This document includes Senate 3rd Reading Floor Amendments incorporated into the bill on Thu, Apr 16, 2020 at 4:58 PM by lpoole.
This document includes House Floor Amendments incorporated into the bill on Fri, Apr 17, 2020 at 10:03 AM by pflowers.
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8 LONG TITLE
9 General Description:
10 This bill expands access to certain treatments and creates limited immunity for certain
11 actions during a declared major public health emergency.
12 Highlighted Provisions:
13 This bill:
14 ▸ defines terms;
15 ▸ provides limited immunity for health care, including the use of certain treatments,
16 provided during a major public health emergency;
17 Ĥ→ [
18 qualified treatment during a major public health emergency;
19 ▸ amends the Utah Right to Try Act to permit the use of certain investigational drugs
20 and devices during a major public health emergency; and
21 ▸ creates limited immunity for health care providers who provide an investigational
22 drug or device to a patient during a major public health emergency.
23 Money Appropriated in this Bill:
24 None
25 Other Special Clauses:
26 This bill provides a special effective date.
27 Utah Code Sections Affected:
28 ENACTS:
29 58-13-2.7, Utah Code Annotated 1953
30 58-85-106, Utah Code Annotated 1953
31
32 Be it enacted by the Legislature of the state of Utah:
33 Section 1. Section 58-13-2.7 is enacted to read:
34 58-13-2.7. Limited immunity during a declared major public health emergency.
35 (1) As used in this section:
36 (a) "Declared major public health emergency" means the same as that term is defined
37 in Section 58-85-106.
38 (b) "Health care" means the same as that term is defined in Section 78B-3-403.
39 (c) "Health care provider" means the same as that term is defined in Section
40 78B-3-403.
41 (d) "Prescription device" means the same as that term is defined in Section 58-17b-102.
42 (e) "Prescription drug" means the same as that term is defined in Section 58-17b-102.
43 (f) "Qualified treatment" means the use of a prescription drug or prescription device:
44 (i) during a declared major public health emergency;
45 (ii) to treat a patient who has been diagnosed with the illness or condition that resulted
46 in the declared major public health emergency; and
47 (iii) that has been approved for sale but not indicated by the United States Food and
48 Drug Administration to treat the illness or condition described in Subsection (1)(f)(ii).
49 (2) (a) A health care provider is immune from civil liability for any harm resulting
50 from any act or omission in the course of providing health care during a declared major public
51 health emergency if:
52 (i) (A) the health care is provided in good faith to treat a patient for the illness or
53 condition that resulted in the declared major public health emergency; or
54 (B) the act or omission was the direct result of providing health care to a patient for the
55 illness or condition that resulted in the declared major public health emergency; and
56 (ii) the acts or omissions of the health care provider were not:
57 (A) grossly negligent; or
58 (B) intentional or malicious misconduct.
59 (b) The immunity in Subsection (2)(a) applies:
60 (i) even if the health care provider has a duty to respond or an expectation Ŝ→ [
60a payment
61 or remuneration; and
62 (ii) in addition to any immunity protections that may apply under state or federal law.
63 (c) During a declared major public health emergency, it is not a breach of the
64 applicable standard of care for a health care provider to provide health care that is not within
65 the health care provider's education, training, or experience, if:
66 (i) the health care is within the applicable scope of practice for the type of license
67 issued to the health care provider;
68 (ii) (A) the health care is provided in good faith to treat a patient for the illness or
69 condition that resulted in the declared major public health emergency; or
70 (B) there is an urgent shortage of health care providers as a direct result of the declared
71 major public health emergency; and
72 (iii) providing the health care is not:
73 (A) grossly negligent; or
74 (B) intentional or malicious misconduct.
75 (3) (a) A health care provider is not subject to civil liability, criminal liability, or
76 sanctions against the health care provider's license for providing a qualified treatment to a
77 patient if:
78 (i) the qualified treatment is within the scope of the health care provider's license;
79 (ii) if written recommendations have been issued by a Ŝ→ [
80 agency regarding the use of the qualified treatment for treatment of the illness or condition that
81 resulted in the declared major public health emergency, the health care provider provides the
82 qualified treatment in accordance with the most current written recommendations issued by the
83 Ŝ→ [
83a Ŝ→ (iii) the health care provider Ĥ→ [
83b informed consent document that,
83ba (A) describes to the patient or the patient's representative, ←Ĥ based on the health care
83bb provider's knowledge of the qualified
83c treatment, Ĥ→ [
83ca experience if
83d the health care provider treats the patient with the qualified treatment; and ←Ŝ
83e Ĥ→ (B) documents in the patient's medical record the information provided to the patient
83f or the patient's representative under Subsection (3)(a)(iii)(A) and whether the patient or the
83g patient's representative consented to the treatment; and ←Ĥ
84 Ŝ→ [
85 (A) grossly negligent; or☆
86 ☆(B) intentional or malicious misconduct.
87 (b) If two or more written recommendations described in Subsection (3)(a)(ii) are
88 issued by Ŝ→ [
88a requirement
89 described in Subsection (3)(a)(ii) by providing the qualified treatment in accordance with the
90 most current written recommendations of any one Ŝ→ [
91 Ĥ→ [
92 the state to manufacture, distribute, dispense, administer, or provide a qualified treatment
93 during a declared major public health emergency if the assistance is provided under contract
94 with and under the direction of the state agency.
95 (b) Subsection (4)(a) does not apply if:
96 (i) the harms are the result of:
97 (A) gross negligence; or
98 (B) intentional or malicious misconduct; or
99 (ii) an act or omission by the person caused Ŝ→ , ←Ŝ in whole or in part Ŝ→ , ←Ŝ the
99a Ŝ→ declared ←Ŝ major public health
100 emergency, and the person would otherwise be liable for the harms.
101 Section 2. Section 58-85-106 is enacted to read:
102 58-85-106. Use of investigational drugs and devices during a major public health
103 emergency -- Limitations -- Immunity.
104 (1) As used in this section:
105 (a) "Declared major public health emergency" means a state of emergency declared by
106 the governor under Section 53-2a-206 as the result of a major public health emergency.
107 (b) "Health care provider" means the same as that term is defined in Section
108 76B-3-403.
109 (c) "Insurer" means the same as that term is defined in Section 31A-22-634.
110 (d) "Major public health emergency" means an occurrence of imminent threat of an
111 illness or health condition that:
112 (i) is believed to be caused by:
113 (A) bioterrorism;
114 (B) the appearance of a novel or previously controlled or eradicated infectious agent or
115 biological toxin;
116 (C) a natural disaster;
117 (D) a chemical attack or accidental release; or
118 (E) a nuclear attack or accident; and
119 (ii) poses a high probability of:
120 (A) a large number of deaths in the affected population;
121 (B) a large number of serious or long-term disabilities in the affected population; or
122 (C) widespread exposure to an infectious or toxic agent that poses a significant risk of
123 substantial future harm to a large number of people in the affected population.
124 (e) "Physician" means the same as that term is defined in Section 58-67-102.
125 (f) "Qualified patient" means a patient who has been diagnosed with a condition that
126 has resulted in a declared major public health emergency.
127 (2) (a) To the extent permitted under federal law, a qualified patient may obtain an
128 investigational drug through an agreement with the investigational drug's manufacturer and the
129 qualified patient's physician that provides:
130 (i) for the transfer of the investigational drug from the manufacturer to the physician;
131 and
132 (ii) that the physician will administer the investigational drug to the qualified patient.
133 (b) To the extent permitted under federal law, a qualified patient may obtain an
134 investigational device through an agreement with the investigational device's manufacturer and
135 the qualified patient's physician that provides:
136 (i) for the transfer of the investigational device from the manufacturer to the physician;
137 and
138 (ii) that the physician will use the investigational device to treat the qualified patient.
139 (c) The agreement described in Subsection (2)(a) or (b) shall include an informed
140 consent document that, based on the physician's knowledge of the relevant investigational drug
141 or investigational device:
142 (i) describes the possible positive and negative outcomes the qualified patient could
143 experience if the physician treats the qualified patient with the investigational drug or
144 investigational device;
145 (ii) states that an insurer is not required to cover the cost of providing the
146 investigational drug or investigational device to the qualified patient;
147 (iii) states that, subject to Subsection (5), an insurer may deny coverage for the
148 qualified patient; and
149 (iv) states that the qualified patient may be liable for all expenses caused by the
150 physician treating the patient with the investigational drug or investigational device, unless the
151 agreement provides otherwise.
152 (3) The physician of a qualified patient shall notify the qualified patient's insurer of:
153 (a) the day on which the physician treated the qualified patient with an investigational
154 drug or investigational device; and
155 (b) the investigational drug or investigational device used under an agreement
156 described in Subsection (2).
157 (4) (a) It is not a breach of the applicable standard of care for a health care provider to
158 treat a qualified patient with an investigational drug or investigational device under this
159 section.
160 (b) A health care provider that treats a qualified patient with an investigational drug or
161 investigational device in accordance with this section is not subject to civil liability, criminal
162 liability, or sanctions against the health care provider's license for any harm to the qualified
163 patient resulting from the qualified patient's use of the investigational drug or device.
164 (5) (a) This section does not:
165 (i) require a manufacturer of an investigational drug or investigational device to agree
166 to make an investigational drug or investigational device available to a qualified patient or a
167 qualified patient's physician;
168 (ii) require a physician to agree to:
169 (A) administer an investigational drug to a qualified patient under this section; or
170 (B) treat a qualified patient with an investigational device under this section;
171 (iii) create a private right of action for a qualified patient against a health care provider
172 for the health care provider's refusal to:
173 (A) administer an investigational drug to a qualified patient under this section; or
174 (B) treat a qualified patient with an investigational device under this section; or
175 (iv) create a private right of action for a qualified patient against a manufacturer for the
176 manufacturer's refusal to provide a qualified patient with an investigational drug or an
177 investigational device under this section.
178 (b) This section does not:
179 (i) require an insurer to cover the cost of:
180 (A) administering an investigational drug under this section; or
181 (B) treating a patient with an investigational device under this section; or
182 (ii) prohibit an insurer from covering the cost of:
183 (A) administering an investigational drug under this section; or
184 (B) treating a patient with an investigational device under this section.
185 (c) Except as described in Subsection (5)(d), an insurer may deny coverage to a
186 qualified patient who is treated with an investigational drug or investigational device for harm
187 to the qualified patient caused by the investigational drug or investigational device.
188 (d) An insurer may not deny coverage to a qualified patient under Subsection (5)(c) for:
189 (i) the qualified patient's preexisting condition;
190 (ii) benefits that commenced before the day on which the qualified patient was treated
191 with the investigational drug or investigational device; or
192 (iii) palliative or hospice care for a qualified patient that has been treated with an
193 investigational drug or investigational device but is no longer receiving curative treatment with
194 the investigational drug or investigational device.
195 Section 3. Effective date.
196 If approved by two-thirds of all the members elected to each house, this bill takes effect
197 upon approval by the governor, or the day following the constitutional time limit of Utah
198 Constitution, Article VII, Section 8, without the governor's signature, or in the case of a veto,
199 the date of veto override.