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 committee concerned

A BILL

To amend the Controlled Substances Act to promote pain

management and palliative care without permitting assisted suicide and euthanasia, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Pain Relief Promotion

5 Act of 2000’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—
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1 (1) in the first decade of the new millennium

2 there should be a new emphasis on pain manage3 ment and palliative care;

4 (2) the use of certain narcotics and other drugs

5 or substances with a potential for abuse is strictly

6 regulated under the Controlled Substances Act;

7 (3) the dispensing and distribution of certain

8 controlled substances by properly registered practi9 tioners for legitimate medical purposes are permitted

10 under the Controlled Substances Act and imple11 menting regulations;

12 (4) the dispensing or distribution of certain

13 controlled substances for the purpose of relieving

14 pain and discomfort even if it increases the risk of

15 death is a legitimate medical purpose and is permis16 sible under the Controlled Substances Act;

17 (5) inadequate treatment of pain, especially for

18 chronic diseases and conditions, irreversible diseases

19 such as cancer, and end-of-life care, is a serious pub20 lic health problem affecting hundreds of thousands

21 of patients every year; physicians should not hesitate

22 to dispense or distribute controlled substances when

23 medically indicated for these conditions; and

24 (6) for the reasons set forth in section 101 of

25 the Controlled Substances Act (21 U.S.C. 801), the
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1 dispensing and distribution of controlled substances

2 for any purpose affect interstate commerce.

3 TITLE I—PROMOTING PAIN MAN4 AGEMENT AND PALLIATIVE

5 CARE

6 SEC. 101. ACTIVITIES OF AGENCY FOR HEALTH CARE RE7 SEARCH AND QUALITY.

8 Part A of title IX of the Public Health Service Act

9 (42 U.S.C. 299 et seq.) is amended by adding at the end

10 the following:

11 ‘‘SEC. 903. PROGRAM FOR PAIN MANAGEMENT AND PALLIA12 TIVE CARE RESEARCH AND QUALITY.

13 ‘‘(a) IN GENERAL.—Subject to subsections (e) and

14 (f) of section 902, the Director shall carry out a program

15 to accomplish the following:

16 ‘‘(1) Promote and advance scientific under17 standing of pain management and palliative care.

18 ‘‘(2) Collect and disseminate protocols and evi19 dence-based practices regarding pain management

20 and palliative care, with priority given to pain man21 agement for terminally ill patients, and make such

22 information available to public and private health

23 care programs and providers, health professions

24 schools, and hospices, and to the general public.
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1 ‘‘(b) DEFINITION.—In this section, the term ‘pain

2 management and palliative care’ means—

3 ‘‘(1) the active, total care of patients whose dis4 ease or medical condition is not responsive to cura5 tive treatment or whose prognosis is limited due to

6 progressive, far-advanced disease; and

7 ‘‘(2) the evaluation, diagnosis, treatment, and

8 management of primary and secondary pain, wheth9 er acute, chronic, persistent, intractable, or associ10 ated with the end of life;

11 the purpose of which is to diagnose and alleviate pain and

12 other distressing signs and symptoms and to enhance the

13 quality of life, not to hasten or postpone death.’’.

14 SEC. 102. ACTIVITIES OF HEALTH RESOURCES AND SERV15 ICES ADMINISTRATION.

16 (a) IN GENERAL.—Part D of title VII of the Public

17 Health Service Act (42 U.S.C. 294 et seq.) is amended—

18 (1) by redesignating sections 754 through 757

19 as sections 755 through 758, respectively; and

20 (2) by inserting after section 753 the following:

21 ‘‘SEC. 754. PROGRAM FOR EDUCATION AND TRAINING IN

22 PAIN MANAGEMENT AND PALLIATIVE CARE.

23 ‘‘(a) IN GENERAL.—The Secretary, in consultation

24 with the Director of the Agency for Healthcare Research

25 and Quality, may award grants, cooperative agreements,
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1 and contracts to health professions schools, hospices, and

2 other public and private entities for the development and

3 implementation of programs to provide education and

4 training to health care professionals in pain management

5 and palliative care.

6 ‘‘(b) PRIORITY.—In making awards under subsection

7 (a), the Secretary shall give priority to awards for the im8 plementation of programs under such subsection.

9 ‘‘(c) CERTAIN TOPICS.—An award may be made

10 under subsection (a) only if the applicant for the award

11 agrees that the program to be carried out with the award

12 will include information and education on—

13 ‘‘(1) means for diagnosing and alleviating pain

14 and other distressing signs and symptoms of pa15 tients, especially terminally ill patients, including the

16 medically appropriate use of controlled substances;

17 ‘‘(2) applicable laws on controlled substances,

18 including laws permitting health care professionals

19 to dispense or administer controlled substances as

20 needed to relieve pain even in cases where such ef21 forts may unintentionally increase the risk of death;

22 and

23 ‘‘(3) recent findings, developments, and im24 provements in the provision of pain management

25 and palliative care.
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1 ‘‘(d) PROGRAM SITES.—Education and training

2 under subsection (a) may be provided at or through health

3 professions schools, residency training programs and other

4 graduate programs in the health professions, entities that

5 provide continuing medical education, hospices, and such

6 other programs or sites as the Secretary determines to be

7 appropriate.

8 ‘‘(e) EVALUATION OF PROGRAMS.—The Secretary

9 shall (directly or through grants or contracts) provide for

10 the evaluation of programs implemented under subsection

11 (a) in order to determine the effect of such programs on

12 knowledge and practice regarding pain management and

13 palliative care.

14 ‘‘(f) PEER REVIEW GROUPS.—In carrying out section

15 799(f) with respect to this section, the Secretary shall en16 sure that the membership of each peer review group in17 volved includes individuals with expertise and experience

18 in pain management and palliative care for the population

19 of patients whose needs are to be served by the program.

20 ‘‘(g) DEFINITION.—In this section, the term ‘pain

21 management and palliative care’ means—

22 ‘‘(1) the active, total care of patients whose dis23 ease or medical condition is not responsive to cura24 tive treatment or whose prognosis is limited due to

25 progressive, far-advanced disease; and
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1 ‘‘(2) the evaluation, diagnosis, treatment, and

2 management of primary and secondary pain, wheth3 er acute, chronic, persistent, intractable, or associ4 ated with the end of life;

5 the purpose of which is to diagnose and alleviate pain and

6 other distressing signs and symptoms and to enhance the

7 quality of life, not to hasten or postpone death.’’.

8 (b) AUTHORIZATION OF APPROPRIATIONS; ALLOCA9 TION.—

10 (1) IN GENERAL.—Section 758 of the Public

11 Health Service Act (as redesignated by subsection

12 (a)(1) of this section) is amended, in subsection

13 (b)(1)(C), by striking ‘‘sections 753, 754, and 755’’

14 and inserting ‘‘sections 753, 754, 755, and 756’’.

15 (2) AMOUNT.—With respect to section 758 of

16 the Public Health Service Act (as redesignated by

17 subsection (a)(1) of this section), the dollar amount

18 specified in subsection (b)(1)(C) of such section is

19 deemed to be increased by $5,000,000.

20 SEC. 103. EFFECTIVE DATE.

21 The amendments made by this title shall take effect

22 on the date of enactment of this Act.
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1 TITLE II—USE OF CONTROLLED

2 SUBSTANCES CONSISTENT

3 WITH THE CONTROLLED SUB4 STANCES ACT

5 SEC. 201. REINFORCING EXISTING STANDARD FOR LEGITI6 MATE USE OF CONTROLLED SUBSTANCES.

7 (a) IN GENERAL.—Section 303 of the Controlled

8 Substances Act (21 U.S.C. 823) is amended by adding at

9 the end the following:

10 ‘‘(i)(1) For purposes of this Act and any regulations

11 to implement this Act, alleviating pain or discomfort in

12 the usual course of professional practice is a legitimate

13 medical purpose for the dispensing, distributing, or admin14 istering of a controlled substance that is consistent with

15 public health and safety, even if the use of such a sub16 stance may increase the risk of death. Nothing in this sec17 tion authorizes intentionally dispensing, distributing, or

18 administering a controlled substance for the purpose of

19 causing death or assisting another person in causing

20 death.

21 ‘‘(2)(A) Notwithstanding any other provision of this

22 Act, in determining whether a registration is consistent

23 with the public interest under this Act, the Attorney Gen24 eral shall give no force and effect to State law authorizing

25 or permitting assisted suicide or euthanasia.
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1 ‘‘(B) Paragraph (2) applies only to conduct occurring

2 after the date of enactment of this subsection.

3 ‘‘(3) Nothing in this subsection shall be construed to

4 alter the roles of the Federal and State governments in

5 regulating the practice of medicine. Regardless of whether

6 the Attorney General determines pursuant to this section

7 that the registration of a practitioner is inconsistent with

8 the public interest, it remains solely within the discretion

9 of State authorities to determine whether action should

10 be taken with respect to the State professional license of

11 the practitioner or State prescribing privileges.

12 ‘‘(4) Nothing in the Pain Relief Promotion Act of

13 2000 (including the amendments made by such Act) shall

14 be construed—

15 ‘‘(A) to modify the Federal requirements that a

16 controlled substance be dispensed only for a legiti17 mate medical purpose pursuant to paragraph (1); or

18 ‘‘(B) to provide the Attorney General with the

19 authority to issue national standards for pain man20 agement and palliative care clinical practice, re21 search, or quality;

22 except that the Attorney General may take such other ac23 tions as may be necessary to enforce this Act.’’.

24 (b) PAIN RELIEF.—Section 304(c) of the Controlled

25 Substances Act (21 U.S.C. 824(c)) is amended—
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1 (1) by striking ‘‘(c) Before’’ and inserting the

2 following:

3 ‘‘(c) PROCEDURES.—

4 ‘‘(1) ORDER TO SHOW CAUSE.—Before’’; and

5 (2) by adding at the end the following:

6 ‘‘(2) BURDEN OF PROOF.—At any proceeding

7 under paragraph (1), where the order to show cause

8 is based on the alleged intentions of the applicant or

9 registrant to cause or assist in causing death, and

10 the practitioner claims a defense under paragraph

11 (1) of section 303(i), the Attorney General shall

12 have the burden of proving, by clear and convincing

13 evidence, that the practitioner’s intent was to dis14 pense, distribute, or administer a controlled sub15 stance for the purpose of causing death or assisting

16 another person in causing death. In meeting such

17 burden, it shall not be sufficient to prove that the

18 applicant or registrant knew that the use of con19 trolled substance may increase the risk of death.’’.

20 SEC. 202. EDUCATION AND TRAINING PROGRAMS.

21 Section 502(a) of the Controlled Substances Act (21

22 U.S.C. 872(a)) is amended—

23 (1) by striking ‘‘and’’ at the end of paragraph

24 (5);
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1 (2) by striking the period at the end of para2 graph (6) and inserting ‘‘; and’’; and

3 (3) by adding at the end the following:

4 ‘‘(7) educational and training programs for

5 Federal, State, and local personnel, incorporating

6 recommendations, subject to the provisions of sub7 sections (e) and (f) of section 902 of the Public

8 Health Service Act, by the Secretary of Health and

9 Human Services, on the means by which investiga10 tion and enforcement actions by law enforcement

11 personnel may better accommodate the necessary

12 and legitimate use of controlled substances in pain

13 management and palliative care.

14 Nothing in this subsection shall be construed to alter the

15 roles of the Federal and State governments in regulating

16 the practice of medicine.’’.

17 SEC. 203. FUNDING AUTHORITY.

18 Notwithstanding any other provision of law, the oper19 ation of the diversion control fee account program of the

20 Drug Enforcement Administration shall be construed to

21 include carrying out section 303(i) of the Controlled Sub22 stances Act (21 U.S.C. 823(i)), as added by this Act, and

23 subsections (a)(4) and (c)(2) of section 304 of the Con24 trolled Substances Act (21 U.S.C. 824), as amended by

25 this Act.
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1 SEC. 204. EFFECTIVE DATE.

2 The amendments made by this title shall take effect

3 on the date of enactment of this Act.

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