Fla. Stat. 627.42393
Step-therapy protocol
(1)
As used in this section, the term:“Health coverage plan” means any of the following which is currently or was previously providing major medical or similar comprehensive coverage or benefits to the insured:A health insurer or health maintenance organization.
A plan established or maintained by an individual employer as provided by the Employee Retirement Income Security Act of 1974, Pub. L. No. 93-406.
A multiple-employer welfare arrangement as defined in s. 624.437.
A governmental entity providing a plan of self-insurance.
“Protocol exemption” means a determination by a health insurer to authorize the use of another prescription drug, medical procedure, or course of treatment prescribed or recommended by the treating health care provider for the insured’s condition rather than the one specified by the health insurer’s step-therapy protocol.“Step-therapy protocol” means a written protocol that specifies the order in which certain prescription drugs, medical procedures, or courses of treatment must be used to treat an insured’s condition.(a)
“Health coverage plan” means any of the following which is currently or was previously providing major medical or similar comprehensive coverage or benefits to the insured:A health insurer or health maintenance organization.A plan established or maintained by an individual employer as provided by the Employee Retirement Income Security Act of 1974, Pub. L. No. 93-406.A multiple-employer welfare arrangement as defined in s. 624.437.A governmental entity providing a plan of self-insurance.(b)
“Protocol exemption” means a determination by a health insurer to authorize the use of another prescription drug, medical procedure, or course of treatment prescribed or recommended by the treating health care provider for the insured’s condition rather than the one specified by the health insurer’s step-therapy protocol.(c)
“Step-therapy protocol” means a written protocol that specifies the order in which certain prescription drugs, medical procedures, or courses of treatment must be used to treat an insured’s condition.(2)
In addition to the protocol exemptions granted under subsection (3), a health insurer issuing a major medical individual or group policy may not require a step-therapy protocol under the policy for a covered prescription drug requested by an insured if:The insured has previously been approved to receive the prescription drug through the completion of a step-therapy protocol required by a separate health coverage plan; andThe insured provides documentation originating from the health coverage plan that approved the prescription drug as described in paragraph (a) indicating that the health coverage plan paid for the drug on the insured’s behalf during the 90 days immediately before the request.(a)
The insured has previously been approved to receive the prescription drug through the completion of a step-therapy protocol required by a separate health coverage plan; and(b)
The insured provides documentation originating from the health coverage plan that approved the prescription drug as described in paragraph (a) indicating that the health coverage plan paid for the drug on the insured’s behalf during the 90 days immediately before the request.(3)(a)
A health insurer shall publish on its website and provide to an insured in writing a procedure for the insured and his or her health care provider to request a protocol exemption or an appeal of the health insurer’s denial of a protocol exemption request. The procedure must include, at a minimum:The manner in which the insured or health care provider may request a protocol exemption, including a form to request the protocol exemption.
The manner and timeframe in which the health insurer authorizes or denies a protocol exemption request, which must occur within a reasonable time.
The manner and timeframe in which the insured or health care provider may appeal the health insurer’s denial of a protocol exemption request.
An authorization of a protocol exemption request must specify the approved prescription drug, medical procedure, or course of treatment. A denial of a protocol exemption request must include a written explanation of the reason for the denial, the clinical rationale that supports the denial, and the procedure for appealing the health insurer’s denial.A health insurer may request relevant medical records in support of a protocol exemption request.(3)(a)
A health insurer shall publish on its website and provide to an insured in writing a procedure for the insured and his or her health care provider to request a protocol exemption or an appeal of the health insurer’s denial of a protocol exemption request. The procedure must include, at a minimum:The manner in which the insured or health care provider may request a protocol exemption, including a form to request the protocol exemption.The manner and timeframe in which the health insurer authorizes or denies a protocol exemption request, which must occur within a reasonable time.The manner and timeframe in which the insured or health care provider may appeal the health insurer’s denial of a protocol exemption request.(b)
An authorization of a protocol exemption request must specify the approved prescription drug, medical procedure, or course of treatment. A denial of a protocol exemption request must include a written explanation of the reason for the denial, the clinical rationale that supports the denial, and the procedure for appealing the health insurer’s denial.(c)
A health insurer may request relevant medical records in support of a protocol exemption request.(4)
This section does not require a health insurer to add a drug to its prescription drug formulary or to cover a prescription drug that the insurer does not otherwise cover.(5)
This section applies to a pharmacy benefit manager acting on behalf of a health insurer.
Source:
Section 627.42393 — Step-therapy protocol, https://www.flsenate.gov/Laws/Statutes/2024/0627.42393 (accessed Aug. 7, 2025).