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-137, December 5, 2024
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 initial prescription of 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 met ALL
of the following criteria have been met or
most current recommendations for CGMS use from the American Diabetes
Association (ADA) Standards of Care in Diabetes:
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.
4.1 Diagnosis of diabetes
(type 1, type 2, gestational, or other rare form); and
4.2 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
4.3 Beneficiary has completed
a comprehensive diabetic education program including training on use
of the prescribed device(s); and
4.4 Treatment regimen includes
daily insulin injections or insulin pump therapy.
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
(DE));
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 HCPCS
codes 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 11;
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).
9.4 January 1, 2023 for
updated policy requirements to follow ADA recommendations in paragraphs 4.0 through 4.4.