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).