II 

108TH CONGRESS 

1ST SESSION S. 2003

To amend the Public Health Service Act to promote higher quality health 

care and better health by strengthening health information, information 

infrastructure, and the use of health information by providers and patients. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 9, 2003

Mrs. CLINTON introduced the following bill; which was read twice and referred 

to the Committee on Finance 

A BILL

To amend the Public Health Service Act to promote higher 

quality health care and better health by strengthening 

health information, information infrastructure, and the 

use of health information by providers and patients.

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 ‘‘Health Information for Quality Improvement Act’’. 

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

7 this Act is as follows:

Sec. 1. Short title; table of contents. 
2

•S 2003 IS 

Sec. 2. Findings and purpose. 

TITLE I—INFORMATION TECHNOLOGY 

Sec. 101. Information infrastructure improvement. 

‘‘Sec. 918. National healthcare information infrastructure. 

‘‘Sec. 919. Data and communications standards for interoperability. 

‘‘Sec. 920. Grants to hospitals and other health care providers for information technologies. 

Sec. 102. Improving clinical practice and reducing barriers to information technology. 

‘‘Sec. 409J. Research on information technology and other systems-based 

approaches to changing clinical practice. 

‘‘Sec. 478B. Certification of information websites. 

TITLE II—INCREASED EVIDENCE-BASE FOR QUALITY 

IMPROVEMENT AND MEASUREMENT 

Sec. 201. Coverage for individuals participating in approved clinical trials. 

Sec. 202. Grants for primary care research for older patients. 

Sec. 203. Study on effectiveness of certain prescription drugs. 

TITLE III—MEASURING AND COMPARING QUALITY 

Sec. 301. Priority area quality indicators. 

Sec. 302. Standardized quality indicators for Federal agencies. 

Sec. 303. Demonstration program for community health care quality data reporting. 

Sec. 304. Demonstration project for the collection of data on race and ethnicity. 

TITLE IV—PRODUCTION, EVALUATION, AND DISTRIBUTION OF 

PRACTICE GUIDELINES FOR CARE 

Sec. 401. Production, evaluation, and distribution of practice guidelines for 

care. 

TITLE V—REWARDING QUALITY 

Sec. 501. Institute of medicine report on payment incentives and performance. 

TITLE VI—INFORMATION TO CONSUMERS 

Sec. 601. Dissemination of information to consumers. 

TITLE VII—PROMOTING PATIENT ENGAGEMENT 

Sec. 701. Promoting patient engagement.

1 SEC. 2. FINDINGS AND PURPOSE. 

2 (a) FINDINGS.—Congress makes the following find3 ings: 

4 (1) In spite of the best intentions of clinicians 

5 and patients, the United States health care system 
3

•S 2003 IS 

1 is plagued with underuse, overuse, and misuse. Only 

2 about 50 percent of health care treatments of serv3 ices that are known to be effective are provided. At 

4 the same time, only 20 percent of the treatments 

5 and services that are provided are supported by sci6 entific evidence. 

7 (2) The pace of the dissemination of new evi8 dence relating to appropriate health care treatments 

9 and services is shockingly slow. It may take up to 

10 15 years for treatments found to be effective to be11 come common practice. 

12 (3) These problems cannot be redressed until 

13 the United States has the right information and that 

14 information is provided to the right people at the 

15 right time. 

16 (b) PURPOSE.—It is the purpose of this Act to pro17 mote higher quality health care and better health by 

18 strengthening health information, its infrastructure, and 

19 its use by clinicians and consumers. 

20 TITLE I—INFORMATION 

21 TECHNOLOGY 

22 SEC. 101. INFORMATION INFRASTRUCTURE IMPROVEMENT. 

23 (a) IN GENERAL.—Part B of title IX of the Public 

24 Health Service Act (42 U.S.C. 299b et seq) is amended 

25 by adding at the end the following: 
4

•S 2003 IS 

1 ‘‘SEC. 918. NATIONAL HEALTHCARE INFORMATION INFRA2 STRUCTURE. 

3 ‘‘(a) IN GENERAL.—By not later than 6 months after 

4 the date of the enactment of this Act, the Secretary shall 

5 establish within the Office of the Secretary an Office of 

6 National Healthcare Information Infrastructure (in this 

7 section referred to as the ‘Office’). The Office shall be 

8 headed by a Director who shall report directly to the Sec9 retary and who shall be responsible for providing ongoing 

10 national leadership in the planning, development, and 

11 adoption of a national healthcare information infrastruc12 ture. The Office shall, in cooperation with key stake13 holders, develop a strategic plan to create a comprehensive 

14 national healthcare information infrastructure that en15 compasses public-sector and private-sector health informa16 tion activities, and that includes a national agenda to 

17 guide policymaking, technology investments, research, and 

18 integration with ongoing health care and health care infor19 mation technology activities. 

20 ‘‘(b) GOALS.—The goals of the national healthcare 

21 information infrastructure are—

22 ‘‘(1) to maximize positive outcomes in clinical 

23 care; 

24 ‘‘(2) to minimize preventable medical errors, es25 pecially in hospitals and in the administration of 

26 contraindicated drugs; 
5

•S 2003 IS 

1 ‘‘(3) to reduce redundant paperwork, such as 

2 the repeated taking of patient histories; 

3 ‘‘(4) to decrease costs from duplicative or other4 wise unnecessary testing or procedures; and 

5 ‘‘(5) to establish a compatible information tech6 nology architecture that facilitates future quality 

7 and cost-saving needs and that avoids the financing 

8 and development of information technology systems 

9 that are not readily compatible. 

10 ‘‘(c) COLLABORATION WITH STAKEHOLDERS.—

11 ‘‘(1) IN GENERAL.—The Secretary shall assure 

12 that activities of the Department of Health and 

13 Human Services that relate to the national 

14 healthcare information infrastructure are under15 taken after consultation with and based on the rec16 ommendations of the parties described in paragraph 

17 (3). 

18 ‘‘(2) PERIODIC MEETINGS.—The Secretary, 

19 through the Office, shall convene as a group the par20 ties described in paragraph (3). Such group shall 

21 meet periodically and collaborate to make rec22 ommendations to the Office and the Secretary on 

23 the matters described in subsection (d). 

24 ‘‘(3) PARTIES REPRESENTED.—The parties de25 scribed in this paragraph are the following:
6

•S 2003 IS 

1 ‘‘(A) The National Committee on Vital and 

2 Health Statistics. 

3 ‘‘(B) Experts from the fields of healthcare 

4 information, information technology, medical 

5 continuous quality improvement, and medical 

6 records security and privacy. 

7 ‘‘(C) Representatives from individual and 

8 institutional health care clinical providers, in9 cluding teaching hospitals, children’s hospitals, 

10 and small hospitals. 

11 ‘‘(D) Clinical and health services research12 ers. 

13 ‘‘(E) Health care purchasers. 

14 ‘‘(F) One or more representatives of clin15 ical professional societies or associations. 

16 ‘‘(G) Representatives of private organiza17 tions with expertise in medical informatics. 

18 ‘‘(H) One or more representatives of pa19 tient groups. 

20 ‘‘(I) One ore more representatives from 

21 State or local public health departments. 

22 ‘‘(J) One or more representatives of the 

23 health care information technology industry and 

24 national alliances formed to achieve standards25 based health care information systems. 
7

•S 2003 IS 

1 ‘‘(K) Appropriate staff experts from Fed2 eral agencies, including those within the De3 partment of Health and Human Services and 

4 the Department of Veterans Affairs. 

5 ‘‘(d) DUTIES.—In carrying out subsection (a), the 

6 Office shall make recommendations to and advise the Sec7 retary on the following, in order to promote the goals de8 scribed in subsection (b): 

9 ‘‘(1)(A) An assessment of the best current prac10 tices in the development, purchase, and maintenance 

11 of medical information technology. 

12 ‘‘(B) Recommendations, and the specifications, 

13 for a uniform healthcare information system inter14 face, and methods for its adoption (not later than 2 

15 years after the date of the enactment of this Act) to 

16 ensure compatibility between and among old and 

17 new information systems. 

18 ‘‘(C) Recommendations for health care data 

19 standards (such as vocabulary and messaging), com20 munications standards, and other medical standards 

21 (including a common lexicon) necessary to achieve 

22 the interoperability of healthcare information sys23 tems. 

24 ‘‘(2) Coordination of the evolution of the na25 tional healthcare information infrastructure and 
8

•S 2003 IS 

1 working with other key stakeholders in the public 

2 and private sectors to develop a strategic plan that 

3 will ensure the interoperability of all elements of 

4 such infrastructure. 

5 ‘‘(3) Coordination of spending across Federal 

6 agencies relating to the establishment of such infra7 structure. 

8 ‘‘(4) Development of policies to ensure compli9 ance with the security and confidentiality standards 

10 of this part C for protected health information and 

11 promote patient control of protected health informa12 tion. 

13 ‘‘(5) Ensure thorough testing of data and com14 munications standards prior to their adoption. 

15 ‘‘(e) DETAIL OF FEDERAL EMPLOYEES.—Upon the 

16 request of the Secretary, the head of any Federal agency 

17 is authorized to detail, without reimbursement from the 

18 Office, any of the personnel of such agency to the Office 

19 to assist it in carrying out its duties under this section. 

20 Any such detail shall not interrupt or otherwise affect the 

21 civil service status or privileges of the Federal employee. 

22 ‘‘SEC. 919. DATA AND COMMUNICATIONS STANDARDS FOR 

23 INTEROPERABILITY. 

24 ‘‘(a) IN GENERAL.—By not later than 2 years after 

25 the date of the enactment of this Act, the Secretary shall 
9

•S 2003 IS 

1 as needed adopt (and shall periodically review, update, and 

2 expand) a set of voluntary, national data and communica3 tions standards that promote the interoperability of health 

4 care information technology systems across all public and 

5 private health care settings. In adopting such standards, 

6 the Secretary shall ensure that such standards are de7 signed and are carefully monitored to ensure that linkage 

8 of data resulting from such interoperability does not com9 promise privacy and security. The Secretary shall take 

10 into account—

11 ‘‘(1) the ability of such standards to enable 

12 clinically-specific data collection in order to promote 

13 evidence-based medicine and the electronic exchange 

14 of patient medical record information; and 

15 ‘‘(2) the costs of compliance and the savings 

16 and other benefits from improved efficiency and 

17 quality in health care delivery. 

18 ‘‘(b) REPORTS.—

19 ‘‘(1) INITIAL REPORT.—No later than 12 

20 months after the date of the enactment of this Act, 

21 the Secretary shall submit to Congress a comprehen22 sive national healthcare information infrastructure 

23 strategic plan that includes—
10

•S 2003 IS 

1 ‘‘(A) a survey of health care information 

2 technology standards being developed by private 

3 sector and public-private groups; 

4 ‘‘(B) recommendations for accelerating the 

5 development of common health care vocabulary 

6 standards; 

7 ‘‘(C) recommendations for completing de8 velopment of health care information system 

9 messaging standards; and 

10 ‘‘(D) progress toward meeting the deadline 

11 described in section 2(d)(1)(B) for adoption of 

12 methods described in such paragraph (relating 

13 to a uniform system interface). 

14 ‘‘(2) SUBSEQUENT REPORTS.—During each of 

15 the 2 years after the year in which the report is sub16 mitted under paragraph (1), the Secretary shall sub17 mit to Congress an annual report relating to addi18 tional recommendations, best practices, results of in19 formation technology improvements, analyses of pri20 vate sector efforts to implement the data and com21 munications standards established under this sec22 tion, and such other matters as may help ensure the 

23 most rapid dissemination of best practices in health 

24 care information technology.
11

•S 2003 IS 

1 ‘‘(c) CONTRACT AUTHORITY.—The Secretary is au2 thorized—

3 ‘‘(1) to enter into contracts for services and ac4 tivities necessary to carry out this section and sec5 tion 918; and 

6 ‘‘(2) to the extent practicable, to test the stand7 ards under consideration under this section. 

8 ‘‘(d) DISSEMINATION.—The Secretary shall provide 

9 for the maintenance and dissemination of the standards 

10 developed and updated under this section. 

11 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated such sums as may be 

13 necessary for each fiscal year to carry out this section and 

14 section 918. 

15 ‘‘SEC. 920. GRANTS TO HOSPITALS AND OTHER HEALTH 

16 CARE PROVIDERS FOR INFORMATION TECH17 NOLOGIES. 

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

19 with the Director of the Agency for Healthcare Research 

20 and Quality, shall award grants to hospitals and other 

21 health care providers (but not more than 1 such grant may 

22 be awarded to any 1 hospital or provider) to pay the costs 

23 of acquiring or implementing information technologies—

24 ‘‘(1) to improve quality of care and patient 

25 safety; and 
12

•S 2003 IS 

1 ‘‘(2) to reduce adverse events and health care 

2 complications resulting from medication errors. 

3 ‘‘(b) SPECIAL CONSIDERATIONS.—In awarding 

4 grants under subsection (a), the Secretary shall give spe5 cial consideration to applicants who seek to promote the 

6 following: 

7 ‘‘(1) Interoperability across hospital services or 

8 departments using standards referred to in section 

9 919. 

10 ‘‘(2) Electronic communication of patient data 

11 across the spectrum of health care delivery. 

12 ‘‘(3) Computerized physician order entry or bar 

13 coding applications. 

14 ‘‘(4) Electronic communication of patient data 

15 in hospitals that provide services to underserved or 

16 low-income populations. 

17 ‘‘(5) Improved clinical decisionmaking through 

18 the acquisition and implementation of decision-sup19 port technologies. 

20 ‘‘(6) The sharing by hospitals of electronic 

21 health records with patients. 

22 ‘‘(c) CERTAIN GRANT CONDITIONS.—A condition for 

23 the receipt of a grant under subsection (a) is that the ap24 plicant involved meet the following requirements: 

25 ‘‘(1) The applicant agrees—
13

•S 2003 IS 

1 ‘‘(A) to carry out a program to measure, 

2 analyze, and report patient safety and medical 

3 errors at the hospital or other health care pro4 vider involved to patient safety organizations; 

5 ‘‘(B) to submit to the Secretary a descrip6 tion of the methodology that will be used for 

7 such program; and 

8 ‘‘(C) to have such program in effect as 

9 soon as practicable after the application for the 

10 grant is approved, without regard to whether 

11 information technologies under the grant have 

12 been implemented. 

13 ‘‘(2) The applicant has—

14 ‘‘(A) arranged for an evaluation that ad15 dresses the effectiveness and cost-effectiveness 

16 of the information technology for which the 

17 grant is provided and its impact on the quality 

18 and safety of patient care; 

19 ‘‘(B) submitted the evaluation plan to the 

20 Secretary; and 

21 ‘‘(C) received approval from the Secretary 

22 of the methodology described in the plan. 

23 ‘‘(3) The applicant has or is developing a pa24 tient safety evaluation system for reporting health 

25 care errors to a patient safety organization. 
14

•S 2003 IS 

1 ‘‘(4) The applicant agrees to provide the Sec2 retary with such information as the Secretary may 

3 require regarding the use of funds under this pro4 gram or its impact. 

5 ‘‘(5) The applicant provides assurances satisfac6 tory to the Secretary that any information tech7 nology planned, acquired, or implemented with grant 

8 funds under this section will be part of an informa9 tion program that—

10 ‘‘(A) carries out the purposes described in 

11 subsection (a); and 

12 ‘‘(B) is comprehensive or will be expanded 

13 to become comprehensive, regardless of whether 

14 Federal assistance is available for such expan15 sion. 

16 ‘‘(d) TECHNICAL ASSISTANCE TO GRANTEES.—The 

17 Secretary, acting through the Director, shall provide tech18 nical assistance to applicants and grantees to ensure the 

19 appropriate evaluation of the information technologies for 

20 which grants are awarded under this section, such as—

21 ‘‘(1) reviewing and providing technical assist22 ance on the applicant’s proposed evaluation; 

23 ‘‘(2) developing mechanisms to ensure ongoing 

24 communications between grantees and evaluators to 

25 facilitate the identification and resolution of prob-
15

•S 2003 IS 

1 lems as they arise, ensure mutual learning, and pro2 mote the rapid dissemination of information; 

3 ‘‘(3) reviewing the interim and final reports re4 quired under subsection (e); and 

5 ‘‘(4) disseminating evidence-based information 

6 in interim and final reports to patient safety organi7 zations, as appropriate. 

8 ‘‘(e) EVALUATION REPORTS BY GRANTEE.—

9 ‘‘(1) IN GENERAL.—A condition for the receipt 

10 of a grant under subsection (a) is that the applicant 

11 agree to submit an interim and a final report to the 

12 Secretary in accordance with this subsection. 

13 ‘‘(2) INTERIM REPORT.—Not later than 1 year 

14 after the implementation of information technologies 

15 under a grant under this section is completed, the 

16 applicant shall submit an interim report to the Sec17 retary describing the initial effectiveness of such 

18 technologies in carrying out the purposes described 

19 in subsection (a). 

20 ‘‘(3) FINAL REPORT.—Not later than 3 years 

21 after the implementation of information technologies 

22 under a grant under this section is completed, the 

23 applicant shall submit a final report to the Secretary 

24 describing the effectiveness and cost-effectiveness of 

25 such technologies and addressing other issues deter-
16

•S 2003 IS 

1 mined to be important in carrying out the purposes 

2 described in subsection (a). 

3 ‘‘(4) RELATION TO DISBURSEMENT OF

4 GRANT.—In making payments under a grant under 

subsection (a), the Secretary shall withhold 1 5 ⁄3 of the 

6 amount of the grant until the grantee submits to the 

7 Secretary the report required under paragraph (2). 

8 ‘‘(f) REPORTS BY THE SECRETARY.—

9 ‘‘(1) INTERIM REPORTS.—

10 ‘‘(A) IN GENERAL.—Through the fiscal 

11 year preceding the fiscal year in which the final 

12 report under paragraph (2) is prepared, the 

13 Secretary shall submit to the Committee on En14 ergy and Commerce of the House of Represent15 atives and the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate peri17 odic reports on the grant program under sub18 section (a). Such reports shall be submitted not 

19 less frequently than once each fiscal year, be20 ginning with fiscal year 2004. 

21 ‘‘(B) CONTENTS.—A report under sub22 paragraph (A) shall include information on—

23 ‘‘(i) the number of grants awarded;
17

•S 2003 IS 

1 ‘‘(ii) the nature of the projects for 

2 which funding is provided under the grant 

3 program; 

4 ‘‘(iii) the geographic distribution of 

5 grant recipients; and 

6 ‘‘(iv) such other matters as the Sec7 retary determines appropriate. 

8 ‘‘(2) FINAL REPORT.—Not later than 180 days 

9 after the date on which the last of the reports is due 

10 under subsection (e)(3), the Secretary shall submit 

11 a final report to the committees referred to in para12 graph (1)(A) on the grant program under subsection 

13 (a), together with such recommendations for legisla14 tion and administrative action as the Secretary de15 termines appropriate. 

16 ‘‘(g) DEFINITIONS.—In this section: 

17 ‘‘(1) COSTS.—The term ‘costs’, with respect to 

18 information technologies referred to in subsection 

19 (a), includes total expenditures incurred for—

20 ‘‘(A) purchasing, leasing, and installing 

21 computer software and hardware, including 

22 hand-held computer technologies; 

23 ‘‘(B) making improvements to existing 

24 computer software and hardware; and 
18

•S 2003 IS 

1 ‘‘(C) purchasing or leasing communications 

2 capabilities necessary for clinical data access, 

3 storage, and exchange. 

4 ‘‘(2) HEALTH CARE PROVIDER.—The term 

5 ‘health care provider’ includes a physician or other 

6 health care professional, as well as an institutional 

7 or other facility or agency that provides health care 

8 services and that is licensed, accredited, or certified 

9 to provide health care items and services under ap10 plicable State law. 

11 ‘‘(h) TERMINATION OF GRANT AUTHORITIES.—The 

12 authority of the Secretary to award grants under sub13 section (a) terminates upon the expiration of fiscal year 

14 2011. 

15 ‘‘(i) MATCHING FUNDS.—

16 ‘‘(1) IN GENERAL.—With respect to the costs of 

17 a grant to be carried out under this section, such 

18 grant may be made only if the applicant agrees to 

19 make available (directly or through donations from 

20 public or private entities) non-Federal contributions 

21 toward such costs in an amount that is not less than 

22 50 percent of such costs ($1 for each $1 of Federal 

23 funds provided under the grant). 

24 ‘‘(2) DETERMINATION OF AMOUNTS CONTRIB25 UTED.—Amounts provided by the Federal Govern-
19

•S 2003 IS 

1 ment, or services assisted or subsidized to any sig2 nificant extent by the Federal Government, may not 

3 be included in determining the amount of such non4 Federal contributions. 

5 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—For the 

6 purpose of carrying out this section, there are authorized 

7 to be appropriated $20,000,000 for each of fiscal years 

8 2004 and 2005.’’. 

9 (b) UNDERSTANDING BARRIERS TO INFORMATION

10 TECHNOLOGY ADOPTION AND EFFECTIVE USE.—Section 

11 914(a) of the Public Health Service Act (42 U.S.C. 299b–

12 3(a)) is amended—

13 (1) in paragraph (6), by striking ‘‘and’’ at the 

14 end; 

15 (2) in paragraph (7), by striking the period and 

16 inserting ‘‘; and’’; and 

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

18 ‘‘(8) and understand the barriers to information 

19 technology adoption and effective use as well as 

20 methods to overcome those barriers.’’. 

21 SEC. 102. IMPROVING CLINICAL PRACTICE AND REDUCING 

22 BARRIERS TO INFORMATION TECHNOLOGY. 

23 (a) IMPROVING CLINICAL PRACTICES.—

24 (1) TELEMEDICINE.—
20

•S 2003 IS 

1 (A) LICENSING.—Section 1834(m)(4)(C)(i) 

2 of the Social Security Act (42 U.S.C. 

3 1395m(m)(4)(C)(i)) is amended—

4 (i) in subclause (II), by striking ‘‘or’’ 

5 at the end; 

6 (ii) in subclause (III), by striking the 

7 period and inserting ‘‘; or’’; and 

8 (iii) by adding at the end the fol9 lowing: 

10 ‘‘(IV) in a State in which the re11 spective State medical board has 

12 adopted a formal policy regarding li13 censing or certification requirements 

14 for providers at distant sites who do 

15 not have a license to practice medicine 

16 at the originating site.’’. 

17 (B) EXPANDING ELIGIBILITY FOR REIM18 BURSEMENT.—Section 1834(m)(4)(C)(i)(I) (42 

19 U.S.C. 1395m(m)(4)(C)(i)(I)) is amended by 

20 striking ‘‘rural’’. 

21 (2) CLINICAL TRIALS FOR INFORMATION AND

22 SYSTEMS TECHNOLOGY IN ADDITION TO MEDICAL

23 TECHNOLOGY.—

24 (A) FINDINGS.—Congress makes the fol25 lowing findings: 
21

•S 2003 IS 

1 (i) An estimated 80,000 to 100,000 

2 patients die every year from errors suf3 fered during hospitalization. 

4 (ii) Many of these errors could have 

5 been avoided with changes to the system of 

6 health care delivery. 

7 (iii) These systemwide changes have 

8 the potential to decrease the cost of pro9 viding health care and to increase the qual10 ity of services provided. 

11 (iv) These improvements in cost and 

12 quality can be as dramatic as improve13 ments seen with new medical technology or 

14 pharmaceutical advances. 

15 (v) Currently new medical devices and 

16 medications undergo rigorous randomized 

17 controlled clinical trials to document their 

18 effect on a patient’s health. 

19 (vi) These clinical trials form the 

20 basis for providers to practice evidence21 based medicine and to change their prac22 tices to improve their patients’ outcomes. 

23 (vii) Similar controlled clinical studies 

24 of new information technologies and sys25 tems-based approaches to changing prac-
22

•S 2003 IS 

1 tice can help providers implement systems2 based measures to improve outcomes. 

3 (B) RESEARCH ON INFORMATION TECH4 NOLOGY AND OTHER SYSTEMS-BASED AP5 PROACHES TO CHANGING CLINICAL PRAC6 TICE.—Part B of title IV of the Public Health 

7 Service Act (42 U.S.C. 284 et seq.) is amended 

8 by adding at the end the following: 

9 ‘‘SEC. 409J. RESEARCH ON INFORMATION TECHNOLOGY 

10 AND OTHER SYSTEMS-BASED APPROACHES 

11 TO CHANGING CLINICAL PRACTICE. 

12 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

13 through the Director of the Agency for Healthcare Re14 search and Quality and in collaboration with the Director 

15 of NIH, shall establish a Medical Systems Safety Initiative 

16 (referred to in this section as the ‘Initiative’) to conduct 

17 and support research regarding information technology 

18 and other systems-based approaches to improving and ad19 vancing medical care. 

20 ‘‘(b) PURPOSE.—The purpose of the Initiative is to 

21 enable the Director of the Agency for Healthcare Research 

22 and Quality and the Director of NIH—

23 ‘‘(1) to conduct and support research (including 

24 both intramural and extramural research), research 

25 training, the dissemination of health information,
23

•S 2003 IS 

1 and other programs with respect to systems re2 search, user-centered design, and human factors en3 gineering (including research related to information 

4 technology) to realize the expanding opportunities 

5 for improving health outcomes through the analysis 

6 and redesign of medical systems; 

7 ‘‘(2) to enhance collaborative efforts among 

8 Federal agencies to conduct and support multidisci9 plinary research in the areas that the Director deter10 mines to be most promising; and 

11 ‘‘(3) to encourage and support studies, includ12 ing clinical studies, to provide scientifically and sta13 tistically rigorous and meaningful information about 

14 the utility and effectiveness of various systems-based 

15 interventions, including information technology de16 velopments. 

17 ‘‘(c) APPROPRIATE SCIENTIFIC EXPERTISE AND CO18 ORDINATION WITH FEDERAL AGENCIES.—The Director 

19 of the Agency for Healthcare Research and Quality and 

20 the Director of NIH shall ensure that scientists with ap21 propriate expertise in research on health systems, informa22 tion technology, user-centered design, and human factors 

23 engineering are incorporated into the review, oversight, 

24 and management processes of all research projects and 

25 other activities funded by the Initiative. In carrying out 
24

•S 2003 IS 

1 this subsection, the Directors, as necessary, may establish 

2 review groups with appropriate scientific expertise. The 

3 Directors shall coordinate efforts with other Federal agen4 cies to ensure appropriate scientific input and manage5 ment. 

6 ‘‘(d) DEFINITIONS.—In this section: 

7 ‘‘(1) HUMAN FACTORS ENGINEERING.—The 

8 term ‘human factors engineering’ means the study 

9 and optimization of the interaction of humans, ma10 chines, and the environment to achieve the perform11 ance objectives of a given health care workplace. 

12 ‘‘(2) SYSTEMS RESEARCH.—The term ‘systems 

13 research’ means research into the organization and 

14 design of the work environment within a health care 

15 setting, and their effects on health outcomes, as well 

16 as research to improve such designs so as to improve 

17 health outcomes.’’. 

18 (b) IMPROVING AND PROMOTING ELECTRONIC

19 HEALTH RECORDS.—

20 (1) AUTHENTICATION STANDARDS.—The Direc21 tor of the National Center for Vital and Health Sta22 tistics shall provide assistance to the Secretary of 

23 Health and Human Services in the development of 

24 authentication standards for health records. In de-
25

•S 2003 IS 

1 veloping such standards, the Secretary shall take 

2 into consideration the following: 

3 (A) Recommendations for authentication 

4 technology and identification information stand5 ards that—

6 (i) provide for the reliable identifica7 tion and retrieval of a patient’s electronic 

8 health data; 

9 (ii) allow the patient to have detailed 

10 control over the access of individual com11 ponents of his or her electronic health 

12 record by being able to specify specific pro13 viders, each of whom will have access to 

14 limited portions of the electronic health 

15 record; 

16 (iii) minimize security risks, including 

17 the potential for—

18 (I) the patient to misrepresent 

19 his or her true identity; 

20 (II) a health care provider to ac21 cess data for which the patient has 

22 not consented to grant such access; 

23 (III) a third party to access iden24 tification information; or 
26

•S 2003 IS 

1 (IV) a third party to circumvent 

2 or exploit the authentication process 

3 in order to access electronic health 

4 data without the consent of the pa5 tient; 

6 (iv) allow for the timely and conven7 ient creation of identification information 

8 at the time of contact between a patient 

9 and a provider, so as to minimize any dis10 ruption or delay in the provision of needed 

11 medical services to a patient who does not 

12 already have identification information; 

13 and 

14 (v) maximize the probability of accu15 rate identification, secure authentication, 

16 and rapid access to health data even in sit17 uations where the patient—

18 (I) does not possess the identi19 fication information that is usually re20 quired for successful authentication, 

21 but wishes to grant consent to the 

22 provider to access necessary health 

23 data; 

24 (II) possesses the identification 

25 information but is not able to provide 
27

•S 2003 IS 

1 consent for the emergency access of 

2 health data due to incapacitation; and 

3 (III) is not able to provide identi4 fication information nor consent for 

5 emergency data access due to inca6 pacitation. 

7 (2) FRAUD AND ABUSE.—Section 1128D of the 

8 Social Security Act (42 U.S.C. 1320a–7d) is amend9 ed—

10 (1) in subsection (a)(2), by adding at the end 

11 the following: 

12 ‘‘(J) The arrangements and information 

13 exchange allowed for the purposes of promoting 

14 the use of electronic health records, including 

15 personal health records.’’; and 

16 (2) in subsection (b)(2), by adding at the end 

17 the following: 

18 ‘‘(F) Whether the arrangements and infor19 mation exchange allowed for the purposes of 

20 promoting the use of electronic health records, 

21 including personal health records achieve their 

22 purposes.’’. 

23 (3) PERSONAL HEALTH RECORD.—

24 (A) FEDERAL HEALTH INFORMATION EX25 CHANGE STANDARDS INITIATIVE.—The Sec-
28

•S 2003 IS 

1 retary of Health and Human Services, the Sec2 retary of Defense, and the Secretary of Vet3 erans’ Affairs, in carrying out activities under 

4 the Federal e-Goverment Health Information 

5 Exchange Standards Initiative, shall develop, 

6 implement, and evaluate procedures and meth7 ods to enable patients to access and append to 

8 their personal health data through personal 

9 health records that—

10 (i) include the capability for patients 

11 to append to their electronic record infor12 mation about—

13 (I) illnesses for which the patient 

14 did not seek professional medical care; 

15 (II) health information not re16 lated to a specific disease, episode, or 

17 illness; and 

18 (III) information related to the 

19 correction of errors of omission and 

20 commission; and 

21 (ii) permit patients convenient access 

22 to their full electronic medical record and 

23 permit them to share data with their pro24 viders. 

25 (B) MEDICAL TRANSLATION RESEARCH.—
29

•S 2003 IS 

1 (i) IN GENERAL.—The Director of the 

2 Agency for Healthcare Research and Qual3 ity shall award grants to public and non4 profit private entities for the conduct of re5 search on innovative approaches to improve 

6 patients’ understanding and comprehension 

7 of their electronic health record. Research 

8 areas may include technology for the auto9 mated—

10 (I) translation of medical infor11 mation to improve patient comprehen12 sion; 

13 (II) reorganization of the elec14 tronic health record for improved util15 ity for the patient; and 

16 (III) integration of links to rel17 evant information from other sources 

18 into the electronic health record. 

19 (ii) MERIT REVIEW; COMPETITION.—

20 Grants shall be awarded under this sub21 paragraph on a merit-reviewed competitive 

22 basis. 

23 (iii) AUTHORIZATION OF APPROPRIA24 TIONS.—There are authorized to be appro25 priated to the Agency for Healthcare Re-
30

•S 2003 IS 

1 search and Quality to carry out this sub2 paragraph $5,000,000 for fiscal year 2004, 

3 and such sums as may be necessary for 

4 each fiscal year thereafter. 

5 (3) DEFINITIONS.—In this subsection: 

6 (A) IDENTIFICATION INFORMATION.—The 

7 term ‘‘identification information’’ with respect 

8 to the health records of a patient, means any 

9 data necessary to reliably associate a patient 

10 with their health data. 

11 (B) AUTHENTICATION.—The term ‘‘au12 thentication’’ means the process of using the 

13 identification information to validate the pa14 tient’s identification and gain access to his or 

15 her electronic health data. 

16 (c) IMPROVING INFORMATION TECHNOLOGY INFRA17 STRUCTURE IN THE BASIC LIFE SCIENCES.—Not later 

18 than 18 months after the date of enactment of this Act, 

19 the Director of the National Institute of General Medical 

20 Sciences shall submit to Congress a report on the activities 

21 of the Biomedical Information Science and Technology 

22 Initiative. Such report shall include—

23 (1) a description of current activities of the 

24 Biomedical Information Science and Technology Ini25 tiative Consortium; 
31

•S 2003 IS 

1 (2) a summary of recently completed and ongo2 ing grant programs; and 

3 (3) recommendations for the further advance4 ment of the Biomedical Information Science and 

5 Technology Initiative and bioinformatics and com6 putational biology research in general. 

7 (d) ELECTRONIC BILLING.—

8 (1) IN GENERAL.—The Director of the Centers 

9 for Medicare & Medicaid Services shall conduct a 

10 demonstration project to test and evaluate a process 

11 to certify software programs that analyze medical 

12 records or other health care provider documentation 

13 to determine appropriate billing categories for each 

14 medicare billing criteria under title XVIII of the So15 cial Security Act (42 U.S.C. 1395 et seq.). 

16 (2) USE OF APPROVED SOFTWARE.—If the Sec17 retary of Health and Human Services determines—

18 (A) that a health care provider, physician, 

19 practitioner, or other supplier in good faith uses 

20 a software program that is certified under the 

21 project established under paragraph (1); and 

22 (B) there is no indication of fraud or abuse 

23 committed by the provider, physician, practi24 tioner, or supplier against the program under 

25 title XVIII of the Social Security Act; 
32

•S 2003 IS 

1 the provider, physician, practitioner, or supplier 

2 shall not be subject to any penalty or interest under 

3 such title XVIII, or the provisions of title XI of such 

4 Act insofar as they relate to such title XVIII, relat5 ing to the provision of such items or service or such 

6 claim. 

7 TITLE II—INCREASED EVI8 DENCE-BASE FOR QUALITY 

9 IMPROVEMENT AND MEAS10 UREMENT 

11 SEC. 201. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

12 APPROVED CLINICAL TRIALS. 

13 (a) GROUP HEALTH PLANS.—

14 (1) PUBLIC HEALTH SERVICE ACT.—Subpart 2 

15 of part A of title XXVII of the Public Health Serv16 ice Act (42 U.S.C. 300gg–4 et seq.) is amended by 

17 adding at the end the following: 

18 ‘‘SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING 

19 IN APPROVED CLINICAL TRIALS. 

20 ‘‘(a) COVERAGE.—

21 ‘‘(1) IN GENERAL.—If a group health plan, or 

22 a health insurance issuer that offers health insur23 ance coverage in connection with a group health 

24 plan, provides coverage to a qualified individual (as 

25 defined in subsection (b)), the plan or issuer—
33

•S 2003 IS 

1 ‘‘(A) may not deny the individual partici2 pation in the clinical trial referred to in sub3 section (b)(2); 

4 ‘‘(B) subject to subsections (b), (c), and 

5 (d) may not deny (or limit or impose additional 

6 conditions on) the coverage of routine patient 

7 costs for items and services furnished in con8 nection with participation in the trial; and 

9 ‘‘(C) may not discriminate against the in10 dividual on the basis of the enrollee’s participa11 tion in such trial. 

12 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—

13 ‘‘(A) IN GENERAL.—For purposes of para14 graph (1)(B), subject to subparagraph (B), rou15 tine patient costs include all items and services 

16 provided in the clinical trial that are otherwise 

17 generally available to the qualified individual, 

18 except—

19 ‘‘(i) in the cases of drugs and devices, 

20 the investigational item or service, itself; or 

21 ‘‘(ii) items and services that are pro22 vided solely to satisfy data collection and 

23 analysis needs and that are not used in the 

24 direct clinical management of the patient.
34

•S 2003 IS 

1 ‘‘(B) EXCLUSION.—Such routine patient 

2 costs do include costs for the following: 

3 ‘‘(i) CONVENTIONAL CARE.—Items or 

4 services that are typically provided absent 

5 a clinical trial. 

6 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items 

7 or services required solely for the provision 

8 of the investigational item or service, the 

9 clinically appropriate monitoring of the ef10 fects of the item or service, or the preven11 tion of complications. 

12 ‘‘(iii) REASONABLE AND NECESSARY

13 CARE.—Items or services needed for rea14 sonable and necessary care arising from 

15 the provision of an investigational item or 

16 service, including the diagnosis or treat17 ment of complications. 

18 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 

19 or more participating provider is participating in a 

20 clinical trial, nothing in paragraph (1) shall be con21 strued as preventing a plan or issuer from requiring 

22 that a qualified individual participate in the trial 

23 through such a participating provider if the provider 

24 will accept the individual as a participant in the 

25 trial. 
35

•S 2003 IS 

1 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur2 poses of subsection (a), the term ‘qualified individual’ 

3 means an individual who is a participant or beneficiary 

4 in a group health plan or an enrollee in health insurance 

5 coverage and who meets the following conditions: 

6 ‘‘(1)(A) The individual has a life-threatening or 

7 serious illness for which no standard treatment is ef8 fective. 

9 ‘‘(B) The individual is eligible to participate in 

10 an approved clinical trial according to the trial pro11 tocol with respect to treatment of such illness. 

12 ‘‘(C) The individual’s participation in the trial 

13 offers meaningful potential for significant clinical 

14 benefit for the individual. 

15 ‘‘(2) Either—

16 ‘‘(A) the referring physician is a partici17 pating health care professional and has con18 cluded that the individual’s participation in 

19 such trial would be appropriate based upon the 

20 individual meeting the conditions described in 

21 paragraph (1); or 

22 ‘‘(B) the participant, beneficiary, or en23 rollee provides medical and scientific informa24 tion establishing that the individual’s participa25 tion in such trial would be appropriate based 
36

•S 2003 IS 

1 upon the individual meeting the conditions de2 scribed in paragraph (1). 

3 ‘‘(c) PAYMENT.—

4 ‘‘(1) IN GENERAL.—Under this section a group 

5 health plan, and a health insurance issuer that of6 fers health insurance coverage in connection with a 

7 group health plan, shall provide for payment for rou8 tine patient costs described in subsection (a)(2) but 

9 is not required to pay for costs of items and services 

10 that are reasonably expected to be paid for by the 

11 sponsors of an approved clinical trial. 

12 ‘‘(2) PAYMENT RATE.—In the case of covered 

13 items and services provided by—

14 ‘‘(A) a participating provider, the payment 

15 rate shall be at the agreed upon rate; or 

16 ‘‘(B) a nonparticipating provider, the pay17 ment rate shall be at the rate the plan or issuer 

18 would normally pay for comparable services 

19 under subparagraph (A). 

20 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—

21 ‘‘(1) IN GENERAL.—In this section, the term 

22 ‘approved clinical trial’ means a clinical research 

23 study or clinical investigation and is described in any 

24 of the following subparagraphs: 
37

•S 2003 IS 

1 ‘‘(A) FEDERALLY FUNDED TRIALS.—The 

2 study or investigation is approved or funded 

3 (which may include funding through in-kind 

4 contributions) by one or more of the following: 

5 ‘‘(i) NIH.—The National Institutes of 

6 Health. 

7 ‘‘(ii) CDC.—The Centers for Disease 

8 Control and Prevention. 

9 ‘‘(iii) AHRQ.—The Agency for Health 

10 Care Research and Quality. 

11 ‘‘(iv) CMS.—The Center for Medicare 

12 & Medicaid Services. 

13 ‘‘(v) COOPERATIVE CENTER.—A coop14 erative group or center of any of the enti15 ties described in clauses (i) through (iv) or 

16 the Departments of Defense or Veterans 

17 Affairs. 

18 ‘‘(vi) CENTER SUPPORT GRANTEES.—

19 A qualified nongovernmental research enti20 ty identified in the guidelines issued by the 

21 National Institutes of Health for center 

22 support grants. 

23 ‘‘(vii) DOD; VA; DOE.—Any of the fol24 lowing if the conditions described in para25 graph (2) are met: 
38

•S 2003 IS 

1 ‘‘(I) The Department of Veterans 

2 Affairs. 

3 ‘‘(II) The Department of De4 fense. 

5 ‘‘(III) The Department of En6 ergy. 

7 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The 

8 study or investigation is conducted under an in9 vestigational new drug application reviewed by 

10 the Food and Drug Administration. 

11 ‘‘(C) EXEMPT DRUG TRIAL.—The study or 

12 investigation is a drug trial that is exempt from 

13 having such an investigational new drug appli14 cation. 

15 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The 

16 conditions described in this paragraph, for a study 

17 or investigation conducted by a Department, are 

18 that the study or investigation has been reviewed 

19 and approved through a system of peer review that 

20 the Secretary determines—

21 ‘‘(A) to be comparable to the system of 

22 peer review of studies and investigations used 

23 by the National Institutes of Health; and 

24 ‘‘(B) assures unbiased review of the high25 est scientific standards by qualified individuals
39

•S 2003 IS 

1 who have no interest in the outcome of the re2 view. 

3 ‘‘(e) CONSTRUCTION.—Nothing in this section 

4 shall be construed to preclude a plan or issuer from 

5 offering coverage that is broader than the coverage 

6 required under this section with respect to clinical 

7 trials.’’. 

8 (2) ERISA AMENDMENTS.—

9 (A) IN GENERAL.—Subpart B of put 7 of 

10 subtitle B of title I of the Employee Retirement 

11 Income Security Act of 1974 (29 U.S.C. 1185 

12 et seq.) is amended by adding at the end the 

13 following: 

14 ‘‘SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 

15 APPROVED CLINICAL TRIALS. 

16 ‘‘(a) COVERAGE.—

17 ‘‘(1) IN GENERAL.—If a group health plan, or 

18 a health insurance issuer that offers health insur19 ance coverage in connection with a group health 

20 plan, provides coverage to a qualified individual (as 

21 defined in subsection (b)), the plan or issuer—

22 ‘‘(A) may not deny the individual partici23 pation in the clinical trial referred to in sub24 section (b)(2); 
40

•S 2003 IS 

1 ‘‘(B) subject to subsections (b), (c), and 

2 (d) may not deny (or limit or impose additional 

3 conditions on) the coverage of routine patient 

4 costs for items and services furnished in con5 nection with participation in the trial; and 

6 ‘‘(C) may not discriminate against the in7 dividual on the basis of the enrollee’s participa8 tion in such trial. 

9 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—

10 ‘‘(A) IN GENERAL.—For purposes of para11 graph (1)(B), subject to subparagraph (B), rou12 tine patient costs include all items and services 

13 provided in the clinical trial that are otherwise 

14 generally available to the qualified individual, 

15 except—

16 ‘‘(i) in the cases of drugs and devices, 

17 the investigational item or service, itself; or 

18 ‘‘(ii) items and services that are pro19 vided solely to satisfy data collection and 

20 analysis needs and that are not used in the 

21 direct clinical management of the patient. 

22 ‘‘(B) EXCLUSION.—Such routine patient 

23 costs do include costs for the following: 
41

•S 2003 IS 

1 ‘‘(i) CONVENTIONAL CARE.—Items or 

2 services that are typically provided absent 

3 a clinical trial. 

4 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items 

5 or services required solely for the provision 

6 of the investigational item or service, the 

7 clinically appropriate monitoring of the ef8 fects of the item or service, or the preven9 tion of complications. 

10 ‘‘(iii) REASONABLE AND NECESSARY

11 CARE.—Items or services needed for rea12 sonable and necessary care arising from 

13 the provision of an investigational item or 

14 service, including the diagnosis or treat15 ment of complications. 

16 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 

17 or more participating provider is participating in a 

18 clinical trial, nothing in paragraph (1) shall be con19 strued as preventing a plan or issuer from requiring 

20 that a qualified individual participate in the trial 

21 through such a participating provider if the provider 

22 will accept the individual as a participant in the 

23 trial. 

24 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur25 poses of subsection (a), the term ‘qualified individual’ 
42

•S 2003 IS 

1 means an individual who is a participant or beneficiary 

2 in a group health plan or an enrollee in health insurance 

3 coverage and who meets the following conditions: 

4 ‘‘(1)(A) The individual has a life-threatening or 

5 serious illness for which no standard treatment is ef6 fective. 

7 ‘‘(B) The individual is eligible to participate in 

8 an approved clinical trial according to the trial pro9 tocol with respect to treatment of such illness. 

10 ‘‘(C) The individual’s participation in the trial 

11 offers meaningful potential for significant clinical 

12 benefit for the individual. 

13 ‘‘(2) Either—

14 ‘‘(A) the referring physician is a partici15 pating health care professional and has con16 cluded that the individual’s participation in 

17 such trial would be appropriate based upon the 

18 individual meeting the conditions described in 

19 paragraph (1); or 

20 ‘‘(B) the participant, beneficiary, or en21 rollee provides medical and scientific informa22 tion establishing that the individual’s participa23 tion in such trial would be appropriate based 

24 upon the individual meeting the conditions de25 scribed in paragraph (1). 
43

•S 2003 IS 

1 ‘‘(c) PAYMENT.—

2 ‘‘(1) IN GENERAL.—Under this section a group 

3 health plan, and a health insurance issuer that of4 fers health insurance coverage in connection with a 

5 group health plan, shall provide for payment for rou6 tine patient costs described in subsection (a)(2) but 

7 is not required to pay for costs of items and services 

8 that are reasonably expected to be paid for by the 

9 sponsors of an approved clinical trial. 

10 ‘‘(2) PAYMENT RATE.—In the case of covered 

11 items and services provided by—

12 ‘‘(A) a participating provider, the payment 

13 rate shall be at the agreed upon rate; or 

14 ‘‘(B) a nonparticipating provider, the pay15 ment rate shall be at the rate the plan or issuer 

16 would normally pay for comparable services 

17 under subparagraph (A). 

18 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—

19 ‘‘(1) IN GENERAL.—In this section, the term 

20 ‘approved clinical trial’ means a clinical research 

21 study or clinical investigation and is described in any 

22 of the following subparagraphs: 

23 ‘‘(A) FEDERALLY FUNDED TRIALS.—The 

24 study or investigation is approved or funded 
44

•S 2003 IS 

1 (which may include funding through in-kind 

2 contributions) by one or more of the following: 

3 ‘‘(i) NIH.—The National Institutes of 

4 Health. 

5 ‘‘(ii) CDC.—The Centers for Disease 

6 Control and Prevention. 

7 ‘‘(iii) AHRQ.—The Agency for Health 

8 Care Research and Quality. 

9 ‘‘(iv) CMS.—The Center for Medicare 

10 & Medicaid Services. 

11 ‘‘(v) COOPERATIVE CENTER.—A coop12 erative group or center of any of the enti13 ties described in clauses (i) through (iv) or 

14 the Departments of Defense or Veterans 

15 Affairs. 

16 ‘‘(vi) CENTER SUPPORT GRANTEES.—

17 A qualified nongovernmental research enti18 ty identified in the guidelines issued by the 

19 National Institutes of Health for center 

20 support grants. 

21 ‘‘(vii) DOD; VA; DOE.—Any of the fol22 lowing if the conditions described in para23 graph (2) are met: 

24 ‘‘(I) The Department of Veterans 

25 Affairs.
45

•S 2003 IS 

1 ‘‘(II) The Department of De2 fense. 

3 ‘‘(III) The Department of En4 ergy. 

5 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The 

6 study or investigation is conducted under an in7 vestigational new drug application reviewed by 

8 the Food and Drug Administration. 

9 ‘‘(C) EXEMPT DRUG TRIAL.—The study or 

10 investigation is a drug trial that is exempt from 

11 having such an investigational new drug appli12 cation. 

13 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The 

14 conditions described in this paragraph, for a study 

15 or investigation conducted by a Department, are 

16 that the study or investigation has been reviewed 

17 and approved through a system of peer review that 

18 the Secretary determines—

19 ‘‘(A) to be comparable to the system of 

20 peer review of studies and investigations used 

21 by the National Institutes of Health; and 

22 ‘‘(B) assures unbiased review of the high23 est scientific standards by qualified individuals 

24 who have no interest in the outcome of the re25 view. 
46

•S 2003 IS 

1 ‘‘(e) CONSTRUCTION.—Nothing in this section shall 

2 be construed to preclude a plan or issuer from offering 

3 coverage that is broader than the coverage required under 

4 this section with respect to clinical trials.’’. 

5 (B) TECHNICAL AMENDMENT.—Section 

6 732(a) of the Employee Retirement Income Se7 curity Act of 1974 (29 U.S.C. 1191a(a)) is 

8 amended by striking ‘‘section 711’’ and insert9 ing ‘‘sections 711 and 714’’. 

10 (C) TABLE OF CONTENTS.—The table of 

11 contents in section 1 of the Employee Retire12 ment Income Security Act of 1974 is amended 

13 by inserting after the item relating to section 

14 713 the following new item:

‘‘Sec. 714. Coverage for individuals participating in approved cancer clinical 

trials.’’.

15 (3) INTERNAL REVENUE CODE OF 1986.—

16 (A) IN GENERAL.—Subchapter B of chap17 ter 100 of the Internal Revenue Code of 1986 

18 is amended—

19 (i) in the table of sections, by insert20 ing after the item relating to section 9812 

21 the following new item:

‘‘Sec. 9813. Coverage for individuals participating in approved clinical trials.’’;

22 and
47

•S 2003 IS 

1 (ii) by inserting after section 9812 the 

2 following: 

3 ‘‘SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING 

4 IN APPROVED CLINICAL TRIALS. 

5 ‘‘(a) COVERAGE.—

6 ‘‘(1) IN GENERAL.—If a group health plan pro7 vides coverage to a qualified individual (as defined in 

8 subsection (b)), the plan—

9 ‘‘(A) may not deny the individual partici10 pation in the clinical trial referred to in sub11 section (b)(2); 

12 ‘‘(B) subject to subsections (b), (c), and 

13 (d) may not deny (or limit or impose additional 

14 conditions on) the coverage of routine patient 

15 costs for items and services furnished in con16 nection with participation in the trial; and 

17 ‘‘(C) may not discriminate against the in18 dividual on the basis of the enrollee’s participa19 tion in such trial. 

20 ‘‘(2) EXCLUSION OF CERTAIN COSTS.—

21 ‘‘(A) IN GENERAL.—For purposes of para22 graph (1)(B), subject to subparagraph (B), rou23 tine patient costs include all items and services 

24 provided in the clinical trial that are otherwise 
48

•S 2003 IS 

1 generally available to the qualified individual, 

2 except—

3 ‘‘(i) in the cases of drugs and devices, 

4 the investigational item or service, itself; or 

5 ‘‘(ii) items and services that are pro6 vided solely to satisfy data collection and 

7 analysis needs and that are not used in the 

8 direct clinical management of the patient. 

9 ‘‘(B) EXCLUSION.—Such routine patient 

10 costs do include costs for the following: 

11 ‘‘(i) CONVENTIONAL CARE.—Items or 

12 services that are typically provided absent 

13 a clinical trial. 

14 ‘‘(ii) ADMINISTRATIVE ITEMS.—Items 

15 or services required solely for the provision 

16 of the investigational item or service, the 

17 clinically appropriate monitoring of the ef18 fects of the item or service, or the preven19 tion of complications. 

20 ‘‘(iii) REASONABLE AND NECESSARY

21 CARE.—Items or services needed for rea22 sonable and necessary care arising from 

23 the provision of an investigational item or 

24 service, including the diagnosis or treat25 ment of complications. 
49

•S 2003 IS 

1 ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one 

2 or more participating provider is participating in a 

3 clinical trial, nothing in paragraph (1) shall be con4 strued as preventing a plan from requiring that a 

5 qualified individual participate in the trial through 

6 such a participating provider if the provider will ac7 cept the individual as a participant in the trial. 

8 ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur9 poses of subsection (a), the term ‘qualified individual’ 

10 means an individual who is a participant or beneficiary 

11 in a group health plan and who meets the following condi12 tions: 

13 ‘‘(1)(A) The individual has a life-threatening or 

14 serious illness for which no standard treatment is ef15 fective. 

16 ‘‘(B) The individual is eligible to participate in 

17 an approved clinical trial according to the trial pro18 tocol with respect to treatment of such illness. 

19 ‘‘(C) The individual’s participation in the trial 

20 offers meaningful potential for significant clinical 

21 benefit for the individual. 

22 ‘‘(2) Either—

23 ‘‘(A) the referring physician is a partici24 pating health care professional and has con25 cluded that the individual’s participation in
50

•S 2003 IS 

1 such trial would be appropriate based upon the 

2 individual meeting the conditions described in 

3 paragraph (1); or 

4 ‘‘(B) the participant, beneficiary, or en5 rollee provides medical and scientific informa6 tion establishing that the individual’s participa7 tion in such trial would be appropriate based 

8 upon the individual meeting the conditions de9 scribed in paragraph (1). 

10 ‘‘(c) PAYMENT.—

11 ‘‘(1) IN GENERAL.—Under this section a group 

12 health plan shall provide for payment for routine pa13 tient costs described in subsection (a)(2) but is not 

14 required to pay for costs of items and services that 

15 are reasonably expected to be paid for by the spon16 sors of an approved clinical trial. 

17 ‘‘(2) PAYMENT RATE.—In the case of covered 

18 items and services provided by—

19 ‘‘(A) a participating provider, the payment 

20 rate shall be at the agreed upon rate; or 

21 ‘‘(B) a nonparticipating provider, the pay22 ment rate shall be at the rate the plan would 

23 normally pay for comparable services under 

24 subparagraph (A). 

25 ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
51

•S 2003 IS 

1 ‘‘(1) IN GENERAL.—In this section, the term 

2 ‘approved clinical trial’ means a clinical research 

3 study or clinical investigation and is described in any 

4 of the following subparagraphs: 

5 ‘‘(A) FEDERALLY FUNDED TRIALS.—The 

6 study or investigation is approved or funded 

7 (which may include funding through in-kind 

8 contributions) by one or more of the following: 

9 ‘‘(i) NIH.—The National Institutes of 

10 Health. 

11 ‘‘(ii) CDC.—The Centers for Disease 

12 Control and Prevention. 

13 ‘‘(iii) AHRQ.—The Agency for Health 

14 Care Research and Quality. 

15 ‘‘(iv) CMS.—The Center for Medicare 

16 & Medicaid Services. 

17 ‘‘(v) COOPERATIVE CENTER.—A coop18 erative group or center of any of the enti19 ties described in clauses (i) through (iv) or 

20 the Departments of Defense or Veterans 

21 Affairs. 

22 ‘‘(vi) CENTER SUPPORT GRANTEES.—

23 A qualified nongovernmental research enti24 ty identified in the guidelines issued by the 
52

•S 2003 IS 

1 National Institutes of Health for center 

2 support grants. 

3 ‘‘(vii) DOD; VA; DOE.—Any of the fol4 lowing if the conditions described in para5 graph (2) are met: 

6 ‘‘(I) The Department of Veterans 

7 Affairs. 

8 ‘‘(II) The Department of De9 fense. 

10 ‘‘(III) The Department of En11 ergy. 

12 ‘‘(B) FDA DRUG TRIAL UNDER IND.—The 

13 study or investigation is conducted under an in14 vestigational new drug application reviewed by 

15 the Food and Drug Administration. 

16 ‘‘(C) EXEMPT DRUG TRIAL.—The study or 

17 investigation is a drug trial that is exempt from 

18 having such an investigational new drug appli19 cation. 

20 ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The 

21 conditions described in this paragraph, for a study 

22 or investigation conducted by a Department, are 

23 that the study or investigation has been reviewed 

24 and approved through a system of peer review that 

25 the Secretary determines—
53

•S 2003 IS 

1 ‘‘(A) to be comparable to the system of 

2 peer review of studies and investigations used 

3 by the National Institutes of Health; and 

4 ‘‘(B) assures unbiased review of the high5 est scientific standards by qualified individuals 

6 who have no interest in the outcome of the re7 view. 

8 ‘‘(e) CONSTRUCTION.—Nothing in this section 

9 shall be construed to preclude a plan from offering 

10 coverage that is broader than the coverage required 

11 under this section with respect to clinical trials.’’. 

12 (b) INDIVIDUAL HEALTH INSURANCE COVERAGE.—

13 Part B of title XXVII of the Public Health Service Act 

14 (42 U.S.C. 300gg–41 et seq.) is amended—

15 (1) by redesignating the first subpart 3 (relat16 ing to other requirements) as subpart 2; and 

17 (2) by adding at the end of subpart 2 the fol18 lowing: 

19 ‘‘SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING 

20 IN APPROVED CLINICAL TRIALS. 

21 ‘‘The provisions of section 2707 shall apply to health 

22 insurance coverage offered by a health insurance issuer 

23 in the individual market in the same manner as they apply 

24 to health insurance coverage offered by a health insurance 
54

•S 2003 IS 

1 issuer in connection with a group health plan in the small 

2 or large group market.’’. 

3 (c) EFFECTIVE DATES.—

4 (1) GROUP HEALTH PLANS.—Subject to para5 graph (3), the amendments made by subsection (a) 

6 apply with respect to group health plans for plan 

7 years beginning on or after January 1, 2004. 

8 (2) INDIVIDUAL HEALTH INSURANCE COV9 ERAGE.—The amendments made by subsection (b) 

10 apply with respect to health insurance coverage of11 fered, sold, issued, renewed, in effect, or operated in 

12 the individual market on or after January 1, 2004. 

13 (3) COLLECTIVE BARGAINING EXCEPTION.—In 

14 the case of a group health plan maintained pursuant 

15 to 1 or more collective bargaining agreements be16 tween employee representatives and 1 or more em17 ployers ratified before the date of enactment of this 

18 Act, the amendments made by subsection (a) shall 

19 not apply to plan years beginning before the later 

20 of—

21 (A) the date on which the last collective 

22 bargaining agreements relating to the plan ter23 minates (determined without regard to any ex24 tension thereof agreed to after the date of en25 actment of this Act); or 
55

•S 2003 IS 

1 (B) January 1, 2004.

2 For purposes of subparagraph (A), any plan amend3 ment made pursuant to a collective bargaining 

4 agreement relating to the plan which amends the 

5 plan solely to conform to any requirement added by 

6 subsection (a) shall not be treated as a termination 

7 of such collective bargaining agreement. 

8 (d) COORDINATION OF ADMINISTRATION.—The Sec9 retary of Labor, the Secretary of the Treasury, and the 

10 Secretary of Health and Human Services shall ensure, 

11 through the execution of an interagency memorandum of 

12 understanding among such Secretaries, that—

13 (1) regulations, rulings, and interpretations 

14 issued by such Secretaries relating to the same mat15 ter over which two or more such Secretaries have re16 sponsibility under the provisions of this section (and 

17 the amendments made thereby) are administered so 

18 as to have the same effect at all times; and 

19 (2) coordination of policies relating to enforcing 

20 the same requirements through such Secretaries in 

21 order to have a coordinated enforcement strategy 

22 that avoids duplication of enforcement efforts and 

23 assigns priorities in enforcement. 

24 (e) STUDY AND REPORT.—
56

•S 2003 IS 

1 (1) STUDY.—The Secretary of Health and 

2 Human Services, jointly with the Secretary of Labor 

3 and the Secretary of the Treasury, shall study the 

4 impact on group health plans and health insurance 

5 issuers for covering routine patient care costs for in6 dividuals who are entitled to benefits under this sec7 tion and who are enrolled in an approved clinical 

8 trial program. 

9 (2) REPORT.—Not later than January 1, 2006, 

10 the Secretary of Health and Human Services shall 

11 submit a report to Congress that contains an assess12 ment of—

13 (A) any incremental cost to group health 

14 plans and health insurance issuers resulting 

15 from the provisions of this section; 

16 (B) a projection of expenditures to such 

17 plans and issuers resulting from this section; 

18 (C) any impact on premiums resulting 

19 from this section; and 

20 (D) any impact on the ability of health 

21 plans to make coverage decisions in a more 

22 timely fashion. 
57

•S 2003 IS 

1 SEC. 202. GRANTS FOR PRIMARY CARE RESEARCH FOR 

2 OLDER PATIENTS. 

3 Part B of title IX of the Public Health Service Act 

4 (42 U.S.C. 299b et seq.), as amended by section 101, is 

5 further amended by adding at the end the following: 

6 ‘‘SEC. 920A. GRANTS FOR PRIMARY CARE RESEARCH FOR 

7 OLDER PATIENTS. 

8 ‘‘(a) IN GENERAL.—The Director shall award grants 

9 to public and nonprofit private entities for primary care 

10 research relating to older patients with multiple chronic 

11 conditions to gather information on how best to care for 

12 such patients. 

13 ‘‘(b) FOCUS.—In awarding grants under subsection 

14 (a), the Director shall ensure that research is focused on 

15 the population of individuals who are 65 years of age and 

16 older. 

17 ‘‘(c) REQUIREMENTS.—Research conducted under a 

18 grant under this section shall—

19 ‘‘(1) examine the role of disease-specific guide20 lines in the population described in subsection (a); 

21 ‘‘(2) examine the feasibility of developing guide22 lines that focus on the interaction of diseases and 

23 conditions; and 

24 ‘‘(3) investigate appropriate outcomes of care to 

25 be considered in evaluating the quality of care for 
58

•S 2003 IS 

1 such population, including outcomes from the per2 spective of patients, families, and clinicians. 

3 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section, 

5 $10,000,000 for fiscal year 2004, and such sums as may 

6 be necessary for each fiscal year thereafter.’’. 

7 SEC. 203. STUDY ON EFFECTIVENESS OF CERTAIN PRE8 SCRIPTION DRUGS. 

9 (a) IN GENERAL.—

10 (1) RESEARCH BY NIH.—The Director of the 

11 National Institutes of Health, in coordination with 

12 the Director of the Agency for Healthcare Research 

13 and Quality and the Commissioner of Food and 

14 Drugs, shall conduct research, which may include 

15 clinical research, to develop valid scientific evidence 

16 regarding the comparative effectiveness and, where 

17 appropriate, comparative safety of covered prescrip18 tion drugs relative to other drugs and treatments for 

19 the same disease or condition. 

20 (2) ANALYSIS BY THE AGENCY FOR

21 HEALTHCARE RESEARCH AND QUALITY.—

22 (A) IN GENERAL.—The Agency for 

23 Healthcare Research and Quality, taking into 

24 consideration the research and data from the 

25 National Institutes of Health and the Food and 
59

•S 2003 IS 

1 Drug Administration, shall use evidence-based 

2 practice centers to synthesize available data or 

3 conduct other analyses of the comparative effec4 tiveness and, where appropriate, comparative 

5 safety of covered prescription drugs relative to 

6 other drugs and treatments for the same dis7 ease or condition. 

8 (B) SAFETY.—In any analysis of compara9 tive effectiveness under this subparagraph, the 

10 Institute of Medicine shall include a discussion 

11 of available information on relative safety. 

12 (3) STANDARDS.—The Director of the Agency 

13 for Healthcare Research and Quality, in consultation 

14 with the Commissioner of Food and Drugs, the Di15 rector of the National Institutes of Health, and with 

16 input from stakeholders, shall develop standards for 

17 the design and conduct of studies under this sub18 section. 

19 (b) COVERED PRESCRIPTION DRUGS.—For purposes 

20 of this section, the term ‘‘covered prescription drugs’’ 

21 means prescription drugs that, as determined by the Di22 rector of the Agency for Healthcare Research and Quality 

23 in consultation with the Administrator of the Centers for 

24 Medicare & Medicaid Services, the Secretary of Defense, 

25 and the Secretary of Veterans Affairs, account for high 
60

•S 2003 IS 

1 levels of use or high levels of risk to individuals in federally 

2 funded health programs, including Medicare and Med3 icaid. 

4 (c) DISSEMINATION.—

5 (1) BIENNIAL REPORT.—Every 2 years, the 

6 Secretary shall prepare a report on the progress and 

7 results, if available, of the research, studies, and

8 analyses conducted by the National Institutes of 

9 Health and the Agency for Healthcare Research and 

10 Quality, and the Food and Drug Administration 

11 under this section and submit the report to the fol12 lowing: 

13 (A) Congress. 

14 (B) The President. 

15 (C) The Secretary of Defense. 

16 (D) The Secretary of Veterans Affairs. 

17 (2) REPORTS FOR PRACTITIONERS AND PA18 TIENTS.—As soon as possible, but not later than a 

19 year after the completion of any study pursuant to 

20 subsection (a)(2), the Director of the Agency for 

21 Healthcare Research and Quality shall—

22 (A) prepare a report on the results of such 

23 study for the purpose of informing health care 

24 practitioners and patients; and 
61

•S 2003 IS 

1 (B) transmit the report to the Director of 

2 the National Institutes of Health. 

3 (3) FDA DRUG INFORMATION.—The Commis4 sioner of Food and Drugs shall—

5 (A) review all data and information from 

6 studies and analyses conducted or prepared 

7 under this section; and 

8 (B) when determined appropriate by the 

9 Commissioner, develop summaries of such infor10 mation for inclusion in adequate directions for 

11 use under section 502(f)(1) of the Federal 

12 Food, Drug, and Cosmetic Act and in sum13 maries relating to side effects, contraindica14 tions, and effectiveness under section 502(n) of 

15 that Act. 

16 (4) NIH INTERNET SITE.—The Director of the 

17 National Institutes of Health shall publish on the 

18 Institutes’ Internet site and through other means 

19 that will facilitate access by practitioners and pa20 tients each report prepared under this subsection by 

21 the Director of the Agency for Healthcare Research 

22 and Quality. 

23 (d) EVIDENCE.—In carrying out this section, the Di24 rector of the National Institutes of Health and the Agency 

25 for Healthcare Research and Quality shall consider only 
62

•S 2003 IS 

1 methodologically sound studies, giving preference to stud2 ies for which the Directors have access to sufficient under3 lying data and analysis to address any significant concerns 

4 about methodology or the reliability of data. 

5 (e) AUTHORIZATIONS OF APPROPRIATIONS.—There 

6 are authorized to be appropriated to carry out this section, 

7 $75,000,000 for fiscal year 2004, and such sums as may 

8 be necessary for each fiscal year thereafter. 

9 TITLE III—MEASURING AND 

10 COMPARING QUALITY 

11 SEC. 301. PRIORITY AREA QUALITY INDICATORS. 

12 Part B of title IX of the Public Health Service Act 

13 (42 U.S.C. 299b et seq.), as amended by section 201, is 

14 further amended by adding at the end the following: 

15 ‘‘SEC. 920B. PRIORITY AREA QUALITY INDICATORS. 

16 ‘‘(a) IN GENERAL.—The Director, in consultation 

17 with the Quality Interagency Coordination Task Force, 

18 the Institute of Medicine, the Joint Commission on Ac19 creditation of Healthcare Organizations, the National 

20 Committee for Quality Assurance, the American Health 

21 Quality Association, the National Quality Forum, the 

22 Medicare Payment Advisory Committee, and other individ23 uals and organizations determined appropriate by the Sec24 retary, shall assemble, evaluate, and, where necessary, de25 velop or update quality indicators for each of the 20 pri-
63

•S 2003 IS 

1 ority areas for improvement in health care quality as iden2 tified by the Institute of Medicine in their report entitled 

3 ‘Priority Areas for National Action’ in 2003, or other such 

4 areas as identified by the Secretary in order to assist bene5 ficiaries in making informed choices about health plans or 

6 care delivery systems, and make such indicators available 

7 for purchasers to develop or align payment and perform8 ance. The selection of appropriate quality indicators under 

9 this subsection shall include the evaluation criteria formu10 lated by clinical professionals, consumers, and data collec11 tion experts. Performance indicators developed or updated 

12 under this subsection shall in the aggregate reflect the 

13 spectrum of care patients receive and may include a range 

14 of process and outcome measures such as clinical outcome 

15 measures and indicators reflecting the provision of cul16 turally and linguistically appropriate care. 

17 ‘‘(b) RISK ADJUSTMENT.—In developing the quality 

18 indicators under subsection (a), the Director shall ensure 

19 that adequate risk adjustment is provided for. 

20 ‘‘(c) BEST PRACTICES.—In carrying out this section, 

21 the Director shall—

22 ‘‘(1) assess data concerning appropriate clinical 

23 treatments based on the best scientific evidence 

24 available; 
64

•S 2003 IS 

1 ‘‘(2) determine areas in which there is insuffi2 cient evidence to determine best practices; and 

3 ‘‘(3) compare existing quality indicators to best 

4 clinical practices, validate appropriate indicators, 

5 and report on areas where additional research is 

6 needed before indicators can be developed. 

7 ‘‘(d) REPORT.—Not later than 1 year after the date 

8 of enactment of this section, and annually thereafter, the 

9 Director shall—

10 ‘‘(1) submit to the Director of the National In11 stitutes of Health a report concerning areas of clin12 ical care requiring further research necessary to es13 tablish effective clinical treatments that will serve as 

14 a basis for quality indicators; and 

15 ‘‘(2) submit to Congress a report on the state 

16 of quality measurement for priority areas that links 

17 data to the report submitted under paragraph (1) 

18 for the year involved. 

19 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

20 are authorized to be appropriated to carry out this section 

21 $12,000,000 for fiscal year 2004, and $8,000,000 for each 

22 of fiscal years 2005 through 2009.’’. 
65

•S 2003 IS 

1 SEC. 302. STANDARDIZED QUALITY INDICATORS FOR FED2 ERAL AGENCIES. 

3 (a) IN GENERAL.—In addition to other activities to 

4 be carried out by the Quality Interagency Coordination 

5 Taskforce (as established by executive order on March 13, 

6 1998), such Taskforce shall use indicators standardized 

7 by the National Quality Forum to standardize indicators 

8 of health care quality that are used in all Federal agencies, 

9 as appropriate.

10 (b) CONSULTATION.—In carrying out subsection (a), 

11 the Quality Interagency Coordination Taskforce shall con12 sult with a public-private consensus organization (such as 

13 the National Quality Forum) to enhance the likelihood of 

14 the simultaneous application of the standardized indica15 tors under subsection (a) in the private sector. 

16 (c) REPORT.—Not later than 1 year after the date 

17 of enactment of this Act, and annually thereafter, the Sec18 retary of Health and Human Services shall submit to Con19 gress a report on the progress made by the Quality Inter20 agency Coordination Taskforce to standardizing quality 

21 indicators throughout the Federal Government. 

22 SEC. 303. DEMONSTRATION PROGRAM FOR COMMUNITY 

23 HEALTH CARE QUALITY DATA REPORTING. 

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

25 Human Services, acting through the Director of the Cen26 ters for Disease Control and Prevention and the Director 
66

•S 2003 IS 

1 of the Agency for Healthcare Quality and Research, shall 

2 award not to exceed 20 grants to eligible communities for 

3 the establishment of demonstration programs for the re4 porting of health care quality information at the commu5 nity level. 

6 (b) QUALITY INDICATORS.—

7 (1) IN GENERAL.—For purposes of reporting 

8 information under the demonstration programs 

9 under this section, indicators of health care quality 

10 shall include the indicators developed for the 20 pri11 ority areas as identified by the Institute of Medicine 

12 in the report entitled ‘‘Priority Areas for National 

13 Action’’, 2003, or other indicators determined appro14 priate by the Secretary of Health and Human Serv15 ices. 

16 (2) TYPE OF DATA.—All quality indicators with 

17 respect to which reporting will be carried out under 

18 the demonstration program shall be reported by 

19 race, ethnicity, gender, and age and shall be appro20 priately risk-adjusted. 

21 (c) ELIGIBILITY.—The Secretary of Health and 

22 Human Services shall award grants to communities (which 

23 may be cities, standard metropolitan statistical areas, 

24 counties, Indian tribes, or States) under this section based 

25 on competitive proposals and criteria to be determined 
67

•S 2003 IS 

1 jointly by the Director of the Centers for Disease Control 

2 and Prevention and the Director of the Agency for 

3 Healthcare Research and Quality. Such criteria may in4 clude a demonstrated ability of the community to collect 

5 data on quality indicators and a demonstrated ability to 

6 effectively transmit community-level health status results 

7 to relevant stakeholders, including clinicians and patients. 

8 (d) TECHNICAL ADVISORY COMMITTEE.—The Sec9 retary of Health and Human Services shall establish an 

10 external technical advisory committee to assist grantees 

11 in data collection, data analysis, and report dissemination. 

12 (e) REPORT.—Not later than 1 year after the date 

13 of enactment of this Act, and annually thereafter, the Di14 rector of the Centers for Disease Control and Prevention 

15 and the Director of the Agency for Healthcare Research 

16 and Quality shall—

17 (1) submit to the Congress a report on the 

18 progress and results of the demonstration programs 

19 under this section; and 

20 (2) make such reports publicly available, includ21 ing by posting the reports on the Internet. 

22 (f) EVALUATION.—The Secretary of Health and 

23 Human Services shall, upon awarding grants under sub24 section (a), enter into a contract for the evaluation of dem25 onstration programs under this section. Such evaluation 
68

•S 2003 IS 

1 shall compare the effectiveness of such demonstration pro2 grams in collecting and reporting required data, and on 

3 the effectiveness of distributing information to key stake4 holders in a timely fashion. Such evaluations shall provide 

5 for a report on best practices. 

6 (g) AUTHORIZATION OF APPROPRIATIONS.—There 

7 are authorized to be appropriated to carry out this section 

8 $25,000,000 for fiscal year 2004, and such sums as may 

9 be necessary for each fiscal year thereafter. 

10 SEC. 304. DEMONSTRATION PROJECT FOR THE COLLEC11 TION OF DATA ON RACE, ETHNICITY, AND 

12 LINGUISTIC PREFERENCES. 

13 Section 903(c) of the Public Health Service Act (42 

14 U.S.C. 299a–1(c)) is amended by adding at the end the 

15 following: 

16 ‘‘(4) COLLECTION OF DATA ON RACE, ETH17 NICITY, AND LINGUISTIC PREFERENCES.—

18 ‘‘(A) IN GENERAL.—The Secretary, acting 

19 through the Director, shall conduct demonstra20 tion programs in conjunction with physicians, 

21 physician groups, patients, and consumer 

22 groups to investigate effective ways to collect 

23 reliable and valid data regarding an individual 

24 patient’s race, ethnicity, and linguistic pref25 erences. Such demonstrations may include—
69

•S 2003 IS 

1 ‘‘(i) the use of focus groups to develop 

2 appropriate language and modalities for 

3 requesting such information; 

4 ‘‘(ii) the conduct of training programs 

5 for front line staff and clinical profes6 sionals; 

7 ‘‘(iii) the use of specific culturally and 

8 linguistically appropriate scripts, trans9 lation of scripts and supporting material, 

10 ‘‘(iv) the use of general informational 

11 materials; 

12 ‘‘(v) designs for community awareness 

13 programs that are culturally and linguis14 tically appropriate; and 

15 ‘‘(vi) the collection and dissemination 

16 of best practices for the collection of race, 

17 ethnicity, and linguistic preference infor18 mation. 

19 ‘‘(B) ELIGIBILITY.—To be eligible to par20 ticipate in a demonstration project under sub21 paragraph (A), an individual or entity shall—

22 ‘‘(i) be a domestic or foreign, public 

23 or private not-for-profit organization, in24 cluding a university, clinic, unit of State or 
70

•S 2003 IS 

1 local government, or an eligible agency of 

2 the Federal Government; and 

3 ‘‘(ii) submit to the Secretary an appli4 cation at such time, in such manner, and 

5 containing such information as the Sec6 retary may require, including—

7 ‘‘(I) a description of the popu8 lations to be included in the project; 

9 ‘‘(II) documentation of the will10 ingness to participate in the project 

11 from appropriate community groups; 

12 ‘‘(III) documentation of the pre13 vious ability of the applicant to work 

14 with such groups; and 

15 ‘‘(IV) evidence of necessary skill 

16 sets to develop needed materials and 

17 interventions. 

18 ‘‘(C) DURATION.—A demonstration project 

19 under this paragraph shall be for 1 or 2 years 

20 and shall be conducted over a period com21 mencing not later than 6 months after the date 

22 of enactment of this paragraph. 

23 ‘‘(D) REPORTS.—Not later than 1 year 

24 after the date of enactment of this paragraph, 

25 and annually thereafter for the duration of 
71

•S 2003 IS 

1 projects under this paragraph, the Secretary 

2 shall submit to Congress annual reports on 

3 such projects. The final report submitted under 

4 this subparagraph shall contain a summation of 

5 best practices to be posted on appropriate 

6 websites and disseminated to providers and 

7 communities. 

8 ‘‘(E) AUTHORIZATION OF APPROPRIA9 TIONS.—There are authorized to be appro10 priated to carry out this section, $5,000,000 for 

11 each of fiscal years 2004 and 2005.’’. 

12 TITLE IV—PRODUCTION, EVAL13 UATION, AND DISTRIBUTION 

14 OF PRACTICE GUIDELINES 

15 FOR CARE 

16 SEC. 401. PRODUCTION, EVALUATION, AND DISTRIBUTION 

17 OF PRACTICE GUIDELINES FOR CARE. 

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

19 Human Services shall enter into a contract with the Insti20 tute of Medicine of the National Academy of Sciences, or 

21 another appropriate entity, to conduct a study on ap22 proaches to developing and disseminating seed practice 

23 guidelines to be used as a basis for regional or local appli24 cation in accordance with subsection (b). 
72

•S 2003 IS 

1 (b) CONTENT.—The study conducted under sub2 section (a) shall—

3 (1) study how and under what circumstances 

4 the coordinated development of evidence-based prac5 tice guidelines would be feasible and would improve 

6 health outcomes; 

7 (2) identify any available prototypes for the de8 velopment and dissemination of guidelines regionally, 

9 in the United States, or in other countries; 

10 (3) consider how to involve health care con11 sumers in the development of such guidelines and 

12 gain the acceptance of clinicians; 

13 (4) consider how guidelines should account for 

14 cultural and linguistic differences among patients; 

15 (5) consider how guidelines should reflect vari16 ations in patients preferences; 

17 (6) determine potential guideline models, in18 cluding public and private options; 

19 (7) compare and contrast the strengths and 

20 limitations of each such model; 

21 (8) determine both start-up and operating costs 

22 of different guideline development and dissemination 

23 models; 

24 (9) explore alternative funding options; 
73

•S 2003 IS 

1 (10) evaluate guideline dissemination strategies; 

2 and 

3 (11) develop a recommended strategy for imple4 mentation in the United States, including the poten5 tial role of the Federal Government. 

6 (c) REPORT.—Not later than 12 months after the 

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

8 Human Services shall submit to the appropriate commit9 tees of Congress a report containing the results of the 

10 study conducted under this section. 

11 (d) DISSEMINATION OF FINDINGS.—The Secretary 

12 shall disseminate the findings of the study conducted 

13 under subsection (a) to appropriate public and private en14 tities, including the posting of such findings on appro15 priate websites. 

16 (e) DEFINITION.—In this section, the term ‘‘seed 

17 practice guidelines’’ means guidelines that represent a 

18 synthesis of the scientific evidence to support clinical prac19 tice. 

20 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 

21 authorized to be appropriated to carry out this section 

22 $750,000 for fiscal year 2004. 
74

•S 2003 IS 

1 TITLE V—REWARDING QUALITY 

2 SEC. 501. INSTITUTE OF MEDICINE REPORT ON PAYMENT 

3 INCENTIVES AND PERFORMANCE. 

4 (a) EVALUATION.—

5 (1) IN GENERAL.—Not later than 2 months 

6 after the date of enactment of this Act, the Sec7 retary of Health and Human Services shall enter 

8 into an arrangement under which the Institute of 

9 Medicine of the National Academy of Sciences (in 

10 this section referred to as the ‘‘Institute’’) shall con11 duct an evaluation of options to align performance 

12 with payment, including payment under the medi13 care program under title XVIII of the Social Secu14 rity Act (42 U.S.C. 1395 et seq.). 

15 (2) SPECIFIC MATTERS EVALUATED.—In con16 ducting the evaluation under paragraph (1), the In17 stitute shall—

18 (A) catalogue, review, and evaluate the va19 lidity of leading health care performance meas20 ures to determine what subset of measures is 

21 appropriate for payment; 

22 (B) catalogue and evaluate the success, 

23 utility, and effects of alternative performance 

24 incentive programs in public or private sector 

25 settings; and 
75

•S 2003 IS 

1 (C) identify and prioritize options to imple2 ment policies that align performance with pay3 ment under the medicare program that indi4 cate—

5 (i) the performance measurement set 

6 to be used and how that measurement set 

7 will be updated; 

8 (ii) the payment policy that will re9 ward performance; and

10 (iii) the key implementation issues 

11 (such as data and information technology 

12 requirements, and necessary risk adjust13 ment) that must be addressed. 

14 (3) SCOPE OF HEALTH CARE PERFORMANCE

15 MEASURES.—The evaluation and selection of health 

16 care performance measures described in paragraph 

17 (2)(A) shall reflect a variety of perspectives, includ18 ing clinical professionals, hospitals, health plans, 

19 purchasers, and consumers, and data collection ex20 perts. 

21 (4) CONSULTATION WITH MEDPAC.—In evalu22 ating the matters described in paragraph (2)(C), the 

23 Institute shall consult with the Medicare Payment 

24 Advisory Commission established under section 1805 

25 of the Social Security Act (42 U.S.C. 1395b–6). 
76

•S 2003 IS 

1 (b) REPORT.—Not later than 6 months after the 

2 issuance of a report by the Secretary on priority area qual3 ity indicators, the Institute shall submit to the Secretary 

4 of Health and Human Services, the Committees on Ways 

5 and Means and Energy and Commerce of the House of 

6 Representatives, and the Committees on Finance and 

7 Health, Education, Labor and Pensions of the Senate a 

8 report on the evaluation conducted under subsection (a)(1) 

9 that describes the findings of such evaluation and contains 

10 recommendations for an overall strategy and approach for 

11 aligning payment with performance in various types of pri12 vate and public health plans, including, the original medi13 care fee-for-service program under parts A and B of title 

14 XVIII of the Social Security Act, the Medicare+Choice 

15 program under part C of such title, and any other pro16 grams under such title XVIII. 

17 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

18 are authorized to be appropriated, $1,000,000 for pur19 poses of conducting the evaluation and preparing the re20 port required by this section. 
77

•S 2003 IS 

1 TITLE VI—INFORMATION TO 

2 CONSUMERS 

3 SEC. 601. DISSEMINATION OF INFORMATION TO CON4 SUMERS. 

5 Part B of title IX of the Public Health Service Act 

6 (42 U.S.C. 299b et seq.), as amended by section 301, is 

7 further amended by adding at the end the following: 

8 ‘‘SEC. 920C. DISSEMINATION OF INFORMATION TO CON9 SUMERS. 

10 ‘‘(a) DEMONSTRATION PROJECTS.—

11 ‘‘(1) IN GENERAL.—The Secretary, acting 

12 through the Director, shall support research and 

13 demonstration projects to assess the feasibility of 

14 using community-based and voluntary public and 

15 private organizations to disseminate information 

16 about health care quality to consumers. 

17 ‘‘(2) REQUIREMENTS.—The research and dem18 onstration projects under paragraph (1) shall ad19 dress the following: 

20 ‘‘(A) The ability and costs to train staff in 

21 community-based and voluntary public and pri22 vate organizations to disseminate such informa23 tion. 

24 ‘‘(B) The materials needed for such train25 ing. 
78

•S 2003 IS 

1 ‘‘(C) The types of audiences reached by 

2 such community-based and voluntary public and 

3 private organizations. 

4 ‘‘(D) The effectiveness of the transmission 

5 of information from such community-based and 

6 voluntary public and private organizations to 

7 the target audiences. 

8 ‘‘(3) REPORT.—Not later than 3 years after the 

9 date of enactment of this section, the Secretary shall 

10 ensure that a report containing the results of the re11 search and demonstration projects under paragraph 

12 (1) is submitted to the appropriate committees of 

13 Congress. 

14 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

15 There is authorized to be appropriated such sums as 

16 may be necessary to carry out this subsection. 

17 ‘‘(b) TRAINING FOR LONG-TERM CARE OMBUDS18 MAN.—

19 ‘‘(1) IN GENERAL.—The Secretary, acting 

20 through the Director of the Administration on Aging 

21 and in consultation with the Director of the Agency 

22 for Healthcare Research and Quality and the Ad23 ministrator of the Centers for Medicare & Medicaid 

24 Services, shall authorize a program, to be developed 

25 and implemented by the National Long-Term Care 
79

•S 2003 IS 

1 Ombudsman Resource Center, for the training of 

2 long-term care ombudsmen in the use of quality of 

3 care information. 

4 ‘‘(2) TRAINING.—Under the program developed 

5 under paragraph (2), training shall be provided to 

6 long-term care ombudsman to enable such ombuds7 man to educate consumers concerning—

8 ‘‘(A) nursing home, home health care, and 

9 other long-term care quality of care issues; 

10 ‘‘(B) available nursing home and home 

11 health care quality of care reports, including ex12 isting quality data that the Administrator of 

13 the Centers for Medicare & Medicaid Services 

14 has released for use by the public in choosing 

15 long-term care facilities or home health care 

16 services; and 

17 ‘‘(C) the manner in which an individual 

18 can successfully integrate quality information 

19 into health care decision making regarding 

20 nursing home and home health care decisions. 

21 ‘‘(3) DUTIES OF RESOURCE CENTER.—The Na22 tional Long-Term Care Ombudsman Resource Cen23 ter shall— 

24 ‘‘(A) develop and maintain a curriculum 

25 for ombudsmen; 
80

•S 2003 IS 

1 ‘‘(B) develop, produce, and maintain train2 ing materials; 

3 ‘‘(C) conduct train-the-trainer programs at 

4 regional and national levels; and 

5 ‘‘(D) act as a clearinghouse for best prac6 tices in communicating the significance of nurs7 ing home and home health care quality indica8 tors to residents and their caregivers. 

9 ‘‘(4) PILOT PROGRAMS.—The Secretary shall 

10 award grants for the establishment of 1-year pilot 

11 demonstration programs in 10 States using dedi12 cated long-term care ombudsmen to educate con13 sumers regarding nursing home and home health

14 care quality. Such pilot demonstration programs 

15 shall test the effectiveness of having a committed po16 sition within the State dedicated to helping con17 sumers use nursing home and home health care 

18 quality indicators. 

19 ‘‘(5) REPORT.—Not later than 18 months after 

20 the date of enactment of this section, and annually 

21 thereafter, the Secretary shall submit to Congress a 

22 report concerning the effectiveness of the program 

23 established under this subsection, including the ben24 efits of providing for dedicated staff who are respon25 sible for educating consumers to use nursing home 
81

•S 2003 IS 

1 and home health quality indicators in their health 

2 care decision-making. 

3 ‘‘(6) AUTHORIZATION.—In addition to any 

4 other amounts authorized to be appropriated for 

5 long-term care ombudsman programs, there are au6 thorized to be appropriated to carry out this sub7 section $4,000,000 for fiscal year 2004 (of which 

8 $1,000,000 shall be used to carry out paragraph 

9 (4)), and $2,000,000 for each fiscal year there10 after.’’. 

11 TITLE VII—PROMOTING 

12 PATIENT ENGAGEMENT 

13 SEC. 701. PROMOTING PATIENT ENGAGEMENT. 

14 Part B of title IX of the Public Health Service Act 

15 (42 U.S.C. 299b et seq.), as amended by section 601, is 

16 further amended by adding at the end the following: 

17 ‘‘SEC. 920D. PROMOTING PATIENT ENGAGEMENT. 

18 ‘‘(a) GRANTS.—

19 ‘‘(1) IN GENERAL.—The Secretary, acting 

20 through the Director, shall award grants to public 

21 and private non-profit entities to conduct research 

22 on patient experiences in their care. 

23 ‘‘(2) REQUIREMENTS.—Activities conducted 

24 under grants awarded under paragraph (1) shall—
82

•S 2003 IS 

1 ‘‘(A) evaluate the impact of sharing health 

2 records with patients; 

3 ‘‘(B) provide for the conduct of studies on 

4 understanding and describing patient value sys5 tems, including risk aversion, self-care orienta6 tion, and time horizon; 

7 ‘‘(C) evaluate how patients seek health in8 formation and how they use it; 

9 ‘‘(D) evaluate how changes in consumer 

10 behavior based on information about quality af11 fect changes in provider behavior; and 

12 ‘‘(E) study how the effects of the studies 

13 conducted under this subsection vary by race, 

14 ethnicity, cultural and linguistic groups, edu15 cation, age, and gender. 

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

17 There is authorized to be appropriated such sums as 

18 may be necessary to carry out this subsection. 

19 ‘‘(b) HEALTH LITERACY STANDARDS.—

20 ‘‘(1) IN GENERAL.—For purposes of assisting 

21 eligible entities in providing quality assurance meas22 ures, the Secretary, acting through the Director, the 

23 Administrator of Health Resources and Services Ad24 ministration, the Director of the National Library of 

25 Medicine, and the Commissioner of Food and Drugs, 
83

•S 2003 IS 

1 shall develop standardized materials that phar2 macists may use to assist non-English speaking or 

3 functionally illiterate patients in the safe and appro4 priate use of prescription drugs. Such materials may 

5 include the use of pictures and the development of 

6 standardized translations in multiple languages of 

7 prescription labels and bottle labels and other pa8 tient safety initiative information. Such materials 

9 shall be available electronically for direct access by 

10 pharmacists. 

11 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

12 There are authorized to be appropriated to carry out 

13 this subsection, such sums as may be necessary for 

14 each of fiscal years 2004 and 2005.’’.

Æ