Continuous glucose monitors, sensors and transmitters
Defines medical necessity and prior authorization criteria for coverage of continuous glucose monitors (CGMs), sensors and transmitters for UnitedHealthcare members, including brand-specific guidance and a State of Illinois section; affects prescribers and pharmacy/benefit administrators.
Added MiniMed Instinct to program.
Added Simplera to program and added definitions to hypoglycemia criteria; added section for State of Illinois.
Removed requirement for inadequate glycemic control and added criteria for hypoglycemia.
Added Guardian 4 to criteria and updated diabetes mandate language.
Coverage Criteria for Continuous Glucose Monitors
Initial Therapy (specified brands)
Covered when ALL of the following are met for Guardian Connect/3/4, MiniMed Instinct, Simplera and Simplera Sync:
Document the limitation
Initial Therapy (other CGMs)
Covered when ALL of the following are met for all other continuous glucose monitors:
Reauthorization / Continuation Therapy
Covered when ALL of the following are met for continuation of therapy:
Authorization issued for 12 months; state mandates and member benefit plans may affect coverage
Initial Therapy (State of Illinois)
Illinois: Covered when ALL of the following are met:
Authorization will be issued indefinitely
Coverage is not provided for indications that are unproven per medical benefit drug policy. UnitedHealthcare may also employ program-specific automated approval and re-approval processes that vary by therapeutic class; these processes do not change the exclusion for unproven indications.
There is no separate, explicit list of items designated as "not medically necessary" beyond the policy statement that coverage is not provided for indications unproven per medical benefit drug policy. Additional program-level rules (including automated approvals or supply limits) may apply but do not create a distinct NMN list in this policy.
Coding and Key Clinical Thresholds
| No codes listed |
Provider Actions and Prior Authorization
Prior Authorization Required
Prior authorization required — Initial approvals are issued for 12 months. Reauthorizations require documentation of ongoing need and adherence to the plan of care; supply limits may apply.
- Initial authorizations issued for 12 months
- Reauthorizations require documentation of ongoing need and adherence
- Supply limits may be in place
Coverage Specifics for Certain Brands
Coverage is provided for Guardian Connect, Guardian 3, Guardian 4, MiniMed Instinct, Simplera and Simplera Sync when Dexcom or Freestyle Libre monitors are not appropriate for the patient.
- Applies when Dexcom or Freestyle Libre monitors are unsafe, inaccurate, or not feasible due to physical or mental limitations (e.g., manual dexterity)
- Must document limitation
Provider Documentation Requirements
Provider must document diagnosis of diabetes; that the patient or caregiver received sufficient training in use of the continuous glucose monitor; that the patient is motivated/knowledgeable about CGM use and is adherent to the diabetes treatment plan where required. Provider should also document specific clinical reasons why Dexcom G6/G7 or Freestyle Libre 2/3 series are not appropriate when claiming coverage for Guardian/MiniMed/Simplera products (e.g., history of level 2/3 hypoglycemia, physical or mental limitations).
- Document diagnosis of diabetes
- Document that patient/caregiver received sufficient training
- Document patient is motivated and knowledgeable about CGM use
- Document adherence to diabetic treatment plan when required
- If applicable, document history of level 3 hypoglycemia (glucose <54 mg/dL) or recurrent level 2 hypoglycemia despite treatment adjustments
- If applicable, document specific physical/mental limitations making Dexcom or Freestyle Libre systems unsafe or infeasible
Automated Approval and Re-approval Processes
Use of automated approval and re-approval processes varies by program; UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Coverage is not provided for indications unproven per the medical benefit drug policy.
- Automated approvals may occur based on claims/medication history, diagnosis codes, and claim logic
- Processes vary by program and therapeutic class
- Coverage not provided for unproven indications per medical benefit drug policy
Background
Continuous glucose monitors provide glucose monitoring beyond standard blood glucose meters and are indicated for patients with diabetes who require enhanced glucose surveillance. The policy specifies device- and program-level criteria for coverage, and allows alternative devices when preferred options are unsafe, inaccurate, or not feasible for the individual patient.
Definitions
Revision History and Policy Changes
Added MiniMed Instinct and Simplera to the program; incorporated hypoglycemia definitions and removed the inadequate glycemic control requirement; added a State of Illinois section and updated mandate/state language and device listings.
Added MiniMed Instinct to the program.
Added Simplera to the program and added definitions to hypoglycemia criteria; added section for State of Illinois.
Added Guardian 4 to criteria and updated diabetes mandate language.
Added criteria for all continuous glucose monitors (program-wide criteria update).
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