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    v1.0.30
    OpenPayerPolicy UpdatesClinical/Medical PolicyNC Medicaid Therapeutic CGM Prior Auth | OpenPayer
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    CurrentNorth Carolina MedicaidPolicy 5A-3

    NC Medicaid Outpatient Pharmacy Prior Approval Criteria Systems (CGM) and Related Supplies

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    This policy governs North Carolina Medicaid outpatient pharmacy prior approval and coverage criteria for FDA-classified therapeutic continuous glucose monitoring systems and supplies, including special EPSDT considerations for beneficiaries under 21 years of age.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyTherapeutic continuous glucose monitoring systems and related supplies
    Policy CodePolicy 5A-3
    Change TypeMaterial revision
    Effective DateJuly 1, 2020
    Next Review DateNot specified
    Key ActionObtain prior approval for covered therapeutic CGM systems and related supplies.
    SourceLink
    POLICY UPDATE CHANGES

    Coverage for FreeStyle Libre 2 was added for beneficiaries ages 4 and older.

    The policy added Dexcom G7 and FreeStyle Libre 3 products and removed G5 and NC Health Choice language.

    Coverage for gestational diabetes was added.

    The requirements for two or more daily insulin injections and frequent insulin-regimen adjustment based on standard BGM or non-therapeutic CGM testing were removed.

    Coverage was added for beneficiaries with Type 1 diabetes who do not yet require insulin.

    FreeStyle Libre 2 Plus and FreeStyle Libre 3 Plus products were added.

    The policy changed the qualifying diabetes requirement from insulin-dependent diabetes to diabetes that requires insulin.

    The reauthorization period is specified as up to 12 months and requires continued satisfaction of the coverage criteria.

    Y9ATherapeutic class code

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    12 months
    Initial prior approval
    12 monthsReauthorization
    2+ to 18+Minimum coverage age range
    4Qualifying pathways

    Coverage Criteria

    Qualifying Clinical Indications

    Coverage requires at least ONE of the following qualifying clinical circumstances:

    ONE of

    • The beneficiary has a diagnosis of diabetes and requires insulin.
    • The beneficiary has a diagnosis of Type 1 diabetes but does not yet require insulin.
    • The beneficiary uses an external insulin pump.
    • The beneficiary has a diagnosis of gestational diabetes.

    Product-Specific Age Criteria

    The requested therapeutic CGM product must meet the applicable minimum age requirement:

    Requested product and minimum age

    • Dexcom G6; beneficiary is age 2 or older.>= 2 years
    • Dexcom G7 (10-day); beneficiary is age 2 or older.>= 2 years
    • Dexcom G7 (15-day); beneficiary is age 18 or older.>= 18 years
    • FreeStyle Libre; beneficiary is age 18 or older.>= 18 years
    • FreeStyle Libre 2; beneficiary is age 4 or older.

    EPSDT Special Provision

    For beneficiaries under 21, EPSDT requirements apply. Clinical policy limitations may be exceeded or may not apply when the provider documents medical necessity under EPSDT.

    ALL of the following

    • The beneficiary is under 21 years of age and the requested service, product, or procedure is medically necessary health care to correct or ameliorate a defect, physical or mental illness, or health condition identified through a screening examination, including an evaluation by a physician or other licensed clinician.

      Documentation must explain how the requested service corrects, improves, or maintains the beneficiary's health; compensates for a health problem; prevents the condition from worsening; or prevents development of additional health problems.

    • The service is provided in the most economic mode, provided the alternative treatment is similarly efficacious to the service requested by the beneficiary's physician, therapist, or other licensed practitioner.
    • The medical-necessity determination does not delay delivery of the needed service and does not limit the beneficiary's right to free choice of providers.

    Reauthorization

    Reauthorization requires continued satisfaction of the applicable coverage criteria.

    ALL of the following

    • The beneficiary continues to meet the applicable qualifying clinical indication criteria.
    • The requested product continues to meet the applicable product-specific minimum age requirement.
    • The authorization period is up to 12 months.<= 12 months

    Only continuous glucose monitoring (CGM) systems classified by the FDA as therapeutic will be considered for coverage under Outpatient Pharmacy Criteria. Coverage criteria for non-therapeutic CGM systems are addressed under the North Carolina Medicaid Durable Medical Equipment (DME) benefit in Clinical Coverage Policy 5A-3.

    Therapeutic CGMs are FDA-approved as non-adjunctive devices to replace information obtained from standard blood glucose monitors in making diabetes treatment decisions. Additional information is available through the NC Medicaid DME program: https://medicaid.ncdhhs.gov/providers/programs-services/medical/durable-medical-equipment

    EPSDT does not require North Carolina Medicaid to provide a service, product, or procedure that is unsafe, ineffective, or experimental/investigational, or that is not medical in nature or generally recognized as an accepted method of medical practice or treatment.

    Product, Age, and Authorization Details

    Therapeutic class codemixed
    Y9AContinuous Glucose Monitoring Systems and Supplies
    Dexcom G6
    ProductDexcom G6
    Minimum ageAges 2 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    Dexcom G7 10-day
    ProductDexcom G7 (10-day)
    Minimum ageAges 2 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.

    Prior Approval and Documentation Requirements

    Prior Authorization

    Prior Approval Required

    Prior approval is required for covered therapeutic continuous glucose monitoring (CGM) systems and related supplies under the outpatient pharmacy benefit. Beneficiary age under 21 does not eliminate the prior approval requirement.

    Documentation Required

    Authorization Duration and Renewal

    Initial prior authorization and reauthorization may each be approved for up to 12 months when the applicable coverage criteria remain satisfied.

    Documentation Required

    EPSDT Medical-Necessity Documentation

    For beneficiaries under 21, document medical necessity when requesting an exception to policy limitations. Documentation must show that the requested service, product, or procedure will correct or ameliorate a defect, illness, or condition and meet applicable EPSDT criteria.

    Therapeutic Continuous Glucose Monitoring

    A continuous glucose monitoring (CGM) system continuously measures glucose values in interstitial fluid. A typical system includes a glucose sensor, which measures glucose; a transmitter, which communicates the measurements; and a receiver, which receives the information. Therapeutic CGMs are FDA-approved as non-adjunctive devices and may replace information from standard blood glucose monitors when making diabetes treatment decisions.

    Key Definitions

    Continuous glucose monitoring system
    FunctionContinuously measures glucose values in interstitial fluid.
    SensorGlucose sensor
    Other componentsTransmitter and receiver
    Therapeutic CGM
    Regulatory classificationFDA-classified therapeutic continuous glucose monitor
    UseApproved for non-adjunctive use
    Clinical roleMay replace information obtained from standard blood glucose monitors when making diabetes treatment decisions.
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyTherapeutic continuous glucose monitoring systems and related supplies
    Policy CodePolicy 5A-3
    Change TypeMaterial revision
    Effective DateJuly 1, 2020
    Next Review DateNot specified
    Key ActionObtain prior approval for covered therapeutic CGM systems and related supplies.
    SourceLink
    On This Page
    Coverage CriteriaProduct, Age, and Authorization DetailsPrior Approval and Documentation RequirementsTherapeutic Continuous Glucose MonitoringKey Definitions
    >= 4 years
  1. FreeStyle Libre 2 Plus; beneficiary is age 2 or older.>= 2 years
  2. FreeStyle Libre 3; beneficiary is age 4 or older.>= 4 years
  3. FreeStyle Libre 3 Plus; beneficiary is age 2 or older.>= 2 years
    4. Provider documentation supports that the requested service, product, or procedure meets all applicable EPSDT criteria and supports exceeding or not applying the relevant clinical-policy limitation, if applicable.
  4. Any applicable prior approval requirement remains in effect; being under 21 does not eliminate the requirement for prior approval.
    5. Dexcom G7 15-day
    ProductDexcom G7 (15-day)
    Minimum ageAges 18 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    FreeStyle Libre
    ProductFreeStyle Libre
    Minimum ageAges 18 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    FreeStyle Libre 2
    ProductFreeStyle Libre 2
    Minimum ageAges 4 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    FreeStyle Libre 2 Plus
    ProductFreeStyle Libre 2 Plus
    Minimum ageAges 2 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    FreeStyle Libre 3
    ProductFreeStyle Libre 3
    Minimum ageAges 4 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    FreeStyle Libre 3 Plus
    ProductFreeStyle Libre 3 Plus
    Minimum ageAges 2 and older
    Coverage basisCoverage is subject to the listed clinical criteria and product-specific age requirement.
    Initial prior authorization
    Authorization typeInitial prior authorization
    Maximum periodUp to 12 months
    RequirementPrior authorization is required for covered therapeutic CGM systems and related supplies.
    Reauthorization
    Authorization typeReauthorization
    Maximum periodUp to 12 months
    Renewal requirementThe beneficiary must continue to meet the applicable coverage criteria.
    Documentation Required

    Qualifying Clinical Indication

    Document the beneficiary’s qualifying clinical indication for the requested therapeutic CGM.

    • Diagnosis of diabetes requiring insulin
    • Type 1 diabetes before insulin is required
    • Use of an external insulin pump
    • Gestational diabetes
    Documentation Required

    Product-Specific Age Verification

    Verify and document the beneficiary’s age against the minimum age requirement for the requested product.

    • Dexcom G6: age 2 or older
    • Dexcom G7 (10 day): age 2 or older
    • Dexcom G7 (15 day): age 18 or older
    • FreeStyle Libre: age 18 or older
    • FreeStyle Libre 2: age 4 or older
    • FreeStyle Libre 2 Plus: age 2 or older
    • FreeStyle Libre 3: age 4 or older
    • FreeStyle Libre 3 Plus: age 2 or older
    Denial Risk

    Noncovered Product or Unmet Eligibility Criteria

    Identify requests that involve a non-therapeutic CGM or otherwise fail the applicable coverage requirements. Only FDA-classified therapeutic CGM systems are considered under the outpatient pharmacy criteria; non-therapeutic systems are addressed under the DME benefit.

    • Confirm the requested product is therapeutic and FDA-classified for non-adjunctive use.
    • Confirm at least one qualifying clinical indication is documented.
    • Confirm the product-specific minimum age requirement is met.
    Denial Risk

    Beneficiary Eligibility Must Be Confirmed

    Coverage is unavailable when the beneficiary is not enrolled on the date of service or has an eligibility-category service restriction that makes the beneficiary ineligible for this service.

    • Verify enrollment on the date of service.
    • Review eligibility-category restrictions before submitting the request.
    Denial Risk

    EPSDT Safety or Medical-Necessity Exclusion

    EPSDT does not require coverage of a service, product, or procedure that is unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment.

    Denial Risk

    Continued Criteria Required for Reauthorization

    Reauthorization requires documentation that the beneficiary continues to meet the applicable clinical and product criteria. Reauthorizations may be approved for up to 12 months.

    • If continued criteria are not documented, reauthorization may be denied.
    • Confirm the qualifying indication and product-specific age requirement remain applicable.