Florida Senate - 2021 SB 1292
By Senator Bean
1 A bill to be entitled
2 An act relating to Medicaid; amending s. 402.81, F.S.;
3 deleting a requirement for the Agency for Health Care
4 Administration to submit an annual report to the
5 Legislature on the operation of the pharmaceutical
6 expense assistance program; amending s. 409.815, F.S.;
7 conforming a provision to changes made by the act;
8 amending s. 409.908, F.S.; deleting a requirement for
9 the agency to submit an annual report to the
10 Legislature on certain direct and indirect care costs;
11 revising the method for determining prescribed drug
12 provider reimbursements; deleting a requirement for
13 the agency to implement certain fees for prescribed
14 medicines; deleting authorization for the agency to
15 increase certain dispensing fees by certain amounts;
16 reenacting and amending s. 409.91195, F.S., relating
17 to the Medicaid Pharmaceutical and Therapeutics
18 Committee; deleting a requirement for the agency to
19 ensure that the committee reviews certain drugs under
20 certain circumstances; designating the agency, rather
21 than the Department of Children and Families, as the
22 administrator for certain hearings; amending s.
23 409.912, F.S.; requiring the agency to establish
24 certain procedures related to prior authorization
25 requests rather than prior consultation requests;
26 revising the method for determining prescribed drug
27 provider reimbursements; deleting a requirement for
28 the agency to expand home delivery of pharmacy
29 products; deleting a dosage limitation on certain
30 drugs; deleting a requirement for the agency to submit
31 certain quarterly reports to the Governor and the
32 Legislature; repealing s. 409.91213, F.S., relating to
33 quarterly progress reports and annual reports;
34 amending s. 409.913, F.S.; revising the definitions of
35 the terms “medical necessity” and “medically
36 necessary” to delete a requirement that determinations
37 of medical necessity be made by certain licensed
38 physicians; repealing s. 765.53, F.S., relating to the
39 Organ Transplant Advisory Council; providing an
40 effective date.
42 Be It Enacted by the Legislature of the State of Florida:
45 Section 1. Subsection (4) of section 402.81, Florida
46 Statutes, is amended to read:
47 402.81 Pharmaceutical expense assistance.—
48 (4) ADMINISTRATION.—The agency shall administer the
49 pharmaceutical expense assistance program
shall be administered
50 by the agency, in collaboration with the Department of Elderly
51 Affairs and the Department of Children and Families. By January
52 1 of each year, the agency shall report to the Legislature on
53 the operation of the program. The report shall include
54 information on the number of individuals served, use rates, and
55 expenditures under the program.
56 Section 2. Paragraph (e) of subsection (2) of section
57 409.815, Florida Statutes, is amended to read:
58 409.815 Health benefits coverage; limitations.—
59 (2) BENCHMARK BENEFITS.—In order for health benefits
60 coverage to qualify for premium assistance payments for an
61 eligible child under ss. 409.810-409.821, the health benefits
62 coverage, except for coverage under Medicaid and Medikids, must
63 include the following minimum benefits, as medically necessary.
64 (e) Organ transplantation services.—Covered services
65 include pretransplant, transplant, and postdischarge services
66 and treatment of complications after transplantation for
67 transplants deemed necessary and appropriate within the
68 guidelines set by the Organ Transplant Advisory Council under s.
69 765.53 or the Bone Marrow Transplant Advisory Panel under s.
71 Section 3. Paragraph (b) of subsection (2) and subsection
72 (14) of section 409.908, Florida Statutes, are amended to read:
73 409.908 Reimbursement of Medicaid providers.—Subject to
74 specific appropriations, the agency shall reimburse Medicaid
75 providers, in accordance with state and federal law, according
76 to methodologies set forth in the rules of the agency and in
77 policy manuals and handbooks incorporated by reference therein.
78 These methodologies may include fee schedules, reimbursement
79 methods based on cost reporting, negotiated fees, competitive
80 bidding pursuant to s. 287.057, and other mechanisms the agency
81 considers efficient and effective for purchasing services or
82 goods on behalf of recipients. If a provider is reimbursed based
83 on cost reporting and submits a cost report late and that cost
84 report would have been used to set a lower reimbursement rate
85 for a rate semester, then the provider’s rate for that semester
86 shall be retroactively calculated using the new cost report, and
87 full payment at the recalculated rate shall be effected
88 retroactively. Medicare-granted extensions for filing cost
89 reports, if applicable, shall also apply to Medicaid cost
90 reports. Payment for Medicaid compensable services made on
91 behalf of Medicaid eligible persons is subject to the
92 availability of moneys and any limitations or directions
93 provided for in the General Appropriations Act or chapter 216.
94 Further, nothing in this section shall be construed to prevent
95 or limit the agency from adjusting fees, reimbursement rates,
96 lengths of stay, number of visits, or number of services, or
97 making any other adjustments necessary to comply with the
98 availability of moneys and any limitations or directions
99 provided for in the General Appropriations Act, provided the
100 adjustment is consistent with legislative intent.
102 (b) Subject to any limitations or directions in the General
103 Appropriations Act, the agency shall establish and implement a
104 state Title XIX Long-Term Care Reimbursement Plan for nursing
105 home care in order to provide care and services in conformance
106 with the applicable state and federal laws, rules, regulations,
107 and quality and safety standards and to ensure that individuals
108 eligible for medical assistance have reasonable geographic
109 access to such care.
110 1. The agency shall amend the long-term care reimbursement
111 plan and cost reporting system to create direct care and
112 indirect care subcomponents of the patient care component of the
113 per diem rate. These two subcomponents together shall equal the
114 patient care component of the per diem rate. Separate prices
115 shall be calculated for each patient care subcomponent,
116 initially based on the September 2016 rate setting cost reports
117 and subsequently based on the most recently audited cost report
118 used during a rebasing year. The direct care subcomponent of the
119 per diem rate for any providers still being reimbursed on a cost
120 basis shall be limited by the cost-based class ceiling, and the
121 indirect care subcomponent may be limited by the lower of the
122 cost-based class ceiling, the target rate class ceiling, or the
123 individual provider target. The ceilings and targets apply only
124 to providers being reimbursed on a cost-based system. Effective
125 October 1, 2018, a prospective payment methodology shall be
126 implemented for rate setting purposes with the following
128 a. Peer Groups, including:
129 (I) North-SMMC Regions 1-9, less Palm Beach and Okeechobee
130 Counties; and
131 (II) South-SMMC Regions 10-11, plus Palm Beach and
132 Okeechobee Counties.
133 b. Percentage of Median Costs based on the cost reports
134 used for September 2016 rate setting:
135 (I) Direct Care Costs........................100 percent.
136 (II) Indirect Care Costs......................92 percent.
137 (III) Operating Costs.........................86 percent.
138 c. Floors:
139 (I) Direct Care Component.....................95 percent.
140 (II) Indirect Care Component................92.5 percent.
141 (III) Operating Component...........................None.
142 d. Pass-through Payments..................Real Estate and
143 ...............................................Personal Property
144 ...................................Taxes and Property Insurance.
145 e. Quality Incentive Program Payment Pool..6.5 percent of
147 .......................................2016 non-property related
148 ................................payments of included facilities.
149 f. Quality Score Threshold to Quality for Quality Incentive
150 Payment..................20th percentile of included facilities.
151 g. Fair Rental Value System Payment Parameters:
152 (I) Building Value per Square Foot based on 2018 RS Means.
153 (II) Land Valuation...10 percent of Gross Building value.
154 (III) Facility Square Footage......Actual Square Footage.
155 (IV) Moveable Equipment Allowance.........$8,000 per bed.
156 (V) Obsolescence Factor......................1.5 percent.
157 (VI) Fair Rental Rate of Return................8 percent.
158 (VII) Minimum Occupancy.......................90 percent.
159 (VIII) Maximum Facility Age.....................40 years.
160 (IX) Minimum Square Footage per Bed..................350.
161 (X) Maximum Square Footage for Bed...................500.
162 (XI) Minimum Cost of a renovation/replacements$500 per bed.
163 h. Ventilator Supplemental payment of $200 per Medicaid day
164 of 40,000 ventilator Medicaid days per fiscal year.
165 2. The direct care subcomponent shall include salaries and
166 benefits of direct care staff providing nursing services
167 including registered nurses, licensed practical nurses, and
168 certified nursing assistants who deliver care directly to
169 residents in the nursing home facility, allowable therapy costs,
170 and dietary costs. This excludes nursing administration, staff
171 development, the staffing coordinator, and the administrative
172 portion of the minimum data set and care plan coordinators. The
173 direct care subcomponent also includes medically necessary
174 dental care, vision care, hearing care, and podiatric care.
175 3. All other patient care costs shall be included in the
176 indirect care cost subcomponent of the patient care per diem
177 rate, including complex medical equipment, medical supplies, and
178 other allowable ancillary costs. Costs may not be allocated
179 directly or indirectly to the direct care subcomponent from a
180 home office or management company.
181 4. On July 1 of each year, the agency shall report to the
182 Legislature direct and indirect care costs, including average
183 direct and indirect care costs per resident per facility and
184 direct care and indirect care salaries and benefits per category
185 of staff member per facility.
186 5. Every fourth year, the agency shall rebase nursing home
187 prospective payment rates to reflect changes in cost based on
188 the most recently audited cost report for each participating
190 5. 6. A direct care supplemental payment may be made to
191 providers whose direct care hours per patient day are above the
192 80th percentile and who provide Medicaid services to a larger
193 percentage of Medicaid patients than the state average.
194 6. 7. For the period beginning July 1, 2020, the agency
195 shall establish a unit cost increase as an equal percentage for
196 each nursing home.
197 7. 8. For the period beginning on October 1, 2018, and
198 ending on September 30, 2021, the agency shall reimburse
199 providers the greater of their September 2016 cost-based rate
200 plus the July 1, 2020, unit cost increase or their prospective
201 payment rate plus the July 1, 2020, unit cost increase.
202 Effective October 1, 2021, the agency shall reimburse providers
203 the greater of 95 percent of their cost-based rate plus the July
204 1, 2020, unit cost increase or their rebased prospective payment
205 rate plus the July 1, 2020, unit cost increase, using the most
206 recently audited cost report for each facility. This
207 subparagraph shall expire September 30, 2023.
208 8. 9. Pediatric, Florida Department of Veterans Affairs, and
209 government-owned facilities are exempt from the pricing model
210 established in this subsection and shall remain on a cost-based
211 prospective payment system. Effective October 1, 2018, the
212 agency shall set rates for all facilities remaining on a cost
213 based prospective payment system using each facility’s most
214 recently audited cost report, eliminating retroactive
217 It is the intent of the Legislature that the reimbursement plan
218 achieve the goal of providing access to health care for nursing
219 home residents who require large amounts of care while
220 encouraging diversion services as an alternative to nursing home
221 care for residents who can be served within the community. The
222 agency shall base the establishment of any maximum rate of
223 payment, whether overall or component, on the available moneys
224 as provided for in the General Appropriations Act. The agency
225 may base the maximum rate of payment on the results of
226 scientifically valid analysis and conclusions derived from
227 objective statistical data pertinent to the particular maximum
228 rate of payment.
229 (14) A provider of prescribed drugs shall be reimbursed in
230 an amount not to exceed the lesser of the actual acquisition
231 cost based on the Centers for Medicare and Medicaid Services
232 National Average Drug Acquisition Cost pricing files plus a
233 professional dispensing fee, the wholesale acquisition cost plus
234 a professional dispensing fee, the state maximum allowable cost
235 plus a professional dispensing fee, or the usual and customary
236 charge billed by the provider the least of the amount billed by
237 the provider, the provider’s usual and customary charge, or the
238 Medicaid maximum allowable fee established by the agency, plus a
239 dispensing fee. The Medicaid maximum allowable fee for
240 ingredient cost must be based on the lowest of: the average
241 wholesale price (AWP) minus 16.4 percent, the wholesaler
242 acquisition cost (WAC) plus 1.5 percent, the federal upper limit
243 (FUL), the state maximum allowable cost (SMAC), or the usual and
244 customary (UAC) charge billed by the provider.
245 (a) Medicaid providers must dispense generic drugs if
246 available at lower cost and the agency has not determined that
247 the branded product is more cost-effective, unless the
248 prescriber has requested and received approval to require the
249 branded product.
250 (b) The agency shall implement a variable dispensing fee
251 for prescribed medicines while ensuring continued access for
252 Medicaid recipients. The variable dispensing fee may be based
253 upon, but not limited to, either or both the volume of
254 prescriptions dispensed by a specific pharmacy provider, the
255 volume of prescriptions dispensed to an individual recipient,
256 and dispensing of preferred-drug-list products.
257 (c) The agency may increase the pharmacy dispensing fee
258 authorized by statute and in the General Appropriations Act by
259 $0.50 for the dispensing of a Medicaid preferred-drug-list
260 product and reduce the pharmacy dispensing fee by $0.50 for the
261 dispensing of a Medicaid product that is not included on the
262 preferred drug list.
263 (d) The agency may establish a supplemental pharmaceutical
264 dispensing fee to be paid to providers returning unused unit
265 dose packaged medications to stock and crediting the Medicaid
266 program for the ingredient cost of those medications if the
267 ingredient costs to be credited exceed the value of the
268 supplemental dispensing fee.
269 (c) (e) The agency may limit reimbursement for prescribed
270 medicine in order to comply with any limitations or directions
271 provided in the General Appropriations Act, which may include
272 implementing a prospective or concurrent utilization review
274 Section 4. Subsections (9) and (11) of section 409.91195,
275 Florida Statutes, are amended, and subsection (4) of that
276 section is reenacted for the purpose of incorporating the
277 amendment made by this act to section 409.912, Florida Statutes,
278 in a reference thereto, to read:
279 409.91195 Medicaid Pharmaceutical and Therapeutics
280 Committee.—There is created a Medicaid Pharmaceutical and
281 Therapeutics Committee within the agency for the purpose of
282 developing a Medicaid preferred drug list.
283 (4) Upon recommendation of the committee, the agency shall
284 adopt a preferred drug list as described in s. 409.912(5). To
285 the extent feasible, the committee shall review all drug classes
286 included on the preferred drug list every 12 months, and may
287 recommend additions to and deletions from the preferred drug
288 list, such that the preferred drug list provides for medically
289 appropriate drug therapies for Medicaid patients which achieve
290 cost savings contained in the General Appropriations Act.
291 (9) Upon timely notice, the agency shall ensure that any
292 therapeutic class of drugs which includes a drug that has been
293 removed from distribution to the public by its manufacturer or
294 the United States Food and Drug Administration or has been
295 required to carry a black box warning label by the United States
296 Food and Drug Administration because of safety concerns is
297 reviewed by the committee at the next regularly scheduled
298 meeting. After such review, the committee must recommend whether
299 to retain the therapeutic class of drugs or subcategories of
300 drugs within a therapeutic class on the preferred drug list and
301 whether to institute prior authorization requirements necessary
302 to ensure patient safety.
303 (10) (11) Medicaid recipients may appeal agency preferred
304 drug formulary decisions using the Medicaid fair hearing process
305 administered by the Agency for Health Care Administration
306 Department of Children and Families.
307 Section 5. Paragraphs (a) and (c) of subsection (5) of
308 section 409.912, Florida Statutes, are amended to read:
309 409.912 Cost-effective purchasing of health care.—The
310 agency shall purchase goods and services for Medicaid recipients
311 in the most cost-effective manner consistent with the delivery
312 of quality medical care. To ensure that medical services are
313 effectively utilized, the agency may, in any case, require a
314 confirmation or second physician’s opinion of the correct
315 diagnosis for purposes of authorizing future services under the
316 Medicaid program. This section does not restrict access to
317 emergency services or poststabilization care services as defined
318 in 42 C.F.R. s. 438.114. Such confirmation or second opinion
319 shall be rendered in a manner approved by the agency. The agency
320 shall maximize the use of prepaid per capita and prepaid
321 aggregate fixed-sum basis services when appropriate and other
322 alternative service delivery and reimbursement methodologies,
323 including competitive bidding pursuant to s. 287.057, designed
324 to facilitate the cost-effective purchase of a case-managed
325 continuum of care. The agency shall also require providers to
326 minimize the exposure of recipients to the need for acute
327 inpatient, custodial, and other institutional care and the
328 inappropriate or unnecessary use of high-cost services. The
329 agency shall contract with a vendor to monitor and evaluate the
330 clinical practice patterns of providers in order to identify
331 trends that are outside the normal practice patterns of a
332 provider’s professional peers or the national guidelines of a
333 provider’s professional association. The vendor must be able to
334 provide information and counseling to a provider whose practice
335 patterns are outside the norms, in consultation with the agency,
336 to improve patient care and reduce inappropriate utilization.
337 The agency may mandate prior authorization, drug therapy
338 management, or disease management participation for certain
339 populations of Medicaid beneficiaries, certain drug classes, or
340 particular drugs to prevent fraud, abuse, overuse, and possible
341 dangerous drug interactions. The Pharmaceutical and Therapeutics
342 Committee shall make recommendations to the agency on drugs for
343 which prior authorization is required. The agency shall inform
344 the Pharmaceutical and Therapeutics Committee of its decisions
345 regarding drugs subject to prior authorization. The agency is
346 authorized to limit the entities it contracts with or enrolls as
347 Medicaid providers by developing a provider network through
348 provider credentialing. The agency may competitively bid single
349 source-provider contracts if procurement of goods or services
350 results in demonstrated cost savings to the state without
351 limiting access to care. The agency may limit its network based
352 on the assessment of beneficiary access to care, provider
353 availability, provider quality standards, time and distance
354 standards for access to care, the cultural competence of the
355 provider network, demographic characteristics of Medicaid
356 beneficiaries, practice and provider-to-beneficiary standards,
357 appointment wait times, beneficiary use of services, provider
358 turnover, provider profiling, provider licensure history,
359 previous program integrity investigations and findings, peer
360 review, provider Medicaid policy and billing compliance records,
361 clinical and medical record audits, and other factors. Providers
362 are not entitled to enrollment in the Medicaid provider network.
363 The agency shall determine instances in which allowing Medicaid
364 beneficiaries to purchase durable medical equipment and other
365 goods is less expensive to the Medicaid program than long-term
366 rental of the equipment or goods. The agency may establish rules
367 to facilitate purchases in lieu of long-term rentals in order to
368 protect against fraud and abuse in the Medicaid program as
369 defined in s. 409.913. The agency may seek federal waivers
370 necessary to administer these policies.
371 (5)(a) The agency shall implement a Medicaid prescribed
372 drug spending-control program that includes the following
374 1. A Medicaid preferred drug list, which shall be a listing
375 of cost-effective therapeutic options recommended by the
376 Medicaid Pharmacy and Therapeutics Committee established
377 pursuant to s. 409.91195 and adopted by the agency for each
378 therapeutic class on the preferred drug list. At the discretion
379 of the committee, and when feasible, the preferred drug list
380 should include at least two products in a therapeutic class. The
381 agency may post the preferred drug list and updates to the list
382 on an Internet website without following the rulemaking
383 procedures of chapter 120. Antiretroviral agents are excluded
384 from the preferred drug list. The agency shall also limit the
385 amount of a prescribed drug dispensed to no more than a 34-day
386 supply unless the drug products’ smallest marketed package is
387 greater than a 34-day supply, or the drug is determined by the
388 agency to be a maintenance drug in which case a 100-day maximum
389 supply may be authorized. The agency may seek any federal
390 waivers necessary to implement these cost-control programs and
391 to continue participation in the federal Medicaid rebate
392 program, or alternatively to negotiate state-only manufacturer
393 rebates. The agency may adopt rules to administer this
394 subparagraph. The agency shall continue to provide unlimited
395 contraceptive drugs and items. The agency must establish
396 procedures to ensure that:
397 a. There is a response to a request for prior authorization
398 consultation by telephone or other telecommunication device
399 within 24 hours after receipt of a request for prior
400 authorization consultation; and
401 b. A 72-hour supply of the drug prescribed is provided in
402 an emergency or when the agency does not provide a response
403 within 24 hours as required by sub-subparagraph a.
404 2. A provider of prescribed drugs is reimbursed in an
405 amount not to exceed the lesser of the actual acquisition cost
406 based on the Centers for Medicare and Medicaid Services National
407 Average Drug Acquisition Cost pricing files plus a professional
408 dispensing fee, the wholesale acquisition cost plus a
409 professional dispensing fee, the state maximum allowable cost
410 plus a professional dispensing fee, or the usual and customary
411 charge billed by the provider Reimbursement to pharmacies for
412 Medicaid prescribed drugs shall be set at the lowest of: the
413 average wholesale price (AWP) minus 16.4 percent, the wholesaler
414 acquisition cost (WAC) plus 1.5 percent, the federal upper limit
415 (FUL), the state maximum allowable cost (SMAC), or the usual and
416 customary (UAC) charge billed by the provider.
417 3. The agency shall develop and implement a process for
418 managing the drug therapies of Medicaid recipients who are using
419 significant numbers of prescribed drugs each month. The
420 management process may include, but is not limited to,
421 comprehensive, physician-directed medical-record reviews, claims
422 analyses, and case evaluations to determine the medical
423 necessity and appropriateness of a patient’s treatment plan and
424 drug therapies. The agency may contract with a private
425 organization to provide drug-program-management services. The
426 Medicaid drug benefit management program shall include
427 initiatives to manage drug therapies for HIV/AIDS patients,
428 patients using 20 or more unique prescriptions in a 180-day
429 period, and the top 1,000 patients in annual spending. The
430 agency shall enroll any Medicaid recipient in the drug benefit
431 management program if he or she meets the specifications of this
432 provision and is not enrolled in a Medicaid health maintenance
434 4. The agency may limit the size of its pharmacy network
435 based on need, competitive bidding, price negotiations,
436 credentialing, or similar criteria. The agency shall give
437 special consideration to rural areas in determining the size and
438 location of pharmacies included in the Medicaid pharmacy
439 network. A pharmacy credentialing process may include criteria
440 such as a pharmacy’s full-service status, location, size,
441 patient educational programs, patient consultation, disease
442 management services, and other characteristics. The agency may
443 impose a moratorium on Medicaid pharmacy enrollment if it is
444 determined that it has a sufficient number of Medicaid
445 participating providers. The agency must allow dispensing
446 practitioners to participate as a part of the Medicaid pharmacy
447 network regardless of the practitioner’s proximity to any other
448 entity that is dispensing prescription drugs under the Medicaid
449 program. A dispensing practitioner must meet all credentialing
450 requirements applicable to his or her practice, as determined by
451 the agency.
452 5. The agency shall develop and implement a program that
453 requires Medicaid practitioners who issue written prescriptions
454 for medicinal drugs to use a counterfeit-proof prescription pad
455 for Medicaid prescriptions. The agency shall require the use of
456 standardized counterfeit-proof prescription pads by prescribers
457 who issue written prescriptions for Medicaid recipients. The
458 agency may implement the program in targeted geographic areas or
460 6. The agency may enter into arrangements that require
461 manufacturers of generic drugs prescribed to Medicaid recipients
462 to provide rebates of at least 15.1 percent of the average
463 manufacturer price for the manufacturer’s generic products.
464 These arrangements shall require that if a generic-drug
465 manufacturer pays federal rebates for Medicaid-reimbursed drugs
466 at a level below 15.1 percent, the manufacturer must provide a
467 supplemental rebate to the state in an amount necessary to
468 achieve a 15.1-percent rebate level.
469 7. The agency may establish a preferred drug list as
470 described in this subsection, and, pursuant to the establishment
471 of such preferred drug list, negotiate supplemental rebates from
472 manufacturers that are in addition to those required by Title
473 XIX of the Social Security Act and at no less than 14 percent of
474 the average manufacturer price as defined in 42 U.S.C. s. 1936
475 on the last day of a quarter unless the federal or supplemental
476 rebate, or both, equals or exceeds 29 percent. There is no upper
477 limit on the supplemental rebates the agency may negotiate. The
478 agency may determine that specific products, brand-name or
479 generic, are competitive at lower rebate percentages. Agreement
480 to pay the minimum supplemental rebate percentage guarantees a
481 manufacturer that the Medicaid Pharmaceutical and Therapeutics
482 Committee will consider a product for inclusion on the preferred
483 drug list. However, a pharmaceutical manufacturer is not
484 guaranteed placement on the preferred drug list by simply paying
485 the minimum supplemental rebate. Agency decisions will be made
486 on the clinical efficacy of a drug and recommendations of the
487 Medicaid Pharmaceutical and Therapeutics Committee, as well as
488 the price of competing products minus federal and state rebates.
489 The agency may contract with an outside agency or contractor to
490 conduct negotiations for supplemental rebates. For the purposes
491 of this section, the term “supplemental rebates” means cash
492 rebates. Value-added programs as a substitution for supplemental
493 rebates are prohibited. The agency may seek any federal waivers
494 to implement this initiative.
495 8.a. The agency shall expand home delivery of pharmacy
496 products. The agency may amend the state plan and issue a
497 procurement, as necessary, in order to implement this program.
498 The procurements must include agreements with a pharmacy or
499 pharmacies located in the state to provide mail order delivery
500 services at no cost to the recipients who elect to receive home
501 delivery of pharmacy products. The procurement must focus on
502 serving recipients with chronic diseases for which pharmacy
503 expenditures represent a significant portion of Medicaid
504 pharmacy expenditures or which impact a significant portion of
505 the Medicaid population. The agency may seek and implement any
506 federal waivers necessary to implement this subparagraph.
507 9. The agency shall limit to one dose per month any drug
508 prescribed to treat erectile dysfunction.
509 10 . a. The agency may implement a Medicaid behavioral drug
510 management system. The agency may contract with a vendor that
511 has experience in operating behavioral drug management systems
512 to implement this program. The agency may seek federal waivers
513 to implement this program.
514 b. The agency, in conjunction with the Department of
515 Children and Families, may implement the Medicaid behavioral
516 drug management system that is designed to improve the quality
517 of care and behavioral health prescribing practices based on
518 best practice guidelines, improve patient adherence to
519 medication plans, reduce clinical risk, and lower prescribed
520 drug costs and the rate of inappropriate spending on Medicaid
521 behavioral drugs. The program may include the following
523 (I) Provide for the development and adoption of best
524 practice guidelines for behavioral health-related drugs such as
525 antipsychotics, antidepressants, and medications for treating
526 bipolar disorders and other behavioral conditions; translate
527 them into practice; review behavioral health prescribers and
528 compare their prescribing patterns to a number of indicators
529 that are based on national standards; and determine deviations
530 from best practice guidelines.
531 (II) Implement processes for providing feedback to and
532 educating prescribers using best practice educational materials
533 and peer-to-peer consultation.
534 (III) Assess Medicaid beneficiaries who are outliers in
535 their use of behavioral health drugs with regard to the numbers
536 and types of drugs taken, drug dosages, combination drug
537 therapies, and other indicators of improper use of behavioral
538 health drugs.
539 (IV) Alert prescribers to patients who fail to refill
540 prescriptions in a timely fashion, are prescribed multiple same
541 class behavioral health drugs, and may have other potential
542 medication problems.
543 (V) Track spending trends for behavioral health drugs and
544 deviation from best practice guidelines.
545 (VI) Use educational and technological approaches to
546 promote best practices, educate consumers, and train prescribers
547 in the use of practice guidelines.
548 (VII) Disseminate electronic and published materials.
549 (VIII) Hold statewide and regional conferences.
550 (IX) Implement a disease management program with a model
551 quality-based medication component for severely mentally ill
552 individuals and emotionally disturbed children who are high
553 users of care.
554 9. 11. The agency shall implement a Medicaid prescription
555 drug management system.
556 a. The agency may contract with a vendor that has
557 experience in operating prescription drug management systems in
558 order to implement this system. Any management system that is
559 implemented in accordance with this subparagraph must rely on
560 cooperation between physicians and pharmacists to determine
561 appropriate practice patterns and clinical guidelines to improve
562 the prescribing, dispensing, and use of drugs in the Medicaid
563 program. The agency may seek federal waivers to implement this
565 b. The drug management system must be designed to improve
566 the quality of care and prescribing practices based on best
567 practice guidelines, improve patient adherence to medication
568 plans, reduce clinical risk, and lower prescribed drug costs and
569 the rate of inappropriate spending on Medicaid prescription
570 drugs. The program must:
571 (I) Provide for the adoption of best practice guidelines
572 for the prescribing and use of drugs in the Medicaid program,
573 including translating best practice guidelines into practice;
574 reviewing prescriber patterns and comparing them to indicators
575 that are based on national standards and practice patterns of
576 clinical peers in their community, statewide, and nationally;
577 and determine deviations from best practice guidelines.
578 (II) Implement processes for providing feedback to and
579 educating prescribers using best practice educational materials
580 and peer-to-peer consultation.
581 (III) Assess Medicaid recipients who are outliers in their
582 use of a single or multiple prescription drugs with regard to
583 the numbers and types of drugs taken, drug dosages, combination
584 drug therapies, and other indicators of improper use of
585 prescription drugs.
586 (IV) Alert prescribers to recipients who fail to refill
587 prescriptions in a timely fashion, are prescribed multiple drugs
588 that may be redundant or contraindicated, or may have other
589 potential medication problems.
590 10. 12. The agency may contract for drug rebate
591 administration, including, but not limited to, calculating
592 rebate amounts, invoicing manufacturers, negotiating disputes
593 with manufacturers, and maintaining a database of rebate
595 11. 13. The agency may specify the preferred daily dosing
596 form or strength for the purpose of promoting best practices
597 with regard to the prescribing of certain drugs as specified in
598 the General Appropriations Act and ensuring cost-effective
599 prescribing practices.
600 12. 14. The agency may require prior authorization for
601 Medicaid-covered prescribed drugs. The agency may prior
602 authorize the use of a product:
603 a. For an indication not approved in labeling;
604 b. To comply with certain clinical guidelines; or
605 c. If the product has the potential for overuse, misuse, or
608 The agency may require the prescribing professional to provide
609 information about the rationale and supporting medical evidence
610 for the use of a drug. The agency shall post prior
611 authorization, step-edit criteria and protocol, and updates to
612 the list of drugs that are subject to prior authorization on the
613 agency’s Internet website within 21 days after the prior
614 authorization and step-edit criteria and protocol and updates
615 are approved by the agency. For purposes of this subparagraph,
616 the term “step-edit” means an automatic electronic review of
617 certain medications subject to prior authorization.
618 13. 15. The agency, in conjunction with the Pharmaceutical
619 and Therapeutics Committee, may require age-related prior
620 authorizations for certain prescribed drugs. The agency may
621 preauthorize the use of a drug for a recipient who may not meet
622 the age requirement or may exceed the length of therapy for use
623 of this product as recommended by the manufacturer and approved
624 by the Food and Drug Administration. Prior authorization may
625 require the prescribing professional to provide information
626 about the rationale and supporting medical evidence for the use
627 of a drug.
628 14. 16. The agency shall implement a step-therapy prior
629 authorization approval process for medications excluded from the
630 preferred drug list. Medications listed on the preferred drug
631 list must be used within the previous 12 months before the
632 alternative medications that are not listed. The step-therapy
633 prior authorization may require the prescriber to use the
634 medications of a similar drug class or for a similar medical
635 indication unless contraindicated in the Food and Drug
636 Administration labeling. The trial period between the specified
637 steps may vary according to the medical indication. The step
638 therapy approval process shall be developed in accordance with
639 the committee as stated in s. 409.91195(7) and (8). A drug
640 product may be approved without meeting the step-therapy prior
641 authorization criteria if the prescribing physician provides the
642 agency with additional written medical or clinical documentation
643 that the product is medically necessary because:
644 a. There is not a drug on the preferred drug list to treat
645 the disease or medical condition which is an acceptable clinical
647 b. The alternatives have been ineffective in the treatment
648 of the beneficiary’s disease; or
649 c. Based on historic evidence and known characteristics of
650 the patient and the drug, the drug is likely to be ineffective,
651 or the number of doses have been ineffective.
653 The agency shall work with the physician to determine the best
654 alternative for the patient. The agency may adopt rules waiving
655 the requirements for written clinical documentation for specific
656 drugs in limited clinical situations.
657 15. 17. The agency shall implement a return and reuse
658 program for drugs dispensed by pharmacies to institutional
659 recipients, which includes payment of a $5 restocking fee for
660 the implementation and operation of the program. The return and
661 reuse program shall be implemented electronically and in a
662 manner that promotes efficiency. The program must permit a
663 pharmacy to exclude drugs from the program if it is not
664 practical or cost-effective for the drug to be included and must
665 provide for the return to inventory of drugs that cannot be
666 credited or returned in a cost-effective manner. The agency
667 shall determine if the program has reduced the amount of
668 Medicaid prescription drugs which are destroyed on an annual
669 basis and if there are additional ways to ensure more
670 prescription drugs are not destroyed which could safely be
672 (c) The agency shall submit quarterly reports to the
673 Governor, the President of the Senate, and the Speaker of the
674 House of Representatives which must include, but need not be
675 limited to, the progress made in implementing this subsection
676 and its effect on Medicaid prescribed-drug expenditures.
677 Section 6. Section 409.91213, Florida Statutes, is
679 Section 7. Paragraph (d) of subsection (1) of section
680 409.913, Florida Statutes, is amended to read:
681 409.913 Oversight of the integrity of the Medicaid
682 program.—The agency shall operate a program to oversee the
683 activities of Florida Medicaid recipients, and providers and
684 their representatives, to ensure that fraudulent and abusive
685 behavior and neglect of recipients occur to the minimum extent
686 possible, and to recover overpayments and impose sanctions as
687 appropriate. Each January 15, the agency and the Medicaid Fraud
688 Control Unit of the Department of Legal Affairs shall submit a
689 report to the Legislature documenting the effectiveness of the
690 state’s efforts to control Medicaid fraud and abuse and to
691 recover Medicaid overpayments during the previous fiscal year.
692 The report must describe the number of cases opened and
693 investigated each year; the sources of the cases opened; the
694 disposition of the cases closed each year; the amount of
695 overpayments alleged in preliminary and final audit letters; the
696 number and amount of fines or penalties imposed; any reductions
697 in overpayment amounts negotiated in settlement agreements or by
698 other means; the amount of final agency determinations of
699 overpayments; the amount deducted from federal claiming as a
700 result of overpayments; the amount of overpayments recovered
701 each year; the amount of cost of investigation recovered each
702 year; the average length of time to collect from the time the
703 case was opened until the overpayment is paid in full; the
704 amount determined as uncollectible and the portion of the
705 uncollectible amount subsequently reclaimed from the Federal
706 Government; the number of providers, by type, that are
707 terminated from participation in the Medicaid program as a
708 result of fraud and abuse; and all costs associated with
709 discovering and prosecuting cases of Medicaid overpayments and
710 making recoveries in such cases. The report must also document
711 actions taken to prevent overpayments and the number of
712 providers prevented from enrolling in or reenrolling in the
713 Medicaid program as a result of documented Medicaid fraud and
714 abuse and must include policy recommendations necessary to
715 prevent or recover overpayments and changes necessary to prevent
716 and detect Medicaid fraud. All policy recommendations in the
717 report must include a detailed fiscal analysis, including, but
718 not limited to, implementation costs, estimated savings to the
719 Medicaid program, and the return on investment. The agency must
720 submit the policy recommendations and fiscal analyses in the
721 report to the appropriate estimating conference, pursuant to s.
722 216.137, by February 15 of each year. The agency and the
723 Medicaid Fraud Control Unit of the Department of Legal Affairs
724 each must include detailed unit-specific performance standards,
725 benchmarks, and metrics in the report, including projected cost
726 savings to the state Medicaid program during the following
727 fiscal year.
728 (1) For the purposes of this section, the term:
729 (d) “Medical necessity” or “medically necessary” means any
730 goods or services necessary to palliate the effects of a
731 terminal condition, or to prevent, diagnose, correct, cure,
732 alleviate, or preclude deterioration of a condition that
733 threatens life, causes pain or suffering, or results in illness
734 or infirmity, which goods or services are provided in accordance
735 with generally accepted standards of medical practice. For
736 purposes of determining Medicaid reimbursement, the agency is
737 the final arbiter of medical necessity. Determinations of
738 medical necessity must be made by a licensed physician employed
739 by or under contract with the agency and must be based upon
740 information available at the time the goods or services are
742 Section 8. Section 765.53, Florida Statutes, is repealed.
743 Section 9. This act shall take effect July 1, 2021.