Medicare Advantage

Medical Policy

Notification

Continuous Glucose Monitors and Home Blood Glucose Monitors and Supplies

Notification Issued Date:

This AmeriHealth New Jersey Medicare Advantage policy will become effective 01/01/2024.

Title:

Continuous Glucose Monitors and Home Blood Glucose Monitors and Supplies

Policy #:

MA00.002q

Policy

CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) AND SUPPLIES

MEDICALLY NECESSARY

Short-term Interstitial Continuous Glucose Monitoring System (CGMS)

When reported as a professional service, use of a US Food and Drug Administration (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 pregnant and develops gestational diabetes.
The individual has diabetes mellitus and requires determination of basal insulin level measurements prior to insulin pump initiation.
The individual has diabetes mellitus and documentation of all of the following:
- The individual has received diabetes self-management education and instruction from a healthcare 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, suspected postprandial hyperglycemia, persistent hyperglycemia, or hemoglobin A1c [HbA1c] levels above target).
- The individual is on an intensive insulin regimen, requiring three or more insulin injections per day, or utilizes an insulin pump.

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.

Long-Term Interstitial CGMS (Non-Implantable)

An FDA-approved, long-term CGMS is considered medically necessary and, therefore, covered as durable medical equipment (DME) when all of the following criteria are met:

The long-term CGMS is prescribed by a professional provider
The continuous glucose monitoring (CGM) is prescribed in accordance with its FDA indications for use
The individual has diabetes mellitus and either of the following:

Insulin treated; or,
Non-insulin treated and a history of problematic hypoglycemia as evidenced by one of the following criteria:

Recurrent (more than one) level 2 hypoglycemic events: glucose <54 mg/dL (3.0 mmol/L) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan.
A history of one level 3 hypoglycemic event: glucose <54 mg/dL (3.0 mmol/L) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia (e.g., assistance from another person)

Within 6 months prior to ordering the CGM, the treating professional provider has an in-person or telehealth visit with the individual to evaluate their diabetes control and determined that all of the above criteria are met.

Continued Use Of A Long-Term Interstitial CGMS (Non-Implantable)

Every 6 months following the initial prescription of the CGM, the treating professional provider has an in-person or telehealth visit with the individual to assess adherence to their CGM regimen and diabetes treatment plan.

Supplies and Equipment For Long-Term CGMS (Non-Implantable)

Supplies (e.g., sensors and transmitters) for long-term CGMS are considered medically necessary and, therefore, covered, up to a maximum of three units of service per 90 days while the individual is utilizing a long-term CGMS and must be reordered by the treating professional provider on a yearly basis. One unit equals a 1-month supply.

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

Implantable Long-Term Interstitial CGMS 

The implantation of an implantable continuous glucose monitor (I-CGM) (e.g.,

Eversense® E3 ), when used in accordance with its FDA-labeled indication and intended purpose, is considered medically necessary and, therefore, covered when all of the following criteria are met:

The I-CGM is prescribed by a professional provider
The individual has diabetes mellitus and either of the following:

Insulin treated; or,
Non-insulin treated and a history of problematic hypoglycemia as evidenced by one of the following criteria:

Recurrent (more than one) level 2 hypoglycemic events (glucose <54 mg/dL (3.0 mmol/L) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan.
A history of one level 3 hypoglycemic event (glucose <54 mg/dL [3.0 mmol/L]) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia. (e.g., assistance from another person)

Continued Use Of A Long-Term Interstitial CGMS (Implantable)

Every 6 months following the initial prescription of the I-CGM, the treating professional provider has an in-person or telehealth visit with the individual to assess adherence to their I-CGM regimen and diabetes treatment plan.

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.

Long-Term Interstitial CGMS (Non-Implantable)

Long-term interstitial CGMS devices that solely display glucose results on a smartphone and never utilize a durable stand-alone receiver or do not integrate with a durable insulin infusion pump (e.g., stand-alone adjunctive CGMS [Guardian™ Connect]) do not meet Medicare's definition of DME and, therefore, are not covered.

Accessories and Supplies For Long-Term CGMS (Non-Implantable)

Accessories and supplies (e.g., sensors and transmitters) for long-term CGMS are considered not medically necessary and, therefore, not covered, when the individual never uses a durable stand-alone receiver or durable insulin infusion pump to display CGMS glucose data.

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 nonmedical items. Therefore, smart devices are not eligible for reimbursement consideration.

HOME BLOOD GLUCOSE MONITORS AND SUPPLIES

MEDICALLY NECESSARY

Home Blood Glucose Monitors

Home blood glucose monitors, when prescribed by a professional provider, are considered medically necessary and, therefore, covered, when ALL of the following coverage criteria are met:

The individual is diagnosed with diabetes by having one of the following:
- A fasting blood glucose greater than or equal to 126 mg/dL on two different occasions
- A 2-hour post-glucose challenge greater than or equal to 200 mg/dL on two different occasions
- A random glucose test over 200 mg/dL for a person with symptoms of uncontrolled diabetes
The individual is capable of being trained to use the glucose monitor prescribed in an appropriate manner or another responsible individual can be trained to use the equipment and monitor the individual who is being treated for diabetes.
The glucose monitor is designed for home, rather than clinical, use.

Home Blood Glucose Monitors With Special Features

Home blood glucose monitors with special features are considered medically necessary and, therefore, covered, when the coverage criteria above are met and the treating professional provider documents the following criteria:

A blood glucose monitor with integrated voice synthesizer (E2100) when used for individuals with a severe visual impairment (i.e., best corrected visual acuity of 20/200 or worse in at least one eye) who require use of this special monitoring system.
A blood glucose monitor with integrated lancing/blood sample (E2101) when used for individuals with a severe visual impairment (i.e., best corrected visual acuity of 20/200 or worse in at least one eye) who require use of this special monitoring system and/or when used for individuals with impairment of manual dexterity.

Reflectance colorimeter devices are used for measuring blood glucose levels in clinical settings. Some types of home blood glucose monitors that use the reflectance colorimeter technology in the monitors may be eligible for coverage.

Supplies

Lancets (A4259), blood glucose test reagent strips (A4253), glucose control solutions (A4256), and spring-powered devices for lancets (A4258) are covered for individuals for whom the glucose monitor is covered. More than one spring-powered device (A4258) per 6 months is considered not medically necessary and, therefore, not covered.

The quantity of test strips (A4253) and lancets (A4259) that are covered depends on the usual medical needs of the diabetic individual and whether or not the individual is being treated with insulin, regardless of their diagnostic classification of type 1 or type 2 diabetes mellitus. Coverage of testing supplies is based on the following guidelines:

Usual Utilization

Up to 300 test strips and up to 300 lancets per month are eligible for reimbursement consideration when the basic coverage criteria above are met.

High Utilization

More than 300 test strips and/or more than 300 lancets per month are eligible for reimbursement consideration when there is documentation in the professional provider's records (e.g., a specific narrative statement that adequately documents the frequency at which the individual is actually testing or a copy of the individual's log) that the individual requires testing at a frequency that corroborates the quantity of supplies that have been dispensed.

If the individual is regularly using quantities of supplies that exceed the usual utilization guidelines, new documentation must be present at least every 6 months.

NOT MEDICALLY NECESSARY
All other uses for home glucose monitors and related accessories and supplies are considered not medically necessary and, therefore, not covered.

A laser skin-piercing device (E0620) and related lens shield cartridge (A4257) are considered not medically necessary and, therefore, not covered because the medical necessity has not been established.

NOT COVERED
Home blood glucose disposable monitors are not covered by the Company because they are an item or service not covered by Medicare because these monitors do not meet the definition of DME. Therefore, they are not eligible for reimbursement consideration.

PREFERRED BRANDS

Blood glucose meters and test strips for Medicare Advantage members must be a preferred brand product for coverage, with no coinsurance, copayment, or deductible.

The Company-preferred brands are:

Accu-Chek® products (Roche)
One Touch® products (LifeScan)

Blood glucose meters and test strips other than

Accu-Chek and One-Touch are not covered, with the following exceptions:

Coverage of meters and supplies with special features for the visually impaired
Coverage of meters and supplies that are used with an insulin pump

Please refer to the Evidence of Coverage for more information.

COLUMN I/COLUMN II REIMBURSEMENT EDITS

The reimbursement for the item(s) represented by the code(s) in column II are included in the reimbursement for the item represented by the code in column I.

Column I	Column II
E0607	A4233, A4234, A4235, A4236
E2100	A4233, A4234, A4235, A4236
E2101	A4233, A4234, A4235, A4236
E2104	A4233, A4234, A4235, A4236
A4239	E0607, E2100, E2101, E2104, A4233,A4234, A4235, A4236, A4253, A4255, A4256, A4258, A4259, A4271

REQUIRED DOCUMENTATION

PROBLEMATIC HYPOGLYCEMIA IN NON-INSULIN TREATED DIABETES

Medical record documentation must be consistent with one of the following pathways to coverage for long-term CGMS (non-implantable) in individuals with non-insulin treated diabetes and a history of problematic hypoglycemia.

For a history of recurrent (more than one) level 2 hypoglycemia events:

The glucose values for the qualifying event(s) (glucose <54 mg/dL [3.0 mmol/L]); or
Classification of the hypoglycemic episode(s) as level 2 event(s); or
A copy of the individual's blood glucose monitoring (BGM) testing log into the medical record reflecting the specific qualifying events (glucose <54 mg/dL [3.0 mmol/L]); and
Documentation of more than one previous medication adjustment and/or modification to the treatment plan (such as raising A1c targets) prior to the most recent level 2 event.

For a history of at least one level 3 hypoglycemic event:

The glucose value for the qualifying event (glucose <54 mg/dL [3.0 mmol/L]); or,
Classification of the hypoglycemic episode as level 3 event; or,
A copy of the individual's BGM testing log into the medical record reflecting the specific qualifying event (glucose <54 mg/dL [3.0 mmol/L]); and,
An indication in the medical record that the individual required third-party assistance for treatment (e.g., assistance from another person).

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 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 7 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 5 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 DME supplier may be required to reimburse the Company for overpayments. 

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

There are specific Healthcare Common Procedure Coding System (HCPCS) codes that describe therapeutic (non-adjunctive) CGM devices and the related supply allowance (E2103, A4239) and non-therapeutic (adjunctive) CGM devices and the related supply allowance (E2102, A4238). The use of additional HCPCS codes other than those described in this policy are not eligible for reimbursement consideration. 
 
HCPCS code E2103 reported with an insulin pump is used to describe an external ambulatory insulin infusion pump that incorporates dose rate adjustment using non-adjunctive continuous glucose sensing. (Please refer to the specific policy, MA05.060 External Infusion Pumps.) The use of additional HCPCS codes other than those described in these policies are not eligible for reimbursement consideration.
 
HCPCS code E2102 reported with an insulin pump is used to describe an external ambulatory insulin infusion pump with integrated adjunctive continuous glucose monitor receiver functionality. (Please refer to the specific policy, MA05.060 External Infusion Pumps.) The use of additional HCPCS codes other than those described in these policies are not eligible for reimbursement consideration. 

Therapeutic (non-adjunctive) CGM supply allowance (A4239) includes a home blood glucose meter and related supplies (test strips, lancets, lancing device, calibration solution, and batteries); therefore, these items are not eligible for separate reimbursement consideration. ​​

Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

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 6 months.

Interstitial CGMS devices 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), long-term CGM, and home blood glucose monitors and supplies 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.

Certain drugs and supplies are available through either the member's medical benefit or pharmacy benefit, depending on how the item is prescribed, dispensed, or administered. This medical policy only addresses instances when blood glucose monitors and supplies are covered under a member's medical benefit. It does not address instances when supplies may be covered under a member’s pharmacy benefit.

Description

CONTINUOUS GLUCOSE MONITORS

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 CONTINUOUS GLUCOSE MONITORING SYSTEM
A short-term continuous glucose monitoring system (CGMS) is a healthcare 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 healthcare 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.

Therapeutic (Non-Adjunctive) CGMS

Most long-term interstitial CGMS devices are FDA approved as therapeutic or 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.

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 2 years of age and older for diabetes treatment decisions. The system features a 10-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 Dexcom G7 CGM System was approved by the FDA on December 7, 2022, as a real time, continuous glucose monitoring device indicated for the treatment of diabetes in individuals 2 years and older. The device is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. It is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 can be used alone or in conjunction with these digitally connected medical devices for the purposes of managing diabetes.

The FreeStyle® Libre 14 Day Flash 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 fingerstick 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.

The FreeStyle® Libre 2 Flash CGM was approved by the FDA on June 12, 2020, as a therapeutic CGM system with real time alarms capability indicated for the management of diabetes in individuals 4 years of age and older.

The FreeStyle® Libre 3 Continuous Glucose Monitoring System was approved by the FDA on May 26, 2022, as a real-time CGM device with alarms capability indicated for the management of diabetes in individuals 4 years of age and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The system is also intended to autonomously communicate with digitally connected devices. The system can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The Eversense® Continuous Glucose Monitoring System is an implantable device that is placed in the subcutaneous skin layer and provides continuous glucose measurements over a 40- to 400-mg/dL range. The system provides real-time glucose values, glucose trends, and alerts for hypoglycemia and hyperglycemia and low glucose through a mobile application installed on a compatible mobile device platform. The Eversense® CGM System is a prescription device indicated for use in adults (18 years and older) with diabetes for up to 90 days. The device was initially approved by the FDA as an adjunctive glucose monitoring device to complement information obtained from standard home blood glucose monitoring devices. Expanded approval was granted in June 2019; Eversense is now approved as a device to replace fingerstick blood glucose measurements for diabetes treatment decisions. The newest version, the Eversense E3 Continuous Glucose Monitoring System, received FDA approval on February 10, 2022, and is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 180 days. Prescribing providers are required to participate in insertion and removal training certification.

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

Nontherapeutic (Non-Adjunctive) CGMS

CGM devices approved by the FDA for use as nontherapeutic (adjunctive devices) require the individual to verify their glucose levels with fingerstick testing prior to making treatment decisions, such as changing one's diet or insulin dosage.

The Guardian™ Sensor 3 was approved by the FDA on March 8, 2018, and is indicated for use with Medtronic Diabetes glucose-sensing systems to continuously monitor glucose levels in persons with diabetes. The Guardian Sensor 3 is indicated for 7 days of continuous use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. The Guardian Sensor 3 can be integrated with an insulin pump system that also operates as the CGM's receiver component or used as part of the Guardian Connect stand-alone CGM system that displays glucose data solely through a smartphone application.

HOME BLOOD GLUCOSE MONITORS

Home blood glucose monitors are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen and may be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.

Blood glucose monitors with integrated voice synthesizers for visually impaired individuals are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen but are also digitized and converted to sound output. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.

Blood glucose monitors with integrated lancing and/or blood sampling are devices that measure capillary whole blood for determination of blood glucose levels. The lancing device for obtaining the capillary blood sample is integrated into the glucose monitor rather than a separate accessory. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.

Reflectance colorimeter devices are meter devices that read color changes produced on specially treated reagent strips by glucose concentrations in the individual's blood. The individual, using a disposable sterile lancet, draws a drop of blood, places it on a reagent strip and, following instructions that may vary with the device used, inserts it into the device to obtain a reading.

References

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American Diabetes Association. Management of diabetes in pregnancy: standards of medical care in diabetes-2024. Diabetes Care. 2024;47(Supplement 1):S282-S294.

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.

Beck RW, Bergenstal RM, Riddlesworth TD, et al. Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials. Diabetes Care. 2019;42:400-405. Available at: Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials - PMC (nih.gov). Accessed July 2, 2024.

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.

Centers for Disease Control and Prevention (CDC). National Diabetes Statistics Report, 2024. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available at: National Diabetes Statistics Report | Diabetes | CDC. Accessed July 1, 2024.

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]. 02/08/2024. Available at: https://www.cms.gov/Regulations-a nd-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed July 1, 2024.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) NCD 40.4 Insulin syringe. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=133&ncdver=1&DocID=40.4&kq=true&bc=gAAAAAgAAAAAAA==&. Accessed July 1, 2024.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) NCD 40.2 Home Blood Glucose Monitors. Effective 6/19/2006. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=222&ncdver=2&NCAId=35&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA|CAL|NCD|MEDCAC|TA|MCD&ArticleType=Ed|Key|SAD|FAQ&PolicyType=Final&s=All&KeyWord=glucose+monitor&KeyWordLookUp=Title&KeyWordSearchType=And&kq=true&bc=IAAAABAAQAAA&. Accessed July 1, 2024.

Christiansen MP, Klaff LJ, Bailey TS, et al. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study. Diabetes Technol & Ther. 2019;21:231-237.

Christiansen MP, Klaff LJ, Brazg R, et al. A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II. Diabetes Technol & Ther. 2018;20:197-206.

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.

Deiss D, Irace C, Carlson G, et al. Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. Diabetes Technol Ther. 2020;22(1):48-52.

Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS). CMS Ruling No.: [CMS-1738-F, CMS 1687-F, CMS 5531-F] Date: December 28, 2021. Available at: Federal Register: Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas. Accessed July 1, 2024.

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.

Fonseca VA, Grunberger G, Anhalt H, et al. Continuous Glucose Monitoring: A Consensus Conference of the American Association of Clinical Endocrinologists and American College of Endocrinology. Endocr Pract. 2016;22(8):1008-1021.

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. 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):573-586.

Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology-Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan-2015-Executive Summary. Endocr Pract. 2015;21(4):413-437.

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.

Kropff J, Choudhary P, Neupane S, et al. Accuracy and longevity of an implantable continuous glucose sensor in the PRECISE study: a 180-day, prospective, multicenter, pivotal trial. Diabetes Care. 2017;40:63-68.

Laffel LM, Kanapka LG, Beck RW, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020;323(23):2388-2396.

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]. 08/17//2022. Available at: https://www.nice.org.uk/guidance/ng17?unlid=382286372016220232952. Accessed July 1, 2024.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD) for Glucose Monitors L33822. Original Effective: 10/01/2015. Revised Effective 04/01/2024. Available at: LCD - Glucose Monitors (L33822) (cms.gov). Accessed July 1, 2024.

Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA) for Glucose Monitors A52464. Original Effective: 10/01/2015. Revised Effective 04/01/2024. Available at: Article - Glucose Monitor - Policy Article (A52464) (cms.gov). Accessed July 1, 2024.

Novitas Solutions, Inc. Local Coverage Determination (LCD) for Implantable Continuous Glucose Monitors (I-CGM) L38617. Original Effective: 10/11/2020. Revised Effective 08/11/2024. Available at: LCD - Implantable Continuous Glucose Monitors (I-CGM) (L38617) (cms.gov). Accessed July1, 2024.

Novitas Solutions, Inc. Local Coverage Article (LCA) Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) A58110. Original Effective: 10/11/2020. Revised Effective: 08/11/2024. Available at: Article - Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) (A58110) (cms.gov). Accessed July 1, 2024.

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.

Riddlesworth T, Price D, Cohen N, et al. Hypoglycemic event frequency and the effect of continuous glucose monitoring in adults with type 1 diabetes using multiple daily insulin injections. Diabetes Ther. 2017;8(4):947-951.

Samson SL, Vellanki P, Blonde L et al. American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm-2023 Update. Endocrine Practice. 2023;29:305-340. Available at: American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm - 2023 Update (endocrinepractice.org). Accessed July 1, 2024.

Sanchez P, Ghosh-Dastidar S, Tweden K, Kaufman F. Real-world data from the first US commercial users of an implantable continuous glucose sensor. Diabetes Technol Ther. 2019;21:677-668.

Sato J, Kanazawa A, Ikeda F, et al. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. 2016;44(1):109-121.

Secher AL, Ringholm L, Andersen HU, et al. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013;36(7):1877-1883.

Tweden KS, Deiss D, Rastogi R, et al. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles. Diabetes Technol Ther. 2020;22(5);422-427.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Dexcom G6 Glucose Program Continuous Glucose Monitoring System. 510(k) summary. [FDA Web site]. 10/26/18. Available at: 510(k) Premarket Notification (fda.gov). Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Dexcom G7 Continuous Glucose Monitoring (CGM) System. 510(k) summary. [FDA Web site]. 12/07/22. Available at: K213919.pdf (fda.gov). Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. FreeStyle Libre 14 Day Flash Glucose Monitoring System. [FDA Web site]. 07/23/2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160030S017a.pdf. Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. FreeStyle Libre 2 Flash Glucose Monitoring System. 510(k) summary. [FDA Web site]. 06/12/2020. Available at: K193371 (fda.gov). Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. FreeStyle Libre 3 Glucose Monitoring System. 510(k) summary. [FDA Web site]. 05/26/2022. Available at: 510(k) Premarket Notification (fda.gov). Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). Premarket approval supplement letter (PMA) for the Eversense Continuous Glucose Monitoring System. [FDA Web site]. 6/06/2019. Available at: https://www.accessd ata.fda.gov/cdrh_docs/pdf16/P160048S006a.pdf. Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). Premarket approval supplement letter (PMA) for the Eversense ® E3 Continuous Glucose Monitoring System. [FDA Web site]. 02/10/2022. Available at: P160048/S016 (fda.gov). Accessed July 1, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). Premarket approval letter (PMA) for the Guardian Connect System. [FDA Web site]. 03/08/2018. Available at: Premarket Approval (PMA) (fda.gov). Accessed July 1, 2024.

US Food and Drug Administration (FDA). Medical Devices. The Artificial Pancreas Device System. FDA's Efforts to Advance Artificial Pancreas Device Systems. Last updated 08/30/2018. Available at: https://www.fda.gov/medicaldevices/produc tsandmedicalprocedures/homehealthandconsumer/consumerproducts/artificialpancreas/default.htm. Accessed July 1, 2024.

van Beers CA, DeVries JH, Kleijer SJ, et al. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016;4(11):893-902.

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.

Voormolen DN, Devries JH, Evers IM, et al. The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. Obstet Gynecol Surv. 2013;68(11):753-763.

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.

Wei Q, Sun Z, Yang Y, et al. Effect of a CGMS and SMBG on maternal and neonatal outcomes in gestational diabetes mellitus: a randomized controlled trial. Sci Rep. 2016;6:19920.

Wright EE, Jr., Kerr MSD, Reyes IJ, et al. Use of Flash Continuous Glucose Monitoring is Associated With A1C Reduction in People with Type 2 Diabetes Treated with Basal Insulin or Noninsulin Therapy. Diabetes Spectr. 2021;32(2);184-189.

Yeoh E, Choudhary P, Nwokolo M, et al. Interventions that restore awareness of hypoglycemia in adults with type 1 diabetes: a systematic review and meta-analysis. Diabetes Care. 2015;38(8):1592-1609.

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.

Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

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

95249, 95250, 95251

THE FOLLOWING PROCEDURE CODES ARE USED TO REPRESENT INSERTION/REMOVAL OF IMPLANTABLE CONTINUOUS GLUCOSE MONITORING SYSTEMS (I-CGMs) (e.g. Eversense®):

0446T, 0447T, 0448T

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

FOR SHORT-TERM INTERSTITIAL CGMS AND HOME BLOOD GLUCOSE MONITORS AND SUPPLIES, REPORT THE MOST APPROPRIATE DIAGNOSIS CODE IN SUPPORT OF MEDICALLY NECESSARY CRITERIA AS LISTED IN THE POLICY.

LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM IS MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT A.

IMPLANTABLE CONTINOUS GLUCOSE MONITORS (I-CGM) ARE MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT B.

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT NON-IMPLANTED CONTINUOUS GLUCOSE MONITORING SYSTEMS AND SUPPLIES:

A4238 Supply allowance for adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service

A4239 Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service

E2102 Adjunctive, non-implanted continuous glucose monitor or receiver

E2103 Non-adjunctive, non-implanted continuous glucose monitor or receiver

THE FOLLOWING CODE IS USED TO REPRESENT HOME BLOOD GLUCOSE MONITOR:

E0607 Home blood glucose monitor

E2104 Home blood glucose monitor for use with integrated lancing/blood sample testing cartridge

THE FOLLOWING CODES ARE USED TO REPRESENT HOME BLOOD GLUCOSE MONITORS WITH SPECIAL FEATURES:

E2100 Blood glucose monitor with integrated voice synthesizer

E2101 Blood glucose monitor with integrated lancing/blood sample

THE FOLLOWING CODES ARE USED TO REPRESENT SUPPLIES FOR HOME BLOOD GLUCOSE MONITORS

A4233 Replacement battery, alkaline (other than J cell), for use with medically necessary home blood glucose monitor owned by patient, each

A4234 Replacement battery, alkaline, J cell, for use with medically necessary home blood glucose monitor owned by patient, each

A4235 Replacement battery, lithium, for use with medically necessary home blood glucose monitor owned by patient, each

A4236 Replacement battery, silver oxide, for use with medically necessary home blood glucose monitor owned by patient, each

A4253 Blood glucose test or reagent strips for home blood glucose monitor, per 50 strips

A4255 Platforms for home blood glucose monitor, 50 per box

A4256 Normal, low, and high calibrator solution/chips

A4258 Spring-powered device for lancet, each

A4259 Lancets, per box of 100

A4271 Integrated lancing and blood sample testing cartridges for home blood glucose monitor, per 50 tests

NOT MEDICALLY NECESSARY

A4257 Replacement lens shield cartridge for use with laser skin piercing device, each

E0620 Skin piercing device for collection of capillary blood, laser, each

NOT COVERED

A9275 Home glucose disposable monitor, includes test strips

A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment interstitial continuous glucose monitoring system, one unit = 1 day supply

A9277 Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring system

A9278 Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring system

THE FOLLOWING CODE IS USED TO REPRESENT GUARDIAN™ CONNECT CONTINUOUS GLUCOSE MONITORING SYSTEM

A9279 Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified

THE FOLLOWING CODES ARE USED TO REPRESENT INSERTION/REMOVAL OF IMPLANTABLE CONTINUOUS GLUCOSE MONITORING SYSTEMS

G0564 Creation of subcutaneous pocket with insertion of 365 day implantable interstitial glucose sensor, including system activation and patient training

G0565 Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new 365 day implantable sensor, including system activation

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA00.002q:

01/01/2025

This policy has been identified for the HCPCS code update, effective 01/01/2025.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS codes have been added this policy:

G0564 Creation of subcutaneous pocket with insertion of 365 day implantable interstitial glucose sensor, including system activation and patient training

G0565 Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new 365 day implantable sensor, including system activation

Revisions From MA00.002p:

10/01/2024

This policy has been identified for the HCPCS and ICD-10 code update, effective 10/01/2024.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following ICD codes have been added to Attachment A and B of this policy:
E10.A0 Type 1 diabetes mellitus, presymptomatic, unspecified
E10.A1 Type 1 diabetes mellitus, presymptomatic, Stage 1
E10.A2 Type 1 diabetes mellitus, presymptomatic, Stage 2

The following HCPCS code narrative has been revised in this policy:
Changed From:
A4271 Integrated lancing and blood sample testing cartridges for home blood glucose monitor, per month

Changed To:
Integrated lancing and blood sample testing cartridges for home blood glucose monitor, per 50 tests

Revisions From MA00.002o:

08/11/2024

This version of this policy was published on 09/09/2024 with a retro-effective date of 08/11/2024.

This policy has been updated to revise criteria for the implantable long-term interstitial continuous glucose monitoring system (CGMS) in accordance with Novitas' local coverage determination regarding implantable continuous glucose monitors (I-CGM) as follows:

Revised the requirement for multiple (three or more) daily administrations of insulin or utilization of a continuous subcutaneous insulin infusion pump.
Added criteria for individuals with non-insulin treated diabetes and problematic hypoglycemia.
Added criteria for continued use of a long-term interstitial CGMS (implantable)

Revisions From MA00.002n:

04/01/2024

This version of this policy was published on 07/01/2024 with a reto-effective date of 04/01/2024 in accordance with Noridian's local coverage determination (L33822) and local coverage article (A52464): Glucose Monitors.

The following HCPCS codes were added to this policy:

E2104 Home blood glucose monitor for use with integrated lancing/blood sample testing cartridge

A4271 Integrated lancing and blood sample testing cartridges for home blood glucose monitor, per month

Revisions From MA00.002m:

03/25/2024

This version of this policy will become effective on 03/25/2024.

This policy has been updated to revise criteria for supplies and equipment for long-term CGMS from once monthly to up to a maximum of three units of service per 90 days.

In addition, the policy statement for remote glucose monitors (e.g., mySentry™) was deleted. This device has been discontinued.

Revisions From MA00.002l:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
11/01/2023	This version of this policy will become effective on 11/01/2023. This policy has been updated to revise criteria for Short-Term Interstitial Continuous Glucose Monitors to include individuals with gestational diabetes.

Revisions From MA00.002k:

04/16/2023

This version of the policy was published on 04/21/2023 with a retro-effective date of 04/16/2023.

This policy has been updated to revise criteria for Long-Term Interstitial Continuous Glucose Monitors (non-implantable) in accordance with Noridian's local coverage determination (L33822) and policy article (A52464): Glucose Monitors.

Revised the requirement for multiple (three or more) daily administrations of insulin or utilizes a continuous subcutaneous insulin infusion pump to insulin treated.
Added criteria for individuals with non-insulin treated diabetes and problematic hypoglycemia.
Revised the initial and continued coverage criteria to include a telehealth visit.
Added documentation requirements related to problematic hypoglycemia and level 2 and 3 hypoglycemic events.

A criteria section specific to Implantable Continuous Glucose Monitor Systems

(I-CGM) was added in accordance with Novitas local coverage determination (L38617).

In addition, the following attachment was added to this policy in accordance with Novitas local coverage determination (L38617) and policy article (A58110): Implantable Continuous Glucose Monitors (I-CGM): 

Attachment D: Implantable Continuous Glucose Monitors (I-CGM).

Attachment B of this policy was revised to address ICD-10 codes for non-implantable CGM systems in accordance with ​Noridian's local coverage determination (L33822) and policy article (A55426): Glucose Monitors:​​​​

Attachment B: ICD10: Long-Term Interstitial CGMS (Non-Implantable)​​​

Revisions From MA00.002j:

01/01/2023

This policy has been identified for the HCPCS code update, effective 01/01/2023.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS codes have been termed and removed from this policy:

G0308 Creation of subcutaneous pocket with insertion of 180 day implantable interstitial glucose sensor, including system activation and patient training

G0309 Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new 180 day implantable sensor, including system activation

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

The following HCPCS codes have been added this policy:

A4239 Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

E2103 Non-adjunctive, non-implanted continuous glucose monitor or receiver

The following HCPS codes have been revised in this policy:

A4238 Supply allowance for adjunctive, non-implanted continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment interstitial continuous glucose monitoring system, one unit = 1 day supply

A9277 Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring system

A9278 Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring system

E2102 Adjunctive, non-implanted continuous glucose monitor or receiver

Revisions From MA00.002i:

12/05/2022

This version of the policy will become effective 12/05/2022.

The Title of this policy has been changed to Continuous Glucose Monitors and Home Blood Glucose Monitors and Supplies.

This policy has been updated to revise criteria for Long-Term Interstitial Continuous Glucose Monitors in accordance with the Centers for Medicare & Medicaid Services (CMS) final rule (CMS-1738-F/CMS1687-F/CMS-5531-F) Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) published in the federal register on December 28, 2021, that addressed the classification and payment of adjunctive continuous glucose monitors (CGMS) under the Medicare Part B benefit for DME and Noridian's local coverage determination (L33822) and policy article (A55426) : Glucose Monitors.

Policy criteria was added for the following:

implantable therapeutic glucose CGMS (e.g., Eversense® E3).
a non-coverage statement for Long-Term Interstitial CGMS that solely displays glucose results on a smartphone and do not utilize a durable stand-alone receiver or does not integrate with a durable insulin infusion pump

In addition, Medicare Advantage policy #MA05.015e Home Blood Glucose Monitors and Supplies coverage criteria was incorporated into this policy.

Billing requirements were added to this policy regarding the following:

therapeutic (non-adjunctive) and non-therapeutic (adjunctive) CGM devices
CGMS integrated with an external ambulatory insulin infusion pump
home blood glucose monitoring items are not eligible for separate reimbursement consideration when reported with K0553

The following CPT codes were added to the policy as Medically Necessary:

0446T
0447T
0448T

The following HCPCS codes were added to this policy as Medically Necessary:

A4238 Supply allowance for adjunctive continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

E2102 Adjunctive continuous glucose monitor or receiver

The following HCPCS code was added to this policy as Not Covered to represent the stand-alone adjunctive GUARDIAN™ CONNECT CONTINUOUS GLUCOSE MONITORING SYSTEM:

A9279 Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified

The following HCPCS codes have been removed from this policy:

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

The following Attachment was added to this policy:
Attachment C ICD10:Home Blood Glucose Monitors and Supplies

Revisions From MA00.002h:

07/18/2021

This version of the policy was published on 09/10/2021 with a retro-effective date of 07/18/2021.

This policy has been updated to revise criteria for therapeutic (non-adjunctive) long-term interstitial continuous glucose monitors in accordance with Noridian's local coverage determination (L33822) and policy article (A55426): Glucose Monitors:

removed the requirement of blood glucose testing four or more times a day
revised injections of insulin to administrations of insulin to accommodate for inhaled insulin
added requirements for the initial provision and continued use of a long-term interstitial CGMS.

Revisions From MA00.002g:

06/02/2021

This policy has been reissued in accordance with the Company's annual review process.

10/26/2020

This version of the policy will become effective 10/26/2020.

The Company’s coverage position has changed from Medically Necessary to Experimental/Investigational for short-term interstitial continuous glucose monitoring use in gestational diabetes; therefore, the following criteria for short-term interstitial continuous glucose monitoring were deleted from this policy:

The individual is pregnant and develops gestational diabetes, defined as any degree of glucose intolerance with onset or first recognition during pregnancy, which requires insulin therapy.

The following criteria have been revised for SHORT-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS):

The individual is on an intensive insulin regimen, requiring three or more insulin injections per day, or utilizes an insulin pump.

In addition, coverage was added for type 2 diabetes in individuals requiring determination of basal insulin level measurements prior to insulin pump initiation; therefore, the following criteria have been revised for SHORT-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS):

The individual has type 1 or type 2 diabetes and requires determination of basal insulin level measurements prior to insulin pump initiation.

The following criteria have been revised in accordance with Medicare for THERAPEUTIC (NON-ADJUNCTIVE) LONG-TERM INTERSTITIAL CGMS:

The individual has insulin-dependent diabetes mellitus requiring multiple (three or more) daily injections of insulin or a continuous subcutaneous insulin infusion pump.

The following ICD-10 codes have been deleted from Attachment A of this policy:

O24.414 Gestational diabetes mellitus in pregnancy, insulin controlled
O24.419 Gestational diabetes mellitus in pregnancy, unspecified control
O24.424 Gestational diabetes mellitus in childbirth, insulin controlled
O24.429 Gestational diabetes mellitus in childbirth, unspecified control
O24.434 Gestational diabetes mellitus in the puerperium, insulin controlled
O24.439 Gestational diabetes mellitus in the puerperium, unspecified control

Revisions From MA00.002f:

04/25/2018	The policy has been reviewed and reissued to communicate the Company’s continuing position on Interstitial Continuous Glucose Monitoring Systems (CGMSs) and Artificial Pancreas Device Systems (APDS).
01/01/2018	This version of the policy will become effective 01/01/2018. The following CPT code has been added to this policy: 95249 The following CPT codes have been revised, in this policy: 95250, 95251

Revisions From MA00.002e:

11/03/2017

This policy has been updated to include the Medicare Coding for the therapeutic non-adjunctive continuous glucose monitors (CGM) and supplies.

The following codes were added to the policy

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

The Following codes were removed from the policy

THE FOLLOWING CODE IS USED TO REPRESENT THE THERAPEUTIC LONG-TERM INTERSTITIAL CGMS (RECEIVER/MONITOR):

E1399 Durable medical equipment, miscellaneous

THE FOLLOWING CODE IS USED TO REPRESENT THERAPEUTIC LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM SUPPLIES (e.g., SENSORS AND TRANSMITTERS):

A9999 Miscellaneous DME supply or accessory, not otherwise specified

Codes removed from Attachment A

E08.00 E08.01 E08.10 E08.11 E08.21 E08.22 E08.29 E08.311 E08.319 E08.3211 E08.3212 E08.3213 E08.3219 E08.3291 E08.3292 E08.3293 E08.3299 E08.3311 E08.3312 E08.3313 E08.3319 E08.3391 E08.3392 E08.3393 E08.3399 E08.3411 E08.3412 E08.3413 E08.3419 E08.3491 E08.3492 E08.3493 E08.3499 E08.3511 E08.3512 E08.3513 E08.3519 E08.3521 E08.3522 E08.3523 E08.3529 E08.3531 E08.3532 E08.3533 E08.3539 E08.3541 E08.3542 E08.3543 E08.3549 E08.3551 E08.3552 E08.3553 E08.3559 E08.3591 E08.3592 E08.3593 E08.3599 E08.36 E08.37X1 E08.37X2 E08.37X3 E08.37X9 E08.39 E08.40 E08.41 E08.42 E08.43 E08.44 E08.49 E08.51 E08.52 E08.59 E08.610 E08.618 E08.620 E08.621 E08.622 E08.628 E08.630 E08.638 E08.641 E08.649 E08.65 E08.69 E08.8 E08.9

E13.00 E13.01 E13.10 E13.11 E13.21 E13.22 E13.29 E13.311 E13.319 E13.3211 E13.3212 E13.3213 E13.3219 E13.3291 E13.3292 E13.3293 E13.3299 E13.3311 E13.3312 E13.3313 E13.3319 E13.3391 E13.3392 E13.3393 E13.3399 E13.3411 E13.3412 E13.3413 E13.3419 E13.3491 E13.3492 E13.3493 E13.3499 E13.3511 E13.3512 E13.3513 E13.3519 E13.3521 E13.3522 E13.3523 E13.3529 E13.3531 E13.3532 E13.3533 E13.3539 E13.3541 E13.3542 E13.3543 E13.3549 E13.3551 E13.3552 E13.3553 E13.3559 E13.3591 E13.3592 E13.3593 E13.3599 E13.36 E13.37X1 E13.37X2 E13.37X3 E13.37X9 E13.39 E13.40 E13.41 E13.42 E13.43 E13.44 E13.49 E13.51 E13.52 E13.59 E13.610 E13.618 E13.620 E13.621 E13.622 E13.628 E13.630 E13.638 E13.641 E13.649 E13.65 E13.69 E13.8 E13.9

O24.311 O24.312 O24.313 O24.319 O24.33 O24.811 O24.812 O24.813 O24.819 O24.83 O24.911 O24.912 O24.913 O24.919 O24.93 O99.810 O99.815

Codes Added Attachment A

O24.02 Pre-existing type 1 diabetes mellitus, in childbirth

O24.12 Pre-existing type 2 diabetes mellitus, in childbirth

O24.424 Gestational diabetes mellitus in childbirth, insulin controlled

O24.429 Gestational diabetes mellitus in childbirth, unspecified control

Codes Added to Attachment B

E09.00 E09.01 E09.10 E09.11 E09.21 E09.22 E09.29 E09.311 E09.319 E09.3211 E09.3212 E09.3213 E09.3219 E09.3291 E09.3292 E09.3293 E09.3299 E09.3311 E09.3312 E09.3313 E09.3319 E09.3391 E09.3392 E09.3393 E09.3399 E09.3411 E09.3412 E09.3413 E09.3419 E09.3491 E09.3492 E09.3493 E09.3499 E09.3511 E09.3512 E09.3513 E09.3519 E09.3521 E09.3522 E09.3523 E09.3529 E09.3531 E09.3532 E09.3533 E09.3539 E09.3541 E09.3542 E09.3543 E09.3549 E09.3551 E09.3552 E09.3553 E09.3559 E09.3591 E09.3592 E09.3593 E09.3599 E09.36 E09.37X1 E09.37X2 E09.37X3 E09.37X9 E09.39 E09.40 E09.41 E09.42 E09.43 E09.44 E09.49 E09.51 E09.52 E09.59 E09.610 E09.618 E09.620 E09.621 E09.622 E09.628 E09.630 E09.638 E09.641 E09.649 E09.65 E09.69 E09.8 E09.9 O24.02 O24.12 O24.32 O24.82 O24.92

Revisions From MA00.002d:

10/01/2017

This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 CM codes have been added to this policy: In Attachments A and B

E11.10 Type 2 diabetes mellitus with ketoacidosis without coma

E11.11 Type 2 diabetes mellitus with ketoacidosis with coma

Revisions From MA00.002c:

01/12/2017

This policy has been updated to include the Medicare Coding and Coverage position for the therapeutic continuous glucose monitors (CGM).

Revisions From MA00.002b:

10/01/2016

This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.

The following ICD-10 CM codes have been revised in this policy:

FROM: O24.011 Pre-existing diabetes mellitus, type 1, in pregnancy, first trimester
TO: O24.011 Pre-existing type 1 diabetes mellitus, in pregnancy, first trimester

FROM: O24.012 Pre-existing diabetes mellitus, type 1, in pregnancy, second trimester
TO: O24.012 Pre-existing type 1 diabetes mellitus, in pregnancy, second trimester

FROM; 24.013 Pre-existing diabetes mellitus, type 1, in pregnancy, third trimester
TO; O24.013 Pre-existing type 1 diabetes mellitus, in pregnancy, third trimester

TO; O24.019 Pre-existing diabetes mellitus, type 1, in pregnancy, unspecified trimester
FROM; O24.019 Pre-existing type 1 diabetes mellitus, in pregnancy, unspecified trimester

FROM; O24.03 Pre-existing diabetes mellitus, type 1, in the puerperium
TO; O24.03 Pre-existing type 1 diabetes mellitus, in the puerperium

FROM; O24.111 Pre-existing diabetes mellitus, type 2, in pregnancy, first trimester
TO; O24.111 Pre-existing type 2 diabetes mellitus, in pregnancy, first trimester

FROM; O24.112 Pre-existing diabetes mellitus, type 2, in pregnancy, second trimester
TO; O24.112 Pre-existing type 2 diabetes mellitus, in pregnancy, second trimester

FROM; O24.113 Pre-existing diabetes mellitus, type 2, in pregnancy, third trimester
TO; O24.113 Pre-existing type 2 diabetes mellitus, in pregnancy, third trimester

FROM; O24.119 Pre-existing diabetes mellitus, type 2, in pregnancy, unspecified trimester
TO; O24.119 Pre-existing type 2 diabetes mellitus, in pregnancy, unspecified trimester

FROM: O24.13 Pre-existing diabetes mellitus, type 2, in the puerperium
TO: O24.13 Pre-existing type 2 diabetes mellitus, in the puerperium

The following ICD-10 CM codes have been deleted from this policy:

E08.321, E08.329, E08.331, E08.339, E08.341, E08.349, E08.351, E08.359, E10.321, E10.329, E10.331 E10.339, E10.341, E10.349 E10.351, E10.359, E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E11.359, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351, E13.359

The following ICD-10 CM codes have been added to this policy:

E08.3211, E08.3212, E08.3213, E08.3219, E08.3291, E08.3292, E08.3293, E08.3299, E08.3311, E08.3312, E08.3313, E08.3319, E08.3391, E08.3392, E08.3393, E08.3399, E08.3411, E08.3412, E08.3413, E08.3419, E08.3491, E08.3492, E08.3493, E08.3499, E08.3511, E08.3512, E08.3513 E08.3519, E08.3521, E08.3522, E08.3523, E08.3529, E08.3531, E08.3532, E08.3533, E08.3539 E08.3541, E08.3542, E08.3543, E08.3549, E08.3551, E08.3552, E08.3553, E08.3559, E08.3591, E08.3592, E08.3593, E08.3599, E08.37X1, E08.37X2, E08.37X3, E08.37X9, E10.3211, E10.3212, E10.3213, E10.3219, E10.3291, E10.3292, E10.3293, E10.3299, E10.3311, E10.3312, E10.3313, E10.3319, E10.3391, E10.3392, E10.3393, E10.3399, E10.3411, E10.3412, E10.3413, E10.3419, E10.3491, E10.3492, E10.3493, E10.3499, E10.3511, E10.3512, E10.3513, E10.3519, E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541, E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E10.3591, E10.3592, E10.3593, E10.3599, E10.37X1 E10.37X2, E10.37X3, E10.37X9, E11.3211, E11.3212, E11.3213, E11.3219, E11.3291, E11.3292, E11.3293, E11.3299, E11.3311, E11.3312, E11.3313, E11.3319, E11.3391, E11.3392, E11.3393, E11.3399, E11.3411, E11.3412, E11.3413, E11.3419, E11.3491, E11.3492, E11.3493, E11.3499, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531 E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E11.3591, E11.3592, E11.3593, E11.3599, E11.37X1, E11.37X2, E11.37X3, E11.37X9, E13.3211, E13.3212, E13.3213, E13.3219, E13.3291, E13.3292, E13.3293, E13.3299, E13.3311, E13.3312, E13.3313, 13.3319, E13.3391, E13.3392, E13.3393, E13.3399, E13.3411, E13.3412, E13.3413, E13.3419, E13.3491, E13.3492, E13.3493, E13.3499, E13.3511, E13.3512, E13.3513, E13.3519, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531, E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552, E13.3553, E13.3559, E13.3591, E13.3592, E13.3593, E13.3599, E13.37X1, E13.37X2, E13.37X3, E13.37X9, O24.415, O24.425, O24.435.

Revisions From MA00.002a:

05/11/2016

The policy has been reviewed and reissued to communicate the Company’s continuing position on Interstitial Continuous Glucose Monitoring Systems (CGMSs) and Artificial Pancreas Device Systems (APDS).

02/11/2015

The following requirements have been added to this policy:

ARTIFICIAL PANCREAS DEVICE SYSTEMS

Artificial pancreas device systems (i.e. the Threshold Suspend Device System, Control to Range [CTR] and Control to Target [CTT], does not meet Medicare's definition of durable medical equipment (DME) because they contain components that are not covered by Medicare. Therefore, the artificial pancreas device systems are considered not covered.

The following policy statement has been deleted from this policy:

ARTIFICIAL PANCREAS DEVICE SYSTEM

The artificial pancreas device system is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

The Description has been updated.
The following ICD-9 codes has been removed:

Revisions From MA00.002:

01/01/2015

This is a new policy.

Version Effective Date:

1/1/2025

Version Issued Date:

12/31/2024

Version Reissued Date: