Maryland 2022 Regular Session

Maryland Senate Bill SB200 Compare Versions

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1- LAWRENCE J. HOGAN, JR., Governor Ch. 224
21
3-– 1 –
4-Chapter 224
5-(Senate Bill 200)
62
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*
89
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
1120
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 ______
1722
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
2324
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
2927
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
3233
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
3439
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
3645
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
3849
39- (b) “Board” means the Advisory Board on Prescription Drug Monitoring.
4050
41- (c) (1) “Dispense” has the meaning stated in § 12 –101 of the Health
42-Occupations Article.
51+Article – Health – General 1
4352
44- (2) “Dispense” does not include:
53+21–2A–01. 2
4554
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
4856
49- (ii) Giving out prescription drug samples. Ch. 224 2022 LAWS OF MARYLAND
57+ (b) “Board” means the Advisory Board on Prescription Drug Monitoring. 4
5058
51-– 2 –
59+ (c) (1) “Dispense” has the meaning stated in § 12 –101 of the Health 5
60+Occupations Article. 6
5261
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
5563
56- (2) “Dispenser” includes a nonresident pharmacy.
64+ (i) Directly administering a monitored prescription drug to a 8
65+patient; or 9
5766
58- (3) “Dispenser” does not include:
67+ (ii) Giving out prescription drug samples. 10
5968
60- (i) A licensed hospital pharmacy that only dispenses a monitored
61-prescription drug for direct administration to an inpatient of the hospital;
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
6271
63- (ii) An opioid treatment services program;
72+ (2) “Dispenser” includes a nonresident pharmacy. 13
6473
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
6875
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
7278
73- (v) A pharmacy that:
79+ (ii) An opioid treatment services program; 17
7480
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
7684
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
7988
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
8290
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
8692
87- (2) “MONITORED PRESCRIPTIO N DRUG” DOES NOT INCLUDE
88-NALOXONE MEDICATION .
93+ 2. Has been granted a waiver under § 21–2A–03(f) of this 26
94+subtitle. 27
8995
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
9398
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
9799
98-– 3 –
99- [(g)] (I) “Office” means the Office of Controlled Substances Administration in
100-the Department.
101100
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
103104
104- (1) Is certified in accordance with § 8–401 of this article or licensed by the
105-State under § 7.5–401 of this article;
105+ (2) “MONITORED PRESCRIPTIO N DRUG” DOES NOT INCLUDE 4
106+NALOXONE MEDICATION . 5
106107
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
109111
110- (3) Complies with:
112+ (H) “NALOXONE MEDICATION DATA” MEANS THE INFORMATIO N SUBMITTED 9
113+TO THE PROGRAM FOR NALOXONE MEDICATION. 10
111114
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
113117
114- (ii) COMAR 10.47.02.11; and
118+ [(h)] (J) “Opioid treatment services program” means a program that: 13
115119
116- (iii) Requirements for the secure storage and accounting of opioid
117-medication imposed by the federal Drug Enforcement Administration and the Office; and
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
118122
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
122125
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
125127
126- [(j)] (L) “Pharmacist delegate” means an individual who is:
128+ (i) The Code of Federal Regulations 42, Part 8; 19
127129
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
130131
131- (2) Employed by or under contract with the same professional practice as
132-the registered pharmacist.
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
133134
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
136138
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
138141
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
141143
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
145146
146-– 4 –
147- [(m)] (O) “Prescription drug” has the meaning stated in § 21–201 of this title.
148147
149- [(n)] (P) “Prescription monitoring data” means the information submitted to the
150-Program for a monitored prescription drug.
151148
152- [(o)] (Q) “Program” means the Prescription Drug Monitoring Program
153-established under this subtitle.
149+ (2) Employed by or under contract with the same professional practice as 1
150+the registered pharmacist. 2
154151
155- [(p)] (R) “Registered” means registered with the Program to request or access
156-prescription monitoring data for clinical use.
152+ [(k)] (M) “Prescriber” means a licensed health care professional authorized by 3
153+law to prescribe a monitored prescription drug. 4
157154
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
161156
162-21–2A–02.
157+ (1) Authorized by a registered prescriber to request or access prescription 6
158+monitoring data; and 7
163159
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
165162
166- (b) The mission of the Program is to:
163+ [(m)] (O) “Prescription drug” has the meaning stated in § 21–201 of this title. 10
167164
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
169167
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
171170
172- (ii) The identification and investigation of unlawful prescription
173-drug diversion; and
171+ [(p)] (R) “Registered” means registered with the Program to request or access 15
172+prescription monitoring data for clinical use. 16
174173
175- (2) Promote a balanced use of prescription monitoring data to assist
176-appropriate law enforcement activities while preserving the professional practice of health
177-care providers and the access of patients to optimal pharmaceutical care.
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
178177
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
183179
184-21–2A–03.
180+ (a) There is a Prescription Drug Monitoring Program in the Department. 21
185181
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
188183
189- (b) The Secretary may:
184+ (1) Assist prescribers, pharmacists, and public health professionals in: 23
190185
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
193187
194-– 5 –
188+ (ii) The identification and investigation of unlawful prescription 25
189+drug diversion; and 26
195190
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
198194
199- (3) Identify and publish a list of monitored prescription drugs that have a
200-low potential for abuse by individuals.
201195
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.
205196
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
209201
210- (e) The Secretary, in consultation with the Maryland Health Care Commission
211-and the Board, shall:
202+21–2A–03. 5
212203
213- (1) Determine the appropriate technology to support the operation of the
214-Program; and
204+ (a) The Department shall implement the Program, subject to the availability of 6
205+funds. 7
215206
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
218208
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
222211
223- (i) The pharmacy demonstrates how it will distinguish hospice
224-inpatients from other consumers receiving medications from the pharmacy; and
212+ (2) Contract with any qualified person for the efficient and economical 11
213+operation of the Program; and 12
225214
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
229217
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
232221
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
235225
236-21–2A–04.
226+ (e) The Secretary, in consultation with the Maryland Health Care Commission 21
227+and the Board, shall: 22
237228
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
241231
242-– 6 –
243- (b) The regulations adopted by the Secretary shall:
232+ (2) Educate dispensers, prescribers, pharmacists, prescriber delegates, 25
233+pharmacist delegates, and consumers about the purpose and operation of the Program. 26
244234
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
247238
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
250242
251- (i) Without unduly increasing the workload and expense on
252-dispensers; and
253243
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
256247
257- (3) Specify that the information be submitted by dispensers once every 24
258-hours;
248+ (2) A waiver granted under this subsection may remain in effect for up to 4
249+2 years. 5
259250
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
261253
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
265255
266- (ii) May not impose any fees or other assessments on prescribers or
267-dispensers to support the operation of the Program;
256+ (a) The Secretary, in consultation with the Board, shall adopt regulations to carry 9
257+out this subtitle. 10
268258
269- (5) Identify the mechanism by which [prescription]:
259+ (b) The regulations adopted by the Secretary shall: 11
270260
271- (I) PRESCRIPTION monitoring data are disclosed to a person, in
272-accordance with § 21–2A–06 of this subtitle; AND
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
273263
274- (II) NALOXONE MEDICATION DATA ARE DISCLOSED T O A
275-PERSON, IN ACCORDANCE WITH § 21–2A–06.1 OF THIS SUBTITLE;
264+ (2) Specify the electronic or other means by which information is to be 14
265+submitted: 15
276266
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
280269
281- (7) Specify the process for the Program’s review of prescription monitoring
282-data AND NALOXONE MEDICAT ION DATA and reporting of:
270+ (ii) In a manner as compatible as possible with existing data 18
271+submission practices of dispensers; 19
283272
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
287275
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
291277
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
294281
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
296284
297- (i) Confidential or privileged patient information be kept
298-confidential; and
285+ (5) Identify the mechanism by which [prescription]: 28
299286
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
304290
305-21–2A–06.1.
306291
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
308294
309- (1) ARE CONFIDENTIAL AND PRIVILEGED, AND NOT SUBJECT TO
310-DISCOVERY, SUBPOENA, OR OTHER MEANS OF LE GAL COMPULSION IN CI VIL
311-LITIGATION;
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
312298
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
314301
315- (3) EXCEPT AS PROVIDED IN SUBSECTION (B) OF THIS SECTION OR A S
316-OTHERWISE BY LAW , MAY NOT BE DISCLOSED TO A NY PERSON.
302+ (i) Possible misuse or abuse of a monitored prescription drug under 8
303+§ 21–2A–06(c) of this subtitle; or 9
317304
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
323307
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
328310
329-21–2A–08.
311+ (9) Require that: 14
330312
331- (a) With respect to the administration and operation of the Program, the
332-Department and its agents and employees are not subject to liability arising from: Ch. 224 2022 LAWS OF MARYLAND
313+ (i) Confidential or privileged patient information be kept 15
314+confidential; and 16
333315
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
335320
336- (1) The inaccuracy of any information submitted to the Program in
337-accordance with this subtitle; or
321+21–2A–06.1. 21
338322
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
343324
344- (b) Except as provided in § 21–2A–09(b)(3) of this subtitle, a prescriber, prescriber
345-delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability
346-or disciplinary action arising solely from:
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
347328
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
350330
351- (2) Acting, or failing to act, on the basis of prescription monitoring data
352-provided by the Program.
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
353333
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
355337
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.
359338
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
364341
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
370346
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
373348
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
379351
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
383354
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.