Senate Bill 1612 (2021) — Prescription drug coverage
SB 1612
Florida Bills
Florida Senate - 2021 SB 1612 By Senator Rodriguez 39-01348-21 20211612__ Page 1 of 11 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1
An act relating to prescription drug coverage; 2 creating s. 627.42394, F.S.; requiring individual and 3 group health insurers to provide notice of 4 prescription drug formulary changes to current and 5 prospective insureds and the insureds’ treating 6 physicians; specifying the timeframe and manner in 7 which such notice must be provided; specifying 8 requirements for a notice of medical necessity 9 submitted by the treating physician; authorizing 10 insurers to provide certain means for submitting the 11 notice of medical necessity; requiring the Financial 12 Services Commission to adopt a certain form by rule by 13 a specified date; specifying a coverage requirement 14 and restrictions on coverage modification by insurers 15 receiving such notice; providing construction and 16 applicability; requiring insurers to maintain a record 17 of formulary changes; requiring insurers to annually 18 submit a specified report to the Office of Insurance 19 Regulation; requiring the office to annually compile 20 certain data, prepare a report and make the report 21 publicly accessible on its website, and submit the 22 report to the Governor and the Legislature; amending 23 s. 627.6699, F.S.; requiring small employer carriers 24 to comply with certain requirements for prescription 25 drug formulary changes; amending s. 641.31, F.S.; 26 providing an exception; requiring health maintenance 27 organizations to provide notice of prescription drug 28 formulary changes to current and prospective 29
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 2 of 11 CODING: Words stricken are deletions; words underlined are additions. subscribers and the subscribers’ treating physicians; 30 specifying the timeframe and manner in which such 31 notice must be provided; specifying requirements for a 32 notice of medical necessity submitted by the treating 33 physician; authorizing health maintenance 34 organizations to provide certain means for submitting 35 the notice of medical necessity; requiring the 36 commission to adopt a certain form by rule by a 37 specified date; specifying a coverage requirement and 38 restrictions on coverage modification by health 39 maintenance organizations receiving such notice; 40 providing construction and applicability; requiring 41 health maintenance organizations to maintain a record 42 of formulary changes; requiring health maintenance 43 organizations to annually submit a specified report to 44 the office; requiring the office to annually compile 45 certain data, prepare a report and make the report 46 publicly accessible on its website, and submit the 47 report to the Governor and the Legislature; providing 48 applicability; providing a declaration of important 49 state interest; providing an effective date. 50 51 Be It Enacted by the Legislature of the State of Florida: 52 53
Section
Section 627.42394, Florida Statutes, is created 54 to read: 55 627.42394 Health insurance policies; changes to 56 prescription drug formularies; requirements.— 57
(1) At least 60 days before the effective date of any 58
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 3 of 11 CODING: Words stricken are deletions; words underlined are additions. change to a prescription drug formulary during a policy year, an 59 insurer issuing individual or group health insurance policies in 60 this state shall notify: 61 (
a) Current and prospective insureds of the change in the 62 formulary in a readily accessible format on the insurer’s 63 website; and 64 (
b) Electronically and by first-class mail, any insured 65 currently receiving coverage for a prescription drug for which 66 the formulary change modifies coverage and the insured’s 67 treating physician. Such notification must include information 68 on the specific drugs involved and a statement that the 69 submission of a notice of medical necessity by the insured’s 70 treating physician to the insurer at least 30 days before the 71 effective date of the formulary change will result in 72 continuation of coverage at the existing level. 73
(2) The notice provided by the treating physician to the 74 insurer must include a completed one-page form in which the 75 treating physician certifies to the insurer that the 76 prescription drug for the insured is medically necessary as 77 defined under s. 627.732(2). The treating physician shall submit 78 the notice electronically or by first-class mail. The insurer 79 may provide the treating physician with access to an electronic 80 portal through which the treating physician may electronically 81 submit the notice. By January 1, 2022, the commission shall 82 adopt by rule a form for the notice. 83
(3) If the treating physician certifies to the insurer in 84 accordance with subsection (2) that the prescription drug is 85 medically necessary for the insured, the insurer: 86 (
a) Must authorize coverage for the prescribed drug until 87
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 4 of 11 CODING: Words stricken are deletions; words underlined are additions. the end of the policy year, based solely on the treating 88 physician’s certification that the drug is medically necessary; 89 and 90 (
b) May not modify the coverage related to the covered drug 91 during the policy year by: 92 1. Increasing the out-of-pocket costs for the covered drug; 93 2. Moving the covered drug to a more restrictive tier; 94 3. Denying an insured coverage of the drug for which the 95 insured has been previously approved for coverage by the 96 insurer; or 97 4. Limiting or reducing coverage of the drug in any other 98 way, including subjecting it to a new prior authorization or 99 step therapy requirement. 100 (4) Subsections (1), (2), and (3) do 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 or to benefits specified in s. 627.6513(1)-(14). 105 (
c) Alter or amend s. 465.025, which provides conditions 106 under which a pharmacist may substitute a generically equivalent 107 drug product for a brand name drug product. 108 (
d) Alter or amend s. 465.0252, which provides conditions 109 under which a pharmacist may dispense a substitute biological 110 product for the prescribed biological product. 111 (
e) Apply to a Medicaid managed care plan under
part IV of 112
chapter 409. 113
(5) A health insurer shall maintain a record of any change 114 in its formulary during a calendar year. By March 1 annually, a 115 health insurer shall submit to the office a report delineating 116
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 5 of 11 CODING: Words stricken are deletions; words underlined are additions. such changes made in the previous calendar year. The annual 117 report must include, at a minimum: 118 (
a) A list of all drugs that were removed from the 119 formulary and the reasons for the removal; 120 (
b) A list of all drugs that were moved to a tier resulting 121 in additional out-of-pocket costs to insureds; 122 (
c) The number of insureds notified by the insurer of a 123 change in the formulary; and 124 (
d) The increased cost, by dollar amount, incurred by 125 insureds because of such change in the formulary. 126
(6) By May 1 annually, the office shall: 127 (
a) Compile the data in such annual reports submitted by 128 health insurers and prepare a report summarizing the data 129 submitted; 130 (
b) Make the report publicly accessible on its website; and 131 (
c) Submit the report to the Governor, the President of the 132 Senate, and the Speaker of the House of Representatives. 133
Section 2. Paragraph (
e) of subsection (5) of
section 134 627.6699, Florida Statutes, is amended to read: 135 627.6699 Employee Health Care Access Act.— 136
(5) AVAILABILITY OF COVERAGE.— 137 (
e) All health benefit plans issued under this
section must 138 comply with the following conditions: 139 1. For employers who have fewer than two employees, a late 140 enrollee may be excluded from coverage for no longer than 24 141 months if he or she was not covered by creditable coverage 142 continually to a date not more than 63 days before the effective 143 date of his or her new coverage. 144 2. Any requirement used by a small employer carrier in 145
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 6 of 11 CODING: Words stricken are deletions; words underlined are additions. determining whether to provide coverage to a small employer 146 group, including requirements for minimum participation of 147 eligible employees and minimum employer contributions, must be 148 applied uniformly among all small employer groups having the 149 same number of eligible employees applying for coverage or 150 receiving coverage from the small employer carrier, except that 151 a small employer carrier that participates in, administers, or 152 issues health benefits pursuant to s. 381.0406 which do not 153 include a preexisting condition exclusion may require as a 154 condition of offering such benefits that the employer has had no 155 health insurance coverage for its employees for a period of at 156 least 6 months.
A small employer carrier may vary application of 157 minimum participation requirements and minimum employer 158 contribution requirements only by the size of the small employer 159 group. 160 3. In applying minimum participation requirements with 161 respect to a small employer, a small employer carrier shall not 162 consider as an eligible employee employees or dependents who 163 have qualifying existing coverage in an employer-based group 164 insurance plan or an ERISA qualified self-insurance plan in 165 determining whether the applicable percentage of participation 166 is met.
However, a small employer carrier may count eligible 167 employees and dependents who have coverage under another health 168 plan that is sponsored by that employer. 169 4. A small employer carrier shall not increase any 170 requirement for minimum employee participation or any 171 requirement for minimum employer contribution applicable to a 172 small employer at any time after the small employer has been 173 accepted for coverage, unless the employer size has changed, in 174
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 7 of 11 CODING: Words stricken are deletions; words underlined are additions. which case the small employer carrier may apply the requirements 175 that are applicable to the new group size. 176 5. If a small employer carrier offers coverage to a small 177 employer, it must offer coverage to all the small employer’s 178 eligible employees and their dependents. A small employer 179 carrier may not offer coverage limited to certain persons in a 180 group or to part of a group, except with respect to late 181 enrollees. 182 6.
A small employer carrier may not modify any health 183 benefit plan issued to a small employer with respect to a small 184 employer or any eligible employee or dependent through riders, 185 endorsements, or otherwise to restrict or exclude coverage for 186 certain diseases or medical conditions otherwise covered by the 187 health benefit plan. 188 7. An initial enrollment period of at least 30 days must be 189 provided. An annual 30-day open enrollment period must be 190 offered to each small employer’s eligible employees and their 191 dependents.
A small employer carrier must provide special 192 enrollment periods as required by s. 627.65615. 193 8. A small employer carrier shall comply with s. 627.42394 194 for any change to a prescription drug formulary. 195
Section 3. Subsection (36) of
section 641.31, Florida 196 Statutes, is amended to read: 197 641.31 Health maintenance contracts.— 198
(36) Except as provided in paragraphs (a), (b), and (c), a 199 health maintenance organization may increase the copayment for 200 any benefit, or delete, amend, or limit any of the benefits to 201 which a subscriber is entitled under the group contract only, 202 upon written notice to the contract holder at least 45 days in 203
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 8 of 11 CODING: Words stricken are deletions; words underlined are additions. advance of the time of coverage renewal. The health maintenance 204 organization may amend the contract with the contract holder, 205 with such amendment to be effective immediately at the time of 206 coverage renewal.
The written notice to the contract holder must 207 shall specifically identify any deletions, amendments, or 208 limitations to any of the benefits provided in the group 209 contract during the current contract period which will be 210 included in the group contract upon renewal. This subsection 211 does not apply to any increases in benefits. The 45-day notice 212 requirement does shall not apply if benefits are amended, 213 deleted, or limited at the request of the contract holder. 214 (
a) At least 60 days before the effective date of any 215 change to a prescription drug formulary during a contract year, 216 a health maintenance organization shall notify: 217 1. Current and prospective subscribers of the change in the 218 formulary in a readily accessible format on the health 219 maintenance organization’s website; and 220 2. Electronically and by first-class mail, any subscriber 221 currently receiving coverage for a prescription drug for which 222 the formulary change modifies coverage and the subscriber’s 223 treating physician.
Such notification must include information 224 on the specific drugs involved and a statement that the 225 submission of a notice of medical necessity by the subscriber’s 226 treating physician to the health maintenance organization at 227 least 30 days before the effective date of the formulary change 228 will result in continuation of coverage at the existing level. 229 (
b) The notice provided by the treating physician to the 230 health maintenance organization must include a completed one-231 page form in which the treating physician certifies to the 232
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 9 of 11 CODING: Words stricken are deletions; words underlined are additions. health maintenance organization that the prescription drug for 233 the subscriber is medically necessary as defined under s. 234 627.732(2). The treating physician shall submit the notice 235 electronically or by first-class mail. The health maintenance 236 organization may provide the treating physician with access to 237 an electronic portal through which the treating physician may 238 electronically submit the notice. By January 1, 2022, the 239 commission shall adopt by rule a form for the notice. 240 (
c) If the treating physician certifies to the health 241 maintenance organization in accordance with paragraph (
b) that 242 the prescription drug is medically necessary for the subscriber, 243 the health maintenance organization: 244 1. Must authorize coverage for the prescribed drug until 245 the end of the contract year, based solely on the treating 246 physician’s certification that the drug is medically necessary; 247 and 248 2. May not modify the coverage related to the covered drug 249 during the contract year by: 250 a. Increasing the out-of-pocket costs for the covered drug; 251 b. Moving the covered drug to a more restrictive tier; 252 c.
Denying a subscriber coverage of the drug for which the 253 subscriber has been previously approved for coverage by the 254 health maintenance organization; or 255 d. Limiting or reducing coverage of the drug in any other 256 way, including subjecting it to a new prior authorization or 257 step therapy requirement. 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
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 10 of 11 CODING: Words stricken are deletions; words underlined are additions. 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) A health maintenance organization shall maintain a 272 record of any change in its formulary during a calendar year. By 273 March 1 annually, a health maintenance organization shall submit 274 to the office a report delineating such changes made in the 275 previous calendar year. The annual report must include, at a 276 minimum: 277 1. A list of all drugs that were removed from the formulary 278 and the reasons for the removal; 279 2. A list of all drugs that were moved to a tier resulting 280 in additional out-of-pocket costs to subscribers; 281 3.
The number of subscribers notified by the health 282 maintenance organization of a change in the formulary; and 283 4. The increased cost, by dollar amount, incurred by 284 subscribers because of such change in the formulary. 285 (
f) By May 1 annually, the office shall: 286 1. Compile the data in such annual reports submitted by 287 health maintenance organizations and prepare a report 288 summarizing the data submitted; 289 2. Make the report publicly accessible on its website; and 290
Florida Senate - 2021 SB 1612 39-01348-21 20211612__ Page 11 of 11 CODING: Words stricken are deletions; words underlined are additions. 3. Submit the report to the Governor, the President of the 291 Senate, and the Speaker of the House of Representatives. 292
Section 4. This act applies to health insurance policies, 293 health benefit plans, and health maintenance contracts entered 294 into or renewed on or after January 1, 2022. 295