Minnesota Session Laws - 2012, Regular Session

CHAPTER 215--H.F.No. 1236

An act

relating to health; establishing a pharmacy audit integrity program;

proposing coding for new law in Minnesota Statutes, chapter 151.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [151.60] PHARMACY AUDIT INTEGRITY PROGRAM. new text end

new text begin The pharmacy audit integrity program is established to provide standards for an audit of pharmacy records carried out by a pharmacy benefits manager or any entity that represents pharmacy benefits managers. new text end

Sec. 2.

new text begin [151.61] DEFINITIONS. new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin For the purposes of sections 151.60 to 151.70, the following terms have the meanings given. new text end

new text begin Subd. 2. new text end

new text begin Entity. new text end

new text begin "Entity" means a pharmacy benefits manager or any person or organization that represents these companies, groups, or organizations. new text end

new text begin Subd. 3. new text end

new text begin Pharmacy benefits manager or PBM. new text end

new text begin "Pharmacy benefits manager" or "PBM" means a person, business, or other entity that performs pharmacy benefits management. The term includes a person or entity acting for a PBM in a contractual or employment relationship in the performance of pharmacy benefits management. new text end

new text begin Subd. 4. new text end

new text begin Plan sponsor. new text end

new text begin "Plan sponsor" means the employer in the case of an employee benefit plan established or maintained by a single employer, a group purchaser as defined in section 62J.03, subdivision 6, or the employee organization in the case of a plan established or maintained by an employee organization, an association, joint board trustees, committee, or other similar group that establishes or maintains the plan. new text end

Sec. 3.

new text begin [151.62] PHARMACY BENEFIT MANAGER CONTRACT. new text end

new text begin An amendment to pharmacy audit terms in a contract between a PBM and a pharmacy must be disclosed to the pharmacy at least 60 days prior to the effective date of the proposed change. new text end

Sec. 4.

new text begin [151.63] PROCEDURE AND PROCESS FOR CONDUCTING AND REPORTING AN AUDIT. new text end

new text begin Subdivision 1. new text end

new text begin Audit procedures. new text end

new text begin Unless otherwise prohibited by federal requirements or regulations, any entity conducting a pharmacy audit must follow the following procedures. new text end

new text begin (1) A pharmacy must be given notice 14 days before an initial on-site audit is conducted. new text end

new text begin (2) An audit that involves clinical or professional judgment must be conducted by or in consultation with a licensed pharmacist. new text end

new text begin (3) Each pharmacy shall be audited under the same standards and parameters as other similarly situated pharmacies. new text end

new text begin Subd. 2. new text end

new text begin Audit process. new text end

new text begin Unless otherwise prohibited by federal requirements or regulations, for any entity conducting a pharmacy audit the following audit items apply. new text end

new text begin (1) The period covered by the audit may not exceed 24 months from the date that the claim was submitted to or adjudicated by the entity, unless a longer period is required under state or federal law. new text end

new text begin (2) If an entity uses random sampling as a method for selecting a set of claims for examination, the sample size must be appropriate for a statistically reliable sample. Notwithstanding section 151.69, the auditing entity shall provide the pharmacy a masked list that provides a prescription number or date range that the auditing entity is seeking to audit. new text end

new text begin (3) An on-site audit may not take place during the first five business days of the month unless consented to by the pharmacy. new text end

new text begin (4) Auditors may not enter the pharmacy area unless escorted where patient-specific information is available and to the extent possible must be out of sight and hearing range of the pharmacy customers. new text end

new text begin (5) Any recoupment will not be deducted against future remittances until after the appeals process and both parties have received the results of the final audit. new text end

new text begin (6) A PBM may not require information to be written on a prescription unless the information is required to be written on the prescription by state or federal law. Recoupment may be assessed for items not written on the prescription if: new text end

new text begin (i) additional information is required in the provider manual; or new text end

new text begin (ii) the information is required by the Food and Drug Administration (FDA); or new text end

new text begin (iii) the information is required by the drug manufacturer's product safety program; and new text end

new text begin (iv) the information in clauses (i), (ii), or (iii) is not readily available for the auditor at the time of the audit. new text end

new text begin (7) The auditing company or agent may not receive payment based on a percentage of the amount recovered. This section does not prevent the entity conducting the audit from charging or assessing the responsible party, directly or indirectly, based on amounts recouped if both of the following conditions are met: new text end

new text begin (i) the plan sponsor and the entity conducting the audit have a contract that explicitly states the percentage charge or assessment to the plan sponsor; and new text end

new text begin (ii) a commission to an agent or employee of the entity conducting the audit is not based, directly or indirectly, on amounts recouped. new text end

Sec. 5.

new text begin [151.64] REQUIREMENTS FOR RECOUPMENT OR CHARGEBACK. new text end

new text begin For recoupment or chargeback, the following criteria apply. new text end

new text begin (1) Audit parameters must consider consumer-oriented parameters based on manufacturer listings. new text end

new text begin (2) A pharmacy's usual and customary price for compounded medications is considered the reimbursable cost unless the pricing methodology is outlined in the provider contract. new text end

new text begin (3) A finding of overpayment or underpayment must be based on the actual overpayment or underpayment and not a projection based on the number of patients served having a similar diagnosis or on the number of similar orders or refills for similar drugs. new text end

new text begin (4) The entity conducting the audit shall not use extrapolation in calculating the recoupment or penalties for audits unless required by state or federal law or regulations. new text end

new text begin (5) Calculations of overpayments must not include dispensing fees unless a prescription was not actually dispensed; the prescriber denied authorization; the prescription dispensed was a medication error by the pharmacy; or the identified overpayment is solely based on an extra dispensing fee. new text end

new text begin (6) An entity may not consider any clerical or record-keeping error, such as a typographical error, scrivener's error, or computer error regarding a required document or record as fraud, however such errors may be subject to recoupment. new text end

new text begin (7) In the case of errors that have no actual financial harm to the patient or plan, the PBM must not assess any chargebacks. Errors that are a result of the pharmacy failing to comply with a formal corrective action plan may be subject to recovery. new text end

new text begin (8) Interest may not accrue during the audit period for either party, beginning with the notice of the audit and ending with the final audit report. new text end

Sec. 6.

new text begin [151.65] DOCUMENTATION. new text end

new text begin (a) To validate the pharmacy record and delivery, the pharmacy may use authentic and verifiable statements or records including medication administration records of a nursing home, assisted living facility, hospital, physician, or other authorized practitioner or additional audit documentation parameters located in the provider manual. new text end

new text begin (b) Any legal prescription that meets the requirements in this chapter may be used to validate claims in connection with prescriptions, refills, or changes in prescriptions, including medication administration records, faxes, e-prescriptions, or documented telephone calls from the prescriber or the prescriber's agents. new text end

Sec. 7.

new text begin [151.66] APPEALS PROCESS. new text end

new text begin The entity conducting the audit must establish a written appeals process which must include appeals of preliminary reports and final reports. new text end

Sec. 8.

new text begin [151.67] AUDIT INFORMATION AND REPORTS. new text end

new text begin (a) A preliminary audit report must be delivered to the pharmacy within 60 days after the conclusion of the audit. new text end

new text begin (b) A pharmacy must be allowed at least 45 days following receipt of the preliminary audit to provide documentation to address any discrepancy found in the audit. new text end

new text begin (c) A final audit report must be delivered to the pharmacy within 120 days after receipt of the preliminary audit report or final appeal, whichever is later. new text end

new text begin (d) An entity shall remit any money due to a pharmacy or pharmacist as a result of an underpayment of a claim within 45 days after the appeals process has been exhausted and the final audit report has been issued. new text end

Sec. 9.

new text begin [151.68] DISCLOSURES TO PLAN SPONSOR. new text end

new text begin Where contractually required, an auditing entity must provide a copy to the plan sponsor of its claims that were included in the audit, and any recouped money shall be returned to the plan sponsor. new text end

Sec. 10.

new text begin [151.69] APPLICABILITY OF OTHER LAWS AND REGULATIONS. new text end

new text begin Sections 151.62 to 151.67 do not apply to any investigative audit that involves suspected fraud, willful misrepresentation, abuse, or any audit completed by Minnesota health care programs. new text end

Sec. 11.

new text begin [151.70] VIOLATIONS. new text end

new text begin Violations of sections 151.62 to 151.68 may be grounds for action, but are not deemed misdemeanors as described in section 151.29. new text end

Presented to the governor April 19, 2012

Signed by the governor April 23, 2012, 11:13 a.m.