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).