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-26, December 6, 2024
1.0 CPT 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 finger stick Blood Glucose Monitor (BGM) testing
or it can be used as a device intended to replace finger sticks,
also called “therapeutic CGMS.”
4.0 POLICY
United States (US) 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 1 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 finger stick BGM testing). Therapeutic
CGMS devices and all related supplies shall be reported using Healthcare
Common Procedure Coding System (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 finger stick 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 The contractor 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 the requirement that TRICARE reimburse consistent with Medicare
whenever practicable, 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 The contractor shall reimburse
CGMS 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 DME, for example, personal computers (PCs), 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 BGM 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 (Current
Procedural Terminology (CPT) codes 0446T-0448T).
9.4 January 1, 2023 for
updated policy requirements to follow ADA recommendations in paragraphs 4.0 through 4.4.