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Date Printed: June 28, 2017: 11:52 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-99000-04

Original Effective Date: 11/15/02

Reviewed: 09/23/10

Revised: 11/01/15

Subject: Chronic Intermittent Intravenous Insulin Therapy (CIIIT) [Pulsatile Intravenous Insulin Therapy (PIVIT), Hepatic Activation, Metabolic Activation]

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

DESCRIPTION:

Chronic intermittent intravenous insulin therapy (CIIIT), 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 insulin dosages based on frequent blood glucose monitoring. 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 improved glucose control can be achieved through improved hepatic function. CIIIT is typically administered once weekly as an outpatient therapy combined with daily intensive subcutaneous insulin therapy. CIIIT is intended to improve glycemic control while decreasing the incidence of hypoglycemic events, improve hypertension, and slow the progression of overt diabetic nephropathy while reversing some manifestations of diabetic neuropathy. The exact physiological mechanism of CIIIT is unclear. CIIIT is also referred to as pulsatile intravenous insulin therapy (PIVIT), hepatic activation or metabolic activation.

POSITION STATEMENT:

Chronic intermittent intravenous insulin therapy is considered experimental or investigational, as there is insufficient scientific evidence to support the use of CIIIT. There is inadequate published scientific literature to permit conclusions regarding the effect of CIIIT on health outcomes.

BILLING/CODING INFORMATION:

The following code may be used to describe chronic intermittent intravenous insulin therapy.

HCPCS Coding:

G9147

Outpatient Intravenous Insulin Treatment (OIVIT) either pulsatile or continuous, by any means, guided by the results of measurements for: respiratory quotient; and/or, urine urea nitrogen (UUN); and/or, arterial, venous or capillary glucose; and/or potassium concentration. (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Outpatient INTRAVENOUS INSULIN Treatment (40.7) located at cms.gov.

DEFINITIONS:

No guideline-specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Index terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

CIIIT
Hepatic Activation
Metabolic Activation
Pulsatile Intravenous Insulin Therapy (PIVIT)

REFERENCES:

  1. American Association of Clinical Endocrinologists. Medical Guidelines for the Management of Diabetes Mellitus: The AACE System of Intensive Diabetes Self-management. 2002 Update. Endocr Pract 2002; 8 (suppl 1): 0-65.
  2. American Diabetes Association Clinical Practice Recommendations, 2006. Diabetes Care 2006 29: S75-77.
  3. American Diabetes Association. Standards of Medical Care in Diabetes, 2008. Diabetes Care, Vol 31 Supplement 1, January 2008. Accessed 07/22/08.
  4. American Diabetes Association. Standards of Medical Care in Diabetes, 2009. Diabetes Care, Vol 32 Supplement 1, January 2009. Accessed 07/31/09.
  5. Blue Cross Blue Shield Association Medical Policy Reference Manual. 2.01.43 Chronic Intermittent Intravenous Insulin Therapy (CIIIT), (04/17/07).
  6. Clinical Trials.gov. Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus. Identifier: NCT00539409. Verified by Florida Atlantic University, October 2007. (Accessed 09/01/10).
  7. Clinical Trials.gov. Effects of Pulsatile Intravenous Insulin Therapy Cardiac Disease in Patients With Diabetes Mellitus. Identifier: NCT00539435. Verified by Florida Atlantic University, October 2007. (Accessed 09/01/10).
  8. Clinical Trials.gov. Effects of Pulsatile IV Insulin Delivery on Diabetic Neuropathy in Patients With Type 1 and Type 2 Diabetes Mellitus. Identifier: NCT00228891. Verified by Florida Atlantic University, October 2007. (Accessed 09/01/10).
  9. Clinical Trials.gov. Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy in Patients With Types 1 and 2 Diabetes Mellitus. Identifier: NCT00287651. Verified by Florida Atlantic University, October 2007. (Accessed 09/01/10).
  10. Clinical Trials.gov. Effects of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes. Identifier: NCT00361907. Verified by Florida Atlantic University, October 2007. (Accessed 09/01/10).
  11. Clinical Trials.gov. Effects of Pulsatile IV Insulin Therapy on the Quality of Life in Patients With Types 1 and 2 Diabetes. Identifier: NCT00228878. Verified by Florida Atlantic University, October 2007. (Accessed 09/01/10).
  12. First Coast Service Options Local Coverage Determination (LCD), The List of Non-Covered Services - L29288. (pulsatile intravenous insulin therapy), (07/01/09).
  13. HAYES Alert Technology Assessment Brief. “Chronic Intermittent Intravenous Insulin Therapy for Type 1 DM”, (06/06).
  14. HAYES Medical Technology Directory. “Chronic Intermittent Intravenous Insulin Therapy (CIIIT) for Type 1 Diabetes Mellitus”, (07/14/06). Updated 08/15/07.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/23/10.

GUIDELINE UPDATE INFORMATION:

11/15/02

New Medical Coverage Guideline.

10/15/03

Reviewed; no change in coverage statement (investigational).

07/15/04

Scheduled review; no changes.

08/15/05

Scheduled review; no changes to coverage statement (investigational).

08/15/06

Scheduled review; no change in coverage statement.

07/15/07

Scheduled review; reformatted guideline; no change in coverage statement; references updated.

09/15/08

Scheduled review; no change in position statement. Update references.

09/15/09

Scheduled review; no change in position statement. Update references.

04/01/10

2nd quarter HCPCS coding update. Added code G9147.

10/15/10

Scheduled review; updated references; no change in position statement.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 28, 2017: 11:52 PM