Oklahoma 2022 Regular Session

Oklahoma House Bill HB3492 Compare Versions

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2828 STATE OF OKLAHOMA
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3030 2nd Session of the 58th Legislature (2022)
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3232 HOUSE BILL 3492 By: McEntire
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3838 AS INTRODUCED
3939
4040 An Act relating to healthcare; creating the Oklahoma
4141 Rebate Pass Through and PBM Meaningful Transparency
4242 Act of 2022; amending 59 O.S. 2021, Sections 357 and
4343 358, which relate to definitions; modifying
4444 definitions; creating duties; creating licensing
4545 application requirements; amending 36 O.S. 2021,
4646 Section 6960, which relates to definitions; defining
4747 terms; creating PBM disclosures; amending 36 O.S.
4848 2021, Section 6962, which relates to pharmacy
4949 benefits manager compliance; creating duties;
5050 amending 36 O.S. 2021, Section 6964, which relates to
5151 a formulary for prescription drugs; creating agency
5252 duties; creating PBM fairness in cost sharing;
5353 creating penalties; creating insurer fairness in cost
5454 sharing; providing for noncodification; providing for
5555 codification; and providing an effecti ve date.
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6060 BE IT ENACTED BY THE PEOP LE OF THE STATE OF OKLAHOMA :
6161 SECTION 1. NEW LAW A new section of law not to b e
6262 codified in the Oklahoma Statutes reads as follows:
6363 This act shall be known and may be cited as the "Oklahoma Rebate
6464 Pass Through and PBM Meaningful Transparency Act of 2022 ".
6565 SECTION 2. AMENDATORY 59 O.S. 2021, Section 357, is
6666 amended to read as fo llows:
6767 Section 357. As used in this act:
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9494 1. "Covered entity" means a nonprofit hospital or medical
9595 service organization, insurer, heal th coverage plan or health
9696 maintenance organization; a health program administered by the state
9797 in the capacity of pro vider of health coverage; or an employer,
9898 labor union, or other entity organized in the state that provides
9999 health coverage to covered ind ividuals who are employed o r reside in
100100 the state. This term does not include a health plan that provides
101101 coverage only for accidental injury, specified disease, hospital
102102 indemnity, disability income, or other limited benefit he alth
103103 insurance policies and contracts that do not inclu de prescription
104104 drug coverage;
105105 2. "Covered individual" means a member, participant, enroll ee,
106106 contract holder or policy holder or beneficiary of a covered entity
107107 who is provided health coverage by the covered entity. A covered
108108 individual includes any dep endent or other person provided health
109109 coverage through a policy, contract or plan for a co vered
110110 individual;
111111 3. "Department" means the Oklahoma Insurance Department;
112112 4. "Maximum allowable cost " or "MAC" means the list of drug
113113 products delineating the max imum per-unit reimbursement for
114114 multiple-source prescription drugs, medical product or devi ce;
115115 5. "Multisource drug product reimbursement " (reimbursement)
116116 means the total amount paid to a pharmacy inc lusive of any reduction
117117 in payment to the pharmacy, exc luding prescription dispense fees;
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144144 6. "Pharmacy benefits management " means a service provi ded to
145145 covered entities to facilitate the provision of prescription drug
146146 benefits to covered individuals withi n the state, including
147147 negotiating pricing and other te rms with drug manufacturers and
148148 providers. Pharmacy benefits management may include any or all of
149149 the following services:
150150 a. claims processing, performance of drug-utilization
151151 review, processing of dr ug prior authorization
152152 requests, retail network managem ent and payment of
153153 claims to pharmacies for prescription drugs dispensed
154154 to covered individuals,
155155 b. clinical formulary development and management
156156 services,
157157 c. rebate contracting an d administration,
158158 d. certain patient compliance, therapeutic intervention
159159 and generic substitution programs, or
160160 e. disease management programs ,
161161 f. adjudication of appeals and grievances related to the
162162 prescription drug benefit, and/or
163163 g. controlling the cost of prescription drugs;
164164 7. "Pharmacy benefits manager" or "PBM" means a person,
165165 business or other entity that, either directly or through an
166166 intermediary, performs pharmacy benefits management. The term
167167 includes a person or entity acting for a PBM in a contractual or
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194194 employment relationship in the pe rformance of pharmacy benef its
195195 management for a managed care company, nonprofit hospital, medical
196196 service organization, insurance company, third-party payor, or a
197197 health program administered by an agency of this state;
198198 8. "Plan sponsor" means the employers, insurance companies,
199199 unions and health maintenance organizations or any other entity
200200 responsible for establishing, maintaining, or administering a health
201201 benefit plan on behalf of covered individuals; and
202202 9. "Provider" means a pharmacy licensed by the State Board of
203203 Pharmacy, or an agent or representative of a pharmacy, including,
204204 but not limited to, the pharmacy 's contracting agent, which
205205 dispenses prescription drugs or devices to covered individuals.
206206 SECTION 3. AMENDATORY 59 O.S. 2021, Section 358, is
207207 amended to read as follows:
208208 Section 358. A. In order to provide pharmacy benefits
209209 management or any of the services included under the defi nition of
210210 pharmacy benefits management in this state, a pharma cy benefits
211211 manager or any entity acting as one in a co ntractual or employment
212212 relationship for a covered entity shall first obtain a license from
213213 the Oklahoma Insurance Department, and the Depa rtment may charge a
214214 fee for such licensure.
215215 B. The Department shall establish, by regulat ion, licensure
216216 procedures, required disclosures for pharmacy benefits managers
217217 (PBMs) and other rules as may be necessar y for carrying out and
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244244 enforcing the provision s of this act. The licensure procedures
245245 shall, at a minimum, include the completion of an application form
246246 that shall include the name and address of an agent for service of
247247 process, the payment of a requisite fee, and evidence of the
248248 procurement of a sur ety bond the following:
249249 1. The name, address, and telephone contact number of the PBM;
250250 2. The name and address of the PBM's agent for service of
251251 process in the state;
252252 3. The name and address of each person wit h management or
253253 control over the PBM;
254254 4. Evidence of the procurement of a surety bon d;
255255 5. The name and address of each person with a beneficial
256256 ownership interest in the PBMs;
257257 6. In the case of a PBM applicant that is a partnership or
258258 other unincorporated association, limited liability corporation o r
259259 corporation, and has five or more partners, members, or
260260 stockholders:
261261 a. the applicant shall specify its legal structure and
262262 the total number of partners, members, or
263263 stockholders,
264264 b. the applicant shall specify the name, address, usual
265265 occupation, and professional qualifications of the
266266 five partners, members , or stockholders with the five
267267 largest ownership interests in the PBM, and
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294294 c. the applicant shall agree that, upon request by the
295295 Department, it shall furnish the Department with
296296 information regarding the name, address, usual
297297 occupation, and professional qualifications of any
298298 other partners, members, or stockhol ders; and
299299 7. A signed statement indicating that the PBM has not been
300300 convicted of a felony and has not violated any of the requireme nts
301301 of the Oklahoma Pharmacy Act and the Patient 's Right to Pharmacy
302302 Choice Act, or, if the ap plicant cannot provide such a statement, a
303303 signed statement describing the relevant convi ction(s) or
304304 violation(s).
305305 C. The Department may subpoena witnesses and informa tion. Its
306306 compliance officers may take and copy records for i nvestigative use
307307 and prosecutions. Nothing in this subsection shall limit the Offic e
308308 of the Attorney General from using its investi gative demand
309309 authority to investigate and prosecute violation s of the law.
310310 D. The Department may suspend, revoke or refuse to issue or
311311 renew a license for noncompliance with any of the provisions hereby
312312 established or with the rules promulgated by the D epartment; for
313313 conduct likely to mislead, deceive or defraud th e public or the
314314 Department; for unfair or deceptive business p ractices or for
315315 nonpayment of a renewal fee or fine . The Department may also levy
316316 administrative fines for each count of which a PBM has been
317317 convicted in a Department hearing.
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344344 SECTION 4. AMENDATORY 36 O.S. 2021, Section 6960, is
345345 amended to read as follows :
346346 Section 6960. For purposes of the Patient's Right to Pharmacy
347347 Choice Act:
348348 1. "Administrative fees" means fees or payments from
349349 pharmaceutical manufacturers to, or otherwise retained by, a
350350 pharmacy benefits manager (PBM) or its designee pursuant to a
351351 contract between a PBM or a ffiliate and the manufacturer in
352352 connection with the PBM's administering, invoicing, alloc ating and
353353 collecting the rebates;
354354 2. "Aggregate-retained rebate percentage" means the percentage
355355 of all rebates received by a PBM from all pharmaceutical
356356 manufacturers which is not passed on to the PBM's health plan or
357357 health insurer clients. Aggregate-retained rebate percentage shall
358358 be expressed without disclosing any identifying information
359359 regarding any health pla n, prescription drug, or the rapeutic class,
360360 and shall be calculated by dividi ng:
361361 a. the aggregate dollar amount of all rebates that the
362362 PBM received during t he prior calendar year from all
363363 pharmaceutical manufacturers and did not pass through
364364 to the PBM's health plan or health in surer clients, by
365365 b. the aggregate dollar amount of all rebates that the
366366 pharmacy benefits manager received duri ng the prior
367367 calendar year from all pharmaceutical manufacturers;
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394394 3. "Defined cost sharing" means a deductible payment or
395395 coinsurance amount impo sed on an enrollee for a cover ed prescription
396396 drug under the enrol lee's health plan;
397397 4. "Formulary" means a list of prescription drugs , as well as
398398 accompanying tiering and other coverage information, that has been
399399 developed by an issuer, a health plan, or t he designee of a health
400400 insurer or health plan, which the health insurer, health plan, or
401401 designee of the health insurer or health plan references in
402402 determining applicable coverage and benefit levels;
403403 5. "Generic equivalent" means a drug that is designate d to be
404404 therapeutically equivalent, as indicated by the United States Food
405405 and Drug Administration's "Approved Drug Products with Therapeutic
406406 Equivalence Evaluatio ns"; provided, however, that a drug shall not
407407 be considered a generic equivalent until the drug becomes nationally
408408 available;
409409 6. "Health insurer" means any corporation, associa tion, benefit
410410 society, exchange, partnership or individual licensed by the
411411 Oklahoma Insurance Code;
412412 7. "Health insurer administrative service fees" means fees or
413413 payments from a health insurer or a designee of the health insurer
414414 to, or otherwise retained by, a PBM or its design ee pursuant to a
415415 contract between a PBM or affiliate, and the health insurer or
416416 designee of the health insurer in connec tion with the PBM managing
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443443 or administering the pharmacy benefit and administering, invoicin g,
444444 allocating and collecting rebates;
445445 8. "Health plan" means a policy, contract, certification, or
446446 agreement offered or issued by a health insurer to provide, deli ver,
447447 arrange for, pay for , or reimburse any of the costs of health
448448 services;
449449 2. 9. "Mail-order pharmacy" means a pharmacy licensed by t his
450450 state that primarily dispenses and delivers covered drugs via common
451451 carrier;
452452 3. 10. "Pharmacy benefits manager " or "PBM" means a person
453453 that, either directly or through a n intermediary, performs pharmacy
454454 benefits management, as defined in paragraph 6 of Section 357 of
455455 Title 59 of the Oklahoma Statutes and any other person acting for
456456 such person under a contractual or employment relationship in th e
457457 performance of pharmacy benefits management for a managed -care
458458 company, nonprofit hospital, m edical service organization, insurance
459459 company, third-party payor or a health program administered by a
460460 department of this state;
461461 4. 11. "Pharmacy and therapeut ics committee" or "P&T committee"
462462 means a committee at a hospit al or a health insurance plan th at
463463 decides which drugs will appear on that entity 's drug formulary;
464464 12. "Price-protection rebate" means a negotiated-price
465465 concession that accrues directly or indirectly to the health
466466 insurer, or other party on behalf of the health insurer, in the
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493493 event of an increase in the wholesale acquisition of a drug above a
494494 specified threshold;
495495 13. "Rebates" means:
496496 a. negotiated-price concessions including, but not
497497 limited to, base-price concessions (whether described
498498 as a rebate or otherwise) and reasonable estima tes of
499499 any price-protection rebates and performance -based
500500 price concessions that may accrue directly or
501501 indirectly to the PBM during the coverage year from a
502502 manufacturer, dispensing pharmacy, or other party in
503503 connection with the dispensing or administrat ion of a
504504 prescription drug, and
505505 b. reasonable estimates of any price concessions, fees ,
506506 and other administrative costs that are pass ed
507507 through, or are reasonably anticipated to be passed
508508 through, to the PBM and serve to redu ce the PBM's
509509 liabilities for a pr escription drug;
510510 5. 14. "Retail pharmacy network " means retail pharmacy
511511 providers contracted with a PBM in which the pharmacy prim arily
512512 fills and sells prescri ptions via a retail, storefront location;
513513 6. 15. "Rural service area" means a five-digit ZIP code in
514514 which the population density is less than one thousand (1,0 00)
515515 individuals per square mile;
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542542 7. 16. "Suburban service area " means a five-digit ZIP code in
543543 which the population de nsity is between one thousand (1,000) a nd
544544 three thousand (3,000) individu als per square mile; and
545545 8. 17. "Urban service area" means a five-digit ZIP code in
546546 which the population density is greater than three thousand (3,000)
547547 individuals per square mile.
548548 SECTION 5. NEW LAW A new section of law to be codi fied
549549 in the Oklahoma Statutes as Section 6962.1 of Title 36, unless there
550550 is created a duplication in numbering, reads as follows :
551551 A. Beginning on January 1, 2022, and on an annual basi s
552552 thereafter, a pharmacy benefits ma nager (PBM) shall provide the
553553 Insurance Department with a report containing the following
554554 information from the prior calendar year as it pertai ns to pharmacy
555555 benefits provided by health insurer s to enrollees in the state:
556556 1. The aggregate dollar amount of all rebates that the PBM
557557 received from all phar maceutical manufacturers;
558558 2. The aggregate dollar amount of al l administrative fees that
559559 the PBM received;
560560 3. The aggregate dollar amount of al l issuer administrative
561561 service fees that the PBM received;
562562 4. The aggregate dollar amount of all rebates that the PBM
563563 received from all pharmaceutical manufacturers and did not pass
564564 through to health plans or he alth insurers;
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591591 5. The aggregate dollar amo unt of all administrative fees that
592592 the PBM received from all pharmaceutical manufacturers and did not
593593 pass through to health plans or health insurers;
594594 6. The aggregate-retained rebate percentage; and
595595 7. Across all of the PBM's contractual or other relationships
596596 with all health plans or health insurers, the highest aggregate-
597597 retained rebate percentage, the lowest aggregate -retained rebate
598598 percentage, and the mean aggregate-retained rebate perc entage.
599599 B. The Department shall p ublish in a timely manner the
600600 information that it receives under subsection A of this section on a
601601 publicly available website ; provided that such information shall be
602602 made available in a form that does not disclose the identity of a
603603 specific health plan or the identity of a specific manufacturer, the
604604 prices charged for specific drugs or classes o f drugs, or the amount
605605 of any rebates provided for specific drugs or classes of drugs.
606606 C. The PBM and the Department shall not publish or otherwise
607607 disclose any information that would reveal the identity of a
608608 specific health plan, the price(s) charged for a specific drug or
609609 class of drugs, the amount of any rebates provided for a specific
610610 drug or class of drugs, the manufacturer, or that would otherw ise
611611 have the potential to compromise the financial, competitive, o r
612612 proprietary nature of the information. Any such information shall
613613 be protected from disclosure as confidential and proprietary
614614 information, is not a public record as defined in the Oklahoma Open
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641641 Records Act, Section 24A.1 et seq. of Title 51 of the Oklahoma
642642 Statutes, and shall not be disclosed directly or indirectly. A PBM
643643 shall impose the confidential ity protections of this section on any
644644 vendor or downstream third pa rty that performs health care or
645645 administrative services on beha lf of the PBM and that may receive or
646646 have access to rebate info rmation.
647647 SECTION 6. AMENDATORY 36 O.S. 2021, Section 6962, is
648648 amended to read as follows :
649649 Section 6962. A. The Oklahoma Insurance Departme nt shall
650650 review and approve retail pharmacy network access for all pharmacy
651651 benefits managers (PBMs) to ensure compliance with Se ction 4 6961 of
652652 this act title.
653653 B. A PBM, or an agent of a PBM, shall n ot:
654654 1. Cause or knowingly permit the us e of advertisement,
655655 promotion, solicitation , representation, proposal or offer that is
656656 untrue, deceptive or misleading;
657657 2. Charge a pharmacist or pharmacy a fee related to the
658658 adjudication of a claim, including with out limitation a fee for:
659659 a. the submission of a claim,
660660 b. enrollment or participat ion in a retail pharmacy
661661 network, or
662662 c. the development or manag ement of claims processing
663663 services or claims payment services related to
664664 participation in a retail pharmacy network;
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691691 3. Reimburse a pharmacy or pha rmacist in the state an amount
692692 less than the amount that the PBM reimburses a pharmacy owned by or
693693 under common ownership with a PBM for providi ng the same covered
694694 services. The reimbursement amount paid to the phar macy shall be
695695 equal to the reimbursement amount calculated on a per-unit basis
696696 using the same generic product identifier or generic code number
697697 paid to the PBM-owned or PBM-affiliated pharmacy;
698698 4. Deny a pharmacy the oppo rtunity to participate in any
699699 pharmacy network at preferred participation status if the pharmacy
700700 is willing to accept the terms and conditions that the PBM has
701701 established for other pharmacies as a condition of preferr ed network
702702 participation status;
703703 5. Deny, limit or terminate a pharmacy 's contract based on
704704 employment status of any employee who has an active license to
705705 dispense, despite probation status, with the State Board of
706706 Pharmacy;
707707 6. Retroactively deny or redu ce reimbursement for a covered
708708 service claim after returning a paid clai m response as part of the
709709 adjudication of the claim, unless:
710710 a. the original claim was submitted fraudulently, or
711711 b. to correct errors identified i n an audit, so long as
712712 the audit was conducted in compliance with Sections
713713 356.2 and 356.3 of Title 59 of the Oklahoma Statutes;
714714 or
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741741 7. Fail to make any payment due to a pharmacy or pharmacist for
742742 covered services properly rendered in the event a PBM termi nates a
743743 pharmacy or pharmacist from a pharmacy benefits manager network ; or
744744 8. Contractually prohibit or penalize a pharmacy or pharmacist
745745 for:
746746 a. disclosing to an individual information rega rding the
747747 existence and clinical efficacy of a generic
748748 equivalent that would be less expensive to the
749749 enrollee,
750750 (1) under his or her health pla n prescription drug
751751 benefit, or
752752 (2) outside his or her health plan pres cription drug
753753 benefit, without requesting any health plan
754754 reimbursement,
755755 than the drug that was original ly prescribed, or
756756 b. selling to an individual, instead of a particular
757757 prescribed drug, a therapeutically equivalent drug
758758 that would be less expensive t o the enrollee,
759759 (1) under his or her hea lth plan prescription drug
760760 benefit, or
761761 (2) outside his or her h ealth plan prescription drug
762762 benefit, without requesting any health plan
763763 reimbursement,
764764 than the drug that was originally prescribed .
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791791 C. The prohibitions under this section shall apply to con tracts
792792 between pharmacy benefits managers and pharmacists or pha rmacies for
793793 participation in retail phar macy networks.
794794 1. A PBM contract shall:
795795 a. not restrict, directly or indirectly, any pharmacy
796796 that dispenses a prescription drug from informing, or
797797 penalize such pharmacy for informing, an individual of
798798 any differential between the individual 's out-of-
799799 pocket cost or coverage with respect to acqu isition of
800800 the drug and the amount an individual would pay to
801801 purchase the drug directly, and
802802 b. ensure that any entity that provides pharmacy benefits
803803 management services und er a contract with any such
804804 health plan or health insurance coverage does not,
805805 with respect to such plan or coverage, restrict,
806806 directly or indirectly, a pharmacy that dispenses a
807807 prescription drug from informing, or penalize such
808808 pharmacy for informing, a covered individual of any
809809 differential between the individual 's out-of-pocket
810810 cost under the plan or coverage with respect to
811811 acquisition of the drug an d the amount an individual
812812 would pay for acquisition of the drug without using
813813 any health plan or healt h insurance coverage.
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840840 2. A pharmacy benefits manager's contract with a participa ting
841841 pharmacist or pharmacy shall not prohibit, restrict or limit
842842 disclosure of information to the Insurance Co mmissioner, law
843843 enforcement or state and federal governmental of ficials
844844 investigating or examining a com plaint or conducting a review of a
845845 pharmacy benefits manager's compliance with the requirements under
846846 the Patient's Right to Pharmacy Choice Act.
847847 3. A pharmacy benefits manager shall establish and maintain an
848848 electronic claim inquiry processing system usi ng the National
849849 Council for Prescription Drug Programs' current standards to
850850 communicate information to pharmacie s submitting claim inquiries.
851851 D. For each of the PBM's contracts or other relationships with
852852 a health plan, a PBM shall publish on an easily a ccessible website
853853 the health plan formula ry, and timely notification of formulary
854854 changes and/or product exclusion s.
855855 SECTION 7. AMENDATORY 36 O.S. 2021, Section 6964, is
856856 amended to read as fol lows:
857857 Section 6964. A. A health insurer's insurer or its agent's,
858858 including pharmacy benefits managers, pharmacy and therapeutics
859859 committee (P&T committee) shall establish a formulary, which shall
860860 be a list of prescription drugs, both generic and brand n ame, used
861861 by practitioners to identif y drugs that offer the greatest overall
862862 value.
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889889 B. A health insurer shall prohibit conflicts of interest for
890890 members of the P&T committee. The P&T committee shall review the
891891 formulary annually and must meet the followin g requirements:
892892 1. A person may not serve on a P&T committee if the person is
893893 currently employed or was employe d within the preceding year by a
894894 pharmaceutical manufacturer, developer, labeler , wholesaler or
895895 distributor. A majority of P&T committee members must be practicing
896896 physicians, practicing pharmacists, or both, and must be licens ed in
897897 Oklahoma;
898898 2. A health insurer shall require any member of the P&T
899899 committee to disclose any compensati on or funding from a
900900 pharmaceutical manufacturer, deve loper, labeler, wholesaler or
901901 distributor. Such P&T committee member shall be recused from v oting
902902 on any product manufactured or sold by such pharmaceutical
903903 manufacturer, developer, labeler, wholesaler or distributor. P&T
904904 committee members must practice in various clinical specialties that
905905 adequately represent the needs of health plan enrollees, and there
906906 must be an adequate number of high -volume specialists and
907907 specialists treating rare and orphan dise ases;
908908 3. The P&T committee must meet no less frequently than on a
909909 quarterly basis;
910910 4. P&T committee formulary development must be conducted
911911 pursuant to a transparent process, and formulary decisions and
912912 rationale must be docum ented in writing, with any r ecords and
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939939 documents relating to the process ava ilable upon request to the
940940 health plan, subject to the c onditions in subsection C of this
941941 section. In the case of P&T committee decisions that relate to
942942 Medicaid managed care orga nizations' prescription drug coverage
943943 policies, if the P&T committee relies upon any third party to
944944 provide cost-effectiveness analysis or research, the P&T committee
945945 must:
946946 a. disclose to the health benefit plan, the state, and
947947 the general public the name of the relevant third-
948948 party, and
949949 b. provide a process through which patients and providers
950950 potentially impacted by the third -party's analysis or
951951 research may provide input to the P&T commit tee;
952952 5. Specialists with current clinical expertise who actively
953953 treat patients in a specifi c therapeutic area, and the specific
954954 conditions within a therape utic area, must participate in formular y
955955 decisions regarding each therapeutic area and specific co ndition;
956956 6. The P&T committee must base its clinical decisions on the
957957 strength of scientific evidence, standards of practice, and
958958 nationally accepted treatme nt guidelines;
959959 7. The P&T committee mu st consider whether a particular drug
960960 has a clinically mean ingful therapeutic advantage over other drugs
961961 in terms of safety, effectiveness, or clinical o utcome for patient
962962 populations who may be treated with the drug;
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989989 8. The P&T committee must evaluate an d analyze treatment
990990 protocols and procedures related to the health plan's formulary at
991991 least annually;
992992 9. The P&T committee must review formulary manage ment
993993 activities, including exceptions and appeals processes, pri or
994994 authorization, step therapy, quantit y limits, generic subs titutions,
995995 therapeutic interchange, a nd other drug utilization management
996996 activities for clinical appropriateness and consistency with
997997 industry standards and patient and provider organization guidelines;
998998 10. The P&T committee must annually review and provide a
999999 written report to the pharmacy benefits manager on:
10001000 a. the percentage of prescription drugs on fo rmulary
10011001 subject to each of the types of utilization management
10021002 described in paragraph 9 of this subsection,
10031003 b. rates of adherence and nonadherence to medicin es by
10041004 therapeutic area,
10051005 c. rates of abandonment of medicines by therapeutic area,
10061006 d. recommendations for improved adherence and reduced
10071007 abandonment,
10081008 e. recommendations for improvement in f ormulary
10091009 management practices consistent with patient , and
10101010 provider organization and other clinica l guidelines; provided that
10111011 the report shall be subject to the con ditions in subsection C of
10121012 this section;
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10391039 11. The P&T committee must review and make a formu lary decision
10401040 on a new U.S. Food and Drug Administration approved drug with in
10411041 ninety (90) days of such drug's approval, or must provide a clinical
10421042 justification if this timeframe is not met;
10431043 12. The P&T committee must review procedures for medical review
10441044 of, and transitioning new plan enrollees to, appropriate formulary
10451045 alternatives to ensure that such procedures a ppropriately address
10461046 situations involving enrollees stabilized on drugs that are not on
10471047 the health plan formulary (or that are on formulary but subject to
10481048 prior authorization, step therapy, or other utilization management
10491049 requirements).
10501050 C. The health insurer, its agents, including pharmacy benefits
10511051 managers, and the Department shall not publish or otherwise disclose
10521052 any confidential, proprietary information, including , but not
10531053 limited to, any information that would reveal the identi ty of a
10541054 specific health plan, the prices charged for a specific drug or
10551055 class of drugs, the amount of any rebates provided for a specific
10561056 drug or class of drugs, the ma nufacturer, or that would otherwise
10571057 have the potential to compromise the financial, co mpetitive, or
10581058 proprietary nature of the information. Any such information sha ll
10591059 be protected from disclosure as confidential and proprietary
10601060 information, is not a public record as defined in the Oklahoma Open
10611061 Records Act, Section 24A.1 et seq. of Title 51 of the Oklaho ma
10621062 Statutes, and shall not be disclosed directly or indirectly. A
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10891089 health insurer shall impose the confidentiality protections of this
10901090 section on any vendor or downstream third party that performs health
10911091 care or administrative services on behalf of the pharmac y benefits
10921092 manager that may receive or have access to rebate information.
10931093 SECTION 8. NEW LAW A new section of law to be codified
10941094 in the Oklahoma Statutes as Section 6962.2 of Title 36, unless there
10951095 is created a duplication in numbering, reads as follows:
10961096 A. An enrollee's defined cost sharin g for each prescription
10971097 drug shall be calculated at the point of s ale based on a price that
10981098 is reduced by an amount equal to at least eighty-five percent (85%)
10991099 of all rebates received, or to be received, in connection with the
11001100 dispensing or administration of the prescription drug.
11011101 B. For any violation of this section, the Insurance
11021102 Commissioner may subject a PBM to an administrative penalty of not
11031103 less than One Hundred Dollars ( $100.00) nor more than Five Thousand
11041104 Dollars ($5,000.00) for each occurrence. Such administrative
11051105 penalty may be enforced in the same manner in w hich civil judgments
11061106 may be enforced.
11071107 C. Nothing in subsections A and B of this section shall
11081108 preclude a PBM from decreasing an enrollee 's defined cost sharing by
11091109 an amount greater than that required under subsection A of this
11101110 section.
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11371137 D. In implementing the requi rements of this section, the state
11381138 shall only regulate a PBM to the extent permissible under applicable
11391139 law.
11401140 E. In complying with the provisi ons of this section, a PBM or
11411141 its agents shall not publish or otherwise reveal information
11421142 regarding the actual amount of rebates a PBM receives on a product
11431143 or therapeutic class of products , manufacturer, or pharmacy -specific
11441144 basis. Such information is p rotected as a trade secret, is not a
11451145 public record as defined in the Oklahoma Open Records Act, Section
11461146 24A.1 et seq. of Title 51 of the Oklahoma Statutes and shall not be
11471147 disclosed directly or indirectly, or in a manner that would allow
11481148 for the identification of an indivi dual product, therapeutic class
11491149 of products, or manufacturer, or in a manner that would have the
11501150 potential to compromise the financial, compe titive, or proprietary
11511151 nature of the information. A PBM shall impose the confidentiality
11521152 protections of this secti on on any vendor or downstream third party
11531153 that performs health care or administrative services on behalf of
11541154 the insurer that may receive or have access to rebate information.
11551155 SECTION 9. NEW LAW A new section of law to be codified
11561156 in the Oklahoma Statutes as Section 6970 of Title 36, unless there
11571157 is created a duplication in numbering, reads a s follows:
11581158 A. For purposes of this section:
11591159
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11851185 1. "Defined cost sharing " means a deductible payment or
11861186 coinsurance amount imposed on an enrollee for a cove red prescription
11871187 drug under the enrollee's health plan;
11881188 2. "Insurer" means any health insurance issue r that is subject
11891189 to state law regulating insurance and offers health insuranc e
11901190 coverage, as defined in 42 U.S.C. , Section 300gg-91, or any state or
11911191 local governmental employer plan;
11921192 3. "Price-protection rebate" means a negotiated price
11931193 concession that accrues directly or indirectly to the insurer, or
11941194 other party on behalf of the i nsurer, in the event of an increase in
11951195 the wholesale acquisition cost of a d rug above a specified
11961196 threshold;
11971197 4. "Rebate" means:
11981198 a. negotiated price concessions including , but not
11991199 limited to, base price concessions (whether described
12001200 as a rebate or otherwise) and reasonable estimates of
12011201 any price-protection rebates and performance -based
12021202 price concessions that may accrue directly or
12031203 indirectly to the insurer during the coverage yea r
12041204 from a manufacturer, dispensing pharmacy, or other
12051205 party in connection with the dispensing or
12061206 administration of a prescription drug, and
12071207 b. reasonable estimates of any negotiated price
12081208 concessions, fees, and other administrative costs that
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12351235 are passed through, or are reasonably anticipated to
12361236 be passed through, to the insurer and s erve to reduce
12371237 the insurer's liabilities for a prescription drug.
12381238 B. An enrollee's defined cost sharing for each prescription
12391239 drug shall be calculated at the point of sale based on a price that
12401240 is reduced by an amount equal to a t least eighty-five percent (85%)
12411241 of all rebates received, or to be received, in connection with the
12421242 dispensing or administration of the prescription drug.
12431243 C. For any violation of this section, the Insura nce
12441244 Commissioner may subjec t an insurer to an administrative penal ty of
12451245 not less than One Hundred Dollars ($100.00) nor more than Five
12461246 Thousand Dollars ($5,000.00) for each occurrence. Such
12471247 administrative penalty may be enforced in the same manner in whic h
12481248 civil judgments may be en forced.
12491249 D. Nothing in subsections A through C of this section shall
12501250 preclude an insurer fro m decreasing an enrollee 's defined cost
12511251 sharing by an amount greater than that required under subsection B
12521252 of this section.
12531253 E. In implementing the requirements of this section, the state
12541254 shall only regulate an insurer to the extent permissible under
12551255 applicable law.
12561256 F. In complying with the provisio ns of this section, an insurer
12571257 or its agents shall not publish or otherwise reveal informati on
12581258 regarding the actual amount of rebates an insurer receives on a
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12851285 product or therapeutic class of pr oducts, manufacturer, or pharmacy -
12861286 specific basis. Such information is protected as a trade secret, is
12871287 not a public record as defined in the Oklahoma Open Records Act,
12881288 Section 24A.1 et seq. of Title 51 of the Oklahoma St atutes, and
12891289 shall not be disclosed directly or indirectly, or in a manner that
12901290 would allow for the identification of an individual pro duct,
12911291 therapeutic class of product s, or manufacturer, or in a manner that
12921292 would have the potential to compromise the financial, competitive,
12931293 or proprietary nature of the information. An insurer shall impose
12941294 the confidentiality protections of this section on any vendor or
12951295 downstream third party that performs health care or administrative
12961296 services on behalf of the insurer and that may receive or have
12971297 access to rebate information.
12981298 SECTION 10. This act shall become effective November 1, 2022.
12991299
13001300 58-2-8520 KN 01/17/22