Notification to All Pharmacy Benefit Managers to Be Regulated as Insurance Administrators
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Notifies PBMs and pharmacy benefits plans/programs of new Florida statutory requirements under the Prescription Drug Reform Act, including PBMs being regulated as insurance administrators and related reporting, contracting, and examination requirements that take effect starting Jan 1, 2024.
PBMs must hold a certificate of authority (COA) as administrators and complete an application to obtain a COA prior to operating in Florida beginning January 1, 2024.
PBMs are subject to new transparent reporting requirements including audited financials, notification of violations, network adequacy attestations, ownership change reporting, and periodic reporting of pharmacy appeals/denials.
Contracts between PBMs and plans or pharmacies must include specified standard terms for agreements executed or renewed on/after July 1, 2023, applicable to benefits on/after Jan 1, 2024.
Prohibitions on PBM practices were expanded, including restrictions on data sharing for commercial purposes, protections for pharmacy communications, price display rules at point-of-sale, and application of 'fail twice' step therapy prohibition to plans and PBMs.
PBMs will be subject to biennial examinations beginning January 1, 2025, and may face additional penalties for knowing and willful violations.
PBM Regulatory Requirements & Compliance
PBM regulatory requirements and compliance actions
Regulatory requirements, reporting obligations, contract provisions, prohibited practices, and examination protocols for PBMs:
ALL of the following
ALL of the following
- Submit audited annual financial statements electronically to iPortal (Form OIR-A3-975) within three months after the end of the administrator's fiscal year.
- Notify OIR of any administrative, civil, or criminal complaints, settlements, or disciplinary actions relating to insurance or pharmacy benefit laws within 30 days via iPortal as a periodic filing.
- File an annual network adequacy attestation beginning January 1, 2024, to iPortal and provide supporting documentation (e.g., network files, analyses) as requested; include this attestation in annual filings thereafter.
- Report material changes of ownership immediately to iPortal and report changes of ownership affiliation with any pharmacy (per s. 626.8814(2)) in writing or electronically to iPortal within 60 days as applicable.
- Report the total number of appeals and denials by pharmacies or pharmacists regarding maximum allowable cost and reimbursement every 90 days to PBMreporting@floir.com using OIR's suggested template when available.
ALL of the following
- Include statutory standard terms in PBM–Pharmacy Benefit Plan or Program contracts executed, amended, adjusted, or renewed on or after July 1, 2023 that apply to pharmacy benefits covered on or after January 1, 2024; statutory terms supersede any contrary contractual provisions (see s. 626.8825(2)).
- Include statutory standard terms in PBM–Participating Pharmacy contracts executed, amended, adjusted, or renewed on or after July 1, 2023 that apply to pharmacy services on or after January 1, 2024; statutory terms supersede any contrary contractual provisions (see s. 626.8825(3)).
- Follow OIR draft rules regarding remittance methods to participating pharmacies as published in the Florida Administrative Register.
ALL of the following
- Do not transfer or share patient-identifiable or prescriber-identifiable prescription records with an affiliated pharmacy for commercial purposes, except for facilitating pharmacy reimbursement, formulary compliance, or utilization review on behalf of the applicable plan or program.
ALL of the following
- Do not restrict or penalize a pharmacy or pharmacist from disclosing information to a patient, government officials, or law enforcement or from providing information to OIR in response to a complaint or compliance query.
- Ensure point-of-sale cost sharing does not exceed the lesser of the covered person's applicable plan amount or the usual and customary price.
- Apply Florida's 'fail twice' prohibition to both plans and PBMs (step therapy limitation).
- Provide anti-retaliation protections for pharmacists or pharmacies that report or provide information to OIR.
ALL of the following
- PBMs will be subject to biennial examinations beginning January 1, 2025; OIR may also examine or investigate upon referral or complaint.
- PBMs found to exhibit a pattern or practice of knowing and willful violations of relevant sections may be subject to additional penalties under section 626.8828, Florida Statutes; OIR will report violations to the Governor, President of the Senate, and Speaker of the House.
- Operating without a valid Certificate of Authority (COA) as an administrator beginning January 1, 2024 may result in fines of $10,000 per violation per day; PBMs should promptly apply for a COA and submit required background reports.
ALL of the following
- Review the statute and memorandum in its entirety and update operations, policies, contracts, and reporting processes to ensure compliance with the new regulatory requirements; OIR has initiated rulemaking and published draft rules on remittance methods and types of independent examiners.
Coding and Filing Deadlines
Certificate of Authority (COA) Requirement
COA application and enforcement — obtain COA before operating in FL (effective Jan 1, 2024)
Beginning January 1, 2024, any PBM operating in Florida must complete the OIR application and hold a valid certificate of authority (COA) as an administrator; PBMs currently registered and any new PBMs must apply for a COA. Operating without a valid COA after that date may result in fines of $10,000 per violation per day.
- Complete and submit the OIR COA application (form available from OIR).
- Obtain any required background reports included in the Florida Insurance Code as part of the application.
- PBMs already registered must still apply for a COA; issuance occurs after receipt and review of a complete application that meets Florida law.
Key Definitions
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