Pharmacy Prior Authorization Criteria

Continuous Glucose Monitors, Sensors, and Transmitters - PA, NF

Indications for Prior Authorization

Criteria

Dexcom Products*, Freestyle Libre Products*

*If patient meets criteria above, please approve all CGM components at NDC list “PREFCGMPA”

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• ALL of the following:
• Diagnosis of diabetes mellitus
AND
• Patient is adherent to current diabetes treatment plan and participates in ongoing diabetes education and support
AND
• ONE of the following:
• Patient is being treated with insulin
OR
• Patient has a history of problematic hypoglycemia with at least one of the following:
• 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
• Patient has 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

Dexcom Products*, Freestyle Libre Products*

*If patient meets criteria above, please approve all CGM components at NDC list “PREFCGMPA”

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• ONE of the following:
• Patient demonstrates positive clinical response as evidenced by ONE of the following:
• Improvement in glycemic control (e.g., lower and/or maintain A1C levels)
• Reduction or improvement in hypoglycemic events
OR
• Patient is being assessed by the prescriber for adherence to their CGM regimen and diabetes treatment plan

All Other Continuous Glucose Monitors, Sensors, and Transmitters*

*If patient meets criteria above, please approve all CGM components at GPI list “CGMPA”

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• ALL of the following:
• Diagnosis of diabetes mellitus
AND
• Patient is adherent to current diabetes treatment plan and participates in ongoing diabetes education and support
AND
• ONE of the following:
• Patient is being treated with insulin
OR
• Patient has a history of problematic hypoglycemia with at least one of the following:
• 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
• Patient has 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
AND
• Both of the following:
• Minimum 90 day trial within the last 180 days, to both of the following:
• Dexcom Products
• Freestyle Products
AND
• Valid clinical rationale provided, explaining how the requested device is the only product that will provide benefit when the Dexcom and Freestyle products have not shown to be effective

All Other Continuous Glucose Monitors, Sensors, and Transmitters*

*If patient meets criteria above, please approve all CGM components at GPI list “CGMPA”

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• ONE of the following:
• Patient demonstrates positive clinical response as evidenced by ONE of the following:
• Improvement in glycemic control (e.g., lower and/or maintain A1C levels)
• Reduction or improvement in hypoglycemic events
OR
• Patient is being assessed by the prescriber for adherence to their CGM regimen and diabetes treatment plan
AND
• Minimum 90 day trial to both of the following:
• Dexcom Products
• Freestyle Products

Continuous Glucose Monitors, Sensors, and Transmitters*

*If patient meets criteria above, please approve all CGM components at GPI list “CGMPA”

Non Formulary

Length of Approval: 12 Month(s)

• ALL of the following:
• Diagnosis of diabetes mellitus
AND
• Patient is adherent to current diabetes treatment plan and participates in ongoing diabetes education and support
AND
• ONE of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming patient is being treated with insulin
OR
• Submission of medical records (e.g., chart notes) confirming patient has a history of problematic hypoglycemia with at least one of the following:
• 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
• Patient has 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
AND
• Both of the following (Applies to all products except Dexcom):
• Submission of medical records (e.g., chart notes) or paid claims confirming minimum 90 day trial within the last 180 days, to Dexcom products
AND
• Submission of medical records (e.g., chart notes) providing valid clinical rationale explaining how the requested device is the only product that will provide benefit when Dexcom products have not shown to be effective

P & T Revisions

2024-06-25, 2024-06-11, 2024-01-16, 2023-12-18, 2023-12-14, 2023-11-06, 2023-10-16, 2023-08-27, 2023-07-05, 2023-06-23, 2023-04-21, 2023-01-21, 2022-09-16, 2022-09-12, 2022-04-14, 2021-09-10, 2021-07-20

References

1. CMS. Provider compliance tips for glucose monitors & diabetic accessories/supplies. CMS Website. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33822. Accessed March 21, 2023.
2. American Diabetes Association. Diabetes Care. Available at Volume 45 Issue Supplement_1 Diabetes Care | American Diabetes Association (diabetesjournals.org). Available at https://diabetesjournals.org/care/issue/45/Supplement_1. Accessed April 12, 2022.
3. BigFoot Unity PDF. Available at: https://f.hubspotusercontent40.net/hubfs/5085144/PDFs/Bigfoot%20Unity%E2%84%A2%20System%20User%20Guide.pdf. Accessed May 23, 2023.

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Revision History

• 2024-06-25: 2024 Annual Review
• 2024-06-11: update guideline
• 2024-01-16: update guideline.
• 2023-12-18: update product list
• 2023-12-14: update guideline
• 2023-11-06: update guideline
• 2023-10-16: No criteria changes. Attached EHB formulary to guideline.
• 2023-08-27: update guideline
• 2023-07-05: 2023 Annual Review
• 2023-06-23: update guideline
• 2023-04-21: Update Guideline
• 2023-01-21: update guideline
• 2022-09-16: update guideline
• 2022-09-12: guideline update
• 2022-04-14: Update guideline
• 2021-09-10: added GPIs for target products
• 2021-07-20: New program.

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