: Added information/reference showing CGM doesn’t improve outcomes with T2DM.

5)    Effective 10/01/2020: Updated coverage criteria of Dexcom and Freestyle Libre as preferred products covered under the pharmacy benefit; noted Minimed as non-preferred product.

6)    Effective 01/01/2022: Removed PA requirement reference for Freestyle Libre and Dexcom.

7)    Effective 06/01/2023: Removed PA requirement for short-term CGM codes.

8)    Effective 07/01/2023: Noted that K0553 and K0554 were deleted as of 12/31/2022.