1
2
3
4
5
6
7
8 LONG TITLE
9 General Description:
10 This bill amends the Online Prescribing, Dispensing, and Facilitation Licensing Act.
11 Highlighted Provisions:
12 This bill:
13 ▸ amends definitions;
14 ▸ authorizes an optometrist to engage in the delivery of online pharmaceutical
15 services;
16 ▸ modifies the composition of the Online Prescribing, Dispensing, and Facilitation
17 Licensing Board;
18 ▸ authorizes the online prescribing and dispensing of medical devices; and
19 ▸ makes technical changes.
20 Money Appropriated in this Bill:
21 None
22 Other Special Clauses:
23 None
24 Utah Code Sections Affected:
25 AMENDS:
26 58-83-102, as enacted by Laws of Utah 2010, Chapter 180
27 58-83-201, as enacted by Laws of Utah 2010, Chapter 180
28 58-83-301, as enacted by Laws of Utah 2010, Chapter 180
29 58-83-302, as enacted by Laws of Utah 2010, Chapter 180
30 58-83-305, as enacted by Laws of Utah 2010, Chapter 180
31 58-83-306, as last amended by Laws of Utah 2015, Chapter 321
32 58-83-307, as enacted by Laws of Utah 2010, Chapter 180
33 58-83-308, as enacted by Laws of Utah 2010, Chapter 180
34 58-83-401, as last amended by Laws of Utah 2011, Chapter 367
35 58-83-501, as enacted by Laws of Utah 2010, Chapter 180
36 58-83-503, as enacted by Laws of Utah 2010, Chapter 180
37
38 Be it enacted by the Legislature of the state of Utah:
39 Section 1. Section 58-83-102 is amended to read:
40 58-83-102. Definitions.
41 In addition to the definitions in Section 58-1-102, as used in this chapter:
42 (1) "Board" means the Online Prescribing, Dispensing, and Facilitation Licensing
43 Board created in Section 58-83-201.
44 (2) "Branching questionnaire" means an adaptive and progressive assessment tool
45 approved by the board.
46 (3) "Controlled substance" means the same as that term is defined in Section
47 58-17b-102.
48 [
49
50 the drugs or devices authorized by Section 58-83-306, using:
51 (a) a branching questionnaire or other assessment tool approved by the division for the
52 purpose of diagnosing and assessing a patient's health status;
53 (b) an Internet contract pharmacy to:
54 (i) dispense the prescribed drug or device; or
55 (ii) transfer the prescription to another pharmacy; and
56 (c) an Internet facilitator to facilitate the practices described in Subsections [
57 and (b).
58 (5) "Device" means a prescription device, as that term is defined in Section
59 58-17b-102, except that "device" does not include a prescription device that requires surgical
60 implantation.
61 (6) "Dispense" means the same as that term is defined in Section 58-17b-102.
62 [
63 Licensing.
64 (8) "Drug" means the same as that term is defined in Section 58-17b-102.
65 [
66 electronic communication between and among an online prescriber, the online prescriber's
67 patient, and the online contract pharmacy.
68 (10) "Legend drug" means a prescription drug.
69 [
70 under Chapter 17b, Pharmacy Practice Act, as either a [
71 pharmacy or a [
72 under this chapter to fulfill prescriptions issued by an online prescriber through a specific
73 Internet facilitator.
74 [
75
76
77 (a) a physician licensed under Chapter 67, Utah Medical Practice Act, or Chapter 68,
78 Utah Osteopathic Medical Practice Act, who has obtained a license under [
79
80 (b) an optometrist licensed under Chapter 16A, Utah Optometry Practice Act, who has
81 obtained a license under Part 3, Licensing, to prescribe online.
82 (13) "Pharmacist" means the same as that term is defined in Section 58-17b-102.
83 (14) "Pharmacy" means the same as that term is defined in Section 58-17b-102.
84 (15) "Prescribe" means the same as that term is defined in Section 58-17b-102.
85 (16) "Prescription" means the same as that term is defined in Section 58-17b-102.
86 (17) "Prescription drug" means the same as that term is defined in Section 58-17b-102.
87 [
88 58-1-501 [
89 [
90
91
92 (a) in Sections 58-1-501, 58-1-203, and 58-83-502; and
93 (b) by rule made pursuant to Section 58-1-203 or 58-83-502.
94 Section 2. Section 58-83-201 is amended to read:
95 58-83-201. Board.
96 (1) There is created the Online Prescribing, Dispensing, and Facilitation Licensing
97 Board consisting of the following seven members:
98 (a) two members who are licensed under either Chapter 67, Utah Medical Practice Act,
99 or Chapter 68, Utah Osteopathic Medical Practice Act, of [
100 (i) one shall be engaged in the delivery of online pharmaceutical services; and
101 (ii) one may not be an online prescriber [
102 (b) two members who are licensed as a pharmacist under Chapter 17b, Pharmacy
103 Practice Act, of [
104 (i) one shall be associated with an online contract pharmacy; and
105 (ii) one may not be associated with an online contract pharmacy;
106 (c) [
107 (i) an online prescriber;
108 (ii) an online contract pharmacy; or
109 (iii) an Internet facilitator; and
110 (d) [
111 Internet facilitator, of whom:
112 (i) one shall be associated with the online prescribing of prescription drugs; and
113 (ii) one shall be associated with the online prescribing of prescription devices.
114 (2) Notwithstanding any other requirement for membership on the board, no more than
115 one member of the board may be associated in any of the following ways with the same
116 Internet facilitator:
117 (a) as an owner;
118 (b) as an employee;
119 (c) as an officer;
120 (d) as a director;
121 (e) contracted with;
122 (f) as an agent of; or
123 (g) having any direct or indirect financial interest.
124 (3) The board shall be appointed and serve in accordance with Section 58-1-201.
125 (4) (a) The duties and responsibilities of the board shall be in accordance with Sections
126 58-1-202 and 58-1-203, and as otherwise provided in this chapter.
127 (b) The board may designate one of its members on a permanent or rotating basis to:
128 (i) assist the division in reviewing complaints concerning the unlawful or
129 unprofessional conduct of a licensee; and
130 (ii) advise the division in its investigation of a complaint.
131 (5) A board member who has, under Subsection (4), reviewed a complaint or advised
132 in its investigation may be disqualified from participating with the board when the board serves
133 as a presiding officer of an administrative proceeding concerning the complaint.
134 Section 3. Section 58-83-301 is amended to read:
135 58-83-301. Licensure required -- Issuance of licenses.
136 (1) [
137 (a) an optometrist licensed under Chapter 16A, Utah Optometry Practice Act, shall be
138 licensed under this chapter to engage in the delivery of online pharmaceutical services;
139 [
140 68, Utah Osteopathic Medical Practice Act, shall be licensed under this chapter to engage in the
141 delivery of online pharmaceutical services;
142 [
143 the delivery of online pharmaceutical services; and
144 [
145 delivery of online pharmaceutical services.
146 (2) The division shall issue, to any person who qualifies under this chapter, a license:
147 (a) to prescribe online;
148 (b) to operate as an online contract pharmacy; or
149 (c) to operate as an Internet facilitator.
150 (3) (a) A license under this chapter is not required to engage in electronic prescribing
151 under Chapter 82, Electronic Prescribing Act[
152 (b) Nothing in this chapter shall prohibit [
153 16A, Utah Optometry Practice Act, or physician licensed under Chapter 67, Utah Medical
154 Practice Act, or Chapter 68, Utah Osteopathic Medical Practice Act, from electronic
155 prescribing or Internet prescribing as permitted by Chapter 16A, Utah Optometry Practice Act,
156 Chapter 67, Utah Medical Practice Act, [
157 Act, or other law.
158 Section 4. Section 58-83-302 is amended to read:
159 58-83-302. Qualifications for licensure.
160 (1) Each applicant for licensure as an online prescriber under this chapter shall:
161 (a) submit an application in a form prescribed by the division;
162 (b) pay a fee determined by the department under Section 63J-1-504;
163 (c) be of good moral character;
164 (d) document that the applicant holds a Utah license that is active and in good standing
165 and authorizes the licensee to engage in the assessment, diagnosis, and treatment of human
166 ailments and the [
167 (e) document that any other professional license the applicant possesses from other
168 jurisdictions is in good standing;
169 (f) (i) submit to the division an outline of the applicant's proposed online assessment,
170 diagnosis, and prescribing tool, such as a branching questionnaire; and
171 (ii) demonstrate the proposed online assessment, diagnosis, and prescribing tool to the
172 board and establish to the board's satisfaction that the utilization of that assessment tool to
173 facilitate the [
174 under Section [
175 welfare;
176 (g) submit policies and procedures that address patient confidentiality, including
177 measures that will be taken to ensure that the age and other identifying information of the
178 person completing the online branching questionnaire are accurate;
179 (h) describe the mechanism by which the online prescriber and patient will
180 communicate with one another, including electronic and telephonic communication;
181 (i) describe how the online prescriber/patient relationship will be established and
182 maintained;
183 (j) submit the name, address, and contact person of the Internet facilitator with whom
184 the online prescriber has contracted to provide services that the online prescriber will use to
185 engage in online assessment, diagnosis, and prescribing; and
186 (k) submit documentation satisfactory to the board regarding public health, safety, and
187 welfare demonstrating:
188 (i) how the online prescriber will comply with the requirements of Section 58-83-305;
189 (ii) the contractual services arrangement between the online prescriber and:
190 (A) the Internet facilitator; and
191 (B) the online contract pharmacy; and
192 (iii) how the online prescriber will allow and facilitate the division's ability to conduct
193 audits in accordance with Section 58-83-308.
194 (2) An online prescriber may not use the services of an Internet facilitator or online
195 contract pharmacy whose license is not active and in good standing.
196 (3) Each applicant for licensure as an online contract pharmacy under this chapter
197 shall:
198 (a) be licensed in good standing [
199 as a [
200 class B closed-door pharmacy;
201 (b) submit a written application in the form prescribed by the division;
202 (c) pay a fee as determined by the department under Section 63J-1-504;
203 (d) submit any contract between the applicant and the Internet facilitator with which
204 the applicant is or will be affiliated;
205 (e) submit proof of liability insurance acceptable to the division that expressly covers
206 all activities the online contract pharmacy will engage in under this chapter, which coverage
207 shall be in a minimum amount of $1,000,000 per occurrence with a policy limit of not less than
208 $3,000,000;
209 (f) submit a signed affidavit to the division attesting that the online contract pharmacy
210 will not dispense a drug or device that is prescribed by an online prescriber engaged in the
211 delivery of online pharmaceutical services under the provisions of this chapter unless:
212 (i) the drug or device is specifically approved by the division under Section 58-83-306;
213 and
214 (ii) both the prescribing and the dispensing of the drug or device were facilitated by the
215 Internet facilitator with whom the Internet contract pharmacy is associated under Subsection
216 58-83-302(3)(d);
217 (g) document that any other professional license the applicant possesses from other
218 jurisdictions is active and in good standing; and
219 (h) demonstrate to the division that the applicant has satisfied any background check
220 required by Section 58-17b-307, and each owner, officer, or manager of the applicant online
221 contract pharmacy has not engaged in any act, practice, or omission, which when considered
222 with the duties and responsibilities of a licensee under this chapter indicates there is cause to
223 believe that issuing a license under this chapter is inconsistent with the public's health, safety,
224 or welfare.
225 (4) Each applicant for licensure as an Internet facilitator under this chapter shall:
226 (a) submit a written application in the form prescribed by the division;
227 (b) pay a fee as determined by the department under Section 63J-1-504;
228 (c) submit any contract between the applicant and the following with which the
229 applicant will be affiliated:
230 (i) each online prescriber; and
231 (ii) the single online contract pharmacy;
232 (d) submit written policies and procedures satisfactory to the division that:
233 (i) address patient privacy, including compliance with 45 C.F.R. Parts 160, 162, and
234 164, Health Insurance Portability and Accountability Act of 1996;
235 (ii) ensure compliance with all applicable laws by health care personnel and the online
236 prescriber who will process patient communications;
237 (iii) list the hours of operation;
238 (iv) describe the types of services that will be permitted electronically;
239 (v) describe the required patient information to be included in the communication, such
240 as patient name, identification number, and type of transaction;
241 (vi) establish procedures for archiving and retrieving information; and
242 (vii) establish quality oversight mechanisms;
243 (e) submit written documentation of the applicant's security measures to ensure the
244 confidentiality and integrity of any user-identifiable medical information;
245 (f) submit a description of the mechanism for:
246 (i) patients to access, supplement, and amend patient-provided personal health
247 information;
248 (ii) back-up regarding the Internet facilitator electronic interface;
249 (iii) the quality of information and services provided via the interface; and
250 (iv) patients to register complaints regarding the Internet facilitator, the online
251 prescriber, or the online contract pharmacy;
252 (g) submit a copy of the Internet facilitator's website;
253 (h) sign an affidavit attesting that:
254 (i) the applicant will not access any medical records or information contained in the
255 medical record except as necessary to administer the website and the branching questionnaire;
256 and
257 (ii) the applicant and its principals, and any entities affiliated with them, will only use
258 the services of a single online contract pharmacy named on the license approved by the
259 division; and
260 (i) submit any other information required by the division.
261 Section 5. Section 58-83-305 is amended to read:
262 58-83-305. Duties and responsibilities.
263 (1) The online prescriber shall:
264 (a) be held to the same standards of appropriate practice as those applicable in
265 traditional settings which, for purposes of this chapter, include the delivery of online
266 pharmaceutical services;
267 (b) conduct an assessment and diagnosis based upon a comprehensive health history
268 and an assessment tool such as a branching questionnaire;
269 (c) ensure that a comprehensive health history, assessment, and diagnosis have been
270 made before prescribing [
271 (d) conduct the online assessment and diagnosis only through the approved Internet
272 facilitator identified in the online prescriber's application;
273 (e) comply with all applicable state and federal laws, rules, regulations, and orders;
274 (f) inform the patient electronically of the benefits and risks of appropriate treatment;
275 (g) guide the patient regarding the optimal course of action;
276 (h) treat the patient with courtesy, respect, dignity, responsiveness, and timely attention
277 to the patient's needs;
278 (i) comply with the requirements for confidentiality as required by this title and
279 applicable federal law;
280 (j) continue to provide the user with reasonable assistance and sufficient opportunity to
281 make alternative arrangements for care;
282 (k) be available for ongoing consultation with the patient through e-mail or other forms
283 of communication;
284 (l) not delegate to a third party the professional responsibility to:
285 (i) review and evaluate the results of the branching questionnaire;
286 (ii) consult with the patient electronically or through other means about the patient's
287 medical condition; and
288 (iii) diagnose and prescribe [
289 (m) conduct the online assessment and diagnosis and the electronic communication
290 between the online prescriber and the patient only through the approved Internet facilitator;
291 (n) (i) maintain the online medical records of the patient; and
292 (ii) if maintenance of the records is delegated by the online prescriber, delegate that
293 authority only to the approved Internet facilitator;
294 (o) inform a patient of the patient's freedom of choice to select the pharmacy to
295 dispense the patient's prescription by providing the patient with the phone number of the online
296 contract pharmacy so that the patient may contact the online contract pharmacy and request a
297 transfer of the prescription to another pharmacy; and
298 (p) authorize the Internet facilitator to provide the online contract pharmacy with the
299 patient's:
300 (i) full name;
301 (ii) current address and telephone number;
302 (iii) date of birth or age and gender;
303 (iv) height, weight, and vital signs (if known);
304 (v) medication allergies or drug reactions; and
305 (vi) current medications, including over-the-counter products, and any additional
306 comments relevant to the patient's drug or device use.
307 (2) The online contract pharmacy shall:
308 (a) only dispense a prescription [
309 (i) [
310 (ii) [
311 is under contract with the online contract pharmacy;
312 (b) maintain a toll-free number with a pharmacist available for patients using the
313 services of the online contract pharmacy to receive [
314 prescribed online;
315 (c) use a tracking identification number system when shipping [
316 medication or device prescribed for [
317 (d) provide to the division a quarterly report of all drugs and devices dispensed in
318 accordance with this chapter.
319 (3) The Internet facilitator shall:
320 (a) provide services that the online prescriber will use in implementing the branching
321 questionnaire;
322 (b) provide electronic or telephonic communication between the online prescriber and
323 the patient that:
324 (i) is secure and confidential;
325 (ii) allows the online prescriber to be directly accessible to a patient to answer
326 questions regarding the patient's treatment plan; and
327 (iii) provides privacy and security that complies with the provisions of 45 C.F.R. Parts
328 160, 162, and 164, Health Insurance Portability and Accountability Act of 1996;
329 (c) facilitate secure and confidential communication of the prescription issued by the
330 online prescriber to the online contract pharmacy in accordance with Subsection (1)(p);
331 (d) disclose on its website:
332 (i) the owner of the website;
333 (ii) the specific services provided by any associated online prescribers; and
334 (iii) other information the division may require by rule; and
335 (e) (i) only facilitate the delivery of online pharmaceutical services for the specific
336 legend drugs or devices approved by the division in accordance with Section 58-83-306; or
337 (ii) not facilitate, directly or indirectly, through related entities or affiliates, the
338 dispensing or online prescribing of any drug [
339 specifically approved under Section 58-83-306.
340 Section 6. Section 58-83-306 is amended to read:
341 58-83-306. Drugs and devices approved for online prescribing, dispensing, and
342 facilitation -- Delivery of prescription drugs or devices.
343 (1) An online prescriber may only prescribe, an online contract pharmacy may only
344 dispense, and an Internet facilitator may only facilitate the prescribing and dispensing of[
345
346 (a) that [
347 (b) that [
348 approved, within the drug or device manufacturer's guidelines;
349 (c) that [
350 administrative rule adopted in accordance with Title 63G, Chapter 3, Utah Administrative
351 Rulemaking Act, which rule shall limit the drugs and devices approved for online prescribing
352 by an optometrist to drugs and devices an optometrist may prescribe under Chapter 16a, Utah
353 Optometry Practice Act;
354 (d) that [
355 (i) 18 years of age or older; or
356 (ii) at least 16 years of age:
357 (A) if permitted by the state or country in which the patient will receive the drug or
358 device;
359 (B) with parental consent, if required by the state or country in which the patient will
360 receive the drug or device; and
361 (C) only if the prescription is for a hormonal based contraceptive; and
362 (e) to a person who is located in another country, if the country is designated by the
363 division, by administrative rule, as a country with a regulatory framework for prescribing and
364 dispensing of drugs or devices.
365 (2) If[
366 box warning with respect to any drug or device approved by the board under Subsection (1),
367 the division shall determine what action, if any, is necessary to protect the public health or
368 welfare as a result of the black box warning.
369 Section 7. Section 58-83-307 is amended to read:
370 58-83-307. Approval of additional drugs or devices -- Request to facilitate.
371 (1) An Internet facilitator licensed under this chapter may seek the division's approval
372 to facilitate the online prescribing and dispensing of prescriptions for additional drugs or
373 devices.
374 (2) The Internet facilitator shall make a request for approval of additional drugs or
375 devices by petitioning for an amendment to the administrative rule adopted by the division in
376 accordance with Section 58-83-306 and Title 63G, Chapter 3, Utah Administrative Rulemaking
377 Act.
378 Section 8. Section 58-83-308 is amended to read:
379 58-83-308. Audits.
380 (1) Each licensee under this chapter shall allow and facilitate an audit by the division
381 regarding the licensee's delivery of online pharmaceutical services to ensure compliance with
382 state and federal statutes, rules, and regulations including ensuring that:
383 (a) a comprehensive history and assessment have been obtained and a diagnosis has
384 been made for a patient before [
385 (b) only [
386 (2) The division shall be provided with the following, in the manner that allows access
387 from the division's office for the purpose of conducting an audit:
388 (a) full remote, read-only access rights to the data related to the online prescribing and
389 dispensing of a drug or device under this chapter and that is used and stored in the Internet
390 facilitator's system; and
391 (b) the information available to the online prescriber.
392 (3) An Internet facilitator licensed under this chapter shall provide to the division, at
393 the times designated by the division by administrative rule, a report containing the following
394 information:
395 (a) the number of prescriptions issued by the online prescribers associated with the
396 Internet facilitator by drug or device name;
397 (b) the number of comprehensive histories/assessments received by the Internet
398 facilitator;
399 (c) the number of comprehensive histories/assessments reviewed by an online
400 prescriber;
401 (d) the demographic data of the patients receiving prescriptions through the Internet
402 facilitator;
403 (e) the number of prescriptions:
404 (i) dispensed by the online contract pharmacy; or
405 (ii) transferred to a different pharmacy at the patient's request; and
406 (f) any other information specified by the division by administrative rule.
407 (4) The division's authority to conduct an audit pursuant to this chapter shall survive
408 any termination or expiration of any prescriptive authority for online prescribing, dispensing, or
409 facilitation.
410 Section 9. Section 58-83-401 is amended to read:
411 58-83-401. Grounds for denial of license -- Disciplinary proceedings --
412 Termination of authority to prescribe -- Immediate and significant danger.
413 (1) Grounds for refusing to issue a license to an applicant, for refusing to renew the
414 license of a licensee, for revoking, suspending, restricting, or placing on probation the license
415 of a licensee, for issuing a public reprimand to a licensee, and for issuing a cease and desist
416 order:
417 (a) shall be in accordance with Section 58-1-401; and
418 (b) includes:
419 (i) prescribing, dispensing, or facilitating the prescribing or dispensing of a drug or
420 device not approved by the board under Section 58-83-306; or
421 (ii) any other violation of this chapter.
422 (2) The termination or expiration of a license under this chapter for any reason does not
423 limit the division's authority to start or continue any investigation or adjudicative proceeding.
424 (3) (a) Because of the working business relationship between and among the online
425 prescriber, the Internet facilitator, and the online contract pharmacy, each entity's ability to
426 comply with this chapter may depend in some respects on the actions of the others.
427 (b) It is possible that a particular action or inaction by the online prescriber, the Internet
428 facilitator, or the online contract pharmacy could have the effect of causing the other licensed
429 entities to be out of compliance with this chapter, and each entity may, therefore, be held
430 accountable for any related party's non-compliance, if the party knew or reasonably should
431 have known of the other person's non-compliance.
432 (4) (a) An online prescriber may lose the [
433 professional license to prescribe [
434 knew or reasonably should have known that the provisions of this chapter were violated by the
435 online prescriber, the Internet facilitator, or the online contract pharmacy.
436 (b) It is not a defense to an alleged violation under this chapter that the alleged
437 violation was a result of an action or inaction not by the charged party but by the related online
438 prescriber, the online contract pharmacy, or the Internet facilitator.
439 (5) The following actions may result in an immediate suspension of the online
440 prescriber's license, the online contract pharmacy's license, or the Internet facilitator's license,
441 and each is considered an immediate and significant danger to the public health, safety, or
442 welfare requiring immediate action by the division pursuant to Section 63G-4-502 to terminate
443 the delivery of online pharmaceutical services by the licensee:
444 (a) online prescribing, dispensing, or facilitation with respect to:
445 (i) a person under the age of 18 years;
446 (ii) a legend drug or device not authorized by the division in accordance with Section
447 58-83-306; and
448 (iii) any controlled substance;
449 (b) violating this chapter after having been given reasonable opportunity to cure the
450 violation;
451 (c) using the name or official seal of the state, the Utah Department of Commerce, or
452 the Utah Division of Occupational and Professional Licensing, or their boards, in an
453 unauthorized manner; or
454 (d) failing to respond to a request from the division within the time frame requested
455 for:
456 (i) an audit of the website; or
457 (ii) records of the online prescriber, the Internet facilitator, or the online contract
458 pharmacy.
459 Section 10. Section 58-83-501 is amended to read:
460 58-83-501. Practice without a license.
461 [
462 Section 58-1-501, engaging in the practice of Internet prescribing without a license under this
463 chapter.
464 Section 11. Section 58-83-503 is amended to read:
465 58-83-503. Unlawful conduct.
466 Unlawful conduct includes, in addition to the definition in Section 58-1-501:
467 (1) online prescribing, dispensing, or facilitating of a legend drug or device not
468 authorized by the division in accordance with Section 58-83-306; or
469 (2) online prescribing, dispensing, or facilitating of a controlled substance.