Pharmacy Audits

HB 1209 2026

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A bill to be entitled 1
An act relating to pharmacy audits; amending s. 2
624.491, F.S.; revising requirements for audits of 3
licensed pharmacies conducted by or on behalf of 4
pharmacy benefit plans or programs; revising audit 5
procedures, documentation requirements, recoupment 6
limits, and reporting and appeal requirements; 7
providing procedures for conducting audits of fraud, 8
waste, or abuse; revising applicability; providing for 9
enforcement; authorizing the Office of Insurance 10
Regulation to impose fines and other administrative 11
penalties; authorizing the suspension or revocation of 12
a pharmacy benefit manager's registration under 13
certain circumstances; requiring the Financial 14
Services Commission to adopt rules; providing an 15
effective date. 16
17
Be It Enacted by the Legislature of the State of Florida: 18
19
Section 1. Section 624.491, Florida Statutes, is amended 20
to read: 21
624.491 Pharmacy audits; enforcement; penalties; 22
rulemaking.— 23
(1) A pharmacy benefits plan or program as defined in s. 24
626.8825 providing pharmacy benefits must comply with the 25

HB 1209 2026

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requirements of this section when the pharmacy benefits plan or 26
program or any person or entity acting on behalf of the pharmacy 27
benefits plan or program, including, but not limited to, a 28
pharmacy benefit manager as defined in s. 626.88, audits the 29
records of a pharmacy licensed under chapter 465. The person or 30
entity conducting such audit must: 31
(a) Apply uniform audit standards, scope, frequency, and 32
penalty practices to all pharmacies within the pharmacy benefits 33
plan or program's network, including pharmacy benefit manager-34
owned or affiliated pharmacies and nonaffiliated pharmacies. 35
(b) Not impose stricter audit methodologies, higher error 36
thresholds, expanded documentation requirements, or more 37
frequent audits on nonaffiliated pharmacies than on pharmacy 38
benefit manager-owned or affiliated pharmacies. 39
(c) Upon request by the office or a network pharmacy 40
subject to audit, provide documentation demonstrating compliance 41
with paragraph (a) or paragraph (b), including a comparison of 42
audit frequency, scope, methodologies and recoupment rates 43
between pharmacy benefit manager-owned or affiliated pharmacies 44
and nonaffiliated pharmacies. 45
(d)(a) Except as provided in subsection (5) (3), notify 46
the pharmacy in writing at least 30 7 calendar days before any 47
the initial onsite or remote audit for each audit cycle. 48
(e)(b) Not schedule an onsite audit during the first 7 3 49
calendar days of a month unless the pharmacist consents in 50

HB 1209 2026

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writing otherwise. 51
(f) Not disrupt patient care or otherwise interfere with 52
the pharmacy's daily operations. 53
(g)(c) Limit the duration of the audit period to 24 months 54
after the date a claim is submitted to or adjudicated by the 55
entity. 56
(h) Limit each audit to a random sampling of no more than 57
0.1 percent of prescriptions. Additional claims may be audited 58
only if fraud, waste, or abuse is reasonably suspected and 59
stated in writing. 60
(i) Use a random selection process for conducting audits. 61
Targeted selection based on drug class, cost, or therapeutic 62
category is prohibited unless fraud, waste, or abuse is 63
reasonably suspected and stated in writing. 64
(j)(d) In the case of an audit that requires clinical or 65
professional judgment, conduct the audit in consultation with, 66
or allow the audit to be conducted by, a pharmacist licensed in 67
this state. 68
(k)(e) Allow the pharmacy to use the written and 69
verifiable records of a prescriber, hospital, physician, or 70
other authorized practitioner, which are transmitted by any 71
means of communication, to validate the pharmacy records in 72
accordance with state and federal law. Electronic records and 73
scanned prescriptions are valid. 74
(l)(f) Reimburse the pharmacy for a claim that was 75

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retroactively denied for a clerical error, typographical error, 76
scrivener's error, or computer error, or an omission or 77
discrepancy in documentation that does not affect the identity 78
of the patient, the identity of the prescriber, the drug 79
dispensed, the quantity dispensed, the date of service, or the 80
accuracy of the amount paid under the claim, if the prescription 81
was properly and correctly dispensed, unless a pattern of such 82
errors exists, fraudulent billing is alleged, or the error 83
results in actual financial loss to the entity. Such errors are 84
not considered fraud unless there is clear and convincing 85
evidence of intent to defraud. 86
(m)(g) Provide the pharmacy with a copy of the preliminary 87
audit report within 30 120 days after the conclusion of the 88
audit. 89
(n)(h) Allow the pharmacy to produce documentation to 90
address a discrepancy or audit finding, or to initiate an 91
appeal, within 30 10 business days after the preliminary audit 92
report is delivered to the pharmacy. A written audit appeals 93
process is required. 94
(o)(i) Provide the pharmacy and the plan sponsor with a 95
copy of the final audit report within 90 days 6 months after the 96
pharmacy's receipt of the preliminary audit report. 97
(p)(j) Calculate any recoupment or penalties based on 98
actual overpayments. Recoupment may and not be calculated 99
according to the accounting practice of extrapolation unless 100

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agreed upon in writing as part of a settlement. Recoupment is 101
limited to the dispensing fee unless the pharmacy failed to 102
dispense the drug or acted with willful intent to defraud. 103
Ingredient cost recoupment is prohibited unless fraud or willful 104
misrepresentation is proven. All recouped funds must be returned 105
in full to the plan sponsor. Recoupment may not occur until: 106
l. The pharmacy has had at least 30 days to respond. 107
2. All appeals are resolved. 108
3. A final audit report is issued. 109
(q) Not be compensated based on recovery amounts. 110
(2) The person or entity conducting such audit may not: 111
(a) Disregard valid inventory acquired in accordance with 112
state and federal law and legitimate business practices. All 113
legally sourced products held by the pharmacy at the time of 114
dispensing must count toward inventory reconciliation. 115
(b) Impose additional notification or approval 116
requirements for routine pharmacy business decisions. 117
(c) Require sourcing from a narrower list of distributors 118
than what is permitted under state or federal licensure 119
standards. 120
(d) Impose manufacturer-driven restrictions on the source 121
of drug products used in audit reconciliation. 122
(e) Reject purchases from pharmacy-to-pharmacy transfers 123
conducted in accordance with state and federal law and 124
accompanied by appropriate transaction documentation. 125

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(f) Require bank statements, deposit records, including 126
copies of the front or back of checks, and point-of-sale 127
transaction records, or a combination of such records if any one 128
or more of these records sufficiently demonstrates copay 129
collection consistent with industry norms. Reasonable proof of 130
copay collection shall be limited to standard pharmacy records, 131
including signature logs, point-of-sale transaction records, and 132
accounting records. 133
(g) Require subsequent attestations from the patient. Lack 134
of subsequent attestation may not be used to justify claim 135
reversal or recoupment if a pharmacy possesses valid 136
documentation that medication was dispensed to the patient or 137
his or her authorized representative, including, but not limited 138
to, signature logs, electronic dispensing records, point-of-sale 139
transaction records, or an in-person pharmacist acknowledgement 140
of dispensing. 141
(h) Initiate subsequent attestations more than 180 days 142
after the date of service. 143
(i) Require duplicate or extraordinary documentation 144
beyond what is required under state and federal law in invoice 145
audits. The following is deemed sufficient proof of lawful 146
acquisition of products for audit reconciliation purposes: 147
1. Invoices from licensed wholesalers or distributors. 148
2. Valid documentation of pharmacy-to-pharmacy transfers 149
conducted in accordance with state or federal law. 150

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3. Records consistent with Drug Supply Chain Security Act, 151
21 U.S.C. ss. 351 et seq., and Board of Pharmacy requirements. 152
153
Documentation may not be required unless reasonably necessary to 154
validate lawful inventory acquisitions. 155
(3)(a) An audit designated as a fraud, waste, or abuse 156
audit must be based on specific, documented evidence or a 157
credible allegation of fraud, waste, or abuse involving the 158
pharmacy or a specific claim or set of claims under review. 159
(b) The person or entity conducting a fraud, waste, or 160
abuse audit must provide the pharmacy with, in writing, before 161
commencement of such audit: 162
1. A clear statement that the audit is designated as a 163
fraud, waste, or abuse audit. 164
2. A list of the specific facts, data, or allegations 165
forming the basis for the fraud, waste, or abuse designation. 166
3. Identification of the specific claims or classes of 167
claims to which the fraud, waste, or abuse designation applies. 168
(c) A person or entity auditing the records of a pharmacy 169
licensed under chapter 465 may not use a fraud, waste, or abuse 170
audit designation to circumvent any provision of this section 171
unless the audit complies fully with this subsection. 172
(4)(2) This section does not apply to: 173
(a) Audits conducted by the Medicaid Fraud Control Unit or 174
initiated under a criminal investigation supported by probable 175

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cause; 176
(b)(a) Audits in which suspected fraudulent activity or 177
other intentional or willful misrepresentation is evidenced by a 178
physical review, review of claims data or statements, or other 179
investigative methods; 180
(c)(b) Audits of claims paid for by federally funded 181
programs; or 182
(d)(c) Concurrent reviews or desk audits that occur within 183
3 business days after transmission of a claim and where no 184
chargeback or recoupment is demanded. 185
(5)(3) An entity that audits a pharmacy located within a 186
Health Care Fraud Prevention and Enforcement Action Team (HEAT) 187
Task Force area designated by the United States Department of 188
Health and Human Services and the United States Department of 189
Justice may dispense with the notice requirements of paragraph 190
(1)(d) (1)(a) if such pharmacy has been a member of a 191
credentialed provider network for less than 12 months. 192
(6)(4) Pursuant to s. 408.7057, and after receipt of the 193
final audit report issued under paragraph (1)(o) (1)(i), a 194
pharmacy may appeal the findings of the final audit report as to 195
whether a claim payment is due and as to the amount of a claim 196
payment. 197
(7)(5) A pharmacy benefits plan or program that, under 198
terms of a contract, transfers to a pharmacy benefit manager the 199
obligation to pay a pharmacy licensed under chapter 465 for any 200

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pharmacy benefit claims arising from services provided to or for 201
the benefit of an insured or subscriber remains responsible for 202
a violation of this section. 203
(8) The office shall enforce this section and may: 204
(a) Investigate complaints of violations of this section. 205
(b) Issue cease and desist orders. 206
(c) Impose administrative fines as follows: 207
1. For misuse of the fraud, waste, or abuse designation in 208
violation of subsection (3), a fine not to exceed $100,000 per 209
violation. 210
2. For a violation of paragraph (1)(a), paragraph (1)(b), 211
or paragraph (1)(c), a fine not to exceed $50,000 per violation. 212
3. For any other violation of this section, a fine not to 213
exceed $25,000 per violation. 214
(d) Order restitution for improper recoupments. 215
(e) Prohibit any person or entity from conducting audits 216
under this section for up to 2 years upon a finding that such 217
person or entity has committed willful abuse of the fraud, 218
waste, or abuse designation in violation of subsection (3). 219
(f) Suspend or revoke a pharmacy benefit manager's 220
registration under s. 624.490 for repeated or willful 221
violations. 222
(9) The commission shall adopt rules necessary to 223
implement this section. 224
Section 2. This act shall take effect July 1, 2026. 225