Posted on Tue, Apr. 08, 2008

PORTLAND, Ore., April 8, 2008 -- While many health plan insurers will pay for patients with type 1 diabetes mellitus to have an insulin pump, the criteria for approval is not always clear.

"Continuous subcutaneous insulin infusion (CSII) or insulin pump therapy is an ideal tool for the patient in need of intensive insulin therapy and carbohydrate counting," explains Dr. Skip Freedman, Executive Medical Director at AllMed Healthcare Management, a leading independent review organization (IRO). "But only when they can also put in the time and effort needed to use a pump effectively. In general, patients need a pump when they cannot achieve acceptable control using a regimen of multiple daily injections or when they have frequent hypoglycemic episodes or hypoglycemic unawareness."

Accepted Guidelines

The American Association of Clinical Endocrinologists (AACE) current guidelines recommend insulin pump use for patients who are willing and able to comply with prescribed type 1 diabetes mellitus self-care behavior that includes frequent monitoring of blood sugars, carbohydrate counting and insulin adjustment. This implies that CSII is not only appropriate as a last-ditch effort when all else fails for the patient, but is also appropriate for any patient who is complying with the general recommendations for good type 1 diabetes care.

According to Freedman, patients who are unable to achieve acceptable control using a regimen of multiple daily injections and patients with frequent hypoglycemic episodes or hypoglycemic unawareness should discuss the value of an insulin pump with their doctors. Patients who are very insulin sensitive; those unable to sense when blood sugars are too low; and those with high morning blood sugars often can benefit from the ability of a pump to adjust their insulin rates hour by hour.

Criteria to Meet

Most health insurers and third-party payers will reimburse for an insulin pump if the patient meets specific criteria. They require that the patient has type 1 diabetes (or at least is insulinopenic by c-peptide, medicare criteria with a c-peptide less than 110 percent of the upper limit of normal with a simultaneous glucose of less than 225 mg/dl). In addition, a patient must be under the care of an endocrinologist who manages patients on pumps. And, the patient must be taking at least four shots of insulin a day, monitoring their blood sugars at least four times a day and still not meeting glycemic control goals. Usually these goals are:

    --  having an A1C (also known as glycated hemoglobin or HbA1c) of less
        than 7 percent,
    --  avoiding hypoglycemia and
    --  avoiding high morning blood sugars (also called dawn phenomenon).

"A patient also needs to complete an education program that usually includes how to use and operate the pump and perform carbohydrate counting," said Dr. Freedman. "Few patients with type 1 diabetes mellitus meet all three of theses goals all the time. So the decision usually comes down to determining whether the patient has been on a reasonable insulin regimen and is compliant with home monitoring."

The biggest challenge that endocrinologists face today is convincing health insurers and third-party payers about the benefits of pump technology. However, this is becoming easier because increasingly studies show the benefits of controlling the frequency of hypoglycemia and hyperglycemia, as well as improving A1C values.

For more information on leading-edge treatments and their medical necessity, check out http://www.allmedmd.com/peerpoints/cuttingedge/cutting_edge_email.htm. To find out more about the medical review services that IROs offer, go to AllMed's Website at http://www.allmedmd.com.

SOURCE AllMed Healthcare Management

Martin Middlewood, +1-360-882-1164, martinm@pacifier.com, for AllMed Healthcare Management,