Continuous Glucose Monitoring Form

Page 1 of 9

Medical Policy Number: 1.01.VT20

Continuous Glucose Monitoring Corporate Medical Policy

File Name: Continuous Glucose Monitoring
File Code: 1.01.VT20 Origination: 01/2005
Last Review: 04/2024 Next Review: Policy Archived Effective Date: Policy Archived Effective 07/01/2024

Description/Summary Tight glucose control in patients with diabetes has been associated with improved health outcomes. Continuous Glucose Monitoring Systems (CGMS), also known as Continuous Glucose Monitoring (CGM) Devices, allow for automatic measurement of glucose levels in interstitial fluid every few minutes while the device is in use. Many devices are available to measure glucose levels automatically and frequently (e.g., every 5-10 minutes). The devices measure glucose in the interstitial fluid and are approved as adjuncts to or replacements for traditional self-monitoring of blood glucose levels. Devices can be used on a long-term (continuous) or short-term (intermittent) basis. Short-term use is generally conducted over a 72-hour period.

Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I- Code Table & Instructions

See the BCBSVT prior approval list for durable medical equipment (DME) to determine prior approval requirements for CGMS.

When a service may be considered medically necessary

Long-term CGM Device Monitoring of Glucose Levels in Interstitial Fluid:

Long-term CGM device monitoring of glucose levels in interstitial fluid, as a technique of diabetic monitoring, may be considered medically necessary for initial authorization for a 12-month duration when: • Patient has a diagnosis of diabetes mellitus, AND;

Page 2 of 9

Medical Policy Number: 1.01.VT20

• Patient is on multiple daily doses of rapid/short acting insulin, OR; • Patient is on an insulin pump.

Long-term CGM device monitoring of glucose levels in interstitial fluid, as a technique of diabetic monitoring, may be considered medically necessary for reauthorization for an additional 12month period when: • Patient is adherent to their CGM regimen and diabetes treatment plan.

Short-term (Intermittent) CGM Device Monitoring of Glucose Levels in Interstitial Fluid:

Short-term CGM device monitoring of glucose levels in interstitial fluid may be considered medically necessary in patients with type 1 diabetes whose diabetes is poorly controlled, despite current use of best practices (see Policy Guidelines section). Poorly controlled type 1 diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis.

Short-term CGM device monitoring of glucose levels in interstitial fluid may be considered medically necessary in patients with type 1 diabetes prior to insulin pump initiation to determine basal insulin levels.

Short-term CGM device monitoring of glucose levels in interstitial fluid may be considered medically necessary in patients with type 2 diabetes who require multiple daily doses of insulin whose diabetes is poorly controlled, despite current use of best practices (see Policy Guidelines section). Poorly controlled type 2 diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, and persistent hyperglycemia and A1C levels above target.

Short-term CGM device monitoring of glucose levels in interstitial fluid may be considered medically necessary in patients with type 2 diabetes who require multiple daily doses of insulin to determine basal insulin levels prior to insulin pump initiation.

When a service is considered not medically necessary

Any additional software or hardware required for downloading data from blood glucose monitors to computers is not medically necessary.

When a service is considered investigational

Glucose monitors that are not FDA-approved, including but not limited to those using infrared spectroscopy, are considered investigational.

Other uses of long-term and short-term CGM monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring are considered investigational.

Page 3 of 9

Medical Policy Number: 1.01.VT20

Replacement of lost, stolen or destroyed Durable Medical Equipment We will replace one lost, stolen or destroyed Durable Medical Equipment, prosthetic or orthotic per Plan Year if not covered by an alternative entity (including but not limited to homeowners insurance and automobile insurance) if: • the Durable Medical Equipment, prosthetic or orthotic’ s absence would put the member at risk of death, disability or significant negative health consequences such as a hospital admission; • the Durable Medical Equipment is still under warranty.

Note: In order to replace a stolen item, we require you to submit documentation, such as a police report, with the request.

Exclusions We do not cover the replacement of a lost, stolen or destroyed Durable Medical Equipment, prosthetic or orthotic: • if the criteria above have not been met; AND • for more than one lost, stolen or destroyed Durable Medical Equipment, prosthetic or orthotic per Plan Year.

Policy Guidelines

Short-term intermittent monitoring is generally conducted over 72-hour periods. It may be repeated subsequently depending on the patient’s level of diabetes control.

Best practices in diabetes control include compliance with a self-monitoring blood glucose regimen of 4 or more finger sticks each day and use of an insulin pump or multiple daily injections of insulin. During pregnancy, 3 or more insulin injections daily could be considered best practice for patients not on an insulin pump prior to the pregnancy. Prior short-term (72-hour) use of an intermittent glucose monitor would be considered a part of best practices for those considering long-term use of a continuous glucose monitor.

Significant hypoglycemia may include recurrent, unexplained, severe (generally blood glucose levels <50 mg/dL) hypoglycemia or impaired awareness of hypoglycemia that puts the patient or others at risk.

Individuals with type 1 diabetes taking insulin who are pregnant or about to become pregnant with poorly controlled diabetes are another subset of patients to whom the policy statement on intermittent monitoring may apply.

Reference Resources

1. Blue Cross and Blue Shield Association Policy MPRM 1.01.20 – Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid. Last reviewed 08/2023. Accessed 11/2023.
2. Glucose monitoring in the ambulatory management of nonpregnant adults with diabetes mellitus – UpToDate. Literature review current through 10/2023.

Page 4 of 9

Medical Policy Number: 1.01.VT20

Accessed 11/2023. Related Policies External Insulin Pumps Document Precedence

Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The applicable group/individual contract and member certificate language, or employer’s benefit plan if an ASO group, determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, BCBSVT reserves the right to review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract/employer benefit plan language, the member’s contract/employer benefit plan language takes precedence. Audit Information BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, BCBSVT reserves the right to recoup all non- compliant payments. Administrative and Contractual Guidance Benefit Determination Guidance Prior approval may be required and benefits are subject to all terms, limitations and conditions of the subscriber contract.

Incomplete authorization requests may result in a delay of decision pending submission of missing information. To be considered compete, see policy guidelines above.

NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member’s health plan.

Federal Employee Program (FEP): Members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. It is important to verify the member’s benefits prior to providing the service to determine if benefits are available or if there is a specific exclusion in the member’s benefit.

Coverage varies according to the member’s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict.

Page 5 of 9

Medical Policy Number: 1.01.VT20

If the member receives benefits through an Administrative Services Only (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member’s employer benefit plan documents or contact the customer service department. Language in the employer benefit plan documents takes precedence over medical policy when there is a conflict. Policy Implementation/Update information

01/2006 Annual review, CPT codes updated, no other changes. 02/2007 Annual review; clarified language that this policy is specific for 72 hour monitoring provided in an outpatient setting. Reviewed by the CAC 05/2007 01/2008 Annual review. No changes made. To be reviewed by the CAC 03/2008 11/2009 Annual review. Policy revised to adopt the BCBSA Medical Policy in its entirety. Name changed to reflect the expanded scope of policy to address both short-term and long-term use of continuous glucose monitoring. New policy statement added that intermittent (72 hours) glucose monitoring may be considered medically necessary when specific criteria are met; continuous (long-term) monitoring also may be considered medically necessary when specific, but different, criteria are met. 11/2011 Updated and placed in new format. New language on investigational uses of CGMS added. Additional CPT code added for interpretation of physiologic data. New criteria added. Reimbursement language for professional interpretation added. 02/2014 ICD-10 remediated, minor format changes. Prior approval statement revised. RLJ 08/2015 ICD-9 codes removed. Sections headers and standard language updated and clarified. 08/2018 External feedback received. Description Summary updated Added language under medically necessary criteria. Investigational medial criteria updated. Updated eligible provider language. Removed ICD- 10_CM table. Added codes 95250, 95251, K0553, K0554. Revised code descriptors for 95250 & 95251- added 95249. 11/2018 Clarified wording and reviewed references. 03/2019 Updated procedure codes, removed PA requirement for the following: A9276, A9277, A9278, K0553, K0554. 04/2020 Remove A9274-PA required over dollar threshold requirement. 12/2020 Policy reviewed. Aligned with BCBSA MPRM 1.01.20 with updated language for Diabetes Type I and Type II indications. Removed “Continuous glucose monitoring is not medically necessary for intermittent glucose monitoring for periods of less than 72 hours.” 02/2021 Policy statement unchanged. Coding table added codes 0446T, 0447T, & 0448T as medically necessary if medical policy criteria has been met.

Page 6 of 9

Medical Policy Number: 1.01.VT20

12/2021 Updated to align with pharmacy channel policy. Codes A9276, A9277, A9278 will require prior approval. 02/2022 Name changed from “Continuous or Intermittent Glucose Monitoring (CGMS) in Interstitial Fluid” to “Continuous Glucose Monitoring”; references updated. Removed policy statement around implantable CGM devices as investigational. 06/2022 Adaptive Maintenance effective 07/01/2022. Added codes G0308&G0309 added to coding table 07/2022 Added codes A4238 & E2102 will require prior approval. 12/2022 Adaptive Maintenance Effective 01/01/2023: Deleted codes: G0308, G0309, K0553, K0554. Updated Descriptors: A4238, A9276, A9277, A9278, E2102. Added codes 0740T & 0741T as investigational to the coding table. Added codes A4239 & E2103 as requiring prior approval. 12/2023 Policy reviewed. Minor formatting changes. References updated. 04/2024 Policy archived effective 07/01/2024.

Eligible providers Qualified healthcare professionals practicing within the scope of their license(s).

Approved by BCBSVT Medical Directors

Tom Weigel, MD, MBA Vice President and Chief Medical Officer

Tammaji P. Kulkarni, MD Senior Medical Director

Page 7 of 9

Medical Policy Number: 1.01.VT20

Attachment I Code Table & Instructions

Code Type Number Description Policy Instructions The following codes are considered medically necessary when applicable criteria have been met. CPT® 95249 Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; patient- provided equipment, sensor placement, hook-up, calibration of monitor, patient training, and printout of recording CPT® 95250 Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording CPT® 95251 Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; interpretation and report CPT® 0446T Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training CPT® 0447T Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision CPT® 0448T Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation

Page 8 of 9

Medical Policy Number: 1.01.VT20

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

HCPCS

A4239 Supply allowance for nonadjunctive, nonimplanted continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service Prior Approval Required HCPCS A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories HCPCS A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment interstitial continuous glucose monitoring system, one unit = 1 day supply Prior Approval Required HCPCS A9277 Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring system Prior Approval Required HCPCS A9278 Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring system Prior Approval Required HCPCS E2102 Adjunctive, non-implanted continuous glucose monitor or receiver Prior Approval Required HCPCS E2103 Non-adjunctive, non-implanted continuous glucose monitor or receiver Prior Approval Required HCPCS S1030 Continuous noninvasive glucose monitoring device, purchase (for physician interpretation of data, use CPT® code) Prior approval is required for DME with a purchase price over the dollar threshold.

Page 9 of 9

Medical Policy Number: 1.01.VT20

HCPCS S1031 Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT® code) Prior approval is required for DME with a purchase price over the dollar threshold. The following codes will be denied as not medically necessary CPT® 99091 Collection and interpretation of physiologic data (e.g. ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, requiring a minimum of 30 minutes of time. Not medically necessary The following codes will be denied as investigational CPT® 0741T Remote autonomous algorithm- based recommendation system for insulin dose calculation and titration; initial set-up and patient education Investigational CPT® 0741T Remote autonomous algorithm- based recommendation system for insulin dose calculation and titration; initial set-up and patient education; provision of software, data collection, transmission, and storage, each
30 days Investigational