[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1101 Introduced in Senate (IS)]



108th CONGRESS
  1st Session
                                S. 1101

    To provide for a comprehensive Federal effort relating to early 
  detection of, treatments for, and the prevention of cancer, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 21, 2003

 Mrs. Feinstein (for herself, Mr. Smith, Mr. Daschle, Mr. Jeffords, Mr. 
        Kennedy, Ms. Collins, Ms. Landrieu, Mrs. Hutchison, Mr. 
        Johnson, Mr. Corzine, Mrs. Lincoln, Ms. Cantwell, Mrs. Clinton, 
        Mr. Lautenberg, Mrs. Murray, Mr. Dodd, Mrs. Boxer, Ms. 
        Stabenow, Mr. Nelson of Florida, Mr. Schumer, Mr. Hollings, Mr. 
        Reed, Mr. Kerry, Ms. Mikulski, and Mr. Leahy) introduced the 
        following bill; which was read twice and referred to the 
        Committee on Health Education, Labor, and PensionsYYYYYYYYYYYYY

_______________________________________________________________________

                                 A BILL


 
    To provide for a comprehensive Federal effort relating to early 
  detection of, treatments for, and the prevention of cancer, and for 
                            other purposes.

    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 ``National Cancer 
Act of 2003''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
 TITLE I--EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, DETECTION, 
                         AND TREATMENT PROGRAMS

Sec. 101. Sense of the Senate concerning investments in cancer research 
                            funding.
Sec. 102. Sense of the Senate concerning investments in cancer research 
                            to develop targeted drugs.
Sec. 103. Expansion of cancer-related research, prevention, detection, 
                            treatment, and survivorship programs.
Sec. 104. National Institute for Environmental Health Sciences.
Sec. 105. Comprehensive cancer control plans.
Sec. 106. Breast, cervical, and colorectal cancer screening.
Sec. 107. IHS grants for model community cancer and chronic disease 
                            care and prevention; IHS grants for patient 
                            navigators.
        TITLE II--EXPANDING ACCESS TO CANCER DRUGS AND TREATMENT

Sec. 201. Acceleration of the drug treatment approval process of the 
                            Food and Drug Administration.
Sec. 202. FDA amendment.
          TITLE III--CANCER-RELATED HEALTH INSURANCE COVERAGE

                  Subtitle A--Clinical Trials Coverage

Sec. 301. Coverage for clinical trials under the Public Health Service 
                            Act.
Sec. 302. Coverage for clinical trials under the Employee Retirement 
                            Income Security Act of 1974.
Sec. 303. Coverage for clinical trials under other public health 
                            insurance.
            Subtitle B--Cancer Screening and Other Coverage

Sec. 311. Cancer screening coverage.
               Subtitle C--Physicians and Quality of Care

Sec. 321. Managing physicians and quality of care for cancer patients 
                            under the Public Health Service Act.
Sec. 322. Managing physicians and quality of care for cancer patients 
                            under the Employee Retirement Income 
                            Security Act of 1974.
Sec. 323. Managing physicians and quality of care for cancer patients 
                            under medicare.
Sec. 324. Managing physicians and quality of care for cancer patients 
                            under medicaid and SCHIP.
                     Subtitle D--General Provisions

Sec. 331. Coverage under other public health insurance.
TITLE IV--PATIENT NAVIGATOR AND CANCER CARE WITHIN THE HEALTH RESOURCES 
                      AND SERVICES ADMINISTRATION

Sec. 401. HRSA grants for model community cancer and chronic disease 
                            care and prevention and grants for patient 
                            navigators.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Each year 1,300,000 Americans are diagnosed with 
        cancer. Each year 560,000 Americans die from cancer. 
        Approximately 40 percent of all Americans in the United States 
        will be diagnosed with cancer at some point in their lives.
            (2) Since 1971, when the National Cancer Act was enacted, 
        and the ``War on Cancer'' was declared, the science of cancer 
        has advanced dramatically. The revolution in molecular and 
        cellular biology has created unprecedented opportunities for 
        understanding cancer and the role of genetics, environmental 
        risk factors, and lifestyle factors in relation to cancer.
            (3) Since 1971, mortality rates for some cancers have 
        decreased, while such rates for other cancers have not.
            (4) Since 1971, the Nation's population has become 
        increasingly diverse and cancer affects various minority, 
        socioeconomic, and ethnic groups disproportionately.
            (5) Cancer screening can reduce cancer mortality, in some 
        cases by 30 percent or more. While effective screening tools 
        have yet to be developed for the majority of cancers, proven 
        screening tools for early detection do exist for some of the 
        more common cancers. Screening for some cancers, such as 
        breast, colorectal, and cervical cancers, has improved 
        dramatically; however, screening rates are still lower than 
        optimal. Cancer screening rates vary by cancer site, population 
        group, and health insurance coverage.
            (6) Public and private health insurance coverage offered in 
        the United States has dramatically changed since 1971. Today, 
        managed care coverage is more typical than the fee-for-service 
        coverage that was more common in the past. This change in the 
        form of coverage has introduced more economic considerations 
        into medical decisionmaking, which can affect the quality of 
        all health care provided, including cancer care.
            (7) Fewer than 5 percent of adult cancer patients 
        participate in cancer trials.
            (8) New translational cancer research centers are needed to 
        provide the preclinical and early clinical trials support 
        required to advance scientific discoveries into new drugs and 
        technologies to prevent, detect, treat, and diagnose cancer.
            (9) The quality of cancer care is uneven across the Nation 
        and can be based on pure coincidence of where one lives. Many 
        cancer patients do not receive optimal care.
            (10) Cancer is a disease of aging and as the American 
        population ages, cancer incidence will grow. It is estimated 
        that the number of cancer diagnoses in 2010 will increase by 20 
        percent. The number of cancer deaths is anticipated to increase 
        by 20 percent, at an annual cost of over $200,000,000,000. With 
        such increases in the incidence of cancer, there will be a 
        serious shortage of individuals in the workforce to provide 
        cancer care, particularly in long-term care settings.
            (11) The number of medical researchers is declining, a 
        decrease which will negatively affect the prevention, 
        detection, and treatment of cancer.
            (12) Since 1971, there has been a shift in cancer care, 
        such as the administration of chemotherapy, moving from 
        inpatient to outpatient settings.
            (13) Since 1971, the conduct of research has involved more 
        collaboration between the public and private sectors and more 
        multidisciplinary approaches. The biotechnology pharmaceutical 
        and device industry has grown and provided a broad array of new 
treatment options and scientific opportunities for cancer patients, 
providers, and researchers.
            (14) Since 1971, technology and communications have 
        expanded and increased in complexity, transforming research 
        methodologies and making the accessing and transmitting of 
        information more widespread and more readily available.
            (15) Tobacco use is the leading preventable cause of 
        disease and premature death in the United States, resulting in 
        \1/3\ of all cancer deaths, including 87 percent of lung cancer 
        deaths. Research consistently shows that smoking cessation 
        services can be 1 of the most cost-effective health 
        interventions and can reduce smoking-related health care costs. 
        Cessation services offered as a combination of tobacco 
        medication therapy and counseling effectively help smokers quit 
        successfully and prevent premature death from tobacco-related 
        cancers.

 TITLE I--EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, DETECTION, 
                         AND TREATMENT PROGRAMS

SEC. 101. SENSE OF THE SENATE CONCERNING INVESTMENTS IN CANCER RESEARCH 
              FUNDING.

    It is the sense of the Senate that--
            (1) past investments in cancer research have resulted in 
        better health, an improved quality of life, and a reduction in 
        national health care expenditures; and
            (2) to build on, and sustain, the progress made over the 
        past 5 years during which Congress doubled the budget at the 
        National Institutes of Health, the National Cancer Institute 
        requires continued increases in Federal funding, as outlined in 
        the National Cancer Institute Directors Bypass Budget, to 
        achieve a balanced research portfolio and to develop more 
        targeted, more effective therapies or drugs and other cancer 
        treatments and to address those rare, deadly cancers lacking 
        effective early detection tests or treatments for a wide range 
        of cancers, commensurable with the National Cancer Institute 
        bypass budget.

SEC. 102. SENSE OF THE SENATE CONCERNING INVESTMENTS IN CANCER RESEARCH 
              TO DEVELOP TARGETED DRUGS.

    (a) Findings.--The Senate finds that--
            (1) all cells have molecular signatures, unique 
        identifiable characteristics related to a cells' function in 
        the body;
            (2) as a normal cell becomes malignant, its signature 
        changes and this change becomes a signal of the presence of 
        cancer; and
            (3) with new technologies, scientists are reading cancer-
        associated signatures and using this information to devise 
        treatments that target specific cells.
    (b) Sense of the Senate.--It is the sense of the Senate that to 
build on the research currently conducted by the National Institutes of 
Health, increased funding is necessary to further develop this new 
generation of low toxicity, high efficacy agents which target only the 
cancer cells leaving in place the healthy cells.

SEC. 103. EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, DETECTION, 
              TREATMENT, AND SURVIVORSHIP PROGRAMS.

    Subpart 1 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285) is amended--
            (1) by inserting after the subpart heading the following:

   ``CHAPTER I--PURPOSE OF INSTITUTE AND NATIONAL CANCER PROGRAMS'';

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

           ``CHAPTER II--PROGRAMS TO PREVENT AND TREAT CANCER

``SEC. 417E. STUDY AND STRATEGIC PLANS.

    ``(a) In General.--Not later than July 1, 2005, the Institute shall 
prepare 1 or more strategic plans to identify unmet needs and the level 
of funding in the areas of prevention, treatment, early detection, and 
quality of life, and to expand and intensify cancer research and 
cancer-related research by July 1, 2006, for--
            ``(1) behavioral research associated with causing and 
        preventing cancer;
            ``(2) research regarding prevention of cancer other than 
        behavioral interventions;
            ``(3) research to reduce disparities among racial and 
        ethnic minorities and other disparity populations;
            ``(4) research regarding palliative care, pain management;
            ``(5) research regarding preserving and restoring quality-
        of-life for cancer patients;
            ``(6) research regarding environmental risk factors for 
        cancer and gene-environment interactions;
            ``(7) research regarding management of symptoms;
            ``(8) research regarding tools for early detection, 
        especially for which there currently are no adequate screening 
        technologies; and
            ``(9) cancer survivorship.
    ``(b) Priorities.--The Institute shall determine priorities based 
on scientific opportunities, in consultation with medical, scientific, 
patient, and provider representatives, and prepare 1 or more strategic 
plans by July 1, 2005.

``SEC. 417E-1. GRANTS FOR TRANSLATIONAL CANCER RESEARCH.

    ``(a) In General.--The Director of the Institute shall carry out a 
program to establish translational cancer research centers.
    ``(b) Duties of Director.--In carrying out the program, the 
Director of the Institute shall--
            ``(1) award grants to public or nonprofit private entities 
        to plan and operate a national network of at least 20 existing 
        or new translational cancer research centers to conduct 
        translational, multidisciplinary cancer research;
            ``(2) establish networks and partnerships linking the 
        translational cancer research centers described in paragraph 
        (1) to community cancer providers (hospitals, clinics, 
        providers' practices, particularly in underserved areas) and 
        expand opportunities for all cancer patients to participate in 
        clinical trials of new agents developed by these centers;
            ``(3) facilitate the process to award grants, contracts, 
        and cooperative agreements to private entities to conduct 
        translational cancer research in the following areas--
                    ``(A) cancer drugs, biologics, and devices; and
                    ``(B) cancer detection diagnostic tests, 
                techniques, and technology; and
            ``(4) develop and implement a strategic plan by July 1, 
        2005, in collaboration with translational centers as authorized 
        in paragraph (7) for intensifying, expanding, and disseminating 
        results of translational research to providers of cancer care.
    ``(c) Grants.--
            ``(1) In general.--The Director of the Institute shall 
        award grants to public or nonprofit private entities to 
        establish translational cancer research centers to conduct 
        translational, multidisciplinary cancer research. Funds shall 
        not be used for construction of new facilities.
            ``(2) Equity.--The Director of the Institute shall award 
        grants under subsection (b)(1) to provide, to the greatest 
        extent practicable, a broad distribution of such grants among 
        geographic regions of the United States.
            ``(3) Duties.--A public or nonprofit entity that receives a 
        grant under subsection (b)(1) shall use funds received through 
        such grant to establish and operate a translational cancer 
        research center.
            ``(4) Application.--A public or nonprofit entity desiring a 
        grant under this subsection shall submit an application to the 
        Director of the Institute at such time, in such manner, and 
        containing such information as the Director of the Institute 
        may reasonably require.
    ``(d) Duties of Translational Research Centers.--The translational 
research centers shall--
            ``(1) perform research for discovery and preclinical 
        evaluation of drugs, biologics, devices, technologies, and 
        strategies with potential to improve the prevention, detection, 
        diagnosis, and treatment of cancer and to improve pain and 
symptom management and quality of life of cancer patients;
            ``(2) perform clinical research studies on promising cancer 
        treatments or strategies, in appropriate human populations;
            ``(3) evaluate promising cancer diagnostic tests, 
        techniques, or technologies in individuals being evaluated for 
        the presence of cancer;
            ``(4) perform all phases of clinical trials of new drugs, 
        devices, biologics, or other strategies for treating patients 
        with cancer, in collaboration with the existing NCI Cooperative 
        Groups;
            ``(5) develop and implement a plan to ensure the 
        availability of adequate sources of patients for each type of 
        clinical research study;
            ``(6) create systems and external relationships, which do 
        not duplicate capabilities available in the private sector, to 
        accelerate the findings from translational research to a stage 
        that private companies can assume development and 
        commercialization; and
            ``(7) develop and implement a plan expanding and 
        disseminating the efficacious products of translational 
        research to providers of cancer care, including products 
        approved by the Food and Drug Administration.
    ``(e) Definitions.--In this section:
            ``(1) Clinical trial.--The term `clinical trial' means a 
        scientifically-designed clinical investigation in which a 
        patient participates in examining the effects of a drug, 
        biologic medical treatment, or medical device for the 
        prevention, early detection, or treatment of cancer or the 
        potential side effects of treatment or of the disease.
            ``(2) Translational cancer research.--The term 
        `translational cancer research' means scientific laboratory and 
        clinical research and testing needed to transform scientific 
        discoveries into new approaches and products that can prevent, 
        detect, control, diagnose, and treat cancer, optimize quality 
        of life, and ultimately, cure cancer.
    ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $100,000,000 in fiscal year 
2004, and $100,000,000 for each of the fiscal years 2005, 2006, 2007, 
and 2008.

``SEC. 417E-2. GRANTS FOR DEVELOPMENT OF TARGETED DRUGS.

    ``(a) In General.--The Director of the Institute shall carry out a 
research grant program to provide funding to projects that seek to 
develop cancer treatments that target cancer cells.
    ``(b) Duties of Director.--In carrying out the program under 
subsection (a), the Director of the Institute shall--
            ``(1) award grants and facilitate the process to award 
        grants to public or nonprofit private entities to conduct 
        research to develop a molecularly-oriented, knowledge-based 
        approach to cancer drug discovery and development; and
            ``(2) not later than July 1, 2005, develop and implement a 
        strategic plan for intensifying and expanding research 
        conducted to increase the number of cancer treatments available 
        that are low toxicity, high efficacy agents, and in particular, 
        research to develop treatments that selectively target 
        malignant or cancerous cells.
    ``(c) Limitations.--Amounts awarded under grants under this section 
shall not be used for the construction of facilities.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $20,000,000 in fiscal year 
2004, and $20,000,000 for each of the fiscal years 2005, 2006, 2007, 
and 2008.

``SEC. 417E-3. CLINICAL TRIALS.

    ``(a) In General.--The Director of the Institute shall carry out a 
program to increase patient and provider participation in clinical 
trials.
    ``(b) Program.--The program described in subsection (a) shall 
include--
            ``(1) an outreach program;
            ``(2) a diversity assurance program;
            ``(3) an assistance program, including recommending sources 
        of funding for patients support costs; and
            ``(4) culturally appropriate materials.
    ``(c) Outreach Program.--In carrying out the outreach program 
described in subsection (a), the Director of the Institute shall 
regularly provide information to cancer care providers, professional 
and patient organizations, including community-based organizations, and 
patients to increase provider participation and patient enrollment in 
clinical trials.
    ``(d) Diversity Assurance Program.--In carrying out the diversity 
assurance program described in subsection (a), the Director of the 
Institute shall require that all research grant applications include 
assurances that the applicant will actively recruit a diverse patient 
population, including disparity populations, to participate in trials, 
when such recruitment is medically appropriate.

``SEC. 417E-4. CANCER CARE RESEARCHERS.

    ``(a) Supply of Cancer Researchers.--In order to ensure a 
sufficient number of researchers trained in the prevention, early 
detection, diagnosis, cure, and treatment of cancer in future fiscal 
years, the Director of the Institute, in coordination with the 
Secretary of Veterans Affairs, shall carry out activities to--
            ``(1) increase the number and amount of institutional 
        training grants to institutions supporting cancer research; and
            ``(2) increase the number of career development awards for 
        health professionals, particularly minorities, who intend to 
        have, or who expand, careers in basic, clinical, and 
        translational cancer research, including cancer prevention, 
        cancer information technology, bioinformatics, behavioral 
        research, and research on palliative, psychosocial, and end-of-
        life care.
    ``(b) Loan Repayment.--
            ``(1) Establishment.--The Director of the Institute, in 
        consultation with the Director of the National Institutes of 
        Health, shall establish a cancer research loan repayment 
        program.
            ``(2) Contracts.--Under the program established under 
        paragraph (1), the Director of the Institute shall enter into 
        contracts with qualified health professionals under which such 
        professionals will agree to conduct cancer research, in 
        consideration of the Federal Government agreeing to repay, for 
        each year of such services, not more than $35,000 of the 
        principal and interest of the educational loans of such 
        professionals obtained to support training for degrees or 
        licenses, as determined appropriate by the Director of the 
        Institute.
    ``(c) Postdoctoral Stipends.--
            ``(1) In general.--The Director of the Institute, shall 
        develop and implement, for postdoctoral trainees and fellows, a 
        stipend schedule that by October 1, 2004, begins for entry-
        level positions and individuals with no or limited experience 
        comparable to grade 11 of the Federal general schedule under 
        title 5, United States Code (civil service salary schedule) and 
        that adequately reflects training, education, experience, and 
        comparable salaries or stipends for comparable work in non-
        Federal settings, and provides for annual cost-of-living 
        adjustments.
            ``(2) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection, $79,000,000 
        for fiscal year 2004, and $86,000,000 for fiscal year 2005, 
        $95,000,000 for fiscal year 2006, $105,000,000 for fiscal year 
        2007, and $115,000,000 for fiscal year 2008.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $10,500,000 for fiscal year 
2004, and $10,500,000 for each of fiscal years 2005 through 2008.

``SEC. 417E-5. CANCER CARE WORKFORCE.

    ``(a) In General.--The Secretary shall establish a program to 
address current and future cancer care workforce needs.
    ``(b) Program.--The program described in subsection (a) shall--
            ``(1) set annual and long-term training goals to assure an 
        adequate cancer care workforce;
            ``(2) prepare and implement a plan to provide assistance to 
        individuals based on cancer health professions with the most 
        severe shortages;
            ``(3) award grants, scholarships, fellowships, and loans to 
        eligible individuals to increase the cancer care workforce;
            ``(4) make awards to eligible individuals to increase 
        cancer care workforce training for all individuals to become 
        cancer care providers, especially but not limited to, such 
        individuals who make a commitment to serve in underserved 
        communities or areas with disproportionately high cancer 
        incidence or mortality and for health professions for which 
        there are anticipated shortages, including providers, 
        pharmacists, nurses for all settings, allied health 
        professionals, physicians, specialists, and public health 
        professionals; and
            ``(5) be coordinated with existing programs to prevent 
        duplication.
    ``(c) Eligibility.--To be eligible to receive a scholarship, loan, 
or fellowship under this section, an individual shall submit an 
application to the Secretary at such time, in such manner, and 
containing such information as the Secretary reasonably requires. In 
such application, such individual shall demonstrate the intent to seek 
training to get a certificate, license, or postsecondary degree in 
health care, or in the case of licensed health care professionals, the 
intent to seek professional development to upgrade skills and knowledge 
or to obtain specialized knowledge according to criteria developed by 
the Secretary.
    ``(d) Use of Funds.--A recipient of a grant, scholarship, loan, or 
fellowship under this section may use funds from such grant, 
scholarship, loan, or fellowship to pay the costs of tuition and fees 
for training in--
            ``(1) care and treatment of cancer patients and survivors;
            ``(2) quality of life and symptom management;
            ``(3) early detection and diagnosis;
            ``(4) cancer prevention;
            ``(5) genetic testing and counseling;
            ``(6) language and cultural competency in cancer care; and
            ``(7) palliative and end-of-life care.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $100,000,000 in fiscal year 
2004 and such sums as may be necessary in each year for fiscal years 
2005, 2006, 2007, and 2008.

``SEC. 417E-6. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    ``(a) Program.--The Director of the Centers for Disease Control and 
Prevention shall--
            ``(1) expand and update the National Comprehensive Cancer 
        Control Program;
            ``(2) assist States, territories, tribal organizations, and 
        the District of Columbia in developing and implementing a 
        cancer prevention and control program so that each entity will 
        have an active plan in place and so that States, territories, 
        tribal organizations, and the District of Columbia will conduct 
        activities to prevent and control cancer and so that 
        disparities in specific populations will be addressed;
            ``(3) establish programs that demonstrate how to prevent 
        and control cancer and improve access to and the quality of 
        cancer care among racial and ethnic minority and medically 
        underserved populations with disproportionate incidence of or 
        death from cancer;
            ``(4) promote cancer education, prevention, and early 
        detection of cancer; and
            ``(5) award grants to public and nonprofit organizations 
        for cancer control and prevention.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $65,000,000 for fiscal year 
2004 and such sums as may be necessary for fiscal years 2005, 2006, 
2007, and 2008.

``SEC. 417E-7. CANCER SURVIVORSHIP.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall conduct a study 
of the unique health challenges associated with cancer survivorship and 
carry out projects and interventions to improve the long-term health 
status of cancer survivors. Such projects shall be carried out directly 
or through the awarding of grants or contracts.
    ``(b) Activities.--Activities that may be carried out under 
subsection (a) include--
            ``(1) the expansion of current cancer surveillance systems 
        to track the health status of cancer survivors and determine 
        whether cancer survivors are at-risk for other chronic and 
        disabling conditions;
            ``(2) assess the unique challenges associated with cancer 
        survivorship; and
            ``(3) the development of a national cancer survivorship 
        action plan, in partnership with health organizations focused 
        on cancer survivorship, to be carried out in coordination with 
        the State-based comprehensive cancer control program of the 
        Centers for Disease Control and Prevention to--
                    ``(A) develop unique and innovative post-treatment 
                programs, services, and demonstrations designed to 
                support and advance cancer survivorship through--
                            ``(i) promotion of physical activity and 
                        healthy lifestyles;
                            ``(ii) educational outreach programs for 
                        health care providers;
                            ``(iii) support for innovative programs to 
                        improve the quality of life among cancer 
                        survivors;
                            ``(iv) home and community-based 
                        interventions;
                            ``(v) peer support and mentor programs;
                            ``(vi) public awareness and outreach 
                        campaigns; and
                            ``(vii) information dissemination to inform 
                        health care providers and cancer survivors of 
                        their health care options and available 
                        survivorship programs; and
                    ``(B) develop unique cancer survivorship 
                demonstration programs designed to address the needs of 
                underserved populations, including minorities, 
                children, and individuals residing in rural areas.
    ``(c) Coordination of Activities.--The Secretary shall ensure that 
activities carried out under this section are coordinated as 
appropriate with other agencies of the Public Health Service.
    ``(d) Report to Congress.--Not later than October 1, 2004, the 
Secretary shall submit to Congress a report describing the results of 
the study conducted under subsection (a), and as applicable, the 
strategies developed under such subsection.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $35,000,000 for fiscal year 
2004, and such sums as may be necessary for each of fiscal years 2005 
through 2008.

``SEC. 417E-8. OFFICE OF CANCER SURVIVORSHIP.

    ``(a) Establishment.--There is established within the Institute an 
Office on Cancer Survivorship (in this section referred to as the 
`Office'), to be headed by an Associate Director, to implement and 
direct the expansion and coordination of the activities of the 
Institute with respect to cancer survivorship research.
    ``(b) Collaboration Among Agencies.--In carrying out the activities 
described in subsection (a), the Office shall collaborate with other 
institutes, centers, and offices within the National Institutes of 
Health that are determined appropriate by the Office.
    ``(c) Report.--Not later than 1 year after the date of enactment of 
this section, the Secretary shall prepare and submit to the appropriate 
committees of Congress a report providing a description of the 
survivorship activities of the Office and strategies for future 
activities.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as may be necessary 
for each of fiscal years 2004 through 2008.

``SEC. 417E-9. MONITORING AND EVALUATING QUALITY CANCER CARE AND CANCER 
              SURVIVORSHIP.

    ``(a) In General.--The Secretary, acting through the Director of 
the Institute and the Director of the Centers for Disease Control and 
Prevention, shall make grants to eligible entities for the purpose of 
enabling such entities to monitor and evaluate quality cancer care, 
develop information concerning quality cancer care, and monitor cancer 
survivorship.
    ``(b) Eligible Entities.--An entity shall be eligible for a grant 
under this section for a fiscal year if such entity--
            ``(1) operates a statewide cancer registry with funds from 
        a grant made under section 399B for such fiscal year; and
            ``(2) is certified by the North American Association of 
        Central Cancer Registries or another similar certification 
        organization.
    ``(c) Contracting Authority.--In carrying the purpose described in 
subsection (a), an eligible entity may expend a grant under such 
subsection to enter into contracts with academic institutions, cancer 
centers, and other entities, when determined appropriate by the 
Secretary.
    ``(d) Application.--To be eligible for a grant under subsection 
(a), an eligible entity shall submit to the Secretary an application at 
such time, in such manner, and containing such agreements, assurances, 
and information as the Secretary determines to be necessary to carry 
out this section.
    ``(e) Authority of Secretary Regarding Use of Grant Funds.--The 
Secretary shall determine the appropriate uses of grant funds under 
subsection (a) to achieve the purpose described in such subsection.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of fiscal years 2004 through 2008.

``SEC. 417E-10. MODEL COMMUNITY CANCER AND CHRONIC DISEASE CARE AND 
              PREVENTION; PATIENT NAVIGATORS.

    ``(a) Definitions.--In this section:
            ``(1) Appropriate follow-up care.--The term `appropriate 
        follow-up care' includes palliative and end-of-life care.
            ``(2) Culturally competent.--The term `culturally 
        competent', with respect to providing health-related services, 
        means services that, in accordance with standards and measures 
        of the Secretary, are designed to effectively and efficiently 
        respond to the cultural and linguistic needs of patients.
            ``(3) Eligible entity.--The term `eligible entity' means 
        any public or private entity determined to be appropriate by 
        the Director of the Institute that provides services described 
        in subsection (b)(1)(A) for cancer and chronic diseases, or any 
        of the following entities that demonstrates the ability to 
        perform all of the functions outlined in subsections (b) 
        through (d):
                    ``(A) A designated cancer center of the Institute.
                    ``(B) An academic institution.
                    ``(C) An Indian Health Service Clinic.
                    ``(D) A tribal government.
                    ``(E) An urban Indian organization.
                    ``(F) A tribal organization.
                    ``(G) A hospital.
                    ``(H) A qualified nonprofit entity that partners 
                with 1 or more centers providing health care to provide 
                navigation services.
            ``(4) Health disparity population.--The term `health 
        disparity population' means a population where there exists a 
        significant disparity in the overall rate of disease incidence, 
        morbidity, mortality, or survival rates in the population as 
        compared to the health status of the general population. Such 
        term includes--
                    ``(A) racial and ethnic minority groups (as defined 
                under section 1707); and
                    ``(B) medically underserved groups, such as rural 
                and low-income individuals and individuals with low 
                levels of literacy.
            ``(5) Patient navigator.--
                    ``(A) In general.--The term `patient navigator' 
                means an individual whose functions include--
                            ``(i) assisting and guiding patients with a 
                        symptom, abnormal finding, or diagnosis of 
                        cancer or other chronic disease within the 
                        health care system to accomplish the follow-up 
                        and diagnosis of an abnormal finding as well as 
                        the treatment and appropriate follow-up care of 
                        cancer or other chronic disease, including 
                        providing information about clinical trials; 
                        and
                            ``(ii) identifying, anticipating, and 
                        helping patients overcome barriers within the 
                        health care system to ensure prompt diagnostic 
                        and treatment resolution of an abnormal finding 
                        of cancer or other chronic disease.
                    ``(B) Inclusions.--The term `patient navigator' 
                includes representatives of the target health disparity 
                population, such as nurses, social workers, cancer 
                survivors, and patient advocates.
    ``(b) Model Community Cancer and Chronic Disease Care and 
Prevention.--
            ``(1) In general.--The Director of the Institute may make 
        grants to eligible entities for the development and operation 
        of model programs that--
                    ``(A) provide to individuals of health disparity 
                populations prevention, early detection, treatment, and 
                appropriate follow-up care services for cancer and 
                chronic diseases;
                    ``(B) ensure that the health services are provided 
                to such individuals in a culturally competent manner;
                    ``(C) assign patient navigators, in accordance with 
                applicable criteria of the Secretary, for managing the 
                care of individuals of health disparity populations 
                to--
                            ``(i) accomplish, to the extent possible, 
                        the follow-up and diagnosis of an abnormal 
                        finding and the treatment and appropriate 
                        follow-up care of cancer or other chronic 
                        disease; and
                            ``(ii) facilitate access to appropriate 
                        health care services within the health care 
                        system to ensure optimal patient utilization of 
                        such services, including aid in coordinating 
                        and scheduling appointments and referrals, 
                        community outreach, assistance with 
                        transportation arrangements, and assistance 
                        with insurance issues and other barriers to 
                        care and providing information about clinical 
                        trials;
                    ``(D) require training for patient navigators 
                employed through such model programs to ensure the 
                ability of navigators to perform all of the duties 
                required in this subsection and in subsection (c), 
                including training to ensure that navigators are 
                informed about health insurance systems and are able to 
                aid patients in resolving access issues; and
                    ``(E) ensure that consumers have direct access to 
                patient navigators during regularly scheduled hours of 
                business operation.
            ``(2) Application for grant.--An eligible entity that 
        desires to receive a grant under paragraph (1) shall submit an 
        application to the Director of the Institute at such time, in 
        such manner, and containing such agreements, assurances, and 
        information as the Director of the Institute determines to be 
        necessary to carry out this section.
            ``(3) Outreach services.--In order to be eligible to 
        receive a grant under paragraph (1), an eligible entity shall 
        agree to provide ongoing outreach activities while receiving 
        the grant, in a manner that is culturally competent for the 
        health disparity population served by the program, to inform 
        the public and the specific community that the program is 
        serving of the services of the model program under the grant. 
        Such activities shall include facilitating access to 
        appropriate health care services and patient navigators within 
        the health care system to ensure optimal patient utilization of 
        such services.
            ``(4) Data collection and report.--In order to allow for 
        effective program evaluation, an eligible entity that receives 
        a grant under this subsection shall collect specific patient 
        data recording services provided to each patient served by the 
        program and shall establish and implement procedures and 
        protocols, consistent with applicable Federal and State laws 
        (including sections 160 and 164 of title 45, Code of Federal 
        Regulations) to ensure the confidentiality of all information 
        shared by a participant in the program, or their personal 
        representative and their health care providers, group health 
        plans, or health insurance insurers with the program. The 
        program may, consistent with applicable Federal and State 
        confidentiality laws, collect, use, or disclose aggregate 
        information that is not individually identifiable (as defined 
        in sections 160 and 164 of title 45, Code of Federal 
        Regulations). With this data, the grantee shall submit an 
        annual report to the Secretary that summarizes and analyzes the 
        data and provides information on needs for navigation services, 
        types of access difficulties resolved, sources of repeated 
        resolution, and flaws in the system of access, including 
        insurance barriers.
            ``(5) Evaluations.--
                    ``(A) In general.--The Director of the Institute, 
                directly or through grants or contracts, shall provide 
                for evaluations to determine which outreach activities 
                under paragraph (3) were most effective in informing 
                the public and the specific community that the program 
                is serving of the model program services and to 
                determine the extent to which such programs were 
                effective in providing culturally competent services to 
                the health disparity population served by the programs.
                    ``(B) Dissemination of findings.--The Director of 
                the Institute shall, as appropriate, disseminate to 
                public and private entities the findings made in 
                evaluations under subparagraph (A).
            ``(6) Coordination with other programs.--The Secretary 
        shall coordinate the program under this subsection with--
                    ``(A) the program under subsection (c);
                    ``(B) the program under section 330M; and
                    ``(C) to the extent practicable, programs for 
                prevention centers that are carried out by the Director 
                of the Centers for Disease Control and Prevention.
    ``(c) Program for Patient Navigators.--
            ``(1) In general.--The Director of the Institute may make 
        grants to eligible entities for the development and operation 
        of programs to pay the costs of such entities in--
                    ``(A) assigning patient navigators, in accordance 
                with applicable criteria of the Secretary, for managing 
                the care of individuals of health disparity populations 
                for the duration of receipt of health services from the 
                health centers, including aid in coordinating and 
                scheduling appointments and referrals, community 
                outreach, assistance with transportation arrangements, 
                assistance with insurance issues and other barriers to 
                care, and providing information about clinical trials;
                    ``(B) ensuring that the services provided by the 
                patient navigators to such individuals include case 
                management and psychosocial assessment and care or 
                information and referral to such services;
                    ``(C) ensuring that the patient navigators with 
                direct knowledge of the communities they serve provide 
                services to such individuals in a culturally competent 
                manner;
                    ``(D) developing model practices for patient 
                navigators, including with respect to--
                            ``(i) coordination of health services, 
                        including psychosocial assessment and care;
                            ``(ii) follow-up services, including 
                        psychosocial assessment and care;
                            ``(iii) determining coverage under health 
                        insurance and health plans for all services;
                            ``(iv) ensuring the initiation, 
                        continuation, or sustained access to care 
                        prescribed by the patients' health care 
                        providers; and
                            ``(v) aiding patients with health insurance 
                        coverage issues;
                    ``(E) requiring training for patient navigators to 
                ensure the ability of navigators to perform all of the 
                duties required in this subsection and in subsection 
                (b), including training, to ensure that navigators are 
                informed about health insurance systems and are able to 
                aid patients in resolving access issues; and
                    ``(F) ensuring that consumers have direct access to 
                patient navigators during regularly scheduled hours of 
                business operation.
            ``(2) Application for grant.--An eligible entity that 
        desires to receive a grant under paragraph (1) shall submit an 
        application to the Director of the Institute at such time, in 
        such manner, and containing such agreements, assurances, and 
        information as the Director of the Institute determines to be 
        necessary to carry out this section.
            ``(3) Outreach services.--In order to be eligible to 
        receive a grant under paragraph (1), an eligible entity shall 
        agree to provide ongoing outreach activities while receiving 
        the grant, in a manner that is culturally competent for the 
        health disparity population served by the program, to inform 
        the public and the specific community that the patient 
        navigator is serving of the services of the model program under 
        the grant.
            ``(4) Data collection and report.--In order to allow for 
        effective patient navigator program evaluation, an eligible 
        entity that receives a grant under this subsection shall 
        collect specific patient data recording navigation services 
        provided to each patient served by the program and shall 
        establish and implement procedures and protocols, consistent 
        with applicable Federal and State laws (including sections 160 
        and 164 of title 45, Code of Federal Regulations) to ensure the 
        confidentiality of all information shared by a participant in 
        the program, or their personal representative and their health 
        care providers, group health plans, or health insurance 
        insurers with the program. The patient navigator program may, 
        consistent with applicable Federal and State confidentiality 
        laws, collect, use, or disclose aggregate information that is 
        not individually identifiable (as defined in sections 160 and 
        164 of title 45, Code of Federal Regulations). With this data, 
        the grantee shall submit an annual report to the Secretary that 
        summarizes and analyzes the data and provides information on 
        needs for navigation services, types of access difficulties 
        resolved, sources of repeated resolution, and flaws in the 
        system of access, including insurance barriers.
            ``(5) Evaluations.--
                    ``(A) In general.--The Director of the Institute, 
                directly or through grants or contracts, shall provide 
                for evaluations to determine the effects of the 
                services of patient navigators on the health disparity 
                population for whom the services were provided, taking 
                into account the matters referred to in paragraph 
                (1)(C).
                    ``(B) Dissemination of findings.--The Director of 
                the Institute shall as appropriate disseminate to 
                public and private entities the findings made in 
                evaluations under subparagraph (A).
            ``(6) Coordination with other programs.--The Secretary 
        shall coordinate the program under this subsection with the 
        programs under subsection (b) and section 330M.
    ``(d) Requirements Regarding Fees.--
            ``(1) In general.--In order to be eligible to receive a 
        grant under subsection (b) or (c), the program for which the 
        grant is made shall have in effect--
                    ``(A) a schedule of fees or payments for the 
                provision of such program's health care services 
                related to the prevention and treatment of disease that 
                is consistent with locally prevailing rates or charges 
                and is designed to cover such program's reasonable 
                costs of operation; and
                    ``(B) a corresponding schedule of discounts to be 
                applied to the payment of such fees or payments, which 
                discounts are adjusted on the basis of the ability of 
                the patient to pay.
            ``(2) Rule of construction.--Nothing in this subsection 
        shall be construed to require payment for navigation services 
        or to require payment for health care services in cases where 
        care is provided free of charge, including the case of services 
        provided through programs of the Indian Health Service.
    ``(e) Model.--Not later than 5 years after the date of enactment of 
this section, the Director of the Institute shall develop a peer-
reviewed model of systems for the services provided by this section. 
The Director of the Institute shall update such model as may be 
necessary to ensure that the best practices are being utilized.
    ``(f) Duration of Grant.--The period during which payments are made 
to an eligible entity from a grant under subsection (b)(1) or (c)(1) 
may not exceed 5 years. The provision of such payments are subject to 
annual approval by the Director of the Institute and subject to the 
availability of appropriations for the fiscal year involved. Nothing in 
this subsection shall be construed as establishing a limitation on the 
number of grants under subsections (b) and (c) that may be made to an 
eligible entity.
    ``(g) Authorization of Appropriations.--
            ``(1) Model programs.--For the purpose of carrying out 
        subsection (b), there are authorized to be appropriated such 
        sums as may be necessary for each of the fiscal years 2004 
        through 2008.
            ``(2) Patient navigators.--For the purpose of carrying out 
        subsection (c), there are authorized to be appropriated such 
        sums as may be necessary for each of the fiscal years 2004 
        through 2008.
            ``(3) Relation to other authorizations.--Authorizations of 
        appropriations under paragraphs (1) and (2) are in addition to 
        other authorizations of appropriations that are available for 
        the purposes of carrying out subsections (b) and (c).

``SEC. 417E-11. CANCER CARE GUIDELINES.

    ``The Agency for Healthcare Research and Quality shall regularly 
convene cancer experts, providers, patients, representatives of 
disparity populations, and other relevant experts, including 
representatives of the Institute, the Health Resources Administration, 
and the Centers for Disease Control and Prevention, to coordinate the 
development and regularly update--
            ``(1) consensus protocols and practice guidelines for 
        optimal cancer treatments and prevention, including palliation, 
        symptom management, and end-of-life care;
            ``(2) quality of care measures to assist providers and 
        patients in making and evaluating treatment decisions; and
            ``(3) guidelines for providing patients with multi-
        disciplinary consultation before treatment is initiated and 
        with 1 physician, preferably a specialist when feasible, to 
        provide overall coordination and management of cancer care 
        among all providers of the patient's treatment and services.

``SEC. 417E-12. RESEARCH AND OTHER ACTIVITIES OF THE AGENCY FOR 
              HEALTHCARE RESEARCH AND QUALITY TO IMPROVE THE QUALITY 
              AND OUTCOMES OF CANCER CARE.

    ``(a) In General.--
            ``(1) Research.--The Director for Healthcare Research and 
        Quality shall conduct and support research and other activities 
        to build an evidence base regarding effective clinical and 
        organizational intervention strategies to improve the quality 
        and outcomes of cancer care, and access to such care, at all 
        stages of the health care continuum and to facilitate the 
        prompt use of that information to improve practice.
            ``(2) Factors.--In carrying out paragraph (1), the Director 
        for Healthcare Research and Quality shall take into account the 
        breadth of the continuum of cancer care, from prevention and 
        early detection, through diagnosis and treatment, to 
        rehabilitation, long term survivorship and remission, through 
        psychosocial, palliative, and end-of-life care.
    ``(b) Specific Requirements.--The Agency for Healthcare Research 
and Quality shall--
            ``(1) conduct and support research to develop new 
        scientific knowledge regarding the effectiveness and cost-
        effectiveness of interventions that improve the quality and 
        outcomes of cancer care, and access to such care;
            ``(2) regularly assess and synthesize existing scientific 
        evidence on the effectiveness of such interventions;
            ``(3) ensure the targeted dissemination of the most current 
        scientific evidence in appropriate formats for use by 
        professional societies and organizations representing 
        clinicians and other caregivers, organizations through which 
        health care and support services are delivered, and 
        organizations representing cancer patients and their families;
            ``(4) facilitate, as appropriate, the prompt use of 
        existing scientific information by the professional societies 
        and organization listed in paragraph (3) to develop guidance, 
        best practices, quality improvement strategies or other 
        initiatives to improve practice;
            ``(5) develop quality of care measures to assist clinicians 
        and other caregivers, providers and health plans, patients and 
        their families, and purchasers;
            ``(6) collect information, as appropriate, and conduct and 
        support research on trends in medical care practice patterns 
        and the relationship of such trends to the quality and outcomes 
of cancer care; and
            ``(7) assess effective strategies by which an individual 
        physician can provide overall coordination and management of 
        cancer care.
    ``(c) Coordination of Federal Quality Improvement Activities and 
Reporting of Data.--In carrying out subsection (b)--
            ``(1) the Director for Healthcare Research and Quality, 
        working through the Quality Interagency Coordination (QUIC) 
        Task Force, and in collaboration with the Director of the 
        Institute, shall facilitate coordination of Federal research 
        and implementation initiatives to improve the quality and 
        outcomes of cancer care;
            ``(2) the Agency for Healthcare Research and Quality shall 
        serve as a resource for other Federal agencies in the 
        measurement of the quality of cancer care;
            ``(3) the Director for Healthcare Research and Quality and 
        the Director of the Institute shall work cooperatively to 
        develop data in order to set benchmarks for, and subsequently 
        measure changes in the quality of cancer care for inclusion, as 
        soon as practicable, in the annual report required by section 
        913(b)(2); and
            ``(4) the Director for Healthcare Research and Quality 
        shall ensure coordination of these activities, as appropriate, 
        with his responsibilities for research on health disparities 
        under section 903.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of fiscal years 2004 through 2008.

``SEC. 417E-13. INSTITUTE OF MEDICINE STUDY ON CANCER.

    ``(a) Institute of Medicine Study.--The Secretary shall request the 
Institute of Medicine of the National Academies of Sciences to initiate 
a study by January 1, 2004, of the feasibility and costs of providing 
medicare coverage under title XVIII of the Social Security Act to 
individuals who are diagnosed with cancer and cancer survivors through 
5 years of remission of cancer at any age and who have no other means 
of purchasing health care or health insurance, as determined under 
criteria established by the Secretary.
    ``(b) Content.--
            ``(1) In general.--The study under subsection (a) shall be 
        conducted in 2 parts.
            ``(2) First part.--The first part shall--
                    ``(A) examine options for providing medicare 
                coverage to such individuals;
                    ``(B) estimate the cost to the medicare program and 
                to current and future beneficiaries; and
                    ``(C) identify advantages associated with medicare 
                coverage in terms of access to cancer care, improved 
                quality of care and patient outcomes and assess the 
                feasibility of providing medicare coverage to uninsured 
                cancer patients through 5 years of remission and make a 
                recommendation to Congress about whether medicare 
                should be expanded to this population group.
            ``(3) Second part.--The second part shall--
                    ``(A) identify changes in medicare benefits to 
                facilitate the provision of care consistent with 
                quality cancer care standards, including prescription 
                drug benefits and benefits to improve home care, 
                symptom management, psychosocial services, and 
                palliative and hospice care;
                    ``(B) estimate the cost to the medicare program and 
                to beneficiaries; and
                    ``(C) assess the medical advantages and 
                disadvantages associated with expanding benefits.
            ``(4) Deadlines.--The first part shall be completed by June 
        30, 2005, and the second part shall be completed by December 
        31, 2005.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $1,000,000 in fiscal year 2004 
and $1,200,000 in fiscal year 2005.''.

SEC. 104. NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES.

    (a) In General.--Not later than October 1, 2004, the Director of 
the National Institute for Environmental Health Sciences shall, in 
coordination with the National Cancer Institute, prepare and submit to 
the Secretary of Health and Human Services a strategic plan that 
identifies the unmet needs regarding research on environmental risk 
factors for cancer and gene-environment interactions and describes how 
to increase the amount of such research and resources for such 
research.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary.

SEC. 105. COMPREHENSIVE CANCER CONTROL PLANS.

    Section 412 of the Public Health Service Act (42 U.S.C. 285a-1) is 
amended--
            (1) in the first sentence, by inserting ``, for 
        survivorship,'' after ``treatment of cancer'';
            (2) in paragraph (1)(B), by striking ``cancer patients'' 
        and all that follows and inserting the following: ``cancer 
        patients, families of cancer patients, and cancer survivors, 
        and''; and
            (3) in paragraph (3), by inserting ``and concerning cancer 
        survivorship programs,'' after ``control of cancer''.

SEC. 106. BREAST, CERVICAL, AND COLORECTAL CANCER SCREENING.

    (a) Breast and Cervical Cancer.--Section 1510(a) of the Public 
Health Service Act (42 U.S.C. 300n-5(a)) is amended by striking 
``$50,000,000'' and all that follows through the period, and inserting 
``$250,000,000 for fiscal year 2004, and such sums as may be necessary 
for fiscal years 2005 through 2008.''.
    (b) Colorectal Cancer.--Title XV of the Public Health Service Act 
(42 U.S.C. 300k et seq.) is amended by adding at the end the following:

``SEC. 1511. COLORECTAL CANCER SCREENING DEMONSTRATION PROJECT.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall award competitive 
grants to public and nonprofit private entities to enable such entities 
to establish demonstration programs pursuant to the general authority 
of title III to carry out colorectal screening activities including--
            ``(1) screening asymptomatic individuals for colorectal 
        cancer as a preventive health measure according to scientific 
        evidence-based screening guidelines;
            ``(2) providing appropriate referrals for medical treatment 
        of individuals screened pursuant to this section and to ensure, 
        to the extent practicable, the provision of appropriate follow-
        up services and support services such as case management;
            ``(3) activities to improve the education, training, and 
        skills of health professionals (including allied health 
        professionals) in the detection and control of colorectal 
        cancer;
            ``(4) activities to evaluate the programs under this 
        section through appropriate surveillance or program monitoring 
        activities;
            ``(5) the development and dissemination of findings derived 
        through such evaluations through public and professional 
        education; and
            ``(6) activities to promote the benefits of colorectal 
        cancer screening.
    ``(b) Payments for Screenings.--The amount paid by a grantee under 
this section to an entity on behalf of an individual for the furnishing 
of services to such individual shall not exceed the amount that would 
be paid under part B of title XVIII of the Social Security Act for such 
services if such payment were made under such part for such services.
    ``(c) Requirements.--
            ``(1) Priority.--To be eligible for a grant under 
        subsection (a), an entity shall agree to give priority with 
        respect to activities and services under the grant to a low-
        income--
                    ``(A) individual who is at least 50 years of age; 
                or
                    ``(B) individual at high risk for colorectal cancer 
                (as defined in section 1861(pp)(2) of the Social 
                Security Act (42 U.S.C. 1395x(pp)(2))).
            ``(2) Relationship to items and services under other 
        programs.--To be eligible for a grant under subsection (a), an 
        entity shall agree that grant funds will not be expended to 
        make payments for any item or service to the extent that 
        payment has been made, or can reasonably be expected to be 
        made, with respect to such item or service--
                    ``(A) under any State compensation program, under 
                an insurance policy, or under any Federal or State 
                health benefits program; or
                    ``(B) by an entity that provides health service on 
                a prepaid basis.
            ``(3) Restrictions on use of grant.--To be eligible for a 
        grant under subsection (a), an entity shall agree that grant 
        funds will not be expended to provide inpatient hospital 
        services for an individual.
            ``(4) Records and audits.--To be eligible for a grant under 
        subsection (a), an entity shall agree that the entity will--
                    ``(A) establish such fiscal control and fund 
                accounting procedures as may be necessary to ensure 
                proper disbursal of, and accounting for, amounts 
                received under this section; and
                    ``(B) provide agreed upon annual reports to the 
                Secretary or the Comptroller of the United States for 
                the purposes of auditing the expenditures by the 
                entity.
            ``(5) Reports.--To be eligible for a grant under subsection 
        (a), an entity shall agree to submit to the Secretary such 
        reports as the Secretary determines appropriate.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $50,000,000 for fiscal year 
2004, and such sums as may be necessary for each of fiscal years 2005 
through 2008.''.

SEC. 107. IHS GRANTS FOR MODEL COMMUNITY CANCER AND CHRONIC DISEASE 
              CARE AND PREVENTION; IHS GRANTS FOR PATIENT NAVIGATORS.

    (a) Definitions.--In this section:
            (1) In general.--The terms ``culturally competent'', 
        ``appropriate follow-up care'', ``health disparity 
        population'', and ``patient navigator'' have the meanings given 
        those terms in section 417E-10 of the Public Health Service 
        Act.
            (2) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (b) Model Community Cancer and Chronic Disease Care and 
Prevention.--
            (1) In general.--The Director of the Indian Health Service 
        may make grants, for the development and operation of model 
        programs that perform the same functions outlined in section 
        417E-10(b)(1) of the Public Health Service Act, to Indian 
        Health Service Centers, tribal governments, urban Indian 
        organizations, tribal organizations, and qualified nonprofit 
        entities demonstrating the ability to perform all of the 
        functions in this subsection and subsections (c) and (d) that 
        partner with providers or centers providing health care 
        services to Native American populations to provide navigation 
        services.
            (2) Application for grant.--An entity that desires to 
        receive a grant under paragraph (1) shall submit an application 
        to the Secretary at such time, in such manner, and containing 
        such agreements, assurances, and information as the Secretary 
        determines to be necessary to carry out this section.
            (3) Outreach services.--In order to be eligible to receive 
        a grant under paragraph (1), an entity shall agree to provide 
        ongoing outreach activities while receiving the grant, in a 
        manner that is culturally competent for the health disparity 
        population served by the program, to inform the public and the 
        specific community that the program is serving of the services 
        of the model program under the grant. Such activities shall 
        include facilitating access to appropriate health care services 
        and patient navigators within the health care system to ensure 
optimal patient utilization of such services.
            (4) Data collection and report.--In order to allow for 
        effective program evaluation, an entity that receives a grant 
        under this subsection shall collect specific patient data 
        recording services provided to each patient served by the 
        program and shall establish and implement procedures and 
        protocols, consistent with applicable Federal and State laws 
        (including sections 160 and 164 of title 45, Code of Federal 
        Regulations) to ensure the confidentiality of all information 
        shared by a participant in the program, or their personal 
        representative and their health care providers, group health 
        plans, or health insurance insurers with the program. The 
        program may, consistent with applicable Federal and State 
        confidentiality laws, collect, use, or disclose aggregate 
        information that is not individually identifiable (as defined 
        in sections 160 and 164 of title 45, Code of Federal 
        Regulations). With this data, the grantee shall submit an 
        annual report to the Secretary that summarizes and analyzes the 
        data and provides information on needs for navigation services, 
        types of access difficulties resolved, sources of repeated 
        resolution, and flaws in the system of access, including 
        insurance barriers.
            (5) Evaluations.--
                    (A) In general.--The Secretary, acting through the 
                Director of the Indian Health Service, shall, directly 
                or through grants or contracts, provide for evaluations 
                to determine which outreach activities under paragraph 
                (3) were most effective in informing the public and the 
                specific community that the program is serving of the 
                model program services and to determine the extent to 
                which such programs were effective in providing 
                culturally competent services to the health disparity 
                population served by the programs.
                    (B) Dissemination of findings.--The Secretary shall 
                as appropriate disseminate to public and private 
                entities the findings made in evaluations under 
                subparagraph (A).
            (6) Coordination with other programs.--The Secretary shall 
        coordinate the program under this subsection with--
                    (A) the program under subsection (c);
                    (B) the program under section 417E-10 of the Public 
                Health Service Act; and
                    (C) to the extent practicable, programs for 
                prevention centers that are carried out by the Director 
                of the Centers for Disease Control and Prevention.
    (c) Program for Patient Navigators.--
            (1) In general.--The Secretary, acting through the Director 
        of the Indian Health Service, may make grants to Indian Health 
        Service Centers, tribal governments, urban Indian 
        organizations, tribal organizations, and qualified nonprofit 
        entities demonstrating the ability to perform all of the 
        functions in this subsection and subsections (b) and (d) that 
        partner with providers or centers providing health care 
        services to Native American populations to provide navigation 
        services, for the development and operation of model programs 
        to pay the costs of such entities in carrying out the same 
        activities outlined in section 417E-10(c)(1) of the Public 
        Health Service Act.
            (2) Application for grant.--An entity that desires to 
        receive a grant under paragraph (1) shall submit an application 
        to the Secretary at such time, in such manner, and containing 
        such agreements, assurances, and information as the Secretary 
        determines to be necessary to carry out this section.
            (3) Outreach services.--In order to be eligible to receive 
        a grant under paragraph (1), an entity shall agree to provide 
        ongoing outreach activities while receiving the grant, in a 
        manner that is culturally competent for the health disparity 
        population served by the program, to inform the public and the 
        specific community that the patient navigator is serving of the 
        services of the model program under the grant.
            (4) Data collection and report.--In order to allow for 
        effective patient navigator program evaluation, an entity that 
        receives a grant under this subsection shall collect specific 
        patient data recording navigation services provided to each 
        patient served by the program and shall establish and implement 
        procedures and protocols, consistent with applicable Federal 
        and State laws (including sections 160 and 164 of title 45, 
        Code of Federal Regulations) to ensure the confidentiality of 
        all information shared by a participant in the program, or 
        their personal representative and their health care providers, 
        group health plans, or health insurance insurers with the 
        program. The patient navigator program may, consistent with 
        applicable Federal and State confidentiality laws, collect, 
        use, or disclose aggregate information that is not individually 
        identifiable (as defined in sections 160 and 164 of title 45, 
        Code of Federal Regulations). With this data, the grantee shall 
        submit an annual report to the Secretary that summarizes and 
        analyzes the data and provides information on needs for 
        navigation services, types of access difficulties resolved, 
        sources of repeated resolution, and flaws in the system of 
        access, including insurance barriers.
            (5) Evaluations.--
                    (A) In general.--The Secretary, acting through the 
                Director of the Indian Health Service, shall, directly 
                or through grants or contracts, provide for evaluations 
                to determine the effects of the services of patient 
                navigators on the individuals of health disparity 
                populations for whom the services were provided, taking 
                into account the matters referred to in section 417E-
                10(c)(1)(C) of the Public Health Service Act.
                    (B) Dissemination of findings.--The Secretary shall 
                as appropriate disseminate to public and private 
                entities the findings made in evaluations under 
                subparagraph (A).
            (6) Coordination with other programs.--The Secretary shall 
        coordinate the program under this subsection with the programs 
        under subsection (b) and section 417E-10 of the Public Health 
        Service Act.
    (d) Requirements Regarding Fees.--
            (1) In general.--In order to be eligible to receive a grant 
        under subsection (b) or (c), the program for which the grant is 
        made shall have in effect--
                    (A) a schedule of fees or payments for the 
                provision of such program's health care services 
                related to the prevention and treatment of disease that 
                is consistent with locally prevailing rates or charges 
                and is designed to cover such program's reasonable 
                costs of operation; and
                    (B) a corresponding schedule of discounts to be 
                applied to the payment of such fees or payments, which 
                discounts are adjusted on the basis of the ability of 
                the patient to pay.
            (2) Rule of construction.--Nothing in this subsection shall 
        be construed to require payment for navigation services or to 
        require payment for health care services in cases where care is 
        provided free of charge, including the case of services 
        provided through programs of the Indian Health Service.
    (e) Model.--Not later than 5 years after the date of enactment of 
this section, the Secretary shall develop a peer-reviewed model of 
systems for the services provided by this section. The Secretary shall 
update such model as may be necessary to ensure that the best practices 
are being utilized.
    (f) Duration of Grant.--The period during which payments are made 
to an entity from a grant under subsection (b)(1) or (c)(1) may not 
exceed 5 years. The provision of such payments are subject to annual 
approval by the Secretary and subject to the availability of 
appropriations for the fiscal year involved. Nothing in this subsection 
shall be construed as establishing a limitation on the number of grants 
under subsections (b) and (c) that may be made to an entity.
    (g) Authorization of Appropriations.--
            (1) In general.--
                    (A) Model programs.--For the purpose of carrying 
                out subsection (b), there are authorized to be 
                appropriated such sums as may be necessary for each of 
                the fiscal years 2004 through 2008.
                    (B) Patient navigators.--For the purpose of 
                carrying out subsection (c), there are authorized to be 
                appropriated such sums as may be necessary for each of 
                the fiscal years 2004 through 2008.
                    (C) Bureau of primary health 13 care.--Amounts 
                appropriated under subparagraph (A) or (B) shall be 
                administered through the Bureau of Primary Health Care.
            (2) Programs in rural areas.--
                    (A) Model programs.--For the purpose of carrying 
                out subsection (b) in making grants under such 
                subsection for model programs in rural areas, there are 
                authorized to be appropriated such sums as may be 
                necessary for each of the fiscal years 2004 through 
                2008.
                    (B) Patient navigators.--For the purpose of 
                carrying out subsection (c) in making grants under such 
                subsection for programs in rural areas, there are 
                authorized to be appropriated such sums as may be 
                necessary for each of the fiscal years 2004 through 
                2008.
                    (C) Office of rural health policy.--Amounts 
                appropriated under subparagraph (A) or (B) shall be 
                administered through the Office of Rural Health Policy.
            (3) Relation to other authorizations.--Authorizations of 
        appropriations under paragraphs (1) and (2) are in addition to 
        other authorizations of appropriations that are available for 
        the purposes of carrying out subsections (b) and (c).

        TITLE II--EXPANDING ACCESS TO CANCER DRUGS AND TREATMENT

SEC. 201. ACCELERATION OF THE DRUG TREATMENT APPROVAL PROCESS OF THE 
              FOOD AND DRUG ADMINISTRATION.

    Not later than July 1, 2004, the Commissioner of Food and Drugs 
shall prepare and submit to Congress a strategic plan that outlines the 
steps that the Commissioner is taking to accelerate the process for 
reviewing and approving new cancer drugs and treatments.

SEC. 202. FDA AMENDMENT.

    Section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bb(a)(2)) is amended by inserting ``or targets and mechanisms 
of pathogenesis of diseases'' after ``disease or condition''.

          TITLE III--CANCER-RELATED HEALTH INSURANCE COVERAGE

                  Subtitle A--Clinical Trials Coverage

SEC. 301. COVERAGE FOR CLINICAL TRIALS UNDER THE PUBLIC HEALTH SERVICE 
              ACT.

    (a) Group.--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 CLINICAL TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan, or health 
        insurance issuer that is providing health insurance coverage, 
        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 subsection (c), 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.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(3) Use of in-network providers.--If 1 or more 
        participating providers is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that, if a qualified individual 
        is enrolling in the same clinical trial, the qualified 
        individual participate in the trial through such a 
        participating provider if the provider will accept the 
        individual as a participant in that same trial. If the 
        qualified individual is to enroll in a trial and no acceptable 
        in-network provider is participating in the trial or if a 
        participating provider cannot accept new enrollees, then the 
        qualified individual may enroll in the trial through an out-of-
        network provider.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who has cancer 
and is a participant or beneficiary in a group health plan, or who is 
an enrollee under health insurance coverage, and who meets the 
following conditions:
            ``(1) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) Either the referring physician is authorized by the 
        plan to treat the patient and has concluded that the 
        individual's participation in such trial would be appropriate 
        based upon the individual meeting the condition described in 
        paragraph (1), or 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 condition 
        described in paragraph (1).
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan 
        and a health insurance issuer shall provide for payment for 
        routine patient costs described in subsection (a)(2) but are 
        not required to pay for costs of items and services that are 
        reasonably expected (as determined by the appropriate 
        Secretary) 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.--In this section, the term 
`approved clinical trial' means a clinical research study or clinical 
investigation--
            ``(1) approved and funded (which may include funding 
        through in-kind contributions) by--
                    ``(A) the National Institutes of Health;
                    ``(B) a cooperative group or center of the National 
                Institutes of Health, including a qualified 
                nongovernmental research entity to which the National 
                Cancer Institute has awarded a center support grant;
                    ``(C) the Department of Veterans Affairs, if the 
                conditions described in subsection (e) are met; or
                    ``(D) the Department of Defense, if the conditions 
                described in subsection (e) are met;
            ``(2) approved by the Food and Drug Administration; or
            ``(3) approved by a qualified nongovernmental research 
        entity identified in the guidelines issued by the National 
        Institutes of Health for center support grants or an 
        institutional review board that--
                    ``(A) is registered with the Department of Health 
                and Human Services; and
                    ``(B) is associated with an institution that has a 
                Federal assurance approved by the Department of Health 
                and Human Services specifying compliance with section 
                46 of title 45, Code of Federal Regulations.
    ``(e) Conditions for Departments.--The conditions 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 appropriate Secretary determines--
            ``(1) to be comparable to the system of peer review of 
        studies and investigations used by the National Institutes of 
        Health; and
            ``(2) assures unbiased review of the highest ethical 
        standards by an institutional review board or other body that 
        meets the standards outlined in section 46 of title 45, and 
        sections 50 and 56 of title 21, Code of Federal Regulations.
    ``(f) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials.''.
    (b) Individual.--Part B of title XXVII of the Public Health Service 
Act is amended by inserting after section 2752 (42 U.S.C. 300gg-52) the 
following:

``SEC. 2753. PATIENT PROTECTION STANDARDS.

    ``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 such provisions apply to health insurance 
coverage offered by a health insurance issuer in connection with a 
group health plan.''.

SEC. 302. COVERAGE FOR CLINICAL TRIALS UNDER THE EMPLOYEE RETIREMENT 
              INCOME SECURITY ACT OF 1974.

    (a) In General.--Subpart B of part 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 CLINICAL TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan, or health 
        insurance issuer that is providing health insurance coverage, 
        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 subsection (c), 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.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(3) Use of in-network providers.--If 1 or more 
        participating providers is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that, if a qualified individual 
        is enrolling in the same clinical trial, the qualified 
        individual participate in the trial through such a 
        participating provider if the provider will accept the 
        individual as a participant in that same trial. If the 
        qualified individual is to enroll in a trial and no acceptable 
        in-network provider is participating in the trial or if a 
        participating provider cannot accept new enrollees, then the 
        qualified individual may enroll in the trial through an out-of-
        network provider.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who has cancer 
and is a participant or beneficiary in a group health plan, or who is 
an enrollee under health insurance coverage, and who meets the 
following conditions:
            ``(1) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) Either the referring physician is authorized by the 
        plan to treat the patient and has concluded that the 
        individual's participation in such trial would be appropriate 
        based upon the individual meeting the condition described in 
        paragraph (1), or 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 condition 
        described in paragraph (1).
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan 
        and a health insurance issuer shall provide for payment for 
        routine patient costs described in subsection (a)(2) but are 
        not required to pay for costs of items and services that are 
        reasonably expected (as determined by the appropriate 
        Secretary) 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.--In this section, the term 
`approved clinical trial' means a clinical research study or clinical 
investigation--
            ``(1) approved and funded (which may include funding 
        through in-kind contributions) by--
                    ``(A) the National Institutes of Health;
                    ``(B) a cooperative group or center of the National 
                Institutes of Health, including a qualified 
                nongovernmental research entity to which the National 
                Cancer Institute has awarded a center support grant;
                    ``(C) the Department of Veterans Affairs, if the 
                conditions described in subsection (e) are met; or
                    ``(D) the Department of Defense, if the conditions 
                described in subsection (e) are met;
            ``(2) approved by the Food and Drug Administration; or
            ``(3) approved by a qualified nongovernmental research 
        entity identified in the guidelines issued by the National 
        Institutes of Health for center support grants or an 
        institutional review board that--
                    ``(A) is registered with the Department of Health 
                and Human Services; and
                    ``(B) is associated with an institution that has a 
                Federal assurance approved by the Department of Health 
                and Human Services specifying compliance with section 
                46 of title 45, Code of Federal Regulations.
    ``(e) Conditions for Departments.--The conditions 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 appropriate Secretary determines--
            ``(1) to be comparable to the system of peer review of 
        studies and investigations used by the National Institutes of 
        Health; and
            ``(2) assures unbiased review of the highest ethical 
        standards by an institutional review board or other body that 
        meets the standards outlined in section 46 of title 45, and 
        sections 50 and 56 of title 21, Code of Federal Regulations.
    ``(f) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials.''.
    (b) Conforming Amendment.--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 clinical 
                            trials.''.

SEC. 303. COVERAGE FOR CLINICAL TRIALS UNDER OTHER PUBLIC HEALTH 
              INSURANCE.

    Coverage for individuals participating in clinical trials, as 
described in section 2707 and 2753 of the Public Health Service Act (as 
added under section 301), shall be provided for any individual, 
participant, or beneficiary who have coverage under--
            (1) the medicaid program under title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.);
            (2) the medicare program under title XVIII of the Social 
        Security Act (42 U.S.C. 1395 et seq.);
            (3) the State Children's Health Insurance Program under 
        title XXI of the Social Security Act (42 U.S.C. 1398 et seq.);
            (4) a health plan offered under chapter 89 of title 5, 
        United States Code;
            (5) programs offered by the Department of Defense;
            (6) a medical care program of the Indian Health Service or 
        of a tribal organization; and
            (7) a health benefit plan under section 5(e) of the Peace 
        Corps Act (22 U.S.C. 2504(e)).

            Subtitle B--Cancer Screening and Other Coverage

SEC. 311. CANCER SCREENING COVERAGE.

    (a) Group Health Plans.--
            (1) Public health service act amendments.--
                    (A) In general.--Subpart 2 of part A of title XXVII 
                of the Public Health Service Act (42 U.S.C. 300gg-4 et 
                seq.), as amended by section 301(a), is further amended 
                by adding at the end the following:

``SEC. 2708. COVERAGE OF CANCER SCREENING.

    ``(a) Requirement.--A group health plan, and a health insurance 
issuer offering group health insurance coverage, shall provide coverage 
and payment under the plan or coverage for the following items and 
services under terms and conditions that are no less favorable than the 
terms and conditions applicable to other screening benefits otherwise 
provided under the plan or coverage:
            ``(1) Mammograms.--In the case of a female participant or 
        beneficiary who is 40 years of age or older, or is under 40 
        years of age but is at high risk (as defined in subsection (e)) 
        of developing breast cancer, an annual mammography (as defined 
        in section 1861(jj) of the Social Security Act) conducted by a 
        facility that has a certificate (or provisional certificate) 
        issued under section 354.
            ``(2) Clinical breast examinations.--In the case of a 
        female participant or beneficiary who--
                    ``(A)(i) is 40 years of age or older or (ii) is at 
                least 20 (but less than 40) years of age and is at high 
                risk of developing breast cancer, an annual clinical 
                breast examination; or
                    ``(B) is at least 20, but less than 40, years of 
                age and who is not at high risk of developing breast 
                cancer, a clinical breast examination each 3 years.
            ``(3) Pap tests and pelvic examinations.--In the case of a 
        female participant or beneficiary who is 18 years of age or 
        older, or who is under 18 years of age and is or has been 
        sexually active--
                    ``(A) an annual diagnostic laboratory test 
                (popularly known as a `pap smear') consisting of a 
                routine exfoliative cytology test (Papanicolaou test) 
                provided to a woman for the purpose of early detection 
                of cervical or vaginal cancer and including an 
                interpretation by a qualified health professional of 
                the results of the test; and
                    ``(B) an annual pelvic examination.
            ``(4) Colorectal cancer screening procedures.--
                    ``(A) In general.--In the case of a participant or 
                beneficiary who is 50 years of age or older, or who is 
                under 50 years of age and is an individual at high risk 
                for colorectal cancer, the group health plan or health 
                insurance issuer shall cover methods of colorectal 
                cancer screening that--
                            ``(i) are deemed appropriate by a physician 
                        (as defined in section 1861(r) of the Social 
                        Security Act (42 U.S.C. 1395x(r))) treating the 
                        participant or beneficiary, in consultation 
                        with the participant or beneficiary;
                            ``(ii) are--
                                    ``(I) described in section 
                                1861(pp)(1) of the Social Security Act 
                                (42 U.S.C. 1395x(pp)(1)) or section 
                                410.37 of title 42, Code of Federal 
                                Regulations; or
                                    ``(II) specified by the Secretary 
                                based upon the recommendations of 
                                appropriate organizations with special 
                                expertise in the field of colorectal 
                                cancer; and
                            ``(iii) are performed at a frequency not 
                        greater than that--
                                    ``(I) described for such method in 
                                section 1834(d) of the Social Security 
                                Act (42 U.S.C. 1395m(d)) or section 
                                410.37 of title 42, Code of Federal 
                                Regulations; or
                                    ``(II) specified by the Secretary 
                                for such method if the Secretary finds, 
                                based upon new scientific knowledge and 
                                consistent with the recommendations of 
                                appropriate organizations with special 
                                expertise in the field of colorectal 
                                cancer, that a different frequency 
                                would not adversely affect the 
                                effectiveness of such screening.
                    ``(B) Definition of high risk.--In this paragraph, 
                the term `individual at high risk for colorectal 
                cancer' has the meaning given the term in section 
                1861(pp)(2) of the Social Security Act (42 U.S.C. 
                1395x(pp)(2)).
            ``(5) Prostate cancer screening.--In the case of a male 
        participant or beneficiary who is 50 years of age or older, or 
        who is younger than 50 years of age and is at high risk for 
        prostate cancer (including African American men or a male who 
        has a history of prostate cancer in a first degree family 
member), the procedures described in section 1861(oo)(2) of Social 
Security Act (42 U.S.C. 1395x(oo)(2)) shall be furnished to the 
individual for the early detection of prostate cancer. The group health 
plan or health insurance issuer shall provide coverage for the method 
and frequency of prostate cancer screening determined to be appropriate 
by a health care provider treating such participant or beneficiary, in 
consultation with the participant or beneficiary.
            ``(6) Tobacco therapy and counseling.--
                    ``(A) In general.--Therapy and counseling for 
                cessation of tobacco use for individuals who use 
                tobacco products or who are being treated for tobacco 
                use that is furnished--
                            ``(i) by or under the supervision of a 
                        physician; or
                            ``(ii) by any other health care 
                        professional--
                                    ``(I) who is legally authorized to 
                                furnish such services under State law 
                                (or the State regulatory mechanism 
                                provided by State law) of the State in 
                                which the services are furnished; and
                                    ``(II) who, for medicare 
                                beneficiaries, is authorized to receive 
                                payment for other services under this 
                                title or is designated by the Secretary 
                                for this purpose.
                    ``(B) Limitation.--Subject to subparagraph (C), 
                such therapy and counseling are limited to--
                            ``(i) therapy and counseling services 
                        recommended in `Treating Tobacco Use and 
                        Dependence: A Clinical Practice Guideline', 
                        published by the Public Health Service in June 
                        2000, or any subsequent modification of such 
                        Guideline; and
                            ``(ii) such other therapy and counseling 
                        services that the Secretary recognizes to be 
                        effective.
                    ``(C) Exclusion.--Such therapy and counseling shall 
                not include coverage for drugs or biologicals that are 
                not otherwise covered under the plan or coverage.
            ``(7) Medical nutrition therapy services.--Medical 
        nutrition therapy services, as defined in section 1861(vv) of 
        the Social Security Act (42 U.S.C. 1395x(vv)) for the purpose 
        of improving the health of cancer patients and preventing 
        cancer in other beneficiaries.
            ``(8) Genetic tests and genetic services.--
                    ``(A) In general.--Genetic tests and genetic 
                services provided by a licensed health care 
                professional to obtain predictive genetic information 
                about an individual at risk of cancer for purposes of a 
                health assessment, cancer management, cancer 
                prevention, other diagnostic or therapeutic purposes, 
                or genetic education and counseling.
                    ``(B) Definitions.--In this paragraph:
                            ``(i) Family member.--The term `family 
                        member' means with respect to an individual--
                                    ``(I) the spouse of the individual;
                                    ``(II) a dependent child of the 
                                individual, including a child who is 
                                born to or placed for adoption with the 
                                individual; and
                                    ``(III) all other individuals 
                                related by blood to the individual or 
                                the spouse or child described in 
                                subclause (I) or (II).
                            ``(ii) Genetic information.--The term 
                        `genetic information' means information about 
                        genes, gene products, or inherited 
                        characteristics that may derive from an 
                        individual or a family member of such 
                        individual (including information about a 
                        request for or the receipt of genetic services 
                        by such individual or family member of such 
                        individual).
                            ``(iii) Genetic services.--The term 
                        `genetic services' means health services, 
                        including genetic tests, provided to obtain, 
                        assess, or interpret genetic information for 
                        diagnostic and therapeutic purposes, and for 
                        genetic education and counseling.
                            ``(iv) Genetic test.--The term `genetic 
                        test' means the analysis of human DNA, RNA, 
                        chromosomes, proteins, and certain metabolites 
                        in order to detect genotypes, mutations, or 
                        chromosomal changes.
                            ``(v) Predictive genetic information.--
                                    ``(I) In general.--The term 
                                `predictive genetic information' 
                                means--
                                            ``(aa) information about an 
                                        individual's genetic tests;
                                            ``(bb) information about 
                                        genetic tests of family members 
                                        of the individual; or
                                            ``(cc) information about 
                                        the occurrence of a disease or 
                                        disorder in family members.
                                    ``(II) Limitations.--The term 
                                `predictive genetic information' shall 
                                not include--
                                            ``(aa) information about 
                                        the sex or age of the 
                                        individual;
                                            ``(bb) information about 
                                        chemical, blood, or urine 
                                        analyses of the individual, 
                                        unless these analyses are 
                                        genetic tests; or
                                            ``(cc) information about 
                                        physical exams of the 
                                        individual, and other 
                                        information relevant to 
                                        determining the current health 
                                        status of the individual.
            ``(9) Other tests and procedures.--Such other tests or 
        procedures for the detection of cancer, and modifications to 
        the tests and procedures, with such frequency, as the Secretary 
        determines to be appropriate, in consultation with appropriate 
        organizations and agencies, for the diagnosis or detection of 
        cancer.
    ``(b) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, shall not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(c) Rules of Construction.--
            ``(1) Nothing in this section shall be construed to require 
        an individual who is a participant or beneficiary to undergo a 
        procedure, examination, or test described in subsection (a).
            ``(2) Nothing in this section shall be construed as 
        preventing a group health plan or issuer from imposing 
        deductibles, coinsurance, or other cost-sharing in relation to 
        benefits described in subsection (a) consistent with such 
        subsection, except that such coinsurance or other cost-sharing 
        shall not discriminate on any basis related to the coverage 
        required under this section.
            ``(3) Nothing in this section shall be construed to result 
        in a reduction, diminishment, or change in coverage resulting 
        in less coverage.
    ``(d) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.
    ``(e) Risk Defined.--For purposes of this section, an individual is 
considered to be at `risk' of developing a particular type of cancer 
if, under guidelines developed or recognized by the Secretary based 
upon scientific evidence, the individual--
            ``(1) has 1 or more first degree family members who have 
        developed that type of cancer;
            ``(2) has previously had that type of cancer;
            ``(3) has the presence of an appropriate recognized gene 
        marker that is identified as putting the individual at a higher 
        risk of developing that type of cancer; or
            ``(4) has other predisposing or environmental risk factors 
        that significantly increases the risk of the individual 
        contracting that type of cancer.
For purposes of this subsection, the term `type of cancer' includes 
other types of cancer that the Secretary recognizes as closely related 
for purposes of establishing risk.

``SEC. 2709. PATIENT ACCESS TO INFORMATION.

    ``(a) Disclosure Requirement.--A group health plan, and health 
insurance issuer offering group health insurance coverage shall--
            ``(1) provide to participants and beneficiaries at the time 
        of initial coverage under the plan (or the effective date of 
        this section, in the case of individuals who are participants 
        or beneficiaries as of such date), and at least annually 
        thereafter, the information described in subsection (b) in 
        printed form;
            ``(2) provide to participants and beneficiaries, within a 
        reasonable period (as specified by the appropriate Secretary) 
        before or after the date of significant changes in the 
        information described in subsection (b), information in printed 
        form regarding such significant changes; and
            ``(3) upon request, make available to participants and 
        beneficiaries, the applicable authority, and prospective 
        participants and beneficiaries, the information described in 
        subsection (b) in printed form.
    ``(b) Information Provided.--The information described in 
subsection (a) that shall be disclosed includes the following, as such 
relates to cancer screening required under section 2708(a):
            ``(1) Benefits.--Benefits offered under the plan or 
        coverage, including--
                    ``(A) covered benefits, including benefit limits 
                and coverage exclusions;
                    ``(B) cost-sharing, such as deductibles, 
                coinsurance, and copayment amounts, including any 
                liability for balance billing, any maximum limitations 
                on out of pocket expenses, and the maximum out of 
                pocket costs for services that are provided by 
                nonparticipating providers or that are furnished 
                without meeting the applicable utilization review 
                requirements;
                    ``(C) the extent to which benefits may be obtained 
                from nonparticipating providers; and
                    ``(D) the extent to which a participant, 
                beneficiary, or enrollee may select from among 
                participating providers and the types of providers 
                participating in the plan or issuer network.
            ``(2) Access.--A description of the following:
                    ``(A) The number, mix, and distribution of 
                providers under the plan or coverage.
                    ``(B) Out-of-network coverage (if any) provided by 
                the plan or coverage.
                    ``(C) Any point-of-service option (including any 
                supplemental premium or cost-sharing for such option).
                    ``(D) The procedures for participants, 
                beneficiaries, and enrollees to select, access, and 
                change participating primary and specialty providers.
                    ``(E) The rights and procedures for obtaining 
                referrals (including standing referrals) to 
                participating and nonparticipating providers.
                    ``(F) The name, address, and telephone number of 
                participating health care providers and an indication 
                of whether each such provider is available to accept 
                new patients.
                    ``(G) How the plan or issuer addresses the needs of 
                participants, beneficiaries, and enrollees and others 
                who do not speak English or who have other special 
                communications needs in accessing providers under the 
                plan or coverage, including the provision of 
                information under this subsection.''.
                    (B) Technical amendment.--Section 2723(c) of the 
                Public Health Service Act (42 U.S.C. 300gg-23(c)) is 
                amended by striking ``section 2704'' and inserting 
                ``sections 2704 and 2708''.
            (2) ERISA amendments.--
                    (A) In general.--Subpart B of part 7 of subtitle B 
                of title I of the Employee Retirement Income Security 
                Act of 1974 (29 U.S.C. 1185 et seq.), as amended by 
                section 302, is further amended by adding at the end 
                the following new section:

``SEC. 715. COVERAGE OF CANCER SCREENING.

    ``(a) Requirement.--A group health plan, and a health insurance 
issuer offering group health insurance coverage, shall provide coverage 
and payment under the plan or coverage for the following items and 
services under terms and conditions that are no less favorable than 
the  terms and conditions applicable to other screening benefits 
otherwise provided under the plan or coverage:
            ``(1) Mammograms.--In the case of a female participant or 
        beneficiary who is 40 years of age or older, or is under 40 
        years of age but is at high risk (as defined in subsection (e)) 
        of developing breast cancer, an annual mammography (as defined 
        in section 1861(jj) of the Social Security Act) conducted by a 
        facility that has a certificate (or provisional certificate) 
        issued under section 354 of the Public Health Service Act.
            ``(2) Clinical breast examinations.--In the case of a 
        female participant or beneficiary who--
                    ``(A)(i) is 40 years of age or older or (ii) is at 
                least 20 (but less than 40) years of age and is at high 
                risk of developing breast cancer, an annual clinical 
                breast examination; or
                    ``(B) is at least 20, but less than 40, years of 
                age and who is not at high risk of developing breast 
                cancer, a clinical breast examination each 3 years.
            ``(3) Pap tests and pelvic examinations.--In the case of a 
        female participant or beneficiary who is 18 years of age or 
        older, or who is under 18 years of age and is or has been 
        sexually active--
                    ``(A) an annual diagnostic laboratory test 
                (popularly known as a `pap smear') consisting of a 
                routine exfoliative cytology test (Papanicolaou test) 
                provided to a woman for the purpose of early detection 
                of cervical or vaginal cancer and including an 
                interpretation by a qualified health professional of 
                the results of the test; and
                    ``(B) an annual pelvic examination.
            ``(4) Colorectal cancer screening procedures.--
                    ``(A) In general.--In the case of a participant or 
                beneficiary who is 50 years of age or older, or who is 
                under 50 years of age and is an individual at high risk 
                for colorectal cancer, the group health plan or health 
                insurance issuer shall cover methods of colorectal 
                cancer screening that--
                            ``(i) are deemed appropriate by a physician 
                        (as defined in section 1861(r) of the Social 
                        Security Act (42 U.S.C. 1395x(r))) treating the 
                        participant or beneficiary, in consultation 
                        with the participant or beneficiary;
                            ``(ii) are--
                                    ``(I) described in section 
                                1861(pp)(1) of the Social Security Act 
                                (42 U.S.C. 1395x(pp)(1)) or section 
                                410.37 of title 42, Code of Federal 
                                Regulations; or
                                    ``(II) specified by the Secretary 
                                based upon the recommendations of 
                                appropriate organizations with special 
                                expertise in the field of colorectal 
                                cancer; and
                            ``(iii) are performed at a frequency not 
                        greater than that--
                                    ``(I) described for such method in 
                                section 1834(d) of the Social Security 
                                Act (42 U.S.C. 1395m(d)) or section 
                                410.37 of title 42, Code of Federal 
                                Regulations; or
                                    ``(II) specified by the Secretary 
                                for such method if the Secretary finds, 
                                based upon new scientific knowledge and 
                                consistent with the recommendations of 
                                appropriate organizations with special 
                                expertise in the field of colorectal 
                                cancer, that a different frequency 
                                would not adversely affect the 
                                effectiveness of such screening.
                    ``(B) Definition of high risk.--In this paragraph, 
                the term `individual at high risk for colorectal 
                cancer' has the meaning given the term in section 
                1861(pp)(2) of the Social Security Act (42 U.S.C. 
                1395x(pp)(2)).
            ``(5) Prostate cancer screening.--In the case of a male 
        participant or beneficiary who is 50 years of age or older, or 
        who is younger than 50 years of age and is at high risk for 
        prostate cancer (including African American men or a male who 
        has a history of prostate cancer in a first degree family 
        member), the procedures described in section 1861(oo)(2) of the 
        Social Security Act (42 U.S.C. 1395x(oo)(2)) shall be furnished 
        to the individual for the early detection of prostate cancer. 
        The group health plan or health insurance issuer shall provide 
coverage for the method and frequency of prostate cancer screening 
determined to be appropriate by a health care provider treating such 
participant or beneficiary, in consultation with the participant or 
beneficiary.
            ``(6) Tobacco therapy and counseling.--
                    ``(A) In general.--Therapy and counseling for 
                cessation of tobacco use for individuals who use 
                tobacco products or who are being treated for tobacco 
                use that is furnished--
                            ``(i) by or under the supervision of a 
                        physician; or
                            ``(ii) by any other health care 
                        professional who--
                                    ``(I) is legally authorized to 
                                furnish such services under State law 
                                (or the State regulatory mechanism 
                                provided by State law) of the State in 
                                which the services are furnished; and
                                    ``(II) for medicare beneficiaries, 
                                is authorized to receive payment for 
                                other services under this title or is 
                                designated by the Secretary for this 
                                purpose.
                    ``(B) Limitation.--Subject to subparagraph (C), 
                such therapy and counseling are limited to--
                            ``(i) therapy and counseling services 
                        recommended in `Treating Tobacco Use and 
                        Dependence: A Clinical Practice Guideline', 
                        published by the Public Health Service in June 
                        2000, or any subsequent modification of such 
                        Guideline; and
                            ``(ii) such other therapy and counseling 
                        services that the Secretary recognizes to be 
                        effective.
                    ``(C) Exclusion.--Such therapy and counseling shall 
                not include coverage for drugs or biologicals that are 
                not otherwise covered under the plan or coverage.
            ``(7) Medical nutrition therapy services.--Medical 
        nutrition therapy services, as defined in section 1861(vv) of 
        the Social Security Act (42 U.S.C. 1395x(vv)) for the purpose 
        of improving the health of cancer patients and preventing 
        cancer in other beneficiaries.
            ``(8) Genetic tests and genetic services.--
                    ``(A) In general.--Genetic tests and genetic 
                services provided by a licensed health care 
                professional to obtain predictive genetic information 
                about an individual at risk of cancer for purposes of a 
                health assessment, cancer management, cancer 
                prevention, other diagnostic or therapeutic purposes, 
                or genetic education and counseling.
                    ``(B) Definitions.--In this paragraph:
                            ``(i) Family member.--The term `family 
                        member' means with respect to an individual--
                                    ``(I) the spouse of the individual;
                                    ``(II) a dependent child of the 
                                individual, including a child who is 
                                born to or placed for adoption with the 
                                individual; and
                                    ``(III) all other individuals 
                                related by blood to the individual or 
                                the spouse or child described in 
                                subclause (I) or (II).
                            ``(ii) Genetic information.--The term 
                        `genetic information' means information about 
                        genes, gene products, or inherited 
                        characteristics that may derive from an 
                        individual or a family member of such 
                        individual (including information about a 
                        request for or the receipt of genetic services 
                        by such individual or family member of such 
                        individual).
                            ``(iii) Genetic services.--The term 
                        `genetic services' means health services, 
                        including genetic tests, provided to obtain, 
                        assess, or interpret genetic information for 
                        diagnostic and therapeutic purposes, and for 
                        genetic education and counseling.
                            ``(iv) Genetic test.--The term `genetic 
                        test' means the analysis of human DNA, RNA, 
                        chromosomes, proteins, and certain metabolites 
                        in order to detect  genotypes, mutations, or 
chromosomal changes.
                            ``(v) Predictive genetic information.--
                                    ``(I) In general.--The term 
                                `predictive genetic information' 
                                means--
                                            ``(aa) information about an 
                                        individual's genetic tests;
                                            ``(bb) information about 
                                        genetic tests of family members 
                                        of the individual; or
                                            ``(cc) information about 
                                        the occurrence of a disease or 
                                        disorder in family members.
                                    ``(II) Limitations.--The term 
                                `predictive genetic information' shall 
                                not include--
                                            ``(aa) information about 
                                        the sex or age of the 
                                        individual;
                                            ``(bb) information about 
                                        chemical, blood, or urine 
                                        analyses of the individual, 
                                        unless these analyses are 
                                        genetic tests; or
                                            ``(cc) information about 
                                        physical exams of the 
                                        individual, and other 
                                        information relevant to 
                                        determining the current health 
                                        status of the individual.
            ``(9) Other tests and procedures.--Such other tests or 
        procedures for the detection of cancer, and modifications to 
        the tests and procedures, with such frequency, as the Secretary 
        determines to be appropriate, in consultation with appropriate 
        organizations and agencies, for the diagnosis or detection of 
        cancer.
    ``(b) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, may not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(c) Rules of Construction.--
            ``(1) Nothing in this section shall be construed to require 
        an individual who is a participant or beneficiary to undergo a 
        procedure, examination, or test described in subsection (a).
            ``(2) Nothing in this section shall be construed as 
        preventing a group health plan or issuer from imposing 
        deductibles, coinsurance, or other cost-sharing in relation to 
        benefits described in subsection (a) consistent with such 
        subsection, except that such coinsurance or other cost-sharing 
        shall not discriminate on any basis related to the coverage 
        required under this section.
            ``(3) Nothing in this section shall be construed to result 
        in a reduction, diminishment, or change in coverage resulting 
        in less coverage.
    ``(d) Notice Under Group Health Plan.--The imposition of the 
requirement of this section shall be treated as a material modification 
in the terms of the plan described in section 102(a), for purposes of 
assuring notice of such requirements under the plan; except that the 
summary description required to be provided under the last sentence of 
section 104(b)(1) with respect to such modification shall be provided 
by not later than 60 days after the first day of the first plan year in 
which such requirement apply.
    ``(e) Risk Defined.--For purposes of this section, an individual is 
considered to be at `risk' of developing a particular type of cancer 
if, under guidelines developed or recognized by the Secretary based 
upon scientific evidence, the individual--
            ``(1) has 1 or more first degree family members who have 
        developed that type of cancer;
            ``(2) has previously had that type of cancer;
            ``(3) has the presence of an appropriate recognized gene 
        marker that is identified as putting the individual at a higher 
        risk of developing that type of cancer; or
            ``(4) has other predisposing or environmental risk factors 
        that significantly increases the risk of the individual 
        contracting that type of cancer.
For purposes of this subsection, the term `type of cancer' includes 
other types of cancer that the Secretary recognizes as closely related 
for purposes of establishing risk.

``SEC. 716. PATIENT ACCESS TO INFORMATION.

    ``(a) Disclosure Requirement.--A group health plan, and health 
insurance issuer offering group health insurance coverage shall--
            ``(1) provide to participants and beneficiaries at the time 
        of initial coverage under the plan (or the effective date of 
        this section, in the case of individuals who are participants 
        or beneficiaries as of such date), and at least annually 
        thereafter, the information described in subsection (b) in 
        printed form;
            ``(2) provide to participants and beneficiaries, within a 
        reasonable period (as specified by the appropriate Secretary) 
        before or after the date of significant changes in the 
        information described in subsection (b), information in printed 
        form regarding such significant changes; and
            ``(3) upon request, make available to participants and 
        beneficiaries, the applicable authority, and prospective 
        participants and beneficiaries, the information described in 
        subsection (b) in printed form.
    ``(b) Information Provided.--The information described in 
subsection (a) that shall be disclosed includes the following, as such 
relates to cancer screening required under section 715(a):
            ``(1) Benefits.--Benefits offered under the plan or 
        coverage, including--
                    ``(A) covered benefits, including benefit limits 
                and coverage exclusions;
                    ``(B) cost-sharing, such as deductibles, 
                coinsurance, and copayment amounts, including any 
                liability for balance billing, any maximum limitations 
                on out of pocket expenses, and the maximum out of 
                pocket costs for services that are provided by 
nonparticipating providers or that are furnished without meeting the 
applicable utilization review requirements;
                    ``(C) the extent to which benefits may be obtained 
                from nonparticipating providers; and
                    ``(D) the extent to which a participant, 
                beneficiary, or enrollee may select from among 
                participating providers and the types of providers 
                participating in the plan or issuer network.
            ``(2) Access.--A description of the following:
                    ``(A) The number, mix, and distribution of 
                providers under the plan or coverage.
                    ``(B) Out-of-network coverage (if any) provided by 
                the plan or coverage.
                    ``(C) Any point-of-service option (including any 
                supplemental premium or cost-sharing for such option).
                    ``(D) The procedures for participants, 
                beneficiaries, and enrollees to select, access, and 
                change participating primary and specialty providers.
                    ``(E) The rights and procedures for obtaining 
                referrals (including standing referrals) to 
                participating and nonparticipating providers.
                    ``(F) The name, address, and telephone number of 
                participating health care providers and an indication 
                of whether each such provider is available to accept 
                new patients.
                    ``(G) How the plan or issuer addresses the needs of 
                participants, beneficiaries, and enrollees and others 
                who do not speak English or who have other special 
                communications needs in accessing providers under the 
                plan or coverage, including the provision of 
                information under this subsection.''.
                    (B) Technical amendments.--
                            (i) Section 731(c) of the Employee 
                        Retirement Income Security Act of 1974 (29 
                        U.S.C. 1191(c)) is amended by striking 
                        ``section 711'' and inserting ``sections 711 
                        and 715''.
                            (ii) 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 715''.
                            (iii) The table of contents in section 1 of 
                        the Employee Retirement Income Security Act of 
                        1974, as amended by section 302, is further 
                        amended by inserting after the item relating to 
                        section 714 the following new items:

``Sec. 715. Coverage of cancer screening.
``Sec. 716. Patient access to information.''.
    (b) Individual Health Insurance.--
            (1) In general.--Part B of title XXVII of the Public Health 
        Service Act is amended by inserting after section 2753, as 
        added by section 301(b), the following new section:

``SEC. 2754. STANDARD RELATING PATIENT FREEDOM OF CHOICE.

    ``(a) In General.--The provisions of section 2708 (other than 
subsection (d)) shall apply to health insurance coverage offered by a 
health insurance issuer in the individual market with respect to an 
enrollee under such coverage 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 to a 
participant or beneficiary in such plan.
    ``(b) Notice.--A health insurance issuer under this part shall 
comply with the notice requirement under section 715(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
referred to in subsection (a) as if such section applied to such issuer 
and such issuer were a group health plan.

``SEC. 2755. PATIENT ACCESS TO INFORMATION.

    ``The provisions of section 2709 shall apply health insurance 
coverage offered by a health insurance issuer in the individual market 
with respect to an enrollee under such coverage 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 to a participant or beneficiary in such plan.''.
            (2) Technical amendment.--Section 2762(b)(2) of such Act 
        (42 U.S.C. 300gg-62(b)(2)) is amended by striking ``section 
        2751'' and inserting ``sections 2751 and 2754''.
    (c) Effective Dates.--
            (1) Group health plans.--Subject to paragraph (3), the 
        amendments made by subsection (a) shall apply with respect to 
        group health plans for plan years beginning on or after January 
        1, 2004.
            (2) Individual plans.--The amendment made by subsection (b) 
        shall apply with respect to health insurance coverage offered, 
        sold, issued, renewed, in effect, or operated in the individual 
        market on or after such date.
            (3) Collective bargaining agreement.--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 to 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) Coordinated Regulations.--Section 104(1) of the Health 
Insurance Portability and Accountability Act of 1996 (Public Law 104-
191) is amended by striking ``this subtitle (and the amendments made by 
this subtitle and section 401)'' and inserting ``the provisions of part 
7 of subtitle B of title I of the Employee Retirement Income Security 
Act of 1974, the provisions of parts A and C of title XXVII of the 
Public Health Service Act, and chapter 100 of the Internal Revenue Code 
of 1986''.
    (e) Modification of Coverage.--
            (1) In general.--The Secretary of Health and Human Services 
        may modify the coverage requirements for the amendments under 
        this subtitle to allow such requirements to incorporate and 
        reflect new scientific and technological advances regarding 
        cancer screening, practice pattern changes in such screening, 
        or other updated medical practices regarding such screening, 
        such as the use of new tests or other emerging technologies. 
        Such modifications shall not in any way diminish the coverage 
        requirements listed under this subtitle. Such modifications may 
        be made on the Secretary's own initiative or upon petition to 
        the Secretary by an individual or organization.
            (2) Consultation.--In modifying coverage requirements under 
        paragraph (1), the Secretary of Health and Human Services shall 
        consult with appropriate organizations, experts, and agencies.
            (3) Petitions.--The Secretary of Health and Human Services 
        may issue requirements for the petitioning process under 
        paragraph (1), including requirements that the petition be in 
        writing and include scientific or medical bases for the 
        modification sought. Upon receipt of such a petition, the 
        Secretary shall respond to the petitioner and decide whether to 
        propose a regulation proposing a change within 90 days of such 
        receipt. If a regulation is required, the Secretary shall 
        propose such regulation within 6 months of such determination. 
        The Secretary shall provide the petitioner the reasons for the 
        decision of the Secretary. The Secretary may  make changes 
requested by a petitioner in whole or in part.

               Subtitle C--Physicians and Quality of Care

SEC. 321. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER THE PUBLIC HEALTH SERVICE ACT.

    (a) Group.--Subpart 2 of part A of title XXVII of the Public Health 
Service Act (42 U.S.C. 300gg-4 et seq.), as amended by sections 301 and 
311, is further amended by adding at the end the following:

``SEC. 2710. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER 
              PATIENTS.

    ``(a) Managing Physician.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall ensure that 
with respect to items or services provided under the plan or coverage 
relating to the treatment of cancer, a lead managing physician be 
designated at the time of diagnosis by the provider and paid a bonus by 
the plan, in consultation with the participant or beneficiary, and 
other providers involved to provide for the overall coordination and 
management of the cancer care of the participant or beneficiary among 
all providers who provide items or services to the participant or 
beneficiary and paid for overall coordination of services.
    ``(b) Quality of Care.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall require that 
all participating health care professionals who provide primary care 
cancer services follow the most current quality-of-care cancer care 
guidelines, as developed by medical professionals with expertise in the 
field of medicine for which the guidelines are designed and widely 
recognized as medically necessary and appropriate.
    ``(c) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, shall not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(d) Rules of Construction.--Nothing in this section shall be 
construed as preventing a group health plan or issuer from imposing 
deductibles, coinsurance, or other cost-sharing in relation to benefits 
described in subsections (a) or (b) consistent with such subsections, 
except that such coinsurance or other cost-sharing shall not 
discriminate on any basis related to the coverage required under this 
section.
    ``(e) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.''.
    (b) Individual.--Part B of title XXVII of the Public Health Service 
Act is amended by inserting after section 2755, as added by section 
311, the following:

``SEC. 2756. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER 
              PATIENTS.

    ``The provisions of section 2710 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as such provisions apply to health insurance 
coverage offered by a health insurance issuer in connection with a 
group health plan.''.

SEC. 322. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 
              1974.

    (a) In General.--Subpart B of part 7 of subtitle B of title I of 
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et 
seq.), as amended by sections 302 and 311, is further amended by adding 
at the end the following:

``SEC. 717. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER 
              PATIENTS.

    ``(a) Managing Physician.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall ensure that 
with respect to items or services provided under the plan or coverage 
relating to the treatment of cancer, a lead managing physician be 
designated at the time of diagnosis by the participant or beneficiary 
involved to provide for the overall coordination and management of the 
cancer care of the participant or beneficiary among all providers who 
provide items or services to the participant or beneficiary and paid 
for overall coordination of services.
    ``(b) Quality of Care.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall require that 
all participating health care professionals who provide primary care 
cancer services follow the most current quality-of-care cancer care 
guidelines, as developed by medical professionals with expertise in the 
field of medicine for which the guidelines are designed and widely 
recognized as medically necessary and appropriate.
    ``(c) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, shall not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(d) Rules of Construction.--Nothing in this section shall be 
construed as preventing a group health plan or issuer from imposing 
deductibles, coinsurance, or other cost-sharing in relation to benefits 
described in subsections (a) or (b) consistent with such subsections, 
except that such coinsurance or other cost-sharing shall not 
discriminate on any basis related to the coverage required under this 
section.
    ``(e) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.''.
    (b) Conforming Amendment.--The table of contents in section 1 of 
the Employee Retirement Income Security Act of 1974, as amended by 
sections 302 and 311, is further amended by inserting after the item 
relating to section 716 the following new item:

``Sec. 717. Managing physicians and quality of care for cancer 
                            patients.''.

SEC. 323. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER MEDICARE.

    (a) Application of Cancer Coverage Requirements.--Part B of title 
XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) is amended 
by adding at the end the following:

             ``application of cancer coverage requirements

    ``Sec. 1849. The provisions of sections 2707, 2708, and 2710 of the 
Public Health Service Act shall apply to an individual who has been 
diagnosed with cancer and who is covered under the insurance program 
established under this part.''.
    (b) Additional Payment.--Section 1833(m) of the Social Security Act 
(42 U.S.C. 1395l(m)) is amended--
            (1) by inserting ``(1)'' after ``(m)''; and
            (2) by adding at the end the following new paragraph:
    ``(2) In the case of physicians' services furnished to an 
individual who has been diagnosed with cancer, who is covered under the 
insurance program established under this part who receives care for 
such cancer from a team of physicians, and who incurs expenses for 
physicians' services that are related to that diagnosis, there shall be 
paid to the physician designated by such team of physicians at the time 
of diagnosis of the individual as the physician responsible for the 
overall coordination and management of the medical and other health 
services provided to that individual during the period in which that 
individual is undergoing treatment for such cancer (or to an employer 
or facility in the cases described in subparagraph (A) of section 
1842(b)(6)) (on a monthly or quarterly basis) from the Federal 
Supplementary Medical Insurance Trust Fund a separate and additional 
payment amount for the services under this part in addition to any 
amount otherwise paid under this part.''.

SEC. 324. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER MEDICAID AND SCHIP.

    (a) Medicaid.--Section 1902(a) of the Social Security Act (42 
U.S.C. 1396a(a)) is amended--
            (1) in paragraph (64), by striking ``and'' at the end;
            (2) in paragraph (65), by striking the period and inserting 
        ``; and''; and
            (3) by inserting after paragraph (65) the following:
            ``(66) provide--
                    ``(A) that the provisions of sections 2707, 2708, 
                and 2710 of the Public Health Service Act shall apply 
                to individuals eligible for medical assistance under 
                the State plan who have been diagnosed with cancer; and
                    ``(B) that, in the case of an individual who has 
                been diagnosed with cancer, who is eligible for medical 
                assistance under this title, and who receives care for 
                such cancer from a team of physicians, and who incurs 
                expenses for physicians' services that are related to 
                that diagnosis, that there shall be paid to the 
                physician designated by such team of physicians at the 
                time of diagnosis of the individual as the physician 
                responsible for the overall coordination and management 
                of the medical and other health services provided to 
                that individual during the period in which that 
                individual is undergoing treatment for such cancer, a 
separate and additional payment amount for the services provided in 
addition to any amount otherwise paid under the State plan.''.
    (b) SCHIP.--Section 2103(f) of the Social Security Act (42 U.S.C. 
1397cc(f)) is amended by adding at the end the following:
            ``(3) Application of cancer coverage provisions.--
                    ``(A) In general.--The provisions of sections 2707, 
                2708, and 2710 of the Public Health Service Act shall 
                apply to the coverage offered under the State child 
                health plan.
                    ``(B) Additional payment.--The State child health 
                plan shall provide in the case of an individual who has 
                been diagnosed with cancer, who is eligible for child 
                health assistance under this title, and who receives 
                care for such cancer from a team of physicians, and who 
                incurs expenses for physicians' services that are 
                related to that diagnosis, that there shall be paid to 
                the physician designated by such team of physicians at 
                the time of diagnosis of the individual as the 
                physician responsible for the overall coordination and 
                management of the medical and other health services 
                provided to that individual during the period in which 
                that individual is undergoing treatment for such 
                cancer, a separate and additional payment amount for 
                the services provided in addition to any amount 
                otherwise paid under the State child health plan.''.

                     Subtitle D--General Provisions

SEC. 331. COVERAGE UNDER OTHER PUBLIC HEALTH INSURANCE.

    (a) In General.--The coverage described in subsection (b) shall be 
provided for any individual, participant, or beneficiary who has 
coverage under--
            (1) the medicaid program under title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.);
            (2) the medicare program under title XVIII of the Social 
        Security Act (42 U.S.C. 1395 et seq.);
            (3) the State Children's Health Insurance Program under 
        title XXI of the Social Security Act (42 U.S.C. 1398 et seq.);
            (4) a health plan offered under chapter 89 of title 5, 
        United States Code;
            (5) programs offered by the Department of Defense;
            (6) a medical care program of the Indian Health Service or 
        of a tribal organization; and
            (7) a health benefit plan under section 5(e) of the Peace 
        Corps Act (22 U.S.C. 2504(e)).
    (b) Coverage Described.--The coverage described in this subsection 
is--
            (1) the coverage described in section 2708 of the Public 
        Health Service Act (as added by section  311) for individuals 
participating in cancer screening activities; and
            (2) the coverage described in section 2710 of the Public 
        Health Service Act (as added by section 321) for individuals 
        receiving cancer-related items or services.
    (c) Application to Other Health Care Coverage.--Chapter 89 of title 
5, United States Code, is amended by adding at the end the following:
``Sec. 8915. Standards relating to coverage of cancer-related 
              activities
    ``(a) The provisions of sections 2707, 2708, 2709, and 2710 of the 
Public Health Service Act shall apply to the provision of items and 
services under this chapter.
    ``(b) Nothing in this section or section 2707, 2708, 2709, or 2710 
of the Public Health Service Act shall be construed as authorizing a 
health insurance issuer or entity to impose cost-sharing with respect 
to the coverage or benefits required to be provided under such sections 
that is inconsistent with the cost-sharing that is otherwise permitted 
under this chapter.''.

TITLE IV--PATIENT NAVIGATOR AND CANCER CARE WITHIN THE HEALTH RESOURCES 
                      AND SERVICES ADMINISTRATION

SEC. 401. HRSA GRANTS FOR MODEL COMMUNITY CANCER AND CHRONIC DISEASE 
              CARE AND PREVENTION AND GRANTS FOR PATIENT NAVIGATORS.

    Subpart I of part D of title III of the Public Health Service Act 
(42 U.S.C. 254b et seq.) is amended by adding at the end the following:

``SEC. 330M. MODEL COMMUNITY CANCER AND CHRONIC DISEASE CARE AND 
              PREVENTION; PATIENT NAVIGATORS.

    ``(a) Definitions.--In this section, the terms ``culturally 
competent'', ``appropriate follow-up care'', ``health disparity 
population'', and ``patient navigator'' have the meanings given those 
terms in section 417E-10.
    ``(b) Model Community Cancer and Chronic Disease Care and 
Prevention.--
            ``(1) In general.--The Secretary, acting through the 
        Administrator of the Health Resources and Services 
        Administration, may make grants to public and nonprofit private 
        health centers (including health centers under section 330, 
        Indian Health Service Centers, tribal governments, urban Indian 
        organizations, tribal organizations, clinics serving Asian 
        Americans and Pacific Islanders and Alaskan Natives, rural 
        health clinics, and qualified nonprofit entities that partner 
        with 1 or more centers providing health care services to 
        provide navigation services that demonstrate the ability to 
        perform all of the functions outlined in this subsection and 
        subsections (c) and (d)) for the development and operation of 
        model programs that perform the same functions outlined in 
        section 417E-10(b)(1).
            ``(2) Application for grant.--An entity that desires to 
        receive a grant under paragraph (1) shall submit an application 
        to the Secretary at such time, in such manner, and containing 
        such agreements, assurances, and information as the Secretary 
        determines to be necessary to carry out this section.
            ``(3) Outreach services.--In order to be eligible to 
        receive a grant under paragraph (1), an entity shall agree to 
        provide ongoing outreach activities while receiving the grant, 
        in a manner that is culturally competent for the health 
        disparity population served by the program, to inform the 
public and the specific community that the program is serving of the 
services of the model program under the grant. Such activities shall 
include facilitating access to appropriate health care services and 
patient navigators within the health care system to ensure optimal 
patient utilization of such services.
            ``(4) Data collection and report.--In order to allow for 
        effective program evaluation, an entity that receives a grant 
        under this subsection shall collect specific patient data 
        recording services provided to each patient served by the 
        program and shall establish and implement procedures and 
        protocols, consistent with applicable Federal and State laws 
        (including sections 160 and 164 of title 45, Code of Federal 
        Regulations) to ensure the confidentiality of all information 
        shared by a participant in the program, or their personal 
        representative and their health care providers, group health 
        plans, or health insurance insurers with the program. The 
        program may, consistent with applicable Federal and State 
        confidentiality laws, collect, use, or disclose aggregate 
        information that is not individually identifiable (as defined 
        in sections 160 and 164 of title 45, Code of Federal 
        Regulations). With this data, the grantee shall submit an 
        annual report to the Secretary that summarizes and analyzes the 
        data and provides information on needs for navigation services, 
        types of access difficulties resolved, sources of repeated 
        resolution, and flaws in the system of access, including 
        insurance barriers.
            ``(5) Evaluations.--
                    ``(A) In general.--The Secretary, acting through 
                the Administrator of the Health Resources and Services 
                Administration, shall, directly or through grants or 
                contracts, provide for evaluations to determine which 
                outreach activities under paragraph (3) were most 
                effective in informing the public and the specific 
                community that the program is serving of the model 
                program services and to determine the extent to which 
                such programs were effective in providing culturally 
                competent services to the health disparity population 
                served by the programs.
                    ``(B) Dissemination of findings.--The Secretary 
                shall as appropriate disseminate to public and private 
                entities the findings made in evaluations under 
                subparagraph (A).
            ``(6) Coordination with other programs.--The Secretary 
        shall coordinate the program under this subsection with--
                    ``(A) the program under subsection (c);
                    ``(B) the program under section 417E-10 of the 
                Public Health Service Act; and
                    ``(C) to the extent practicable, programs for 
                prevention centers that are carried out by the Director 
                of the Centers for Disease Control and Prevention.
    ``(c) Program for Patient Navigators.--
            ``(1) In general.--The Secretary, acting through the 
        Administrator of the Health Resources and Services 
        Administration, may make grants to public and nonprofit private 
        health centers (including health centers under section 330, 
        Indian Health Service Centers, tribal governments, urban Indian 
        organizations, tribal organizations, clinics serving Asian 
        Americans and Pacific Islanders and Alaskan Natives, rural 
        health clinics, and qualified nonprofit entities that partner 
        with 1 or more centers providing health care to provide 
        navigation services, that demonstrate the ability to perform 
        all of the functions outlined in this subsection and 
        subsections (b) and (d)) for the development and operation of 
        programs to pay the costs of such health centers in carrying 
        out the same activities outlined in section 417E-10(c)(1).
            ``(2) Application for grant.--An entity that desires to 
        receive a grant under paragraph (1) shall submit an application 
        to the Secretary at such time, in such manner, and containing 
        such agreements, assurances, and information as the Secretary 
        determines to be necessary to carry out this section.
            ``(3) Outreach services.--In order to be eligible to 
        receive a grant under paragraph (1), an entity shall agree to 
        provide ongoing outreach activities while receiving the grant, 
        in a manner that is culturally competent for the health 
        disparity population served by the program, to inform the 
        public and the specific community that the patient navigator is 
        serving of the services of the model program under the grant.
            ``(4) Data collection and report.--In order to allow for 
        effective patient navigator program evaluation, an entity that 
        receives a grant under this subsection shall collect specific 
        patient data recording navigation services provided to each 
        patient served by the program and shall establish and implement 
        procedures and protocols, consistent with applicable Federal 
        and State laws (including sections 160 and 164 of title 45, 
        Code of Federal Regulations) to ensure the confidentiality of 
        all information shared by a participant in the program, or 
        their personal representative and their health care providers, 
        group health plans, or health insurance insurers with the 
        program. The patient navigator program may, consistent with 
        applicable Federal and State confidentiality laws, collect, 
        use, or disclose aggregate information that is not individually 
        identifiable (as defined in sections 160 and 164 of title 45, 
        Code of Federal Regulations). With this data, the grantee shall 
        submit an annual report to the Secretary that summarizes and 
        analyzes the data and provides information on needs for 
        navigation services, types of access difficulties resolved, 
        sources of repeated resolution, and flaws in the system of 
        access, including insurance barriers.
            ``(5) Evaluations.--
                    ``(A) In general.--The Secretary, acting through 
                the Administrator of the Health Resources and Services 
                Administration, shall, directly or through grants or 
                contracts, provide for evaluations to determine the 
                effects of the services of patient navigators on the 
                individuals of health disparity populations for whom 
the services were provided, taking into account the matters referred to 
in section 417E-10(c)(1)(C).
                    ``(B) Dissemination of findings.--The Secretary 
                shall, as appropriate, disseminate to public and 
                private entities the findings made in evaluations under 
                subparagraph (A).
            ``(6) Coordination with other programs.--The Secretary 
        shall coordinate the program under this subsection with the 
        programs under subsection (b) and section 417E-10.
    ``(d) Requirements Regarding Fees.--
            ``(1) In general.--In order to be eligible to receive a 
        grant under subsection (b) or (c), the program for which the 
        grant is made shall have in effect--
                    ``(A) a schedule of fees or payments for the 
                provision of such program's health care services 
                related to the prevention and treatment of disease that 
                is consistent with locally prevailing rates or charges 
                and is designed to cover such program's reasonable 
                costs of operation; and
                    ``(B) a corresponding schedule of discounts to be 
                applied to the payment of such fees or payments, which 
                discounts are adjusted on the basis of the ability of 
                the patient to pay.
            ``(2) Rule of construction.--Nothing in this subsection 
        shall be construed to require payment for navigation services 
        or to require payment for health care services in cases where 
        care is provided free of charge, including the case of services 
        provided through programs of the Indian Health Service.
    ``(e) Model.--Not later than 5 years after the date of enactment of 
this section, the Secretary shall develop a peer-reviewed model of 
systems for the services provided by this section. The Secretary shall 
update such model as may be necessary to ensure that the best practices 
are being utilized.
    ``(f) Duration of Grant.--The period during which payments are made 
to an entity from a grant under subsection (b)(1) or (c)(1) may not 
exceed 5 years. The provision of such payments are subject to annual 
approval by the Secretary and subject to the availability of 
appropriations for the fiscal year involved. Nothing in this subsection 
shall be construed as establishing a limitation on the number of grants 
under subsections (b) and (c) that may be made to an entity.
    ``(g) Authorization of Appropriations.--
            ``(1) In general.--
                    ``(A) Model programs.--For the purpose of carrying 
                out subsection (b), there are authorized to be 
                appropriated such sums as may be necessary for each of 
                the fiscal years 2004 through 2008.
                    ``(B) Patient navigators.--For the purpose of 
                carrying out subsection (c), there are authorized to be 
                appropriated such sums as may be necessary for each of 
                the fiscal years 2004 through 2008.
                    ``(C) Bureau of primary health care.--Amounts 
                appropriated under subparagraph (A) or (B) shall be 
                administered through the Bureau of Primary Health Care.
            ``(2) Programs in rural areas.--
                    ``(A) Model programs.--For the purpose of carrying 
                out subsection (b) in making grants under such 
                subsection for model programs in rural areas, there are 
                authorized to be appropriated such sums as may be 
                necessary for each of the fiscal years 2004 through 
                2008.
                    ``(B) Patient navigators.--For the purpose of 
                carrying out subsection (c) in making grants under such 
                subsection for programs in rural areas, there are 
                authorized to be appropriated such sums as may be 
                necessary for each of the fiscal years 2004 through 
                2008.
                    ``(C) Office of rural health policy.--Amounts 
                appropriated under subparagraph (A) or (B) shall be 
                administered through the Office of Rural Health Policy.
            ``(3) Relation to other authorizations.--Authorizations of 
        appropriations under paragraphs (1) and (2) are in addition to 
        other authorizations of appropriations that are available for 
        the purposes of carrying out subsections (b) and (c).''.
                                 <all>