HB 459: An Important Step Toward Reforming Step-Therapy Protocols
By Jeff Scott, Esq. FMA General Counsel | Updated May 5, 2022


For decades, the FMA has sought legislative reforms for a long list of abusive practices engaged in by the healthcare insurance industry. High on this list are reforms to the “fail-first” protocols – insurance companies prefer the term “step therapy” protocols – that insurers impose, requiring patients to first try and fail certain drugs and therapies before qualifying for coverage of other treatments. These protocols are especially problematic for patients who change health plans and are required to disrupt their current treatment to retry previously failed therapeutic regimens to meet the “step-therapy” requirements of their new plans.

For years, the FMA has supported legislation to reform the fail-first process by:

  • Requiring health insurers to post on their websites the procedure for requesting a fail-first protocol exception.
  • Provide certainty to patients and physicians by requiring health insurers to deny or approve fail-first protocol exceptions within 24 hours for urgent situations and within three business days for nonurgent situations.
  • Prevent health insurers from denying a fail-first protocol exception request if: (1) the drug or treatment will likely cause an adverse reaction or physical/mental harm to the patient, (2) the protocol is expected to be ineffective, (3) the patient has already tried and failed the same or a similar drug, or (4) there is a chance the drug/treatment will create a barrier to the adherence of a treatment plan, worsen another condition, or decrease a patient’s ability to perform daily activities.
  • Encourage health insurers to make clinically sound decisions by requiring a written explanation and the clinical rationale behind any denial of a fail-first protocol exception request.

During the 2021 Legislative Session, the FMA supported fail-first legislation that was held in committee and did not receive a hearing. This year, longtime FMA champion Sen. Gayle Harrell teamed up with Rep. Matt Wilhite to introduce a milder version of last year’s bill with the hope that limited reforms would be more palatable to the committee chairs who decide the bill’s fate.

The strategy worked. HB 459 passed both chambers and was signed into law by Gov. Ron DeSantis on April 6, 2022. This bill, which will go into effect on July 1, 2022, will require the following:
  • Health insurers will have to publish on their websites and provide to an insured in writing a procedure for the insured and his or her healthcare provider to request a fail-first protocol exemption or an appeal of the health insurer’s denial of a protocol exemption request.
  • The procedure provided must include the way in which the insured or healthcare provider may request the exemption (and a form for making the request).
  • The procedure provided must also include the manner and timeframe in which the health insurer authorizes or denies the request, and the manner and timeframe in which the insured or the healthcare 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.

This bill represents an excellent first step forward in correcting the problems with the current fail-first system. The FMA hopes to capitalize on this momentum and will seek further reforms in 2023. FMA members who have any questions about this bill can contact the General Counsel’s office at (850) 224-6496 or jscott@flmedical.org.