Florida Senate - 2022 SB 534
By Senator Harrell
25-00651A-22 2022534__
1 A bill to be entitled
2 An act relating to prescription drugs used in the
3 treatment of schizophrenia for Medicaid recipients;
4 amending s. 409.912, F.S.; authorizing the approval of
5 drug products or certain medication prescribed for the
6 treatment of schizophrenia or schizotypal or
7 delusional disorders for Medicaid recipients who have
8 not met the step-therapy prior authorization criteria,
9 when the drug product or certain medication meets
10 specified criteria; providing an effective date.
11
12 Be It Enacted by the Legislature of the State of Florida:
13
14 Section 1. Paragraph (a) of subsection (5) of section
15 409.912, Florida Statutes, is amended to read:
16 409.912 Cost-effective purchasing of health care.—The
17 agency shall purchase goods and services for Medicaid recipients
18 in the most cost-effective manner consistent with the delivery
19 of quality medical care. To ensure that medical services are
20 effectively utilized, the agency may, in any case, require a
21 confirmation or second physician’s opinion of the correct
22 diagnosis for purposes of authorizing future services under the
23 Medicaid program. This section does not restrict access to
24 emergency services or poststabilization care services as defined
25 in 42 C.F.R. s. 438.114. Such confirmation or second opinion
26 shall be rendered in a manner approved by the agency. The agency
27 shall maximize the use of prepaid per capita and prepaid
28 aggregate fixed-sum basis services when appropriate and other
29 alternative service delivery and reimbursement methodologies,
30 including competitive bidding pursuant to s. 287.057, designed
31 to facilitate the cost-effective purchase of a case-managed
32 continuum of care. The agency shall also require providers to
33 minimize the exposure of recipients to the need for acute
34 inpatient, custodial, and other institutional care and the
35 inappropriate or unnecessary use of high-cost services. The
36 agency shall contract with a vendor to monitor and evaluate the
37 clinical practice patterns of providers in order to identify
38 trends that are outside the normal practice patterns of a
39 provider’s professional peers or the national guidelines of a
40 provider’s professional association. The vendor must be able to
41 provide information and counseling to a provider whose practice
42 patterns are outside the norms, in consultation with the agency,
43 to improve patient care and reduce inappropriate utilization.
44 The agency may mandate prior authorization, drug therapy
45 management, or disease management participation for certain
46 populations of Medicaid beneficiaries, certain drug classes, or
47 particular drugs to prevent fraud, abuse, overuse, and possible
48 dangerous drug interactions. The Pharmaceutical and Therapeutics
49 Committee shall make recommendations to the agency on drugs for
50 which prior authorization is required. The agency shall inform
51 the Pharmaceutical and Therapeutics Committee of its decisions
52 regarding drugs subject to prior authorization. The agency is
53 authorized to limit the entities it contracts with or enrolls as
54 Medicaid providers by developing a provider network through
55 provider credentialing. The agency may competitively bid single
56 source-provider contracts if procurement of goods or services
57 results in demonstrated cost savings to the state without
58 limiting access to care. The agency may limit its network based
59 on the assessment of beneficiary access to care, provider
60 availability, provider quality standards, time and distance
61 standards for access to care, the cultural competence of the
62 provider network, demographic characteristics of Medicaid
63 beneficiaries, practice and provider-to-beneficiary standards,
64 appointment wait times, beneficiary use of services, provider
65 turnover, provider profiling, provider licensure history,
66 previous program integrity investigations and findings, peer
67 review, provider Medicaid policy and billing compliance records,
68 clinical and medical record audits, and other factors. Providers
69 are not entitled to enrollment in the Medicaid provider network.
70 The agency shall determine instances in which allowing Medicaid
71 beneficiaries to purchase durable medical equipment and other
72 goods is less expensive to the Medicaid program than long-term
73 rental of the equipment or goods. The agency may establish rules
74 to facilitate purchases in lieu of long-term rentals in order to
75 protect against fraud and abuse in the Medicaid program as
76 defined in s. 409.913. The agency may seek federal waivers
77 necessary to administer these policies.
78 (5)(a) The agency shall implement a Medicaid prescribed
79 drug spending-control program that includes the following
80 components:
81 1. A Medicaid preferred drug list, which shall be a listing
82 of cost-effective therapeutic options recommended by the
83 Medicaid Pharmacy and Therapeutics Committee established
84 pursuant to s. 409.91195 and adopted by the agency for each
85 therapeutic class on the preferred drug list. At the discretion
86 of the committee, and when feasible, the preferred drug list
87 should include at least two products in a therapeutic class. The
88 agency may post the preferred drug list and updates to the list
89 on an Internet website without following the rulemaking
90 procedures of chapter 120. Antiretroviral agents are excluded
91 from the preferred drug list. The agency shall also limit the
92 amount of a prescribed drug dispensed to no more than a 34-day
93 supply unless the drug products’ smallest marketed package is
94 greater than a 34-day supply, or the drug is determined by the
95 agency to be a maintenance drug in which case a 100-day maximum
96 supply may be authorized. The agency may seek any federal
97 waivers necessary to implement these cost-control programs and
98 to continue participation in the federal Medicaid rebate
99 program, or alternatively to negotiate state-only manufacturer
100 rebates. The agency may adopt rules to administer this
101 subparagraph. The agency shall continue to provide unlimited
102 contraceptive drugs and items. The agency must establish
103 procedures to ensure that:
104 a. There is a response to a request for prior authorization
105 by telephone or other telecommunication device within 24 hours
106 after receipt of a request for prior authorization; and
107 b. A 72-hour supply of the drug prescribed is provided in
108 an emergency or when the agency does not provide a response
109 within 24 hours as required by sub-subparagraph a.
110 2. A provider of prescribed drugs is reimbursed in an
111 amount not to exceed the lesser of the actual acquisition cost
112 based on the Centers for Medicare and Medicaid Services National
113 Average Drug Acquisition Cost pricing files plus a professional
114 dispensing fee, the wholesale acquisition cost plus a
115 professional dispensing fee, the state maximum allowable cost
116 plus a professional dispensing fee, or the usual and customary
117 charge billed by the provider.
118 3. The agency shall develop and implement a process for
119 managing the drug therapies of Medicaid recipients who are using
120 significant numbers of prescribed drugs each month. The
121 management process may include, but is not limited to,
122 comprehensive, physician-directed medical-record reviews, claims
123 analyses, and case evaluations to determine the medical
124 necessity and appropriateness of a patient’s treatment plan and
125 drug therapies. The agency may contract with a private
126 organization to provide drug-program-management services. The
127 Medicaid drug benefit management program shall include
128 initiatives to manage drug therapies for HIV/AIDS patients,
129 patients using 20 or more unique prescriptions in a 180-day
130 period, and the top 1,000 patients in annual spending. The
131 agency shall enroll any Medicaid recipient in the drug benefit
132 management program if he or she meets the specifications of this
133 provision and is not enrolled in a Medicaid health maintenance
134 organization.
135 4. The agency may limit the size of its pharmacy network
136 based on need, competitive bidding, price negotiations,
137 credentialing, or similar criteria. The agency shall give
138 special consideration to rural areas in determining the size and
139 location of pharmacies included in the Medicaid pharmacy
140 network. A pharmacy credentialing process may include criteria
141 such as a pharmacy’s full-service status, location, size,
142 patient educational programs, patient consultation, disease
143 management services, and other characteristics. The agency may
144 impose a moratorium on Medicaid pharmacy enrollment if it is
145 determined that it has a sufficient number of Medicaid
146 participating providers. The agency must allow dispensing
147 practitioners to participate as a part of the Medicaid pharmacy
148 network regardless of the practitioner’s proximity to any other
149 entity that is dispensing prescription drugs under the Medicaid
150 program. A dispensing practitioner must meet all credentialing
151 requirements applicable to his or her practice, as determined by
152 the agency.
153 5. The agency shall develop and implement a program that
154 requires Medicaid practitioners who issue written prescriptions
155 for medicinal drugs to use a counterfeit-proof prescription pad
156 for Medicaid prescriptions. The agency shall require the use of
157 standardized counterfeit-proof prescription pads by prescribers
158 who issue written prescriptions for Medicaid recipients. The
159 agency may implement the program in targeted geographic areas or
160 statewide.
161 6. The agency may enter into arrangements that require
162 manufacturers of generic drugs prescribed to Medicaid recipients
163 to provide rebates of at least 15.1 percent of the average
164 manufacturer price for the manufacturer’s generic products.
165 These arrangements shall require that if a generic-drug
166 manufacturer pays federal rebates for Medicaid-reimbursed drugs
167 at a level below 15.1 percent, the manufacturer must provide a
168 supplemental rebate to the state in an amount necessary to
169 achieve a 15.1-percent rebate level.
170 7. The agency may establish a preferred drug list as
171 described in this subsection, and, pursuant to the establishment
172 of such preferred drug list, negotiate supplemental rebates from
173 manufacturers that are in addition to those required by Title
174 XIX of the Social Security Act and at no less than 14 percent of
175 the average manufacturer price as defined in 42 U.S.C. s. 1936
176 on the last day of a quarter unless the federal or supplemental
177 rebate, or both, equals or exceeds 29 percent. There is no upper
178 limit on the supplemental rebates the agency may negotiate. The
179 agency may determine that specific products, brand-name or
180 generic, are competitive at lower rebate percentages. Agreement
181 to pay the minimum supplemental rebate percentage guarantees a
182 manufacturer that the Medicaid Pharmaceutical and Therapeutics
183 Committee will consider a product for inclusion on the preferred
184 drug list. However, a pharmaceutical manufacturer is not
185 guaranteed placement on the preferred drug list by simply paying
186 the minimum supplemental rebate. Agency decisions will be made
187 on the clinical efficacy of a drug and recommendations of the
188 Medicaid Pharmaceutical and Therapeutics Committee, as well as
189 the price of competing products minus federal and state rebates.
190 The agency may contract with an outside agency or contractor to
191 conduct negotiations for supplemental rebates. For the purposes
192 of this section, the term “supplemental rebates” means cash
193 rebates. Value-added programs as a substitution for supplemental
194 rebates are prohibited. The agency may seek any federal waivers
195 to implement this initiative.
196 8.a. The agency may implement a Medicaid behavioral drug
197 management system. The agency may contract with a vendor that
198 has experience in operating behavioral drug management systems
199 to implement this program. The agency may seek federal waivers
200 to implement this program.
201 b. The agency, in conjunction with the Department of
202 Children and Families, may implement the Medicaid behavioral
203 drug management system that is designed to improve the quality
204 of care and behavioral health prescribing practices based on
205 best practice guidelines, improve patient adherence to
206 medication plans, reduce clinical risk, and lower prescribed
207 drug costs and the rate of inappropriate spending on Medicaid
208 behavioral drugs. The program may include the following
209 elements:
210 (I) Provide for the development and adoption of best
211 practice guidelines for behavioral health-related drugs such as
212 antipsychotics, antidepressants, and medications for treating
213 bipolar disorders and other behavioral conditions; translate
214 them into practice; review behavioral health prescribers and
215 compare their prescribing patterns to a number of indicators
216 that are based on national standards; and determine deviations
217 from best practice guidelines.
218 (II) Implement processes for providing feedback to and
219 educating prescribers using best practice educational materials
220 and peer-to-peer consultation.
221 (III) Assess Medicaid beneficiaries who are outliers in
222 their use of behavioral health drugs with regard to the numbers
223 and types of drugs taken, drug dosages, combination drug
224 therapies, and other indicators of improper use of behavioral
225 health drugs.
226 (IV) Alert prescribers to patients who fail to refill
227 prescriptions in a timely fashion, are prescribed multiple same
228 class behavioral health drugs, and may have other potential
229 medication problems.
230 (V) Track spending trends for behavioral health drugs and
231 deviation from best practice guidelines.
232 (VI) Use educational and technological approaches to
233 promote best practices, educate consumers, and train prescribers
234 in the use of practice guidelines.
235 (VII) Disseminate electronic and published materials.
236 (VIII) Hold statewide and regional conferences.
237 (IX) Implement a disease management program with a model
238 quality-based medication component for severely mentally ill
239 individuals and emotionally disturbed children who are high
240 users of care.
241 9. The agency shall implement a Medicaid prescription drug
242 management system.
243 a. The agency may contract with a vendor that has
244 experience in operating prescription drug management systems in
245 order to implement this system. Any management system that is
246 implemented in accordance with this subparagraph must rely on
247 cooperation between physicians and pharmacists to determine
248 appropriate practice patterns and clinical guidelines to improve
249 the prescribing, dispensing, and use of drugs in the Medicaid
250 program. The agency may seek federal waivers to implement this
251 program.
252 b. The drug management system must be designed to improve
253 the quality of care and prescribing practices based on best
254 practice guidelines, improve patient adherence to medication
255 plans, reduce clinical risk, and lower prescribed drug costs and
256 the rate of inappropriate spending on Medicaid prescription
257 drugs. The program must:
258 (I) Provide for the adoption of best practice guidelines
259 for the prescribing and use of drugs in the Medicaid program,
260 including translating best practice guidelines into practice;
261 reviewing prescriber patterns and comparing them to indicators
262 that are based on national standards and practice patterns of
263 clinical peers in their community, statewide, and nationally;
264 and determine deviations from best practice guidelines.
265 (II) Implement processes for providing feedback to and
266 educating prescribers using best practice educational materials
267 and peer-to-peer consultation.
268 (III) Assess Medicaid recipients who are outliers in their
269 use of a single or multiple prescription drugs with regard to
270 the numbers and types of drugs taken, drug dosages, combination
271 drug therapies, and other indicators of improper use of
272 prescription drugs.
273 (IV) Alert prescribers to recipients who fail to refill
274 prescriptions in a timely fashion, are prescribed multiple drugs
275 that may be redundant or contraindicated, or may have other
276 potential medication problems.
277 10. The agency may contract for drug rebate administration,
278 including, but not limited to, calculating rebate amounts,
279 invoicing manufacturers, negotiating disputes with
280 manufacturers, and maintaining a database of rebate collections.
281 11. The agency may specify the preferred daily dosing form
282 or strength for the purpose of promoting best practices with
283 regard to the prescribing of certain drugs as specified in the
284 General Appropriations Act and ensuring cost-effective
285 prescribing practices.
286 12. The agency may require prior authorization for
287 Medicaid-covered prescribed drugs. The agency may prior
288 authorize the use of a product:
289 a. For an indication not approved in labeling;
290 b. To comply with certain clinical guidelines; or
291 c. If the product has the potential for overuse, misuse, or
292 abuse.
293
294 The agency may require the prescribing professional to provide
295 information about the rationale and supporting medical evidence
296 for the use of a drug. The agency shall post prior
297 authorization, step-edit criteria and protocol, and updates to
298 the list of drugs that are subject to prior authorization on the
299 agency’s Internet website within 21 days after the prior
300 authorization and step-edit criteria and protocol and updates
301 are approved by the agency. For purposes of this subparagraph,
302 the term “step-edit” means an automatic electronic review of
303 certain medications subject to prior authorization.
304 13. The agency, in conjunction with the Pharmaceutical and
305 Therapeutics Committee, may require age-related prior
306 authorizations for certain prescribed drugs. The agency may
307 preauthorize the use of a drug for a recipient who may not meet
308 the age requirement or may exceed the length of therapy for use
309 of this product as recommended by the manufacturer and approved
310 by the Food and Drug Administration. Prior authorization may
311 require the prescribing professional to provide information
312 about the rationale and supporting medical evidence for the use
313 of a drug.
314 14. The agency shall implement a step-therapy prior
315 authorization approval process for medications excluded from the
316 preferred drug list. Medications listed on the preferred drug
317 list must be used within the previous 12 months before the
318 alternative medications that are not listed. The step-therapy
319 prior authorization may require the prescriber to use the
320 medications of a similar drug class or for a similar medical
321 indication unless contraindicated in the Food and Drug
322 Administration labeling. The trial period between the specified
323 steps may vary according to the medical indication. The step
324 therapy approval process shall be developed in accordance with
325 the committee as stated in s. 409.91195(7) and (8). A drug
326 product may be approved without meeting the step-therapy prior
327 authorization criteria if the prescribing physician provides the
328 agency with additional written medical or clinical documentation
329 that the product is medically necessary because:
330 a. There is not a drug on the preferred drug list to treat
331 the disease or medical condition which is an acceptable clinical
332 alternative;
333 b. The alternatives have been ineffective in the treatment
334 of the beneficiary’s disease; or
335 c. The drug product or medication of a similar drug class
336 is prescribed for the treatment of schizophrenia or schizotypal
337 or delusional disorders; prior authorization has been granted
338 previously for the prescribed drug; and the medication was
339 dispensed to the patient during the previous 12 months; or
340 d. Based on historic evidence and known characteristics of
341 the patient and the drug, the drug is likely to be ineffective,
342 or the number of doses have been ineffective.
343
344 The agency shall work with the physician to determine the best
345 alternative for the patient. The agency may adopt rules waiving
346 the requirements for written clinical documentation for specific
347 drugs in limited clinical situations.
348 15. The agency shall implement a return and reuse program
349 for drugs dispensed by pharmacies to institutional recipients,
350 which includes payment of a $5 restocking fee for the
351 implementation and operation of the program. The return and
352 reuse program shall be implemented electronically and in a
353 manner that promotes efficiency. The program must permit a
354 pharmacy to exclude drugs from the program if it is not
355 practical or cost-effective for the drug to be included and must
356 provide for the return to inventory of drugs that cannot be
357 credited or returned in a cost-effective manner. The agency
358 shall determine if the program has reduced the amount of
359 Medicaid prescription drugs which are destroyed on an annual
360 basis and if there are additional ways to ensure more
361 prescription drugs are not destroyed which could safely be
362 reused.
363 Section 2. This act shall take effect July 1, 2022.