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DESCRIPTIONChronic intermittent intravenous insulin therapy (CIIIT) is a technique for delivering variable-dosage insulin to diabetic patients with the goal of improved long-term glycemic control. Through an unknown mechanism, it is postulated to induce insulin-dependent hepatic enzymes to suppress glucose production.
There are 3 main sites of insulin-mediated glucose homeostasis that must function in a coordinated fashion to maintain euglycemia: 1) insulin secretion by the pancreas; 2) glucose uptake, primarily in the muscle, liver, gut, and fat; and 3) hepatic glucose production. For example, in the fasting state, when insulin levels are low, the majority of glucose uptake is non-insulin mediated. Glucose uptake is then balanced by liver production of glucose, critical to nourish vital organs, such as the brain. However, after a glucose challenge, insulin binds to specific receptors on the hepatocyte to suppress glucose production. Without this inhibition, as can be seen in diabetic patients, marked hyperglycemia may result. Different classes of diabetic drug therapy target different aspects of glucose metabolism. Various insulin secretagogues (i.e., sulfonylureas) function by increasing the pancreatic secretion of insulin; thiazolidinediones (i.e, pioglitazone [Actosâ] and rosiglitazone [Avandiaâ]) function in part by increasing glucose uptake in the peripheral (principally skeletal) tissues; and biguanides (i.e., metformin) function by decreasing hepatic glucose production. While patients with type 2 diabetes may be treated with various combinations of all 3 of these classes of drugs, without or without additional insulin, patients with type 1 diabetes, who have no baseline insulin secretion, receive exogenous insulin therapy. Large-scale randomized studies have established that tight glucose control is associated with a decreased incidence of microvascular complications of diabetes (i.e., nephropathy, neuropathy, and retinopathy). Currently, the American Diabetics Association recommends a target hemoglobin A1c (HbA1c) concentration of less than 7%.
Chronic intermittent intravenous insulin therapy (CIIIT) also referred to as outpatient intravenous insulin therapy (OIVIT); pulsatile intravenous insulin therapy; hepatic activation; or metabolic activation, involves delivering insulin intravenously over a 6- to 7-hour period in a pulsatile fashion using a specialized pump controlled by a computerized program that adjusts the dosages based on frequent blood glucose monitoring. CIIIT therapy is principally designed to normalize the hepatic metabolism of glucose. In a 1993 article describing the development of the technique, Aoki and colleagues proposed that in patients with insulin-dependent diabetes mellitus (IDDM), lower levels of insulin in the portal vein are associated with a decreased concentration of the liver enzymes required for hepatic metabolism of glucose. The authors state, “We reasoned that if the liver of an IDDM patient could be perfused with near-normal concentrations of insulin during meals, the organ could be reactivated,” and proposed that once weekly 6-hour intravenous pulsatile infusions of insulin while the patient ingests a carbohydrate meal will increase the portal vein concentrations of insulin, ultimately stimulating the synthesis of glucokinase and other insulin-dependent enzymes. The pulses are designed to deliver a higher, more physiologic concentration of insulin to the liver than is delivered by traditional subcutaneous injections. This higher level of insulin is thought to more closely mimic the body’s natural levels of insulin as they are delivered to the liver. It is hoped that this therapy ultimately results in improved glucose control through improved hepatic activation.
CIIIT is typically delivered once weekly as an outpatient therapy.
Any insulin infusion pump can be used for the purposes of CIIIT. Infusion pumps have received U.S. Food and Drug Administration (FDA) marketing clearance through the 510(k) process, as they are determined to be substantially equivalent to predicate devices for the delivery of intravenous medications.
Chronic intermittent intravenous insulin therapy is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/2002: Approved by Medical Policy Advisory Committee (MPAC)
1/13/2004: Code Reference section updated, ICD-9 procedure code 99.17 deleted, ICD-9 diagnosis code range 250.00-250.93 listed separately
03/10/2006: Coding updated. CPT4 revisions added to policy
1/7/2009: Policy reviewed, no changes
04/26/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Added HCPCS code G9147.
10/21/2010: Policy reviewed; no changes.
09/23/2011: Policy reviewed. Policy description updated regarding techniques and devices; policy statement unchanged.
05/07/2013: Policy reviewed; no changes.
11/06/2013: Policy reviewed; no changes.
09/02/2014: Policy reviewed; description updated. Policy statement unchanged.
Blue Cross Blue Shield Association policy # 2.01.43
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.