National Coverage Analysis (NCA) Tracking Sheet

Outpatient Intravenous Insulin Treatment (Therapy)



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.

Benefit Category

No Benefit Category

Requestor Information

Requestor NameRequestor Letter
Internally generated N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
03/25/2009 - 04/24/2009
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
09/25/2009 - 10/25/2009
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Sandra D. Jones, RN, MS
Lead Medical Officers
Elizabeth A. Koller, MD

Actions Taken

March 25, 2009

CMS initiates this national coverage analysis for the use of a class of therapies included under Outpatient Intravenous Insulin Therapy. The public has 30 days to submit comments on this topic. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information related to 1) this class of insulin therapy, 2) the infusion devices, the laboratory monitoring, and the medical-nursing surveillance for implementation of the therapy, and 3) metabolic measurements and their role as an endpoint and as a guidepost in modifying insulin therapy. If the evidence is determined to be inadequate for coverage, we are especially interested in what types of studies are needed.

To submit comments, please use the orange "COMMENT" button at the top of the page.

August 31, 2009

CMS met with Dr. Thomas Aoki, Mr. Bruce Parsons and Mr. Dick Costigan from the Aoki Institute.

September 25, 2009

CMS posts the proposed decision and opens a 30 day public comment period on the proposed decision. CMS is particularly interested in relevant new evidence, including clinical studies and other scientific information, about any effect of outpatient intravenous insulin treatment on health outcomes in the Medicare beneficiary population. Instructions on submitting public comments can be found at To submit a comment, we strongly urge the use of the orange "Comment" button at the top of the page. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

December 23, 2009

CMS posts the final decision.