What This Bill Does
This bill tells the Secretary of Veterans Affairs to run a study about how cannabis affects veterans with chronic pain and post-traumatic stress disorder (PTSD). If the study goes well, the Secretary must then run clinical trials (medical testing on human volunteers) to test cannabis on these same groups of veterans.
Who It Affects
Veterans enrolled in the Department of Veterans Affairs patient enrollment system who have chronic pain or PTSD. The Veterans Affairs department and its research offices. Congressional committees on veterans' affairs.
Key Provisions
The Secretary of Veterans Affairs must carry out a large-scale study looking at how cannabis use affects veterans with chronic pain and PTSD, using existing health records and interviews (Sec. 3(a)). This initial study must last 18 months and measure specific health outcomes including pain levels, medication use, alcohol use, sleep quality and mental health changes (Sec. 3(a), 3(c)). If the Secretary determines the department can safely run clinical trials, the Secretary must begin those trials not later than 180 days after reporting the study results (Sec. 4(a)). The clinical trials must test different forms of cannabis including whole plant material and extracts, with varying ratios of tetrahydrocannabinol (THC, the ingredient that causes the "high") to cannabidiol (CBD, a non-intoxicating ingredient) (Sec. 4(c)). Participation in the study or trials cannot affect a veteran's eligibility for any other VA benefits (Sec. 5(d)).
What Changes
The Department of Veterans Affairs begins a structured process to study cannabis effects on specific veteran populations. A research program is established that did not exist before.
Important Definitions
"Covered veteran" means a veteran enrolled in the VA's patient enrollment system. "Secretary" means the Secretary of Veterans Affairs.
Effective Date
The Secretary must start the study within 180 days after the bill becomes law (Sec. 3(b)).
I
118TH CONGRESS
1ST SESSION H. R. 1003
To direct the Secretary of Veterans Affairs to carry out a study and clinical
trials on the effects of cannabis on certain health outcomes of veterans
with chronic pain and post-traumatic stress disorder, and for other pur-
poses.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 14, 2023
Mr. CORREA (for himself and Mr. BERGMAN) introduced the following bill;
which was referred to the Committee on Veterans’ Affairs
A BILL
To direct the Secretary of Veterans Affairs to carry out
a study and clinical trials on the effects of cannabis
on certain health outcomes of veterans with chronic pain
and post-traumatic stress disorder, and for other pur-
poses.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘VA Medicinal Cannabis
4
Research Act of 2023’’.
5
SEC. 2. DEFINITIONS.
6
In this Act:
7
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(1) COVERED
VETERAN.—The term ‘‘covered
1
veteran’’ means a veteran who is enrolled in the pa-
2
tient enrollment system of the Department of Vet-
3
erans Affairs established and operated under section
4
1705(a) of title 38, United States Code.
5
(2) SECRETARY.— The term ‘‘Secretary’’
6
means the Secretary of Veterans Affairs.
7
SEC. 3. DEPARTMENT OF VETERANS AFFAIRS LARGE-
8
SCALE, MIXED METHODS, RETROSPECTIVE
9
QUALITATIVE STUDY ON THE EFFECTS OF
10
CANNABIS ON CERTAIN HEALTH OUTCOMES
11
OF VETERANS WITH CHRONIC PAIN AND
12
POST-TRAUMATIC STRESS DISORDER.
13
(a) STUDY REQUIRED.—
14
(1) IN GENERAL.—The Secretary, through the
15
Office of Research and Development of the Depart-
16
ment of Veterans Affairs, shall carry out a large-
17
scale, mixed methods, retrospective, and qualitative
18
study on the effects of cannabis on the health out-
19
comes of covered veterans diagnosed with chronic
20
pain and covered veterans diagnosed with post-trau-
21
matic stress disorder.
22
(2) OBSERVATIONAL
STUDY.—The study re-
23
quired by paragraph (1) shall be conducted as an
24
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observational study on the effects of cannabis use on
1
the health of covered veterans.
2
(3) ELEMENTS.—
3
(A) IN GENERAL.—The study required by
4
paragraph (1) shall—
5
(i) triangulate a range of data
6
sources;
7
(ii) compare the positive and negative
8
health outcomes of covered veterans who
9
use cannabis, utilizing outcomes that can
10
be measured in an electronic health record
11
of the Department and through data sets
12
of the Department relating to claims for
13
benefits under the laws administered by
14
the Secretary;
15
(iii) elicit the positive and negative
16
outcomes of cannabis use for covered vet-
17
erans through semi-structured interviews;
18
(iv) estimate current and future
19
health system needs to address positive
20
and negative outcomes of cannabis use for
21
covered veterans;
22
(v) include a qualitative, open-ended
23
survey provided to covered veterans who
24
have sought care from the Department for
25
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chronic pain or post-traumatic stress dis-
1
order during the five-year period preceding
2
the survey; and
3
(vi) include an assessment of—
4
(I) all records within the Vet-
5
erans Health Administration for cov-
6
ered veterans participating in the
7
study; and
8
(II) all records within the Vet-
9
erans Benefits Administration for cov-
10
ered veterans participating in the
11
study.
12
(B) HEALTH
OUTCOMES.—A comparison
13
of health outcomes under subparagraph (A)(ii)
14
shall include an assessment of the following:
15
(i) The reduction or increase in opiate
16
use or dosage.
17
(ii) The reduction or increase in
18
benzodiazepine use or dosage.
19
(iii) The reduction or change in use of
20
other types of medication.
21
(iv) The reduction or increase in alco-
22
hol use.
23
(v) The reduction or increase in the
24
prevalence of substance abuse disorders.
25
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(vi) Sleep quality.
1
(vii) Osteopathic pain (including pain
2
intensity and pain-related outcomes).
3
(viii) Agitation.
4
(ix) Quality of life.
5
(x) Mortality and morbidity.
6
(xi) Hospital readmissions.
7
(xii) Any newly developed or exacer-
8
bated health conditions, including mental
9
health conditions.
10
(b) IMPLEMENTATION.—Not later than 180 days
11
after the date of the enactment of this Act, the Secretary
12
shall commence the implementation of the study required
13
by subsection (a)(1).
14
(c) DURATION OF STUDY.—The study required by
15
subsection (a)(1) shall be carried out for an 18-month pe-
16
riod.
17
(d) REPORT.—
18
(1) IN GENERAL.—Not later than 90 days after
19
the completion of the study required by subsection
20
(a)(1), the Secretary shall submit to the Committee
21
on Veterans’ Affairs of the Senate and the Com-
22
mittee on Veterans’ Affairs of the House of Rep-
23
resentatives a report on the study.
24
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(2) ABILITY TO CONDUCT CLINICAL TRIALS.—
1
The Secretary shall include in the report required by
2
paragraph (1) an assessment of whether the Sec-
3
retary is able to meet the criteria necessary to con-
4
duct the clinical trials required under section 4, in-
5
cluding consideration of subsection (e)(1) of such
6
section.
7
SEC. 4. DEPARTMENT OF VETERANS AFFAIRS CLINICAL
8
TRIALS ON THE EFFECTS OF CANNABIS ON
9
CERTAIN HEALTH OUTCOMES OF VETERANS
10
WITH CHRONIC PAIN AND POST-TRAUMATIC
11
STRESS DISORDER.
12
(a) CLINICAL TRIALS REQUIRED.—
13
(1) IN GENERAL.—If the Secretary indicates in
14
the report required by section 3(d) that the Sec-
15
retary is able to meet the criteria necessary to pro-
16
ceed to clinical trials, commencing not later than
17
180 days after the submittal of that report, the Sec-
18
retary shall carry out a series of clinical trials on the
19
effects of cannabis appropriate for investigational
20
use, as determined by the Food and Drug Adminis-
21
tration under section 505(i) of the Federal Food,
22
Drug, and Cosmetic Act (21 U.S.C. 355(i)), on the
23
health outcomes of covered veterans diagnosed with
24
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chronic pain and covered veterans diagnosed with
1
post-traumatic stress disorder.
2
(2) CONSIDERATIONS.—The clinical trials re-
3
quired by paragraph (1) shall include, as appro-
4
priate, an evaluation of key symptoms, clinical out-
5
comes, and conditions associated with chronic pain
6
and post-traumatic stress disorder, which may in-
7
clude—
8
(A) with respect to covered veterans diag-
9
nosed with chronic pain, an evaluation of the
10
effects of the use of cannabis on—
11
(i) osteopathic pain (including pain in-
12
tensity and pain-related outcomes);
13
(ii) the reduction or increase in opioid
14
use or dosage;
15
(iii) the reduction or increase in
16
benzodiazepine use or dosage;
17
(iv) the reduction or increase in alco-
18
hol use;
19
(v) the reduction or increase in the
20
prevalence of substance use disorders;
21
(vi) inflammation;
22
(vii) sleep quality;
23
(viii) agitation;
24
(ix) quality of life;
25
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(x) exacerbated or new mental health
1
conditions; and
2
(xi) suicidal ideation.
3
(B) with respect to covered veterans diag-
4
nosed with post-traumatic stress disorder, an
5
evaluation of the effects of the use of cannabis
6
on—
7
(i) the symptoms of post-traumatic
8
stress disorder (PTSD) as established by
9
or derived from the clinician administered
10
PTSD scale, the PTSD checklist, the
11
PTSD symptom scale, the post-traumatic
12
diagnostic scale, and other applicable
13
methods of evaluating symptoms of post-
14
traumatic stress disorder;
15
(ii) the reduction or increase in
16
benzodiazepine use or dosage;
17
(iii) the reduction or increase in alco-
18
hol use;
19
(iv) the reduction or increase in the
20
prevalence of substance use disorders;
21
(v) mood;
22
(vi) anxiety;
23
(vii) social functioning;
24
(viii) agitation;
25
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(ix) suicidal ideation; and
1
(x) sleep quality, including frequency
2
of nightmares and night terrors.
3
(3) OPTIONAL ELEMENTS.—The clinical trials
4
required by paragraph (1) may include, as appro-
5
priate, an evaluation of the effects of the use of can-
6
nabis to treat chronic pain and post-traumatic stress
7
disorder on other symptoms, clinical outcomes, and
8
conditions not covered by paragraph (2), which may
9
include—
10
(A) pulmonary function;
11
(B) cardiovascular events;
12
(C) head, neck, and oral cancer;
13
(D) testicular cancer;
14
(E) ovarian cancer;
15
(F) transitional cell cancer;
16
(G) intestinal inflammation;
17
(H) motor vehicle accidents; or
18
(I) spasticity.
19
(b) LONG-TERM OBSERVATIONAL STUDY.—The Sec-
20
retary may carry out a long-term observational study of
21
the participants in the clinical trials required by sub-
22
section (a).
23
(c) TYPE OF CANNABIS.—
24
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(1) IN GENERAL.—In carrying out the clinical
1
trials required by subsection (a), the Secretary shall
2
study varying forms of cannabis, including whole
3
plant raw material and extracts, and may study
4
varying routes of administration.
5
(2) PLANT CULTIVARS.—Of the varying forms
6
of cannabis required under paragraph (1), the Sec-
7
retary shall study plant cultivars with varying ratios
8
of tetrahydrocannabinol to cannabidiol.
9
(d) IMPLEMENTATION.—Not later than 18 months
10
after the date of the enactment of this Act, the Secretary
11
shall—
12
(1) develop a plan to implement this section
13
and submit such plan to the Committee on Veterans’
14
Affairs of the Senate and the Committee on Vet-
15
erans’ Affairs of the House of Representatives; and
16
(2) issue any requests for proposals the Sec-
17
retary determines appropriate for such implementa-
18
tion.
19
(e) TERMINATION OF CLINICAL TRIALS.—
20
(1) CLINICAL
GUIDELINE
REQUIREMENTS
OR
21
EXCESSIVE RISK.—The Secretary may terminate the
22
clinical trials required by subsection (a) if the Sec-
23
retary determines that the Department of Veterans
24
Affairs is unable to meet clinical guideline require-
25
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ments necessary to conduct such trials or the clinical
1
trials would create excessive risk to participants.
2
(2) COMPLETION UPON SUBMITTAL OF FINAL
3
REPORT.—The Secretary may terminate the clinical
4
trials required by subsection (a) upon submittal of
5
the final report required under subsection (f)(2).
6
(f) REPORTS.—
7
(1) PERIODIC REPORTS.—During the five-year
8
period beginning on the date of the commencement
9
of clinical trials required by subsection (a), the Sec-
10
retary shall submit periodically, but not less fre-
11
quently than annually, to the Committee on Vet-
12
erans’ Affairs of the Senate and the Committee on
13
Veterans’ Affairs of the House of Representatives
14
reports on the implementation of this section.
15
(2) FINAL REPORT.—Not later than one year
16
after the completion of the five-year period specified
17
in paragraph (1), the Secretary shall submit to the
18
Committee on Veterans’ Affairs of the Senate and
19
the Committee on Veterans’ Affairs of the House of
20
Representatives a final report on the implementation
21
of this section.
22
SEC. 5. ADMINISTRATION OF STUDY AND CLINICAL TRIALS.
23
(a) DEMOGRAPHIC REPRESENTATION.—In carrying
24
out the study required by section 3 and the clinical trials
25
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required by section 4, the Secretary shall ensure represen-
1
tation in such study and trials of demographics that rep-
2
resent the population of veterans in the United States, as
3
determined by the most recently available data from the
4
American Community Survey of the Bureau of the Census.
5
(b) DATA PRESERVATION.—The Secretary shall en-
6
sure that the study required by section 3 and the clinical
7
trials required by section 4 include a mechanism to en-
8
sure—
9
(1) the preservation of all data, including all
10
data sets and survey results, collected or used for
11
purposes of such study and trials in a manner that
12
will facilitate further research; and
13
(2) registration of such data in the database of
14
privately and publicly funded clinical studies main-
15
tained by the National Library of Medicine (or suc-
16
cessor database).
17
(c) ANONYMOUS DATA.—The Secretary shall ensure
18
that data relating to any study or clinical trial conducted
19
under this Act is anonymized and cannot be traced back
20
to an individual patient.
21
(d) EFFECT ON OTHER BENEFITS.—The eligibility
22
or entitlement of a covered veteran to any other benefit
23
under the laws administered by the Secretary or any other
24
provision of law shall not be affected by the participation
25
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of the covered veteran in the study under section 3, a clin-
1
ical trial under section 4(a), or a study under section 4(b).
2
(e) EFFECT ON OTHER LAWS.—Nothing in this Act
3
shall affect or modify—
4
(1) the Federal Food, Drug, and Cosmetic Act
5
(21 U.S.C. 301 et seq.);
6
(2) section 351 of the Public Health Service
7
Act (42 U.S.C. 262); or
8
(3) the authority of the Commissioner of Food
9
and Drugs and the Secretary of Health
[Text truncated for display. Full text available on Congress.gov.]