THE BILL ITSELF
HB 1209
Pharmacy Audits
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A bill to be entitled
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An act relating to pharmacy audits; amending s.
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624.491, F.S.; revising requirements for audits of
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licensed pharmacies conducted by or on behalf of
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pharmacy benefit plans or programs; revising audit
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procedures, documentation requirements, recoupment
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limits, and reporting and appeal requirements;
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providing procedures for conducting audits of fraud,
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waste, or abuse; revising applicability; providing for
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enforcement; authorizing the Office of Insurance
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Regulation to impose fines and other administrative
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penalties; authorizing the suspension or revocation of
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a pharmacy benefit manager's registration under
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certain circumstances; requiring the Financial
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Services Commission to adopt rules; providing an
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effective date.
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Be It Enacted by the Legislature of the State of Florida:
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Section 1. Section 624.491, Florida Statutes, is amended
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to read:
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624.491 Pharmacy audits; enforcement; penalties;
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rulemaking.—
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(1) A pharmacy benefits plan or program as defined in s.
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626.8825 providing pharmacy benefits must comply with the
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requirements of this section when the pharmacy benefits plan or
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program or any person or entity acting on behalf of the pharmacy
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benefits plan or program, including, but not limited to, a
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pharmacy benefit manager as defined in s. 626.88, audits the
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records of a pharmacy licensed under chapter 465. The person or
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entity conducting such audit must:
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(a) Apply uniform audit standards, scope, frequency, and
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penalty practices to all pharmacies within the pharmacy benefits
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plan or program's network, including pharmacy benefit manager-
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owned or affiliated pharmacies and nonaffiliated pharmacies.
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(b) Not impose stricter audit methodologies, higher error
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thresholds, expanded documentation requirements, or more
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frequent audits on nonaffiliated pharmacies than on pharmacy
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benefit manager-owned or affiliated pharmacies.
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(c) Upon request by the office or a network pharmacy
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subject to audit, provide documentation demonstrating compliance
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with paragraph (a) or paragraph (b), including a comparison of
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audit frequency, scope, methodologies and recoupment rates
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between pharmacy benefit manager-owned or affiliated pharmacies
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and nonaffiliated pharmacies.
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(d)(a) Except as provided in subsection (5) (3), notify
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the pharmacy in writing at least 30 7 calendar days before any
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the initial onsite or remote audit for each audit cycle.
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(e)(b) Not schedule an onsite audit during the first 7 3
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calendar days of a month unless the pharmacist consents in
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writing otherwise.
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(f) Not disrupt patient care or otherwise interfere with
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the pharmacy's daily operations.
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(g)(c) Limit the duration of the audit period to 24 months
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after the date a claim is submitted to or adjudicated by the
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entity.
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(h) Limit each audit to a random sampling of no more than
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0.1 percent of prescriptions. Additional claims may be audited
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only if fraud, waste, or abuse is reasonably suspected and
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stated in writing.
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(i) Use a random selection process for conducting audits.
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Targeted selection based on drug class, cost, or therapeutic
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category is prohibited unless fraud, waste, or abuse is
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reasonably suspected and stated in writing.
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(j)(d) In the case of an audit that requires clinical or
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professional judgment, conduct the audit in consultation with,
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or allow the audit to be conducted by, a pharmacist licensed in
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this state.
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(k)(e) Allow the pharmacy to use the written and
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verifiable records of a prescriber, hospital, physician, or
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other authorized practitioner, which are transmitted by any
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means of communication, to validate the pharmacy records in
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accordance with state and federal law. Electronic records and
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scanned prescriptions are valid.
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(l)(f) Reimburse the pharmacy for a claim that was
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retroactively denied for a clerical error, typographical error,
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scrivener's error, or computer error, or an omission or
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discrepancy in documentation that does not affect the identity
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of the patient, the identity of the prescriber, the drug
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dispensed, the quantity dispensed, the date of service, or the
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accuracy of the amount paid under the claim, if the prescription
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was properly and correctly dispensed, unless a pattern of such
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errors exists, fraudulent billing is alleged, or the error
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results in actual financial loss to the entity. Such errors are
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not considered fraud unless there is clear and convincing
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evidence of intent to defraud.
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(m)(g) Provide the pharmacy with a copy of the preliminary
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audit report within 30 120 days after the conclusion of the
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audit.
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(n)(h) Allow the pharmacy to produce documentation to
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address a discrepancy or audit finding, or to initiate an
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appeal, within 30 10 business days after the preliminary audit
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report is delivered to the pharmacy. A written audit appeals
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process is required.
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(o)(i) Provide the pharmacy and the plan sponsor with a
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copy of the final audit report within 90 days 6 months after the
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pharmacy's receipt of the preliminary audit report.
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(p)(j) Calculate any recoupment or penalties based on
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actual overpayments. Recoupment may and not be calculated
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according to the accounting practice of extrapolation unless
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agreed upon in writing as part of a settlement. Recoupment is
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limited to the dispensing fee unless the pharmacy failed to
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dispense the drug or acted with willful intent to defraud.
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Ingredient cost recoupment is prohibited unless fraud or willful
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misrepresentation is proven. All recouped funds must be returned
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in full to the plan sponsor. Recoupment may not occur until:
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l. The pharmacy has had at least 30 days to respond.
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2. All appeals are resolved.
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3. A final audit report is issued.
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(q) Not be compensated based on recovery amounts.
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(2) The person or entity conducting such audit may not:
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(a) Disregard valid inventory acquired in accordance with
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state and federal law and legitimate business practices. All
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legally sourced products held by the pharmacy at the time of
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dispensing must count toward inventory reconciliation.
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(b) Impose additional notification or approval
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requirements for routine pharmacy business decisions.
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(c) Require sourcing from a narrower list of distributors
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than what is permitted under state or federal licensure
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standards.
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(d) Impose manufacturer-driven restrictions on the source
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of drug products used in audit reconciliation.
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(e) Reject purchases from pharmacy-to-pharmacy transfers
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conducted in accordance with state and federal law and
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accompanied by appropriate transaction documentation.
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(f) Require bank statements, deposit records, including
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copies of the front or back of checks, and point-of-sale
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transaction records, or a combination of such records if any one
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or more of these records sufficiently demonstrates copay
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collection consistent with industry norms. Reasonable proof of
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copay collection shall be limited to standard pharmacy records,
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including signature logs, point-of-sale transaction records, and
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accounting records.
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(g) Require subsequent attestations from the patient. Lack
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of subsequent attestation may not be used to justify claim
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reversal or recoupment if a pharmacy possesses valid
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documentation that medication was dispensed to the patient or
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his or her authorized representative, including, but not limited
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to, signature logs, electronic dispensing records, point-of-sale
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transaction records, or an in-person pharmacist acknowledgement
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of dispensing.
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(h) Initiate subsequent attestations more than 180 days
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after the date of service.
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(i) Require duplicate or extraordinary documentation
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beyond what is required under state and federal law in invoice
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audits. The following is deemed sufficient proof of lawful
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acquisition of products for audit reconciliation purposes:
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1. Invoices from licensed wholesalers or distributors.
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2. Valid documentation of pharmacy-to-pharmacy transfers
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conducted in accordance with state or federal law.
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3. Records consistent with Drug Supply Chain Security Act,
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21 U.S.C. ss. 351 et seq., and Board of Pharmacy requirements.
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Documentation may not be required unless reasonably necessary to
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validate lawful inventory acquisitions.
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(3)(a) An audit designated as a fraud, waste, or abuse
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audit must be based on specific, documented evidence or a
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credible allegation of fraud, waste, or abuse involving the
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pharmacy or a specific claim or set of claims under review.
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(b) The person or entity conducting a fraud, waste, or
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abuse audit must provide the pharmacy with, in writing, before
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commencement of such audit:
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1. A clear statement that the audit is designated as a
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fraud, waste, or abuse audit.
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2. A list of the specific facts, data, or allegations
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forming the basis for the fraud, waste, or abuse designation.
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3. Identification of the specific claims or classes of
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claims to which the fraud, waste, or abuse designation applies.
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(c) A person or entity auditing the records of a pharmacy
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licensed under chapter 465 may not use a fraud, waste, or abuse
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audit designation to circumvent any provision of this section
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unless the audit complies fully with this subsection.
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(4)(2) This section does not apply to:
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(a) Audits conducted by the Medicaid Fraud Control Unit or
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initiated under a criminal investigation supported by probable
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cause;
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(b)(a) Audits in which suspected fraudulent activity or
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other intentional or willful misrepresentation is evidenced by a
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physical review, review of claims data or statements, or other
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investigative methods;
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(c)(b) Audits of claims paid for by federally funded
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programs; or
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(d)(c) Concurrent reviews or desk audits that occur within
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3 business days after transmission of a claim and where no
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chargeback or recoupment is demanded.
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(5)(3) An entity that audits a pharmacy located within a
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Health Care Fraud Prevention and Enforcement Action Team (HEAT)
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Task Force area designated by the United States Department of
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Health and Human Services and the United States Department of
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Justice may dispense with the notice requirements of paragraph
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(1)(d) (1)(a) if such pharmacy has been a member of a
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credentialed provider network for less than 12 months.
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(6)(4) Pursuant to s. 408.7057, and after receipt of the
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final audit report issued under paragraph (1)(o) (1)(i), a
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pharmacy may appeal the findings of the final audit report as to
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whether a claim payment is due and as to the amount of a claim
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payment.
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(7)(5) A pharmacy benefits plan or program that, under
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terms of a contract, transfers to a pharmacy benefit manager the
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obligation to pay a pharmacy licensed under chapter 465 for any
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pharmacy benefit claims arising from services provided to or for
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the benefit of an insured or subscriber remains responsible for
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a violation of this section.
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(8) The office shall enforce this section and may:
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(a) Investigate complaints of violations of this section.
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(b) Issue cease and desist orders.
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(c) Impose administrative fines as follows:
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1. For misuse of the fraud, waste, or abuse designation in
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violation of subsection (3), a fine not to exceed $100,000 per
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violation.
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2. For a violation of paragraph (1)(a), paragraph (1)(b),
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or paragraph (1)(c), a fine not to exceed $50,000 per violation.
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3. For any other violation of this section, a fine not to
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exceed $25,000 per violation.
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(d) Order restitution for improper recoupments.
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(e) Prohibit any person or entity from conducting audits
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under this section for up to 2 years upon a finding that such
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person or entity has committed willful abuse of the fraud,
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waste, or abuse designation in violation of subsection (3).
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(f) Suspend or revoke a pharmacy benefit manager's
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registration under s. 624.490 for repeated or willful
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violations.
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(9) The commission shall adopt rules necessary to
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implement this section.
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Section 2. This act shall take effect July 1, 2026.