Print

Date Printed: August 18, 2017: 10:23 AM

Private Property of Blue Cross and Blue Shield of Florida.
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-E0000-14

Original Effective Date: 12/15/02

Reviewed: 01/24/13

Revised: 10/01/16

Subject: Blood Glucose Monitors 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 Updates    
           

DESCRIPTION:

Diabetes mellitus (DM) is a disease characterized by hyperglycemia resulting from abnormal insulin secretion and/or abnormal insulin action within the body. Diabetes is diagnosed and monitored by routine testing of blood glucose levels. Self-management of diabetes is essential for the control of the disease and curtailing irreversible dysfunction and possible failure of multiple body systems.

Blood glucose monitors (glucometers) are portable battery-powered devices used to determine the blood glucose level by exposing a reagent strip to a small blood sample. The patient inserts a reagent strip into the monitor and uses a disposable lancet to draw a drop of blood to place on the reagent strip. The monitor provides the patient with a direct readout of the blood glucose level.

Glucometers designed specifically for use by individuals with visual impairments or impairment of manual dexterity are similar to standard blood glucose monitors in terms of reliability and sensitivity. They differ from standard monitors by having features such as voice synthesizers, automatic timers, and specially designed arrangements of supplies and materials to enable these patients to use the equipment without assistance.

POSITION STATEMENT:

NOTE: To expedite the medical review process, we recommend submitting a completed Certificate of Medical Necessity with your request for Blood Glucose Monitors and Supplies.

Click the link below to open the form. Complete all fields on the form thoroughly. Print and submit a copy of the form with your faxed request.

Home blood glucose monitors meet the definition of medical necessity when ALL of the following conditions are met:

In addition, home blood glucose monitors with special features (E2100, E2101) meet the definition of medical necessity when:

NOTE: E2101 may also meet the definition of medical necessity for individuals with impairment in manual dexterity when the above criteria is met and the physician certifies that the patient has an impairment of manual dexterity that is severe enough to require the use of this special monitoring device. Documentation submitted by the physician must include the exact nature of the physical impairment. Also, coverage of E2101 for patients with manual dexterity impairments is not dependent upon a visual impairment.

Accessories and supplies used in conjunction with these devices are covered if the device is covered.

Blood glucose monitoring devices with special features do not meet the definition of medical necessity when the above criteria are not met.

The following supplies do not meet the definition of medical necessity and are non-covered:

  1. Laser skin piercing devices used in place of spring powered devices for lancets
  2. Alcohol or peroxide, betadine or pHisoHex (not required for proper functioning of the device)

NOTE: The written dispensing order (written, faxed, or verbal order followed by a written order) must be received from a physician or provider licensed to treat diabetes mellitus must be obtained prior to dispensing a blood glucose monitor and/or supplies. The dispensing order should be updated no less than once per year. The supplier must maintain a copy of the dispensing order. The detailed written order must contain all of the following:

  1. All item(s) to be dispensed;
  2. The specific frequency of testing based on the members medical condition;
  3. The treating physician's signature, including the date;
  4. A start date of the order – only required if the start date is different than the signature date;
  5. The specific diagnosis (insulin or non-insulin dependent).

Replacement of a functioning blood glucose monitor for any purpose, including upgrading due to changes in technology, does not meet the definition of medical necessity.

Blood glucose monitors will be eligible for replacement if the warranty has expired or the monitor is damaged beyond repair.

Replacement batteries that may be purchased over-the-counter for use in blood glucose monitors are not specific to the treatment of diabetes and do not meet the definition of medical necessity, and are therefore non-covered.

Software or hardware for the purpose of downloading or storage of data to a computer does not meet the definition of medical necessity.

BILLING/CODING INFORMATION:

HCPCS Coding:

Blood Glucose Monitors:

E0607

Blood glucose monitor

Blood Glucose Monitors with special features:

E2100

Blood glucose monitor with integrated voice synthesizer

E2101

Blood glucose monitor with integrated lancing/blood sample

Supplies:

A4233

Replacement battery, alkaline (other than J cell), for use with medically necessary home blood glucose monitor owned by patient, each (non-covered)

A4234

Replacement battery, alkaline, J cell, for use with medically necessary home blood glucose monitor owned by patient, each (non-covered)

A4235

Replacement battery, lithium, for use with medically necessary home blood glucose monitor owned by patient, each (non-covered)

A4236

Replacement battery, silver oxide, for use with medically necessary home blood glucose monitor owned by patient, each (non-covered)

A4245

Alcohol wipes, per box (non-covered)

A4253

Blood glucose test or reagent strips for home blood glucose monitor, per 50 strips

A4256

Normal, low, high calibrator solution/chips

A4257

Replacement lens shield cartridge for use with laser skin piercing device, each (non-covered)

A4258

Spring-powered device for lancet, each

A4259

Lancets, per box of 100

E0620

Skin piercing device for collection of capillary blood, laser, each (non-covered)

REIMBURSEMENT INFORMATION:

Refer also to sections entitled POSITION STATEMENT.

Reimbursement for covered accessories and supplies used in conjunction with home blood glucose monitors (with or without special features) is limited to the following:

Non-Insulin dependent Diabetes Mellitus:

HCPCS code A4253 (test/reagent strips) is limited to quantities of 2 units per 3-month period (1 unit equals 50 strips) when dispensed for treatment of non-insulin dependent diabetes mellitus.

HCPCS code A4259 (lancets, per box of 100) is limited to quantities of 1 unit per 3-month period (1 units equals 100 lancets) when dispensed for treatment of non-insulin dependent diabetes mellitus.

Insulin Dependent Diabetes Mellitus:

HCPCS code A4253 (test/reagent strips) is limited to quantities of 6 to 8 units per 3-month period (1 unit equals 50 strips) when dispensed for treatment of insulin dependent diabetes mellitus.

HCPCS code A4259 (lancets, per box of 100) is limited to quantities of 3 to 4 units per 3-month period (1 unit equals 100 lancets) when dispensed for treatment of insulin dependent diabetes mellitus.

Insulin Pump Therapy:

HCPCS code A4253 (test/reagent strips) is limited to quantities of 8 to 18 units per 3-month period (1 unit equals 50 strips) when dispensed for treatment of insulin dependent diabetes mellitus treated with insulin pump therapy.

HCPCS code A4259 (lancets, per box of 100) is limited to quantities 4 to 9 units per 3-month period (1 units equals 100 lancets) when dispensed for treatment of insulin dependent diabetes mellitus treated with insulin pump therapy.

Additional Supplies:

HCPCS code A4256 (Glucose control solutions (Calibrator solution/chips)) is limited to a quantity of 4 per year when dispensed for treatment of diabetes mellitus.

HCPCS code A4258 (Spring powered devices for lancets) is limited to a quantity of 2 per year when dispensed for treatment of diabetes mellitus.

HCPCS code E0607 (Blood glucose monitors) is limited to a quantity of 1 every 3 years when dispensed for treatment of diabetes mellitus.

NOTE: BCBSFL will cover quantities in excess of these amounts with appropriate documentation of medical necessity. Additional quantities of these supplies will be covered if the treating physician has ordered a frequency of testing that exceeds the utilization guidelines and has documented the specific reason for the additional testing in the patient’s medical record (e.g., new onset of insulin dependent diabetes).

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 Determinations (NCDs) were reviewed on the last guideline reviewed date: Blood Glucose Testing (190.20), Home Blood Glucose Monitors (40.2) and Closed-Loop Blood Glucose Control Device (CBGCD) (40.3), located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Glucose Monitors (L11520) located at cgsmedicare.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Continuous Monitoring of Glucose in the Interstitial Fluid, 01-99000-03

OTHER:

Florida statute 627.6408 Diabetes treatment services – effective 07/01/95

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 statute 641.31 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 be 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. Agency for Healthcare Research & Quality. Technology Assessment: Applicability of the Evidence Regarding Intensive Glycemic Control and Self-Monitored Blood Glucose to Medicare Patients with Type 2 Diabetes. September 10, 2007.
  2. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse Guideline Summary NGC-7374: Gestational diabetes mellitus (GDM). Evidence-based nutrition practice guideline. American Dietetic Association (ADA); 2008.
  3. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse Guideline Summary NGC-8116: VA/DoD clinical practice guideline for the management of diabetes mellitus. Department of Veteran Affairs, Department of Defense; 2010 Aug.
  4. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse Guideline Summary NGC-8904: Diabetes management at camps for children with diabetes. American Diabetes Association. Diabetes Care 2012 Jan;35(Suppl 1):S72-5.
  5. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse Guideline Summary NGC-8917: Standards of medical care in diabetes. IX. Diabetes care in specific settings. American Diabetes Association. Diabetes Care 2011 Jan;34(Suppl 1):S43-6.
  6. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse Guideline Summary NGC-9095: Diagnosis and management of type 2 diabetes mellitus in adults. Institute for Clinical Systems Improvement (ICSI); 2010 Jul.
  7. American Association of Diabetes Educators (AADE) Position Statement: AADE 7™ Self-Care Behaviors. 2011.
  8. American Diabetes Association. Standards of Medical Care in Diabetes – 2008. Diabetes Care, Vol 31 supplement 1, January 2008. (Accessed 12/15/08).
  9. American Diabetes Association: Urine Testing. Diabetes Forecast 2008 Resource Guide.
  10. American Diabetes Association. Standards of Medical Care in Diabetes – 2009. Diabetes Care, Volume 32, supplement 1, 2009. (Accessed 01/12/09).
  11. Blue Cross Blue Shield Association Medical Policy Reference Manual – Blood Glucose Monitors (Glucometers) 1.01.03 (12/14/05).
  12. Centers for Medicare and Medicaid Services, Medicare Local Coverage Determination-L11520 Glucose Monitors (updated 11/01/12).
  13. Centers for Medicare and Medicaid Services, Medicare National Coverage Determination-Publication 100-3, Sections 190.20 Blood Glucose Testing (updated 12/17/04).
  14. Cohen L, et al. American Association of Diabetes Educators Position Statement: Diabetic Kidney Disease. 2009.
  15. Florida Statue 627.6408 Diabetes treatment services.
  16. Florida Statue 641.31 health maintenance contracts.
  17. Guerci B, et al. Measuring Capillary Blood Ketones by Fingerstick Samples During Metabolic Deterioration After Continuous Subcutaneous Insulin Infusion Interruption in Type 1 Diabetic Patients. Diabetes Care 26:1137–1141, 2003.
  18. Handelsman Y, et al. American College 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.
  19. Medicare Coverage Issues Manual (CIM 60-11).
  20. Medicare Region C DMERC Medical Review Policy – Home Blood Glucose Monitors, (04/01/03).
  21. Rodbard HW, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel on Type 2 Diabetes Mellitus: An Algorithm for Glycemic Control. Endocrine Practice 2009; 15 (No. 6).
  22. St. Anthony’s ICD-9-CM Code Book (current edition).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/24/13.

GUIDELINE UPDATE INFORMATION:

12/15/02

Medical Coverage Guideline Reformatted and Revised.

04/15/03

Revised to clarify reimbursement information for supplies used with blood glucose monitors, with or without special features.

10/15/04

Scheduled review; no change in coverage statement.

02/15/06

HCPCS coding update: remove A4254; add A4233 – A4236. Revision consisting of removal of the limitation for test/reagent strips and lancets.

07/15/06

Revisions consisting of adding Florida statute language and non-coverage statement regarding over-the-counter replacement batteries.

04/20/09

Revision with updated references. Add Medicare Advantage information.

08/15/09

Revision to add information to the position statement regarding dispensing orders. Update reimbursement section for supplies. Updated Medicare Advantage exception. Add ICD 9 codes for gestational diabetes to diagnoses that support medical necessity.

06/15/10

Revise reimbursement statement by adding limit for A4253 and A4259 for treatment with insulin pump therapy; add requirement for Certificate of Medical Necessity with link to the form.

10/15/10

Revision; related ICD-10 codes added.

11/15/10

Revision; guideline reformatted.

09/15/11

Revision; formatting changes.

02/15/13

Unscheduled review. Revised description. Revised position statement (urine reagent strips/tablets are eligible for coverage). Updated references.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision: Billing/Coding Information section updated.

Date Printed: August 18, 2017: 10:23 AM