Continuous Glucose Monitor
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Coverage criteria and utilization guidance for non-implantable and implantable continuous glucose monitors and related supplies for Scripps Health Plan beneficiaries; applies to providers prescribing CGMs and to utilization management reviewers.
No material clinical or coverage changes in this revision.
Coverage criteria for CGMs
Initial Therapy
Covered when ALL of the following are met:
Implantable CGM
Therapeutic I-CGM covered when ALL of the following are met:
Continuation / Supplies
Continued coverage rules
I-CGM devices are implantable Class III medical devices that require FDA premarket approval and an FDA indication that includes therapeutic use. These devices will not be considered reasonable and necessary for short-term (72 hours to 1 week) diagnostic use. This exclusion applies regardless of other clinical factors and reflects the device’s intended role as a longer-term therapeutic monitoring tool rather than a brief diagnostic sensor.
If any of the initial coverage criteria (1)-(5) or the continued coverage criterion are not met, the CGM and related supply allowance will be denied as not reasonable and necessary. When a CGM is covered, the related supply allowance is covered; however, supplies for an adjunctive CGM that are integrated into an external insulin infusion pump are covered only when the beneficiary meets both the CGM coverage criteria and the external insulin infusion pump coverage criteria.
Key thresholds and definitions
What providers must do / watch for
Prior authorization requires meeting all initial coverage criteria
Prior authorization will be approved only when all initial coverage criteria listed in the policy are met, including: (1) diabetes mellitus diagnosis; (2) treating practitioner documents beneficiary (or caregiver) has sufficient training as evidenced by providing a prescription; (3) CGM/I‑CGM is prescribed in accordance with its FDA indication for use; (4) beneficiary meets at least one qualifying clinical criterion (insulin-treated or documented problematic hypoglycemia as defined in policy); and (5) an in‑person or Medicare‑approved telehealth visit within six months prior to ordering to evaluate diabetes control. Switching from a non‑implantable CGM to an implantable CGM also requires a provider order plus fulfillment of all I‑CGM coverage criteria.
- All initial coverage criteria (1)–(5) must be satisfied for prior authorization.
- I‑CGM switch allowed with provider order but only if all I‑CGM criteria are fulfilled.
Required documentation to support coverage
Document in the medical record the beneficiary’s diabetes mellitus diagnosis, that the treating practitioner has determined the beneficiary (or caregiver) has sufficient training using the prescribed CGM/I‑CGM (evidenced by providing a prescription), and that the device is prescribed in accordance with its FDA indication for use. For hypoglycemia-based indications, include documentation of recurrent level 2 events (glucose <54 mg/dL) despite multiple attempts to adjust therapy, or a level 3 event requiring third‑party assistance.
- Diagnosis of diabetes mellitus.
- Evidence beneficiary (or caregiver) has sufficient training (prescription as evidence).
- Device prescribed per FDA indication (I‑CGM must include therapeutic indication).
- For hypoglycemia: documentation of recurrent level 2 events (glucose <54 mg/dL) despite >1 attempts to adjust meds/plan, or one level 3 event requiring third‑party assistance.
Pre‑order in‑person or telehealth visit required within 6 months
Obtain and document an in‑person or Medicare‑approved telehealth visit with the treating practitioner within six months prior to ordering the CGM to evaluate diabetes control and confirm that the initial coverage criteria (1)–(4) are met.
- Visit must occur within six (6) months before the CGM order.
Supplies integrated with external insulin pumps require both device criteria
When supplies are for an adjunctive CGM integrated into an external insulin infusion pump, ensure the beneficiary meets both the CGM coverage criteria and the coverage criteria for the external insulin infusion pump; document satisfaction of both sets of criteria to support coverage of supplies.
- Supplies covered only if both CGM and external insulin infusion pump criteria are met.
Denial will follow if initial or continued criteria are not met
Deny coverage will be issued if any of the initial coverage criteria (1)–(5) or the continued coverage criterion are not met; absence of required documentation, missing pre‑order visit within six months, or failure to meet FDA indication/training requirements are grounds for denial of the CGM and related supplies.
- Failure to meet any initial criteria (1)–(5) results in denial of CGM and related supply allowance.
- Failure to meet continued coverage rules (including supplies requirements) results in denial.
Background on continuous glucose monitors
Continuous glucose monitors (CGMs) measure interstitial glucose continuously and are used to monitor glucose trends and levels over time. A non-adjunctive CGM (where FDA indication permits) may be used to make treatment decisions without confirmatory fingerstick testing, while an adjunctive CGM requires verification with a blood glucose meter before making treatment changes. Implantable CGMs (I-CGMs) are Class III devices requiring FDA premarket approval and, when approved for therapeutic use, can replace fingerstick measurements for diabetes treatment decisions. Coverage determinations require documentation of diabetes diagnosis, evidence of sufficient training, adherence to the device’s FDA indication, and meeting the applicable clinical criteria for insulin treatment or problematic hypoglycemia.
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