Pharmacy Benefit Managers
Overview
The Prescription Drug Reform Act (SB 1550), signed by Governor DeSantis in May 2023, institutes new regulatory requirements for all Pharmacy Benefit Managers (PBMs), including a requirement to become fully regulated as Insurance Administrators.
A pharmacy benefit manager, defined in section 626.88, Florida Statutes (F.S.), means a person or an entity doing business in this state which contracts to administer prescription drug benefits on behalf of a pharmacy benefits plan or program as defined in section 626.8825, F.S. The term includes, but is not limited to, a person or an entity that performs one or more of the following services on behalf of such plan or program:
- Pharmacy claims processing.
- Administration or management of a pharmacy discount card program and performance of any other service listed in this subsection.
- Managing pharmacy networks or pharmacy reimbursement.
- Paying or managing claims for pharmacist services provided to covered persons.
- Developing or managing a clinical formulary, including utilization management or quality assurance programs.
- Pharmacy rebate administration.
- Managing patient compliance, therapeutic intervention, or generic substitution programs.
- Administration or management of a mail-order pharmacy program.
This page provides information and resources on statutory requirements for PBMs.
Filing a Complaint
Complaints on PBM issues regarding Florida Medicaid providers should be submitted to the Agency for Health Care Administration (AHCA). More information is available on AHCA's website here. |
Application for Certificate of Authority
Beginning on January 1, 2024, PBMs operating in Florida must continue to be registered with the OIR, using the form linked below (section 624.490, F.S.), and hold a valid certificate of authority (COA) as an administrator (sections 626.88 and 626.8805, F.S.). Additionally, the Prescription Drug Reform Act requires that PBMs submit the following documentation to OIR:
- A self-disclosure of any administrative, civil, or criminal complaints, settlements, or discipline, or any of its affiliates, which relates to a violation of the insurance laws, including pharmacy benefit manager laws, in any state.
- A statement attesting to compliance with the network requirements in Section 626.8825, Florida Statutes. Companies may also wish to submit supporting documentation (i.e. Network Files, Analyses, etc.) to the attestation to ensure compliance with the requirements set forth in Chapter 626, Florida Statutes.
- A statement identifying any ownership affiliation of any kind with any pharmacy which, directly or indirectly, through one or more intermediaries: Has an investment or ownership interest in a PBM holding a Florida certificate of authority; shares common ownership with a PBM holding a Florida certificate of authority; or has an investor or a holder of an ownership interest which is a PBM holding a Florida certificate of authority.
- A PBM shall also make available to the OIR copies of all contract templates with any pharmacy as defined in Section 465.003, Florida Statutes, and copies of all subcontracts to support the company's operations. This includes copies of all contract templates between the PBM and any pharmacy benefit plan or program as defined in Section 626.8825(u), Florida Statutes.
Upon receipt and review of a complete application by a PBM that meets the requirements of Florida Law, the OIR will issue a COA.
Any PBM operating in Florida without a valid COA beginning on January 1, 2024, will be subject to a fine of $10,000 per violation per day.
The application form is available here.
Transparent Reporting Requirements
The PBM’s financial condition (subsection 626.89(1), F.S.) and the PBM’s audited annual financial statements (subsection 626.89(2), F.S.). These should be submitted electronically within three months after the end of the administrator’s fiscal year, through http://www.floir.com/iportal. See form OIR-A3-975 to submit financial information.
The notification of any administrative, civil, or criminal complaints, settlements, or discipline of the pharmacy benefit manager or any of its affiliates which relate to a violation of the insurance laws, including pharmacy benefit laws in any state should be submitted electronically to http://www.floir.com/iportal, as a periodic filing, within 30 days of the complaint, settlement, or discipline (subsection 626.89(5), F.S.).
Beginning January 1, 2024, the requirement for an annual attestation of compliance with network requirements (subsection 626.89(6), F.S.) should be submitted electronically to http://www.floir.com/iportal, and included in the annual filings thereafter. PBMs are encouraged to provide additional documentation (i.e. Network Files, Analyses, etc.) to support this attestation annually, as it will also be requested during the biennial examination cycle.
Material changes of ownership (subsection 626.89(4), F.S.) should immediately be submitted electronically to http://www.floir.com/iportal, as a periodic filing. A change of ownership affiliation of any kind with any pharmacy, which meets the requirements of section 626.8814(2) F.S., must be reported to the OIR in writing, and may be submitted electronically to http://www.floir.com/iportal, within 60 days of the change in ownership interest.
A report of the total number of appeals and denials by pharmacies or pharmacists of the PBM’s decisions regarding a drug’s maximum allowable cost and reimbursement (section 626.8825, F.S.) is required to be filed with the OIR every 90 days.
This report may be filed through iPortal. A sample template is available here.
PBMs are also directed to notify any pharmacy benefits plans or programs they are contracted with of the requirement (subsection 626.8825(2)(h)2., F.S.) to annually submit a statement of attestation of compliance with the requirements of subsection 626.8825(2), F.S., governing contracts between the PBM and the pharmacy benefits plans or programs. This requirement applies to all pharmacy benefits plans or programs as defined in subsection 626.8825(1)(u), F.S.
A sample attestation form is available here.
The attestations may be submitted to: PBMreporting@floir.com. If the plan or program is directed by a licensed insurer or HMO, the attestation may be submitted electronically as a periodic filing to http://www.floir.com/iportal.
The PBM’s financial condition (subsection 626.89(1), F.S.) and the PBM’s audited annual financial statements (subsection 626.89(2), F.S.). These should be submitted electronically within three months after the end of the administrator’s fiscal year, through http://www.floir.com/iportal. See form OIR-A3-975 to submit financial information.
A report of the total number of appeals and denials by pharmacies or pharmacists of the PBM’s decisions regarding a drug’s maximum allowable cost and reimbursement (section 626.8825, F.S.) is required to be filed with the OIR every 90 days.
This report may be filed through iPortal. A sample template is available here.
PBMs are also directed to notify any pharmacy benefits plans or programs they are contracted with of the requirement (subsection 626.8825(2)(h)2., F.S.) to annually submit a statement of attestation of compliance with the requirements of subsection 626.8825(2), F.S., governing contracts between the PBM and the pharmacy benefits plans or programs. This requirement applies to all pharmacy benefits plans or programs as defined in subsection 626.8825(1)(u), F.S.
A sample attestation form is available here.
The attestations may be submitted to: PBMreporting@floir.com. If the plan or program is directed by a licensed insurer or HMO, the attestation may be submitted electronically as a periodic filing to http://www.floir.com/iportal.
Contract Provisions, Patient Data Practices, & Prohibited PBM Practices
All contractual arrangements executed, amended, adjusted, or renewed on or after July 1, 2023, which are applicable to pharmacy benefits covered on or after January 1, 2024, between a PBM and a Pharmacy Benefits Plan or Program must include, in substantial form, standard terms, except to the extent not allowed by law, shall supersede any contractual terms to the contrary.
Participation contracts between the PBM and participating pharmacy executed, amended, adjusted, or renewed on or after July 1, 2023, which are applicable to pharmacy services on or after January 1, 2024, between a PBM and one or more pharmacies or pharmacists must include, in substantial form, standard terms, except to the extent not allowed by law, shall supersede any contractual terms to the contrary.
A complete listing of contract terms can be found in section 626.8825(2), F.S.
All contractual arrangements executed, amended, adjusted, or renewed on or after July 1, 2023, which are applicable to pharmacy benefits covered on or after January 1, 2024, between a PBM and a Pharmacy Benefits Plan or Program must include, in substantial form, standard terms, except to the extent not allowed by law, shall supersede any contractual terms to the contrary.
Participation contracts between the PBM and participating pharmacy executed, amended, adjusted, or renewed on or after July 1, 2023, which are applicable to pharmacy services on or after January 1, 2024, between a PBM and one or more pharmacies or pharmacists must include, in substantial form, standard terms, except to the extent not allowed by law, shall supersede any contractual terms to the contrary.
A complete listing of contract terms can be found in section 626.8825(2), F.S.
The Prescription Drug Reform Act prohibits PBMs from transferring or sharing records relative to prescription information containing patient-identifiable or prescriber-identifiable data to an affiliated pharmacy for any commercial purpose other than the limited purposes of facilitating pharmacy reimbursement, formulary compliance, or utilization review on behalf of the applicable pharmacy benefits plan or program.
The Prescription Drug Reform Act includes additional prohibitions against PBM practices, including: restricting or penalizing a pharmacy or pharmacist from disclosing relevant information to a patient, government officials, or law enforcement; communicating at the point-of-sale, or otherwise requiring, a cost-sharing obligation for a covered person that exceeds the lesser of the applicable amount in the covered person’s plan or the usual and customary price.
Additionally, the bill clarifies that Florida’s prohibition against “fail twice” step therapy protocols apply to both plans and PBMs.
The Act also provides additional protections against PBMs exerting retaliatory action against pharmacists or pharmacies that provide information to the OIR pursuant to a compliant or a query regarding compliance with this act.
The Prescription Drug Reform Act includes additional prohibitions against PBM practices, including: restricting or penalizing a pharmacy or pharmacist from disclosing relevant information to a patient, government officials, or law enforcement; communicating at the point-of-sale, or otherwise requiring, a cost-sharing obligation for a covered person that exceeds the lesser of the applicable amount in the covered person’s plan or the usual and customary price.
Additionally, the bill clarifies that Florida’s prohibition against “fail twice” step therapy protocols apply to both plans and PBMs.
The Act also provides additional protections against PBMs exerting retaliatory action against pharmacists or pharmacies that provide information to the OIR pursuant to a compliant or a query regarding compliance with this act.