Florida Senate - 2026 SB 1256
By Senator Grall
29-01367A-26 20261256__
1 A bill to be entitled
2 An act relating to pharmacy audits; amending s.
3 624.491, F.S.; revising requirements for audits of
4 licensed pharmacies conducted by or on behalf of
5 pharmacy benefit plans or programs; revising audit
6 procedures, documentation requirements, reporting and
7 appeal requirements, and recoupment limits and
8 procedures; prohibiting the person or entity
9 conducting such audit from taking certain actions;
10 requiring that an audit designated as a fraud, waste,
11 or abuse audit be based on specified evidence or
12 credible allegations or claims; providing requirements
13 for the person or entity conducting such fraud, waste,
14 or abuse audit; prohibiting a person or entity
15 auditing the records of a licensed pharmacy from using
16 a fraud, waste, or abuse audit designation to
17 circumvent certain provisions; providing an exception;
18 revising applicability; providing for enforcement;
19 authorizing the Office of Insurance Regulation to
20 investigate complaints of violations, issue cease and
21 desist orders, impose fines and other administrative
22 penalties, order restitution for improper recoupments,
23 prohibit any person or entity from conducting audits
24 for a specified timeframe upon certain findings, and
25 suspend or revoke a pharmacy benefit manager’s
26 registration under certain circumstances; requiring
27 the Financial Services Commission to adopt rules;
28 providing an effective date.
29
30 Be It Enacted by the Legislature of the State of Florida:
31
32 Section 1. Section 624.491, Florida Statutes, is amended to
33 read:
34 624.491 Pharmacy audits; enforcement; penalties;
35 rulemaking.—
36 (1) A pharmacy benefits plan or program as defined in s.
37 626.8825 providing pharmacy benefits must comply with the
38 requirements of this section when the pharmacy benefits plan or
39 program or any person or entity acting on behalf of the pharmacy
40 benefits plan or program, including, but not limited to, a
41 pharmacy benefit manager as defined in s. 626.88, audits the
42 records of a pharmacy licensed under chapter 465. The person or
43 entity conducting such audit must:
44 (a) Apply uniform audit standards, scope, frequency, and
45 penalty practices to all pharmacies within the pharmacy benefits
46 plan’s or program’s network, including pharmacy benefit manager
47 owned or -affiliated pharmacies and nonaffiliated pharmacies.
48 (b) Not impose stricter audit methodologies, higher error
49 thresholds, expanded documentation requirements, or more
50 frequent audits on nonaffiliated pharmacies than on pharmacy
51 benefit manager-owned or -affiliated pharmacies.
52 (c) Upon request by the office or a network pharmacy
53 subject to audit, provide documentation demonstrating compliance
54 with paragraph (a) or paragraph (b), including a comparison of
55 audit frequency, scope, methodologies, and recoupment rates
56 between pharmacy benefit manager-owned or -affiliated pharmacies
57 and nonaffiliated pharmacies.
58 (d)(a) Except as provided in subsection (5) (3), notify the
59 pharmacy in writing at least 30 7 calendar days before any the
60 initial onsite or remote audit for each audit cycle.
61 (e)(b) Not schedule an onsite audit during the first 7 3
62 calendar days of a month unless the pharmacist consents in
63 writing otherwise.
64 (f) Not disrupt patient care or otherwise interfere with
65 the pharmacy’s daily operations.
66 (g)(c) Limit the duration of the audit period to 24 months
67 after the date a claim is submitted to or adjudicated by the
68 entity.
69 (h) Limit each audit to a random sampling of no more than
70 0.1 percent of prescriptions. Additional claims may be audited
71 only if fraud, waste, or abuse is reasonably suspected and
72 stated in writing.
73 (i) Use a random selection process for conducting audits.
74 Targeted selection based on drug class, cost, or therapeutic
75 category is prohibited unless fraud, waste, or abuse is
76 reasonably suspected and stated in writing.
77 (j)(d) In the case of an audit that requires clinical or
78 professional judgment, conduct the audit in consultation with,
79 or allow the audit to be conducted by, a pharmacist licensed in
80 this state.
81 (k)(e) Allow the pharmacy to use the written and verifiable
82 records of a prescriber, hospital, physician, or other
83 authorized practitioner, which are transmitted by any means of
84 communication, to validate the pharmacy records in accordance
85 with state and federal law. Electronic records and scanned
86 prescriptions are valid.
87 (l)(f) Reimburse the pharmacy for a claim that was
88 retroactively denied for a clerical error, typographical error,
89 scrivener’s error, or computer error or for an omission or
90 discrepancy in documentation which does not affect the identity
91 of the patient, the identity of the prescriber, the drug
92 dispensed, the quantity dispensed, the date of service, or the
93 accuracy of the amount paid under the claim, if the prescription
94 was properly and correctly dispensed, unless a pattern of such
95 errors exists, fraudulent billing is alleged, or the error
96 results in actual financial loss to the entity. Such errors are
97 not considered fraud unless there is clear and convincing
98 evidence of intent to defraud.
99 (m)(g) Provide the pharmacy with a copy of the preliminary
100 audit report within 30 120 days after the conclusion of the
101 audit.
102 (n)(h) Allow the pharmacy to produce documentation to
103 address a discrepancy or audit finding, or to initiate an
104 appeal, within 30 10 business days after the preliminary audit
105 report is delivered to the pharmacy. A written audit appeals
106 process is required.
107 (o)(i) Provide the pharmacy and the plan sponsor with a
108 copy of the final audit report within 90 days 6 months after the
109 pharmacy’s receipt of the preliminary audit report.
110 (p)(j) Calculate any recoupment or penalties based on
111 actual overpayments. Recoupment may and not be calculated
112 according to the accounting practice of extrapolation unless
113 agreed upon in writing as part of a settlement. Recoupment is
114 limited to the dispensing fee unless the pharmacy failed to
115 dispense the drug or acted with willful intent to defraud.
116 Ingredient cost recoupment is prohibited unless fraud or willful
117 misrepresentation is proven. All recouped funds must be returned
118 in full to the plan sponsor. Recoupment may not occur until:
119 l. The pharmacy has had at least 30 days to respond;
120 2. All appeals are resolved; and
121 3. A final audit report is issued.
122 (q) Not be compensated based on recovery amounts.
123 (2) The person or entity conducting such audit may not:
124 (a) Disregard valid inventory acquired in accordance with
125 state and federal law and legitimate business practices. All
126 legally sourced products held by the pharmacy at the time of
127 dispensing must count toward inventory reconciliation.
128 (b) Impose additional notification or approval requirements
129 for routine pharmacy business decisions.
130 (c) Require sourcing from a narrower list of distributors
131 than what is permitted under state or federal licensure
132 standards.
133 (d) Impose manufacturer-driven restrictions on the source
134 of drug products used in audit reconciliation.
135 (e) Reject purchases from pharmacy-to-pharmacy transfers
136 conducted in accordance with state and federal law and
137 accompanied by appropriate transaction documentation.
138 (f) Require bank statements, deposit records, including
139 copies of the front or back of checks, and point-of-sale
140 transaction records, or a combination of such records if any one
141 or more of these records sufficiently demonstrates copay
142 collection consistent with industry norms. Reasonable proof of
143 copay collection shall be limited to standard pharmacy records,
144 including signature logs, point-of-sale transaction records, and
145 accounting records.
146 (g) Require subsequent attestations from the patient. Lack
147 of subsequent attestation may not be used to justify claim
148 reversal or recoupment if a pharmacy possesses valid
149 documentation that medication was dispensed to the patient or
150 his or her authorized representative, including, but not limited
151 to, signature logs, electronic dispensing records, point-of-sale
152 transaction records, or an in-person pharmacist acknowledgement
153 of dispensing.
154 (h) Initiate subsequent attestations more than 180 days
155 after the date of service.
156 (i) Require duplicate or extraordinary documentation beyond
157 what is required under state and federal law in invoice audits.
158 The following is deemed sufficient proof of lawful acquisition
159 of products for audit reconciliation purposes:
160 1. Invoices from licensed wholesalers or distributors.
161 2. Valid documentation of pharmacy-to-pharmacy transfers
162 conducted in accordance with state or federal law.
163 3. Records consistent with the Drug Supply Chain Security
164 Act, 21 U.S.C. ss. 351 et seq., and Board of Pharmacy
165 requirements.
166
167 Documentation may not be required unless reasonably necessary to
168 validate lawful inventory acquisitions.
169 (3)(a) An audit designated as a fraud, waste, or abuse
170 audit must be based on specific, documented evidence or a
171 credible allegation of fraud, waste, or abuse involving the
172 pharmacy or a specific claim or set of claims under review.
173 (b) The person or entity conducting a fraud, waste, or
174 abuse audit must provide the pharmacy with, in writing, before
175 commencement of such audit:
176 1. A clear statement that the audit is designated as a
177 fraud, waste, or abuse audit.
178 2. A list of the specific facts, data, or allegations
179 forming the basis for the fraud, waste, or abuse designation.
180 3. Identification of the specific claims or classes of
181 claims to which the fraud, waste, or abuse designation applies.
182 (c) A person or entity auditing the records of a pharmacy
183 licensed under chapter 465 may not use a fraud, waste, or abuse
184 audit designation to circumvent any provision of this section
185 unless the audit complies fully with this subsection.
186 (4)(2) This section does not apply to:
187 (a) Audits conducted by the Medicaid Fraud Control Unit or
188 initiated under a criminal investigation supported by probable
189 cause;
190 (b)(a) Audits in which suspected fraudulent activity or
191 other intentional or willful misrepresentation is evidenced by a
192 physical review, review of claims data or statements, or other
193 investigative methods;
194 (c)(b) Audits of claims paid for by federally funded
195 programs; or
196 (d)(c) Concurrent reviews or desk audits that occur within
197 3 business days after transmission of a claim and where no
198 chargeback or recoupment is demanded.
199 (5)(3) An entity that audits a pharmacy located within a
200 Health Care Fraud Prevention and Enforcement Action Team (HEAT)
201 Task Force area designated by the United States Department of
202 Health and Human Services and the United States Department of
203 Justice may dispense with the notice requirements of paragraph
204 (1)(d) (1)(a) if such pharmacy has been a member of a
205 credentialed provider network for less than 12 months.
206 (6)(4) Pursuant to s. 408.7057, and after receipt of the
207 final audit report issued under paragraph (1)(o) (1)(i), a
208 pharmacy may appeal the findings of the final audit report as to
209 whether a claim payment is due and as to the amount of a claim
210 payment.
211 (7)(5) A pharmacy benefits plan or program that, under
212 terms of a contract, transfers to a pharmacy benefit manager the
213 obligation to pay a pharmacy licensed under chapter 465 for any
214 pharmacy benefit claims arising from services provided to or for
215 the benefit of an insured or subscriber remains responsible for
216 a violation of this section.
217 (8) The office shall enforce this section and may:
218 (a) Investigate complaints of violations of this section.
219 (b) Issue cease and desist orders.
220 (c) Impose administrative fines as follows:
221 1. For misuse of the fraud, waste, or abuse designation in
222 violation of subsection (3), a fine not to exceed $100,000 per
223 violation.
224 2. For a violation of paragraph (1)(a), paragraph (1)(b),
225 or paragraph (1)(c), a fine not to exceed $50,000 per violation.
226 3. For any other violation of this section, a fine not to
227 exceed $25,000 per violation.
228 (d) Order restitution for improper recoupments.
229 (e) Prohibit any person or entity from conducting audits
230 under this section for up to 2 years upon a finding that such
231 person or entity has committed willful abuse of the fraud,
232 waste, or abuse designation in violation of subsection (3).
233 (f) Suspend or revoke a pharmacy benefit manager’s
234 registration under s. 624.490 for repeated or willful
235 violations.
236 (9) The commission shall adopt rules necessary to implement
237 this section.
238 Section 2. This act shall take effect July 1, 2026.