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:
18 409.901 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 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:
38 409.912 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 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 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 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 patient’s 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 pharmacy’s 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 practitioner’s 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 manufacturer’s 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 agency’s 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 beneficiary’s 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:
390 409.910 Responsibility 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.