Florida Senate - 2012 SENATOR AMENDMENT
Bill No. CS for CS for HB 787
Barcode 482012
LEGISLATIVE ACTION
Senate . House
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Floor: 1c/AD/2R . Floor: C
03/09/2012 10:51 PM . 03/10/2012 12:03 AM
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Senator Hays moved the following:
1 Senate Amendment to Amendment (109490) (with title
2 amendment)
3
4 Between lines 1141 and 1142
5 insert:
6 Section 34. Subsection (37) of section 409.912, Florida
7 Statutes, is amended to read:
8 409.912 Cost-effective purchasing of health care.—The
9 agency shall purchase goods and services for Medicaid recipients
10 in the most cost-effective manner consistent with the delivery
11 of quality medical care. To ensure that medical services are
12 effectively utilized, the agency may, in any case, require a
13 confirmation or second physician’s opinion of the correct
14 diagnosis for purposes of authorizing future services under the
15 Medicaid program. This section does not restrict access to
16 emergency services or poststabilization care services as defined
17 in 42 C.F.R. part 438.114. Such confirmation or second opinion
18 shall be rendered in a manner approved by the agency. The agency
19 shall maximize the use of prepaid per capita and prepaid
20 aggregate fixed-sum basis services when appropriate and other
21 alternative service delivery and reimbursement methodologies,
22 including competitive bidding pursuant to s. 287.057, designed
23 to facilitate the cost-effective purchase of a case-managed
24 continuum of care. The agency shall also require providers to
25 minimize the exposure of recipients to the need for acute
26 inpatient, custodial, and other institutional care and the
27 inappropriate or unnecessary use of high-cost services. The
28 agency shall contract with a vendor to monitor and evaluate the
29 clinical practice patterns of providers in order to identify
30 trends that are outside the normal practice patterns of a
31 provider’s professional peers or the national guidelines of a
32 provider’s professional association. The vendor must be able to
33 provide information and counseling to a provider whose practice
34 patterns are outside the norms, in consultation with the agency,
35 to improve patient care and reduce inappropriate utilization.
36 The agency may mandate prior authorization, drug therapy
37 management, or disease management participation for certain
38 populations of Medicaid beneficiaries, certain drug classes, or
39 particular drugs to prevent fraud, abuse, overuse, and possible
40 dangerous drug interactions. The Pharmaceutical and Therapeutics
41 Committee shall make recommendations to the agency on drugs for
42 which prior authorization is required. The agency shall inform
43 the Pharmaceutical and Therapeutics Committee of its decisions
44 regarding drugs subject to prior authorization. The agency is
45 authorized to limit the entities it contracts with or enrolls as
46 Medicaid providers by developing a provider network through
47 provider credentialing. The agency may competitively bid single
48 source-provider contracts if procurement of goods or services
49 results in demonstrated cost savings to the state without
50 limiting access to care. The agency may limit its network based
51 on the assessment of beneficiary access to care, provider
52 availability, provider quality standards, time and distance
53 standards for access to care, the cultural competence of the
54 provider network, demographic characteristics of Medicaid
55 beneficiaries, practice and provider-to-beneficiary standards,
56 appointment wait times, beneficiary use of services, provider
57 turnover, provider profiling, provider licensure history,
58 previous program integrity investigations and findings, peer
59 review, provider Medicaid policy and billing compliance records,
60 clinical and medical record audits, and other factors. Providers
61 are not entitled to enrollment in the Medicaid provider network.
62 The agency shall determine instances in which allowing Medicaid
63 beneficiaries to purchase durable medical equipment and other
64 goods is less expensive to the Medicaid program than long-term
65 rental of the equipment or goods. The agency may establish rules
66 to facilitate purchases in lieu of long-term rentals in order to
67 protect against fraud and abuse in the Medicaid program as
68 defined in s. 409.913. The agency may seek federal waivers
69 necessary to administer these policies.
70 (37)(a) The agency shall implement a Medicaid prescribed
71 drug spending-control program that includes the following
72 components:
73 1. A Medicaid preferred drug list, which shall be a listing
74 of cost-effective therapeutic options recommended by the
75 Medicaid Pharmacy and Therapeutics Committee established
76 pursuant to s. 409.91195 and adopted by the agency for each
77 therapeutic class on the preferred drug list. At the discretion
78 of the committee, and when feasible, the preferred drug list
79 should include at least two products in a therapeutic class. The
80 agency may post the preferred drug list and updates to the list
81 on an Internet website without following the rulemaking
82 procedures of chapter 120. Antiretroviral agents are excluded
83 from the preferred drug list. The agency shall also limit the
84 amount of a prescribed drug dispensed to no more than a 34-day
85 supply unless the drug products’ smallest marketed package is
86 greater than a 34-day supply, or the drug is determined by the
87 agency to be a maintenance drug in which case a 100-day maximum
88 supply may be authorized. The agency may seek any federal
89 waivers necessary to implement these cost-control programs and
90 to continue participation in the federal Medicaid rebate
91 program, or alternatively to negotiate state-only manufacturer
92 rebates. The agency may adopt rules to administer this
93 subparagraph. The agency shall continue to provide unlimited
94 contraceptive drugs and items. The agency must establish
95 procedures to ensure that:
96 a. There is a response to a request for prior consultation
97 by telephone or other telecommunication device within 24 hours
98 after receipt of a request for prior consultation; and
99 b. A 72-hour supply of the drug prescribed is provided in
100 an emergency or when the agency does not provide a response
101 within 24 hours as required by sub-subparagraph a.
102 2. Reimbursement to pharmacies for Medicaid prescribed
103 drugs shall be set at the lowest of: the average wholesale price
104 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
105 plus 1.5 percent, the federal upper limit (FUL), the state
106 maximum allowable cost (SMAC), or the usual and customary (UAC)
107 charge billed by the provider.
108 3. The agency shall develop and implement a process for
109 managing the drug therapies of Medicaid recipients who are using
110 significant numbers of prescribed drugs each month. The
111 management process may include, but is not limited to,
112 comprehensive, physician-directed medical-record reviews, claims
113 analyses, and case evaluations to determine the medical
114 necessity and appropriateness of a patient’s treatment plan and
115 drug therapies. The agency may contract with a private
116 organization to provide drug-program-management services. The
117 Medicaid drug benefit management program shall include
118 initiatives to manage drug therapies for HIV/AIDS patients,
119 patients using 20 or more unique prescriptions in a 180-day
120 period, and the top 1,000 patients in annual spending. The
121 agency shall enroll any Medicaid recipient in the drug benefit
122 management program if he or she meets the specifications of this
123 provision and is not enrolled in a Medicaid health maintenance
124 organization.
125 4. The agency may limit the size of its pharmacy network
126 based on need, competitive bidding, price negotiations,
127 credentialing, or similar criteria. The agency shall give
128 special consideration to rural areas in determining the size and
129 location of pharmacies included in the Medicaid pharmacy
130 network. A pharmacy credentialing process may include criteria
131 such as a pharmacy’s full-service status, location, size,
132 patient educational programs, patient consultation, disease
133 management services, and other characteristics. The agency may
134 impose a moratorium on Medicaid pharmacy enrollment if it is
135 determined that it has a sufficient number of Medicaid
136 participating providers. The agency must allow dispensing
137 practitioners to participate as a part of the Medicaid pharmacy
138 network regardless of the practitioner’s proximity to any other
139 entity that is dispensing prescription drugs under the Medicaid
140 program. A dispensing practitioner must meet all credentialing
141 requirements applicable to his or her practice, as determined by
142 the agency.
143 5. The agency shall develop and implement a program that
144 requires Medicaid practitioners who prescribe drugs to use a
145 counterfeit-proof prescription pad for Medicaid prescriptions.
146 The agency shall require the use of standardized counterfeit
147 proof prescription pads by Medicaid-participating prescribers or
148 prescribers who write prescriptions for Medicaid recipients. The
149 agency may implement the program in targeted geographic areas or
150 statewide.
151 6. The agency may enter into arrangements that require
152 manufacturers of generic drugs prescribed to Medicaid recipients
153 to provide rebates of at least 15.1 percent of the average
154 manufacturer price for the manufacturer’s generic products.
155 These arrangements shall require that if a generic-drug
156 manufacturer pays federal rebates for Medicaid-reimbursed drugs
157 at a level below 15.1 percent, the manufacturer must provide a
158 supplemental rebate to the state in an amount necessary to
159 achieve a 15.1-percent rebate level.
160 7. The agency may establish a preferred drug list as
161 described in this subsection, and, pursuant to the establishment
162 of such preferred drug list, negotiate supplemental rebates from
163 manufacturers that are in addition to those required by Title
164 XIX of the Social Security Act and at no less than 14 percent of
165 the average manufacturer price as defined in 42 U.S.C. s. 1936
166 on the last day of a quarter unless the federal or supplemental
167 rebate, or both, equals or exceeds 29 percent. There is no upper
168 limit on the supplemental rebates the agency may negotiate. The
169 agency may determine that specific products, brand-name or
170 generic, are competitive at lower rebate percentages. Agreement
171 to pay the minimum supplemental rebate percentage guarantees a
172 manufacturer that the Medicaid Pharmaceutical and Therapeutics
173 Committee will consider a product for inclusion on the preferred
174 drug list. However, a pharmaceutical manufacturer is not
175 guaranteed placement on the preferred drug list by simply paying
176 the minimum supplemental rebate. Agency decisions will be made
177 on the clinical efficacy of a drug and recommendations of the
178 Medicaid Pharmaceutical and Therapeutics Committee, as well as
179 the price of competing products minus federal and state rebates.
180 The agency may contract with an outside agency or contractor to
181 conduct negotiations for supplemental rebates. For the purposes
182 of this section, the term “supplemental rebates” means cash
183 rebates. Value-added programs as a substitution for supplemental
184 rebates are prohibited. The agency may seek any federal waivers
185 to implement this initiative.
186 8. The agency shall expand home delivery of pharmacy
187 products. The agency may amend the state plan and issue a
188 procurement, as necessary, in order to implement this program.
189 The procurements must include agreements with a pharmacy or
190 pharmacies located in the state to provide mail order delivery
191 services at no cost to the recipients who elect to receive home
192 delivery of pharmacy products. The procurement must focus on
193 serving recipients with chronic diseases for which pharmacy
194 expenditures represent a significant portion of Medicaid
195 pharmacy expenditures or which impact a significant portion of
196 the Medicaid population. The agency may seek and implement any
197 federal waivers necessary to implement this subparagraph.
198 9. The agency shall limit to one dose per month any drug
199 prescribed to treat erectile dysfunction.
200 10.a. The agency may implement a Medicaid behavioral drug
201 management system. The agency may contract with a vendor that
202 has experience in operating behavioral drug management systems
203 to implement this program. The agency may seek federal waivers
204 to implement this program.
205 b. The agency, in conjunction with the Department of
206 Children and Family Services, may implement the Medicaid
207 behavioral drug management system that is designed to improve
208 the quality of care and behavioral health prescribing practices
209 based on best practice guidelines, improve patient adherence to
210 medication plans, reduce clinical risk, and lower prescribed
211 drug costs and the rate of inappropriate spending on Medicaid
212 behavioral drugs. The program may include the following
213 elements:
214 (I) Provide for the development and adoption of best
215 practice guidelines for behavioral health-related drugs such as
216 antipsychotics, antidepressants, and medications for treating
217 bipolar disorders and other behavioral conditions; translate
218 them into practice; review behavioral health prescribers and
219 compare their prescribing patterns to a number of indicators
220 that are based on national standards; and determine deviations
221 from best practice guidelines.
222 (II) Implement processes for providing feedback to and
223 educating prescribers using best practice educational materials
224 and peer-to-peer consultation.
225 (III) Assess Medicaid beneficiaries who are outliers in
226 their use of behavioral health drugs with regard to the numbers
227 and types of drugs taken, drug dosages, combination drug
228 therapies, and other indicators of improper use of behavioral
229 health drugs.
230 (IV) Alert prescribers to patients who fail to refill
231 prescriptions in a timely fashion, are prescribed multiple same
232 class behavioral health drugs, and may have other potential
233 medication problems.
234 (V) Track spending trends for behavioral health drugs and
235 deviation from best practice guidelines.
236 (VI) Use educational and technological approaches to
237 promote best practices, educate consumers, and train prescribers
238 in the use of practice guidelines.
239 (VII) Disseminate electronic and published materials.
240 (VIII) Hold statewide and regional conferences.
241 (IX) Implement a disease management program with a model
242 quality-based medication component for severely mentally ill
243 individuals and emotionally disturbed children who are high
244 users of care.
245 11. The agency shall implement a Medicaid prescription drug
246 management system.
247 a. The agency may contract with a vendor that has
248 experience in operating prescription drug management systems in
249 order to implement this system. Any management system that is
250 implemented in accordance with this subparagraph must rely on
251 cooperation between physicians and pharmacists to determine
252 appropriate practice patterns and clinical guidelines to improve
253 the prescribing, dispensing, and use of drugs in the Medicaid
254 program. The agency may seek federal waivers to implement this
255 program.
256 b. The drug management system must be designed to improve
257 the quality of care and prescribing practices based on best
258 practice guidelines, improve patient adherence to medication
259 plans, reduce clinical risk, and lower prescribed drug costs and
260 the rate of inappropriate spending on Medicaid prescription
261 drugs. The program must:
262 (I) Provide for the adoption of best practice guidelines
263 for the prescribing and use of drugs in the Medicaid program,
264 including translating best practice guidelines into practice;
265 reviewing prescriber patterns and comparing them to indicators
266 that are based on national standards and practice patterns of
267 clinical peers in their community, statewide, and nationally;
268 and determine deviations from best practice guidelines.
269 (II) Implement processes for providing feedback to and
270 educating prescribers using best practice educational materials
271 and peer-to-peer consultation.
272 (III) Assess Medicaid recipients who are outliers in their
273 use of a single or multiple prescription drugs with regard to
274 the numbers and types of drugs taken, drug dosages, combination
275 drug therapies, and other indicators of improper use of
276 prescription drugs.
277 (IV) Alert prescribers to recipients who fail to refill
278 prescriptions in a timely fashion, are prescribed multiple drugs
279 that may be redundant or contraindicated, or may have other
280 potential medication problems.
281 12. The agency may contract for drug rebate administration,
282 including, but not limited to, calculating rebate amounts,
283 invoicing manufacturers, negotiating disputes with
284 manufacturers, and maintaining a database of rebate collections.
285 13. The agency may specify the preferred daily dosing form
286 or strength for the purpose of promoting best practices with
287 regard to the prescribing of certain drugs as specified in the
288 General Appropriations Act and ensuring cost-effective
289 prescribing practices.
290 14. The agency may require prior authorization for
291 Medicaid-covered prescribed drugs. The agency may prior
292 authorize the use of a product:
293 a. For an indication not approved in labeling;
294 b. To comply with certain clinical guidelines; or
295 c. If the product has the potential for overuse, misuse, or
296 abuse.
297
298 The agency may require the prescribing professional to provide
299 information about the rationale and supporting medical evidence
300 for the use of a drug. The agency shall may post prior
301 authorization, step-edit criteria and protocol, and updates to
302 the list of drugs that are subject to prior authorization on the
303 agency’s an Internet website within 21 days after the prior
304 authorization and step-edit criteria and protocol and updates
305 are approved by the agency. For purposes of this subparagraph,
306 the term “step-edit” means an automatic electronic review of
307 certain medications subject to prior authorization without
308 amending its rule or engaging in additional rulemaking.
309 15. The agency, in conjunction with the Pharmaceutical and
310 Therapeutics Committee, may require age-related prior
311 authorizations for certain prescribed drugs. The agency may
312 preauthorize the use of a drug for a recipient who may not meet
313 the age requirement or may exceed the length of therapy for use
314 of this product as recommended by the manufacturer and approved
315 by the Food and Drug Administration. Prior authorization may
316 require the prescribing professional to provide information
317 about the rationale and supporting medical evidence for the use
318 of a drug.
319 16. The agency shall implement a step-therapy prior
320 authorization approval process for medications excluded from the
321 preferred drug list. Medications listed on the preferred drug
322 list must be used within the previous 12 months before the
323 alternative medications that are not listed. The step-therapy
324 prior authorization may require the prescriber to use the
325 medications of a similar drug class or for a similar medical
326 indication unless contraindicated in the Food and Drug
327 Administration labeling. The trial period between the specified
328 steps may vary according to the medical indication. The step
329 therapy approval process shall be developed in accordance with
330 the committee as stated in s. 409.91195(7) and (8). A drug
331 product may be approved without meeting the step-therapy prior
332 authorization criteria if the prescribing physician provides the
333 agency with additional written medical or clinical documentation
334 that the product is medically necessary because:
335 a. There is not a drug on the preferred drug list to treat
336 the disease or medical condition which is an acceptable clinical
337 alternative;
338 b. The alternatives have been ineffective in the treatment
339 of the beneficiary’s disease; or
340 c. 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 17. 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 (b) The agency shall implement this subsection to the
364 extent that funds are appropriated to administer the Medicaid
365 prescribed-drug spending-control program. The agency may
366 contract all or any part of this program to private
367 organizations.
368 (c) The agency shall submit quarterly reports to the
369 Governor, the President of the Senate, and the Speaker of the
370 House of Representatives which must include, but need not be
371 limited to, the progress made in implementing this subsection
372 and its effect on Medicaid prescribed-drug expenditures.
373
374 ================= T I T L E A M E N D M E N T ================
375 And the title is amended as follows:
376 Delete line 1323
377 and insert:
378 provisions to changes made by the act; amending s.
379 409.912, F.S.; revising provisions requiring the
380 agency to post certain information relating to drugs
381 subject to prior authorization on its Internet
382 website; providing a definition of the term “step
383 edit”; providing an