Req. No. 3567 Page 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 STATE OF OKLAHOMA 2nd Session of the 59th Legislature (2024) COMMITTEE SUBSTITUTE FOR SENATE BILL 1670 By: McCortney, Prieto, and Jett of the Senate and McEntire of the House COMMITTEE SUBSTITUTE An Act relating to pharmacy benefits management; amending 59 O.S. 2021, Sections 356.1, 356.2, 356.3, 357, 358, and 360, which relate to the Pharmacy Audit Integrity Act and pharmacy reimbursement; providing for rule promulgation; modifying audit notice requirements; requiring notice and reporting to the Office of the Attorney General; providing for fines and fees; modifying definitions; requiring certain recouped funds from audit to be paid to patients first; making certain audits null and void ; requiring certain notice to include certain dec laration; modifying definition ; modifying reimbursement appeal process; requiring reimbursement at certain rate under certain circumstances; updating statutory references; and declaring an emergency. BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: SECTION 1. AMENDATORY 59 O.S. 2021, Section 356.1, is amended to read as follows: Section 356.1. A. For purposes of the Pharmacy Audit Integrity Act, “pharmacy benefits manager ” or “PBM” means a person, business, or other entity that performs pharmacy benefits management. The Req. No. 3567 Page 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 term includes a person or entity acting for a PBM in a contractual or employment relationship in the performance of pharmacy benefits management for a managed care company, nonprofit hospital, medical service organization, insuran ce company, third-party payor, or a health program administered by a dep artment of this state. B. The purpose of the Pharmacy Audit Integrity Act is to establish minimum and uniform standar ds and criteria for the audit of pharmacy records by or on behalf of certain entities. C. The Pharmacy Audit Integrity Act shall apply to any audit of the records of a pharmacy conducted by a managed care company, nonprofit hospital, medical service organization, insurance company, third-party payor, pharmacy benefits m anager, a health program administered by a department of this state, or any entity that represents these companies, groups, or departments. D. The Attorney General may promulgate rules to i mplement the provisions of the Ph armacy Audit Integrity Act. SECTION 2. AMENDATORY 59 O.S. 2021, Section 356.2, is amended to read as follows: Section 356.2. A. The entity conducting an audit of a pharmacy shall: 1. Identify and specifically describe the audit and appeal procedures in the pha rmacy contract. Prescription claim documentation and record -keeping requirements shall not exceed the Req. No. 3567 Page 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 requirements set forth by the Oklahoma Pharmacy Act or other applicable state or federal law s 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 and fill dates to be audited, at least two (2) weeks 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 prov ider; provided, however, that wholesale purchase au dits 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 m inimize 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; Req. No. 3567 Page 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 5. Not consider as fraud any clerical or record -keeping error, such as a typographical error, scrivener ’s error or computer error, including, but not limited to, a miscalculated day supply, incorrectly billed prescr iption 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 record -keeping errors in lieu of recoupment. To the extent that an audit results in the identification of any clerical or record -keeping errors such as typographical errors, scrivener’s errors or computer errors i n a required document or record, the pharmacy shall not be subject to recoupment of funds by the ph armacy 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 art s for drugs or medicinal supplies written or transmit ted by any means of communication for purposes of validating the pharmacy r ecord 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 Req. No. 3567 Page 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 recoupment unless a prescription was not act ually 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 entit y 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 mont h 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 ; and 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 s mallest package size available; and Req. No. 3567 Page 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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. 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 d ispensing report. Wholesaler invoice reviews shall be li mited to verification of purchase inventory specifi c to the pharmacy claims paid by the health benefits plan or pharmacy benefits manage r conducting the audit. 2. Any entity conducting an audit sha ll not identify or label a prescription claim as an audit discrepancy when: a. the National Drug Code for the dis pensed 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 d igits of the Nationa l Drug Code of the drug reflected on th e supplier invoice. Req. No. 3567 Page 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 3. An entity conducting an audit shall a ccept as evidence, subject to validation, to support th e 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 sha ll provide, no later than five (5) business days after the date of a request by the pharmacist or pharmacy, all supporting docum ents 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 aut horized practitioner of the healing arts for drugs or medicinal supp lies written or transmitted by any me ans of communication for purposes of supporting the pharmacy record with respect to orders or refill s of a legend or narcotic dr ug. D. The entity conducting the audit shall not audit more tha n fifty prescriptions, with specific date of service, per calendar year. The annual limit to t he number of prescription claims audited shall be inclusive of all audits, including any prescription -related Req. No. 3567 Page 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 documentation requests from the health insurer, pharmacy benefits manager or any third-party company conducting aud its on behalf of any health insurer or pharmacy benefits manager during a calendar year. E. If paper copies of records are requ ested 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 pro vide 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 audi t 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 withi n ten (10) calendar days after receipt of additional documentation provided by the pharmacy , as provided for in Section 356.3 of this title; Req. No. 3567 Page 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 4. Allow the pharmacy to reverse and resubmit claims electronically within thir ty (30) 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; and 6. Not accrue interest d uring the audit and appeal per iod. G. Each entity conducting an audit shall provide a copy of the final audit results, and a final audit report upon request, after completion of any review process to the plan sponsor. H. 1. The full amount of any recoup ment on an audit shall be refunded to the plan sponso r. Except as provided for in paragraph 2 of this subsection, a char ge or assessment for an audit shall n ot be based, directly or indirectly, on amounts recouped. 2. This subsection does not prevent the entity conducting the audit from charging or assessing t he 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 expli citly states the percentage charge or assessment to t he plan sponsor, and Req. No. 3567 Page 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 b. a commission to an agent or employee of the entity conducting the audit is not ba sed, directly or indirectly, on amounts recouped. I. Unless superseded by state or federal law, a uditors 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 insur er. An auditing vendor contracting with multiple pharmacy benefits managers or h ealth insurance plans shall not use audit reports or other information gained from an audit on a pharmacy to conduct anot her audit for a different pharmacy benefits manager or health insurance plan. J. An audit shall be considered null and void if the entity conducting the audit fails to follow any of the requi rements under this section. Any violation of this section by a pharmacy benefits manager or auditing entity shall be deemed a violation of the Pharmacy Audit Integrity Act. SECTION 3. AMENDATORY 59 O.S. 2021, Section 356.3, i s amended to read as follows: Section 356.3. A. Each entity conducting an audit shall establish a written appeals process under which a pharmacy may appeal an unfavorable preliminary audit report and/ or final audit report to the entity. B. Following an appeal, if the entity finds that an unfavorable audit report or any portion thereof is unsubstantiated, the entity Req. No. 3567 Page 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 shall dismiss the audit report or the unsubstantiated portion of the audit report without any further action. C. Any final audit report , following the final audit appeal period, with a finding of fraud or wil lful misrepresentation shall be referred to the district attorney having proper jur isdiction or the Attorney General for prosecution u pon completion of the appeals process. D. This act does section and Section 356.2 of this title do not apply to any audit, review or investigation that is initiated based on or that involves fraud, willful misrepresentation or abuse so long as the auditing entity provides in writing at the time of the audit, a clear and conspicuous declaration that the audit is being conducted under suspicion of fraud, willful misrepresentation, or abuse and a statement of facts that supports the reasonable suspicion. Any monies recouped from a null and void audit shall be returned to the affected pharmacy within fourteen (14) calendar days. E. Any entity conducting an audit based on or that involves fraud, willful misrepresentation , or abuse shall provide to the Office of the Attorney General : 1. Notice at least two (2) business days prior to beginning performance of an audit under this section; 2. A preliminary report within thirty (30) days of performing the audit; and Req. No. 3567 Page 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 3. A final report within thirty (30) days following the closure of the final audit appeal period . F. The Attorney General shall have unrestricted access to any documents relevant to an audit that is based on or that involves fraud, willful misrepresentation, or abuse. G. The Attorney General may levy a civil or administrative fine not less than One Hundred Dollars ($100.00) and not greater than Ten Thousand Dollars ($10,000.00) for each violation of this section and assess any other penalty or remedy authorized by law. SECTION 4. AMENDATORY 59 O.S. 2021, Section 357, is amended to read as follows: Section 357. As used in this act section through Section 360 of this title: 1. “Covered entity” means a nonprofit hospital or medical service organization, insurer, health coverage benefit plan, or health maintenance organization; a, health program administered by the state in the capacity of provider of providing health coverage;, or an employer, labor union, or other entity organized in the state group of persons that provides health coverage to covered individuals who are employed or res ide in the persons in this state. This term does not include a health benefit plan that provides coverage only for accidental injury, specified disease , hospital indemnity, disability income, or other limited benefit health Req. No. 3567 Page 13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 insurance policies and contracts that do not include prescription drug coverage; 2. “Covered individual” means a member, participant, e nrollee, contract holder or p olicy holder or beneficiary of a covered entity who is provided health coverage by the covered entity. A covered individual includes any dependent or other person provided health coverage through a p olicy, contract or plan for a covered individual; 3. “Department” means the Oklahoma Insurance Department; 4. “Maximum allowable cost ”, or “MAC”, or “MAC list” means the list of drug products delineating the maximum per -unit reimbursement for multiple-source prescription drugs, me dical product products, or device devices including, but not limited to: a. average acquisition cost, including the nati onal drug acquisition cost, b. average manufacturer price, c. average wholesale price, d. brand effective rate or generic effective rate , e. discount indexing, f. federal upper limits, g. wholesale acquisition cost, and h. any other term that a pharmacy benefi ts manager or an insurer of a health benefit plan may use to establish Req. No. 3567 Page 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 reimbursement rates to a pharmac ist or pharmacy for pharmacist services; 5. “Multisource drug product r eimbursement” (reimbursement) means the total amount paid to a pharmacy inclusive of any reduction in payment to the pharmacy, excluding prescription dispense fees; 6. “Office” means the Office of the Attorney General ; 7. “Pharmacy benefits management ” means a service provided to covered entities to facilitate the provisio n of prescription drug benefits to covered individuals within the state, including negotiating pricing and other terms with drug manufacturers and providers. Pharmacy benefits management may include any or all of the following services: a. claims processing, retail network management and payment of claims to pharmacies for prescription drugs dispensed to covered individuals, b. administration or management of pharmacy discount cards or programs, c. clinical formulary development and management services, c. d. rebate contracting and adm inistration, d. e. certain patient compliance, t herapeutic intervention and generic substitution programs, or e. f. administration or management of mai l-order pharmacy programs, or Req. No. 3567 Page 15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 g. disease management programs; 7. 8. “Pharmacy benefits manager ” or “PBM” means a person, business, or other entity that performs pharmacy b enefits management. The term includes shall include a person or entity acting for on behalf of a PBM in a contractual or employment relationship in the performance of pharmacy benefits man agement for a managed care company, nonprofit hospital, medical service organization, insurance company, third -party payor, or a health program administered by an agency or department of this state; 8. 9. “Plan sponsor” means the employers, insurance companies, unions and health maintenance organizations or any other entity responsible for establishing, maintainin g, or administering a health benefit plan on behalf of covered individuals; and 9. 10. “Provider” means a pharmacy licensed by the State Board of Pharmacy, or an agent or representative of a pharmacy, including, but not limited to, the pharmacy ’s contracting agent, which dispenses prescription drugs or devices to covered individuals. SECTION 5. AMENDATORY 59 O.S. 2021, Section 35 8, is amended to read as follows: Section 358. A. In order to provide pharmacy benefits management or any of the services included under the definit ion of pharmacy benefits management in this state, a pharmac y benefits manager or any entity actin g as one in a contractual or employment relationship for a covered entity shall first obtain a license from Req. No. 3567 Page 16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 the Oklahoma Insurance Department, and the Departm ent may charge a fee for such licensure. B. The Department shall establish, by regulation, licensure procedures, required disclosures for p harmacy benefits managers (PBMs) and other rules as may be necessary for carrying out and enforcing the provisions of this act the Oklahoma Pharmacy Act . The licensure procedures shall, at a minimum, i nclude the completion of an application form that shall include the name and address of an agent for service of process, the payment of a requisite fee, and evidence of the procurement of a suret y bond. C. The Department may subpoena witnesses and informa tion. Its compliance officers may take and copy recor ds for investigative use and prosecutions. Nothing in this subsection shall limit the Office of the Attorney General from using its investigative demand authority to investigate and prosecute violation s of the law. D. The Department may suspend, revoke or refuse to issue or renew a license for noncompliance with any of the provisions hereby established or with the rules promulgated by the D epartment; for conduct likely to mislead, deceive or defraud th e public or the Department; for unfair or deceptive bu siness practices or for nonpayment of a renewal fee or fine . The Department may also levy administrative fines for each count of which a PBM has been convicted in a Department hearing. Req. No. 3567 Page 17 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 E. The Attorney General may promulgate rules to implement the provisions of Sections 357 through 360 of this title. SECTION 6. AMENDATORY 59 O.S. 2021, Section 360, is amended to read as follows: Section 360. A. The pharmacy benefits manager shall, with respect to contracts between a pharmacy benefits manag er and a provider, including a pharmacy service admi nistrative organization : l. Include in such contracts the specific sources utilized to determine the maximum allowable cost (MAC) pricing of the pharm acy, update MAC pricing at least every seven (7) calendar days, and establish a process for providers to readily access the MAC list specific to that provider; 2. In order to place a drug on the MAC list, ensure that the drug is listed as “A” or “B” rated in the most recent version of the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, and the drug is generally available for purchase by pharmacies in the state from national or regional wholesalers and i s not obsolete; 3. Ensure dispensing fees are not included in the c alculation of MAC price reimbursement to phar macy providers; 4. Provide a reasonable administration appeal s procedure to allow a provider, a provider’s representative and a pharmacy service administrative organization to contest reimburseme nt amounts within fourteen (14) business days of the final adjusted payment d ate. The Req. No. 3567 Page 18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 pharmacy benefits manager shall not prevent the pharmacy or the pharmacy service administrative organization from fi ling reimbursement appeals in an electronic batch format . The pharmacy benefits manager must respond to a provid er, a provider’s representative and a pharmacy service administra tive organization who have contested a reimbursement amount through this procedure within ten (10) business days . The pharmacy benefits manager must respond in an electronic batch fo rmat to reimbursement app eals filed in an electronic batch format . The pharmacy benefits manager shall not require a pharmacy or pharmacy services adm inistrative organization to log into a system to upload individual c laim appeals or to download individual appeal responses. If a price update is warranted, the pharmacy benefit s manager shall make the change in the reimbursement amount, permit th e dispensing pharmacy to reverse and rebill the claim in ques tion, and make the reimbursement amount change retroactive and effective for all contracted providers; and 5. If a below-cost reimbursement appeal is denied, the PBM shall provide the reason for the den ial, including the National Drug Code (NDC) number from and the name of the specific national or regional wholesalers doing business in this state where the drug is currently in stock and available for purchase b y the dispensing pharmacy at a price below the PBM’s reimbursement price. If the pharmacy benefits manager cannot provide a specific national or regional wholesaler where the drug can be purchased by the Req. No. 3567 Page 19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 dispensing pharmacy at a price below the pharmacy be nefits manager’s reimbursement price If the NDC number provided by the pharmacy benefits manager is not availab le below the acquisition cost obtained from the pharmaceutical wholesal er from whom the dispensing pharmacy purchases the majority of the prescription drugs that are dispensed, the pharmacy benefits manager shall immediately adjust the reimbursement amount, permit the dispensing pharmacy to r everse and rebill the claim in question, and make the reimbursemen t amount adjustment retroactive and effective for all con tracted providers. B. The pharmacy benefits manager shall not place a drug on a MAC list, unless there are at least two therapeutically equi valent, multiple-source drugs, generally available for purchase b y dispensing retail pharmacies from national or regional wholesale rs. C. In the event that a drug is placed on the FDA Drug Shortages Database, pharmacy benefits managers shall reimbu rse claims to pharmacies at no less than the whole sale acquisition cost for the specific NDC number being dispensed. D. The pharmacy benefits manager shall not require accreditation or licensing of providers , or any entity licensed or regulated by the State Boar d of Pharmacy, other than by the State Board of Pharmacy or federal government entity as a condition for participation as a network provider. D. E. A pharmacy or pharmacist may decline to provide the pharmacist clinical or dispensing services to a patient or pharmacy Req. No. 3567 Page 20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 benefits manager if the pharmacy or pharmacist is to be paid less than the pharmacy’s cost for providing the pharmacist cli nical or dispensing services. E. F. The pharmacy benefits manager shall pro vide a dedicated telephone number, email add ress and names of the personnel with decision-making authority regarding MA C appeals and pricing . SECTION 7. It being immediately nece ssary for the preservation of the public peace, health or safety, an emergency is hereby declared to exist, by reason whereof this act shall take effect and be in full force from and after its passage and approval. 59-2-3567 RD 2/27/2024 2:10:20 PM