Florida Senate - 2020 SB 1682
By Senator Rodriguez
37-00392A-20 20201682__
1 A bill to be entitled
2 An act relating to prescription drug price
3 transparency; providing a short title; amending s.
4 465.003, F.S.; defining the terms “pharmacy benefit
5 manager” and “pharmacy benefit management services”;
6 creating s. 465.203, F.S.; defining terms; authorizing
7 specified pharmacies and pharmacists to contract with
8 pharmacy benefit managers; prohibiting pharmacy
9 benefit managers from engaging in certain practices;
10 requiring pharmacy benefit managers to allow payors
11 access to specified records, data, and information;
12 requiring pharmacy benefit managers to disclose and
13 report specified information to the payor; requiring
14 certain income and financial benefits to be passed
15 through to payors; requiring pharmacy benefit managers
16 to allow the Department of Financial Services access
17 to specified records, data, and information; requiring
18 the department to investigate certain violations;
19 providing penalties; providing that specified
20 violations are subject to the Florida Deceptive and
21 Unfair Trade Practices Act; providing applicability;
22 creating s. 499.0284, F.S.; defining terms; requiring
23 prescription drug manufacturers to annually report
24 certain information to the Department of Business and
25 Professional Regulation by a specified date; requiring
26 the department to publish the reported information on
27 its website; specifying circumstances under which
28 prescription drug manufacturers are required to report
29 certain information to the department; prescribing the
30 contents of such reports; requiring the department to
31 publish the reports on its website within a specified
32 timeframe; authorizing the department to adopt rules;
33 amending s. 624.490, F.S.; conforming provisions to
34 changes made by the act; creating s. 624.491, F.S.;
35 defining terms; requiring pharmacy benefit managers to
36 submit annual reports to the Office of Insurance
37 Regulation by a specified date; prescribing the
38 contents of such reports; prohibiting the annual
39 reports from disclosing certain information; requiring
40 the office to publish the data from the annual reports
41 on its website by a specified date; prohibiting the
42 office from publishing the data in a manner that may
43 disclose certain information; authorizing the
44 Financial Services Commission to adopt rules; creating
45 s. 627.42385, F.S.; defining terms; requiring group
46 health plans, health insurers, and certain pharmacy
47 benefit managers to base plan beneficiaries’ and
48 insureds’ coinsurance obligations for certain
49 prescription drugs on specified drug prices; providing
50 applicability; prohibiting such group health plans,
51 health insurers, and pharmacy benefit managers from
52 revealing specified information; requiring such
53 entities to protect such information and impose the
54 confidentiality protections on other entities;
55 providing penalties; requiring the department to
56 investigate certain violations; providing
57 construction; amending ss. 627.64741, 627.6572, and
58 641.314, F.S.; conforming provisions to changes made
59 by the act; providing requirements for contracts;
60 requiring pharmacy benefit managers to allow insurers,
61 health maintenance organizations, and payors access to
62 specified records, data, and information; requiring
63 pharmacy benefit managers to disclose and report
64 specified information to the insurer, health
65 maintenance organization, or payor; requiring the
66 department to investigate certain violations;
67 providing penalties; providing applicability; creating
68 ss. 627.64745, 627.65725, and 641.262, F.S.; defining
69 the terms “specialty drug” and “utilization
70 management”; requiring insurers issuing individual and
71 group health insurance policies, and health
72 maintenance organizations, respectively, to annually
73 submit reports to the office by a specified date;
74 prescribing the contents of such reports; prohibiting
75 such reports from disclosing certain information;
76 requiring the office to publish data from the reports
77 on its website by a specified date; prohibiting the
78 office from publishing the data in a manner that may
79 disclose certain information; authorizing the
80 commission to adopt rules; amending ss. 409.9201,
81 458.331, 459.015, 465.014, 465.015, 465.0156, 465.016,
82 465.0197, 465.022, 465.023, 465.1901, 499.003, and
83 893.02, F.S.; conforming cross-references; providing
84 an effective date.
85
86 Be It Enacted by the Legislature of the State of Florida:
87
88 Section 1. This act may be cited as the “Prescription Drug
89 Price Transparency Act.”
90 Section 2. Section 465.003, Florida Statutes, is amended to
91 read:
92 465.003 Definitions.—As used in this chapter, the term:
93 (1) “Administration” means the obtaining and giving of a
94 single dose of medicinal drugs by a legally authorized person to
95 a patient for her or his consumption.
96 (3)(2) “Board” means the Board of Pharmacy.
97 (9)(3) “Consultant pharmacist” means a pharmacist licensed
98 by the department and certified as a consultant pharmacist
99 pursuant to s. 465.0125.
100 (10)(4) “Data communication device” means an electronic
101 device that receives electronic information from one source and
102 transmits or routes it to another, including, but not limited
103 to, any such bridge, router, switch, or gateway.
104 (11)(5) “Department” means the Department of Health.
105 (12)(6) “Dispense” means the transfer of possession of one
106 or more doses of a medicinal drug by a pharmacist to the
107 ultimate consumer or her or his agent. As an element of
108 dispensing, the pharmacist shall, prior to the actual physical
109 transfer, interpret and assess the prescription order for
110 potential adverse reactions, interactions, and dosage regimen
111 she or he deems appropriate in the exercise of her or his
112 professional judgment, and the pharmacist shall certify that the
113 medicinal drug called for by the prescription is ready for
114 transfer. The pharmacist shall also provide counseling on proper
115 drug usage, either orally or in writing, if in the exercise of
116 her or his professional judgment counseling is necessary. The
117 actual sales transaction and delivery of such drug shall not be
118 considered dispensing. The administration shall not be
119 considered dispensing.
120 (13)(7) “Institutional formulary system” means a method
121 whereby the medical staff evaluates, appraises, and selects
122 those medicinal drugs or proprietary preparations which in the
123 medical staff’s clinical judgment are most useful in patient
124 care, and which are available for dispensing by a practicing
125 pharmacist in a Class II or Class III institutional pharmacy.
126 (14)(8) “Medicinal drugs” or “drugs” means those substances
127 or preparations commonly known as “prescription” or “legend”
128 drugs which are required by federal or state law to be dispensed
129 only on a prescription, but shall not include patents or
130 proprietary preparations as hereafter defined.
131 (17)(9) “Patent or proprietary preparation” means a
132 medicine in its unbroken, original package which is sold to the
133 public by, or under the authority of, the manufacturer or
134 primary distributor thereof and which is not misbranded under
135 the provisions of the Florida Drug and Cosmetic Act.
136 (18)(10) “Pharmacist” means any person licensed pursuant to
137 this chapter to practice the profession of pharmacy.
138 (19)(11)(a) “Pharmacy” includes a community pharmacy, an
139 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
140 and an Internet pharmacy.
141 1. The term “community pharmacy” includes every location
142 where medicinal drugs are compounded, dispensed, stored, or sold
143 or where prescriptions are filled or dispensed on an outpatient
144 basis.
145 2. The term “institutional pharmacy” includes every
146 location in a hospital, clinic, nursing home, dispensary,
147 sanitarium, extended care facility, or other facility,
148 hereinafter referred to as “health care institutions,” where
149 medicinal drugs are compounded, dispensed, stored, or sold.
150 3. The term “nuclear pharmacy” includes every location
151 where radioactive drugs and chemicals within the classification
152 of medicinal drugs are compounded, dispensed, stored, or sold.
153 The term “nuclear pharmacy” does not include hospitals licensed
154 under chapter 395 or the nuclear medicine facilities of such
155 hospitals.
156 4. The term “special pharmacy” includes every location
157 where medicinal drugs are compounded, dispensed, stored, or sold
158 if such locations are not otherwise defined in this subsection.
159 5. The term “Internet pharmacy” includes locations not
160 otherwise licensed or issued a permit under this chapter, within
161 or outside this state, which use the Internet to communicate
162 with or obtain information from consumers in this state and use
163 such communication or information to fill or refill
164 prescriptions or to dispense, distribute, or otherwise engage in
165 the practice of pharmacy in this state. Any act described in
166 this definition constitutes the practice of pharmacy as defined
167 in subsection (23) (13).
168 (b) The pharmacy department of any permittee shall be
169 considered closed whenever a Florida licensed pharmacist is not
170 present and on duty. The term “not present and on duty” shall
171 not be construed to prevent a pharmacist from exiting the
172 prescription department for the purposes of consulting or
173 responding to inquiries or providing assistance to patients or
174 customers, attending to personal hygiene needs, or performing
175 any other function for which the pharmacist is responsible,
176 provided that such activities are conducted in a manner
177 consistent with the pharmacist’s responsibility to provide
178 pharmacy services.
179 (20) “Pharmacy benefit manager” means an entity that
180 performs pharmacy benefit management services for a health plan,
181 a health plan sponsor, a health plan provider, a health insurer,
182 or any other payor. The term does not include a provider as
183 defined in s. 641.19, a physician as defined in s. 458.305, or
184 an osteopathic physician as defined in s. 459.003.
185 (21) “Pharmacy benefit management services” means services
186 that:
187 (a) Are provided, directly or through another entity, to a
188 health plan, a health plan sponsor, a health plan provider, a
189 health insurer, or any other payor, regardless of whether the
190 services provider and the health plan, health plan sponsor,
191 health plan provider, health insurer, or other payor are related
192 or associated by ownership, common ownership, organization, or
193 otherwise.
194 (b) Include the procurement of prescription drugs to be
195 dispensed to patients and the administration or management of
196 prescription drug benefits, including, but not limited to, any
197 of the following:
198 1. A mail service pharmacy or a specialty pharmacy.
199 2. Claims processing, retail network management, or payment
200 of claims to pharmacies for dispensing drugs.
201 3. Clinical or other formulary or preferred-drug-list
202 development or management.
203 4. Negotiation, administration, or receipt of rebates,
204 discounts, payment differentials, or other incentives, to
205 include particular drugs in a particular category or to promote
206 the purchase of particular drugs.
207 5. Patients’ compliance, therapeutic intervention, or
208 generic substitution programs.
209 6. Disease management.
210 7. Drug use review, step-therapy protocol, or prior
211 authorization.
212 8. Adjudication of appeals or grievances related to
213 prescription drug coverage.
214 9. Contracts with network pharmacies.
215 10. Control of the cost of covered prescription drugs.
216 (22)(12) “Pharmacy intern” means a person who is currently
217 registered in, and attending, a duly accredited college or
218 school of pharmacy, or who is a graduate of such a school or
219 college of pharmacy, and who is duly and properly registered
220 with the department as provided for under its rules.
221 (23)(13) “Practice of the profession of pharmacy” includes
222 compounding, dispensing, and consulting concerning contents,
223 therapeutic values, and uses of any medicinal drug; consulting
224 concerning therapeutic values and interactions of patent or
225 proprietary preparations, whether pursuant to prescriptions or
226 in the absence and entirely independent of such prescriptions or
227 orders; and conducting other pharmaceutical services. For
228 purposes of this subsection, “other pharmaceutical services”
229 means the monitoring of the patient’s drug therapy and assisting
230 the patient in the management of his or her drug therapy, and
231 includes review of the patient’s drug therapy and communication
232 with the patient’s prescribing health care provider as licensed
233 under chapter 458, chapter 459, chapter 461, or chapter 466, or
234 similar statutory provision in another jurisdiction, or such
235 provider’s agent or such other persons as specifically
236 authorized by the patient, regarding the drug therapy. However,
237 nothing in this subsection may be interpreted to permit an
238 alteration of a prescriber’s directions, the diagnosis or
239 treatment of any disease, the initiation of any drug therapy,
240 the practice of medicine, or the practice of osteopathic
241 medicine, unless otherwise permitted by law. “Practice of the
242 profession of pharmacy” also includes any other act, service,
243 operation, research, or transaction incidental to, or forming a
244 part of, any of the foregoing acts, requiring, involving, or
245 employing the science or art of any branch of the pharmaceutical
246 profession, study, or training, and shall expressly permit a
247 pharmacist to transmit information from persons authorized to
248 prescribe medicinal drugs to their patients. The practice of the
249 profession of pharmacy also includes the administration of
250 vaccines to adults pursuant to s. 465.189 and the preparation of
251 prepackaged drug products in facilities holding Class III
252 institutional pharmacy permits.
253 (24)(14) “Prescription” includes any order for drugs or
254 medicinal supplies written or transmitted by any means of
255 communication by a duly licensed practitioner authorized by the
256 laws of the state to prescribe such drugs or medicinal supplies
257 and intended to be dispensed by a pharmacist. The term also
258 includes an orally transmitted order by the lawfully designated
259 agent of such practitioner. The term also includes an order
260 written or transmitted by a practitioner licensed to practice in
261 a jurisdiction other than this state, but only if the pharmacist
262 called upon to dispense such order determines, in the exercise
263 of her or his professional judgment, that the order is valid and
264 necessary for the treatment of a chronic or recurrent illness.
265 The term “prescription” also includes a pharmacist’s order for a
266 product selected from the formulary created pursuant to s.
267 465.186. Prescriptions may be retained in written form or the
268 pharmacist may cause them to be recorded in a data processing
269 system, provided that such order can be produced in printed form
270 upon lawful request.
271 (15) “Nuclear pharmacist” means a pharmacist licensed by
272 the department and certified as a nuclear pharmacist pursuant to
273 s. 465.0126.
274 (5)(16) “Centralized prescription filling” means the
275 filling of a prescription by one pharmacy upon request by
276 another pharmacy to fill or refill the prescription. The term
277 includes the performance by one pharmacy for another pharmacy of
278 other pharmacy duties such as drug utilization review,
279 therapeutic drug utilization review, claims adjudication, and
280 the obtaining of refill authorizations.
281 (2)(17) “Automated pharmacy system” means a mechanical
282 system that delivers prescription drugs received from a Florida
283 licensed pharmacy and maintains related transaction information.
284 (8)(18) “Compounding” means combining, mixing, or altering
285 the ingredients of one or more drugs or products to create
286 another drug or product.
287 (16)(19) “Outsourcing facility” means a single physical
288 location registered as an outsourcing facility under the federal
289 Drug Quality and Security Act, Pub. L. No. 113-54, at which
290 sterile compounding of a drug or product is conducted.
291 (7)(20) “Compounded sterile product” means a drug that is
292 intended for parenteral administration, an ophthalmic or oral
293 inhalation drug in aqueous format, or a drug or product that is
294 required to be sterile under federal or state law or rule, which
295 is produced through compounding, but is not approved by the
296 United States Food and Drug Administration.
297 (4)(21) “Central distribution facility” means a facility
298 under common control with a hospital holding a Class III
299 institutional pharmacy permit that may dispense, distribute,
300 compound, or fill prescriptions for medicinal drugs; prepare
301 prepackaged drug products; and conduct other pharmaceutical
302 services.
303 (6)(22) “Common control” means the power to direct or cause
304 the direction of the management and policies of a person or an
305 organization, whether by ownership of stock, voting rights,
306 contract, or otherwise.
307 Section 3. Section 465.203, Florida Statutes, is created to
308 read:
309 465.203 Pharmacy benefit managers.—
310 (1) As used in this section, the term:
311 (a) “Affiliate” means a pharmacy:
312 1. In which a pharmacy benefit manager, directly or
313 indirectly, has an investment, financial interest, or ownership
314 interest; or
315 2. The ownership of which is shared, directly or
316 indirectly, with a pharmacy benefit manager.
317 (b) “Covered individual” means a member, participant,
318 enrollee, contract holder, policyholder, or beneficiary of a
319 payor.
320 (c) “Make a referral” means any of the following:
321 1. To order, direct, or influence, orally or in writing, a
322 covered individual to use an affiliate, including by sending
323 messages to the covered individual through electronic mail, a
324 cellular telephone, or a facsimile machine, or by making
325 telephone calls.
326 2. To offer or implement plan designs that require a
327 covered individual to use an affiliate.
328 3. To target a covered individual or a prospective patient
329 with advertisement, marketing, or promotion of an affiliate,
330 including by placing a specific pharmacy name on an insurance
331 card or health plan card supplied to the covered individual.
332 (d) “Maximum allowable cost” means the per-unit amount that
333 a pharmacy benefit manager reimburses a pharmacy or pharmacist
334 for a generic drug, brand name drug, specialty drug, biological
335 product, or other prescription drug, excluding dispensing fees,
336 before the application of copayments, coinsurance, and other
337 cost-sharing charges, if any.
338 (e) “Maximum allowable cost list” means a listing of
339 generic drugs, brand name drugs, specialty drugs, biological
340 products, or other prescription drugs or other methodology used
341 directly or indirectly by a pharmacy benefit manager to set the
342 maximum allowable costs for the drugs.
343 (f) “Payor” means a health plan, a health plan sponsor, a
344 health plan provider, a health insurer, or any other payor that
345 uses pharmacy benefit management services in this state.
346 (g) “Spread pricing” means the practice by a pharmacy
347 benefit manager of charging or claiming from a payor an amount
348 that is more than the amount the pharmacy benefit manager paid
349 to the pharmacy or pharmacist who filled the prescription or who
350 provided the pharmacy services.
351 (2) A pharmacy or pharmacist licensed or registered under
352 this chapter who has a pharmacy permit and is in good standing
353 with the Board of Pharmacy may contract directly or indirectly
354 with a pharmacy benefit manager within 30 days after filing an
355 application with the pharmacy benefit manager, without a
356 probation period, an exclusion period, or minimum inventory
357 requirements.
358 (3) A pharmacy benefit manager may not do any of the
359 following:
360 (a) Conduct or participate in spread pricing in this state.
361 (b) Charge a pharmacy or pharmacist a fee related to the
362 adjudication of a claim, including, without limitation, a fee
363 for:
364 1. The submission of a claim;
365 2. The enrollment or participation in a retail pharmacy
366 network; or
367 3. The development or management of claims processing
368 services or claims payment services related to participation in
369 a retail pharmacy network.
370 (c) Prohibit a pharmacy or pharmacist from providing to a
371 covered individual or a covered individual’s caregiver
372 information regarding the pricing of a prescription drug and
373 whether the cost-sharing obligation to the covered individual
374 exceeds the retail price of the prescription in the absence of
375 prescription drug coverage or from selling to a covered
376 individual or a covered individual’s caregiver a more affordable
377 alternative drug.
378 (d) Penalize or remove from a pharmacy network or plan a
379 pharmacy or pharmacist for providing to a covered individual or
380 a covered individual’s caregiver information regarding the
381 pricing of a prescription drug and whether the cost-sharing
382 obligation to the covered individual exceeds the retail price of
383 the prescription in the absence of prescription drug coverage or
384 for selling to a covered individual or a covered individual’s
385 caregiver a more affordable alternative drug.
386 (e) Deny a pharmacy or pharmacist the opportunity to
387 participate in a pharmacy network at the preferred participation
388 status even though the pharmacy or pharmacist is willing to
389 accept, as a condition of the preferred participation status,
390 the terms and conditions that the pharmacy benefit manager has
391 established for other pharmacies that are in a pharmacy network
392 at the preferred participation status and that are not owned in
393 whole or in part by the pharmacy benefit manager.
394 (f) Impose registration or permit requirements for a
395 pharmacy or accreditation standards or recertification
396 requirements for a pharmacist which are inconsistent with, more
397 stringent than, or in addition to federal and state requirements
398 for licensure as a pharmacy or pharmacist in this state.
399 (g) Pay or reimburse a pharmacy or pharmacist an amount for
400 a drug, product, or pharmacy service in the state which is:
401 1. Less than the amount the pharmacy benefit manager
402 reimburses a pharmacy benefit manager affiliate for providing
403 the same drug, product, or pharmacy service in this state;
404 2. Less than the actual cost incurred by the pharmacy or
405 pharmacist for providing the drug, product, or pharmacy service
406 in this state; or
407 3. Different from the combined maximum allowable cost and
408 dispensing fees for a drug. The dispensing fees must be at least
409 equal to the fees for service set by the Agency for Health Care
410 Administration.
411 (h) Retroactively deny, hold back, or reduce reimbursement
412 for a covered service claim after paying a claim, unless the
413 original claim was submitted fraudulently.
414 (i) Prohibit a pharmacy or pharmacist from providing
415 information regarding drug pricing, contract terms, or drug
416 reimbursement rates to a member of the Legislature.
417 (j) Remove a pharmacy or pharmacist from a pharmacy network
418 or plan or otherwise engage in any action to retaliate against a
419 pharmacy or pharmacist for providing information regarding drug
420 pricing, contract terms, or drug reimbursement rates to a member
421 of the Legislature.
422 (k) Engage in the practice of the profession of pharmacy.
423 (l) Engage in the practice of medicine as defined s.
424 458.305 or the practice of osteopathic medicine as defined in s.
425 459.003.
426 (m) Make a referral.
427 (n) Publish or otherwise reveal information regarding the
428 actual amount of rebates, discounts, payment differentials,
429 concessions, reductions, or any other incentives that the
430 pharmacy benefit plan receives on a product-, manufacturer-, or
431 pharmacy-specific basis. The pharmacy benefit manager shall
432 protect such information as a trade secret and shall impose the
433 confidentiality protections on any vendor or third-party entity
434 performing services on behalf of the pharmacy benefit manager
435 that has access to rebate, discount, payment differential,
436 concession, reduction, or any other incentive information.
437 (4) A payor shall have access to all financial and
438 utilization records, data, and information used by the pharmacy
439 benefit manager in relation to the pharmacy benefit management
440 services provided to the payor.
441 (5) A pharmacy benefit manager shall:
442 (a) Disclose in writing to the payor any activity, policy,
443 practice, contract, or arrangement of the pharmacy benefit
444 manager which directly or indirectly presents conflicts of
445 interest with the pharmacy benefit manager’s relationship with,
446 or fiduciary duty or obligation to, the covered individuals and
447 the payor.
448 (b) Report quarterly to the payor any income resulting from
449 pricing discounts, rebates of any kind, inflationary payments,
450 credits, clawbacks, fees, grants, chargebacks, reimbursements,
451 or other financial benefits received by the pharmacy benefit
452 manager from any person or entity. The pharmacy benefit manager
453 shall ensure that such income and financial benefits are passed
454 through in full, at least quarterly, to the payor to reduce the
455 cost of prescription drugs and pharmacy services to covered
456 individuals.
457 (6) The Department of Financial Services shall have access
458 to all financial and utilization records, data, and information
459 used by pharmacy benefit managers in relation to pharmacy
460 benefit management services provided to payors in this state.
461 The department shall investigate any alleged violation of this
462 section.
463 (7)(a) A pharmacy benefit manager that violates this
464 section is liable for a civil fine of $10,000 for each violation
465 and may have its registration revoked by the Department of
466 Financial Services.
467 (b) A violation of this section which is committed or
468 performed with such frequency as to indicate a general business
469 practice is subject to the Florida Deceptive and Unfair Trade
470 Practices Act under part II of chapter 501.
471 (8) This section applies to contracts entered into or
472 renewed on or after January 1, 2021.
473 Section 4. Section 499.0284, Florida Statutes, is created
474 to read:
475 499.0284 Prescription drug manufacturers; disclosure of
476 drug pricing information; reports.—
477 (1) As used in this section, the term:
478 (a) “Prescription drug” has the same meaning as defined in
479 this part, but is limited to prescription drugs intended for
480 human use.
481 (b) “Prescription drug manufacturer” means a person or
482 entity permitted under this part to manufacture or distribute
483 prescription drugs in this state.
484 (c) “Prompt pay” means a discount offered in exchange for
485 early payment of an invoice.
486 (d) “Wholesale acquisition cost” means the list price of
487 the prescription drug which the manufacturer charged to
488 wholesalers or direct purchasers in the United States, not
489 including prompt pay or other discounts, rebates, or reductions
490 in price, for the most recent month for which the information is
491 available, as reported in wholesale price guides or other drug
492 pricing data sources.
493 (2)(a) By January 15 of each year, each prescription drug
494 manufacturer manufacturing or distributing prescription drugs in
495 this state shall submit to the department a report of its
496 wholesale acquisition cost information for all United States
497 Food and Drug Administration-approved drugs the manufacturer
498 sold in or into this state during the previous calendar year.
499 (b) The department shall publish on its website the
500 wholesale acquisition cost information it receives pursuant to
501 paragraph (a). The link to this information must be prominently
502 displayed and easily accessible on the home page of the
503 department’s website.
504 (c) A prescription drug manufacturer shall report to the
505 department when the price of a drug it manufactures increases by
506 40 percent or more during the preceding 3 years or by 15 percent
507 in the preceding calendar year, if the wholesale acquisition
508 cost of the drug was at least $100 for a 30-day supply before
509 the effective date of the increase. The manufacturer shall
510 submit such report to the department within 30 days after the
511 effective date of the increase. The report must include all of
512 the following:
513 1. The name of the drug.
514 2. Whether the drug is a brand name or generic equivalent.
515 3. The effective date of the change in wholesale
516 acquisition cost.
517 4. Aggregate, company-level research and development costs
518 for the most recent year for which final audit data is
519 available.
520 5. The name of each of the manufacturer’s prescription
521 drugs approved by the United States Food and Drug Administration
522 in the previous 3 calendar years.
523 6. The name of each of the manufacturer’s prescription
524 drugs that lost patent exclusivity in the United States in the
525 previous 3 calendar years.
526 7. A statement regarding the factors, if any, that caused
527 the increase in the wholesale acquisition cost and an
528 explanation of each factor’s impact on the cost.
529 (d) The quality and types of information and data which a
530 prescription drug manufacturer submits to the department under
531 paragraph (c) must be consistent with the quality and types of
532 information and data which the manufacturer includes in the
533 manufacturer’s annual consolidated report to the United States
534 Securities and Exchange Commission or in any other public
535 disclosure.
536 (e) The department shall publish on its website a report
537 provided under paragraph (c) within 60 days after receiving it.
538 (f) The department may adopt rules to implement this
539 section.
540 Section 5. Subsection (1) of section 624.490, Florida
541 Statutes, is amended to read:
542 624.490 Registration of pharmacy benefit managers.—
543 (1) As used in this section, the term “pharmacy benefit
544 manager” means an a person or entity that performs pharmacy
545 benefit management services for a health plan, a health plan
546 sponsor, a health plan provider, a health insurer, or any other
547 payor that uses pharmacy benefit management services doing
548 business in this state which contracts to administer
549 prescription drug benefits on behalf of a health insurer or a
550 health maintenance organization to residents of this state. The
551 term does not include a provider as defined in s. 641.19, a
552 physician as defined in s. 458.305, or an osteopathic physician
553 as defined in s. 459.003. As used in this subsection, the term
554 “pharmacy benefit management services” means services that:
555 (a) Are provided, directly or through another entity, to a
556 health plan, a health plan sponsor, a health plan provider, a
557 health insurer, or any other payor, regardless of whether the
558 services provider and the health plan, health plan sponsor,
559 health plan provider, health insurer, or other payor are related
560 or associated by ownership, common ownership, organization, or
561 otherwise.
562 (b) Include the procurement of prescription drugs to be
563 dispensed to patients and the administration or management of
564 prescription drug benefits, including, but not limited to, any
565 of the following:
566 1. A mail service pharmacy or a specialty pharmacy.
567 2. Claims processing, retail network management, or payment
568 of claims to pharmacies for dispensing drugs.
569 3. Clinical or other formulary or preferred-drug-list
570 development or management.
571 4. Negotiation, administration, or receipt of rebates,
572 discounts, payment differentials, or other incentives, to
573 include particular drugs in a particular category or to promote
574 the purchase of particular drugs.
575 5. Patients’ compliance, therapeutic intervention, or
576 generic substitution programs.
577 6. Disease management.
578 7. Drug use review, step-therapy protocol, or prior
579 authorization.
580 8. Adjudication of appeals or grievances related to
581 prescription drug coverage.
582 9. Contracts with network pharmacies.
583 10. Control of the cost of covered prescription drugs.
584 Section 6. Section 624.491, Florida Statutes, is created to
585 read:
586 624.491 Pharmacy benefit managers; reports.—
587 (1) As used in this section, the term:
588 (a) “Enrollee” means an individual insured under an
589 individual or group health insurance policy or a subscriber as
590 defined in s. 641.19.
591 (b) “Health insurance” has the same meaning as in s.
592 624.603.
593 (c) “Health insurer” means an authorized insurer as defined
594 in s. 624.03 providing health insurance or a health maintenance
595 organization as defined in s. 641.19.
596 (d) “Pharmacy benefit manager” means a person or entity
597 registered with the office under s. 624.490 to contract on
598 behalf of a health insurer to administer prescription drug
599 benefits to residents of this state.
600 (e) “Prescription drug” has the same meaning as in s.
601 499.003, but is limited to prescription drugs intended for human
602 use.
603 (f) “Prescription drug manufacturer” means a person or
604 entity permitted under part I of chapter 499 to manufacture or
605 distribute prescription drugs in this state.
606 (2) By February 1 of each year, each pharmacy benefit
607 manager shall submit a report to the office including all of the
608 following information for the previous calendar year:
609 (a) The aggregated rebates, fees, price protection
610 payments, and any other payments collected from prescription
611 drug manufacturers; and
612 (b) The aggregated dollar amount of rebates, fees, price
613 protection payments, and any other payments collected from
614 prescription drug manufacturers which were:
615 1. Passed on to the health insurers or the enrollees, at
616 the point of sale of the prescription drug; or
617 2. Retained by the pharmacy benefit manager as revenue.
618 (3) A report submitted under this section must not disclose
619 the identity of a specific health insurer or enrollee, the price
620 charged for a specific prescription drug or class of
621 prescription drugs, or the amount of any rebate or fee provided
622 for a specific prescription drug or class of prescription drugs.
623 (4) By May 1 of each year, the office shall publish on its
624 website the combined aggregated data from all reports it
625 received under this section for that year. The data from the
626 reports may not be published in a manner that would disclose or
627 tend to disclose any health insurer’s proprietary or
628 confidential information.
629 (5) The commission may adopt rules to implement this
630 section.
631 Section 7. Section 627.42385, Florida Statutes, is created
632 to read:
633 627.42385 Coinsurance obligations for prescription drugs.—
634 (1) As used in this section, the term:
635 (a) “Coinsurance” means, with respect to prescription drug
636 coverage under a group health plan or health insurance coverage,
637 a payment obligation of a plan beneficiary or an insured that is
638 based on a percentage of the specified cost of a prescription
639 drug, which may be up to 100 percent of that cost.
640 (b) “Deductible” means the payment obligation of a group
641 health plan beneficiary or a health insurance coverage insured
642 before the plan or coverage will pay any portion of the cost of
643 prescription drug coverage.
644 (c) “Health insurer” has the same meaning as provided in s.
645 627.42392.
646 (d) “List price” means the manufacturer’s price for a drug
647 for wholesalers or direct purchasers in this country, not
648 including any rebate, discount, payment differential,
649 concession, or reduction in price, for the most recent month for
650 which the information is available, as reported in wholesale
651 price guides or other publications of drug or biological pricing
652 data.
653 (e) “Net price” means the price of a drug paid by a group
654 health plan or a health insurer, or a pharmacy benefit manager
655 performing pharmacy benefit management services for a group
656 health plan or a health insurer, after all rebates, discounts,
657 payment differentials, concessions, and reductions in price have
658 been applied to the list price.
659 (f) “Pharmacy benefit manager” has the same meaning as
660 provided in s. 465.003.
661 (g) “Pharmacy benefit management services” has the same
662 meaning as provided in s. 465.003.
663 (h) “Prescription drug” has the same meaning as provided in
664 s. 409.9201.
665 (2) Unless otherwise expressly provided in this section, a
666 group health plan or a health insurer offering group or
667 individual health insurance coverage, or a pharmacy benefit
668 manager performing pharmacy benefit management services for a
669 group health plan or a health insurer, shall base a plan
670 beneficiary’s or an insured’s coinsurance obligation for a
671 prescription drug covered by the plan or coverage on the net
672 price, and not the list price, of the drug.
673 (3)(a) Subsection (2) applies to a prescription drug
674 benefit if a plan beneficiary or an insured is required to pay a
675 deductible with respect to such benefit and if the plan
676 beneficiary or insured:
677 1. Has not yet satisfied the deductible under the plan or
678 coverage; or
679 2. Has another coinsurance obligation with respect to such
680 benefit under the plan or coverage.
681 (b) Subsection (2) does not apply if, with respect to the
682 dispensed quantity of a prescription drug, the net price and
683 list price of the drug are different by not more than 1 percent.
684 (4) In complying with this section, a group health plan or
685 a health insurer, or a pharmacy benefit manager performing
686 pharmacy benefit management services for a group health plan or
687 a health insurer, may not publish or otherwise reveal
688 information regarding the actual amount of rebates, discounts,
689 payment differentials, concessions, or reductions in price that
690 the plan, health insurer, or pharmacy benefit plan receives on a
691 product-, manufacturer-, or pharmacy-specific basis. The plan,
692 health insurer, or pharmacy benefit manager shall protect such
693 information as a trade secret and shall impose the
694 confidentiality protections on any vendor or third party
695 performing health care or pharmacy administrative services on
696 behalf of the plan, health insurer, or pharmacy benefit manager
697 that have access to rebate, discount, payment differential,
698 concession, or reduction information.
699 (5) A group health plan, health insurer, or pharmacy
700 benefit manager that violates any provision of this section is
701 liable for a civil fine of $10,000 for each violation and may be
702 required to discontinue the issuance or renewal of the plan or
703 health insurance coverage or the provision of pharmacy benefit
704 management services, as applicable.
705 (6) The department shall investigate any alleged violation
706 of this section.
707 (7) This section does not prevent a group health plan,
708 health insurer, or pharmacy benefit manager from requiring a
709 copayment for any prescription drug if such copayment is not
710 tied to a percentage of the cost of the drug.
711 Section 8. Present subsection (5) of section 627.64741,
712 Florida Statutes, is redesignated as subsection (10), new
713 subsections (5) through (9) are added to that section, and
714 subsection (1) and present subsection (5) are amended, to read:
715 627.64741 Pharmacy benefit manager contracts.—
716 (1) As used in this section, the term:
717 (a) “Maximum allowable cost” means the per-unit amount that
718 a pharmacy benefit manager reimburses a pharmacy or pharmacist
719 for a generic drug, brand name drug, specialty drug, biological
720 product, or other prescription drug, excluding dispensing fees,
721 before prior to the application of copayments, coinsurance, and
722 other cost-sharing charges, if any.
723 (b) “Maximum allowable cost list” means a listing of
724 generic drugs, brand name drugs, specialty drugs, biological
725 products, or other prescription drugs or other methodology used
726 directly or indirectly by a pharmacy benefit manager to set the
727 maximum allowable costs for the drugs.
728 (c) “Payor” means a health plan, a health plan sponsor, a
729 health plan provider, or any other payor that uses pharmacy
730 benefit management services in this state.
731 (d)(b) “Pharmacy benefit manager” means an a person or
732 entity that performs pharmacy benefit management services for
733 doing business in this state which contracts to administer or
734 manage prescription drug benefits on behalf of a health insurer
735 or payor to residents of this state. The term does not include a
736 provider as defined in s. 641.19, a physician as defined in s.
737 458.305, or an osteopathic physician as defined in s. 459.003.
738 (e) “Pharmacy benefit management services” means services
739 that:
740 1. Are provided, directly or through another entity, to a
741 health insurer or payor, regardless of whether the services
742 provider and the health insurer or payor are related or
743 associated by ownership, common ownership, organization, or
744 otherwise.
745 2. Include the procurement of prescription drugs to be
746 dispensed to patients and the administration or management of
747 prescription drug benefits, including, but not limited to, any
748 of the following:
749 a. A mail service pharmacy or a specialty pharmacy.
750 b. Claims processing, retail network management, or payment
751 of claims to pharmacies for dispensing drugs.
752 c. Clinical or other formulary or preferred-drug-list
753 development or management.
754 d. Negotiation, administration, or receipt of rebates,
755 discounts, payment differentials, or other incentives, to
756 include particular drugs in a particular category or to promote
757 the purchase of particular drugs.
758 e. Patients’ compliance, therapeutic intervention, or
759 generic substitution programs.
760 f. Disease management.
761 g. Drug use review, step-therapy protocol, or prior
762 authorization.
763 h. Adjudication of appeals or grievances related to
764 prescription drug coverage.
765 i. Contracts with network pharmacies.
766 j. Control of the cost of covered prescription drugs.
767 (5) A contract between a health insurer or payor and a
768 pharmacy benefit manager must require the maximum allowable cost
769 list to include:
770 (a) Average acquisition cost, including national average
771 drug acquisition cost.
772 (b) Average manufacturer price.
773 (c) Average wholesale price.
774 (d) Brand effective rate or generic effective rate.
775 (e) Discount indexing.
776 (f) Federal upper limits.
777 (g) Wholesale acquisition cost.
778 (h) Any other item that a pharmacy benefit manager or a
779 health insurer or payor may use to establish reimbursement rates
780 to a pharmacist or pharmacy for filling prescriptions or
781 providing other pharmacy services.
782 (6) A health insurer that uses pharmacy benefit management
783 services or a payor shall have access to all financial and
784 utilization records, data, and information used by the pharmacy
785 benefit manager in relation to the pharmacy benefit management
786 services provided to the health insurer or payor.
787 (7) A pharmacy benefit manager shall:
788 (a) Disclose in writing to the health insurer that uses
789 pharmacy benefit management services or to the payor any
790 activity, policy, practice, contract, or arrangement of the
791 pharmacy benefit manager which directly or indirectly presents
792 conflicts of interest with the pharmacy benefit manager’s
793 relationship with, or fiduciary duty or obligation to, the
794 insureds and the health insurer or payor.
795 (b) Report quarterly to the health insurer or payor any
796 income resulting from pricing discounts, rebates of any kind,
797 inflationary payments, credits, clawbacks, fees, grants,
798 chargebacks, reimbursements, or other financial benefits
799 received by the pharmacy benefit manager from any person or
800 entity. The pharmacy benefit manager shall ensure that such
801 income and financial benefits are passed through in full, at
802 least quarterly, to the health insurer or payor to reduce the
803 cost of prescription drugs and pharmacy services to the
804 insureds.
805 (8) The department shall investigate any alleged violation
806 of this section.
807 (9)(a) A pharmacy benefit manager that violates any
808 provision of this section is liable for a civil fine of $10,000
809 for each violation and may have its registration revoked by the
810 department.
811 (b) A violation by a pharmacy benefit manager of any
812 provision of this section which is committed or performed with
813 such frequency as to indicate a general business practice is
814 subject to the Florida Deceptive and Unfair Trade Practices Act
815 under part II of chapter 501.
816 (10)(5) This section applies to contracts entered into or
817 renewed on or after January 1, 2021 July 1, 2018.
818 Section 9. Section 627.64745, Florida Statutes, is created
819 to read:
820 627.64745 Health insurers; prescription drug spending
821 reports.—
822 (1) As used in this section, the term:
823 (a) “Specialty drug” means a prescription drug on a health
824 insurer’s formulary which is also covered under Medicare Part D
825 and exceeds the specialty tier cost threshold established by the
826 federal Centers for Medicare and Medicaid Services.
827 (b) “Utilization management” means a set of formal
828 techniques designed to monitor the use of or evaluate the
829 medical necessity, appropriateness, efficacy, or efficiency of
830 health care services, procedures, or settings.
831 (2) By February 1 of each year, each health insurer shall
832 submit to the office a report including all of the following
833 information across all health insurance policies for the
834 preceding calendar year:
835 (a) The names of the 25 most frequently prescribed
836 prescription drugs.
837 (b) The percentage of any increase in annual net spending
838 for prescription drugs.
839 (c) The percentage of any increase in premiums which was
840 attributable to prescription drugs.
841 (d) The percentage of specialty drugs with utilization
842 management requirements prescribed.
843 (e) Any premium reductions that were attributable to
844 specialty drug utilization management.
845 (3) A report submitted under this section must not disclose
846 the identity of a specific health insurance policy or the price
847 charged for a specific prescription drug or class of
848 prescription drugs.
849 (4) By May 1 of each year, the office shall publish on its
850 website aggregated data from all reports it received under this
851 section for that year. The data from the reports may not be
852 published in a manner that would disclose or tend to disclose
853 any health insurer’s proprietary or confidential information.
854 (5) The commission may adopt rules to implement this
855 section.
856 Section 10. Present subsection (5) of section 627.6572,
857 Florida Statutes, is redesignated as subsection (10) and
858 amended, a new subsection (5) and subsections (6) through (9)
859 are added to that section, and subsection (1) is amended, to
860 read:
861 627.6572 Pharmacy benefit manager contracts.—
862 (1) As used in this section, the term:
863 (a) “Maximum allowable cost” means the per-unit amount that
864 a pharmacy benefit manager reimburses a pharmacy or pharmacist
865 for a generic drug, brand name drug, specialty drug, biological
866 product, or other prescription drug, excluding dispensing fees,
867 before prior to the application of copayments, coinsurance, and
868 other cost-sharing charges, if any.
869 (b) “Maximum allowable cost list” means a listing of
870 generic drugs, brand name drugs, specialty drugs, biological
871 products, or other prescription drugs or other methodology used
872 directly or indirectly by a pharmacy benefit manager to set the
873 maximum allowable costs for the drugs.
874 (c) “Payor” means a health plan, a health plan sponsor, a
875 health plan provider, or any other payor that uses pharmacy
876 benefit management services in this state.
877 (d)(b) “Pharmacy benefit manager” means an a person or
878 entity that performs pharmacy benefit management services for
879 doing business in this state which contracts to administer or
880 manage prescription drug benefits on behalf of a health insurer
881 or payor to residents of this state. The term does not include a
882 provider as defined in s. 641.19, a physician as defined in s.
883 458.305, or an osteopathic physician as defined in s. 459.003.
884 (e) “Pharmacy benefit management services” means services
885 that:
886 1. Are provided, directly or through another entity, to a
887 health insurer or payor, regardless of whether the services
888 provider and the health insurer or payor are related or
889 associated by ownership, common ownership, organization, or
890 otherwise.
891 2. Include the procurement of prescription drugs to be
892 dispensed to patients and the administration or management of
893 prescription drug benefits, including, but not limited to, any
894 of the following:
895 a. A mail service pharmacy or a specialty pharmacy.
896 b. Claims processing, retail network management, or payment
897 of claims to pharmacies for dispensing drugs.
898 c. Clinical or other formulary or preferred-drug-list
899 development or management.
900 d. Negotiation, administration, or receipt of rebates,
901 discounts, payment differentials, or other incentives, to
902 include particular drugs in a particular category or to promote
903 the purchase of particular drugs.
904 e. Patients’ compliance, therapeutic intervention, or
905 generic substitution programs.
906 f. Disease management.
907 g. Drug use review, step-therapy protocol, or prior
908 authorization.
909 h. Adjudication of appeals or grievances related to
910 prescription drug coverage.
911 i. Contracts with network pharmacies.
912 j. Control of the cost of covered prescription drugs.
913 (5) A contract between a health insurer or payor and a
914 pharmacy benefit manager must require the maximum allowable cost
915 list to include:
916 (a) Average acquisition cost, including national average
917 drug acquisition cost.
918 (b) Average manufacturer price.
919 (c) Average wholesale price.
920 (d) Brand effective rate or generic effective rate.
921 (e) Discount indexing.
922 (f) Federal upper limits.
923 (g) Wholesale acquisition cost.
924 (h) Any other item that a pharmacy benefit manager or a
925 health insurer or payor may use to establish reimbursement rates
926 to a pharmacist or pharmacy for filling prescriptions or
927 providing other pharmacy services.
928 (6) A health insurer that uses pharmacy benefit management
929 services or a payor shall have access to all financial and
930 utilization records, data, and information used by the pharmacy
931 benefit manager in relation to the pharmacy benefit management
932 services provided to the health insurer or payor.
933 (7) A pharmacy benefit manager shall:
934 (a) Disclose in writing to the health insurer that uses
935 pharmacy benefit management services or the payor any activity,
936 policy, practice, contract, or arrangement of the pharmacy
937 benefit manager which directly or indirectly presents conflicts
938 of interest with the pharmacy benefit manager’s relationship
939 with, or fiduciary duty or obligation to, the insureds and the
940 health insurer or payor.
941 (b) Report quarterly to the health insurer or payor any
942 income resulting from pricing discounts, rebates of any kind,
943 inflationary payments, credits, clawbacks, fees, grants,
944 chargebacks, reimbursements, or other financial benefits
945 received by the pharmacy benefit manager from any person or
946 entity. The pharmacy benefit manager shall ensure that such
947 income and financial benefits are passed through in full, at
948 least quarterly, to the health insurer or payor to reduce the
949 cost of prescription drugs and pharmacy services to the
950 insureds.
951 (8) The department shall investigate any alleged violation
952 of this section.
953 (9)(a) A pharmacy benefit manager that violates any
954 provision of this section is liable for a civil fine of $10,000
955 for each violation and may have its registration revoked by the
956 department.
957 (b) A violation by a pharmacy benefit manager of any
958 provision of this section which is committed or performed with
959 such frequency as to indicate a general business practice is
960 subject to the Florida Deceptive and Unfair Trade Practices Act
961 under part II of chapter 501.
962 (10)(5) This section applies to contracts entered into or
963 renewed on or after January 1, 2021 July 1, 2018.
964 Section 11. Section 627.65725, Florida Statutes, is created
965 to read:
966 627.65725 Health insurers; prescription drug spending
967 reports.—
968 (1) As used in this section, the term:
969 (a) “Specialty drug” means a prescription drug on a health
970 insurer’s formulary which is also covered under Medicare Part D
971 and exceeds the specialty tier cost threshold established by the
972 federal Centers for Medicare and Medicaid Services.
973 (b) “Utilization management” means a set of formal
974 techniques designed to monitor the use of or evaluate the
975 medical necessity, appropriateness, efficacy, or efficiency of
976 health care services, procedures, or settings.
977 (2) By February 1 of each year, each health insurer shall
978 submit to the office a report including all of the following
979 information across all group health insurance policies for the
980 preceding calendar year:
981 (a) The names of the 25 most frequently prescribed
982 prescription drugs.
983 (b) The percentage of any increase in annual net spending
984 for prescription drugs.
985 (c) The percentage of any increase in premiums which was
986 attributable to prescription drugs.
987 (d) The percentage of specialty drugs with utilization
988 management requirements prescribed.
989 (e) Any premium reduction that was attributable to
990 specialty drug utilization management.
991 (3) A report submitted under this section must not disclose
992 the identity of a specific health insurance policy or the price
993 charged for a specific prescription drug or class of
994 prescription drugs.
995 (4) By May 1 of each year, the office shall publish on its
996 website aggregated data from all reports it received under this
997 section for that year. The data from the reports may not be
998 published in a manner that would disclose or tend to disclose
999 any health insurer’s proprietary or confidential information.
1000 (5) The commission may adopt rules to implement this
1001 section.
1002 Section 12. Section 641.262, Florida Statutes, is created
1003 to read:
1004 641.262 Health maintenance organizations; prescription drug
1005 spending reports.—
1006 (1) As used in this section, the term:
1007 (a) “Specialty drug” means a prescription drug on a health
1008 maintenance organization’s formulary which is also covered under
1009 Medicare Part D and exceeds the specialty tier cost threshold
1010 established by the federal Centers for Medicare and Medicaid
1011 Services.
1012 (b) “Utilization management” means a set of formal
1013 techniques designed to monitor the use of or evaluate the
1014 medical necessity, appropriateness, efficacy, or efficiency of
1015 health care services, procedures, or settings.
1016 (2) By February 1 of each year, each health maintenance
1017 organization shall submit to the office a report including all
1018 of the following information across all health maintenance
1019 contracts for the preceding calendar year:
1020 (a) The names of the 25 most frequently prescribed
1021 prescription drugs.
1022 (b) The percentage of any increase in annual net spending
1023 for prescription drugs.
1024 (c) The percentage of any increase in premiums which was
1025 attributable to prescription drugs.
1026 (d) The percentage of specialty drugs with utilization
1027 management requirements prescribed.
1028 (e) Any premium reduction that was attributable to
1029 specialty drug utilization management.
1030 (3) A report submitted under this section must not disclose
1031 the identity of a specific health maintenance contract or the
1032 price charged for a specific prescription drug or class of
1033 prescription drugs.
1034 (4) By May 1 of each year, the office shall publish on its
1035 website aggregated data from all reports it received under this
1036 section for that year. The data from the reports may not be
1037 published in a manner that would disclose or tend to disclose
1038 any health maintenance organization’s proprietary or
1039 confidential information.
1040 (5) The commission may adopt rules to implement this
1041 section.
1042 Section 13. Present subsection (5) of section 641.314,
1043 Florida Statutes, is redesignated as subsection (10) and
1044 amended, a new subsection (5) and subsections (6) through (9)
1045 are added to that section, and subsection (1) is amended, to
1046 read:
1047 641.314 Pharmacy benefit manager contracts.—
1048 (1) As used in this section, the term:
1049 (a) “Maximum allowable cost” means the per-unit amount that
1050 a pharmacy benefit manager reimburses a pharmacy or pharmacist
1051 for a generic drug, brand name drug, specialty drug, biological
1052 product, or other prescription drug, excluding dispensing fees,
1053 before prior to the application of copayments, coinsurance, and
1054 other cost-sharing charges, if any.
1055 (b) “Maximum allowable cost list” means a listing of
1056 generic drugs, brand name drugs, specialty drugs, biological
1057 products, or other prescription drugs or other methodology used
1058 directly or indirectly by a pharmacy benefit manager to set the
1059 maximum allowable costs for the drugs.
1060 (c) “Payor” means a health plan, a health plan sponsor, a
1061 health plan provider, or any other payor that uses pharmacy
1062 benefit management services in this state.
1063 (d)(b) “Pharmacy benefit manager” means an a person or
1064 entity that performs pharmacy benefit management services for
1065 doing business in this state which contracts to administer or
1066 manage prescription drug benefits on behalf of a health
1067 maintenance organization or payor to residents of this state.
1068 The term does not include a provider as defined in s. 641.19, a
1069 physician as defined in s. 458.305, or an osteopathic physician
1070 as defined in s. 459.003.
1071 (e) “Pharmacy benefit management services” means services
1072 that:
1073 1. Are provided, directly or through another entity, to a
1074 health maintenance organization or payor, regardless of whether
1075 the services provider and the health maintenance organization or
1076 payor are related or associated by ownership, common ownership,
1077 organization, or otherwise.
1078 2. Include the procurement of prescription drugs to be
1079 dispensed to patients and the administration or management of
1080 prescription drug benefits, including, but not limited to, any
1081 of the following:
1082 a. A mail service pharmacy or a specialty pharmacy.
1083 b. Claims processing, retail network management, or payment
1084 of claims to pharmacies for dispensing drugs.
1085 c. Clinical or other formulary or preferred-drug-list
1086 development or management.
1087 d. Negotiation, administration, or receipt of rebates,
1088 discounts, payment differentials, or other incentives, to
1089 include particular drugs in a particular category or to promote
1090 the purchase of particular drugs.
1091 e. Patients’ compliance, therapeutic intervention, or
1092 generic substitution programs.
1093 f. Disease management.
1094 g. Drug use review, step-therapy protocol, or prior
1095 authorization.
1096 h. Adjudication of appeals or grievances related to
1097 prescription drug coverage.
1098 i. Contracts with network pharmacies.
1099 j. Control of the cost of covered prescription drugs.
1100 (5) A contract between a health maintenance organization or
1101 payor and a pharmacy benefit manager must require the maximum
1102 allowable cost list to include:
1103 (a) Average acquisition cost, including national average
1104 drug acquisition cost.
1105 (b) Average manufacturer price.
1106 (c) Average wholesale price.
1107 (d) Brand effective rate or generic effective rate.
1108 (e) Discount indexing.
1109 (f) Federal upper limits.
1110 (g) Wholesale acquisition cost.
1111 (h) Any other item that a pharmacy benefit manager or a
1112 health maintenance organization or payor may use to establish
1113 reimbursement rates to a pharmacist or pharmacy for filling
1114 prescriptions or providing other pharmacy services.
1115 (6) A health maintenance organization that uses pharmacy
1116 benefit management services or a payor shall have access to all
1117 financial and utilization records, data, and information used by
1118 the pharmacy benefit manager in relation to the pharmacy benefit
1119 management services provided to the health maintenance
1120 organization or payor.
1121 (7) A pharmacy benefit manager shall:
1122 (a) Disclose in writing to the health maintenance
1123 organization that uses pharmacy benefit management services or
1124 the payor any activity, policy, practice, contract, or
1125 arrangement of the pharmacy benefit manager which directly or
1126 indirectly presents conflicts of interest with the pharmacy
1127 benefit manager’s relationship with, or fiduciary duty or
1128 obligation to, the subscribers and the health maintenance
1129 organization or payor.
1130 (b) Report quarterly to the health maintenance organization
1131 or payor any income resulting from pricing discounts, rebates of
1132 any kind, inflationary payments, credits, clawbacks, fees,
1133 grants, chargebacks, reimbursements, or other financial benefits
1134 received by the pharmacy benefit manager from any person or
1135 entity. The pharmacy benefit manager shall ensure that such
1136 income and financial benefits are passed through in full, at
1137 least quarterly, to the health maintenance organization or payor
1138 to reduce the cost of prescription drugs and pharmacy services
1139 to the subscribers.
1140 (8) The department shall investigate any alleged violation
1141 of this section.
1142 (9)(a) A pharmacy benefit manager that violates any
1143 provision of this section is liable for a civil fine of $10,000
1144 for each violation and may have its registration revoked by the
1145 department.
1146 (b) A violation of any provision of this section which is
1147 committed or performed with such frequency as to indicate a
1148 general business practice is subject to the Florida Deceptive
1149 and Unfair Trade Practices Act under part II of chapter 501.
1150 (10)(5) This section applies to contracts entered into or
1151 renewed on or after January 1, 2021 July 1, 2018.
1152 Section 14. Paragraph (a) of subsection (1) of section
1153 409.9201, Florida Statutes, is amended to read:
1154 409.9201 Medicaid fraud.—
1155 (1) As used in this section, the term:
1156 (a) “Prescription drug” means any drug, including, but not
1157 limited to, finished dosage forms or active ingredients that are
1158 subject to, defined in, or described in s. 503(b) of the Federal
1159 Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s.
1160 499.003(17), s. 499.007(13), or s. 499.82(10).
1161
1162 The value of individual items of the legend drugs or goods or
1163 services involved in distinct transactions committed during a
1164 single scheme or course of conduct, whether involving a single
1165 person or several persons, may be aggregated when determining
1166 the punishment for the offense.
1167 Section 15. Paragraph (pp) of subsection (1) of section
1168 458.331, Florida Statutes, is amended to read:
1169 458.331 Grounds for disciplinary action; action by the
1170 board and department.—
1171 (1) The following acts constitute grounds for denial of a
1172 license or disciplinary action, as specified in s. 456.072(2):
1173 (pp) Applicable to a licensee who serves as the designated
1174 physician of a pain-management clinic as defined in s. 458.3265
1175 or s. 459.0137:
1176 1. Registering a pain-management clinic through
1177 misrepresentation or fraud;
1178 2. Procuring, or attempting to procure, the registration of
1179 a pain-management clinic for any other person by making or
1180 causing to be made, any false representation;
1181 3. Failing to comply with any requirement of chapter 499,
1182 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
1183 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
1184 the Drug Abuse Prevention and Control Act; or chapter 893, the
1185 Florida Comprehensive Drug Abuse Prevention and Control Act;
1186 4. Being convicted or found guilty of, regardless of
1187 adjudication to, a felony or any other crime involving moral
1188 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
1189 the courts of this state, of any other state, or of the United
1190 States;
1191 5. Being convicted of, or disciplined by a regulatory
1192 agency of the Federal Government or a regulatory agency of
1193 another state for, any offense that would constitute a violation
1194 of this chapter;
1195 6. Being convicted of, or entering a plea of guilty or nolo
1196 contendere to, regardless of adjudication, a crime in any
1197 jurisdiction of the courts of this state, of any other state, or
1198 of the United States which relates to the practice of, or the
1199 ability to practice, a licensed health care profession;
1200 7. Being convicted of, or entering a plea of guilty or nolo
1201 contendere to, regardless of adjudication, a crime in any
1202 jurisdiction of the courts of this state, of any other state, or
1203 of the United States which relates to health care fraud;
1204 8. Dispensing any medicinal drug based upon a communication
1205 that purports to be a prescription as defined in s. 465.003 s.
1206 465.003(14) or s. 893.02 if the dispensing practitioner knows or
1207 has reason to believe that the purported prescription is not
1208 based upon a valid practitioner-patient relationship; or
1209 9. Failing to timely notify the board of the date of his or
1210 her termination from a pain-management clinic as required by s.
1211 458.3265(3).
1212 Section 16. Paragraph (rr) of subsection (1) of section
1213 459.015, Florida Statutes, is amended to read:
1214 459.015 Grounds for disciplinary action; action by the
1215 board and department.—
1216 (1) The following acts constitute grounds for denial of a
1217 license or disciplinary action, as specified in s. 456.072(2):
1218 (rr) Applicable to a licensee who serves as the designated
1219 physician of a pain-management clinic as defined in s. 458.3265
1220 or s. 459.0137:
1221 1. Registering a pain-management clinic through
1222 misrepresentation or fraud;
1223 2. Procuring, or attempting to procure, the registration of
1224 a pain-management clinic for any other person by making or
1225 causing to be made, any false representation;
1226 3. Failing to comply with any requirement of chapter 499,
1227 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
1228 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
1229 the Drug Abuse Prevention and Control Act; or chapter 893, the
1230 Florida Comprehensive Drug Abuse Prevention and Control Act;
1231 4. Being convicted or found guilty of, regardless of
1232 adjudication to, a felony or any other crime involving moral
1233 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
1234 the courts of this state, of any other state, or of the United
1235 States;
1236 5. Being convicted of, or disciplined by a regulatory
1237 agency of the Federal Government or a regulatory agency of
1238 another state for, any offense that would constitute a violation
1239 of this chapter;
1240 6. Being convicted of, or entering a plea of guilty or nolo
1241 contendere to, regardless of adjudication, a crime in any
1242 jurisdiction of the courts of this state, of any other state, or
1243 of the United States which relates to the practice of, or the
1244 ability to practice, a licensed health care profession;
1245 7. Being convicted of, or entering a plea of guilty or nolo
1246 contendere to, regardless of adjudication, a crime in any
1247 jurisdiction of the courts of this state, of any other state, or
1248 of the United States which relates to health care fraud;
1249 8. Dispensing any medicinal drug based upon a communication
1250 that purports to be a prescription as defined in s. 465.003 s.
1251 465.003(14) or s. 893.02 if the dispensing practitioner knows or
1252 has reason to believe that the purported prescription is not
1253 based upon a valid practitioner-patient relationship; or
1254 9. Failing to timely notify the board of the date of his or
1255 her termination from a pain-management clinic as required by s.
1256 459.0137(3).
1257 Section 17. Subsection (1) of section 465.014, Florida
1258 Statutes, is amended to read:
1259 465.014 Pharmacy technician.—
1260 (1) A person other than a licensed pharmacist or pharmacy
1261 intern may not engage in the practice of the profession of
1262 pharmacy, except that a licensed pharmacist may delegate to
1263 pharmacy technicians who are registered pursuant to this section
1264 those duties, tasks, and functions that do not fall within the
1265 purview of s. 465.003 s. 465.003(13). All such delegated acts
1266 must be performed under the direct supervision of a licensed
1267 pharmacist who is responsible for all such acts performed by
1268 persons under his or her supervision. A registered pharmacy
1269 technician, under the supervision of a pharmacist, may initiate
1270 or receive communications with a practitioner or his or her
1271 agent, on behalf of a patient, regarding refill authorization
1272 requests. A licensed pharmacist may not supervise more than one
1273 registered pharmacy technician unless otherwise permitted by the
1274 guidelines adopted by the board. The board shall establish
1275 guidelines to be followed by licensees or permittees in
1276 determining the circumstances under which a licensed pharmacist
1277 may supervise more than one pharmacy technician.
1278 Section 18. Paragraph (c) of subsection (2) of section
1279 465.015, Florida Statutes, is amended to read:
1280 465.015 Violations and penalties.—
1281 (2) It is unlawful for any person:
1282 (c) To sell or dispense drugs as defined in s. 465.003 s.
1283 465.003(8) without first being furnished with a prescription.
1284 Section 19. Subsection (9) of section 465.0156, Florida
1285 Statutes, is amended to read:
1286 465.0156 Registration of nonresident pharmacies.—
1287 (9) Notwithstanding s. 465.003 s. 465.003(10), for purposes
1288 of this section, the registered pharmacy and the pharmacist
1289 designated by the registered pharmacy as the prescription
1290 department manager or the equivalent must be licensed in the
1291 state of location in order to dispense into this state.
1292 Section 20. Paragraph (s) of subsection (1) of section
1293 465.016, Florida Statutes, is amended to read:
1294 465.016 Disciplinary actions.—
1295 (1) The following acts constitute grounds for denial of a
1296 license or disciplinary action, as specified in s. 456.072(2):
1297 (s) Dispensing any medicinal drug based upon a
1298 communication that purports to be a prescription as defined in
1299 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
1300 knows or has reason to believe that the purported prescription
1301 is not based upon a valid practitioner-patient relationship.
1302 Section 21. Subsection (4) of section 465.0197, Florida
1303 Statutes, is amended to read:
1304 465.0197 Internet pharmacy permits.—
1305 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
1306 of this section, the Internet pharmacy and the pharmacist
1307 designated by the Internet pharmacy as the prescription
1308 department manager or the equivalent must be licensed in the
1309 state of location in order to dispense into this state.
1310 Section 22. Paragraph (j) of subsection (5) of section
1311 465.022, Florida Statutes, is amended to read:
1312 465.022 Pharmacies; general requirements; fees.—
1313 (5) The department or board shall deny an application for a
1314 pharmacy permit if the applicant or an affiliated person,
1315 partner, officer, director, or prescription department manager
1316 or consultant pharmacist of record of the applicant:
1317 (j) Has dispensed any medicinal drug based upon a
1318 communication that purports to be a prescription as defined in
1319 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
1320 knows or has reason to believe that the purported prescription
1321 is not based upon a valid practitioner-patient relationship that
1322 includes a documented patient evaluation, including history and
1323 a physical examination adequate to establish the diagnosis for
1324 which any drug is prescribed and any other requirement
1325 established by board rule under chapter 458, chapter 459,
1326 chapter 461, chapter 463, chapter 464, or chapter 466.
1327
1328 For felonies in which the defendant entered a plea of guilty or
1329 nolo contendere in an agreement with the court to enter a
1330 pretrial intervention or drug diversion program, the department
1331 shall deny the application if upon final resolution of the case
1332 the licensee has failed to successfully complete the program.
1333 Section 23. Paragraph (h) of subsection (1) of section
1334 465.023, Florida Statutes, is amended to read:
1335 465.023 Pharmacy permittee; disciplinary action.—
1336 (1) The department or the board may revoke or suspend the
1337 permit of any pharmacy permittee, and may fine, place on
1338 probation, or otherwise discipline any pharmacy permittee if the
1339 permittee, or any affiliated person, partner, officer, director,
1340 or agent of the permittee, including a person fingerprinted
1341 under s. 465.022(3), has:
1342 (h) Dispensed any medicinal drug based upon a communication
1343 that purports to be a prescription as defined in s. 465.003 by
1344 s. 465.003(14) or s. 893.02 when the pharmacist knows or has
1345 reason to believe that the purported prescription is not based
1346 upon a valid practitioner-patient relationship that includes a
1347 documented patient evaluation, including history and a physical
1348 examination adequate to establish the diagnosis for which any
1349 drug is prescribed and any other requirement established by
1350 board rule under chapter 458, chapter 459, chapter 461, chapter
1351 463, chapter 464, or chapter 466.
1352 Section 24. Section 465.1901, Florida Statutes, is amended
1353 to read:
1354 465.1901 Practice of orthotics and pedorthics.—The
1355 provisions of chapter 468 relating to orthotics or pedorthics do
1356 not apply to any licensed pharmacist or to any person acting
1357 under the supervision of a licensed pharmacist. The practice of
1358 orthotics or pedorthics by a pharmacist or any of the
1359 pharmacist’s employees acting under the supervision of a
1360 pharmacist shall be construed to be within the meaning of the
1361 term “practice of the profession of pharmacy” as defined set
1362 forth in s. 465.003 s. 465.003(13), and shall be subject to
1363 regulation in the same manner as any other pharmacy practice.
1364 The Board of Pharmacy shall develop rules regarding the practice
1365 of orthotics and pedorthics by a pharmacist. Any pharmacist or
1366 person under the supervision of a pharmacist engaged in the
1367 practice of orthotics or pedorthics is not precluded from
1368 continuing that practice pending adoption of these rules.
1369 Section 25. Subsection (40) of section 499.003, Florida
1370 Statutes, is amended to read:
1371 499.003 Definitions of terms used in this part.—As used in
1372 this part, the term:
1373 (40) “Prescription drug” means a prescription, medicinal,
1374 or legend drug, including, but not limited to, finished dosage
1375 forms or active pharmaceutical ingredients subject to, defined
1376 by, or described by s. 503(b) of the federal act or s. 465.003
1377 s. 465.003(8), s. 499.007(13), subsection (31), or subsection
1378 (47), except that an active pharmaceutical ingredient is a
1379 prescription drug only if substantially all finished dosage
1380 forms in which it may be lawfully dispensed or administered in
1381 this state are also prescription drugs.
1382 Section 26. Paragraph (c) of subsection (24) of section
1383 893.02, Florida Statutes, is amended to read:
1384 893.02 Definitions.—The following words and phrases as used
1385 in this chapter shall have the following meanings, unless the
1386 context otherwise requires:
1387 (24) “Prescription” includes any order for drugs or
1388 medicinal supplies which is written or transmitted by any means
1389 of communication by a licensed practitioner authorized by the
1390 laws of this state to prescribe such drugs or medicinal
1391 supplies, is issued in good faith and in the course of
1392 professional practice, is intended to be dispensed by a person
1393 authorized by the laws of this state to do so, and meets the
1394 requirements of s. 893.04.
1395 (c) A prescription for a controlled substance may not be
1396 issued on the same prescription blank with another prescription
1397 for a controlled substance that is named or described in a
1398 different schedule or with another prescription for a medicinal
1399 drug, as defined in s. 465.003 s. 465.003(8), that is not a
1400 controlled substance.
1401 Section 27. This act shall take effect July 1, 2020.