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-74, November 5, 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 Type I diabetes, gestational
diabetes, and rare forms of diabetes which have 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 Supplies
5.1 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 Considerations
6.1 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 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).