Old | New | Differences | |
---|---|---|---|
1 | - | *HB1158.2* | |
2 | - | Reprinted | |
3 | - | January 28, 2022 | |
1 | + | *HB1158.1* | |
2 | + | January 20, 2022 | |
4 | 3 | HOUSE BILL No. 1158 | |
5 | 4 | _____ | |
6 | - | DIGEST OF HB 1158 (Updated January | |
5 | + | DIGEST OF HB 1158 (Updated January 19, 2022 5:09 pm - DI 77) | |
7 | 6 | Citations Affected: IC 5-10; IC 12-8; IC 12-9; IC 12-11; IC 12-28; | |
8 | - | IC 16-18; IC 16-41; IC 21-38; IC 25-26; IC 27-8; IC 34-30; | |
9 | - | IC 35-52; noncode. | |
7 | + | IC 16-18; IC 16-41; IC 21-38; IC 25-1; IC 25-26; IC 27-8; IC 34-30; | |
8 | + | IC 34-46; IC 35-52; noncode. | |
10 | 9 | Synopsis: Health and human services matters. Allows an advanced | |
11 | 10 | practice registered nurse or physician assistant to sign certain | |
12 | 11 | individualized family service plans. Changes the composition and | |
13 | - | duties of the division of disability and rehabilitative services | |
14 | - | council. Requires the services for individuals with intellectual | |
15 | - | other developmental disabilities task force to establish a | |
16 | - | to make certain recommendations to the task force. | |
17 | - | concerning records and information about the | |
18 | - | immunodeficiency virus (HIV) and acquired immune deficiency | |
12 | + | duties of the division of the disability and rehabilitative services | |
13 | + | advisory council. Requires the services for individuals with intellectual | |
14 | + | and other developmental disabilities task force to establish a | |
15 | + | subcommittee to make certain recommendations to the task force. | |
16 | + | Modifies provisions concerning records and information about the | |
17 | + | human immunodeficiency virus (HIV) and acquired immune deficiency | |
19 | 18 | syndrome. Repeals provisions concerning the following: (1) Reports to | |
20 | 19 | a health officer about a person who is believed to be a serious and | |
21 | 20 | present risk to the health of others. (2) Physician notification to: (A) a | |
22 | 21 | patient with a serious communicable disease; (B) a health officer; and | |
23 | - | (C) a person at risk. Changes the membership on the Indiana board of | |
24 | - | pharmacy. Removes the requirement that a qualifying pharmacist is | |
25 | - | responsible for the legal operations of a pharmacy. Specifies | |
26 | - | responsibilities of pharmacists concerning duties previously | |
27 | 22 | (Continued next page) | |
28 | 23 | Effective: Upon passage; July 1, 2022. | |
29 | 24 | Clere, Olthoff, Davisson J., | |
30 | 25 | Shackleford | |
31 | 26 | January 6, 2022, read first time and referred to Committee on Public Health. | |
32 | 27 | January 20, 2022, amended, reported — Do Pass. | |
33 | - | January 27, 2022, read second time, amended, ordered engrossed. | |
34 | 28 | HB 1158—LS 7067/DI 137 Digest Continued | |
29 | + | (C) a person at risk. Provides that for purposes of enforcing the health | |
30 | + | professions standards of practice, a practitioner includes an individual | |
31 | + | who holds or has held a license. Changes the membership on the | |
32 | + | Indiana board of pharmacy. Removes the requirement that a qualifying | |
33 | + | pharmacist is responsible for the legal operations of a pharmacy. | |
34 | + | Specifies responsibilities of pharmacists concerning duties previously | |
35 | 35 | responsible by a qualifying pharmacist. Allows a qualified pharmacy | |
36 | 36 | technician to administer immunizations delegated by the pharmacist. | |
37 | 37 | (Current law allows pharmacy technicians to administer influenza and | |
38 | 38 | coronavirus disease immunizations.) Amends requirements for remote | |
39 | - | pharmacies. Adds an exception to the definition of "wholesale | |
40 | - | distribution" for prescription drugs. Repeals certain offenses | |
41 | - | concerning: (1) notification, reporting, and investigation related to | |
42 | - | communicable diseases; and (2) the donation, sale, or transfer of semen | |
43 | - | that contains antibodies for HIV. Makes technical and conforming | |
44 | - | changes. | |
45 | - | HB 1158—LS 7067/DI 137HB 1158—LS 7067/DI 137 Reprinted | |
46 | - | January 28, 2022 | |
39 | + | pharmacies. Adds exception to definition of "wholesale distribution" | |
40 | + | for prescription drugs. Repeals certain offenses concerning: (1) | |
41 | + | notification, reporting, and investigation related to communicable | |
42 | + | diseases; and (2) the donation, sale, or transfer of semen that contains | |
43 | + | antibodies for HIV. Makes technical and conforming changes. | |
44 | + | HB 1158—LS 7067/DI 137HB 1158—LS 7067/DI 137 January 20, 2022 | |
47 | 45 | Second Regular Session of the 122nd General Assembly (2022) | |
48 | 46 | PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana | |
49 | 47 | Constitution) is being amended, the text of the existing provision will appear in this style type, | |
50 | 48 | additions will appear in this style type, and deletions will appear in this style type. | |
51 | 49 | Additions: Whenever a new statutory provision is being enacted (or a new constitutional | |
52 | 50 | provision adopted), the text of the new provision will appear in this style type. Also, the | |
53 | 51 | word NEW will appear in that style type in the introductory clause of each SECTION that adds | |
54 | 52 | a new provision to the Indiana Code or the Indiana Constitution. | |
55 | 53 | Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts | |
56 | 54 | between statutes enacted by the 2021 Regular Session of the General Assembly. | |
57 | 55 | HOUSE BILL No. 1158 | |
58 | 56 | A BILL FOR AN ACT to amend the Indiana Code concerning | |
59 | 57 | health. | |
60 | 58 | Be it enacted by the General Assembly of the State of Indiana: | |
61 | 59 | 1 SECTION 1. IC 5-10-8-7.3, AS AMENDED BY P.L.133-2020, | |
62 | 60 | 2 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
63 | 61 | 3 JULY 1, 2022]: Sec. 7.3. (a) As used in this section, "covered | |
64 | 62 | 4 individual" means an individual who is: | |
65 | 63 | 5 (1) covered under a self-insurance program established under | |
66 | 64 | 6 section 7(b) of this chapter to provide group health coverage; or | |
67 | 65 | 7 (2) entitled to services under a contract with a prepaid health care | |
68 | 66 | 8 delivery plan that is entered into or renewed under section 7(c) of | |
69 | 67 | 9 this chapter. | |
70 | 68 | 10 (b) As used in this section, "early intervention services" means | |
71 | 69 | 11 services provided to a first steps child under IC 12-12.7-2 and 20 | |
72 | 70 | 12 U.S.C. 1432(4). | |
73 | 71 | 13 (c) As used in this section, "first steps child" means an infant or | |
74 | 72 | 14 toddler from birth through two (2) years of age who is enrolled in the | |
75 | 73 | 15 Indiana first steps program and is a covered individual. | |
76 | 74 | 16 (d) As used in this section, "first steps program" refers to the | |
77 | 75 | 17 program established under IC 12-12.7-2 and 20 U.S.C. 1431 et seq. to | |
78 | 76 | HB 1158—LS 7067/DI 137 2 | |
79 | 77 | 1 meet the needs of: | |
80 | 78 | 2 (1) children who are eligible for early intervention services; and | |
81 | 79 | 3 (2) their families. | |
82 | 80 | 4 The term includes the coordination of all available federal, state, local, | |
83 | 81 | 5 and private resources available to provide early intervention services | |
84 | 82 | 6 within Indiana. | |
85 | 83 | 7 (e) As used in this section, "health benefits plan" means a: | |
86 | 84 | 8 (1) self-insurance program established under section 7(b) of this | |
87 | 85 | 9 chapter to provide group health coverage; or | |
88 | 86 | 10 (2) contract with a prepaid health care delivery plan that is | |
89 | 87 | 11 entered into or renewed under section 7(c) of this chapter. | |
90 | 88 | 12 (f) A health benefits plan that provides coverage for early | |
91 | 89 | 13 intervention services shall reimburse the first steps program a monthly | |
92 | 90 | 14 fee established by the division of disability and rehabilitative services | |
93 | 91 | 15 established by IC 12-9-1-1. Except when the monthly fee is less than | |
94 | 92 | 16 the product determined under IC 12-12.7-2-23(b), the monthly fee shall | |
95 | 93 | 17 be provided instead of claims processing of individual claims. | |
96 | 94 | 18 (g) The reimbursement required under subsection (f) may not be | |
97 | 95 | 19 applied to any annual or aggregate lifetime limit on the first steps | |
98 | 96 | 20 child's coverage under the health benefits plan. | |
99 | 97 | 21 (h) The first steps program may pay required deductibles, | |
100 | 98 | 22 copayments, or other out-of-pocket expenses for a first steps child | |
101 | 99 | 23 directly to a provider. A health benefits plan shall apply any payments | |
102 | 100 | 24 made by the first steps program to the health benefits plan's | |
103 | 101 | 25 deductibles, copayments, or other out-of-pocket expenses according to | |
104 | 102 | 26 the terms and conditions of the health benefits plan. | |
105 | 103 | 27 (i) A health benefits plan may not require authorization for services | |
106 | 104 | 28 specified in the covered individual's individualized family service plan, | |
107 | 105 | 29 if those services are a covered benefit under the plan, once the | |
108 | 106 | 30 individualized family service plan is signed by a physician, a physician | |
109 | 107 | 31 assistant, or an advanced practice registered nurse. | |
110 | 108 | 32 (j) The department of insurance shall adopt rules under IC 4-22-2 | |
111 | 109 | 33 to ensure compliance with this section. | |
112 | 110 | 34 SECTION 2. IC 12-8-2.5-3, AS ADDED BY P.L.160-2012, | |
113 | 111 | 35 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
114 | 112 | 36 JULY 1, 2022]: Sec. 3. Unless Except as provided in IC 12-9-4-7, or | |
115 | 113 | 37 otherwise provided by a another statute, this chapter applies to the | |
116 | 114 | 38 following: | |
117 | 115 | 39 (1) The following advisory councils: | |
118 | 116 | 40 (A) The division of disability and rehabilitative services | |
119 | 117 | 41 advisory council. | |
120 | 118 | 42 (B) The division of family resources advisory council. | |
121 | 119 | HB 1158—LS 7067/DI 137 3 | |
122 | 120 | 1 (C) The division of mental health and addiction advisory | |
123 | 121 | 2 council. | |
124 | 122 | 3 (2) A body: | |
125 | 123 | 4 (A) established by statute for a division; and | |
126 | 124 | 5 (B) whose enabling statute makes this chapter applicable to | |
127 | 125 | 6 the body. | |
128 | 126 | 7 SECTION 3. IC 12-9-4-2, AS AMENDED BY P.L.141-2006, | |
129 | 127 | 8 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
130 | 128 | 9 JULY 1, 2022]: Sec. 2. The division of disability and rehabilitative | |
131 | 129 | 10 services advisory council is established to advise and assist the | |
132 | 130 | 11 division of disability and rehabilitative services in its effort to | |
133 | 131 | 12 develop and sustain a system of supports and services for people | |
134 | 132 | 13 with intellectual and developmental disabilities. The council will | |
135 | 133 | 14 provide technical expertise and lived experiences and advise on | |
136 | 134 | 15 specific areas such as: | |
137 | 135 | 16 (1) technology; | |
138 | 136 | 17 (2) health; | |
139 | 137 | 18 (3) policy; | |
140 | 138 | 19 (4) law; | |
141 | 139 | 20 (5) marketing; | |
142 | 140 | 21 (6) public relations; | |
143 | 141 | 22 (7) provider services; and | |
144 | 142 | 23 (8) advocacy. | |
145 | 143 | 24 SECTION 4. IC 12-9-4-3 IS AMENDED TO READ AS FOLLOWS | |
146 | 144 | 25 [EFFECTIVE JULY 1, 2022]: Sec. 3. The council consists of the | |
147 | 145 | 26 following eleven (11) sixteen (16) members: | |
148 | 146 | 27 (1) The director. | |
149 | 147 | 28 (2) Ten (10) individuals: | |
150 | 148 | 29 (A) appointed by the secretary; and | |
151 | 149 | 30 (B) who have a recognized knowledge of or interest in the | |
152 | 150 | 31 programs administered by the division. | |
153 | 151 | 32 (2) An individual representing The Arc of Indiana, appointed | |
154 | 152 | 33 by The Arc of Indiana. | |
155 | 153 | 34 (3) An individual representing the Indiana Association of | |
156 | 154 | 35 Rehabilitation Facilities (INARF), appointed by INARF. | |
157 | 155 | 36 (4) An individual representing the Self-Advocates of Indiana, | |
158 | 156 | 37 appointed by the Self-Advocates of Indiana. | |
159 | 157 | 38 (5) A representative of the governor's council for people with | |
160 | 158 | 39 disabilities established by IC 4-23-29-7, appointed by the | |
161 | 159 | 40 director. | |
162 | 160 | 41 (6) A representative of a case management provider | |
163 | 161 | 42 contracting with the bureau of developmental disabilities | |
164 | 162 | HB 1158—LS 7067/DI 137 4 | |
165 | 163 | 1 services established by IC 12-11-1.1-1 to provide family | |
166 | 164 | 2 supports Medicaid waiver and community integration | |
167 | 165 | 3 habilitation Medicaid waiver case management services, | |
168 | 166 | 4 appointed by the director. | |
169 | 167 | 5 (7) An individual representing the Indiana Association of | |
170 | 168 | 6 Behavior Consultants, appointed by the Indiana Association | |
171 | 169 | 7 of Behavior Consultants. | |
172 | 170 | 8 (8) An individual representing the Indiana Institute on | |
173 | 171 | 9 Disability and Community, appointed by the Indiana Institute | |
174 | 172 | 10 on Disability and Community. | |
175 | 173 | 11 (9) An individual representing the Indiana Resource Center | |
176 | 174 | 12 for Families with Special Needs (INSOURCE), appointed by | |
177 | 175 | 13 INSOURCE. | |
178 | 176 | 14 (10) An individual representing Indiana Disability Rights, | |
179 | 177 | 15 appointed by Indiana Disability Rights. | |
180 | 178 | 16 (11) An individual representing Indiana Family to Family, | |
181 | 179 | 17 appointed by Indiana Family to Family. | |
182 | 180 | 18 (12) Two (2) members, appointed by the director, each of | |
183 | 181 | 19 whom is an individual with an intellectual or other | |
184 | 182 | 20 developmental disability. | |
185 | 183 | 21 (13) Two (2) members, appointed by the director, each of | |
186 | 184 | 22 whom is an immediate or extended family member of an | |
187 | 185 | 23 individual with an intellectual or other developmental | |
188 | 186 | 24 disability. | |
189 | 187 | 25 (14) One (1) member, appointed by the director, who is | |
190 | 188 | 26 employed by an agency that provides services to people with | |
191 | 189 | 27 intellectual or other developmental disabilities. | |
192 | 190 | 28 SECTION 5. IC 12-9-4-4, AS AMENDED BY P.L.160-2012, | |
193 | 191 | 29 SECTION 23, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
194 | 192 | 30 JULY 1, 2022]: Sec. 4. Each member of the council appointed under | |
195 | 193 | 31 section 3(2) through 3(14) of this chapter has a fixed term as provided | |
196 | 194 | 32 in IC 12-8-2.5-4. serves at the will of the appointing authority. | |
197 | 195 | 33 SECTION 6. IC 12-9-4-6 IS AMENDED TO READ AS FOLLOWS | |
198 | 196 | 34 [EFFECTIVE JULY 1, 2022]: Sec. 6. The council shall meet at least | |
199 | 197 | 35 monthly six (6) times annually and is subject to special meetings at the | |
200 | 198 | 36 call of its presiding officer. | |
201 | 199 | 37 SECTION 7. IC 12-9-4-6.5 IS ADDED TO THE INDIANA CODE | |
202 | 200 | 38 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY | |
203 | 201 | 39 1, 2022]: Sec. 6.5. (a) The division shall provide the council with a | |
204 | 202 | 40 quarterly report containing the following information relating to | |
205 | 203 | 41 Medicaid waivers: | |
206 | 204 | 42 (1) The number of current applications for an emergency | |
207 | 205 | HB 1158—LS 7067/DI 137 5 | |
208 | 206 | 1 placement priority waiver. | |
209 | 207 | 2 (2) The number of individuals served on a particular | |
210 | 208 | 3 Medicaid waiver. | |
211 | 209 | 4 (3) The number of individuals who are currently on a wait list | |
212 | 210 | 5 to be included in a Medicaid waiver. | |
213 | 211 | 6 (b) The division shall provide the council with a quarterly | |
214 | 212 | 7 report containing the following information relating to vocational | |
215 | 213 | 8 rehabilitation services: | |
216 | 214 | 9 (1) A status report of the division's effort to fill vocational | |
217 | 215 | 10 counselor vacancies. | |
218 | 216 | 11 (2) A status report of the order of selection. | |
219 | 217 | 12 (3) The number of individuals who submitted applications for | |
220 | 218 | 13 vocational rehabilitation services. | |
221 | 219 | 14 (4) The number of individuals who are currently on a wait list | |
222 | 220 | 15 to obtain vocational rehabilitation services. | |
223 | 221 | 16 (5) The number of individuals who are currently receiving | |
224 | 222 | 17 vocational rehabilitation services. | |
225 | 223 | 18 (c) The division shall provide the council with an annual report | |
226 | 224 | 19 summarizing any rate analysis, study, or review conducted by the | |
227 | 225 | 20 division. | |
228 | 226 | 21 (d) The division shall report to the council prior to any | |
229 | 227 | 22 submission of a Medicaid waiver amendment regarding the | |
230 | 228 | 23 changes being sought and an explanation of purpose. | |
231 | 229 | 24 (e) The division shall report to the council prior to any | |
232 | 230 | 25 submission for a renewal of a Medicaid waiver: | |
233 | 231 | 26 (1) any changes being proposed to the Medicaid waiver; | |
234 | 232 | 27 (2) the current and projected needs of each geographic area | |
235 | 233 | 28 of Indiana for residential services for individuals with | |
236 | 234 | 29 intellectual or developmental disabilities; and | |
237 | 235 | 30 (3) the availability of developmental or vocational services to | |
238 | 236 | 31 individuals with an intellectual or developmental disability | |
239 | 237 | 32 living in their own home. | |
240 | 238 | 33 SECTION 8. IC 12-9-4-7, AS AMENDED BY P.L.160-2012, | |
241 | 239 | 34 SECTION 24, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
242 | 240 | 35 JULY 1, 2022]: Sec. 7. IC 12-8-2.5 applies IC 12-8-2.5-9 through | |
243 | 241 | 36 IC 12-8-2.5-11.5 apply to the council. | |
244 | 242 | 37 SECTION 9. IC 12-11-15.5-4.5 IS ADDED TO THE INDIANA | |
245 | 243 | 38 CODE AS A NEW SECTION TO READ AS FOLLOWS | |
246 | 244 | 39 [EFFECTIVE UPON PASSAGE]: Sec. 4.5. (a) The task force shall | |
247 | 245 | 40 establish a subcommittee to make recommendations to the task | |
248 | 246 | 41 force regarding the: | |
249 | 247 | 42 (1) establishment of a statewide training curriculum for | |
250 | 248 | HB 1158—LS 7067/DI 137 6 | |
251 | 249 | 1 individuals who provide services to individuals with an | |
252 | 250 | 2 intellectual or other developmental disability; | |
253 | 251 | 3 (2) feasibility of establishing training certification; | |
254 | 252 | 4 (3) establishment of a statewide training registry; and | |
255 | 253 | 5 (4) feasibility of a pilot project to implement any | |
256 | 254 | 6 recommendations made under this section. | |
257 | 255 | 7 (b) Not later than September 1, 2022, the subcommittee shall | |
258 | 256 | 8 prepare and submit to the task force recommendations made by | |
259 | 257 | 9 the subcommittee. | |
260 | 258 | 10 (c) This section expires January 1, 2024. | |
261 | 259 | 11 SECTION 10. IC 12-11-15.5-4.6 IS ADDED TO THE INDIANA | |
262 | 260 | 12 CODE AS A NEW SECTION TO READ AS FOLLOWS | |
263 | 261 | 13 [EFFECTIVE UPON PASSAGE]: Sec. 4.6. (a) The task force shall | |
264 | 262 | 14 establish a subcommittee to make recommendations to the task | |
265 | 263 | 15 force regarding: | |
266 | 264 | 16 (1) current trends related to health and safety requests for the | |
267 | 265 | 17 community integration habilitation Medicaid waiver or any | |
268 | 266 | 18 other service; and | |
269 | 267 | 19 (2) the feasibility of the division establishing a pilot program | |
270 | 268 | 20 to create special service review teams to assist families or | |
271 | 269 | 21 individuals in a crisis situation to identify available resources | |
272 | 270 | 22 and sources of assistance. | |
273 | 271 | 23 (b) Not later than September 1, 2022, the subcommittee shall | |
274 | 272 | 24 prepare and submit to the task force recommendations made by | |
275 | 273 | 25 the subcommittee. | |
276 | 274 | 26 (c) This section expires January 1, 2024. | |
277 | 275 | 27 SECTION 11. IC 12-28-5-10, AS AMENDED BY P.L.210-2015, | |
278 | 276 | 28 SECTION 62, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
279 | 277 | 29 JULY 1, 2022]: Sec. 10. The division of disability and rehabilitative | |
280 | 278 | 30 services shall do the following: | |
281 | 279 | 31 (1) Determine the current and projected needs of each geographic | |
282 | 280 | 32 area of Indiana for residential services for individuals with a | |
283 | 281 | 33 developmental disability and, beginning July 1, 2012, annually | |
284 | 282 | 34 report the findings to the division of disability and rehabilitative | |
285 | 283 | 35 services advisory council established by IC 12-9-4-2. | |
286 | 284 | 36 (2) Determine how the provision of developmental or vocational | |
287 | 285 | 37 services for residents in these geographic areas affects the | |
288 | 286 | 38 availability of developmental or vocational services to individuals | |
289 | 287 | 39 with a developmental disability living in their own homes and, | |
290 | 288 | 40 beginning July 1, 2012, report the findings to the division of | |
291 | 289 | 41 disability and rehabilitative services advisory council established | |
292 | 290 | 42 by IC 12-9-4-2. | |
293 | 291 | HB 1158—LS 7067/DI 137 7 | |
294 | 292 | 1 (3) (1) Develop standards for licensure of supervised group living | |
295 | 293 | 2 facilities regarding the following: | |
296 | 294 | 3 (A) A sanitary and safe environment for residents and | |
297 | 295 | 4 employees. | |
298 | 296 | 5 (B) Classification of supervised group living facilities. | |
299 | 297 | 6 (C) Any other matters that will ensure that the residents will | |
300 | 298 | 7 receive a residential environment. | |
301 | 299 | 8 (4) (2) Develop standards for the approval of entities providing | |
302 | 300 | 9 supported living services. | |
303 | 301 | 10 SECTION 12. IC 12-28-5-12, AS AMENDED BY P.L.210-2015, | |
304 | 302 | 11 SECTION 63, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
305 | 303 | 12 JULY 1, 2022]: Sec. 12. (a) The division may license only those | |
306 | 304 | 13 supervised group living facilities that: | |
307 | 305 | 14 (1) meet the standards established under section 10 of this | |
308 | 306 | 15 chapter; and | |
309 | 307 | 16 (2) are necessary to provide adequate services to individuals with | |
310 | 308 | 17 a developmental disability in that geographic area. | |
311 | 309 | 18 (b) Notwithstanding 460 IAC 9-3-7(c) and 460 IAC 9-3-7(d), the | |
312 | 310 | 19 division shall license one (1) supervised group living facility that is | |
313 | 311 | 20 located less than one thousand (1,000) feet from another supervised | |
314 | 312 | 21 group living facility or a sheltered workshop under the following | |
315 | 313 | 22 conditions: | |
316 | 314 | 23 (1) Both of the supervised group living facilities meet all | |
317 | 315 | 24 standards for licensure as provided in section 10(3) 10(1) of this | |
318 | 316 | 25 chapter. | |
319 | 317 | 26 (2) Both of the supervised group living facilities are built on land | |
320 | 318 | 27 that is owned by one (1) private entity. | |
321 | 319 | 28 (3) The supervised group living facilities provides job | |
322 | 320 | 29 opportunities for residents of the supervised group living | |
323 | 321 | 30 facilities, as appropriate. | |
324 | 322 | 31 (c) The division may approve an entity to provide supported living | |
325 | 323 | 32 services only if the entity meets the standards established under section | |
326 | 324 | 33 10 of this chapter. | |
327 | 325 | 34 SECTION 13. IC 16-18-2-275 IS AMENDED TO READ AS | |
328 | 326 | 35 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 275. (a) "Person at | |
329 | 327 | 36 risk", for purposes of IC 16-41-7-4, has the meaning set forth in | |
330 | 328 | 37 IC 16-41-7-4(a). | |
331 | 329 | 38 (b) "Person at risk", for purposes of IC 16-41-7-1, and IC 16-41-7-3, | |
332 | 330 | 39 has the meaning set forth in IC 16-41-7-1(c). | |
333 | 331 | 40 SECTION 14. IC 16-18-2-328, AS AMENDED BY P.L.112-2020, | |
334 | 332 | 41 SECTION 10, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
335 | 333 | 42 JULY 1, 2022]: Sec. 328. "Serious and present risk to the health of | |
336 | 334 | HB 1158—LS 7067/DI 137 8 | |
337 | 335 | 1 others", for purposes of IC 16-41-7 and IC 16-41-9, has the meaning set | |
338 | 336 | 2 forth in IC 16-41-7-2. means an individual with a communicable | |
339 | 337 | 3 disease who meets the following conditions: | |
340 | 338 | 4 (1) The individual with a communicable disease engages | |
341 | 339 | 5 repeatedly in a behavior that has been demonstrated | |
342 | 340 | 6 epidemiologically (as defined by rules adopted by the state | |
343 | 341 | 7 department under IC 4-22-2) to transmit a serious | |
344 | 342 | 8 communicable disease or that indicates a careless disregard | |
345 | 343 | 9 for the transmission of the disease to others. | |
346 | 344 | 10 (2) The individual with a communicable disease's past | |
347 | 345 | 11 behavior or statements indicate an imminent risk that the | |
348 | 346 | 12 individual with a communicable disease will engage in | |
349 | 347 | 13 behavior that transmits a serious communicable disease to | |
350 | 348 | 14 others. | |
351 | 349 | 15 (3) The individual with a communicable disease has failed or | |
352 | 350 | 16 refused to carry out the individual with a communicable | |
353 | 351 | 17 disease's duty to inform under IC 16-41-7-1. | |
354 | 352 | 18 SECTION 15. IC 16-41-1-5 IS ADDED TO THE INDIANA CODE | |
355 | 353 | 19 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY | |
356 | 354 | 20 1, 2022]: Sec. 5. Local health officers may submit advisory | |
357 | 355 | 21 guidelines to the state department to implement this chapter. The | |
358 | 356 | 22 state department shall fully consider such advisory guidelines | |
359 | 357 | 23 before adopting a rule under IC 4-22-2-29 implementing this | |
360 | 358 | 24 chapter. | |
361 | 359 | 25 SECTION 16. IC 16-41-2-3 IS AMENDED TO READ AS | |
362 | 360 | 26 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The following | |
363 | 361 | 27 persons shall report to the state department each case of human | |
364 | 362 | 28 immunodeficiency virus (HIV) infection, including each confirmed | |
365 | 363 | 29 case of acquired immune deficiency syndrome (AIDS): | |
366 | 364 | 30 (1) A licensed physician. | |
367 | 365 | 31 (2) A hospital licensed under IC 16-21. | |
368 | 366 | 32 (3) A medical laboratory. | |
369 | 367 | 33 (4) The department of correction. | |
370 | 368 | 34 The report must comply with rules adopted by the state department. | |
371 | 369 | 35 (b) The records of the state department must indicate, if known: | |
372 | 370 | 36 (1) whether the individual had undergone any blood transfusions | |
373 | 371 | 37 before being diagnosed as having AIDS or HIV or AIDS | |
374 | 372 | 38 infection; | |
375 | 373 | 39 (2) the place the transfusions took place; | |
376 | 374 | 40 (3) the blood center that furnished the blood; and | |
377 | 375 | 41 (4) any other known risk factors. | |
378 | 376 | 42 (c) A case report concerning HIV infection that does not involve a | |
379 | 377 | HB 1158—LS 7067/DI 137 9 | |
380 | 378 | 1 confirmed case of AIDS submitted to the state department under this | |
381 | 379 | 2 section that involves an individual: | |
382 | 380 | 3 (1) enrolled in a formal research project for which a written study | |
383 | 381 | 4 protocol has been filed with the state department; | |
384 | 382 | 5 (2) who is tested anonymously at a designated counseling or | |
385 | 383 | 6 testing site; or | |
386 | 384 | 7 (3) who is tested by a health care provider permitted by rule by | |
387 | 385 | 8 the state department to use a number identifier code; | |
388 | 386 | 9 may not include the name or other identifying characteristics of the | |
389 | 387 | 10 individual tested. | |
390 | 388 | 11 SECTION 17. IC 16-41-2-5 IS AMENDED TO READ AS | |
391 | 389 | 12 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 5. A person who | |
392 | 390 | 13 reports information as required by this chapter does not satisfy the | |
393 | 391 | 14 duties that exist under IC 16-41-7-3 or in other laws to provide | |
394 | 392 | 15 notification to persons identified as being at significant risk of being | |
395 | 393 | 16 infected by the individual who is the subject of the report. | |
396 | 394 | 17 SECTION 18. IC 16-41-3-1, AS AMENDED BY P.L.112-2020, | |
397 | 395 | 18 SECTION 14, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
398 | 396 | 19 JULY 1, 2022]: Sec. 1. (a) The state department may adopt rules under | |
399 | 397 | 20 IC 4-22-2 concerning the compilation for statistical purposes of | |
400 | 398 | 21 information collected under IC 16-41-2. | |
401 | 399 | 22 (b) The state department shall adopt procedures to gather, monitor, | |
402 | 400 | 23 and tabulate case reports of incidents involving serious communicable | |
403 | 401 | 24 diseases or unnatural outbreaks of diseases known or suspected to be | |
404 | 402 | 25 used as weapons. The state department shall specifically engage in | |
405 | 403 | 26 medical surveillance, tabulation, and reporting of confirmed or | |
406 | 404 | 27 suspected cases set forth by the Centers for Disease Control and | |
407 | 405 | 28 Prevention of the United States Department of Health and Human | |
408 | 406 | 29 Services and the United States Public Health Service of the United | |
409 | 407 | 30 States Department of Health and Human Services. | |
410 | 408 | 31 (c) The state department shall notify the: | |
411 | 409 | 32 (1) department of homeland security; | |
412 | 410 | 33 (2) Indiana State Police; and | |
413 | 411 | 34 (3) county health department and local law enforcement agency | |
414 | 412 | 35 having jurisdiction of each unnatural outbreak or reported case | |
415 | 413 | 36 described in subsection (b); | |
416 | 414 | 37 as soon as possible after the state department receives a report under | |
417 | 415 | 38 subsection (b). Notification under this subsection must be made not | |
418 | 416 | 39 more than twenty-four (24) hours after receiving a report. | |
419 | 417 | 40 (d) Local health officers may submit advisory guidelines to the | |
420 | 418 | 41 state department to implement this chapter. The state department | |
421 | 419 | 42 shall fully consider such advisory guidelines before adopting a rule | |
422 | 420 | HB 1158—LS 7067/DI 137 10 | |
423 | 421 | 1 under IC 4-22-2-29 implementing this chapter. | |
424 | 422 | 2 SECTION 19. IC 16-41-5-4 IS ADDED TO THE INDIANA CODE | |
425 | 423 | 3 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY | |
426 | 424 | 4 1, 2022]: Sec. 4. Local health officers may submit advisory | |
427 | 425 | 5 guidelines to the state department to implement this chapter. The | |
428 | 426 | 6 state department shall fully consider such advisory guidelines | |
429 | 427 | 7 before adopting a rule under IC 4-22-2-29 implementing this | |
430 | 428 | 8 chapter. | |
431 | 429 | 9 SECTION 20. IC 16-41-6-11, AS AMENDED BY P.L.112-2020, | |
432 | 430 | 10 SECTION 21, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
433 | 431 | 11 JULY 1, 2022]: Sec. 11. (a) The state department shall adopt rules | |
434 | 432 | 12 under IC 4-22-2 that include procedures: | |
435 | 433 | 13 (1) to inform the woman of the test results under this chapter, | |
436 | 434 | 14 whether they are positive or negative; | |
437 | 435 | 15 (2) for explaining the side effects of any treatment for HIV if the | |
438 | 436 | 16 test results under this chapter are positive; and | |
439 | 437 | 17 (3) to establish a process for a woman who tests positive under | |
440 | 438 | 18 this chapter to appeal the woman's status on a waiting list on a | |
441 | 439 | 19 treatment program for which the woman is eligible. The rule | |
442 | 440 | 20 must: | |
443 | 441 | 21 (A) include a requirement that the state department make a | |
444 | 442 | 22 determination in the process described in this subdivision not | |
445 | 443 | 23 later than seventy-two (72) hours after the state department | |
446 | 444 | 24 receives all the requested medical information; and | |
447 | 445 | 25 (B) set forth the necessary medical information that must be | |
448 | 446 | 26 provided to the state department and reviewed by the state | |
449 | 447 | 27 department in the process described in this subdivision. | |
450 | 448 | 28 (b) The state department shall maintain rules under IC 4-22-2 that | |
451 | 449 | 29 set forth standards to provide to women who are pregnant, before | |
452 | 450 | 30 delivery, at delivery, and after delivery, information concerning HIV. | |
453 | 451 | 31 The rules must include: | |
454 | 452 | 32 (1) an explanation of the nature of AIDS and HIV; | |
455 | 453 | 33 (2) information concerning discrimination and legal protections; | |
456 | 454 | 34 (3) information concerning the duty to notify persons at risk as | |
457 | 455 | 35 described in IC 16-41-7-1; | |
458 | 456 | 36 (4) information about risk behaviors for HIV transmission; | |
459 | 457 | 37 (5) information about the risk of transmission through breast | |
460 | 458 | 38 feeding; | |
461 | 459 | 39 (6) notification that if the woman chooses not to be tested for HIV | |
462 | 460 | 40 before delivery, at delivery the child will be tested subject to | |
463 | 461 | 41 section 4 of this chapter; | |
464 | 462 | 42 (7) procedures for obtaining informed, written consent for testing | |
465 | 463 | HB 1158—LS 7067/DI 137 11 | |
466 | 464 | 1 under this chapter; | |
467 | 465 | 2 (8) procedures for post-test counseling by a health care provider | |
468 | 466 | 3 when the test results are communicated to the woman, whether | |
469 | 467 | 4 the results are positive or negative; | |
470 | 468 | 5 (9) procedures for referral for physical and emotional services if | |
471 | 469 | 6 the test results are positive; | |
472 | 470 | 7 (10) procedures for explaining the importance of immediate entry | |
473 | 471 | 8 into medical care if the test results are positive; and | |
474 | 472 | 9 (11) procedures for explaining that the use of antiretroviral drugs | |
475 | 473 | 10 and other medical interventions lessen the likelihood of | |
476 | 474 | 11 transmitting HIV to the child during childbirth. | |
477 | 475 | 12 SECTION 21. IC 16-41-7-2 IS REPEALED [EFFECTIVE JULY 1, | |
478 | 476 | 13 2022]. Sec. 2. (a) An individual with a communicable disease is a | |
479 | 477 | 14 "serious and present risk to the health of others" under the following | |
480 | 478 | 15 conditions: | |
481 | 479 | 16 (1) The individual with a communicable disease engages | |
482 | 480 | 17 repeatedly in a behavior that has been demonstrated | |
483 | 481 | 18 epidemiologically (as defined by rules adopted by the state | |
484 | 482 | 19 department under IC 4-22-2) to transmit a serious communicable | |
485 | 483 | 20 disease or that indicates a careless disregard for the transmission | |
486 | 484 | 21 of the disease to others. | |
487 | 485 | 22 (2) The individual with a communicable disease's past behavior | |
488 | 486 | 23 or statements indicate an imminent risk that the individual with | |
489 | 487 | 24 a communicable disease will engage in behavior that transmits a | |
490 | 488 | 25 serious communicable disease to others. | |
491 | 489 | 26 (3) The individual with a communicable disease has failed or | |
492 | 490 | 27 refused to carry out the individual with a communicable disease's | |
493 | 491 | 28 duty to inform under section 1 of this chapter. | |
494 | 492 | 29 (b) A person who has reasonable cause to believe that a person: | |
495 | 493 | 30 (1) is a serious and present risk to the health of others as | |
496 | 494 | 31 described in subsection (a); | |
497 | 495 | 32 (2) has engaged in noncompliant behavior; or | |
498 | 496 | 33 (3) is suspected of being a person at risk (as described in section | |
499 | 497 | 34 1 of this chapter); | |
500 | 498 | 35 may report that information to a health officer. | |
501 | 499 | 36 (c) A person who makes a report under subsection (b) in good faith | |
502 | 500 | 37 is not subject to liability in a civil, an administrative, a disciplinary, or | |
503 | 501 | 38 a criminal action. | |
504 | 502 | 39 (d) A person who knowingly or recklessly makes a false report | |
505 | 503 | 40 under subsection (b) is civilly liable for actual damages suffered by a | |
506 | 504 | 41 person reported on and for punitive damages. | |
507 | 505 | 42 SECTION 22. IC 16-41-7-3 IS REPEALED [EFFECTIVE JULY 1, | |
508 | 506 | HB 1158—LS 7067/DI 137 12 | |
509 | 507 | 1 2022]. Sec. 3. (a) A licensed physician who diagnoses, treats, or | |
510 | 508 | 2 counsels a patient with a serious communicable disease shall inform | |
511 | 509 | 3 the patient of the patient's duty under section 1 of this chapter. | |
512 | 510 | 4 (b) A physician described in subsection (a) may notify the | |
513 | 511 | 5 following: | |
514 | 512 | 6 (1) A health officer if the physician has reasonable cause to | |
515 | 513 | 7 believe that a patient: | |
516 | 514 | 8 (A) is a serious and present risk to the health of others as | |
517 | 515 | 9 described in section 2(a) of this chapter; | |
518 | 516 | 10 (B) has engaged in noncompliant behavior; or | |
519 | 517 | 11 (C) is suspected of being a person at risk (as defined in section | |
520 | 518 | 12 1 of this chapter). | |
521 | 519 | 13 (2) A person at risk (as defined in section 1 of this chapter) or a | |
522 | 520 | 14 person legally responsible for the patient if the physician: | |
523 | 521 | 15 (A) has medical verification that the patient is an individual | |
524 | 522 | 16 with a communicable disease; | |
525 | 523 | 17 (B) knows the identity of the person at risk; | |
526 | 524 | 18 (C) has a reasonable belief of a significant risk of harm to the | |
527 | 525 | 19 identified person at risk; | |
528 | 526 | 20 (D) has reason to believe the identified person at risk has not | |
529 | 527 | 21 been informed and will not be informed of the risk by the | |
530 | 528 | 22 patient or another person; and | |
531 | 529 | 23 (E) has made reasonable efforts to inform the individual with | |
532 | 530 | 24 a communicable disease of the physician's intent to make or | |
533 | 531 | 25 cause the state department of health to make a disclosure to | |
534 | 532 | 26 the person at risk. | |
535 | 533 | 27 (c) A physician who notifies a person at risk under this section shall | |
536 | 534 | 28 do the following: | |
537 | 535 | 29 (1) Identify the serious communicable disease. | |
538 | 536 | 30 (2) Inform the person of available health care measures such as | |
539 | 537 | 31 counseling and testing. | |
540 | 538 | 32 (d) A physician who in good faith provides notification under this | |
541 | 539 | 33 section is not subject to liability in a civil, an administrative, a | |
542 | 540 | 34 disciplinary, or a criminal action. | |
543 | 541 | 35 (e) A patient's privilege with respect to a physician under | |
544 | 542 | 36 IC 34-46-3-1 is waived regarding: | |
545 | 543 | 37 (1) notification under subsection (b); and | |
546 | 544 | 38 (2) information provided about a patient's noncompliant behavior | |
547 | 545 | 39 in an investigation or action under this chapter, IC 16-41-2, | |
548 | 546 | 40 IC 16-41-3, IC 16-41-5, IC 16-41-6, IC 16-41-8, IC 16-41-9, | |
549 | 547 | 41 IC 16-41-13, IC 16-41-14, and IC 16-41-16. | |
550 | 548 | 42 (f) A physician's immunity from liability under subsection (d) | |
551 | 549 | HB 1158—LS 7067/DI 137 13 | |
552 | 550 | 1 applies only to the provision of information reasonably calculated to | |
553 | 551 | 2 protect an identified person who is at epidemiological risk of infection. | |
554 | 552 | 3 (g) A physician who notifies a person under this section is also | |
555 | 553 | 4 required to satisfy the reporting requirements under IC 16-41-2-2 | |
556 | 554 | 5 through IC 16-41-2-8. | |
557 | 555 | 6 SECTION 23. IC 16-41-7-4 IS REPEALED [EFFECTIVE JULY 1, | |
558 | 556 | 7 2022]. Sec. 4. (a) As used in this section, "person at risk" means an | |
559 | 557 | 8 individual who in the best judgment of a licensed physician: | |
560 | 558 | 9 (1) has engaged in high risk activity (as defined in section 1 of | |
561 | 559 | 10 this chapter); or | |
562 | 560 | 11 (2) is in imminent risk of engaging in high risk activity (as | |
563 | 561 | 12 defined in section 1 of this chapter). | |
564 | 562 | 13 (b) If a health officer is notified in writing by a physician under | |
565 | 563 | 14 section 3(b)(1)(A) of this chapter of a patient: | |
566 | 564 | 15 (1) for whom the physician has medical verification that the | |
567 | 565 | 16 patient is an individual with a communicable disease; and | |
568 | 566 | 17 (2) who, in the best judgment of the physician, is a serious and | |
569 | 567 | 18 present risk to the health of others; | |
570 | 568 | 19 the health officer shall make an investigation of the individual with a | |
571 | 569 | 20 communicable disease as authorized in IC 16-41-5-2 to determine | |
572 | 570 | 21 whether the environmental conditions surrounding the individual with | |
573 | 571 | 22 a communicable disease or the conduct of the individual with a | |
574 | 572 | 23 communicable disease requires the intervention by the health officer or | |
575 | 573 | 24 designated health official to prevent the transmission of disease to | |
576 | 574 | 25 others. | |
577 | 575 | 26 (c) If the state department is requested in writing by a physician who | |
578 | 576 | 27 has complied with the requirements of section 3(b)(2) of this chapter | |
579 | 577 | 28 to notify a person at risk, the state department shall notify the person | |
580 | 578 | 29 at risk unless, in the opinion of the state department, the person at risk: | |
581 | 579 | 30 (1) has already been notified; | |
582 | 580 | 31 (2) will be notified; or | |
583 | 581 | 32 (3) will otherwise be made aware that the person is a person at | |
584 | 582 | 33 risk. | |
585 | 583 | 34 (d) The state department shall establish a confidential registry of all | |
586 | 584 | 35 persons submitting written requests under subsection (c). | |
587 | 585 | 36 (e) The state department shall adopt rules under IC 4-22-2 to | |
588 | 586 | 37 implement this section. Local health officers may submit advisory | |
589 | 587 | 38 guidelines to the state department to implement this chapter, | |
590 | 588 | 39 IC 16-41-1, IC 16-41-3, IC 16-41-5, IC 16-41-8, or IC 16-41-9. The | |
591 | 589 | 40 state department shall fully consider such advisory guidelines before | |
592 | 590 | 41 adopting a rule under IC 4-22-2-29 implementing this chapter, | |
593 | 591 | 42 IC 16-41-1, IC 16-41-3, IC 16-41-5, IC 16-41-8, or IC 16-41-9. | |
594 | 592 | HB 1158—LS 7067/DI 137 14 | |
595 | 593 | 1 SECTION 24. IC 16-41-7-5 IS REPEALED [EFFECTIVE JULY 1, | |
596 | 594 | 2 2022]. Sec. 5. (a) Except as provided in IC 35-45-21-3, a person who | |
597 | 595 | 3 recklessly violates or fails to comply with this chapter commits a Class | |
598 | 596 | 4 B misdemeanor. | |
599 | 597 | 5 (b) Each day a violation continues constitutes a separate offense. | |
600 | 598 | 6 SECTION 25. IC 16-41-8-7 IS ADDED TO THE INDIANA CODE | |
601 | 599 | 7 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY | |
602 | 600 | 8 1, 2022]: Sec. 7. Local health officers may submit advisory | |
603 | 601 | 9 guidelines to the state department to implement this chapter. The | |
604 | 602 | 10 state department shall fully consider such advisory guidelines | |
605 | 603 | 11 before adopting a rule under IC 4-22-2-29 implementing this | |
606 | 604 | 12 chapter. | |
607 | 605 | 13 SECTION 26. IC 16-41-9-7, AS AMENDED BY P.L.112-2020, | |
608 | 606 | 14 SECTION 36, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
609 | 607 | 15 JULY 1, 2022]: Sec. 7. (a) An individual with a communicable disease | |
610 | 608 | 16 who: | |
611 | 609 | 17 (1) poses a serious and present risk to the health of others; | |
612 | 610 | 18 (2) has been voluntarily admitted to a hospital or other facility for | |
613 | 611 | 19 the treatment of tuberculosis or another serious communicable | |
614 | 612 | 20 disease; and | |
615 | 613 | 21 (3) who leaves the facility without authorized leave or against | |
616 | 614 | 22 medical advice or who fails to return from authorized leave; | |
617 | 615 | 23 shall be reported to a health officer by the facility not more than | |
618 | 616 | 24 twenty-four (24) hours after discovery of the individual with a | |
619 | 617 | 25 communicable disease's absence. | |
620 | 618 | 26 (b) If a health officer fails or refuses to institute or complete | |
621 | 619 | 27 necessary legal measures to prevent a health threat (as defined in | |
622 | 620 | 28 IC 16-41-7-2) by the individual with a communicable disease, the case | |
623 | 621 | 29 shall be referred to a designated health official for appropriate action | |
624 | 622 | 30 under this article. | |
625 | 623 | 31 SECTION 27. IC 16-41-9-16 IS ADDED TO THE INDIANA | |
626 | 624 | 32 CODE AS A NEW SECTION TO READ AS FOLLOWS | |
627 | 625 | 33 [EFFECTIVE JULY 1, 2022]: Sec. 16. Local health officers may | |
628 | 626 | 34 submit advisory guidelines to the state department to implement | |
629 | 627 | 35 this chapter. The state department shall fully consider such | |
630 | 628 | 36 advisory guidelines before adopting a rule under IC 4-22-2-29 | |
631 | 629 | 37 implementing this chapter. | |
632 | 630 | 38 SECTION 28. IC 16-41-14-17 IS REPEALED [EFFECTIVE JULY | |
633 | 631 | 39 1, 2022]. Sec. 17. (a) This section does not apply to a person who | |
634 | 632 | 40 transfers for research purposes semen that contains antibodies for the | |
635 | 633 | 41 human immunodeficiency virus (HIV). | |
636 | 634 | 42 (b) A person who, for the purpose of artificial insemination, | |
637 | 635 | HB 1158—LS 7067/DI 137 15 | |
638 | 636 | 1 recklessly, knowingly, or intentionally donates, sells, or transfers semen | |
639 | 637 | 2 that contains antibodies for the human immunodeficiency virus (HIV) | |
640 | 638 | 3 commits transferring contaminated semen, a Level 5 felony. The | |
641 | 639 | 4 offense is a Level 4 felony if the offense results in the transmission of | |
642 | 640 | 5 the virus to another person. | |
643 | 641 | 6 SECTION 29. IC 21-38-6-1, AS AMENDED BY P.L.133-2020, | |
644 | 642 | 7 SECTION 18, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
645 | 643 | 8 JULY 1, 2022]: Sec. 1. (a) An employee health plan that provides | |
646 | 644 | 9 coverage for early intervention services shall reimburse the first steps | |
647 | 645 | 10 program a monthly fee established by the division of disability and | |
648 | 646 | 11 rehabilitative services. Except when the monthly fee is less than the | |
649 | 647 | 12 product determined under IC 12-12.7-2-23(b), the monthly fee shall be | |
650 | 648 | 13 provided instead of claims processing of individual claims. | |
651 | 649 | 14 (b) An employee health plan may not require authorization for | |
652 | 650 | 15 services specified in the covered individual's individualized family | |
653 | 651 | 16 service plan, if those services are a covered benefit under the plan, | |
654 | 652 | 17 once the individualized family service plan is signed by a physician, a | |
655 | 653 | 18 physician assistant, or an advanced practice registered nurse. | |
656 | 654 | 19 (c) The department of insurance shall adopt rules under IC 4-22-2 | |
657 | 655 | 20 to ensure compliance with this section. | |
658 | - | 21 SECTION 30. IC 25- | |
659 | - | 22 | |
660 | - | 23 | |
661 | - | 24 | |
662 | - | 25 | |
663 | - | 26 | |
664 | - | 27 | |
665 | - | 28 | |
666 | - | 29 | |
667 | - | 30 | |
668 | - | 31 | |
669 | - | 32 " | |
670 | - | 33 | |
671 | - | 34 | |
672 | - | 35 | |
673 | - | 36 | |
674 | - | 37 " | |
675 | - | 38 | |
676 | - | 39 | |
677 | - | 40 " | |
678 | - | 41 | |
679 | - | 42 | |
656 | + | 21 SECTION 30. IC 25-1-9-2 IS AMENDED TO READ AS | |
657 | + | 22 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 2. (a) As used in this | |
658 | + | 23 chapter, "practitioner" means an individual who holds: | |
659 | + | 24 (1) an unlimited license, certificate, or registration; | |
660 | + | 25 (2) a limited or probationary license, certificate, or registration; | |
661 | + | 26 (3) a temporary license, certificate, registration, or permit; | |
662 | + | 27 (4) an intern permit; or | |
663 | + | 28 (5) a provisional license; | |
664 | + | 29 issued by the board regulating the profession in question, including a | |
665 | + | 30 certificate of registration issued under IC 25-20. | |
666 | + | 31 (b) The term includes all license statuses, including "active", | |
667 | + | 32 "expired", "retired", "inactive", and any other status that a | |
668 | + | 33 license may be held in. | |
669 | + | 34 SECTION 31. IC 25-26-13-2, AS AMENDED BY P.L.207-2021, | |
670 | + | 35 SECTION 30, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
671 | + | 36 UPON PASSAGE]: Sec. 2. As used in this chapter: | |
672 | + | 37 "Administering" means the direct application of a drug to the body | |
673 | + | 38 of a person by injection, inhalation, ingestion, or any other means. | |
674 | + | 39 "Board" means the Indiana board of pharmacy. | |
675 | + | 40 "Controlled drugs" are those drugs on schedules I through V of the | |
676 | + | 41 federal Controlled Substances Act or on schedules I through V of | |
677 | + | 42 IC 35-48-2. | |
680 | 678 | HB 1158—LS 7067/DI 137 16 | |
681 | - | 1 | |
682 | - | 2 | |
683 | - | 3 | |
684 | - | 4 | |
685 | - | 5 | |
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687 | - | 7 | |
688 | - | 8 | |
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707 | - | 27 or | |
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718 | - | 38 | |
719 | - | 39 | |
720 | - | 40 | |
721 | - | 41 | |
722 | - | 42 | |
679 | + | 1 "Coronavirus disease" means the disease caused by the severe acute | |
680 | + | 2 respiratory syndrome coronavirus 2 virus (SARS-CoV-2). | |
681 | + | 3 "Counseling" means effective communication between a pharmacist | |
682 | + | 4 and a patient concerning the contents, drug to drug interactions, route, | |
683 | + | 5 dosage, form, directions for use, precautions, and effective use of a | |
684 | + | 6 drug or device to improve the therapeutic outcome of the patient | |
685 | + | 7 through the effective use of the drug or device. | |
686 | + | 8 "Dispensing" means issuing one (1) or more doses of a drug in a | |
687 | + | 9 suitable container with appropriate labeling for subsequent | |
688 | + | 10 administration to or use by a patient. | |
689 | + | 11 "Drug" means: | |
690 | + | 12 (1) articles or substances recognized in the official United States | |
691 | + | 13 Pharmacopoeia, official National Formulary, official | |
692 | + | 14 Homeopathic Pharmacopoeia of the United States, or any | |
693 | + | 15 supplement to any of them; | |
694 | + | 16 (2) articles or substances intended for use in the diagnosis, cure, | |
695 | + | 17 mitigation, treatment, or prevention of disease in man or animals; | |
696 | + | 18 (3) articles other than food intended to affect the structure or any | |
697 | + | 19 function of the body of man or animals; or | |
698 | + | 20 (4) articles intended for use as a component of any article | |
699 | + | 21 specified in subdivisions (1) through (3) and devices. | |
700 | + | 22 "Drug order" means a written order in a hospital or other health care | |
701 | + | 23 institution for an ultimate user for any drug or device, issued and | |
702 | + | 24 signed by a practitioner, or an order transmitted by other means of | |
703 | + | 25 communication from a practitioner, which is immediately reduced to | |
704 | + | 26 writing by the pharmacist, registered nurse, or other licensed health | |
705 | + | 27 care practitioner authorized by the hospital or institution. The order | |
706 | + | 28 shall contain the name and bed number of the patient; the name and | |
707 | + | 29 strength or size of the drug or device; unless specified by individual | |
708 | + | 30 institution policy or guideline, the amount to be dispensed either in | |
709 | + | 31 quantity or days; adequate directions for the proper use of the drug or | |
710 | + | 32 device when it is administered to the patient; and the name of the | |
711 | + | 33 prescriber. | |
712 | + | 34 "Drug regimen review" means the retrospective, concurrent, and | |
713 | + | 35 prospective review by a pharmacist of a patient's drug related history | |
714 | + | 36 that includes the following areas: | |
715 | + | 37 (1) Evaluation of prescriptions or drug orders and patient records | |
716 | + | 38 for drug allergies, rational therapy contradictions, appropriate | |
717 | + | 39 dose and route of administration, appropriate directions for use, | |
718 | + | 40 or duplicative therapies. | |
719 | + | 41 (2) Evaluation of prescriptions or drug orders and patient records | |
720 | + | 42 for drug-drug, drug-food, drug-disease, and drug-clinical | |
723 | 721 | HB 1158—LS 7067/DI 137 17 | |
724 | - | 1 | |
725 | - | 2 or | |
726 | - | 3 | |
727 | - | 4 | |
728 | - | 5 | |
729 | - | 6 | |
730 | - | 7 | |
731 | - | 8 | |
732 | - | 9 | |
733 | - | 10 | |
734 | - | 11 | |
735 | - | 12 | |
736 | - | 13 | |
737 | - | 14 | |
738 | - | 15 | |
739 | - | 16 (3) | |
740 | - | 17 | |
741 | - | 18 | |
742 | - | 19 | |
743 | - | 20 | |
744 | - | 21 | |
745 | - | 22 | |
746 | - | 23 | |
747 | - | 24 | |
748 | - | 25 | |
749 | - | 26 | |
750 | - | 27 | |
751 | - | 28 | |
752 | - | 29 | |
753 | - | 30 | |
754 | - | 31 | |
755 | - | 32 | |
756 | - | 33 | |
757 | - | 34 | |
758 | - | 35 | |
759 | - | 36 | |
760 | - | 37 | |
761 | - | 38 | |
762 | - | 39 | |
763 | - | 40 | |
764 | - | 41 | |
765 | - | 42 | |
722 | + | 1 laboratory interactions. | |
723 | + | 2 (3) Evaluation of prescriptions or drug orders and patient records | |
724 | + | 3 for adverse drug reactions. | |
725 | + | 4 (4) Evaluation of prescriptions or drug orders and patient records | |
726 | + | 5 for proper utilization and optimal therapeutic outcomes. | |
727 | + | 6 "Drug utilization review" means a program designed to measure and | |
728 | + | 7 assess on a retrospective and prospective basis the proper use of drugs. | |
729 | + | 8 "Device" means an instrument, apparatus, implement, machine, | |
730 | + | 9 contrivance, implant, in vitro reagent, or other similar or related article | |
731 | + | 10 including any component part or accessory, which is: | |
732 | + | 11 (1) recognized in the official United States Pharmacopoeia, | |
733 | + | 12 official National Formulary, or any supplement to them; | |
734 | + | 13 (2) intended for use in the diagnosis of disease or other conditions | |
735 | + | 14 or the cure, mitigation, treatment, or prevention of disease in man | |
736 | + | 15 or other animals; or | |
737 | + | 16 (3) intended to affect the structure or any function of the body of | |
738 | + | 17 man or other animals and which does not achieve any of its | |
739 | + | 18 principal intended purposes through chemical action within or on | |
740 | + | 19 the body of man or other animals and which is not dependent | |
741 | + | 20 upon being metabolized for the achievement of any of its | |
742 | + | 21 principal intended purposes. | |
743 | + | 22 "Electronic data intermediary" means an entity that provides the | |
744 | + | 23 infrastructure that connects a computer system or another electronic | |
745 | + | 24 device used by a prescribing practitioner with a computer system or | |
746 | + | 25 another electronic device used by a pharmacy to facilitate the secure | |
747 | + | 26 transmission of: | |
748 | + | 27 (1) an electronic prescription order; | |
749 | + | 28 (2) a refill authorization request; | |
750 | + | 29 (3) a communication; and | |
751 | + | 30 (4) other patient care information; | |
752 | + | 31 between a practitioner and a pharmacy. | |
753 | + | 32 "Electronic signature" means an electronic sound, symbol, or | |
754 | + | 33 process: | |
755 | + | 34 (1) attached to or logically associated with a record; and | |
756 | + | 35 (2) executed or adopted by a person; | |
757 | + | 36 with the intent to sign the record. | |
758 | + | 37 "Electronically transmitted" or "electronic transmission" means the | |
759 | + | 38 transmission of a prescription in electronic form. The term does not | |
760 | + | 39 include the transmission of a prescription by facsimile. | |
761 | + | 40 "Investigational or new drug" means any drug which is limited by | |
762 | + | 41 state or federal law to use under professional supervision of a | |
763 | + | 42 practitioner authorized by law to prescribe or administer such drug. | |
766 | 764 | HB 1158—LS 7067/DI 137 18 | |
767 | - | 1 | |
768 | - | 2 | |
769 | - | 3 | |
770 | - | 4 | |
771 | - | 5 | |
772 | - | 6 | |
773 | - | 7 | |
774 | - | 8 | |
775 | - | 9 | |
776 | - | 10 | |
777 | - | 11 | |
778 | - | 12 | |
779 | - | 13 | |
780 | - | 14 | |
781 | - | 15 | |
782 | - | 16 | |
783 | - | 17 ( | |
784 | - | 18 | |
785 | - | 19 | |
786 | - | 20 | |
787 | - | 21 | |
788 | - | 22 | |
789 | - | 23 | |
790 | - | 24 | |
791 | - | 25 | |
792 | - | 26 | |
793 | - | 27 | |
794 | - | 28 | |
795 | - | 29 | |
796 | - | 30 | |
797 | - | 31 | |
798 | - | 32 | |
799 | - | 33 | |
800 | - | 34 | |
801 | - | 35 | |
802 | - | 36 | |
803 | - | 37 | |
804 | - | 38 | |
805 | - | 39 | |
806 | - | 40 " | |
807 | - | 41 | |
808 | - | 42 | |
765 | + | 1 "Legend drug" has the meaning set forth in IC 16-18-2-199. | |
766 | + | 2 "License" and "permit" are interchangeable and mean a written | |
767 | + | 3 certificate from the Indiana board of pharmacy for the practice of | |
768 | + | 4 pharmacy or the operation of a pharmacy. | |
769 | + | 5 "Medication therapy management" means a distinct service or group | |
770 | + | 6 of services that optimize therapeutic outcomes for individuals that are | |
771 | + | 7 independent of, but may occur in conjunction with, the provision of a | |
772 | + | 8 medication or medical device. The term includes the following | |
773 | + | 9 services: | |
774 | + | 10 (1) Performing or obtaining assessments of an individual's health | |
775 | + | 11 status. | |
776 | + | 12 (2) Formulating a medication treatment plan. | |
777 | + | 13 (3) Selecting, initiating, modifying, or administering medication | |
778 | + | 14 therapy. | |
779 | + | 15 (4) Monitoring and evaluating an individual's response to therapy, | |
780 | + | 16 including safety and effectiveness. | |
781 | + | 17 (5) Performing a comprehensive medication review to identify, | |
782 | + | 18 resolve, and prevent medication related problems, including | |
783 | + | 19 adverse drug events. | |
784 | + | 20 (6) Documenting the care delivered and communicating essential | |
785 | + | 21 information to the patient's other health care providers. | |
786 | + | 22 (7) Providing education and training designed to enhance patient | |
787 | + | 23 understanding and appropriate use of the individual's medications. | |
788 | + | 24 (8) Providing information and support services and resources | |
789 | + | 25 designed to enhance patient adherence with the individual's | |
790 | + | 26 therapeutic regimens, including medication synchronization. | |
791 | + | 27 (9) Coordinating and integrating medication therapy management | |
792 | + | 28 services within the broader health care services being provided to | |
793 | + | 29 an individual. | |
794 | + | 30 (10) Providing other patient care services allowable by law. | |
795 | + | 31 "Nonprescription drug" means a drug that may be sold without a | |
796 | + | 32 prescription and that is labeled for use by a patient in accordance with | |
797 | + | 33 state and federal laws. | |
798 | + | 34 "Person" means any individual, partnership, copartnership, firm, | |
799 | + | 35 company, corporation, association, joint stock company, trust, estate, | |
800 | + | 36 or municipality, or a legal representative or agent, unless this chapter | |
801 | + | 37 expressly provides otherwise. | |
802 | + | 38 "Practitioner" has the meaning set forth in IC 16-42-19-5. | |
803 | + | 39 "Pharmacist" means a person licensed under this chapter. | |
804 | + | 40 "Pharmacist intern" means a person who is: | |
805 | + | 41 (1) permitted by the board to engage in the practice of pharmacy | |
806 | + | 42 while under the personal supervision of a pharmacist and who is | |
809 | 807 | HB 1158—LS 7067/DI 137 19 | |
810 | - | 1 | |
811 | - | 2 | |
812 | - | 3 a | |
813 | - | 4 | |
814 | - | 5 pharmacy | |
815 | - | 6 | |
816 | - | 7 | |
817 | - | 8 | |
818 | - | 9 or | |
819 | - | 10 | |
820 | - | 11 | |
821 | - | 12 | |
822 | - | 13 or | |
823 | - | 14 | |
824 | - | 15 | |
825 | - | 16 | |
826 | - | 17 | |
827 | - | 18 | |
828 | - | 19 | |
829 | - | 20 devices | |
830 | - | 21 | |
831 | - | 22 | |
832 | - | 23 | |
833 | - | 24 | |
834 | - | 25 | |
835 | - | 26 | |
836 | - | 27 | |
837 | - | 28 ( | |
838 | - | 29 of drugs | |
839 | - | 30 | |
840 | - | 31 | |
841 | - | 32 | |
842 | - | 33 | |
843 | - | 34 ( | |
844 | - | 35 | |
845 | - | 36 | |
846 | - | 37 | |
847 | - | 38 | |
848 | - | 39 | |
849 | - | 40 | |
850 | - | 41 | |
851 | - | 42 | |
808 | + | 1 satisfactorily progressing toward meeting the requirements for | |
809 | + | 2 licensure as a pharmacist; | |
810 | + | 3 (2) a graduate of an approved college of pharmacy or a graduate | |
811 | + | 4 who has established educational equivalency by obtaining a | |
812 | + | 5 Foreign Pharmacy Graduate Examination Committee Certificate | |
813 | + | 6 and who is permitted by the board to obtain practical experience | |
814 | + | 7 as a requirement for licensure as a pharmacist; | |
815 | + | 8 (3) a qualified applicant awaiting examination for licensure; or | |
816 | + | 9 (4) an individual participating in a residency or fellowship | |
817 | + | 10 program. | |
818 | + | 11 "Pharmacy" means any facility, department, or other place where | |
819 | + | 12 prescriptions are filled or compounded and are sold, dispensed, offered, | |
820 | + | 13 or displayed for sale and which has as its principal purpose the | |
821 | + | 14 dispensing of drug and health supplies intended for the general health, | |
822 | + | 15 welfare, and safety of the public, without placing any other activity on | |
823 | + | 16 a more important level than the practice of pharmacy. | |
824 | + | 17 "The practice of pharmacy" or "the practice of the profession of | |
825 | + | 18 pharmacy" means a patient oriented health care profession in which | |
826 | + | 19 pharmacists interact with and counsel patients and with other health | |
827 | + | 20 care professionals concerning drugs and devices used to enhance | |
828 | + | 21 patients' wellness, prevent illness, and optimize the outcome of a drug | |
829 | + | 22 or device, by accepting responsibility for performing or supervising a | |
830 | + | 23 pharmacist intern or an unlicensed person under section 18.5 of this | |
831 | + | 24 chapter to do the following acts, services, and operations: | |
832 | + | 25 (1) The offering of or performing of those acts, service operations, | |
833 | + | 26 or transactions incidental to the interpretation, evaluation, and | |
834 | + | 27 implementation of prescriptions or drug orders. | |
835 | + | 28 (2) The compounding, labeling, administering, dispensing, or | |
836 | + | 29 selling of drugs and devices, including radioactive substances, | |
837 | + | 30 whether dispensed under a practitioner's prescription or drug | |
838 | + | 31 order or sold or given directly to the ultimate consumer. | |
839 | + | 32 (3) The proper and safe storage and distribution of drugs and | |
840 | + | 33 devices. | |
841 | + | 34 (4) The maintenance of proper records of the receipt, storage, | |
842 | + | 35 sale, and dispensing of drugs and devices. | |
843 | + | 36 (5) Counseling, advising, and educating patients, patients' | |
844 | + | 37 caregivers, and health care providers and professionals, as | |
845 | + | 38 necessary, as to the contents, therapeutic values, uses, significant | |
846 | + | 39 problems, risks, and appropriate manner of use of drugs and | |
847 | + | 40 devices. | |
848 | + | 41 (6) Assessing, recording, and reporting events related to the use | |
849 | + | 42 of drugs or devices. | |
852 | 850 | HB 1158—LS 7067/DI 137 20 | |
853 | - | 1 | |
854 | - | 2 | |
855 | - | 3 | |
856 | - | 4 | |
857 | - | 5 ( | |
858 | - | 6 | |
859 | - | 7 | |
860 | - | 8 | |
861 | - | 9 | |
862 | - | 10 | |
863 | - | 11 the | |
864 | - | 12 | |
865 | - | 13 | |
866 | - | 14 | |
867 | - | 15 | |
868 | - | 16 | |
869 | - | 17 | |
870 | - | 18 ( | |
871 | - | 19 | |
872 | - | 20 ( | |
873 | - | 21 | |
874 | - | 22 | |
875 | - | 23 | |
876 | - | 24 | |
877 | - | 25 | |
878 | - | 26 | |
879 | - | 27 | |
880 | - | 28 | |
881 | - | 29 | |
882 | - | 30 | |
883 | - | 31 | |
884 | - | 32 | |
885 | - | 33 (2) | |
886 | - | 34 | |
887 | - | 35 | |
888 | - | 36 | |
889 | - | 37 | |
890 | - | 38 | |
891 | - | 39 | |
892 | - | 40 | |
893 | - | 41 | |
894 | - | 42 ( | |
851 | + | 1 (7) Provision of the professional acts, professional decisions, and | |
852 | + | 2 professional services necessary to maintain all areas of a patient's | |
853 | + | 3 pharmacy related care as specifically authorized to a pharmacist | |
854 | + | 4 under this article. | |
855 | + | 5 (8) Provision of medication therapy management. | |
856 | + | 6 "Prescription" means a written order or an order transmitted by other | |
857 | + | 7 means of communication from a practitioner to or for an ultimate user | |
858 | + | 8 for any drug or device containing: | |
859 | + | 9 (1) the name and address of the patient; | |
860 | + | 10 (2) the date of issue; | |
861 | + | 11 (3) the name and strength or size (if applicable) of the drug or | |
862 | + | 12 device; | |
863 | + | 13 (4) the amount to be dispensed (unless indicated by directions and | |
864 | + | 14 duration of therapy); | |
865 | + | 15 (5) adequate directions for the proper use of the drug or device by | |
866 | + | 16 the patient; | |
867 | + | 17 (6) the name of the practitioner; and | |
868 | + | 18 (7) if the prescription: | |
869 | + | 19 (A) is in written form, the signature of the practitioner; or | |
870 | + | 20 (B) is in electronic form, the electronic signature of the | |
871 | + | 21 practitioner. | |
872 | + | 22 "Qualifying pharmacist" means the pharmacist who will qualify the | |
873 | + | 23 pharmacy by being responsible to the board for the legal operations of | |
874 | + | 24 the pharmacy under the permit. | |
875 | + | 25 "Record" means all papers, letters, memoranda, notes, prescriptions, | |
876 | + | 26 drug orders, invoices, statements, patient medication charts or files, | |
877 | + | 27 computerized records, or other written indicia, documents, or objects | |
878 | + | 28 which are used in any way in connection with the purchase, sale, or | |
879 | + | 29 handling of any drug or device. | |
880 | + | 30 "Sale" means every sale and includes: | |
881 | + | 31 (1) manufacturing, processing, transporting, handling, packaging, | |
882 | + | 32 or any other production, preparation, or repackaging; | |
883 | + | 33 (2) exposure, offer, or any other proffer; | |
884 | + | 34 (3) holding, storing, or any other possession; | |
885 | + | 35 (4) dispensing, giving, delivering, or any other supplying; and | |
886 | + | 36 (5) applying, administering, or any other using. | |
887 | + | 37 SECTION 32. IC 25-26-13-3, AS AMENDED BY P.L.249-2019, | |
888 | + | 38 SECTION 113, IS AMENDED TO READ AS FOLLOWS | |
889 | + | 39 [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of | |
890 | + | 40 pharmacy is created. The board consists of seven (7) members | |
891 | + | 41 appointed by the governor for terms under IC 25-1-6.5. | |
892 | + | 42 (b) Subject to IC 25-1-6.5-3, the board consists of the following: | |
895 | 893 | HB 1158—LS 7067/DI 137 21 | |
896 | - | 1 ( | |
897 | - | 2 | |
898 | - | 3 | |
899 | - | 4 | |
900 | - | 5 | |
901 | - | 6 | |
902 | - | 7 | |
903 | - | 8 | |
904 | - | 9 | |
905 | - | 10 | |
906 | - | 11 | |
907 | - | 12 board | |
908 | - | 13 ( | |
909 | - | 14 | |
910 | - | 15 | |
911 | - | 16 | |
912 | - | 17 | |
913 | - | 18 ( | |
914 | - | 19 | |
915 | - | 20 | |
916 | - | 21 | |
917 | - | 22 | |
918 | - | 23 | |
919 | - | 24 | |
920 | - | 25 | |
921 | - | 26 | |
922 | - | 27 | |
923 | - | 28 | |
924 | - | 29 | |
925 | - | 30 | |
926 | - | 31 ( | |
927 | - | 32 | |
928 | - | 33 | |
929 | - | 34 | |
930 | - | 35 ( | |
931 | - | 36 | |
932 | - | 37 | |
933 | - | 38 | |
934 | - | 39 | |
935 | - | 40 | |
936 | - | 41 | |
937 | - | 42 | |
894 | + | 1 (1) One (1) member of the board, to represent the general public, | |
895 | + | 2 who is a resident of this state who has never been associated with | |
896 | + | 3 pharmacy in any way other than as a consumer. | |
897 | + | 4 (2) Six (6) Five (5) members who are pharmacists in good | |
898 | + | 5 standing of recognized experience and ability from varied practice | |
899 | + | 6 settings who hold a current license to practice pharmacy in | |
900 | + | 7 Indiana, including one (1) member of the board who must be a | |
901 | + | 8 practicing hospital pharmacist. | |
902 | + | 9 (3) One (1) member who is a pharmacy technician in good | |
903 | + | 10 standing, engaged in active practice as a pharmacy technician, | |
904 | + | 11 and holds a current certification from the Pharmacy | |
905 | + | 12 Technician Certification Board. | |
906 | + | 13 (c) A member may be removed under IC 25-1-6.5-4. | |
907 | + | 14 (d) Not later than ten (10) days after a member's appointment, the | |
908 | + | 15 member must subscribe by oath or affirmation to faithfully uphold the | |
909 | + | 16 duties of the member's office. If a member fails to qualify as provided, | |
910 | + | 17 a new member shall be appointed in the member's place. | |
911 | + | 18 (e) At the first meeting of each year the board shall elect from | |
912 | + | 19 among its members a president and vice president who shall perform | |
913 | + | 20 duties and have powers as the board prescribes. | |
914 | + | 21 (f) The board shall meet at least eight (8) times per year at such | |
915 | + | 22 times and places as the board selects. At each meeting the board shall | |
916 | + | 23 continue in session from day to day, for not more than five (5) days, | |
917 | + | 24 until the business of the meeting is complete. Four (4) members of the | |
918 | + | 25 board shall constitute a quorum. | |
919 | + | 26 (g) Each member of the board is entitled to compensation as | |
920 | + | 27 determined by the rules of the budget agency for each day the member | |
921 | + | 28 is actually engaged in business of the board, together with necessary | |
922 | + | 29 travel and other expenses incurred in the performance of the member's | |
923 | + | 30 duties. | |
924 | + | 31 (h) Approval by a majority of the quorum is required for any action | |
925 | + | 32 to be taken by the board. | |
926 | + | 33 SECTION 33. IC 25-26-13-10, AS AMENDED BY P.L.101-2020, | |
927 | + | 34 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
928 | + | 35 JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a | |
929 | + | 36 pharmacist intern must furnish proof satisfactory to the board that the | |
930 | + | 37 applicant: | |
931 | + | 38 (1) is actively enrolled in a school of pharmacy accredited by the | |
932 | + | 39 American Council of Pharmaceutical for Pharmacy Education; | |
933 | + | 40 (2) has obtained the Foreign Pharmacy Graduate Examination | |
934 | + | 41 Committee Certificate; or | |
935 | + | 42 (3) is a qualified applicant awaiting the examination for licensure | |
938 | 936 | HB 1158—LS 7067/DI 137 22 | |
939 | - | 1 | |
940 | - | 2 | |
941 | - | 3 | |
942 | - | 4 | |
943 | - | 5 | |
944 | - | 6 ( | |
945 | - | 7 | |
946 | - | 8 ( | |
947 | - | 9 | |
948 | - | 10 pharmacy accredited | |
949 | - | 11 Pharmaceutical for Pharmacy | |
950 | - | 12 | |
951 | - | 13 | |
952 | - | 14 | |
953 | - | 15 ( | |
954 | - | 16 | |
955 | - | 17 | |
956 | - | 18 ( | |
957 | - | 19 | |
958 | - | 20 | |
959 | - | 21 | |
960 | - | 22 | |
961 | - | 23 | |
962 | - | 24 | |
963 | - | 25 | |
964 | - | 26 | |
965 | - | 27 ( | |
966 | - | 28 a school of | |
967 | - | 29 | |
968 | - | 30 ( | |
969 | - | 31 | |
970 | - | 32 | |
971 | - | 33 | |
972 | - | 34 | |
973 | - | 35 | |
974 | - | 36 | |
975 | - | 37 | |
976 | - | 38 | |
977 | - | 39 | |
978 | - | 40 | |
979 | - | 41 | |
980 | - | 42 | |
937 | + | 1 as a pharmacist. | |
938 | + | 2 (b) A registration issued under subsection (a) is valid for one (1) | |
939 | + | 3 year and may be renewed by the board in accordance with subsection | |
940 | + | 4 (c) until the expiration date established by the Indiana professional | |
941 | + | 5 licensing agency under IC 25-1-5-4. | |
942 | + | 6 (c) An application for registration or renewal must be accompanied | |
943 | + | 7 by the appropriate fee and one (1) of the following: | |
944 | + | 8 (1) Proof of having obtained the Foreign Pharmacy Graduate | |
945 | + | 9 Examination Committee Certificate. | |
946 | + | 10 (2) Proof of active enrollment in a school of pharmacy accredited | |
947 | + | 11 by the American Council of Pharmaceutical for Pharmacy | |
948 | + | 12 Education. | |
949 | + | 13 SECTION 34. IC 25-26-13-11, AS AMENDED BY P.L.98-2006, | |
950 | + | 14 SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
951 | + | 15 JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a | |
952 | + | 16 pharmacist, an individual must file such evidence as is required by the | |
953 | + | 17 board that: | |
954 | + | 18 (1) the individual is at least eighteen (18) years of age; | |
955 | + | 19 (2) the individual does not have a conviction for a crime that has | |
956 | + | 20 a direct bearing on the individual's ability to practice competently; | |
957 | + | 21 (3) the individual: | |
958 | + | 22 (A) has graduated with a professional degree from a school of | |
959 | + | 23 pharmacy accredited by the American Council of | |
960 | + | 24 Pharmaceutical for Pharmacy Education or the Canadian | |
961 | + | 25 Council on Pharmacy Accreditation for Accreditation of | |
962 | + | 26 Pharmacy Programs and approved by the board; or | |
963 | + | 27 (B) has: | |
964 | + | 28 (i) graduated with a professional degree from a school of | |
965 | + | 29 pharmacy located outside the United States and Canada; and | |
966 | + | 30 (ii) met the requirements under subsection (c); and | |
967 | + | 31 (4) the individual has satisfactorily completed a pharmacist intern | |
968 | + | 32 program approved by the board. | |
969 | + | 33 (b) An applicant who has graduated with a professional degree from | |
970 | + | 34 a school of pharmacy accredited by the Canadian Council on Pharmacy | |
971 | + | 35 Accreditation for Accreditation of Pharmacy Programs and | |
972 | + | 36 approved by the board must obtain the Foreign Pharmacy Graduate | |
973 | + | 37 Examination Committee Certificate administered by the National | |
974 | + | 38 Association of Boards of Pharmacy before taking the examination | |
975 | + | 39 required under subsection (d). | |
976 | + | 40 (c) An applicant who has graduated with a professional degree from | |
977 | + | 41 a school of pharmacy located outside the United States and Canada | |
978 | + | 42 must do the following: | |
981 | 979 | HB 1158—LS 7067/DI 137 23 | |
982 | - | 1 | |
983 | - | 2 | |
984 | - | 3 ( | |
985 | - | 4 National Association | |
986 | - | 5 | |
987 | - | 6 | |
988 | - | 7 | |
989 | - | 8 | |
990 | - | 9 | |
991 | - | 10 | |
992 | - | 11 | |
993 | - | 12 | |
994 | - | 13 | |
995 | - | 14 | |
996 | - | 15 | |
997 | - | 16 | |
998 | - | 17 | |
999 | - | 18 | |
1000 | - | 19 | |
1001 | - | 20 | |
1002 | - | 21 | |
1003 | - | 22 | |
1004 | - | 23 ( | |
1005 | - | 24 | |
1006 | - | 25 | |
1007 | - | 26 Pharmacy | |
1008 | - | 27 | |
1009 | - | 28 Pharmacy | |
1010 | - | 29 | |
1011 | - | 30 | |
1012 | - | 31 | |
1013 | - | 32 | |
1014 | - | 33 | |
1015 | - | 34 | |
1016 | - | 35 | |
1017 | - | 36 | |
1018 | - | 37 | |
1019 | - | 38 | |
1020 | - | 39 | |
1021 | - | 40 | |
980 | + | 1 (1) Provide the board with verification of the applicant's academic | |
981 | + | 2 record and graduation. | |
982 | + | 3 (2) Obtain the Foreign Pharmacy Graduate Examination | |
983 | + | 4 Committee Certificate administered by the National Association | |
984 | + | 5 of Boards of Pharmacy. | |
985 | + | 6 (d) After filing an application on a form provided by the board, | |
986 | + | 7 submitting the information required in subsection (a), and successfully | |
987 | + | 8 completing the examination administered by the board, the applicant | |
988 | + | 9 may be licensed as a pharmacist. | |
989 | + | 10 SECTION 35. IC 25-26-13-12, AS AMENDED BY P.L.98-2006, | |
990 | + | 11 SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
991 | + | 12 JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a | |
992 | + | 13 pharmacist in another state where the requirements for licensure were | |
993 | + | 14 not less than those required in this state at the time of original licensure | |
994 | + | 15 may be issued a license in this state if: | |
995 | + | 16 (1) the individual has registered with and been approved by the | |
996 | + | 17 National Association of Boards of Pharmacy; | |
997 | + | 18 (2) the individual has graduated with a professional degree in | |
998 | + | 19 pharmacy from a school of pharmacy accredited by the American | |
999 | + | 20 Council of Pharmaceutical for Pharmacy Education or the | |
1000 | + | 21 Canadian Council on Pharmacy Accreditation for Accreditation | |
1001 | + | 22 of Pharmacy Programs and approved by the board; and | |
1002 | + | 23 (3) the individual has successfully completed an examination | |
1003 | + | 24 administered by the board concerning the federal statutes and | |
1004 | + | 25 regulations and the Indiana statutes and rules governing the | |
1005 | + | 26 practice of pharmacy. | |
1006 | + | 27 (b) An individual who has a professional pharmacy degree from a | |
1007 | + | 28 school of pharmacy located outside the United States and Canada and | |
1008 | + | 29 who is licensed in another state where the requirements for licensure | |
1009 | + | 30 are substantially the same as those in this state may be issued a license | |
1010 | + | 31 under this chapter if: | |
1011 | + | 32 (1) the individual has registered with and been approved by the | |
1012 | + | 33 National Association of Boards of Pharmacy; | |
1013 | + | 34 (2) the individual has provided the board with proof of the | |
1014 | + | 35 applicant's: | |
1015 | + | 36 (A) academic record and graduation with a professional degree | |
1016 | + | 37 from a school of pharmacy; and | |
1017 | + | 38 (B) completion of the requirements for obtaining a Foreign | |
1018 | + | 39 Pharmacy Graduate Examination Committee Certificate | |
1019 | + | 40 administered by the National Association of Boards of | |
1022 | 1020 | 41 Pharmacy; and | |
1023 | - | 42 (3) the | |
1021 | + | 42 (3) the individual has successfully completed an examination | |
1024 | 1022 | HB 1158—LS 7067/DI 137 24 | |
1025 | - | 1 | |
1026 | - | 2 | |
1027 | - | 3 | |
1028 | - | 4 | |
1029 | - | 5 | |
1030 | - | 6 | |
1031 | - | 7 | |
1032 | - | 8 | |
1033 | - | 9 | |
1034 | - | 10 | |
1035 | - | 11 | |
1036 | - | 12 | |
1037 | - | 13 | |
1038 | - | 14 | |
1039 | - | 15 | |
1040 | - | 16 | |
1041 | - | 17 | |
1042 | - | 18 | |
1043 | - | 19 | |
1044 | - | 20 | |
1045 | - | 21 | |
1046 | - | 22 | |
1047 | - | 23 | |
1048 | - | 24 | |
1049 | - | 25 ( | |
1050 | - | 26 | |
1051 | - | 27 | |
1052 | - | 28 | |
1053 | - | 29 | |
1054 | - | 30 shall | |
1055 | - | 31 | |
1056 | - | 32 | |
1057 | - | 33 | |
1058 | - | 34 | |
1059 | - | 35 ( | |
1060 | - | 36 | |
1061 | - | 37 | |
1062 | - | 38 ( | |
1063 | - | 39 | |
1064 | - | 40 | |
1065 | - | 41 SECTION | |
1066 | - | 42 | |
1023 | + | 1 administered by the board concerning the federal statutes and | |
1024 | + | 2 regulations and the Indiana statutes and rules governing the | |
1025 | + | 3 practice of pharmacy. | |
1026 | + | 4 SECTION 36. IC 25-26-13-20, AS AMENDED BY P.L.207-2021, | |
1027 | + | 5 SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1028 | + | 6 JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish, | |
1029 | + | 7 operate, or maintain a pharmacy shall apply to the board for a | |
1030 | + | 8 pharmacy permit on a form provided by the board. The applicant shall | |
1031 | + | 9 set forth: | |
1032 | + | 10 (1) the name and occupation of the persons desiring the permit; | |
1033 | + | 11 (2) the location, including street address and city, of the | |
1034 | + | 12 pharmacy; and | |
1035 | + | 13 (3) the name of the pharmacist who will qualify the pharmacy by | |
1036 | + | 14 being responsible to the board for the legal operation of the | |
1037 | + | 15 pharmacy under the permit; and | |
1038 | + | 16 (4) (3) such other information as the board may require. | |
1039 | + | 17 (b) If the applicant desires to open, establish, operate, or maintain | |
1040 | + | 18 more than one (1) pharmacy, the applicant must file a separate | |
1041 | + | 19 application for each. Each pharmacy must be qualified by a different | |
1042 | + | 20 pharmacist. | |
1043 | + | 21 (c) The board shall permit a pharmacist to serve as a qualifying | |
1044 | + | 22 pharmacist for more than one (1) pharmacy holding a Category II | |
1045 | + | 23 pharmacy permit upon the holder of the Category II permit showing | |
1046 | + | 24 circumstances establishing that: | |
1047 | + | 25 (1) the permit holder has made a reasonable effort, without | |
1048 | + | 26 success, to obtain a qualifying pharmacist who is not serving as | |
1049 | + | 27 a qualifying pharmacist at another Category II pharmacy; and | |
1050 | + | 28 (2) the single pharmacist could effectively fulfill all duties and | |
1051 | + | 29 responsibilities of the qualifying pharmacist at both locations. | |
1052 | + | 30 However, the board shall hold the permit holder responsible and may | |
1053 | + | 31 not discipline or otherwise hold the qualifying pharmacist an | |
1054 | + | 32 individual licensed under this chapter responsible for staffing | |
1055 | + | 33 deficiencies of the pharmacy if the qualifying pharmacist individual | |
1056 | + | 34 does not have authority for staffing determinations of the pharmacy. | |
1057 | + | 35 (d) The board shall grant or deny an application for a permit not | |
1058 | + | 36 later than one hundred twenty (120) days after the application and any | |
1059 | + | 37 additional information required by the board are submitted. | |
1060 | + | 38 (e) The board may not issue a pharmacy permit to a person who | |
1061 | + | 39 desires to operate the pharmacy out of a residence. | |
1062 | + | 40 SECTION 37. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021, | |
1063 | + | 41 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1064 | + | 42 JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy | |
1067 | 1065 | HB 1158—LS 7067/DI 137 25 | |
1068 | - | 1 | |
1069 | - | 2 | |
1070 | - | 3 pharmacy | |
1071 | - | 4 ( | |
1072 | - | 5 | |
1073 | - | 6 ( | |
1074 | - | 7 | |
1075 | - | 8 | |
1076 | - | 9 | |
1077 | - | 10 | |
1078 | - | 11 | |
1079 | - | 12 | |
1080 | - | 13 | |
1081 | - | 14 ( | |
1082 | - | 15 | |
1083 | - | 16 | |
1084 | - | 17 ( | |
1085 | - | 18 | |
1086 | - | 19 | |
1087 | - | 20 | |
1088 | - | 21 | |
1089 | - | 22 | |
1090 | - | 23 | |
1091 | - | 24 | |
1092 | - | 25 | |
1093 | - | 26 | |
1094 | - | 27 | |
1095 | - | 28 | |
1096 | - | 29 | |
1097 | - | 30 | |
1098 | - | 31 | |
1099 | - | 32 | |
1100 | - | 33 | |
1101 | - | 34 | |
1102 | - | 35 ( | |
1103 | - | 36 | |
1104 | - | 37 | |
1105 | - | 38 | |
1106 | - | 39 | |
1107 | - | 40 ( | |
1108 | - | 41 | |
1109 | - | 42 | |
1066 | + | 1 shall transfer to another pharmacy a prescription for the patient, | |
1067 | + | 2 including a prescription for a schedule II controlled substance, that the | |
1068 | + | 3 pharmacy has received but not filled unless: | |
1069 | + | 4 (1) prohibited in writing on the prescription by the prescriber; or | |
1070 | + | 5 (2) otherwise prohibited by federal law. | |
1071 | + | 6 (b) Unless prohibited by federal law, a prescription for a patient may | |
1072 | + | 7 be transferred electronically or by facsimile by a pharmacy to another | |
1073 | + | 8 pharmacy if the pharmacies do not share a common data base. | |
1074 | + | 9 (c) A licensed pharmacy technician may transfer a prescription, | |
1075 | + | 10 under subsection (b) including making a verbal transfer, as | |
1076 | + | 11 delegated by a pharmacist. | |
1077 | + | 12 SECTION 38. IC 25-26-13-27 IS AMENDED TO READ AS | |
1078 | + | 13 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 27. (a) If a pharmacy | |
1079 | + | 14 will be closed for five (5) consecutive days or more, the permit holder | |
1080 | + | 15 shall notify the board and take such steps to secure the drugs in the | |
1081 | + | 16 pharmacy as the board may direct. | |
1082 | + | 17 (b) If a pharmacy is to be permanently closed for any reason, the | |
1083 | + | 18 owner or qualifying pharmacist shall: | |
1084 | + | 19 (1) notify the board not less than twenty (20) days before the | |
1085 | + | 20 transfer of any controlled substances and submit a copy of the | |
1086 | + | 21 inventory form required by the federal drug enforcement | |
1087 | + | 22 administration together with the name, address, and registration | |
1088 | + | 23 number of the person to whom the drugs will be transferred; | |
1089 | + | 24 (2) remove all legend drugs from stock by: | |
1090 | + | 25 (A) returning them to the wholesaler or manufacturer if he | |
1091 | + | 26 consents; | |
1092 | + | 27 (B) transferring them to another pharmacy; or | |
1093 | + | 28 (C) destroying them in the presence of a representative | |
1094 | + | 29 appointed by the board; | |
1095 | + | 30 (3) before disposing of any other merchandise in the pharmacy, | |
1096 | + | 31 dispose of all controlled drugs and legend drugs as provided in | |
1097 | + | 32 clauses (1) and (2) and submit the licensed premises to an | |
1098 | + | 33 inspection by a representative of the board to certify that all | |
1099 | + | 34 legend and controlled drugs have been removed; | |
1100 | + | 35 (4) remove from inside and outside the licensed area all symbols | |
1101 | + | 36 and signs using the words "drugs", "drugstore", "prescriptions", | |
1102 | + | 37 "pharmacy", "pharmacy department", "apothecary", or | |
1103 | + | 38 "apothecary shop", or any combination of such titles; and | |
1104 | + | 39 (5) return the pharmacy permit for cancellation by the board | |
1105 | + | 40 within ten (10) days after all legend drugs, controlled drugs, drugs | |
1106 | + | 41 and devices are removed from the premises. | |
1107 | + | 42 SECTION 39. IC 25-26-13-31.7, AS AMENDED BY P.L.207-2021, | |
1110 | 1108 | HB 1158—LS 7067/DI 137 26 | |
1111 | - | 1 | |
1112 | - | 2 | |
1113 | - | 3 | |
1114 | - | 4 | |
1115 | - | 5 | |
1116 | - | 6 subsection | |
1117 | - | 7 | |
1118 | - | 8 | |
1119 | - | 9 | |
1120 | - | 10 | |
1121 | - | 11 IC 4-22-2 | |
1122 | - | 12 | |
1123 | - | 13 | |
1124 | - | 14 | |
1125 | - | 15 | |
1126 | - | 16 | |
1127 | - | 17 JULY 1, | |
1128 | - | 18 | |
1129 | - | 19 | |
1130 | - | 20 | |
1131 | - | 21 | |
1132 | - | 22 | |
1133 | - | 23 under | |
1134 | - | 24 | |
1135 | - | 25 | |
1136 | - | 26 | |
1137 | - | 27 | |
1138 | - | 28 | |
1139 | - | 29 | |
1140 | - | 30 | |
1141 | - | 31 facility | |
1142 | - | 32 | |
1143 | - | 33 | |
1144 | - | 34 ( | |
1145 | - | 35 | |
1146 | - | 36 | |
1147 | - | 37 ( | |
1148 | - | 38 | |
1149 | - | 39 ( | |
1150 | - | 40 | |
1151 | - | 41 ( | |
1152 | - | 42 | |
1109 | + | 1 SECTION 38, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1110 | + | 2 JULY 1, 2022]: Sec. 31.7. (a) Subject to rules adopted under | |
1111 | + | 3 subsection (c), a pharmacy technician may administer an influenza or | |
1112 | + | 4 coronavirus disease any immunization to an individual under a drug | |
1113 | + | 5 order or prescription, as delegated by the pharmacist. | |
1114 | + | 6 (b) Subject to rules adopted under subsection (c), a pharmacy | |
1115 | + | 7 technician may administer an influenza or coronavirus disease | |
1116 | + | 8 immunization to an individual or a group of individuals under a drug | |
1117 | + | 9 order, under a prescription, or according to a protocol approved by a | |
1118 | + | 10 physician, as delegated by the pharmacist. | |
1119 | + | 11 (c) The board shall adopt rules under IC 4-22-2 to establish | |
1120 | + | 12 requirements applying to a pharmacy technician who administers an | |
1121 | + | 13 influenza or coronavirus disease immunization to an individual or | |
1122 | + | 14 group of individuals. The rules adopted under this section must provide | |
1123 | + | 15 for the direct supervision of the pharmacy technician by a pharmacist, | |
1124 | + | 16 a physician, a physician assistant, or an advanced practice registered | |
1125 | + | 17 nurse. Before July 1, 2021, the board shall adopt emergency rules | |
1126 | + | 18 under IC 4-22-2-37.1 to establish the requirements described in this | |
1127 | + | 19 subsection. concerning the influenza immunization and the coronavirus | |
1128 | + | 20 disease immunization. Notwithstanding IC 4-22-2-37.1(g), an | |
1129 | + | 21 emergency rule adopted by the board under this subsection and in the | |
1130 | + | 22 manner provided by IC 4-22-2-37.1 expires on the date on which a rule | |
1131 | + | 23 that supersedes the emergency rule is adopted by the board under | |
1132 | + | 24 IC 4-22-2-24 through IC 4-22-2-36. | |
1133 | + | 25 (d) The board must approve all programs that provide training to | |
1134 | + | 26 pharmacy technicians to administer influenza and coronavirus disease | |
1135 | + | 27 immunizations as permitted by this section. | |
1136 | + | 28 SECTION 40. IC 25-26-13.5-6, AS AMENDED BY P.L.207-2021, | |
1137 | + | 29 SECTION 39, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1138 | + | 30 JULY 1, 2022]: Sec. 6. (a) Before a remote dispensing facility may do | |
1139 | + | 31 business in Indiana, the remote dispensing facility must be registered | |
1140 | + | 32 with the board under this chapter and in the manner prescribed by the | |
1141 | + | 33 board. | |
1142 | + | 34 (b) Before a pharmacy licensed under this article may operate a | |
1143 | + | 35 remote dispensing facility, the pharmacy must register with the board | |
1144 | + | 36 under this chapter. | |
1145 | + | 37 (c) A facility must meet the following requirements in order to be | |
1146 | + | 38 registered as a remote dispensing facility under this chapter: | |
1147 | + | 39 (1) If the remote dispensing facility is not jointly owned by the | |
1148 | + | 40 pharmacy, operate under a contract with a supervising pharmacy. | |
1149 | + | 41 (2) Be supervised by a qualifying pharmacist who is licensed | |
1150 | + | 42 under this article and who is designated by the supervising | |
1153 | 1151 | HB 1158—LS 7067/DI 137 27 | |
1154 | - | 1 | |
1155 | - | 2 | |
1156 | - | 3 | |
1157 | - | 4 | |
1158 | - | 5 (A) | |
1159 | - | 6 | |
1160 | - | 7 | |
1161 | - | 8 | |
1162 | - | 9 | |
1163 | - | 10 | |
1164 | - | 11 | |
1165 | - | 12 | |
1166 | - | 13 ( | |
1167 | - | 14 | |
1168 | - | 15 ( | |
1169 | - | 16 | |
1170 | - | 17 | |
1171 | - | 18 | |
1172 | - | 19 | |
1173 | - | 20 ( | |
1174 | - | 21 | |
1175 | - | 22 | |
1176 | - | 23 | |
1177 | - | 24 | |
1178 | - | 25 | |
1179 | - | 26 ( | |
1180 | - | 27 | |
1181 | - | 28 | |
1182 | - | 29 | |
1183 | - | 30 ( | |
1184 | - | 31 the | |
1185 | - | 32 | |
1186 | - | 33 ( | |
1187 | - | 34 | |
1188 | - | 35 | |
1189 | - | 36 | |
1190 | - | 37 | |
1191 | - | 38 | |
1192 | - | 39 | |
1193 | - | 40 | |
1194 | - | 41 | |
1195 | - | 42 | |
1152 | + | 1 pharmacy to be responsible for oversight of the remote dispensing | |
1153 | + | 2 facility. | |
1154 | + | 3 (3) Be located at least ten (10) miles from an existing retail | |
1155 | + | 4 pharmacy unless: | |
1156 | + | 5 (A) the applicant with the proposed remote dispensing facility | |
1157 | + | 6 demonstrates to the board how the proposed remote dispensing | |
1158 | + | 7 facility will promote public health; or | |
1159 | + | 8 (B) the remote dispensing facility exclusively serves the | |
1160 | + | 9 patients of: | |
1161 | + | 10 (i) a community mental health center established under | |
1162 | + | 11 IC 12-29; | |
1163 | + | 12 (ii) a health care facility (as defined in IC 16-28-13-0.5); or | |
1164 | + | 13 (iii) a physician clinic. | |
1165 | + | 14 (4) Maintain a patient counseling area. | |
1166 | + | 15 (5) Display a sign visible to the public indicating that the location | |
1167 | + | 16 is a remote dispensing facility. The sign must include the | |
1168 | + | 17 following information: | |
1169 | + | 18 (A) That the facility provides remote services supervised by a | |
1170 | + | 19 pharmacist located in another pharmacy. | |
1171 | + | 20 (B) The identification and address of the supervising | |
1172 | + | 21 pharmacy. | |
1173 | + | 22 (C) Disclosure that a pharmacist is required to speak to the | |
1174 | + | 23 consumer using audio and video communication systems any | |
1175 | + | 24 time a new drug or device is dispensed at the remote | |
1176 | + | 25 dispensing facility. | |
1177 | + | 26 (D) Whether patient counseling is provided on a prescription | |
1178 | + | 27 drug refill at the remote dispensing facility. | |
1179 | + | 28 (E) That the facility is under continuous video surveillance and | |
1180 | + | 29 that the video is recorded. | |
1181 | + | 30 (d) If the remote dispensing facility is operating under a contract | |
1182 | + | 31 with a supervising pharmacy, the contract must: | |
1183 | + | 32 (1) specify the responsibilities of each party to the contract; and | |
1184 | + | 33 (2) be available for review by the board at the board's request. | |
1185 | + | 34 SECTION 41. IC 25-26-13.5-7, AS ADDED BY P.L.202-2017, | |
1186 | + | 35 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1187 | + | 36 JULY 1, 2022]: Sec. 7. A supervising pharmacy shall implement | |
1188 | + | 37 policies and procedures that address each of the following before | |
1189 | + | 38 engaging in the practice of telepharmacy under this chapter: | |
1190 | + | 39 (1) Minimum standards and practices that ensure the safety, | |
1191 | + | 40 accuracy, security, sanitation, record keeping, and patient | |
1192 | + | 41 confidentiality at the remote dispensing facility. The standards | |
1193 | + | 42 and practices must include the following: | |
1196 | 1194 | HB 1158—LS 7067/DI 137 28 | |
1197 | - | 1 ( | |
1198 | - | 2 | |
1199 | - | 3 | |
1200 | - | 4 | |
1201 | - | 5 | |
1202 | - | 6 | |
1203 | - | 7 | |
1204 | - | 8 | |
1205 | - | 9 ( | |
1206 | - | 10 | |
1207 | - | 11 | |
1208 | - | 12 | |
1209 | - | 13 | |
1210 | - | 14 ( | |
1211 | - | 15 remote dispensing facility | |
1212 | - | 16 | |
1213 | - | 17 | |
1214 | - | 18 | |
1215 | - | 19 | |
1216 | - | 20 | |
1217 | - | 21 | |
1218 | - | 22 | |
1219 | - | 23 | |
1220 | - | 24 | |
1221 | - | 25 ( | |
1222 | - | 26 | |
1223 | - | 27 qualifying pharmacist | |
1224 | - | 28 | |
1225 | - | 29 | |
1226 | - | 30 | |
1227 | - | 31 | |
1228 | - | 32 | |
1229 | - | 33 dispensing facility | |
1230 | - | 34 | |
1231 | - | 35 | |
1232 | - | 36 | |
1233 | - | 37 | |
1234 | - | 38 remote dispensing facility is | |
1235 | - | 39 | |
1236 | - | 40 | |
1237 | - | 41 | |
1238 | - | 42 | |
1195 | + | 1 (A) Identification of personnel authorized to accept delivery of | |
1196 | + | 2 the drugs and to have access to drug storage and dispensing | |
1197 | + | 3 areas at the remote dispensing facility. | |
1198 | + | 4 (B) Procedures for the procurement of drugs and devices at the | |
1199 | + | 5 remote dispensing facility and any automated dispensing | |
1200 | + | 6 machine system used. | |
1201 | + | 7 (C) Criteria for the required inspection of the remote | |
1202 | + | 8 dispensing facility by the qualifying a pharmacist. | |
1203 | + | 9 (2) The adoption of training standards required for personnel | |
1204 | + | 10 employed at a remote dispensing facility to ensure the | |
1205 | + | 11 competence and ability of employees in operating the electronic | |
1206 | + | 12 verification, electronic record keeping, and communication | |
1207 | + | 13 systems. | |
1208 | + | 14 (3) A written plan for recovery from an event that interrupts or | |
1209 | + | 15 prevents pharmacist supervision of the remote dispensing facility. | |
1210 | + | 16 (4) Policies concerning the dispensing of prescription drugs. | |
1211 | + | 17 SECTION 42. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE JULY | |
1212 | + | 18 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist on | |
1213 | + | 19 duty are responsible for ensuring that the supervising pharmacy and | |
1214 | + | 20 remote dispensing facility are sufficiently staffed to avoid the risk of | |
1215 | + | 21 harm to public health and safety. | |
1216 | + | 22 (b) In order to serve as a qualifying pharmacist, the pharmacist must | |
1217 | + | 23 be in good standing with the board. | |
1218 | + | 24 (c) A qualifying pharmacist may have this designation for only one | |
1219 | + | 25 (1) supervising pharmacy and for one (1) remote dispensing facility at | |
1220 | + | 26 a time. | |
1221 | + | 27 (d) A qualifying pharmacist must be able to be physically at the | |
1222 | + | 28 remote dispensing facility within a certain time set by the board to | |
1223 | + | 29 address emergencies and safety issues that arise. However, in the | |
1224 | + | 30 qualifying pharmacist's absence the qualifying pharmacist may | |
1225 | + | 31 designate another pharmacist to fulfill the qualifying pharmacist's | |
1226 | + | 32 duties at the remote dispensing facility. | |
1227 | + | 33 (e) A qualifying pharmacist shall visit a remote dispensing facility | |
1228 | + | 34 at least as often as required by the board to inspect the facility and | |
1229 | + | 35 address personnel matters. The qualifying pharmacist shall complete | |
1230 | + | 36 any forms required by the board concerning the required inspection and | |
1231 | + | 37 maintain the records in a manner specified by the board. | |
1232 | + | 38 (f) If the remote dispensing facility is located at a hospital or | |
1233 | + | 39 physician clinic and uses an automated dispensing machine, the | |
1234 | + | 40 qualifying pharmacist shall maintain an up to date inventory of any | |
1235 | + | 41 schedule II controlled substances. The qualifying pharmacist shall at | |
1236 | + | 42 least monthly inventory all controlled substances. | |
1239 | 1237 | HB 1158—LS 7067/DI 137 29 | |
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1241 | - | 2 | |
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1268 | - | 29 | |
1269 | - | 30 | |
1270 | - | 31 | |
1271 | - | 32 | |
1272 | - | 33 | |
1273 | - | 34 | |
1274 | - | 35 | |
1275 | - | 36 | |
1276 | - | 37 | |
1277 | - | 38 as | |
1278 | - | 39 | |
1279 | - | 40 | |
1280 | - | 41 | |
1281 | - | 42 | |
1238 | + | 1 (g) The qualifying pharmacist shall develop and implement a | |
1239 | + | 2 continuous quality improvement program. The program must include | |
1240 | + | 3 a reporting mechanism for errors that occur concerning the remote | |
1241 | + | 4 dispensing facility. Information concerning the program must be | |
1242 | + | 5 available to the board upon request. | |
1243 | + | 6 SECTION 43. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA | |
1244 | + | 7 CODE AS A NEW SECTION TO READ AS FOLLOWS | |
1245 | + | 8 [EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a | |
1246 | + | 9 remote dispensing facility is responsible for ensuring the following: | |
1247 | + | 10 (1) The remote dispensing facility is sufficiently staffed to | |
1248 | + | 11 avoid the risk of harm to public health and safety. | |
1249 | + | 12 (2) The pharmacist servicing the remote dispensing facility is | |
1250 | + | 13 in good standing with the board. | |
1251 | + | 14 (3) A pharmacy may not operate more than one (1) remote | |
1252 | + | 15 dispensing facility at a time, unless otherwise approved by the | |
1253 | + | 16 board. | |
1254 | + | 17 (4) A pharmacist must be able to be physically present at the | |
1255 | + | 18 remote dispensing facility within a certain time set by the | |
1256 | + | 19 board to address emergencies and safety issues that arise. | |
1257 | + | 20 (5) A pharmacist shall visit the remote dispensing facility at | |
1258 | + | 21 least as often as required by the board to inspect the facility, | |
1259 | + | 22 address personnel matters, complete any forms required by | |
1260 | + | 23 the board concerning the required inspection, and maintain | |
1261 | + | 24 records in the manner specified by the board. | |
1262 | + | 25 (6) If the remote dispensing facility is located at a hospital or | |
1263 | + | 26 physician clinic and uses an automated dispensing machine, | |
1264 | + | 27 a pharmacist must maintain an up to date inventory of any | |
1265 | + | 28 schedule II controlled substances. An inventory of all | |
1266 | + | 29 controlled substances must be completed at least once a | |
1267 | + | 30 month. | |
1268 | + | 31 (7) The pharmacy must develop a continuous quality | |
1269 | + | 32 improvement program, which must include a reporting | |
1270 | + | 33 mechanism for errors that occur concerning the remote | |
1271 | + | 34 dispensing facility. Information concerning the remote | |
1272 | + | 35 dispensing facility must be made available to the board upon | |
1273 | + | 36 request. | |
1274 | + | 37 SECTION 44. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019, | |
1275 | + | 38 SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1276 | + | 39 JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist | |
1277 | + | 40 working at a remote dispensing facility for every six (6) pharmacist | |
1278 | + | 41 interns, licensed pharmacy technicians, and pharmacy technicians in | |
1279 | + | 42 training at the supervising pharmacy and remote dispensing facility. | |
1282 | 1280 | HB 1158—LS 7067/DI 137 30 | |
1283 | - | 1 | |
1284 | - | 2 | |
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1303 | - | 21 | |
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1305 | - | 23 | |
1306 | - | 24 | |
1307 | - | 25 dispensing facility | |
1308 | - | 26 | |
1309 | - | 27 | |
1310 | - | 28 | |
1311 | - | 29 ( | |
1312 | - | 30 dispensing facility. | |
1313 | - | 31 ( | |
1314 | - | 32 | |
1315 | - | 33 | |
1316 | - | 34 | |
1317 | - | 35 | |
1318 | - | 36 | |
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1321 | - | 39 | |
1322 | - | 40 | |
1323 | - | 41 | |
1324 | - | 42 | |
1281 | + | 1 However, an individual whose only duty is to act as the cashier is not | |
1282 | + | 2 included in the number of employees that may work for one (1) | |
1283 | + | 3 pharmacist under this subsection. | |
1284 | + | 4 (b) A remote dispensing facility that is not staffed by a pharmacist | |
1285 | + | 5 must be staffed by at least one (1) pharmacy technician who meets the | |
1286 | + | 6 following requirements: | |
1287 | + | 7 (1) Is licensed under IC 25-26-19. | |
1288 | + | 8 (2) Has at least two thousand (2,000) hours of experience working | |
1289 | + | 9 as a pharmacy technician in a pharmacy licensed under this article | |
1290 | + | 10 and under the direct supervision of a pharmacist. | |
1291 | + | 11 (3) Has successfully passed a certification examination offered by | |
1292 | + | 12 the Pharmacy Technician Certification Board or another | |
1293 | + | 13 nationally recognized certification body approved by the board. | |
1294 | + | 14 (4) If the remote dispensing facility is located in a hospital or | |
1295 | + | 15 physician clinic setting, either: | |
1296 | + | 16 (A) has graduated from a pharmacy technician training | |
1297 | + | 17 program accredited by the American Council of | |
1298 | + | 18 Pharmaceutical for Pharmacy Education or the American | |
1299 | + | 19 Society of Health System Pharmacists; or | |
1300 | + | 20 (B) obtained the hours described in subdivision (2) before July | |
1301 | + | 21 1, 2017. | |
1302 | + | 22 (5) Is supervised by a pharmacist at the supervising pharmacy at | |
1303 | + | 23 all times that the remote dispensing facility is operational. As | |
1304 | + | 24 used in this subdivision, supervision does not require that the | |
1305 | + | 25 pharmacist be physically present at the remote dispensing facility | |
1306 | + | 26 as long as the pharmacist is supervising telepharmacy operations | |
1307 | + | 27 electronically through a computer link, video link, and audio link. | |
1308 | + | 28 (6) Is currently in good standing with the board. | |
1309 | + | 29 (c) A pharmacy technician in training may not work at a remote | |
1310 | + | 30 dispensing facility unless a pharmacist is on site. | |
1311 | + | 31 (d) The board shall adopt rules that require pharmacy technicians | |
1312 | + | 32 working at a remote dispensing facility that is not staffed by a | |
1313 | + | 33 pharmacist to complete continuing education requirements established | |
1314 | + | 34 by the board. | |
1315 | + | 35 SECTION 45. IC 25-26-13.5-11, AS AMENDED BY P.L.207-2021, | |
1316 | + | 36 SECTION 40, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1317 | + | 37 JULY 1, 2022]: Sec. 11. (a) A supervising pharmacy of a remote | |
1318 | + | 38 dispensing facility must maintain a video and audio communication | |
1319 | + | 39 system that provides for effective communication between the | |
1320 | + | 40 supervising pharmacy, the remote dispensing facility, and any | |
1321 | + | 41 consumers. The system must do the following: | |
1322 | + | 42 (1) Provide an adequate number of views of the entire remote | |
1325 | 1323 | HB 1158—LS 7067/DI 137 31 | |
1326 | - | 1 | |
1327 | - | 2 ( | |
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1331 | - | 6 | |
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1336 | - | 11 the | |
1337 | - | 12 | |
1338 | - | 13 | |
1339 | - | 14 | |
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1341 | - | 16 | |
1342 | - | 17 (1) | |
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1351 | - | 26 | |
1352 | - | 27 | |
1353 | - | 28 ( | |
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1356 | - | 31 | |
1357 | - | 32 | |
1358 | - | 33 | |
1359 | - | 34 ( | |
1360 | - | 35 | |
1361 | - | 36 ( | |
1362 | - | 37 | |
1363 | - | 38 | |
1364 | - | 39 ( | |
1365 | - | 40 | |
1366 | - | 41 ( | |
1367 | - | 42 | |
1324 | + | 1 dispensing facility. | |
1325 | + | 2 (2) Facilitate adequate pharmacist supervision. | |
1326 | + | 3 (3) Allow an appropriate exchange of visual, verbal, and written | |
1327 | + | 4 communications for patient counseling and other matters | |
1328 | + | 5 concerning the lawful transaction of business. | |
1329 | + | 6 (b) The remote dispensing facility must retain a recording of facility | |
1330 | + | 7 surveillance, excluding patient communications, for at least thirty (30) | |
1331 | + | 8 days. | |
1332 | + | 9 (c) A qualifying pharmacist is adequately supervising through the | |
1333 | + | 10 use of video surveillance by maintaining constant visual supervision | |
1334 | + | 11 and auditory communication with the remote dispensing facility and by | |
1335 | + | 12 maintaining full supervisory control of the automated system, if | |
1336 | + | 13 applicable. The auditory communication must be available, as needed, | |
1337 | + | 14 with the remote dispensing facility and the qualifying pharmacist. | |
1338 | + | 15 (d) A video monitor that is being used to properly identify and | |
1339 | + | 16 communicate with consumers must meet the following requirements: | |
1340 | + | 17 (1) Provide both the supervising pharmacy and the remote | |
1341 | + | 18 dispensing facility with direct visual contact between the | |
1342 | + | 19 pharmacist and the consumer. | |
1343 | + | 20 (2) Be secure and compliant with the federal Health Insurance | |
1344 | + | 21 Portability and Accountability Act (HIPAA). | |
1345 | + | 22 (e) If any component of the communication system is not in | |
1346 | + | 23 operating order, the remote dispensing facility shall remain closed until | |
1347 | + | 24 the communication system is fully operational, unless a pharmacist is | |
1348 | + | 25 located at the remote dispensing facility. | |
1349 | + | 26 SECTION 46. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017, | |
1350 | + | 27 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1351 | + | 28 JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have | |
1352 | + | 29 adequate security. The security must do the following: | |
1353 | + | 30 (1) Record the entrance and exit of individuals to the facility. | |
1354 | + | 31 (2) Use alarms or other comparable monitoring systems that | |
1355 | + | 32 protect the equipment, records, drug supply, devices, and other | |
1356 | + | 33 items from unauthorized access, acquisition, or use. | |
1357 | + | 34 (3) Use at least two (2) factoring credentials for employee entry | |
1358 | + | 35 to the remote dispensing facility, using two (2) of the following: | |
1359 | + | 36 (A) A knowledge factor, including a password. | |
1360 | + | 37 (B) Biometrics. | |
1361 | + | 38 (C) An inanimate object. | |
1362 | + | 39 (b) The qualifying A pharmacist shall periodically review the record | |
1363 | + | 40 of entries into the remote dispensing facility. | |
1364 | + | 41 (c) The prescription storage area may remain open while a | |
1365 | + | 42 pharmacist or pharmacy technician is on duty. | |
1368 | 1366 | HB 1158—LS 7067/DI 137 32 | |
1369 | - | 1 | |
1370 | - | 2 | |
1371 | - | 3 | |
1372 | - | 4 | |
1373 | - | 5 facility | |
1374 | - | 6 | |
1375 | - | 7 | |
1376 | - | 8 | |
1377 | - | 9 | |
1378 | - | 10 | |
1379 | - | 11 | |
1380 | - | 12 | |
1381 | - | 13 drugs | |
1382 | - | 14 | |
1383 | - | 15 | |
1384 | - | 16 | |
1385 | - | 17 | |
1386 | - | 18 | |
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1390 | - | 22 | |
1391 | - | 23 | |
1392 | - | 24 | |
1393 | - | 25 | |
1394 | - | 26 | |
1395 | - | 27 ( | |
1396 | - | 28 | |
1397 | - | 29 | |
1398 | - | 30 | |
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1401 | - | 33 | |
1402 | - | 34 | |
1403 | - | 35 | |
1404 | - | 36 | |
1405 | - | 37 | |
1406 | - | 38 | |
1407 | - | 39 | |
1408 | - | 40 | |
1409 | - | 41 | |
1410 | - | 42 | |
1367 | + | 1 SECTION 47. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017, | |
1368 | + | 2 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1369 | + | 3 JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be | |
1370 | + | 4 dispensed at the remote dispensing facility unless: | |
1371 | + | 5 (1) the facility maintains a perpetual inventory of controlled | |
1372 | + | 6 substances; and | |
1373 | + | 7 (2) the supervising pharmacist checks the Indiana scheduled | |
1374 | + | 8 prescription electronic collection and tracking program | |
1375 | + | 9 established by IC 25-1-13-4 or as directed by the board before: | |
1376 | + | 10 (A) verification of the finished controlled substance | |
1377 | + | 11 prescription; and | |
1378 | + | 12 (B) counseling the patient. | |
1379 | + | 13 (b) Drugs may be transported to a remote dispensing facility that | |
1380 | + | 14 uses an automated dispensing machine only in a sealed container with | |
1381 | + | 15 a list identifying each drug, drug strength, and quantity included in the | |
1382 | + | 16 container. | |
1383 | + | 17 (c) A delivery of drugs may be accepted at the remote dispensing | |
1384 | + | 18 facility only if a pharmacist or a licensed pharmacy technician is | |
1385 | + | 19 present to accept delivery and verify and sign for the receipt of the | |
1386 | + | 20 drugs, unless the drugs are placed in a secured delivery area that | |
1387 | + | 21 complies with federal and state law. | |
1388 | + | 22 (d) If the delivery is received by a pharmacy technician, a | |
1389 | + | 23 pharmacist at the supervising pharmacy shall ensure through the use of | |
1390 | + | 24 the electronic audio and video communication system or bar code | |
1391 | + | 25 technology that the pharmacy technician has accurately restocked the | |
1392 | + | 26 drugs. | |
1393 | + | 27 (e) A remote dispensing facility must store drugs in a manner that: | |
1394 | + | 28 (1) complies with federal and state law; | |
1395 | + | 29 (2) protects the identity, safety, security, and integrity of the drug; | |
1396 | + | 30 and | |
1397 | + | 31 (3) limits access to: | |
1398 | + | 32 (A) a pharmacist employed by the supervising pharmacy; and | |
1399 | + | 33 (B) a pharmacy technician who has written authorization of the | |
1400 | + | 34 qualifying a pharmacist to access the facility. | |
1401 | + | 35 SECTION 48. IC 25-26-14-11, AS AMENDED BY P.L.264-2019, | |
1402 | + | 36 SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1403 | + | 37 JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale | |
1404 | + | 38 distribution" means to distribute legend drugs to persons other than a | |
1405 | + | 39 consumer or patient. The term does not include: | |
1406 | + | 40 (1) a sale or transfer between a division, a subsidiary, a parent, an | |
1407 | + | 41 affiliated, or a related company under the common ownership and | |
1408 | + | 42 control of a corporate entity; | |
1411 | 1409 | HB 1158—LS 7067/DI 137 33 | |
1412 | - | 1 | |
1413 | - | 2 | |
1414 | - | 3 | |
1415 | - | 4 | |
1416 | - | 5 | |
1417 | - | 6 | |
1418 | - | 7 | |
1419 | - | 8 | |
1420 | - | 9 ( | |
1421 | - | 10 | |
1422 | - | 11 | |
1423 | - | 12 | |
1424 | - | 13 ( | |
1425 | - | 14 | |
1426 | - | 15 ( | |
1427 | - | 16 | |
1428 | - | 17 | |
1429 | - | 18 | |
1430 | - | 19 | |
1431 | - | 20 | |
1432 | - | 21 | |
1433 | - | 22 ( | |
1434 | - | 23 | |
1435 | - | 24 ( | |
1436 | - | 25 | |
1437 | - | 26 ( | |
1438 | - | 27 | |
1439 | - | 28 | |
1440 | - | 29 | |
1441 | - | 30 | |
1442 | - | 31 | |
1443 | - | 32 | |
1444 | - | 33 ( | |
1445 | - | 34 | |
1446 | - | 35 | |
1447 | - | 36 | |
1448 | - | 37 | |
1449 | - | 38 | |
1450 | - | 39 | |
1451 | - | 40 | |
1452 | - | 41 | |
1453 | - | 42 | |
1410 | + | 1 (2) the purchase or acquisition by a hospital or other health care | |
1411 | + | 2 entity that is a member of a group purchasing organization of a | |
1412 | + | 3 drug for the hospital's or health care entity's own use from the | |
1413 | + | 4 group purchasing organization or from other hospitals or health | |
1414 | + | 5 care entities that are members of the organization; | |
1415 | + | 6 (3) the sale or transfer of a drug by a charitable organization | |
1416 | + | 7 described in Section 501(c)(3) of the Internal Revenue Code, to: | |
1417 | + | 8 (A) a nonprofit affiliate of the organization; or | |
1418 | + | 9 (B) a nonprofit entity described in Section 501(c)(3) of the | |
1419 | + | 10 Internal Revenue Code that is not affiliated with the | |
1420 | + | 11 organization; | |
1421 | + | 12 to the extent otherwise permitted by law; | |
1422 | + | 13 (4) the sale of a drug among hospitals or other health care entities | |
1423 | + | 14 that are under common control; | |
1424 | + | 15 (5) the sale of a drug for emergency medical reasons, including | |
1425 | + | 16 transfers of legend drugs by a retail pharmacy to another retail | |
1426 | + | 17 pharmacy to alleviate a temporary shortage, if the gross dollar | |
1427 | + | 18 value of the transfers does not exceed five percent (5%) of the | |
1428 | + | 19 total legend drug sales revenue of either the transferor or | |
1429 | + | 20 transferee pharmacy during any twelve (12) consecutive month | |
1430 | + | 21 period; | |
1431 | + | 22 (6) the sale of a drug or the dispensing of a drug pursuant to a | |
1432 | + | 23 prescription; | |
1433 | + | 24 (7) the distribution of drug samples by manufacturers' | |
1434 | + | 25 representatives or distributors' representatives; | |
1435 | + | 26 (8) the sale of blood and blood components intended for | |
1436 | + | 27 transfusion; | |
1437 | + | 28 (9) the sale of a drug by a retail pharmacy to a practitioner (as | |
1438 | + | 29 defined in IC 25-26-13-2) for office use, if the gross dollar value | |
1439 | + | 30 of the transfers does not exceed five percent (5%) of the retail | |
1440 | + | 31 pharmacy's total legend drug sales during any twelve (12) | |
1441 | + | 32 consecutive months; | |
1442 | + | 33 (10) the sale of a drug by a retail pharmacy that is ending its | |
1443 | + | 34 business and liquidating its inventory to another retail pharmacy; | |
1444 | + | 35 (11) drug returns by a hospital, health care entity, or charitable | |
1445 | + | 36 institution conducted under 21 CFR 203.23; | |
1446 | + | 37 (12) the sale of minimal quantities of drugs by retail pharmacies | |
1447 | + | 38 to licensed practitioners for office use; | |
1448 | + | 39 (13) the distribution of prescription drugs by the original | |
1449 | + | 40 manufacturer of the finished form of the prescription drug or the | |
1450 | + | 41 distribution of the co-licensed products by a partner of the | |
1451 | + | 42 original manufacturer of the finished form of the prescription | |
1454 | 1452 | HB 1158—LS 7067/DI 137 34 | |
1455 | - | 1 product determined under IC 12-12.7-2-23(b), the monthly fee shall be | |
1456 | - | 2 provided instead of claims processing of individual claims. | |
1457 | - | 3 (b) A health insurance plan may not require authorization for | |
1458 | - | 4 services specified in the covered individual's individualized family | |
1459 | - | 5 service plan, if those services are a covered benefit under the plan, | |
1460 | - | 6 once the individualized family service plan is signed by a physician, a | |
1461 | - | 7 physician assistant, or an advanced practice registered nurse. | |
1462 | - | 8 (c) The department of insurance shall adopt rules under IC 4-22-2 | |
1463 | - | 9 to ensure compliance with this section. | |
1464 | - | 10 SECTION 49. IC 34-30-2-81 IS REPEALED [EFFECTIVE JULY | |
1465 | - | 11 1, 2022]. Sec. 81. (a) IC 16-41-7-2 (Concerning the good faith | |
1466 | - | 12 reporting to a health officer of an individual thought to present a | |
1467 | - | 13 serious and present risk to the health of others, to have engaged in | |
1468 | - | 14 noncompliant behavior, or to be at risk of carrying a serious | |
1469 | - | 15 communicable disease). | |
1470 | - | 16 (b) IC 16-41-7-3 (Concerning a physician who provides notification | |
1471 | - | 17 to certain individuals regarding a patient's serious communicable | |
1472 | - | 18 disease). | |
1473 | - | 19 SECTION 50. IC 34-46-2-10 IS REPEALED [EFFECTIVE JULY | |
1474 | - | 20 1, 2022]. Sec. 10. IC 16-41-7-3 (Concerning warning by physician of | |
1475 | - | 21 serious communicable disease). | |
1476 | - | 22 SECTION 51. IC 35-52-16-42 IS REPEALED [EFFECTIVE JULY | |
1477 | - | 23 1, 2022]. Sec. 42. IC 16-41-7-5 defines a crime concerning | |
1478 | - | 24 communicable diseases. | |
1479 | - | 25 SECTION 52. IC 35-52-16-58 IS REPEALED [EFFECTIVE JULY | |
1480 | - | 26 1, 2022]. Sec. 58. IC 16-41-14-17 defines a crime concerning | |
1481 | - | 27 communicable diseases. | |
1482 | - | 28 SECTION 53. [EFFECTIVE UPON PASSAGE] (a) The terms of | |
1483 | - | 29 members appointed to the division of disability and rehabilitative | |
1484 | - | 30 services advisory council under IC 12-9-4-3, before its amendment | |
1485 | - | 31 by this act, expire June 30, 2022. | |
1486 | - | 32 (b) This SECTION expires July 1, 2023. | |
1487 | - | 33 SECTION 54. An emergency is declared for this act. | |
1453 | + | 1 drug; or | |
1454 | + | 2 (14) drug returns that meet criteria established by rules adopted | |
1455 | + | 3 by the board; or | |
1456 | + | 4 (15) the sale of a drug for research or clinical trial purposes, | |
1457 | + | 5 provided the seller is authorized by the federal Food and Drug | |
1458 | + | 6 Administration to sell the drug for research or clinical trial | |
1459 | + | 7 purposes. | |
1460 | + | 8 SECTION 49. IC 27-8-27-6, AS AMENDED BY P.L.133-2020, | |
1461 | + | 9 SECTION 19, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1462 | + | 10 JULY 1, 2022]: Sec. 6. (a) A health insurance plan that provides | |
1463 | + | 11 coverage for early intervention services shall reimburse the first steps | |
1464 | + | 12 program a monthly fee established by the division of disability and | |
1465 | + | 13 rehabilitative services. Except when the monthly fee is less than the | |
1466 | + | 14 product determined under IC 12-12.7-2-23(b), the monthly fee shall be | |
1467 | + | 15 provided instead of claims processing of individual claims. | |
1468 | + | 16 (b) A health insurance plan may not require authorization for | |
1469 | + | 17 services specified in the covered individual's individualized family | |
1470 | + | 18 service plan, if those services are a covered benefit under the plan, | |
1471 | + | 19 once the individualized family service plan is signed by a physician, a | |
1472 | + | 20 physician assistant, or an advanced practice registered nurse. | |
1473 | + | 21 (c) The department of insurance shall adopt rules under IC 4-22-2 | |
1474 | + | 22 to ensure compliance with this section. | |
1475 | + | 23 SECTION 50. IC 34-30-2-81 IS REPEALED [EFFECTIVE JULY | |
1476 | + | 24 1, 2022]. Sec. 81. (a) IC 16-41-7-2 (Concerning the good faith | |
1477 | + | 25 reporting to a health officer of an individual thought to present a | |
1478 | + | 26 serious and present risk to the health of others, to have engaged in | |
1479 | + | 27 noncompliant behavior, or to be at risk of carrying a serious | |
1480 | + | 28 communicable disease). | |
1481 | + | 29 (b) IC 16-41-7-3 (Concerning a physician who provides notification | |
1482 | + | 30 to certain individuals regarding a patient's serious communicable | |
1483 | + | 31 disease). | |
1484 | + | 32 SECTION 51. IC 34-46-2-10 IS REPEALED [EFFECTIVE JULY | |
1485 | + | 33 1, 2022]. Sec. 10. IC 16-41-7-3 (Concerning warning by physician of | |
1486 | + | 34 serious communicable disease). | |
1487 | + | 35 SECTION 52. IC 35-52-16-42 IS REPEALED [EFFECTIVE JULY | |
1488 | + | 36 1, 2022]. Sec. 42. IC 16-41-7-5 defines a crime concerning | |
1489 | + | 37 communicable diseases. | |
1490 | + | 38 SECTION 53. IC 35-52-16-58 IS REPEALED [EFFECTIVE JULY | |
1491 | + | 39 1, 2022]. Sec. 58. IC 16-41-14-17 defines a crime concerning | |
1492 | + | 40 communicable diseases. | |
1493 | + | 41 SECTION 54. [EFFECTIVE UPON PASSAGE] (a) The terms of | |
1494 | + | 42 members appointed to the division of disability and rehabilitative | |
1488 | 1495 | HB 1158—LS 7067/DI 137 35 | |
1496 | + | 1 services advisory council under IC 12-9-4-3, before its amendment | |
1497 | + | 2 by this act, expire June 30, 2022. | |
1498 | + | 3 (b) This SECTION expires July 1, 2023. | |
1499 | + | 4 SECTION 55. An emergency is declared for this act. | |
1500 | + | HB 1158—LS 7067/DI 137 36 | |
1489 | 1501 | COMMITTEE REPORT | |
1490 | 1502 | Mr. Speaker: Your Committee on Public Health, to which was | |
1491 | 1503 | referred House Bill 1158, has had the same under consideration and | |
1492 | 1504 | begs leave to report the same back to the House with the | |
1493 | 1505 | recommendation that said bill be amended as follows: | |
1494 | 1506 | Page 2, line 30, after "physician" insert ", a physician assistant,". | |
1495 | 1507 | Page 2, delete lines 34 through 38. | |
1496 | 1508 | Page 6, delete lines 32 through 42. | |
1497 | 1509 | Page 7, delete lines 1 through 31. | |
1498 | 1510 | Page 8, delete lines 39 through 42. | |
1499 | 1511 | Delete pages 9 through 10. | |
1500 | 1512 | Page 11, delete lines 1 through 16. | |
1501 | 1513 | Page 18, delete lines 31 through 42. | |
1502 | 1514 | Page 19, delete lines 1 through 5. | |
1503 | 1515 | Page 19, line 17, after "physician" insert ", a physician assistant,". | |
1504 | 1516 | Page 19, delete lines 21 through 42, begin a new paragraph and | |
1505 | 1517 | insert: | |
1506 | 1518 | "SECTION 28. IC 25-1-9-2 IS AMENDED TO READ AS | |
1507 | 1519 | FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 2. (a) As used in this | |
1508 | 1520 | chapter, "practitioner" means an individual who holds: | |
1509 | 1521 | (1) an unlimited license, certificate, or registration; | |
1510 | 1522 | (2) a limited or probationary license, certificate, or registration; | |
1511 | 1523 | (3) a temporary license, certificate, registration, or permit; | |
1512 | 1524 | (4) an intern permit; or | |
1513 | 1525 | (5) a provisional license; | |
1514 | 1526 | issued by the board regulating the profession in question, including a | |
1515 | 1527 | certificate of registration issued under IC 25-20. | |
1516 | 1528 | (b) The term includes all license statuses, including "active", | |
1517 | 1529 | "expired", "retired", "inactive", and any other status that a | |
1518 | 1530 | license may be held in.". | |
1519 | 1531 | Delete pages 20 through 21. | |
1520 | 1532 | Page 22, delete lines 1 through 36. | |
1521 | 1533 | Page 23, delete lines 1 through 9. | |
1522 | 1534 | Page 28, delete lines 7 through 42, begin a new paragraph and | |
1523 | 1535 | insert: | |
1524 | 1536 | "SECTION 30. IC 25-26-13-3, AS AMENDED BY P.L.249-2019, | |
1525 | 1537 | SECTION 113, IS AMENDED TO READ AS FOLLOWS | |
1526 | 1538 | [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of | |
1527 | 1539 | pharmacy is created. The board consists of seven (7) members | |
1528 | 1540 | appointed by the governor for terms under IC 25-1-6.5. | |
1529 | 1541 | (b) Subject to IC 25-1-6.5-3, the board consists of the following: | |
1530 | - | HB 1158—LS 7067/DI 137 | |
1542 | + | HB 1158—LS 7067/DI 137 37 | |
1531 | 1543 | (1) One (1) member of the board, to represent the general public, | |
1532 | 1544 | who is a resident of this state who has never been associated with | |
1533 | 1545 | pharmacy in any way other than as a consumer. | |
1534 | 1546 | (2) Six (6) Five (5) members who are pharmacists in good | |
1535 | 1547 | standing of recognized experience and ability from varied practice | |
1536 | 1548 | settings who hold a current license to practice pharmacy in | |
1537 | 1549 | Indiana, including one (1) member of the board who must be a | |
1538 | 1550 | practicing hospital pharmacist. | |
1539 | 1551 | (3) One (1) member who is a pharmacy technician in good | |
1540 | 1552 | standing, engaged in active practice as a pharmacy technician, | |
1541 | 1553 | and holds a current certification from the Pharmacy | |
1542 | 1554 | Technician Certification Board. | |
1543 | 1555 | (c) A member may be removed under IC 25-1-6.5-4. | |
1544 | 1556 | (d) Not later than ten (10) days after a member's appointment, the | |
1545 | 1557 | member must subscribe by oath or affirmation to faithfully uphold the | |
1546 | 1558 | duties of the member's office. If a member fails to qualify as provided, | |
1547 | 1559 | a new member shall be appointed in the member's place. | |
1548 | 1560 | (e) At the first meeting of each year the board shall elect from | |
1549 | 1561 | among its members a president and vice president who shall perform | |
1550 | 1562 | duties and have powers as the board prescribes. | |
1551 | 1563 | (f) The board shall meet at least eight (8) times per year at such | |
1552 | 1564 | times and places as the board selects. At each meeting the board shall | |
1553 | 1565 | continue in session from day to day, for not more than five (5) days, | |
1554 | 1566 | until the business of the meeting is complete. Four (4) members of the | |
1555 | 1567 | board shall constitute a quorum. | |
1556 | 1568 | (g) Each member of the board is entitled to compensation as | |
1557 | 1569 | determined by the rules of the budget agency for each day the member | |
1558 | 1570 | is actually engaged in business of the board, together with necessary | |
1559 | 1571 | travel and other expenses incurred in the performance of the member's | |
1560 | 1572 | duties. | |
1561 | 1573 | (h) Approval by a majority of the quorum is required for any action | |
1562 | 1574 | to be taken by the board.". | |
1563 | 1575 | Delete pages 29 through 30. | |
1564 | 1576 | Page 31, delete lines 1 through 40, begin a new paragraph and | |
1565 | 1577 | insert: | |
1566 | 1578 | "SECTION 31. IC 25-26-13-10, AS AMENDED BY P.L.101-2020, | |
1567 | 1579 | SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1568 | 1580 | JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a | |
1569 | 1581 | pharmacist intern must furnish proof satisfactory to the board that the | |
1570 | 1582 | applicant: | |
1571 | 1583 | (1) is actively enrolled in a school of pharmacy accredited by the | |
1572 | 1584 | American Council of Pharmaceutical for Pharmacy Education; | |
1573 | - | HB 1158—LS 7067/DI 137 | |
1585 | + | HB 1158—LS 7067/DI 137 38 | |
1574 | 1586 | (2) has obtained the Foreign Pharmacy Graduate Examination | |
1575 | 1587 | Committee Certificate; or | |
1576 | 1588 | (3) is a qualified applicant awaiting the examination for licensure | |
1577 | 1589 | as a pharmacist. | |
1578 | 1590 | (b) A registration issued under subsection (a) is valid for one (1) | |
1579 | 1591 | year and may be renewed by the board in accordance with subsection | |
1580 | 1592 | (c) until the expiration date established by the Indiana professional | |
1581 | 1593 | licensing agency under IC 25-1-5-4. | |
1582 | 1594 | (c) An application for registration or renewal must be accompanied | |
1583 | 1595 | by the appropriate fee and one (1) of the following: | |
1584 | 1596 | (1) Proof of having obtained the Foreign Pharmacy Graduate | |
1585 | 1597 | Examination Committee Certificate. | |
1586 | 1598 | (2) Proof of active enrollment in a school of pharmacy accredited | |
1587 | 1599 | by the American Council of Pharmaceutical for Pharmacy | |
1588 | 1600 | Education. | |
1589 | 1601 | SECTION 32. IC 25-26-13-11, AS AMENDED BY P.L.98-2006, | |
1590 | 1602 | SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1591 | 1603 | JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a | |
1592 | 1604 | pharmacist, an individual must file such evidence as is required by the | |
1593 | 1605 | board that: | |
1594 | 1606 | (1) the individual is at least eighteen (18) years of age; | |
1595 | 1607 | (2) the individual does not have a conviction for a crime that has | |
1596 | 1608 | a direct bearing on the individual's ability to practice competently; | |
1597 | 1609 | (3) the individual: | |
1598 | 1610 | (A) has graduated with a professional degree from a school of | |
1599 | 1611 | pharmacy accredited by the American Council of | |
1600 | 1612 | Pharmaceutical for Pharmacy Education or the Canadian | |
1601 | 1613 | Council on Pharmacy Accreditation for Accreditation of | |
1602 | 1614 | Pharmacy Programs and approved by the board; or | |
1603 | 1615 | (B) has: | |
1604 | 1616 | (i) graduated with a professional degree from a school of | |
1605 | 1617 | pharmacy located outside the United States and Canada; and | |
1606 | 1618 | (ii) met the requirements under subsection (c); and | |
1607 | 1619 | (4) the individual has satisfactorily completed a pharmacist intern | |
1608 | 1620 | program approved by the board. | |
1609 | 1621 | (b) An applicant who has graduated with a professional degree from | |
1610 | 1622 | a school of pharmacy accredited by the Canadian Council on Pharmacy | |
1611 | 1623 | Accreditation for Accreditation of Pharmacy Programs and | |
1612 | 1624 | approved by the board must obtain the Foreign Pharmacy Graduate | |
1613 | 1625 | Examination Committee Certificate administered by the National | |
1614 | 1626 | Association of Boards of Pharmacy before taking the examination | |
1615 | 1627 | required under subsection (d). | |
1616 | - | HB 1158—LS 7067/DI 137 | |
1628 | + | HB 1158—LS 7067/DI 137 39 | |
1617 | 1629 | (c) An applicant who has graduated with a professional degree from | |
1618 | 1630 | a school of pharmacy located outside the United States and Canada | |
1619 | 1631 | must do the following: | |
1620 | 1632 | (1) Provide the board with verification of the applicant's academic | |
1621 | 1633 | record and graduation. | |
1622 | 1634 | (2) Obtain the Foreign Pharmacy Graduate Examination | |
1623 | 1635 | Committee Certificate administered by the National Association | |
1624 | 1636 | of Boards of Pharmacy. | |
1625 | 1637 | (d) After filing an application on a form provided by the board, | |
1626 | 1638 | submitting the information required in subsection (a), and successfully | |
1627 | 1639 | completing the examination administered by the board, the applicant | |
1628 | 1640 | may be licensed as a pharmacist. | |
1629 | 1641 | SECTION 33. IC 25-26-13-12, AS AMENDED BY P.L.98-2006, | |
1630 | 1642 | SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1631 | 1643 | JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a | |
1632 | 1644 | pharmacist in another state where the requirements for licensure were | |
1633 | 1645 | not less than those required in this state at the time of original licensure | |
1634 | 1646 | may be issued a license in this state if: | |
1635 | 1647 | (1) the individual has registered with and been approved by the | |
1636 | 1648 | National Association of Boards of Pharmacy; | |
1637 | 1649 | (2) the individual has graduated with a professional degree in | |
1638 | 1650 | pharmacy from a school of pharmacy accredited by the American | |
1639 | 1651 | Council of Pharmaceutical for Pharmacy Education or the | |
1640 | 1652 | Canadian Council on Pharmacy Accreditation for Accreditation | |
1641 | 1653 | of Pharmacy Programs and approved by the board; and | |
1642 | 1654 | (3) the individual has successfully completed an examination | |
1643 | 1655 | administered by the board concerning the federal statutes and | |
1644 | 1656 | regulations and the Indiana statutes and rules governing the | |
1645 | 1657 | practice of pharmacy. | |
1646 | 1658 | (b) An individual who has a professional pharmacy degree from a | |
1647 | 1659 | school of pharmacy located outside the United States and Canada and | |
1648 | 1660 | who is licensed in another state where the requirements for licensure | |
1649 | 1661 | are substantially the same as those in this state may be issued a license | |
1650 | 1662 | under this chapter if: | |
1651 | 1663 | (1) the individual has registered with and been approved by the | |
1652 | 1664 | National Association of Boards of Pharmacy; | |
1653 | 1665 | (2) the individual has provided the board with proof of the | |
1654 | 1666 | applicant's: | |
1655 | 1667 | (A) academic record and graduation with a professional degree | |
1656 | 1668 | from a school of pharmacy; and | |
1657 | 1669 | (B) completion of the requirements for obtaining a Foreign | |
1658 | 1670 | Pharmacy Graduate Examination Committee Certificate | |
1659 | - | HB 1158—LS 7067/DI 137 | |
1671 | + | HB 1158—LS 7067/DI 137 40 | |
1660 | 1672 | administered by the National Association of Boards of | |
1661 | 1673 | Pharmacy; and | |
1662 | 1674 | (3) the individual has successfully completed an examination | |
1663 | 1675 | administered by the board concerning the federal statutes and | |
1664 | 1676 | regulations and the Indiana statutes and rules governing the | |
1665 | 1677 | practice of pharmacy. | |
1666 | 1678 | SECTION 34. IC 25-26-13-20, AS AMENDED BY P.L.207-2021, | |
1667 | 1679 | SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1668 | 1680 | JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish, | |
1669 | 1681 | operate, or maintain a pharmacy shall apply to the board for a | |
1670 | 1682 | pharmacy permit on a form provided by the board. The applicant shall | |
1671 | 1683 | set forth: | |
1672 | 1684 | (1) the name and occupation of the persons desiring the permit; | |
1673 | 1685 | (2) the location, including street address and city, of the | |
1674 | 1686 | pharmacy; and | |
1675 | 1687 | (3) the name of the pharmacist who will qualify the pharmacy by | |
1676 | 1688 | being responsible to the board for the legal operation of the | |
1677 | 1689 | pharmacy under the permit; and | |
1678 | 1690 | (4) (3) such other information as the board may require. | |
1679 | 1691 | (b) If the applicant desires to open, establish, operate, or maintain | |
1680 | 1692 | more than one (1) pharmacy, the applicant must file a separate | |
1681 | 1693 | application for each. Each pharmacy must be qualified by a different | |
1682 | 1694 | pharmacist. | |
1683 | 1695 | (c) The board shall permit a pharmacist to serve as a qualifying | |
1684 | 1696 | pharmacist for more than one (1) pharmacy holding a Category II | |
1685 | 1697 | pharmacy permit upon the holder of the Category II permit showing | |
1686 | 1698 | circumstances establishing that: | |
1687 | 1699 | (1) the permit holder has made a reasonable effort, without | |
1688 | 1700 | success, to obtain a qualifying pharmacist who is not serving as | |
1689 | 1701 | a qualifying pharmacist at another Category II pharmacy; and | |
1690 | 1702 | (2) the single pharmacist could effectively fulfill all duties and | |
1691 | 1703 | responsibilities of the qualifying pharmacist at both locations. | |
1692 | 1704 | However, the board shall hold the permit holder responsible and may | |
1693 | 1705 | not discipline or otherwise hold the qualifying pharmacist an | |
1694 | 1706 | individual licensed under this chapter responsible for staffing | |
1695 | 1707 | deficiencies of the pharmacy if the qualifying pharmacist individual | |
1696 | 1708 | does not have authority for staffing determinations of the pharmacy. | |
1697 | 1709 | (d) The board shall grant or deny an application for a permit not | |
1698 | 1710 | later than one hundred twenty (120) days after the application and any | |
1699 | 1711 | additional information required by the board are submitted. | |
1700 | 1712 | (e) The board may not issue a pharmacy permit to a person who | |
1701 | 1713 | desires to operate the pharmacy out of a residence. | |
1702 | - | HB 1158—LS 7067/DI 137 | |
1714 | + | HB 1158—LS 7067/DI 137 41 | |
1703 | 1715 | SECTION 35. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021, | |
1704 | 1716 | SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1705 | 1717 | JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy | |
1706 | 1718 | shall transfer to another pharmacy a prescription for the patient, | |
1707 | 1719 | including a prescription for a schedule II controlled substance, that the | |
1708 | 1720 | pharmacy has received but not filled unless: | |
1709 | 1721 | (1) prohibited in writing on the prescription by the prescriber; or | |
1710 | 1722 | (2) otherwise prohibited by federal law. | |
1711 | 1723 | (b) Unless prohibited by federal law, a prescription for a patient may | |
1712 | 1724 | be transferred electronically or by facsimile by a pharmacy to another | |
1713 | 1725 | pharmacy if the pharmacies do not share a common data base. | |
1714 | 1726 | (c) A licensed pharmacy technician may transfer a prescription, | |
1715 | 1727 | under subsection (b) including making a verbal transfer, as | |
1716 | 1728 | delegated by a pharmacist.". | |
1717 | 1729 | Page 33, delete lines 15 through 42. | |
1718 | 1730 | Page 34, delete lines 1 through 10. | |
1719 | 1731 | Page 35, line 33, delete "supervising". | |
1720 | 1732 | Page 35, delete line 42, begin a new paragraph and insert: | |
1721 | 1733 | "SECTION 40. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE | |
1722 | 1734 | JULY 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist | |
1723 | 1735 | on duty are responsible for ensuring that the supervising pharmacy and | |
1724 | 1736 | remote dispensing facility are sufficiently staffed to avoid the risk of | |
1725 | 1737 | harm to public health and safety. | |
1726 | 1738 | (b) In order to serve as a qualifying pharmacist, the pharmacist must | |
1727 | 1739 | be in good standing with the board. | |
1728 | 1740 | (c) A qualifying pharmacist may have this designation for only one | |
1729 | 1741 | (1) supervising pharmacy and for one (1) remote dispensing facility at | |
1730 | 1742 | a time. | |
1731 | 1743 | (d) A qualifying pharmacist must be able to be physically at the | |
1732 | 1744 | remote dispensing facility within a certain time set by the board to | |
1733 | 1745 | address emergencies and safety issues that arise. However, in the | |
1734 | 1746 | qualifying pharmacist's absence the qualifying pharmacist may | |
1735 | 1747 | designate another pharmacist to fulfill the qualifying pharmacist's | |
1736 | 1748 | duties at the remote dispensing facility. | |
1737 | 1749 | (e) A qualifying pharmacist shall visit a remote dispensing facility | |
1738 | 1750 | at least as often as required by the board to inspect the facility and | |
1739 | 1751 | address personnel matters. The qualifying pharmacist shall complete | |
1740 | 1752 | any forms required by the board concerning the required inspection and | |
1741 | 1753 | maintain the records in a manner specified by the board. | |
1742 | 1754 | (f) If the remote dispensing facility is located at a hospital or | |
1743 | 1755 | physician clinic and uses an automated dispensing machine, the | |
1744 | 1756 | qualifying pharmacist shall maintain an up to date inventory of any | |
1745 | - | HB 1158—LS 7067/DI 137 | |
1757 | + | HB 1158—LS 7067/DI 137 42 | |
1746 | 1758 | schedule II controlled substances. The qualifying pharmacist shall at | |
1747 | 1759 | least monthly inventory all controlled substances. | |
1748 | 1760 | (g) The qualifying pharmacist shall develop and implement a | |
1749 | 1761 | continuous quality improvement program. The program must include | |
1750 | 1762 | a reporting mechanism for errors that occur concerning the remote | |
1751 | 1763 | dispensing facility. Information concerning the program must be | |
1752 | 1764 | available to the board upon request. | |
1753 | 1765 | SECTION 41. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA | |
1754 | 1766 | CODE AS A NEW SECTION TO READ AS FOLLOWS | |
1755 | 1767 | [EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a | |
1756 | 1768 | remote dispensing facility is responsible for ensuring the following: | |
1757 | 1769 | (1) The remote dispensing facility is sufficiently staffed to | |
1758 | 1770 | avoid the risk of harm to public health and safety. | |
1759 | 1771 | (2) The pharmacist servicing the remote dispensing facility is | |
1760 | 1772 | in good standing with the board. | |
1761 | 1773 | (3) A pharmacy may not operate more than one (1) remote | |
1762 | 1774 | dispensing facility at a time, unless otherwise approved by the | |
1763 | 1775 | board. | |
1764 | 1776 | (4) A pharmacist must be able to be physically present at the | |
1765 | 1777 | remote dispensing facility within a certain time set by the | |
1766 | 1778 | board to address emergencies and safety issues that arise. | |
1767 | 1779 | (5) A pharmacist shall visit the remote dispensing facility at | |
1768 | 1780 | least as often as required by the board to inspect the facility, | |
1769 | 1781 | address personnel matters, complete any forms required by | |
1770 | 1782 | the board concerning the required inspection, and maintain | |
1771 | 1783 | records in the manner specified by the board. | |
1772 | 1784 | (6) If the remote dispensing facility is located at a hospital or | |
1773 | 1785 | physician clinic and uses an automated dispensing machine, | |
1774 | 1786 | a pharmacist must maintain an up to date inventory of any | |
1775 | 1787 | schedule II controlled substances. An inventory of all | |
1776 | 1788 | controlled substances must be completed at least once a | |
1777 | 1789 | month. | |
1778 | 1790 | (7) The pharmacy must develop a continuous quality | |
1779 | 1791 | improvement program, which must include a reporting | |
1780 | 1792 | mechanism for errors that occur concerning the remote | |
1781 | 1793 | dispensing facility. Information concerning the remote | |
1782 | 1794 | dispensing facility must be made available to the board upon | |
1783 | 1795 | request. | |
1784 | 1796 | SECTION 42. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019, | |
1785 | 1797 | SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1786 | 1798 | JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist | |
1787 | 1799 | working at a remote dispensing facility for every six (6) pharmacist | |
1788 | - | HB 1158—LS 7067/DI 137 | |
1800 | + | HB 1158—LS 7067/DI 137 43 | |
1789 | 1801 | interns, licensed pharmacy technicians, and pharmacy technicians in | |
1790 | 1802 | training at the supervising pharmacy and remote dispensing facility. | |
1791 | 1803 | However, an individual whose only duty is to act as the cashier is not | |
1792 | 1804 | included in the number of employees that may work for one (1) | |
1793 | 1805 | pharmacist under this subsection. | |
1794 | 1806 | (b) A remote dispensing facility that is not staffed by a pharmacist | |
1795 | 1807 | must be staffed by at least one (1) pharmacy technician who meets the | |
1796 | 1808 | following requirements: | |
1797 | 1809 | (1) Is licensed under IC 25-26-19. | |
1798 | 1810 | (2) Has at least two thousand (2,000) hours of experience working | |
1799 | 1811 | as a pharmacy technician in a pharmacy licensed under this article | |
1800 | 1812 | and under the direct supervision of a pharmacist. | |
1801 | 1813 | (3) Has successfully passed a certification examination offered by | |
1802 | 1814 | the Pharmacy Technician Certification Board or another | |
1803 | 1815 | nationally recognized certification body approved by the board. | |
1804 | 1816 | (4) If the remote dispensing facility is located in a hospital or | |
1805 | 1817 | physician clinic setting, either: | |
1806 | 1818 | (A) has graduated from a pharmacy technician training | |
1807 | 1819 | program accredited by the American Council of | |
1808 | 1820 | Pharmaceutical for Pharmacy Education or the American | |
1809 | 1821 | Society of Health System Pharmacists; or | |
1810 | 1822 | (B) obtained the hours described in subdivision (2) before July | |
1811 | 1823 | 1, 2017. | |
1812 | 1824 | (5) Is supervised by a pharmacist at the supervising pharmacy at | |
1813 | 1825 | all times that the remote dispensing facility is operational. As | |
1814 | 1826 | used in this subdivision, supervision does not require that the | |
1815 | 1827 | pharmacist be physically present at the remote dispensing facility | |
1816 | 1828 | as long as the pharmacist is supervising telepharmacy operations | |
1817 | 1829 | electronically through a computer link, video link, and audio link. | |
1818 | 1830 | (6) Is currently in good standing with the board. | |
1819 | 1831 | (c) A pharmacy technician in training may not work at a remote | |
1820 | 1832 | dispensing facility unless a pharmacist is on site. | |
1821 | 1833 | (d) The board shall adopt rules that require pharmacy technicians | |
1822 | 1834 | working at a remote dispensing facility that is not staffed by a | |
1823 | 1835 | pharmacist to complete continuing education requirements established | |
1824 | 1836 | by the board.". | |
1825 | 1837 | Page 36, delete lines 1 through 34. | |
1826 | 1838 | Page 37, delete lines 26 through 42, begin a new paragraph and | |
1827 | 1839 | insert: | |
1828 | 1840 | "SECTION 44. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017, | |
1829 | 1841 | SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1830 | 1842 | JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have | |
1831 | - | HB 1158—LS 7067/DI 137 | |
1843 | + | HB 1158—LS 7067/DI 137 44 | |
1832 | 1844 | adequate security. The security must do the following: | |
1833 | 1845 | (1) Record the entrance and exit of individuals to the facility. | |
1834 | 1846 | (2) Use alarms or other comparable monitoring systems that | |
1835 | 1847 | protect the equipment, records, drug supply, devices, and other | |
1836 | 1848 | items from unauthorized access, acquisition, or use. | |
1837 | 1849 | (3) Use at least two (2) factoring credentials for employee entry | |
1838 | 1850 | to the remote dispensing facility, using two (2) of the following: | |
1839 | 1851 | (A) A knowledge factor, including a password. | |
1840 | 1852 | (B) Biometrics. | |
1841 | 1853 | (C) An inanimate object. | |
1842 | 1854 | (b) The qualifying A pharmacist shall periodically review the record | |
1843 | 1855 | of entries into the remote dispensing facility. | |
1844 | 1856 | (c) The prescription storage area may remain open while a | |
1845 | 1857 | pharmacist or pharmacy technician is on duty. | |
1846 | 1858 | SECTION 45. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017, | |
1847 | 1859 | SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1848 | 1860 | JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be | |
1849 | 1861 | dispensed at the remote dispensing facility unless: | |
1850 | 1862 | (1) the facility maintains a perpetual inventory of controlled | |
1851 | 1863 | substances; and | |
1852 | 1864 | (2) the supervising pharmacist checks the Indiana scheduled | |
1853 | 1865 | prescription electronic collection and tracking program | |
1854 | 1866 | established by IC 25-1-13-4 or as directed by the board before: | |
1855 | 1867 | (A) verification of the finished controlled substance | |
1856 | 1868 | prescription; and | |
1857 | 1869 | (B) counseling the patient. | |
1858 | 1870 | (b) Drugs may be transported to a remote dispensing facility that | |
1859 | 1871 | uses an automated dispensing machine only in a sealed container with | |
1860 | 1872 | a list identifying each drug, drug strength, and quantity included in the | |
1861 | 1873 | container. | |
1862 | 1874 | (c) A delivery of drugs may be accepted at the remote dispensing | |
1863 | 1875 | facility only if a pharmacist or a licensed pharmacy technician is | |
1864 | 1876 | present to accept delivery and verify and sign for the receipt of the | |
1865 | 1877 | drugs, unless the drugs are placed in a secured delivery area that | |
1866 | 1878 | complies with federal and state law. | |
1867 | 1879 | (d) If the delivery is received by a pharmacy technician, a | |
1868 | 1880 | pharmacist at the supervising pharmacy shall ensure through the use of | |
1869 | 1881 | the electronic audio and video communication system or bar code | |
1870 | 1882 | technology that the pharmacy technician has accurately restocked the | |
1871 | 1883 | drugs. | |
1872 | 1884 | (e) A remote dispensing facility must store drugs in a manner that: | |
1873 | 1885 | (1) complies with federal and state law; | |
1874 | - | HB 1158—LS 7067/DI 137 | |
1886 | + | HB 1158—LS 7067/DI 137 45 | |
1875 | 1887 | (2) protects the identity, safety, security, and integrity of the drug; | |
1876 | 1888 | and | |
1877 | 1889 | (3) limits access to: | |
1878 | 1890 | (A) a pharmacist employed by the supervising pharmacy; and | |
1879 | 1891 | (B) a pharmacy technician who has written authorization of the | |
1880 | 1892 | qualifying a pharmacist to access the facility. | |
1881 | 1893 | SECTION 46. IC 25-26-14-11, AS AMENDED BY P.L.264-2019, | |
1882 | 1894 | SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE | |
1883 | 1895 | JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale | |
1884 | 1896 | distribution" means to distribute legend drugs to persons other than a | |
1885 | 1897 | consumer or patient. The term does not include: | |
1886 | 1898 | (1) a sale or transfer between a division, a subsidiary, a parent, an | |
1887 | 1899 | affiliated, or a related company under the common ownership and | |
1888 | 1900 | control of a corporate entity; | |
1889 | 1901 | (2) the purchase or acquisition by a hospital or other health care | |
1890 | 1902 | entity that is a member of a group purchasing organization of a | |
1891 | 1903 | drug for the hospital's or health care entity's own use from the | |
1892 | 1904 | group purchasing organization or from other hospitals or health | |
1893 | 1905 | care entities that are members of the organization; | |
1894 | 1906 | (3) the sale or transfer of a drug by a charitable organization | |
1895 | 1907 | described in Section 501(c)(3) of the Internal Revenue Code, to: | |
1896 | 1908 | (A) a nonprofit affiliate of the organization; or | |
1897 | 1909 | (B) a nonprofit entity described in Section 501(c)(3) of the | |
1898 | 1910 | Internal Revenue Code that is not affiliated with the | |
1899 | 1911 | organization; | |
1900 | 1912 | to the extent otherwise permitted by law; | |
1901 | 1913 | (4) the sale of a drug among hospitals or other health care entities | |
1902 | 1914 | that are under common control; | |
1903 | 1915 | (5) the sale of a drug for emergency medical reasons, including | |
1904 | 1916 | transfers of legend drugs by a retail pharmacy to another retail | |
1905 | 1917 | pharmacy to alleviate a temporary shortage, if the gross dollar | |
1906 | 1918 | value of the transfers does not exceed five percent (5%) of the | |
1907 | 1919 | total legend drug sales revenue of either the transferor or | |
1908 | 1920 | transferee pharmacy during any twelve (12) consecutive month | |
1909 | 1921 | period; | |
1910 | 1922 | (6) the sale of a drug or the dispensing of a drug pursuant to a | |
1911 | 1923 | prescription; | |
1912 | 1924 | (7) the distribution of drug samples by manufacturers' | |
1913 | 1925 | representatives or distributors' representatives; | |
1914 | 1926 | (8) the sale of blood and blood components intended for | |
1915 | 1927 | transfusion; | |
1916 | 1928 | (9) the sale of a drug by a retail pharmacy to a practitioner (as | |
1917 | - | HB 1158—LS 7067/DI 137 | |
1929 | + | HB 1158—LS 7067/DI 137 46 | |
1918 | 1930 | defined in IC 25-26-13-2) for office use, if the gross dollar value | |
1919 | 1931 | of the transfers does not exceed five percent (5%) of the retail | |
1920 | 1932 | pharmacy's total legend drug sales during any twelve (12) | |
1921 | 1933 | consecutive months; | |
1922 | 1934 | (10) the sale of a drug by a retail pharmacy that is ending its | |
1923 | 1935 | business and liquidating its inventory to another retail pharmacy; | |
1924 | 1936 | (11) drug returns by a hospital, health care entity, or charitable | |
1925 | 1937 | institution conducted under 21 CFR 203.23; | |
1926 | 1938 | (12) the sale of minimal quantities of drugs by retail pharmacies | |
1927 | 1939 | to licensed practitioners for office use; | |
1928 | 1940 | (13) the distribution of prescription drugs by the original | |
1929 | 1941 | manufacturer of the finished form of the prescription drug or the | |
1930 | 1942 | distribution of the co-licensed products by a partner of the | |
1931 | 1943 | original manufacturer of the finished form of the prescription | |
1932 | 1944 | drug; or | |
1933 | 1945 | (14) drug returns that meet criteria established by rules adopted | |
1934 | 1946 | by the board; or | |
1935 | 1947 | (15) the sale of a drug for research or clinical trial purposes, | |
1936 | 1948 | provided the seller is authorized by the federal Food and Drug | |
1937 | 1949 | Administration to sell the drug for research or clinical trial | |
1938 | 1950 | purposes.". | |
1939 | 1951 | Delete pages 38 through 39. | |
1940 | 1952 | Page 40, delete lines 1 through 23. | |
1941 | 1953 | Page 40, line 35, after "physician" insert ", a physician assistant,". | |
1942 | 1954 | Page 40, delete lines 39 through 42. | |
1943 | 1955 | Delete pages 41 through 43. | |
1944 | 1956 | Page 44, delete lines 1 through 27. | |
1945 | 1957 | Page 44, delete lines 37 through 42. | |
1946 | 1958 | Delete page 45. | |
1947 | 1959 | Page 46, delete lines 1 through 17. | |
1948 | 1960 | Page 46, delete lines 21 through 27. | |
1949 | 1961 | Page 46, delete lines 39 through 42. | |
1950 | 1962 | Page 47, delete lines 1 through 7. | |
1951 | 1963 | Renumber all SECTIONS consecutively. | |
1952 | 1964 | and when so amended that said bill do pass. | |
1953 | 1965 | (Reference is to HB 1158 as introduced.) | |
1954 | 1966 | BARRETT | |
1955 | 1967 | Committee Vote: yeas 11, nays 0. | |
1956 | - | HB 1158—LS 7067/DI 137 46 | |
1957 | - | HOUSE MOTION | |
1958 | - | Mr. Speaker: I move that House Bill 1158 be amended to read as | |
1959 | - | follows: | |
1960 | - | Page 15, delete lines 21 through 33. | |
1961 | - | Renumber all SECTIONS consecutively. | |
1962 | - | (Reference is to HB 1158 as printed January 20, 2022.) | |
1963 | - | CLERE | |
1964 | 1968 | HB 1158—LS 7067/DI 137 |