Bill Text: FL S1310 | 2012 | Regular Session | Introduced

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Bill Title: Pharmacy Audits

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2012-03-09 - Died in Health Regulation [S1310 Detail]

Download: Florida-2012-S1310-Introduced.html

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       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.