§ 626.8828 — Investigations and examinations of pharmacy benefit managers; expenses; penalties

Florida § 626.8828

• Jurisdiction: Florida
• Title: XXXVII
• Ch. 626: INSURANCE FIELD REPRESENTATIVES AND OPERATIONS

Text

(1) The office may investigate administrators who are pharmacy benefit managers and applicants for authorization as provided in ss. 624.307 and 624.317. The office shall review any referral made pursuant to s. 624.307(10) and shall investigate any referral that, as determined by the Commissioner of Insurance Regulation or his or her designee, reasonably indicates a possible violation of this part.

(2)(a) The office shall examine the business and affairs of each pharmacy benefit manager at least biennially. The biennial examination of each pharmacy benefit manager must be a systematic review for the purpose of determining the pharmacy benefit manager’s compliance with all provisions of this part and all other laws or rules applicable to pharmacy benefit managers and must include a detailed review of the pharmacy benefit manager’s compliance with ss. 626.8825 and 626.8827. The first 2-year cycle for conducting biennial reviews begins January 1, 2025. By January 15, 2026, and each January 15 thereafter, the office shall submit to the Governor, the President of the Senate, and the Speaker of the House of Representatives a report summarizing the results of the prior year’s examinations which includes detailed descriptions of any violations committed by each pharmacy benefit manager and detailed reporting of actions taken by the office against each pharmacy benefit manager for such violations. Beginning with the 2027 report, and every 2 years thereafter, the report must document the office’s compliance with the examination timeframe requirements as provided in this paragraph. The office must specify the number and percentage of all examination completed within the timeframe. (b) The office also may conduct additional examinations as often as it deems advisable or necessary for the purpose of ascertaining compliance with this part and any other laws or rules applicable to pharmacy benefit managers or applicants for authorization. (c) If a referral made pursuant to s. 624.307(10) reasonably indicates a pattern or practice of violations of this part by a pharmacy benefit manager, the office must begin an examination of the pharmacy benefit manager or include findings related to such referral within an ongoing examination. (d) Based on the findings of an examination that a pharmacy benefit manager or an applicant for authorization has exhibited a pattern or practice of knowing and willful violations of s. 626.8825 or s. 626.8827, the office may, pursuant to chapter 120, order a pharmacy benefit manager to file all contracts between the pharmacy benefit manager and pharmacies or pharmacy benefits plans or programs and any policies, guidelines, rules, protocols, standard operating procedures, instructions, or directives that govern or guide the manner in which the pharmacy benefit manager or applicant conducts business related to such knowing and willful violations for review and inspection for the following 36-month period. Such documents are public records and are not trade secrets or otherwise exempt from s. 119.07(1). As used in this section, the term: 1. “Contracts” means any contract to which s. 626.8825 is applicable. 2. “Knowing and willful” means any act of commission or omission which is committed intentionally, as opposed to accidentally, and which is committed with knowledge of the act’s unlawfulness or with reckless disregard as to the unlawfulness of the act. (e) Examinations may be conducted by an independent professional examiner under contract to the office, in which case payment must be made directly to the contracted examiner by the pharmacy benefit manager examined in accordance with the rates and terms agreed to by the office and the examiner. The commission shall adopt rules providing for the types of independent professional examiners who may conduct examinations under this section, which types must include, but need not be limited to, independent certified public accountants, actuaries, investment specialists, information technology specialists, or others meeting criteria specified by commission rule. The rules must also require that: 1. The rates charged to the pharmacy benefit manager being examined are consistent with rates charged by other firms in a similar profession and are comparable with the rates charged for comparable examinations. 2. The firm selected by the office to perform the examination has no conflicts of interest which might affect its ability to independently perform its responsibilities for the examination.

(3) In making investigations and examinations of pharmacy benefit managers and applicants for authorization, the office and such pharmacy benefit manager are subject to all of the following provisions: (a) Section 624.318, as to the conduct of examinations. (b) Section 624.319, as to examination and investigation reports. (c) Section 624.321, as to witnesses and evidence. (d) Section 624.322, as to compelled testimony. (e) Section 624.324, as to hearings. (f) Any other provision of chapter 624 applicable to the investigation or examination of a licensee under this part.

(4)(a) A pharmacy benefit manager must maintain an accurate record of all contracts and records with all pharmacies and pharmacy benefits plans or programs for the duration of the contract, and for 5 years thereafter. Such contracts must be made available to the office and kept in a form accessible to the office. (b) The office may order any pharmacy benefit manager or applicant to produce any records, books, files, contracts, advertising and solicitation materials, or other information and may take statements under oath to determine whether the pharmacy benefit manager or applicant is in violation of the law or is acting contrary to the public interest.

(5)(a) Notwithstanding s. 624.307(3), each pharmacy benefit manager and applicant for authorization must pay to the office the expenses of the examination or investigation. Such expenses include actual travel expenses; a reasonable living expense allowance; compensation of the examiner, investigator, or other person making the examination or investigation; and necessary costs of the office directly related to the examination or investigation. Such travel expenses and living expense allowances are limited to those expenses necessarily incurred on account of the examination or investigation and shall be paid by the examined pharmacy benefit manager or applicant together with compensation upon presentation by the office to such pharmacy benefit manager or applicant of such charges and expenses after a detailed statement has been filed by the examiner and approved by the office. (b) All moneys collected from pharmacy benefit managers and applicants for authorization pursuant to this subsection shall be deposited into the Insurance Regulatory Trust Fund, and the office may make deposits from time to time into such fund from moneys appropriated for the operation of the office. (c) Notwithstanding s. 112.061, the office may pay to the examiner, investigator, or person making such examination or investigation out of such trust fund the actual travel expenses, reasonable living expense allowance, and compensation in accordance with the statement filed with the office by the examiner, investigator, or other person, as provided in paragraph (a).

(6) In addition to any other enforcement authority available to the office, the office shall impose an administrative fine of $5,000 for each violation of s. 626.8825 or s. 626.8827. Each instance of a violation of such sections by a pharmacy benefit manager against each individual pharmacy or prescription benefits plan or program constitutes a separate violation. Notwithstanding any other provision of law, there is no limitation on aggregate fines issued pursuant to this section. The proceeds from any administrative fine shall be deposited into the General Revenue Fund.

(7) Failure by a pharmacy benefit manager to pay expenses incurred or administrative fines imposed under this section is grounds for the denial, suspension, or revocation of its certificate of authority.

Legislative History

s. 13, ch. 2023-29.