CurrentFlorida BluePolicy N/A

Step Therapy Exemption Request Form Coverage Criteria

Form and instructions for providers and members to request an exemption from a health plan's pharmacy step therapy protocol; affects prescribers, members, and Prime Therapeutics staff processing Florida Blue plan requests.

Policy Summary

PayerFlorida Blue

PolicyStep Therapy Exemption Request Form Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Provider Protocol Exemption Form with supporting documentation; indicate new vs continuation therapy and whether expedited review is requested.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1fax number to submit form

pages 2-3provider completion pages

page 4member completion page

must includesupporting medical documentation (required)

Coverage Criteria

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Step Therapy Exemption Criteria

Exemption may be granted when ANY of the following apply

Clinical criteria: (1) All required formulary alternative(s) have been ineffective in treating the enrollee's condition; OR (2) Based on sound clinical and scientific evidence and the enrollee's characteristics, the alternatives are likely to be ineffective or adversely affect effectiveness or compliance; OR (3) The alternatives have caused, or are likely to cause, an adverse reaction or other harm to the enrollee.

Supporting documentation must be attached for any asserted criterion

Requests must include ALL related medical documentation supporting the exemption request. The form states explicitly that supporting documentation must accompany the request and that requests submitted without the related medical documentation will not be considered valid.

Ensure documentation documents prior trials of the formulary alternative(s), clinical justification that alternatives are likely to be ineffective, or evidence alternatives caused or are likely to cause harm; the prescriber's attestation and signature must also be included on the form.

Provider Actions & Form Submission

Step Therapy

Provider step therapy exemption procedure

Use this form to request an exemption to the plan's step therapy requirement. Step therapy drugs are formulary drugs that are covered only if certain first-line formulary alternatives have already been tried. To process this request, the Provider Protocol Exemption Form (pages 2–3) must be completed by the prescriber and include medical justification explaining why the member should not follow the plan's step-therapy protocol (e.g., prior failures, expected ineffectiveness, or risk of adverse reaction). Expedited requests may be requested when applying the standard review time frame could seriously jeopardize the member's life or health or ability to regain maximum function.

Provider must complete the Provider Protocol Exemption Form (pages 2–3).
Indicate whether this is New Therapy or Continuation of Therapy and whether the request is Expedited.
If expedited is selected, the prescriber certifies standard timeframes may seriously jeopardize the member.

Documentation Required

Required supporting documentation

Provide clinical information and supporting documentation demonstrating prior use of required formulary alternatives or clear medical justification why alternatives are not appropriate. Attach ALL related medical records, chart notes, prior medication history, laboratory or imaging results, and any supporting clinical literature. Requests submitted without the related medical documentation will not be considered valid and may be denied.

List medication name, diagnosis code, dose and frequency.
Describe prior treatments and responses, including dates and specific agents tried.
If no formulary alternative has been tried, check the box and explain why alternatives are unavailable or inappropriate.
Attach copies of medical records and any objective evidence supporting the request.

Documentation Required

Request for Step Therapy Exemption — medical justification & submission

Please provide detailed medical justification in the space provided on the form: explain why the member should be exempt from the step therapy protocol, including specific prior treatment experience, expected harm or adverse reactions, or sound clinical evidence the required alternatives are likely to be ineffective. The prescriber (and patient/guardian where indicated) must attest and sign the form. ALL supporting documentation must accompany the request at time of submission — incomplete submissions will not be accepted.

Complete the Request Information section: Medication name, diagnosis, dose & frequency.
Use the Request for Step Therapy Exemption Criteria box to document clinical rationale; attach additional pages if needed.
Prescriber signature and date required; patient/parent signature where applicable.
Prime Therapeutics/Florida Blue use: follow protocol for step therapy exemptions.

Background

Step therapy requires that specified first‑line formulary alternatives be tried before covering the requested medication. An exemption to step therapy may be granted when any of the following are met: (1) the required formulary alternative(s) have been ineffective for the enrollee's condition; (2) based on sound clinical and scientific evidence and the enrollee's characteristics, the alternatives are likely to be ineffective or to adversely affect effectiveness or adherence; or (3) the alternatives have caused, or are likely to cause an adverse reaction or other harm to the enrollee. Supporting documentation must be attached for any asserted criterion.

To request an exemption, the provider must complete the Provider Protocol Exemption Form (including pages for provider completion) and indicate whether the request is for new therapy or continuation of therapy; the form must be submitted with the required clinical evidence to support the exemption request.

Definitions

Definition — Step therapy

TermStep therapy

DefinitionFormulary drugs that are covered only if certain first-line formulary alternatives have already been tried.

Documentation neededClinical information or other evidence that first-line formulary medications have been tried or are likely to cause adverse effects.

PurposeEnsures a member tries specified first-line alternatives before the requested medication is covered.

Initial Therapy Criteria

Initial Therapy Requests

New therapy requests

New therapy indication: Form must indicate if request is for new therapy and include clinical justification and supporting documentation.

If expedited review is requested, provider must certify that standard time frames may seriously jeopardize the member's life, health, or ability to regain maximum function.

Continuation Therapy Criteria

Continuation Requests

Continuation requests must be indicated on the form.

Continuation of therapy indication: Form must indicate whether request is for continuation of therapy; expedited option may be selected if standard time frames could seriously jeopardize the member's life or health.

Supporting medical documentation must accompany the request.

Step Therapy Form & Submission Table

Action	Details / Instructions	Form pages	Supporting documentation required
Complete and submit the Provider Protocol Exemption Form
Use this form to request an exemption to the plan's step therapy requirement. Provide medical justification describing why the member should not follow the plan's step therapy protocol, including prior treatments tried, reasons formulary alternatives are likely to be ineffective, or risk of adverse reactions. Indicate whether the request is for New Therapy or Continuation of Therapy and whether Expedited Review is requested.
Pages 2-3 (provider completion)
All related medical documentation must accompany the request; requests submitted without required supporting documentation will not be considered valid.