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[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2003 Introduced in Senate (IS)]

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.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Health Information 
for Quality Improvement Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

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

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) In spite of the best intentions of clinicians and 
        patients, the United States health care system is plagued with 
        underuse, overuse, and misuse. Only about 50 percent of health 
        care treatments of services that are known to be effective are 
        provided. At the same time, only 20 percent of the treatments 
        and services that are provided are supported by scientific 
        evidence.
            (2) The pace of the dissemination of new evidence relating 
        to appropriate health care treatments and services is 
        shockingly slow. It may take up to 15 years for treatments 
        found to be effective to become common practice.
            (3) These problems cannot be redressed until the United 
        States has the right information and that information is 
        provided to the right people at the right time.
    (b) Purpose.--It is the purpose of this Act to promote higher 
quality health care and better health by strengthening health 
information, its infrastructure, and its use by clinicians and 
consumers.

                    TITLE I--INFORMATION TECHNOLOGY

SEC. 101. INFORMATION INFRASTRUCTURE IMPROVEMENT.

    (a) In General.--Part B of title IX of the Public Health Service 
Act (42 U.S.C. 299b et seq) is amended by adding at the end the 
following:

``SEC. 918. NATIONAL HEALTHCARE INFORMATION INFRASTRUCTURE.

    ``(a) In General.--By not later than 6 months after the date of the 
enactment of this Act, the Secretary shall establish within the Office 
of the Secretary an Office of National Healthcare Information 
Infrastructure (in this section referred to as the `Office'). The 
Office shall be headed by a Director who shall report directly to the 
Secretary and who shall be responsible for providing ongoing national 
leadership in the planning, development, and adoption of a national 
healthcare information infrastructure. The Office shall, in cooperation 
with key stakeholders, develop a strategic plan to create a 
comprehensive national healthcare information infrastructure that 
encompasses public-sector and private-sector health information 
activities, and that includes a national agenda to guide policymaking, 
technology investments, research, and integration with ongoing health 
care and health care information technology activities.
    ``(b) Goals.--The goals of the national healthcare information 
infrastructure are--
            ``(1) to maximize positive outcomes in clinical care;
            ``(2) to minimize preventable medical errors, especially in 
        hospitals and in the administration of contraindicated drugs;
            ``(3) to reduce redundant paperwork, such as the repeated 
        taking of patient histories;
            ``(4) to decrease costs from duplicative or otherwise 
        unnecessary testing or procedures; and
            ``(5) to establish a compatible information technology 
        architecture that facilitates future quality and cost-saving 
        needs and that avoids the financing and development of 
        information technology systems that are not readily compatible.
    ``(c) Collaboration With Stakeholders.--
            ``(1) In general.--The Secretary shall assure that 
        activities of the Department of Health and Human Services that 
        relate to the national healthcare information infrastructure 
        are undertaken after consultation with and based on the 
        recommendations of the parties described in paragraph (3).
            ``(2) Periodic meetings.--The Secretary, through the 
        Office, shall convene as a group the parties described in 
        paragraph (3). Such group shall meet periodically and 
        collaborate to make recommendations to the Office and the 
        Secretary on the matters described in subsection (d).
            ``(3) Parties represented.--The parties described in this 
        paragraph are the following:
                    ``(A) The National Committee on Vital and Health 
                Statistics.
                    ``(B) Experts from the fields of healthcare 
                information, information technology, medical continuous 
                quality improvement, and medical records security and 
                privacy.
                    ``(C) Representatives from individual and 
                institutional health care clinical providers, including 
                teaching hospitals, children's hospitals, and small 
                hospitals.
                    ``(D) Clinical and health services researchers.
                    ``(E) Health care purchasers.
                    ``(F) One or more representatives of clinical 
                professional societies or associations.
                    ``(G) Representatives of private organizations with 
                expertise in medical informatics.
                    ``(H) One or more representatives of patient 
                groups.
                    ``(I) One ore more representatives from State or 
                local public health departments.
                    ``(J) One or more representatives of the health 
                care information technology industry and national 
                alliances formed to achieve standards-based health care 
                information systems.
                    ``(K) Appropriate staff experts from Federal 
                agencies, including those within the Department of 
                Health and Human Services and the Department of 
                Veterans Affairs.
    ``(d) Duties.--In carrying out subsection (a), the Office shall 
make recommendations to and advise the Secretary on the following, in 
order to promote the goals described in subsection (b):
            ``(1)(A) An assessment of the best current practices in the 
        development, purchase, and maintenance of medical information 
        technology.
            ``(B) Recommendations, and the specifications, for a 
        uniform healthcare information system interface, and methods 
        for its adoption (not later than 2 years after the date of the 
        enactment of this Act) to ensure compatibility between and 
        among old and new information systems.
            ``(C) Recommendations for health care data standards (such 
        as vocabulary and messaging), communications standards, and 
        other medical standards (including a common lexicon) necessary 
        to achieve the interoperability of healthcare information 
        systems.
            ``(2) Coordination of the evolution of the national 
        healthcare information infrastructure and working with other 
        key stakeholders in the public and private sectors to develop a 
        strategic plan that will ensure the interoperability of all 
        elements of such infrastructure.
            ``(3) Coordination of spending across Federal agencies 
        relating to the establishment of such infrastructure.
            ``(4) Development of policies to ensure compliance with the 
        security and confidentiality standards of this part C for 
        protected health information and promote patient control of 
        protected health information.
            ``(5) Ensure thorough testing of data and communications 
        standards prior to their adoption.
    ``(e) Detail of Federal Employees.--Upon the request of the 
Secretary, the head of any Federal agency is authorized to detail, 
without reimbursement from the Office, any of the personnel of such 
agency to the Office to assist it in carrying out its duties under this 
section. Any such detail shall not interrupt or otherwise affect the 
civil service status or privileges of the Federal employee.

``SEC. 919. DATA AND COMMUNICATIONS STANDARDS FOR INTEROPERABILITY.

    ``(a) In General.--By not later than 2 years after the date of the 
enactment of this Act, the Secretary shall as needed adopt (and shall 
periodically review, update, and expand) a set of voluntary, national 
data and communications standards that promote the interoperability of 
health care information technology systems across all public and 
private health care settings. In adopting such standards, the Secretary 
shall ensure that such standards are designed and are carefully 
monitored to ensure that linkage of data resulting from such 
interoperability does not compromise privacy and security. The 
Secretary shall take into account--
            ``(1) the ability of such standards to enable clinically-
        specific data collection in order to promote evidence-based 
        medicine and the electronic exchange of patient medical record 
        information; and
            ``(2) the costs of compliance and the savings and other 
        benefits from improved efficiency and quality in health care 
        delivery.
    ``(b) Reports.--
            ``(1) Initial report.--No later than 12 months after the 
        date of the enactment of this Act, the Secretary shall submit 
        to Congress a comprehensive national healthcare information 
        infrastructure strategic plan that includes--
                    ``(A) a survey of health care information 
                technology standards being developed by private sector 
                and public-private groups;
                    ``(B) recommendations for accelerating the 
                development of common health care vocabulary standards;
                    ``(C) recommendations for completing development of 
                health care information system messaging standards; and
                    ``(D) progress toward meeting the deadline 
                described in section 2(d)(1)(B) for adoption of methods 
                described in such paragraph (relating to a uniform 
                system interface).
            ``(2) Subsequent reports.--During each of the 2 years after 
        the year in which the report is submitted under paragraph (1), 
        the Secretary shall submit to Congress an annual report 
        relating to additional recommendations, best practices, results 
        of information technology improvements, analyses of private 
        sector efforts to implement the data and communications 
        standards established under this section, and such other 
        matters as may help ensure the most rapid dissemination of best 
        practices in health care information technology.
    ``(c) Contract Authority.--The Secretary is authorized--
            ``(1) to enter into contracts for services and activities 
        necessary to carry out this section and section 918; and
            ``(2) to the extent practicable, to test the standards 
        under consideration under this section.
    ``(d) Dissemination.--The Secretary shall provide for the 
maintenance and dissemination of the standards developed and updated 
under this section.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each fiscal year to 
carry out this section and section 918.

``SEC. 920. GRANTS TO HOSPITALS AND OTHER HEALTH CARE PROVIDERS FOR 
              INFORMATION TECHNOLOGIES.

    ``(a) In General.--The Secretary, in consultation with the Director 
of the Agency for Healthcare Research and Quality, shall award grants 
to hospitals and other health care providers (but not more than 1 such 
grant may be awarded to any 1 hospital or provider) to pay the costs of 
acquiring or implementing information technologies--
            ``(1) to improve quality of care and patient safety; and
            ``(2) to reduce adverse events and health care 
        complications resulting from medication errors.
    ``(b) Special Considerations.--In awarding grants under subsection 
(a), the Secretary shall give special consideration to applicants who 
seek to promote the following:
            ``(1) Interoperability across hospital services or 
        departments using standards referred to in section 919.
            ``(2) Electronic communication of patient data across the 
        spectrum of health care delivery.
            ``(3) Computerized physician order entry or bar coding 
        applications.
            ``(4) Electronic communication of patient data in hospitals 
        that provide services to underserved or low-income populations.
            ``(5) Improved clinical decisionmaking through the 
        acquisition and implementation of decision-support 
        technologies.
            ``(6) The sharing by hospitals of electronic health records 
        with patients.
    ``(c) Certain Grant Conditions.--A condition for the receipt of a 
grant under subsection (a) is that the applicant involved meet the 
following requirements:
            ``(1) The applicant agrees--
                    ``(A) to carry out a program to measure, analyze, 
                and report patient safety and medical errors at the 
                hospital or other health care provider involved to 
                patient safety organizations;
                    ``(B) to submit to the Secretary a description of 
                the methodology that will be used for such program; and
                    ``(C) to have such program in effect as soon as 
                practicable after the application for the grant is 
                approved, without regard to whether information 
                technologies under the grant have been implemented.
            ``(2) The applicant has--
                    ``(A) arranged for an evaluation that addresses the 
                effectiveness and cost-effectiveness of the information 
                technology for which the grant is provided and its 
                impact on the quality and safety of patient care;
                    ``(B) submitted the evaluation plan to the 
                Secretary; and
                    ``(C) received approval from the Secretary of the 
                methodology described in the plan.
            ``(3) The applicant has or is developing a patient safety 
        evaluation system for reporting health care errors to a patient 
        safety organization.
            ``(4) The applicant agrees to provide the Secretary with 
        such information as the Secretary may require regarding the use 
        of funds under this program or its impact.
            ``(5) The applicant provides assurances satisfactory to the 
        Secretary that any information technology planned, acquired, or 
        implemented with grant funds under this section will be part of 
        an information program that--
                    ``(A) carries out the purposes described in 
                subsection (a); and
                    ``(B) is comprehensive or will be expanded to 
                become comprehensive, regardless of whether Federal 
                assistance is available for such expansion.
    ``(d) Technical Assistance to Grantees.--The Secretary, acting 
through the Director, shall provide technical assistance to applicants 
and grantees to ensure the appropriate evaluation of the information 
technologies for which grants are awarded under this section, such as--
            ``(1) reviewing and providing technical assistance on the 
        applicant's proposed evaluation;
            ``(2) developing mechanisms to ensure ongoing 
        communications between grantees and evaluators to facilitate 
        the identification and resolution of problems as they arise, 
        ensure mutual learning, and promote the rapid dissemination of 
        information;
            ``(3) reviewing the interim and final reports required 
        under subsection (e); and
            ``(4) disseminating evidence-based information in interim 
        and final reports to patient safety organizations, as 
        appropriate.
    ``(e) Evaluation Reports by Grantee.--
            ``(1) In general.--A condition for the receipt of a grant 
        under subsection (a) is that the applicant agree to submit an 
        interim and a final report to the Secretary in accordance with 
        this subsection.
            ``(2) Interim report.--Not later than 1 year after the 
        implementation of information technologies under a grant under 
        this section is completed, the applicant shall submit an 
        interim report to the Secretary describing the initial 
        effectiveness of such technologies in carrying out the purposes 
        described in subsection (a).
            ``(3) Final report.--Not later than 3 years after the 
        implementation of information technologies under a grant under 
        this section is completed, the applicant shall submit a final 
        report to the Secretary describing the effectiveness and cost-
        effectiveness of such technologies and addressing other issues 
        determined to be important in carrying out the purposes 
        described in subsection (a).
            ``(4) Relation to disbursement of grant.--In making 
        payments under a grant under subsection (a), the Secretary 
        shall withhold \1/3\ of the amount of the grant until the 
        grantee submits to the Secretary the report required under 
        paragraph (2).
    ``(f) Reports by the Secretary.--
            ``(1) Interim reports.--
                    ``(A) In general.--Through the fiscal year 
                preceding the fiscal year in which the final report 
                under paragraph (2) is prepared, the Secretary shall 
                submit to the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on Health, 
                Education, Labor, and Pensions of the Senate periodic 
                reports on the grant program under subsection (a). Such 
                reports shall be submitted not less frequently than 
                once each fiscal year, beginning with fiscal year 2004.
                    ``(B) Contents.--A report under subparagraph (A) 
                shall include information on--
                            ``(i) the number of grants awarded;
                            ``(ii) the nature of the projects for which 
                        funding is provided under the grant program;
                            ``(iii) the geographic distribution of 
                        grant recipients; and
                            ``(iv) such other matters as the Secretary 
                        determines appropriate.
            ``(2) Final report.--Not later than 180 days after the date 
        on which the last of the reports is due under subsection 
        (e)(3), the Secretary shall submit a final report to the 
        committees referred to in paragraph (1)(A) on the grant program 
        under subsection (a), together with such recommendations for 
        legislation and administrative action as the Secretary 
        determines appropriate.
    ``(g) Definitions.--In this section:
            ``(1) Costs.--The term `costs', with respect to information 
        technologies referred to in subsection (a), includes total 
        expenditures incurred for--
                    ``(A) purchasing, leasing, and installing computer 
                software and hardware, including hand-held computer 
                technologies;
                    ``(B) making improvements to existing computer 
                software and hardware; and
                    ``(C) purchasing or leasing communications 
                capabilities necessary for clinical data access, 
                storage, and exchange.
            ``(2) Health care provider.--The term `health care 
        provider' includes a physician or other health care 
        professional, as well as an institutional or other facility or 
        agency that provides health care services and that is licensed, 
        accredited, or certified to provide health care items and 
        services under applicable State law.
    ``(h) Termination of Grant Authorities.--The authority of the 
Secretary to award grants under subsection (a) terminates upon the 
expiration of fiscal year 2011.
    ``(i) Matching Funds.--
            ``(1) In general.--With respect to the costs of a grant to 
        be carried out under this section, such grant may be made only 
        if the applicant agrees to make available (directly or through 
        donations from public or private entities) non-Federal 
        contributions toward such costs in an amount that is not less 
        than 50 percent of such costs ($1 for each $1 of Federal funds 
        provided under the grant).
            ``(2) Determination of amounts contributed.--Amounts 
        provided by the Federal Government, or services assisted or 
        subsidized to any significant extent by the Federal Government, 
        may not be included in determining the amount of such non-
        Federal contributions.
    ``(j) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $20,000,000 
for each of fiscal years 2004 and 2005.''.
    (b) Understanding Barriers to Information Technology Adoption and 
Effective Use.--Section 914(a) of the Public Health Service Act (42 
U.S.C. 299b-3(a)) is amended--
            (1) in paragraph (6), by striking ``and'' at the end;
            (2) in paragraph (7), by striking the period and inserting 
        ``; and''; and
            (3) by adding at the end the following:
            ``(8) and understand the barriers to information technology 
        adoption and effective use as well as methods to overcome those 
        barriers.''.

SEC. 102. IMPROVING CLINICAL PRACTICE AND REDUCING BARRIERS TO 
              INFORMATION TECHNOLOGY.

    (a) Improving Clinical Practices.--
            (1) Telemedicine.--
                    (A) Licensing.--Section 1834(m)(4)(C)(i) of the 
                Social Security Act (42 U.S.C. 1395m(m)(4)(C)(i)) is 
                amended--
                            (i) in subclause (II), by striking ``or'' 
                        at the end;
                            (ii) in subclause (III), by striking the 
                        period and inserting ``; or''; and
                            (iii) by adding at the end the following:
                                    ``(IV) in a State in which the 
                                respective State medical board has 
                                adopted a formal policy regarding 
                                licensing or certification requirements 
                                for providers at distant sites who do 
                                not have a license to practice medicine 
                                at the originating site.''.
                    (B) Expanding eligibility for reimbursement.--
                Section 1834(m)(4)(C)(i)(I) (42 U.S.C. 
                1395m(m)(4)(C)(i)(I)) is amended by striking ``rural''.
            (2) Clinical trials for information and systems technology 
        in addition to medical technology.--
                    (A) Findings.--Congress makes the following 
                findings:
                            (i) An estimated 80,000 to 100,000 patients 
                        die every year from errors suffered during 
                        hospitalization.
                            (ii) Many of these errors could have been 
                        avoided with changes to the system of health 
                        care delivery.
                            (iii) These systemwide changes have the 
                        potential to decrease the cost of providing 
                        health care and to increase the quality of 
                        services provided.
                            (iv) These improvements in cost and quality 
                        can be as dramatic as improvements seen with 
                        new medical technology or pharmaceutical 
                        advances.
                            (v) Currently new medical devices and 
                        medications undergo rigorous randomized 
                        controlled clinical trials to document their 
                        effect on a patient's health.
                            (vi) These clinical trials form the basis 
                        for providers to practice evidence-based 
                        medicine and to change their practices to 
                        improve their patients' outcomes.
                            (vii) Similar controlled clinical studies 
                        of new information technologies and systems-
                        based approaches to changing practice can help 
                        providers implement systems-based measures to 
                        improve outcomes.
                    (B) Research on information technology and other 
                systems-based approaches to changing clinical 
                practice.--Part B of title IV of the Public Health 
                Service Act (42 U.S.C. 284 et seq.) is amended by 
                adding at the end the following:

``SEC. 409J. RESEARCH ON INFORMATION TECHNOLOGY AND OTHER SYSTEMS-BASED 
              APPROACHES TO CHANGING CLINICAL PRACTICE.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Agency for Healthcare Research and Quality and in collaboration 
with the Director of NIH, shall establish a Medical Systems Safety 
Initiative (referred to in this section as the `Initiative') to conduct 
and support research regarding information technology and other 
systems-based approaches to improving and advancing medical care.
    ``(b) Purpose.--The purpose of the Initiative is to enable the 
Director of the Agency for Healthcare Research and Quality and the 
Director of NIH--
            ``(1) to conduct and support research (including both 
        intramural and extramural research), research training, the 
        dissemination of health information, and other programs with 
respect to systems research, user-centered design, and human factors 
engineering (including research related to information technology) to 
realize the expanding opportunities for improving health outcomes 
through the analysis and redesign of medical systems;
            ``(2) to enhance collaborative efforts among Federal 
        agencies to conduct and support multidisciplinary research in 
        the areas that the Director determines to be most promising; 
        and
            ``(3) to encourage and support studies, including clinical 
        studies, to provide scientifically and statistically rigorous 
        and meaningful information about the utility and effectiveness 
        of various systems-based interventions, including information 
        technology developments.
    ``(c) Appropriate Scientific Expertise and Coordination With 
Federal Agencies.--The Director of the Agency for Healthcare Research 
and Quality and the Director of NIH shall ensure that scientists with 
appropriate expertise in research on health systems, information 
technology, user-centered design, and human factors engineering are 
incorporated into the review, oversight, and management processes of 
all research projects and other activities funded by the Initiative. In 
carrying out this subsection, the Directors, as necessary, may 
establish review groups with appropriate scientific expertise. The 
Directors shall coordinate efforts with other Federal agencies to 
ensure appropriate scientific input and management.
    ``(d) Definitions.--In this section:
            ``(1) Human factors engineering.--The term `human factors 
        engineering' means the study and optimization of the 
        interaction of humans, machines, and the environment to achieve 
        the performance objectives of a given health care workplace.
            ``(2) Systems research.--The term `systems research' means 
        research into the organization and design of the work 
        environment within a health care setting, and their effects on 
        health outcomes, as well as research to improve such designs so 
        as to improve health outcomes.''.
    (b) Improving and Promoting Electronic Health Records.--
            (1) Authentication standards.--The Director of the National 
        Center for Vital and Health Statistics shall provide assistance 
        to the Secretary of Health and Human Services in the 
        development of authentication standards for health records. In 
        developing such standards, the Secretary shall take into 
        consideration the following:
                    (A) Recommendations for authentication technology 
                and identification information standards that--
                            (i) provide for the reliable identification 
                        and retrieval of a patient's electronic health 
                        data;
                            (ii) allow the patient to have detailed 
                        control over the access of individual 
                        components of his or her electronic health 
                        record by being able to specify specific 
                        providers, each of whom will have access to 
                        limited portions of the electronic health 
                        record;
                            (iii) minimize security risks, including 
                        the potential for--
                                    (I) the patient to misrepresent his 
                                or her true identity;
                                    (II) a health care provider to 
                                access data for which the patient has 
                                not consented to grant such access;
                                    (III) a third party to access 
                                identification information; or
                                    (IV) a third party to circumvent or 
                                exploit the authentication process in 
                                order to access electronic health data 
                                without the consent of the patient;
                            (iv) allow for the timely and convenient 
                        creation of identification information at the 
                        time of contact between a patient and a 
                        provider, so as to minimize any disruption or 
                        delay in the provision of needed medical 
                        services to a patient who does not already have 
                        identification information; and
                            (v) maximize the probability of accurate 
                        identification, secure authentication, and 
                        rapid access to health data even in situations 
                        where the patient--
                                    (I) does not possess the 
                                identification information that is 
                                usually required for successful 
                                authentication, but wishes to grant 
                                consent to the provider to access 
                                necessary health data;
                                    (II) possesses the identification 
                                information but is not able to provide 
                                consent for the emergency access of 
                                health data due to incapacitation; and
                                    (III) is not able to provide 
                                identification information nor consent 
                                for emergency data access due to 
                                incapacitation.
            (2) Fraud and abuse.--Section 1128D of the Social Security 
        Act (42 U.S.C. 1320a-7d) is amended--
            (1) in subsection (a)(2), by adding at the end the 
        following:
                    ``(J) The arrangements and information exchange 
                allowed for the purposes of promoting the use of 
                electronic health records, including personal health 
                records.''; and
            (2) in subsection (b)(2), by adding at the end the 
        following:
                    ``(F) Whether the arrangements and information 
                exchange allowed for the purposes of promoting the use 
                of electronic health records, including personal health 
                records achieve their purposes.''.
            (3) Personal health record.--
                    (A) Federal health information exchange standards 
                initiative.--The Secretary of Health and Human 
                Services, the Secretary of Defense, and the Secretary 
                of Veterans' Affairs, in carrying out activities under 
                the Federal e-Goverment Health Information Exchange 
                Standards Initiative, shall develop, implement, and 
                evaluate procedures and methods to enable patients to 
                access and append to their personal health data through 
                personal health records that--
                            (i) include the capability for patients to 
                        append to their electronic record information 
                        about--
                                    (I) illnesses for which the patient 
                                did not seek professional medical care;
                                    (II) health information not related 
                                to a specific disease, episode, or 
                                illness; and
                                    (III) information related to the 
                                correction of errors of omission and 
                                commission; and
                            (ii) permit patients convenient access to 
                        their full electronic medical record and permit 
                        them to share data with their providers.
                    (B) Medical translation research.--
                            (i) In general.--The Director of the Agency 
                        for Healthcare Research and Quality shall award 
                        grants to public and nonprofit private entities 
                        for the conduct of research on innovative 
                        approaches to improve patients' understanding 
                        and comprehension of their electronic health 
                        record. Research areas may include technology 
                        for the automated--
                                    (I) translation of medical 
                                information to improve patient 
                                comprehension;
                                    (II) reorganization of the 
                                electronic health record for improved 
                                utility for the patient; and
                                    (III) integration of links to 
                                relevant information from other sources 
                                into the electronic health record.
                            (ii) Merit review; competition.--Grants 
                        shall be awarded under this subparagraph on a 
                        merit-reviewed competitive basis.
                            (iii) Authorization of appropriations.--
                        There are authorized to be appropriated to the 
                        Agency for Healthcare Research and Quality to 
                        carry out this subparagraph $5,000,000 for 
                        fiscal year 2004, and such sums as may be 
                        necessary for each fiscal year thereafter.
            (3) Definitions.--In this subsection:
                    (A) Identification information.--The term 
                ``identification information'' with respect to the 
                health records of a patient, means any data necessary 
                to reliably associate a patient with their health data.
                    (B) Authentication.--The term ``authentication'' 
                means the process of using the identification 
                information to validate the patient's identification 
                and gain access to his or her electronic health data.
    (c) Improving Information Technology Infrastructure in the Basic 
Life Sciences.--Not later than 18 months after the date of enactment of 
this Act, the Director of the National Institute of General Medical 
Sciences shall submit to Congress a report on the activities of the 
Biomedical Information Science and Technology Initiative. Such report 
shall include--
            (1) a description of current activities of the Biomedical 
        Information Science and Technology Initiative Consortium;
            (2) a summary of recently completed and ongoing grant 
        programs; and
            (3) recommendations for the further advancement of the 
        Biomedical Information Science and Technology Initiative and 
        bioinformatics and computational biology research in general.
    (d) Electronic Billing.--
            (1) In general.--The Director of the Centers for Medicare & 
        Medicaid Services shall conduct a demonstration project to test 
        and evaluate a process to certify software programs that 
        analyze medical records or other health care provider 
        documentation to determine appropriate billing categories for 
        each medicare billing criteria under title XVIII of the Social 
        Security Act (42 U.S.C. 1395 et seq.).
            (2) Use of approved software.--If the Secretary of Health 
        and Human Services determines--
                    (A) that a health care provider, physician, 
                practitioner, or other supplier in good faith uses a 
                software program that is certified under the project 
                established under paragraph (1); and
                    (B) there is no indication of fraud or abuse 
                committed by the provider, physician, practitioner, or 
                supplier against the program under title XVIII of the 
                Social Security Act;
        the provider, physician, practitioner, or supplier shall not be 
        subject to any penalty or interest under such title XVIII, or 
        the provisions of title XI of such Act insofar as they relate 
        to such title XVIII, relating to the provision of such items or 
        service or such claim.

     TITLE II--INCREASED EVIDENCE-BASE FOR QUALITY IMPROVEMENT AND 
                              MEASUREMENT

SEC. 201. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL 
              TRIALS.

    (a) Group Health Plans.--
            (1) Public health service act.--Subpart 2 of part A of 
        title XXVII of the Public Health Service Act (42 U.S.C. 300gg-4 
        et seq.) is amended by adding at the end the following:

``SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
              CLINICAL TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan, or a health 
        insurance issuer that offers health insurance coverage in 
        connection with a group health plan, provides coverage to a 
        qualified individual (as defined in subsection (b)), the plan 
        or issuer--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsections (b), (c), and (d) may 
                not deny (or limit or impose additional conditions on) 
                the coverage of routine patient costs for items and 
                services furnished in connection with participation in 
                the trial; and
                    ``(C) may not discriminate against the individual 
                on the basis of the enrollee's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(B), subject to subparagraph (B), routine patient 
                costs include all items and services provided in the 
                clinical trial that are otherwise generally available 
                to the qualified individual, except--
                            ``(i) in the cases of drugs and devices, 
                        the investigational item or service, itself; or
                            ``(ii) items and services that are provided 
                        solely to satisfy data collection and analysis 
                        needs and that are not used in the direct 
                        clinical management of the patient.
                    ``(B) Exclusion.--Such routine patient costs do 
                include costs for the following:
                            ``(i) Conventional care.--Items or services 
                        that are typically provided absent a clinical 
                        trial.
                            ``(ii) Administrative items.--Items or 
                        services required solely for the provision of 
                        the investigational item or service, the 
                        clinically appropriate monitoring of the 
                        effects of the item or service, or the 
                        prevention of complications.
                            ``(iii) Reasonable and necessary care.--
                        Items or services needed for reasonable and 
                        necessary care arising from the provision of an 
                        investigational item or service, including the 
                        diagnosis or treatment of complications.
            ``(3) Use of in-network providers.--If one or more 
        participating provider is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that a qualified individual 
        participate in the trial through such a participating provider 
        if the provider will accept the individual as a participant in 
        the trial.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who is a 
participant or beneficiary in a group health plan or an enrollee in 
health insurance coverage and who meets the following conditions:
            ``(1)(A) The individual has a life-threatening or serious 
        illness for which no standard treatment is effective.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(C) The individual's participation in the trial offers 
        meaningful potential for significant clinical benefit for the 
        individual.
            ``(2) Either--
                    ``(A) the referring physician is a participating 
                health care professional and has concluded that the 
                individual's participation in such trial would be 
                appropriate based upon the individual meeting the 
                conditions described in paragraph (1); or
                    ``(B) the participant, beneficiary, or enrollee 
                provides medical and scientific information 
                establishing that the individual's participation in 
                such trial would be appropriate based upon the 
                individual meeting the conditions described in 
                paragraph (1).
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan, 
        and a health insurance issuer that offers health insurance 
        coverage in connection with a group health plan, shall provide 
        for payment for routine patient costs described in subsection 
        (a)(2) but is not required to pay for costs of items and 
        services that are reasonably expected to be paid for by the 
        sponsors of an approved clinical trial.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate; or
                    ``(B) a nonparticipating provider, the payment rate 
                shall be at the rate the plan or issuer would normally 
                pay for comparable services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a clinical research study or clinical 
        investigation and is described in any of the following 
        subparagraphs:
                    ``(A) Federally funded trials.--The study or 
                investigation is approved or funded (which may include 
                funding through in-kind contributions) by one or more 
                of the following:
                            ``(i) NIH.--The National Institutes of 
                        Health.
                            ``(ii) CDC.--The Centers for Disease 
                        Control and Prevention.
                            ``(iii) AHRQ.--The Agency for Health Care 
                        Research and Quality.
                            ``(iv) CMS.--The Center for Medicare & 
                        Medicaid Services.
                            ``(v) Cooperative center.--A cooperative 
                        group or center of any of the entities 
                        described in clauses (i) through (iv) or the 
                        Departments of Defense or Veterans Affairs.
                            ``(vi) Center support grantees.--A 
                        qualified nongovernmental research entity 
                        identified in the guidelines issued by the 
                        National Institutes of Health for center 
                        support grants.
                            ``(vii) DOD; va; doe.--Any of the following 
                        if the conditions described in paragraph (2) 
                        are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(B) FDA drug trial under ind.--The study or 
                investigation is conducted under an investigational new 
                drug application reviewed by the Food and Drug 
                Administration.
                    ``(C) Exempt drug trial.--The study or 
                investigation is a drug trial that is exempt from 
                having such an investigational new drug application.
            ``(2) Conditions for departments.--The conditions described 
        in this paragraph, for a study or investigation conducted by a 
        Department, are that the study or investigation has been 
        reviewed and approved through a system of peer review that the 
        Secretary determines--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health; and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
no interest in the outcome of the review.
            ``(e) Construction.--Nothing in this section shall be 
        construed to preclude a plan or issuer from offering coverage 
        that is broader than the coverage required under this section 
        with respect to clinical trials.''.
            (2) ERISA amendments.--
                    (A) In general.--Subpart B of put 7 of subtitle B 
                of title I of the Employee Retirement Income Security 
                Act of 1974 (29 U.S.C. 1185 et seq.) is amended by 
                adding at the end the following:

``SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL 
              TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan, or a health 
        insurance issuer that offers health insurance coverage in 
        connection with a group health plan, provides coverage to a 
        qualified individual (as defined in subsection (b)), the plan 
        or issuer--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsections (b), (c), and (d) may 
                not deny (or limit or impose additional conditions on) 
                the coverage of routine patient costs for items and 
                services furnished in connection with participation in 
                the trial; and
                    ``(C) may not discriminate against the individual 
                on the basis of the enrollee's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(B), subject to subparagraph (B), routine patient 
                costs include all items and services provided in the 
                clinical trial that are otherwise generally available 
                to the qualified individual, except--
                            ``(i) in the cases of drugs and devices, 
                        the investigational item or service, itself; or
                            ``(ii) items and services that are provided 
                        solely to satisfy data collection and analysis 
                        needs and that are not used in the direct 
                        clinical management of the patient.
                    ``(B) Exclusion.--Such routine patient costs do 
                include costs for the following:
                            ``(i) Conventional care.--Items or services 
                        that are typically provided absent a clinical 
                        trial.
                            ``(ii) Administrative items.--Items or 
                        services required solely for the provision of 
                        the investigational item or service, the 
                        clinically appropriate monitoring of the 
                        effects of the item or service, or the 
                        prevention of complications.
                            ``(iii) Reasonable and necessary care.--
                        Items or services needed for reasonable and 
                        necessary care arising from the provision of an 
                        investigational item or service, including the 
                        diagnosis or treatment of complications.
            ``(3) Use of in-network providers.--If one or more 
        participating provider is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that a qualified individual 
        participate in the trial through such a participating provider 
        if the provider will accept the individual as a participant in 
        the trial.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who is a 
participant or beneficiary in a group health plan or an enrollee in 
health insurance coverage and who meets the following conditions:
            ``(1)(A) The individual has a life-threatening or serious 
        illness for which no standard treatment is effective.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(C) The individual's participation in the trial offers 
        meaningful potential for significant clinical benefit for the 
        individual.
            ``(2) Either--
                    ``(A) the referring physician is a participating 
                health care professional and has concluded that the 
                individual's participation in such trial would be 
                appropriate based upon the individual meeting the 
                conditions described in paragraph (1); or
                    ``(B) the participant, beneficiary, or enrollee 
                provides medical and scientific information 
                establishing that the individual's participation in 
                such trial would be appropriate based upon the 
                individual meeting the conditions described in 
                paragraph (1).
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan, 
        and a health insurance issuer that offers health insurance 
        coverage in connection with a group health plan, shall provide 
        for payment for routine patient costs described in subsection 
        (a)(2) but is not required to pay for costs of items and 
        services that are reasonably expected to be paid for by the 
        sponsors of an approved clinical trial.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate; or
                    ``(B) a nonparticipating provider, the payment rate 
                shall be at the rate the plan or issuer would normally 
                pay for comparable services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a clinical research study or clinical 
        investigation and is described in any of the following 
        subparagraphs:
                    ``(A) Federally funded trials.--The study or 
                investigation is approved or funded (which may include 
                funding through in-kind contributions) by one or more 
                of the following:
                            ``(i) NIH.--The National Institutes of 
                        Health.
                            ``(ii) CDC.--The Centers for Disease 
                        Control and Prevention.
                            ``(iii) AHRQ.--The Agency for Health Care 
                        Research and Quality.
                            ``(iv) CMS.--The Center for Medicare & 
                        Medicaid Services.
                            ``(v) Cooperative center.--A cooperative 
                        group or center of any of the entities 
                        described in clauses (i) through (iv) or the 
                        Departments of Defense or Veterans Affairs.
                            ``(vi) Center support grantees.--A 
                        qualified nongovernmental research entity 
                        identified in the guidelines issued by the 
                        National Institutes of Health for center 
                        support grants.
                            ``(vii) DOD; va; doe.--Any of the following 
                        if the conditions described in paragraph (2) 
                        are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(B) FDA drug trial under ind.--The study or 
                investigation is conducted under an investigational new 
                drug application reviewed by the Food and Drug 
                Administration.
                    ``(C) Exempt drug trial.--The study or 
                investigation is a drug trial that is exempt from 
                having such an investigational new drug application.
            ``(2) Conditions for departments.--The conditions described 
        in this paragraph, for a study or investigation conducted by a 
        Department, are that the study or investigation has been 
        reviewed and approved through a system of peer review that the 
        Secretary determines--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health; and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
                no interest in the outcome of the review.
    ``(e) Construction.--Nothing in this section shall be construed to 
preclude a plan or issuer from offering coverage that is broader than 
the coverage required under this section with respect to clinical 
trials.''.
                    (B) Technical amendment.--Section 732(a) of the 
                Employee Retirement Income Security Act of 1974 (29 
                U.S.C. 1191a(a)) is amended by striking ``section 711'' 
                and inserting ``sections 711 and 714''.
                    (C) Table of contents.--The table of contents in 
                section 1 of the Employee Retirement Income Security 
                Act of 1974 is amended by inserting after the item 
                relating to section 713 the following new item:

``Sec. 714. Coverage for individuals participating in approved cancer 
                            clinical trials.''.
            (3) Internal revenue code of 1986.--
                    (A) In general.--Subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986 is amended--
                            (i) in the table of sections, by inserting 
                        after the item relating to section 9812 the 
                        following new item:

``Sec. 9813. Coverage for individuals participating in approved 
                            clinical trials.'';
                        and
                            (ii) by inserting after section 9812 the 
                        following:

``SEC. 9813. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
              CLINICAL TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan provides coverage 
        to a qualified individual (as defined in subsection (b)), the 
        plan--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsections (b), (c), and (d) may 
                not deny (or limit or impose additional conditions on) 
                the coverage of routine patient costs for items and 
                services furnished in connection with participation in 
                the trial; and
                    ``(C) may not discriminate against the individual 
                on the basis of the enrollee's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(B), subject to subparagraph (B), routine patient 
                costs include all items and services provided in the 
                clinical trial that are otherwise generally available 
                to the qualified individual, except--
                            ``(i) in the cases of drugs and devices, 
                        the investigational item or service, itself; or
                            ``(ii) items and services that are provided 
                        solely to satisfy data collection and analysis 
                        needs and that are not used in the direct 
                        clinical management of the patient.
                    ``(B) Exclusion.--Such routine patient costs do 
                include costs for the following:
                            ``(i) Conventional care.--Items or services 
                        that are typically provided absent a clinical 
                        trial.
                            ``(ii) Administrative items.--Items or 
                        services required solely for the provision of 
                        the investigational item or service, the 
                        clinically appropriate monitoring of the 
                        effects of the item or service, or the 
                        prevention of complications.
                            ``(iii) Reasonable and necessary care.--
                        Items or services needed for reasonable and 
                        necessary care arising from the provision of an 
                        investigational item or service, including the 
                        diagnosis or treatment of complications.
            ``(3) Use of in-network providers.--If one or more 
        participating provider is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan from requiring that a qualified individual participate in 
        the trial through such a participating provider if the provider 
        will accept the individual as a participant in the trial.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who is a 
participant or beneficiary in a group health plan and who meets the 
following conditions:
            ``(1)(A) The individual has a life-threatening or serious 
        illness for which no standard treatment is effective.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(C) The individual's participation in the trial offers 
        meaningful potential for significant clinical benefit for the 
        individual.
            ``(2) Either--
                    ``(A) the referring physician is a participating 
                health care professional and has concluded that the 
                individual's participation in such trial would be 
appropriate based upon the individual meeting the conditions described 
in paragraph (1); or
                    ``(B) the participant, beneficiary, or enrollee 
                provides medical and scientific information 
                establishing that the individual's participation in 
                such trial would be appropriate based upon the 
                individual meeting the conditions described in 
                paragraph (1).
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan 
        shall provide for payment for routine patient costs described 
        in subsection (a)(2) but is not required to pay for costs of 
        items and services that are reasonably expected to be paid for 
        by the sponsors of an approved clinical trial.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate; or
                    ``(B) a nonparticipating provider, the payment rate 
                shall be at the rate the plan would normally pay for 
                comparable services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a clinical research study or clinical 
        investigation and is described in any of the following 
        subparagraphs:
                    ``(A) Federally funded trials.--The study or 
                investigation is approved or funded (which may include 
                funding through in-kind contributions) by one or more 
                of the following:
                            ``(i) NIH.--The National Institutes of 
                        Health.
                            ``(ii) CDC.--The Centers for Disease 
                        Control and Prevention.
                            ``(iii) AHRQ.--The Agency for Health Care 
                        Research and Quality.
                            ``(iv) CMS.--The Center for Medicare & 
                        Medicaid Services.
                            ``(v) Cooperative center.--A cooperative 
                        group or center of any of the entities 
                        described in clauses (i) through (iv) or the 
                        Departments of Defense or Veterans Affairs.
                            ``(vi) Center support grantees.--A 
                        qualified nongovernmental research entity 
                        identified in the guidelines issued by the 
                        National Institutes of Health for center 
                        support grants.
                            ``(vii) DOD; va; doe.--Any of the following 
                        if the conditions described in paragraph (2) 
                        are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(B) FDA drug trial under ind.--The study or 
                investigation is conducted under an investigational new 
                drug application reviewed by the Food and Drug 
                Administration.
                    ``(C) Exempt drug trial.--The study or 
                investigation is a drug trial that is exempt from 
                having such an investigational new drug application.
            ``(2) Conditions for departments.--The conditions described 
        in this paragraph, for a study or investigation conducted by a 
        Department, are that the study or investigation has been 
        reviewed and approved through a system of peer review that the 
        Secretary determines--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health; and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
                no interest in the outcome of the review.
            ``(e) Construction.--Nothing in this section shall be 
        construed to preclude a plan from offering coverage that is 
        broader than the coverage required under this section with 
        respect to clinical trials.''.
    (b) Individual Health Insurance Coverage.--Part B of title XXVII of 
the Public Health Service Act (42 U.S.C. 300gg-41 et seq.) is amended--
            (1) by redesignating the first subpart 3 (relating to other 
        requirements) as subpart 2; and
            (2) by adding at the end of subpart 2 the following:

``SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
              CLINICAL TRIALS.

    ``The provisions of section 2707 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as they apply to health insurance coverage offered 
by a health insurance issuer in connection with a group health plan in 
the small or large group market.''.
    (c) Effective Dates.--
            (1) Group health plans.--Subject to paragraph (3), the 
        amendments made by subsection (a) apply with respect to group 
        health plans for plan years beginning on or after January 1, 
        2004.
            (2) Individual health insurance coverage.--The amendments 
        made by subsection (b) apply with respect to health insurance 
        coverage offered, sold, issued, renewed, in effect, or operated 
        in the individual market on or after January 1, 2004.
            (3) Collective bargaining exception.--In the case of a 
        group health plan maintained pursuant to 1 or more collective 
        bargaining agreements between employee representatives and 1 or 
        more employers ratified before the date of enactment of this 
        Act, the amendments made by subsection (a) shall not apply to 
        plan years beginning before the later of--
                    (A) the date on which the last collective 
                bargaining agreements relating to the plan terminates 
                (determined without regard to any extension thereof 
                agreed to after the date of enactment of this Act); or
                    (B) January 1, 2004.
        For purposes of subparagraph (A), any plan amendment made 
        pursuant to a collective bargaining agreement relating to the 
        plan which amends the plan solely to conform to any requirement 
        added by subsection (a) shall not be treated as a termination 
        of such collective bargaining agreement.
    (d) Coordination of Administration.--The Secretary of Labor, the 
Secretary of the Treasury, and the Secretary of Health and Human 
Services shall ensure, through the execution of an interagency 
memorandum of understanding among such Secretaries, that--
            (1) regulations, rulings, and interpretations issued by 
        such Secretaries relating to the same matter over which two or 
        more such Secretaries have responsibility under the provisions 
        of this section (and the amendments made thereby) are 
        administered so as to have the same effect at all times; and
            (2) coordination of policies relating to enforcing the same 
        requirements through such Secretaries in order to have a 
        coordinated enforcement strategy that avoids duplication of 
        enforcement efforts and assigns priorities in enforcement.
    (e) Study and Report.--
            (1) Study.--The Secretary of Health and Human Services, 
        jointly with the Secretary of Labor and the Secretary of the 
        Treasury, shall study the impact on group health plans and 
        health insurance issuers for covering routine patient care 
        costs for individuals who are entitled to benefits under this 
        section and who are enrolled in an approved clinical trial 
        program.
            (2) Report.--Not later than January 1, 2006, the Secretary 
        of Health and Human Services shall submit a report to Congress 
        that contains an assessment of--
                    (A) any incremental cost to group health plans and 
                health insurance issuers resulting from the provisions 
                of this section;
                    (B) a projection of expenditures to such plans and 
                issuers resulting from this section;
                    (C) any impact on premiums resulting from this 
                section; and
                    (D) any impact on the ability of health plans to 
                make coverage decisions in a more timely fashion.

SEC. 202. GRANTS FOR PRIMARY CARE RESEARCH FOR OLDER PATIENTS.

    Part B of title IX of the Public Health Service Act (42 U.S.C. 299b 
et seq.), as amended by section 101, is further amended by adding at 
the end the following:

``SEC. 920A. GRANTS FOR PRIMARY CARE RESEARCH FOR OLDER PATIENTS.

    ``(a) In General.--The Director shall award grants to public and 
nonprofit private entities for primary care research relating to older 
patients with multiple chronic conditions to gather information on how 
best to care for such patients.
    ``(b) Focus.--In awarding grants under subsection (a), the Director 
shall ensure that research is focused on the population of individuals 
who are 65 years of age and older.
    ``(c) Requirements.--Research conducted under a grant under this 
section shall--
            ``(1) examine the role of disease-specific guidelines in 
        the population described in subsection (a);
            ``(2) examine the feasibility of developing guidelines that 
        focus on the interaction of diseases and conditions; and
            ``(3) investigate appropriate outcomes of care to be 
        considered in evaluating the quality of care for such 
        population, including outcomes from the perspective of 
        patients, families, and clinicians.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $10,000,000 for fiscal year 
2004, and such sums as may be necessary for each fiscal year 
thereafter.''.

SEC. 203. STUDY ON EFFECTIVENESS OF CERTAIN PRESCRIPTION DRUGS.

    (a) In General.--
            (1) Research by nih.--The Director of the National 
        Institutes of Health, in coordination with the Director of the 
        Agency for Healthcare Research and Quality and the Commissioner 
        of Food and Drugs, shall conduct research, which may include 
        clinical research, to develop valid scientific evidence 
        regarding the comparative effectiveness and, where appropriate, 
        comparative safety of covered prescription drugs relative to 
        other drugs and treatments for the same disease or condition.
            (2) Analysis by the agency for healthcare research and 
        quality.--
                    (A) In general.--The Agency for Healthcare Research 
                and Quality, taking into consideration the research and 
                data from the National Institutes of Health and the 
                Food and Drug Administration, shall use evidence-based 
                practice centers to synthesize available data or 
                conduct other analyses of the comparative effectiveness 
                and, where appropriate, comparative safety of covered 
                prescription drugs relative to other drugs and 
                treatments for the same disease or condition.
                    (B) Safety.--In any analysis of comparative 
                effectiveness under this subparagraph, the Institute of 
                Medicine shall include a discussion of available 
                information on relative safety.
            (3) Standards.--The Director of the Agency for Healthcare 
        Research and Quality, in consultation with the Commissioner of 
        Food and Drugs, the Director of the National Institutes of 
        Health, and with input from stakeholders, shall develop 
        standards for the design and conduct of studies under this 
        subsection.
    (b) Covered Prescription Drugs.--For purposes of this section, the 
term ``covered prescription drugs'' means prescription drugs that, as 
determined by the Director of the Agency for Healthcare Research and 
Quality in consultation with the Administrator of the Centers for 
Medicare & Medicaid Services, the Secretary of Defense, and the 
Secretary of Veterans Affairs, account for high levels of use or high 
levels of risk to individuals in federally funded health programs, 
including Medicare and Medicaid.
    (c) Dissemination.--
            (1) Biennial report.--Every 2 years, the Secretary shall 
        prepare a report on the progress and results, if available, of 
        the research, studies, and analyses conducted by the National 
Institutes of Health and the Agency for Healthcare Research and 
Quality, and the Food and Drug Administration under this section and 
submit the report to the following:
                    (A) Congress.
                    (B) The President.
                    (C) The Secretary of Defense.
                    (D) The Secretary of Veterans Affairs.
            (2) Reports for practitioners and patients.--As soon as 
        possible, but not later than a year after the completion of any 
        study pursuant to subsection (a)(2), the Director of the Agency 
        for Healthcare Research and Quality shall--
                    (A) prepare a report on the results of such study 
                for the purpose of informing health care practitioners 
                and patients; and
                    (B) transmit the report to the Director of the 
                National Institutes of Health.
            (3) FDA drug information.--The Commissioner of Food and 
        Drugs shall--
                    (A) review all data and information from studies 
                and analyses conducted or prepared under this section; 
                and
                    (B) when determined appropriate by the 
                Commissioner, develop summaries of such information for 
                inclusion in adequate directions for use under section 
                502(f)(1) of the Federal Food, Drug, and Cosmetic Act 
                and in summaries relating to side effects, 
                contraindications, and effectiveness under section 
                502(n) of that Act.
            (4) NIH internet site.--The Director of the National 
        Institutes of Health shall publish on the Institutes' Internet 
        site and through other means that will facilitate access by 
        practitioners and patients each report prepared under this 
        subsection by the Director of the Agency for Healthcare 
        Research and Quality.
    (d) Evidence.--In carrying out this section, the Director of the 
National Institutes of Health and the Agency for Healthcare Research 
and Quality shall consider only methodologically sound studies, giving 
preference to studies for which the Directors have access to sufficient 
underlying data and analysis to address any significant concerns about 
methodology or the reliability of data.
    (e) Authorizations of Appropriations.--There are authorized to be 
appropriated to carry out this section, $75,000,000 for fiscal year 
2004, and such sums as may be necessary for each fiscal year 
thereafter.

               TITLE III--MEASURING AND COMPARING QUALITY

SEC. 301. PRIORITY AREA QUALITY INDICATORS.

    Part B of title IX of the Public Health Service Act (42 U.S.C. 299b 
et seq.), as amended by section 201, is further amended by adding at 
the end the following:

``SEC. 920B. PRIORITY AREA QUALITY INDICATORS.

    ``(a) In General.--The Director, in consultation with the Quality 
Interagency Coordination Task Force, the Institute of Medicine, the 
Joint Commission on Accreditation of Healthcare Organizations, the 
National Committee for Quality Assurance, the American Health Quality 
Association, the National Quality Forum, the Medicare Payment Advisory 
Committee, and other individuals and organizations determined 
appropriate by the Secretary, shall assemble, evaluate, and, where 
necessary, develop or update quality indicators for each of the 20 
priority areas for improvement in health care quality as identified by 
the Institute of Medicine in their report entitled `Priority Areas for 
National Action' in 2003, or other such areas as identified by the 
Secretary in order to assist beneficiaries in making informed choices 
about health plans or care delivery systems, and make such indicators 
available for purchasers to develop or align payment and performance. 
The selection of appropriate quality indicators under this subsection 
shall include the evaluation criteria formulated by clinical 
professionals, consumers, and data collection experts. Performance 
indicators developed or updated under this subsection shall in the 
aggregate reflect the spectrum of care patients receive and may include 
a range of process and outcome measures such as clinical outcome 
measures and indicators reflecting the provision of culturally and 
linguistically appropriate care.
    ``(b) Risk Adjustment.--In developing the quality indicators under 
subsection (a), the Director shall ensure that adequate risk adjustment 
is provided for.
    ``(c) Best Practices.--In carrying out this section, the Director 
shall--
            ``(1) assess data concerning appropriate clinical 
        treatments based on the best scientific evidence available;
            ``(2) determine areas in which there is insufficient 
        evidence to determine best practices; and
            ``(3) compare existing quality indicators to best clinical 
        practices, validate appropriate indicators, and report on areas 
        where additional research is needed before indicators can be 
        developed.
    ``(d) Report.--Not later than 1 year after the date of enactment of 
this section, and annually thereafter, the Director shall--
            ``(1) submit to the Director of the National Institutes of 
        Health a report concerning areas of clinical care requiring 
        further research necessary to establish effective clinical 
        treatments that will serve as a basis for quality indicators; 
        and
            ``(2) submit to Congress a report on the state of quality 
        measurement for priority areas that links data to the report 
        submitted under paragraph (1) for the year involved.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $12,000,000 for fiscal year 
2004, and $8,000,000 for each of fiscal years 2005 through 2009.''.

SEC. 302. STANDARDIZED QUALITY INDICATORS FOR FEDERAL AGENCIES.

    (a) In General.--In addition to other activities to be carried out 
by the Quality Interagency Coordination Taskforce (as established by 
executive order on March 13, 1998), such Taskforce shall use indicators 
standardized by the National Quality Forum to standardize indicators of 
health care quality that are used in all Federal agencies, as 
appropriate.
    (b) Consultation.--In carrying out subsection (a), the Quality 
Interagency Coordination Taskforce shall consult with a public-private 
consensus organization (such as the National Quality Forum) to enhance 
the likelihood of the simultaneous application of the standardized 
indicators under subsection (a) in the private sector.
    (c) Report.--Not later than 1 year after the date of enactment of 
this Act, and annually thereafter, the Secretary of Health and Human 
Services shall submit to Congress a report on the progress made by the 
Quality Interagency Coordination Taskforce to standardizing quality 
indicators throughout the Federal Government.

SEC. 303. DEMONSTRATION PROGRAM FOR COMMUNITY HEALTH CARE QUALITY DATA 
              REPORTING.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the Centers for Disease Control and Prevention 
and the Director of the Agency for Healthcare Quality and Research, 
shall award not to exceed 20 grants to eligible communities for the 
establishment of demonstration programs for the reporting of health 
care quality information at the community level.
    (b) Quality Indicators.--
            (1) In general.--For purposes of reporting information 
        under the demonstration programs under this section, indicators 
        of health care quality shall include the indicators developed 
        for the 20 priority areas as identified by the Institute of 
        Medicine in the report entitled ``Priority Areas for National 
        Action'', 2003, or other indicators determined appropriate by 
        the Secretary of Health and Human Services.
            (2) Type of data.--All quality indicators with respect to 
        which reporting will be carried out under the demonstration 
        program shall be reported by race, ethnicity, gender, and age 
        and shall be appropriately risk-adjusted.
    (c) Eligibility.--The Secretary of Health and Human Services shall 
award grants to communities (which may be cities, standard metropolitan 
statistical areas, counties, Indian tribes, or States) under this 
section based on competitive proposals and criteria to be determined 
jointly by the Director of the Centers for Disease Control and 
Prevention and the Director of the Agency for Healthcare Research and 
Quality. Such criteria may include a demonstrated ability of the 
community to collect data on quality indicators and a demonstrated 
ability to effectively transmit community-level health status results 
to relevant stakeholders, including clinicians and patients.
    (d) Technical Advisory Committee.--The Secretary of Health and 
Human Services shall establish an external technical advisory committee 
to assist grantees in data collection, data analysis, and report 
dissemination.
    (e) Report.--Not later than 1 year after the date of enactment of 
this Act, and annually thereafter, the Director of the Centers for 
Disease Control and Prevention and the Director of the Agency for 
Healthcare Research and Quality shall--
            (1) submit to the Congress a report on the progress and 
        results of the demonstration programs under this section; and
            (2) make such reports publicly available, including by 
        posting the reports on the Internet.
    (f) Evaluation.--The Secretary of Health and Human Services shall, 
upon awarding grants under subsection (a), enter into a contract for 
the evaluation of demonstration programs under this section. Such 
evaluation shall compare the effectiveness of such demonstration 
programs in collecting and reporting required data, and on the 
effectiveness of distributing information to key stakeholders in a 
timely fashion. Such evaluations shall provide for a report on best 
practices.
    (g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $25,000,000 for fiscal year 
2004, and such sums as may be necessary for each fiscal year 
thereafter.

SEC. 304. DEMONSTRATION PROJECT FOR THE COLLECTION OF DATA ON RACE, 
              ETHNICITY, AND LINGUISTIC PREFERENCES.

    Section 903(c) of the Public Health Service Act (42 U.S.C. 299a-
1(c)) is amended by adding at the end the following:
            ``(4) Collection of data on race, ethnicity, and linguistic 
        preferences.--
                    ``(A) In general.--The Secretary, acting through 
                the Director, shall conduct demonstration programs in 
                conjunction with physicians, physician groups, 
                patients, and consumer groups to investigate effective 
                ways to collect reliable and valid data regarding an 
                individual patient's race, ethnicity, and linguistic 
                preferences. Such demonstrations may include--
                            ``(i) the use of focus groups to develop 
                        appropriate language and modalities for 
                        requesting such information;
                            ``(ii) the conduct of training programs for 
                        front line staff and clinical professionals;
                            ``(iii) the use of specific culturally and 
                        linguistically appropriate scripts, translation 
                        of scripts and supporting material,
                            ``(iv) the use of general informational 
                        materials;
                            ``(v) designs for community awareness 
                        programs that are culturally and linguistically 
                        appropriate; and
                            ``(vi) the collection and dissemination of 
                        best practices for the collection of race, 
                        ethnicity, and linguistic preference 
                        information.
                    ``(B) Eligibility.--To be eligible to participate 
                in a demonstration project under subparagraph (A), an 
                individual or entity shall--
                            ``(i) be a domestic or foreign, public or 
                        private not-for-profit organization, including 
                        a university, clinic, unit of State or local 
                        government, or an eligible agency of the 
                        Federal Government; and
                            ``(ii) submit to the Secretary an 
                        application at such time, in such manner, and 
                        containing such information as the Secretary 
                        may require, including--
                                    ``(I) a description of the 
                                populations to be included in the 
                                project;
                                    ``(II) documentation of the 
                                willingness to participate in the 
                                project from appropriate community 
                                groups;
                                    ``(III) documentation of the 
                                previous ability of the applicant to 
                                work with such groups; and
                                    ``(IV) evidence of necessary skill 
                                sets to develop needed materials and 
                                interventions.
                    ``(C) Duration.--A demonstration project under this 
                paragraph shall be for 1 or 2 years and shall be 
                conducted over a period commencing not later than 6 
                months after the date of enactment of this paragraph.
                    ``(D) Reports.--Not later than 1 year after the 
                date of enactment of this paragraph, and annually 
                thereafter for the duration of projects under this 
                paragraph, the Secretary shall submit to Congress 
                annual reports on such projects. The final report 
                submitted under this subparagraph shall contain a 
                summation of best practices to be posted on appropriate 
                websites and disseminated to providers and communities.
                    ``(E) Authorization of appropriations.--There are 
                authorized to be appropriated to carry out this 
                section, $5,000,000 for each of fiscal years 2004 and 
                2005.''.

    TITLE IV--PRODUCTION, EVALUATION, AND DISTRIBUTION OF PRACTICE 
                          GUIDELINES FOR CARE

SEC. 401. PRODUCTION, EVALUATION, AND DISTRIBUTION OF PRACTICE 
              GUIDELINES FOR CARE.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into a contract with the Institute of Medicine of the National 
Academy of Sciences, or another appropriate entity, to conduct a study 
on approaches to developing and disseminating seed practice guidelines 
to be used as a basis for regional or local application in accordance 
with subsection (b).
    (b) Content.--The study conducted under subsection (a) shall--
            (1) study how and under what circumstances the coordinated 
        development of evidence-based practice guidelines would be 
        feasible and would improve health outcomes;
            (2) identify any available prototypes for the development 
        and dissemination of guidelines regionally, in the United 
        States, or in other countries;
            (3) consider how to involve health care consumers in the 
        development of such guidelines and gain the acceptance of 
        clinicians;
            (4) consider how guidelines should account for cultural and 
        linguistic differences among patients;
            (5) consider how guidelines should reflect variations in 
        patients preferences;
            (6) determine potential guideline models, including public 
        and private options;
            (7) compare and contrast the strengths and limitations of 
        each such model;
            (8) determine both start-up and operating costs of 
        different guideline development and dissemination models;
            (9) explore alternative funding options;
            (10) evaluate guideline dissemination strategies; and
            (11) develop a recommended strategy for implementation in 
        the United States, including the potential role of the Federal 
        Government.
    (c) Report.--Not later than 12 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall submit to 
the appropriate committees of Congress a report containing the results 
of the study conducted under this section.
    (d) Dissemination of Findings.--The Secretary shall disseminate the 
findings of the study conducted under subsection (a) to appropriate 
public and private entities, including the posting of such findings on 
appropriate websites.
    (e) Definition.--In this section, the term ``seed practice 
guidelines'' means guidelines that represent a synthesis of the 
scientific evidence to support clinical practice.
    (f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $750,000 for fiscal year 2004.

                       TITLE V--REWARDING QUALITY

SEC. 501. INSTITUTE OF MEDICINE REPORT ON PAYMENT INCENTIVES AND 
              PERFORMANCE.

    (a) Evaluation.--
            (1) In general.--Not later than 2 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall enter into an arrangement under which the 
        Institute of Medicine of the National Academy of Sciences (in 
        this section referred to as the ``Institute'') shall conduct an 
        evaluation of options to align performance with payment, 
        including payment under the medicare program under title XVIII 
        of the Social Security Act (42 U.S.C. 1395 et seq.).
            (2) Specific matters evaluated.--In conducting the 
        evaluation under paragraph (1), the Institute shall--
                    (A) catalogue, review, and evaluate the validity of 
                leading health care performance measures to determine 
                what subset of measures is appropriate for payment;
                    (B) catalogue and evaluate the success, utility, 
                and effects of alternative performance incentive 
                programs in public or private sector settings; and
                    (C) identify and prioritize options to implement 
                policies that align performance with payment under the 
                medicare program that indicate--
                            (i) the performance measurement set to be 
                        used and how that measurement set will be 
                        updated;
                            (ii) the payment policy that will reward 
                        performance; and
                            (iii) the key implementation issues (such 
                        as data and information technology 
                        requirements, and necessary risk adjustment) 
                        that must be addressed.
            (3) Scope of health care performance measures.--The 
        evaluation and selection of health care performance measures 
        described in paragraph (2)(A) shall reflect a variety of 
        perspectives, including clinical professionals, hospitals, 
        health plans, purchasers, and consumers, and data collection 
        experts.
            (4) Consultation with medpac.--In evaluating the matters 
        described in paragraph (2)(C), the Institute shall consult with 
        the Medicare Payment Advisory Commission established under 
        section 1805 of the Social Security Act (42 U.S.C. 1395b-6).
    (b) Report.--Not later than 6 months after the issuance of a report 
by the Secretary on priority area quality indicators, the Institute 
shall submit to the Secretary of Health and Human Services, the 
Committees on Ways and Means and Energy and Commerce of the House of 
Representatives, and the Committees on Finance and Health, Education, 
Labor and Pensions of the Senate a report on the evaluation conducted 
under subsection (a)(1) that describes the findings of such evaluation 
and contains recommendations for an overall strategy and approach for 
aligning payment with performance in various types of private and 
public health plans, including, the original medicare fee-for-service 
program under parts A and B of title XVIII of the Social Security Act, 
the Medicare+Choice program under part C of such title, and any other 
programs under such title XVIII.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated, $1,000,000 for purposes of conducting the evaluation and 
preparing the report required by this section.

                   TITLE VI--INFORMATION TO CONSUMERS

SEC. 601. DISSEMINATION OF INFORMATION TO CONSUMERS.

    Part B of title IX of the Public Health Service Act (42 U.S.C. 299b 
et seq.), as amended by section 301, is further amended by adding at 
the end the following:

``SEC. 920C. DISSEMINATION OF INFORMATION TO CONSUMERS.

    ``(a) Demonstration Projects.--
            ``(1) In general.--The Secretary, acting through the 
        Director, shall support research and demonstration projects to 
        assess the feasibility of using community-based and voluntary 
        public and private organizations to disseminate information 
        about health care quality to consumers.
            ``(2) Requirements.--The research and demonstration 
        projects under paragraph (1) shall address the following:
                    ``(A) The ability and costs to train staff in 
                community-based and voluntary public and private 
                organizations to disseminate such information.
                    ``(B) The materials needed for such training.
                    ``(C) The types of audiences reached by such 
                community-based and voluntary public and private 
                organizations.
                    ``(D) The effectiveness of the transmission of 
                information from such community-based and voluntary 
                public and private organizations to the target 
                audiences.
            ``(3) Report.--Not later than 3 years after the date of 
        enactment of this section, the Secretary shall ensure that a 
        report containing the results of the research and demonstration 
        projects under paragraph (1) is submitted to the appropriate 
        committees of Congress.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.
    ``(b) Training for Long-Term Care Ombudsman.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Administration on Aging and in consultation 
        with the Director of the Agency for Healthcare Research and 
        Quality and the Administrator of the Centers for Medicare & 
        Medicaid Services, shall authorize a program, to be developed 
        and implemented by the National Long-Term Care Ombudsman 
        Resource Center, for the training of long-term care ombudsmen 
        in the use of quality of care information.
            ``(2) Training.--Under the program developed under 
        paragraph (2), training shall be provided to long-term care 
        ombudsman to enable such ombudsman to educate consumers 
        concerning--
                    ``(A) nursing home, home health care, and other 
                long-term care quality of care issues;
                    ``(B) available nursing home and home health care 
                quality of care reports, including existing quality 
                data that the Administrator of the Centers for Medicare 
                & Medicaid Services has released for use by the public 
                in choosing long-term care facilities or home health 
                care services; and
                    ``(C) the manner in which an individual can 
                successfully integrate quality information into health 
                care decision making regarding nursing home and home 
                health care decisions.
            ``(3) Duties of resource center.--The National Long-Term 
        Care Ombudsman Resource Center shall--
                    ``(A) develop and maintain a curriculum for 
                ombudsmen;
                    ``(B) develop, produce, and maintain training 
                materials;
                    ``(C) conduct train-the-trainer programs at 
                regional and national levels; and
                    ``(D) act as a clearinghouse for best practices in 
                communicating the significance of nursing home and home 
                health care quality indicators to residents and their 
                caregivers.
            ``(4) Pilot programs.--The Secretary shall award grants for 
        the establishment of 1-year pilot demonstration programs in 10 
        States using dedicated long-term care ombudsmen to educate 
        consumers regarding nursing home and home health care quality. 
Such pilot demonstration programs shall test the effectiveness of 
having a committed position within the State dedicated to helping 
consumers use nursing home and home health care quality indicators.
            ``(5) Report.--Not later than 18 months after the date of 
        enactment of this section, and annually thereafter, the 
        Secretary shall submit to Congress a report concerning the 
        effectiveness of the program established under this subsection, 
        including the benefits of providing for dedicated staff who are 
        responsible for educating consumers to use nursing home and 
        home health quality indicators in their health care decision-
        making.
            ``(6) Authorization.--In addition to any other amounts 
        authorized to be appropriated for long-term care ombudsman 
        programs, there are authorized to be appropriated to carry out 
        this subsection $4,000,000 for fiscal year 2004 (of which 
        $1,000,000 shall be used to carry out paragraph (4)), and 
        $2,000,000 for each fiscal year thereafter.''.

                TITLE VII--PROMOTING PATIENT ENGAGEMENT

SEC. 701. PROMOTING PATIENT ENGAGEMENT.

    Part B of title IX of the Public Health Service Act (42 U.S.C. 299b 
et seq.), as amended by section 601, is further amended by adding at 
the end the following:

``SEC. 920D. PROMOTING PATIENT ENGAGEMENT.

    ``(a) Grants.--
            ``(1) In general.--The Secretary, acting through the 
        Director, shall award grants to public and private non-profit 
        entities to conduct research on patient experiences in their 
        care.
            ``(2) Requirements.--Activities conducted under grants 
        awarded under paragraph (1) shall--
                    ``(A) evaluate the impact of sharing health records 
                with patients;
                    ``(B) provide for the conduct of studies on 
                understanding and describing patient value systems, 
                including risk aversion, self-care orientation, and 
                time horizon;
                    ``(C) evaluate how patients seek health information 
                and how they use it;
                    ``(D) evaluate how changes in consumer behavior 
                based on information about quality affect changes in 
                provider behavior; and
                    ``(E) study how the effects of the studies 
                conducted under this subsection vary by race, 
                ethnicity, cultural and linguistic groups, education, 
                age, and gender.
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.
    ``(b) Health Literacy Standards.--
            ``(1) In general.--For purposes of assisting eligible 
        entities in providing quality assurance measures, the 
        Secretary, acting through the Director, the Administrator of 
        Health Resources and Services Administration, the Director of 
        the National Library of Medicine, and the Commissioner of Food 
        and Drugs, shall develop standardized materials that 
        pharmacists may use to assist non-English speaking or 
        functionally illiterate patients in the safe and appropriate 
        use of prescription drugs. Such materials may include the use 
        of pictures and the development of standardized translations in 
        multiple languages of prescription labels and bottle labels and 
        other patient safety initiative information. Such materials 
        shall be available electronically for direct access by 
        pharmacists.
            ``(2) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection, 
        such sums as may be necessary for each of fiscal years 2004 and 
        2005.''.
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