CMS Pub. 100-03, ch. 1, § 40.7

23, 2009)

(Rev. 117, Issued: 03-09-10, Effective Date: 12-23-09; Implementation Date: 04-05- 10)

A. General

The term outpatient intravenous (IV) insulin therapy (OIVIT) refers to an outpatient

regimen that integrates pulsatile or continuous intravenous infusion of insulin via any

means, guided by the results of measurement of:

• respiratory quotient; and/or

• urine urea nitrogen (UUN); and/or

• arterial, venous, or capillary glucose; and/or

• potassium concentration; and

performed in scheduled recurring periodic intermittent episodes.

This regimen is also sometimes termed Cellular Activation Therapy (CAT), Chronic

Intermittent Intravenous Insulin Therapy (CIIT), Hepatic Activation Therapy (HAT),

Intercellular Activation Therapy (iCAT), Metabolic Activation Therapy (MAT), Pulsatile

Intravenous Insulin Treatment (PIVIT), Pulse Insulin Therapy (PIT), and Pulsatile

Therapy (PT).

In OIVIT, insulin is intravenously administered in the outpatient setting for a variety of

indications. Most commonly, it is delivered in pulses, but it may be delivered as a more

conventional drip solution. The insulin administration is adjunctive to the patient’s

routine diabetic management regimen (oral agent or insulin-based) or other disease

management regimen, typically performed on an intermittent basis (often weekly), and

frequently performed chronically without duration limits. Glucose or other carbohydrate

is available ad libitum (in accordance with patient desire).

B. Nationally Covered Indications

N/A

C. Nationally Non-Covered Indications

Effective for claims with dates of service on and after December 23, 2009, the Centers

for Medicare and Medicaid Services (CMS) determines that the evidence does not

support a conclusion that OIVIT improves health outcomes in Medicare beneficiaries.

Therefore, CMS has determined that OIVIT is not reasonable and necessary for any

indication under section 1862(a)(1)(A) of the Social Security Act. Services comprising

an OIVIT regimen are nationally non-covered under Medicare when furnished pursuant

to an OIVIT regimen (see subsection A. above).

D. Other

Individual components of OIVIT may have medical uses in conventional treatment

regimens for diabetes and other conditions. Coverage for such other uses may be

determined by other local or national Medicare determinations, and do not pertain to

OIVIT. For example, see Pub. 100-03, NCD Manual, Section 40.2, Home Blood Glucose

Monitors, Section 40.3, Closed-loop Blood Glucose Control Devices (CBGCD), Section

190.20, Blood Glucose Testing, and Section 280.14, Infusion Pumps, as well as Pub. 100-

04, Claims Processing Manual, Chapter 18, Section 90, Diabetics Screening.

(This NCD last reviewed December 2009.)