1     
INVESTIGATIONAL DRUG AND DEVICE ACCESS FOR

2     
TERMINALLY ILL PATIENTS

3     
2015 GENERAL SESSION

4     
STATE OF UTAH

5     
Chief Sponsor: Gage Froerer

6     
Senate Sponsor: Evan J. Vickers

7     

8     LONG TITLE
9     General Description:
10          This bill amends provisions related to investigational drugs and devices.
11     Highlighted Provisions:
12          This bill:
13          ▸     provides that a terminally ill patient may obtain an investigational drug or device
14     from the drug's or device's manufacturer under certain circumstances;
15          ▸     exempts certain conduct from the definition of unlawful and unprofessional conduct
16     for a physician who administers an investigational drug or uses an investigational
17     device to treat a terminally ill patient;
18          ▸     allows an insurance company to deny, under certain circumstances, coverage to an
19     individual who is treated with an investigational drug or device; and
20          ▸     provides that certain health care providers are not subject to civil or criminal
21     liability or licensure sanctions for treating a patient with an investigational drug or
22     device.
23     Money Appropriated in this Bill:
24          None
25     Other Special Clauses:
26          None
27     Utah Code Sections Affected:
28     AMENDS:
29          58-67-501, as last amended by Laws of Utah 2001, Chapter 116

30          58-67-502, as last amended by Laws of Utah 2014, Chapter 72
31          58-68-501, as last amended by Laws of Utah 2001, Chapter 116
32          58-68-502, as last amended by Laws of Utah 2014, Chapter 72
33     ENACTS:
34          58-85-101, Utah Code Annotated 1953
35          58-85-102, Utah Code Annotated 1953
36          58-85-103, Utah Code Annotated 1953
37          58-85-104, Utah Code Annotated 1953
38          58-85-105, Utah Code Annotated 1953
39     

40     Be it enacted by the Legislature of the state of Utah:
41          Section 1. Section 58-67-501 is amended to read:
42          58-67-501. Unlawful conduct.
43          (1) "Unlawful conduct" includes, in addition to the definition in Section 58-1-501:
44          (a) buying, selling, or fraudulently obtaining, any medical diploma, license, certificate,
45     or registration;
46          (b) aiding or abetting the buying, selling, or fraudulently obtaining of any medical
47     diploma, license, certificate, or registration;
48          (c) substantially interfering with a licensee's lawful and competent practice of medicine
49     in accordance with this chapter by:
50          (i) any person or entity that manages, owns, operates, or conducts a business having a
51     direct or indirect financial interest in the licensee's professional practice; or
52          (ii) anyone other than another physician licensed under this title, who is engaged in
53     direct clinical care or consultation with the licensee in accordance with the standards and ethics
54     of the profession of medicine; or
55          (d) entering into a contract that limits a licensee's ability to advise the licensee's
56     patients fully about treatment options or other issues that affect the health care of the licensee's
57     patients.

58          (2) "Unlawful conduct" does not include:
59          (a) establishing, administering, or enforcing the provisions of a policy of accident and
60     health insurance by an insurer doing business in this state in accordance with Title 31A,
61     Insurance Code;
62          (b) adopting, implementing, or enforcing utilization management standards related to
63     payment for a licensee's services, provided that:
64          (i) utilization management standards adopted, implemented, and enforced by the payer
65     have been approved by a physician or by a committee that contains one or more physicians; and
66          (ii) the utilization management standards does not preclude a licensee from exercising
67     independent professional judgment on behalf of the licensee's patients in a manner that is
68     independent of payment considerations;
69          (c) developing and implementing clinical practice standards that are intended to reduce
70     morbidity and mortality or developing and implementing other medical or surgical practice
71     standards related to the standardization of effective health care practices, provided that:
72          (i) the practice standards and recommendations have been approved by a physician or
73     by a committee that contains one or more physicians; and
74          (ii) the practice standards do not preclude a licensee from exercising independent
75     professional judgment on behalf of the licensee's patients in a manner that is independent of
76     payment considerations;
77          (d) requesting or recommending that a patient obtain a second opinion from a licensee;
78          (e) conducting peer review, quality evaluation, quality improvement, risk management,
79     or similar activities designed to identify and address practice deficiencies with health care
80     providers, health care facilities, or the delivery of health care;
81          (f) providing employment supervision or adopting employment requirements that do
82     not interfere with the licensee's ability to exercise independent professional judgment on behalf
83     of the licensee's patients, provided that employment requirements that may not be considered to
84     interfere with an employed licensee's exercise of independent professional judgment include:
85          (i) an employment requirement that restricts the licensee's access to patients with

86     whom the licensee's employer does not have a contractual relationship, either directly or
87     through contracts with one or more third-party payers; or
88          (ii) providing compensation incentives that are not related to the treatment of any
89     particular patient;
90          (g) providing benefit coverage information, giving advice, or expressing opinions to a
91     patient or to a family member of a patient to assist the patient or family member in making a
92     decision about health care that has been recommended by a licensee; [or]
93          (h) in compliance with Section 58-85-103:
94          (i) obtaining an investigational drug or investigational device;
95          (ii) administering the investigational drug to an eligible patient; or
96          (iii) treating an eligible patient with the investigational drug or investigational device;
97     or
98          [(h)] (i) any otherwise lawful conduct that does not substantially interfere with the
99     licensee's ability to exercise independent professional judgment on behalf of the licensee's
100     patients and that does not constitute the practice of medicine as defined in this chapter.
101          Section 2. Section 58-67-502 is amended to read:
102          58-67-502. Unprofessional conduct.
103          (1) "Unprofessional conduct" includes, in addition to the definition in Section
104     58-1-501:
105          [(1)] (a) using or employing the services of any individual to assist a licensee in any
106     manner not in accordance with the generally recognized practices, standards, or ethics of the
107     profession, state law, or division rule;
108          [(2)] (b) making a material misrepresentation regarding the qualifications for licensure
109     under Section 58-67-302.7; or
110          [(3)] (c) violating the dispensing requirements of Section 58-17b-309 or Chapter 17b,
111     Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy,
112     if applicable.
113          (2) "Unprofessional conduct" does not include, in compliance with Section 58-85-103:

114          (a) obtaining an investigational drug or investigational device;
115          (b) administering the investigational drug to an eligible patient; or
116          (c) treating an eligible patient with the investigational drug or investigational device.
117          Section 3. Section 58-68-501 is amended to read:
118          58-68-501. Unlawful conduct.
119          (1) "Unlawful conduct" includes, in addition to the definition in Section 58-1-501:
120          (a) buying, selling, or fraudulently obtaining any osteopathic medical diploma, license,
121     certificate, or registration; and
122          (b) aiding or abetting the buying, selling, or fraudulently obtaining of any osteopathic
123     medical diploma, license, certificate, or registration;
124          (c) substantially interfering with a licensee's lawful and competent practice of medicine
125     in accordance with this chapter by:
126          (i) any person or entity that manages, owns, operates, or conducts a business having a
127     direct or indirect financial interest in the licensee's professional practice; or
128          (ii) anyone other than another physician licensed under this title, who is engaged in
129     direct clinical care or consultation with the licensee in accordance with the standards and ethics
130     of the profession of medicine; or
131          (d) entering into a contract that limits a licensee's ability to advise the licensee's
132     patients fully about treatment options or other issues that affect the health care of the licensee's
133     patients.
134          (2) "Unlawful conduct" does not include:
135          (a) establishing, administering, or enforcing the provisions of a policy of accident and
136     health insurance by an insurer doing business in this state in accordance with Title 31A,
137     Insurance Code;
138          (b) adopting, implementing, or enforcing utilization management standards related to
139     payment for a licensee's services, provided that:
140          (i) utilization management standards adopted, implemented, and enforced by the payer
141     have been approved by a physician or by a committee that contains one or more physicians; and

142          (ii) the utilization management standards does not preclude a licensee from exercising
143     independent professional judgment on behalf of the licensee's patients in a manner that is
144     independent of payment considerations;
145          (c) developing and implementing clinical practice standards that are intended to reduce
146     morbidity and mortality or developing and implementing other medical or surgical practice
147     standards related to the standardization of effective health care practices, provided that:
148          (i) the practice standards and recommendations have been approved by a physician or
149     by a committee that contains one or more physicians; and
150          (ii) the practice standards do not preclude a licensee from exercising independent
151     professional judgment on behalf of the licensee's patients in a manner that is independent of
152     payment considerations;
153          (d) requesting or recommending that a patient obtain a second opinion from a licensee;
154          (e) conducting peer review, quality evaluation, quality improvement, risk management,
155     or similar activities designed to identify and address practice deficiencies with health care
156     providers, health care facilities, or the delivery of health care;
157          (f) providing employment supervision or adopting employment requirements that do
158     not interfere with the licensee's ability to exercise independent professional judgment on behalf
159     of the licensee's patients, provided that employment requirements that may not be considered to
160     interfere with an employed licensee's exercise of independent professional judgment include:
161          (i) an employment requirement that restricts the licensee's access to patients with
162     whom the licensee's employer does not have a contractual relationship, either directly or
163     through contracts with one or more third-party payers; or
164          (ii) providing compensation incentives that are not related to the treatment of any
165     particular patient;
166          (g) providing benefit coverage information, giving advice, or expressing opinions to a
167     patient or to a family member of a patient to assist the patient or family member in making a
168     decision about health care that has been recommended by a licensee; [or]
169          (h) in compliance with Section 58-85-103:

170          (i) obtaining an investigational drug or investigational device;
171          (ii) administering the investigational drug to an eligible patient; or
172          (iii) treating an eligible patient with the investigational drug or investigational device;
173     or
174          [(h)] (i) any otherwise lawful conduct that does not substantially interfere with the
175     licensee's ability to exercise independent professional judgment on behalf of the licensee's
176     patients and that does not constitute the practice of medicine as defined in this chapter.
177          Section 4. Section 58-68-502 is amended to read:
178          58-68-502. Unprofessional conduct.
179          (1) "Unprofessional conduct" includes, in addition to the definition in Section
180     58-1-501:
181          [(1)] (a) using or employing the services of any individual to assist a licensee in any
182     manner not in accordance with the generally recognized practices, standards, or ethics of the
183     profession, state law, or division rule; or
184          [(2)] (b) violating the dispensing requirements of Section 58-17b-309 or Chapter 17b,
185     Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy,
186     if applicable.
187          (2) "Unprofessional conduct" does not include, in compliance with Section 58-85-103:
188          (a) obtaining an investigational drug or investigational device;
189          (b) administering the investigational drug to an eligible patient; or
190          (c) treating an eligible patient with the investigational drug or investigational device.
191          Section 5. Section 58-85-101 is enacted to read:
192     
CHAPTER 85. UTAH RIGHT TO TRY ACT

193          58-85-101. Title.
194          This chapter is known as the "Utah Right to Try Act."
195          Section 6. Section 58-85-102 is enacted to read:
196          58-85-102. Definitions.
197          As used in this chapter:

198          (1) "Eligible patient" means an individual who has been diagnosed with a terminal
199     illness by a physician.
200          (2) "Insurer" means the same as that term is defined in Section 31A-1-301.
201          (3) "Investigational device" means a device that:
202          (a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; and
203          (b) has successfully completed the United States Food and Drug Administration Phase
204     1 testing for an investigational device described in 21 C.F.R. Part 812.
205          (4) "Investigational drug" means a drug that:
206          (a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and
207          (b) has successfully completed the United States Food and Drug Administration Phase
208     1 testing for an investigational new drug described in 21 C.F.R. Part 312.
209          (5) "Physician" means an individual who is licensed under:
210          (a) Title 58, Chapter 67, Utah Medical Practice Act; or
211          (b) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act.
212          (6) "Terminal illness" means a condition of a patient that:
213          (a) as determined by a physician:
214          (i) is likely to pose a greater risk to the patient than the risk posed to the patient by
215     treatment with an investigational drug or investigational device; and
216          (ii) will inevitably lead to the patient's death; and
217          (b) presents the patient, after the patient has explored conventional therapy options,
218     with no treatment option that is satisfactory or comparable to treatment with an investigational
219     drug or device.
220          Section 7. Section 58-85-103 is enacted to read:
221          58-85-103. Right to request investigational drug or device.
222          (1) An eligible patient may obtain an investigational drug through an agreement with
223     the investigational drug's manufacturer and the eligible patient's physician that provides:
224          (a) for the transfer of the investigational drug from the manufacturer to the physician;
225     and

226          (b) that the physician will administer the investigational drug to the patient.
227          (2) An eligible patient may obtain an investigational device through an agreement with
228     the investigational device's manufacturer and the eligible patient's physician that provides:
229          (a) for the transfer of the investigational device from the manufacturer to the physician;
230     and
231          (b) that the physician will use the investigational device to treat the patient.
232          (3) An agreement described in Subsection (1) or (2), between an eligible patient, a
233     physician, and a manufacturer, shall include an informed consent document that, based on the
234     physician's knowledge of the relevant investigational drug or investigational device:
235          (a) describes the possible positive and negative outcomes the eligible patient could
236     experience if the physician treats the eligible patient with the investigational drug or
237     investigational device, including that the investigational drug or investigational device could
238     increase the possibility of death;
239          (b) states that an insurer is not required to cover the cost of providing the
240     investigational drug or investigational device to the patient;
241          (c) states that, subject to Section 58-85-105, an insurer may deny coverage for the
242     eligible patient; and
243          (d) states that the patient may be liable for all expenses caused by the physician treating
244     the patient with the investigational drug or investigational device, unless the agreement
245     provides otherwise.
246          (4) A physician or an eligible patient shall notify the eligible patient's insurer of the day
247     on which the physician treated an eligible patient with an investigational drug or investigational
248     device, and the investigational drug or device used, under an agreement described in
249     Subsection (1) or (2).
250          Section 8. Section 58-85-104 is enacted to read:
251          58-85-104. Standard of care -- Medical practitioners not liable -- No private right
252     of action.
253          (1) It is not a breach of the applicable standard of care for a physician, other licensed

254     health care provider, or hospital to treat an eligible patient with an investigational drug or
255     investigational device under this chapter.
256          (2) A physician, other licensed health care provider, or hospital that treats an eligible
257     patient with an investigational drug or investigational device under this chapter may not, for
258     any harm done to the eligible patient by the investigational drug or device, be subject to:
259          (a) civil liability;
260          (b) criminal liability;
261          (c) licensure sanctions under:
262          (i) for a physician:
263          (A) Title 58, Chapter 67, Utah Medical Practice Act; or
264          (B) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;
265          (ii) for the other licensed health care provider, the act governing the other licensed
266     health care provider's license; or
267          (iii) for the hospital, Title 26, Chapter 21, Health Care Facility Licensing and
268     Inspection Act.
269          (3) This chapter does not:
270          (a) require a manufacturer of an investigational drug or investigational device to agree
271     to make an investigational drug or investigational device available to an eligible patient or an
272     eligible patient's physician;
273          (b) require a physician to agree to:
274          (i) administer an investigational drug to an eligible patient under this chapter; or
275          (ii) treat an eligible patient with an investigational device under this chapter; or
276          (c) create a private right of action for an eligible patient:
277          (i) against a physician or hospital, for the physician's or hospital's refusal to:
278          (A) administer an investigational drug to an eligible patient under this chapter; or
279          (B) treat an eligible patient with an investigational device under this chapter; or
280          (ii) against a manufacturer, for the manufacturer's refusal to provide an eligible patient
281     with an investigational drug or an investigational device under this chapter.

282          Section 9. Section 58-85-105 is enacted to read:
283          58-85-105. Insurance coverage.
284          (1) This chapter does not:
285          (a) require an insurer to cover the cost of:
286          (i) administering an investigational drug under this chapter; or
287          (ii) treating a patient with an investigational device under this chapter; or
288          (b) prohibit an insurer from covering the cost of:
289          (i) administering an investigational drug under this chapter; or
290          (ii) treating a patient with an investigational device under this chapter.
291          (2) Except as described in Subsection (3), an insurer may deny coverage to an eligible
292     patient who is treated with an investigational drug or investigational device, for harm to the
293     eligible patient caused by the investigational drug or investigational device.
294          (3) An insurer may not deny coverage to an eligible patient under Subsection (2) for:
295          (a) the eligible patient's preexisting condition;
296          (b) benefits that commenced before the day on which the eligible patient is treated with
297     the investigational drug or investigational device; or
298          (c) palliative or hospice care for an eligible patient that has been treated with an
299     investigational drug or device, but is no longer receiving curative treatment with the
300     investigational drug or device.