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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: 09/28/17

Revised: 10/15/17

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 patients in the home revolutionized the management of diabetes. Using fingersticks, patients can monitor their blood glucose levels 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 level in the range of 7%, is now considered standard of care for diabetic patients. The American Diabetes Association has recommended a glycated hemoglobin level below 7% for most patients. Randomized controlled trials assessing tight control have demonstrated benefits in decreasing microvascular complications.

Hypoglycemia, defined as plasma glucose below 70 mg/dL, may place a limit on the ability to achieve tighter glycemic control. Hypoglycemic events in adults range from mild to severe, based on a number of factors including the glucose nadir, presence of symptoms, and whether the episode can be self-treated or requires help for recovery.

Continuous Glucose Monitoring Systems (CGMS)

Continuous glucose monitoring systems (CGMS) are devices that measure glucose levels in interstitial fluid at programmable intervals. These readings, used along with fingerstick results, help detect any patterns or trends with an individual’s glucose levels and are intended to assist in calculating the insulin dosage needed to manage glycemic control. CGMS use sensors that are inserted under the skin in the abdomen and work by extracting glucose from the interstitial fluid, measuring and recording the glucose level, and converting these measurements into equivalent blood glucose readings. Sensors are designed to be worn three to seven days, depending on the product. Calibration is required whenever a new glucose sensor is inserted, which requires obtaining blood glucose from a traditional fingerstick sample. Measurements of glucose in interstitial fluid provide glucose values automatically throughout the day, producing data that show the trends in glucose levels.

Continuous Glucose Monitoring Systems (CGMS) with Low Glucose Suspend Feature (LGS)

The first device (MiniMed 530G) categorized by FDA as an artificial pancreas device system (subcategory: threshold suspend device system) was approved in 2013. The system integrates a continuous glucose monitor (CGM) and insulin pump and includes a low-glucose suspend (LGS) feature that can automatically and temporarily suspend insulin delivery when glucose levels fall below a prespecified level. Threshold suspend is the first step towards an artificial pancreas device system (APDS). This technology allows the user to set a low blood sugar threshold value. When the CGM sensor detects the preset low glucose threshold, insulin delivery is suspended. The MiniMed 530G System is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons requiring insulin, as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 630G with SmartGuard™ was approved in 2016. The system is similar to the 530G but offers updates to the system components including waterproofing.

Artificial pancreas

FDA has described 3 main categories of artificial pancreas device systems: threshold suspend device, control-to-range, and control-to-target systems. With threshold suspend device systems, also called LGS systems, the delivery of insulin is suspended for a set time when 2 glucose levels are below a specified low level indicating hypoglycemia. With control-to-range systems, the patient sets his or her own insulin dosing within a specified range, but the artificial pancreas device system takes over if glucose levels are detected outside that range (higher or lower). Patients using this type of system still need to check blood glucose levels and administer insulin as needed. With control-to-target systems, the device aims to maintain glucose levels near a target level (eg, 100 mg/dL). Control-to-target systems are automated and do not require user participation except to calibrate the continuous glucose monitoring system. The MiniMed® 670G, a hybrid closed loop insulin delivery system, was approved by FDA in 2016. It consists of an insulin pump, a glucose meter, and a transmitter, linked by a proprietary algorithm, the SmartGuard HCL. The system includes an LGS feature that suspends insulin delivery when glucose levels get low and has an optional alarm. Additionally, the system involves semiautomatic insulin-level adjustment to preset targets. It is called a hybrid system; basal insulin levels are automatically adjusted but the patient needs to administer premeal insulin boluses.

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:

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

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 [such as low glucose suspend devices or hybrid closed loop systems] meets the definition of medical necessity when ALL the following have been 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.

(See Reimbursement Section for Medical Supplies)

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

K0553

Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

K0554

Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system

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 intermittent 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), located at cgsmedicare.com. The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: National Coverage Determination (NCD) for Closed-Loop Blood Glucose Control Device (CBGCD) (40.3), located at cms.gov.

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 09/28/17.

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.

07/01/17

Quarterly CPT/HCPCS update. Added codes K0553, K0554. Revised Reimbursement Information section.

10/15/17

Unscheduled review. Revised description section, position statement section, HCPCS coding section, reimbursement information section, and program exceptions section. Updated references.

Date Printed: October 23, 2017: 07:31 AM