Step‑therapy protocol requirements and protocol exemptions (HB 459)
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Amendments to Florida law governing when health insurers and HMOs may require step‑therapy protocols, definitions of key terms, and required procedures for publishing exemption request and appeal processes; applies to health insurers and HMOs issuing major medical or similar coverage in Florida.
Revises circumstances under which step-therapy protocols may not be required and adds required procedures for protocol exemption requests and appeals, including website publication and written procedures.
Defines 'protocol exemption' and 'step-therapy protocol' and requires insurers and HMOs to publish procedures on their websites and provide them in writing to insureds/subscribers.
Requires that denials of protocol exemption requests include a written explanation, clinical rationale, and appeal procedure; authorizations must specify the approved drug/procedure/treatment.
Permits insurers and HMOs to request relevant medical records to support a protocol exemption request.
Step-Therapy Exemption Criteria
Step-therapy exemption criteria and procedures
Covered when ALL of the following criteria and procedural requirements are met:
Coding and Prior Coverage Details
| No codes listed |
Request, Documentation, and Decision Requirements
Publish and provide procedure for protocol exemption requests and appeals
Insurers and HMOs must publish on their website and provide in writing a procedure for insureds/subscribers and their health care providers to request a protocol exemption and to appeal denials; the procedure must, at minimum, state how to request the exemption (including a form) and the manner and timeframe for the insurer/HMO to authorize or deny and for the insured/provider to appeal, and these actions must occur within a reasonable time.
- Must be published on website and provided in writing to insured/subscriber
- Must describe the manner to request a protocol exemption, including a form
- Must specify timelines for authorization/denial and for appeals; actions must occur within a reasonable time
Insurer/HMO may request medical records to support exemption requests
An insurer or HMO may request relevant medical records to support a protocol exemption request.
- Requests may be made to support review of the protocol exemption request
Content required in authorizations and denials of protocol exemptions
Authorizations of protocol exemption requests must specify the approved prescription drug, medical procedure, or course of treatment. Denials of protocol exemption requests must include a written explanation of the reason for the denial, the clinical rationale that supports the denial, and the procedure for appealing the denial.
- Authorization: must specify the approved drug, procedure, or course of treatment
- Denial: must include written explanation, clinical rationale, and appeal procedure
Key Definitions
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