II

106TH CONGRESS

1ST SESSION S. 628

To amend titles XVIII and XIX of the Social Security Act to expand and

clarify the requirements regarding advance directives in order to ensure

that an individual’s health care decisions are complied with, and for

other purposes.

IN THE SENATE OF THE UNITED STATES

MARCH 16, 1999

Mr. ROCKEFELLER (for himself, Ms. COLLINS, Mr. COCHRAN, Mr. CONRAD,

Mr. WYDEN, and Mr. JEFFORDS) introduced the following bill; which was

read twice and referred to the Committee on Finance

A BILL

To amend titles XVIII and XIX of the Social Security Act

to expand and clarify the requirements regarding advance directives in order to ensure that an individual’s

health care decisions are complied with, 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; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Advance Planning and Compassionate Care Act of

6 1999’’.
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1 (b) TABLE OF CONTENTS.—The table of contents of

2 this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Development of standards to assess end-of-life care.

Sec. 3. Study and recommendations to Congress on issues relating to advance

directive expansion.

Sec. 4. Study and legislative proposal to Congress.

Sec. 5. Expansion of advance directives.

Sec. 6. National information hotline for end-of-life decisionmaking.

Sec. 7. Evaluation of and demonstration projects for innovative and new approaches to end-of-life care for medicare beneficiaries.

Sec. 8. Medicare coverage of self-administered medication for certain patients

with chronic pain.

3 SEC. 2. DEVELOPMENT OF STANDARDS TO ASSESS END–OF–

4 LIFE CARE.

5 (a) IN GENERAL.—The Secretary of Health and

6 Human Services, acting through the Administrator of the

7 Health Care Financing Administration, the Director of

8 the National Institutes of Health, and the Administrator

9 of the Agency for Health Care Policy and Research, shall

10 develop outcome standards and measures to evaluate the

11 performance of health care programs and projects that

12 provide end-of-life care to individuals and the quality of

13 such care.

14 (b) REPORT TO CONGRESS.—Not later than 2 years

15 after the date of enactment of this Act, the Secretary of

16 Health and Human Services shall submit a report to Con17 gress concerning the outcome standards and measures de18 veloped under subsection (a).
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1 SEC. 3. STUDY AND RECOMMENDATIONS TO CONGRESS ON

2 ISSUES RELATING TO ADVANCE DIRECTIVE

3 EXPANSION.

4 (a) STUDY.—The Secretary of Health and Human

5 Services shall conduct a thorough study regarding the im6 plementation of the amendments made by section 5.

7 (b) REPORT.—Not later than 18 months after the

8 date of enactment of this Act, the Secretary of Health and

9 Human Services shall submit a report to Congress that

10 contains a detailed statement of the findings and conclu11 sions of the Secretary regarding the study conducted pur12 suant to subsection (a), together with the Secretary’s rec13 ommendations for such legislation and administrative ac14 tions as the Secretary considers appropriate.

15 SEC. 4. STUDY AND LEGISLATIVE PROPOSAL TO CONGRESS.

16 (a) STUDY.—

17 (1) IN GENERAL.—The Secretary of Health and

18 Human Services shall conduct a thorough study of

19 all matters relating to the creation of a national uni20 form policy on advance directives for individuals re21 ceiving items and services under titles XVIII and

22 XIX of the Social Security Act (42 U.S.C. 1395 et

23 seq.; 1396 et seq.).

24 (2) MATTERS STUDIED.—The matters studied

25 by the Secretary of Health and Human Services
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1 under paragraph (1) shall include issues

2 concerning—

3 (A) the election or refusal of life-sustaining

4 treatment;

5 (B) the provision of adequate palliative

6 care including pain management;

7 (C) the portability of advance directives,

8 including the cases involving the transfer of an

9 individual from 1 health care setting to another;

10 (D) immunity for health care providers

11 that follow the instructions in an individual’s

12 advance directive;

13 (E) exemptions for health care providers

14 from following the instructions in an individ15 ual’s advance directive;

16 (F) conditions under which an advance di17 rective is operative;

18 (G) revocation of an advance directive by

19 an individual;

20 (H) the criteria for determining that an in21 dividual is in terminal status; and

22 (I) surrogate decision making regarding

23 end of life care.

24 (b) REPORT TO CONGRESS.—Not later than 18

25 months after the date of enactment of this Act, the Sec-
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1 retary of Health and Human Services shall submit a re2 port to Congress that contains a detailed description of

3 the results of the study conducted pursuant to subsection

4 (a).

5 (c) CONSULTATION.—In conducting the study and

6 developing the report under this section, the Secretary of

7 Health and Human Services shall consult with physicians

8 and other health care provider groups, consumer groups,

9 the Uniform Law Commissioners, and other interested

10 parties.

11 SEC. 5. EXPANSION OF ADVANCE DIRECTIVES.

12 (a) MEDICARE.—Section 1866(f) of the Social Secu13 rity Act (42 U.S.C. 1395cc(f)) is amended—

14 (1) in paragraph (1)—

15 (A) in subparagraph (B), by inserting

16 ‘‘and if presented by the individual, to include

17 the content of such advance directive in a

18 prominent part of such record’’ before the semi19 colon;

20 (B) in subparagraph (D), by striking

21 ‘‘and’’ at the end;

22 (C) in subparagraph (E), by striking the

23 period and inserting ‘‘; and’’; and

24 (D) by inserting after subparagraph (E)

25 the following:
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1 ‘‘(F) to provide each individual with the oppor2 tunity to discuss issues relating to the information

3 provided to that individual pursuant to subpara4 graph (A) with an appropriately trained profes5 sional.’’; and

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

7 ‘‘(5)(A) An advance directive validly executed outside

8 of the State in which such advance directive is presented

9 by an adult individual to a provider of services, a

10 Medicare+Choice organization, or a prepaid or eligible or11 ganization shall be given the same effect by that provider

12 or organization as an advance directive validly executed

13 under the law of the State in which it is presented would

14 be given effect.

15 ‘‘(B) Nothing in this paragraph shall be construed

16 to authorize the administration, withholding, or with17 drawal of health care unless it is consistent with the laws

18 of the State in which an advance directive is presented.

19 ‘‘(C) The provisions of this paragraph shall preempt

20 any State law to the extent such law is inconsistent with

21 such provisions. The provisions of this paragraph shall not

22 preempt any State law that provides for greater port23 ability, more deference to a patient’s wishes, or more lati24 tude in determining a patient’s wishes.’’.
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1 (b) MEDICAID.—Section 1902(w) of the Social Secu2 rity Act (42 U.S.C. 1396a(w)) is amended—

3 (1) in paragraph (1)—

4 (A) in subparagraph (B)—

5 (i) by striking ‘‘in the individual’s

6 medical record’’ and inserting ‘‘in a promi7 nent part of the individual’s current med8 ical record’’; and

9 (ii) by inserting ‘‘and if presented by

10 the individual, to include the content of

11 such advance directive in a prominent part

12 of such record’’ before the semicolon;

13 (B) in subparagraph (D), by striking

14 ‘‘and’’ at the end;

15 (C) in subparagraph (E), by striking the

16 period and inserting ‘‘; and’’; and

17 (D) by inserting after subparagraph (E)

18 the following:

19 ‘‘(F) to provide each individual with the oppor20 tunity to discuss issues relating to the information

21 provided to that individual pursuant to subpara22 graph (A) with an appropriately trained profes23 sional.’’; and

24 (2) by adding at the end the following:
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1 ‘‘(6)(A) An advance directive validly executed outside

2 of the State in which such advance directive is presented

3 by an adult individual to a provider or organization shall

4 be given the same effect by that provider or organization

5 as an advance directive validly executed under the law of

6 the State in which it is presented would be given effect.

7 ‘‘(B) Nothing in this paragraph shall be construed

8 to authorize the administration, withholding, or with9 drawal of health care otherwise prohibited by the laws of

10 the State in which an advance directive is presented.

11 ‘‘(C) The provisions of this paragraph shall preempt

12 any State law to the extent such law is inconsistent with

13 such provisions. The provisions of this paragraph shall not

14 preempt any State law that provides for greater port15 ability, more deference to a patient’s wishes, or more lati16 tude in determining a patient’s wishes.’’.

17 (c) EFFECTIVE DATES.—

18 (1) IN GENERAL.—Subject to paragraph (2),

19 the amendments made by subsections (a) and (b)

20 shall apply to provider agreements and contracts en21 tered into, renewed, or extended under title XVIII of

22 the Social Security Act (42 U.S.C. 1395 et seq.),

23 and to State plans under title XIX of such Act (42

24 U.S.C. 1396 et seq.), on or after such date as the

25 Secretary of Health and Human Services specifies,
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1 but in no case may such date be later than 1 year

2 after the date of the enactment of this Act.

3 (2) EXTENSION OF EFFECTIVE DATE FOR

4 STATE LAW AMENDMENT.—In the case of a State

5 plan under title XIX of the Social Security Act (42

6 U.S.C. 1396 et seq.) which the Secretary of Health

7 and Human Services determines requires State legis8 lation in order for the plan to meet the additional

9 requirements imposed by the amendments made by

10 subsection (b), the State plan shall not be regarded

11 as failing to comply with the requirements of such

12 title solely on the basis of its failure to meet these

13 additional requirements before the first day of the

14 first calendar quarter beginning after the close of

15 the first regular session of the State legislature that

16 begins after the date of the enactment of this Act.

17 For purposes of the previous sentence, in the case

18 of a State that has a 2-year legislative session, each

19 year of the session is considered to be a separate

20 regular session of the State legislature.

21 SEC. 6. NATIONAL INFORMATION HOTLINE FOR END–OF–

22 LIFE DECISIONMAKING.

23 The Secretary of Health and Human Services, acting

24 through the Administrator of the Health Care Financing

25 Administration, shall establish and operate directly, or by
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1 grant, contract, or interagency agreement, out of funds

2 otherwise appropriated to the Secretary, a clearinghouse

3 and a 24-hour toll-free telephone hotline, to provide con4 sumer information about advance directives, as defined in

5 section 1866(f)(3) of the Social Security Act (42 U.S.C.

6 1395cc(f)(3)), and end-of-life decisionmaking.

7 SEC. 7. EVALUATION OF AND DEMONSTRATION PROJECTS

8 FOR INNOVATIVE AND NEW APPROACHES TO

9 END–OF–LIFE CARE FOR MEDICARE BENE10 FICIARIES.

11 (a) DEFINITIONS.—In this section:

12 (1) MEDICARE BENEFICIARIES.—The term

13 ‘‘medicare beneficiaries’’ means individuals who are

14 entitled to benefits under part A or eligible for bene15 fits under part B of the medicare program.

16 (2) MEDICARE PROGRAM.—The term ‘‘medicare

17 program’’ means the health care program under title

18 XVIII of the Social Security Act (42 U.S.C. 1395 et

19 seq.).

20 (3) SECRETARY.—The term ‘‘Secretary’’ means

21 the Secretary of Health and Human Services.

22 (b) EVALUATION OF EXISTING PROGRAMS.—

23 (1) IN GENERAL.—The Secretary, acting

24 through the Administrator of the Health Care Fi25 nancing Administration, shall conduct ongoing eval-
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1 uations of innovative health care programs that pro2 vide end-of-life care to medicare beneficiaries who

3 are seriously ill or who suffer from a medical condi4 tion that is likely to be fatal.

5 (2) REQUIREMENTS.—Evaluations conducted

6 under this subsection shall include the following:

7 (A) Evidence that the evaluated program

8 implements practices or procedures that result

9 in improved patient outcomes, resource utiliza10 tion, or both.

11 (B) A definition of the population served

12 by the program and a determination as to how

13 accurately that population reflects the total

14 medicare beneficiaries in the area who are in

15 need of services offered by the program.

16 (C) A description of the eligibility require17 ments and enrollment procedures for the pro18 gram.

19 (D) A detailed description of the services

20 provided to medicare beneficiaries served by the

21 program and the utilization rates for such serv22 ices.

23 (E) A description of the structure for the

24 provision of specific services.
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1 (F) A detailed accounting of the costs of

2 providing specific services under the program.

3 (G) A description of any procedures for of4 fering medicare beneficiaries a choice of services

5 and how the program responds to the pref6 erences of the medicare beneficiaries served by

7 the program.

8 (H) An assessment of the quality of care

9 and of the outcomes for medicare beneficiaries

10 and the families of such beneficiaries served by

11 the program.

12 (I) An assessment of any ethical, cultural,

13 or legal concerns regarding the evaluated pro14 gram and with the replication of such program

15 in other settings.

16 (J) Identification of any changes to regula17 tions, or of any additional funding, that would

18 result in more efficient procedures or improved

19 outcomes, for the program.

20 (3) EXTERNAL EVALUATORS.—The Secretary

21 shall contract with 1 or more external evaluators to

22 coordinate and conduct the evaluations required

23 under this subsection and under subsection (c)(4).

24 (4) USE OF OUTCOME MEASURES AND STAND25 ARDS.—An evaluation conducted under this sub-
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1 section and subsection (c)(4) shall use the outcome

2 standards and measures required to be developed

3 under section 2 as soon as those standards and

4 measures are available.

5 (c) DEMONSTRATION PROJECTS.—

6 (1) AUTHORITY.—The Secretary, acting

7 through the Administrator of the Health Care Fi8 nancing Administration, shall conduct demonstration

9 projects to develop new and innovative approaches to

10 providing end-of-life care to medicare beneficiaries

11 who are seriously ill or who suffer from a medical

12 condition that is likely to be fatal.

13 (2) APPLICATION.—Any entity seeking to con14 duct a demonstration project under this subsection

15 shall submit to the Secretary an application in such

16 form and manner as the Secretary may require.

17 (3) SELECTION CRITERIA.—

18 (A) IN GENERAL.—In selecting entities to

19 conduct demonstration projects under this sub20 section, the Secretary shall select entities that

21 will allow for demonstration projects to be con22 ducted in a variety of States, in an array of

23 care settings, and that reflect—

24 (i) a balance between urban and rural

25 settings;
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1 (ii) cultural diversity; and

2 (iii) various modes of medical care

3 and insurance, such as fee-for-service, pre4 ferred provider organizations, health main5 tenance organizations, hospice care, home

6 care services, long-term care, and inte7 grated delivery systems.

8 (B) PREFERENCES.—The Secretary shall

9 give preference to applications for demonstra10 tion projects that—

11 (i) will serve medicare beneficiaries

12 who are dying of illnesses that are most

13 prevalent under the medicare program, in14 cluding cancer, heart failure, chronic ob15 structive respiratory disease, dementia,

16 stroke, and progressive multifactorial frail17 ty associated with advanced age; and

18 (ii) appear capable of sustained serv19 ice and broad replication at a reasonable

20 cost within commonly available organiza21 tional structures.

22 (4) EVALUATIONS.—Each demonstration

23 project conducted under this subsection shall be

24 evaluated at such regular intervals as the Secretary

25 determines are appropriate. An evaluation of a
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1 project conducted under this subsection shall include

2 the items described in subsection (b)(2) and the fol3 lowing:

4 (A) A comparison of the quality of care

5 and of the outcomes for medicare beneficiaries

6 and the families of such beneficiaries served by

7 the demonstration project to the quality of care

8 and outcomes for such individuals that would

9 have resulted if care had been provided under

10 existing delivery systems.

11 (B) An analysis of how ongoing measures

12 of quality and accountability for improvement

13 and excellence could be incorporated into the

14 demonstration project.

15 (C) A comparison of the costs of the care

16 provided to medicare beneficiaries under the

17 demonstration project to the costs of that care

18 if it had been provided under the medicare pro19 gram.

20 (5) WAIVER AUTHORITY.—The Secretary may

21 waive compliance with any of the requirements of ti22 tles XI, XVIII, and XIX of the Social Security Act

23 (42 U.S.C. 1301 et seq.; 1395 et seq.; 1396 et seq.)

24 which, if applied, would prevent a demonstration
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1 project carried out under this subsection from effec2 tively achieving the purpose of such a project.

3 (d) ANNUAL REPORTS TO CONGRESS.—

4 (1) IN GENERAL.—Beginning 1 year after the

5 date of enactment of this Act, and annually there6 after, the Secretary shall submit to Congress a re7 port on the quality of end-of-life care under the

8 medicare program, together with any suggestions for

9 legislation to improve the quality of such care under

10 that program.

11 (2) SUMMARY OF RECENT STUDIES.—A report

12 submitted under this subsection shall include a sum13 mary of any recent studies and advice from experts

14 in the health care field regarding the ethical, cul15 tural, and legal issues that may arise when attempt16 ing to improve the health care system to meet the

17 needs of individuals with serious and eventually fatal

18 illnesses.

19 (3) CONTINUATION OR REPLICATION OF DEM20 ONSTRATION PROJECTS.—Beginning 3 years after

21 the date of enactment of this Act, the report re22 quired under this subsection shall include rec23 ommendations regarding whether the demonstration

24 projects conducted under subsection (c) should be
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1 continued and whether broad replication of any of

2 those projects should be initiated.

3 (e) FUNDING.—The Secretary shall provide for the

4 transfer from the Federal Hospital Insurance Trust Fund

5 established under section 1817 of the Social Security Act

6 (42 U.S.C. 1395i) of such sums as are necessary for the

7 costs of conducting evaluations under subsection (b), con8 ducting demonstration projects under subsection (c), and

9 preparing and submitting the annual reports required

10 under subsection (d). Amounts may be transferred under

11 the preceding sentence without regard to amounts appro12 priated in advance in appropriations Acts.

13 SEC. 8. MEDICARE COVERAGE OF SELF-ADMINISTERED

14 MEDICATION FOR CERTAIN PATIENTS WITH

15 CHRONIC PAIN.

16 (a) IN GENERAL.—Section 1861(s)(2) of the Social

17 Security Act (42 U.S.C. 1395x(s)(2)) is amended—

18 (1) in subparagraph (S), by striking ‘‘and’’ at

19 the end;

20 (2) in subparagraph (T), by striking the period

21 at the end and inserting ‘‘; and’’; and

22 (3) by inserting after subparagraph (T) the fol23 lowing:

24 ‘‘(U) self-administered drugs which may be dis25 pensed only upon prescription and which are pre-
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1 scribed for the relief of chronic pain in patients with

2 a life-threatening disease or condition;’’.

3 (b) EFFECTIVE DATE.—The amendments made by

4 subsection (a) shall apply to items and services furnished

5 on or after January 1, 2000.

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