Improved clinical outcomes†‡5,6,8-13

Reduced resource utilization†‡2-4,7,14,15

Budget-neutrality for a health plan (Commercial/Medicaid)†‡1,16

Lower HbA1c†‡8-13

Increased Time in Range†‡5,13

Reduction in time in hypoglycemia†‡5,6

Reduction in number of hypoglycemic events†‡5,6

66%

reduction in number of diabetes-related hospital admissions†‡§3

[over 12 months (P<0.001)]

61%

reduction in acute diabetes events among patients with T2DM†‡||4

(P<0.001)

Comparative effectiveness

Similar acute diabetes event rates compared to a competitor CGM device†‡¶17

Advantages of pharmacy benefit

  • Utilization management

  • Operational efficiencies

  • Cost savings**††

Female diabetes patient discusses FreeStyle Libre 3 system with female doctor

Time in Range is a new standard of care18,19

  • Every 10% change in Time in Range is associated with 0.8% change in HbA1c19

  • Time in Range complements HbA1c with more actionable information than using HbA1c alone for a wide range of people with diabetes18

smartphone screen showing FreeStyle Libre 3 time in range data

Highlights of clinical guidelines for the use of CGM

Several clinical organizations, including the ADA and AACE, have published guidelines for the use of CGM in the management of diabetes20,21. Highlights from the published guidelines are included below.

View highlights from clinical guidelines

American Diabetes Association (ADA)

The ADA published diabetes treatment guidelines as part of the 2022 Standards of Medical Care in Diabetes20, making the following clinical and access recommendations specific to FreeStyle Libre Personal CGMs:

  • [CGM] should be offered for diabetes management in adults with diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are capable of using devices safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs20
  • [CGM] should be offered for diabetes management in youth with type 1 [or type 2] diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are capable of using the device safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs20
  • [CGM] can be used for diabetes management in adults with diabetes on basal insulin who are capable of using devices safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs20
  • People who have been using continuous glucose monitoring, continuous subcutaneous insulin infusion, and/or automated insulin delivery for diabetes management should have continued access across third-party payers20

American Association of Clinical Endocrinologists (AACE)

The AACE published recommendations in 202121, regarding the use of CGMs in the management of people with diabetes. The following recommendations were highlighed with respect to continuous glucose monitoring:

  • CGMs are strongly recomended for all persons with diabetes treated with intensive insulin therapy, defined as 3 or more injections of insulin per day or the use of an insulin pump21
  • CGMs are recommened for all individuals with problematic hypoglycemia (frequent/severe hypoglycemia, nocturnal hypoglycemia, hypoglycemia unawareness21)

Recommendations from the ADA and AACE on CGM Metrics:

  • Two metrics, %TIR (Time in Range) and %TBR (Time Below Range), should be used as a starting point for the assessment of quality of glycemic control and as the basis for therapy adjustment, with emphasis on reducing %TBR when the percentages of CGM values failing below 54 mg/dL or 70 mg/dL are close to or exceed targets21
  • Time in range (TIR) is associated with the risk of microvascular complications and can be used for assessment of glycemic control. Additionally, time below target and time above target are useful parameters for the evaluation of the treatment regimen22

The role of CGM in reducing costs and complications

NDC & HCPCS Codes

NDC Codes23

  • 57599-0002-00: FreeStyle Libre 14 day reader
  • 57599-0001-01: FreeStyle Libre 14 day sensor
  • 57599-0803-00: FreeStyle Libre 2 reader
  • 57599-0800-00: FreeStyle Libre 2 sensor
  • 57599-0818-00: FreeStyle Libre 3 sensor

HCPCS Codes

For therapeutic CGM, the following codes are applicable24:

  • 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
  • Class II DME (including FreeStyle Libre 2 system) does not utilize a modifier
  • KF modifier applies to Class III DME (including FreeStyle Libre 14 day system)

Please contact us for more information about the FreeStyle Libre 3 system and FreeStyle Libre portfolio.

At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.

Medicare coverage is available for the FreeStyle Libre 2 system if the FreeStyle Libre 2 reader is used to review glucose data on some days every month. Medicare and other third party payor criteria apply.

Abbott provides this information as a courtesy, it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.

The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app. Use of the FreeStyle Libre 3 app requires registration with LibreView.

FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes age 4 and older.

* Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
† Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore the study data is applicable to both products.
‡ Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional real-time glucose alarms. Therefore the study data is applicable to both products.
§ Represents percentage of people experiencing a diabetes-related hospital admission.
|| Represents inpatient events or emergency outpatient events for hypoglycemia, hyperglycemia, diabetic ketoacidosis, or hyperosmolarity.
¶ Compared to Dexcom.
# Given that the coverage criteria of CGM for Medicare, the Veterans Administration, Department of Defense, and Indian Health Services is governed at the federal level through policy decisions, a budget impact analysis was not completed for persons covered by these payers.
** Cost savings results from removal of manual prior authorization (PA) process. Under pharmacy benefit, PAs can either be eliminated or automated via smart PA.
†† Does not apply to Medicare and Medicaid.

References: 1. FreeStyle Libre 2 AMCP Dossier  2. Charleer S, et al. Diabetes Care (2020): https://doi.org/10.2337/dc19-1610 3. Fokkert, M. BMJ Open Diabetes Res Care (2019): https://doi.org/10.1136/bmjdrc-2019-000809 4. Bergenstal, R. J Endocr Soc (2021): https://doi.org/10.1210/jendso/bvab013 5. Bolinder, J. The Lancet (2016): https://doi.org/10.1016/s0140-6736(16)31535-5 6. Haak, T. Diabetes Ther (2017): https://doi.org/10.1007/s13300-016-0223-6 7. Miller E, et al. AJMC (2021): https://doi.org/10.37765/ajmc.2021.88780 8. Tyndall, V. Diabetologia (2019): https://doi.org/10.1007/s00125-019-4894-1 9. Evans M, et al. Diabetes Therapy (2022): https://doi.org/10.1007/s13300-022-01253-9 10. Wright, E. Diabetes Spectr (2021): https://doi.org/10.2337/ds20-0069 11. Kroger, J. Diabetes Ther (2020): https://doi.org/10.1007/s13300-019-00741-9 12. Carlson AL, et al. BMJ Open Diabetes Res Care (2022): https://doi.org/10.1136/bmjdrc-2021-002590 13. Campbell, F. Pediatr Diabetes (2018): https://doi.org/10.1111/pedi.12735 14. Kerr M, et al. Poster presented at the ATTD Conference, Madrid, Spain, February 19-22, 2020. https://doi.org/10.1089/dia.2020.2525.abstracts 15. Deshmukh, H. Diabetes Care (2020): https://doi.org/10.2337/dc20-0738 16. Frank, JR. Diabetes Technol Ther (2021): https://doi.org/10.1089/dia.2021.0263 17. Miller E, et al. Am J Med Open (2022): https://doi.org/10.1016/j.ajmo.2022.100008 18. Battelino, T. Diabetes Care (2019): https://doi.org/10.2337/dci19-0028 19. Vigersky, RA. Diabetes Technol Ther (2019): https://doi.org/10.1089/dia.2018.0310 20. ADA Standards of Medical Care in Diabetes. Diabetes Care (2022): https://doi.org/10.2337/dc22-S007 21. Grunberger G, et al. Endocr Pract (2021): https://doi.org/10.1016/j.eprac.2021.04.008 22. ADA Standards of Medical Care in Diabetes. Diabetes Care (2022): https://doi.org/10.2337/dc22-S006 23. First DataBank, June 2022. 24. Centers for Medicare & Medicaid Services. CMS Local Coverage Article A52464. Revision Effective July 18, 2021. Accessed February 02, 2022. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52464

ADC-52428 v2.0 06/22