LCO No. 3074 1 of 11 General Assembly Raised Bill No. 415 February Session, 2022 LCO No. 3074 Referred to Committee on INSURANCE AND REAL ESTATE Introduced by: (INS) AN ACT CONCERNING STEP THERAPY, ADVERSE DETERMINATION AND UTILIZATION REVIEWS. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. Subsection (a) of 38a-510 of the general statutes is repealed 1 and the following is substituted in lieu thereof (Effective January 1, 2023): 2 (a) No insurance company, hospital service corporation, medical 3 service corporation, health care center or other entity delivering, issuing 4 for delivery, renewing, amending or continuing an individual health 5 insurance policy or contract that provides coverage for prescription 6 drugs may: 7 (1) Require any person covered under such policy or contract to 8 obtain prescription drugs from a mail order pharmacy as a condition of 9 obtaining benefits for such drugs; or 10 (2) Require, if such insurance company, hospital service corporation, 11 medical service corporation, health care center or other entity uses step 12 therapy for such drugs, the use of step therapy for: 13 Raised Bill No. 415 LCO No. 3074 2 of 11 (A) [any] Any prescribed drug for longer than sixty days; [,] or 14 (B) [a] A prescribed drug for [cancer] treatment of a behavioral health 15 condition or a chronic, disabling or life-threatening condition or disease 16 for an insured who has been diagnosed with [stage IV metastatic cancer] 17 such a condition or disease, provided such prescribed drug is in 18 compliance with approved federal Food and Drug Administration 19 indications. 20 (3) At the expiration of the time period specified in subparagraph (A) 21 of subdivision (2) of this subsection, [or for a prescribed drug described 22 in subparagraph (B) of subdivision (2) of this subsection,] an insured's 23 treating health care provider may deem such step therapy drug regimen 24 clinically ineffective for the insured, at which time the insurance 25 company, hospital service corporation, medical service corporation, 26 health care center or other entity shall authorize dispensation of and 27 coverage for the drug prescribed by the insured's treating health care 28 provider, provided such drug is a covered drug under such policy or 29 contract. If such provider does not deem such step therapy drug 30 regimen clinically ineffective or has not requested an override pursuant 31 to subdivision (1) of subsection (b) of this section, such drug regimen 32 may be continued. For purposes of this section, "step therapy" means a 33 protocol or program that establishes the specific sequence in which 34 prescription drugs for a specified medical condition are to be prescribed. 35 Sec. 2. Subsection (a) of section 38a-544 of the general statutes is 36 repealed and the following is substituted in lieu thereof (Effective January 37 1, 2023): 38 (a) No insurance company, hospital service corporation, medical 39 service corporation, health care center or other entity delivering, issuing 40 for delivery, renewing, amending or continuing a group health 41 insurance policy or contract that provides coverage for prescription 42 drugs may: 43 (1) Require any person covered under such policy or contract to 44 obtain prescription drugs from a mail order pharmacy as a condition of 45 Raised Bill No. 415 LCO No. 3074 3 of 11 obtaining benefits for such drugs; or 46 (2) Require, if such insurance company, hospital service corporation, 47 medical service corporation, health care center or other entity uses step 48 therapy for such drugs, the use of step therapy for: 49 (A) [any] Any prescribed drug for longer than sixty days; [,] or 50 (B) [a] A prescribed drug for [cancer] treatment of a behavioral health 51 condition or a chronic, disabling or life-threatening condition or disease 52 for an insured who has been diagnosed with [stage IV metastatic cancer] 53 such a condition or disease, provided such prescribed drug is in 54 compliance with approved federal Food and Drug Administration 55 indications. 56 (3) At the expiration of the time period specified in subparagraph (A) 57 of subdivision (2) of this subsection, [or for a prescribed drug described 58 in subparagraph (B) of subdivision (2) of this subsection,] an insured's 59 treating health care provider may deem such step therapy drug regimen 60 clinically ineffective for the insured, at which time the insurance 61 company, hospital service corporation, medical service corporation, 62 health care center or other entity shall authorize dispensation of and 63 coverage for the drug prescribed by the insured's treating health care 64 provider, provided such drug is a covered drug under such policy or 65 contract. If such provider does not deem such step therapy drug 66 regimen clinically ineffective or has not requested an override pursuant 67 to subdivision (1) of subsection (b) of this section, such drug regimen 68 may be continued. For purposes of this section, "step therapy" means a 69 protocol or program that establishes the specific sequence in which 70 prescription drugs for a specified medical condition are to be prescribed. 71 Sec. 3. Subdivision (7) of section 38a-591a of the general statutes is 72 repealed and the following is substituted in lieu thereof (Effective January 73 1, 2023): 74 (7) "Clinical peer" means a physician or other health care professional 75 who: 76 Raised Bill No. 415 LCO No. 3074 4 of 11 (A) [holds] For a review other than as specified under subparagraph 77 (B) or (C) of subdivision (38) of this section: 78 (i) Holds a nonrestricted license in a state of the United States [and] 79 in the same [or similar] specialty as [typically manages the medical 80 condition, procedure or treatment] the treating physician or other health 81 care professional under review; [, and] 82 (ii) Holds a doctoral or medical degree; and 83 (iii) (I) Holds an applicable national board certification including at 84 the subspecialty level, where available, or (II) actively practices and 85 typically manages the medical condition under review or provides the 86 procedure or treatment under review; or 87 (B) [for] For a review specified under subparagraph (B) or (C) of 88 subdivision (38) of this section concerning: 89 (i) [a] A child or adolescent substance use disorder or a child or 90 adolescent mental disorder, holds (I) a national board certification in 91 child and adolescent psychiatry, or (II) a doctoral level psychology 92 degree with training and clinical experience in the treatment of child 93 and adolescent substance use disorder or child and adolescent mental 94 disorder, as applicable; [,] or 95 (ii) [an] An adult substance use disorder or an adult mental disorder, 96 holds (I) a national board certification in psychiatry, or (II) a doctoral 97 level psychology degree with training and clinical experience in the 98 treatment of adult substance use disorders or adult mental disorders, as 99 applicable. 100 Sec. 4. Subsection (a) of section 38a-591c of the general statutes is 101 repealed and the following is substituted in lieu thereof (Effective January 102 1, 2023): 103 (a) (1) Each health carrier shall contract with (A) health care 104 professionals to administer such health carrier's utilization review 105 program, and (B) clinical peers to evaluate the clinical appropriateness 106 Raised Bill No. 415 LCO No. 3074 5 of 11 of an adverse determination. 107 (2) (A) Each utilization review program shall use documented clinical 108 review criteria that are based on sound clinical evidence and are 109 evaluated periodically by the health carrier's organizational mechanism 110 specified in subparagraph (F) of subdivision (2) of subsection (c) of 111 section 38a-591b to assure such program's ongoing effectiveness. 112 (B) Except as provided in subdivisions (3), (4) and (5) of this 113 subsection, a health carrier may develop its own clinical review criteria 114 or it may purchase or license clinical review criteria from qualified 115 vendors approved by the commissioner, provided such clinical review 116 criteria conform to the requirements of subparagraph (A) of this 117 subdivision. 118 (C) Each health carrier shall (i) post on its Internet web site (I) any 119 clinical review criteria it uses, and (II) links to any rule, guideline, 120 protocol or other similar criterion a health carrier may rely upon to make 121 an adverse determination as described in subparagraph (F) of 122 subdivision (1) of subsection (e) of section 38a-591d, as amended by this 123 act, and (ii) make its clinical review criteria available upon request to 124 authorized government agencies. 125 (D) For each utilization review, there shall be a rebuttable 126 presumption that each health care service under review is medically 127 necessary if such health care service was ordered by a health care 128 professional acting within the health care professional's scope of 129 practice. A health carrier, or any utilization review company or designee 130 of a health carrier that performs utilization review on behalf of the 131 health carrier, shall have the burden of proving that a health care service 132 is not medically necessary. 133 (3) For any utilization review for the treatment of a substance use 134 disorder, as described in section 17a-458, the clinical review criteria used 135 shall be: (A) The most recent edition of the American Society of 136 Addiction Medicine Treatment Criteria for Addictive, Substance-137 Related, and Co-Occurring Conditions; or (B) clinical review criteria that 138 Raised Bill No. 415 LCO No. 3074 6 of 11 the health carrier demonstrates to the Insurance Department is 139 consistent with the most recent edition of the American Society of 140 Addiction Medicine Treatment Criteria for Addictive, Substance-141 Related, and Co-Occurring Conditions, except that nothing in this 142 subdivision shall prohibit a health carrier from developing its own 143 clinical review criteria or purchasing or licensing additional clinical 144 review criteria from qualified vendors approved by the commissioner, 145 to address advancements in technology or types of care for the 146 treatment of a substance use disorder, that are not covered in the most 147 recent edition of the American Society of Addiction Medicine Treatment 148 Criteria for Addictive, Substance-Related, and Co-Occurring 149 Conditions. Any such clinical review criteria developed by a health 150 carrier or purchased or licensed from a qualified vendor shall conform 151 to the requirements of subparagraph (A) of subdivision (2) of this 152 subsection. 153 (4) For any utilization review for the treatment of a child or 154 adolescent mental disorder, the clinical review criteria used shall be: (A) 155 The most recent guidelines of the American Academy of Child and 156 Adolescent Psychiatry's Child and Adolescent Service Intensity 157 Instrument; or (B) clinical review criteria that the health carrier 158 demonstrates to the Insurance Department is consistent with the most 159 recent guidelines of the American Academy of Child and Adolescent 160 Psychiatry's Child and Adolescent Service Intensity Instrument, except 161 that nothing in this subdivision shall prohibit a health carrier from 162 developing its own clinical review criteria or purchasing or licensing 163 additional clinical review criteria from qualified vendors approved by 164 the commissioner, to address advancements in technology or types of 165 care for the treatment of a child or adolescent mental disorder, that are 166 not covered in the most recent guidelines of the American Academy of 167 Child and Adolescent Psychiatry's Child and Adolescent Service 168 Intensity Instrument. Any such clinical review criteria developed by a 169 health carrier or purchased or licensed from a qualified vendor shall 170 conform to the requirements of subparagraph (A) of subdivision (2) of 171 this subsection. 172 Raised Bill No. 415 LCO No. 3074 7 of 11 (5) For any utilization review for the treatment of an adult mental 173 disorder, the clinical review criteria used shall be: (A) The most recent 174 guidelines of the American Psychiatric Association or the most recent 175 Standards and Guidelines of the Association for Ambulatory Behavioral 176 Healthcare; or (B) clinical review criteria that the health carrier 177 demonstrates to the Insurance Department is consistent with the most 178 recent guidelines of the American Psychiatric Association or the most 179 recent Standards and Guidelines of the Association for Ambulatory 180 Behavioral Healthcare, except that nothing in this subdivision shall 181 prohibit a health carrier from developing its own clinical review criteria 182 or purchasing or licensing additional clinical review criteria from 183 qualified vendors approved by the commissioner, to address 184 advancements in technology or types of care for the treatment of an 185 adult mental disorder, that are not covered in the most recent guidelines 186 of the American Psychiatric Association or the most recent Standards 187 and Guidelines of the Association for Ambulatory Behavioral 188 Healthcare. Any such clinical review criteria developed by a health 189 carrier or purchased or licensed from a qualified vendor shall conform 190 to the requirements of subparagraph (A) of subdivision (2) of this 191 subsection. 192 Sec. 5. Subsection (a) of section 38a-591d of the general statutes is 193 repealed and the following is substituted in lieu thereof (Effective January 194 1, 2023): 195 (a) (1) Each health carrier shall maintain written procedures for (A) 196 utilization review and benefit determinations, (B) expedited utilization 197 review and benefit determinations with respect to prospective urgent 198 care requests and concurrent review urgent care requests, and (C) 199 notifying covered persons or covered persons' authorized 200 representatives of such review and benefit determinations. Each health 201 carrier shall make such review and benefit determinations within the 202 specified time periods under this section. 203 (2) In determining whether a benefit request shall be considered an 204 urgent care request, an individual acting on behalf of a health carrier 205 Raised Bill No. 415 LCO No. 3074 8 of 11 shall apply the judgment of a prudent layperson who possesses an 206 average knowledge of health and medicine, except that any benefit 207 request (A) determined to be an urgent care request by a health care 208 professional with knowledge of the covered person's medical condition, 209 or (B) specified under subparagraph (B) or (C) of subdivision (38) of 210 section 38a-591a, as amended by this act, shall be deemed an urgent care 211 request. 212 (3) (A) At the time a health carrier notifies a covered person, a covered 213 person's authorized representative or a covered person's health care 214 professional of an initial adverse determination that was based, in whole 215 or in part, on medical necessity, of a concurrent or prospective 216 utilization review or of a benefit request, the health carrier shall notify 217 the covered person's health care professional (i) of the opportunity for a 218 conference as provided in subparagraph (B) of this subdivision, and (ii) 219 that such conference shall not be considered a grievance of such initial 220 adverse determination as long as a grievance has not been filed as set 221 forth in subparagraph (B) of this subdivision. 222 (B) After a health carrier notifies a covered person, a covered person's 223 authorized representative or a covered person's health care professional 224 of an initial adverse determination that was based, in whole or in part, 225 on medical necessity, of a concurrent or prospective utilization review 226 or of a benefit request, the health carrier shall offer a covered person's 227 health care professional the opportunity to confer, at the request of the 228 covered person's health care professional, with a clinical peer of such 229 health carrier, provided such covered person, covered person's 230 authorized representative or covered person's health care professional 231 has not filed a grievance of such initial adverse determination prior to 232 such conference. Such conference shall not be considered a grievance of 233 such initial adverse determination. Such health carrier shall grant such 234 clinical peer authority to reverse such initial adverse determination. 235 Sec. 6. Subsection (c) of section 38a-591e of the general statutes is 236 repealed and the following is substituted in lieu thereof (Effective January 237 1, 2023): 238 Raised Bill No. 415 LCO No. 3074 9 of 11 (c) (1) (A) When conducting a review of an adverse determination 239 under this section, the health carrier shall ensure that such review is 240 conducted in a manner to ensure the independence and impartiality of 241 the clinical peer or peers involved in making the review decision. 242 (B) If the adverse determination involves utilization review, the 243 health carrier shall designate an appropriate clinical peer or peers to 244 review such adverse determination. Such clinical peer or peers shall not 245 have been involved in the initial adverse determination. 246 (C) (i) For each review of an adverse determination under this section, 247 there shall be a rebuttable presumption that each health care service 248 under review is medically necessary if such health care service was 249 ordered by a health care professional acting within the scope of the 250 health care professional's practice. The health carrier may rebut such 251 presumption by reasonably substantiating to the clinical peer or peers 252 conducting the review under this section that such health care service is 253 not medically necessary. 254 [(C)] (ii) The clinical peer or peers conducting a review under this 255 section shall take into consideration all comments, documents, records 256 and other information relevant to the covered person's benefit request 257 that is the subject of the adverse determination under review, that are 258 submitted by the covered person or the covered person's authorized 259 representative, regardless of whether such information was submitted 260 or considered in making the initial adverse determination. 261 (D) Prior to issuing a decision, the health carrier shall provide free of 262 charge, by facsimile, electronic means or any other expeditious method 263 available, to the covered person or the covered person's authorized 264 representative, as applicable, any new or additional documents, 265 communications, information and evidence relied upon and any new or 266 additional scientific or clinical rationale used by the health carrier in 267 connection with the grievance. Such documents, communications, 268 information, evidence and rationale shall be provided sufficiently in 269 advance of the date the health carrier is required to issue a decision to 270 Raised Bill No. 415 LCO No. 3074 10 of 11 permit the covered person or the covered person's authorized 271 representative, as applicable, a reasonable opportunity to respond prior 272 to such date. 273 (2) If the review under subdivision (1) of this subsection is an 274 expedited review, all necessary information, including the health 275 carrier's decision, shall be transmitted between the health carrier and the 276 covered person or the covered person's authorized representative, as 277 applicable, by telephone, facsimile, electronic means or any other 278 expeditious method available. 279 (3) If the review under subdivision (1) of this subsection is an 280 expedited review of a grievance involving an adverse determination of 281 a concurrent review request, pursuant to 45 CFR 147.136, as amended 282 from time to time, the treatment shall be continued without liability to 283 the covered person until the covered person has been notified of the 284 review decision. 285 This act shall take effect as follows and shall amend the following sections: Section 1 January 1, 2023 38a-510(a) Sec. 2 January 1, 2023 38a-544(a) Sec. 3 January 1, 2023 38a-591a(7) Sec. 4 January 1, 2023 38a-591c(a) Sec. 5 January 1, 2023 38a-591d(a) Sec. 6 January 1, 2023 38a-591e(c) Statement of Purpose: To (1) prohibit certain health carriers from requiring the use of step therapy for drugs prescribed to treat behavioral health conditions or chronic, disabling or life-threatening conditions or diseases; (2) redefine "clinical peer" for the purposes of adverse determination and utilization reviews; (3) require health carriers to bear the burden of proving that certain health care services under adverse determination or utilization review are not medically necessary; and (4) require health carriers to provide certain clinical peers with authority to reverse initial adverse determinations. Raised Bill No. 415 LCO No. 3074 11 of 11 [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.]