Florida Senate - 2023 SB 746 By Senator Rodriguez 40-00498-23 2023746__ 1 A bill to be entitled 2 An act relating to prescription drug coverage; 3 creating s. 627.42394, F.S.; requiring individual and 4 group health insurers to provide notice of 5 prescription drug formulary changes within a certain 6 timeframe to current and prospective insureds and the 7 insureds’ treating physicians; specifying requirements 8 for the content of such notice and the manner in which 9 it must be provided; specifying requirements for a 10 notice of medical necessity submitted by the treating 11 physician; authorizing insurers to provide certain 12 means for submitting the notice of medical necessity; 13 requiring the Financial Services Commission to adopt a 14 certain form by rule by a specified date; specifying a 15 coverage requirement and restrictions on coverage 16 modification by insurers receiving a notice of medical 17 necessity; providing construction and applicability; 18 requiring insurers to maintain a record of formulary 19 changes; requiring insurers to annually submit a 20 specified report to the Office of Insurance Regulation 21 by a specified date; requiring the office to annually 22 compile certain data and prepare a report, make the 23 report publicly accessible on its website, and submit 24 the report to the Governor and the Legislature by a 25 specified date; amending s. 627.6699, F.S.; requiring 26 small employer carriers to comply with certain 27 requirements for prescription drug formulary changes; 28 amending s. 641.31, F.S.; providing an exception to 29 requirements relating to changes in a health 30 maintenance organization’s group contract; requiring 31 health maintenance organizations to provide notice of 32 prescription drug formulary changes within a certain 33 timeframe to current and prospective subscribers and 34 the subscribers’ treating physicians; specifying 35 requirements for the content of such notice and the 36 manner in which it must be provided; specifying 37 requirements for a notice of medical necessity 38 submitted by the treating physician; authorizing 39 health maintenance organizations to provide certain 40 means for submitting the notice of medical necessity; 41 requiring the commission to adopt a certain form by 42 rule by a specified date; specifying a coverage 43 requirement and restrictions on coverage modification 44 by health maintenance organizations receiving a notice 45 of medical necessity; providing construction and 46 applicability; requiring health maintenance 47 organizations to maintain a record of formulary 48 changes; requiring health maintenance organizations to 49 annually submit a specified report to the office by a 50 specified date; requiring the office to annually 51 compile certain data and prepare a report, make the 52 report publicly accessible on its website, and submit 53 the report to the Governor and the Legislature by a 54 specified date; providing applicability; providing a 55 declaration of important state interest; providing an 56 effective date. 57 58 Be It Enacted by the Legislature of the State of Florida: 59 60 Section 1. Section 627.42394, Florida Statutes, is created 61 to read: 62 627.42394 Health insurance policies; changes to 63 prescription drug formularies; requirements.— 64 (1) At least 60 days before the effective date of any 65 change to a prescription drug formulary during a policy year, an 66 insurer issuing individual or group health insurance policies in 67 this state shall notify: 68 (a) Current and prospective insureds of the change in the 69 formulary in a readily accessible format on the insurer’s 70 website; and 71 (b) Any insured currently receiving coverage for a 72 prescription drug for which the formulary change modifies 73 coverage and the insured’s treating physician. Such notification 74 must be sent electronically and by first-class mail and must 75 include information on the specific drugs involved and a 76 statement that the submission of a notice of medical necessity 77 by the insured’s treating physician to the insurer at least 30 78 days before the effective date of the formulary change will 79 result in continuation of coverage at the existing level. 80 (2) The notice provided by the treating physician to the 81 insurer must include a completed one-page form in which the 82 treating physician certifies to the insurer that the 83 prescription drug for the insured is medically necessary as 84 defined in s. 627.732(2). The treating physician shall submit 85 the notice electronically or by first-class mail. The insurer 86 may provide the treating physician with access to an electronic 87 portal through which the treating physician may electronically 88 submit the notice. By January 1, 2024, the commission shall 89 adopt by rule a form for the notice. 90 (3) If the treating physician certifies to the insurer in 91 accordance with subsection (2) that the prescription drug is 92 medically necessary for the insured, the insurer: 93 (a) Must authorize coverage for the prescribed drug until 94 the end of the policy year, based solely on the treating 95 physician’s certification that the drug is medically necessary; 96 and 97 (b) May not modify the coverage related to the covered drug 98 during the policy year by: 99 1. Increasing the out-of-pocket costs for the covered drug; 100 2. Moving the covered drug to a more restrictive tier; 101 3. Denying an insured coverage of the drug for which the 102 insured has been previously approved for coverage by the 103 insurer; or 104 4. Limiting or reducing coverage of the drug in any other 105 way, including subjecting it to a new prior authorization or 106 step-therapy requirement. 107 (4) Subsections (1), (2), and (3) do not: 108 (a) Prohibit the addition of prescription drugs to the list 109 of drugs covered under the policy during the policy year. 110 (b) Apply to a grandfathered health plan as defined in s. 111 627.402 or to benefits specified in s. 627.6513(1)-(14). 112 (c) Alter or amend s. 465.025, which provides conditions 113 under which a pharmacist may substitute a generically equivalent 114 drug product for a brand name drug product. 115 (d) Alter or amend s. 465.0252, which provides conditions 116 under which a pharmacist may dispense a substitute biological 117 product for the prescribed biological product. 118 (e) Apply to a Medicaid managed care plan under part IV of 119 chapter 409. 120 (5) A health insurer shall maintain a record of any change 121 in its formulary during a calendar year. By March 1 annually, a 122 health insurer shall submit to the office a report delineating 123 such changes made in the previous calendar year. The annual 124 report must include, at a minimum: 125 (a) A list of all drugs removed from the formulary and the 126 reasons for the removal; 127 (b) A list of all drugs moved to a tier resulting in 128 additional out-of-pocket costs to insureds; 129 (c) The number of insureds notified by the insurer of a 130 change in the formulary; and 131 (d) The increased cost, by dollar amount, incurred by 132 insureds because of such change in the formulary. 133 (6) By May 1 annually, the office shall: 134 (a) Compile the data in such annual reports submitted by 135 health insurers and prepare a report summarizing the data 136 submitted; 137 (b) Make the report publicly accessible on its website; and 138 (c) Submit the report to the Governor, the President of the 139 Senate, and the Speaker of the House of Representatives. 140 Section 2. Paragraph (e) of subsection (5) of section 141 627.6699, Florida Statutes, is amended to read: 142 627.6699 Employee Health Care Access Act.— 143 (5) AVAILABILITY OF COVERAGE.— 144 (e) All health benefit plans issued under this section must 145 comply with the following conditions: 146 1. For employers who have fewer than two employees, a late 147 enrollee may be excluded from coverage for no longer than 24 148 months if he or she was not covered by creditable coverage 149 continually to a date not more than 63 days before the effective 150 date of his or her new coverage. 151 2. Any requirement used by a small employer carrier in 152 determining whether to provide coverage to a small employer 153 group, including requirements for minimum participation of 154 eligible employees and minimum employer contributions, must be 155 applied uniformly among all small employer groups having the 156 same number of eligible employees applying for coverage or 157 receiving coverage from the small employer carrier, except that 158 a small employer carrier that participates in, administers, or 159 issues health benefits pursuant to s. 381.0406 which do not 160 include a preexisting condition exclusion may require as a 161 condition of offering such benefits that the employer has had no 162 health insurance coverage for its employees for a period of at 163 least 6 months. A small employer carrier may vary application of 164 minimum participation requirements and minimum employer 165 contribution requirements only by the size of the small employer 166 group. 167 3. In applying minimum participation requirements with 168 respect to a small employer, a small employer carrier shall not 169 consider as an eligible employee employees or dependents who 170 have qualifying existing coverage in an employer-based group 171 insurance plan or an ERISA qualified self-insurance plan in 172 determining whether the applicable percentage of participation 173 is met. However, a small employer carrier may count eligible 174 employees and dependents who have coverage under another health 175 plan that is sponsored by that employer. 176 4. A small employer carrier shall not increase any 177 requirement for minimum employee participation or any 178 requirement for minimum employer contribution applicable to a 179 small employer at any time after the small employer has been 180 accepted for coverage, unless the employer size has changed, in 181 which case the small employer carrier may apply the requirements 182 that are applicable to the new group size. 183 5. If a small employer carrier offers coverage to a small 184 employer, it must offer coverage to all the small employer’s 185 eligible employees and their dependents. A small employer 186 carrier may not offer coverage limited to certain persons in a 187 group or to part of a group, except with respect to late 188 enrollees. 189 6. A small employer carrier may not modify any health 190 benefit plan issued to a small employer with respect to a small 191 employer or any eligible employee or dependent through riders, 192 endorsements, or otherwise to restrict or exclude coverage for 193 certain diseases or medical conditions otherwise covered by the 194 health benefit plan. 195 7. An initial enrollment period of at least 30 days must be 196 provided. An annual 30-day open enrollment period must be 197 offered to each small employer’s eligible employees and their 198 dependents. A small employer carrier must provide special 199 enrollment periods as required by s. 627.65615. 200 8. A small employer carrier shall comply with s. 627.42394 201 for any change to a prescription drug formulary. 202 Section 3. Subsection (36) of section 641.31, Florida 203 Statutes, is amended to read: 204 641.31 Health maintenance contracts.— 205 (36) Except as provided in paragraphs (a), (b), and (c), a 206 health maintenance organization may increase the copayment for 207 any benefit, or delete, amend, or limit any of the benefits to 208 which a subscriber is entitled under the group contract only, 209 upon written notice to the contract holder at least 45 days in 210 advance of the time of coverage renewal. The health maintenance 211 organization may amend the contract with the contract holder, 212 with such amendment to be effective immediately at the time of 213 coverage renewal. The written notice to the contract holder must 214shallspecifically identify any deletions, amendments, or 215 limitations to any of the benefits provided in the group 216 contract during the current contract period which will be 217 included in the group contract upon renewal. This subsection 218 does not apply to any increases in benefits. The 45-day notice 219 requirement doesshallnot apply if benefits are amended, 220 deleted, or limited at the request of the contract holder. 221 (a) At least 60 days before the effective date of any 222 change to a prescription drug formulary during a contract year, 223 a health maintenance organization shall notify: 224 1. Current and prospective subscribers of the change in the 225 formulary in a readily accessible format on the health 226 maintenance organization’s website; and 227 2. Any subscriber currently receiving coverage for a 228 prescription drug for which the formulary change modifies 229 coverage and the subscriber’s treating physician. Such 230 notification must be sent electronically and by first-class mail 231 and must include information on the specific drugs involved and 232 a statement that the submission of a notice of medical necessity 233 by the subscriber’s treating physician to the health maintenance 234 organization at least 30 days before the effective date of the 235 formulary change will result in continuation of coverage at the 236 existing level. 237 (b) The notice provided by the treating physician to the 238 health maintenance organization must include a completed one 239 page form in which the treating physician certifies to the 240 health maintenance organization that the prescription drug for 241 the subscriber is medically necessary as defined in s. 242 627.732(2). The treating physician shall submit the notice 243 electronically or by first-class mail. The health maintenance 244 organization may provide the treating physician with access to 245 an electronic portal through which the treating physician may 246 electronically submit the notice. By January 1, 2024, the 247 commission shall adopt by rule a form for the notice. 248 (c) If the treating physician certifies to the health 249 maintenance organization in accordance with paragraph (b) that 250 the prescription drug is medically necessary for the subscriber, 251 the health maintenance organization: 252 1. Must authorize coverage for the prescribed drug until 253 the end of the contract year, based solely on the treating 254 physician’s certification that the drug is medically necessary; 255 and 256 2. May not modify the coverage related to the covered drug 257 during the contract year by: 258 a. Increasing the out-of-pocket costs for the covered drug; 259 b. Moving the covered drug to a more restrictive tier; 260 c. Denying a subscriber coverage of the drug for which the 261 subscriber has been previously approved for coverage by the 262 health maintenance organization; or 263 d. Limiting or reducing coverage of the drug in any other 264 way, including subjecting it to a new prior authorization or 265 step-therapy requirement. 266 (d) Paragraphs (a), (b), and (c) do not: 267 1. Prohibit the addition of prescription drugs to the list 268 of drugs covered under the contract during the contract year. 269 2. Apply to a grandfathered health plan as defined in s. 270 627.402 or to benefits specified in s. 627.6513(1)-(14). 271 3. Alter or amend s. 465.025, which provides conditions 272 under which a pharmacist may substitute a generically equivalent 273 drug product for a brand name drug product. 274 4. Alter or amend s. 465.0252, which provides conditions 275 under which a pharmacist may dispense a substitute biological 276 product for the prescribed biological product. 277 5. Apply to a Medicaid managed care plan under part IV of 278 chapter 409. 279 (e) A health maintenance organization shall maintain a 280 record of any change in its formulary during a calendar year. By 281 March 1 annually, a health maintenance organization shall submit 282 to the office a report delineating such changes made in the 283 previous calendar year. The annual report must include, at a 284 minimum: 285 1. A list of all drugs removed from the formulary and the 286 reasons for the removal; 287 2. A list of all drugs moved to a tier resulting in 288 additional out-of-pocket costs to subscribers; 289 3. The number of subscribers notified by the health 290 maintenance organization of a change in the formulary; and 291 4. The increased cost, by dollar amount, incurred by 292 subscribers because of such change in the formulary. 293 (f) By May 1 annually, the office shall: 294 1. Compile the data in such annual reports submitted by 295 health maintenance organizations and prepare a report 296 summarizing the data submitted; 297 2. Make the report publicly accessible on its website; and 298 3. Submit the report to the Governor, the President of the 299 Senate, and the Speaker of the House of Representatives. 300 Section 4. This act applies to health insurance policies, 301 health benefit plans, and health maintenance contracts entered 302 into or renewed on or after January 1, 2024. 303 Section 5. The Legislature finds that this act fulfills an 304 important state interest. 305 Section 6. This act shall take effect January 1, 2024.