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 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 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.
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); 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 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).