LCO 1 of 13 General Assembly Substitute Bill No. 6895 January Session, 2025 AN ACT CONCERNING HEALTH BENEFIT REVIEW AND REQUIRING HEALTH INSURANCE COVERAGE FOR BIOMARKER TESTING. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. Section 38a-21 of the general statutes is repealed and the 1 following is substituted in lieu thereof (Effective January 1, 2026): 2 (a) As used in this section: 3 (1) "Commissioner" means the Insurance Commissioner. 4 (2) "Exchange" has the same meaning as provided in section 38a-1080. 5 (3) "Health carrier" has the same meaning as provided in section 38a-6 1080. 7 [(2)] (4) "Mandated health benefit" means [an existing] any statutory 8 obligation [of, or proposed legislation] that would require [,] an insurer, 9 health care center, hospital service corporation, medical service 10 corporation, fraternal benefit society or other entity that offers 11 individual or group health insurance or medical or health care benefits 12 plan in this state or a health carrier that offers a qualified health plan 13 through the exchange or the state employee plan to [: (A) Permit an 14 insured or enrollee to obtain health care treatment or services from a 15 particular type of health care provider; (B) offer or provide coverage for 16 Substitute Bill No. 6895 LCO 2 of 13 the screening, diagnosis or treatment of a particular disease or 17 condition; or (C)] offer or provide coverage for a particular type of 18 health care treatment or service, or for medical equipment, medical 19 supplies or drugs used in connection with a health care treatment or 20 service. ["Mandated health benefit" includes any proposed legislation to 21 expand or repeal an existing statutory obligation relating to health 22 insurance coverage or medical benefits.] 23 (5) "Qualified health plan" has the same meaning as provided in 24 section 38a-1080. 25 (6) "State employee plan" has the same meaning as provided in 26 section 3-123rrr. 27 (b) (1) There is established within the Insurance Department a health 28 benefit review program for the review and evaluation of any mandated 29 health benefit that is [requested by the joint standing committee of] 30 passed by the General Assembly [having cognizance of matters relating 31 to insurance] on or after January 1, 2026. Such program shall be funded 32 by the Insurance Fund established under section 38a-52a. The 33 commissioner shall be authorized to make assessments in a manner 34 consistent with the provisions of chapter 698 for the costs of carrying 35 out the requirements of this section. Such assessments shall be in 36 addition to any other taxes, fees and moneys otherwise payable to the 37 state. The commissioner shall deposit all payments made under this 38 section with the State Treasurer. The moneys deposited shall be credited 39 to the Insurance Fund and shall be accounted for as expenses recovered 40 from insurance companies. Such moneys shall be expended by the 41 commissioner to carry out the provisions of this section and section 2 of 42 public act 09-179. 43 (2) The commissioner shall [contract with The University of 44 Connecticut Center for Public Health and Health Policy to conduct] 45 engage the services of any actuary, actuarial firm, quality improvement 46 clearinghouse, health policy research organization or any other 47 independent expert as the commissioner deems necessary to assist said 48 Substitute Bill No. 6895 LCO 3 of 13 commissioner in the review and evaluation of any mandated health 49 benefit review [requested pursuant to subsection (c) of] required 50 pursuant to this section. [The director of said center may engage the 51 services of an actuary, quality improvement clearinghouse, health 52 policy research organization or any other independent expert, and may 53 engage or consult with any dean, faculty or other personnel said director 54 deems appropriate within The University of Connecticut schools and 55 colleges, including, but not limited to, The University of Connecticut (A) 56 School of Business, (B) School of Dental Medicine, (C) School of Law, 57 (D) School of Medicine, and (E) School of Pharmacy. 58 (c) Not later than August first of each year, the joint standing 59 committee of the General Assembly having cognizance of matters 60 relating to insurance shall submit to the commissioner a list of any 61 mandated health benefits for which said committee is requesting a 62 review. Not later than January first of the succeeding year, the 63 commissioner shall submit a report, in accordance with section 11-4a, of 64 the findings of such review and the information set forth in subsection 65 (d) of this section. 66 (d) The review report shall include at least the following, to the extent 67 information is available: 68 (1) The social impact of mandating the benefit, including:] 69 (c) Any mandated health benefit passed by the General Assembly on 70 or after January 1, 2026, shall be terminated for all individual and group 71 health insurance policies delivered, issued for delivery, renewed, 72 amended or continued in this state four years after the effective date of 73 such mandated health benefit, unless, prior to such termination and 74 after the joint standing committee of the General Assembly having 75 cognizance of matters relating to insurance receives a mandated health 76 benefit review report pursuant to the provisions of subsection (d) of this 77 section, the General Assembly approves such mandated health benefit 78 by a majority vote of both houses. 79 (d) Not later than three years after the effective date of any mandated 80 Substitute Bill No. 6895 LCO 4 of 13 health benefit, the commissioner shall submit a mandated health benefit 81 review report, in accordance with the provisions of section 11-4a, to the 82 joint standing committee of the General Assembly having cognizance of 83 matters relating to insurance. Such report shall provide an assessment 84 of each mandated health benefit passed by the General Assembly on or 85 after January 1, 2026. Such report shall include an evaluation of the 86 quality and cost impacts of mandating each such health benefit, 87 including: 88 [(A)] (1) The extent to which the treatment, service or equipment, 89 supplies or drugs, as applicable, is utilized by a significant portion of 90 the population; 91 [(B)] (2) The extent to which the treatment, service or equipment, 92 supplies or drugs, as applicable, is currently available to the population, 93 including, but not limited to, coverage under Medicare, or through 94 public programs administered by charities, public schools, the 95 Department of Public Health, municipal health departments or health 96 districts or the Department of Social Services; 97 [(C)] (3) The extent to which insurance coverage is already available 98 for the treatment, service or equipment, supplies or drugs, as applicable; 99 [(D) If the coverage is not generally available, the extent to which 100 such lack of coverage results in persons being unable to obtain necessary 101 health care treatment; 102 (E) If the coverage is not generally available, the extent to which such 103 lack of coverage results in unreasonable financial hardships on those 104 persons needing treatment; 105 (F) The level of public demand and the level of demand from 106 providers for the treatment, service or equipment, supplies or drugs, as 107 applicable; 108 (G) The level of public demand and the level of demand from 109 providers for insurance coverage for the treatment, service or 110 Substitute Bill No. 6895 LCO 5 of 13 equipment, supplies or drugs, as applicable; 111 (H) The likelihood of achieving the objectives of meeting a consumer 112 need as evidenced by the experience of other states; 113 (I) The relevant findings of state agencies or other appropriate public 114 organizations relating to the social impact of the mandated health 115 benefit; 116 (J) The alternatives to meeting the identified need, including, but not 117 limited to, other treatments, methods or procedures; 118 (K) Whether the benefit is a medical or a broader social need and 119 whether it is consistent with the role of health insurance and the concept 120 of managed care; 121 (L) The potential social implications of the coverage with respect to 122 the direct or specific creation of a comparable mandated benefit for 123 similar diseases, illnesses or conditions; 124 (M) The impact of the benefit on the availability of other benefits 125 currently offered; 126 (N) The impact of the benefit as it relates to employers shifting to self-127 insured plans and the extent to which the benefit is currently being 128 offered by employers with self-insured plans;] 129 [(O)] (4) The impact of making the mandated health benefit 130 applicable to the state employee [health insurance or health benefits] 131 plan; [and] 132 [(P)] (5) The extent to which credible scientific evidence published in 133 peer-reviewed medical literature generally recognized by the relevant 134 medical community determines the treatment, service or equipment, 135 supplies or drugs, as applicable, to be safe and effective; [and 136 (2) The financial impact of mandating the benefit, including:] 137 [(A)] (6) The extent to which the mandated health benefit may 138 Substitute Bill No. 6895 LCO 6 of 13 increase or decrease the cost of the treatment, service or equipment, 139 supplies or drugs, as applicable, over the next five years; 140 [(B)] (7) The extent to which the mandated health benefit may 141 increase the appropriate or inappropriate use of the treatment, service 142 or equipment, supplies or drugs, as applicable, over the next five years; 143 [(C)] (8) The extent to which the mandated health benefit may serve 144 as an alternative for more expensive or less expensive treatment, service 145 or equipment, supplies or drugs, as applicable; 146 [(D)] (9) The methods that will be implemented to manage the 147 utilization and costs of the mandated health benefit; 148 [(E)] (10) The extent to which insurance coverage for the treatment, 149 service or equipment, supplies or drugs, as applicable, may be 150 reasonably expected to increase or decrease the insurance premiums 151 and administrative expenses for policyholders; 152 [(F)] (11) The extent to which the treatment, service or equipment, 153 supplies or drugs, as applicable, is more or less expensive than an 154 existing treatment, service or equipment, supplies or drugs, as 155 applicable, that is determined to be equally safe and effective by credible 156 scientific evidence published in peer-reviewed medical literature 157 generally recognized by the relevant medical community; 158 [(G)] (12) The impact of insurance coverage for the treatment, service 159 or equipment, supplies or drugs, as applicable, on the total cost of health 160 care, including potential benefits or savings to insurers and employers 161 resulting from prevention or early detection of disease or illness related 162 to such coverage; 163 [(H)] (13) The impact of the mandated health care benefit on the cost 164 of health care for small employers, as defined in section 38a-564, and for 165 employers other than small employers; [and] 166 [(I)] (14) The impact of the mandated health benefit on cost-shifting 167 between private and public payors of health care coverage and on the 168 Substitute Bill No. 6895 LCO 7 of 13 overall cost of the health care delivery system in the state; and 169 (15) The impact of the mandated health benefit on the cost of qualified 170 health plans offered through the exchange. 171 (e) The joint standing committee of the General Assembly having 172 cognizance of matters relating to insurance may conduct an 173 informational public hearing following such committee's receipt of the 174 mandated health benefit review report provided pursuant to the 175 provisions of subsection (d) of this section. The commissioner and the 176 Commissioner of Health Strategy shall attend any such public hearing 177 and be available for questions from the members of such committee at 178 such public hearing. 179 Sec. 2. Section 2-24 of the general statutes is repealed and the 180 following is substituted in lieu thereof (Effective January 1, 2026): 181 The words "State of Connecticut" shall be printed at the head of each 182 bill and document printed by order of the General Assembly, or either 183 house thereof, and on its title page or cover, if any. Before printed, 184 electronic or photographic copies of an original bill are made, the bill 185 shall be endorsed with (1) the date of its introduction; (2) its number; (3) 186 the name of the member or committee introducing it; and (4) the name 187 of the committee to which it was referred. Copies of bills or resolutions 188 printed or produced electronically after favorable report by a committee 189 or reprinted or produced electronically after amendment on the third 190 reading, i.e., files, shall bear the file number of such bill or resolution, 191 placed conspicuously at the head of the same, which file number shall 192 be assigned by the Legislative Commissioners' Office in the order 193 printed or produced, the number and title of the bill, the name of the 194 committee to which it was referred, the date and nature of the 195 committee's report, in any case where the bill, if passed, would (A) 196 require the expenditure of state or municipal funds, [or] (B) affect state 197 or municipal revenue, or (C) impact the premiums paid by enrollees of 198 health benefit plans offered through the exchange, as provided in 199 section 38a-1080, a fiscal note, including an estimate of the cost or of the 200 Substitute Bill No. 6895 LCO 8 of 13 revenue impact shall be appended thereto, [and,] in any case where the 201 bill, if passed, would have a financial impact on electric ratepayers, a 202 ratepayer impact statement, as described in subsection (b) of section 2-203 24a, as amended by this act, and, in any case where the bill, if passed, 204 would have a financial impact on the premiums paid by enrollees of 205 health benefit plans offered through the exchange, an enrollee impact 206 statement, as described in subsection (b) of section 2-24a, as amended 207 by this act. When a bill or resolution is accompanied with a report of a 208 committee, other than a recommendation that it ought or ought not to 209 pass, it shall then have an additional endorsement, as follows: 210 "Accompanied by special report, No.-". Bills shall be designated in the 211 calendar of each house by their file numbers, as well as by the titles and 212 numbers of the bills. 213 Sec. 3. Section 2-24a of the general statutes is repealed and the 214 following is substituted in lieu thereof (Effective January 1, 2026): 215 (a) No bill without a fiscal note appended thereto which, if passed, 216 would require the expenditure of state or municipal funds or affect state 217 or municipal revenue in the current fiscal year or any of the next ensuing 218 five fiscal years shall be acted upon by either house of the General 219 Assembly unless said requirement of a fiscal note is dispensed with by 220 a vote of at least two-thirds of such house. Such fiscal note shall clearly 221 identify the cost and revenue impact to the state and municipalities in 222 the current fiscal year and in each of the next ensuing five fiscal years. 223 (b) Beginning with the session of the General Assembly commencing 224 on January 9, 2019, no bill without a ratepayer impact statement 225 appended thereto which, if passed, would have a financial impact on 226 electric ratepayers, shall be acted upon by either house of the General 227 Assembly unless said requirement of a ratepayer impact statement is 228 dispensed with by a vote of at least two-thirds of such house. Such 229 statement shall (1) be prepared by the Office of Fiscal Analysis; and (2) 230 provide an assessment as to whether such bill will have a significant 231 direct financial impact on the cost of electricity to the majority of 232 Connecticut electric ratepayers. 233 Substitute Bill No. 6895 LCO 9 of 13 (c) Beginning with the session of the General Assembly commencing 234 on February 4, 2026, no bill without an enrollee impact statement 235 appended thereto which, if passed, would have a financial impact on 236 the premiums paid by enrollees of health benefit plans offered through 237 the exchange, shall be acted upon by either house of the General 238 Assembly, unless said requirement of an enrollee impact statement is 239 dispensed with by a vote of at least two-thirds of such house. Such 240 statement shall (1) be prepared by the Office of Fiscal Analysis, and (2) 241 provide an assessment as to whether such bill will have a significant 242 direct financial impact on the cost of premiums paid by enrollees of 243 health benefit plans offered through the exchange. For the purposes of 244 this section, "health benefit plan" has the same meaning as provided in 245 section 38a-591a. 246 Sec. 4. (NEW) (Effective January 1, 2026) (a) As used in this section: 247 (1) "Biomarker" means a characteristic, including, but not limited to, 248 a gene mutation or protein expression that can be objectively measured 249 and evaluated as an indicator of normal biological processes, pathogenic 250 processes or pharmacologic responses to a specific therapeutic 251 intervention for a disease or condition. 252 (2) "Biomarker testing" means the analysis of a patient's tissue, blood 253 or other biospecimen for the presence of a biomarker, including, but not 254 limited to, tests for a single substance, tests for multiple substances and 255 diseases or conditions. "Biomarker testing" does not include an 256 evaluation of how a patient feels, functions or survives. 257 (3) "Clinical utility" means the test result provides information that is 258 used in the formulation of a treatment or monitoring strategy that 259 informs a patient's outcome and impacts the clinical decision. 260 (4) "Nationally recognized clinical practice guidelines" means 261 evidence-based clinical practice guidelines informed by a systematic 262 review of evidence and an assessment of the benefits and risks of 263 alternative care options intended to optimize patient care developed by 264 independent organizations or medical professional societies utilizing 265 Substitute Bill No. 6895 LCO 10 of 13 transparent methodologies and reporting structures and conflict-of-266 interest policies. 267 (b) Each individual health insurance policy providing coverage of the 268 type specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-469 269 of the general statutes delivered, issued for delivery, renewed, amended 270 or continued in this state on or after January 1, 2026, shall provide 271 coverage for biomarker testing for the purpose of diagnosis, treatment, 272 appropriate management or ongoing monitoring of an insured's disease 273 or condition, provided such biomarker testing provides clinical utility 274 as demonstrated by medical and scientific evidence, including, but not 275 limited to, one or more of the following: (1) Approval or clearance of 276 such test by the federal Food and Drug Administration or 277 recommendations on labels of drugs approved by the federal Food and 278 Drug Administration to conduct such test, (2) national coverage 279 determinations or local coverage determinations for Medicare 280 Administrative Contractors by the Centers for Medicare and Medicaid 281 Services, or (3) nationally recognized clinical practice guidelines. Such 282 policy shall provide such coverage in a manner that limits disruptions 283 in care, including, but not limited to, the need for multiple biopsies or 284 biospecimen samples. Such policy shall require that biomarker testing 285 be performed at an in-network clinical laboratory facility certified under 286 the Clinical Laboratory Improvement Act of 1967, 42 USC Section 263a, 287 as amended from time to time, or any such in-network clinical 288 laboratory facility that has been granted a Clinical Laboratory 289 Amendments of 1988 waiver by the federal Food and Drug 290 Administration to perform such biomarker testing. 291 (c) Each entity providing such coverage shall establish a clear, readily 292 accessible and convenient process through which an insured or an 293 insured's health care provider may (1) request an exception to a 294 coverage policy, or (2) dispute an adverse utilization review 295 determination relating to such coverage. Each such entity shall post 296 such process on the Internet web site maintained by such entity. 297 (d) If prior authorization is required before providing such coverage, 298 Substitute Bill No. 6895 LCO 11 of 13 each entity providing such coverage or each utilization review entity or 299 other third party acting on behalf of such entity shall approve or deny 300 such prior authorization and notify the insured, the insured's health care 301 provider and any other entity requesting such prior authorization of 302 such approval or denial (1) if the prior authorization is not urgent, as 303 determined by the insured's health care provider, not later than seven 304 days after receiving a prior authorization request, or (2) if the prior 305 authorization is urgent, as determined by the insured's health care 306 provider, not later than seventy-two hours after receiving a prior 307 authorization request. 308 Sec. 5. (NEW) (Effective January 1, 2026) (a) As used in this section: 309 (1) "Biomarker" means a characteristic, including, but not limited to, 310 a gene mutation or protein expression that can be objectively measured 311 and evaluated as an indicator of normal biological processes, pathogenic 312 processes or pharmacologic responses to a specific therapeutic 313 intervention for a disease or condition. 314 (2) "Biomarker testing" means the analysis of a patient's tissue, blood 315 or other biospecimen for the presence of a biomarker, including, but not 316 limited to, tests for a single substance, tests for multiple substances and 317 diseases or conditions. "Biomarker testing" does not include an 318 evaluation of how a patient feels, functions or survives. 319 (3) "Clinical utility" means the test result provides information that is 320 used in the formulation of a treatment or monitoring strategy that 321 informs a patient's outcome and impacts the clinical decision. 322 (4) "Nationally recognized clinical practice guidelines" means 323 evidence-based clinical practice guidelines informed by a systematic 324 review of evidence and an assessment of the benefits and risks of 325 alternative care options intended to optimize patient care developed by 326 independent organizations or medical professional societies utilizing 327 transparent methodologies and reporting structures and conflict-of-328 interest policies. 329 Substitute Bill No. 6895 LCO 12 of 13 (b) Each group health insurance policy providing coverage of the 330 type specified in subdivisions (1), (2), (4), (11) and (12) of section 38a-469 331 of the general statutes delivered, issued for delivery, renewed, amended 332 or continued in this state on or after January 1, 2026, shall provide 333 coverage for biomarker testing for the purpose of diagnosis, treatment, 334 appropriate management or ongoing monitoring of an insured's disease 335 or condition, provided such biomarker testing provides clinical utility 336 as demonstrated by medical and scientific evidence, including, but not 337 limited to, one or more of the following: (1) Approval or clearance of 338 such test by the federal Food and Drug Administration or 339 recommendations on labels of drugs approved by the federal Food and 340 Drug Administration to conduct such test, (2) national coverage 341 determinations or local coverage determinations for Medicare 342 Administrative Contractors by the Centers for Medicare and Medicaid 343 Services, or (3) nationally recognized clinical practice guidelines. Such 344 policy shall provide such coverage in a manner that limits disruptions 345 in care, including, but not limited to, the need for multiple biopsies or 346 biospecimen samples. Such policy shall require that biomarker testing 347 be performed at an in-network clinical laboratory facility certified under 348 the Clinical Laboratory Improvement Act of 1967, 42 USC Section 263a, 349 as amended from time to time, or any such in-network clinical 350 laboratory facility that has been granted a Clinical Laboratory 351 Amendments of 1988 waiver by the federal Food and Drug 352 Administration to perform such biomarker testing. 353 (c) Each entity providing such coverage shall establish a clear, readily 354 accessible and convenient process through which an insured or an 355 insured's health care provider may (1) request an exception to a 356 coverage policy, or (2) dispute an adverse utilization review 357 determination relating to such coverage. Each such entity shall post 358 such process on the Internet web site maintained by such entity. 359 (d) If prior authorization is required before providing such coverage, 360 each entity providing such coverage or each utilization review entity or 361 other third party acting on behalf of such entity shall approve or deny 362 such prior authorization and notify the insured, the insured's health care 363 Substitute Bill No. 6895 LCO 13 of 13 provider and any other entity requesting such prior authorization of 364 such approval or denial (1) if the prior authorization is not urgent, as 365 determined by the insured's health care provider, not later than seven 366 days after receiving a prior authorization request, or (2) if the prior 367 authorization is urgent, as determined by the insured's health care 368 provider, not later than seventy-two hours after receiving a prior 369 authorization request. 370 This act shall take effect as follows and shall amend the following sections: Section 1 January 1, 2026 38a-21 Sec. 2 January 1, 2026 2-24 Sec. 3 January 1, 2026 2-24a Sec. 4 January 1, 2026 New section Sec. 5 January 1, 2026 New section INS Joint Favorable Subst.