Chapter 8
Section 5.3
Continuous Glucose Monitoring
System (CGMS) Devices
Issue Date: December 15, 2009
Authority: 32 CFR 199
Copyright: CPT
only © 2006 American Medical Association (or such other date of
publication of CPT).
All Rights Reserved.
Revision: C-58, January 22, 2020
1.0 CPT
Procedure Codes
95250, 95251, 0446T-0448T
2.0 HCPCS Codes
A9276
- A9278, K0553, K0554
3.0 DESCRIPTION
A
CGMS is a minimally-invasive medical
device that provides ongoing, real-time monitoring and
recording of blood glucose levels by continuous measurement of interstitial
fluid. These devices consist
of an external receiver, external transmitter, and a subcutaneously
placed sensor. A
CGMS can be used by the provider for diagnostic purposes or by the
patient for self-monitoring of blood glucose levels. A CGMS is prescribed
for patients with insulin-treated diabetes mellitus. A CGMS can
be an adjunctive device to complement, not replace, standard fingerstick
Blood Glucose Monitor (BGM) testing or it can be used as a device
intended to replace fingersticks, also called “therapeutic CGMS.”
4.0 POLICY
U.S.
Food and Drug Administration (FDA) approved CGMS devices may
be cost-shared when used
according to FDA approved indications and it is documented
that prior to being prescribed the CGMS the recipient of the device has
diabetes, and a TRICARE authorized provider has examined the beneficiary
in person and evaluated the beneficiary’s diabetes control within
six months prior to ordering the CGMS, and a TRICARE authorized
provider documents that ALL of the following criteria have been
met:
4.1 Completion of
a comprehensive diabetic education program; and
4.2 Treatment regimen including at
least three insulin injections per day or insulin pump therapy, with
frequent self-adjustment of insulin doses in the last three months
(except for gestational diabetes, which has no time requirement
for the self-adjustment of insulin); and
4.3 Documented blood glucose self-testing
on average of at least four times per day prior to initiation of
CGMS therapy;
4.4 And
ANY one or more of the following:4.4.1 Glycosylated hemoglobin level (HBA1c) is greater
than 7.0% or less than 4.0%;
4.4.2 History of unexplained large fluctuations in
daily glucose values before meals;
4.4.3 History of early morning fasting hyperglycemia
(“dawn phenomenon”);
4.4.4 History of severe glycemic excursions;
4.4.5 Hypoglycemic unawareness;
4.4.6 History of recurrent, unexplained, severe hypoglycemic
events (i.e., blood glucose less than 50
mg/dl);
4.4.7 History
of recurrent episodes of ketoacidosis;
4.4.8 Hospitalizations for uncontrolled glucose levels;
4.4.9 Frequent nocturnal hypoglycemia; or
4.4.10 The beneficiary
is pregnant and has poorly controlled diabetes
or gestational diabetes.
5.0
CGMS
Devices And Supplies5.1 Therapeutic
CGMS is defined as a device that is approved by the FDA for non-adjunctive
use (i.e., used as a replacement for fingerstick BGM testing). Therapeutic
CGMS devices and all related supplies shall be reported using HCPCS
codes K0553 – K0554.
5.2 Non-therapeutic CGMS is defined
as a device that is approved by the FDA for use to complement, not
replace, information obtained from fingerstick testing. Non-therapeutic
CGMS devices and all related supplies shall be reported using the
following HCPCS codes: A9276, A9277 and A9278.
5.3 Replacement of a CGMS receiver
may be cost-shared when BOTH of the following criteria are met:
• There
is documentation confirming that the monitor/component is malfunctioning,
is no longer under warranty, and cannot be repaired. (See Section 2.1 for additional information on
Durable Equipment); and
• Evidence
of an evaluation by a TRICARE-authorized individual professional
provider (e.g., physician, nurse practitioner, etc.) managing the
diabetes within the last six months that includes a recommendation
supporting the continued use of a CGMS.
5.4 Contractors
shall ensure the provisions of 32 CFR 199.9 and
the TRICARE Operations Manual (TOM), Chapter 13,
are followed to prevent fraud and abuse.
6.0 Reimbursement Considerations6.1 Consistent
with TRICARE’s requirement to reimburse like Medicare, therapeutic
(non-adjunctive) CGMS and supplies shall be reported utilizing HCPCS
codes K0553-K0554 (or subsequent codes if replaced or renumbered).
Devices that are labeled for use as therapeutic (non-adjunctive), even
if the patient continues to perform glucose self-testing (e.g.,
finger sticks), shall be reported utilizing these codes.
6.2 Adjunctive (non-therapeutic)
CGMS and supplies should be reported with A9276 - A9278 or S1030-S1031
(or subsequent codes if replaced or renumbered), with providers
reminded of the requirement to use the most appropriate code for
the service rendered. Only those devices which are not labeled by
the FDA for therapeutic use (i.e., adjunctive, or only labeled to
complement but not replace standard blood glucose monitoring) may
be reported utilizing these codes.
6.3 CGMS shall be reimbursed using
the rate on the Durable Medical Equipment (DME), Prosthetics, Orthotics
and Supplies (DMEPOS) fee schedule. If there is no DMEPOS fee schedule
rate, the allowable charge shall be established in accordance with
the TRICARE Reimbursement Manual (TRM), Chapter 1, Section 39; Chapter 3, Section 1; and Chapter 5.
6.4 When
reimbursement is made in accordance with the TRM, Chapters 3 and 5,
especially when the state prevailing or billed rate is used, the
contractor shall ensure the provisions of 32 CFR 199.9(b)(2), (b)(7), (c)(11) and
the TOM, Chapter 13, are followed to prevent fraud
and abuse.
8.0 EXCLUSIONS
8.1 Use of a CGMS device for any condition or indication
NOT included above.
8.2 Use of a CGMS device that is NOT FDA approved or
used outside of the FDA labeled indications.
8.3 Equipment that does not serve
a primarily medical purpose and/or does not meet TRICARE’s definition
of Durable Medical Equipment (DME), for example, personal computers,
smart phones, tablets, smart watches, even if such devices are able
to receive data from the CGMS or other DME, and/or are marketed
to assist with self-management of diabetes.
8.4 Combination devices that include
a home blood glucose monitor combined with a cellular telephone
or other device not specifically indicated for the management of
diabetes mellitus.
8.5 Remote glucose monitoring devices
(i.e., additional devices that will alarm in a location away from
the person wearing the CGMS).
8.6 Hypoglycemic wristband alarm
(a noninvasive device that does not monitor glucose levels, but measures
perspiration and skin temperature).
8.7 Equipment, including the CGMS
or replacement supplies, which are not medically necessary (e.g.,
charges for replacement supplies which are not medically necessary
or documented.)
9.0 Effective
Dates
9.1 December 1, 2008.
9.2 January 1, 2017 for CGMS (CPT procedure codes
0446T-0448T).