HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 1 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S A bill to be entitled 1 An act relating to Medicaid step -therapy protocols for 2 drugs for serious mental illness treatments; amending 3 s. 409.901, F.S.; defining the term "serious mental 4 illness"; amending s. 409.912, F.S.; requiring the 5 Agency for Health Care Administration to approve drug 6 products for Medicaid recipients for the treatment of 7 serious mental illness without step -therapy prior 8 authorization under certain circumstances; amen ding s. 9 409.910, F.S.; conforming a cross -reference; providing 10 an effective date. 11 12 Be It Enacted by the Legislature of the State of Florida: 13 14 Section 1. Present subsections (27) and (28) of section 15 409.901, Florida Statutes, are redesignated as s ubsections (28) 16 and (29), respectively, and a new subsection (27) is added to 17 that section, to read: 18 409.901 Definitions; ss. 409.901 -409.920.—As used in ss. 19 409.901-409.920, except as otherwise specifically provided, the 20 term: 21 (27) "Serious mental ill ness" means any of the following 22 psychiatric disorders as defined by the American Psychiatric 23 Association in the Diagnostic and Statistical Manual of Mental 24 Disorders, Fifth Edition: 25 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 2 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S (a) Bipolar disorders, including hypomanic, manic, 26 depressive, and mixe d-feature episodes. 27 (b) Depression in childhood or adolescence. 28 (c) Major depressive disorders, including single and 29 recurrent depressive episodes. 30 (d) Obsessive-compulsive disorders. 31 (e) Paranoid personality disorder or other psychotic 32 disorders. 33 (f) Schizoaffective disorders, including bipolar or 34 depressive symptoms. 35 (g) Schizophrenia. 36 Section 2. Paragraph (a) of subsection (5) of section 37 409.912, Florida Statutes, is amended to read: 38 409.912 Cost-effective purchasing of health care. —The 39 agency shall purchase goods and services for Medicaid recipients 40 in the most cost-effective manner consistent with the delivery 41 of quality medical care. To ensure that medical services are 42 effectively utilized, the agency may, in any case, require a 43 confirmation or second physician's opinion of the correct 44 diagnosis for purposes of authorizing future services under the 45 Medicaid program. This section does not restrict access to 46 emergency services or poststabilization care services as defined 47 in 42 C.F.R. s. 438.114. Such confirmation or second opinion 48 shall be rendered in a manner approved by the agency. The agency 49 shall maximize the use of prepaid per capita and prepaid 50 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 3 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S aggregate fixed-sum basis services when appropriate and other 51 alternative service delive ry and reimbursement methodologies, 52 including competitive bidding pursuant to s. 287.057, designed 53 to facilitate the cost -effective purchase of a case -managed 54 continuum of care. The agency shall also require providers to 55 minimize the exposure of recipients to the need for acute 56 inpatient, custodial, and other institutional care and the 57 inappropriate or unnecessary use of high -cost services. The 58 agency shall contract with a vendor to monitor and evaluate the 59 clinical practice patterns of providers in order t o identify 60 trends that are outside the normal practice patterns of a 61 provider's professional peers or the national guidelines of a 62 provider's professional association. The vendor must be able to 63 provide information and counseling to a provider whose practi ce 64 patterns are outside the norms, in consultation with the agency, 65 to improve patient care and reduce inappropriate utilization. 66 The agency may mandate prior authorization, drug therapy 67 management, or disease management participation for certain 68 populations of Medicaid beneficiaries, certain drug classes, or 69 particular drugs to prevent fraud, abuse, overuse, and possible 70 dangerous drug interactions. The Pharmaceutical and Therapeutics 71 Committee shall make recommendations to the agency on drugs for 72 which prior authorization is required. The agency shall inform 73 the Pharmaceutical and Therapeutics Committee of its decisions 74 regarding drugs subject to prior authorization. The agency is 75 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 4 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S authorized to limit the entities it contracts with or enrolls as 76 Medicaid providers by developing a provider network through 77 provider credentialing. The agency may competitively bid single -78 source-provider contracts if procurement of goods or services 79 results in demonstrated cost savings to the state without 80 limiting access to care . The agency may limit its network based 81 on the assessment of beneficiary access to care, provider 82 availability, provider quality standards, time and distance 83 standards for access to care, the cultural competence of the 84 provider network, demographic charac teristics of Medicaid 85 beneficiaries, practice and provider -to-beneficiary standards, 86 appointment wait times, beneficiary use of services, provider 87 turnover, provider profiling, provider licensure history, 88 previous program integrity investigations and findi ngs, peer 89 review, provider Medicaid policy and billing compliance records, 90 clinical and medical record audits, and other factors. Providers 91 are not entitled to enrollment in the Medicaid provider network. 92 The agency shall determine instances in which allow ing Medicaid 93 beneficiaries to purchase durable medical equipment and other 94 goods is less expensive to the Medicaid program than long -term 95 rental of the equipment or goods. The agency may establish rules 96 to facilitate purchases in lieu of long -term rentals in order to 97 protect against fraud and abuse in the Medicaid program as 98 defined in s. 409.913. The agency may seek federal waivers 99 necessary to administer these policies. 100 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 5 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S (5)(a) The agency shall implement a Medicaid prescribed -101 drug spending-control program that includes the following 102 components: 103 1. A Medicaid preferred drug list, which shall be a 104 listing of cost-effective therapeutic options recommended by the 105 Medicaid Pharmacy and Therapeutics Committee established 106 pursuant to s. 409.91195 and adopted by the agency for each 107 therapeutic class on the preferred drug list. At the discretion 108 of the committee, and when feasible, the preferred drug list 109 should include at least two products in a therapeutic class. The 110 agency may post the preferred drug list and updates to the list 111 on an Internet website without following the rulemaking 112 procedures of chapter 120. Antiretroviral agents are excluded 113 from the preferred drug list. The agency shall also limit the 114 amount of a prescribed drug dispensed to no more than a 34 -day 115 supply unless the drug products' sma llest marketed package is 116 greater than a 34-day supply, or the drug is determined by the 117 agency to be a maintenance drug in which case a 100 -day maximum 118 supply may be authorized. The agency may seek any federal 119 waivers necessary to implement these cost -control programs and 120 to continue participation in the federal Medicaid rebate 121 program, or alternatively to negotiate state -only manufacturer 122 rebates. The agency may adopt rules to administer this 123 subparagraph. The agency shall continue to provide unlimited 124 contraceptive drugs and items. The agency must establish 125 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 6 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S procedures to ensure that: 126 a. There is a response to a request for prior 127 authorization by telephone or other telecommunication device 128 within 24 hours after receipt of a request for prior 129 authorization; and 130 b. A 72-hour supply of the drug prescribed is provided in 131 an emergency or when the agency does not provide a response 132 within 24 hours as required by sub -subparagraph a. 133 2. A provider of prescribed drugs is reimbursed in an 134 amount not to exceed t he lesser of the actual acquisition cost 135 based on the Centers for Medicare and Medicaid Services National 136 Average Drug Acquisition Cost pricing files plus a professional 137 dispensing fee, the wholesale acquisition cost plus a 138 professional dispensing fee, the state maximum allowable cost 139 plus a professional dispensing fee, or the usual and customary 140 charge billed by the provider. 141 3. The agency shall develop and implement a process for 142 managing the drug therapies of Medicaid recipients who are using 143 significant numbers of prescribed drugs each month. The 144 management process may include, but is not limited to, 145 comprehensive, physician -directed medical-record reviews, claims 146 analyses, and case evaluations to determine the medical 147 necessity and appropriateness of a patient's treatment plan and 148 drug therapies. The agency may contract with a private 149 organization to provide drug -program-management services. The 150 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 7 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S Medicaid drug benefit management program shall include 151 initiatives to manage drug therapies for HIV/AIDS pat ients, 152 patients using 20 or more unique prescriptions in a 180 -day 153 period, and the top 1,000 patients in annual spending. The 154 agency shall enroll any Medicaid recipient in the drug benefit 155 management program if he or she meets the specifications of this 156 provision and is not enrolled in a Medicaid health maintenance 157 organization. 158 4. The agency may limit the size of its pharmacy network 159 based on need, competitive bidding, price negotiations, 160 credentialing, or similar criteria. The agency shall give 161 special consideration to rural areas in determining the size and 162 location of pharmacies included in the Medicaid pharmacy 163 network. A pharmacy credentialing process may include criteria 164 such as a pharmacy's full -service status, location, size, 165 patient educational p rograms, patient consultation, disease 166 management services, and other characteristics. The agency may 167 impose a moratorium on Medicaid pharmacy enrollment if it is 168 determined that it has a sufficient number of Medicaid -169 participating providers. The agency mu st allow dispensing 170 practitioners to participate as a part of the Medicaid pharmacy 171 network regardless of the practitioner's proximity to any other 172 entity that is dispensing prescription drugs under the Medicaid 173 program. A dispensing practitioner must meet all credentialing 174 requirements applicable to his or her practice, as determined by 175 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 8 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S the agency. 176 5. The agency shall develop and implement a program that 177 requires Medicaid practitioners who issue written prescriptions 178 for medicinal drugs to use a counterf eit-proof prescription pad 179 for Medicaid prescriptions. The agency shall require the use of 180 standardized counterfeit -proof prescription pads by prescribers 181 who issue written prescriptions for Medicaid recipients. The 182 agency may implement the program in targ eted geographic areas or 183 statewide. 184 6. The agency may enter into arrangements that require 185 manufacturers of generic drugs prescribed to Medicaid recipients 186 to provide rebates of at least 15.1 percent of the average 187 manufacturer price for the manufacturer 's generic products. 188 These arrangements must shall require that if a generic -drug 189 manufacturer pays federal rebates for Medicaid -reimbursed drugs 190 at a level below 15.1 percent, the manufacturer must provide a 191 supplemental rebate to the state in an amount n ecessary to 192 achieve a 15.1-percent rebate level. 193 7. The agency may establish a preferred drug list as 194 described in this subsection, and, pursuant to the establishment 195 of such preferred drug list, negotiate supplemental rebates from 196 manufacturers that are in addition to those required by Title 197 XIX of the Social Security Act and at no less than 14 percent of 198 the average manufacturer price as defined in 42 U.S.C. s. 1936 199 on the last day of a quarter unless the federal or supplemental 200 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 9 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S rebate, or both, equals or exceeds 29 percent. There is no upper 201 limit on the supplemental rebates the agency may negotiate. The 202 agency may determine that specific products, brand -name or 203 generic, are competitive at lower rebate percentages. Agreement 204 to pay the minimum supplemen tal rebate percentage guarantees a 205 manufacturer that the Medicaid Pharmaceutical and Therapeutics 206 Committee will consider a product for inclusion on the preferred 207 drug list. However, a pharmaceutical manufacturer is not 208 guaranteed placement on the preferre d drug list by simply paying 209 the minimum supplemental rebate. Agency decisions will be made 210 on the clinical efficacy of a drug and recommendations of the 211 Medicaid Pharmaceutical and Therapeutics Committee, as well as 212 the price of competing products minus f ederal and state rebates. 213 The agency may contract with an outside agency or contractor to 214 conduct negotiations for supplemental rebates. For the purposes 215 of this section, the term "supplemental rebates" means cash 216 rebates. Value-added programs as a substit ution for supplemental 217 rebates are prohibited. The agency may seek any federal waivers 218 to implement this initiative. 219 8.a. The agency may implement a Medicaid behavioral drug 220 management system. The agency may contract with a vendor that 221 has experience in operating behavioral drug management systems 222 to implement this program. The agency may seek federal waivers 223 to implement this program. 224 b. The agency, in conjunction with the Department of 225 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 10 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S Children and Families, may implement the Medicaid behavioral 226 drug management system that is designed to improve the quality 227 of care and behavioral health prescribing practices based on 228 best practice guidelines, improve patient adherence to 229 medication plans, reduce clinical risk, and lower prescribed 230 drug costs and the ra te of inappropriate spending on Medicaid 231 behavioral drugs. The program may include the following 232 elements: 233 (I) Provide for the development and adoption of best 234 practice guidelines for behavioral health -related drugs such as 235 antipsychotics, antidepressant s, and medications for treating 236 bipolar disorders and other behavioral conditions; translate 237 them into practice; review behavioral health prescribers and 238 compare their prescribing patterns to a number of indicators 239 that are based on national standards; and determine deviations 240 from best practice guidelines. 241 (II) Implement processes for providing feedback to and 242 educating prescribers using best practice educational materials 243 and peer-to-peer consultation. 244 (III) Assess Medicaid beneficiaries who are outli ers in 245 their use of behavioral health drugs with regard to the numbers 246 and types of drugs taken, drug dosages, combination drug 247 therapies, and other indicators of improper use of behavioral 248 health drugs. 249 (IV) Alert prescribers to patients who fail to ref ill 250 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 11 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S prescriptions in a timely fashion, are prescribed multiple same -251 class behavioral health drugs, and may have other potential 252 medication problems. 253 (V) Track spending trends for behavioral health drugs and 254 deviation from best practice guidelines. 255 (VI) Use educational and technological approaches to 256 promote best practices, educate consumers, and train prescribers 257 in the use of practice guidelines. 258 (VII) Disseminate electronic and published materials. 259 (VIII) Hold statewide and regional conferences. 260 (IX) Implement a disease management program with a model 261 quality-based medication component for severely mentally ill 262 individuals and emotionally disturbed children who are high 263 users of care. 264 9. The agency shall implement a Medicaid prescription drug 265 management system. 266 a. The agency may contract with a vendor that has 267 experience in operating prescription drug management systems in 268 order to implement this system. Any management system that is 269 implemented in accordance with this subparagraph must rely o n 270 cooperation between physicians and pharmacists to determine 271 appropriate practice patterns and clinical guidelines to improve 272 the prescribing, dispensing, and use of drugs in the Medicaid 273 program. The agency may seek federal waivers to implement this 274 program. 275 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 12 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S b. The drug management system must be designed to improve 276 the quality of care and prescribing practices based on best 277 practice guidelines, improve patient adherence to medication 278 plans, reduce clinical risk, and lower prescribed drug costs and 279 the rate of inappropriate spending on Medicaid prescription 280 drugs. The program must: 281 (I) Provide for the adoption of best practice guidelines 282 for the prescribing and use of drugs in the Medicaid program, 283 including translating best practice guidelines into pra ctice; 284 reviewing prescriber patterns and comparing them to indicators 285 that are based on national standards and practice patterns of 286 clinical peers in their community, statewide, and nationally; 287 and determine deviations from best practice guidelines. 288 (II) Implement processes for providing feedback to and 289 educating prescribers using best practice educational materials 290 and peer-to-peer consultation. 291 (III) Assess Medicaid recipients who are outliers in their 292 use of a single or multiple prescription drugs wi th regard to 293 the numbers and types of drugs taken, drug dosages, combination 294 drug therapies, and other indicators of improper use of 295 prescription drugs. 296 (IV) Alert prescribers to recipients who fail to refill 297 prescriptions in a timely fashion, are prescr ibed multiple drugs 298 that may be redundant or contraindicated, or may have other 299 potential medication problems. 300 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 13 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S 10. The agency may contract for drug rebate 301 administration, including, but not limited to, calculating 302 rebate amounts, invoicing manufacturers, negotiating disputes 303 with manufacturers, and maintaining a database of rebate 304 collections. 305 11. The agency may specify the preferred daily dosing form 306 or strength for the purpose of promoting best practices with 307 regard to the prescribing of certain drugs as specified in the 308 General Appropriations Act and ensuring cost -effective 309 prescribing practices. 310 12. The agency may require prior authorization for 311 Medicaid-covered prescribed drugs. The agency may prior -312 authorize the use of a product: 313 a. For an indication not approved in labeling; 314 b. To comply with certain clinical guidelines; or 315 c. If the product has the potential for overuse, misuse, 316 or abuse. 317 318 The agency may require the prescribing professional to provide 319 information about the rationale an d supporting medical evidence 320 for the use of a drug. The agency shall post prior 321 authorization, step-edit criteria and protocol, and updates to 322 the list of drugs that are subject to prior authorization on the 323 agency's Internet website within 21 days after the prior 324 authorization and step -edit criteria and protocol and updates 325 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 14 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S are approved by the agency. For purposes of this subparagraph, 326 the term "step-edit" means an automatic electronic review of 327 certain medications subject to prior authorization. 328 13. The agency, in conjunction with the Pharmaceutical and 329 Therapeutics Committee, may require age -related prior 330 authorizations for certain prescribed drugs. The agency may 331 preauthorize the use of a drug for a recipient who may not meet 332 the age requirement or ma y exceed the length of therapy for use 333 of this product as recommended by the manufacturer and approved 334 by the Food and Drug Administration. Prior authorization may 335 require the prescribing professional to provide information 336 about the rationale and supporti ng medical evidence for the use 337 of a drug. 338 14. The agency shall implement a step -therapy prior 339 authorization approval process for medications excluded from the 340 preferred drug list. Medications listed on the preferred drug 341 list must be used within the pre vious 12 months before the 342 alternative medications that are not listed. The step -therapy 343 prior authorization may require the prescriber to use the 344 medications of a similar drug class or for a similar medical 345 indication unless contraindicated in the Food an d Drug 346 Administration labeling. The trial period between the specified 347 steps may vary according to the medical indication. The step -348 therapy approval process must shall be developed in accordance 349 with the committee as stated in s. 409.91195(7) and (8). A dr ug 350 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 15 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S product may be approved or, in the case of a drug product for 351 the treatment of a serious mental illness, must be approved 352 without meeting the step -therapy prior authorization criteria if 353 the prescribing physician provides the agency with additional 354 written medical or clinical documentation that the product is 355 medically necessary because: 356 a. There is not a drug on the preferred drug list to treat 357 the disease or medical condition which is an acceptable clinical 358 alternative; 359 b. The alternatives have bee n ineffective in the treatment 360 of the beneficiary's disease; 361 c. The drug product or medication of a similar drug class 362 is prescribed for the treatment of a serious mental illness 363 schizophrenia or schizotypal or delusional disorders ; prior 364 authorization has been granted previously for the prescribed 365 drug; and the medication was dispensed to the patient during the 366 previous 12 months; or 367 d. Based on historical evidence and known characteristics 368 of the patient and the drug, the drug is likely to be 369 ineffective, or the number of doses have been ineffective. 370 371 The agency shall work with the physician to determine the best 372 alternative for the patient. The agency may adopt rules waiving 373 the requirements for written clinical documentation for specific 374 drugs in limited clinical situations. 375 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 16 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S 15. The agency shall implement a return and reuse program 376 for drugs dispensed by pharmacies to institutional recipients, 377 which includes payment of a $5 restocking fee for the 378 implementation and operation of the program. The retu rn and 379 reuse program shall be implemented electronically and in a 380 manner that promotes efficiency. The program must permit a 381 pharmacy to exclude drugs from the program if it is not 382 practical or cost-effective for the drug to be included and must 383 provide for the return to inventory of drugs that cannot be 384 credited or returned in a cost -effective manner. The agency 385 shall determine if the program has reduced the amount of 386 Medicaid prescription drugs which are destroyed on an annual 387 basis and if there are addit ional ways to ensure more 388 prescription drugs are not destroyed which could safely be 389 reused. 390 Section 3. Paragraph (a) of subsection (20) of section 391 409.910, Florida Statutes, is amended to read: 392 409.910 Responsibility for payments on behalf of Medica id-393 eligible persons when other parties are liable. — 394 (20)(a) Entities providing health insurance as defined in 395 s. 624.603, health maintenance organizations and prepaid health 396 clinics as defined in chapter 641, and, on behalf of their 397 clients, third-party administrators, pharmacy benefits managers, 398 and any other third parties, as defined in s. 409.901(28) s. 399 409.901(27), which are legally responsible for payment of a 400 HB 183 2023 CODING: Words stricken are deletions; words underlined are additions. hb0183-00 Page 17 of 17 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S claim for a health care item or service as a condition of doing 401 business in this the state or providing coverage to residents of 402 this state, shall provide such records and information as are 403 necessary to accomplish the purpose of this section, unless such 404 requirement results in an unreasonable burden. 405 Section 4. This act shall take effect July 1, 2023. 406