Responsible Steps Program (step therapy and prior authorization guidance)
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Describes Florida Blue's Responsible Steps Program which lists therapeutic categories, target drugs, and prerequisite (step) therapy requirements that govern prior authorization and coverage for covered members. Affects providers submitting pharmacy authorizations for Florida Blue members enrolled in the program.
No material clinical or coverage changes in this revision.
Coverage Criteria
Program coverage contingent on meeting step therapy/prior-use requirements
Covered when specified prior-use requirements for the therapeutic category are met.
Check member benefit documentation to determine inclusion; certain drugs may be excluded for certain members
Examples: antidepressants require prior use of listed generics (bupropion, citalopram, desvenlafaxine ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline, venlafaxine); some categories require two or more prior generics as specified in the therapeutic category entries
See glucose monitor and phosphate binder entries for exact prior-use requirements
Certain drugs listed in the Responsible Steps Program may be excluded from coverage for some members; check the member's benefit documentation to determine whether the member is included in the program. Newly marketed prescription medications may not be covered until the Pharmacy & Therapeutics Committee reviews them to determine coverage and formulary tier based on safety, efficacy, and availability of other products in the class. If a medication was previously approved by another health plan, step therapy requirements may not apply when documentation of a paid claim from the prior plan is submitted.
Provider Actions and Requirements
Use Authorization Forms and select matching therapeutic category
Providers must submit requests using the Authorization Forms page and select the document that matches the therapeutic category of the drug (for example, select the Antidepressants document for Cymbalta).
Confirm current insulin use for glucose monitor coverage
For glucose monitoring systems (Dexcom G6/G7, FreeStyle Libre series), coverage consideration requires confirmation that the member is a current user of insulin or an insulin combination product.
- Glucose Monitor examples listed: Dexcom G6 and G7 Systems; FreeStyle Libre, FreeStyle Libre 2, FreeStyle Libre 3 (receiver/reader, sensor, transmitter).
- Required documentation: evidence of current use of insulin or insulin combination product.
Document required prior trials of prerequisite/generic agents
Most therapeutic categories define Target Drug(s) and Prerequisite Drug(s); prior use of the specified generic or alternative agents (often one or two generics) must be documented before a target product will be authorized.
- Example (Antidepressants): previous use of a generic version of listed antidepressants (e.g., bupropion, citalopram, desvenlafaxine ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline, venlafaxine) is required; some targets require two or more prior generics.
- Example (Gabapentin ER): previous use of immediate‑release gabapentin is required.
- Example (DPP4 inhibitors / SGLT2 and other diabetes agents): prior use of insulin or metformin may be required as the prerequisite.
Provide prior paid-claim or prior-approval documentation to waive steps
If the medication was previously approved by another health plan, submit documentation of a paid claim from the prior plan to potentially waive the step therapy requirement.
- Include evidence of prior approval or a paid claim from the prior health plan when filing the authorization request.
Risk of denial if prerequisite use is not documented
Failure to document required prior use of the specified generic/prerequisite therapies may result in denial of authorization for the target drug.
- Step therapy requirements may not apply only if documentation of a paid claim by a prior health plan is submitted; absent such documentation, lack of prior trials can trigger denial.
Background
This program organizes medications by therapeutic category and applies step-therapy or prior-use requirements before authorizing specified target drugs. Typical structure groups a Target Drug(s) set and a Prerequisite Drug set; coverage generally requires documentation of prior trials of the listed generic or alternative agents (often one or two generics) for the therapeutic category. Examples include antidepressant categories that require prior use of listed generics and device categories (e.g., glucose monitoring systems) that require documentation of current use of insulin or insulin combination products where specified. Always check member benefit documentation and the program medication guide to confirm which drugs and prerequisite requirements apply.
Definitions
Initial Therapy Criteria
Initial step therapy for CNS/antidepressant agents — prior use of specified generic agents required
Initial coverage requires prior use of specified generic agents.
Some target drugs may require previous use of two or more generic versions (see therapeutic category details)
Step Therapy Details
| Therapeutic category / examples | Prerequisite (prior-use) requirement |
|---|---|
| Central Nervous System (Antidepressants) — e.g., Aplenzin; Cymbalta; Effexor XR; Lexapro; Prozac; Sertraline; Viibryd | |
| Previous use of a generic version of ANY of the following: bupropion, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram (tablets/solution), fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline, venlafaxine (including ER), or vilazodone. Some targets require previous use of two or more generics (e.g., two or more of bupropion, citalopram, desvenlafaxine ER). | |
| Antidepressants (specified targets such as Cymbalta, Drizalma Sprinkle) | |
| Previous use of generic paroxetine, sertraline, venlafaxine or venlafaxine ER, or vilazodone; or previous use of other listed generics as indicated per indication (see antidepressant entries). | |
| Gabapentin ER (Gralise, Horizant) | |
| Previous use of generic immediate‑release gabapentin. | |
| Insomnia agents (e.g., Ambien, Lunesta, Rozerem, Quviviq) | |
| Previous use of a generic non‑benzodiazepine hypnotic such as eszopiclone, zaleplon, or zolpidem IR/ER. | |
| DPP‑4 inhibitors (e.g., Januvia, Onglyza) and combinations | |
| Current or previous use of brand or generic insulin or metformin, alone or in combination. | |
| Glucose monitoring systems (Dexcom G6/G7; FreeStyle Libre series) | |
| Current use of insulin or an insulin combination product is required for glucose monitor coverage consideration. | |
| SGLT2 / Sodium‑Glucose cotransporter agents (e.g., Invokana, Steglatro, Trijardy XR) | |
| Current or previous use of brand or generic insulin or metformin, alone or as part of a combination product. | |
| Phosphate binders / Renal drugs (including ferric citrate) | |
| Previous use of BOTH a non‑targeted generic phosphate binder (e.g., calcium acetate, calcium carbonate, lanthanum carbonate, sevelamer HCl/carbonate) AND ferric citrate 210 mg tablet; for some phosphate binder entries previous use of EITHER a generic iron supplement OR a non‑targeted generic calcium‑containing binder is acceptable per the specific entry. | |
| Topical corticosteroids (grouped by potency: Groups 1–7; examples include betamethasone dipropionate (augmented), clobetasol, desoximetasone, mometasone, hydrocortisone) | |
| Previous use of a topical corticosteroid or topical corticosteroid combination product (examples listed by potency group). Many topical entries require previous use of two or more generic versions of listed agents for the specified potency group. |
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