records - Written report - Copy - Recoupment. A. The entity conducting an audit of a pharmacy shall: 1. Identify and specifically describe the audit and appeal procedures in the pharmacy contract. Prescription claim documentation and recordkeeping requirements shall not exceed the requirements set forth by the Oklahoma Pharmacy Act or other applicable state or federal laws or regulations; 2. Give the pharmacy written notice by certified letter to the pharmacy and the pharmacy’s contracting agent, including identification of specific prescription numbers, fill dates, drug names, and National Drug Code (NDC) numbers to be audited, at least fourteen (14) calendar days prior to conducting the audit, including, but not limited to, an on-site audit, a desk audit, or a wholesale purchase audit, request for documentation related to the dispensing of a prescription drug, or any reimbursed activity by a pharmacy provider; provided, however, that wholesale purchase audits shall require a minimum of thirty (30) calendar days’ written notice. For an on-site audit, the audit date shall be the date the on-site audit occurs. For all other audit types, the audit date shall be the date the pharmacy provides the documentation requested in the audit notice. The pharmacy shall have the opportunity to reschedule the audit no more than seven (7) calendar days from the date designated on the original audit notification; 3. Not interfere with the delivery of pharmacist services to a patient and shall utilize every reasonable effort to minimize inconvenience and disruption to pharmacy operations during the audit process; 4. Conduct any audit involving clinical or professional judgment by means of or in consultation with a licensed pharmacist; 5. Not consider as fraud any clerical or recordkeeping error, such as a typographical error, scrivener’s error or computer error, including, but not limited to, a miscalculated day supply, incorrectly billed prescription written date or prescription origin code, and such errors shall not be subject to recoupment. The pharmacy shall have the right to submit amended claims electronically to correct clerical or recordkeeping errors in lieu of recoupment. To the extent that an audit results in the identification of any clerical or recordkeeping errors such as typographical errors, scrivener’s errors or computer errors in a required document or record, the pharmacy shall not be subject to recoupment of funds by the pharmacy benefits manager unless the pharmacy benefits manager can provide proof of intent to commit fraud. A person shall not be subject to criminal penalties for errors provided for in this paragraph without proof of intent to commit fraud; 6. Permit a pharmacy to use the records of a hospital, physician, or other authorized practitioner of the healing arts for drugs or medicinal supplies written or transmitted by any means of communication for purposes of validating the pharmacy record with respect to orders or refills of a legend or narcotic drug; 7. Not include the dispensing fee amount or the actual invoice cost of the prescription dispensed in a finding of an audit recoupment unless a prescription was not actually dispensed or a physician denied authorization of a dispensing order; 8. Audit each pharmacy under identical standards, regularity and parameters as other similarly situated pharmacies and all pharmacies owned or managed by the pharmacy benefits manager conducting or having conducted the audit; 9. Not exceed one (1) year from the date the claim was submitted to or adjudicated by a managed care company, nonprofit hospital or medical service organization, insurance company, third- party payor, pharmacy benefits manager, a health program administered by a department of this state, or any entity that represents the companies, groups, or departments for the period covered by an audit; 10. Not schedule or initiate an audit during the first seven (7) calendar days of any month unless otherwise consented to by the pharmacy; 11. Disclose to any plan sponsor whose claims were included in the audit any money recouped in the audit; 12. Not require pharmacists to break open packaging labeled “for single-patient-use only”. Packaging labeled “for single- patient-use only” shall be deemed to be the smallest package size available; 13. Upon recoupment of funds from a pharmacy, refund first to the patient the portion of the recovered funds that were originally paid by the patient, provided such funds were part of the recoupment; and 14. Not assess a fine, penalty, or any other financial requirement on the pharmacy or pharmacist for any prescription audited unless there is a valid recoupment under the Pharmacy Audit Integrity Act. B. 1. Any entity that conducts wholesale purchase review during an audit of a pharmacist or pharmacy shall not require the pharmacist or pharmacy to provide a full dispensing report. Wholesaler invoice reviews shall be limited to verification of purchase inventory specific to the pharmacy claims paid by the health benefits plan or pharmacy benefits manager conducting the audit. 2. Any entity conducting an audit shall not identify or label a prescription claim as an audit discrepancy when: a. the National Drug Code for the dispensed drug is in a quantity that is a subunit or multiple of the drug purchased by the pharmacist or pharmacy as supported by a wholesale invoice, b. the pharmacist or pharmacy dispensed the correct quantity of the drug according to the prescription, and c. the drug dispensed by the pharmacist or pharmacy shares all but the last two digits of the National Drug Code of the drug reflected on the supplier invoice. 3. An entity conducting an audit shall accept as evidence, subject to validation, to support the validity of a pharmacy claim related to a dispensed drug: a. redacted copies of supplier invoices in the pharmacist’s or pharmacy’s possession, or b. invoices and any supporting documents from any supplier as authorized by federal or state law to transfer ownership of the drug acquired by the pharmacist or pharmacy. 4. An entity conducting an audit shall provide, no later than five (5) calendar days after the date of a request by the pharmacist or pharmacy, all supporting documents the pharmacist’s or pharmacy’s purchase suppliers provided to the health benefits plan issuer or pharmacy benefits manager. C. A pharmacy shall be allowed to provide the pharmacy’s computerized patterned medical records or the records of a hospital, physician, or other authorized practitioner of the healing arts for drugs or medicinal supplies written or transmitted by any means of communication for purposes of supporting the pharmacy record with respect to orders or refills of a legend or narcotic drug. D. The PBM or its agent shall not exceed an annual limit of fifty prescription claims with a specific prescription number and date of fill per calendar year. The annual limit to the number of prescription claims audited shall be inclusive of all audits by a PBM or its agent, including any prescription-related documentation requests from the health insurer, pharmacy benefits manager or any third-party company conducting audits on behalf of any health insurer or pharmacy benefits manager during a calendar year. E. If paper copies of records are requested by the entity conducting the audit, the entity shall pay twenty-five cents ($0.25) per page to cover the costs incurred by the pharmacy. The entity conducting the audit shall provide the pharmacy with accurate instructions, including any required form for obtaining reimbursement for the copied records. F. The entity conducting the audit shall: 1. Deliver a preliminary audit findings report to the pharmacy and the pharmacy’s contracting agent within forty-five (45) calendar days of conducting the audit; 2. Allow the pharmacy at least ninety (90) calendar days following receipt of the preliminary audit findings report in which to produce documentation to address any discrepancy found during the audit; provided, however, a pharmacy may request an extension, not to exceed an additional forty-five (45) calendar days; 3. Deliver a final audit findings report to the pharmacy and the pharmacy’s contracting agent signed by the auditor within ten (10) calendar days after receipt of additional documentation provided by the pharmacy, as provided for in Section 356.3 of this title; 4. Allow the pharmacy to reverse and resubmit claims electronically within thirty (30) calendar days of receipt of the final audit report in lieu of the auditing entity recouping discrepant claim amounts from the pharmacy; 5. Not recoup any disputed funds until after final disposition of the audit findings, including the appeals process as provided for in Section 356.3 of this title; 6. Not accrue interest during the audit and appeal period; 7. Ensure that each preliminary audit findings report required by this section includes: a. specific prescription numbers, fill dates, drug names, and NDC numbers, and b. the date of receipt of documents from the pharmacy, the pharmacy’s contracting agent, or any other source associated with the audit. In addition to the requirements for a preliminary audit findings report in this paragraph, the final audit findings report shall include any additional documentation that was submitted to the auditing entity; 8. Provide the plan sponsor a copy of the final audit results within thirty (30) calendar days of the final disposition of the audit; and 9. At the request of the plan sponsor, provide a copy of the final audit findings report within thirty (30) calendar days of the request. G. 1. The full amount of any recoupment on an audit shall be refunded to the plan sponsor. Except as provided for in paragraph 2 of this subsection, a charge or assessment for an audit shall not be based, directly or indirectly, on amounts recouped. 2. This subsection 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: a. 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 b. a commission to an agent or employee of the entity conducting the audit is not based, directly or indirectly, on amounts recouped. H. Unless superseded by state or federal law, auditors shall only have access to previous audit reports on a particular pharmacy conducted by the auditing entity for the same pharmacy benefits manager, health plan or insurer. An auditing vendor contracting with multiple pharmacy benefits managers or health insurance plans shall not use audit reports or other information gained from an audit on a pharmacy to conduct another audit for a different pharmacy benefits manager or health insurance plan. I. Paragraph 2 of subsection A of this section through subsection D of this section, and paragraph 1 through paragraph 7 of subsection F of this section shall not apply to any audit initiated based on suspicion of fraud, willful misrepresentation, or abuse. J. If the Attorney General, after notice and opportunity for hearing, finds that the entity conducting the audit failed to follow any of the requirements pursuant to the Pharmacy Audit Integrity Act, the audit shall be considered null and void. Any monies recouped from a null and void audit shall be returned to the affected pharmacy within fourteen (14) calendar days. Any violation of this section by a pharmacy benefits manager or auditing entity shall be deemed a violation of the Pharmacy Audit Integrity Act. Added by Laws 2008, c. 137, § 3, eff. Nov. 1, 2008. Amended by Laws 2011, c. 375, § 1, eff. Nov. 1, 2011; Laws 2021, c. 409, § 1, emerg. eff. May 4, 2021; Laws 2024, c. 332, § 2, emerg. eff. May 22, 2024;
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