I
106TH CONGRESS
2D SESSION
H. R. 5544
To amend the Controlled Substances Act to promote pain management and
palliative care without permitting assisted suicide and euthanasia, and
for other purposes.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 25, 2000
Mr. HYDE introduced the following bill; which was referred to the Committee
on Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned
A BILL
To amend the Controlled Substances Act to promote pain
management and palliative care without permitting as-
sisted suicide and euthanasia, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pain Relief Promotion
Act of 2000’’.
SEC. 2. FINDINGS.
Congress finds that—
HR 5544 IH
(1) in the first decade of the new millennium
there should be a new emphasis on pain manage-
ment and palliative care;
(2) the use of certain narcotics and other drugs
or substances with a potential for abuse is strictly
regulated under the Controlled Substances Act;
(3) the dispensing and distribution of certain
controlled substances by properly registered practi-
tioners for legitimate medical purposes are permitted
under the Controlled Substances Act and imple-
menting regulations;
(4) the dispensing or distribution of certain
controlled substances for the purpose of relieving
pain and discomfort even if it increases the risk of
death is a legitimate medical purpose and is permis-
sible under the Controlled Substances Act;
(5) inadequate treatment of pain, especially for
chronic diseases and conditions, irreversible diseases
such as cancer, and end-of-life care, is a serious pub-
lic health problem affecting hundreds of thousands
of patients every year; physicians should not hesitate
to dispense or distribute controlled substances when
medically indicated for these conditions; and
(6) for the reasons set forth in section 101 of
the Controlled Substances Act (21 U.S.C. 801), the
HR 5544 IH
dispensing and distribution of controlled substances
for any purpose affect interstate commerce.
TITLE I—PROMOTING PAIN MAN-
AGEMENT 
AND 
PALLIATIVE
CARE
SEC. 101. ACTIVITIES OF AGENCY FOR HEALTH CARE RE-
SEARCH AND QUALITY.
Part A of title IX of the Public Health Service Act
(42 U.S.C. 299 et seq.) is amended by adding at the end
the following:
‘‘SEC. 903. PROGRAM FOR PAIN MANAGEMENT AND PALLIA-
TIVE CARE RESEARCH AND QUALITY.
‘‘(a) IN GENERAL.—Subject to subsections (e) and
(f) of section 902, the Director shall carry out a program
to accomplish the following:
‘‘(1) Promote and advance scientific under-
standing of pain management and palliative care.
‘‘(2) Collect and disseminate protocols and evi-
dence-based practices regarding pain management
and palliative care, with priority given to pain man-
agement for terminally ill patients, and make such
information available to public and private health
care programs and providers, health professions
schools, and hospices, and to the general public.
HR 5544 IH
‘‘(b) DEFINITION.—In this section, the term ‘pain
management and palliative care’ means—
‘‘(1) the active, total care of patients whose dis-
ease or medical condition is not responsive to cura-
tive treatment or whose prognosis is limited due to
progressive, far-advanced disease; and
‘‘(2) the evaluation, diagnosis, treatment, and
management of primary and secondary pain, wheth-
er acute, chronic, persistent, intractable, or associ-
ated with the end of life;
the purpose of which is to diagnose and alleviate pain and
other distressing signs and symptoms and to enhance the
quality of life, not to hasten or postpone death.’’.
SEC. 102. ACTIVITIES OF HEALTH RESOURCES AND SERV-
ICES ADMINISTRATION.
(a) IN GENERAL.—Part D of title VII of the Public
Health Service Act (42 U.S.C. 294 et seq.) is amended—
(1) by redesignating sections 754 through 757
as sections 755 through 758, respectively; and
(2) by inserting after section 753 the following:
‘‘SEC. 754. PROGRAM FOR EDUCATION AND TRAINING IN
PAIN MANAGEMENT AND PALLIATIVE CARE.
‘‘(a) IN GENERAL.—The Secretary, in consultation
with the Director of the Agency for Healthcare Research
and Quality, may award grants, cooperative agreements,
HR 5544 IH
and contracts to health professions schools, hospices, and
other public and private entities for the development and
implementation of programs to provide education and
training to health care professionals in pain management
and palliative care.
‘‘(b) PRIORITY.—In making awards under subsection
(a), the Secretary shall give priority to awards for the im-
plementation of programs under such subsection.
‘‘(c) CERTAIN TOPICS.—An award may be made
under subsection (a) only if the applicant for the award
agrees that the program to be carried out with the award
will include information and education on—
‘‘(1) means for diagnosing and alleviating pain
and other distressing signs and symptoms of pa-
tients, especially terminally ill patients, including the
medically appropriate use of controlled substances;
‘‘(2) applicable laws on controlled substances,
including laws permitting health care professionals
to dispense or administer controlled substances as
needed to relieve pain even in cases where such ef-
forts may unintentionally increase the risk of death;
and
‘‘(3) recent findings, developments, and im-
provements in the provision of pain management
and palliative care.
HR 5544 IH
‘‘(d) PROGRAM
SITES.—Education and training
under subsection (a) may be provided at or through health
professions schools, residency training programs and other
graduate programs in the health professions, entities that
provide continuing medical education, hospices, and such
other programs or sites as the Secretary determines to be
appropriate.
‘‘(e) EVALUATION
OF PROGRAMS.—The Secretary
shall (directly or through grants or contracts) provide for
the evaluation of programs implemented under subsection
(a) in order to determine the effect of such programs on
knowledge and practice regarding pain management and
palliative care.
‘‘(f) PEER REVIEW GROUPS.—In carrying out section
799(f) with respect to this section, the Secretary shall en-
sure that the membership of each peer review group in-
volved includes individuals with expertise and experience
in pain management and palliative care for the population
of patients whose needs are to be served by the program.
‘‘(g) DEFINITION.—In this section, the term ‘pain
management and palliative care’ means—
‘‘(1) the active, total care of patients whose dis-
ease or medical condition is not responsive to cura-
tive treatment or whose prognosis is limited due to
progressive, far-advanced disease; and
HR 5544 IH
‘‘(2) the evaluation, diagnosis, treatment, and
management of primary and secondary pain, wheth-
er acute, chronic, persistent, intractable, or associ-
ated with the end of life;
the purpose of which is to diagnose and alleviate pain and
other distressing signs and symptoms and to enhance the
quality of life, not to hasten or postpone death.’’.
(b) AUTHORIZATION OF APPROPRIATIONS; ALLOCA-
TION.—
(1) IN GENERAL.—Section 758 of the Public
Health Service Act (as redesignated by subsection
(a)(1) of this section) is amended, in subsection
(b)(1)(C), by striking ‘‘sections 753, 754, and 755’’
and inserting ‘‘sections 753, 754, 755, and 756’’.
(2) AMOUNT.—With respect to section 758 of
the Public Health Service Act (as redesignated by
subsection (a)(1) of this section), the dollar amount
specified in subsection (b)(1)(C) of such section is
deemed to be increased by $5,000,000.
SEC. 103. EFFECTIVE DATE.
The amendments made by this title shall take effect
on the date of enactment of this Act.
HR 5544 IH
TITLE II—USE OF CONTROLLED
SUBSTANCES 
CONSISTENT
WITH THE CONTROLLED SUB-
STANCES ACT
SEC. 201. REINFORCING EXISTING STANDARD FOR LEGITI-
MATE USE OF CONTROLLED SUBSTANCES.
(a) IN GENERAL.—Section 303 of the Controlled
Substances Act (21 U.S.C. 823) is amended by adding at
the end the following:
‘‘(i)(1) For purposes of this Act and any regulations
to implement this Act, alleviating pain or discomfort in
the usual course of professional practice is a legitimate
medical purpose for the dispensing, distributing, or admin-
istering of a controlled substance that is consistent with
public health and safety, even if the use of such a sub-
stance may increase the risk of death. Nothing in this sec-
tion authorizes intentionally dispensing, distributing, or
administering a controlled substance for the purpose of
causing death or assisting another person in causing
death.
‘‘(2)(A) Notwithstanding any other provision of this
Act, in determining whether a registration is consistent
with the public interest under this Act, the Attorney Gen-
eral shall give no force and effect to State law authorizing
or permitting assisted suicide or euthanasia.
HR 5544 IH
‘‘(B) Paragraph (2) applies only to conduct occurring
after the date of enactment of this subsection.
‘‘(3) Nothing in this subsection shall be construed to
alter the roles of the Federal and State governments in
regulating the practice of medicine. Regardless of whether
the Attorney General determines pursuant to this section
that the registration of a practitioner is inconsistent with
the public interest, it remains solely within the discretion
of State authorities to determine whether action should
be taken with respect to the State professional license of
the practitioner or State prescribing privileges.
‘‘(4) Nothing in the Pain Relief Promotion Act of
2000 (including the amendments made by such Act) shall
be construed—
‘‘(A) to modify the Federal requirements that a
controlled substance be dispensed only for a legiti-
mate medical purpose pursuant to paragraph (1); or
‘‘(B) to provide the Attorney General with the
authority to issue national standards for pain man-
agement and palliative care clinical practice, re-
search, or quality;
except that the Attorney General may take such other ac-
tions as may be necessary to enforce this Act.’’.
(b) PAIN RELIEF.—Section 304(c) of the Controlled
Substances Act (21 U.S.C. 824(c)) is amended—
HR 5544 IH
(1) by striking ‘‘(c) Before’’ and inserting the
following:
‘‘(c) PROCEDURES.—
‘‘(1) ORDER TO SHOW CAUSE.—Before’’; and
(2) by adding at the end the following:
‘‘(2) BURDEN OF PROOF.—At any proceeding
under paragraph (1), where the order to show cause
is based on the alleged intentions of the applicant or
registrant to cause or assist in causing death, and
the practitioner claims a defense under paragraph
(1) of section 303(i), the Attorney General shall
have the burden of proving, by clear and convincing
evidence, that the practitioner’s intent was to dis-
pense, distribute, or administer a controlled sub-
stance for the purpose of causing death or assisting
another person in causing death. In meeting such
burden, it shall not be sufficient to prove that the
applicant or registrant knew that the use of con-
trolled substance may increase the risk of death.’’.
SEC. 202. EDUCATION AND TRAINING PROGRAMS.
Section 502(a) of the Controlled Substances Act (21
U.S.C. 872(a)) is amended—
(1) by striking ‘‘and’’ at the end of paragraph
(5);
HR 5544 IH
(2) by striking the period at the end of para-
graph (6) and inserting ‘‘; and’’; and
(3) by adding at the end the following:
‘‘(7) educational and training programs for
Federal, State, and local personnel, incorporating
recommendations, subject to the provisions of sub-
sections (e) and (f) of section 902 of the Public
Health Service Act, by the Secretary of Health and
Human Services, on the means by which investiga-
tion and enforcement actions by law enforcement
personnel may better accommodate the necessary
and legitimate use of controlled substances in pain
management and palliative care.
Nothing in this subsection shall be construed to alter the
roles of the Federal and State governments in regulating
the practice of medicine.’’.
SEC. 203. FUNDING AUTHORITY.
Notwithstanding any other provision of law, the oper-
ation of the diversion control fee account program of the
Drug Enforcement Administration shall be construed to
include carrying out section 303(i) of the Controlled Sub-
stances Act (21 U.S.C. 823(i)), as added by this Act, and
subsections (a)(4) and (c)(2) of section 304 of the Con-
trolled Substances Act (21 U.S.C. 824), as amended by
this Act.
HR 5544 IH
SEC. 204. EFFECTIVE DATE.
The amendments made by this title shall take effect
on the date of enactment of this Act.
Æ