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INDEX:
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Effective Date: 03/24/2005 Title: Continuous Glucose Monitoring
Revision Date: 01/01/2018 Document: BI096:00
CPT Code(s): A9276, A9277, A9278, K0554, S1030, S1031, 95249, 95250, 95251
Public Statement

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.     Short term continuous glucose monitoring of up to 72 hours is used to help regulate blood sugar in type I diabetics having significant problems with control.

2.     Short term continuous monitoring is setup in a physician’s office using a sensor provided by the physician and requires pre-authorization.

3.     Long term continuous glucose monitoring beyond 72 hours, used in extremely difficult cases to assist in management of type I diabetes, is considered DME and requires pre-authorization.

4.     The Pre-authorization requests for short term and long term continuous glucose monitoring require:

a)  Submission by the ordering provider office AND

b)  Accompanying patient medical records such as provider clinic progress notes. Information on vendor request forms is not acceptable.

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


Medical Statement

Requests for Continuous Glucose Monitors and their supplies require prior authorization.

  1. QualChoice considers the short term (up to 72 hours) continuous glucose monitoring a medically necessary adjunct for members who meet the following criteria:
    1. Members with type 1 diabetes that is poorly controlled despite being compliant with a regimen consisting of 4 or more finger stick glucose measurements and multiple insulin injections per day as manifest by:

                                          i.    Recurrent hypoglycemia and/or Unaware hypoglycemic episodes,

AND

                                        ii.    Uncontrolled hyperglycemia

    1. Members with type 1 diabetes prior to insulin pump initiation to determine basal insulin levels.
    2. Members with type 1 diabetes who are pregnant and despite intense therapy consisting of at least 4 finger sticks and 3 insulin injections per day, cannot achieve proper glycemic control
  1. Long term continuous therapeutic glucose monitoring is considered medically necessary DME for members meeting the following criteria:

a.    Type 1 diabetes under poor control with hyperglycemia not controlled on at least 3 injections per day or insulin pump and at least 4 finger stick glucose tests per day, AND

b.     Recurrent hypoglycemic episodes or at risk of severe hypoglycemia.

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

95249             Glucose monitoring cont (patient provided)

95250             Glucose monitoring cont (office provided)

95251             Gluc monitor cont phys i&r


Limits
  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.

  1. Continuous glucose monitoring will not be covered when an insulin pump is being requested at the same time.
    1. The insulin pump must be tried first for 3 months and meet criterion 2c under the medical policy statement above for continuous monitoring.

4.    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.


Background

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.

4)    Due to decreased insulin sensitivity, glucose levels are generally more stable in insulin-treated type-2 diabetes.  Per UpToDate, such patients typically require less frequent glucose monitoring than in type 1 diabetes.   The DIAMOND trial, published in 2017, showed no meaningful difference in hypoglycemic or quality-of-life outcomes for patients with insulin-treated type 2 diabetics using CGM vs standard care.


Reference
  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.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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