Req. No. 10889 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 58th Legislature (2022) COMMITTEE SUBSTITUTE FOR HOUSE BILL NO. 3514 By: McEntire COMMITTEE SUBSTITUTE An Act relating to professions and occupations; amending 59 O.S. 2021, Section s 357, 358 and 360, which relate to pharmacy benefit plans; modifying definitions; adding definition; modifying powers of Oklahoma Insurance D epartment; modifying denial of certain appeal; and providing an eff ective 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 Req. No. 10889 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 c. an employer, labor union, o r other entity organized in the state that provides health co verage to covered individuals who are employed or reside in the state. 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 benefit health i nsurance 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 cover ed 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" me ans 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 pharmacy 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 individuals within the state, including Req. No. 10889 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 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, 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 programs, 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 relationship 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 em ployers, 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 Req. No. 10889 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 9. "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 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 pharmacy benefits management or any of the services inc luded 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 first obtain a license from the Oklahoma Insurance Depa rtment, 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 carrying 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 evidence of the procurement of a surety bond. Req. No. 10889 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 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 subsection shall limit the Office of the Attorney General f rom 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 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 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 Department hearing any pharmacy benefits manager 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 manager shall, wit h 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 ph armacy, Req. No. 10889 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 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; 2. In order to place a drug on the MAC list, ensure that the drug is listed as "A" or "B" ra ted 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 an d 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 or 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 amount through this pr ocedure 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 manager shall Req. No. 10889 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 not require a pharmacy or pharmacy 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 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 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 adju dication 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 purchase by the dispensing pharmacy at a price below the pharm acy 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 adjustment 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 Req. No. 10889 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 dispensing retail pharmacies from national or regional wholesale rs which are listed as accre dited drug distributors on the National Association of Boards of Ph armacy (NABP) website or other website as recognized and approved 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 netwo rk 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. 58-2-10889 LRB 03/02/22