Continuous Glucose Monitors (CGMS)

Continuous Glucose Monitoring Systems

Policy ID: I-9001-003

Section: Durable Medical Equipment

Effective Date: January 01, 2020

Revised Date: July 13, 2020

Revision Effective Date:August 01, 2020

Last Reviewed: July 22, 2020

Description

Continuous Glucose Monitoring (CGM) Systems (also known as Real-Time or interstitial) monitor, measure, and record glucose levels in interstitial fluid and produce data that show trends in glucose measurements. CGM systems consist of a sensor, transmitter and receiver. The sensor sends the information to a small monitor that stores the data. These devices are used episodically or continuously to monitor direct changes in glycemic management. Currently, CGM system sensors can be used 3-90 days before replacement, depending on purpose and manufacturer.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

A CGM system may be considered medically necessary when ONE of the following criteria are met:

Individual has type 1 diabetes and is receiving short- or rapid-acting insulin therapy or
Individual has type 2 diabetes and is receiving short- or rapid- acting insulin therapy or
Individual has gestational diabetes or is pregnant and a CGM is recommended by the provider or
Individual has an insulin pump

All other uses for CGM systems are considered experimental/investigational and therefore, non-covered because their safety and/or effectiveness cannot be established by the review of the published peer-reviewed literature.

Procedure Codes

0446T	0447T	0448T	95249	95250	95251	A9276
A9277	A9278	K0553	K0554	S1034	S1035	S1036
S1037

Non-invasive CGM

Non-invasive CGM and related supplies are considered experimental/investigational, and therefore, non-covered. Despite the fact that these devices have received FDA approval, there is a lack of long-term studies demonstrating that the use of these devices is associated with an improvement in final health outcomes, i.e., improved diabetic control based either on decreasing hemoglobin A1c values and/or decreasing incidence of hypoglycemia.

Procedure Codes

S1030

S1031

Remote CGM

A remote interstitial CGM (e.g., mySentry™) is considered investigational and therefore, non-covered. Remote interstitial CGM does not provide new or additional clinical information or data that is substantially different from the base CGM.

Procedure Codes

A9999

NOTE: Upgrade to or replacement of an existing CGM is considered not medically necessary when requested for convenience or simply to upgrade to a newer technology, when the current components remain functional, or when the current components remain under warranty. Replacement is not covered due to loss, negligence or improper use.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes Billed with Z79.4 for Procedure Codes: 0446T, 0447T, 0448T, 95249, 95250, 95251, A9276, A9277, A9278, K0553, K0554, S1034, S1035, S1036, S1037

E10.10	E10.11	E10.21	E10.22	E10.29	E10.311	E10.319
E10.3211	E10.3212	E10.3213	E10.3291	E10.3292	E10.3293	E10.3311
E10.3312	E10.3313	E10.3391	E10.3392	E10.3393	E10.3411	E10.3412
E10.3413	E10.3419	E10.3491	E10.3492	E10.3493	E10.3511	E10.3512
E10.3513	E10.3521	E10.3522	E10.3523	E10.3529	E10.3531	E10.3532
E10.3533	E10.3541	E10.3542	E10.3543	E10.3551	E10.3552	E10.3553
E10.3591	E10.3592	E10.3593	E10.36	E10.37X1	E10.37X2	E10.37X3
E10.39	E10.40	E10.41	E10.42	E10.43	E10.44	E10.49
E10.51	E10.52	E10.59	E10.610	E10.618	E10.620	E10.621
E10.622	E10.628	E10.630	E10.638	E10.641	E10.649	E10.65
E10.69	E10.8	E10.9	E11.00	E11.01	E11.10	E11.11
E11.21	E11.22	E11.29	E11.311	E11.319	E11.3211	E11.3212
E11.3213	E11.3291	E11.3292	E11.3293	E11.3311	E11.3312	E11.3313
E11.3391	E11.3392	E11.3393	E11.3411	E11.3412	E11.3413	E11.3491
E11.3492	E11.3493	E11.3511	E11.3512	E11.3513	E11.3521	E11.3522
E11.3523	E11.3531	E11.3532	E11.3533	E11.3541	E11.3542	E11.3543
E11.3551	E11.3552	E11.3553	E11.3591	E11.3592	E11.3593	E11.36
E11.37X1	E11.37X2	E11.37X3	E11.39	E11.40	E11.41	E11.42
E11.43	E11.44	E11.49	E11.51	E11.52	E11.59	E11.610
E11.618	E11.620	E11.621	E11.622	E11.628	E11.630	E11.638
E11.641	E11.649	E11.65	E11.69	E11.8	E11.9	E13.00
E13.01	E13.10	E13.11	E13.21	E13.22	E13.29	E13.311
E13.319	E13.3211	E13.3212	E13.3213	E13.3291	E13.3292	E13.3293
E13.3311	E13.3312	E13.3313	E13.3391	E13.3392	E13.3393	E13.3411
E13.3412	E13.3413	E13.3491	E13.3492	E13.3493	E13.3511	E13.3512
E13.3513	E13.3591	E13.3592	E13.3593	E13.36	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	O24.011	O24.012	O24.013	O24.019	O24.02	O24.03
O24.111	O24.112	O24.113	O24.119	O24.12	O24.13	O24.311
O24.312	O24.313	O24.319	O24.32	O24.33	O24.414	O24.419
O24.424	O24.429	O24.434	O24.439	O24.811	O24.812	O24.813
O24.819	O24.82	O24.83	O24.911	O24.912	O24.913	O24.919
O24.92	O24.93	Z79.4

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Updated policy to mirror pharmacy CGM policy effective 1-1-2020

Internal Medical Policy Committee 3-16-2020 removed invalid diagnosis codes

Internal Medical Policy Committee 7-22-2020 removed Eversense CGM experimental/investigational statement, updated description, added additional diagnosis codes: E11.10, E11.11, E11.8 and E11.9 and added "Billed with Z79.4" to covered diagnosis codes section

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

Section: Durable Medical Equipment

Effective Date: January 01, 2020

Revised Date: December 18, 2019

Archived Date: August 05, 2020

Description

Continuous glucose monitoring systems (CGMS) are devices that automatically measure glucose levels throughout the day. These readings help detect any patterns or trends with an individual’s glucose levels and are intended to assist in calculating the insulin dosage needed to manage glycemic control. CGMS use sensors that are inserted under the skin which measure and record the glucose level and then convert these measurements into equivalent blood glucose readings.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

A continuous glucose monitor (CGM) may be considered medically necessary when ONE of the following criteria are met:

Individual has type 1 diabetes and is receiving short- or rapid-acting insulin therapy; or
Individual has type 2 diabetes and is receiving short- or rapid- acting insulin therapy; or
Individual has gestational diabetes or is pregnant and a CGM is recommended by the provider; or
Individual has an insulin pump

All other uses are considered experimental/investigational and therefore, non-covered because their safety and/or effectiveness cannot be established by the review of the published peer-reviewed literature.

Procedure Codes

0446T	0447T	0448T	95249	95250	95251	A9276
A9277	A9278	K0553	K0554	S1034	S1035	S1036
S1037

Non-invasive CGM

Procedure Codes

S1030

S1031

Remote CGM

Procedure Codes

A9999

Note: Eversense® CGM system is considered investigational and therefore, non-covered. The safety of the device cannot be established by published peer-reviewed literature.

Note: Upgrade to or replacement of an existing CGM is considered not medically necessary when requested for convenience or simply to upgrade to a newer technology, when the current components remain functional, or when the current components remain under warranty. Replacement is not covered due to loss, negligence or improper use.

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 0446T, 0447T, 0448T, 95249, 95250, 95251, A9276, A9277, A9278, K0553, K0554, S1034, S1035, S1036 and S1037

E10.10	E10.11	E10.21	E10.22	E10.29	E10.311	E10.319
E10.3211	E10.3212	E10.3213	E10.3291	E10.3292	E10.3293	E10.3311
E10.3312	E10.3313	E10.3391	E10.3392	E10.3393	E10.3411	E10.3412
E10.3413	E10.3419	E10.3491	E10.3492	E10.3493	E10.3511	E10.3512
E10.3513	E10.3521	E10.3522	E10.3523	E10.3529	E10.3531	E10.3532
E10.3533	E10.3541	E10.3542	E10.3543	E10.3551	E10.3552	E10.3553
E10.3591	E10.3592	E10.3593	E10.36	E10.37X1	E10.37X2	E10.37X3
E10.39	E10.40	E10.41	E10.42	E10.43	E10.44	E10.49
E10.51	E10.52	E10.59	E10.610	E10.618	E10.620	E10.621
E10.622	E10.628	E10.630	E10.638	E10.641	E10.649	E10.65
E10.69	E10.8	E10.9	E11.00	E11.01	E11.21	E11.22
E11.29	E11.311	E11.319	E11.3211	E11.3212	E11.3213	E11.3291
E11.3292	E11.3293	E11.3311	E11.3312	E11.3313	E11.3391	E11.3392
E11.3393	E11.3411	E11.3412	E11.3413	E11.3491	E11.3492	E11.3493
E11.3511	E11.3512	E11.3513	E11.3521	E11.3522	E11.3523	E11.3531
E11.3532	E11.3533	E11.3541	E11.3542	E11.3543	E11.3551	E11.3552
E11.3553	E11.3591	E11.3592	E11.3593	E11.36	E11.37X1	E11.37X2
E11.37X3	E11.39	E11.40	E11.41	E11.42	E11.43	E11.44
E11.49	E11.51	E11.52	E11.59	E11.610	E11.618	E11.620
E11.621	E11.622	E11.628	E11.630	E11.638	E11.641	E11.649
E11.65	E11.69	E13.00	E13.01	E13.10	E13.11	E13.21
E13.22	E13.29	E13.311	E13.319	E13.321	E13.3211	E13.3212
E13.3213	E13.329	E13.3291	E13.3292	E13.3293	E13.331	E13.3311
E13.3312	E13.3313	E13.339	E13.3391	E13.3392	E13.3393	E13.341
E13.3411	E13.3412	E13.3413	E13.349	E13.3491	E13.9492	E13.3493
E13.351	E13.3511	E13.3512	E13.3513	E13.359	E13.3591	E13.3592
E13.3593	E13.36	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	O24.011	O24.012
O24.013	O24.019	O24.02	O24.03	O24.111	O24.112	O24.113
O24.119	O24.12	O24.13	O24.311	O24.312	O24.313	O24.319
O24.32	O24.33	O24.414	O24.415	O24.419	O24.424	O24.425
O24.429	O24.434	O24.435	O24.439	O24.811	O24.812	O24.813
O24.819	O24.82	O24.83	O24.911	O24.912	O24.913	O24.919
O24.92	O24.93	Z79.4

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Continuous Glucose Monitoring Systems

Description

Criteria

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Links