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Date Printed: October 17, 2017: 04:20 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.

09-E0000-11

Original Effective Date: 04/20/09

Reviewed: 08/25/16

Revised: 01/01/17

Subject: External Insulin Infusion Pumps and Supplies

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 Update    
           

DESCRIPTION:

An external insulin infusion pump is a small, battery-powered, programmable device controlled by a micro-computer to provide continuous subcutaneous insulin infusion (CSII) in individuals with diabetes mellitus. Typically, the syringe has a two-three day insulin capacity and is connected to an infusion set attached to a small needle or cannula, which the individual inserts into the subcutaneous tissue. The syringe is activated by a battery operated pump programmed to deliver a continuous dose of insulin (basal insulin dose), and release a surge of insulin at meals and at programmed intervals (bolus insulin dose). The purpose of the insulin pump is to provide accurate, continuous and controlled delivery of insulin, which can be regulated by the user to achieve intensive glucose control and to prevent the metabolic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis.

POSITION STATEMENT:

External insulin infusion pumps and related supplies meet the definition of medical necessity for individuals with insulin dependent diabetes when the following criteria are met:

Has documentation of ANY of the following while on a multiple daily injection regimen:

The use of an insulin pump pre-conception or during pregnancy to reduce the incidence of fetal mortality or anomaly meets the definition of medical necessity.

The individual with diabetes mellitus successfully using a continuous insulin infusion pump prior to enrollment with documented frequency of glucose self-testing on average of at least 4 times per day during the month prior to enrollment meets the definition of medical necessity.

NOTE: If the Medical Necessity criteria for the external insulin infusion pump are met, the pump and related supplies will require an order or prescription signed by a physician or healthcare professional qualified to treat diabetes. A physician order or prescription is required at the onset of external insulin pump therapy and must be updated no less than once per year thereafter.

The physician order or prescription must include:

The replacement of external insulin pumps meets the definition of medical necessity when it is out of warranty, and is malfunctioning and cannot be refurbished. For requests for replacement pumps, an expired warranty must be verified.

Replacement of an external insulin infusion pump that is functional meets the definition of medical necessity when the current device no longer meets the member’s medical needs (e.g., when hemoglobin A1C is not maintained in range, despite documentation of adherence to the physician or health care professional’s plan of care). Documentation of the specific medical need must be submitted for review.

Personal computer or tablet software, or accessories and smartphone apps for use in self-monitoring (including remote self-monitoring) are considered convenience items and do not meet the definition of medical necessity.

The replacement of an external insulin pump for the purpose of upgrading technology does not meet the definition of medical necessity.

Implantable insulin infusion pumps are considered experimental or investigational for treating diabetes mellitus. The available scientific evidence is insufficient to permit conclusions concerning the effect of this technology on net health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to describe insulin infusion pumps and supplies:

HCPCS Coding:

A4224

Supplies for maintenance of insulin infusion catheter, per week

A4225

Supplies for external insulin infusion pump, syringe type cartridge, sterile, each

A4230

Infusion set for external insulin pump, non needle cannula type

A4231

Infusion set for external insulin pump, needle type

A4232

Syringe with needle for external insulin pump, sterile 3cc

A9274

External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories

E0784

External ambulatory infusion pump, insulin

REIMBURSEMENT INFORMATION:

Reimbursement for supplies used with external insulin infusion pumps is as follows:

Supplies used with an external infusion pump, A4224, A4225, A4230, A4231, A4232, and A9274 are limited to a 90-day supply purchase every 90 days.

Batteries that can be used to power non-medical equipment are not considered durable medical equipment and are not eligible for coverage (K0601, K0602, K0603, K0604, and K0605).

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, treatment plan, and prescription for DME and/or supplies.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Prescription for medical equipment or product

57829-4

18807-8

Include all data of the selected type that represents observations made one year or less before starting date of service for the claim.

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: Infusion Pumps (280.14), located at cms.gov.

The following Local Coverage Article was reviewed on the last guideline reviewed date: External Infusion Pumps - Policy Article (A52507), located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: External Infusion Pumps (L33794), located at cgsmedicare.com

DEFINITIONS:

Basal Insulin: a steady trickle of low levels of longer-acting insulin, such as that used in insulin pumps.

Bolus insulin: an extra amount of insulin taken to cover an expected rise in blood glucose, often related to a meal or snack.

Implantable insulin infusion pump: similar to the previously described external insulin pump, but the pump is surgically implanted inside the abdomen with a channel connecting to the outside for monthly insulin refills.

Subcutaneous: beneath the skin or dermal layer.

RELATED GUIDELINES:

Blood Glucose Monitors and Supplies 09-E0000-14
Continuous Monitoring of Glucose in the Interstitial Fluid 01-99000-03

External Infusion Pumps (non-insulin) 09-E0000-10

OTHER:

None applicable.

Florida statute 627.6408: Diabetes treatment services

A health insurance policy or group health insurance policy sold in this state must provide coverage for all medically appropriate and necessary equipment, supplies, and diabetes outpatient self-management training and educational services used to treat diabetes, if the patient’s treating physician or a physician who specializes in the treatment of diabetes certifies that such services are necessary.

The policy may require that diabetes outpatient self-management training and educational services be provided under the direct supervision of a certified diabetes educator or a board-certified endocrinologist. The policy may further require that nutrition counseling be provided by a licensed dietitian.

The Agency for Health Care Administration shall adopt standard for diabetes outpatient self-management training and educational services, taking into consideration standards approved by the American Diabetes Association.

Florida statutes 641.31 and 627.65745: Health maintenance contracts

Each health maintenance organization and prepaid health plan shall provide coverage for all medically appropriate and necessary equipment, supplies, and services used to treat diabetes, including outpatient self-management training and educational services, if the patient’s primary care physician, or the physician to whom the patient has been referred who specializes in treating diabetes, certifies that the equipment, supplies, or services are necessary.

The contract may require that diabetes outpatient self-management training and educational services are provided under the direct supervision of a certified diabetes educator or a board-certified endocrinologist under contract with or designated by the health maintenance organization or prepaid health plan.

The Agency for Health Care Administration shall adopt standards for outpatient self-management training and educational services, taking into consideration standards approved by the American Diabetes Association.

REFERENCES:

  1. Accucheck The Professional’s Pocket Guide to Infusion Site Management, (Accessed 12/08/08).
  2. Agency for Healthcare Research and Quality (AHRQ). Effective Healthcare Program. Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus: Comparative Effectiveness. AHRQ Pub. No. 12-EHC036-3 August 2012.
  3. American Academy of Clinical Endocrinologists. “Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus.” AACE Diabetes Mellitus Clinical Guidelines Task Force. ENDODRINE PRACTICE Vol 13 (Suppl 1) May/June 2007.
  4. American Academy of Clinical Endocrinologists. Statement by the American Association of Clinical Endocrinologists Consensus Panel on Insulin Pump Management. Endocrine Practice. 2010; 16 (No. 5). ©AACE 2010.
  5. American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. Endocrine Practice Volume 17 (Suppl 2) March/April 2011.
  6. American Diabetes Association Diabetes Forecast 2008 Resource Guide. Type1 Type 2 Insulin Delivery, (Accessed 12/08/08).
  7. American Diabetes Association Diabetes Forecast Consumer Guide 2010. Insulin Pumps. (Accessed 04/07/10).
  8. American Diabetes Association. Standards of Medical Care in Diabetes – 2011. Diabetes Care, Volume 34, Supplement 1, January 2011.
  9. American Diabetes Association: Insulin Pumps, (Accessed 12/08/08).
  10. American Diabetes Association. Living With Diabetes | Treatment and Care | Doctors, Nurses & More: Future Visits. August 2013. Accessed at www.diabetes.org on 03/20/14.
  11. American Diabetes Association. Living With Diabetes | Treatment and Care | Medication | Insulin & Other Injectables: Advantages of Using an Insulin Pump; Disadvantages of Using an Insulin Pump; Good Insulin Pump Habits. December 2013. Accessed at www.diabetes.org on 03/20/14.
  12. American Medical Association CPT Coding (current edition).
  13. Blue Cross Blue Shield Association Medical Policy Reference Manual; 1.01.08, External Infusion Pumps, 04/29/03. (Archived February 2011).
  14. Centers for Medicare & Medicaid Services, Medicare National Coverage Determinations (NCD) for Infusion Pumps (280.14), 02/05.
  15. Centers for Medicare & Medicaid Services (CMS). Local Coverage Article: External Infusion Pumps - Policy Article (A52507) (10/01/15). Accessed at https://www.cms.gov/medicare-coverage-database.
  16. Corney SM, et al. Comparison of Insulin Pump Therapy (Continuous Subcutaneous Insulin Infusion) to Alternative Methods for Perioperative Glycemic Management in Patients with Planned Postoperative Admissions. Journal of Diabetes Science and Technology Volume 6, Issue 5, September 2012.
  17. Cyganek K, Klupa T, Szopa M, Katra B, Małecki MT. Medical care of pregnant women with type 1 diabetes: current guidelines and clinical practice. POLSKIE ARCHIWUM MEDYCYNY WEWNĘTRZNEJ 2013; 123 (1-2).
  18. Dovc K, Telic SS, Lusa L, Bratanic N, Zerjav-Tansek Z, Kotnik P, Stefanija MA, Battelino T, Bratina N. Improved Metabolic Control in Pediatric Patients with Type 1 Diabetes: A Nationwide Prospective 12-Year Time Trends Analysis. DIABETES TECHNOLOGY & THERAPEUTICS Volume 16, Number 1, 2014.
  19. Florida Statute 627.6408: Diabetes treatment services, accessed at flsenate.gov on 03/20/14.
  20. Florida Statute 641.31: Health maintenance contracts, accessed at flsenate.gov on 03/20/14.
  21. Florida Statute 627.65745: Diabetes treatment services, accessed at flsenate.gov on 3/20/14.
  22. Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists / American College of Endocrinology Insulin Pump Management Task Force. ENDOCRINE PRACTICE Vol 20 No. 5 May 2014.
  23. Grzanka M, Matejko B, Cyganek K, Kozek E. Maciej T. Malecki1,2, Tomasz Klupa1,2Efficacy and safety of insulin pump treatment in adult T1DM patients – influence of age and social environment. Annals of Agricultural and Environmental Medicine 2012, Vol 19, No 3, 573-575.
  24. Heinemann L, Krinelke L. Insulin Infusion Set: The Achilles Heel of Continuous Subcutaneous Insulin Infusion. Journal of Diabetes Science and Technology Volume 6, Issue 4, July 2012.
  25. Medicare Region C DMERC Local Coverage Determination (LCD) for External Infusion Pumps (L11555), 01/01/14. Retired 09/30/15.
  26. Medicare Region C DMERC Local Coverage Determination (LCD) for External Infusion Pumps (L33794), 10/01/15.
  27. National Institute for Health and Care Excellence (NICE). Technology Appraisal Guidance (TA) 151: Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. February 2011.
  28. Patel PJ, et al. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014 Jan;16(1):15-9.
  29. Pickup JC, Yemane N, Brackenridge A, Pender S. Nonmetabolic complications of continuous subcutaneous insulin infusion: a patient survey. Diabetes Technol Ther. 2014 Mar;16(3):145-9.
  30. Ramchandani N, Heptulla RA. New technologies for diabetes: a review of the present and the future. International Journal of Pediatric Endocrinology 2012, 2012:28.
  31. Renard E, Place J, Cantwell M, Chevassus H, Palerm CC. Closed-loop insulin delivery using a subcutaneous glucose sensor and intraperitoneal insulin delivery: feasibility study testing a new model for the artificial pancreas. Diabetes Care. 2010 Jan;33(1):121-7. Epub 2009 Oct 21.
  32. Schmid V, Hohberg C, Borchert M, Forst T, Pfützner A. Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol. 2010 Jul 1;4(4):976-82.
  33. St. Anthony’s ICD-9-CM Code Book (Current edition).
  34. Tolwinska J, GLowiska-Olszewska B, Bossowski A. Insulin Therapy with Personal Insulin Pumps and Early Angiopathy in Children with Type 1 Diabetes Mellitus. Mediators of Inflammation Volume 2013, Article ID 791283.
  35. Walsh J, Roberts R, Weber D, Faber-Heinemann G, Heinemann L. Insulin Pump and CGM Usage in the United States and Germany: Results of a Real-World Survey With 985 Subjects. J Diabetes Sci Technol. 2015 Jun 12;9(5):1103-10.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/25/16.

GUIDELINE UPDATE INFORMATION:

04/20/09

New Medical Coverage Guideline.

08/15/09

Add HCPCS code A4221 to the Medicare Exception statement.

01/15/10

Unscheduled review; revision to position statement for replacement of functional insulin pumps.

05/15/10

Annual review; no change in position statement. Medicare statement updated. References updated.

10/15/10

Revision; related ICD-10 codes added.

12/15/10

Unscheduled review of position statement requirement that insulin pump users see their medical provider four (4) times per year; no change in position statement. References updated.

04/15/11

Annual review; position statements maintained; Program Exceptions section and References updated.

09/15/11

Revision; formatting changes.

05/15/14

Revision; updated description. Revised position statement, CPT coding, reimbursement section, and program exceptions. Updated references.

05/15/15

Revision; added coverage statement for software, accessories, and smartphone apps.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision; updated Programs Exceptions section.

09/15/16

Revision. Updated Reimbursement Information section with revised limitations for insulin pump supplies.

10/01/16

Revision: Billing/Coding Information section updated.

01/01/17

Annual CPT/HCPCS update. Added A4224, A4225. Deleted K0552. Revised Reimbursement Information section.

Date Printed: October 17, 2017: 04:20 PM