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Continuous Glucose Monitors and Home Blood Glucose Monitors and Supplies
MA00.002k

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 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.

Long-Term Interstitial CGMS (Non-Implantable)

A Food and Drug Administration (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 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 less than 54mg/dL (3.0mmol/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 less than 54mg/dL (3.0mmol/L) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia (e.g., assistance from another person) ​
  • Within six (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 six (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, once monthly 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 one 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 FDA-approved implantable ​continuous glucose monitor ​(I-CGM) (e.g., Eversense® E3 ​) 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 insulin-dependent diabetes mellitus requiring multiple (three or more) daily administrations of insulin or ​utilizes a continuous subcutaneous insulin infusion pump.​ 
  • 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 I-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.​​​​
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 meet Medicare's definition of durable medical equipment 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 non-medical items. Therefore, smart devices are 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.​

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 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 six 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 six 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 durable medical equipment (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, Inc.)
  • One Touch® products (Life scan Inc)
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
A4239

​                   E0607, E2100, E2101, A4233,
                   A4234, A4235, A4236, A4253,
                   A4255, A4256, A4258, A4259​

​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 <54mg/dL (3.0mmol/L)); or
  • Classification of the hypoglycemic episode(s) as level 2 event(s); or
  • A copy of the individual's BGM testing log into the medical record reflecting the specific qualifying events (glucose <54mg/dL (3.0mmol/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 two event.
For a history of at least one level 3 hypoglycemic event:
  • ​The glucose value for the qualifying event (glucose <54mg/dL (3.0mmol/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 <54mg/dL (3.0mmol/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 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.


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 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 code 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 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), 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 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.​​

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.
​
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.

The FreeStyle® Libre 2 Flash Glucose Monitoring System (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 Eversense®​ Continuous Glucose Monitoring System is an implantable device which is placed in the subcutaneous skin layer and provides continuous glucose measurements over a 40-400 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 (age 18 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 and 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 of Medicare and Medicaid (CMS), these devices meet the requirements of a therapeutic (non-adjunctive) CGM by replacing the need for an adjunctive blood glucose monitor.

Non-Therapeutic (Adjunctive) CGMS

 CGM devices approved by the FDA for use as non-therapeutic ​(adjunctive devices), ​require the individual to verify their glucose levels with finger-stick 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 which also operates as the CGMs receiver component or used as part of the Guardian™ Connect standalone CGM system that displays glucose data solely through a Smartphone application. ​
​
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.

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 which may vary with the device used, inserts it into the device to obtain a reading.​

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 Association of Clinical Endocrinology and American College of Endocrinology. Comprehensive Type 2 Diabetes Management Algorithm. 2020. Available at: https://pro.aace.com/disease-state-resources/diabetes/clinical-practice-guidelines-treatment-algorithms/comprehensive. Accessed March 8, 2023. 

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 March 8, 2023. ​

American Diabetes Association. Standards of Medical Care in Diabetes. 2022;45(Suppl 1):S97-S112. Available at: https://diabetesjournals.org/care/article/45/Supplement_1/S97/138911/7-Diabetes-Technology-Standards-of-Medical-Care-in. March 8, 2023. ​

American Diabetes Association. Management of diabetes in pregnancy: standards of medical care in diabetes-2022. Diabetes Care. 2022;45 (Supplement 1): S232-S243.

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 March 8, 2023. ​

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, 2022. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available at: CDC 2022 National Diabete​s Statistics Report​. Accessed March 8, 2023. 

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]. 02/16/2023. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed March 8, 2023. 

Centers for Medicare & Medicaid Services (CMS). National Coverage Analysis (NCA) for Home Blood GLUCOSE MONITORs (CAG-00161N). 40.2. Effective date; 6/19/2006. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=35&NCDId=222&ncdver=1&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=IAAAABAAAAAAAA==&. Accessed March 8, 2023.​

​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 March 8, 2023. 

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 March 8, 2023. 

​Christiansen MP, Klaff LJ, Bailey TS, Brazg R, Carlson G, Tweden KS. 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 March 8, 2023.  

​​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. 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).

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]. 06/29/2022. Available at: https://www.nice.org.uk/guidance/ng17?unlid=382286372016220232952. Accessed March 8, 2023. 

Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD) for Glucose Monitors L33822. Original Effective: 10/01/2015. Revised Effective 04/16/2023. Available at: LCD - Glucose Monitors (L33822) (cms.gov).  Accessed March 8, 2023. 

Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA) for Glucose Monitors A52464. Original Effective: 10/01/2015. Revised Effective 04/16/2023. Available at: ​Article - Glucose Monitor - Policy Article (A52464) (cms.gov)​.  Accessed March 8, 2023. 

Novitas Solutions, Inc. Local Coverage Determination (LCD) for Implantable Continuous Glucose Monitors (I-CGM) L38617. Original Effective: 10/11/2020. Revised Effective 04/21/2022. Available at: ​​LCD - Implantable Continuous Glucose Monitors (I-CGM) (L38617) (cms.gov)​. Accessed March 8, 2023.

Novitas Solutions, Inc. Local Coverage Article (LCA) Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) A58110. Original Effective: 10/11/2020. Revised Effective: 01/01/2023. Available at: Article - Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) (A58110) (cms.gov)​. Accessed March 8, 2023. 
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.

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;21:677-68.​
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 March 8, 2023.

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 March 8, 2023. 

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 March 8, 2023. ​

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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)
SHORT-TERM INTERSTITIAL CGMS IS MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT A.

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

HOME BLOOD GLUCOSE MONITORS AND SUPPLIES ARE MEDICALLY NECESSARY WHEN REPORTED WITH ​DIAGNOSIS CODES IN ATTACHMENT C.

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

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


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​

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

A9999 Miscellaneous DME supply or accessory, not otherwise specified
​

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

A9275 Home glucose disposable monitor, includes test strips 


THE FOLLOWING CODES ARE NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT WHEN REPORTED WITH A4239:
 
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

E0607 Home blood glucose monitor

E2100 Blood glucose monitor with integrated voice synthesizer

E2101 Blood glucose monitor with integrated lancing/blood sample​
Revenue Code Number(s)
N/A

Coding and Billing Requirements

Policy History

4/16/2023
4/21/2023
MA00.002
Medical Policy Bulletin
Medicare Advantage
{"4446": {"Id":4446,"MPAttachmentLetter":"A","Title":"ICD10: Short-Term Interstitial CGMS","MPPolicyAttachmentInternalSourceId":7184,"PolicyAttachmentPageName":"2deffc76-b612-4947-9bd9-a29e4a29f8d5"},"4447": {"Id":4447,"MPAttachmentLetter":"B","Title":"ICD10: Long-Term Interstitial CGMS (Non-Implantable)","MPPolicyAttachmentInternalSourceId":7185,"PolicyAttachmentPageName":"6489dd5f-014a-4bdb-8caa-78b41066dca9"},"4448": {"Id":4448,"MPAttachmentLetter":"C","Title":"ICD10: Home Blood Glucose Monitors and Supplies","MPPolicyAttachmentInternalSourceId":7186,"PolicyAttachmentPageName":"45f80977-b75b-44cd-9f4f-36d02b808e85"},"4449": {"Id":4449,"MPAttachmentLetter":"D","Title":"Implantable Continuous Glucose Monitors (I-CGM)","MPPolicyAttachmentInternalSourceId":7306,"PolicyAttachmentPageName":"70b2ddc6-692e-4ca4-ab79-43773961135d"},}
No
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