LCO No. 582 1 of 24 General Assembly Governor's Bill No. 5054 February Session, 2024 LCO No. 582 Referred to Committee on INSURANCE AND REAL ESTATE Introduced by: Request of the Governor Pursuant to Joint Rule 9 AN ACT ADDRESSING HEALTH CARE AFFORDABILITY. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. (NEW) (Effective October 1, 2024) (a) There is hereby 1 established the Prescription Drug Affordability Board to advise the 2 executive director of the Office of Health Strategy on decisions 3 regarding the affordability of prescription drugs. The board shall be 4 within the Office of Health Strategy for administrative purposes only. 5 (b) The purposes of the Prescription Drug Affordability Board shall 6 be to (1) explore strategies to reduce out-of-pocket drug costs to 7 consumers while supporting innovations in biotechnology and scientific 8 discovery; (2) study the prescription drug supply chain and 9 pharmaceutical pricing strategies to identify opportunities for consumer 10 savings; (3) monitor prescription drug prices in the state; (4) promote 11 innovative strategies for the use of more affordable drugs; and (5) 12 recommend a range of options of prescription drug cost affordability 13 tools to the executive director of the Office of Health Strategy. 14 Governor's Bill No. 5054 LCO No. 582 2 of 24 (c) The board shall consist of five members, each of whom shall have 15 an advanced degree and experience or expertise in health care 16 economics, health services research, pharmoeconomics, pharmacology 17 or clinical medicine. At least one such member shall have direct 18 experience with consumer advocacy and health equity. The members 19 shall be appointed by the Governor with the advice and consent of either 20 house of the General Assembly. The Governor shall make all initial 21 appointments not later than ninety days after the effective date of this 22 section. Any vacancy shall be filled for the remainder of the unexpired 23 term by the Governor. 24 (d) Each member of the board shall serve a term of three years, except 25 as to the terms of the members who are first appointed to the board. 26 Two such members shall serve an initial term of three years, two such 27 members shall serve an initial term of two years, and one such member 28 shall serve an initial term of one year, to be determined by the Governor. 29 The Governor may remove any appointed member of the board for 30 malfeasance in office, failure to regularly attend meetings or any cause 31 that renders the member incapable or unfit to discharge the duties of the 32 member's office. Any such removal is not subject to review. 33 (e) The Governor shall designate one member of the board to serve as 34 the chairperson of the board. Such chairperson shall schedule the first 35 meeting of the board, which shall be held not later than one hundred 36 twenty days after the effective date of this section. 37 (f) The board shall meet not less than four times annually to carry out 38 its purposes as set forth in subsection (b) of this section. A majority of 39 the board constitutes a quorum. The concurrence of a majority of the 40 board in any matter within its powers and duties is required for any 41 determination made by the board. Any conflict of interest involving a 42 member of the board shall be disclosed at the next board meeting after 43 the conflict is identified. 44 (g) Not later than December 31, 2025, and annually thereafter, the 45 board shall report, in accordance with the provisions of section 11-4a of 46 Governor's Bill No. 5054 LCO No. 582 3 of 24 the general statutes, to the joint standing committees of the General 47 Assembly having cognizance of matters relating to aging, human 48 services, insurance and public health. The report shall include, but need 49 not be limited to: (1) Strategies for identifying and eliminating pricing 50 or business practices that do not support or enhance innovation in drug 51 development, (2) price trends and affordability strategies for any drug 52 identified pursuant to subsection (b) or (c) of section 3 of this act, (3) any 53 recommendations the board may have for legislation needed to make 54 prescription drug products more affordable in the state while 55 supporting and enhancing innovation in drug development, (4) 56 purchasing strategies, cost effectiveness evaluations and the 57 development of new technologies and drugs that increase affordability, 58 and (5) a summary and evaluation of state prescription drug advisory 59 board activities and recommendations. 60 (h) Members of the board may engage in private employment, or in 61 a profession or business, subject to any applicable laws, rules and 62 regulations of the state regarding official ethics or conflict of interest. As 63 used in this subsection, (1) "conflict of interest" means (A) an association, 64 including a financial or personal association, that has the potential to 65 bias or appear to bias an individual's decisions in matters related to the 66 board, and (B) any instance in which a board member, a staff member, 67 a contractor of the division on behalf of the board or an immediate 68 family member of a board member has received or could receive (i) a 69 financial benefit of any amount derived from the results or findings of a 70 study or determination that is reached by or for the board, or (ii) a 71 financial benefit from an individual or company that owns or 72 manufacturers a prescription drug, service or item that is being or will 73 be studied by the board, and (2) "financial benefit" means honoraria, 74 fees, stock or any other form of compensation, including increases to the 75 value of existing stock holdings. 76 (i) In carrying out its purposes, the board may: 77 (1) Collect and review publicly available information regarding 78 prescription drug pricing and business practices of health carriers, 79 Governor's Bill No. 5054 LCO No. 582 4 of 24 health maintenance organizations, managed care organizations, 80 manufacturers, wholesale distributors and pharmacy benefit managers, 81 including, but not limited to, the annual report by pharmacy benefit 82 managers required pursuant to section 38a-479ppp of the general 83 statutes; 84 (2) Identify innovative strategies that may reduce the cost of 85 prescription drugs to consumers; 86 (3) Identify states with innovative programs to lower prescription 87 drug costs and, if relevant, enter into memoranda of understanding with 88 such states to aid in the collection of transparency data for prescription 89 drug products or any other information needed to establish similar 90 programs in this state; and 91 (4) Receive and accept aid or contributions from any source of money, 92 property, labor or other things of value, to be held, used and applied to 93 carry out the purposes of the board, provided acceptance of such aid or 94 contributions does not present a conflict of interest for any board 95 member or any purpose of the board. 96 Sec. 2. (NEW) (Effective October 1, 2024) As used in this section and 97 section 3 of this act: 98 (1) "Biologic" means a drug licensed under 42 USC 262, as amended 99 from time to time; 100 (2) "Biosimilar" means a drug that is highly similar to a biologic and 101 is produced or distributed in accordance with a biologics license 102 application approved under 42 USC 262(k), as amended from time to 103 time; 104 (3) "Board" means the Prescription Drug Affordability Board 105 established pursuant to section 1 of this act; 106 (4) "Brand name drug" means a drug that is produced or distributed 107 in accordance with an original new drug application approved under 21 108 USC 355, as amended from time to time, but does not include an 109 Governor's Bill No. 5054 LCO No. 582 5 of 24 authorized generic drug as defined in 42 CFR 447.502, as amended from 110 time to time; 111 (5) "FDA breakthrough drug" means a drug granted expedited 112 review by the United States Food and Drug Administration under 21 113 USC 356, as amended from time to time. 114 (6) "Generic drug" means (A) a prescription drug product that is 115 marketed or distributed in accordance with an abbreviated new drug 116 application approved under 21 USC 355, as amended from time to time, 117 (B) an authorized generic drug as defined in 42 CFR 447.502, as 118 amended from time to time, or (C) a drug that entered the market before 119 calendar year 1962 that was not originally marketed under a new 120 prescription drug product application; 121 (7) "Manufacturer" means an entity that (A) engages in the 122 manufacture of a drug product, or (B) enters into a lease with another 123 manufacturer to market and distribute a prescription drug product 124 under the entity's own name and sets or changes the wholesale 125 acquisition cost of the prescription drug product it manufactures or 126 markets; 127 (8) "Orphan drug" has the same meaning as provided in 21 CFR 316.3, 128 as amended from time to time; and 129 (9) "Prescription drug product" means a brand name drug, a generic 130 drug, a biologic or biosimilar. 131 Sec. 3. (NEW) (Effective October 1, 2024) (a) To the extent practicable, 132 the Prescription Drug Affordability Board established pursuant to 133 section 1 of this act may assess pricing information for prescription drug 134 products by: (1) Entering into a memorandum of understanding with 135 another state to which a manufacturer reports pricing information, (2) 136 assessing spending for the drug in the state, (3) utilizing data and 137 findings, including consumer affordability strategies, developed by 138 another state's board, (4) utilizing data and findings, including cost 139 containment strategies, developed by any other state or federal entity, 140 Governor's Bill No. 5054 LCO No. 582 6 of 24 (5) utilizing the maximum fair price for a prescription drug for persons 141 eligible for Medicare established pursuant to the federal Inflation 142 Reduction Act of 2022, P.L. No. 117-169, and (6) assessing any other 143 available pricing information. 144 (b) On and after October 1, 2026, the board shall identify prescription 145 drug products that, as adjusted annually for inflation in accordance with 146 the consumer price index for all urban consumers published by the 147 United States Department of Labor, Bureau of Labor Statistics, are: 148 (1) Brand name drugs that have a launch wholesale acquisition cost 149 of thirty thousand dollars or more per year or course of treatment; 150 (2) Brand name drugs that have a wholesale acquisition cost increase 151 of three thousand dollars or more in any twelve–month period; 152 (3) Biosimilars that have a launch wholesale acquisition cost that is 153 not at least fifteen per cent lower than the referenced brand biologic at 154 the time the biosimilars are launched; and 155 (4) Generic drugs that have: 156 (A) A wholesale acquisition cost of one hundred dollars or more for 157 (i) a thirty-day supply lasting a patient for a period of thirty consecutive 158 days based on the recommended dosage approved for labeling by the 159 United States Food and Drug Administration, (ii) a supply lasting a 160 patient for fewer than thirty days based on the recommended dosage 161 approved for labeling by the United States Food and Drug 162 Administration, or (iii) one unit of the drug if the labeling approved by 163 the United States Food and Drug Administration does not recommend 164 a finite dosage; and 165 (B) A wholesale acquisition cost that increased by two hundred per 166 cent or more during the immediately preceding twelve-month period, 167 as determined by the difference between the resulting wholesale 168 acquisition cost and the average of the wholesale acquisition cost 169 reported over the immediately preceding twelve months. 170 Governor's Bill No. 5054 LCO No. 582 7 of 24 (c) On and after October 1, 2026, the board shall identify any other 171 prescription drug products or pricing practices that may create 172 affordability challenges for the health care system in the state or 173 patients, including, but not limited to, drugs needed to address 174 significant public health priorities. 175 (d) After identifying prescription drug products as required by 176 subsections (b) and (c) of this section, the board may conduct, within 177 available appropriations, a review for any identified prescription drug 178 product or pricing practice if, after (1) seeking input from relevant 179 stakeholders, and (2) considering the average patient cost share of the 180 prescription drug product, the board determines such review is in the 181 interest of consumers, provided the drug product is not an FDA 182 breakthrough drug, an orphan drug, a drug with a new and unique 183 mechanism of action for treating a medical condition or any other drug 184 that represents a significant innovation or advance in therapy. 185 (e) In conducting a review of prescription drugs, the board shall 186 examine any document and research related to the pricing of the 187 prescription drug product, including, but not limited to, (1) net average 188 price in the state, (2) market competition and context, (3) projected 189 revenue to the manufacturer, (4) the estimated value or cost 190 effectiveness, (5) whether and how the prescription drug product 191 represents an innovative therapy or is likely to improve health or health 192 outcomes for the target consumer, and (6) any rebates, discounts, patient 193 access programs or other cost mitigation strategies relevant to the 194 prescription drug product. 195 (f) The board shall determine whether use of the prescription drug 196 product, consistent with the labeling approved by the United States 197 Food and Drug Administration or standard medical practice, has led or 198 will lead to affordability challenges for the health care system in the 199 state or high out–of–pocket costs for patients but has not led or will not 200 lead to significant improvements in health or health outcomes. In 201 determining whether a prescription drug product has led or will lead to 202 an affordability challenge, the board may consider the following factors: 203 Governor's Bill No. 5054 LCO No. 582 8 of 24 (1) The wholesale acquisition cost for the prescription drug product 204 sold in the state; 205 (2) The average monetary price concession, discount or rebate 206 provided or expected to be provided to health plans in the state as 207 reported by manufacturers and health plans, expressed as a percentage 208 of the wholesale acquisition cost for the prescription drug product 209 under review; 210 (3) The total amount of the price concession, discount or rebate the 211 manufacturer provides to each pharmacy benefits manager operating in 212 the state for the prescription drug product under review, as reported by 213 manufacturers and pharmacy benefits managers, expressed as a 214 percentage of the wholesale acquisition costs; 215 (4) The price at which therapeutic alternatives have been sold in the 216 state; 217 (5) The average monetary concession, discount or rebate the 218 manufacturer provides or is expected to provide to health plan payors 219 and pharmacy benefits managers in the state for therapeutic 220 alternatives; 221 (6) The costs to health plans based on patient access consistent with 222 United States Food and Drug Administration labeled indications and 223 recognized standard medical practice; 224 (7) The impact on patient access resulting from the cost of the 225 prescription drug product relative to health plan benefit design; 226 (8) The current or expected dollar value of drug–specific patient 227 access programs that are supported by the manufacturer; 228 (9) The relative financial impacts to health, medical or social services 229 costs as may be quantified and compared to baseline effects of existing 230 therapeutic alternatives; 231 (10) The average patient copayment or other cost sharing for the 232 Governor's Bill No. 5054 LCO No. 582 9 of 24 prescription drug product in the state; 233 (11) Any information a manufacturer chooses to provide; and 234 (12) Any other factors as determined by the board. 235 (g) If the board finds that the spending on a prescription drug 236 product reviewed under this section has led or will lead to an 237 affordability challenge but has not provided or will not provide 238 significant benefits to health or health outcomes, the board shall 239 recommend potential cost containment strategies and tools to the 240 executive director of the Office of Health Strategy considering: (1) The 241 cost of administering the drug, (2) the cost of delivering the drug to 242 patients, and (3) other administrative costs related to the drug. In 243 making such recommendations, the board may utilize (A) cost 244 containment strategies set by similar boards in other states, (B) cost 245 containment strategies set by any other state or federal entity, and (C) 246 the maximum fair price for a prescription drug for persons eligible for 247 Medicare established pursuant to the federal Inflation Reduction Act of 248 2022. The board's recommendations shall not apply to Medicare Part D 249 prescription drug plans. 250 Sec. 4. (NEW) (Effective July 1, 2024) (a) There is established, within 251 the Office of Health Strategy, the Cost Growth Benchmark Oversight 252 Commission for the purpose of advising the executive director of the 253 Office of Health Strategy regarding implementation of the provisions of 254 sections 19a-754f to 19a-754j, inclusive, of the general statutes, as 255 amended by this act. 256 (b) (1) The commission shall consist of thirteen voting members who 257 shall be appointed by the Governor not later than August 31, 2024. The 258 Governor shall endeavor to appoint members representing the 259 following interests and specialties across the health care continuum, 260 including, but not limited to, (A) academic institutions, (B) employers, 261 (C) philanthropic, medical research and nonprofit organizations with 262 experience addressing health equity, health care costs, health care 263 advocacy and access to health care for underserved communities, (D) 264 Governor's Bill No. 5054 LCO No. 582 10 of 24 health care economists or actuarial experts, (E) health care-related 265 employer coalitions and labor unions, (F) consumers of health care 266 services, and (G) health care advocates. At a minimum, the commission 267 shall include the following voting members: (i) Two representatives of 268 one or more consumer organizations with expertise in cost and quality 269 management; (ii) two health economists; (iii) two experts in health care 270 quality measurement and reporting; (iv) one expert in payment and 271 delivery system reform; and (v) one expert in primary care. Members 272 shall not include representatives of organizations that directly 273 contribute to health care costs in the state, including, but not limited to, 274 hospital systems, health carriers and provider organizations. The 275 executive director of the Office of Health Strategy, or the executive 276 director's designee, the Insurance Commissioner, or the commissioner's 277 designee, the Commissioners of Public Health, Social Services and 278 Mental Health and Addiction Services, or the commissioners' designees, 279 and the chief executive officer of the Connecticut Health Insurance 280 Exchange, or the chief executive officer's designee, shall serve as ex-281 officio nonvoting members of the commission. 282 (2) The membership terms for voting members initially appointed to 283 the commission shall be divided such that seven of the voting members 284 are appointed for an initial two-year term and six of the voting members 285 are appointed for an initial three-year term. Following the expiration of 286 such voting members' initial terms, the membership terms for voting 287 members shall be for two years, commencing on August first of the year 288 of the member's appointment. 289 (3) The Governor shall designate one member of the commission to 290 serve as the chairperson of the commission. 291 (c) The commission shall advise the executive director of the Office of 292 Health Strategy regarding all aspects of the initiatives concerning the 293 health care cost growth and health care quality benchmarks set forth in 294 sections 19a-754f to 19a-754j, inclusive, of the general statutes, as 295 amended by this act, and shall: 296 Governor's Bill No. 5054 LCO No. 582 11 of 24 (1) Provide guidance, direction and oversight with respect to such 297 initiatives; 298 (2) Review and make recommendations to the executive director on 299 the methodology for (A) setting such benchmarks, (B) determining 300 compliance with such benchmarks, (C) analyzing the data regarding 301 drivers of health care cost growth, (D) conducting annual inflation 302 reviews, and (E) establishing additional quality benchmarks and 303 measure sets; 304 (3) Review and make policy recommendations and advise on 305 implementation strategies; and 306 (4) Develop recommendations that advance health equity in the 307 implementation of the health care cost growth benchmark to support 308 equitable access to affordable and high-quality health care for 309 underserved populations. 310 (d) The commission shall vote on each recommendation and submit 311 recommendations approved by the majority of voting members to the 312 executive director. The executive director shall: 313 (1) Review each recommendation; 314 (2) Determine whether to accept each recommendation; and 315 (3) If the executive director does not accept a recommendation from 316 the commission, the executive director shall provide a written response 317 to the commission that outlines the facts concerning such 318 recommendation and explains the factors considered in and rationale 319 for not accepting the recommendation. The executive director shall 320 submit such response to the commission not later than thirty days after 321 the receipt of the commission's recommendation. The commission may 322 allow the executive director additional time to respond. 323 (e) The commission may convene working groups that include 324 volunteer health care experts to advise the commission on any matters 325 related to the provisions of sections 19a-754f to 19a-754j, inclusive, of the 326 Governor's Bill No. 5054 LCO No. 582 12 of 24 general statutes, as amended by this act. 327 (f) The Office of Health Strategy shall provide administrative support 328 to the commission. 329 Sec. 5. Section 19a-754i of the general statutes is amended by adding 330 subsections (c) and (d) as follows (Effective October 1, 2025): 331 (NEW) (c) (1) Not later than January 1, 2026, if the executive director 332 finds, based on the office's annual cost growth benchmark report 333 required pursuant to subsection (b) of section 19a-754h, the office's 334 annual cost trend hearings or any other pertinent information, that the 335 average percentage change in cumulative total health care expenditures 336 from calendar years 2022 to 2023 exceeded the average health care cost 337 growth benchmark for calendar years 2022 to 2023, the executive 338 director shall establish procedures to (A) assist health care entities in 339 improving efficiency and reducing cost growth by requiring certain 340 health care entities to file and implement a performance improvement 341 plan, and (B) support the state's efforts to meet future health care cost 342 growth benchmarks, as established pursuant to section 19a-754g. 343 (2) On and after January 1, 2026, and annually thereafter, if the 344 executive director finds, based on the office's annual cost growth 345 benchmark report required pursuant to subsection (b) of section 19a-346 754h, the office's annual cost trend hearings or any other pertinent 347 information, that the percentage change in cumulative total health care 348 expenditures from one calendar year to the next, beginning with 349 calendar years 2023 to 2024, exceeded the health care cost growth 350 benchmark for such calendar years, the executive director shall establish 351 procedures to (A) assist health care entities in improving efficiency and 352 reducing cost growth by requiring certain health care entities to file and 353 implement a performance improvement plan, and (B) support the state's 354 efforts to meet future health care cost growth benchmarks developed 355 pursuant to section 19a-754g. 356 (3) In addition to the notice provided under subdivision (3) of 357 subsection (a) of this section, the executive director may require any 358 Governor's Bill No. 5054 LCO No. 582 13 of 24 health care entity that is identified by the office under subsection (a) of 359 this section as exceeding the health care cost growth benchmark 360 developed pursuant to section 19a-754g to file a performance 361 improvement plan with the office. The executive director shall provide 362 written notice to such health care entity that the entity is required to file 363 a performance improvement plan. Not later than forty-five days after 364 receipt of such written notice, the health care entity shall either file (A) 365 a performance improvement plan with the office, or (B) an application 366 with the office to waive or extend the requirement to file a performance 367 improvement plan. 368 (4) The health care entity identified under subsection (a) of this 369 section may file any documentation or supporting evidence with the 370 office to support the health care entity's application to waive or extend 371 the requirement to file a performance improvement plan. The executive 372 director shall require the health care entity to submit any other relevant 373 information it deems necessary in considering the waiver or extension 374 application, provided such information shall be made public at the 375 discretion of the office. 376 (5) The executive director may waive or delay the requirement for a 377 health care entity to file a performance improvement plan in response 378 to a waiver or extension request filed under subdivision (3) of this 379 subsection and in consideration of any information received from the 380 health care entity pursuant to subdivision (4) of this subsection, based 381 on a consideration of the following factors: (A) The costs, price and 382 utilization trends of the health care entity over time and any 383 demonstrated reduction in total medical expenses related to the health 384 status of patients; (B) any ongoing strategies or investments that the 385 health care entity is implementing to improve future long-term 386 efficiency and reduce cost growth; (C) whether the factors that led to 387 increased costs for the health care entity may reasonably be considered 388 to be unanticipated and outside of the control of the entity. Such factors 389 may include, but need not be limited to, the age of patients, other factors 390 related to the health status of patients and other cost inputs such as 391 pharmaceutical expenses and medical device expenses; (D) the overall 392 Governor's Bill No. 5054 LCO No. 582 14 of 24 financial condition of the health care entity; (E) a significant difference 393 between the growth rate of the potential gross state product, as defined 394 in section 19a-754f, and the growth rate of the actual gross state product; 395 and (F) any other factors the executive director considers relevant. 396 (6) If the executive director declines to waive or extend the 397 requirement for the health care entity to file a performance 398 improvement plan, the executive director shall provide written notice 399 to the health care entity that its application for a waiver or extension was 400 denied and the health care entity shall file a performance improvement 401 plan pursuant to subdivision (7) of this subsection. 402 (7) A health care entity shall file a performance improvement plan: 403 (A) Not later than forty-five days after receipt of a notice under 404 subdivision (6) of this subsection; (B) if the health care entity has 405 requested a waiver or extension, not later than forty-five days after 406 receipt of a notice that such waiver or extension has been denied; or (C) 407 if the health care entity is granted an extension, on the date for filing 408 provided on the notice of such extension. The performance 409 improvement plan shall identify the causes of the entity's cost growth 410 and shall include, but need not be limited to, specific strategies, 411 adjustments and action steps the entity proposes to implement to 412 improve cost performance. The performance improvement plan shall 413 include specific identifiable and measurable expected outcomes and a 414 timetable for implementation. The timetable for a performance 415 improvement plan shall not exceed eighteen months. 416 (8) The executive director shall approve any performance 417 improvement plan that it determines is reasonably likely to address the 418 underlying cause of the entity's cost growth and has a reasonable 419 expectation for successful implementation. 420 (9) If the executive director determines that the performance 421 improvement plan is unacceptable or incomplete, the executive director 422 may provide consultation on the criteria that have not been met and 423 may allow an additional time period, up to thirty calendar days, for 424 Governor's Bill No. 5054 LCO No. 582 15 of 24 resubmission of the performance improvement plan, provided all 425 aspects of the performance improvement plan shall be proposed by the 426 health care entity and the office shall not require specific elements for 427 approval. 428 (10) Upon approval of a proposed performance improvement plan, 429 the executive director shall notify the health care entity to begin 430 immediate implementation of such plan. The executive director shall 431 provide public notice on the office's Internet web site that the health care 432 entity is implementing a performance improvement plan. All health 433 care entities implementing an approved performance improvement 434 plan shall be subject to additional reporting requirements and 435 compliance monitoring, as determined by the office. 436 (11) All health care entities shall, in good faith, work to implement 437 the performance improvement plan. At any point during the 438 implementation of the performance improvement plan, the health care 439 entity may file amendments to the performance improvement plan, 440 subject to the approval of the executive director. 441 (12) At the conclusion of the timetable established in the performance 442 improvement plan, the health care entity shall report to the office 443 regarding the outcome of the performance improvement plan. If the 444 performance improvement plan is found to be unsuccessful, the 445 executive director shall: (A) Extend the implementation timetable of the 446 existing performance improvement plan; (B) approve amendments to 447 the performance improvement plan as proposed by the health care 448 entity; (C) require the health care entity to submit a new performance 449 improvement plan; or (D) waive or delay the requirement to file any 450 additional performance improvement plans. 451 (13) Upon the successful completion of the perfor mance 452 improvement plan, the executive director shall remove the identity of 453 the health care entity from the office's Internet web site. 454 (14) If the executive director determines that further legislative 455 authority is needed to (A) achieve the health care cost growth 456 Governor's Bill No. 5054 LCO No. 582 16 of 24 benchmarks, primary care spending targets or health care quality 457 benchmarks developed pursuant to section 19a-754g, (B) assist health 458 care entities with the implementation of performance improvement 459 plans, or (C) otherwise ensure compliance with the provisions of this 460 section, the executive director may submit, in accordance with the 461 provisions of section 11-4a, a recommendation for proposed legislation 462 to the joint standing committee of the General Assembly having 463 cognizance of matters relating to public health. 464 (15) If the executive director determines that a health care entity has 465 (A) negligently failed to file a performance improvement plan with the 466 office not later than forty-five days after receipt of notice from the office 467 pursuant to subsection (d) of this section, (B) failed to file an acceptable 468 performance improvement plan in good faith with the office, (C) failed 469 to implement the performance improvement plan in good faith, or (D) 470 knowingly failed to provide required information to the office or 471 knowingly falsified such information, the executive director may assess 472 a civil penalty to the health care entity of not more than five hundred 473 thousand dollars. The executive director shall seek to promote 474 compliance with this section and shall only impose a civil penalty as a 475 last resort. 476 (NEW) (d) (1) If the executive director finds, based on the office's 477 annual report and in addition to the grounds for a cost and market 478 impact review set forth in section 19a-639f, that the percentage change 479 in total health care expenditures exceeded the health care cost growth 480 benchmark in the previous calendar year, the executive director may 481 conduct, within available appropriations, a cost and market impact 482 review of any health care entity identified by the office under this 483 section. 484 (2) The executive director shall initiate a cost and market impact 485 review by sending the identified health care entity a written notice 486 containing a description of the basis for the cost and market impact 487 review and a request for information and documents. Not later than 488 thirty days after receipt of such notice, the identified entity shall submit 489 Governor's Bill No. 5054 LCO No. 582 17 of 24 to the office a written response. 490 (3) A cost and market impact review may examine factors relating to 491 the health care entity's business and its relative market position, 492 including, but not limited to: (A) The health care entity's size and market 493 share within its primary service areas by major service category and 494 within its dispersed service areas; (B) the health care entity's prices for 495 services, including its relative price compared to other health care 496 entities for the same services in the same market; (C) the health care 497 entity's health status adjusted total medical expense, including its health 498 status adjusted total medical expense compared to similar providers; 499 (D) the quality of the services the health care entity provides, including 500 patient experience; (E) the health care entity's provider cost and cost 501 trends in comparison to total health care expenditures state-wide; (F) 502 the availability and accessibility of services similar to those provided, or 503 proposed to be provided, through the health care entity within its 504 primary service areas and dispersed service areas; (G) the health care 505 entity's impact on competing options for the delivery of health care 506 services within its primary service areas and dispersed service areas 507 including, if applicable, the impact on existing service providers of a 508 health care entity's expansion, affiliation, merger or acquisition, to enter 509 a primary or dispersed service area in which it did not previously 510 operate; (H) the methods used by the health care entity to attract patient 511 volume and to recruit or acquire health care professionals or facilities; 512 (I) the role of the health care entity in serving at-risk, underserved and 513 government payer patient populations, including those with behavioral, 514 substance use disorder and mental health conditions, within its primary 515 service areas and dispersed service areas; (J) the role of the health care 516 entity in providing low margin or negative margin services within its 517 primary service areas and dispersed service areas; (K) consumer 518 concerns, including, but not limited to, complaints or other allegations 519 that the health care entity has engaged in any unfair method of 520 competition or any unfair or deceptive act or practice; and (L) any other 521 factors that the executive director determines to be in the public interest. 522 (4) The executive director shall make factual findings and issue a 523 Governor's Bill No. 5054 LCO No. 582 18 of 24 preliminary report on the cost and market impact review. In the report, 524 the executive director shall identify any health care entity that meets all 525 of the following criteria: (A) The health care entity has a dominant 526 market share for the services it provides; (B) the health care entity 527 charges prices for services that are materially higher than the median 528 prices charged by all other providers for the same services in the same 529 market; and (C) the health care entity has a health status adjusted total 530 medical expense that is materially higher than the median total medical 531 expense for all other providers for the same service in the same market. 532 (5) Not later than thirty days after issuance of a preliminary report, 533 the health care entity may respond in writing to the findings of the 534 executive director in the report. After receipt of such written response, 535 or if no response is received by the office on or before thirty days after 536 issuance of its preliminary report, the executive director shall issue the 537 office's final report on the cost and market impact review. 538 Sec. 6. Subsection (a) of section 19a-754j of the general statutes is 539 repealed and the following is substituted in lieu thereof (Effective July 1, 540 2024): 541 (a) (1) Not later than June 30, 2023, and annually thereafter, the 542 executive director shall hold an informational public hearing to 543 compare the growth in total health care expenditures in the performance 544 year to the health care cost growth benchmark established pursuant to 545 section 19a-754g for such year. Such hearing shall involve an 546 examination of: 547 (A) The report most recently prepared by the executive director 548 pursuant to subsection (b) of section 19a-754h; 549 (B) The expenditures of provider entities and payers, including, but 550 not limited to, health care cost trends, primary care spending as a 551 percentage of total medical expenses and the factors contributing to 552 such costs and expenditures; and 553 (C) Any other matters that the executive director, in the executive 554 Governor's Bill No. 5054 LCO No. 582 19 of 24 director's discretion, deems relevant for the purposes of this section. 555 (2) The executive director may require any payer or provider entity 556 that, for the performance year, is found to be a significant contributor to 557 health care cost growth in the state or has failed to meet the primary care 558 spending target, to participate in such hearing. Each such payer or 559 provider entity that is required to participate in such hearing shall 560 provide testimony on issues identified by the executive director and 561 provide additional information on actions taken to reduce such payer's 562 or entity's contribution to future state-wide health care costs and 563 expenditures or to increase such payer's or provider entity's primary 564 care spending as a percentage of total medical expenses. 565 (3) The executive director may require that any other entity that is 566 found to be a significant contributor to health care cost growth in this 567 state during the performance year participate in such hearing. Any other 568 entity that is required to participate in such hearing shall provide 569 testimony on issues identified by the executive director and provide 570 additional information on actions taken to reduce such other entity's 571 contribution to future state-wide health care costs. If such other entity is 572 a drug manufacturer, and the executive director requires that such drug 573 manufacturer participate in such hearing with respect to a specific drug 574 or class of drugs, such hearing may, to the extent possible, include 575 representatives from at least one brand-name manufacturer, one generic 576 manufacturer and one innovator company that is less than ten years old. 577 (4) For any hearing to be held pursuant to this subsection, the 578 executive director or such agent having authority by law to issue such 579 process may subpoena witnesses and require the production of records, 580 papers and documents pertinent to such inquiry. If any person disobeys 581 such process or, having appeared in obedience thereto, refuses to 582 answer any pertinent question put to such person by the executive 583 director or such executive director's authorized agent or to produce any 584 records and papers pursuant thereto, the executive director or such 585 executive director's agent may apply to the superior court for the 586 judicial district of Hartford or for the judicial district wherein the person 587 Governor's Bill No. 5054 LCO No. 582 20 of 24 resides or wherein the business has been conducted, or to any judge of 588 said court if the same is not in session, setting forth such disobedience 589 to process or refusal to answer, and said court or such judge shall cite 590 such person to appear before said court or such judge to answer such 591 question or to produce such records and papers. 592 [(4)] (5) Not later than October 15, 2023, and annually thereafter, the 593 executive director shall prepare and submit a report, in accordance with 594 section 11-4a, to the joint standing committees of the General Assembly 595 having cognizance of matters relating to insurance and public health. 596 Such report shall be based on the executive director's analysis of the 597 information submitted during the most recent informational public 598 hearing conducted pursuant to this subsection and any other 599 information that the executive director, in the executive director's 600 discretion, deems relevant for the purposes of this section, and shall: 601 (A) Describe health care spending trends in this state, including, but 602 not limited to, trends in primary care spending as a percentage of total 603 medical expense, and the factors underlying such trends; 604 (B) Include the findings from the report prepared pursuant to 605 subsection (b) of section 19a-754h; 606 (C) Describe a plan for monitoring any unintended adverse 607 consequences resulting from the adoption of cost growth benchmarks 608 and primary care spending targets and the results of any findings from 609 the implementation of such plan; and 610 (D) Disclose the executive director's recommendations, if any, 611 concerning strategies to increase the efficiency of the state's health care 612 system, including, but not limited to, any recommended legislation 613 concerning the state's health care system. 614 Sec. 7. Section 19a-754k of the general statutes is repealed and the 615 following is substituted in lieu thereof (Effective October 1, 2024): 616 The executive director may adopt regulations, in accordance with 617 Governor's Bill No. 5054 LCO No. 582 21 of 24 chapter 54, to implement the provisions of section 19a-754a and sections 618 19a-754f to 19a-754j, inclusive, as amended by this act. The executive 619 director may implement policies and procedures necessary to 620 administer the provisions of this section while in the process of adopting 621 such policies and procedures in regulation form, provided the executive 622 director holds a public hearing at least thirty days prior to implementing 623 such policies and procedures and publishes notice of intention to adopt 624 the regulations on the Office of Health Strategy's Internet web site and 625 the eRegulations System not later than twenty days after implementing 626 such policies and procedures. Policies and procedures implemented 627 pursuant to this section shall be valid until the time such regulations are 628 effective. 629 Sec. 8. (NEW) (Effective January 1, 2025) (a) As used in this section: 630 (1) "Alternative payment model" means a health care payment 631 method that uses financial incentives to promote or leverage greater 632 value, including higher quality care at lower costs for patients, 633 purchasers, payers and providers. 634 (2) "Health care cost growth benchmark" means the annual 635 benchmark established pursuant to section 19a-754g of the general 636 statutes. 637 (3) "Total medical expenditure" means the total cost of care for the 638 patient population of a payer or provider entity for a given calendar 639 year, where cost is calculated for such year as the sum of (A) all claims-640 based spending paid to providers by public and private payers, and net 641 of pharmacy rebates, (B) all nonclaims payments for such year, 642 including, but not limited to, incentive payments and care coordination 643 payments, and (C) all patient cost-sharing amounts expressed on a per 644 capita basis for the patient population of a payer or provider entity in 645 this state. 646 (4) "Carrier" has the same meaning as provided in section 38a-175 of 647 the general statutes. 648 Governor's Bill No. 5054 LCO No. 582 22 of 24 (b) The executive director of the Office of Health Strategy shall 649 establish an affordability standard for coverage of persons by an 650 individual health insurance policy or a group health insurance policy 651 providing coverage of the type specified in section 38a-469 of the general 652 statutes that is delivered, issued for delivery or renewed in the state. 653 Such standard shall consider a carrier's efforts to keep year over year 654 increases in premiums at or below the health care cost growth 655 benchmark developed pursuant to section 19a-754g of the general 656 statutes, including, but not limited to, the following: 657 (1) Efforts to reach primary care spending targets as established 658 under such benchmark; 659 (2) The number and type of alternative payment models in operation 660 and the dates on which such models were established, including details 661 on models that tie payments to health care quality, health outcomes and 662 decreases in health disparities; 663 (3) The proportion of total medical expenditure and the percentage of 664 covered lives in each market that are associated with alternative 665 payment models; 666 (4) Efforts to tie increases in contracted provider rates to the health 667 care cost growth benchmark; 668 (5) Efforts to reduce unnecessary utilization by addressing health-669 related social needs; and 670 (6) Efforts to incorporate standards of the health care organizations 671 designated by the Comptroller as "Centers for Excellence" into provider 672 contracts. 673 (c) Beginning on April 1, 2025, each carrier shall annually submit, not 674 later than sixty days prior to filing premium rates pursuant to sections 675 38a-481 and 38a-513 of the general statutes, a report to the Office of 676 Health Strategy demonstrating its compliance with the affordability 677 standard established pursuant to subsection (b) of this section. Upon 678 Governor's Bill No. 5054 LCO No. 582 23 of 24 request by the executive director, a carrier shall provide additional 679 information to the office, not later than thirty days after the date of such 680 request, that the executive director of the office determines is necessary 681 to evaluate whether the carrier has met the affordability standard. The 682 office may hold a public hearing on the carrier's report. 683 (d) The executive director shall determine, based on the information 684 provided in the carrier's report and any additional information 685 provided by the carrier, if the carrier is in compliance with the 686 affordability standard established pursuant to subsection (b) of this 687 section. The executive director shall not unreasonably withhold a 688 determination of compliance. For any carrier that has not established 689 compliance with the affordability standard, the executive director may 690 request further explanation from the carrier as to the carrier's inability 691 to comply with the standard and may request that the carrier provide 692 information regarding how the carrier intends to come into compliance 693 with the standard in the following year. 694 (e) Not later than July 1, 2025, and annually thereafter, the executive 695 director shall submit determinations of compliance made pursuant to 696 subsection (d) of this section to the Insurance Commissioner. 697 (f) The executive director may adopt regulations, in accordance with 698 the provisions of chapter 54 of the general statutes, to carry out the 699 provisions of this section. If the executive director decides to adopt 700 regulations, the executive director shall propose such regulations not 701 later than January 1, 2025. The executive director may implement 702 policies and procedures necessary to administer the provisions of this 703 section while in the process of adopting such policies and procedures as 704 regulations, provided notice of intent to adopt regulations is published 705 on the eRegulations System not later than twenty days after the date of 706 implementation. Policies and procedures implemented pursuant to this 707 section shall be valid until the time final regulations are adopted. 708 Sec. 9. (NEW) (Effective January 1, 2025) On and after July 1, 2025, the 709 Insurance Commissioner may consider a carrier's compliance with the 710 Governor's Bill No. 5054 LCO No. 582 24 of 24 affordability standard established by the executive director of the Office 711 of Health Strategy pursuant to section 8 of this act when evaluating a 712 request for a rate increase pursuant to section 38a-481 or 38a-513 of the 713 general statutes. 714 This act shall take effect as follows and shall amend the following sections: Section 1 October 1, 2024 New section Sec. 2 October 1, 2024 New section Sec. 3 October 1, 2024 New section Sec. 4 July 1, 2024 New section Sec. 5 October 1, 2025 19a-754i(c) and (d) Sec. 6 July 1, 2024 19a-754j(a) Sec. 7 October 1, 2024 19a-754k Sec. 8 January 1, 2025 New section Sec. 9 January 1, 2025 New section Statement of Purpose: To implement the Governor's budget recommendations. [Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not underlined.]