Indiana 2023 Regular Session

Indiana House Bill HB1182 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1
2	2	Introduced Version
3	3	HOUSE BILL No. 1182
4	4	_____
5	5	DIGEST OF INTRODUCED BILL
6	6	Citations Affected: IC 16-18-2-298.5; IC 16-19-4-11; IC 25-26;
7	7	IC 34-30-2.1-380.3.
8	8	Synopsis: Pharmacy matters. Removes the authority of the
9	9	commissioner's designated public health authority to issue a standing
10	10	order, prescription, or protocol to allow certain health practitioners to
11	11	administer or dispense an immunization or a pharmacist a smoking
12	12	cessation product. Requires the state health commissioner to issue a
13	13	standing order, prescription, or protocol (standing order) that allows a
14	14	pharmacist to treat or screen, test, administer, or dispense for certain
15	15	health conditions. Allows a pharmacist to order tests that are waived
16	16	under the federal Clinical Laboratory Improvement Amendments
17	17	(CLIA) or established under a standing order. Allows a pharmacy
18	18	intern or a pharmacy technician to perform a test that is: (1) delegated
19	19	by a supervising pharmacist; and (2) a waived test under CLIA. Allows
20	20	a pharmacy technician, who is certified to perform any activity
21	21	delegated by a supervising pharmacist or pharmacist owner if the
22	22	activities: (1) do not require the clinical judgment of a pharmacist; (2)
23	23	are not prohibited by a rule adopted by the Indiana board of pharmacy;
24	24	or (3) are not an activity required by law to be performed only by a
25	25	pharmacist. Provides that a health carrier may not deny reimbursement
26	26	for services and procedures that are performed by a pharmacist and that
27	27	are within the scope of the pharmacist's license if the same services and
28	28	procedures would be covered if performed by a physician, an advanced
29	29	practice registered nurse, or a physician assistant. Provides civil and
30	30	criminal immunity for a pharmacist related to filling a prescription for
31	31	a drug, medicine, or other prescribed substance. Establishes exceptions.
32	32	Effective: July 1, 2023.
33	33	Clere
34	34	January 10, 2023, read first time and referred to Committee on Public Health.
35	35	2023 IN 1182—LS 7429/DI 77 Introduced
36	36	First Regular Session of the 123rd General Assembly (2023)
37	37	PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
38	38	Constitution) is being amended, the text of the existing provision will appear in this style type,
39	39	additions will appear in this style type, and deletions will appear in this style type.
40	40	Additions: Whenever a new statutory provision is being enacted (or a new constitutional
41	41	provision adopted), the text of the new provision will appear in this style type. Also, the
42	42	word NEW will appear in that style type in the introductory clause of each SECTION that adds
43	43	a new provision to the Indiana Code or the Indiana Constitution.
44	44	Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
45	45	between statutes enacted by the 2022 Regular Session of the General Assembly.
46	46	HOUSE BILL No. 1182
47	47	A BILL FOR AN ACT to amend the Indiana Code concerning
48	48	health.
49	49	Be it enacted by the General Assembly of the State of Indiana:
50	50	1 SECTION 1. IC 16-18-2-298.5, AS AMENDED BY P.L.96-2017,
51	51	2 SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
52	52	3 JULY 1, 2023]: Sec. 298.5. (a) "Public health authority", for purposes
53	53	4 of IC 16-22-8 and IC 16-41-9, means:
54	54	5 (1) the state health commissioner of the state department;
55	55	6 (2) a deputy or an assistant state health commissioner appointed
56	56	7 by the state health commissioner, or an agent expressly authorized
57	57	8 by the state health commissioner;
58	58	9 (3) the local health officer; or
59	59	10 (4) a health and hospital corporation established under
60	60	11 IC 16-22-8-6.
61	61	12 (b) "Public health authority", for purposes of IC 16-19 and
62	62	13 IC 16-42-27, means any of the following who is a licensed prescriber:
63	63	14 (1) A deputy or assistant state health commissioner appointed by
64	64	15 the state health commissioner to act as a public health authority.
65	65	16 (2) An agent employed by the state department that is expressly
66	66	17 authorized by the state health commissioner to act as a public
67	67	2023 IN 1182—LS 7429/DI 77 2
68	68	1 health authority.
69	69	2 SECTION 2. IC 16-19-4-11, AS AMENDED BY P.L.1-2022,
70	70	3 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
71	71	4 JULY 1, 2023]: Sec. 11. (a) The state health commissioner or the
72	72	5 commissioner's designated public health authority who is a licensed
73	73	6 prescriber may, as part of the individual's commissioner's official
74	74	7 capacity, issue a standing order, prescription, or protocol that allows a
75	75	8 pharmacist to administer or dispense any of the following:
76	76	9 (1) An immunization that is recommended by the federal Centers
77	77	10 for Disease Control and Prevention Advisory Committee on
78	78	11 Immunization Practices for individuals who are not less than
79	79	12 eleven (11) years of age.
80	80	13 (2) A smoking cessation product. However, the pharmacist must
81	81	14 inform the patient that the patient must have a follow-up
82	82	15 consultation with the patient's licensed prescriber.
83	83	16 (b) This subsection does not apply to a pharmacist. The state health
84	84	17 commissioner or the commissioner's designated public health authority
85	85	18 who is a licensed prescriber may, as part of the individual's
86	86	19 commissioner's official capacity, issue a standing order, prescription,
87	87	20 or protocol that allows an individual who is licensed, certified, or
88	88	21 registered by a board (as defined in IC 25-1-9-1), and if within the
89	89	22 individual's scope of practice, to administer or dispense an
90	90	23 immunization that is recommended by the federal Centers for Disease
91	91	24 Control and Prevention Advisory Committee on Immunization
92	92	25 Practices for individuals who are not less than eleven (11) years of age.
93	93	26 (c) A standing order described in subsection (a), (b), or (e) must
94	94	27 include the following:
95	95	28 (1) The purpose of the order.
96	96	29 (2) The eligible recipients.
97	97	30 (3) The geographic area covered by the standing order.
98	98	31 (4) The procedure for administering or dispensing the
99	99	32 immunization or product.
100	100	33 (5) A timeline for renewing or updating the standing order.
101	101	34 (d) The state health commissioner or designated public health
102	102	35 authority who issues a standing order, prescription, or protocol under
103	103	36 subsection (a), (b), or (e), or (f) is immune from civil liability related
104	104	37 to the issuing of the standing order, prescription, or protocol.
105	105	38 (e) Notwithstanding subsection (a) and subsection (b), the state
106	106	39 health commissioner or the commissioner's designated public health
107	107	40 authority may issue a standing order, prescription, or protocol to
108	108	41 administer or dispense an immunization that is recommended by the
109	109	42 federal Centers for Disease Control and Prevention Advisory
110	110	2023 IN 1182—LS 7429/DI 77 3
111	111	1 Committee on Immunization Practices for individuals who are at least
112	112	2 five (5) years of age. Nothing in this subsection authorizes the state
113	113	3 health commissioner or the commissioner's designated public health
114	114	4 authority to:
115	115	5 (1) require an individual to receive an immunization for
116	116	6 COVID-19; or
117	117	7 (2) waive or otherwise allow a minor to receive an immunization
118	118	8 without the consent of the parent or guardian as required under
119	119	9 IC 16-36-1.
120	120	10 This subsection expires at the conclusion of the federal public health
121	121	11 emergency concerning COVID-19 that was renewed on October 15,
122	122	12 2021, or any subsequent renewal of the declared federal public health
123	123	13 emergency concerning COVID-19.
124	124	14 (f) The state health commissioner shall, as part of the
125	125	15 commissioner's official capacity, issue a standing order,
126	126	16 prescription, or protocol that allows a pharmacist to treat or
127	127	17 screen, test, administer, or dispense for any of the following:
128	128	18 (1) Respiratory illness, including;
129	129	19 (A) influenza;
130	130	20 (B) severe acute respiratory syndrome coronavirus
131	131	21 (SARS-CoV-2 ); and
132	132	22 (C) respiratory syncytial virus (RSV).
133	133	23 (2) Group A streptococcus pharyngitis (strep throat).
134	134	24 (3) Lice.
135	135	25 (4) Certain minor skin conditions.
136	136	26 (5) Emerging or existing public health threats identified by
137	137	27 the state health commissioner.
138	138	28 SECTION 3. IC 25-26-12-31.3 IS ADDED TO THE INDIANA
139	139	29 CODE AS A NEW SECTION TO READ AS FOLLOWS
140	140	30 [EFFECTIVE JULY 1, 2023]: Sec. 31.3. A pharmacist may treat
141	141	31 health conditions and order tests to guide the pharmacist's clinical
142	142	32 decision making under a standing order, prescription, or protocol
143	143	33 issued by the state health commissioner. However, the test must be:
144	144	34 (1) a waived test under the federal Clinical Laboratory
145	145	35 Improvement Amendments (CLIA), including a test system
146	146	36 cleared by the Food and Drug Administration for home use or
147	147	37 a test approved for waiver under the CLIA; or
148	148	38 (2) established under the standing order, prescription, or
149	149	39 protocol issued by the state health commissioner.
150	150	40 SECTION 4. IC 25-26-13-31.5, AS AMENDED BY P.L.207-2021,
151	151	41 SECTION 37, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
152	152	42 JULY 1, 2023]: Sec. 31.5. (a) Subject to rules adopted under
153	153	2023 IN 1182—LS 7429/DI 77 4
154	154	1 subsection (c), a pharmacist intern or a pharmacist student may
155	155	2 administer an immunization to an individual under a drug order or
156	156	3 prescription.
157	157	4 (b) Subject to rules adopted under subsection (c), a pharmacist
158	158	5 intern or a pharmacist student may administer an immunization to an
159	159	6 individual or a group of individuals under a drug order, under a
160	160	7 prescription, or according to a protocol approved by a physician.
161	161	8 (c) The board shall adopt rules under IC 4-22-2 to establish
162	162	9 requirements applying to a pharmacist intern or a pharmacist student
163	163	10 who administers an immunization to an individual or group of
164	164	11 individuals. The rules adopted under this section:
165	165	12 (1) must provide for the direct supervision of the pharmacist
166	166	13 intern or pharmacist student by a pharmacist, a physician, a
167	167	14 physician assistant, an advanced practice registered nurse, or a
168	168	15 registered nurse; and
169	169	16 (2) may not be less stringent than the requirements applying to a
170	170	17 pharmacist who administers an immunization to an individual as
171	171	18 provided under section 31.2 of this chapter.
172	172	19 (d) A pharmacy intern may perform a test that is:
173	173	20 (1) delegated by a supervising pharmacist; and
174	174	21 (2) a waived test under the federal Clinical Laboratory
175	175	22 Improvement Amendments (CLIA), including a test system
176	176	23 cleared by the Food and Drug Administration for home use or
177	177	24 a test approved for waiver under the CLIA.
178	178	25 SECTION 5. IC 25-26-13-31.7, AS AMENDED BY P.L.143-2022,
179	179	26 SECTION 63, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
180	180	27 JULY 1, 2023]: Sec. 31.7. (a) Subject to rules adopted under
181	181	28 subsection (c), a pharmacy technician may administer any
182	182	29 immunization to an individual under a drug order or prescription, as
183	183	30 delegated by the pharmacist.
184	184	31 (b) Subject to rules adopted under subsection (c), a pharmacy
185	185	32 technician may administer an immunization to an individual or a group
186	186	33 of individuals under a drug order, under a prescription, or according to
187	187	34 a protocol approved by a physician, as delegated by the pharmacist.
188	188	35 (c) The board shall adopt rules under IC 4-22-2 to establish
189	189	36 requirements applying to a pharmacy technician who administers an
190	190	37 immunization to an individual or group of individuals. The rules
191	191	38 adopted under this section must provide for the direct supervision of
192	192	39 the pharmacy technician by a pharmacist, a physician, a physician
193	193	40 assistant, or an advanced practice registered nurse. Before July 1, 2021,
194	194	41 the board shall adopt emergency rules under IC 4-22-2-37.1 to establish
195	195	42 the requirements described in this subsection. Notwithstanding
196	196	2023 IN 1182—LS 7429/DI 77 5
197	197	1 IC 4-22-2-37.1(g), an emergency rule adopted by the board under this
198	198	2 subsection and in the manner provided by IC 4-22-2-37.1 expires on
199	199	3 the date on which a rule that supersedes the emergency rule is adopted
200	200	4 by the board under IC 4-22-2-24 through IC 4-22-2-36.
201	201	5 (d) The board must approve all programs that provide training to
202	202	6 pharmacy technicians to administer immunizations as permitted by this
203	203	7 section.
204	204	8 (e) A pharmacy technician may perform a test that is:
205	205	9 (1) delegated by a supervising pharmacist; and
206	206	10 (2) a waived test under the federal Clinical Laboratory
207	207	11 Improvement Amendments (CLIA), including a test system
208	208	12 cleared by the federal Food and Drug Administration for
209	209	13 home use or a test approved for waiver under the CLIA.
210	210	14 SECTION 6. IC 25-26-13-34 IS ADDED TO THE INDIANA
211	211	15 CODE AS A NEW SECTION TO READ AS FOLLOWS
212	212	16 [EFFECTIVE JULY 1, 2023]: Sec. 34. A health carrier (as defined
213	213	17 in IC 27-1-46-3) may not deny reimbursement for services and
214	214	18 procedures that are performed by a pharmacist and that are
215	215	19 within the scope of the pharmacist's license if the same services and
216	216	20 procedures would be covered if performed by a physician, an
217	217	21 advanced practice registered nurse, or a physician assistant.
218	218	22 SECTION 7. IC 25-26-13-35 IS ADDED TO THE INDIANA
219	219	23 CODE AS A NEW SECTION TO READ AS FOLLOWS
220	220	24 [EFFECTIVE JULY 1, 2023]: Sec. 35. (a) Nothing in this section
221	221	25 grants civil immunity to a pharmacist or pharmacy whose actions
222	222	26 or omissions, as proven by clear and convincing evidence,
223	223	27 constitute gross negligence or willful or wanton misconduct,
224	224	28 including fraud and intentional acts.
225	225	29 (b) For purposes of this section, the absence of a diagnosis or a
226	226	30 diagnosis code on the prescription by the prescriber indicating that
227	227	31 the drug, medicine, or other substance is intended for a purpose
228	228	32 other than to cause an abortion does not constitute actual
229	229	33 knowledge.
230	230	34 (c) Unless a pharmacist or pharmacy has actual knowledge that
231	231	35 a prescription is intended for the purpose of causing an abortion,
232	232	36 a pharmacist or pharmacy is not subject to a criminal action
233	233	37 related to filling a prescription for a drug, medicine, or other
234	234	38 prescribed substance.
235	235	39 (d) Unless a pharmacist or pharmacy has actual knowledge that
236	236	40 a prescription is intended for the purpose of causing an abortion,
237	237	41 a pharmacist or pharmacy is immune from civil liability for
238	238	42 damages arising from filling a prescription for a drug, medicine, or
239	239	2023 IN 1182—LS 7429/DI 77 6
240	240	1 other prescribed substance.
241	241	2 SECTION 8. IC 25-26-19-8, AS AMENDED BY P.L.58-2014,
242	242	3 SECTION 15, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
243	243	4 JULY 1, 2023]: Sec. 8. A licensed pharmacy technician may not
244	244	5 perform the following activities:
245	245	6 (1) Providing advice or consultation with the prescribing
246	246	7 practitioner or other licensed health care provider regarding the
247	247	8 patient or the interpretation and application of information
248	248	9 contained in the prescription or drug order, medical record, or
249	249	10 patient profile.
250	250	11 (2) Providing advice or consultation with the patient regarding the
251	251	12 interpretation of the prescription or the application of information
252	252	13 contained in the patient profile or medical record.
253	253	14 (3) Dispensing prescription drug information to the patient.
254	254	15 (4) Final check on all aspects of the completed prescription and
255	255	16 assumption of the responsibility for the filled prescription,
256	256	17 including the appropriateness of the drug for the patient and the
257	257	18 accuracy of the:
258	258	19 (A) drug dispensed;
259	259	20 (B) strength of the drug dispensed; and
260	260	21 (C) labeling of the prescription.
261	261	22 (5) Receiving a new prescription drug order over the telephone or
262	262	23 electronically unless the original information is recorded so a
263	263	24 pharmacist may review the prescription drug order as transmitted.
264	264	25 (6) Any activity required by law to be performed only by a
265	265	26 pharmacist.
266	266	27 (7) Any activity that requires the clinical judgment of a
267	267	28 pharmacist and is prohibited by a rule adopted by the board.
268	268	29 (b) Notwithstanding subsection (a), a licensed pharmacy
269	269	30 technician, who holds an active certification from the Pharmacy
270	270	31 Technician Certification Board or other nationally recognized
271	271	32 certification approved by the board, may perform any activity
272	272	33 delegated by a supervising pharmacist or pharmacist owner,
273	273	34 including those activities described in subsection (a)(4) and (a)(5),
274	274	35 if the activities:
275	275	36 (1) do not require the clinical judgment of a pharmacist;
276	276	37 (2) are not prohibited by a rule adopted by the board; or
277	277	38 (3) are not an activity required by law to be performed only
278	278	39 by a pharmacist.
279	279	40 (c) A technician who performs the activities permitted under
280	280	41 subsection (b) must be properly trained and competent to perform
281	281	42 the delegated task. The pharmacy must keep a record of the
282	282	2023 IN 1182—LS 7429/DI 77 7
283	283	1 technician's training and documentation to support the
284	284	2 technician's competency.
285	285	3 SECTION 9. IC 34-30-2.1-380.3 IS ADDED TO THE INDIANA
286	286	4 CODE AS A NEW SECTION TO READ AS FOLLOWS
287	287	5 [EFFECTIVE JULY 1, 2023]: Sec. 380.3. IC 25-26-13-35
288	288	6 (Concerning filling a prescription).
289	289	2023 IN 1182—LS 7429/DI 77