Kansas 2025-2026 Regular Session

Kansas Senate Bill SB212 Compare Versions

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11 Session of 2025
22 SENATE BILL No. 212
33 By Senator Sykes
44 2-5
55 AN ACT concerning health and healthcare; enacting the prescription drug
66 cost and affordability review act; establishing the prescription drugs
77 pricing board and prescription drug affordability stakeholder council to
88 review the cost of prescription medications and establish upper
99 payment limits for certain prescription drug products.
1010 Be it enacted by the Legislature of the State of Kansas:
1111 Section 1. This act shall be known and may be cited as the
1212 prescription drug cost and affordability review act.
1313 Sec. 2. As used in sections 1 through 8, and amendments thereto:
1414 (a) "340B-covered entity" means an entity that is participating in the
1515 federal 340B drug pricing program authorized by 42 U.S.C. § 256b,
1616 including such entity's pharmacy or pharmacies, or any pharmacy or
1717 pharmacies contracted for the purpose of dispensing drugs purchased
1818 through such program.
1919 (b) "Biologic" means a drug that is produced or distributed in
2020 accordance with a biologics license application approved by the United
2121 States food and drug administration.
2222 (c) "Biosimilar" means a drug that is produced or distributed in
2323 accordance with a biologics license application approved under 42 U.S.C.
2424 § 262(k).
2525 (d) "Board" means the prescription drug affordability board created in
2626 section 3, and amendments thereto.
2727 (e) "Brand name drug" means a drug other than an authorized generic
2828 drug that is produced or distributed in accordance with an original new
2929 drug application approved under 21 U.S.C. § 355.
3030 (f) "Commissioner" means the commissioner of insurance.
3131 (g) "Consumer price index" means the United States consumer price
3232 index for all urban consumers as defined and reported by the United States
3333 department of labor, bureau of labor statistics.
3434 (h) "Council" means the prescription drug affordability stakeholder
3535 council created in section 4, and amendments thereto.
3636 (i) "Department" means the Kansas insurance department.
3737 (j) "Fund" means the prescription drug affordability fund created in
3838 section 7, and amendments thereto.
3939 (k) "Generic drug" means any of the following:
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7676 (1) A retail drug that is marketed or distributed in accordance with an
7777 abbreviated new drug application approved under 21 U.S.C. § 355;
7878 (2) an authorized generic drug as such term is defined in 42 C.F.R.
7979 447.502; or
8080 (3) a drug that entered the market before 1962 that was not originally
8181 marketed under a new drug application.
8282 (l) "Health insurer" means the same as defined in K.S.A. 40-4602,
8383 and amendments thereto.
8484 (m) "Manufacturer" means the same as defined in K.S.A. 65-1626,
8585 and amendments thereto;
8686 (n) "Person" means an individual, corporation or other legal entity.
8787 (o) "Pharmacy" means the same as defined in K.S.A. 65-1626, and
8888 amendments thereto.
8989 (p) "Prescription drug product" means a brand name drug, a generic
9090 drug, a biologic or a biosimilar.
9191 (q) "Prescription drug product purchaser" means an entity that
9292 purchases and takes ownership of a prescription drug product for resale or
9393 providing to patients.
9494 (r) "Rule" means a rule and regulation adopted by the board.
9595 (s) "Third-party payor" means a payor that reimburses a pharmacy for
9696 drugs or services, including a pharmacy benefits manager. "Third-party
9797 payor" does not include the Kansas program of medical assistance under
9898 K.S.A. 39-709, and amendments thereto, or a managed care organization
9999 providing state medicaid or children's health insurance program services
100100 under the Kansas medical assistance or the state healthcare benefits
101101 program.
102102 (t) "Wholesale acquisition cost" means such term as defined in 42
103103 U.S.C. § 1395w-3a(c)(6)(B).
104104 Sec. 3. (a) There is hereby established the prescription drug
105105 affordability board as created as an autonomous entity within the
106106 department.
107107 (b) (1) The board shall consists of five members, which shall be
108108 appointed by the governor. The members of the board shall include
109109 individuals who have expertise in healthcare economics, health policy,
110110 health equity and clinical medicine.
111111 (2) The governor shall not appoint an individual to the board if the
112112 individual:
113113 (A) Is employed by, a consultant to or a board member of a
114114 manufacturer or a trade association for a manufacturer;
115115 (B) has a personal or financial interest that has the potential to bias or
116116 has the appearance of biasing the individual's decision in matters related to
117117 the board or in conducting the board's activities; or
118118 (C) is a lobbyist who is registered in this state.
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162162 (3) An individual who is appointed to the board shall not register as a
163163 lobbyist in this state for a period of five years after the individual's term on
164164 the board expires.
165165 (4) The governor shall appoint two of the initial members of the
166166 board to one-year terms and three of the initial members to two-year terms.
167167 After the initial appointments, the term of a member of the board is four
168168 years or until a successor is appointed, whichever is later.
169169 (5) If a vacancy occurs on the board, the governor shall appoint an
170170 individual to fill the vacancy for the remaining term in the same manner as
171171 the original appointment.
172172 (6) The governor may remove a member of the board for
173173 incompetence, malfeasance, misfeasance or nonfeasance in office, or any
174174 other good cause.
175175 (c) (1) The governor shall call the first meeting of the board. At the
176176 first meeting, the board shall elect from among its members a chairperson
177177 and other officers as such board considers necessary or appropriate. After
178178 the first meeting, the board shall meet at least quarterly or more frequently
179179 at the call of the chairperson or if requested by a quorum of its members.
180180 (2) A majority of the members of the board shall constitute a quorum
181181 for transacting business. Except as otherwise provided in this subsection, a
182182 majority of the members present and serving is required for official action
183183 of the board.
184184 (d) Except as otherwise provided in this subsection, a writing that is
185185 prepared, owned, used, in the possession of or retained by the board in
186186 performing an official function is subject to the Kansas open records act. A
187187 writing containing a trade secret or proprietary information shall be
188188 confidential and privileged and not be subject to the provisions of the
189189 Kansas open records act as provided by K.S.A. 45-215 et seq., and
190190 amendments thereto. The provisions of this subsection shall expire on July
191191 1, 2030, unless the legislature reviews and reenacts this provision pursuant
192192 to K.S.A. 45-229, and amendments thereto, prior to July 1, 2030.
193193 (e) The salaries and other expenses incurred by members of the board
194194 shall be subject to appropriations.
195195 (f) As used in this section, "health equity" means attaining the highest
196196 level of health for all individuals, in which an individual has a fair and just
197197 opportunity to attain such individual's optimal health regardless of race,
198198 ethnicity, disability, sexual orientation, gender identity, socioeconomic
199199 status, geography, preferred language or other factor that affects access to
200200 healthcare and health outcomes.
201201 Sec. 4. (a) There is hereby established the prescription drug
202202 affordability stakeholder council within the department.
203203 (1) Subject to paragraph 2, the council shall consist of the following
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248248 (A) Seven members appointed by the governor as follows:
249249 (i) One individual representing manufacturers of brand name drugs;
250250 (ii) one individual representing manufacturers of generic drugs;
251251 (iii) one individual representing employers;
252252 (iv) one individual representing pharmacy benefit managers;
253253 (v) one individual representing pharmacists;
254254 (vi) one individual representing a mutual insurance company. The
255255 mutual insurance company under this subparagraph shall not be an entity
256256 that, directly or indirectly through one or more intermediaries, controls, is
257257 controlled by or is under common control with the managed care
258258 organization; and
259259 (vii) one member of the public;
260260 (B) seven members appointed by the governor from a list of
261261 nominees submitted by the speaker of the house of representatives. The list
262262 of nominees shall include individuals who represent the following:
263263 (i) A statewide organization that advocates for senior citizens;
264264 (ii) a statewide organization that advocates for healthcare;
265265 (iii) a statewide organization that advocates for diversity within
266266 communities;
267267 (iv) a labor union;
268268 (v) researchers who specialize in prescription drug products; and
269269 (vi) the public; and
270270 (C) seven members appointed by the governor from a list of
271271 nominees submitted by the senate majority leader. The list of nominees
272272 shall include individuals who represent each of the following:
273273 (i) Physicians;
274274 (ii) nurses;
275275 (iii) hospitals;
276276 (iv) managed care organizations. The managed care organization
277277 under this clause shall not be an entity that, directly or indirectly, through
278278 one or more intermediaries, controls, is controlled by or is under common
279279 control with the mutual insurance company under paragraph (1)(A)(vi);
280280 (v) clinical researchers; and
281281 (vi) the public.
282282 (2) The governor shall ensure that the members appointed to the
283283 council have knowledge in one or more of the following areas:
284284 (A) The pharmaceutical business model;
285285 (B) supply chain business models;
286286 (C) the practice of medicine or clinical training;
287287 (D) consumer or patient perspectives;
288288 (E) healthcare costs trends; and
289289 (F) clinical and health services research.
290290 (b) The governor shall appoint seven of the initial members of the
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334334 council to one-year-terms, seven of the initial members to two-year terms
335335 and seven of the initial members to three year terms. After the initial
336336 appointments, the term of a member of the council is three years or until a
337337 successor is appointed, whichever is later.
338338 (1) If a vacancy occurs on the council, the governor shall appoint an
339339 individual to fill the vacancy for the remaining term in the same manner as
340340 the original appointment.
341341 (2) The governor may remove a member of the council for
342342 incompetence, malfeasance, misfeasance or nonfeasance in office or any
343343 other good cause.
344344 (3) At the first meeting of the council, the council shall elect from
345345 among its members a chairperson and other officers as such council
346346 considers necessary or appropriate. After the first meeting, the council
347347 shall meet at least quarterly or more frequently at the call of the
348348 chairperson or if requested by a quorum of its members.
349349 (4) A majority of the members of the council shall constitute a
350350 quorum for transacting business. A majority of the members present and
351351 serving is required for official action of the council.
352352 (c) Except as otherwise provided in this subsection, a writing that is
353353 prepared, owned, used, in the possession of, or retained by the council in
354354 performing an official function is subject to the Kansas open records act. A
355355 writing containing a trade secret or proprietary information shall be
356356 confidential and privileged and not be subject to the provisions of the
357357 Kansas open records act as provided by K.S.A. 45-215 et seq., and
358358 amendments thereto. The provisions of this subsection shall expire on July
359359 1, 2030, unless the legislature reviews and reenacts this provision pursuant
360360 to K.S.A. 45-229, and amendments thereto, prior to July 1, 2030.
361361 (d) Members of the council attending meetings authorized by the
362362 council shall be paid amounts as provided in K.S.A. 75-3223(3), and
363363 amendments thereto.
364364 (e) The council shall assist the board in making decisions required
365365 under this act.
366366 Sec. 5. (a) Beginning on January 1, 2027, subject to subsection (b),
367367 the board, in
368368 consultation with the council, shall select one or more prescription drug
369369 products based on any of the following criteria:
370370 (1) The prescription drug product is a brand name drug or a biologic
371371 that, as adjusted annually for inflation in accordance with the consumer
372372 price index, has a wholesale acquisition cost of $60,000 or more per year
373373 or per course of treatment has a wholesale acquisition cost increase of
374374 $3,000 or more in any 12-month period;
375375 (2) the prescription drug product is a biosimilar that has a wholesale
376376 acquisition cost that is not at least 15% lower than the referenced brand
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420420 biologic; or
421421 (3) the prescription drug product is a generic drug that, as adjusted
422422 annually for inflation in accordance with the consumer price index, has a
423423 wholesale acquisition cost that:
424424 (A) Is $100 or more for any of the following:
425425 (i) A 30-day supply that lasts a patient for a period of 30 consecutive
426426 days based on the recommended dosage approved for labeling by the
427427 United States food and drug administration;
428428 (ii) a supply that lasts a patient for less than 30 days based on the
429429 recommended dosage approved for labeling by the United States food and
430430 drug administration; and
431431 (iii) one unit of the drug if the labeling approved by the United States
432432 food and drug administration does not recommend a finite dosage; and
433433 (B) increased by 200% or more during the immediately preceding 12-
434434 month period, as determined by the difference between the resulting
435435 wholesale acquisition cost and the average wholesale acquisition cost
436436 reported over the immediately preceding 12 months; or
437437 (4) the prescription drug product is a prescription drug product that
438438 may create affordability challenges for healthcare systems in this state and
439439 patients, including, but not limited to, a prescription drug product needed
440440 to address a public health emergency.
441441 (b) In selecting one or more prescription drug products under
442442 subsection (a), the board shall not be required to identify each prescription
443443 drug product that meets the criteria described in subsection (a).
444444 (1) The board shall determine whether to conduct a cost and
445445 affordability review for each prescription drug product that is selected
446446 under subsection (a). In making a determination under this subsection, the
447447 board shall consider input from the council and the average patient cost
448448 share for each prescription drug product.
449449 (2) If the board conducts a cost and affordability review of a
450450 prescription drug product, the board may consider when conducting the
451451 review any document or research related to the manufacturer's selection of
452452 the introductory price or price increase of the prescription drug product,
453453 including life cycle management, net average price in this state, market
454454 competition, projected revenue and, subject to subsection (e), the
455455 estimated cost-effectiveness of the prescription drug product. In its review,
456456 the board shall determine whether the use of a prescription drug product
457457 that is fully consistent with the labeling approved by the United States
458458 food and drug administration or standard medical practice for the
459459 prescription drug product has led or will lead to affordability challenges to
460460 healthcare systems in this state or high out-of-pocket costs for patients in
461461 this state. In making its determination under this subsection, the board
462462 shall consider any information that a manufacturer chooses to provide to
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506506 the board and all of the following factors, to the extent practicable:
507507 (A) The wholesale acquisition cost for the prescription drug product
508508 sold in this state;
509509 (B) the average monetary price concession, discount or rebate that the
510510 manufacturer provides or is expected to provide to health insurers and
511511 pharmacy benefit managers in this state, expressed as a percent of the
512512 wholesale acquisition cost for the prescription drug product under review;
513513 (C) the price at which therapeutic alternatives for the prescription
514514 drug product have been sold in this state;
515515 (D) the average monetary concession, discount or rebate that another
516516 manufacturer provides or is expected to provide to health insurers and
517517 pharmacy benefit managers in this state for therapeutic alternatives;
518518 (E) the cost to health insurers based on patient access consistent with
519519 United States food and drug administration labeled indications or
520520 recognized standard medical practice;
521521 (F) the impact on patient access resulting from the cost of the
522522 prescription drug product relative to insurance benefit design;
523523 (G) the current or expected dollar value of drug-specific patient
524524 access programs that are supported by the manufacturer;
525525 (H) the relative financial impact to health, medical or social service
526526 costs as can be quantified and compared to baseline effects of existing
527527 therapeutic alternatives;
528528 (I) the average patient copay or other cost-sharing measures for the
529529 prescription drug product in this state; and
530530 (J) any other factor established by the board.
531531 (c) If the board determines that spending on a prescription drug
532532 product reviewed under this section has led or will lead to affordability
533533 challenges to healthcare systems in this state or high out-of-pocket costs
534534 for patients in this state, the board may, subject to subsection (d), adopt
535535 rules and regulations establishing an upper payment limit for the
536536 prescription drug product. In establishing an upper payment limit under
537537 this subsection, the board shall consider all of the following:
538538 (1) Relevant administrative costs related to supplying or stocking the
539539 prescription drug product; and
540540 (2) the impact of an upper payment limit for the prescription drug
541541 product on 340-B program entities.
542542 (d) An upper payment limit established under this section shall not
543543 include professional dispensing fees.
544544 (e) If the board considers the estimated cost-effectiveness of a
545545 prescription drug product under this section, the board:
546546 (1) Shall not use a cost-per-quality adjusted life year, or a similar
547547 measure, to identify a subpopulation for which a prescription drug product
548548 would be less cost-effective due to severity of illness, age or preexisting
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592592 disability; and
593593 (2) if the board uses a cost-effectiveness analysis for a prescription drug
594594 product that extends an individual's life, the board shall use a cost-
595595 effectiveness analysis that weighs the value of all additional lifetime
596596 gained equally for any individual, regardless of the severity of illness, age
597597 or preexisting disability.
598598 (f) An upper payment limit established under this section shall take
599599 effect on the date adopted by the board by rule and regulation, except that
600600 such date shall not be sooner than six months after the date that the upper
601601 payment limit is established.
602602 Sec. 6. (a) Except as otherwise provided in subsection (b), if the
603603 board establishes an upper payment limit under section 5, and amendments
604604 thereto, for a prescription drug product intended for use by individuals in
605605 this state, beginning on the effective date of the upper payment limit, a
606606 prescription drug product purchaser or third-party payer shall not
607607 purchase, bill or reimburse for the prescription drug product in an amount
608608 that exceeds the upper payment limit, regardless of whether the
609609 prescription drug product is dispensed or distributed in person, by mail or
610610 by other means.
611611 (b) A prescription drug product purchaser or third-party payer shall
612612 not reimburse a pharmacy for a prescription drug product in an amount
613613 that is less than an upper payment limit established under section 5, and
614614 amendments thereto, for the prescription drug product.
615615 (c) The attorney general may investigate a violation of this section
616616 and may commence a civil action against a person for appropriate relief,
617617 including, but not limited to, injunctive relief for a violation of this section.
618618 (d) This section shall not prohibit any other sanction against a
619619 prescription drug product purchaser or third-party payor as provided by
620620 law.
621621 (e) A person aggrieved by a decision of the board under this act may
622622 request an appeal within 30 days. A hearing and appeal is subject to the
623623 Kansas administrative procedure act.
624624 (f) The board may adopt rules and regulations to implement and
625625 administer this act, and the board may enter into contracts with third
626626 parties to assist the board in carrying out its duties under this act.
627627 Sec. 7. There is hereby established in the state treasury the
628628 prescription drug affordability fund, which shall be administered by the
629629 commissioner. All expenditures from the prescription drug affordability
630630 fund shall be to fund the board and for costs expended by the department
631631 to implement and administer the prescription drug cost and affordability
632632 review act. All expenditures from the prescription drug affordability fund
633633 shall be made in accordance with appropriation acts upon warrants of the
634634 director of accounts and reports issued pursuant to vouchers approved by
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678678 the commissioner or the designee of the commissioner. All moneys
679679 received by the board for the prescription drug cost and affordability
680680 review act shall be deposited in the state treasury in accordance with the
681681 provisions of K.S.A. 75-4215, and amendments thereto. Upon receipt of
682682 each such remittance, the state treasurer shall deposit the entire amount in
683683 the state treasury to the credit of the prescription drug affordability fund.
684684 Sec. 8. (a) Beginning in 2026, on or before December 31 of each
685685 year, the board shall submit a written report to the legislature that includes
686686 all of the following information:
687687 (1) Price trends for prescription drug products;
688688 (2) the number of prescription drug products that were subject to
689689 board review, including the results of the review and the number and
690690 disposition of appeals of board decisions; and
691691 (3) any recommendations that the board may have on further
692692 legislation to make prescription drug products more affordable in this
693693 state.
694694 (b) Prior to the first date of the regular legislative session of 2027, the
695695 board shall conduct a one-time study on all of the following and report its
696696 findings to the legislature:
697697 (1) The prices of generic drugs on a year-to-year basis;
698698 (2) the degree to which the prices of generic drugs affect yearly
699699 insurance premium charges;
700700 (3) annual changes in insurance cost-sharing for generic drugs;
701701 (4) the potential for and history of drug shortages;
702702 (5) the degree to which the prices of generic drugs affect yearly
703703 medical assistance program spending in this state;
704704 (6) the impact of an upper payment limit on 340-B program entities;
705705 and
706706 (7) any other issue that the board considers relevant.
707707 Sec. 9. This act shall take effect and be in force from and after its
708708 publication in the statute book.
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