health professionals under which such professionals 
will agree to conduct cancer research, in consider-
ation 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 edu-
cational loans of such professionals obtained to sup-
port training for degrees or licenses, as determined 
appropriate by the Director of the Institute. 
‘‘(c) POSTDOCTORAL STIPENDS.—
‘‘(1) IN GENERAL.—The Director of the Insti-
tute, shall develop and implement, for postdoctoral 
trainees and fellows, a stipend schedule that by Oc-
tober 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, edu-
cation, experience, and comparable salaries or sti-
pends 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 work-
force needs. 
‘‘(b) PROGRAM.—The program described in sub-
section (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 pro-
fessions with the most severe shortages; 
‘‘(3) award grants, scholarships, fellowships, 
and loans to eligible individuals to increase the can-
cer care workforce; 
‘‘(4) make awards to eligible individuals to in-
crease cancer care workforce training for all individ-
uals to become cancer care providers, especially but 
not limited to, such individuals who make a commit-
ment 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, phar-
macists, nurses for all settings, allied health profes-
sionals, physicians, specialists, and public health 
professionals; and 
‘‘(5) be coordinated with existing programs to 
prevent duplication. 
‘‘(c) ELIGIBILITY.—To be eligible to receive a schol-
arship, 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 ac-
cording to criteria developed by the Secretary. 
‘‘(d) USE OF FUNDS.—A recipient of a grant, schol-
arship, 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 can-
cer 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 PRE-
VENTION. 
‘‘(a) PROGRAM.—The Director of the Centers for 
Disease Control and Prevention shall—
‘‘(1) expand and update the National Com-
prehensive Cancer Control Program; 
‘‘(2) assist States, territories, tribal organiza-
tions, 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 organi-
zations, 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 eth-
nic 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 orga-
nizations 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 Pre-
vention, shall conduct a study of the unique health chal-
lenges 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 con-
tracts.
‘‘(b) ACTIVITIES.—Activities that may be carried out 
under subsection (a) include—
‘‘(1) the expansion of current cancer surveil-
lance systems to track the health status of cancer 
survivors and determine whether cancer survivors 
are at-risk for other chronic and disabling condi-
tions; 
‘‘(2) assess the unique challenges associated 
with cancer survivorship; and 
‘‘(3) the development of a national cancer survi-
vorship action plan, in partnership with health orga-
nizations focused on cancer survivorship, to be car-
ried out in coordination with the State-based com-
prehensive cancer control program of the Centers for 
Disease Control and Prevention to—
‘‘(A) develop unique and innovative post-
treatment programs, services, and demonstra-
tions 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 pro-
grams;
‘‘(vi) public awareness and outreach 
campaigns; and 
‘‘(vii) information dissemination to in-
form health care providers and cancer sur-
vivors 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 Octo-
ber 1, 2004, the Secretary shall submit to Congress a re-
port 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 sec-
tion referred to as the ‘Office’), to be headed by an Asso-
ciate 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 car-
rying out the activities described in subsection (a), the Of-
fice shall collaborate with other institutes, centers, and of-
fices within the National Institutes of Health that are de-
termined 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 Cen-
ters 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 infor-
mation 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 enti-
ty—
‘‘(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 Asso-
ciation of Central Cancer Registries or another simi-
lar 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 con-
tracts with academic institutions, cancer centers, and
other entities, when determined appropriate by the Sec-
retary. 
‘‘(d) APPLICATION.—To be eligible for a grant under 
subsection (a), an eligible entity shall submit to the Sec-
retary 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 ap-
propriate 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 ac-
cordance with standards and measures of the Sec-
retary, are designed to effectively and efficiently re-
spond to the cultural and linguistic needs of pa-
tients. 
‘‘(3) ELIGIBLE ENTITY.—The term ‘eligible en-
tity’ 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 In-
stitute. 
‘‘(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 popu-
lation where there exists a significant disparity in 
the overall rate of disease incidence, morbidity, mor-
tality, or survival rates in the population as com-
pared 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 individ-
uals 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 di-
agnosis of cancer or other chronic disease 
within the health care system to accom-
plish the follow-up and diagnosis of an ab-
normal 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 chron-
ic disease. 
‘‘(B) INCLUSIONS.—The term ‘patient nav-
igator’ includes representatives of the target 
health disparity population, such as nurses, so-
cial workers, cancer survivors, and patient ad-
vocates. 
‘‘(b) MODEL COMMUNITY CANCER
AND CHRONIC 
DISEASE CARE AND PREVENTION.—
‘‘(1) IN GENERAL.—The Director of the Insti-
tute may make grants to eligible entities for the de-
velopment and operation of model programs that—
‘‘(A) provide to individuals of health dis-
parity populations prevention, early detection, 
treatment, and appropriate follow-up care serv-
ices for cancer and chronic diseases; 
‘‘(B) ensure that the health services are 
provided to such individuals in a culturally com-
petent manner; 
‘‘(C) assign patient navigators, in accord-
ance 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 utiliza-
tion of such services, including aid in co-
ordinating and scheduling appointments 
and referrals, community outreach, assist-
ance with transportation arrangements, 
and assistance with insurance issues and 
other barriers to care and providing infor-
mation about clinical trials; 
‘‘(D) require training for patient naviga-
tors 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 resolv-
ing access issues; and
‘‘(E) ensure that consumers have direct ac-
cess to patient navigators during regularly 
scheduled hours of business operation. 
‘‘(2) APPLICATION FOR GRANT.—An eligible en-
tity 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 con-
taining such agreements, assurances, and informa-
tion as the Director of the Institute determines to be 
necessary to carry out this section. 
‘‘(3) OUTREACH SERVICES.—In order to be eli-
gible to receive a grant under paragraph (1), an eli-
gible entity shall agree to provide ongoing outreach 
activities while receiving the grant, in a manner that 
is culturally competent for the health disparity popu-
lation 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 pa-
tient navigators within the health care system to en-
sure 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 sub-
section shall collect specific patient data recording 
services provided to each patient served by the pro-
gram 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 con-
fidentiality 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 ag-
gregate information that is not individually identifi-
able (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 Sec-
retary that summarizes and analyzes the data and 
provides information on needs for navigation serv-
ices, types of access difficulties resolved, sources of 
repeated resolution, and flaws in the system of ac-
cess, including insurance barriers. 
‘‘(5) EVALUATIONS.—
‘‘(A) IN GENERAL.—The Director of the 
Institute, directly or through grants or con-
tracts, shall provide for evaluations to deter-
mine 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 subpara-
graph (A). 
‘‘(6) 
COORDINATION
WITH
OTHER
PRO-
GRAMS.—The Secretary shall coordinate the pro-
gram 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 Insti-
tute may make grants to eligible entities for the de-
velopment and operation of programs to pay the 
costs of such entities in—
‘‘(A) assigning patient navigators, in ac-
cordance with applicable criteria of the Sec-
retary, for managing the care of individuals of 
health disparity populations for the duration of 
receipt of health services from the health cen-
ters, including aid in coordinating and sched-
uling appointments and referrals, community 
outreach, assistance with transportation ar-
rangements, assistance with insurance issues 
and other barriers to care, and providing infor-
mation about clinical trials; 
‘‘(B) ensuring that the services provided by 
the patient navigators to such individuals in-
clude case management and psychosocial as-
sessment 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 psy-
chosocial assessment and care; 
‘‘(iii) 
determining 
coverage 
under 
health insurance and health plans for all 
services; 
‘‘(iv) ensuring the initiation, continu-
ation, or sustained access to care pre-
scribed by the patients’ health care pro-
viders; and 
‘‘(v) aiding patients with health insur-
ance coverage issues; 
‘‘(E) requiring training for patient naviga-
tors to ensure the ability of navigators to per-
form all of the duties required in this sub-
section and in subsection (b), including train-
ing, 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 en-
tity 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 con-
taining such agreements, assurances, and informa-
tion as the Director of the Institute determines to be 
necessary to carry out this section. 
‘‘(3) OUTREACH SERVICES.—In order to be eli-
gible to receive a grant under paragraph (1), an eli-
gible entity shall agree to provide ongoing outreach 
activities while receiving the grant, in a manner that 
is culturally competent for the health disparity popu-
lation served by the program, to inform the public 
and the specific community that the patient navi-
gator 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 pro-
gram evaluation, an eligible entity that receives a 
grant under this subsection shall collect specific pa-
tient data recording navigation services provided to 
each patient served by the program and shall estab-
lish and implement procedures and protocols, con-
sistent with applicable Federal and State laws (in-
cluding sections 160 and 164 of title 45, Code of 
Federal Regulations) to ensure the confidentiality of 
all information shared by a participant in the pro-
gram, 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 individ-
ually 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 naviga-
tion services, types of access difficulties resolved, 
sources of repeated resolution, and flaws in the sys-
tem of access, including insurance barriers. 
‘‘(5) EVALUATIONS.—
‘‘(A) IN GENERAL.—The Director of the 
Institute, directly or through grants or con-
tracts, shall provide for evaluations to deter-
mine the effects of the services of patient navi-
gators 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 subpara-
graph (A). 
‘‘(6) 
COORDINATION
WITH
OTHER
PRO-
GRAMS.—The Secretary shall coordinate the pro-
gram 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 pro-
gram for which the grant is made shall have in ef-
fect—
‘‘(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 pre-
vailing 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 pay-
ment for navigation services or to require payment 
for health care services in cases where care is pro-
vided 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 Insti-
tute shall update such model as may be necessary to en-
sure 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 sub-
ject 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 rel-
evant experts, including representatives of the Institute, 
the Health Resources Administration, and the Centers for 
Disease Control and Prevention, to coordinate the develop-
ment and regularly update—
‘‘(1) consensus protocols and practice guidelines 
for optimal cancer treatments and prevention, in-
cluding palliation, symptom management, and end-
of-life care; 
‘‘(2) quality of care measures to assist providers 
and patients in making and evaluating treatment de-
cisions; 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 re-
search and other activities to build an evidence base 
regarding effective clinical and organizational inter-
vention strategies to improve the quality and out-
comes 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 prac-
tice. 
‘‘(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 psy-
chosocial, 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 inter-
ventions; 
‘‘(3) ensure the targeted dissemination of the 
most current scientific evidence in appropriate for-
mats for use by professional societies and organiza-
tions representing clinicians and other caregivers, or-
ganizations through which health care and support
services are delivered, and organizations rep-
resenting 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 improve-
ment strategies or other initiatives to improve prac-
tice; 
‘‘(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 in-
dividual physician can provide overall coordination 
and management of cancer care. 
‘‘(c) COORDINATION
OF FEDERAL QUALITY IM-
PROVEMENT 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 collabora-
tion with the Director of the Institute, shall facili-
tate coordination of Federal research and implemen-
tation initiatives to improve the quality and out-
comes 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 bench-
marks for, and subsequently measure changes in the 
quality of cancer care for inclusion, as soon as prac-
ticable, 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 CAN-
CER. 
‘‘(a) INSTITUTE OF MEDICINE STUDY.—The Sec-
retary shall request the Institute of Medicine of the Na-
tional Academies of Sciences to initiate a study by Janu-
ary 1, 2004, of the feasibility and costs of providing medi-
care 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 es-
tablished 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 medi-
care coverage to such individuals; 
‘‘(B) estimate the cost to the medicare pro-
gram 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 out-
comes and assess the feasibility of providing 
medicare coverage to uninsured cancer patients
through 5 years of remission and make a rec-
ommendation to Congress about whether medi-
care 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 pre-
scription drug benefits and benefits to improve 
home care, symptom management, psychosocial 
services, and palliative and hospice care; 
‘‘(B) estimate the cost to the medicare pro-
gram and to beneficiaries; and 
‘‘(C) assess the medical advantages and 
disadvantages associated with expanding bene-
fits. 
‘‘(4) DEADLINES.—The first part shall be com-
pleted 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 identi-
fies 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 sur-
vivorship,’’ after ‘‘treatment of cancer’’; 
(2) in paragraph (1)(B), by striking ‘‘cancer 
patients’’ and all that follows and inserting the fol-
lowing: ‘‘cancer patients, families of cancer patients, 
and cancer survivors, and’’; and 
(3) in paragraph (3), by inserting ‘‘and con-
cerning cancer survivorship programs,’’ after ‘‘con-
trol 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 
DEM-
ONSTRATION PROJECT. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall award competitive grants to public and non-
profit private entities to enable such entities to establish 
demonstration programs pursuant to the general authority 
of title III to carry out colorectal screening activities in-
cluding—
‘‘(1) screening asymptomatic individuals for 
colorectal cancer as a preventive health measure ac-
cording to scientific evidence-based screening guide-
lines; 
‘‘(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 sup-
port services such as case management; 
‘‘(3) activities to improve the education, train-
ing, and skills of health professionals (including al-
lied health professionals) in the detection and con-
trol of colorectal cancer; 
‘‘(4) activities to evaluate the programs under 
this section through appropriate surveillance or pro-
gram monitoring activities; 
‘‘(5) the development and dissemination of find-
ings 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 indi-
vidual 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 pay-
ments for any item or service to the extent that pay-
ment has been made, or can reasonably be expected 
to be made, with respect to such item or service—
‘‘(A) under any State compensation pro-
gram, 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 deter-
mines 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 PREVEN-
TION; IHS GRANTS FOR PATIENT NAVIGA-
TORS. 
(a) DEFINITIONS.—In this section:
(1) IN GENERAL.—The terms ‘‘culturally com-
petent’’, ‘‘appropriate follow-up care’’, ‘‘health dis-
parity 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 DIS-
EASE CARE AND PREVENTION.—
(1) IN GENERAL.—The Director of the Indian 
Health Service may make grants, for the develop-
ment 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 quali-
fied 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 deter-
mines to be necessary to carry out this section. 
(3) OUTREACH SERVICES.—In order to be eligi-
ble 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 cul-
turally 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 ap-
propriate health care services and patient navigators
within the health care system to ensure optimal pa-
tient 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 col-
lect specific patient data recording services provided 
to each patient served by the program and shall es-
tablish 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 pro-
gram, 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 aggre-
gate 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 in-
formation on needs for navigation services, types of 
access difficulties resolved, sources of repeated reso-
lution, 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 Serv-
ice, shall, directly or through grants or con-
tracts, 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, trib-
al organizations, and qualified nonprofit entities 
demonstrating the ability to perform all of the func-
tions 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 deter-
mines to be necessary to carry out this section. 
(3) OUTREACH SERVICES.—In order to be eligi-
ble 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 cul-
turally 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 eval-
uation, an entity that receives a grant under this 
subsection shall collect specific patient data record-
ing navigation services provided to each patient 
served by the program and shall establish and imple-
ment procedures and protocols, consistent with ap-
plicable Federal and State laws (including sections 
160 and 164 of title 45, Code of Federal Regula-
tions) to ensure the confidentiality of all information 
shared by a participant in the program, or their per-
sonal 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 aggre-
gate 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 in-
formation on needs for navigation services, types of 
access difficulties resolved, sources of repeated reso-
lution, 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 Serv-
ice, shall, directly or through grants or con-
tracts, 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 Serv-
ice Act. 
(d) REQUIREMENTS REGARDING FEES.—
(1) IN GENERAL.—In order to be eligible to re-
ceive a grant under subsection (b) or (c), the pro-
gram for which the grant is made shall have in ef-
fect—
(A) a schedule of fees or payments for the 
provision of such program’s health care services 
related to the prevention and treatment of dis-
ease 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 sub-
section (b)(1) or (c)(1) may not exceed 5 years. The provi-
sion of such payments are subject to annual approval by 
the Secretary and subject to the availability of appropria-
tions for the fiscal year involved. Nothing in this sub-
section 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 author-
ized to be appropriated such sums as may be 
necessary for each of the fiscal years 2004 
through 2008. 
(B) PATIENT NAVIGATORS.—For the pur-
pose 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 subpara-
graph (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 appro-
priated such sums as may be necessary for each 
of the fiscal years 2004 through 2008.
(B) PATIENT NAVIGATORS.—For the pur-
pose of carrying out subsection (c) in making 
grants under such subsection for programs in 
rural areas, there are authorized to be appro-
priated 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 AP-
PROVAL 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 Commis-
sioner 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 in-
serting ‘‘or targets and mechanisms of pathogenesis of dis-
eases’’ 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 in-
surance coverage, provides coverage to a qualified in-
dividual (as defined in subsection (b)), the plan or 
issuer—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (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 in-
dividual on the basis of the enrollee’s participa-
tion in such trial. 
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses 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 con-
strued 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 pro-
vider cannot accept new enrollees, then the qualified 
individual may enroll in the trial through an out-of-
network provider. 
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses 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 fol-
lowing conditions: 
‘‘(1) The individual is eligible to participate in 
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness. 
‘‘(2) Either the referring physician is author-
ized by the plan to treat the patient and has con-
cluded 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 pro-
vide 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 ex-
pected (as determined by the appropriate Secretary) 
to be paid for by the sponsors of an approved clin-
ical 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 pay-
ment 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 quali-
fied 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 Adminis-
tration; 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 De-
partment of Health and Human Services speci-
fying compliance with section 46 of title 45, 
Code of Federal Regulations. 
‘‘(e) CONDITIONS FOR DEPARTMENTS.—The condi-
tions for a study or investigation conducted by a depart-
ment, are that the study or investigation has been re-
viewed and approved through a system of peer review that 
the appropriate Secretary determines—
‘‘(1) to be comparable to the system of peer re-
view of studies and investigations used by the Na-
tional Institutes of Health; and 
‘‘(2) assures unbiased review of the highest eth-
ical standards by an institutional review board or 
other body that meets the standards outlined in sec-
tion 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 Pub-
lic Health Service Act is amended by inserting after sec-
tion 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 pro-
visions 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 add-
ing 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 in-
surance coverage, provides coverage to a qualified in-
dividual (as defined in subsection (b)), the plan or 
issuer—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (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 in-
dividual on the basis of the enrollee’s participa-
tion in such trial.
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses 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 con-
strued 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 pro-
vider cannot accept new enrollees, then the qualified 
individual may enroll in the trial through an out-of-
network provider. 
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses 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 fol-
lowing conditions:
‘‘(1) The individual is eligible to participate in 
an approved clinical trial according to the trial pro-
tocol with respect to treatment of such illness. 
‘‘(2) Either the referring physician is author-
ized by the plan to treat the patient and has con-
cluded 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 pro-
vide 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 ex-
pected (as determined by the appropriate Secretary) 
to be paid for by the sponsors of an approved clin-
ical 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 pay-
ment 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 quali-
fied 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 Adminis-
tration; 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 De-
partment of Health and Human Services speci-
fying compliance with section 46 of title 45, 
Code of Federal Regulations. 
‘‘(e) CONDITIONS FOR DEPARTMENTS.—The condi-
tions for a study or investigation conducted by a depart-
ment, are that the study or investigation has been re-
viewed and approved through a system of peer review that 
the appropriate Secretary determines—
‘‘(1) to be comparable to the system of peer re-
view of studies and investigations used by the Na-
tional Institutes of Health; and 
‘‘(2) assures unbiased review of the highest eth-
ical standards by an institutional review board or 
other body that meets the standards outlined in sec-
tion 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 con-
tents in section 1 of the Employee Retirement Income Se-
curity 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 Pro-
gram 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 De-
fense;
(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
AMEND-
MENTS.—
(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 sec-
tion 1861(jj) of the Social Security Act) conducted 
by a facility that has a certificate (or provisional cer-
tificate) 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 (Papani-
colaou test) provided to a woman for the pur-
pose 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 PROCE-
DURES.—
‘‘(A) IN GENERAL.—In the case of a par-
ticipant 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 screen-
ing that—
‘‘(i) are deemed appropriate by a phy-
sician (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 bene-
ficiary; 
‘‘(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 can-
cer; 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 orga-
nizations with special expertise in the 
field of colorectal cancer, that a dif-
ferent frequency would not adversely 
affect the effectiveness of such screen-
ing. 
‘‘(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 Secu-
rity 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 coun-
seling for cessation of tobacco use for individ-
uals 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 profes-
sional— 
‘‘(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 bene-
ficiaries, is authorized to receive pay-
ment for other services under this title 
or is designated by the Secretary for 
this purpose. 
‘‘(B) LIMITATION.—Subject to subpara-
graph (C), such therapy and counseling are lim-
ited 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 coun-
seling services that the Secretary recog-
nizes 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
SERV-
ICES.—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
SERV-
ICES.—
‘‘(A) IN GENERAL.—Genetic tests and ge-
netic services provided by a licensed health care 
professional to obtain predictive genetic infor-
mation about an individual at risk of cancer for 
purposes of a health assessment, cancer man-
agement, 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 in-
dividual, including a child who is born 
to or placed for adoption with the in-
dividual; and 
‘‘(III) all other individuals re-
lated by blood to the individual or the 
spouse or child described in subclause 
(I) or (II). 
‘‘(ii) GENETIC
INFORMATION.—The 
term ‘genetic information’ means informa-
tion about genes, gene products, or inher-
ited 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 serv-
ices by such individual or family member 
of such individual). 
‘‘(iii) GENETIC SERVICES.—The term 
‘genetic services’ means health services, in-
cluding 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 ‘ge-
netic 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 INFORMA-
TION.—
‘‘(I) IN
GENERAL.—The term 
‘predictive 
genetic 
information’ 
means—
‘‘(aa) information about an 
individual’s genetic tests; 
‘‘(bb) information about ge-
netic tests of family members of 
the individual; or 
‘‘(cc) information about the 
occurrence of a disease or dis-
order 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 organi-
zations 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 contin-
ued 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 bene-
ficiary 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 man-
ner 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 bene-
ficiary 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 im-
posing deductibles, coinsurance, or other cost-shar-
ing in relation to benefits described in subsection (a) 
consistent with such subsection, except that such co-
insurance or other cost-sharing shall not discrimi-
nate 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 evi-
dence, 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 recog-
nized 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 recog-
nizes 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 in-
surance 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 individ-
uals who are participants or beneficiaries as of such 
date), and at least annually thereafter, the informa-
tion described in subsection (b) in printed form; 
‘‘(2) provide to participants and beneficiaries, 
within a reasonable period (as specified by the ap-
propriate Secretary) before or after the date of sig-
nificant changes in the information described in sub-
section (b), information in printed form regarding 
such significant changes; and 
‘‘(3) upon request, make available to partici-
pants and beneficiaries, the applicable authority, and 
prospective participants and beneficiaries, the infor-
mation described in subsection (b) in printed form. 
‘‘(b) INFORMATION PROVIDED.—The information de-
scribed 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, co-
insurance, 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 applica-
ble 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 pro-
viders participating in the plan or issuer net-
work. 
‘‘(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) pro-
vided 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 pro-
viders. 
‘‘(E) The rights and procedures for obtain-
ing 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 enroll-
ees 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 sec-
tion 1861(jj) of the Social Security Act) conducted 
by a facility that has a certificate (or provisional cer-
tificate) 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 (Papani-
colaou test) provided to a woman for the pur-
pose 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 PROCE-
DURES.—
‘‘(A) IN GENERAL.—In the case of a par-
ticipant 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 screen-
ing that—
‘‘(i) are deemed appropriate by a phy-
sician (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 bene-
ficiary; 
‘‘(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 can-
cer; 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 orga-
nizations with special expertise in the 
field of colorectal cancer, that a dif-
ferent frequency would not adversely 
affect the effectiveness of such screen-
ing. 
‘‘(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 Secu-
rity 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 coun-
seling for cessation of tobacco use for individ-
uals 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 profes-
sional who—
‘‘(I) is legally authorized to fur-
nish such services under State law (or 
the State regulatory mechanism pro-
vided 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 subpara-
graph (C), such therapy and counseling are lim-
ited 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 coun-
seling services that the Secretary recog-
nizes 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
SERV-
ICES.—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
SERV-
ICES.—
‘‘(A) IN GENERAL.—Genetic tests and ge-
netic services provided by a licensed health care 
professional to obtain predictive genetic infor-
mation about an individual at risk of cancer for 
purposes of a health assessment, cancer man-
agement, 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 in-
dividual, including a child who is born
to or placed for adoption with the in-
dividual; and 
‘‘(III) all other individuals re-
lated by blood to the individual or the 
spouse or child described in subclause 
(I) or (II). 
‘‘(ii) GENETIC
INFORMATION.—The 
term ‘genetic information’ means informa-
tion about genes, gene products, or inher-
ited 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 serv-
ices by such individual or family member 
of such individual). 
‘‘(iii) GENETIC SERVICES.—The term 
‘genetic services’ means health services, in-
cluding 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 ‘ge-
netic 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 INFORMA-
TION.—
‘‘(I) IN
GENERAL.—The term 
‘predictive 
genetic 
information’ 
means—
‘‘(aa) information about an 
individual’s genetic tests;
‘‘(bb) information about ge-
netic tests of family members of 
the individual; or 
‘‘(cc) information about the 
occurrence of a disease or dis-
order 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 organi-
zations 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 contin-
ued 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;
100
‘‘(3) penalize or otherwise reduce or limit the 
reimbursement of a provider because such provider 
provided care to an individual participant or bene-
ficiary 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 man-
ner 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 bene-
ficiary 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 im-
posing deductibles, coinsurance, or other cost-shar-
ing in relation to benefits described in subsection (a) 
consistent with such subsection, except that such co-
insurance or other cost-sharing shall not discrimi-
nate 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.
101
‘‘(d) NOTICE UNDER GROUP HEALTH PLAN.—The 
imposition of the requirement of this section shall be treat-
ed as a material modification in the terms of the plan de-
scribed in section 102(a), for purposes of assuring notice 
of such requirements under the plan; except that the sum-
mary description required to be provided under the last 
sentence of section 104(b)(1) with respect to such modi-
fication shall be provided by not later than 60 days after 
the first day of the first plan year in which such require-
ment 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 evi-
dence, 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 recog-
nized 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.
102
For purposes of this subsection, the term ‘type of cancer’ 
includes other types of cancer that the Secretary recog-
nizes 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 in-
surance 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 individ-
uals who are participants or beneficiaries as of such 
date), and at least annually thereafter, the informa-
tion described in subsection (b) in printed form; 
‘‘(2) provide to participants and beneficiaries, 
within a reasonable period (as specified by the ap-
propriate Secretary) before or after the date of sig-
nificant changes in the information described in sub-
section (b), information in printed form regarding 
such significant changes; and 
‘‘(3) upon request, make available to partici-
pants and beneficiaries, the applicable authority, and 
prospective participants and beneficiaries, the infor-
mation described in subsection (b) in printed form. 
‘‘(b) INFORMATION PROVIDED.—The information de-
scribed in subsection (a) that shall be disclosed includes
103
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, co-
insurance, 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 applica-
ble 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 pro-
viders participating in the plan or issuer net-
work. 
‘‘(2) ACCESS.—A description of the following: 
‘‘(A) The number, mix, and distribution of 
providers under the plan or coverage.
104
‘‘(B) Out-of-network coverage (if any) pro-
vided 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 pro-
viders. 
‘‘(E) The rights and procedures for obtain-
ing 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 enroll-
ees 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.—
105
(i) Section 731(c) of the Employee 
Retirement Income Security Act of 1974 
(29 U.S.C. 1191(c)) is amended by strik-
ing ‘‘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 strik-
ing ‘‘section 711’’ and inserting ‘‘sections 
711 and 715’’. 
(iii) The table of contents in section 1 
of the Employee Retirement Income Secu-
rity Act of 1974, as amended by section 
302, is further amended by inserting after 
the item relating to section 714 the fol-
lowing 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:
106
‘‘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 indi-
vidual market with respect to an enrollee under such cov-
erage in the same manner as they apply to health insur-
ance coverage offered by a health insurance issuer in con-
nection 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 sec-
tion 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 in-
surance 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.’’.
107
(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 para-
graph (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 be-
tween employee representatives and 1 or more em-
ployers 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 ter-
minates (determined without regard to any ex-
108
tension thereof agreed to after the date of en-
actment of this Act), or 
(B) January 1, 2004. 
For purposes of subparagraph (A), any plan amend-
ment 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 In-
come 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 require-
ments 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
109
screening, or other updated medical practices re-
garding such screening, such as the use of new tests 
or other emerging technologies. Such modifications 
shall not in any way diminish the coverage require-
ments 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 re-
quirements under paragraph (1), the Secretary of 
Health and Human Services shall consult with ap-
propriate organizations, experts, and agencies. 
(3) PETITIONS.—The Secretary of Health and 
Human Services may issue requirements for the pe-
titioning process under paragraph (1), including re-
quirements that the petition be in writing and in-
clude scientific or medical bases for the modification 
sought. Upon receipt of such a petition, the Sec-
retary 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 re-
quired, the Secretary shall propose such regulation 
within 6 months of such determination. The Sec-
retary shall provide the petitioner the reasons for 
the decision of the Secretary. The Secretary may
110
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 insur-
ance 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 des-
ignated 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 bene-
ficiary and paid for overall coordination of services.
111
‘‘(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 fol-
low the most current quality-of-care cancer care guide-
lines, as developed by medical professionals with expertise 
in the field of medicine for which the guidelines are de-
signed 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 contin-
ued 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 bene-
ficiary in accordance with this section; or
112
‘‘(4) provide incentives (monetary or otherwise) 
to a provider to induce such provider to provide care 
to an individual participant or beneficiary in a man-
ner 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 sub-
sections (a) or (b) consistent with such subsections, except 
that such coinsurance or other cost-sharing shall not dis-
criminate 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 Pub-
lic Health Service Act is amended by inserting after sec-
tion 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 pro-
113
visions 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 EM-
PLOYEE 
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 sec-
tions 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 insur-
ance 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 des-
ignated at the time of diagnosis by the participant or bene-
ficiary involved to provide for the overall coordination and 
management of the cancer care of the participant or bene-
ficiary among all providers who provide items or services 
to the participant or beneficiary and paid for overall co-
ordination of services.
114
‘‘(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 fol-
low the most current quality-of-care cancer care guide-
lines, as developed by medical professionals with expertise 
in the field of medicine for which the guidelines are de-
signed 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 contin-
ued 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 bene-
ficiary in accordance with this section; or
115
‘‘(4) provide incentives (monetary or otherwise) 
to a provider to induce such provider to provide care 
to an individual participant or beneficiary in a man-
ner 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 sub-
sections (a) or (b) consistent with such subsections, except 
that such coinsurance or other cost-sharing shall not dis-
criminate 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 con-
tents in section 1 of the Employee Retirement Income Se-
curity 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.’’.
116
SEC. 323. MANAGING PHYSICIANS AND QUALITY OF CARE 
FOR CANCER PATIENTS UNDER MEDICARE. 
(a) APPLICATION OF CANCER COVERAGE REQUIRE-
MENTS.—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 physi-
cians at the time of diagnosis of the individual as the phy-
sician responsible for the overall coordination and manage-
117
ment 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 em-
ployer 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 Secu-
rity 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 fol-
lowing: 
‘‘(66) provide—
‘‘(A) that the provisions of sections 2707, 
2708, and 2710 of the Public Health Service 
Act shall apply to individuals eligible for med-
118
ical 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 physi-
cians’ services that are related to that diag-
nosis, that there shall be paid to the physician 
designated by such team of physicians at the 
time of diagnosis of the individual as the physi-
cian 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 addi-
tional 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 PRO-
VISIONS.—
119
‘‘(A) IN GENERAL.—The provisions of sec-
tions 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 ex-
penses 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 coordina-
tion and management of the medical and other 
health services provided to that individual dur-
ing the period in which that individual is under-
going treatment for such cancer, a separate and 
additional payment amount for the services pro-
vided in addition to any amount otherwise paid 
under the State child health plan.’’.
120
Subtitle D—General Provisions 
SEC. 331. COVERAGE UNDER OTHER PUBLIC HEALTH IN-
SURANCE. 
(a) IN GENERAL.—The coverage described in sub-
section (b) shall be provided for any individual, partici-
pant, 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 Pro-
gram 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 De-
fense; 
(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
121
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 COV-
ERAGE.—Chapter 89 of title 5, United States Code, is 
amended by adding at the end the following: 
‘‘§ 8915. Standards relating to coverage of cancer-re-
lated 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 enti-
ty 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 per-
mitted under this chapter.’’.
122
TITLE IV—PATIENT NAVIGATOR 
AND CANCER CARE WITHIN 
THE 
HEALTH 
RESOURCES 
AND SERVICES ADMINISTRA-
TION 
SEC. 401. HRSA GRANTS FOR MODEL COMMUNITY CANCER 
AND CHRONIC DISEASE CARE AND PREVEN-
TION AND GRANTS FOR PATIENT NAVIGA-
TORS. 
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 ‘‘cul-
turally 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 (includ-
123
ing 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 pro-
viding health care services to provide navigation 
services that demonstrate the ability to perform all 
of the functions outlined in this subsection and sub-
sections (c) and (d)) for the development and oper-
ation 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 deter-
mines to be necessary to carry out this section. 
‘‘(3) OUTREACH SERVICES.—In order to be eli-
gible to receive a grant under paragraph (1), an en-
tity shall agree to provide ongoing outreach activities 
while receiving the grant, in a manner that is cul-
turally competent for the health disparity population
served by the program, to inform the public and the 
specific community that the program is serving of
124
the services of the model program under the grant. 
Such activities shall include facilitating access to ap-
propriate health care services and patient navigators 
within the health care system to ensure optimal pa-
tient 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 proto-
cols, consistent with applicable Federal and State 
laws (including sections 160 and 164 of title 45, 
Code of Federal Regulations) to ensure the confiden-
tiality 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 ag-
gregate information that is not individually identifi-
able (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 Sec-
retary that summarizes and analyzes the data and
125
provides information on needs for navigation serv-
ices, types of access difficulties resolved, sources of 
repeated resolution, and flaws in the system of ac-
cess, including insurance barriers. 
‘‘(5) EVALUATIONS.—
‘‘(A) IN GENERAL.—The Secretary, acting 
through the Administrator of the Health Re-
sources and Services Administration, shall, di-
rectly or through grants or contracts, provide 
for evaluations to determine which outreach ac-
tivities under paragraph (3) were most effective 
in informing the public and the specific commu-
nity 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 dis-
parity 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
PRO-
GRAMS.—The Secretary shall coordinate the pro-
gram under this subsection with—
‘‘(A) the program under subsection (c);
126
‘‘(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 (includ-
ing 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 pro-
viding 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).
127
‘‘(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 deter-
mines to be necessary to carry out this section. 
‘‘(3) OUTREACH SERVICES.—In order to be eli-
gible to receive a grant under paragraph (1), an en-
tity shall agree to provide ongoing outreach activities 
while receiving the grant, in a manner that is cul-
turally 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 pro-
gram 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 in-
128
formation 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 ag-
gregate information that is not individually identifi-
able (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 Sec-
retary that summarizes and analyzes the data and 
provides information on needs for navigation serv-
ices, types of access difficulties resolved, sources of 
repeated resolution, and flaws in the system of ac-
cess, including insurance barriers. 
‘‘(5) EVALUATIONS.—
‘‘(A) IN GENERAL.—The Secretary, acting 
through the Administrator of the Health Re-
sources and Services Administration, shall, di-
rectly 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
129
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
PRO-
GRAMS.—The Secretary shall coordinate the pro-
gram 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 pro-
gram for which the grant is made shall have in ef-
fect—
‘‘(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 pre-
vailing 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
130
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 pay-
ment for navigation services or to require payment 
for health care services in cases where care is pro-
vided 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 appro-
priations for the fiscal year involved. Nothing in this sub-
section 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.—
131
‘‘(1) IN GENERAL.—
‘‘(A) MODEL PROGRAMS.—For the purpose 
of carrying out subsection (b), there are author-
ized to be appropriated such sums as may be 
necessary for each of the fiscal years 2004 
through 2008. 
‘‘(B) PATIENT NAVIGATORS.—For the pur-
pose 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 subpara-
graph (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 appro-
priated such sums as may be necessary for each 
of the fiscal years 2004 through 2008. 
‘‘(B) PATIENT NAVIGATORS.—For the pur-
pose of carrying out subsection (c) in making 
grants under such subsection for programs in
132
rural areas, there are authorized to be appro-
priated such sums as may be necessary for each 
of the fiscal years 2004 through 2008. 
‘‘(C) OFFICE
OF
RURAL
HEALTH
POL-
ICY.—Amounts appropriated under subpara-
graph (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).’’.
Æ