Florida Senate - 2023 SB 112 By Senator Harrell 31-00251-23 2023112__ 1 A bill to be entitled 2 An act relating to step-therapy protocols; amending s. 3 409.901, 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; amending 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 subsections (28) 16 and (29), respectively, and a new subsection (27) is added to 17 that section, to read: 18 409.901Definitions; 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 illness 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 (a)Bipolar disorders, including hypomanic, manic, 26 depressive, and mixed-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: 38 409.912Cost-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 physicians 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 aggregate fixed-sum basis services when appropriate and other 51 alternative service delivery 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 to identify 60 trends that are outside the normal practice patterns of a 61 providers professional peers or the national guidelines of a 62 providers professional association. The vendor must be able to 63 provide information and counseling to a provider whose practice 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 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 characteristics 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 findings, 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 allowing 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 (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 listing 104 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 smallest 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 procedures to ensure that: 126 a.There is a response to a request for prior authorization 127 by telephone or other telecommunication device within 24 hours 128 after receipt of a request for prior authorization; and 129 b.A 72-hour supply of the drug prescribed is provided in 130 an emergency or when the agency does not provide a response 131 within 24 hours as required by sub-subparagraph a. 132 2.A provider of prescribed drugs is reimbursed in an 133 amount not to exceed the lesser of the actual acquisition cost 134 based on the Centers for Medicare and Medicaid Services National 135 Average Drug Acquisition Cost pricing files plus a professional 136 dispensing fee, the wholesale acquisition cost plus a 137 professional dispensing fee, the state maximum allowable cost 138 plus a professional dispensing fee, or the usual and customary 139 charge billed by the provider. 140 3.The agency shall develop and implement a process for 141 managing the drug therapies of Medicaid recipients who are using 142 significant numbers of prescribed drugs each month. The 143 management process may include, but is not limited to, 144 comprehensive, physician-directed medical-record reviews, claims 145 analyses, and case evaluations to determine the medical 146 necessity and appropriateness of a patients treatment plan and 147 drug therapies. The agency may contract with a private 148 organization to provide drug-program-management services. The 149 Medicaid drug benefit management program shall include 150 initiatives to manage drug therapies for HIV/AIDS patients, 151 patients using 20 or more unique prescriptions in a 180-day 152 period, and the top 1,000 patients in annual spending. The 153 agency shall enroll any Medicaid recipient in the drug benefit 154 management program if he or she meets the specifications of this 155 provision and is not enrolled in a Medicaid health maintenance 156 organization. 157 4.The agency may limit the size of its pharmacy network 158 based on need, competitive bidding, price negotiations, 159 credentialing, or similar criteria. The agency shall give 160 special consideration to rural areas in determining the size and 161 location of pharmacies included in the Medicaid pharmacy 162 network. A pharmacy credentialing process may include criteria 163 such as a pharmacys full-service status, location, size, 164 patient educational programs, patient consultation, disease 165 management services, and other characteristics. The agency may 166 impose a moratorium on Medicaid pharmacy enrollment if it is 167 determined that it has a sufficient number of Medicaid 168 participating providers. The agency must allow dispensing 169 practitioners to participate as a part of the Medicaid pharmacy 170 network regardless of the practitioners proximity to any other 171 entity that is dispensing prescription drugs under the Medicaid 172 program. A dispensing practitioner must meet all credentialing 173 requirements applicable to his or her practice, as determined by 174 the agency. 175 5.The agency shall develop and implement a program that 176 requires Medicaid practitioners who issue written prescriptions 177 for medicinal drugs to use a counterfeit-proof prescription pad 178 for Medicaid prescriptions. The agency shall require the use of 179 standardized counterfeit-proof prescription pads by prescribers 180 who issue written prescriptions for Medicaid recipients. The 181 agency may implement the program in targeted geographic areas or 182 statewide. 183 6.The agency may enter into arrangements that require 184 manufacturers of generic drugs prescribed to Medicaid recipients 185 to provide rebates of at least 15.1 percent of the average 186 manufacturer price for the manufacturers generic products. 187 These arrangements must shall require that if a generic-drug 188 manufacturer pays federal rebates for Medicaid-reimbursed drugs 189 at a level below 15.1 percent, the manufacturer must provide a 190 supplemental rebate to the state in an amount necessary to 191 achieve a 15.1-percent rebate level. 192 7.The agency may establish a preferred drug list as 193 described in this subsection, and, pursuant to the establishment 194 of such preferred drug list, negotiate supplemental rebates from 195 manufacturers that are in addition to those required by Title 196 XIX of the Social Security Act and at no less than 14 percent of 197 the average manufacturer price as defined in 42 U.S.C. s. 1936 198 on the last day of a quarter unless the federal or supplemental 199 rebate, or both, equals or exceeds 29 percent. There is no upper 200 limit on the supplemental rebates the agency may negotiate. The 201 agency may determine that specific products, brand-name or 202 generic, are competitive at lower rebate percentages. Agreement 203 to pay the minimum supplemental rebate percentage guarantees a 204 manufacturer that the Medicaid Pharmaceutical and Therapeutics 205 Committee will consider a product for inclusion on the preferred 206 drug list. However, a pharmaceutical manufacturer is not 207 guaranteed placement on the preferred drug list by simply paying 208 the minimum supplemental rebate. Agency decisions will be made 209 on the clinical efficacy of a drug and recommendations of the 210 Medicaid Pharmaceutical and Therapeutics Committee, as well as 211 the price of competing products minus federal and state rebates. 212 The agency may contract with an outside agency or contractor to 213 conduct negotiations for supplemental rebates. For the purposes 214 of this section, the term supplemental rebates means cash 215 rebates. Value-added programs as a substitution for supplemental 216 rebates are prohibited. The agency may seek any federal waivers 217 to implement this initiative. 218 8.a.The agency may implement a Medicaid behavioral drug 219 management system. The agency may contract with a vendor that 220 has experience in operating behavioral drug management systems 221 to implement this program. The agency may seek federal waivers 222 to implement this program. 223 b.The agency, in conjunction with the Department of 224 Children and Families, may implement the Medicaid behavioral 225 drug management system that is designed to improve the quality 226 of care and behavioral health prescribing practices based on 227 best practice guidelines, improve patient adherence to 228 medication plans, reduce clinical risk, and lower prescribed 229 drug costs and the rate of inappropriate spending on Medicaid 230 behavioral drugs. The program may include the following 231 elements: 232 (I)Provide for the development and adoption of best 233 practice guidelines for behavioral health-related drugs such as 234 antipsychotics, antidepressants, and medications for treating 235 bipolar disorders and other behavioral conditions; translate 236 them into practice; review behavioral health prescribers and 237 compare their prescribing patterns to a number of indicators 238 that are based on national standards; and determine deviations 239 from best practice guidelines. 240 (II)Implement processes for providing feedback to and 241 educating prescribers using best practice educational materials 242 and peer-to-peer consultation. 243 (III)Assess Medicaid beneficiaries who are outliers in 244 their use of behavioral health drugs with regard to the numbers 245 and types of drugs taken, drug dosages, combination drug 246 therapies, and other indicators of improper use of behavioral 247 health drugs. 248 (IV)Alert prescribers to patients who fail to refill 249 prescriptions in a timely fashion, are prescribed multiple same 250 class behavioral health drugs, and may have other potential 251 medication problems. 252 (V)Track spending trends for behavioral health drugs and 253 deviation from best practice guidelines. 254 (VI)Use educational and technological approaches to 255 promote best practices, educate consumers, and train prescribers 256 in the use of practice guidelines. 257 (VII)Disseminate electronic and published materials. 258 (VIII)Hold statewide and regional conferences. 259 (IX)Implement a disease management program with a model 260 quality-based medication component for severely mentally ill 261 individuals and emotionally disturbed children who are high 262 users of care. 263 9.The agency shall implement a Medicaid prescription drug 264 management system. 265 a.The agency may contract with a vendor that has 266 experience in operating prescription drug management systems in 267 order to implement this system. Any management system that is 268 implemented in accordance with this subparagraph must rely on 269 cooperation between physicians and pharmacists to determine 270 appropriate practice patterns and clinical guidelines to improve 271 the prescribing, dispensing, and use of drugs in the Medicaid 272 program. The agency may seek federal waivers to implement this 273 program. 274 b.The drug management system must be designed to improve 275 the quality of care and prescribing practices based on best 276 practice guidelines, improve patient adherence to medication 277 plans, reduce clinical risk, and lower prescribed drug costs and 278 the rate of inappropriate spending on Medicaid prescription 279 drugs. The program must: 280 (I)Provide for the adoption of best practice guidelines 281 for the prescribing and use of drugs in the Medicaid program, 282 including translating best practice guidelines into practice; 283 reviewing prescriber patterns and comparing them to indicators 284 that are based on national standards and practice patterns of 285 clinical peers in their community, statewide, and nationally; 286 and determine deviations from best practice guidelines. 287 (II)Implement processes for providing feedback to and 288 educating prescribers using best practice educational materials 289 and peer-to-peer consultation. 290 (III)Assess Medicaid recipients who are outliers in their 291 use of a single or multiple prescription drugs with regard to 292 the numbers and types of drugs taken, drug dosages, combination 293 drug therapies, and other indicators of improper use of 294 prescription drugs. 295 (IV)Alert prescribers to recipients who fail to refill 296 prescriptions in a timely fashion, are prescribed multiple drugs 297 that may be redundant or contraindicated, or may have other 298 potential medication problems. 299 10.The agency may contract for drug rebate administration, 300 including, but not limited to, calculating rebate amounts, 301 invoicing manufacturers, negotiating disputes with 302 manufacturers, and maintaining a database of rebate collections. 303 11.The agency may specify the preferred daily dosing form 304 or strength for the purpose of promoting best practices with 305 regard to the prescribing of certain drugs as specified in the 306 General Appropriations Act and ensuring cost-effective 307 prescribing practices. 308 12.The agency may require prior authorization for 309 Medicaid-covered prescribed drugs. The agency may prior 310 authorize the use of a product: 311 a.For an indication not approved in labeling; 312 b.To comply with certain clinical guidelines; or 313 c.If the product has the potential for overuse, misuse, or 314 abuse. 315 316 The agency may require the prescribing professional to provide 317 information about the rationale and supporting medical evidence 318 for the use of a drug. The agency shall post prior 319 authorization, step-edit criteria and protocol, and updates to 320 the list of drugs that are subject to prior authorization on the 321 agencys Internet website within 21 days after the prior 322 authorization and step-edit criteria and protocol and updates 323 are approved by the agency. For purposes of this subparagraph, 324 the term step-edit means an automatic electronic review of 325 certain medications subject to prior authorization. 326 13.The agency, in conjunction with the Pharmaceutical and 327 Therapeutics Committee, may require age-related prior 328 authorizations for certain prescribed drugs. The agency may 329 preauthorize the use of a drug for a recipient who may not meet 330 the age requirement or may exceed the length of therapy for use 331 of this product as recommended by the manufacturer and approved 332 by the Food and Drug Administration. Prior authorization may 333 require the prescribing professional to provide information 334 about the rationale and supporting medical evidence for the use 335 of a drug. 336 14.The agency shall implement a step-therapy prior 337 authorization approval process for medications excluded from the 338 preferred drug list. Medications listed on the preferred drug 339 list must be used within the previous 12 months before the 340 alternative medications that are not listed. The step-therapy 341 prior authorization may require the prescriber to use the 342 medications of a similar drug class or for a similar medical 343 indication unless contraindicated in the Food and Drug 344 Administration labeling. The trial period between the specified 345 steps may vary according to the medical indication. The step 346 therapy approval process must shall be developed in accordance 347 with the committee as stated in s. 409.91195(7) and (8). A drug 348 product may be approved or, in the case of a drug product for 349 the treatment of a serious mental illness, must be approved 350 without meeting the step-therapy prior authorization criteria if 351 the prescribing physician provides the agency with additional 352 written medical or clinical documentation that the product is 353 medically necessary because: 354 a.There is not a drug on the preferred drug list to treat 355 the disease or medical condition which is an acceptable clinical 356 alternative; 357 b.The alternatives have been ineffective in the treatment 358 of the beneficiarys disease; 359 c.The drug product or medication of a similar drug class 360 is prescribed for the treatment of a serious mental illness 361 schizophrenia or schizotypal or delusional disorders; prior 362 authorization has been granted previously for the prescribed 363 drug; and the medication was dispensed to the patient during the 364 previous 12 months; or 365 d.Based on historical evidence and known characteristics 366 of the patient and the drug, the drug is likely to be 367 ineffective, or the number of doses have been ineffective. 368 369 The agency shall work with the physician to determine the best 370 alternative for the patient. The agency may adopt rules waiving 371 the requirements for written clinical documentation for specific 372 drugs in limited clinical situations. 373 15.The agency shall implement a return and reuse program 374 for drugs dispensed by pharmacies to institutional recipients, 375 which includes payment of a $5 restocking fee for the 376 implementation and operation of the program. The return and 377 reuse program shall be implemented electronically and in a 378 manner that promotes efficiency. The program must permit a 379 pharmacy to exclude drugs from the program if it is not 380 practical or cost-effective for the drug to be included and must 381 provide for the return to inventory of drugs that cannot be 382 credited or returned in a cost-effective manner. The agency 383 shall determine if the program has reduced the amount of 384 Medicaid prescription drugs which are destroyed on an annual 385 basis and if there are additional ways to ensure more 386 prescription drugs are not destroyed which could safely be 387 reused. 388 Section 3.Paragraph (a) of subsection (20) of section 389 409.910, Florida Statutes, is amended to read: 390 409.910Responsibility for payments on behalf of Medicaid 391 eligible persons when other parties are liable. 392 (20)(a)Entities providing health insurance as defined in 393 s. 624.603, health maintenance organizations and prepaid health 394 clinics as defined in chapter 641, and, on behalf of their 395 clients, third-party administrators, pharmacy benefits managers, 396 and any other third parties, as defined in s. 409.901(28) s. 397 409.901(27), which are legally responsible for payment of a 398 claim for a health care item or service as a condition of doing 399 business in this the state or providing coverage to residents of 400 this state, shall provide such records and information as are 401 necessary to accomplish the purpose of this section, unless such 402 requirement results in an unreasonable burden. 403 Section 4.This act shall take effect July 1, 2023.