2.0 HCPCS
Codes
A9276 - A9278, K0553,
K0554, S1030, S1031
3.0 DESCRIPTION
A CGMS is a medical device used to monitor
patients with diabetes mellitus. These devices, which consist of
an external receiver, external transmitter, and a subcutaneously
placed sensor, monitor diabetic patients by providing the physician
and/or patient with periodic measurements of glucose levels in interstitial
fluid. CGMS devices are usually prescribed to diabetic patients
whose diabetes is not sufficiently controlled with standard diabetic
medical regimens. These devices are intended only to supplement,
not replace, blood glucose readings obtained from standard fingerstick
glucose meters and test strips.
4.0 POLICY
U.S. Food and Drug Administration (FDA) approved
CGMS devices (i.e., MiniMed CGMS® System Gold™, MiniMed Guardian®
Real Time System) (CPT procedure codes 95250, 95251, 0446T-0448T) may be
cost-shared ONLY when it is documented that the recipient of the
device is required to perform at least four self-monitoring blood
glucose checks daily and is compliant with recommended medical regimens.
4.1 Short-term
(up to 72-hour), intermittent (up to six times per year) use of
a CGMS device may be covered for type I diabetic beneficiaries age
seven years and over (or consistent with device labeling) when the
beneficiary has completed a comprehensive diabetic education program,
there is documentation of appropriate modification in insulin regimen,
and the physician documents any one of the following:
4.1.1 Glycosylated
hemoglobin level (HBA1c) is greater than 9.0% or less than 4.0%;
4.1.2 History
of unexplained large fluctuations in daily glucose values before
meals (greater than 150 mg/dl);
4.1.3 History of early morning fasting
hyperglycemia (“dawn phenomenon”);
4.1.4 History of severe glycemic
excursions; or
4.1.5 Hypoglycemic unawareness.
4.2 Long-term
(greater than 72-hour, continuous or periodic) use of a CGMS device
(includes transmitter, receiver, and sensors), may be covered for
beneficiaries who meet the criteria for short-term use and the ordering
physician documents any one or more of the following:
4.2.1 History
of recurrent, unexplained, severe hypoglycemic events or hypoglycemic unawareness
(i.e., blood glucose less than 50 mg/dl);
4.2.2 History of recurrent episodes
of ketoacidosis;
4.2.3 Hospitalizations for uncontrolled
glucose levels;
4.2.4 Frequent nocturnal hypoglycemia;
or
4.2.5 The beneficiary is pregnant and has poorly
controlled type I diabetes or gestational diabetes.
5.0 EXCLUSIONS
5.1 Use of
a CGMS device for any condition or indication NOT included above.
5.2 Use of
a CGMS device that is NOT FDA approved.