[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2260 Reported in Senate (RS)]

                                                       Calendar No. 566
106th CONGRESS
  2d Session
                                H. R. 2260

                          [Report No. 106-299]


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 28, 1999

                                Received

                           November 19, 1999

       Read twice and referred to the Committee on the Judiciary

                              May 23, 2000

                Reported by Mr. Hatch, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 AN ACT


 
 To amend the Controlled Substances Act to promote pain management and 
palliative care without permitting assisted suicide and euthanasia, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Pain Relief Promotion Act 
of 1999''.</DELETED>

  <DELETED>TITLE I--USE OF CONTROLLED SUBSTANCES CONSISTENT WITH THE 
                  CONTROLLED SUBSTANCES ACT</DELETED>

<DELETED>SEC. 101. REINFORCING EXISTING STANDARD FOR LEGITIMATE USE OF 
              CONTROLLED SUBSTANCES.</DELETED>

<DELETED>    Section 303 of the Controlled Substances Act (21 U.S.C. 
823) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(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 administering of a controlled substance 
that is consistent with public health and safety, even if the use of 
such a substance may increase the risk of death. Nothing in this 
section authorizes intentionally dispensing, distributing, or 
administering a controlled substance for the purpose of causing death 
or assisting another person in causing death.</DELETED>
<DELETED>    ``(2) Notwithstanding any other provision of this Act, in 
determining whether a registration is consistent with the public 
interest under this Act, the Attorney General shall give no force and 
effect to State law authorizing or permitting assisted suicide or 
euthanasia.</DELETED>
<DELETED>    ``(3) Paragraph (2) applies only to conduct occurring 
after the date of the enactment of this subsection.''.</DELETED>

<DELETED>SEC. 102. EDUCATION AND TRAINING PROGRAMS.</DELETED>

<DELETED>    Section 502(a) of the Controlled Substances Act (21 U.S.C. 
872(a)) is amended--</DELETED>
        <DELETED>    (1) by striking ``and'' at the end of paragraph 
        (5);</DELETED>
        <DELETED>    (2) by striking the period at the end of paragraph 
        (6) and inserting ``; and''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(7) educational and training programs for local, 
        State, and Federal personnel, incorporating recommendations by 
        the Secretary of Health and Human Services, on the necessary 
        and legitimate use of controlled substances in pain management 
        and palliative care, and means by which investigation and 
        enforcement actions by law enforcement personnel may 
        accommodate such use.''.</DELETED>

         <DELETED>TITLE II--PROMOTING PALLIATIVE CARE</DELETED>

<DELETED>SEC. 201. ACTIVITIES OF AGENCY FOR HEALTH CARE POLICY AND 
              RESEARCH.</DELETED>

<DELETED>    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 
section:</DELETED>

<DELETED>``SEC. 906. PROGRAM FOR PALLIATIVE CARE RESEARCH AND 
              QUALITY.</DELETED>

<DELETED>    ``(a) In General.--The Administrator shall carry out a 
program to accomplish the following:</DELETED>
        <DELETED>    ``(1) Develop and advance scientific understanding 
        of palliative care.</DELETED>
        <DELETED>    ``(2) Collect and disseminate protocols and 
        evidence-based practices regarding palliative care, with 
        priority given to pain management 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.</DELETED>
<DELETED>    ``(b) Definition.--For purposes of this section, the term 
`palliative care' means the active, total care of patients whose 
disease or medical condition is not responsive to curative treatment or 
whose prognosis is limited due to progressive, far-advanced disease. 
The purpose of such care is to alleviate pain and other distressing 
symptoms and to enhance the quality of life, not to hasten or postpone 
death.''.</DELETED>

<DELETED>SEC. 202. ACTIVITIES OF HEALTH RESOURCES AND SERVICES 
              ADMINISTRATION.</DELETED>

<DELETED>    (a) In General.--Part D of title VII of the Public Health 
Service Act (42 U.S.C. 294 et seq.), as amended by section 103 of 
Public Law 105-392 (112 Stat. 3541), is amended--</DELETED>
        <DELETED>    (1) by redesignating sections 754 through 757 as 
        sections 755 through 758, respectively; and</DELETED>
        <DELETED>    (2) by inserting after section 753 the following 
        section:</DELETED>

<DELETED>``SEC. 754. PROGRAM FOR EDUCATION AND TRAINING IN PALLIATIVE 
              CARE.</DELETED>

<DELETED>    ``(a) In General.--The Secretary, in consultation with the 
Administrator for Health Care Policy and Research, may make awards of 
grants, cooperative agreements, 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 palliative care.</DELETED>
<DELETED>    ``(b) Priorities.--In making awards under subsection (a), 
the Secretary shall give priority to awards for the implementation of 
programs under such subsection.</DELETED>
<DELETED>    ``(c) Certain Topics.--An award may be made under 
subsection (a) only if the applicant for the award agrees that the 
program carried out with the award will include information and 
education on--</DELETED>
        <DELETED>    ``(1) means for alleviating pain and discomfort of 
        patients, especially terminally ill patients, including the 
        medically appropriate use of controlled substances;</DELETED>
        <DELETED>    ``(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 efforts may unintentionally increase 
        the risk of death; and</DELETED>
        <DELETED>    ``(3) recent findings, developments, and 
        improvements in the provision of palliative care.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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 palliative 
care.</DELETED>
<DELETED>    ``(f) Peer Review Groups.--In carrying out section 799(f) 
with respect to this section, the Secretary shall ensure that the 
membership of each peer review group involved includes one or more 
individuals with expertise and experience in palliative care.</DELETED>
<DELETED>    ``(g) Definition.--For purposes of this section, the term 
`palliative care' means the active, total care of patients whose 
disease or medical condition is not responsive to curative treatment or 
whose prognosis is limited due to progressive, far-advanced disease. 
The purpose of such care is to alleviate pain and other distressing 
symptoms and to enhance the quality of life, not to hasten or postpone 
death.''.</DELETED>
<DELETED>    (b) Authorization of Appropriations; Allocation.--
</DELETED>
        <DELETED>    (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''.</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 203. EFFECTIVE DATE.</DELETED>

<DELETED>    The amendments made by this title take effect October 1, 
1999, or upon the date of the enactment of this Act, whichever occurs 
later.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pain Relief Promotion Act of 2000''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) in the first decade of the new millennium there should 
        be a new emphasis on pain management 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 practitioners for legitimate 
        medical purposes are permitted under the Controlled Substances 
        Act and implementing 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 permissible 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 public 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 dispensing and 
        distribution of controlled substances for any purpose affect 
        interstate commerce.

         TITLE I--PROMOTING PAIN MANAGEMENT AND PALLIATIVE CARE

SEC. 101. ACTIVITIES OF AGENCY FOR HEALTHCARE RESEARCH 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 PALLIATIVE 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 understanding of pain 
        management and palliative care.
            ``(2) Collect and disseminate protocols and evidence-based 
        practices regarding pain management and palliative care, with 
        priority given to pain management 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.
    ``(b) Definition.--In this section, the term `pain management and 
palliative care' means--
            ``(1) the active, total care of patients whose disease or 
        medical condition is not responsive to curative 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, whether acute, chronic, 
        persistent, intractable, or associated 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 SERVICES 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, 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 implementation 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 patients, 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 efforts may unintentionally increase the 
        risk of death; and
            ``(3) recent findings, developments, and improvements in 
        the provision of pain management and palliative care.
    ``(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 ensure that the membership 
of each peer review group involved 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 disease or 
        medical condition is not responsive to curative 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, whether acute, chronic, 
        persistent, intractable, or associated 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; Allocation.--
            (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. DECADE OF PAIN CONTROL AND RESEARCH.

    The calendar decade beginning January 1, 2001, is designated as the 
``Decade of Pain Control and Research''.

SEC. 104. EFFECTIVE DATE.

    The amendments made by this title shall take effect on the date of 
enactment of this Act.

 TITLE II--USE OF CONTROLLED SUBSTANCES CONSISTENT WITH THE CONTROLLED 
                             SUBSTANCES ACT

SEC. 201. REINFORCING EXISTING STANDARD FOR LEGITIMATE 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 administering of a controlled substance 
that is consistent with public health and safety, even if the use of 
such a substance may increase the risk of death. Nothing in this 
section 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 General shall give no force and 
effect to State law authorizing or permitting assisted suicide or 
euthanasia.
    ``(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 legitimate medical purpose 
        pursuant to paragraph (1); or
            ``(B) to provide the Attorney General with the authority to 
        issue national standards for pain management and palliative 
        care clinical practice, research, or quality;
except that the Attorney General may take such other actions 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--
            (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 dispense, distribute, or 
        administer a controlled substance 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 controlled 
        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);
            (2) by striking the period at the end of paragraph (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 subsections (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 investigation 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 operation 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 Substances Act (21 U.S.C. 823(i)), as added by 
this Act, and subsections (a)(4) and (c)(2) of section 304 of the 
Controlled Substances Act (21 U.S.C. 824), as amended by this Act.

SEC. 204. EFFECTIVE DATE.

    The amendments made by this title shall take effect on the date of 
enactment of this Act.




                                                       Calendar No. 566

106th CONGRESS

  2d Session

                               H. R. 2260

                          [Report No. 106-299]

_______________________________________________________________________

                                 AN ACT

 To amend the Controlled Substances Act to promote pain management and 
palliative care without permitting assisted suicide and euthanasia, and 
                          for other purposes.

_______________________________________________________________________

                              May 23, 2000

                       Reported with an amendment