2
3
4
5
6
7 LONG TITLE
8 General Description:
9 This bill creates the Prescription Drug Price Transparency Act and the Pharmaceutical
10 Development and Marketing Act and amends the Insurance Code.
11 Highlighted Provisions:
12 This bill:
13 ▸ addresses the information a health insurer must provide to a potential enrollee with
14 respect to the insurer's medical exceptions process and the potential enrollee's cost
15 sharing for certain drugs and devices;
16 ▸ requires a health insurer to annually report to the Insurance Department certain
17 information related to prior authorization requests;
18 ▸ creates definitions;
19 ▸ amends provisions related to pharmacy benefit manager information reported to and
20 published by the Insurance Department;
21 ▸ requires insurers, pharmacy benefit managers, pharmacy services administration
22 organizations, pharmaceutical wholesalers or distributors, and pharmacies to
23 annually report information about certain drugs to the Insurance Department;
24 ▸ requires the Insurance Department to annually publish information reported to the
25 department about certain drugs;
26 ▸ requires rulemaking;
27 ▸ requires a pharmacy benefit manager or pharmacy services administration
28 organization to report to a health insurer, upon request, the amount of rebates received by the
29 pharmacy benefit manager or pharmacy services administration organization and the amount of
30 rebates passed on to the insurer;
31 ▸ requires a patient assistance program to publish contributions the program receives
32 from health insurers, drug manufacturers, pharmacy benefit managers, and related
33 trade or advocacy organizations;
34 ▸ prohibits a health care provider or pharmaceutical manufacturer from waiving or
35 taking other actions to reduce an enrollee's deductible, copayment, or coinsurance;
36 ▸ requires the Insurance Department to report to the Legislature on the effectiveness
37 of the Prescription Drug Price Transparency Act;
38 ▸ requires substitution of a drug with a drug product equivalent under certain
39 circumstances;
40 ▸ requires substitution of a biological product with an interchangeable biological
41 product under certain circumstances;
42 ▸ requires a drug manufacturer to make a drug available to a developer seeking to
43 submit an application for approval or licensing of a drug;
44 ▸ limits the price that may be charged by the manufacturer for the supplied drug;
45 ▸ limits the price that may be charged by the developer for the approved drug;
46 ▸ provides an exemption from liability;
47 ▸ provides for injunctive relief;
48 ▸ requires periodic reporting and publication of the names of a pharmaceutical
49 manufacturer's sales representatives;
50 ▸ requires periodic reporting and analysis of the activities of a pharmaceutical
51 manufacturer's sales representatives;
52 ▸ requires a person that engages in prescription drug marketing to provide a health
53 care provider with certain written materials; and
54 ▸ makes technical amendments.
55 Money Appropriated in this Bill:
56 None
57 Other Special Clauses:
58 None
59 Utah Code Sections Affected:
60 AMENDS:
61 31A-22-613.5, as last amended by Laws of Utah 2019, Chapter 439
62 31A-22-650, as enacted by Laws of Utah 2019, Chapter 439
63 31A-46-102, as enacted by Laws of Utah 2019, Chapter 241
64 31A-46-301, as enacted by Laws of Utah 2019, Chapter 241
65 31A-46-302, as renumbered and amended by Laws of Utah 2019, Chapter 241
66 58-17b-605, as last amended by Laws of Utah 2013, Chapter 423
67 58-17b-605.5, as last amended by Laws of Utah 2015, Chapter 266
68 ENACTS:
69 31A-46-305, Utah Code Annotated 1953
70 31A-46-306, Utah Code Annotated 1953
71 31A-47-101, Utah Code Annotated 1953
72 31A-47-102, Utah Code Annotated 1953
73 31A-47-103, Utah Code Annotated 1953
74 31A-47-104, Utah Code Annotated 1953
75 31A-47-105, Utah Code Annotated 1953
76 31A-47-106, Utah Code Annotated 1953
77 31A-47-107, Utah Code Annotated 1953
78 31A-47-108, Utah Code Annotated 1953
79 58-17c-101, Utah Code Annotated 1953
80 58-17c-102, Utah Code Annotated 1953
81 58-17c-103, Utah Code Annotated 1953
82 58-17c-104, Utah Code Annotated 1953
83 58-17c-105, Utah Code Annotated 1953
84
85 Be it enacted by the Legislature of the state of Utah:
86 Section 1. Section 31A-22-613.5 is amended to read:
87 31A-22-613.5. Price and value comparisons of health insurance.
88 (1) (a) This section applies to all health benefit plans.
89 (b) Subsection (2) applies to:
90 (i) all health benefit plans; and
91 (ii) coverage offered to state employees under Subsection 49-20-202(1)(a).
92 (2) The commissioner shall promote informed consumer behavior and responsible
93 health benefit plans by requiring an insurer issuing a health benefit plan to provide to all
94 enrollees, before enrollment in the health benefit plan, written disclosure of:
95 (a) restrictions or limitations on prescription drugs and biologics, including:
96 (i) the use of a formulary;
97 (ii) [
98 drugs; [
99 (iii) requirements for generic substitution; and
100 (iv) information regarding the health benefit plan's medical exceptions process,
101 including information on the procedure though which an enrollee may submit an exceptions
102 request;
103 (b) coverage limits under the plan;
104 (c) any limitation or exclusion of coverage, including:
105 (i) a limitation or exclusion for a secondary medical condition related to a limitation or
106 exclusion from coverage; and
107 (ii) easily understood examples of a limitation or exclusion of coverage for a secondary
108 medical condition;
109 (d) (i) (A) each drug, device, and covered service that is subject to a preauthorization
110 requirement as defined in Section 31A-22-650; or
111 (B) if listing each device or covered service in accordance with Subsection (2)(d)(i)(A)
112 is too numerous to list separately, all devices or covered services in a particular category where
113 all devices or covered services have the same preauthorization requirement;
114 (ii) each requirement for authorization as defined in Section 31A-22-650 for:
115 (A) each drug, device, or covered service described in Subsection (2)(d)(i)(A); and
116 (B) each category of devices or covered services described in Subsection (2)(d)(i)(B);
117 and
118 (iii) sufficient information to allow a network provider or enrollee to submit all of the
119 information to the insurer necessary to meet each requirement for authorization described in
120 Subsection (2)(d)(ii);
121 (e) whether the insurer permits an exchange of the adoption indemnity benefit in
122 Section 31A-22-610.1 for infertility treatments, in accordance with Subsection
123 31A-22-610.1(1)(c)(ii) and the terms associated with the exchange of benefits; and
124 (f) whether the insurer provides coverage for telehealth services in accordance with
125 Section 26-18-13.5 and terms associated with that coverage.
126 (3) An insurer shall provide the disclosure required by Subsection (2) in writing to the
127 commissioner:
128 (a) upon commencement of operations in the state; and
129 (b) anytime the insurer amends any of the following described in Subsection (2):
130 (i) treatment policies;
131 (ii) practice standards;
132 (iii) restrictions;
133 (iv) coverage limits of the insurer's health benefit plan or health insurance policy; or
134 (v) limitations or exclusions of coverage including a limitation or exclusion for a
135 secondary medical condition related to a limitation or exclusion of the insurer's health
136 insurance plan.
137 (4) (a) An insurer shall provide the enrollee with notice of an increase in costs for
138 prescription drug coverage due to a change in benefit design under Subsection (2)(a):
139 (i) either:
140 (A) in writing; or
141 (B) on the insurer's website; and
142 (ii) at least 30 days prior to the date of the implementation of the increase in cost, or as
143 soon as reasonably possible.
144 (b) If under Subsection (2)(a) a formulary is used, the insurer shall make available to
145 prospective enrollees and maintain evidence of the fact of the disclosure of:
146 (i) the drugs included;
147 (ii) the patented drugs not included;
148 (iii) any cost sharing for a drug or device that varies according to the quantity of the
149 drug or device dispensed, including a drug or device that is not subject to a preauthorization
150 requirement, as defined in Section 31A-22-650;
151 [
152 [
153 from the use of an excluded drug.
154 (c) The commissioner shall develop examples of limitations or exclusions of a
155 secondary medical condition that an insurer may use under Subsection (2)(c).
156 (5) Examples of a limitation or exclusion of coverage provided under this section or
157 otherwise are for illustrative purposes only, and the failure of a particular fact situation to fall
158 within the description of an example does not, by itself, support a finding of coverage.
159 (6) An insurer shall:
160 (a) post the information described in Subsection (2)(d) on the insurer's website and
161 provider portal;
162 (b) if requested by an enrollee, provide the enrollee with the information required by
163 this section by mail or email; and
164 (c) if requested by a network provider for a specific drug, device, or covered service,
165 provide the network provider with the information described in Subsection (2)(d) for the drug,
166 device, or covered service by mail or email.
167 Section 2. Section 31A-22-650 is amended to read:
168 31A-22-650. Health care preauthorization requirements.
169 (1) As used in this section:
170 (a) "Adverse preauthorization determination" means a determination by an insurer that
171 health care does not meet the preauthorization requirement for the health care.
172 (b) "Authorization" means a determination by an insurer that for health care with a
173 preauthorization requirement:
174 (i) the proposed drug, device, or covered service meets all requirements, restrictions,
175 limitations, and clinical criteria for authorization established by the insurer;
176 (ii) the drug, device, or covered service is covered by the enrollee's insurance policy;
177 and
178 (iii) the insurer will provide coverage for the drug, device, or covered service subject to
179 the provisions of the insurance policy, including any cost sharing responsibilities of the
180 enrollee.
181 (c) "Device" means a prescription device as defined in Section 58-17b-102.
182 (d) "Drug" means the same as that term is defined in Section 58-17b-102.
183 (e) "Insurer" means the same as that term is defined in Section 31A-22-634.
184 (f) "Preauthorization requirement" means a requirement by an insurer that an enrollee
185 obtain authorization for a drug, device, or service covered by the insurance policy, before
186 receiving the drug, device, or service.
187 (2) (a) An insurer may not modify an existing requirement for authorization unless, at
188 least 30 days before the day on which the modification takes effect, the insurer:
189 (i) posts a notice of the modification on the website described in Subsection
190 31A-22-613.5(6)(a); and
191 (ii) if requested by a network provider or the network provider's representative,
192 provides to the network provider by mail or email a written notice of modification to a
193 particular requirement for authorization described in the request from the network provider.
194 (b) Subsection (2)(a) does not apply if:
195 (i) complying with Subsection (2)(a) would create a danger to the enrollee's health or
196 safety; or
197 (ii) the modification is for a newly covered drug or device.
198 (c) An insurer may not revoke an authorization for a drug, device, or covered service if:
199 (i) the network provider submits a request for authorization for the drug, device, or
200 covered service to the insurer;
201 (ii) the insurer grants the authorization requested under Subsection (2)(c)(i);
202 (iii) the network provider renders the drug, device, or covered service to the enrollee in
203 accordance with the authorization and any terms and conditions of the network provider's
204 contract with the insurer;
205 (iv) on the day on which the network provider renders the drug, device, or covered
206 service to the enrollee:
207 (A) the enrollee is eligible for coverage under the enrollee's insurance policy; and
208 (B) the enrollee's condition or circumstances related to the enrollee's care have not
209 changed;
210 (v) the network provider submits an accurate claim that matches the information in the
211 request for authorization under Subsection (2)(c)(i); and
212 (vi) the authorization was not based on fraudulent or materially incorrect information
213 from the network provider.
214 (3) (a) An insurer that receives a request for authorization shall treat the request as a
215 pre-service claim as defined in 29 C.F.R. Sec. 2560.503-1 and process the request in
216 accordance with:
217 (i) 29 C.F.R. Sec. 2560.503-1, regardless of whether the coverage is offered through an
218 individual or group health insurance policy;
219 (ii) Subsection 31A-4-116(2); and
220 (iii) Section 31A-22-629.
221 (b) If a network provider submits a claim to an insurer that includes an unintentional
222 error that results in a denial of the claim, the insurer shall permit the network provider with an
223 opportunity to resubmit the claim with corrected information within a reasonable amount of
224 time.
225 (c) Except as provided in Subsection (3)(d), the appeal of an adverse preauthorization
226 determination regarding clinical or medical necessity as requested by a physician may only be
227 reviewed by a physician who is currently licensed as a physician and surgeon in a state, district,
228 or territory of the United States.
229 (d) The appeal of an adverse determination requested by a physician regarding clinical
230 or medical necessity of a drug, may only be reviewed by an individual who is currently licensed
231 in a state, district, or territory of the United States as:
232 (i) a physician and surgeon; or
233 (ii) a pharmacist.
234 (e) An insurer shall ensure that an adverse preauthorization determination regarding
235 clinical or medical necessity is made by an individual who:
236 (i) has knowledge of the medical condition or disease of the enrollee for whom the
237 authorization is requested; or
238 (ii) consults with a specialist who has knowledge of the medical condition or disease of
239 the enrollee for whom the authorization is requested regarding the request before making the
240 determination.
241 (f) An insurer shall specify how long an authorization is valid.
242 (4) (a) An insurer that removes a drug from the insurer's formulary shall:
243 (i) permit an enrollee, an enrollee's designee, or an enrollee's network provider to
244 request an exemption from the change to the formulary for the purpose of providing the patient
245 with continuity of care; and
246 (ii) have a process to review and make a decision regarding an exemption requested
247 under Subsection (4)(a)(i).
248 (b) If an insurer makes a change to the formulary for a drug in the middle of a plan
249 year, the insurer may not implement the changes for an enrollee that is on an active course of
250 treatment for the drug unless the insurer provides the enrollee with notice at least 30 days
251 before the day on which the change is implemented.
252 (5) Before April 1, 2021, and before April 1 of each year thereafter, an insurer with a
253 preauthorization requirement shall report to the department, for the previous calendar year, the
254 percentage of authorizations, not including a claim involving urgent care as defined in 29
255 C.F.R. Sec. 2560.503-1, for which the insurer notified a provider regarding an authorization or
256 adverse preauthorization determination more than one week after the day on which the insurer
257 received the request for authorization.
258 (6) An insurer may not have a preauthorization requirement for emergency health care
259 as described in Section 31A-22-627.
260 (7) For each of an insurer's health benefit plans offered in the state, an insurer shall
261 annually report to the department the following information for the plan year:
262 (a) the percentage of prescription drug prior authorization requests denied;
263 (b) the percentage of total adjudicated prior authorization appeals denied at each level
264 of internal or external appeal; and
265 (c) except for prior authorization requests that resulted in an appeal, the minimum,
266 maximum, and average number of hours between the time an enrollee submitted a request for
267 prior authorization and the time the health benefit plan provided the enrollee with notice of a
268 final decision.
269 Section 3. Section 31A-46-102 is amended to read:
270 31A-46-102. Definitions.
271 As used in this chapter:
272 (1) "Administrative fee" means any payment, other than a rebate, that a pharmaceutical
273 manufacturer makes directly or indirectly to a pharmacy benefit manager.
274 (2) "Contracting insurer" means an insurer as defined in Section 31A-22-636 with
275 whom a pharmacy benefit manager contracts to provide a pharmacy benefit management
276 service.
277 (3) "Pharmacist" means the same as that term is defined in Section 58-17b-102.
278 (4) "Pharmacy" means the same as that term is defined in Section 58-17b-102.
279 (5) "Pharmacy benefits management service" means any of the following services
280 provided to a health benefit plan, or to a participant of a health benefit plan:
281 (a) negotiating the amount to be paid by a health benefit plan for a prescription drug; or
282 (b) administering or managing a prescription drug benefit provided by the health
283 benefit plan for the benefit of a participant of the health benefit plan, including administering
284 or managing:
285 (i) a mail service pharmacy;
286 (ii) a specialty pharmacy;
287 (iii) claims processing;
288 (iv) payment of a claim;
289 (v) retail network management;
290 (vi) clinical formulary development;
291 (vii) clinical formulary management services;
292 (viii) rebate contracting;
293 (ix) rebate administration;
294 (x) a participant compliance program;
295 (xi) a therapeutic intervention program;
296 (xii) a disease management program; or
297 (xiii) a service that is similar to, or related to, a service described in Subsection (5)(a)
298 or (5)(b)(i) through (xii).
299 (6) "Pharmacy benefit manager" means a person licensed under this chapter to provide
300 a pharmacy benefits management service.
301 (7) "Pharmacy service" means a product, good, or service provided to an individual by
302 a pharmacy or pharmacist.
303 (8) "Pharmacy services administration organization" means an entity that contracts
304 with a pharmacy to assist with third-party payer interactions and administrative services related
305 to third-party payer interactions, including:
306 (a) contracting with a pharmacy benefit manager on behalf of the pharmacy; and
307 (b) managing a pharmacy's claims payments from third-party payers.
308 [
309 by a pharmaceutical manufacturer to a pharmacy benefit manager based on a prescription
310 drug's utilization or effectiveness.
311 (b) "Rebate" does not include an administrative fee.
312 Section 4. Section 31A-46-301 is amended to read:
313 31A-46-301. Reporting requirements.
314 (1) Before April 1 of each year, a pharmacy benefit manager operating in the state shall
315 report to the department, for the previous calendar year:
316 (a) any insurer, pharmacy, or pharmacist in the state with which the pharmacy benefit
317 manager had a contract;
318 [
319
320 [
321
322
323 (b) for each insurer with which the pharmacy benefit manager had a contract:
324 (i) the total value of all rebates attributable to the insurer's enrollees;
325 (ii) the total value of administrative fees attributable to the insurer's enrollees; and
326 (iii) the percentage of rebates retained by the pharmacy benefit manager.
327 (2) Records submitted to the commissioner under [
328
329 Management Act.
330 (3) (a) The department shall publish the information provided by a pharmacy benefit
331 manager under Subsection (1)[
332 (b) The department may not publish information:
333 (i) submitted under Subsection (1)(b) [
334 [
335 manager or contracting insurer identifiable; or
336 [
337 13-24-2[
338 (ii) submitted under Subsection (1)(a).
339 (c) At least 30 days before the day on which the department publishes the data, the
340 department shall provide a pharmacy benefit manager that submitted data under Subsection
341 (1)(b) [
342 (i) a general description of the data that will be published by the department;
343 (ii) an opportunity to submit to the department, within a reasonable period of time and
344 in a manner established by the department by rule made in accordance with Title 63G, Chapter
345 3, Utah Administrative Rulemaking Act:
346 (A) any correction of errors, with supporting evidence and comments; and
347 (B) information that demonstrates that the publication of the data will violate
348 Subsection (3)(b), with supporting evidence and comments.
349 Section 5. Section 31A-46-302 is amended to read:
350 31A-46-302. Direct or indirect remuneration by pharmacy benefit managers --
351 Disclosure of customer costs -- Limit on customer payment for prescription drugs.
352 (1) As used in this section:
353 (a) "Allowable claim amount" means the amount paid by an insurer under the
354 customer's health benefit plan.
355 (b) "Cost share" means the amount paid by an insured customer under the customer's
356 health benefit plan.
357 (c) "Direct or indirect remuneration" means any adjustment in the total compensation:
358 (i) received by a pharmacy from a pharmacy benefit manager for the sale of a drug,
359 device, or other product or service; and
360 (ii) that is determined after the sale of the product or service.
361 (d) "Health benefit plan" means the same as that term is defined in Section 31A-1-301.
362 (e) "Pharmacy reimbursement" means the amount paid to a pharmacy by a pharmacy
363 benefit manager for a dispensed prescription drug.
364 [
365
366
367 [
368 [
369 [
370 (i) a pharmacy services administration organization; or
371 (ii) a pharmacy benefit manager.
372 [
373 compensation for a claim.
374 (ii) "Reimbursement report" does not include a report on adjustments made pursuant to
375 a pharmacy audit or reprocessing.
376 [
377 (2) If a pharmacy service entity engages in direct or indirect remuneration with a
378 pharmacy, the pharmacy service entity shall make a reimbursement report available to the
379 pharmacy upon the pharmacy's request.
380 (3) For the reimbursement report described in Subsection (2), the pharmacy service
381 entity shall:
382 (a) include the adjusted compensation amount related to a claim and the reason for the
383 adjusted compensation; and
384 (b) provide the reimbursement report:
385 (i) in accordance with the contract between the pharmacy and the pharmacy service
386 entity;
387 (ii) in an electronic format that is easily accessible; and
388 (iii) within 120 days after the day on which the pharmacy benefit manager receives a
389 report of a sale of a product or service by the pharmacy.
390 (4) A pharmacy service entity shall, upon a pharmacy's request, provide the pharmacy
391 with:
392 (a) the reasons for any adjustments contained in a reimbursement report; and
393 (b) an explanation of the reasons provided in Subsection (4)(a).
394 (5) (a) A pharmacy benefit manager may not prohibit or penalize the disclosure by a
395 pharmacist of:
396 (i) an insured customer's cost share for a covered prescription drug;
397 (ii) the availability of any therapeutically equivalent alternative medications; or
398 (iii) alternative methods of paying for the prescription medication, including paying the
399 cash price, that are less expensive than the cost share of the prescription drug.
400 (b) Penalties that are prohibited under Subsection (5)(a) include increased utilization
401 review, reduced payments, and other financial disincentives.
402 (6) A pharmacy benefit manager may not require an insured customer to pay, for a
403 covered prescription drug, more than the lesser of:
404 (a) the applicable cost share of the prescription drug being dispensed;
405 (b) the applicable allowable claim amount of the prescription drug being dispensed;
406 (c) the applicable pharmacy reimbursement of the prescription drug being dispensed; or
407 (d) the retail price of the drug without prescription drug coverage.
408 Section 6. Section 31A-46-305 is enacted to read:
409 31A-46-305. Reporting of rebates.
410 (1) Upon the request of a health insurer, a pharmacy benefit manager shall annually
411 report to the health insurer:
412 (a) the amount of rebates received by the pharmacy benefit manager that are
413 attributable to enrollees of the health insurer's health benefit plans; and
414 (b) the amount of rebates described in Subsection (1)(a) that the pharmacy benefit
415 manager passes on to the health insurer.
416 (2) Upon the request of a health insurer, a pharmacy services administration
417 organization shall annually report to the health insurer:
418 (a) the amount of rebates received by the pharmacy services administration
419 organization that are attributable to enrollees of the health insurer's health benefit plans during
420 the previous plan year; and
421 (b) the amount of rebates described in Subsection (2)(a) that the pharmacy services
422 administration organization passes on to the health insurer.
423 Section 7. Section 31A-46-306 is enacted to read:
424 31A-46-306. Enrollee cost sharing -- Safe harbor -- Rulemaking.
425 (1) As used in this section, "health care provider" means a person that:
426 (a) meets the definition of a health care provider as defined in Section 78B-3-403; and
427 (b) is licensed under this title.
428 (2) Except as provided in Subsection (3), a health care provider or a pharmaceutical
429 manufacturer may not waive or offer to waive, provide a rebate for, or pay all or a portion of an
430 enrollee's deductible, copayment, or coinsurance owed under the enrollee's health benefit plan.
431 (3) Subsection (2) does not apply to a waiver or offer to waive, a rebate, a gift, a
432 payment for, or other offer that falls within a safe harbor:
433 (a) under federal laws related to fraud and abuse regarding patient cost sharing,
434 including federal laws related to anti-kickback, self-referral, false claims, or civil monetary
435 penalties; or
436 (b) described in an advisory opinion issued by the Centers for Medicare and Medicaid
437 Services or the United States Department of Health and Human Services Office of Inspector
438 General related to a federal law described in Subsection (3)(a).
439 (4) The department shall makes rules in accordance with Title 63G, Chapter 3, Utah
440 Administrative Rulemaking Act, to implement this section.
441 Section 8. Section 31A-47-101 is enacted to read:
442
443 31A-47-101. Title.
444 This chapter is known as "Prescription Drug Price Transparency Act."
445 Section 9. Section 31A-47-102 is enacted to read:
446 31A-47-102. Definitions.
447 As used in this chapter:
448 (1) "Drug" means a prescription drug, as defined in Section 58-17b-102.
449 (2) "Health insurer" means:
450 (a) an insurer that offers health care insurance;
451 (b) the Public Employees' Benefit and Insurance Program created in Section
452 49-20-103; or
453 (c) a workers' compensation insurer that is:
454 (i) authorized to provide workers' compensation insurance in the state; or
455 (ii) a self-insured employer as defined in Section 34A-2-201.5.
456 (3) "Manufacturer" means a person that is engaged in the manufacturing of a drug that
457 is available for purchase by residents of the state.
458 (4) "Pharmacy benefit manager" means the same as that term is defined in Section
459 31A-46-102.
460 (5) "Purchaser" means a:
461 (a) health insurer;
462 (b) pharmacy service entity as defined in Section 31A-46-302; or
463 (c) department, division, or other agency or instrumentality of the state, including an
464 independent state agency as defined in Section 63E-1-102.
465 (6) "Wholesale acquisition cost" means the same as that term is defined in 42 U.S.C.
466 Sec. 1395w-3a.
467 Section 10. Section 31A-47-103 is enacted to read:
468 31A-47-103. Prescription drug spending reports to department -- Department
469 report.
470 (1) As used in this section:
471 (a) "Pharmacy services administration organization" means the same as that term is
472 defined in Section 31A-46-102.
473 (b) "Post-rebate spending" means the net amount spent by an insurer for coverage of a
474 drug, after deduction of associated rebates paid to the insurer by a pharmacy benefit manager.
475 (c) "Total post-rebate spending" means the sum of post-rebate spending for a specific
476 drug across all health benefit plans offered by an insurer.
477 (2) (a) Subject to Subsection (2)(b), an insurer shall report to the department no later
478 than May 1 each year the following information for each drug covered by one or more health
479 benefit plans offered by the insurer on or after January 1, 2020:
480 (i) the name of the drug;
481 (ii) the dosage form of the drug;
482 (iii) the strength of the drug;
483 (iv) total post-rebate spending; and
484 (v) the percentage calculated by dividing the amount in Subsection (2)(a)(iv) by total
485 premiums received by the insurer for health benefit plans that:
486 (A) are offered by the insurer; and
487 (B) cover the drug.
488 (b) The report under Subsection (2)(a) is limited to the following drugs covered by the
489 insurer during the preceding health benefit plan year:
490 (i) the 25 drugs for which total post-rebate spending is the greatest; and
491 (ii) the 25 drugs for which total post-rebate spending increased the most since the
492 previous health benefit plan year.
493 (3) (a) Subject to Subsection (3)(b), if a pharmacy benefit manager purchases drugs,
494 the pharmacy benefit manager shall report to the department no later than May 1 each year the
495 following information for each drug purchased by the pharmacy benefit manager during the
496 preceding calendar year:
497 (i) the name of the drug;
498 (ii) the dosage form of the drug;
499 (iii) the strength of the drug; and
500 (iv) the total amount spent by the pharmacy benefit manager for purchases of the drug:
501 (A) prior to the deduction of rebates applicable to the drug; and
502 (B) after the deduction of rebates that are applicable to the drug and retained by the
503 pharmacy benefit manager.
504 (b) The report under Subsection (3)(a) is limited to:
505 (i) the 25 drugs for which spending by the pharmacy benefit manager is the greatest,
506 after the deduction of rebates that are applicable to the drug and retained by the pharmacy
507 benefit manager; and
508 (ii) the 25 drugs for which spending by the pharmacy benefit manager increased the
509 most since the previous year, after the deduction of rebates that are applicable to the drug and
510 retained by the pharmacy benefit manager.
511 (4) (a) Subject to Subsection (4)(b), if a pharmacy services administration organization
512 purchases drugs, the pharmacy services administration organization shall report to the
513 department no later than May 1 each year the following information for each drug purchased by
514 the pharmacy services administration organization during the preceding calendar year:
515 (i) the name of the drug;
516 (ii) the dosage form of the drug;
517 (iii) the strength of the drug; and
518 (iv) the total amount spent by the pharmacy services administration organization for
519 purchases of the drug:
520 (A) prior to the deduction of any applicable refunds, discounts, or other price
521 concessions received by the pharmacy services administration organization; and
522 (B) after the deduction of any applicable refunds, discounts, or other price concessions
523 received and retained by the pharmacy services administration organization.
524 (b) The report under Subsection (4)(a) is limited to:
525 (i) the 25 drugs for which spending by the pharmacy services administration
526 organization is the greatest, after the deduction of any applicable refunds, discounts, or other
527 price concessions received and retained by the pharmacy services administration organization;
528 and
529 (ii) the 25 drugs for which spending by the pharmacy services administration
530 organization increased the most since the previous year, after the deduction of any applicable
531 refunds, discounts, or other price concessions received and retained by the pharmacy services
532 administration organization.
533 (5) (a) Subject to Subsection (5)(b), a wholesaler or distributor shall report to the
534 department no later than May 1 each year the following information for each drug purchased by
535 the wholesaler or distributor during the preceding calendar year for distribution or delivery in
536 the state:
537 (i) the name of the drug;
538 (ii) the dosage form of the drug;
539 (iii) the strength of the drug; and
540 (iv) the total amount spent by the wholesaler or distributor for purchases of the drug:
541 (A) prior to the deduction of any applicable refunds, discounts, or other price
542 concessions received by the wholesaler or distributor; and
543 (B) after the deduction of any applicable refunds, discounts, or other price concessions
544 received by the wholesaler or distributor.
545 (b) The report under Subsection (5)(a) is limited to:
546 (i) the 25 drugs for which spending by the wholesaler or distributor is the greatest, after
547 the deduction of any applicable refunds, discounts, or other price concessions received by the
548 wholesaler or distributor; and
549 (ii) the 25 drugs for which spending by the wholesaler or distributor increased the most
550 since the previous year, after the deduction of any applicable refunds, discounts, or other price
551 concessions received by the wholesaler or distributor.
552 (6) (a) Subject to Subsection (6)(b), a retail pharmacy shall report to the department no
553 later than May 1 each year the following information for each drug purchased by the retail
554 pharmacy during the preceding calendar year:
555 (i) the name of the drug;
556 (ii) the dosage form of the drug;
557 (iii) the strength of the drug; and
558 (iv) the total amount spent by the retail pharmacy for purchases of the drug:
559 (A) prior to the deduction of any applicable refunds, discounts, or other price
560 concessions received by the retail pharmacy; and
561 (B) after the deduction of any applicable refunds, discounts, or other price concessions
562 received by the retail pharmacy.
563 (b) The report under Subsection (6)(a) is limited to:
564 (i) the 25 drugs for which spending by the retail pharmacy is the greatest, after the
565 deduction of any applicable refunds, discounts, or other price concessions received by the retail
566 pharmacy; and
567 (ii) the 25 drugs for which spending by the retail pharmacy increased the most since the
568 previous year, after the deduction of any applicable refunds, discounts, or other price
569 concessions received by the retail pharmacy.
570 (7) (a) Before July 1 each year, the department shall prepare and publish on the
571 department's website a report based on the information received under Subsections (2) through
572 (6).
573 (b) The report shall be published in a manner that does not permit the identification of
574 one or more:
575 (i) insurers;
576 (ii) pharmacy benefit managers;
577 (iii) pharmacy services administration organizations;
578 (iv) pharmaceutical wholesalers or distributors; or
579 (v) pharmacies.
580 (c) The report shall include current-year data and identify multi-year trends regarding:
581 (i) insurer post-rebate spending on individual drugs;
582 (ii) insurer post-rebate spending on individual drugs as a percentage of premiums;
583 (iii) pharmacy benefit manager spending on individual drugs and the retention of
584 rebates;
585 (iv) pharmacy services administration organization spending on individual drugs and
586 the retention of applicable refunds, discounts, or other price concessions;
587 (v) wholesaler or distributor spending on individual drugs; and
588 (vi) pharmacy spending on individual drugs.
589 (8) Except for information published by the department under Subsection (7),
590 information reported to the department under Subsections (2) through (6) is a protected record
591 under Title 63G, Chapter 2, Government Records Access and Management Act.
592 Section 11. Section 31A-47-104 is enacted to read:
593 31A-47-104. Manufacturer notice of drug cost increase.
594 (1) As used in this section:
595 (a) (i) "Qualified drug" means a drug whose wholesale acquisition cost increases 10%
596 or more over a 12-month period.
597 (ii) "Qualified drug" does not include a new drug introduced into the market by a
598 manufacturer.
599 (b) "Registered purchaser" means a purchaser that submits a request for notice to the
600 department under Subsection 31A-47-106(2)(b).
601 (c) "Research and development costs" means all expenses and expenditures by a
602 manufacturer that are:
603 (i) incurred during a calendar year; and
604 (ii) related to the research and development of a new product, process, or service,
605 including the acquisition of a license.
606 (2) A manufacturer shall send a notice in accordance with this section for each
607 qualified drug no later than 60 days before the day on which the increase to the wholesale
608 acquisition cost of the qualified drug results in a one-year percentage increase greater than or
609 equal to 10%.
610 (3) A manufacturer shall send a notice to each registered purchaser that includes:
611 (a) the date on which the wholesale acquisition cost of the qualified drug will increase;
612 (b) a description of any improvements or other changes to the qualified drug that
613 makes the increase in the wholesale acquisition cost of the qualified drug necessary;
614 (c) the wholesale acquisition cost of the qualified drug after the increase to the
615 wholesale acquisition cost;
616 (d) the amount of the increase to the wholesale acquisition cost of the qualified drug;
617 (e) the percentage increase to the wholesale acquisition cost of the qualified drug;
618 (f) the wholesale acquisition cost of the qualified drug 12 months before the date of the
619 increase to the wholesale acquisition cost of the qualified drug;
620 (g) the amount of the increase in the wholesale acquisition cost over the 12-month
621 period immediately before the increase in the wholesale acquisition cost of the qualified drug;
622 and
623 (h) the percentage increase in the wholesale acquisition cost of the qualified drug over
624 the 12-month period immediately before the increase in the wholesale acquisition cost of the
625 qualified drug.
626 (4) Except as provided in Subsection (5), a manufacturer shall send a notice to the
627 department that includes:
628 (a) the information described in Subsection (3);
629 (b) an explanation of how financial and nonfinancial factors justify the increase in the
630 wholesale acquisition cost of the qualified drug, including any improvement or other
631 modification of the qualified drug;
632 (c) (i) for a qualified drug that has been manufactured by the manufacturer for longer
633 than the previous five years:
634 (A) the wholesale acquisition cost of the qualified drug over the previous five-year
635 period;
636 (B) for each of the previous five years, the research and development costs of the drug;
637 and
638 (C) for each of the previous five years, all other costs incurred by the manufacturer for
639 the manufacturing and marketing of the drug; or
640 (ii) for a qualified drug that has been manufactured by the manufacturer for less than
641 five years:
642 (A) the date on which the manufacturer began manufacturing the qualified drug;
643 (B) the date on which the manufacturer began selling the qualified drug;
644 (C) the wholesale acquisition cost of the qualified drug over the period beginning on
645 the day on which the manufacturer began selling the qualified drug;
646 (D) for each of the previous five years, the research and development costs of the drug;
647 and
648 (E) for each of the previous five years, all other costs incurred by the manufacturer for
649 the manufacturing and marketing of the drug; and
650 (d) for a qualified drug that the manufacturer acquired the right to manufacture within
651 the previous five years, to the extent the information is publicly available:
652 (i) the name of the person from which the manufacturer acquired the right to
653 manufacture the qualified drug;
654 (ii) the wholesale acquisition cost of the qualified drug immediately before the
655 manufacturer acquired the right to manufacture the qualified drug; and
656 (iii) the wholesale acquisition cost of the qualified drug one year before the day on
657 which the manufacturer acquired the right to manufacture the qualified drug.
658 (5) A manufacturer is not required to report a trade secret as defined in Section
659 13-24-2, in the notice to the department under Subsection (4).
660 Section 12. Section 31A-47-105 is enacted to read:
661 31A-47-105. Manufacturer submission of new drug information to the
662 department -- Report of new drug.
663 If a new drug available for purchase by residents of the state has a wholesale acquisition
664 cost that exceeds the upper limit of payment for the new drug under 42 C.F.R. Sec. 447.512,
665 the manufacturer of the new drug shall submit to the department:
666 (1) no later than three days after the day on which the new drug is sold in the state, a
667 written notice of the introduction of the new drug; and
668 (2) no later than 30 days after the day on which the new drug is sold in the state, a
669 report that includes publicly available information regarding:
670 (a) the wholesale acquisition cost of the new drug;
671 (b) a description of the marketing and pricing plans used in the launch of the new drug:
672 (i) in the United States; and
673 (ii) outside of the United States;
674 (c) the estimated number of patients that are expected to be prescribed the new drug;
675 (d) whether the new drug was granted breakthrough therapy designation or priority
676 review by the United States Food and Drug Administration; and
677 (e) if the manufacturer did not develop the drug, the acquisition date and price for the
678 new drug.
679 Section 13. Section 31A-47-106 is enacted to read:
680 31A-47-106. Publication of information submitted to the department --
681 Rulemaking -- Penalties.
682 (1) The department shall publish on the department's website the information
683 submitted by a manufacturer under Sections 31A-47-104 and 31A-47-105 no later than 60 days
684 after the day on which the department receives the information from the manufacturer.
685 (2) The department shall make rules in accordance with Title 63G, Chapter 3, Utah
686 Administrative Rulemaking Act, regarding:
687 (a) the format for a manufacturer to submit a notice under Sections 31A-47-104 and
688 31A-47-105;
689 (b) procedures for a purchaser to register to receive notice of a drug price increase as a
690 registered purchaser under Section 31A-47-104; and
691 (c) procedures for a manufacturer to obtain the contact information for each registered
692 purchaser.
693 (3) The department may impose a penalty of up to $1,000 per day for each day a
694 manufacturer is in violation of this chapter.
695 Section 14. Section 31A-47-107 is enacted to read:
696 31A-47-107. Patient assistance program -- Report of contributions.
697 (1) As used in this section:
698 (a) "Applicable entity" means:
699 (i) a health insurer;
700 (ii) a manufacturer;
701 (iii) a pharmacy benefit manager; or
702 (iv) a trade or advocacy organization for an entity described in Subsections (1)(a)(i)
703 through (iii).
704 (b) "Contribution" means money, donations, loans, subsidies, or any other
705 consideration of value.
706 (c) "Gross income" means the sum of income and the fair value of any other
707 contributions received by a patient assistance program from an applicable entity.
708 (d) "Patient assistance program" means a program that is offered by an independent
709 nonprofit organization that:
710 (i) advocates on behalf of patients in the state;
711 (ii) funds medical research in the state;
712 (iii) reduces consumer out-of-pocket costs of a drug; or
713 (iv) provides grants to defray medical expenses.
714 (2) On or before February 1 each year, a patient assistance program shall prepare a
715 report for the preceding calendar year that lists:
716 (a) for each contribution received by the patient assistance program from an applicable
717 entity:
718 (i) the amount of the contribution; and
719 (ii) the applicable entity from which the patient assistance program received the
720 contribution; and
721 (b) for each applicable entity from which the patient assistance program received a
722 contribution, the percentage of the patient assistant program's gross income attributable to
723 contributions from the applicable entity.
724 (3) (a) Except as provided in Subsection (3)(b), a patient assistance program shall post
725 the report described in Subsection (2) to a publicly accessible website maintained by the patient
726 assistance program.
727 (b) If the patient assistance program does not maintain a publicly accessible website:
728 (i) the patient assistance program shall submit the report to the department; and
729 (ii) the department shall post the report to the department's website.
730 Section 15. Section 31A-47-108 is enacted to read:
731 31A-47-108. Report to Legislature.
732 The department shall report to the Business and Labor Interim Committee and the
733 Health and Human Services Interim Committee before October 1, 2022, on the implementation
734 of this chapter, including the effectiveness of the provisions of this chapter in:
735 (1) promoting pharmaceutical pricing transparency;
736 (2) enhancing understanding of pharmaceutical spending trends; and
737 (3) assisting the state and other payers of health care services in the management of
738 pharmaceutical spending.
739 Section 16. Section 58-17b-605 is amended to read:
740 58-17b-605. Drug product equivalents.
741 (1) For the purposes of this section:
742 (a) (i) "Drug" [
743 (ii) "Drug" does not [
744 58-17b-605.5.
745 (b) "Drug product equivalent" means a drug product that is designated as the
746 therapeutic equivalent of another drug product in the Approved Drug Products with
747 Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
748 of the United States Food and Drug Administration.
749 (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
750 by brand or proprietary name [
751 prescribed drug [
752 [
753
754 [
755 therapeutic equivalent in the approved drug products with therapeutic equivalence evaluations
756 prepared by the Center for Drug Evaluation and Research of the Federal Food and Drug
757 Administration;
758 [
759 [
760 expected response to the prescribed drug, whether a substitute or not, and the substitution is not
761 otherwise prohibited by this chapter;
762 [
763 may not be substituted for the drug, as provided in Subsection [
764 [
765 (3) (a) Each out-of-state mail service pharmacy dispensing a drug product equivalent as
766 a substitute for another drug into this state shall notify the patient of the substitution either by
767 telephone or in writing.
768 (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
769 chapter with respect to a drug product equivalent substituted for another drug, including
770 labeling and record keeping.
771 [
772
773
774
775
776 [
777 product equivalent under this section assumes no greater liability than would be incurred had
778 the pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
779 [
780 the patient that a drug product equivalent not be substituted for a prescribed drug, the
781 practitioner may indicate a prohibition on substitution either by writing "dispense as written" or
782 signing in the appropriate space where two lines have been preprinted on a prescription order
783 and captioned "dispense as written" or "substitution permitted".
784 (b) If the prescription is communicated orally by the prescribing practitioner to the
785 pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
786 and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
787 name of the practitioner and the words "orally by" and the initials of the pharmacist or
788 pharmacy intern written after it.
789 [
790 for a prescribed drug shall communicate the substitution to the purchaser. The drug product
791 equivalent container shall be labeled with the name of the drug dispensed, and the pharmacist,
792 pharmacy intern, or pharmacy technician shall indicate on the file copy of the prescription both
793 the name of the prescribed drug and the name of the drug product equivalent dispensed in its
794 place.
795 [
796 (i) a generic drug for another generic drug;
797 (ii) a generic drug for a nongeneric drug;
798 (iii) a nongeneric drug for another nongeneric drug; or
799 (iv) a nongeneric drug for a generic drug.
800 (b) A prescribing practitioner who makes a finding under Subsection [
801 patient with a seizure disorder shall indicate a prohibition on substitution of a drug product
802 equivalent in the manner provided in Subsection [
803 (c) Except as provided in Subsection [
804 cannot dispense the prescribed drug as written, and who needs to substitute a drug product
805 equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the
806 prescribing practitioner prior to the substitution.
807 (d) Notification under Subsection [
808 equivalent is paid for in whole or in part by Medicaid.
809 [
810 authorized does not constitute evidence of negligence.
811 Section 17. Section 58-17b-605.5 is amended to read:
812 58-17b-605.5. Interchangeable biological products.
813 (1) For the purposes of this section:
814 (a) "Biological product" means the same as that term is defined in 42 U.S.C. Sec. 262.
815 (b) "Interchangeable biological product" means a biological product that the federal
816 Food and Drug Administration:
817 (i) has:
818 (A) licensed; and
819 (B) determined meets the standards for interchangeability pursuant to 42 U.S.C. Sec.
820 262(k)(4); or
821 (ii) has determined is therapeutically equivalent as set forth in the latest edition of or
822 supplement to the federal Food and Drug Administration's Approved Drug Products with
823 Therapeutic Equivalence Evaluations.
824 (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific
825 biological product by brand or proprietary name [
826 biological product for the prescribed biological product [
827 [
828
829 [
830 commerce;
831 [
832 expected response to the prescribed biological product, whether a substitute or not, and the
833 substitution is not otherwise prohibited by this chapter;
834 [
835 interchangeable biological product for the prescribed biological product, as provided in
836 Subsection (6); and
837 [
838 (3) Each out-of-state mail service pharmacy dispensing an interchangeable biological
839 product as a substitute for another biological product into this state shall:
840 (a) notify the patient of the substitution either by telephone or in writing; and
841 (b) comply with the requirements of this chapter with respect to an interchangeable
842 biological product substituted for another biological product, including labeling and record
843 keeping.
844 (4) Pharmacists or pharmacy interns may not substitute without the prescriber's
845 authorization biological product prescriptions unless the product has been determined by the
846 United States Food and Drug Administration to be interchangeable with the prescribed
847 biological product.
848 (5) A pharmacist or pharmacy intern who dispenses a prescription with an
849 interchangeable biological product under this section assumes no greater liability than would be
850 incurred had the pharmacist or pharmacy intern dispensed the prescription with the biological
851 product prescribed.
852 (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
853 patient that an interchangeable biological product not be substituted for a prescribed biological
854 product, the practitioner may prohibit a substitution either by writing "dispense as written" or
855 by signing in the appropriate space where two lines have been preprinted on a prescription
856 order and captioned "dispense as written" or "substitution permitted."
857 (b) (i) If the prescription is communicated orally by the prescribing practitioner to the
858 pharmacist or pharmacy intern, the practitioner shall direct the prohibition or substitution.
859 (ii) The pharmacist or pharmacy intern shall make a written note of the practioner's
860 direction by writing the name of the practitioner and the words "orally by" and the initials of
861 the pharmacist or pharmacy intern written after it.
862 (7) A pharmacist or pharmacy intern who substitutes an interchangeable biological
863 product for a prescribed biological product shall communicate the substitution to the purchaser.
864 The interchangeable biological product container shall be labeled with the name of the
865 interchangeable biological product dispensed, and the pharmacist, pharmacy intern, or
866 pharmacy technician shall indicate on the file copy of the prescription both the name of the
867 prescribed biological product and the name of the interchangeable biological product dispensed
868 in its place.
869 [
870
871
872
873
874
875
876
877
878
879 [
880
881 [
882
883 [
884 Section 18. Section 58-17c-101 is enacted to read:
885
886 58-17c-101. Title.
887 This chapter is known as "Pharmaceutical Development and Marketing Act."
888 Section 19. Section 58-17c-102 is enacted to read:
889 58-17c-102. Definitions.
890 As used in this chapter:
891 (1) "Drug" means the same as that term is defined in Section 58-17b-102.
892 (2) "Health care entity" means:
893 (a) a health care provider;
894 (b) a health care facility as that term is defined in Section 26-21-2; or
895 (c) a pharmacy.
896 (3) "Health care provider" means a person that:
897 (a) meets the definition of a health care provider as defined in Section 78B-3-403; and
898 (b) is licensed under this title.
899 (4) "Pharmaceutical manufacturer" means a person that is engaged in the
900 manufacturing of a drug or pharmaceutical device that is available for purchase by residents of
901 the state.
902 (5) "Pharmacy" means the same as that term is defined in Section 58-17b-102.
903 (6) "Prescription drug marketing" means providing to a health care entity, on behalf of
904 a pharmaceutical manufacturer, educational or marketing information or materials regarding a
905 drug that is available to a resident of the state, including through:
906 (a) a face-to-face meeting;
907 (b) a physical mailing;
908 (c) a telephone conversation;
909 (d) electronic mail or facsimile; or
910 (e) an event.
911 Section 20. Section 58-17c-103 is enacted to read:
912 58-17c-103. Availability of drug for testing -- Limits on prices -- Liability
913 exemption -- Enforcement -- Rulemaking.
914 (1) As used in this section:
915 (a) "Application" means an application for:
916 (i) the approval of a drug under 21 U.S.C. Sec. 355(a); or
917 (ii) the licensing of a biological product under 42 U.S.C. Sec. 262(a)(1).
918 (b) "Developer" means a person seeking to submit an application.
919 (c) "Pharmaceutical wholesaler or distributor" means the same as that term is defined
920 in Section 58-17b-102.
921 (d) "Wholesale acquisition cost" means the same as that term is defined in 42 U.S.C.
922 Sec. 1395w-3a.
923 (2) (a) In accordance with Subsection (2)(b), a pharmaceutical manufacturer or a
924 pharmaceutical wholesaler or distributor shall, for a developer, make available for sale a drug
925 distributed in the state for the purpose of conducting testing required to support the application.
926 (b) A pharmaceutical manufacturer or a pharmaceutical wholesaler or distributor shall
927 make the drug available for sale under Subsection (2)(a):
928 (i) at a price no higher than the drug's wholesale acquisition cost; and
929 (ii) without any restriction that would block or delay the application.
930 (3) A developer that buys a drug made available for sale in accordance with Subsection
931 (2) may not charge a consumer a price for the drug higher than the price for which the
932 developer bought the drug.
933 (4) A pharmaceutical manufacturer or a pharmaceutical wholesaler or distributor that
934 makes available a drug for sale under Subsection (2)(a) is not liable for a claim arising out of
935 the failure of a developer that buys the drug to follow adequate safeguards to ensure safe use of
936 the drug during the testing described in Subsection (2)(a), including:
937 (a) transportation;
938 (b) handling;
939 (c) use; or
940 (d) disposal of the drug.
941 (5) (a) Notwithstanding any other provision of law, the attorney general may seek
942 injunctive relief against a pharmaceutical manufacturer or a pharmaceutical wholesaler or
943 distributor that violates the provisions of this section.
944 (b) If the attorney general prevails in an action described in Subsection (5)(a), the court
945 shall order the pharmaceutical manufacturer or the pharmaceutical wholesaler or distributor to
946 pay the attorney general's investigative costs, court costs, and attorney fees.
947 (6) The division shall make rules as necessary, in accordance with Title 63G, Chapter
948 3, Utah Administrative Rulemaking Act, to implement this section.
949 Section 21. Section 58-17c-104 is enacted to read:
950 58-17c-104. Manufacturer reporting of sales representatives -- Sales
951 representative reporting -- Division report -- Rulemaking.
952 (1) As used in this section:
953 (a) "Compensation" means the total payment or transfer of value provided by a
954 pharmaceutical sales representative to a health care entity.
955 (b) "Pharmaceutical sales representative" means an individual who engages in
956 prescription drug marketing to a health care entity.
957 (2) A pharmaceutical manufacturer shall provide to the division each month a list of all
958 pharmaceutical sales representatives that the pharmaceutical manufacturer employs or has a
959 contract with to engage in prescription drug marketing.
960 (3) The division shall provide to a health care entity electronic access to the lists
961 described in Subsection (2).
962 (4) A pharmaceutical sales representative on a list described in Subsection (2):
963 (a) may engage, on behalf of any pharmaceutical manufacturer, in prescription drug
964 marketing to any health care entity; and
965 (b) shall, on or before March 1 each year, submit to the division a report for the
966 immediately preceding calendar year that includes:
967 (i) a list of all health care entities to which the pharmaceutical sales representative
968 provided:
969 (A) compensation by an individual transaction of $10 or more; or
970 (B) compensation for the year totaling a fair market value of $100 or more;
971 (ii) the name and pharmaceutical manufacturer of each drug of which the
972 pharmaceutical sales representative provided a free sample to a health care entity; and
973 (iii) the name of each health care entity to which the pharmaceutical manufacturer
974 provided a free sample of a drug.
975 (5) (a) The division shall develop an annual report, based on the reports to the division
976 described in this section, that includes an analysis of the activities of pharmaceutical sales
977 representatives in the state.
978 (b) The annual report shall include:
979 (i) the names of all pharmaceutical sales representatives included on any list described
980 in Subsection (2);
981 (ii) the names of all pharmaceutical manufacturers that provide to the division a list
982 described in Subsection (2);
983 (iii) the names of all drugs described in Subsection (4)(b)(ii); and
984 (iv) the number of health care entities described in Subsection (4)(b)(i).
985 (c) On or before June 1 of each year, the division shall:
986 (i) post the annual report on the division's website; and
987 (ii) submit the annual report to the governor and the Business and Labor Interim
988 Committee.
989 (6) The division shall make rules as necessary, in accordance with Title 63G, Chapter
990 3, Utah Administrative Rulemaking Act, to implement this section.
991 (7) The division may assess a pharmaceutical manufacturer or a pharmaceutical sales
992 representative a fine of up to $10,000 for each violation of this section.
993 Section 22. Section 58-17c-105 is enacted to read:
994 58-17c-105. Written materials for prescription drug marketing -- Rulemaking.
995 (1) A person that engages in prescription drug marketing to a health care provider with
996 the intent that the health care provider prescribe the drug for use by the health care provider's
997 patients shall provide to the health care provider written materials that include:
998 (a) the date the written materials were prepared;
999 (b) the name of the drug;
1000 (c) the name of the pharmaceutical manufacturer that manufactures the drug;
1001 (d) the average wholesale price of the drug for each labeled indication, including any
1002 differences in the average wholesale price as a result of different strengths or dosage forms
1003 approved for sale; and
1004 (e) (i) if the drug is designed to be administered for 30 days or more, the average
1005 wholesale price of a 30-day supply of the drug; or
1006 (ii) if the drug is designed to be administered for less than 30 days, the average
1007 wholesale price of a supply for the period of time for which the drug is designed to be
1008 administered.
1009 (2) A person shall provide to a health care provider all of the written materials required
1010 by Subsection (1) no later than the earlier of:
1011 (a) the time the person provides any written materials to the health care provider while
1012 engaging in prescription drug marketing regarding the drug; or
1013 (b) one business day after engaging in prescription drug marketing regarding the drug.
1014 (3) The division shall make rules as necessary, in accordance with Title 63G, Chapter
1015 3, Utah Administrative Rulemaking Act, to implement this section.