National Cancer Act of 2003

        [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).''.
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