Florida Senate - 2016 SENATOR AMENDMENT Bill No. CS for CS for SB 212 Ì561928GÎ561928 LEGISLATIVE ACTION Senate . House . . . Floor: WD/2R . 03/08/2016 04:39 PM . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— Senator Hays moved the following: 1 Senate Amendment (with title amendment) 2 3 Delete lines 544 - 571 4 and insert: 5 Section 8. Effective January 1, 2018, section 627.42393, 6 Florida Statutes, is created to read: 7 627.42393 Continuity of care for medically stable 8 patients.— 9 (1) As used in this section, the term: 10 (a) “Complex or chronic medical condition” means a 11 physical, behavioral, or developmental condition that does not 12 have a known cure or that can be severely debilitating or fatal 13 if left untreated or undertreated. 14 (b) “Rare disease” has the same meaning as in 42 U.S.C. s. 15 287a-1(c). 16 (2) A pharmacy benefits manager or an individual or a group 17 insurance policy that is delivered, issued for delivery, 18 renewed, amended, or continued in this state and that provides 19 medical, major medical, or similar comprehensive coverage must 20 continue to cover a drug for an insured with a complex or 21 chronic medical condition or a rare disease if: 22 (a) The drug was previously covered by the insurer for a 23 medical condition or disease of the insured; and 24 (b) The prescribing provider continues to prescribe the 25 drug for the medical condition or disease, the drug is 26 appropriately prescribed, and neither of the following has 27 occurred: 28 1. The United States Food and Drug Administration has 29 issued a notice, a guidance, a warning, an announcement, or any 30 other statement about the drug which calls into question the 31 clinical safety of the drug; or 32 2. The manufacturer of the drug has notified the United 33 States Food and Drug Administration of any manufacturing 34 discontinuance or potential discontinuance as required by s. 35 506C of the Federal Food Drug and Cosmetic Act, 21 U.S.C. s. 36 356c. 37 (3) With respect to a drug for an insured with a complex or 38 chronic medical condition or a rare disease which meets the 39 conditions of paragraphs (2)(a) and (b), except during open 40 enrollment periods, a pharmacy benefits manager or an individual 41 or a group insurance policy may not: 42 (a) Set forth, by contract, limitations on maximum coverage 43 of prescription drug benefits; 44 (b) Subject the insured to increased out-of-pocket costs; 45 or 46 (c) Move a drug for an insured to a more restrictive tier, 47 if an individual or a group insurance policy or a pharmacy 48 benefits manager uses a formulary with tiers. 49 (4) This section does not apply to a grandfathered health 50 plan as defined in s. 627.402, or to benefits set forth in s. 51 627.6561(5)(b)-(e). 52 Section 9. Effective January 1, 2018, paragraph (e) of 53 subsection (5) of section 627.6699, Florida Statutes, is amended 54 to read: 55 627.6699 Employee Health Care Access Act.— 56 (5) AVAILABILITY OF COVERAGE.— 57 (e) All health benefit plans issued under this section must 58 comply with the following conditions: 59 1. For employers who have fewer than two employees, a late 60 enrollee may be excluded from coverage for no longer than 24 61 months if he or she was not covered by creditable coverage 62 continually to a date not more than 63 days before the effective 63 date of his or her new coverage. 64 2. Any requirement used by a small employer carrier in 65 determining whether to provide coverage to a small employer 66 group, including requirements for minimum participation of 67 eligible employees and minimum employer contributions, must be 68 applied uniformly among all small employer groups having the 69 same number of eligible employees applying for coverage or 70 receiving coverage from the small employer carrier, except that 71 a small employer carrier that participates in, administers, or 72 issues health benefits pursuant to s. 381.0406 which do not 73 include a preexisting condition exclusion may require as a 74 condition of offering such benefits that the employer has had no 75 health insurance coverage for its employees for a period of at 76 least 6 months. A small employer carrier may vary application of 77 minimum participation requirements and minimum employer 78 contribution requirements only by the size of the small employer 79 group. 80 3. In applying minimum participation requirements with 81 respect to a small employer, a small employer carrier shall not 82 consider as an eligible employee employees or dependents who 83 have qualifying existing coverage in an employer-based group 84 insurance plan or an ERISA qualified self-insurance plan in 85 determining whether the applicable percentage of participation 86 is met. However, a small employer carrier may count eligible 87 employees and dependents who have coverage under another health 88 plan that is sponsored by that employer. 89 4. A small employer carrier shall not increase any 90 requirement for minimum employee participation or any 91 requirement for minimum employer contribution applicable to a 92 small employer at any time after the small employer has been 93 accepted for coverage, unless the employer size has changed, in 94 which case the small employer carrier may apply the requirements 95 that are applicable to the new group size. 96 5. If a small employer carrier offers coverage to a small 97 employer, it must offer coverage to all the small employer’s 98 eligible employees and their dependents. A small employer 99 carrier may not offer coverage limited to certain persons in a 100 group or to part of a group, except with respect to late 101 enrollees. 102 6. A small employer carrier may not modify any health 103 benefit plan issued to a small employer with respect to a small 104 employer or any eligible employee or dependent through riders, 105 endorsements, or otherwise to restrict or exclude coverage for 106 certain diseases or medical conditions otherwise covered by the 107 health benefit plan. 108 7. An initial enrollment period of at least 30 days must be 109 provided. An annual 30-day open enrollment period must be 110 offered to each small employer’s eligible employees and their 111 dependents. A small employer carrier must provide special 112 enrollment periods as required by s. 627.65615. 113 8. A small employer carrier must provide continuity of care 114 for medically stable patients as required by s. 627.42393. 115 Section 10. Effective January 1, 2018, subsections (44) and 116 (45) are added to section 641.31, Florida Statutes, to read: 117 641.31 Health maintenance contracts.— 118 (44) A health maintenance organization may not require a 119 health care provider, by contract with another health care 120 provider, a patient, or another individual or entity, to use a 121 clinical decision support system or a laboratory benefits 122 management program before the provider may order clinical 123 laboratory services or in an attempt to direct or limit the 124 provider’s medical decisionmaking relating to the use of such 125 services. This subsection may not be construed to prohibit any 126 prior authorization requirements that the health maintenance 127 organization may have regarding the provision of clinical 128 laboratory services. As used in this subsection, the term: 129 (a) “Clinical decision support system” means software 130 designed to direct or assist clinical decisionmaking by matching 131 the characteristics of an individual patient to a computerized 132 clinical knowledge base and providing patient-specific 133 assessments or recommendations based on the match. 134 (b) “Clinical laboratory services” means the examination of 135 fluids or other materials taken from the human body, which 136 examination is ordered by a health care provider for use in the 137 diagnosis, prevention, or treatment of a disease or in the 138 identification or assessment of a medical or physical condition. 139 (c) “Laboratory benefits management program” means a health 140 maintenance organization protocol that dictates or limits health 141 care provider decisionmaking relating to the use of clinical 142 laboratory services. 143 (45)(a) A pharmacy benefits manager or a health maintenance 144 contract that is delivered, issued for delivery, renewed, 145 amended, or continued in this state and that provides medical, 146 major medical, or similar comprehensive coverage must continue 147 to cover a drug for a subscriber with a complex or chronic 148 medical condition or a rare disease if: 149 1. The drug was previously covered by the health 150 maintenance organization for a medical condition or disease of 151 the subscriber; and 152 2. The prescribing provider continues to prescribe the drug 153 for the medical condition or disease, the drug is appropriately 154 prescribed, and neither of the following has occurred: 155 a. The United States Food and Drug Administration has 156 issued a notice, a guidance, a warning, an announcement, or any 157 other statement about the drug which calls into question the 158 clinical safety of the drug; or 159 b. The manufacturer of the drug has notified the United 160 States Food and Drug Administration of any manufacturing 161 discontinuance or potential discontinuance as required by s. 162 506C of the Federal Food Drug and Cosmetic Act, 21 U.S.C. s. 163 356c. 164 (b) With respect to a drug for a subscriber with a complex 165 or chronic medical condition or a rare disease which meets the 166 conditions of subparagraphs (c)1. and (c)2., except during open 167 enrollment periods, a pharmacy benefits manager or a health 168 maintenance contract may not: 169 1. Set forth, by contract, limitations on maximum coverage 170 of prescription drug benefits; 171 2. Subject the subscriber to increased out-of-pocket costs; 172 or 173 3. Move a drug for a subscriber to a more restrictive tier, 174 if a health maintenance contract or a pharmacy benefits manager 175 uses a formulary with tiers. 176 (c) As used in this subsection, the term: 177 1. “Complex or chronic medical condition” means a physical, 178 behavioral, or developmental condition that does not have a 179 known cure or that can be severely debilitating or fatal if left 180 untreated or undertreated. 181 2. “Rare disease” has the same meaning as 42 U.S.C. s. 182 287a-1(c). 183 (d) This section does not apply to a grandfathered health 184 plan as defined in s. 627.402. 185 186 ================= T I T L E A M E N D M E N T ================ 187 And the title is amended as follows: 188 Delete lines 76 - 82 189 and insert: 190 defining the term “fail-first protocol”; creating s. 191 627.42393, F.S.; defining terms; requiring a pharmacy 192 benefits manager or a specified individual or group 193 insurance policy to continue to cover a drug for 194 specified insureds under certain circumstances; 195 prohibiting certain actions by a pharmacy benefits 196 manager or an individual or a group policy with 197 respect to a drug for a certain insured except under 198 certain circumstances; providing applicability; 199 amending s. 627.6699, F.S.; expanding a list of 200 conditions that certain health benefit plans must 201 comply with; amending s. 641.31, F.S.; prohibiting a 202 health maintenance organization from requiring that a 203 health care provider use a clinical decision support 204 system or a laboratory benefits management program in 205 certain circumstances; defining terms; providing for 206 construction; requiring a pharmacy benefits manager or 207 a specified health maintenance contract to continue to 208 cover a drug for specified subscribers under certain 209 circumstances; prohibiting certain actions by a 210 pharmacy benefits manager or a health maintenance 211 contract with respect to a drug for a certain 212 subscriber except under certain circumstances; 213 defining terms; providing applicability; creating s. 214 641.394, F.S.; requiring a