Florida Senate - 2012 SB 1310
By Senator Fasano
11-00369C-12 20121310__
1 A bill to be entitled
2 An act relating to pharmacy audits; providing purpose;
3 providing definitions; providing standards and
4 procedures regulating the auditing of pharmacy records
5 conducted on behalf of a pharmacy benefit manager;
6 providing contract requirements and limitations;
7 providing for the delivery of and response to
8 preliminary and final audit reports; providing for the
9 appeal of audits; providing penalties and remedies;
10 providing for applicability; providing an effective
11 date.
12
13 Be It Enacted by the Legislature of the State of Florida:
14
15 Section 1. Auditing of pharmacy records.—
16 (1) PURPOSE.—The purpose of this section is to establish
17 standards for the audit of pharmacy records conducted by or on
18 behalf of a pharmacy benefit manager or other entity listed in
19 paragraph (2)(b).
20 (2) DEFINITIONS.—As used in this section, the term:
21 (a) “Audit” means a formal review of the records of a
22 pharmacy by an entity that finances or reimburses the cost of
23 health services or pharmaceutical products.
24 (b) “Entity” means a pharmacy benefit manager, a managed
25 care company, a health plan sponsor, an insurance company, a
26 third-party payor, a state agency, or any company, group, or
27 agent that represents or is engaged by such entities.
28 (c) “Pharmacy benefit manager” means a person, business, or
29 other entity that performs pharmacy benefit management or
30 performs pharmacy benefit management on behalf of a pharmacy
31 benefit manager through a contractual or employment
32 relationship.
33 (d) “Pharmacy benefit management” means the provision of
34 administrative services related to processing prescription
35 claims for pharmacy benefit and coverage programs. Such services
36 may include contracting with a network of pharmacies; audit
37 compliance; establishing payment levels for provider pharmacies;
38 negotiating rebate arrangements; and developing and managing
39 formularies, preferred drug lists, and prior authorization
40 programs.
41 (3) AUDITING STANDARDS AND PROCEDURES.—An entity conducting
42 an audit of pharmacy records must adhere to the following
43 standards and procedures:
44 (a) The same standards and parameters must be used to audit
45 all pharmacies.
46 (b) An audit that involves clinical or professional
47 judgment must be conducted by, or in consultation with, a
48 pharmacist licensed in this state.
49 (c) An auditing entity conducting an onsite audit must give
50 the pharmacy at least 30 days’ written notice before conducting
51 the audit. Such notice must identify the prescription numbers to
52 be audited.
53 (d) The audit may not take place during the first 7 days of
54 the month unless otherwise consented to by the pharmacy.
55 (e) The period covered by the audit may not exceed 12
56 months, unless superseded by federal law.
57 (f) The initial audit may not include more than 1 percent
58 of the average monthly prescription claims, not to exceed 200
59 prescription claims. However, the auditing entity may conduct
60 further audits of prescription claims that have substantiated
61 and documented discrepancies.
62 (g) The pharmacy may use the records, or copies of records,
63 of a hospital, physician, or other authorized practitioner to
64 validate the pharmacy record.
65 (h) Any prescription that complies with state law and rule
66 requirements may be used to validate claims in connection with
67 prescriptions, refills, or changes in prescriptions.
68 (i) Calculations of overpayments may not include dispensing
69 fees.
70 (j) Interest may not accrue during the audit period.
71 (k) If an audit results in the identification of any
72 clerical or recordkeeping errors, such as typographical errors,
73 scrivener’s errors, or computer errors, in a required document
74 or record, the pharmacy is not subject to recoupment of funds by
75 the pharmacy benefit manager unless the pharmacy benefit manager
76 can provide proof of intent to commit fraud or such error
77 results in actual financial harm to the pharmacy benefit
78 manager, a health plan managed by a pharmacy benefit manager, or
79 a consumer.
80 (l) The auditing entity must allow the pharmacy to resubmit
81 claims disputed by the audit using any commercially reasonable
82 method, including, but not limited to, faxing, mailing, or
83 electronic submission.
84 (m) An exit interview that provides a pharmacy with an
85 opportunity to respond to questions and comment on and clarify
86 findings must be conducted at the end of an audit. The time of
87 the interview must be agreed to by the pharmacy.
88 (n) The auditing entity may not collect disputed funds
89 until the audit process, including appeals, is complete.
90 (o) The auditing company or agent may not receive payment
91 based on a percentage of the amount recovered.
92 (p) If not superseded by state or federal law, audit
93 information may not be shared and is confidential. Auditors
94 shall have access only to previous audit reports on a particular
95 pharmacy conducted by the same auditing entity.
96 (4) CONTRACT REQUIREMENTS.—
97 (a) Each pharmacy network provider contract must provide:
98 1. The methodology and resources used for calculating the
99 maximum allowable cost (MAC) pricing of the pharmacy benefit
100 manager;
101 2. For updating pricing information at least weekly; and
102 3. A process for promptly notifying network pharmacies of
103 pricing updates.
104 (b) The pharmacy network provider contract may not include
105 a provision that allows the use of extrapolation in calculating
106 the recoupment or penalties for audits, unless agreed to by both
107 parties.
108 (c) A pharmacy benefit manager may not automatically enroll
109 a pharmacy in a contract or modify an existing contract without
110 written agreement from an authorized representative of the
111 pharmacy.
112 (d) Unless required by federal law, a contract entered into
113 or renewed on or after July 1, 2012, may not contain auditing
114 standards, procedures, contract requirements, appeal procedures,
115 or reporting requirements that are more restrictive than those
116 contained in this section.
117 (5) AUDIT APPEALS.—
118 (a) The auditing entity must establish a written process
119 for appealing preliminary and final audit reports. The process
120 must include an option that offers the pharmacy a final appeal
121 to the health plan sponsor. If the pharmacy or pharmacy benefit
122 manager is not satisfied with an appeal, that party may seek
123 mediation.
124 (b) If unsubstantiated audit discrepancies are discovered
125 following the appeal, they shall be dismissed without further
126 proceeding.
127 (6) AUDIT REPORTS.—
128 (a) A preliminary audit report must be delivered to the
129 pharmacy, or its corporate office of record, within 60 days
130 after the conclusion of the audit.
131 (b) A pharmacy shall have at least 30 days following
132 receipt of the preliminary audit to provide documentation to
133 address any discrepancy found in the audit.
134 (c) A final audit report must be delivered to the pharmacy,
135 or its corporate office of record, within 120 days after receipt
136 of the preliminary audit report or final appeal, whichever
137 occurs later.
138 (d) Chargebacks, recoupment, or other penalties may not be
139 assessed until the appeal process has been exhausted and the
140 final report issued.
141 (e) The auditing entity must also provide a copy of the
142 final report, including the disclosure of any money recouped in
143 the audit, to the plan sponsor.
144 (7) PENALTIES AND REMEDIES.—Any person injured as a result
145 of a violation of this section may bring a civil action against
146 the person, corporation, or business entity violating this
147 section for the recovery of all actual damages occurring as a
148 result thereof.
149 (8) APPLICABILITY.—
150 (a) This section applies to contracts entered into,
151 amended, extended, or renewed on or after July 1, 2012.
152 (b) This section does not apply to:
153 1. Audits of Medicaid-related pharmacy records conducted
154 pursuant to s. 465.188, Florida Statutes.
155 2. Any investigative audit that involves fraud or willful
156 misrepresentation.
157 Section 2. This act shall take effect July 1, 2012.