II

105TH CONGRESS

1ST SESSION S. 1345

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

OCTOBER 30, 1997

Mr. ROCKEFELLER (for himself and Ms. COLLINS) 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.

4 This Act may be cited as the ‘‘Advance Planning and

5 Compassionate Care Act of 1997’’.
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1 SEC. 2. EXPANSION OF ADVANCE DIRECTIVES.

2 (a) MEDICARE.—Section 1866(f) of the Social Secu3 rity Act (42 U.S.C. 1395cc(f)) (as amended by section

4 4641 of the Balanced Budget Act of 1997 (Public Law

5 105–33; 111 Stat. 487)) is amended—

6 (1) in paragraph (1)—

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

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

9 the content of such advance directive in a

10 prominent part of such record’’ before the semi11 colon;

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

13 ‘‘and’’ at the end;

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

15 period and inserting ‘‘; and’’; and

16 (D) by inserting after subparagraph (E)

17 the following:

18 ‘‘(F) to provide each individual with the oppor19 tunity to discuss issues relating to the information

20 provided to that individual pursuant to subpara21 graph (A) with an appropriately trained profes22 sional.’’; and

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

24 ‘‘(4)(A) An advance directive validly executed outside

25 of the State in which such advance directive is presented

26 by an adult individual to a provider of services or a pre-
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1 paid or eligible organization shall be given the same effect

2 by that provider or organization as an advance directive

3 validly executed under the law of the State in which it

4 is presented would be given effect.

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

6 to authorize the administration, withholding, or with7 drawal of health care unless it is consistent with the laws

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

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

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

11 such provisions. The provisions of this paragraph shall not

12 preempt any State law that provides for greater port13 ability, more deference to a patient’s wishes, or more lati14 tude in determining a patient’s wishes.’’.

15 (b) MEDICAID.—Section 1902(w) of the Social Secu16 rity Act (42 U.S.C. 1396a(w)) is amended—

17 (1) in paragraph (1)—

18 (A) in subparagraph (B)—

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

20 medical record’’ and inserting ‘‘in a promi21 nent part of the individual’s current medi22 cal record’’; and

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

24 the individual, to include the content of
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1 such advance directive in a prominent part

2 of such record’’ before the semicolon;

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

4 ‘‘and’’ at the end;

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

6 period and inserting ‘‘; and’’; and

7 (D) by inserting after subparagraph (E)

8 the following:

9 ‘‘(F) to provide each individual with the oppor10 tunity to discuss issues relating to the information

11 provided to that individual pursuant to subpara12 graph (A) with an appropriately trained profes13 sional.’’; and

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

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

16 of the State in which such advance directive is presented

17 by an adult individual to a provider or organization shall

18 be given the same effect by that provider or organization

19 as an advance directive validly executed under the law of

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

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

22 to authorize the administration, withholding, or with23 drawal of health care otherwise prohibited by the laws of

24 the State in which an advance directive is presented.
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1 ‘‘(C) The provisions of this paragraph shall preempt

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

3 such provisions. The provisions of this paragraph shall not

4 preempt any State law that provides for greater port5 ability, more deference to a patient’s wishes, or more lati6 tude in determining a patient’s wishes.’’.

7 (c) EFFECTIVE DATES.—

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

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

10 shall apply to provider agreements entered into, re11 newed, or extended under title XVIII of the Social

12 Security Act, and to State plans under title XIX of

13 such Act, on or after such date (not later than 1

14 year after the date of the enactment of this Act) as

15 the Secretary of Health and Human Services speci16 fies.

17 (2) EXTENSION OF EFFECTIVE DATE FOR

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

19 plan under title XIX of the Social Security Act

20 which the Secretary of Health and Human Services

21 determines requires State legislation in order for the

22 plan to meet the additional requirements imposed by

23 the amendments made by subsection (b), the State

24 plan shall not be regarded as failing to comply with

25 the requirements of such title solely on the basis of
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1 its failure to meet these additional requirements be2 fore the first day of the first calendar quarter begin3 ning after the close of the first regular session of the

4 State legislature that begins after the date of the

5 enactment of this Act. For purposes of the previous

6 sentence, in the case of a State that has a 2-year

7 legislative session, each year of the session is consid8 ered to be a separate regular session of the State

9 legislature.

10 SEC. 3. STUDY AND RECOMMENDATIONS TO CONGRESS ON

11 ISSUES RELATING TO ADVANCE DIRECTIVE

12 EXPANSION.

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

14 Services shall conduct a thorough study regarding the im15 plementation of the amendments made by section 2 of this

16 Act.

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

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

19 Human Services shall submit a report to Congress that

20 contains a detailed statement of the findings and conclu21 sions of the Secretary regarding the study conducted pur22 suant to subsection (a), together with the Secretary’s rec23 ommendations for such legislation and administrative ac24 tions as the Secretary considers appropriate.
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1 SEC. 4. STUDY AND LEGISLATIVE PROPOSAL TO CONGRESS.

2 (a) STUDY.—

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

4 Human Services shall conduct a thorough study of

5 all matters relating to the creation of a national uni6 form policy on advance directives for individuals re7 ceiving items and services under titles XVIII and

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

9 seq., 1396 et seq.).

10 (2) MATTERS STUDIED.—The matters studied

11 by the Secretary of Health and Human Services

12 shall include issues concerning—

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

14 treatment;

15 (B) the provision of adequate palliative

16 care including pain management;

17 (C) the portability of advance directives,

18 including the cases involving the transfer of an

19 individual from one health care setting to an20 other;

21 (D) immunity for health care providers

22 that follow the instructions in an individual’s

23 advance directive;

24 (E) exemptions for health care providers

25 from following the instructions in an individ26 ual’s advance directive;
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1 (F) conditions under which an advance di2 rective is operative;

3 (G) revocation of an advance directive by

4 an individual;

5 (H) the criteria for determining that an in6 dividual is in terminal status; and

7 (I) surrogate decision making regarding

8 end of life care.

9 (b) REPORT TO CONGRESS.—Not later than 1 year

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

11 Health and Human Services shall submit a report to Con12 gress that contains a detailed description of the results

13 of the study conducted pursuant to subsection (a).

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

15 developing the report under this section, the Secretary of

16 Health and Human Services shall consult with physicians

17 and other health care provider groups, consumer groups,

18 the Uniform Law Commissioners, and other interested

19 parties.

20 SEC. 5. DEVELOPMENT OF STANDARDS TO ASSESS END–OF–

21 LIFE CARE.

22 The Secretary of Health and Human Services,

23 through the Administrator of the Health Care Financing

24 Administration, the Director of the National Institutes of

25 Health, and the Administrator of the Agency for Health
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1 Care Policy and Research, shall develop outcome stand2 ards and measures to evaluate the performance of health

3 care programs and projects that provide end-of-life care

4 to individuals and the quality of such care.

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

6 LIFE DECISIONMAKING.

7 The Secretary of Health and Human Services,

8 through the Administrator of the Health Care Financing

9 Administration, shall establish and operate directly, or by

10 grant, contract, or interagency agreement, out of funds

11 otherwise appropriated to the Secretary, a clearinghouse

12 and 24-hour toll-free telephone hotline, to provide

13 consumer information about advance directives, as defined

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

15 1395cc(f)(3)), and end-of-life decisionmaking.

16 SEC. 7. EVALUATION OF AND DEMONSTRATION PROJECTS

17 FOR INNOVATIVE AND NEW APPROACHES TO

18 END–OF–LIFE CARE FOR MEDICARE BENE19 FICIARIES.

20 (a) DEFINITIONS.—In this section:

21 (1) MEDICARE BENEFICIARIES.—The term

22 ‘‘medicare beneficiaries’’ means individuals who are

23 entitled to benefits under part A or eligible for bene24 fits under part B of the medicare program.
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1 (2) MEDICARE PROGRAM.—The term ‘‘medicare

2 program’’ means the health care program under title

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

4 seq.).

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

6 the Secretary of Health and Human Services.

7 (b) EVALUATION OF EXISTING PROGRAMS.—

8 (1) IN GENERAL.—The Secretary, through the

9 Administrator of the Health Care Financing Admin10 istration, shall conduct ongoing evaluations of inno11 vative health care programs that provide end-of-life

12 care to medicare beneficiaries who are seriously ill or

13 who suffer from a medical condition that is likely to

14 be fatal.

15 (2) REQUIREMENTS.—Evaluations conducted

16 under this subsection shall include the following:

17 (A) Evidence that the evaluated program

18 implements practices or procedures that result

19 in improved patient outcomes, resource utiliza20 tion, or both.

21 (B) A definition of the population served

22 by the program and a determination as to how

23 accurately that population reflects the total

24 medicare beneficiaries in the area who are in

25 need of services offered by the program.
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1 (C) A description of the eligibility require2 ments and enrollment procedures for the pro3 gram.

4 (D) A detailed description of the services

5 provided to medicare beneficiaries served by the

6 program and the utilization rates for such serv7 ices.

8 (E) A description of the structure for the

9 provision of specific services.

10 (F) A detailed accounting of the costs of

11 providing specific services under the program.

12 (G) A description of any procedures for of13 fering medicare beneficiaries a choice of services

14 and how the program responds to the pref15 erences of the medicare beneficiaries served by

16 the program.

17 (H) An assessment of the quality of care

18 and of the outcomes for medicare beneficiaries

19 and the families of such beneficiaries served by

20 the program.

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

22 or legal concerns regarding the evaluated pro23 gram and with the replication of such program

24 in other settings.
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1 (J) Identification of any changes to regula2 tions, or of any additional funding, that would

3 result in more efficient procedures or improved

4 outcomes, for the program.

5 (3) EXTERNAL EVALUATORS.—The Secretary

6 shall contract with 1 or more external evaluators to

7 coordinate and conduct the evaluations required

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

9 (4) USE OF OUTCOME MEASURES AND STAND10 ARDS.—An evaluation conducted under this sub11 section and subsection (c)(4) shall use the outcome

12 standards and measures required to be developed

13 under section 5 as soon as those standards and

14 measures are available.

15 (c) DEMONSTRATION PROJECTS.—

16 (1) AUTHORITY.—The Secretary, through the

17 Administrator of the Health Care Financing Admin18 istration, shall conduct demonstration projects to de19 velop new and innovative approaches to providing

20 end-of-life care to medicare beneficiaries who are se21 riously ill or who suffer from a medical condition

22 that is likely to be fatal.

23 (2) APPLICATION.—Any entity seeking to con24 duct a demonstration project under this subsection
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1 shall submit to the Secretary an application in such

2 form and manner as the Secretary may require.

3 (3) SELECTION CRITERIA.—

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

5 conduct demonstration projects under this sub6 section, the Secretary shall select entities that

7 will allow for demonstration projects to be con8 ducted in a variety of States, in an array of

9 care settings, and that reflect—

10 (i) a balance between urban and rural

11 settings;

12 (ii) cultural diversity; and

13 (iii) various modes of medical care

14 and insurance, such as fee-for-service, pre15 ferred provider organizations, health main16 tenance organizations, hospice care, home

17 care services, long-term care, and inte18 grated delivery systems.

19 (B) PREFERENCES.—The Secretary shall

20 give preference to applications for demonstra21 tion projects that—

22 (i) will serve medicare beneficiaries

23 who are dying of illnesses that are most

24 prevalent under the medicare program, in25 cluding cancer, heart failure, chronic ob-
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1 structive respiratory disease, dementia,

2 stroke, and progressive multifactorial frail3 ty associated with advanced age; and

4 (ii) appear capable of sustained serv5 ice and broad replication at a reasonable

6 cost within commonly available organiza7 tional structures.

8 (4) EVALUATIONS.—Each demonstration

9 project conducted under this subsection shall be

10 evaluated at such regular intervals as the Secretary

11 determines are appropriate. An evaluation of a

12 project conducted under this subsection shall include

13 the items described in subsection (b)(2) and the fol14 lowing:

15 (A) A comparison of the quality of care

16 and of the outcomes for medicare beneficiaries

17 and the families of such beneficiaries served by

18 the demonstration project to the quality of care

19 and outcomes for such individuals that would

20 have resulted if care had been provided under

21 existing delivery systems.

22 (B) An analysis of how ongoing measures

23 of quality and accountability for improvement

24 and excellence could be incorporated into the

25 demonstration project.
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1 (C) A comparison of the costs of the care

2 provided to medicare beneficiaries under the

3 demonstration project to the costs of that care

4 if it had been provided under the medicare pro5 gram.

6 (5) WAIVER AUTHORITY.—The Secretary may

7 waive compliance with any requirement of titles XI,

8 XVIII, and XIX of the Social Security Act (42

9 U.S.C. 1301 et seq., 1395 et seq., 1396 et seq.)

10 which, if applied, would prevent a demonstration

11 project carried out under this subsection from effec12 tively achieving the purpose of such a project.

13 (d) ANNUAL REPORTS TO CONGRESS.—

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

15 date of enactment of this Act, and annually there16 after, the Secretary shall submit to Congress a re17 port on the quality of end-of-life care under the med18 icare program, together with any suggestions for leg19 islation to improve the quality of such care under

20 that program.

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

22 submitted under this subsection shall include a sum23 mary of any recent studies and advice from experts

24 in the health care field regarding the ethical, cul25 tural, and legal issues that may arise when attempt-
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1 ing to improve the health care system to meet the

2 needs of individuals with serious and eventually fatal

3 illnesses.

4 (3) CONTINUATION OR REPLICATION OF DEM5 ONSTRATION PROJECTS.—Beginning 3 years after

6 the date of enactment of this Act, the report re7 quired under this subsection shall include rec8 ommendations regarding whether the demonstration

9 projects conducted under subsection (c) should be

10 continued and whether broad replication of any of

11 those projects should be initiated.

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

13 transfer from the Federal Hospital Insurance Trust Fund

14 established under section 1817 of the Social Security Act

15 (42 U.S.C. 1395i) of such sums as are necessary for the

16 costs of conducting evaluations under subsection (b), con17 ducting demonstration projects under subsection (c), and

18 preparing and submitting the annual reports required

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

20 the preceding sentence without regard to amounts appro21 priated in advance in appropriations Acts.
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1 SEC. 8. MEDICARE COVERAGE OF SELF-ADMINISTERED

2 MEDICATION FOR CERTAIN PATIENTS WITH

3 CHRONIC PAIN.

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

5 Security Act (42 U.S.C. 1395x(s)(2)) (as amended by sec6 tion 4557 of the Balanced Budget Act (Public Law 105–

7 33; 111 Stat. 463)) is amended—

8 (1) by striking ‘‘and’’ at the end of subpara9 graph (S);

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

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

12 (3) by inserting after subparagraph (T) the fol13 lowing:

14 ‘‘(U) self-administered drugs which may be dis15 pensed only upon prescription and which are pre16 scribed for the relief of chronic pain in patients with

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

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

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

20 on or after June 1, 1998.

Æ