Ohio Admin. Code 5160-10-36 - DMEPOS: continuous glucose monitors
(A)
Definition.
"Continuous glucose monitor (CGM)" is a device that can constantly measure
glucose levels in interstitial body fluid. The sensor, transmitter, and
receiver may be separate parts or may be combined. The receiver may have the
capacity to record data.
(B)
Coverage.
(1)
This rule does not apply to either of the following
items:
(a)
An
insulin infusion pump into which a continuous glucose monitoring sensor is
integrated, coverage and payment policies for which are addressed in rule
5160-10-29 of the Administrative
Code; or
(b)
A disposable tubeless subcutaneous insulin
administration device, which is covered as a pharmacy benefit in accordance
with Chapter 5160-9 of the Administrative Code.
(2)
Payment may be
made for the purchase of a CGM and for the periodic purchase of replaceable CGM
components.
(3)
The default certificate of medical necessity (CMN) form
is the ODM 10277, "Certificate of Medical Necessity: Continuous Glucose
Monitors" (10/2022). The CMN includes the following information, for which
appropriate documentation is kept in the individual's medical record.
(a)
A condition for
which continuous glucose monitoring is indicated for the individual, such as
diabetes mellitus or hypoglycemia;
(b)
The intended
length of monitoring, either short-term (from three to seven consecutive days,
once or twice a year) or long-term; and
(c)
A brief
explanation of why the use of a CGM is indicated, including contributing
conditions and symptoms such as are specified in the following non-exhaustive
list:
(i)
Unexplained hypoglycemic episodes (generally, excessively low blood glucose
levels despite appropriate modifications in insulin therapy);
(ii)
HbA1c level
consistently outside the target range for the individual;
(iii)
Hypoglycemic
unawareness (the inability to recognize hypoglycemic events consistently and
reliably), evidenced in extreme cases by seizures or loss of
consciousness;
(iv)
The presence of microvascular complication (e.g.,
vasculopathy, retinopathy);
(v)
A treatment
regimen that necessitates either of the following activities:
(a)
Frequent
adjustments to insulin dosage throughout the day; or
(b)
Insulin pump
therapy;
(vi)
A coexistent condition (e.g., uncontrolled epilepsy)
that may make hypoglycemia management difficult;
(vii)
Evidence of
fasting or postprandial hyperglycemia; or
(viii)
Recurrent
diabetic ketoacidosis.
(C)
Constraints and
limitations.
(1)
No payment will be made for a CGM if neither the individual
nor anyone assisting the individual is able to operate it.
(2)
Payment for a CGM
includes related software.
(3)
Even if a CGM has
the capability to use a cellular phone as a receiver, no payment will be made
for purchase, rental, lease, subscription, or maintenance associated with a
cellular phone.
(4)
The warranty period for a CGM receiver is at least one
year from the dispensing date.
(5)
No payment may be
made for the purchase of a CGM that has been previously used by another
individual.
(6)
Replacement components are dispensed in units
representing the quantity an individual is expected to use in one month. Before
dispensing additional units, the provider makes contact, either verbally or in
writing, with the individual (or the individual's authorized representative) to
verify the current need. The provider keeps on file a summary of this contact.
If the individual has one unit or less, the provider may dispense up to three
units.
Notes
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
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