Outpatient Intravenous Insulin Treatment

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 is adequate to conclude that OIVIT does not improve health outcomes in Medicare beneficiaries. Therefore, CMS determines that OIVIT is not reasonable and necessary for any indication under section 1862(a)(1)(A) of the Social Security Act. Services comprising an Outpatient Intravenous Insulin Therapy 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.)

02/2010 - Effective Date: 12/23/2009. Implementation Date: 03/08/2010. (TN 112) (CR6775)

03/2010 - There was an error in the OIVIT policy language in the Business Requirements. All other information remains the same. (TN 114) (CR6775)

03/2010 - Transmittal 114, dated February 22, 2010, is being rescinded and replaced by Transmittal 117. The only change is the implementation date from March 8, 2010, to April 5, 2010. All other information remains the same. (TN 117) (CR6775)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1792) (CR9861)

05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1854) (CR10086)