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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNorth Carolina Medicaid SGLT2 Prior Auth | OpenPay…
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    CurrentNorth Carolina MedicaidPolicy N/A

    Outpatient Pharmacy Prior Approval Criteria: SGLT2 Inhibitors and Combinations

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    This North Carolina Medicaid outpatient pharmacy prior approval policy governs coverage of listed SGLT2 inhibitor and combination products for eligible Medicaid beneficiaries. It establishes initial and continuation coverage criteria for preferred and non-preferred products, including qualifying diagnoses, metformin-related requirements, preferred-product trials, and renewal documentation.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicySGLT2 Inhibitors and Combinations
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateMarch 1, 2024
    Next Review DateN/A
    Key ActionObtain prior approval and document applicable diagnosis, metformin-related criteria, and product-preference requirements.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    10Covered medication products
    2Therapeutic class codes
    21EPSDT age threshold
    2Preferred products required for non-preferred coverage

    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.

    03/01/2024Effective date

    Coverage Criteria

    Initial coverage: preferred and non-preferred products

    Covered for preferred and non-preferred products when the beneficiary meets one of the following qualifying pathways:

    Qualifying diagnosis

    • Heart failure: Beneficiary has a diagnosis of heart failure.

    • Type 2 diabetes pathway

      • Beneficiary has a diagnosis of Type 2 Diabetes.

      • Qualifying condition

        • Beneficiary has tried and failed or had an insufficient response to metformin therapy or another metformin-containing product.
        • Beneficiary has a contraindication or adverse event to metformin.
        • Beneficiary has established ASCVD, heart failure, or chronic kidney disease.
        • Beneficiary is considered high-risk for ASCVD.Age ≥55 years plus ≥2 additional risk factors

          Additional risk factors may include smoking, obesity, hypertension, dyslipidemia, or albuminuria.

    Initial coverage: non-preferred products

    For a non-preferred product, the beneficiary must meet the initial coverage criteria and satisfy one of the following preferred-product requirements:

    Non-preferred product criteria

    • Initial coverage criteria: Beneficiary meets the applicable initial coverage criteria for heart failure or Type 2 Diabetes with a qualifying metformin-related, cardiovascular, renal, or ASCVD-risk condition.

    • Preferred-product requirement

      • Beneficiary has tried and failed or experienced an insufficient response to at least two preferred products.At least 2 preferred products
      • There is a clinical reason that preferred products cannot be tried.

    Continuation of coverage

    Continuation of coverage is available when medical documentation supports one of the following:

    Continuation criteria

    • Improvement and goals met: Beneficiary has improved while taking the medication, and individual clinical goals set by the provider are being met.
    • Adequate progress: Beneficiary continues to make adequate progress toward treatment goals.

    EPSDT special provision

    For a beneficiary under 21 years of age, policy limitations may be exceeded or may not apply when all of the following are met:

    • Beneficiary is under 21 years of age.Under 21 years of age
    • Provider documentation shows that the requested product is medically necessary to correct or ameliorate a defect, physical or mental illness, or condition.
    • Provider documentation shows that the product will correct, improve, or maintain the beneficiary's health; compensate for a health problem; prevent the condition from worsening; or prevent additional health problems.
    • If the product requires prior approval, the prior approval requirement is met.

      Being under 21 does not eliminate the prior approval requirement.

    For beneficiaries under 21 years of age, EPSDT may allow limitations on scope, amount, duration, frequency, location, or other policy-specific criteria to be exceeded or not apply when provider documentation establishes that the requested product is medically necessary to correct or ameliorate an identified defect, physical or mental illness, or condition. EPSDT does not require coverage of a service, product, or procedure that is unsafe, ineffective, experimental, or investigational, is not medical in nature, or is not generally recognized as an accepted method of medical practice or treatment.

    Therapeutic Class and Clinical Coding

    Therapeutic Class Codesmixed
    C4DANTIHYPERGLY,SGLT-2 INH
    C4ESGTL2 INH-BIGUANIDE COMBINATIONS
    High ASCVD Risk
    Age thresholdAt least 55 years of age
    Additional risk factorsAt least 2 additional ASCVD risk factors are required
    Examples of qualifying risk factorsSmoking, obesity, hypertension, dyslipidemia, or albuminuria

    Prior Approval and Documentation Requirements

    Prior Authorization

    Prior Approval Required

    Obtain outpatient pharmacy prior approval when required. The beneficiary’s age, including being under 21, does not eliminate the prior approval requirement; the request must also meet the applicable diagnosis criteria.

    Step Therapy

    Preferred-Product Step Requirement

    Before requesting a covered product, document trial and failure or an insufficient response to at least two preferred products, unless an applicable clinical exception prevents those trials.

    Documentation Required

    Renewal Documentation

    For a renewal request, submit medical documentation that the beneficiary has improved on the medication and that individualized clinical goals are being met or the beneficiary continues to make adequate progress toward treatment goals.

    Key Definitions

    EPSDT
    DefinitionEarly and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a federal Medicaid requirement under 42 U.S.C. § 1396d(r).
    Applicable beneficiariesMedicaid beneficiaries under 21 years of age
    Medical-necessity standardThe requested service, product, or procedure must be medically necessary to correct or ameliorate an identified defect, physical or mental illness, or condition, including improving or maintaining health, compensating for a health problem, or preventing deterioration or additional health problems.
    Prior approvalBeing under 21 does not eliminate a prior approval requirement when the service, product, or procedure requires prior approval.

    Initial Therapy

    Initial therapy

    Initial coverage criteria apply to both preferred and non-preferred products. Coverage is available when the beneficiary meets one of the following pathways:

    Initial qualifying pathway

    • Beneficiary has a diagnosis of heart failure.

    • Type 2 diabetes pathway

      • Beneficiary has a diagnosis of Type 2 Diabetes.

      • Qualifying condition

        • Beneficiary has tried and failed or had an insufficient response to metformin therapy or another metformin-containing product.

    Continuation of Coverage

    Continuation of coverage

    Renewal requests are covered when medical documentation supports one of the following:

    Renewal benefit

    • Beneficiary has improved while taking the medication, and individual clinical goals set by the provider are being met.
    • Beneficiary continues to make adequate progress toward treatment goals.

    Metformin Step Requirement

    StepRequirementException or alternative
    1Before initial coverage, the beneficiary must try metformin therapy or another metformin-containing product and experience treatment failure or an insufficient response.The metformin trial is not required when the beneficiary has a metformin contraindication or adverse event, established ASCVD, heart failure, chronic kidney disease, or high-risk ASCVD (age ≥55 years plus at least two additional risk factors).
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicySGLT2 Inhibitors and Combinations
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateMarch 1, 2024
    Next Review DateN/A
    Key ActionObtain prior approval and document applicable diagnosis, metformin-related criteria, and product-preference requirements.
    SourceLink
    On This Page
    Coverage CriteriaTherapeutic Class and Clinical CodingPrior Approval and Documentation RequirementsKey DefinitionsInitial TherapyContinuation of CoverageMetformin Step Requirement
    Documentation Required

    Initial Request Documentation

    For an initial request, document the qualifying diagnosis and the metformin history or applicable exception. A qualifying diagnosis is heart failure, or Type 2 diabetes with metformin trial and failure or insufficient response, unless a listed metformin exception applies.

    • Document a contraindication or adverse event to metformin; established ASCVD, heart failure, or chronic kidney disease; or high ASCVD risk defined as age 55 or older with at least two additional risk factors.
    • For a non-preferred product, also document the required history of trial and failure or insufficient response to at least two preferred products, or the clinical reason preferred products cannot be tried.
    Billing Rule

    Beneficiary Eligibility

    Confirm that the beneficiary is enrolled in NC Medicaid on the date of service and that the beneficiary’s eligibility category does not impose service restrictions that make the beneficiary ineligible for the service.

    Step Therapy

    Non-Preferred Product Requirements

    For a non-preferred product, document trial and failure or an insufficient response to at least two preferred products. An exception may apply when there is a clinical reason the preferred products cannot be tried.

    Beneficiary has a contraindication or adverse event to metformin.
  1. Beneficiary has established ASCVD, heart failure, or chronic kidney disease.
  2. Beneficiary is considered high-risk for ASCVD.Age ≥55 years plus ≥2 additional risk factors

    Additional risk factors may include smoking, obesity, hypertension, dyslipidemia, or albuminuria.