
An external insulin infusion pump is an FDA approved mechanical device used to deliver insulin to manage diabetes mellitus. The pump is about the size of a deck of cards, weighs about 3 ounces, and can be worn on a belt or in a pocket. It contains a cartridge reservoir filled with fast acting insulin. The pump connects to narrow flexible plastic tubing that ends with a needle inserted just under the skin near the abdomen. Users set the pump to give a steady trickle or "basal" amount of insulin continuously throughout the day. Pumps also release additional ("bolus") doses of insulin at meals and at times when blood sugar is too high based on user input. Frequent blood glucose monitoring is essential to determine insulin dosages and to ensure that insulin is delivered appropriately.
Private insurance companies as well as Medicare will pay for infusion pumps as medically necessary for patients with documented diabetes mellitus meeting all the following criteria:
- Has been seen by their medical provider four times within the last year; and
- Completed a comprehensive diabetes education program within the past two years; and
- Follows a program of multiple daily injections of insulin; and
- Has frequent self-adjustments of insulin doses for the past 6 months; and
- Has documented frequency of glucose self-testing an average of at least 4 times per day during the past month; and
- Has documentation of any of the following while on a multiple daily injection regimen:
a. lycosylated hemoglobin level (HbAlc) 7.0 percent; or
b. "Brittle" diabetes mellitus with recurrent episodes of diabetic ketoacidosis, hypoglycemia or both, resulting in recurrent and/or prolonged hospitalization; or
c. History of recurring hypoglycemia or severe glycemic excursions; or
d. Wide fluctuations in blood glucose before mealtime; or
e. "Dawn phenomenon" with fasting blood sugars frequently exceeding 200 mg/dl.
f. Pre- conception or pregnancy to reduce the incidence of fetal mortality or anomaly; or
g. The patient with diabetes mellitus successfully using a continuous insulin infusion pump prior to enrollment in a new health insurance plan has documented frequency of glucose self-testing on average of at least 4 times per day during the month prior to enrollment
Here's the insurance company's rationale:
"External subcutaneous insulin infusion pumps are considered medically necessary only for people who have demonstrated the ability and commitment to engage in a regimen of pump care, frequent self-monitoring of blood glucose and careful attention to diet and exercise.
The pump must be ordered by and follow-up care of the member must be managed by a physician with experience managing persons with insulin infusion pumps and who works closely with a team including nurses, diabetic educators and dieticians who are knowledgeable in the use of insulin infusion pumps.
Documentation of continued medical necessity of the external insulin infusion pump requires that the member be seen and evaluated by the treating physician at least every 6 months.
Some external insulin infusion pumps are able to take results of the blood glucose reading, calculate the appropriate insulin infusion rate, wirelessly transmit the results from the blood blucose monitor to the pump, and automatically adjust the insulin infusion rate, saving the member some extra steps. These insulin pump features, when present, are considered integral to the external insulin infusion pump and blood glucose monitor."

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