THE BILL ITSELF
SB 70
Step-therapy Protocols
Florida Senate - 2026 SB 70 By Senator Harrell 31-00305-26 202670__
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A bill to be entitled
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An act relating to step-therapy protocols; amending s.
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409.901, F.S.; defining the term “serious mental
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illness”; amending s. 409.912, F.S.; requiring the
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Agency for Health Care Administration to approve drug
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products for Medicaid recipients for the treatment of
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serious mental illness without step-therapy prior
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authorization under certain circumstances; amending s.
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409.910, F.S.; conforming a cross-reference; directing
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the agency to include rate impacts resulting from the
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act in certain rates that become effective on a
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specified date; providing effective dates.
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Be It Enacted by the Legislature of the State of Florida:
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Section 1. Present subsections (27) and (28) of section
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409.901, Florida Statutes, are redesignated as subsections (28)
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and (29), respectively, and a new subsection (27) is added to
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that section, to read:
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409.901 Definitions; ss. 409.901-409.920.—As used in ss.
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409.901-409.920, except as otherwise specifically provided, the
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term:
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(27) “Serious mental illness” means any of the following
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psychiatric disorders as defined in the Diagnostic and
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Statistical Manual of Mental Disorders, Fifth Edition, published
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by the American Psychiatric Association:
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(a) Bipolar disorders, including hypomanic, manic,
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depressive, and mixed-feature episodes.
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(b) Depression in childhood or adolescence.
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(c) Major depressive disorders, including single and
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recurrent depressive episodes.
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(d) Obsessive-compulsive disorders.
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(e) Paranoid personality disorder or other psychotic
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disorders.
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(f) Schizoaffective disorders, including bipolar or
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depressive symptoms.
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(g) Schizophrenia.
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Section 2. Paragraph (a) of subsection (5) of section
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409.912, Florida Statutes, is amended to read:
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409.912 Cost-effective purchasing of health care.—The
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agency shall purchase goods and services for Medicaid recipients
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in the most cost-effective manner consistent with the delivery
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of quality medical care. To ensure that medical services are
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effectively utilized, the agency may, in any case, require a
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confirmation or second physician’s opinion of the correct
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diagnosis for purposes of authorizing future services under the
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Medicaid program. This section does not restrict access to
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emergency services or poststabilization care services as defined
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in 42 C.F.R. s. 438.114. Such confirmation or second opinion
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shall be rendered in a manner approved by the agency. The agency
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shall maximize the use of prepaid per capita and prepaid
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aggregate fixed-sum basis services when appropriate and other
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alternative service delivery and reimbursement methodologies,
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including competitive bidding pursuant to s. 287.057, designed
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to facilitate the cost-effective purchase of a case-managed
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continuum of care. The agency shall also require providers to
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minimize the exposure of recipients to the need for acute
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inpatient, custodial, and other institutional care and the
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inappropriate or unnecessary use of high-cost services. The
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agency shall contract with a vendor to monitor and evaluate the
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clinical practice patterns of providers in order to identify
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trends that are outside the normal practice patterns of a
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provider’s professional peers or the national guidelines of a
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provider’s professional association. The vendor must be able to
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provide information and counseling to a provider whose practice
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patterns are outside the norms, in consultation with the agency,
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to improve patient care and reduce inappropriate utilization.
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The agency may mandate prior authorization, drug therapy
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management, or disease management participation for certain
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populations of Medicaid beneficiaries, certain drug classes, or
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particular drugs to prevent fraud, abuse, overuse, and possible
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dangerous drug interactions. The Pharmaceutical and Therapeutics
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Committee shall make recommendations to the agency on drugs for
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which prior authorization is required. The agency shall inform
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the Pharmaceutical and Therapeutics Committee of its decisions
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regarding drugs subject to prior authorization. The agency is
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authorized to limit the entities it contracts with or enrolls as
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Medicaid providers by developing a provider network through
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provider credentialing. The agency may competitively bid single
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source-provider contracts if procurement of goods or services
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results in demonstrated cost savings to the state without
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limiting access to care. The agency may limit its network based
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on the assessment of beneficiary access to care, provider
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availability, provider quality standards, time and distance
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standards for access to care, the cultural competence of the
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provider network, demographic characteristics of Medicaid
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beneficiaries, practice and provider-to-beneficiary standards,
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appointment wait times, beneficiary use of services, provider
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turnover, provider profiling, provider licensure history,
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previous program integrity investigations and findings, peer
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review, provider Medicaid policy and billing compliance records,
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clinical and medical record audits, and other factors. Providers
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are not entitled to enrollment in the Medicaid provider network.
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The agency shall determine instances in which allowing Medicaid
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beneficiaries to purchase durable medical equipment and other
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goods is less expensive to the Medicaid program than long-term
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rental of the equipment or goods. The agency may establish rules
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to facilitate purchases in lieu of long-term rentals in order to
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protect against fraud and abuse in the Medicaid program as
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defined in s. 409.913. The agency may seek federal waivers
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necessary to administer these policies.
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(5)(a) The agency shall implement a Medicaid prescribed
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drug spending-control program that includes the following
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components:
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1. A Medicaid preferred drug list, which shall be a listing
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of cost-effective therapeutic options recommended by the
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Medicaid Pharmacy and Therapeutics Committee established
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pursuant to s. 409.91195 and adopted by the agency for each
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therapeutic class on the preferred drug list. At the discretion
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of the committee, and when feasible, the preferred drug list
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should include at least two products in a therapeutic class. The
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agency may post the preferred drug list and updates to the list
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on an Internet website without following the rulemaking
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procedures of chapter 120. Antiretroviral agents are excluded
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from the preferred drug list. The agency shall also limit the
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amount of a prescribed drug dispensed to no more than a 34-day
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supply unless the drug products’ smallest marketed package is
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greater than a 34-day supply, or the drug is determined by the
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agency to be a maintenance drug , in which case a 100-day maximum
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supply may be authorized. The agency may seek any federal
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waivers necessary to implement these cost-control programs and
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to continue participation in the federal Medicaid rebate
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program, or alternatively to negotiate state-only manufacturer
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rebates. The agency may adopt rules to administer this
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subparagraph. The agency shall continue to provide unlimited
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contraceptive drugs and items. The agency must establish
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procedures to ensure that:
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a. There is a response to a request for prior authorization
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by telephone or other telecommunication device within 24 hours
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after receipt of a request for prior authorization; and
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b. A 72-hour supply of the drug prescribed is provided in
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an emergency or when the agency does not provide a response
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within 24 hours as required by sub-subparagraph a.
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2. A provider of prescribed drugs is reimbursed in an
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amount not to exceed the lesser of the actual acquisition cost
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based on the Centers for Medicare and Medicaid Services National
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Average Drug Acquisition Cost pricing files plus a professional
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dispensing fee, the wholesale acquisition cost plus a
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professional dispensing fee, the state maximum allowable cost
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plus a professional dispensing fee, or the usual and customary
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charge billed by the provider.
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3. The agency shall develop and implement a process for
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managing the drug therapies of Medicaid recipients who are using
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significant numbers of prescribed drugs each month. The
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management process may include, but is not limited to,
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comprehensive, physician-directed medical-record reviews, claims
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analyses, and case evaluations to determine the medical
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necessity and appropriateness of a patient’s treatment plan and
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drug therapies. The agency may contract with a private
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organization to provide drug-program-management services. The
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Medicaid drug benefit management program shall include
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initiatives to manage drug therapies for HIV/AIDS patients,
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patients using 20 or more unique prescriptions in a 180-day
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period, and the top 1,000 patients in annual spending. The
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agency must shall enroll any Medicaid recipient in the drug
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benefit management program if he or she meets the specifications
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of this provision and is not enrolled in a Medicaid health
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maintenance organization.
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4. The agency may limit the size of its pharmacy network
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based on need, competitive bidding, price negotiations,
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credentialing, or similar criteria. The agency shall give
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special consideration to rural areas in determining the size and
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location of pharmacies included in the Medicaid pharmacy
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network. A pharmacy credentialing process may include criteria
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such as a pharmacy’s full-service status, location, size,
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patient educational programs, patient consultation, disease
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management services, and other characteristics. The agency may
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impose a moratorium on Medicaid pharmacy enrollment if it is
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determined that it has a sufficient number of Medicaid
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participating providers. The agency must allow dispensing
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practitioners to participate as a part of the Medicaid pharmacy
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network regardless of the practitioner’s proximity to any other
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entity that is dispensing prescription drugs under the Medicaid
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program. A dispensing practitioner must meet all credentialing
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requirements applicable to his or her practice, as determined by
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the agency.
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5. The agency shall develop and implement a program that
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requires Medicaid practitioners who issue written prescriptions
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for medicinal drugs to use a counterfeit-proof prescription pad
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for Medicaid prescriptions. The agency shall require the use of
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standardized counterfeit-proof prescription pads by prescribers
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who issue written prescriptions for Medicaid recipients. The
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agency may implement the program in targeted geographic areas or
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statewide.
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6. The agency may enter into arrangements that require
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manufacturers of generic drugs prescribed to Medicaid recipients
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to provide rebates of at least 15.1 percent of the average
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manufacturer price for the manufacturer’s generic products.
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These arrangements must shall require that if a generic-drug
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manufacturer pays federal rebates for Medicaid-reimbursed drugs
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at a level below 15.1 percent, the manufacturer must provide a
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supplemental rebate to the state in an amount necessary to
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achieve a 15.1-percent rebate level.
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7. The agency may establish a preferred drug list as
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described in this subsection, and, pursuant to the establishment
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of such preferred drug list, negotiate supplemental rebates from
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manufacturers that are in addition to those required by Title
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XIX of the Social Security Act and at no less than 14 percent of
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the average manufacturer price as defined in 42 U.S.C. s. 1936
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on the last day of a quarter unless the federal or supplemental
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rebate, or both, equals or exceeds 29 percent. There is no upper
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limit on the supplemental rebates the agency may negotiate. The
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agency may determine that specific products, brand-name or
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generic, are competitive at lower rebate percentages. Agreement
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to pay the minimum supplemental rebate percentage guarantees a
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manufacturer that the Medicaid Pharmaceutical and Therapeutics
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Committee will consider a product for inclusion on the preferred
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drug list. However, a pharmaceutical manufacturer is not
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guaranteed placement on the preferred drug list by simply paying
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the minimum supplemental rebate. Agency decisions will be made
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on the clinical efficacy of a drug and recommendations of the
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Medicaid Pharmaceutical and Therapeutics Committee, as well as
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the price of competing products minus federal and state rebates.
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The agency may contract with an outside agency or contractor to
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conduct negotiations for supplemental rebates. For the purposes
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of this section, the term “supplemental rebates” means cash
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rebates. Value-added programs as a substitution for supplemental
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rebates are prohibited. The agency may seek any federal waivers
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to implement this initiative.
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8.a. The agency may implement a Medicaid behavioral drug
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management system. The agency may contract with a vendor that
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has experience in operating behavioral drug management systems
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to implement this program. The agency may seek federal waivers
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to implement this program.
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b. The agency, in conjunction with the Department of
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Children and Families, may implement the Medicaid behavioral
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drug management system that is designed to improve the quality
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of care and behavioral health prescribing practices based on
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best practice guidelines, improve patient adherence to
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medication plans, reduce clinical risk, and lower prescribed
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drug costs and the rate of inappropriate spending on Medicaid
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behavioral drugs. The program may include the following
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elements:
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(I) Provide for the development and adoption of best
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practice guidelines for behavioral health-related drugs such as
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antipsychotics, antidepressants, and medications for treating
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bipolar disorders and other behavioral conditions; translate
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them into practice; review behavioral health prescribers and
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compare their prescribing patterns to a number of indicators
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that are based on national standards; and determine deviations
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from best practice guidelines.
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(II) Implement processes for providing feedback to and
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educating prescribers using best practice educational materials
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and peer-to-peer consultation.
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(III) Assess Medicaid beneficiaries who are outliers in
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their use of behavioral health drugs with regard to the numbers
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and types of drugs taken, drug dosages, combination drug
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therapies, and other indicators of improper use of behavioral
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health drugs.
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(IV) Alert prescribers to patients who fail to refill
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prescriptions in a timely fashion, are prescribed multiple same
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class behavioral health drugs, and may have other potential
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medication problems.
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(V) Track spending trends for behavioral health drugs and
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deviation from best practice guidelines.
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(VI) Use educational and technological approaches to
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promote best practices, educate consumers, and train prescribers
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in the use of practice guidelines.
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(VII) Disseminate electronic and published materials.
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(VIII) Hold statewide and regional conferences.
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(IX) Implement a disease management program with a model
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quality-based medication component for severely mentally ill
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individuals and emotionally disturbed children who are high
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users of care.
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9. The agency shall implement a Medicaid prescription drug
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management system.
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a. The agency may contract with a vendor that has
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experience in operating prescription drug management systems in
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order to implement this system. Any management system that is
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implemented in accordance with this subparagraph must rely on
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cooperation between physicians and pharmacists to determine
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appropriate practice patterns and clinical guidelines to improve
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the prescribing, dispensing, and use of drugs in the Medicaid
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program. The agency may seek federal waivers to implement this
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program.
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b. The drug management system must be designed to improve
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the quality of care and prescribing practices based on best
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practice guidelines, improve patient adherence to medication
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plans, reduce clinical risk, and lower prescribed drug costs and
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the rate of inappropriate spending on Medicaid prescription
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drugs. The program must:
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(I) Provide for the adoption of best practice guidelines
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for the prescribing and use of drugs in the Medicaid program,
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including translating best practice guidelines into practice;
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reviewing prescriber patterns and comparing them to indicators
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that are based on national standards and practice patterns of
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clinical peers in their community, statewide, and nationally;
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and determine deviations from best practice guidelines.
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(II) Implement processes for providing feedback to and
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educating prescribers using best practice educational materials
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and peer-to-peer consultation.
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(III) Assess Medicaid recipients who are outliers in their
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use of a single or multiple prescription drugs with regard to
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the numbers and types of drugs taken, drug dosages, combination
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drug therapies, and other indicators of improper use of
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prescription drugs.
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(IV) Alert prescribers to recipients who fail to refill
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prescriptions in a timely fashion, are prescribed multiple drugs
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that may be redundant or contraindicated, or may have other
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potential medication problems.
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10. The agency may contract for drug rebate administration,
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including, but not limited to, calculating rebate amounts,
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invoicing manufacturers, negotiating disputes with
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manufacturers, and maintaining a database of rebate collections.
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11. The agency may specify the preferred daily dosing form
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or strength for the purpose of promoting best practices with
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regard to the prescribing of certain drugs as specified in the
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General Appropriations Act and ensuring cost-effective
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prescribing practices.
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12. The agency may require prior authorization for
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Medicaid-covered prescribed drugs. The agency may prior
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authorize the use of a product:
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a. For an indication not approved in labeling;
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b. To comply with certain clinical guidelines; or
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c. If the product has the potential for overuse, misuse, or
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abuse.
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The agency may require the prescribing professional to provide
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information about the rationale and supporting medical evidence
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for the use of a drug. The agency shall post prior
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authorization, step-edit criteria and protocol, and updates to
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the list of drugs that are subject to prior authorization on the
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agency’s Internet website within 21 days after the prior
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authorization and step-edit criteria and protocol and updates
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are approved by the agency. For purposes of this subparagraph,
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the term “step-edit” means an automatic electronic review of
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certain medications subject to prior authorization.
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13. The agency, in conjunction with the Pharmaceutical and
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Therapeutics Committee, may require age-related prior
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authorizations for certain prescribed drugs. The agency may
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preauthorize the use of a drug for a recipient who may not meet
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the age requirement or may exceed the length of therapy for use
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of this product as recommended by the manufacturer and approved
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by the Food and Drug Administration. Prior authorization may
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require the prescribing professional to provide information
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about the rationale and supporting medical evidence for the use
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of a drug.
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14. The agency shall implement a step-therapy prior
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authorization approval process for medications excluded from the
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preferred drug list. Medications listed on the preferred drug
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list must be used within the previous 12 months before the
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alternative medications that are not listed. The step-therapy
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prior authorization may require the prescriber to use the
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medications of a similar drug class or for a similar medical
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indication unless contraindicated in the Food and Drug
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Administration labeling. The trial period between the specified
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steps may vary according to the medical indication. The step
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therapy approval process must shall be developed in accordance
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with the committee as stated in s. 409.91195(7) and (8). A drug
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product may be approved , or, in the case of a drug product for
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the treatment of a serious mental illness, must be approved,
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without meeting the step-therapy prior authorization criteria if
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the prescribing physician provides the agency with additional
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written medical or clinical documentation that the product is
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medically necessary because:
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a. There is not a drug on the preferred drug list to treat
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the disease or medical condition which is an acceptable clinical
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alternative;
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b. The alternatives have been ineffective in the treatment
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of the beneficiary’s disease;
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c. The drug product or medication of a similar drug class
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is prescribed for the treatment of a serious mental illness
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schizophrenia or schizotypal or delusional disorders ; prior
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authorization has been granted previously for the prescribed
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drug; and the medication was dispensed to the patient during the
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previous 12 months; or
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d. Based on historical evidence and known characteristics
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of the patient and the drug, the drug is likely to be
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ineffective, or the number of doses have been ineffective.
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The agency shall work with the physician to determine the best
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alternative for the patient. The agency may adopt rules waiving
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the requirements for written clinical documentation for specific
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drugs in limited clinical situations.
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15. The agency shall implement a return and reuse program
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for drugs dispensed by pharmacies to institutional recipients,
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which includes payment of a $5 restocking fee for the
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implementation and operation of the program. The return and
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reuse program must shall be implemented electronically and in a
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manner that promotes efficiency. The program must permit a
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pharmacy to exclude drugs from the program if it is not
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practical or cost-effective for the drug to be included and must
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provide for the return to inventory of drugs that cannot be
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credited or returned in a cost-effective manner. The agency
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shall determine whether if the program has reduced the amount of
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Medicaid prescription drugs which are destroyed on an annual
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basis and whether if there are additional ways to ensure more
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prescription drugs are not destroyed and which could safely be
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reused.
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Section 3. Paragraph (a) of subsection (20) of section
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409.910, Florida Statutes, is amended to read:
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409.910 Responsibility for payments on behalf of Medicaid
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eligible persons when other parties are liable.—
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(20)(a) Entities providing health insurance as defined in
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s. 624.603, health maintenance organizations and prepaid health
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clinics as defined in chapter 641, and, on behalf of their
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clients, third-party administrators, pharmacy benefits managers,
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and any other third parties, as defined in s. 409.901 s.
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409.901(27) , which are legally responsible for payment of a
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claim for a health care item or service as a condition of doing
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business in this the state or providing coverage to residents of
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this state, shall provide such records and information as are
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necessary to accomplish the purpose of this section, unless such
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requirement results in an unreasonable burden.
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Section 4. The Agency for Health Care Administration is
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directed to include the rate impact of this act in the Medicaid
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managed medical assistance program and long-term care managed
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care program rates that become effective on October 1, 2026.
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This section shall take effect upon this act becoming a law.
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Section 5. Except as otherwise expressly provided in this
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act and except for this section, which shall take effect upon
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this act becoming a law, this act shall take effect October 1,
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2026.