HLS 19RS-348 REENGROSSED
2019 Regular Session
HOUSE BILL NO. 169
BY REPRESENTATIVE HOFFMANN
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
HEALTH CARE: Authorizes a data system for collection of information on health effects
and outcomes associated with medical marijuana
1 AN ACT
2To amend and reenact R.S. 44:4.1(B)(26) and to enact R.S. 40:1046(A)(6), Subpart D of
3 Part III of Subchapter A of Chapter 5-D of Title 40 of the Louisiana Revised Statutes
4 of 1950, to be comprised of R.S. 40:1168.1 through 1168.6, and R.S. 40:1046(A)(6)
5 of Section 2 of Act No. 96 of the 2016 Regular Session of the Legislature of
6 Louisiana, relative to information concerning health effects, events, and outcomes
7 associated with patient use of medical marijuana; to authorize the Louisiana State
8 Board of Medical Examiners to establish and maintain an electronic data system for
9 the collection of such information; to require that the board collaborate with certain
10 institutions in the design of the data system; to provide specifications for components
11 of the data system; to provide for reporting of data into the system; to restrict
12 disclosure and uses of data from the system; to provide for a public records
13 exception; to provide legislative findings and definitions; to authorize administrative
14 rulemaking; and to provide for related matters.
15Be it enacted by the Legislature of Louisiana:
16 Section 1. R.S. 40:1046(A)(6) and Subpart D of Part III of Subchapter A of Chapter
175-D of Title 40 of the Louisiana Revised Statutes of 1950, comprised of R.S. 40:1168.1
18through 1168.6, are hereby enacted to read as follows:
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1 §1046. Recommendation of marijuana for therapeutic use; rules and regulations;
2 Louisiana Board of Pharmacy and the adoption of rules and regulations
3 relating to the dispensing of recommended marijuana for therapeutic use; the
4 Department of Agriculture and Forestry and the licensure of a production
5 facility
6 A.
7 * * *
8 (6) Physicians shall report adverse events and health outcomes associated
9 with a patient's use of medical marijuana to the data system provided for in R.S.
10 40:1168.1 et seq.
11 * * *
12 SUBPART D. MEDICAL MARIJUANA:
13 HEALTH INFORMATION DATA SYSTEM
14 §1168.1. Findings and purpose
15 A. The legislature hereby finds and declares that, while specific definitions
16 of the term vary, "evidence-based medicine" refers to the practice of medicine based
17 upon evidence derived from research and in a manner in which the physician bases
18 clinical decisions upon such evidence.
19 B. The purpose of this Subpart is to promote the practice of evidence-based
20 medicine in Louisiana through the creation of a system which facilitates the
21 collection and analysis of information on health effects, events, and outcomes
22 associated with the use of medical marijuana by patients in this state.
23 §1168.2. Definitions
24 For purposes of this Subpart, the following terms have the meaning ascribed
25 to them in this Section:
26 (1) "Adverse event" means any incident relating to the use of a drug
27 prescribed or recommended to a patient that may result in serious harm or injury to
28 the patient or in the patient's death.
29 (2) "Board" means the Louisiana State Board of Medical Examiners.
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1 (3) "Data system" means the system authorized and provided for in R.S.
2 40:1168.3.
3 (4) "Medical marijuana" means the therapeutic substance produced under the
4 authority of and in accordance with R.S. 40:1046.
5 (5) "Physician" has the meaning ascribed in R.S. 37:1262.
6 §1168.3. Data system; components; reporting; design in collaboration with medical
7 schools; public records exception
8 A. The board may create and maintain an electronic system for the collection
9 and analysis of clinical information associated with the use of medical marijuana by
10 patients. The system shall include, at minimum, the following components:
11 (1)(a) A component for the collection of data concerning adverse events
12 experienced by patients which are associated with the use of medical marijuana.
13 (b) The board shall design and administer the data system such that any of
14 the following persons may report an adverse event:
15 (i) The patient.
16 (ii) A family member of the patient.
17 (iii) A physician who prescribes or recommends medical marijuana to a
18 patient.
19 (iv) Any physician who treats a patient other than a physician who prescribes
20 or recommends medical marijuana to the patient.
21 (2)(a) A component for the collection of data concerning health outcomes
22 other than adverse events experienced by patients that are associated with the use of
23 medical marijuana.
24 (b) The board shall design and administer the data system such that reporting
25 of health outcomes is limited to physicians exclusively.
26 B. The board shall collaborate with the following institutions in designing
27 and implementing the data system:
28 (1) The medical school of the Louisiana State University Health Sciences
29 Center at New Orleans.
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1 (2) The medical school of the Louisiana State University Health Sciences
2 Center at Shreveport.
3 (3) The Tulane University School of Medicine.
4 (4) The Pennington Biomedical Research Center.
5 (5) The College of Nursing and Allied Health at Southern University and
6 Agricultural and Mechanical College.
7 C. Except in cases of disclosure of data authorized by R.S. 40:1168.4(B), all
8 data in the data system shall be confidential and shall not be available for subpoena,
9 nor shall such information be disclosed, discoverable, or compelled to be produced
10 in any civil, criminal, administrative, or other proceeding. The data maintained in
11 the data system shall not be subject to any public records request nor shall any such
12 data be considered as a public record pursuant to R.S. 44:1 et seq.
13 §1168.4. Protection of health information; limitations on data use
14 A. The board shall maintain the data system in a secure environment which
15 complies, at minimum, with all applicable federal laws and regulations providing for
16 the protection of health information.
17 B.(1) The board may authorize and facilitate access to data in the system to
18 an outside party only if that party seeks the data for use in a bona fide medical
19 research effort which has been authorized by the institutional review board of the
20 organization conducting the research.
21 (2) The board shall have exclusive authority to determine whether an activity
22 qualifies as a bona fide medical research effort in accordance with Paragraph (1) of
23 this Subsection.
24 (3) Any disclosure of data in the system shall be subject to the approval of
25 the board.
26 §1168.5. Funding sources authorized for data system
27 The board is hereby authorized to receive and expend all funds as may be
28 necessary to implement and maintain the data system. Such funds may include,
29 without limitation, funds appropriated by the legislature, including any appropriation
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1 of federal funds; funding provided by contract or other agreement with a
2 governmental entity; and any public or private donations, gifts, or grants from
3 governmental sources, individuals, corporations, nonprofit organizations, or other
4 business entities.
5 §1168.6. Rulemaking
6 The board shall promulgate all such rules in accordance with the
7 Administrative Procedure Act as are necessary to implement the provisions of this
8 Subpart.
9 Section 2. R.S. 44:4.1(B)(26) is hereby amended and reenacted to read as follows:
10 §4.1. Exceptions
11 * * *
12 B. The legislature further recognizes that there exist exceptions, exemptions,
13 and limitations to the laws pertaining to public records throughout the revised
14 statutes and codes of this state. Therefore, the following exceptions, exemptions, and
15 limitations are hereby continued in effect by incorporation into this Chapter by
16 citation:
17 * * *
18 (26) R.S. 40:3.1, 31.14, 31.27, 39.1, 41, 73, 95, 96, 526, 528, 1007, 1061.21,
19 1079.18, 1081.10, 1105.6, 1105.8, 1133.8, 1168.3, 1171.4, 1203.4, 1231.4,
20 1379.1.1(D), 1379.3, 2009.8, 2009.14, 2010.5, 2017.9, 2018, 2018.5, 2019, 2020,
21 2106, 2138, 2532, 2845.1
22 * * *
23 Section 3. R.S. 40:1046(A)(6) of Section 2 of Act No. 96 of the 2016 Regular
24Session of the Legislature of Louisiana is hereby enacted to read as follows:
25 Section 2. R.S. 40:1046 is hereby amended and reenacted to read as follows:
26 §1046. Prescription of marijuana for therapeutic use; rules and regulations;
27 Louisiana Board of Pharmacy and the adoption of rules and
28 regulations relating to the dispensing of prescribed marijuana for
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1 therapeutic use; the Department of Agriculture and Forestry and the
2 licensure of a production facility
3 A.
4 * * *
5 (6) Physicians shall report adverse events and health outcomes
6 associated with a patient's use of medical marijuana to the data system
7 provided for in R.S. 40:1168.1 et seq.
8 * * *
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 169 Reengrossed 2019 Regular Session Hoffmann
Abstract: Authorizes the La. State Board of Medical Examiners to create and maintain a
data system for collection of information on health effects and outcomes associated
with medical marijuana.
Present law authorizes physicians who are domiciled in La. and licensed by and in good
standing with the La. State Board of Medical Examiners, referred to hereafter as the "board",
to recommend medical marijuana for therapeutic use by patients clinically diagnosed as
suffering from a debilitating medical condition. Authorizes physicians to prescribe, rather
than recommend, medical marijuana for treatment of a patient's debilitating medical
condition if and when the U.S. Drug Enforcement Administration reclassifies marijuana
from a Schedule I drug to a Schedule II drug. Defines "debilitating medical condition" to
mean cancer, glaucoma, Parkinson's disease, positive status for human immunodeficiency
virus, acquired immune deficiency syndrome, cachexia or wasting syndrome, seizure
disorders, epilepsy, spasticity, severe muscle spasms, intractable pain, Crohn's disease,
muscular dystrophy, multiple sclerosis, post traumatic stress disorder, and certain conditions
associated with autism spectrum disorder.
Proposed law retains present law and requires that La.-licensed physicians report adverse
events and health outcomes associated with a patient's use of medical marijuana to the data
system provided for in proposed law. Defines "adverse event" as any incident relating to the
use of a drug prescribed or recommended to a patient that may result in serious harm or
injury to the patient or in the patient's death.
Proposed law provides that its purpose is to promote the practice of evidence-based medicine
in La. through the creation of a system which facilitates the collection and analysis of
information on health effects, events, and outcomes associated with the use of medical
marijuana by patients in this state.
Proposed law authorizes the board to create and maintain an electronic system for the
collection and analysis of clinical information associated with the use of medical marijuana
by patients. Requires that the system include, at minimum, the following components:
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HB NO. 169
(1)A component for the collection of data concerning adverse events experienced by
patients which are associated with the use of medical marijuana. Requires the board
to design and administer the data system such that any of the following persons may
report an adverse event:
(a)The patient.
(b)A family member of the patient.
(c)A physician who prescribes or recommends medical marijuana to a patient.
(d)Any physician who treats a patient other than a physician who prescribes or
recommends medical marijuana to the patient.
(2)A component for the collection of data concerning health outcomes other than
adverse events experienced by patients that are associated with the use of medical
marijuana. Requires the board to design and administer the data system such that
reporting of health outcomes is limited to physicians exclusively.
Proposed law requires the board to collaborate with the following institutions in designing
and implementing the data system:
(1)The medical school of the Louisiana State University Health Sciences Center at New
Orleans.
(2)The medical school of the Louisiana State University Health Sciences Center at
Shreveport.
(3)The Tulane University School of Medicine.
(4)The Pennington Biomedical Research Center.
(5)The College of Nursing and Allied Health at Southern University and A&M College.
Proposed law requires the board to maintain the data system in a secure environment which
complies, at minimum, with all applicable federal laws and regulations providing for the
protection of health information.
Proposed law provides that the board may authorize and facilitate access to data in the
system to an outside party only if that party seeks the data for use in a bona fide medical
research effort which has been authorized by the institutional review board of the
organization conducting the research. Stipulates that the board shall have exclusive
authority to determine whether an activity qualifies as a bona fide medical research effort
in accordance with proposed law, and that any disclosure of data in the system shall be
subject to the approval of the board.
Proposed law provides that except for any disclosure of data specifically authorized by
proposed law, all data in the data system shall be confidential and shall not be available for
subpoena, nor shall such information be disclosed, discoverable, or compelled to be
produced in any civil, criminal, administrative, or other proceeding. Stipulates that the data
maintained in the data system shall not be subject to any public records request nor shall any
such data be considered as a public record pursuant to present law relative to public records,
R.S. 44:1 et seq.
Proposed law authorizes the board to receive and expend all funds as may be necessary to
implement and maintain the data system. Provides that such funds may include, without
limitation, funds appropriated by the legislature, including any appropriation of federal
funds; funding provided by contract or other agreement with a governmental entity; and any
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HB NO. 169
public or private donations, gifts, or grants from governmental sources, individuals,
corporations, nonprofit organizations, or other business entities.
Proposed law requires the board to promulgate administrative rules as necessary to
implement proposed law.
(Amends R.S. 44:4.1(B)(26); Adds R.S. 40:1046(A)(6) and 1168.1-1168.6 and R.S.
40:1046(A)(6) of §2 of Act No. 96 of the 2016 R.S.)
Summary of Amendments Adopted by House
The House Floor Amendments to the engrossed bill:
1. Add the Pennington Biomedical Research Center and the Southern University
College of Nursing and Allied Health as institutions with which the La. State
Board of Medical Examiners shall collaborate in designing and implementing the
data system provided for in proposed law.
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