Effective Date: 03/24/2005
Title: Continuous Glucose Monitoring
Revision Date: 01/01/2018
CPT Code(s): A9276, A9277, A9278, K0554, S1030, S1031, 95249, 95250, 95251
will apply to all services performed on or after the above Revision date which
will become the new effective date.
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
continuous glucose monitoring of up to 72 hours is used to help regulate blood
sugar in type I diabetics having significant problems with control.
continuous monitoring is setup in a physician’s office using a sensor provided
by the physician and requires pre-authorization.
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 requests for short term and long term continuous glucose
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.
GlucoWatch, non-invasive glucose monitoring system, is not covered.
for Continuous Glucose Monitors and their supplies require prior authorization.
the short term (up to 72 hours) continuous glucose monitoring a medically
necessary adjunct for members who meet the following criteria:
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:
hypoglycemia and/or Unaware hypoglycemic episodes,
Members with type
1 diabetes prior to insulin pump initiation to determine basal insulin
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
Long term continuous
therapeutic glucose monitoring is considered medically necessary DME for
members meeting the following criteria:
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
hypoglycemic episodes or at risk of severe hypoglycemia.
Used In This BI:
A9276 Sensor, for CGMS
A9277 Transmitter, external, for CGMS
A9278 Receiver, external, for adjunctive, short-term CGMS
(monitor), dedicated for use with therapeutic glucose continuing monitor (new
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
GlucoWatch Biographer (Cygnus Inc., Redwood
City, CA.), a glucose meter that is worn on the wrist, is considered
experimental and investigational.
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.
Continuous glucose monitoring will not be
covered when an insulin pump is being requested at the same time.
The insulin pump must be tried first for 3
months and meet criterion 2c under the medical policy statement above
for continuous monitoring.
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.
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.
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.
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.
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.
Goldstein DE, Little
RR, Lorenz RA, et al.
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
Inc. MiniMed Web: The
Glucose Monitoring System (CGMS). Sylmar, CA: MiniMed Inc.; 2000. Available
Gerritsen M, Jansen JA, Kros A, et al. Performance of subcutaneously
implanted glucose sensors: A review. J Invest Surg. 1998; 11(3):163-174.
American Diabetes Association. Standards of medical care for patients with
diabetes mellitus. Diabetes Care. 1999; 22(suppl. 1):S32-S41.
Gin H, Catargi B, Rigalleau V, et al. Experience with the Biostator for
diagnosis and assisted surgery of 21 insulinomas. Eur J Endocrinol. 1998;
Tamada JA, Garg S, Jovanovic L, et al.
monitoring: Comprehensive clinical results. Cygnus Research Team. JAMA.
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.
Cygnus, Inc. GlucoWatch® Biographer. Redwood City, CA: Cygnus; 2000.
Available at: http://www.cygn.com/glucowatch.html.
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.
Taking charge of diabetes. Self-care is crucial -- and widely neglected.
Consumer Reports. 2001; 66(10):34-38.
Jungheim K, Koschinsky T. Risk delay of hypoglycemia testing by glucose
monitoring at the arm. Diabetes Care. 2001; 24(7):1303-1306.
Fineberg SE, Bergenstal RM, Bernstein RM, et al.
Use of automated
device for alternative site blood glucose monitoring. Diabetes Care. 2001;
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study
Continuous glucose monitoring and intensive treatment of type 1 diabetes;
NEJM; Oct 2, 2008
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.
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.