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Continuous Glucose Monitors and Artificial Pancreas Device Systems (APDS)
MA00.002h

Policy

MEDICALLY NECESSARY

SHORT-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS)
When reported as a professional service, use of an FDA approved short-term (e.g., 72 hour minimum) interstitial CGMS for detecting trends and patterns in glucose levels is considered medically necessary and, therefore, covered for individuals who meet one of the following criteria:
  • The individual is a pregnant female with type 1 or type 2 diabetes that requires insulin therapy.
  • The individual has type 1 or type 2 diabetes and requires determination of basal insulin level measurements prior to insulin pump initiation.
  • The individual has type 1 or type 2 diabetes and documentation of all of the following:
    • The individual has received diabetes self-management education and instruction from a health care professional with expertise in the management of diabetes.
    • The individual has a documented average of at least three glucose self-tests per day during the previous month.
    • The individual has a documented history of poorly controlled (e.g., severe ketosis or hypoglycemic episodes without experiencing warning and recognition of symptoms or hypoglycemic unawareness).
    • The individual is on an intensive insulin regimen, requiring three or more insulin injections per day, or utilizes an insulin pump.
      • The individual has one or more of the following while on an intensive insulin regimen:
        • Glycated hemoglobin (HbA1c) values less than four or greater than nine
        • Unexplained large fluctuations in daily glucose values before meals
        • Unexplained frequent hypoglycemic attacks
        • Episodes of ketoacidosis or hospitalizations for significantly elevated glucose levels
Short-term interstitial CGMS monitoring is intended only for periodic or occasional testing and to supplement, not replace, self-testing of blood glucose.

Short-term interstitial CGMS monitoring must be reported only once per monitoring period, regardless of the number of days involved. Continuous interstitial glucose monitoring must be performed for a minimum of 72 hours to show glucose trends effectively.

THERAPEUTIC (NON-ADJUNCTIVE) LONG-TERM INTERSTITIAL CGMS
A Food and Drug Administration (FDA) approved, therapeutic long-term CGMS is considered medically necessary and, therefore, covered as durable medical equipment (DME) when all of the following criteria are met:
  • The therapeutic long-term CGMS is prescribed by a professional provider.
  • The individual has insulin-dependent diabetes mellitus requiring multiple (three or more) daily administrations of insulin or ​utilizes a continuous subcutaneous insulin infusion pump.
  • For the initial provision of a CGMS, the individual's insulin ​treatment regimen requires frequent adjustment on the basis of blood glucose monitoring or CGMS testing results.  (Note: It is not a mandate that insulin dose adjustments must be made if glucose levels are within the target range as established collaboratively with the individual's treating professional provider)
  • ​Within six (6) months prior to ordering the CGM, the treating professional provider has an in-person visit with the individual to evaluate their diabetes control and determined that all of the above criteria are met.
  • The CGMS is being used as a non-adjunctive device to replace a blood glucose monitor.​​

​CONTINUED USE OF A THERAPEUTIC (NON-ADJUNCTIVE) LONG-TERM INTERSTITIAL CGMS
​Every six (6) months following the initial prescription of the CGM, the treating professional provider has an in-person visit with the individual to assess adherence to their CGM regimen and diabetes treatment plan. 

SUPPLIES AND EQUIPMENT FOR A THERAPEUTIC LONG-TERM CGMS
Supplies (e.g., sensors and transmitters) for therapeutic long-term CGMS are considered medically necessary and, therefore, covered, once monthly while the individual is utilizing a therapeutic long-term CGMS and must be reordered by the treating professional provider on a yearly basis. One unit equals a one month supply.

A receiver (monitor) is considered medically necessary and, therefore, covered, up to the manufacturer's useful lifetime limit of the device.

NOT COVERED

SHORT-TERM INTERSTITIAL CGMS
For short-term interstitial CGMS devices, a monitoring period of less than 72 hours is considered not medically necessary and, therefore, not covered.

All other uses for a short-term interstitial CGMS are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

NON-THERAPEUTIC LONG-TERM INTERSTITIAL CGMS
A long-term CGMS approved by the FDA for use as adjunctive devices (e.g., blood glucose monitor with traditional finger-stick testing) and not used as the sole device for making diabetes treatment decisions, is not covered by the Company, because it is considered a non-therapeutic item, and not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

REMOTE GLUCOSE MONITORS
Remote glucose monitors (e.g., mySentry™), to measure glucose levels via a subcutaneously implanted sensor, do not meet Medicare's definition of DME because they are considered precautionary. Therefore, remote glucose monitors are not covered.

ARTIFICIAL PANCREAS DEVICE SYSTEMS
Artificial pancreas device systems (e.g., the threshold suspend device system, control-to-range and control-to-target systems) do not meet Medicare's definition of DME because they contain components that are not covered by Medicare. Therefore, the artificial pancreas device systems are considered not covered.

ACCESSORIES AND SUPPLIES
Associated accessories for CGMS devices, such as shower covers and belt clips, are considered not medically necessary and, therefore, not covered.

Any additional software or hardware required for downloading CGMS data to a computer is considered not medically necessary and, therefore, not covered.

Smart devices (e.g., smart phones, tablets, personal computers) are not covered by the Company because they are not covered by Medicare. These items do not meet Medicare's definition of DME because they are non-medical items. Therefore, smart devices are not eligible for reimbursement consideration. 

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.


Guidelines

The use of a short-term interstitial continuous glucose monitoring system (CGMS) that is a provider-owned device loaned to an individual for a minimum of 72 hours is anticipated to be used no more than once every six months.

Interstitial CGMSs have been approved by the US Food and Drug Administration (FDA) for adult and pediatric individuals with diabetes.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, short-term continuous glucose monitoring (CGM) and therapeutic long-term CGMS are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as not covered are not eligible for coverage or reimbursement by the Company.

Description

Developments in the ability to monitor interstitial fluid glucose at frequent intervals and to record them via a transmitter have provided the ability to monitor diabetic control in individuals who have proven refractory to conventional self-monitoring. These devices are of specific value in those individuals who have wide glycemic swings, frequent hospitalizations, and complications of their systemic illness.

SHORT-TERM INTERSTITIAL CONTINUAL GLUCOSE MONITORING SYSTEM

A short-term continuous glucose monitoring system (CGMS) is a health care provider owned device that is loaned to an individual who wears it for a minimum of 72 hours. The individual calibrates the system at least twice a day by entering their glucose measurement obtained from a traditional blood glucose monitor.

The detailed glucose trend and pattern information is collected by the device and reviewed by a professional health care provider. Based on this information, adjustments may be made to the individual's medication, diet, or exercise regimen. Short-term interstitial CGMS are indicated for use in individuals with diabetes who demonstrate marked changes in status, as evidenced by unexplained glycemic fluctuations. These devices can also be used periodically to confirm the status of current diabetic therapy. They are intended only for occasional testing and to supplement, not replace, self-testing of blood glucose.

LONG-TERM CONTINUOUS GLUCOSE MONITORING SYSTEM

A long-term CGMS is indicated for use in individuals with diabetes who require insulin and need to be monitored for unexplained glycemic fluctuations and hypoglycemic unawareness. Hypoglycemic unawareness is the inability of an individual to notice and recognize symptoms of hypoglycemia while they are experiencing them. Complications of unaddressed hypoglycemia may include diabetic coma, brain damage, and seizures.

NON-ADJUNCTIVE CGMS
Most long-term interstitial CGMS devices are FDA approved as non-adjunctive, used to replace traditional blood glucose monitoring for diabetes treatment decisions, such as changing one's diet or insulin dosage based the readings of the CGM. These devices allow individuals to track glucose levels and detect episodes of high and low blood sugar in real-time on an ongoing basis. The device consists of a disposable subcutaneous sensor, an external transmitter, and an external receiver (monitor), which can be a stand-alone device or built into an insulin pump. Sensors are worn as indicated by the device manufacturer in accordance with US Food and Drug Administration (FDA) labeling and are replaced on an ongoing basis.

According to the FDA, on December 20, 2016, the Dexcom G5 Mobile Continuous Glucose Monitoring (GCM) System received supplemental approval, as the first device that can be used as a replacement for finger-stick testing in individuals two years of age and older for diabetes treatment decisions. Interpretation of the results of the device should be based on the glucose trends and several sequential readings over time. The product also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Finger-sticks are required for calibration, at least once every 12 hours. More frequent calibrations may be required if symptoms do not match readings or when taking medications containing acetaminophen, which can falsely elevate the device's readings.

The Dexcom G6 Continuous Glucose Monitoring (CGM) System was approved by the FDA on October 26, 2018, as a therapeutic CGM system intended to replace fingerstick blood glucose testing in individuals two years of age and older for diabetes treatment decisions. The system features a ten day wear sensor, is factory calibrated with optional user calibration, and can autonomously communicate with digitally connected devices such as an automated insulin dosing system.

The FreeStyle® Libre 14 Day Flash Glucose Monitoring System (CGM), was approved by the FDA on July 23, 2018, as a therapeutic CGM system, indicated for the management of diabetes in individuals 18 years of age and older. The system requires no user calibration whatsoever (either by finger-stick or manual data entry), because it is factory-calibrated. The system also does not require the need for routine fingersticks. The high accuracy of the FreeStyle® Libre system allows for patients to dose insulin based on the results. The system interprets glucose levels through a sensor that is worn on the back of the upper arm for up to 14 days. The sensor wire inserted below the skin’s surface on the back of the arm continuously measures and monitors glucose levels. The FreeStyle® Libre system does not have alarms that will automatically alert an individual when a severe low (hypoglycemic) or high (hyperglycemic) glucose event is occurring, unless the sensor is scanned. The goal intended with using the FreeStyle® Libre system, is to replace blood glucose testing for diabetic treatment decision-making.

According to the Centers of Medicare and Medicaid (CMS), these devices meet the requirements of a therapeutic CGM by replacing the need for an adjunctive blood glucose monitor.

ADJUNCTIVE CGMS
CGM devices approved by the FDA for use as adjunctive devices, used with finger-stick testing, and not used solely for making diabetes treatment decisions, such as changing one's diet or insulin dosage based the readings of the CGM, are not considered therapeutic.

REMOTE GLUCOSE MONITORS

A remote glucose monitor (e.g., mySentry) receives information transmitted from a CGM-enabled pump. The CGM-enabled pumps use glucose sensors that report glucose values every five minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels for individuals who have diabetes.

A remote glucose monitor (e.g., mySentry™) has two components: an alarm clock--sized monitor, in the form of a table-top viewing screen, and a small, companion “signal booster", or data transmission device, called the Outpost. It allows a caregiver in another room to see the monitor’s color screen and all the key metrics of the linked pump; if the pump sets off an alarm, that alarm is relayed to the monitor.

The remote glucose monitor (e.g., mySentry™) captures data from a CGM-enabled pump and relays that information, along with blood sugar readings, up to 100 feet away. The CGM-enabled pump works in close proximity (e.g., within six feet) of either the monitor itself or the Outpost signal booster. The primary use of the remote glucose monitor (e.g., mySentry™) is for a caregiver to receive alerts and information from the CGM-enabled pumps during night-time monitoring.

ARTIFICIAL PANCREAS DEVICE SYSTEMS (APDS)

Despite the availability of increasingly effective treatment modalities, a substantial proportion of individuals with insulin-dependent diabetes cannot achieve adequate glycemic control.

One of the critical path initiatives of the US Food and Drug Administration (FDA) is to accelerate the development and availability of a safe and effective artificial pancreas for the treatment of diabetes mellitus. In partnership with the National Institutes of Health (NIH), the FDA has established a multi-disciplinary group of scientists and clinicians to address the clinical, scientific, and regulatory challenges related to the artificial pancreas device systems.

References

Allen NA, Fain JA, Braun B, et al. Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Diabetes Res Clin Pract. 2008;80(3):371-379.

American Diabetes Association. Hypoglycemia. [American Diabetes Association Web site]. Available at: https://www.diabetes.org/diabetes/medication-management/blood-glucose-testing-and-control/hypoglycemia. Accessed June 7, 2021. 

American Diabetes Association. Standards of Medical Care in Diabetes 2020. Diabetes Care. 2020;43(Suppl 1). Available at: https://care.diabetesjournals.org/content/43/Supplement_1. Accessed June 7, 2021.

American Diabetes Association. Management of diabetes in pregnancy: standards of medical care in diabetes-2018. Diabetes Care. 2018;41 (Supplement 1): S137-S143.

Bailey TS, Grunberger G, Bode BW, et al. American Association of Clinical Endocrinologists and American College of Endocrinology 2016 outpatient glucose monitoring consensus statement. Endocr Pract. 2016;22(2):231-261.

Battelino T, Danne T, Bergenstal RM et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care.2019;42(8).

Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial. JAMA. 2017;317(4):371-378.

Beck RW, Riddlesworth TD, Ruedy K, et al. Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial. Ann Intern Med.2017;167(6):365-374.

Benkhadra K, Alahdab F, Tamhane S, et al. Real-time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta-analysis. Clin Endocrinol (Oxf). 2017;86(3):354-360.

Blue Cross and Blue Shield Technology Evaluation Center (TEC). Use of Intermittent or Continuous Interstitial Fluid Glucose Monitoring in Patients with Diabetes Mellitus. TEC Assessments 2003; Volume 18, Tab 16.

Centers for Disease Control and Prevention (CDC). National Diabetes Statistics Report, 2020. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdfAccessed June 7, 2021.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered medical and other health services. §110.1 (B)(2): Equipment presumptively nonmedical. [CMS Web site]. 07/12/19 Available at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed June 7, 2021.

Cosson E, Hamo-Tchatchouang E, Dufaitre-Patouraux L, et al. Multicentre, randomised, controlled study of the impact of continuous sub-cutaneous glucose monitoring (GlucoDay) on glycaemic control in type 1 and type 2 diabetes patients. Diabetes Metab. 2009;35(4):312-318.

Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS). CMS Ruling No.: [CMS-1682-R] Date: January 12, 2017. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf. Accessed June 7, 2021.

Dexcom. Introducing the Dexcom G5 Mobile CGM System. 2017. Available at:
https://www.dexcom.com/get-started-cgm?utm_source=website&utm_medium=cpc&utm_campaign=70133000001LlpgAAC&gclid=CJ3609qviNMCFc6EswodnOwLUA. Accessed June 7, 2021.

Ehrhardt NM, Chellappa M, Walker MS, et al. The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. J Diabetes Sci Technol. 2011;5(3):668-675.
Feig DS, Donovan LE, Corcoy R, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017;390(10110):2347- 2359.

Floyd B, Chandra P, Hall S, et al. Comparative analysis of the efficacy of continuous glucose monitoring and self- monitoring of blood glucose in type 1 diabetes mellitus. J Diabetes Sci Technol. 2012;6(5):1094-1102.

Gandhi GY, Kovalaske M, Kudva Y, et al. Efficacy of continuous glucose monitoring in improving glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol. 2011;5(4):952-965.

Garber AJ, Handelsman Y, Grunberger G, et al. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2020 EXECUTIVE SUMMARY. Endocr Pract. 2020;26(1):107-139.

Gehlaut RR, Dogbey GY, Schwartz FL, et al. Hypoglycemia in type 2 diabetes--more common than you think: a continuous glucose monitoring study. J Diabetes Sci Technol. 2015;9(5):999-1005.
Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care.1994;17(7):697-703.

Haak, TT, Hanaire, HH, Ajjan, RR, et al. GG. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2016;8(1).

Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Use of flash glucose-sensing technology for 12 months as a replacement for blood glucose monitoring in insulin-treated type 2 diabetes. Diabetes Ther. 2017;8(3).

Ida, SS, Kaneko, RR, Murata, KK. Utility of real-time and retrospective continuous glucose monitoring in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. J Diabetes Res. 2019;2019:4684815.

Langendam M, Luijf YM, Hooft L, et al. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2012;1:CD008101.

Lind M, Polonsky W, Hirsch IB, et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: The GOLD randomized clinical trial. JAMA. 2017;317(4):379-387.

Murphy HR, Rayman G, Lewis K, et al. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008;337:a1680.

Newman SP, Cooke D, Casbard A, et al. A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE). Health Technol Assess. 2009;13(28):iii-iv, ix-xi, 1-194.

National Institute for Health and Care Excellence (NICE). Type 1 diabetes in adults: diagnosis and management [NG17]. 2016. Available at: https://www.nice.org.uk/guidance/ng17?unlid=382286372016220232952. Accessed June 7, 2021.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD) for Glucose Monitors L33822. Original Effective: 10/01/2015. Revised Effective 07/18/2021. Available at: Local Coverage Determination for Glucose Monitors (L33822) (cms.gov).  Accessed August 6, 2021.

Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA) for Glucose Monitors A52464. Original Effective: 10/01/2015. Revised Effective 07/18/2021. Available at: Local Coverage Article for Glucose Monitor - Policy Article (A52464) (cms.gov)​.  Accessed August 6, 2021. 

Pazos-Couselo M, Garcia-Lopez JM, Gonzalez-Rodriguez M, et al. High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study. Can J Diabetes. 2015;39(5):428-433.

Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology-continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(11):3922-3937.

Polonsky WH, Hessler D, Ruedy KJ, et al. The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial. Diabetes Care. 2017;40(6):736-741.

Poolsup N, Suksomboon N, Kyaw AM. Systematic review and meta-analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes. Diabetol Metab Syndr. 2013;5(1):39.

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Vigersky RA, Fonda SJ, Chellappa M, et al. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012;35(1):32-38.

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Wojciechowski P, Rys P, Lipowska A, et al. Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: systematic review and meta-analysis. Pol Arch Med Wewn. 2011;121(10):333-343.

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Yoo HJ, An HG, Park SY, et al. Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract. 2008;82(1):73-79.

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Yu Q, Aris IM, Tan KH, et al. Application and Utility of Continuous Glucose Monitoring in Pregnancy: A Systematic Review. Front Endocrinol (Lausanne). 2019 Oct 11;10:697. Available at: https://www.frontiersin.org/articles/10.3389/fendo.2019.00697/full. Accessed June 7, 2021.

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT SHORT-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEMS:

95249, 95250, 95251

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
SHORT-TERM INTERSTITIAL CGMS IS MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT A.

THERAPEUTIC LONG-TERM INTERSTITIAL CGMS IS MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT B.

HCPCS Level II Code Number(s)
MEDICALLY NECESSARY

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

NOT COVERED

THE FOLLOWING CODES ARE USED TO REPRESENT NON-THERAPEUTIC LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM:

A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 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

THE FOLLOWING CODE IS USED TO REPRESENT REMOTE CONTINUOUS GLUCOSE MONITORING SYSTEM (E.G., mySentry™):

A9999 Miscellaneous DME supply or accessory, not otherwise specified

THE FOLLOWING CODES ARE USED TO REPRESENT ARTIFICIAL PANCREAS DEVICE SYSTEM:

S1034 Artificial Pancreas Device System (eg, Low Glucose Suspend [LGS] Feature) Including Continuous Glucose Monitor, Blood Glucose Device, Insulin Pump And Computer Algorithm That Communicates With All Of The Devices

S1035 Sensor; Invasive (eg, Subcutaneous), Disposable, For Use With Artificial Pancreas Device System

S1036 Transmitter; External, For Use With Artificial Pancreas Device System

S1037 Receiver (Monitor); External, For Use With Artificial Pancreas Device System

Revenue Code Number(s)
N/A


Coding and Billing Requirements


Policy History

7/18/2021
9/10/2021
MA00.002
Medical Policy Bulletin
Medicare Advantage
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