ENGR. H. B. NO. 3514 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 ENGROSSED HOUSE BILL NO. 3514 By: McEntire of the House and Jett of the Senate [ professions and occupations - pharmacy benefit plans - modifying powers of Oklahoma Insurance Department - effective date ] BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: SECTION 1. AMENDATORY 59 O.S. 2021, Section 357, is amended to read as follows: Section 357. As used in this act: 1. "Covered entity" mean s: a. a nonprofit hospital or medical service organization, insurer, health coverage plan or health maintenance organization;, b. a health program administered by the state in the capacity of provider of health coverage;, or c. an employer, labor union, o r other entity organized in the state that provi des health coverage to covered individuals who are employed or reside in the state. ENGR. H. B. NO. 3514 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 This term does not include a health plan that provides coverage onl y for accidental injury, specified disease, hospital in demnity, disability income, or other limited ben efit health insurance policies and contracts that do not include prescription drug coverage; 2. "Covered individual" means a member, participant, enroll ee, contract holder or policy 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 policy, contract or plan for a co vered individual; 3. "Department" means the Oklahoma I nsurance Department; 4. "Maximum allowable cost " or "MAC" means the list of drug products delineating the maximum per -unit reimbursement for multiple-source prescription drugs, medical product or devi ce; 5. "Multisource drug product reimbursement" (reimb ursement) means the total amount paid to a pharm acy inclusive of any reduction in payment to the pharmacy, excluding prescription dispense fees; 6. "Pharmacy benefits management" means a service provi ded to covered entities to facilitate the provision of prescription drug benefits to covered individual s 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: ENGR. H. B. NO. 3514 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 a. claims processing, r etail network management and payment of claims to pharmacies for prescription drugs dispensed to covered individuals, b. clinical formulary development and management services, c. rebate contracting an d administration, d. certain patient compliance, therap eutic intervention and generic substitution prog rams, or e. disease management programs; 7. "Pharmacy benefits manager" or "PBM" means a person, business or other entity that performs pharmacy benefit s management. The term includes a person or entity act ing for a PBM in a contractual or employment rel ationship in the performance of pharmacy benefits management for a managed care company, nonprofit hospital, medical service organization, insurance comp any, third- party payor, or a health program administere d by an agency of this state; 8. "Plan sponsor" means the employers, insurance companies, unions and health maintenance organizations or any other entity responsible for establishing, maintaining, or administering a health benefit plan on behalf of covere d individuals; and 9. "Provider" means a pharma cy licensed by the State Board of Pharmacy, or an agent or representative of a pharmacy, including, ENGR. H. B. NO. 3514 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 but not limited to, the pharmacy's contracting agent, which dispenses prescription drugs or devices to cover ed individuals; and 10. "Retail pharmacy" or "pharmacy" means a pharmacy, as defined in Section 353.1 of this title. SECTION 2. AMENDATORY 59 O.S. 2021, Section 358, is amended to read as follows: Section 358. A. In order to provide phar macy benefits management or any of the services included under the definition of pharmacy benefits management in this state, a phar macy benefits manager or any entity acting as one in a contrac tual or employment relationship for a covered entity shall firs t obtain a license from the Oklahoma Insurance Department, and the Department may charge a fee for such licensure. B. The Department shall establish, by regulation, licensure procedures, required disclosures for pharmacy benefits managers (PBMs) and other rules as may be necessary for carryin g out and enforcing the provisions of this act. The licensure procedures shall, at a minimum, include 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 evi dence of the procurement of a surety bond. C. The Department may subpoena witnesses and info rmation. Its compliance officers may take and copy records fo r investigative use and prosecutions. Nothing in this subsecti on shall limit the Office ENGR. H. B. NO. 3514 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 of the Attorney General from using its investigative demand authority to investigate and prosecute violat ions of the law. D. The Department may issue a cease and desist order, place on probation, suspend, revoke or refuse to issu e 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 business practices or for nonpayment of a renewal fee or fine. The Department may also issue or order a reprimand, require restitution, and levy administrative fines not to exceed Ten Thousand Dollars ($10,000.00) for each count of which a PBM has been convicted in a Depar tment hearing any pharmacy benefits ma nager has violated any of the provisions hereby established or with the rules promulgated by the Department . SECTION 3. AMENDATORY 59 O.S. 2021, Section 360, is amended to read as follows: Section 360. A. The pharmacy benefits m anager shall, with respect to contracts between a pharmacy be nefits manager and a provider, including a pharmacy service administrative organization : 1. Include in such contracts the specific sources utilized to determine the maximum allowable cost (MAC) pricing of the pharmacy, update MAC pricing at least every se ven (7) calendar days, and establish a process for providers to readily access the MAC list specific to that provider; ENGR. H. B. NO. 3514 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 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 pur chase by pharmacies in the state from national or regional wholesalers and is not obsolete; 3. Ensure dispensing fee s are not included in the calculation of MAC price reimbursement to pharmacy 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 reimbursement amounts within fourteen (14) business days of the final adjusted payment date . The pharmacy benefits manager shall not pr event the pharmacy o r the pharmacy service administrative organization from filing reimbursement appeals in an electron ic batch format. The pharmacy benefits manager must respond to a provider , a provider's representative and a pharmacy service administra tive organization who have contested a reimbursement amoun t through this procedure within ten (10) business days . The pharmacy benefits manager must respond in an electronic batch format to reimbursement appeals filed in an electronic batch format . The pharmacy benefits man ager shall not require a pharmacy or p harmacy services administrative organization to log into a sy stem to upload individual claim appeals or to download individual appeal responses . If a price update is ENGR. H. B. NO. 3514 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 warranted, the pharmacy benefit s manager shall make the change in the reimbursement amoun t, permit the dispensing pharmacy to reverse and rebill the claim in question, 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 denial, including the National Drug Code number from and the specific national or regional wholesalers where from which the drug is was available for purchase by the dispensing pharmacy at a price below the PBM's reimbursement price as of the date the adjudication of the claim was made. If the pharmacy benefits manager cannot fails to provide a specific national or regional wholesaler where from which the drug can be purchased was available for purchas e by the dispensing pharmacy at a price below the pharmacy benefits manager's reimbursement price, the pharmacy benefits manag er shall immediately adjust the reimbursement amount, permit the di spensing pharmacy to reverse and rebill the claim in question, and make the reimbursement amount adju stment retroactive and effective for all contracted providers . B. The pharmacy benefits manager shall not place a drug on a MAC list, unless there are at least two therapeutically equivalent, multiple-source drugs, generally available for purchase b y dispensing retail pharmacies from national or regional wholesale rs which are listed as accre dited drug distributors on the National ENGR. H. B. NO. 3514 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 Association of Boards of Ph armacy (NABP) website or other website as recognized and approv ed by the State Board of Pharmacy. C. The pharmacy benefits manager shall not require accreditation or licensing of provider s, or any entity licensed or regulated by the State Board of Pharma cy, other than by the State Board of Pharmacy or federal government entity as a condition for participation as a network provider. D. A pharmacy or pharmacist may decline to provide the pharmacist clinical or dispensing services to a patient or pharmacy benefits manager if the pharmacy or pharmacist is to be pa id less than the pharmacy's cost for providing the pharmacist clinical or dispensing services. E. The pharmacy benefits manager sha ll provide a dedicated telephone number, email address and names of the personnel with decision-making authority regarding M AC appeals and pricing. SECTION 4. This act shall become effective November 1, 202 2. Passed the House of Representatives the 22nd day of March, 2022. Presiding Officer of the House of Representatives Passed the Senate the ___ day of __________, 2022. Presiding Officer of the Senate