Diabetes is an important disease in the Medicare beneficiary population. Diabetes in this population is primarily type 2 diabetes, reflecting the older age of most beneficiaries. Diabetic beneficiaries younger than 65 years of age frequently have either type 1 disease and disability from diabetic complications or type 2 disease in the setting of another disabling co-morbidity that impacts diabetes management.
Therapy for type 1 diabetes been focused on insulin replacement to prevent microvascular complications whereas therapy for type 2 diabetes is increasingly focused on risk factors that contribute to cardiovascular disease and/or insulin resistance. Glycemic control itself has not been demonstrated to reverse end-stage microvascular diabetic complications in either type 1 or type 2 patients. Glycemic control does not appear to confer major protection against cardiovascular or renal disease, which is the primary cause of death in older type 2 patients. Nor does it confer protection against an increasing cause of morbidity in type 2 diabetes beneficiaries, renal disease due to hypertension and/or macrovascular disease.
In the quest to manage diabetes or related disorders, some investigators have considered the pulsatile nature of insulin release and the release of insulin into the portal system. These investigators have proposed routes of insulin administration other than the traditional subcutaneous route (primarily intravenous) for outpatient therapy. This broad class of therapies has been termed variously Chronic Intermittent Intravenous Insulin Therapy (CIIT), Hepatic Activation Therapy, Intercellular Activation Therapy (iCAT), Metabolic Activation Therapy (MAT), Pulsatile Intravenous Insulin Treatment (PIVIT), Pulse Insulin Therapy (PIT) and Pulsatile Therapy. Usually the insulin is reportedly "pulsed" versus continuously dripped. The insulin administration is adjunctive to the patient's routine diabetic management regimen, typically performed on an intermittent basis (often weekly) as an outpatient, and performed chronically without duration limits. Infusion sessions may be accompanied by multiple metabolic measurements, primarily the respiratory quotient. Claimed benefits for this therapy include improved glycemic control and blunted progression or reversal of diabetic complications.
Currently, the infusion procedure and related items and services are specifically not covered by some local Medicare contractors.
For purposes of this NCA, this class of therapies will be called outpatient intravenous insulin treatment. This NCA will evaluate the available evidence for outpatient intravenous insulin treatment, as well as the devices used to administer the therapy and the laboratory monitoring and medical-nursing surveillance required for implementation in the various outpatient settings, and the role for accompanying metabolic testing (including respiratory quotients). Based upon this evidence review, CMS will determine whether a national coverage determination is warranted.
