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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.

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 1999’’.
2

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1 TITLE I—USE OF CONTROLLED

2 SUBSTANCES CONSISTENT

3 WITH THE CONTROLLED SUB4 STANCES ACT

5 SEC. 101. REINFORCING EXISTING STANDARD FOR LEGITI6 MATE USE OF CONTROLLED SUBSTANCES.

7 Section 303 of the Controlled Substances Act (21

8 U.S.C. 823) is amended by adding at the end the fol9 lowing:

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) Notwithstanding any other provision of this Act,

22 in determining whether a registration is consistent with

23 the public interest under this Act, the Attorney General

24 shall give no force and effect to State law authorizing or

25 permitting assisted suicide or euthanasia.
3

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1 ‘‘(3) Paragraph (2) applies only to conduct occurring

2 after the date of the enactment of this subsection.’’.

3 SEC. 102. EDUCATION AND TRAINING PROGRAMS.

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

5 U.S.C. 872(a)) is amended—

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

7 (5);

8 (2) by striking the period at the end of para9 graph (6) and inserting ‘‘; and’’; and

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

11 ‘‘(7) educational and training programs for

12 local, State, and Federal personnel, incorporating

13 recommendations by the Secretary of Health and

14 Human Services, on the necessary and legitimate

15 use of controlled substances in pain management

16 and palliative care, and means by which investiga17 tion and enforcement actions by law enforcement

18 personnel may accommodate such use.’’.

19 TITLE II—PROMOTING

20 PALLIATIVE CARE

21 SEC. 201. ACTIVITIES OF AGENCY FOR HEALTH CARE POL22 ICY AND RESEARCH.

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

24 (42 U.S.C. 299 et seq.) is amended by adding at the end

25 the following section:
4

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1 ‘‘SEC. 906. PROGRAM FOR PALLIATIVE CARE RESEARCH

2 AND QUALITY.

3 ‘‘(a) IN GENERAL.—The Administrator shall carry

4 out a program to accomplish the following:

5 ‘‘(1) Develop and advance scientific under6 standing of palliative care.

7 ‘‘(2) Collect and disseminate protocols and evi8 dence-based practices regarding palliative care, with

9 priority given to pain management for terminally ill

10 patients, and make such information available to

11 public and private health care programs and pro12 viders, health professions schools, and hospices, and

13 to the general public.

14 ‘‘(b) DEFINITION.—For purposes of this section, the

15 term ‘palliative care’ means the active, total care of pa16 tients whose disease or medical condition is not responsive

17 to curative treatment or whose prognosis is limited due

18 to progressive, far-advanced disease. The purpose of such

19 care is to alleviate pain and other distressing symptoms

20 and to enhance the quality of life, not to hasten or post21 pone death.’’.

22 SEC. 202. ACTIVITIES OF HEALTH RESOURCES AND SERV23 ICES ADMINISTRATION.

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

25 Health Service Act (42 U.S.C. 294 et seq.), as amended
5

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1 by section 103 of Public Law 105–392 (112 Stat. 3541),

2 is amended—

3 (1) by redesignating sections 754 through 757

4 as sections 755 through 758, respectively; and

5 (2) by inserting after section 753 the following

6 section:

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

8 PALLIATIVE CARE.

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

10 with the Administrator for Health Care Policy and Re11 search, may make awards of grants, cooperative agree12 ments, and contracts to health professions schools, hos13 pices, and other public and private entities for the develop14 ment and implementation of programs to provide edu15 cation and training to health care professionals in pallia16 tive care.

17 ‘‘(b) PRIORITIES.—In making awards under sub18 section (a), the Secretary shall give priority to awards for

19 the implementation of programs under such subsection.

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

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

22 agrees that the program carried out with the award will

23 include information and education on—

24 ‘‘(1) means for alleviating pain and discomfort

25 of patients, especially terminally ill patients, includ-
6

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1 ing the medically appropriate use of controlled sub2 stances;

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

4 including laws permitting health care professionals

5 to dispense or administer controlled substances as

6 needed to relieve pain even in cases where such ef7 forts may unintentionally increase the risk of death;

8 and

9 ‘‘(3) recent findings, developments, and im10 provements in the provision of palliative care.

11 ‘‘(d) PROGRAM SITES.—Education and training

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

13 professions schools, residency training programs and other

14 graduate programs in the health professions, entities that

15 provide continuing medical education, hospices, and such

16 other programs or sites as the Secretary determines to be

17 appropriate.

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

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

20 the evaluation of programs implemented under subsection

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

22 knowledge and practice regarding palliative care.

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

24 799(f) with respect to this section, the Secretary shall en25 sure that the membership of each peer review group in-
7

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1 volved includes one or more individuals with expertise and

2 experience in palliative care.

3 ‘‘(g) DEFINITION.—For purposes of this section, the

4 term ‘palliative care’ means the active, total care of pa5 tients whose disease or medical condition is not responsive

6 to curative treatment or whose prognosis is limited due

7 to progressive, far-advanced disease. The purpose of such

8 care is to alleviate pain and other distressing symptoms

9 and to enhance the quality of life, not to hasten or post10 pone death.’’.

11 (b) AUTHORIZATION OF APPROPRIATIONS; ALLOCA12 TION.—

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

14 Health Service Act (as redesignated by subsection

15 (a)(1) of this section) is amended in subsection

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

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

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

19 the Public Health Service Act (as redesignated by

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

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

22 deemed to be increased by $5,000,000.
8

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1 SEC. 203. EFFECTIVE DATE.

2 The amendments made by this title take effect Octo3 ber 1, 1999, or upon the date of the enactment of this

4 Act, whichever occurs later.

5 SECTION 1. SHORT TITLE.

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

7 Act of 2000’’.

8 SEC. 2. FINDINGS.

9 Congress finds that—

10 (1) in the first decade of the new millennium

11 there should be a new emphasis on pain management

12 and palliative care;

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

14 or substances with a potential for abuse is strictly

15 regulated under the Controlled Substances Act;

16 (3) the dispensing and distribution of certain

17 controlled substances by properly registered practi18 tioners for legitimate medical purposes are permitted

19 under the Controlled Substances Act and imple20 menting regulations;

21 (4) the dispensing or distribution of certain con22 trolled substances for the purpose of relieving pain

23 and discomfort even if it increases the risk of death

24 is a legitimate medical purpose and is permissible

25 under the Controlled Substances Act;
9

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1 (5) inadequate treatment of pain, especially for

2 chronic diseases and conditions, irreversible diseases

3 such as cancer, and end-of-life care, is a serious pub4 lic health problem affecting hundreds of thousands of

5 patients every year; physicians should not hesitate to

6 dispense or distribute controlled substances when

7 medically indicated for these conditions; and

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

9 Controlled Substances Act (21 U.S.C. 801), the dis10 pensing and distribution of controlled substances for

11 any purpose affect interstate commerce.

12 TITLE I—PROMOTING PAIN MAN13 AGEMENT AND PALLIATIVE

14 CARE

15 SEC. 101. ACTIVITIES OF AGENCY FOR HEALTHCARE RE16 SEARCH AND QUALITY.

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

18 (42 U.S.C. 299 et seq.) is amended by adding at the end

19 the following:

20 ‘‘SEC. 903. PROGRAM FOR PAIN MANAGEMENT AND PALLIA21 TIVE CARE RESEARCH AND QUALITY.

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

23 of section 902, the Director shall carry out a program to

24 accomplish the following:
10

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1 ‘‘(1) Promote and advance scientific under2 standing of pain management and palliative care.

3 ‘‘(2) Collect and disseminate protocols and evi4 dence-based practices regarding pain management

5 and palliative care, with priority given to pain man6 agement for terminally ill patients, and make such

7 information available to public and private health

8 care programs and providers, health professions

9 schools, and hospices, and to the general public.

10 ‘‘(b) DEFINITION.—In this section, the term ‘pain

11 management and palliative care’ means—

12 ‘‘(1) the active, total care of patients whose dis13 ease or medical condition is not responsive to curative

14 treatment or whose prognosis is limited due to pro15 gressive, far-advanced disease; and

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

17 management of primary and secondary pain, whether

18 acute, chronic, persistent, intractable, or associated

19 with the end of life;

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

21 other distressing signs and symptoms and to enhance the

22 quality of life, not to hasten or postpone death.’’.
11

HR 2260 RS1S

1 SEC. 102. ACTIVITIES OF HEALTH RESOURCES AND SERV2 ICES ADMINISTRATION.

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

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

5 (1) by redesignating sections 754 through 757 as

6 sections 755 through 758, respectively; and

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

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

9 PAIN MANAGEMENT AND PALLIATIVE CARE.

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

11 with the Director of the Agency for Healthcare Research and

12 Quality, may award grants, cooperative agreements, and

13 contracts to health professions schools, hospices, and other

14 public and private entities for the development and imple15 mentation of programs to provide education and training

16 to health care professionals in pain management and pal17 liative care.

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

19 (a), the Secretary shall give priority to awards for the im20 plementation of programs under such subsection.

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

22 subsection (a) only if the applicant for the award agrees

23 that the program to be carried out with the award will in24 clude information and education on—

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

26 and other distressing signs and symptoms of patients,
12

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1 especially terminally ill patients, including the medi2 cally appropriate use of controlled substances;

3 ‘‘(2) applicable laws on controlled substances, in4 cluding laws permitting health care professionals to

5 dispense or administer controlled substances as needed

6 to relieve pain even in cases where such efforts may

7 unintentionally increase the risk of death; and

8 ‘‘(3) recent findings, developments, and improve9 ments in the provision of pain management and pal10 liative care.

11 ‘‘(d) PROGRAM SITES.—Education and training

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

13 professions schools, residency training programs and other

14 graduate programs in the health professions, entities that

15 provide continuing medical education, hospices, and such

16 other programs or sites as the Secretary determines to be

17 appropriate.

18 ‘‘(e) EVALUATION OF PROGRAMS.—The Secretary shall

19 (directly or through grants or contracts) provide for the

20 evaluation of programs implemented under subsection (a)

21 in order to determine the effect of such programs on knowl22 edge and practice regarding pain management and pallia23 tive care.

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

25 799(f) with respect to this section, the Secretary shall ensure
13

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1 that the membership of each peer review group involved in2 cludes individuals with expertise and experience in pain

3 management and palliative care for the population of pa4 tients whose needs are to be served by the program.

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

6 management and palliative care’ means—

7 ‘‘(1) the active, total care of patients whose dis8 ease or medical condition is not responsive to curative

9 treatment or whose prognosis is limited due to pro10 gressive, far-advanced disease; and

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

12 management of primary and secondary pain, whether

13 acute, chronic, persistent, intractable, or associated

14 with the end of life;

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

16 other distressing signs and symptoms and to enhance the

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

18 (b) AUTHORIZATION OF APPROPRIATIONS; ALLOCA19 TION.—

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

21 Health Service Act (as redesignated by subsection

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

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

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

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

2 Public Health Service Act (as redesignated by sub3 section (a)(1) of this section), the dollar amount spec4 ified in subsection (b)(1)(C) of such section is deemed

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

6 SEC. 103. DECADE OF PAIN CONTROL AND RESEARCH.

7 The calendar decade beginning January 1, 2001, is

8 designated as the ‘‘Decade of Pain Control and Research’’.

9 SEC. 104. EFFECTIVE DATE.

10 The amendments made by this title shall take effect

11 on the date of enactment of this Act.

12 TITLE II—USE OF CONTROLLED

13 SUBSTANCES CONSISTENT

14 WITH THE CONTROLLED SUB15 STANCES ACT

16 SEC. 201. REINFORCING EXISTING STANDARD FOR LEGITI17 MATE USE OF CONTROLLED SUBSTANCES.

18 (a) IN GENERAL.—Section 303 of the Controlled Sub19 stances Act (21 U.S.C. 823) is amended by adding at the

20 end the following:

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

22 to implement this Act, alleviating pain or discomfort in the

23 usual course of professional practice is a legitimate medical

24 purpose for the dispensing, distributing, or administering

25 of a controlled substance that is consistent with public
15

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1 health and safety, even if the use of such a substance may

2 increase the risk of death. Nothing in this section authorizes

3 intentionally dispensing, distributing, or administering a

4 controlled substance for the purpose of causing death or as5 sisting another person in causing death.

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

7 Act, in determining whether a registration is consistent

8 with the public interest under this Act, the Attorney Gen9 eral shall give no force and effect to State law authorizing

10 or permitting assisted suicide or euthanasia.

11 ‘‘(B) Paragraph (2) applies only to conduct occurring

12 after the date of enactment of this subsection.

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

14 alter the roles of the Federal and State governments in regu15 lating the practice of medicine. Regardless of whether the

16 Attorney General determines pursuant to this section that

17 the registration of a practitioner is inconsistent with the

18 public interest, it remains solely within the discretion of

19 State authorities to determine whether action should be

20 taken with respect to the State professional license of the

21 practitioner or State prescribing privileges.

22 ‘‘(4) Nothing in the Pain Relief Promotion Act of 2000

23 (including the amendments made by such Act) shall be

24 construed—
16

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

2 controlled substance be dispensed only for a legitimate

3 medical purpose pursuant to paragraph (1); or

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

5 authority to issue national standards for pain man6 agement and palliative care clinical practice, re7 search, or quality;

8 except that the Attorney General may take such other ac9 tions as may be necessary to enforce this Act.’’.

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

11 Substances Act (21 U.S.C. 824(c)) is amended—

12 (1) by striking ‘‘(c) Before’’ and inserting the fol13 lowing:

14 ‘‘(c) PROCEDURES.—

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

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

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

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

19 is based on the alleged intentions of the applicant or

20 registrant to cause or assist in causing death, and the

21 practitioner claims a defense under paragraph (1) of

22 section 303(i), the Attorney General shall have the

23 burden of proving, by clear and convincing evidence,

24 that the practitioner’s intent was to dispense, dis25 tribute, or administer a controlled substance for the
17

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1 purpose of causing death or assisting another person

2 in causing death. In meeting such burden, it shall not

3 be sufficient to prove that the applicant or registrant

4 knew that the use of controlled substance may in5 crease the risk of death.’’.

6 SEC. 202. EDUCATION AND TRAINING PROGRAMS.

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

8 U.S.C. 872(a)) is amended—

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

10 (5);

11 (2) by striking the period at the end of para12 graph (6) and inserting ‘‘; and’’; and

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

14 ‘‘(7) educational and training programs for Fed15 eral, State, and local personnel, incorporating rec16 ommendations, subject to the provisions of subsections

17 (e) and (f) of section 902 of the Public Health Service

18 Act, by the Secretary of Health and Human Services,

19 on the means by which investigation and enforcement

20 actions by law enforcement personnel may better ac21 commodate the necessary and legitimate use of con22 trolled substances in pain management and palliative

23 care.
18

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1 Nothing in this subsection shall be construed to alter the

2 roles of the Federal and State governments in regulating

3 the practice of medicine.’’.

4 SEC. 203. FUNDING AUTHORITY.

5 Notwithstanding any other provision of law, the oper6 ation of the diversion control fee account program of the

7 Drug Enforcement Administration shall be construed to in8 clude carrying out section 303(i) of the Controlled Sub9 stances Act (21 U.S.C. 823(i)), as added by this Act, and

10 subsections (a)(4) and (c)(2) of section 304 of the Controlled

11 Substances Act (21 U.S.C. 824), as amended by this Act.

12 SEC. 204. EFFECTIVE DATE.

13 The amendments made by this title shall take effect

14 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