Old | New | Differences | |
---|---|---|---|
1 | - | LAWRENCE J. HOGAN, JR., Governor Ch. 224 | |
2 | 1 | ||
3 | - | – 1 – | |
4 | - | Chapter 224 | |
5 | - | (Senate Bill 200) | |
6 | 2 | ||
7 | - | AN ACT concerning | |
3 | + | EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. | |
4 | + | [Brackets] indicate matter deleted from existing law. | |
5 | + | Underlining indicates amendments to bill. | |
6 | + | Strike out indicates matter stricken from the bill by amendment or deleted from the law by | |
7 | + | amendment. | |
8 | + | *sb0200* | |
8 | 9 | ||
9 | - | Public Health – Prescription Drug Monitoring Program – Naloxone Medication | |
10 | - | Data | |
10 | + | SENATE BILL 200 | |
11 | + | J1 2lr0057 | |
12 | + | (PRE–FILED) | |
13 | + | By: Chair, Finance Committee (By Request – Departmental – Health) | |
14 | + | Requested: October 5, 2021 | |
15 | + | Introduced and read first time: January 12, 2022 | |
16 | + | Assigned to: Finance | |
17 | + | Committee Report: Favorable | |
18 | + | Senate action: Adopted | |
19 | + | Read second time: February 8, 2022 | |
11 | 20 | ||
12 | - | FOR the purpose of altering the requirements of the Prescription Drug Monitoring Program | |
13 | - | to require the Program to monitor the dispensing of naloxone medication by all | |
14 | - | prescribers and dispensers in the State and to require dispensers to report naloxone | |
15 | - | medication data to the Program; and generally relating to the Prescription Drug | |
16 | - | Monitoring Program and naloxone medication data. | |
21 | + | CHAPTER ______ | |
17 | 22 | ||
18 | - | BY repealing and reenacting, with amendments, | |
19 | - | Article – Health – General | |
20 | - | Section 21–2A–01 through 21–2A–04, 21–2A–08, and 21–2A–09 | |
21 | - | Annotated Code of Maryland | |
22 | - | (2019 Replacement Volume and 2021 Supplement) | |
23 | + | AN ACT concerning 1 | |
23 | 24 | ||
24 | - | BY adding to | |
25 | - | Article – Health – General | |
26 | - | Section 21–2A–06.1 | |
27 | - | Annotated Code of Maryland | |
28 | - | (2019 Replacement Volume and 2021 Supplement) | |
25 | + | Public Health – Prescription Drug Monitoring Program – Naloxone Medication 2 | |
26 | + | Data 3 | |
29 | 27 | ||
30 | - | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, | |
31 | - | That the Laws of Maryland read as follows: | |
28 | + | FOR the purpose of altering the requirements of the Prescription Drug Monitoring Program 4 | |
29 | + | to require the Program to monitor the dispensing of naloxone medication by all 5 | |
30 | + | prescribers and dispensers in the State and to require dispensers to report naloxone 6 | |
31 | + | medication data to the Program; and generally relating to the Prescription Drug 7 | |
32 | + | Monitoring Program and naloxone medication data. 8 | |
32 | 33 | ||
33 | - | Article – Health – General | |
34 | + | BY repealing and reenacting, with amendments, 9 | |
35 | + | Article – Health – General 10 | |
36 | + | Section 21–2A–01 through 21–2A–04, 21–2A–08, and 21–2A–09 11 | |
37 | + | Annotated Code of Maryland 12 | |
38 | + | (2019 Replacement Volume and 2021 Supplement) 13 | |
34 | 39 | ||
35 | - | 21–2A–01. | |
40 | + | BY adding to 14 | |
41 | + | Article – Health – General 15 | |
42 | + | Section 21–2A–06.1 16 | |
43 | + | Annotated Code of Maryland 17 | |
44 | + | (2019 Replacement Volume and 2021 Supplement) 18 | |
36 | 45 | ||
37 | - | (a) In this subtitle the following words have the meanings indicated. | |
46 | + | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 19 | |
47 | + | That the Laws of Maryland read as follows: 20 | |
48 | + | 2 SENATE BILL 200 | |
38 | 49 | ||
39 | - | (b) “Board” means the Advisory Board on Prescription Drug Monitoring. | |
40 | 50 | ||
41 | - | (c) (1) “Dispense” has the meaning stated in § 12 –101 of the Health | |
42 | - | Occupations Article. | |
51 | + | Article – Health – General 1 | |
43 | 52 | ||
44 | - | ||
53 | + | 21–2A–01. 2 | |
45 | 54 | ||
46 | - | (i) Directly administering a monitored prescription drug to a | |
47 | - | patient; or | |
55 | + | (a) In this subtitle the following words have the meanings indicated. 3 | |
48 | 56 | ||
49 | - | ( | |
57 | + | (b) “Board” means the Advisory Board on Prescription Drug Monitoring. 4 | |
50 | 58 | ||
51 | - | – 2 – | |
59 | + | (c) (1) “Dispense” has the meaning stated in § 12 –101 of the Health 5 | |
60 | + | Occupations Article. 6 | |
52 | 61 | ||
53 | - | (d) (1) “Dispenser” means a person authorized by law to dispense a monitored | |
54 | - | prescription drug to a patient or the patient’s agent in the State. | |
62 | + | (2) “Dispense” does not include: 7 | |
55 | 63 | ||
56 | - | (2) “Dispenser” includes a nonresident pharmacy. | |
64 | + | (i) Directly administering a monitored prescription drug to a 8 | |
65 | + | patient; or 9 | |
57 | 66 | ||
58 | - | ( | |
67 | + | (ii) Giving out prescription drug samples. 10 | |
59 | 68 | ||
60 | - | ( | |
61 | - | prescription drug | |
69 | + | (d) (1) “Dispenser” means a person authorized by law to dispense a monitored 11 | |
70 | + | prescription drug to a patient or the patient’s agent in the State. 12 | |
62 | 71 | ||
63 | - | ( | |
72 | + | (2) “Dispenser” includes a nonresident pharmacy. 13 | |
64 | 73 | ||
65 | - | (iii) A veterinarian licensed under Title 2, Subtitle 3 of the | |
66 | - | Agriculture Article when prescribing controlled substances for animals in the usual course | |
67 | - | of providing professional services; | |
74 | + | (3) “Dispenser” does not include: 14 | |
68 | 75 | ||
69 | - | (iv) A pharmacy issued a waiver permit under COMAR 10.34.17.03 | |
70 | - | that provides pharmaceutical specialty services exclusively to persons living in assisted | |
71 | - | living facilities, comprehensive care facilities, and developmental disabilities facilities; and | |
76 | + | (i) A licensed hospital pharmacy that only dispenses a monitored 15 | |
77 | + | prescription drug for direct administration to an inpatient of the hospital; 16 | |
72 | 78 | ||
73 | - | ( | |
79 | + | (ii) An opioid treatment services program; 17 | |
74 | 80 | ||
75 | - | 1. Dispenses medications to an inpatient hospice; and | |
81 | + | (iii) A veterinarian licensed under Title 2, Subtitle 3 of the 18 | |
82 | + | Agriculture Article when prescribing controlled substances for animals in the usual course 19 | |
83 | + | of providing professional services; 20 | |
76 | 84 | ||
77 | - | 2. Has been granted a waiver under § 21–2A–03(f) of this | |
78 | - | subtitle. | |
85 | + | (iv) A pharmacy issued a waiver permit under COMAR 10.34.17.03 21 | |
86 | + | that provides pharmaceutical specialty services exclusively to persons living in assisted 22 | |
87 | + | living facilities, comprehensive care facilities, and developmental disabilities facilities; and 23 | |
79 | 88 | ||
80 | - | (e) “Licensing entity” means an entity authorized under the Health Occupations | |
81 | - | Article to license, regulate, or discipline a prescriber or dispenser. | |
89 | + | (v) A pharmacy that: 24 | |
82 | 90 | ||
83 | - | (f) (1) “Monitored prescription drug” means a prescription drug that contains | |
84 | - | a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance | |
85 | - | designated under Title 5, Subtitle 4 of the Criminal Law Article. | |
91 | + | 1. Dispenses medications to an inpatient hospice; and 25 | |
86 | 92 | ||
87 | - | ( | |
88 | - | ||
93 | + | 2. Has been granted a waiver under § 21–2A–03(f) of this 26 | |
94 | + | subtitle. 27 | |
89 | 95 | ||
90 | - | (G) “NALOXONE MEDICATION ” MEANS AN OPIOID ANTA GONIST APPROVED | |
91 | - | BY THE FEDERAL FOOD AND DRUG ADMINISTRATION FOR TH E REVERSAL OF AN | |
92 | - | OPIOID OVERDOSE . | |
96 | + | (e) “Licensing entity” means an entity authorized under the Health Occupations 28 | |
97 | + | Article to license, regulate, or discipline a prescriber or dispenser. 29 SENATE BILL 200 3 | |
93 | 98 | ||
94 | - | (H) “NALOXONE MEDICATION D ATA” MEANS THE INFORMATIO N SUBMITTED | |
95 | - | TO THE PROGRAM FOR NALOXONE MEDICATION . | |
96 | - | LAWRENCE J. HOGAN, JR., Governor Ch. 224 | |
97 | 99 | ||
98 | - | – 3 – | |
99 | - | [(g)] (I) “Office” means the Office of Controlled Substances Administration in | |
100 | - | the Department. | |
101 | 100 | ||
102 | - | [(h)] (J) “Opioid treatment services program” means a program that: | |
101 | + | (f) (1) “Monitored prescription drug” means a prescription drug that contains 1 | |
102 | + | a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance 2 | |
103 | + | designated under Title 5, Subtitle 4 of the Criminal Law Article. 3 | |
103 | 104 | ||
104 | - | ( | |
105 | - | ||
105 | + | (2) “MONITORED PRESCRIPTIO N DRUG” DOES NOT INCLUDE 4 | |
106 | + | NALOXONE MEDICATION . 5 | |
106 | 107 | ||
107 | - | (2) Is authorized to treat patients with opioid dependence with a | |
108 | - | medication approved by the federal Food and Drug Administration for opioid dependence; | |
108 | + | (G) “NALOXONE MEDICATION ” MEANS AN OPIOID ANTA GONIST APPROVED 6 | |
109 | + | BY THE FEDERAL FOOD AND DRUG ADMINISTRATION FOR TH E REVERSAL OF AN 7 | |
110 | + | OPIOID OVERDOSE . 8 | |
109 | 111 | ||
110 | - | (3) Complies with: | |
112 | + | (H) “NALOXONE MEDICATION DATA” MEANS THE INFORMATIO N SUBMITTED 9 | |
113 | + | TO THE PROGRAM FOR NALOXONE MEDICATION. 10 | |
111 | 114 | ||
112 | - | (i) The Code of Federal Regulations 42, Part 8; | |
115 | + | [(g)] (I) “Office” means the Office of Controlled Substances Administration in 11 | |
116 | + | the Department. 12 | |
113 | 117 | ||
114 | - | ( | |
118 | + | [(h)] (J) “Opioid treatment services program” means a program that: 13 | |
115 | 119 | ||
116 | - | ( | |
117 | - | ||
120 | + | (1) Is certified in accordance with § 8–401 of this article or licensed by the 14 | |
121 | + | State under § 7.5–401 of this article; 15 | |
118 | 122 | ||
119 | - | (4) Has been granted a certification for operation by the Department, the | |
120 | - | federal Substance Abuse and Mental Health Services Administration, and the federal | |
121 | - | Center for Substance Abuse Treatment. | |
123 | + | (2) Is authorized to treat patients with opioid dependence with a 16 | |
124 | + | medication approved by the federal Food and Drug Administration for opioid dependence; 17 | |
122 | 125 | ||
123 | - | [(i)] (K) “Pharmacist” means an individual who is licensed under Title 12 of the | |
124 | - | Health Occupations Article, or by another state, to dispense a monitored prescription drug. | |
126 | + | (3) Complies with: 18 | |
125 | 127 | ||
126 | - | ||
128 | + | (i) The Code of Federal Regulations 42, Part 8; 19 | |
127 | 129 | ||
128 | - | (1) Authorized by a registered pharmacist to request or access prescription | |
129 | - | monitoring data; and | |
130 | + | (ii) COMAR 10.47.02.11; and 20 | |
130 | 131 | ||
131 | - | ( | |
132 | - | the | |
132 | + | (iii) Requirements for the secure storage and accounting of opioid 21 | |
133 | + | medication imposed by the federal Drug Enforcement Administration and the Office; and 22 | |
133 | 134 | ||
134 | - | [(k)] (M) “Prescriber” means a licensed health care professional authorized by | |
135 | - | law to prescribe a monitored prescription drug. | |
135 | + | (4) Has been granted a certification for operation by the Department, the 23 | |
136 | + | federal Substance Abuse and Mental Health Services Administration, and the federal 24 | |
137 | + | Center for Substance Abuse Treatment. 25 | |
136 | 138 | ||
137 | - | [(l)] (N) “Prescriber delegate” means an individual who is: | |
139 | + | [(i)] (K) “Pharmacist” means an individual who is licensed under Title 12 of the 26 | |
140 | + | Health Occupations Article, or by another state, to dispense a monitored prescription drug. 27 | |
138 | 141 | ||
139 | - | (1) Authorized by a registered prescriber to request or access prescription | |
140 | - | monitoring data; and | |
142 | + | [(j)] (L) “Pharmacist delegate” means an individual who is: 28 | |
141 | 143 | ||
142 | - | (2) Employed by or under contract with the same professional practice as | |
143 | - | the prescriber. | |
144 | - | Ch. 224 2022 LAWS OF MARYLAND | |
144 | + | (1) Authorized by a registered pharmacist to request or access prescription 29 | |
145 | + | monitoring data; and 30 4 SENATE BILL 200 | |
145 | 146 | ||
146 | - | – 4 – | |
147 | - | [(m)] (O) “Prescription drug” has the meaning stated in § 21–201 of this title. | |
148 | 147 | ||
149 | - | [(n)] (P) “Prescription monitoring data” means the information submitted to the | |
150 | - | Program for a monitored prescription drug. | |
151 | 148 | ||
152 | - | ||
153 | - | ||
149 | + | (2) Employed by or under contract with the same professional practice as 1 | |
150 | + | the registered pharmacist. 2 | |
154 | 151 | ||
155 | - | [( | |
156 | - | prescription | |
152 | + | [(k)] (M) “Prescriber” means a licensed health care professional authorized by 3 | |
153 | + | law to prescribe a monitored prescription drug. 4 | |
157 | 154 | ||
158 | - | [(q)] (S) “Terminal illness” means a medical condition that, within reasonable | |
159 | - | medical judgment, involves a prognosis for a patient that likely will result in the patient’s | |
160 | - | death within 6 months. | |
155 | + | [(l)] (N) “Prescriber delegate” means an individual who is: 5 | |
161 | 156 | ||
162 | - | 21–2A–02. | |
157 | + | (1) Authorized by a registered prescriber to request or access prescription 6 | |
158 | + | monitoring data; and 7 | |
163 | 159 | ||
164 | - | (a) There is a Prescription Drug Monitoring Program in the Department. | |
160 | + | (2) Employed by or under contract with the same professional practice as 8 | |
161 | + | the prescriber. 9 | |
165 | 162 | ||
166 | - | ( | |
163 | + | [(m)] (O) “Prescription drug” has the meaning stated in § 21–201 of this title. 10 | |
167 | 164 | ||
168 | - | (1) Assist prescribers, pharmacists, and public health professionals in: | |
165 | + | [(n)] (P) “Prescription monitoring data” means the information submitted to the 11 | |
166 | + | Program for a monitored prescription drug. 12 | |
169 | 167 | ||
170 | - | (i) The identification and prevention of prescription drug abuse; and | |
168 | + | [(o)] (Q) “Program” means the Prescription Drug Monitoring Program 13 | |
169 | + | established under this subtitle. 14 | |
171 | 170 | ||
172 | - | ( | |
173 | - | ||
171 | + | [(p)] (R) “Registered” means registered with the Program to request or access 15 | |
172 | + | prescription monitoring data for clinical use. 16 | |
174 | 173 | ||
175 | - | ( | |
176 | - | ||
177 | - | ||
174 | + | [(q)] (S) “Terminal illness” means a medical condition that, within reasonable 17 | |
175 | + | medical judgment, involves a prognosis for a patient that likely will result in the patient’s 18 | |
176 | + | death within 6 months. 19 | |
178 | 177 | ||
179 | - | (c) To carry out its mission, the Program shall monitor the prescribing and | |
180 | - | dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled | |
181 | - | dangerous substances AND THE DISPENSING O F NALOXONE MEDICATIO N by all | |
182 | - | prescribers and dispensers in the State. | |
178 | + | 21–2A–02. 20 | |
183 | 179 | ||
184 | - | ||
180 | + | (a) There is a Prescription Drug Monitoring Program in the Department. 21 | |
185 | 181 | ||
186 | - | (a) The Department shall implement the Program, subject to the availability of | |
187 | - | funds. | |
182 | + | (b) The mission of the Program is to: 22 | |
188 | 183 | ||
189 | - | ( | |
184 | + | (1) Assist prescribers, pharmacists, and public health professionals in: 23 | |
190 | 185 | ||
191 | - | (1) Assign responsibility for the operation of the Program to any unit in the | |
192 | - | Department; LAWRENCE J. HOGAN, JR., Governor Ch. 224 | |
186 | + | (i) The identification and prevention of prescription drug abuse; and 24 | |
193 | 187 | ||
194 | - | – 5 – | |
188 | + | (ii) The identification and investigation of unlawful prescription 25 | |
189 | + | drug diversion; and 26 | |
195 | 190 | ||
196 | - | (2) Contract with any qualified person for the efficient and economical | |
197 | - | operation of the Program; and | |
191 | + | (2) Promote a balanced use of prescription monitoring data to assist 27 | |
192 | + | appropriate law enforcement activities while preserving the professional practice of health 28 | |
193 | + | care providers and the access of patients to optimal pharmaceutical care. 29 SENATE BILL 200 5 | |
198 | 194 | ||
199 | - | (3) Identify and publish a list of monitored prescription drugs that have a | |
200 | - | low potential for abuse by individuals. | |
201 | 195 | ||
202 | - | (c) Except as provided in subsection (d) of this section, each dispenser shall | |
203 | - | submit prescription monitoring data AND NALOXONE MEDICATION DATA to the Program | |
204 | - | by electronic means, in accordance with regulations adopted by the Secretary. | |
205 | 196 | ||
206 | - | (d) The Secretary, for good cause shown, may authorize a dispenser to submit | |
207 | - | prescription monitoring data OR NALOXONE MEDICATION DATA by an alternative form | |
208 | - | of submission. | |
197 | + | (c) To carry out its mission, the Program shall monitor the prescribing and 1 | |
198 | + | dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled 2 | |
199 | + | dangerous substances AND THE DISPENSING O F NALOXONE MEDICATIO N by all 3 | |
200 | + | prescribers and dispensers in the State. 4 | |
209 | 201 | ||
210 | - | (e) The Secretary, in consultation with the Maryland Health Care Commission | |
211 | - | and the Board, shall: | |
202 | + | 21–2A–03. 5 | |
212 | 203 | ||
213 | - | ( | |
214 | - | ||
204 | + | (a) The Department shall implement the Program, subject to the availability of 6 | |
205 | + | funds. 7 | |
215 | 206 | ||
216 | - | (2) Educate dispensers, prescribers, pharmacists, prescriber delegates, | |
217 | - | pharmacist delegates, and consumers about the purpose and operation of the Program. | |
207 | + | (b) The Secretary may: 8 | |
218 | 208 | ||
219 | - | (f) (1) The Secretary shall grant a waiver to a pharmacy that dispenses | |
220 | - | medications to an inpatient hospice from reporting to the Program prescription monitoring | |
221 | - | data for hospice inpatients if: | |
209 | + | (1) Assign responsibility for the operation of the Program to any unit in the 9 | |
210 | + | Department; 10 | |
222 | 211 | ||
223 | - | ( | |
224 | - | ||
212 | + | (2) Contract with any qualified person for the efficient and economical 11 | |
213 | + | operation of the Program; and 12 | |
225 | 214 | ||
226 | - | (ii) The pharmacy agrees that i t will be subject to onsite, | |
227 | - | unannounced inspections by the Department to verify its reporting of the prescription data | |
228 | - | of consumers who are not hospice inpatients. | |
215 | + | (3) Identify and publish a list of monitored prescription drugs that have a 13 | |
216 | + | low potential for abuse by individuals. 14 | |
229 | 217 | ||
230 | - | (2) A waiver granted under this subsection may remain in effect for up to | |
231 | - | 2 years. | |
218 | + | (c) Except as provided in subsection (d) of this section, each dispenser shall 15 | |
219 | + | submit prescription monitoring data AND NALOXONE MEDICATION DATA to the Program 16 | |
220 | + | by electronic means, in accordance with regulations adopted by the Secretary. 17 | |
232 | 221 | ||
233 | - | (3) The Secretary may establish an application process for a pharmacy to | |
234 | - | apply for a waiver under this subsection. | |
222 | + | (d) The Secretary, for good cause shown, may authorize a dispenser to submit 18 | |
223 | + | prescription monitoring data OR NALOXONE MEDICATION DATA by an alternative form 19 | |
224 | + | of submission. 20 | |
235 | 225 | ||
236 | - | 21–2A–04. | |
226 | + | (e) The Secretary, in consultation with the Maryland Health Care Commission 21 | |
227 | + | and the Board, shall: 22 | |
237 | 228 | ||
238 | - | (a) The Secretary, in consultation with the Board, shall adopt regulations to carry | |
239 | - | out this subtitle. | |
240 | - | Ch. 224 2022 LAWS OF MARYLAND | |
229 | + | (1) Determine the appropriate technology to support the operation of the 23 | |
230 | + | Program; and 24 | |
241 | 231 | ||
242 | - | ||
243 | - | ||
232 | + | (2) Educate dispensers, prescribers, pharmacists, prescriber delegates, 25 | |
233 | + | pharmacist delegates, and consumers about the purpose and operation of the Program. 26 | |
244 | 234 | ||
245 | - | (1) Specify the prescription monitoring data AND NALOXONE | |
246 | - | MEDICATION DATA required to be submitted under § 21–2A–03 of this subtitle; | |
235 | + | (f) (1) The Secretary shall grant a waiver to a pharmacy that dispenses 27 | |
236 | + | medications to an inpatient hospice from reporting to the Program prescription monitoring 28 | |
237 | + | data for hospice inpatients if: 29 | |
247 | 238 | ||
248 | - | (2) Specify the electronic or other means by which information is to be | |
249 | - | submitted: | |
239 | + | (i) The pharmacy demonstrates how it will distinguish hospice 30 | |
240 | + | inpatients from other consumers receiving medications from the pharmacy; and 31 | |
241 | + | 6 SENATE BILL 200 | |
250 | 242 | ||
251 | - | (i) Without unduly increasing the workload and expense on | |
252 | - | dispensers; and | |
253 | 243 | ||
254 | - | (ii) In a manner as compatible as possible with existing data | |
255 | - | submission practices of dispensers; | |
244 | + | (ii) The pharmacy agrees that i t will be subject to onsite, 1 | |
245 | + | unannounced inspections by the Department to verify its reporting of the prescription data 2 | |
246 | + | of consumers who are not hospice inpatients. 3 | |
256 | 247 | ||
257 | - | ( | |
258 | - | ||
248 | + | (2) A waiver granted under this subsection may remain in effect for up to 4 | |
249 | + | 2 years. 5 | |
259 | 250 | ||
260 | - | (4) Specify that the Program: | |
251 | + | (3) The Secretary may establish an application process for a pharmacy to 6 | |
252 | + | apply for a waiver under this subsection. 7 | |
261 | 253 | ||
262 | - | (i) Shall provide the information technology software to dispensers | |
263 | - | necessary to upload prescription drug monitoring data AND NALOXONE MEDICATION | |
264 | - | DATA to the Program; and | |
254 | + | 21–2A–04. 8 | |
265 | 255 | ||
266 | - | ( | |
267 | - | ||
256 | + | (a) The Secretary, in consultation with the Board, shall adopt regulations to carry 9 | |
257 | + | out this subtitle. 10 | |
268 | 258 | ||
269 | - | ( | |
259 | + | (b) The regulations adopted by the Secretary shall: 11 | |
270 | 260 | ||
271 | - | ( | |
272 | - | ||
261 | + | (1) Specify the prescription monitoring data AND NALOXONE 12 | |
262 | + | MEDICATION DATA required to be submitted under § 21–2A–03 of this subtitle; 13 | |
273 | 263 | ||
274 | - | ( | |
275 | - | ||
264 | + | (2) Specify the electronic or other means by which information is to be 14 | |
265 | + | submitted: 15 | |
276 | 266 | ||
277 | - | (6) Identify the circumstances under which a person may disclose | |
278 | - | prescription monitoring data OR NALOXONE MEDICATION DATA received under the | |
279 | - | Program; | |
267 | + | (i) Without unduly increasing the workload and expense on 16 | |
268 | + | dispensers; and 17 | |
280 | 269 | ||
281 | - | ( | |
282 | - | ||
270 | + | (ii) In a manner as compatible as possible with existing data 18 | |
271 | + | submission practices of dispensers; 19 | |
283 | 272 | ||
284 | - | (i) Possible misuse or abuse of a monitored prescription drug under | |
285 | - | § 21–2A–06(c) of this subtitle; or | |
286 | - | LAWRENCE J. HOGAN, JR., Governor Ch. 224 | |
273 | + | (3) Specify that the information be submitted by dispensers once every 24 20 | |
274 | + | hours; 21 | |
287 | 275 | ||
288 | - | – 7 – | |
289 | - | (ii) A possible violation of law or possible breach of professional | |
290 | - | standards under § 21–2A–06(d) of this subtitle; | |
276 | + | (4) Specify that the Program: 22 | |
291 | 277 | ||
292 | - | (8) Establish requirements for Program retention of prescription | |
293 | - | monitoring data AND NALOXONE MEDICATION DATA for 3 years; and | |
278 | + | (i) Shall provide the information technology software to dispensers 23 | |
279 | + | necessary to upload prescription drug monitoring data AND NALOXONE MEDICATION 24 | |
280 | + | DATA to the Program; and 25 | |
294 | 281 | ||
295 | - | (9) Require that: | |
282 | + | (ii) May not impose any fees or other assessments on prescribers or 26 | |
283 | + | dispensers to support the operation of the Program; 27 | |
296 | 284 | ||
297 | - | (i) Confidential or privileged patient information be kept | |
298 | - | confidential; and | |
285 | + | (5) Identify the mechanism by which [prescription]: 28 | |
299 | 286 | ||
300 | - | (ii) Records or information protected by a privilege between a health | |
301 | - | care provider and a patient, or otherwise required by law to be held confidential, be filed in | |
302 | - | a manner that, except as otherwise provided in [§ 21–2A–06] §§ 21–2A–06 AND | |
303 | - | 21–2A–06.1 of this subtitle, does not disclose the identity of the person protected. | |
287 | + | (I) PRESCRIPTION monitoring data are disclosed to a person, in 29 | |
288 | + | accordance with § 21–2A–06 of this subtitle; AND 30 | |
289 | + | SENATE BILL 200 7 | |
304 | 290 | ||
305 | - | 21–2A–06.1. | |
306 | 291 | ||
307 | - | (A) NALOXONE MEDICATION DATA: | |
292 | + | (II) NALOXONE MEDICATION DATA ARE DISCLOSED T O A 1 | |
293 | + | PERSON, IN ACCORDANCE WITH § 21–2A–06.1 OF THIS SUBTITLE; 2 | |
308 | 294 | ||
309 | - | ( | |
310 | - | ||
311 | - | ||
295 | + | (6) Identify the circumstances under which a person may disclose 3 | |
296 | + | prescription monitoring data OR NALOXONE MEDICATION DATA received under the 4 | |
297 | + | Program; 5 | |
312 | 298 | ||
313 | - | (2) ARE NOT PUBLIC RECORD S; AND | |
299 | + | (7) Specify the process for the Program’s review of prescription monitoring 6 | |
300 | + | data AND NALOXONE MEDICAT ION DATA and reporting of: 7 | |
314 | 301 | ||
315 | - | ( | |
316 | - | ||
302 | + | (i) Possible misuse or abuse of a monitored prescription drug under 8 | |
303 | + | § 21–2A–06(c) of this subtitle; or 9 | |
317 | 304 | ||
318 | - | (B) (1) THE PROGRAM SHALL DISCLOS E NALOXONE MEDICATION DATA, | |
319 | - | IN ACCORDANCE WITH R EGULATIONS ADOPTED B Y THE SECRETARY, FOR PUBLIC | |
320 | - | HEALTH SURVEILLANCE , RESEARCH, ANALYSIS, PUBLIC REPORTING , AND | |
321 | - | EDUCATION AFTER REDACTION OF AL L INFORMATION THAT C OULD IDENTIFY A | |
322 | - | PATIENT, PRESCRIBER, DISPENSER, OR ANY OTHER INDIVIDUAL. | |
305 | + | (ii) A possible violation of law or possible breach of professional 10 | |
306 | + | standards under § 21–2A–06(d) of this subtitle; 11 | |
323 | 307 | ||
324 | - | (2) THE SECRETARY MAY REQUIRE SUBMISSI ON OF AN ABSTRACT | |
325 | - | EXPLAINING THE SCOPE AND PURPOSE OF THE R ESEARCH, ANALYSIS, PUBLIC | |
326 | - | REPORTING, OR EDUCATION BEFORE DISC LOSING NALOXONE MEDICATION DATA | |
327 | - | UNDER PARAGRAPH (1) OF THIS SUBSECTION . | |
308 | + | (8) Establish requirements for Program retention of prescription 12 | |
309 | + | monitoring data AND NALOXONE MEDICATION DATA for 3 years; and 13 | |
328 | 310 | ||
329 | - | ||
311 | + | (9) Require that: 14 | |
330 | 312 | ||
331 | - | ( | |
332 | - | ||
313 | + | (i) Confidential or privileged patient information be kept 15 | |
314 | + | confidential; and 16 | |
333 | 315 | ||
334 | - | – 8 – | |
316 | + | (ii) Records or information protected by a privilege between a health 17 | |
317 | + | care provider and a patient, or otherwise required by law to be held confidential, be filed in 18 | |
318 | + | a manner that, except as otherwise provided in [§ 21–2A–06] §§ 21–2A–06 AND 19 | |
319 | + | 21–2A–06.1 of this subtitle, does not disclose the identity of the person protected. 20 | |
335 | 320 | ||
336 | - | (1) The inaccuracy of any information submitted to the Program in | |
337 | - | accordance with this subtitle; or | |
321 | + | 21–2A–06.1. 21 | |
338 | 322 | ||
339 | - | (2) The unauthorized use or disclosure of prescription monitoring data OR | |
340 | - | NALOXONE MEDICATION DATA by a person to whom the Program was authorized to | |
341 | - | provide prescription monitoring data OR NALOXONE MEDICATION DATA under this | |
342 | - | subtitle. | |
323 | + | (A) NALOXONE MEDICATION DATA: 22 | |
343 | 324 | ||
344 | - | ( | |
345 | - | ||
346 | - | ||
325 | + | (1) ARE CONFIDENTIAL AND PRIVILEGED, AND NOT SUBJECT TO 23 | |
326 | + | DISCOVERY, SUBPOENA, OR OTHER MEANS OF LE GAL COMPULSION IN CI VIL 24 | |
327 | + | LITIGATION; 25 | |
347 | 328 | ||
348 | - | (1) Requesting or receiving, or failing to request or receive, prescription | |
349 | - | monitoring data from the Program; or | |
329 | + | (2) ARE NOT PUBLIC RECORD S; AND 26 | |
350 | 330 | ||
351 | - | ( | |
352 | - | ||
331 | + | (3) EXCEPT AS PROVIDED IN SUBSECTION (B) OF THIS SECTION OR A S 27 | |
332 | + | OTHERWISE BY LAW , MAY NOT BE DISCLOSED TO A NY PERSON. 28 | |
353 | 333 | ||
354 | - | 21–2A–09. | |
334 | + | (B) (1) THE PROGRAM SHALL DISCLOS E NALOXONE MEDICATION DATA, 29 | |
335 | + | IN ACCORDANCE WITH R EGULATIONS ADOPTED B Y THE SECRETARY, FOR PUBLIC 30 | |
336 | + | HEALTH SURVEILLANCE , RESEARCH, ANALYSIS, PUBLIC REPORTING , AND 31 8 SENATE BILL 200 | |
355 | 337 | ||
356 | - | (a) A dispenser who knowingly fails to submit prescription monitoring data OR | |
357 | - | NALOXONE MEDICATION DATA to the Program as required under this subtitle shall be | |
358 | - | subject to a civil penalty not exceeding $500 for each failure to submit required information. | |
359 | 338 | ||
360 | - | (b) (1) A person who knowingly discloses, uses, obtains, or attempts to obtain | |
361 | - | by fraud or deceit, prescription monitoring data OR NALOXONE MEDICATION DATA in | |
362 | - | violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to | |
363 | - | imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both. | |
339 | + | EDUCATION AFTER REDACTION OF AL L INFORMATION THAT C OULD IDENTIFY A 1 | |
340 | + | PATIENT, PRESCRIBER, DISPENSER, OR ANY OTHER INDIVIDUAL. 2 | |
364 | 341 | ||
365 | - | (2) In addition to the penalties under paragraph (1) of this subsection, a | |
366 | - | prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly | |
367 | - | discloses or uses prescription monitoring data OR NALOXONE MEDICATI ON DATA in | |
368 | - | violation of this subtitle shall be subject to disciplinary action by the appropriate licensing | |
369 | - | entity. | |
342 | + | (2) THE SECRETARY MAY REQUIRE SUBMISSI ON OF AN ABSTRACT 3 | |
343 | + | EXPLAINING THE SCOPE AND PURPOSE OF THE R ESEARCH, ANALYSIS, PUBLIC 4 | |
344 | + | REPORTING, OR EDUCATION BEFORE DISC LOSING NALOXONE MEDICATION DATA 5 | |
345 | + | UNDER PARAGRAPH (1) OF THIS SUBSECTION . 6 | |
370 | 346 | ||
371 | - | (3) A prescriber or pharmacist who violates § 21–2A–04.1 or § 21–2A–04.2 | |
372 | - | of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. | |
347 | + | 21–2A–08. 7 | |
373 | 348 | ||
374 | - | (4) The release of prescription monitoring data by a prescriber, prescriber | |
375 | - | delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely | |
376 | - | for treatment purposes in a manner otherwise consistent with State and federal law is not | |
377 | - | a violation of this subtitle. | |
378 | - | LAWRENCE J. HOGAN, JR., Governor Ch. 224 | |
349 | + | (a) With respect to the administration and operation of the Program, the 8 | |
350 | + | Department and its agents and employees are not subject to liability arising from: 9 | |
379 | 351 | ||
380 | - | – 9 – | |
381 | - | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect | |
382 | - | October 1, 2022. | |
352 | + | (1) The inaccuracy of any information submitted to the Program in 10 | |
353 | + | accordance with this subtitle; or 11 | |
383 | 354 | ||
384 | - | Approved by the Governor, April 21, 2022. | |
355 | + | (2) The unauthorized use or disclosure of prescription monitoring data OR 12 | |
356 | + | NALOXONE MEDICATION DATA by a person to whom the Program was authorized to 13 | |
357 | + | provide prescription monitoring data OR NALOXONE MEDICATION DATA under this 14 | |
358 | + | subtitle. 15 | |
359 | + | ||
360 | + | (b) Except as provided in § 21–2A–09(b)(3) of this subtitle, a prescriber, prescriber 16 | |
361 | + | delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability 17 | |
362 | + | or disciplinary action arising solely from: 18 | |
363 | + | ||
364 | + | (1) Requesting or receiving, or failing to request or receive, prescription 19 | |
365 | + | monitoring data from the Program; or 20 | |
366 | + | ||
367 | + | (2) Acting, or failing to act, on the basis of prescription monitoring data 21 | |
368 | + | provided by the Program. 22 | |
369 | + | ||
370 | + | 21–2A–09. 23 | |
371 | + | ||
372 | + | (a) A dispenser who knowingly fails to submit prescription monitoring data OR 24 | |
373 | + | NALOXONE MEDICATION DATA to the Program as required under this subtitle shall be 25 | |
374 | + | subject to a civil penalty not exceeding $500 for each failure to submit required information. 26 | |
375 | + | ||
376 | + | (b) (1) A person who knowingly discloses, uses, obtains, or attempts to obtain 27 | |
377 | + | by fraud or deceit, prescription monitoring data OR NALOXONE MEDICATION DATA in 28 | |
378 | + | violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to 29 | |
379 | + | imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both. 30 | |
380 | + | ||
381 | + | (2) In addition to the penalties under paragraph (1) of this subsection, a 31 | |
382 | + | prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly 32 | |
383 | + | discloses or uses prescription monitoring data OR NALOXONE MEDICATI ON DATA in 33 SENATE BILL 200 9 | |
384 | + | ||
385 | + | ||
386 | + | violation of this subtitle shall be subject to disciplinary action by the appropriate licensing 1 | |
387 | + | entity. 2 | |
388 | + | ||
389 | + | (3) A prescriber or pharmacist who violates § 21–2A–04.1 or § 21–2A–04.2 3 | |
390 | + | of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. 4 | |
391 | + | ||
392 | + | (4) The release of prescription monitoring data by a prescriber, prescriber 5 | |
393 | + | delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely 6 | |
394 | + | for treatment purposes in a manner otherwise consistent with State and federal law is not 7 | |
395 | + | a violation of this subtitle. 8 | |
396 | + | ||
397 | + | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 9 | |
398 | + | October 1, 2022. 10 | |
399 | + | ||
400 | + | ||
401 | + | ||
402 | + | ||
403 | + | ||
404 | + | Approved: | |
405 | + | ________________________________________________________________________________ | |
406 | + | Governor. | |
407 | + | ________________________________________________________________________________ | |
408 | + | President of the Senate. | |
409 | + | ________________________________________________________________________________ | |
410 | + | Speaker of the House of Delegates. |