Bill Text: FL S1084 | 2016 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Health Care Protocols
Spectrum: Bipartisan Bill
Status: (Failed) 2016-03-11 - Died in Appropriations [S1084 Detail]
Download: Florida-2016-S1084-Introduced.html
Bill Title: Health Care Protocols
Spectrum: Bipartisan Bill
Status: (Failed) 2016-03-11 - Died in Appropriations [S1084 Detail]
Download: Florida-2016-S1084-Introduced.html
Florida Senate - 2016 SB 1084 By Senator Gaetz 1-00098B-16 20161084__ 1 A bill to be entitled 2 An act relating to health care protocols; providing a 3 short title; amending s. 409.967, F.S.; requiring a 4 managed care plan to establish a process by which a 5 prescribing physician may request an override of 6 certain restrictions in certain circumstances; 7 providing the circumstances under which an override 8 must be granted; defining the term “fail-first 9 protocol”; creating s. 627.6466, F.S.; requiring an 10 insurer to establish a process by which a prescribing 11 physician may request an override of certain 12 restrictions in certain circumstances; providing the 13 circumstances under which an override must be granted; 14 defining the term “fail-first protocol”; amending s. 15 641.31, F.S.; prohibiting a health maintenance 16 organization from requiring that a health care 17 provider use a clinical decision support system or a 18 laboratory benefits management program in certain 19 circumstances; defining terms; providing for 20 construction; creating s. 641.394, F.S.; requiring a 21 health maintenance organization to establish a process 22 by which a prescribing physician may request an 23 override of certain restrictions in certain 24 circumstances; providing the circumstances under which 25 an override must be granted; defining the term “fail 26 first protocol”; providing an effective date. 27 28 Be It Enacted by the Legislature of the State of Florida: 29 30 Section 1. This act may be known as the “Right Medicine 31 Right Time Act.” 32 Section 2. Paragraph (c) of subsection (2) of section 33 409.967, Florida Statutes, is amended to read: 34 409.967 Managed care plan accountability.— 35 (2) The agency shall establish such contract requirements 36 as are necessary for the operation of the statewide managed care 37 program. In addition to any other provisions the agency may deem 38 necessary, the contract must require: 39 (c) Access.— 40 1. The agency shall establish specific standards for the 41 number, type, and regional distribution of providers in managed 42 care plan networks to ensure access to care for both adults and 43 children. Each plan must maintain a regionwide network of 44 providers in sufficient numbers to meet the access standards for 45 specific medical services for all recipients enrolled in the 46 plan. The exclusive use of mail-order pharmacies may not be 47 sufficient to meet network access standards. Consistent with the 48 standards established by the agency, provider networks may 49 include providers located outside the region. A plan may 50 contract with a new hospital facility before the date the 51 hospital becomes operational if the hospital has commenced 52 construction, will be licensed and operational by January 1, 53 2013, and a final order has issued in any civil or 54 administrative challenge. Each plan shall establish and maintain 55 an accurate and complete electronic database of contracted 56 providers, including information about licensure or 57 registration, locations and hours of operation, specialty 58 credentials and other certifications, specific performance 59 indicators, and such other information as the agency deems 60 necessary. The database must be available online to both the 61 agency and the public and have the capability to compare the 62 availability of providers to network adequacy standards and to 63 accept and display feedback from each provider’s patients. Each 64 plan shall submit quarterly reports to the agency identifying 65 the number of enrollees assigned to each primary care provider. 66 2.a. Each managed care plan must publish any prescribed 67 drug formulary or preferred drug list on the plan’s website in a 68 manner that is accessible to and searchable by enrollees and 69 providers. The plan must update the list within 24 hours after 70 making a change. Each plan must ensure that the prior 71 authorization process for prescribed drugs is readily accessible 72 to health care providers, including posting appropriate contact 73 information on its website and providing timely responses to 74 providers. For Medicaid recipients diagnosed with hemophilia who 75 have been prescribed anti-hemophilic-factor replacement 76 products, the agency shall provide for those products and 77 hemophilia overlay services through the agency’s hemophilia 78 disease management program. 79 b. If a managed care plan restricts the use of prescribed 80 drugs through a fail-first protocol, it must establish a clear 81 and convenient process that a prescribing physician may use to 82 request an override of the restriction from the managed care 83 plan. The managed care plan shall grant an override of the 84 protocol within 24 hours if: 85 (I) Based on sound clinical evidence, the prescribing 86 provider concludes that the preferred treatment required under 87 the fail-first protocol has been ineffective in the treatment of 88 the enrollee’s disease or medical condition; or 89 (II) Based on sound clinical evidence or medical and 90 scientific evidence, the prescribing provider believes that the 91 preferred treatment required under the fail-first protocol: 92 (A) Is likely to be ineffective given the known relevant 93 physical or mental characteristics and medical history of the 94 enrollee and the known characteristics of the drug regimen; or 95 (B) Will cause or is likely to cause an adverse reaction or 96 other physical harm to the enrollee. 97 98 If the prescribing provider follows the fail-first protocol 99 recommended by the managed care plan for an enrollee, the 100 duration of treatment under the fail-first protocol may not 101 exceed a period deemed appropriate by the prescribing provider. 102 Following such period, if the prescribing provider deems the 103 treatment provided under the protocol clinically ineffective, 104 the enrollee is entitled to receive the course of therapy that 105 the prescribing provider recommends, and the provider is not 106 required to seek approval of an override of the fail-first 107 protocol. As used in this subparagraph, the term “fail-first 108 protocol” means a prescription practice that begins medication 109 for a medical condition with the most cost-effective drug 110 therapy and progresses to other more costly or risky therapies 111 only if necessary. 112 3. Managed care plans, and their fiscal agents or 113 intermediaries, must accept prior authorization requests for any 114 service electronically. 115 4. Managed care plans serving children in the care and 116 custody of the Department of Children and Families shallmust117 maintain complete medical, dental, and behavioral health 118 encounter information and participate in making such information 119 available to the department or the applicable contracted 120 community-based care lead agency for use in providing 121 comprehensive and coordinated case management. The agency and 122 the department shall establish an interagency agreement to 123 provide guidance for the format, confidentiality, recipient, 124 scope, and method of information to be made available and the 125 deadlines for submission of the data. The scope of information 126 available to the department areshall bethe data that managed 127 care plans are required to submit to the agency. The agency 128 shall determine the plan’s compliance with standards for access 129 to medical, dental, and behavioral health services; the use of 130 medications; and followup on all medically necessary services 131 recommended as a result of early and periodic screening, 132 diagnosis, and treatment. 133 Section 3. Section 627.6466, Florida Statutes, is created 134 to read: 135 627.6466 Fail-first protocols.—If an insurer restricts the 136 use of prescribed drugs through a fail-first protocol, it must 137 establish a clear and convenient process that a prescribing 138 physician may use to request an override of the restriction from 139 the insurer. The insurer shall grant an override of the protocol 140 within 24 hours if: 141 (1) Based on sound clinical evidence, the prescribing 142 provider concludes that the preferred treatment required under 143 the fail-first protocol has been ineffective in the treatment of 144 the insured’s disease or medical condition; or 145 (2) Based on sound clinical evidence or medical and 146 scientific evidence, the prescribing provider believes that the 147 preferred treatment required under the fail-first protocol: 148 (a) Is likely to be ineffective given the known relevant 149 physical or mental characteristics and medical history of the 150 insured and the known characteristics of the drug regimen; or 151 (b) Will cause or is likely to cause an adverse reaction or 152 other physical harm to the insured. 153 154 If the prescribing provider follows the fail-first protocol 155 recommended by the insurer for an insured, the duration of 156 treatment under the fail-first protocol may not exceed a period 157 deemed appropriate by the prescribing provider. Following such 158 period, if the prescribing provider deems the treatment provided 159 under the protocol clinically ineffective, the insured is 160 entitled to receive the course of therapy that the prescribing 161 provider recommends, and the provider is not required to seek 162 approval of an override of the fail-first protocol. As used in 163 this section, the term “fail-first protocol” means a 164 prescription practice that begins medication for a medical 165 condition with the most cost-effective drug therapy and 166 progresses to other more costly or risky therapies only if 167 necessary. 168 Section 4. Subsection (44) is added to section 641.31, 169 Florida Statutes, to read: 170 641.31 Health maintenance contracts.— 171 (44) A health maintenance organization may not require a 172 health care provider, by contract with another health care 173 provider, a patient, or another individual or entity, to use a 174 clinical decision support system or a laboratory benefits 175 management program before the provider may order clinical 176 laboratory services or in an attempt to direct or limit the 177 provider’s medical decisionmaking relating to the use of such 178 services. This subsection may not be construed to prohibit any 179 prior authorization requirements that the health maintenance 180 organization may have regarding the provision of clinical 181 laboratory services. As used in this subsection, the term: 182 (a) “Clinical decision support system” means software 183 designed to direct or assist clinical decisionmaking by matching 184 the characteristics of an individual patient to a computerized 185 clinical knowledge base and providing patient-specific 186 assessments or recommendations based on the match. 187 (b) “Clinical laboratory services” means the examination of 188 fluids or other materials taken from the human body, which 189 examination is ordered by a health care provider for use in the 190 diagnosis, prevention, or treatment of a disease or in the 191 identification or assessment of a medical or physical condition. 192 (c) “Laboratory benefits management program” means a health 193 maintenance organization protocol that dictates or limits health 194 care provider decisionmaking relating to the use of clinical 195 laboratory services. 196 Section 5. Section 641.394, Florida Statutes, is created to 197 read: 198 641.394 Fail-first protocols.—If a health maintenance 199 organization restricts the use of prescribed drugs through a 200 fail-first protocol, it must establish a clear and convenient 201 process that a prescribing physician may use to request an 202 override of the restriction from the health maintenance 203 organization. The health maintenance organization shall grant an 204 override of the protocol within 24 hours if: 205 (1) Based on sound clinical evidence, the prescribing 206 provider concludes that the preferred treatment required under 207 the fail-first protocol has been ineffective in the treatment of 208 the subscriber’s disease or medical condition; or 209 (2) Based on sound clinical evidence or medical and 210 scientific evidence, the prescribing provider believes that the 211 preferred treatment required under the fail-first protocol: 212 (a) Is likely to be ineffective given the known relevant 213 physical or mental characteristics and medical history of the 214 subscriber and the known characteristics of the drug regimen; or 215 (b) Will cause or is likely to cause an adverse reaction or 216 other physical harm to the subscriber. 217 218 If the prescribing provider follows the fail-first protocol 219 recommended by the health maintenance organization for a 220 subscriber, the duration of treatment under the fail-first 221 protocol may not exceed a period deemed appropriate by the 222 prescribing provider. Following such period, if the prescribing 223 provider deems the treatment provided under the protocol 224 clinically ineffective, the subscriber is entitled to receive 225 the course of therapy that the prescribing provider recommends, 226 and the provider is not required to seek approval of an override 227 of the fail-first protocol. As used in this section, the term 228 “fail-first protocol” means a prescription practice that begins 229 medication for a medical condition with the most cost-effective 230 drug therapy and progresses to other more costly or risky 231 therapies only if necessary. 232 Section 6. This act shall take effect July 1, 2016.