Oklahoma 2024 Regular Session

Oklahoma House Bill HB2853 Compare Versions

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29-SENATE FLOOR VERSION
30-April 11, 2023
31-
32-
3328 ENGROSSED HOUSE
3429 BILL NO. 2853 By: Wallace and Caldwell (Chad)
3530 of the House
3631
3732 and
3833
39- Montgomery, Rogers, Hicks,
40-Kirt, Kidd, Murdock,
41-Stanley, Standridge, a nd
42-Garvin of the Senate
43-
34+ Montgomery of the Senate
4435
4536
4637
4738 An Act relating to health care; creating the Oklahoma
4839 Rebate Pass-Through and PBM Meaningful Transparency
4940 Act of 2023; amending 59 O.S. 2021, Sections 357 and
5041 358, which relate to definitions; modifying
5142 definitions, procedures, and penalties; creating
5243 duties; creating licensing application requirements;
5344 amending 36 O.S. 2021, Section 6960, as amended by
5445 Section 1, Chapter 38, O.S.L. 20 22 (36 O.S. Supp.
5546 2022, Section 6960), which relates to definitions;
5647 defining terms; creating PBM disclosures; amending 36
5748 O.S. 2021, Section 6962, as amended by Section 2,
5849 Chapter 38, O.S.L. 2022 (36 O.S. Supp. 2022, Section
5950 6962), which relates to pharma cy benefits manager
6051 compliance; creating duties; amending 36 O.S. 2021,
6152 Section 6964, which relates to a formulary for
6253 prescription drugs; creating agency duties; providing
6354 cost sharing calculation methodo logy, limitations,
6455 and requirements; creating penalties; clarifying
6556 authority to take certain actions; prohibiting the
6657 disclosure of certain informat ion; declaring that
6758 certain information not be considere d public record;
6859 providing for noncodification; providing for
6960 codification; and providing an effecti ve date.
7061
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64+BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
65+SECTION 1. NEW LAW A new section of law not to be
66+codified in the Oklahoma Statutes reads as follows:
67+This act shall be known and may be cited as the "Oklahoma Rebate
68+Pass-Through and PBM Meaningful Transparency Act of 2023".
7369
74-
75-BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
76-
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103-SECTION 1. NEW LAW A new section of law not to be
104-codified in the Oklahoma Statutes reads as follows:
105-This act shall be known and may be cited as the "Oklahoma Rebate
106-Pass-Through and PBM Meaningful Transparency Act of 2023".
10795 SECTION 2. AMENDATORY 59 O.S. 2021, Section 357, is
10896 amended to read as follows:
10997 Section 357. As used in this act:
11098 1. "Covered entity" means a nonprofit hospital or medical
11199 service organization, insurer, health coverage plan or health
112100 maintenance organization; a health program administered by the state
113101 in the capacity of pro vider of health coverage; or an employer,
114102 labor union, or other entity organized in the state that provides
115103 health coverage to covered individuals who are employed or reside in
116104 the state. This term does not include a health pla n that provides
117105 coverage only for accidental injury, specified diseas e, hospital
118106 indemnity, disability income, or other li mited benefit health
119107 insurance policies and contracts that do not include prescription
120108 drug coverage;
121109 2. "Covered individual" means a member, participant, enroll ee,
122110 contract holder or policy holder or b eneficiary of a covered entity
123111 who is provided health coverage by the covered entity. A covered
124112 individual includes any dependent or other person pr ovided health
125113 coverage through a polic y, contract or plan for a co vered
126114 individual;
115+3. "Department" means the Oklahoma Insurance Department;
116+4. "Maximum allowable cost" or "MAC" means the list of drug
117+products delineating the maximum per -unit reimbursement for
118+multiple-source prescription dr ugs, medical product or devi ce;
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154-3. "Department" means the Oklahoma Insurance Department;
155-4. "Maximum allowable cost" or "MAC" means the list of drug
156-products delineating the maximum per -unit reimbursement for
157-multiple-source prescription dr ugs, medical product or device;
158145 5. "Multisource drug product reimbur sement" (reimbursement)
159146 means the total amount paid t o a pharmacy inclusive of any reduction
160147 in payment to the pharmacy, excluding prescription dispe nse fees;
161148 6. "Pharmacy benefits manag ement" means a service provi ded to
162149 covered entities to facilitate the provision of prescription drug
163150 benefits to covered i ndividuals within the state, including
164151 negotiating pricing and other terms with drug manufacture rs and
165152 providers. Pharmacy benefits m anagement may include any or all of
166153 the following services:
167154 a. claims processing, performance of drug utilization
168155 review, processing of drug prior authorization
169156 requests, retail network management and payment of
170157 claims to pharmacies for prescription drugs dispensed
171158 to covered individuals,
172159 b. clinical formulary development a nd management
173160 services,
174161 c. rebate contracting an d administration,
175162 d. certain patient compliance, therapeutic intervention
176163 and generic substitution pr ograms, or
177164 e. disease management progr ams,
165+f. adjudication of appeals and grievances related to the
166+prescription drug benefit, or
167+g. controlling the cost of pre scription drugs;
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205-f. adjudication of appeals and grievances related to the
206-prescription drug benefit, or
207-g. controlling the cost of pre scription drugs;
208194 7. "Pharmacy benefits manager" or "PBM" means a person,
209195 business or other enti ty that, either directly or through an
210196 intermediary, performs pharmacy benefit s management. The term
211197 includes a person or entity acting for a PBM in a contract ual or
212198 employment relationship in the performance of pharmacy benefits
213199 management for a managed care company, nonprofit hospital, medi cal
214200 service organization, insurance comp any, third-party payor, or a
215201 health program administered by an agency of this stat e. PBM does
216202 not include a Pharmacy Services Administrative Organization ;
217203 8. "Plan sponsor" means the employers, insurance companies,
218204 unions and health maintenance organizations or any other entity
219205 responsible for establishing, maintaining, or administering a health
220206 benefit plan on behalf of covered individuals; and
221207 9. "Provider" means a pharmacy licensed by the State Board of
222208 Pharmacy, or an agent or representative of a pharmacy, including,
223209 but not limited to, the pharmacy's contracting agent, which
224210 dispenses prescription drugs or devices to covered individuals.
225211 SECTION 3. AMENDATORY 59 O.S. 2021, Section 358, is
226212 amended to read as follows:
227213 Section 358. A. In order to provide pharmacy benefits
228214 management or any of the services included under the definition of
215+pharmacy benefits management in this state, a pharmac y benefits
216+manager or any entity acting as one in a contractual or employment
217+relationship for a covered entity sha ll first obtain a license from
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256-pharmacy benefits management in this state, a pharmac y benefits
257-manager or any entity acting as one in a contractual or employment
258-relationship for a covered entity sha ll first obtain a license from
259244 the Oklahoma Insurance D epartment, and the Department may charge a
260245 fee for such licensure.
261246 B. The Department shall establish, by regulation, licensure
262247 procedures, required disclosures for pharmacy benefits managers
263248 (PBMs) and other rules as may be necessary for carrying out and
264249 enforcing the provisions of this act. The licensure procedures
265250 shall, at a minimum, i nclude the completion of an application form
266251 that shall include the name and address of an agent for service of
267252 process, the payment of a requisite fee, and evidence of t he
268253 procurement of a surety bond the following:
269254 1. The name, address, and telephone contact number of the PBM;
270255 2. The name and address of the PBM's agent for service of
271256 process in the state;
272257 3. The name and address of each person with management or
273258 control over the PBM;
274259 4. Evidence of the procurement of a surety bon d;
275260 5. The name and address of each person with a beneficial
276261 ownership interest in the PBMs;
277262 6. In the case of a PBM applicant that is a partnership or
278263 other unincorporated association, limited liability corporation, or
264+corporation, and has five or more partners, members, or
265+stockholders:
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306-corporation, and has five or more partners, members, or
307-stockholders:
308292 a. the applicant shall specify its legal structure and
309293 the total number of partners, members, or
310294 stockholders,
311295 b. the applicant shall specify the name, address, usual
312296 occupation, and professional qualifications of the
313297 five partners, members , or stockholders with the five
314298 largest ownership interests in the PBM, and
315299 c. the applicant shall agree that, upon request by the
316300 Department, it shall furnish the Department with
317301 information regarding the name, address, usual
318302 occupation, and professional qualifications of any
319303 other partners, members, or stockholders;
320304 7. A signed statement indicating that the PBM has not been
321305 convicted of a felony and has not violated any of the requirements
322306 of the Oklahoma Pharmacy Act and the Patient 's Right to Pharmacy
323307 Choice Act, or, if the applicant cannot provide such a statement, a
324308 signed statement describing all relevant convictions or violations;
325309 and
326310 8. Any other information the Com missioner deems necessary to
327311 review.
328312 C. The Department may subpoena witnesses and informa tion. Its
329313 compliance officers may take and copy records for investigative use
314+and prosecutions. Nothing in this subsection shall limit the Office
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357-and prosecutions. Nothing in this subsection shall limit the Office
358341 of the Attorney General from using its investigative demand
359342 authority to investigate and prosecute violation s of the law.
360343 D. The Department may suspend , revoke or refuse to issue or
361344 renew a license for noncompliance wi th any of the provisions hereby
362345 established or with the rules promulgated by the Department; for
363346 conduct likely to mislead, deceive or defraud th e public or the
364347 Department; for unfair or de ceptive business practices or for
365348 nonpayment of a renewal fee or fi ne. The Department may also levy
366349 administrative fines for each count of which a PBM has been
367350 convicted in a Department hearing.
368351 SECTION 4. AMENDATORY 36 O.S. 2021 , Section 6960, as
369352 amended by Section 1, Chapter 38, O.S.L. 2022 (3 6 O.S. Supp. 2022,
370353 Section 6960), is amended to read as follows:
371354 Section 6960. For purposes of the Patient 's Right to Pharmacy
372355 Choice Act:
373356 1. "Administrative fees" means fees or payments from
374357 pharmaceutical manufacturers to, or otherwise retained by, a
375358 pharmacy benefits manager (PBM) or its designee pursuant to a
376359 contract between a PBM or affiliate and the manufacturer in
377360 connection with the PBM's administering, invoicing, alloc ating, and
378361 collecting the rebates;
379362 2. "Aggregate retained rebate percentage" means the percentage
380363 of all rebates received by a PBM from all pharmaceutical
364+manufacturers which is not passed on t o the PBM's health plan or
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408-manufacturers which is not passed on t o the PBM's health plan or
409391 health insurer clients. Aggregate retained rebate percentage shall
410392 be expressed without disclosing any identifyi ng information
411393 regarding any health plan, prescription drug, or therapeutic class,
412394 and shall be calculated by dividi ng:
413395 a. the aggregate dollar amount of all rebates that the
414396 PBM received during the prior calendar year from al l
415397 pharmaceutical manufacturers and did not pass through
416398 to the PBM's health plan or health insurer clients, by
417399 b. the aggregate dollar amount of all rebates that the
418400 pharmacy benefits manager received duri ng the prior
419401 calendar year from all pharmaceutical manufacturers;
420402 3. "Defined cost sharing" means a deductible payment or
421403 coinsurance amount imposed on an enrollee for a cover ed prescription
422404 drug under the enrollee's health plan;
423405 4. "Formulary" means a list of prescription drugs, as well as
424406 accompanying tiering and other coverage inf ormation, that has been
425407 developed by an issuer, a health plan, or the designee of a health
426408 insurer or health plan, which the health insurer, health pla n, or
427409 designee of the health insurer or health plan references in
428410 determining applicable coverage and ben efit levels;
429411 5. "Generic equivalent" means a drug that is designated to be
430412 therapeutically equivalent, as indicated by the United States Food
431413 and Drug Administration's "Approved Drug Products with Therapeutic
414+Equivalence Evaluations"; provided, however, t hat a drug shall not
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459-Equivalence Evaluations"; provided, however, t hat a drug shall not
460441 be considered a generic equivalent until the drug becomes nationally
461442 available;
462443 6. "Health insurer" means any corporation, associ ation, benefit
463444 society, exchange, partnership or individual subject to state law
464445 requires insurance and licensed by under the Oklahoma Insurance
465446 Code;
466447 7. "Health insurer administrative service fees" means fees or
467448 payments from a health insurer or a designee of the health insurer
468449 to, or otherwise retained by, a PBM or its designee pursuant to a
469450 contract between a PBM or affiliate, and the health insurer or
470451 designee of the health insurer in connection with the PBM managing
471452 or administering the pharmacy benefit and administering, invoicing,
472453 allocating, and collecting rebates;
473454 2. 8. "Health insurer payor" means a health insurance company,
474455 health maintenance organization, union, hospital and medical
475456 services organization or any entity providing or admin istering a
476457 self-funded health benefit plan;
477458 9. "Health plan" means a policy, contract, certification, or
478459 agreement offered or issued by a health insurer to provide, deliver,
479460 arrange for, pay for, or reimburse any of the costs of health
480461 services;
462+3. 10. "Mail-order pharmacy" means a pharmacy licensed by this
463+state that primarily dispenses and delivers covered drugs via common
464+carrier;
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508-3. 10. "Mail-order pharmacy" means a pharmacy licensed by this
509-state that primarily dispenses and delivers covered drugs via common
510-carrier;
511491 4. 11. "Pharmacy benefits manager" or "PBM" means a person
512492 that, either directly or t hrough an intermediary, performs pharmacy
513493 benefits management, as defined in paragra ph 6 of Section 357 of
514494 Title 59 of the Oklahoma Statutes, and any other person acting for
515495 such person under a contractual or employment relationship in the
516496 performance of pharmacy benefits management for a managed -care
517497 company, nonprofit hospital, medical service organization, insurance
518498 company, third-party payor or a health program administered by a
519499 department of this state. PBM does not include a Pharmacy Services
520500 Administrative Organiz ation;
521501 12. "Pharmacy and therapeutics committee" or "P&T committee"
522502 means a committee at a hospital or a health insurance plan that
523503 decides which drugs will appear on that entity's drug formulary;
524504 13. "Price protection rebate" means a negotiated price
525505 concession that accrues directly or indirectly to the health
526506 insurer, or other party on behalf of the health insurer, in the
527507 event of an increase in the wholesale acquisition of a drug above a
528508 specified threshold;
529509 5. 14. "Provider" means a pharmacy, as defined in Section 353.1
530510 of Title 59 of the Oklahoma Statutes or an agent or representative
531511 of a pharmacy;
512+15. "Rebates" means:
513+a. negotiated price concessions including, but not
514+limited to, base price concessions (whether described
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559-15. "Rebates" means:
560-a. negotiated price concessions including, but not
561-limited to, base price concessions (whether described
562541 as a rebate or otherwise) and reasonable estima tes of
563542 any price protection rebates and performa nce-based
564543 price concessions that may accrue d irectly or
565544 indirectly to a health insurer, health plan, or PBM
566545 during the coverage year from a manufacturer,
567546 dispensing pharmacy, or other party in connection with
568547 the dispensing or administration of a prescription
569548 drug, and
570549 b. reasonable estimates of any price concessions, fees ,
571550 and other administrative costs that are passed
572551 through, or are reasonably anticipated to be passed
573552 through, to a health insurer, health plan, or PBM and
574553 serve to reduce the health insurer, health plan, or
575554 PBM's liabilities for a pr escription drug;
576555 6. 16. "Retail pharmacy network" means retail pharmacy
577556 providers contracted with a PBM in which the pharmacy primari ly
578557 fills and sells prescriptions via a retail, storefront location;
579558 7. 17. "Rural service area" means a five-digit ZIP code in
580559 which the population density is less than one thousand (1,000)
581560 individuals per square mile;
561+8. 18. "Spread pricing" means a prescription drug pricing model
562+utilized by a pharmacy benefits manager in which the PBM charges a
563+health benefit plan a contracted price for prescri ption drugs that
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609-8. 18. "Spread pricing" means a prescription drug pricing model
610-utilized by a pharmacy benefits manager in which the PBM charges a
611-health benefit plan a contracted price for prescri ption drugs that
612590 differs from the amount the PBM directly or indirectly pays the
613591 pharmacy or pharmacist for pr oviding pharmacy services;
614592 9. 19. "Suburban service area" means a five-digit ZIP code in
615593 which the population density is between one thousand (1, 000) and
616594 three thousand (3,000) individuals per square mile; and
617595 10. 20. "Urban service area" means a five-digit ZIP code in
618596 which the population density is greater than three thous and (3,000)
619597 individuals per square mile.
620598 SECTION 5. AMENDATORY 36 O.S. 2021, Section 6962, as
621599 amended by Section 2, Chapter 38, O.S.L. 2022 (36 O.S. Supp. 2022,
622600 Section 6962), is am ended to read as follows:
623601 Section 6962. A. The Oklahoma Insurance Department shall
624602 review and approve retail pharmacy net work access for all pharmacy
625603 benefits managers (PBMs) to ensure compliance with Section 6961 of
626604 this title.
627605 B. A PBM, or an agent of a PBM, shall not:
628606 1. Cause or knowingly pe rmit the use of advertisement,
629607 promotion, solicitation, representation, proposa l or offer that is
630608 untrue, deceptive or misleading;
631609 2. Charge a pharmacist or pharmacy a fee related to the
632610 adjudication of a claim including without limitation a fee for:
611+a. the submission of a claim,
612+b. enrollment or participation in a retail pharmacy
613+network, or
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660-a. the submission of a claim,
661-b. enrollment or participation in a retail pharmacy
662-network, or
663640 c. the development or management of claims processing
664641 services or claims payment services related to
665642 participation in a retail pharmacy network;
666643 3. Reimburse a pharmacy or pharmacist in the state an amount
667644 less than the amount that the PBM reim burses a pharmacy owned by or
668645 under common ownership with a PBM for providing the same covered
669646 services. The reimbursement amount paid to the pharmacy shall be
670647 equal to the reimbursement amount calculated on a per -unit basis
671648 using the same generic product identifier or generic code number
672649 paid to the PBM-owned or PBM-affiliated pharmacy;
673650 4. Deny a provider the opportunity to participate in any
674651 pharmacy network at preferred participation status if the provider
675652 is willing to accept the terms and conditions that the PBM has
676653 established for other providers as a condition of preferred network
677654 participation status;
678655 5. Deny, limit or terminate a provider's contract based on
679656 employment status of any employee who has an active license to
680657 dispense, despite probatio n status, with the State Board of
681658 Pharmacy;
659+6. Retroactively deny or reduce reimbursement for a covered
660+service claim after returning a paid claim response as part of the
661+adjudication of the claim, unless:
662+a. the original claim was submitted fraudulently, or
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709-6. Retroactively deny or reduce reimbursement for a covered
710-service claim after returning a paid claim response as part of the
711-adjudication of the claim, unless:
712-a. the original claim was submitted fraudulently, or
713689 b. to correct errors identified in an audit, so long as
714690 the audit was conducted in compliance with Sections
715691 356.2 and 356.3 of Title 59 of the Oklahoma Statutes;
716692 7. Fail to make any payment due to a pharmacy or pharmacist for
717693 covered services properly rendered in the event a PBM terminates a
718694 provider from a pharmacy benefits manager network ;
719695 8. Conduct or practice Either directly or through an
720696 intermediary, agent, or affiliate, engag e in, facilitate, or enter
721697 into a contract with another person involv ing spread pricing, as
722698 defined in Section 1 6960 of this act title, in this state; or
723699 9. Charge a pharmacist or pharmacy a fee related to
724700 participation in a retail pharmacy network inclu ding but not limited
725701 to the following:
726702 a. an application fee,
727703 b. an enrollment or participation fee,
728704 c. a credentialing or re-credentialing fee,
729705 d. a change of ownership fee , or
730706 e. a fee for the development or manageme nt of claims
731707 processing services or cl aims payment services ; or
732708 10. Prohibit or penalize a pharmacy or pha rmacist for:
709+a. disclosing to an individual information regarding the
710+existence and clinical efficacy of a generic
711+equivalent that would be less expe nsive to the
712+enrollee:
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760-a. disclosing to an individual information regarding the
761-existence and clinical efficacy of a generic
762-equivalent that would be less expe nsive to the
763-enrollee:
764739 (1) under his or her health plan prescription drug
765740 benefit, or
766741 (2) outside his or her health plan prescription drug
767742 benefit, without requesting any health plan
768743 reimbursement, than the drug that was orig inally
769744 prescribed, or
770745 b. selling to an individual, instead of a parti cular
771746 prescribed drug, a therapeutically equivalent drug
772747 that would be less expensive to the enrollee:
773748 (1) under his or her health plan prescription drug
774749 benefit, or
775750 (2) outside his or her health plan prescription drug
776751 benefit, without requesting any healt h plan
777752 reimbursement, than the drug that was originally
778753 prescribed.
779754 C. The prohibitions under this section shall apply to contracts
780755 between pharmacy benefits managers and providers for participation
781756 in retail pharmacy networks.
782757 1. A PBM contract shall:
758+a. not restrict, directly or indirectly, any pharmacy
759+that dispenses a prescription drug from informing, or
760+penalize such pharmacy for informing, an individual of
761+any differential between the individual's out-of-
762+pocket cost or coverage with respect to acqui sition of
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810-a. not restrict, directly or indirectly, any pharmacy
811-that dispenses a prescription drug from informing, or
812-penalize such pharmacy for informing, an individual of
813-any differential between the individual's out-of-
814-pocket cost or coverage with respect to acqui sition of
815789 the drug and the amount an individual would pay to
816790 purchase the drug directly, and
817791 b. ensure that any entity that provides pharmacy benefits
818792 management services under a contract with any such
819793 health plan or health insurance coverage does not,
820794 with respect to such plan or coverage, restrict,
821795 directly or indirectly, a pharmacy that dispenses a
822796 prescription drug from informing, or penalize such
823797 pharmacy for informing, a covered individual of any
824798 differential between the individual's out-of-pocket
825799 cost under the plan or coverage with respect to
826800 acquisition of the drug and the amount an individual
827801 would pay for acquisition of the drug without using
828802 any health plan or health insurance coverage.
829803 2. A pharmacy benefit s manager's contract with a provider shall
830804 not prohibit, restrict or limit disclosure of information to the
831805 Insurance Commissioner, law enforcement or state and federal
832806 governmental officials investigating or examining a complaint or
807+conducting a review of a pharmacy benefits manager 's compliance with
808+the requirements under the Patient's Right to Pharmacy Choice Act.
809+D. A pharmacy benefits manager shall:
810+1. Establish and maintain an electronic claim inquiry
811+processing system using the National Council for Prescription Drug
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860-conducting a review of a pharmacy benefits manager 's compliance with
861-the requirements under the Patient's Right to Pharmacy Choice Act.
862-D. A pharmacy benefits manager shall:
863-1. Establish and maintain an electronic claim inquiry
864-processing system using the National Council for Prescription Drug
865838 Programs' current standards to communica te information to pharmacies
866839 submitting claim inquiries;
867840 2. Fully disclose to insurers, self-funded employers, unions or
868841 other PBM clients the existence of the respective aggregate
869842 prescription drug discounts, rebates received from dr ug
870843 manufacturers and pharmacy audit recoupments;
871844 3. Provide the Insu rance Commissioner, insurers, self-funded
872845 employer plans and unions unrestricted audit rights of and access to
873846 the respective PBM pharmaceutical manu facturer and provider
874847 contracts, plan utilization data, plan pricing data, pharmacy
875848 utilization data and ph armacy pricing data;
876849 4. Maintain, for no less than three (3) years, documentation of
877850 all network development activities including but not limited to
878851 contract negotiations and any denials to providers to join networks.
879852 This documentation shall be made ava ilable to the Commissioner upon
880853 request;
881854 5. Report to the Commissioner, on a quarterly basis in a manner
882855 and form prescribed by the Commissioner , along with any applicable
883856 fees set by the Commissioner, a report on the first day of each
857+calendar year, containing aggregate information for the prior
858+calendar year. The report shall include the following information
859+as it pertains to the PB M's contracts with insurers in the state,
860+broken out for each health insurer payor, on the following
861+information:
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911-calendar year, containing aggregate information for the prior
912-calendar year. The report shall include the following information
913-as it pertains to the PB M's contracts with insurers in the state,
914-broken out for each health insurer payor, on the following
915-information:
916888 a. the aggregate amount of rebates received by the PBM
917889 received from all pharmaceutical manufacturers ,
918890 b. the aggregate amount of rebates distributed to the
919891 appropriate health insurer payor,
920892 c. the aggregate amount of rebates that the PBM received
921893 from all pharmaceutical manufacturers and did not pass
922894 through to health insurers,
923895 d. the aggregate amount of rebates passed on to the
924896 enrollees of each health insur er payor at the point of
925897 sale that reduced the applicable deductible,
926898 copayment, coinsure or other defined cost sharing
927899 amount of the enrollee,
928900 d.
929901 e. the aggregate amount of all administrative fees the
930902 PBM received,
931903 f. the aggregate amount of health insurer administrative
932904 service fees that the PBM received,
905+g. the aggregate amount of all administrative fees tha t
906+the PBM received from all pharmaceutical manufacturers
907+and did not pass through to health insurers,
908+h. the aggregate retained rebate perc entage, across all
909+the PBM's contractual or othe r relationships with all
910+health insurers, the highest aggregate re tained rebate
911+percentage, the lowest aggregate retained rebate
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960-g. the aggregate amount of all administrative fees tha t
961-the PBM received from all pharmaceutical manufacturers
962-and did not pass through to health insurers,
963-h. the aggregate retained rebate perc entage, across all
964-the PBM's contractual or othe r relationships with all
965-health insurers, the highest aggregate re tained rebate
966-percentage, the lowest aggregate retained rebate
967938 percentage, and the mean aggregate retained rebate
968939 percentage,
969940 i. the individual and aggregate amount paid by the health
970941 insurer payor to the PBM for pharmacy services
971942 itemized by pharmacy, dru g product and service
972943 provided, and
973944 e.
974945 j. the individual and aggregate amount a PBM paid a
975946 provider for pharmacy services itemize d by pharmacy,
976947 drug product and service provided.
977948 The Department shall publish in a timely manner the information
978949 that it receives under paragraph 5 of this subsection on a publicly
979950 available website; provided that such information shall be made
980951 available in a form that does not disclose the identity of a
981952 specific health plan or the identity of a specific manufacturer, the
982953 prices charged for specific drugs or classes of drugs, or the amount
983954 of any rebates provided for specific drugs or classes of drugs.
955+E. For each of the PBM's contracts or other relationships with
956+a health plan, a PBM shall publish on an easily a ccessible website
957+the health plan formulary, and timely notification of formulary
958+changes and/or product exclusions.
959+F. The PBM and the Department shall not publish or otherwise
960+disclose any information tha t would reveal the identity of a
961+specific health plan, the price(s ) charged for a specific drug or
984962
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1011-E. For each of the PBM's contracts or other relationships with
1012-a health plan, a PBM shall publish on an easily a ccessible website
1013-the health plan formulary, and timely notification of formulary
1014-changes and/or product exclusions.
1015-F. The PBM and the Department shall not publish or otherwise
1016-disclose any information tha t would reveal the identity of a
1017-specific health plan, the price(s ) charged for a specific drug or
1018988 class of drugs, the amount of any rebates provided for a specific
1019989 drug or class of drugs, the manufacturer, or that wou ld otherwise
1020990 have the potential to com promise the financial, competitive, or
1021991 proprietary nature of the information. Any such information shall
1022992 be protected from disclosure as confidential and proprietary
1023993 information, is not a public record as defined in t he Oklahoma Open
1024994 Records Act, Section 24A.1 et seq. of Title 51 of the Oklahoma
1025995 Statutes, and shall not be disclosed directly or indirectly. A PBM
1026996 shall impose the confidentiality protections of this section o n any
1027997 vendor or downstream third party that pe rforms health care or
1028998 administrative services on behalf of the PBM and that may receive or
1029999 have access to rebate information.
10301000 SECTION 6. AMENDATORY 36 O.S. 2021, Section 6964, is
10311001 amended to read as follows:
10321002 Section 6964. A. A health insurer's insurer or its agent's,
10331003 including pharmacy benefits managers, pharmacy and therapeutics
10341004 committee (P&T committee) shall establish a formulary, which shall
1005+be a list of prescription drugs, both generic and brand name, used
1006+by practitioners to identify drugs that offer the greates t overall
1007+value.
1008+B. A health insurer shall prohibit conflicts of interest for
1009+members of the P&T committee. The P&T committee shall review the
1010+formulary annually and must meet the foll owing requirements:
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1062-be a list of prescription drugs, both generic and brand name, used
1063-by practitioners to identify drugs that offer the greates t overall
1064-value.
1065-B. A health insurer shall prohibit conflicts of interest for
1066-members of the P&T committee. The P&T committee shall review the
1067-formulary annually and must meet the foll owing requirements:
10681037 1. A person may not serve on a P&T committee if th e person is
10691038 currently employed or was employe d within the precedin g year by a
10701039 pharmaceutical manufacturer, developer, labeler, wholesaler or
1071-distributor. A majority of P&T committee members shall be
1072-practicing physicians, practicing pharmacists, or both, and shall be
1073-licensed in Oklahoma;
1040+distributor. A majority of P&T committee members shall be practicing
1041+physicians, practicing pharmacists, or both, and shall be licensed
1042+in Oklahoma;
10741043 2. A health insurer shall requi re any member of the P&T
10751044 committee to disclose any compensation or funding from a
10761045 pharmaceutical manufacturer, deve loper, labeler, wholesaler or
10771046 distributor. Such P&T committee member shall be recused from voting
10781047 on any product manufactured or sold by suc h pharmaceutical
10791048 manufacturer, developer, labeler, wholesaler or distributor. P&T
10801049 committee members shall practice in various clinical specialties
10811050 that adequately represent the needs of health plan enrollees, and
10821051 there shall be an adequate number of high -volume specialists and
10831052 specialists treating rare and orphan diseases;
10841053 3. The P&T committee shall meet no less frequently than on a
10851054 quarterly basis;
1055+4. P&T committee formulary development shall be conducted
1056+pursuant to a transparent process, and formulary decisions and
1057+rationale shall be documented in writing, with any records and
1058+documents relating to the process ava ilable upon request to the
1059+health plan, subject to the conditions in subsection C of this
1060+section. In the case of P&T committee decisions th at relate to
10861061
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1113-4. P&T committee formulary development shall be conducted
1114-pursuant to a transparent process, and formulary decisions and
1115-rationale shall be documented in writing, with any records and
1116-documents relating to the process ava ilable upon request to the
1117-health plan, subject to the conditions in subsection C of this
1118-section. In the case of P&T committee decisions th at relate to
11191087 Medicaid managed care organizations' prescription drug coverage
11201088 policies, if the P&T committee relies upon any thi rd party to
11211089 provide cost-effectiveness analysis or research, the P&T committee
11221090 shall:
11231091 a. disclose to the health benefit plan, the state, and
11241092 the general public the name of the relevant third
11251093 party, and
11261094 b. provide a process through which patients and provi ders
11271095 potentially impacted by the third party's analysis or
11281096 research may provide input to the P&T committee;
11291097 5. Specialists with current clinical expertise who actively
11301098 treat patients in a specific therapeutic area, and the specific
11311099 conditions within a the rapeutic area, shall participate in formulary
11321100 decisions regarding each therapeutic area an d specific condition;
11331101 6. The P&T committee shall base its clinical decisions on the
11341102 strength of scientific evidence, standards of practice, and
11351103 nationally accepted tre atment guidelines;
1104+7. The P&T committee shall consider whether a particular drug
1105+has a clinically meaningful therapeutic advant age over other drugs
1106+in terms of safety, effectiveness, or clinical outcome for patient
1107+populations who may be treated with the d rug;
1108+8. The P&T committee shall evaluate and analyze treatment
1109+protocols and procedures related to the health plan's formulary at
1110+least annually;
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1163-7. The P&T committee shall consider whether a particular drug
1164-has a clinically meaningful therapeutic advant age over other drugs
1165-in terms of safety, effectiveness, or clinical outcome for patient
1166-populations who may be treated with the d rug;
1167-8. The P&T committee shall evaluate and analyze treatment
1168-protocols and procedures related to the health plan's formulary at
1169-least annually;
11701137 9. The P&T committee shall review formulary management
11711138 activities, including exceptions and appeals processes, prior
11721139 authorization, step therapy, quantity limits, generic substitutions,
11731140 therapeutic interchange, a nd other drug utilizati on management
11741141 activities for clinical appropriateness and consistency with
11751142 industry standards and patient and provider organization guidelines;
11761143 10. The P&T committee shall annually review and provide a
11771144 written report to the pharmacy benefits manager on:
11781145 a. the percentage of prescription drugs on formulary
11791146 subject to each of the types of utilization management
11801147 described in paragraph 9 of this subsection,
11811148 b. rates of adherence and nonadherence to medicines by
11821149 therapeutic area,
11831150 c. rates of abandonment of medicines by therapeutic area,
11841151 d. recommendations for improved adherence and reduced
11851152 abandonment,
1153+e. recommendations for improvement in formulary
1154+management practices consistent with patient and
1155+provider organization and other clinica l guidelines;
1156+provided that the report shall be subject to the
1157+conditions in subsection C of this section;
1158+11. The P&T committee shall review and make a fo rmulary
1159+decision on a new U.S. Food and Drug Administration approved drug
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1213-e. recommendations for improvement in formulary
1214-management practices consistent with patient and
1215-provider organization and other clinical guidelines;
1216-provided that the report shall be subject to the
1217-conditions in subsection C of this section;
1218-11. The P&T committee shall review and make a fo rmulary
1219-decision on a new U.S. Food and Drug Administration approved drug
12201186 within ninety (90) days of such drug's approval, or shall provide a
12211187 clinical justification if this time frame is not met;
12221188 12. The P&T committee shall review procedures for medical
12231189 review of, and transiti oning new plan enrollees to, appropria te
12241190 formulary alternatives to en sure that such procedures a ppropriately
12251191 address situations involving enrollees stabilized on drugs that are
12261192 not on the health plan formulary (or that are on formulary but
12271193 subject to prior authorization, step therapy, or other utilization
12281194 management requirements).
12291195 C. The health insurer, its agents, including pharmacy benefits
12301196 managers, and the Department shall not publish or otherwise disclose
12311197 any confidential, propriet ary information, inc luding, but not
12321198 limited to, any information that would reveal the identi ty of a
12331199 specific health plan, the prices charged for a specific drug or
12341200 class of drugs, the amount of any rebates provided for a specific
12351201 drug or class of drugs, th e manufacturer, or t hat would otherwise
12361202 have the potential to compromise the financial, co mpetitive, or
1203+proprietary nature of the information. Any such information shall
1204+be protected from disclosure as confidential and proprietary
1205+information, is not a pu blic record as defin ed in the Oklahoma Open
1206+Records Act, Section 24A.1 et seq. of Title 51 of the Oklaho ma
1207+Statutes, and shall not be disclosed directly or indirectly. A
1208+health insurer shall impose the confidentiality protections of this
1209+section on any vendor or downstream t hird party that performs health
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1264-proprietary nature of the information. Any such information shall
1265-be protected from disclosure as confidential and proprietary
1266-information, is not a pu blic record as defin ed in the Oklahoma Open
1267-Records Act, Section 24A.1 et seq. of Title 51 of the Oklaho ma
1268-Statutes, and shall not be disclosed directly or indirectly. A
1269-health insurer shall impose the confidentiality protections of this
1270-section on any vendor or downstream t hird party that performs health
12711236 care or administrative services on behalf of the pharmac y benefits
12721237 manager that may receive or have access to rebate information.
12731238 SECTION 7. NEW LAW A new section of law to be codified
12741239 in the Oklahoma Statutes as Section 6962.2 of Title 36, unless there
12751240 is created a duplication in numbering, reads as fo llows:
12761241 A. An enrollee's defined cost sharing for each prescription
12771242 drug shall be calculated at the point of s ale based on a price that
12781243 is reduced by an amount equal to at least eighty-five percent (85%)
12791244 of all rebates received, or to be received, in connection with the
12801245 dispensing or administration of the prescription drug.
12811246 B. For any violation of this section, the Insurance
12821247 Commissioner may subject a PB M to an administrative penalty of not
12831248 less than One Hundred Dollars ( $100.00) nor more than Ten Thousand
12841249 Dollars ($10,000.00) for each occurrence. Such administrative
12851250 penalty may be enforced in the same manner in w hich civil judgments
12861251 may be enforced.
1252+C. Nothing in subsections A and B of this section shall
1253+preclude a PBM from decreasing an enrollee 's defined cost sharing by
1254+an amount greater than that required under subsection A of this
1255+section.
1256+D. In implementing the requi rements of this section, the st ate
1257+shall only regulate a PBM to the extent permissible under applicable
1258+law.
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1314-C. Nothing in subsections A and B of this section shall
1315-preclude a PBM from decreasing an enrollee 's defined cost sharing by
1316-an amount greater than that required under subsection A of this
1317-section.
1318-D. In implementing the requi rements of this section, the st ate
1319-shall only regulate a PBM to the extent permissible under applicable
1320-law.
13211285 E. In complying with the provisions of this section, a PBM or
13221286 its agents shall not publish or otherwise reveal information
13231287 regarding the actual amount of reb ates a PBM receives on a product
13241288 or therapeutic class of p roducts, manufacturer, or pharmacy -specific
13251289 basis. Such information is protected as a trade secret, is not a
13261290 public record as defined in the Oklahoma Open Records Act, Section
13271291 24A.1 et seq. of Title 51 of the Oklahoma Statutes, and shall not be
13281292 disclosed directly or indirectly, or in a manner that would allow
13291293 for the identification of an individual product, therapeutic class
13301294 of products, or manufacturer, or in a manner that would have the
13311295 potential to compromise the fi nancial, competitive, or proprietary
13321296 nature of the information. A PBM shall impose the confidentiality
13331297 protections of this section on any vendor or downstream third party
13341298 that performs health care or administrative services on behalf o f
13351299 the insurer that may receive or have access to rebate information.
1300+SECTION 8. NEW LAW A new sectio n of law to be codified
1301+in the Oklahoma Statutes as Section 6970 of Title 36, unless there
1302+is created a duplication in numbering, reads as follows:
1303+A. For purposes of this section:
1304+1. "Defined cost sharing" means a deductible payment or
1305+coinsurance amount imposed on an enrollee for a covered prescription
1306+drug under the enrollee's health plan;
1307+2. "Insurer" means any health insurance issuer that is subje ct
1308+to state law regulating in surance and offers health insuranc e
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1363-SECTION 8. NEW LAW A new sectio n of law to be codified
1364-in the Oklahoma Statutes as Section 6970 of Title 36, unless there
1365-is created a duplication in numbering, reads as follows:
1366-A. For purposes of this section:
1367-1. "Defined cost sharing" means a deductible payment or
1368-coinsurance amount imposed on an enrollee for a covered prescription
1369-drug under the enrollee's health plan;
1370-2. "Insurer" means any health insurance issuer that is subje ct
1371-to state law regulating in surance and offers health insurance
13721335 coverage, as defined in 42 U.S.C. , Section 300gg-91, or any state or
13731336 local governmental employer plan;
13741337 3. "Price protection rebate" means a negotiated price
13751338 concession that accrues directly or indirectly to the insurer, or
13761339 other party on behalf of the i nsurer, in the event of an increase in
13771340 the wholesale acquisition cost of a drug above a specified
13781341 threshold;
13791342 4. "Rebate" means:
13801343 a. negotiated price concessions including , but not
13811344 limited to, base price concessions (whethe r described
13821345 as a rebate or otherwise) and reasonable estimates of
13831346 any price protection rebates and performance-based
13841347 price concessions that may accrue directly or
13851348 indirectly to the insurer during the coverag e year
13861349 from a manufacturer, dispensing pharmacy, or other
1350+party in connection with the dispensing or
1351+administration of a pre scription drug, and
1352+b. reasonable estimates of any negotiated price
1353+concessions, fees, and other administrative costs that
1354+are passed through, or are re asonably anticipated to
1355+be passed through, to the insurer and s erve to reduce
1356+the insurer's liabilities for a prescription drug.
1357+B. An enrollee's defined cost sharing for each prescription
1358+drug shall be calculated at the point of sale based on a price tha t
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1414-party in connection with the dispensing or
1415-administration of a pre scription drug, and
1416-b. reasonable estimates of any negotiated price
1417-concessions, fees, and other administrative costs that
1418-are passed through, or are re asonably anticipated to
1419-be passed through, to the insurer and serve to reduce
1420-the insurer's liabilities for a prescription drug.
1421-B. An enrollee's defined cost sharing for each prescription
1422-drug shall be calculated at the point of sale based on a price tha t
14231385 is reduced by an amount equ al to at least eighty-five percent (85%)
14241386 of all rebates received, or to be received, in connection with the
14251387 dispensing or administration of the prescription drug.
14261388 C. For any violation of this section, the I nsurance
14271389 Commissioner may subject an insurer to an administrative penalty of
14281390 not less than One Hundred Dollars ($100.00) nor more than Ten
14291391 Thousand Dollars ($10,000.00) for each occurrence. Such
14301392 administrative penalty may be enforced in the same manner in which
14311393 civil judgments may be enforced.
14321394 D. Nothing in subsections A through C of this section shall
14331395 preclude an insurer fro m decreasing an enrollee's defined cost
14341396 sharing by an amount greater than that required under subsection B
14351397 of this section.
1398+E. In implementing the requ irements of this section, the state
1399+shall only regulate an insurer to the extent permissible under
1400+applicable law.
1401+F. In complying with the provisions of this section, an insurer
1402+or its agents shall not publish or otherwise reveal info rmation
1403+regarding the actual amount of rebates an insurer receives on a
1404+product or therapeutic class of pr oducts, manufacturer, or pharmacy-
1405+specific basis. Such information is protected as a trade secret, is
1406+not a public record as defined in the Oklahoma Open Records Act,
1407+Section 24A.1 et seq. of Title 51 of the Oklahoma Statutes, and
1408+shall not be disclosed directly or indirectly, or in a manner that
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1463-E. In implementing the requ irements of this section, the state
1464-shall only regulate an insurer to the extent permissible under
1465-applicable law.
1466-F. In complying with the provisions of this section, an insurer
1467-or its agents shall not publish or otherwise reveal info rmation
1468-regarding the actual amount of rebates an insurer receives on a
1469-product or therapeutic class of pr oducts, manufacturer, or pharmacy-
1470-specific basis. Such information is protected as a trade secret, is
1471-not a public record as defined in the Oklahoma Open Records Act,
1472-Section 24A.1 et seq. of Title 51 of the Oklahoma Statutes, and
1473-shall not be disclosed directly or indirectly, or in a manner that
14741435 would allow for the identification of an individual product,
14751436 therapeutic class of product s, or manufacturer, or in a manner tha t
14761437 would have the potential to compromise the financial, competitive,
14771438 or proprietary nature of the information. An insurer shall impose
14781439 the confidentiality protections of this section on any vendor or
14791440 downstream third party that performs health care or adm inistrative
14801441 services on behalf of the insurer and that may receive or have
14811442 access to rebate information.
14821443 SECTION 9. This act shall become effective November 1, 2023.
1483-COMMITTEE REPORT BY: COMMITTEE ON RETIREMENT AND INSURANCE
1484-April 11, 2023 - DO PASS
1444+Passed the House of Representatives the 20th day of March, 2023.
1445+
1446+
1447+
1448+
1449+ Presiding Officer of the House
1450+ of Representatives
1451+
1452+
1453+Passed the Senate the ____ day of __________, 2023.
1454+
1455+
1456+
1457+
1458+ Presiding Officer of the Senate
1459+
1460+