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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.

01-99000-03

Original Effective Date: 07/15/01

Reviewed: 01/22/15

Revised: 04/15/17

Subject: Continuous Monitoring of Glucose in the Interstitial Fluid

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:

The advent of blood glucose monitors, for use by those with diabetes in the home over 20 years ago, revolutionized the management of diabetes. Using finger sticks, individuals could monitor their blood glucose level both to determine the adequacy of hyperglycemia control and to evaluate hypoglycemic episodes. Tight diabetic control, defined as a strategy involving frequent glucose checks and a target hemoglobin A1c (HgA1c) in the range of 7%, is now considered standard of care for those with diabetes.

Measurements of glucose in interstitial fluid have been developed as a technique of automatically measuring glucose values throughout the day, producing data that show the trends in glucose measurements, in contrast to the isolated glucose measurements of the traditional blood glucose measurements. Although devices measure glucose in interstitial fluid on a periodic rather than a continuous basis, this type of monitoring is referred to as continuous glucose monitoring (CGM).

Several CGM devices have received FDA approval. Devices initially measured interstitial glucose every 5 to 10 minutes and, with currently available devices the time intervals at which interstitial glucose is measured ranges from every 1 to 2 minutes to 5 minutes. CGM devices may be used intermittently, eg, time periods of 72 hours, or on a long-term basis. In addition to stand-alone CGMs, several insulin pump systems have included a built-in CGM.

According to FDA labeling, it is considered standard of care that CGM monitoring be used as an adjunct to regular finger sticks to confirm blood glucose levels. CGM testing should not be used alone to measure blood glucose levels.

Current research is also underway on what is known as an artificial pancreas or artificial pancreas device system (APDS). The proposed artificial pancreas is a series of devices, e.g.,, a CGM, blood glucose device and an insulin pump, plus a computer algorithm that communicates with all of the devices. The goal of the APDS is to automatically monitor glucose levels and adjust insulin levels. These systems are also called closed-loop systems or autonomous systems for glucose control. One technology associated with artificial pancreas development is a “low glucose suspend (LGS)” feature included with an insulin pump. The LGS feature is designed to suspend insulin delivery when plasma glucose levels fall below a pre-specified threshold. The U.S. Food and Drug Administration (FDA) has described 3 main categories of artificial pancreas device systems:

• Threshold Suspend Device System

The goal of a threshold suspend device system is to help reduce the severity or reverse a dangerous drop in blood glucose level (hypoglycemia) by temporarily suspending insulin delivery when the glucose level falls to or approaches a low glucose threshold. These are sometimes referred to as “low glucose suspend systems.” To date, one device, the Medtronic MiniMed® 530G with Enlite® falls in the subcategory of a Threshold Suspend Device System and has been cleared for marketing by FDA.

• Control-to-Range (CTR) System

A CTR system reduces the likelihood of a hypoglycemic event or a hyperglycemic event (when blood glucose is dangerously high) by adjusting insulin dosing only if a person’s glucose level approaches the low or high glucose thresholds. Patients using this system will still need to check blood glucose levels and give themselves insulin to maintain control of glucose levels.

• Control-to-Target (CTT) System

A CTT system sets target glucose levels and tries to achieve these levels at all times. This system is fully automated and requires no interaction from the user (except for calibration of the continuous glucose monitoring system). CTR and CTT System Subtypes are dependent upon the drug or drugs being delivered and how each drug affects glucose levels. Three subtypes are being investigated: insulin-only, bi-hormonal and hybrid.

POSITION STATEMENT:

Intermittent 72-Hour Interstitial Glucose Monitoring

Short-term intermittent monitoring, up to 72 hours, of glucose levels in interstitial fluid meets the definition of medical necessity in members who are insulin dependent and whose diabetes is poorly controlled*, despite current use of best practices. Best practices include compliance with a treatment regimen of 4 or more finger sticks per day, for the purpose of identifying glucose excursions and facilitating therapy adjustments.

Short term intermittent monitoring, up to 72 hours, of glucose levels in interstitial fluid also meets the definition of medical necessity in members with who are insulin dependent prior to insulin pump initiation to determine basal insulin levels.

Continuous Long-Term Interstitial Glucose Monitoring

Continuous long-term monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique of diabetic monitoring, meets the definition of medical necessity when the following situations occur despite use of best practices which include compliance with:

In addition, one of the following must be met:

If the Medical Necessity criteria for long term continuous glucose monitoring are met, the monitoring device 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 continuous long-term glucose monitoring therapy and must be updated no less than once per year thereafter. The physician order or prescription must include the number of sensors required per month, and the type of glucose monitoring device ordered to verify the number of sensors required. The number of sensors will differ by device for 3-day or 7-day monitors.

*Poorly controlled insulin dependent diabetes includes the following clinical situations:

(See Reimbursement Section for Medical Supplies)

The use of an external insulin pump with wireless communication to a compatible continuous glucose monitoring sensor/transmitter, or an integrated continuous glucose monitor and insulin pump meets the definition of medical necessity when ALL the following have been met:

The replacement of an existing CGM device meets the definition of medical necessity when it is out of warranty, and is malfunctioning and cannot be refurbished. For requests for replacement devices, an expired warranty must be verified.

Replacement of existing functional equipment for the purpose of obtaining wireless technology does not meet the definition of medical necessity.

The following devices are considered experimental or investigational, as there is insufficient clinical evidence that demonstrates the use of these devices results in improved health outcomes:

BILLING/CODING INFORMATION:

CPT Coding

95250

Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording.

95251

Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; interpretation and report

99091

Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable), requiring a minimum of 30 minutes of time.

HCPCS Coding

A9276

Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one unit = 1 day supply

A9277

Transmitter; external, for use with interstitial continuous glucose monitoring system

A9278

Receiver (monitor); external, for use with interstitial continuous glucose monitoring system

S1030

Continuous non-invasive glucose monitoring device, purchase (for physician interpretation of data, use CPT code) (non-covered)

S1031

Continuous non-invasive glucose monitoring device, rental, including sensor, sensor placement, and download to monitor (for physician interpretation of data, use CPT code) (non-covered)

S1034

Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices (investigational)

S1035

Sensor; invasive (eg, subcutaneous), disposable, for use with artificial pancreas device system, 1 unit = 1 day supply (investigational)

S1036

Transmitter; external, for use with artificial pancreas device system (investigational)

S1037

Receiver (monitor); external, for use with artificial pancreas device system (investigational)

NOTE: Procedure code 95250 does not include reimbursement for data interpretation. The interpretation of this testing should be reported by using code 95251 at the time that the results are presented and the treatment options are discussed.

It is not appropriate to report code 95251 in conjunction with 99091 (Collection and interpretation of physiologic data digitally stored and/or transmitted by the member and/or caregiver to the physician or other qualified health care professional, requiring a minimum of 30 minutes of time).

LOINC Codes:

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

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.

History of medication use

10160-0

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.

Laboratory studies

26436-6

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.

REIMBURSEMENT INFORMATION:

Sensors used with a continuous glucose monitoring device, or a combination infusion and monitoring device, are limited to a 90-day supply purchase every 90 days.

*NOTE: Transmitter devices (A9277) with non-replaceable batteries (e.g., silver oxide) may require more frequent replacement (e.g., every 6 months).

The intermitted 72-hour monitoring (codes 95250, 95251, and 99091) should be reported only once per monitoring period, and is limited to two 72-hour monitoring periods in twelve months.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Glucose Monitors (L33822) (Article A52464), located at cgsmedicare.com.

DEFINITIONS:

Artificial pancreas: a closed-loop glucose management system with a continuous glucose monitor and an insulin pump programmed with a computer algorithm that calculates insulin doses from the CGM readings and sends a signal to the pump to deliver the medication.

Hemoglobin A1c: the main fraction of glycosylated hemoglobin (glycohemoglobin) that is hemoglobin to which glucose is bound. Hemoglobin A1c is tested to monitor the long-term control of diabetes mellitus.

Interstitial fluid: an extracellular fluid found between cells in tissue that provides much of the liquid environment of the body.

Insulin dependent diabetes: diabetes mellitus that requires daily insulin therapy.

Low glucose suspend: automatic suspension of insulin delivery when glucose levels fall below a pre-programmed threshold.

RELATED GUIDELINES:

External Insulin Infusion Pumps and Supplies, 09-E0000-11
Blood Glucose Monitors and Supplies, 09-E0000-14

OTHER:

None applicable.

REFERENCES:

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COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/23/16.

GUIDELINE UPDATE INFORMATION:

07/15/01

Medical Coverage Guideline Original effective date.

01/01/02

New codes added.

06/15/02

Annual review for investigational; references updated.

11/15/02

Medicare coverage information added; references updated.

12/15/02

Addition of near-infrared information; references updated.

12/15/03

Reviewed; no change (investigational).

11/15/04

Scheduled review; no change (investigational).

01/01/06

Scheduled review; no change in coverage statement; references updated; HCPCS coding update (95250 revised; 95251 added).

10/15/06

Scheduled review; revised title of MCG; added descriptive information and investigational statement for combination glucose monitor & insulin pump systems; added cross-reference to other related MCGs; no change in investigational status for continuous glucose monitoring in the interstitial fluid.

09/15/07

Reviewed; added, “real time monitoring” to the position statement; reformatted guidelines; updated references.

01/01/08

Annual HCPCS coding update: added A9276, A9277, and A9278.

04/15/08

Scheduled review; revised description section; add coverage statement for 72 hour testing by healthcare professional. Update references.

01/01/09

Annual HCPCS coding update: updated descriptors for 95250 and 95251.

04/20/09

Unscheduled review. Revise position statement. Add Medicare statement. Add supply limitations. Update references.

08/15/09

Revision with removal of Medicare Advantage Exception from policy: LCD retired 02/02/09.

10/15/09

Revision of reimbursement for coverage of A9276.

05/15/10

Annual review with revision of position statement to include short term 72 hour intermittent continuous glucose monitoring for insulin requiring diabetics, and revision to long term monitoring use in pregnancy for poorly controlled insulin requiring diabetes. References updated.

11/15/10

Revision; position statement revised to include coverage for long-term glucose monitoring for patients with type II diabetes who are insulin dependent; related ICD-10 codes added; references updated; guideline reformatted.

09/15/11

Revision; formatting changes.

07/15/12

Scheduled review. Added E/I statement for remote glucose monitors. Revised description, index terms and examples of CGM devices and components. Updated references and reformatted guideline.

01/01/13

Annual CPT coding update. Revised code descriptor for 99091.

07/15/13

Scheduled review. Revised description. Revised position statement to include a coverage statement for the artificial pancreas (E/I); updated product names and descriptions. Revised definitions and program exceptions sections. Updated references and reformatted guideline.

02/15/14

Scheduled review. Revised description, position statement, reimbursement section, program exceptions and definitions. Updated references.

07/01/14

Quarterly HCPCS update. Added codes S1034, S1035, S1036 and S1037.

02/15/15

Scheduled review. Revised description, added coverage statement for remote, mobile communication devices (E/I), revised definitions section, updated references. Reformatted guideline.

07/15/15

Revision; changes to the position statement regarding required documentation and length of coverage for CGM devices. Revised Medicare Advantage Products program exception. Reformatted guideline.

08/15/15

Revision; verbiage changes for clarity and formatting changes.Deleted requirement of prior use of a 72 hour monitor.

09/15/15

Revision; continuation criteria deleted.

11/15/15

Revision; updated Program Exceptions section.

12/15/15

Revision; updated Reimbursement Information section.

01/01/16

Revision; updated Reimbursement Information section.

07/15/16

Revision; addition of coverage statement regarding CGM device replacement.

10/01/16

Revision: Billing/Coding Information section updated.

04/15/17

Revision: deleted continuous glucose monitoring device proprietary names. Reformatted guideline.

Date Printed: June 26, 2017: 01:17 AM