Florida Senate - 2019 CS for CS for CS for SB 1180 By the Committees on Rules; Health Policy; and Banking and Insurance; and Senators Mayfield and Harrell 595-04820-19 20191180c3 1 A bill to be entitled 2 An act relating to prescription drug formulary 3 consumer protection; creating s. 627.42393, F.S.; 4 requiring insurers issuing individual or group health 5 insurance policies to provide certain notices to 6 current and prospective insureds within a certain 7 timeframe before the effective date of any change to a 8 prescription drug formulary during a policy year; 9 specifying requirements for a notice of medical 10 necessity that an insured’s treating physician may 11 submit to the insurer within a certain timeframe; 12 specifying means by which the notice is to be 13 submitted; requiring the Financial Services Commission 14 to adopt a certain rule; specifying a requirement and 15 prohibited acts relating to certain coverage changes 16 by an insurer if the treating physician provides 17 certain certification; providing construction and 18 applicability; providing an exception for certain 19 increases in prescription drug prices by the drug 20 manufacturer; specifying notification requirements for 21 insurers under such circumstances; requiring insurers 22 to maintain a record of formulary changes and submit 23 an annual report to the Office of Insurance Regulation 24 delineating such changes within a certain timeframe; 25 requiring the commission to adopt a certain form by 26 rule; amending s. 627.6699, F.S.; requiring small 27 employer carriers to comply with certain requirements 28 for any change to a prescription drug formulary under 29 the health benefit plan; amending s. 641.31, F.S.; 30 requiring health maintenance organizations to provide 31 certain notices to current and prospective subscribers 32 within a certain timeframe before the effective date 33 of any change to a prescription drug formulary during 34 a contract year; specifying requirements for a notice 35 of medical necessity that a subscriber’s treating 36 physician may submit to the health maintenance 37 organization within a certain timeframe; specifying 38 means by which the notice is to be submitted; 39 requiring the commission to adopt a certain rule; 40 specifying a requirement and prohibited acts relating 41 to certain coverage changes by a health maintenance 42 organization if the treating physician provides 43 certain certification; providing construction and 44 applicability; providing an exception for certain 45 increases in prescription drug prices by the drug 46 manufacturer; specifying notification requirements for 47 health maintenance organizations under such 48 circumstances; requiring health maintenance 49 organizations to maintain a record of formulary 50 changes and submit an annual report to the office 51 delineating such changes within a certain timeframe; 52 requiring the commission to adopt a certain form by 53 rule; providing a declaration of important state 54 interest; providing an effective date. 55 56 Be It Enacted by the Legislature of the State of Florida: 57 58 Section 1. Section 627.42393, Florida Statutes, is created 59 to read: 60 627.42393 Health insurance policies; changes to 61 prescription drug formularies; requirements.— 62 (1) At least 60 days before the effective date of any 63 change to a prescription drug formulary during a policy year, an 64 insurer issuing individual or group health insurance policies in 65 this state shall: 66 (a) Provide general notification of the change in the 67 formulary to current and prospective insureds in a readily 68 accessible format on the insurer’s website; and 69 (b) Notify, electronically or by first-class mail, any 70 insured currently receiving coverage for a prescription drug for 71 which the formulary change modifies coverage and the insured’s 72 treating physician, including information on the specific drugs 73 involved and a statement that the submission of a notice of 74 medical necessity by the insured’s treating physician to the 75 insurer at least 30 days before the effective date of the 76 formulary change will result in continuation of coverage at the 77 existing level. 78 (2) The notice provided by the treating physician to the 79 insurer must include a completed one-page form in which the 80 treating physician certifies to the insurer that coverage of the 81 prescription drug for the insured is medically necessary. The 82 treating physician shall submit the notice electronically or by 83 first-class mail. The insurer may provide the treating physician 84 with access to an electronic portal through which the treating 85 physician may electronically file the notice. The commission 86 shall prescribe a form by rule for the notice. 87 (3) If the treating physician certifies to the insurer, in 88 accordance with subsection (2), that the prescription drug is 89 medically necessary for the insured, the insurer: 90 (a) Must authorize coverage for the prescribed drug based 91 solely on the treating physician’s certification that coverage 92 is medically necessary; and 93 (b) May not modify the coverage related to the covered drug 94 by: 95 1. Increasing the out-of-pocket costs for the covered drug; 96 2. Moving the covered drug to a more restrictive tier; or 97 3. Denying an insured coverage of the drug for which the 98 insured has been previously approved for coverage by the 99 insurer. 100 (4) This section does not: 101 (a) Prohibit the addition of prescription drugs to the list 102 of drugs covered under the policy during the policy year. 103 (b) Apply to a grandfathered health plan as defined in s. 104 627.402, to benefits specified in s. 627.6513(1)-(14), or to any 105 policy issued or delivered between March 23, 2010, and December 106 31, 2013, inclusive. 107 (c) Alter or amend s. 465.025, which provides conditions 108 under which a pharmacist may substitute a generically equivalent 109 drug product for a brand name drug product. 110 (d) Alter or amend s. 465.0252, which provides conditions 111 under which a pharmacist may dispense a substitute biological 112 product for the prescribed biological product. 113 (e) Apply to a Medicaid managed care plan under part IV of 114 chapter 409. 115 (5)(a) This section does not apply if a drug manufacturer 116 increases the list price of a prescription drug on the health 117 insurer’s formulary to the health insurer or the pharmacy 118 benefit manager after November 1 of the year before the health 119 insurer’s earliest required rate submission date to applicable 120 state and federal rate review authorities for the succeeding 121 calendar or policy year. 122 (b) However, at least 60 days before the effective date of 123 a formulary change as a result of circumstances described in 124 paragraph (a), the health insurer shall provide general 125 notification of the formulary change to current and prospective 126 insureds in a readily accessible format on the insurer’s 127 website; and notify, electronically or by first-class mail, any 128 insured currently receiving coverage for a prescription drug for 129 which the formulary change modifies coverage and the insured’s 130 treating physician, including information on the specific drugs 131 involved. 132 (6) A health insurer shall maintain a record of any change 133 in its formulary during the calendar or plan year and, within 45 134 days after the end of the plan year, submit an annual report to 135 the office delineating such changes. The commission shall 136 prescribe a form by rule for such reports. 137 Section 2. Paragraph (e) of subsection (5) of section 138 627.6699, Florida Statutes, is amended to read: 139 627.6699 Employee Health Care Access Act.— 140 (5) AVAILABILITY OF COVERAGE.— 141 (e) All health benefit plans issued under this section must 142 comply with the following conditions: 143 1. For employers who have fewer than two employees, a late 144 enrollee may be excluded from coverage for no longer than 24 145 months if he or she was not covered by creditable coverage 146 continually to a date not more than 63 days before the effective 147 date of his or her new coverage. 148 2. Any requirement used by a small employer carrier in 149 determining whether to provide coverage to a small employer 150 group, including requirements for minimum participation of 151 eligible employees and minimum employer contributions, must be 152 applied uniformly among all small employer groups having the 153 same number of eligible employees applying for coverage or 154 receiving coverage from the small employer carrier, except that 155 a small employer carrier that participates in, administers, or 156 issues health benefits pursuant to s. 381.0406 which do not 157 include a preexisting condition exclusion may require as a 158 condition of offering such benefits that the employer has had no 159 health insurance coverage for its employees for a period of at 160 least 6 months. A small employer carrier may vary application of 161 minimum participation requirements and minimum employer 162 contribution requirements only by the size of the small employer 163 group. 164 3. In applying minimum participation requirements with 165 respect to a small employer, a small employer carrier shall not 166 consider as an eligible employee employees or dependents who 167 have qualifying existing coverage in an employer-based group 168 insurance plan or an ERISA qualified self-insurance plan in 169 determining whether the applicable percentage of participation 170 is met. However, a small employer carrier may count eligible 171 employees and dependents who have coverage under another health 172 plan that is sponsored by that employer. 173 4. A small employer carrier shall not increase any 174 requirement for minimum employee participation or any 175 requirement for minimum employer contribution applicable to a 176 small employer at any time after the small employer has been 177 accepted for coverage, unless the employer size has changed, in 178 which case the small employer carrier may apply the requirements 179 that are applicable to the new group size. 180 5. If a small employer carrier offers coverage to a small 181 employer, it must offer coverage to all the small employer’s 182 eligible employees and their dependents. A small employer 183 carrier may not offer coverage limited to certain persons in a 184 group or to part of a group, except with respect to late 185 enrollees. 186 6. A small employer carrier may not modify any health 187 benefit plan issued to a small employer with respect to a small 188 employer or any eligible employee or dependent through riders, 189 endorsements, or otherwise to restrict or exclude coverage for 190 certain diseases or medical conditions otherwise covered by the 191 health benefit plan. 192 7. An initial enrollment period of at least 30 days must be 193 provided. An annual 30-day open enrollment period must be 194 offered to each small employer’s eligible employees and their 195 dependents. A small employer carrier must provide special 196 enrollment periods as required by s. 627.65615. 197 8. A small employer carrier shall comply with s. 627.42393 198 for any change to a prescription drug formulary. 199 Section 3. Subsection (36) of section 641.31, Florida 200 Statutes, is amended to read: 201 641.31 Health maintenance contracts.— 202 (36) Except as provided in paragraphs (a), (b), and (c), a 203 health maintenance organization may increase the copayment for 204 any benefit, or delete, amend, or limit any of the benefits to 205 which a subscriber is entitled under the group contract only, 206 upon written notice to the contract holder at least 45 days in 207 advance of the time of coverage renewal. The health maintenance 208 organization may amend the contract with the contract holder, 209 with such amendment to be effective immediately at the time of 210 coverage renewal. The written notice to the contract holder must 211shallspecifically identify any deletions, amendments, or 212 limitations to any of the benefits provided in the group 213 contract during the current contract period which will be 214 included in the group contract upon renewal. This subsection 215 does not apply to any increases in benefits. The 45-day notice 216 requirement doesshallnot apply if benefits are amended, 217 deleted, or limited at the request of the contract holder. 218 (a) At least 60 days before the effective date of any 219 change to a prescription drug formulary during a contract year, 220 the health maintenance organization shall: 221 1. Provide general notification of the change in the 222 formulary to current and prospective subscribers in a readily 223 accessible format on the health maintenance organization’s 224 website; and 225 2. Notify, electronically or by first-class mail, any 226 subscriber currently receiving coverage for a prescription drug 227 for which the formulary change modifies coverage and the 228 subscriber’s treating physician, including information on the 229 specific drugs involved and a statement that the submission of a 230 notice of medical necessity by the subscriber’s treating 231 physician to the health maintenance organization at least 30 232 days before the effective date of the formulary change will 233 result in continuation of coverage at the existing level. 234 (b) The notice provided by the treating physician to the 235 insurer must include a completed one-page form in which the 236 treating physician certifies to the health maintenance 237 organization that coverage of the prescription drug for the 238 subscriber is medically necessary. The treating physician shall 239 submit the notice electronically or by first-class mail. The 240 health maintenance organization may provide the treating 241 physician with access to an electronic portal through which the 242 treating physician may electronically file the notice. The 243 commission shall prescribe a form by rule for the notice. 244 (c) If the treating physician certifies to the health 245 maintenance organization, in accordance with paragraph (b), that 246 the prescription drug is medically necessary for the subscriber, 247 the health maintenance organization: 248 1. Must authorize coverage for the prescribed drug based 249 solely on the treating physician’s certification that coverage 250 is medically necessary; and 251 2. May not modify the coverage related to the covered drug 252 by: 253 a. Increasing the out-of-pocket costs for the covered drug; 254 b. Moving the covered drug to a more restrictive tier; or 255 c. Denying a subscriber coverage of the drug for which the 256 subscriber has been previously approved for coverage by the 257 health maintenance organization. 258 (d) Paragraphs (a), (b), and (c) do not: 259 1. Prohibit the addition of prescription drugs to the list 260 of drugs covered under the contract during the contract year. 261 2. Apply to a grandfathered health plan as defined in s. 262 627.402 or to benefits specified in s. 627.6513(1)-(14). 263 3. Alter or amend s. 465.025, which provides conditions 264 under which a pharmacist may substitute a generically equivalent 265 drug product for a brand name drug product. 266 4. Alter or amend s. 465.0252, which provides conditions 267 under which a pharmacist may dispense a substitute biological 268 product for the prescribed biological product. 269 5. Apply to a Medicaid managed care plan under part IV of 270 chapter 409. 271 (e)1. Paragraphs (a), (b), and (c) do not apply if a drug 272 manufacturer increases the list price of a prescription drug on 273 the health maintenance organization’s formulary to the health 274 maintenance organization or the pharmacy benefit manager after 275 November 1 of the year before the health maintenance 276 organization’s earliest required rate submission date to 277 applicable state and federal rate review authorities for the 278 succeeding calendar or policy year. 279 2. However, at least 60 days before the effective date of a 280 formulary change as a result of circumstances described in 281 subparagraph 1., the health maintenance organization shall 282 provide general notification of the formulary change to current 283 and prospective subscribers in a readily accessible format on 284 the health maintenance organization’s website; and notify, 285 electronically or by first-class mail, any subscriber currently 286 receiving coverage for a prescription drug for which the 287 formulary change modifies coverage and the subscriber’s treating 288 physician, including information on the specific drugs involved. 289 (f) A health maintenance organization shall maintain a 290 record of any change in its formulary during the calendar or 291 plan year and, within 45 days after the end of the plan year, 292 submit an annual report to the office delineating such changes. 293 The commission shall prescribe a form by rule for such reports. 294 Section 4. The Legislature finds that this act fulfills an 295 important state interest. 296 Section 5. This act shall take effect January 1, 2020.