Florida Senate - 2016 SENATOR AMENDMENT Bill No. HB 85 Ì861542ÂÎ861542 LEGISLATIVE ACTION Senate . House . . . Floor: 1c/OO/2R . 03/08/2016 05:32 PM . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— Senator Hays moved the following: 1 Senate Amendment to Amendment (725590) (with title 2 amendment) 3 4 Delete lines 442 - 469 5 and insert: 6 Section 8. Effective January 1, 2018, section 627.42393, 7 Florida Statutes, is created to read: 8 627.42393 Continuity of care for medically stable 9 patients.— 10 (1) As used in this section, the term: 11 (a) “Complex or chronic medical condition” means a 12 physical, behavioral, or developmental condition that does not 13 have a known cure or that can be severely debilitating or fatal 14 if left untreated or undertreated. 15 (b) “Rare disease” has the same meaning as in 42 U.S.C. s. 16 287a-1(c). 17 (2) A pharmacy benefits manager or an individual or a group 18 insurance policy that is delivered, issued for delivery, 19 renewed, amended, or continued in this state and that provides 20 medical, major medical, or similar comprehensive coverage must 21 continue to cover a drug for an insured with a complex or 22 chronic medical condition or a rare disease if: 23 (a) The drug was previously covered by the insurer for a 24 medical condition or disease of the insured; and 25 (b) The prescribing provider continues to prescribe the 26 drug for the medical condition or disease, the drug is 27 appropriately prescribed, and neither of the following has 28 occurred: 29 1. The United States Food and Drug Administration has 30 issued a notice, a guidance, a warning, an announcement, or any 31 other statement about the drug which calls into question the 32 clinical safety of the drug; or 33 2. The manufacturer of the drug has notified the United 34 States Food and Drug Administration of any manufacturing 35 discontinuance or potential discontinuance as required by s. 36 506C of the Federal Food Drug and Cosmetic Act, 21 U.S.C. s. 37 356c. 38 (3) With respect to a drug for an insured with a complex or 39 chronic medical condition or a rare disease which meets the 40 conditions of paragraphs (2)(a) and (b), except during open 41 enrollment periods, a pharmacy benefits manager or an individual 42 or a group insurance policy may not: 43 (a) Set forth, by contract, limitations on maximum coverage 44 of prescription drug benefits; 45 (b) Subject the insured to increased out-of-pocket costs; 46 or 47 (c) Move a drug for an insured to a more restrictive tier, 48 if an individual or a group insurance policy or a pharmacy 49 benefits manager uses a formulary with tiers. 50 (4) This section does not apply to a grandfathered health 51 plan as defined in s. 627.402, or to benefits set forth in s. 52 627.6561(5)(b)-(e). 53 Section 9. Effective January 1, 2018, paragraph (e) of 54 subsection (5) of section 627.6699, Florida Statutes, is amended 55 to read: 56 627.6699 Employee Health Care Access Act.— 57 (5) AVAILABILITY OF COVERAGE.— 58 (e) All health benefit plans issued under this section must 59 comply with the following conditions: 60 1. For employers who have fewer than two employees, a late 61 enrollee may be excluded from coverage for no longer than 24 62 months if he or she was not covered by creditable coverage 63 continually to a date not more than 63 days before the effective 64 date of his or her new coverage. 65 2. Any requirement used by a small employer carrier in 66 determining whether to provide coverage to a small employer 67 group, including requirements for minimum participation of 68 eligible employees and minimum employer contributions, must be 69 applied uniformly among all small employer groups having the 70 same number of eligible employees applying for coverage or 71 receiving coverage from the small employer carrier, except that 72 a small employer carrier that participates in, administers, or 73 issues health benefits pursuant to s. 381.0406 which do not 74 include a preexisting condition exclusion may require as a 75 condition of offering such benefits that the employer has had no 76 health insurance coverage for its employees for a period of at 77 least 6 months. A small employer carrier may vary application of 78 minimum participation requirements and minimum employer 79 contribution requirements only by the size of the small employer 80 group. 81 3. In applying minimum participation requirements with 82 respect to a small employer, a small employer carrier shall not 83 consider as an eligible employee employees or dependents who 84 have qualifying existing coverage in an employer-based group 85 insurance plan or an ERISA qualified self-insurance plan in 86 determining whether the applicable percentage of participation 87 is met. However, a small employer carrier may count eligible 88 employees and dependents who have coverage under another health 89 plan that is sponsored by that employer. 90 4. A small employer carrier shall not increase any 91 requirement for minimum employee participation or any 92 requirement for minimum employer contribution applicable to a 93 small employer at any time after the small employer has been 94 accepted for coverage, unless the employer size has changed, in 95 which case the small employer carrier may apply the requirements 96 that are applicable to the new group size. 97 5. If a small employer carrier offers coverage to a small 98 employer, it must offer coverage to all the small employer’s 99 eligible employees and their dependents. A small employer 100 carrier may not offer coverage limited to certain persons in a 101 group or to part of a group, except with respect to late 102 enrollees. 103 6. A small employer carrier may not modify any health 104 benefit plan issued to a small employer with respect to a small 105 employer or any eligible employee or dependent through riders, 106 endorsements, or otherwise to restrict or exclude coverage for 107 certain diseases or medical conditions otherwise covered by the 108 health benefit plan. 109 7. An initial enrollment period of at least 30 days must be 110 provided. An annual 30-day open enrollment period must be 111 offered to each small employer’s eligible employees and their 112 dependents. A small employer carrier must provide special 113 enrollment periods as required by s. 627.65615. 114 8. A small employer carrier must provide continuity of care 115 for medically stable patients as required by s. 627.42393. 116 Section 10. Effective January 1, 2018, subsections (44) and 117 (45) are added to section 641.31, Florida Statutes, to read: 118 641.31 Health maintenance contracts.— 119 (44) A health maintenance organization may not require a 120 health care provider, by contract with another health care 121 provider, a patient, or another individual or entity, to use a 122 clinical decision support system or a laboratory benefits 123 management program before the provider may order clinical 124 laboratory services or in an attempt to direct or limit the 125 provider’s medical decisionmaking relating to the use of such 126 services. This subsection may not be construed to prohibit any 127 prior authorization requirements that the health maintenance 128 organization may have regarding the provision of clinical 129 laboratory services. As used in this subsection, the term: 130 (a) “Clinical decision support system” means software 131 designed to direct or assist clinical decisionmaking by matching 132 the characteristics of an individual patient to a computerized 133 clinical knowledge base and providing patient-specific 134 assessments or recommendations based on the match. 135 (b) “Clinical laboratory services” means the examination of 136 fluids or other materials taken from the human body, which 137 examination is ordered by a health care provider for use in the 138 diagnosis, prevention, or treatment of a disease or in the 139 identification or assessment of a medical or physical condition. 140 (c) “Laboratory benefits management program” means a health 141 maintenance organization protocol that dictates or limits health 142 care provider decisionmaking relating to the use of clinical 143 laboratory services. 144 (45)(a) A pharmacy benefits manager or a health maintenance 145 contract that is delivered, issued for delivery, renewed, 146 amended, or continued in this state and that provides medical, 147 major medical, or similar comprehensive coverage must continue 148 to cover a drug for a subscriber with a complex or chronic 149 medical condition or a rare disease if: 150 1. The drug was previously covered by the health 151 maintenance organization for a medical condition or disease of 152 the subscriber; and 153 2. The prescribing provider continues to prescribe the drug 154 for the medical condition or disease, the drug is appropriately 155 prescribed, and neither of the following has occurred: 156 a. The United States Food and Drug Administration has 157 issued a notice, a guidance, a warning, an announcement, or any 158 other statement about the drug which calls into question the 159 clinical safety of the drug; or 160 b. The manufacturer of the drug has notified the United 161 States Food and Drug Administration of any manufacturing 162 discontinuance or potential discontinuance as required by s. 163 506C of the Federal Food Drug and Cosmetic Act, 21 U.S.C. s. 164 356c. 165 (b) With respect to a drug for a subscriber with a complex 166 or chronic medical condition or a rare disease that meets the 167 conditions of subparagraph (c)1. or subparagraph (c)2., except 168 during open enrollment periods, a pharmacy benefits manager or a 169 health maintenance contract may not: 170 1. Set forth, by contract, limitations on maximum coverage 171 of prescription drug benefits; 172 2. Subject the subscriber to increased out-of-pocket costs; 173 or 174 3. Move a drug for a subscriber to a more restrictive tier, 175 if a health maintenance contract or a pharmacy benefits manager 176 uses a formulary with tiers. 177 (c) As used in this subsection, the term: 178 1. “Complex or chronic medical condition” means a physical, 179 behavioral, or developmental condition that does not have a 180 known cure or that can be severely debilitating or fatal if left 181 untreated or undertreated. 182 2. “Rare disease” has the same meaning as in 42 U.S.C. s. 183 287a-1(c). 184 (d) This section does not apply to a grandfathered health 185 plan as defined in s. 627.402. 186 187 ================= T I T L E A M E N D M E N T ================ 188 And the title is amended as follows: 189 Delete lines 798 - 804 190 and insert: 191 defining the term “fail-first protocol”; creating s. 192 627.42393, F.S.; defining terms; requiring a pharmacy 193 benefits manager or a specified individual or group 194 insurance policy to continue to cover a drug for 195 specified insureds under certain circumstances; 196 prohibiting certain actions by a pharmacy benefits 197 manager or an individual or a group policy with 198 respect to a drug for a certain insured except under 199 certain circumstances; providing applicability; 200 amending s. 627.6699, F.S.; expanding a list of 201 conditions that certain health benefit plans must 202 comply with; amending s. 641.31, F.S.; prohibiting a 203 health maintenance organization from requiring that a 204 health care provider use a clinical decision support 205 system or a laboratory benefits management program in 206 certain circumstances; providing for construction; 207 defining terms; requiring a pharmacy benefits manager 208 or a specified health maintenance contract to continue 209 to cover a drug for specified subscribers under 210 certain circumstances; prohibiting certain actions by 211 a pharmacy benefits manager or a health maintenance 212 contract with respect to a drug for a certain 213 subscriber except under certain circumstances; 214 defining terms; providing applicability; creating s. 215 641.394, F.S.; requiring a