Florida 2023 2023 Regular Session

Florida House Bill H0183 Introduced / Bill

Filed 01/11/2023

                       
 
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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     
 
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 (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     
 
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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     
 
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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     
 
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 (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     
 
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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     
 
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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     
 
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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     
 
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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     
 
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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     
 
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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     
 
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 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     
 
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 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     
 
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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     
 
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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     
 
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 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     
 
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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