Medically Necessary:

External insulin pumps are considered medically necessary for diabetic patients in any of the following groups:

1. Patients with documented diabetes mellitus meeting all the following criteria (a-f):
   1. Patient has been seen by their medical provider four times within the last year; and
   2. Completed a comprehensive diabetes education program within the past two years; and
   3. Follows a program of multiple daily injections of insulin; and
   4. Has frequent self-adjustments of insulin doses for the past 6 months; and
   5. Has documented frequency of glucose self-testing an average of at least 4 times per day during the past month; and
   6. Has documentation of any of the following while on a multiple daily injection regimen:
   1. Glycosylated hemoglobin level (HbAlc) > 7.0 percent; or
   2. “Brittle�?diabetes mellitus with recurrent episodes of diabetic ketoacidosis, hypoglycemia or both, resulting in recurrent and/or prolonged hospitalization; or
   3. History of recurring hypoglycemia or severe glycemic excursions; or
   4. Wide fluctuations in blood glucose before mealtime; or
   5. “Dawn phenomenon�?with fasting blood sugars frequently exceeding 200 mg/dl.
2. Pre- conception or pregnancy to reduce the incidence of fetal mortality or anomaly; or
3. The patient with diabetes mellitus successfully using a continuous insulin infusion pump prior to enrollment has documented frequency of glucose self-testing on average of at least 4 times per day during the month prior to enrollment.

Not Medically Necessary:

The use of external insulin pumps for any indication other than those listed above is considered not medically necessary.

Insulin Infusion Pump Procedure Review Form

Patient Name: _________________	ID#:_____________________________
Patient Date of Birth: __________________________
Pump supplier name or ID#: _______________________________

Reason for Insulin Pump

Diagnosis:

 Diabetes Type I	Years _______	Complications: ______________________
 Diabetes Type II	Years _______	Complications: ______________________

Insulin regimen:

Year insulin was started
(Type) ____________	(Dosage) _______	(Frequency)  ____________________
(Type) ____________	(Dosage) _______	(Frequency)  ____________________
Most recent HbA1c level: _________		Date: __________________________

I attest that there is documentation in the patient’s medical record confirming the information checked below:

The patient has completed a comprehensive diabetes education program in the last 2 years	 yes	 no
Self monitoring of blood sugar, 4 times per day for the past month, has occurred and is supported by submission of sugar levels from monitoring	 yes	 no
History of recurrent repeated clinical episodes of hypoglycemia or ketoacidosis.	 yes	 no
Patients (or for children, their caregivers) who willing and able to actively participate in intensive glucose management and to acquire the cognitive and technical skills required by their diabetes regimen.	 yes	 no
Glycosylated hemoglobin level (HbA1c) greater than 7.0%	 yes	 no
Diagnosis of pre-conception or pregnancy diabetes.	 yes	 no
The patient has been seen by the medical provider four times within the last year and demonstrated documented evidence of 6 months of insulin therapy.	 yes	 no
Wide fluctuations in blood glucose before mealtime.	 yes	 no
“Dawn phenomenon�?with fasting blood glucose frequently exceeding 200mg/dl	 yes	 no

Printed name of ordering Physician: ___________________________
Signature of ordering Physician: ______________________________	Date: _____________
Return decision to: __________________________________________	Phone: ____________
	Fax:     ____________

CERTIFICATE OF MEDICAL NECESSITY

PATIENT INFORMATION
Patient Name:	DOB:
Sex:	SSN:
Address:	Phone (day)
City/State/Zip	Phone (night)
Subscriber Name:	(Please send copy of insurance card)
Primary Insurance:	Secondary Insurance:
Policy #:	Policy#:
Group:	Group:
Insurance Phone #:	Insurance Phone #:
Employer:
STATEMENT OF MEDICAL NECESSITY
Diabetes type: Type 1:               Type 2:                    Gestational:                 Duration:
# Insulin shots/day in last 6 months:	# Glucose checks/day:
Fluctuation of blood glucose values:  mg/dl	Date:                   HbA1c:
Current Diabetic Complications:
25091 Type 1 IDDM	25061 Gastroparesis (type 1)
25081  Hypoglycemia (type 1)	25051  Retinopathy
Any emergency room visits/hospital admissions related to diabetes in the 2yrs (give detail incl. date, duration:
Additional Notes:
Is this person capable of using an insulin pump safely and effectively?
If this patient is not on multi-dose insulin injection regimen, why is an insulin pump being recommended rather than multi-dose insulin injection?
I certify that the above patient demonstrates one or more of the following: Hemoglobin HbA1C level is 7.0% or 1% over upper range of normal History of severe glycemic excursions (commonly associated with brittle diabetes, hypoglycemic unawareness, nocturnal hypoglycemia, extreme insulin sensitivity and/or very low insulin requirements.) Wide fluctuations in preprandial BG levels (e.g., levels commonly exceed 100 mg.dl.) Dawn phenomenon where fasting blood glucose level often exceeds 200 mg/dl. Day-to-day variations in work schedule, mealtimes and/or activity level, which confound the degree of regimentation required to self- manage glycemia with multiple insulin injections. History of suboptimal glycemic control before or during pregnancy. Suboptimal glycemic and metabolic control after renal transplantation. Poor glycemic control evidenced by CGMS sensing.
SUPPORTING CRITERIA
Member has demonstrated ability to self-monitor blood glucose levels > 4x/day Member is motivated to achieve and maintain improved glycemic control
PHYSICIAN INFORMATION
Physician:  Hospital/Clinic: Address:  City/State/Zip:	Office Contact: Phone #:  Fax #: UPIN #:
This document serves as a Prescription and Statement of Medical Necessity for the above referenced patient for a Medtronic MiniMed insulin infusion pump, pump supplies, and diabetes supplies.
Signature:	Date: