21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act - Amends the Public Health Service Act to revise provisions related to the National Cancer Program, including to require the establishment of an entity within the National Cancer Institute (NCI) to augment ongoing efforts to advance new technologies in cancer research, support the national collection of tissues for cancer research purposes, and ensure the quality of tissue collection.
Sets forth provisions governing clinical trials, including ethical and privacy standards.
Requires the Director of NCI to award grants for research on cancers with a low five-year survival rate and rare cancers.
Expands coverage of colorectal screenings and treatment, including through authorizing grants and allowing states to provide coverage under Medicaid for individuals needing treatment for colorectal cancer.
Provides for biomarkers research.
Expands coverage of tobacco cessation products under Medicaid.
Provides for coverage under Medicare for payment of routine costs of care furnished to individuals participating in cancer clinical trials, comprehensive cancer planning services, and comprehensive cancer patient treatment education services.
Requires the Commissioner of Food and Drugs to review and improve the policies, programs and activities of the Food and Drug Administration (FDA) relating to oncology products.
Requires the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), to expand and intensify CDC's cancer control programs.
Provides for research on cancer survivorship related to childhood cancer and health disparities in outcomes.
Requires the Secretary to convene a Workforce Development Collaborative on Psychosocial Care During Chronic Medical Illness.
[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6224 Introduced in House (IH)]
111th CONGRESS
2d Session
H. R. 6224
To modernize cancer research, increase access to preventative cancer
services, provide cancer treatment and survivorship initiatives, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 28, 2010
Mrs. Capps (for herself and Mr. Pallone) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on Ways and Means, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To modernize cancer research, increase access to preventative cancer
services, provide cancer treatment and survivorship initiatives, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``21st Century
Cancer ALERT (Access to Life-Saving Early detection, Research and
Treatment) Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings and purpose.
Sec. 3. Advancement of the National Cancer Program.
Sec. 4. Comprehensive and Responsible Access to Research, Data, and
Outcomes.
Sec. 5. Enhanced focus and reporting on cancer research.
Sec. 6. Continuing access to care for prevention and early detection.
Sec. 7. Early recognition and treatment of cancer through use of
biomarkers.
Sec. 8. Extending coverage under Medicaid of counseling and
pharmacotherapy for cessation of tobacco
use.
Sec. 9. Comprehensive cancer care and coverage under Medicare.
Sec. 10. Targeted Cancers program.
Sec. 11. Activities of the Food and Drug Administration.
Sec. 12. CDC Cancer Control Programs.
Sec. 13. NIH cancer survivorship programs.
Sec. 14. Clinics for comprehensive long-term follow-up services for
childhood cancer survivors.
Sec. 15. Grants to improve access to care for childhood cancer
survivors.
SEC. 2. FINDINGS AND PURPOSE.
(a) Findings.--Congress makes the following findings:
(1) One in 2 men and one in 3 women are expected to develop
cancer in their lifetimes.
(2) Cancer is the leading cause of death for people under
the age of 85 and is expected to claim more than 1,500 lives
per day in 2008.
(3) At least 30 percent of all cancer deaths and 87 percent
of lung cancer deaths are attributed to smoking.
(4) The National Institutes of Health estimates that in
2007 alone, the overall cost of cancer to the United States was
more than $219,000,000,000.
(5) In recent decades, the biomedical research enterprise
has made considerable advances in the knowledge required to
understand, prevent, diagnose, and treat cancer; however, it
still takes 17 years, on average, to translate these
discoveries into viable treatment options.
(6) While clinical trials are vital to the discovery and
implementation of new preventative, diagnostic, and treatment
options, only 3 to 5 percent of the more than 10,000,000 adults
with cancer in the United States participate in cancer clinical
trials.
(7) Where people reside should not determine whether they
live, yet women in rural areas are less likely to obtain
preventative cancer screenings than those residing in urban
areas.
(8) Two-thirds of childhood cancer survivors are likely to
experience at least one late effect from treatment and one-
fourth are expected to experience a late effect that is life
threatening.
(9) In 1971, there were only 3,000,000 cancer survivors.
Today, cancer survivors account for 3 percent of the United
States population, approximately 12,000,000.
(10) The National Cancer Act of 1971 (Public Law 92-218)
advanced the ability of the United States to develop new
scientific leads and help increase the rate of cancer
survivorship.
(11) Yet in the 37 years since the national declaration of
the War on Cancer, the age adjusted mortality rate for cancer
is still extraordinarily high. Eight forms of cancer have a 5-
year survival rate of less than 50 percent (pancreatic, liver,
lung, esophageal, stomach, brain, multiple myeloma, and
ovarian).
(12) While there have been substantial achievements since
the crusade began, we are far from winning the war on cancer.
(13) Many obstacles have hindered our progress in cancer
prevention, research, and treatment.
(b) Purposes.--The purposes of this Act are as follows:
(1) To reauthorize the National Cancer Program in order to
benefit cancer patients by enhancing and improving the cancer
research conducted and supported by the National Cancer
Institute and the National Cancer Program.
(2) To recognize that with an increased understanding of
cancer as more than 200 different diseases with genetic and
molecular variations, there is a need for increased
coordination and greater flexibility in how cancer research is
conducted and coordinated in order to maximize the return the
United States receives on its investment in such research.
(3) To prepare for the looming impact of an aging
population of the United States and the anticipated financial
burden associated with medical treatment and lost productivity,
along with the toll of human suffering that accompanies a
cancer diagnosis.
(4) To support the National Cancer Institute in
establishing relationships and scientific consortia with an
emphasis on public-private partnership development, which will
further the development of advanced technologies that will
improve the prevention, diagnosis, and treatment of cancer.
SEC. 3. ADVANCEMENT OF THE NATIONAL CANCER PROGRAM.
Section 411 of the Public Health Service Act (42 U.S.C. 285a) is
amended to read as follows:
``SEC. 411. NATIONAL CANCER PROGRAM.
``(a) In General.--There shall be established a National Cancer
Program (referred to in this section as the `Program') that shall
consist of--
``(1) an expanded, intensified, and coordinated cancer
research program encompassing the research programs conducted
and supported by the Institute and the related research
programs of the other national research institutes, including
an expanded and intensified research program for the prevention
of cancer caused by occupational or environmental exposure to
carcinogens; and
``(2) the other programs and activities of the Institute.
``(b) Collaboration.--In carrying out the Program--
``(1) the Secretary and the Director of the Institute shall
identify relevant Federal agencies that shall collaborate with
respect to activities conducted under the Program (including
the Institute, the other Institutes and Centers of the National
Institutes of Health, the Office of the Director of the
National Institutes of Health, the Food and Drug
Administration, the Centers for Medicare & Medicaid Services,
the Centers for Disease Control and Prevention, the Department
of Defense, the Department of Energy, the Agency for Healthcare
Research and Quality, the Office for Human Research
Protections, the Health Resources and Services Administration,
and the Office for Human Research Protections); and
``(2) the Secretary shall ensure that the policies related
to the promotion of cancer research of all agencies within the
Department of Health and Human Services (including the
Institute, the Food and Drug Administration, and the Centers
for Medicare & Medicaid Services) are harmonized, and shall
ensure that such agencies collaborate with regard to cancer
research and development.
``(c) Transparency and Efficiency.--
``(1) Budgeting.--In carrying out the Program, the Director
of the Institute shall, in preparing and submitting to the
President the annual budget estimate for the Program--
``(A) develop the budgetary needs of the entire
Program and submit the budget estimate relating to such
needs to the National Cancer Advisory Board for review
prior to submitting such estimate to the President; and
``(B) submit such budget estimate to the Committee
on the Budget and the Committee on Appropriations of
the Senate and the Committee on the Budget and
Committee on Appropriations of the House of
Representatives at the same time that such estimate is
submitted to the President.
``(2) National cancer advisory board.--In establishing the
priorities of the Program, the National Cancer Advisory Board
shall provide for increased coordination by increasing the
participation of representatives (to the extent practicable,
representatives who have appropriate decision making authority)
of appropriate Federal agencies, including--
``(A) the Centers for Medicare & Medicaid Services;
``(B) the Health Resources and Services
Administration;
``(C) the Centers for Disease Control and
Prevention; and
``(D) the Agency for Healthcare Research and
Quality.
``(d) Programs To Encourage Early Detection Research.--The Director
of the Institute shall develop a standard process through which Federal
agencies, including the Department of Defense, and administrators of
federally funded programs may engage in early cancer detection
research.
``(e) Identification of Promising Translational Research
Opportunities.--
``(1) In general.--The Director of the Institute, acting
through the Program and in accordance with the NIH Reform Act
of 2007, shall continue to identify promising translational
research opportunities across all disease sites, populations,
and pathways to clinical goals through a transparent, inclusive
process by--
``(A) continuing to support efforts to develop a
robust number of public or nonprofit entities to carry
out early translational research activities;
``(B) emphasizing the role of the young researcher
in the program under this section; and
``(C) modifying guidelines for multiproject,
collaborative, early translational research awards to
focus research and reward collaborative team science.
``(2) Matching funds for research.--
``(A) In general.--The Secretary may provide
assistance to eligible entities to match the amount of
non-Federal funds made available by such entity for
translational research of the type described in
paragraph (1) relating to cancer.
``(B) Eligibility.--To be eligible to receive
assistance under subparagraph (A), an entity shall
submit to the Secretary an application at such time, in
such manner, and containing such information as the
Secretary may require.
``(C) Recommendations and prioritization.--In
providing assistance under subparagraph (A), the
Secretary shall--
``(i) select entities based on the
recommendations of--
``(I) the Director of NIH; and
``(II) a peer review process; and
``(ii) give priority to those entities
submitting applications under subparagraph (B)
that demonstrate that the research involved is
high risk or translational research (as
determined by the Secretary).
``(D) Amount.--The amount of assistance to be
provided to an entity under subparagraph (A) shall be
at the discretion of the Secretary but shall not exceed
an amount equal to 100 percent of the amount of non-
Federal funds ($1 for each $2 of non-Federal funds)
made available for research described in subparagraph
(A).
``(E) Determination of amount of non-federal
contribution.--Non-Federal funds to be matched under
subparagraph (A) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services.
Amounts provided by the Federal Government, and any
portion of any service subsidized by the Federal
Government, may not be included in determining the
amount of such non-Federal funds.
``(f) Biological Resource Coordination and Advancement of
Technologies for Cancer Research.--
``(1) Establishment.--The Director of the Institute, acting
through the Program, shall establish an entity within the
Institute to augment ongoing efforts to advance new
technologies in cancer research, support the national
collection of tissues for cancer research purposes, and ensure
the quality of tissue collection.
``(2) Goals.--The entity established under paragraph (1)
shall--
``(A) be designed to expand the access of
researchers to biospecimens for cancer research
purposes;
``(B) establish uniform standards for the handling
and preservation of patient tissue specimens by
entities participating in the network established under
paragraph (3);
``(C) require adequate annotation of all relevant
clinical data while assuring patient privacy;
``(D) facilitate the linkage of public and private
entities into the national network under paragraph (3);
``(E) provide for the linkage of cancer registries
to other administrative Federal Government data
sources, including the Centers for Medicare & Medicaid
Services, the Social Security Administration, and the
Centers for Disease Control and Prevention, with the
goal of understanding the determinants of cancer
treatment, care, and outcomes by allowing economic,
social, genetic, and other factors to be analyzed in an
independent manner; and
``(F) develop strategies to ensure patient rights
and privacy, including an assessment of the regulations
promulgated pursuant to HIPAA privacy and security law
(as defined in section 3009(a)(2)), while facilitating
advances in medical research.
``(3) Advancement of new technologies for cancer research
and expansion of cancer biorepository networks.--
``(A) In general.--As part of the entity
established under paragraph (1), the Director of the
Institute shall build upon existing initiatives to
establish an interconnected network of biorepositories
(referred to in this subsection as the `Network') with
consistent, interoperable systems for the collection
and storage of tissues and information, the annotation
of such information, and the sharing of such
information through an interoperable information
system.
``(B) Guidelines.--A biorepository in the Network
that receives Federal funds shall adopt the Institute's
Best Practices for Biospecimen Resources for Institute-
supported biospecimen resources (as published by the
Institute and including any successor guidelines) for
the collection of biospecimens and any accompanying
data.
``(C) Representation.--The composition of any
leadership entity of the Network shall be determined by
the Director of the Institute and shall, at a minimum,
include a representative of--
``(i) private sector entities and
individuals, including cancer researchers and
health care providers;
``(ii) the Centers for Disease Control and
Prevention;
``(iii) the Agency for Healthcare Research
and Quality;
``(iv) the Office of National Coordination
of Health Information Technology;
``(v) the National Library of Medicine;
``(vi) the Office for the Protection of
Research Subjects; and
``(vii) the National Science Foundation.
``(D) Partnerships with tissue source sites.--The
Director of the Institute may enter into contracts with
tissue source sites to acquire data from such sites.
Any such data shall be acquired through the use of
protocols and closely monitored, transparent procedures
within appropriate ethical and legal frameworks.
``(4) Collection of data.--
``(A) Hospitals.--A hospital or ambulatory cancer
center that receives Federal funds shall offer patients
the opportunity to contribute their biospecimens and
clinical data to the entity established under paragraph
(1).
``(B) Clinical trial data.--Clinical trial data
relating to cancer care and treatment shall be provided
to the entity established under paragraph (1).''.
SEC. 4. COMPREHENSIVE AND RESPONSIBLE ACCESS TO RESEARCH, DATA, AND
OUTCOMES.
(a) In General.--Not later than 180 days after the date of the
enactment of this Act, the Director of the Office for Human Research
Protections shall issue guidance to National Institutes of Health
grantees concerning use of the facilitated review process in
conjunction with the central institutional review board of the National
Cancer Institute as the preferred mechanism to satisfy regulatory
requirements to review ethical or scientific issues for all National
Cancer Institute-supported translational and clinical research.
(b) Improved Privacy Standards in Clinical Research.--
(1) Permitted disclosure under the privacy rule.--For
purposes of HIPAA privacy and security law (as referred to in
section 411(f)(2)(F) of the Public Health Service Act, as
amended by section 3), a covered entity (as defined for
purposes of such law) shall be in compliance with such law
relating to the disclosure of de-identified patient information
if such disclosure is--
(A) pursuant to a waiver that had been granted by
an institutional review board or privacy board relating
to such disclosure; and
(B) in the case that such entity is a research
institution, the entity informs patients when they make
first patient contact with the entity that the entity
is a research institution that may conduct research
using their de-identified medical records.
(2) Synchronization of standards.--
(A) In general.--The Secretary of Health and Human
Services shall study the advantages and disadvantages
of the synchronization of the standards for research
under the Common Rule (under part 46 of title 45, Code
of Federal Regulations) and the HIPAA privacy and
security law (as described in section 411(f)(2)(F) of
the Public Health Service Act, as amended by section 3)
in order to determine the appropriate data elements
that should be omitted under the strict de-
identification standards relating to personal
information.
(B) Review of recommendations.--In carrying out
subparagraph (A), the Secretary of Health and Human
Services shall conduct a review of recommendations made
by the Advisory Committee on Human Research Protections
as well as recommendations from the appropriate
leadership of the National Committee on Vital and
Health Statistics.
(C) Additional areas.--In carrying out subparagraph
(A), the Secretary of Health and Human Services shall--
(i) make recommendations concerning the
conduct of international research to determine
the boundaries and applications of
extraterritoriality under such HIPAA privacy
and security law; and
(ii) include biorepository storage
information when obtaining patient consent.
(D) Report.--Not later than 180 days after the date
of the enactment of this Act, the Secretary of Health
and Human Services shall submit to the appropriate
committee of Congress, a report concerning the
recommendations made under this paragraph.
(3) Application of hipaa privacy and security law to
external researchers.--
(A) In general.--Notwithstanding any other
provision of law, the HIPAA privacy and security law
(as described in section 411(f)(2)(F) of the Public
Health Service Act, as amended by section 3) shall
apply to external researchers.
(B) Definition.--
(i) In general.--In this paragraph, the
term ``external researcher'' means a researcher
who is on the staff of a covered entity (as
defined for purposes of the HIPAA privacy and
security law) but who is not actually employed
by such covered entity.
(ii) Internal and external researchers.--
With respect to determining the distinction of
whether or not a researcher has the ability to
use protected health information under the
provisions of this paragraph, such
determination shall be based on whether the
covered entity involved exercises effective
control over that researcher's activities. For
purposes of the preceding sentence, effective
control may include membership and privileges
of staff or the ability to terminate staff
membership or discipline staff.
(c) Liability.--The Director of the Office of Human Research
Protection, the Director of the National Institutes of Health, and the
Director of the National Cancer Institute shall issue guidance for
entities awarded grants by such Federal agencies to provide instruction
on how such entities may best address concerns or issues relating to
the liability that institutions or researchers may incur as a result of
using the facilitated review process of the Central Institutional
Review Board Initiative, as sponsored by the National Cancer Institute.
SEC. 5. ENHANCED FOCUS AND REPORTING ON CANCER RESEARCH.
Part C of title IV of the Public Health Service Act (42 U.S.C. 285
et seq.) is amended by inserting after section 417A the following:
``SEC. 417B. ENHANCED FOCUS AND REPORTING ON CANCER RESEARCH.
``(a) Annual Independent Report.--
``(1) In general.--The Director of the Institute shall
complete an annual independent report that shall be submitted
to Congress on the same date that the annual budget estimate
described in section 413(b)(9) is submitted to the President.
``(2) Contents of report.--
``(A) Cancer categories.--The report required under
paragraph (1) shall address the following categories of
cancer:
``(i) Cancers that result in a 5-year
survival rate of less than 50 percent.
``(ii) Cancers in which the incidence rate
is fewer than 15 cases per 100,000 people, or
fewer than 40,000 new cases per year.
``(B) Information.--With regard to each of the
categories of cancer described in subparagraph (A), the
report shall contain information regarding--
``(i) a strategic plan for reducing the
mortality rate for the annual year, including
specific research areas of interest and budget
amounts;
``(ii) identification of any barriers to
implementing the strategic plan described in
clause (i) for the annual year;
``(iii) if the report for the prior year
contained a strategic plan described in clause
(i), an assessment of the success of such plan;
``(iv) the total amount of grant funding,
including the total dollar amount awarded per
grant and per funding year, under--
``(I) the National Cancer
Institute; and
``(II) the National Institutes of
Health;
``(v) the percentage of grant applications
favorably reviewed by the Institute that the
Institute funded in the previous annual year;
``(vi) the total number of grant
applications, with greater than 50 percent
relevance to each of the categories of cancer
described in subparagraph (A), received by the
Institute for awards in the previous annual
year;
``(vii) the total number of grants awarded,
with greater than 50 percent relevance to each
of the categories of cancer described in
subparagraph (A), for the previous annual year
and the number of awards per grant type,
including the Common Scientific Outline
designation specific to each such grant; and
``(viii) the total number of primary
investigators that received grants from the
Institute for projects with greater than 50
percent relevance to each of the categories of
cancer described in paragraph (1), including
the total number of awards granted to
experienced investigators and the total number
of awards granted to investigators receiving
their first grant from the National Institutes
of Health.
``(3) Definition.--In this section, the term `annual year'
means the year for which the strategic plan described in
paragraph (2)(B)(i) applies, which shall be the same fiscal
year for which the Director of the Institute submits the annual
budget estimate described in section 413(b)(9) for that year.
``(b) Grant Program.--
``(1) In general.--The Director of the Institute, in
cooperation with the Director of the Fogarty International
Center for Advanced Study in the Health Sciences and the
Directors of other Institutes, as appropriate, shall award
grants to researchers to conduct research regarding cancers for
which--
``(A) the incidence is fewer than 40,000 new cases
per year; and
``(B) the 5-year survival rate is less than 50
percent.
``(2) Prioritization.--In awarding grants for research
regarding cancers described in paragraph (1)(A), the Director
of the Institute shall give priority to collaborative research
projects between adult and pediatric cancer research, with
preference for projects building upon existing multi-
institutional research infrastructures.
``(3) Tissue samples.--
``(A) In general.--Except as provided in
subparagraph (B), the Director of the Institute shall
require each recipient receiving a grant under this
subsection to submit tissue samples to designated tumor
banks.
``(B) Waiver.--The Director of the Institute may
grant a waiver of the requirement described in
subparagraph (A) to a recipient who receives a grant
for research described in paragraph (1)(B) and who
submits an application for such waiver to the Director
of the Institute, in the manner in which such Director
may require.''.
SEC. 6. CONTINUING ACCESS TO CARE FOR PREVENTION AND EARLY DETECTION.
(a) Preventive Health Measures With Respect to Colorectal Cancer.--
Part B of title III of the Public Health Service Act (42 U.S.C. 243 et
seq.) is amended by inserting after section 317T the following new
section:
``SEC. 317U. PREVENTIVE HEALTH MEASURES WITH RESPECT TO COLORECTAL
CANCER.
``(a) Grant Program Authorization.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention, may
make grants to eligible entities for the purpose of carrying
out a program described in subsection (b). An eligible entity
that is a recipient of a grant under this subsection may use
such grant to carry out such programs directly or through
grants to, or contracts with, public and not-for-profit private
entities.
``(2) Eligible entity defined.--For purposes of this
section, the term `eligible entity' includes the following:
``(A) A State, including, in addition to the
several States, the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Northern Mariana
Islands, the Virgin Islands, American Samoa, and the
Trust Territory of the Pacific Islands.
``(B) An Indian tribe or tribal organization, as
such terms are defined in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(b) Programs Described.--
``(1) In general.--Subject to paragraph (2), a program
described in this subsection is a program for planning or
implementing each of the following:
``(A) Providing screenings for colorectal cancer to
individuals who--
``(i) are 50 years of age or older; or
``(ii)(I) are under 50 years of age; and
``(II) are at high risk for such cancer, as
determined in accordance with subsection
(e)(2).
``(B) Providing appropriate case management and
referrals for medical treatment of individuals screened
pursuant to subparagraph (A).
``(C) Ensuring (directly or through coordination or
an arrangement with health care providers or programs)
the full continuum of follow-up and cancer care for
individuals so screened, including appropriate follow-
up for abnormal tests, diagnostic services, therapeutic
services, and treatment of detected cancers and
management of unanticipated medical complications.
``(D) Carrying out activities to improve the
education, training, and skills of health professionals
(including allied health professionals) in the
detection and control of colorectal cancer, which
activities are carried out pursuant to the
participation of the health professionals in the
program.
``(E) Establishing mechanisms through which the
eligible entity involved can monitor the quality of
screening and diagnostic follow-up procedures for
colorectal cancer, including the interpretation of such
procedures.
``(F) Evaluating the activities described in this
subsection through appropriate surveillance and program
monitoring activities.
``(G) Developing and disseminating findings derived
through such evaluations and the collection of data on
outcomes.
``(H) Developing and disseminating public
information and education programs for the detection
and control of colorectal cancer and promoting the
benefits of receiving screenings through this program.
``(2) Supplement not supplant.--In the case of an eligible
entity that implements a universal colorectal screening program
under which the eligible entity makes available funds for
activities described in subparagraph (A), (B), or (C) of
paragraph (1), such entity shall be able to receive grant funds
under subsection (a) only for purposes of--
``(A) carrying out those activities under this
subsection that are not so funded; or
``(B) supplementing (and not supplanting) funds
made available by the entity for such funded program.
``(c) Priority for Low-Income, Uninsured, and Underinsured
Individuals.--A grant may be made under subsection (a) to an eligible
entity only if the eligible entity agrees that, in providing screenings
under subsection (b)(1)(A), the eligible entity will give priority to
low-income individuals who lack adequate coverage, as determined by the
Secretary, under health insurance and health plans with respect to
screenings for colorectal cancer.
``(d) Special Consideration for Certain Applicants.--In making
grants under subsection (a) for a fiscal year, the Secretary shall give
special consideration to the following eligible entities:
``(1) In the case of services under such subsection for
women, to such entities that, for such year, are grantees under
title XV.
``(2) In the case of services under such subsection for
men, to such entities that, for such year, are grantees under
section 317D.
``(3) To such entities that coordinate with other Federal,
State, and local colorectal cancer programs.
``(4) To such entities with an existing program to provide
cancer screening to individuals.
``(e) Use of Certain Standards Under Medicare Program.--A grant may
be made under subsection (a) to an eligible entity only if the eligible
entity provides, as applicable, assurances as follows:
``(1) Screenings under subsection (b)(1)(A) will be carried
out as preventive health measures in accordance with evidence-
based screening guidelines and procedures and in accordance
with the standard of care required for purposes of title XVIII
of the Social Security Act to carry out colorectal screening
tests defined in section 1861(pp)(1) of such Act.
``(2) An individual will be considered high risk for
purposes of subsection (b)(1)(A)(ii) only if the individual is
high risk within the meaning of section 1861(pp)(2) of such
Act.
``(3) The payment made from the grant for a screening
procedure under subsection (b)(1)(A) will not exceed the amount
that would be paid under part B of title XVIII of such Act if
payment were made under such part for furnishing the procedure
to an individual enrolled under such part.
``(f) Relationship to Items and Services Under Other Programs.--A
grant under subsection (a) may be made to an eligible entity only if
the eligible entity, as applicable, provides assurances that the grant
will not be expended to make payment for any item or service to the
extent that payment has been made, or can reasonably be expected to be
made, with respect to such item or service--
``(1) under any State compensation program, under an
insurance policy, or under any Federal or State health benefits
program; or
``(2) by an entity that provides health services on a
prepaid basis.
``(g) Records and Audits.--A grant under subsection (a) may be made
to an eligible entity only if the eligible entity provides assurances
that the eligible entity will--
``(1) establish such fiscal control and fund accounting
procedures as may be necessary to ensure proper disbursal of,
and accounting for, amounts received under subsection (a); and
``(2) upon request, provide records maintained pursuant to
paragraph (1) to the Secretary or the Comptroller General of
the United States for purposes of auditing the expenditures of
the grant by the eligible entity.
``(h) Requirement of Matching Funds.--
``(1) In general.--The Secretary may not make a grant under
subsection (a) to an eligible entity for a fiscal year unless
the eligible entity agrees, with respect to the costs to be
incurred by the eligible entity for such fiscal year in
carrying out the activities described in subsection (b), to
make available non-Federal contributions (in cash or in kind
under paragraph (2)) toward such costs in an amount equal to
not less than $1 for each $3 of Federal funds provided in the
grant for such fiscal year. Such contributions may be made
directly or through donations from public or private entities.
``(2) Determination of amount of non-federal
contribution.--
``(A) In general.--Non-Federal contributions
required in paragraph (1) may be in cash or in kind,
fairly evaluated, including equipment or services (and
excluding indirect or overhead costs). Amounts provided
by the Federal Government, or services assisted or
subsidized to any significant extent by the Federal
Government, may not be included in determining the
amount of such non-Federal contributions.
``(B) Maintenance of effort.--In making a
determination of the amount of non-Federal
contributions for purposes of paragraph (1), the
Secretary may include only non-Federal contributions in
excess of the average amount of non-Federal
contributions made by the eligible entity involved
toward the activities described in subsection (b) for
the 2-year period preceding the first fiscal year for
which the eligible entity is applying to receive a
grant under subsection (a).
``(C) Inclusion of relevant non-federal
contributions for medicaid.--In making a determination
of the amount of non-Federal contributions for purposes
of paragraph (1), the Secretary shall, subject to
subparagraphs (A) and (B) of this paragraph, include
any non-Federal amounts expended pursuant to title XIX
of the Social Security Act by the eligible entity
involved toward the activities described in
subparagraphs (A) and (B) of subsection (b)(1).
``(i) Additional Requirements.--
``(1) Limitation on administrative expenses.--The Secretary
may not make a grant to an eligible entity under subsection (a)
unless the eligible entity provides assurances that not more
than 10 percent of the grant will be expended for
administrative expenses with respect to the activities funded
by the grant.
``(2) Statewide provision of services.--
``(A) In general.--Subject to subparagraph (B), the
Secretary may not make a grant under subsection (a) to
an eligible entity unless the eligible entity provides
assurances that any program funded by such grant will
be made available throughout the State, including
availability to members of an Indian tribe or tribal
organization (as such terms are defined in section 4 of
the Indian Self-Determination and Education Assistance
Act).
``(B) Waiver.--The Secretary may waive the
requirement under subparagraph (A) for an eligible
entity if the Secretary determines that compliance by
the eligible entity with the requirement would result
in an inefficient allocation of resources with respect
to carrying out the purposes described in subsection
(a).
``(j) Technical Assistance and Provision of Supplies and Services
in Lieu of Grant Funds.--
``(1) Technical assistance.--The Secretary may provide
training and technical assistance with respect to the planning,
development, and operation of any program funded by a grant
under subsection (a). The Secretary may provide such technical
assistance directly to eligible entities or through grants to,
or contracts with, public and private entities.
``(2) Provision of supplies and services in lieu of grant
funds.--
``(A) In general.--Subject to subparagraph (B),
upon the request of an eligible entity receiving a
grant under subsection (a), the Secretary for the
purpose of aiding the eligible entity to carry out a
program under subsection (b)--
``(i) may provide supplies, equipment, and
services to the eligible entity; and
``(ii) may detail to the eligible entity
any officer or employee of the Department of
Health and Human Services.
``(B) Corresponding reduction in payments.--With
respect to a request made by an eligible entity under
subparagraph (A), the Secretary shall reduce the amount
of payments made under the grant under subsection (a)
to the eligible entity by an amount equal to the fair
market value of any supplies, equipment, or services
provided by the Secretary and the costs of detailing
personnel (including pay, allowances, and travel
expenses) under subparagraph (A). The Secretary shall,
for the payment of expenses incurred in complying with
such request, expend the amounts withheld.
``(k) Reports.--A grant under subsection (a) may be made only if
the applicant involved agrees to submit to the Secretary such reports
as the Secretary may require with respect to the grant.
``(l) Authorization of Appropriations.--
``(1) In general.--For the purpose of carrying out this
section, there are authorized to be appropriated--
``(A) for fiscal year 2012, $50,000,000;
``(B) for fiscal year 2013, $75,000,000;
``(C) for fiscal year 2014, $150,000,000;
``(D) for fiscal year 2015, $200,000,000; and
``(E) for fiscal year 2016, $250,000,000.
``(2) Set-aside for technical assistance and provision of
supplies and services.--Of the amount appropriated under
paragraph (1) for a fiscal year, the Secretary shall reserve
not to exceed 20 percent for carrying out subsection (j).''.
(b) Optional Medicaid Coverage of Certain Persons Screened and
Found To Have Colorectal Cancer.--
(1) Coverage as optional categorically needy group.--
(A) In general.--Section 1902(a)(10)(A)(ii) of the
Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)), as
amended by section 2402(d)(1) of the Patient Protection
and Affordable Care Act (Public Law 111-148) is further
amended--
(i) in subclause (XXI), by striking ``or''
at the end;
(ii) in subclause (XXII), by adding ``or''
at the end; and
(iii) by adding at the end the following:
``(XXIII) who are described in
subsection (kk) (relating to certain
persons screened and found to need
treatment from complications from
screening or have colorectal
cancer);''.
(B) Group described.--Section 1902 of the Social
Security Act (42 U.S.C. 1396a), as amended by section
211(a)(1)(A)(ii) of Public Law 111-3, section
5006(b)(1) of division B of Public Law 111-5, and
section 1202 of the Patient Protection and Affordable
Care Act (Public Law 111-148), is further amended by
adding at the end the following:
``(kk) Individuals described in this subsection are individuals
who--
``(1) are not described in subsection (a)(10)(A)(i);
``(2) have not attained age 65;
``(3) have been screened for colorectal cancer and need
treatment for complications due to screening or colorectal
cancer; and
``(4) are not otherwise covered under creditable coverage,
as defined in section 2704(c) of the Public Health Service
Act.''.
(C) Limitation on benefits.--Section 1902(a)(10) of
the Social Security Act (42 U.S.C. 1396a(a)(10)) is
amended in the matter following subparagraph (G)--
(i) by striking ``(XV)'' and inserting ``,
(XV)'';
(ii) by striking ``and (XVI) the medical
assistance'' and inserting ``, (XVI) the
medical assistance'';
(iii) by striking ``and (XVI) if an
individual'' and inserting ``, (XVII) if an
individual''; and
(iv) by inserting ``, and (XVIII) the
medical assistance made available to an
individual described in subsection (kk) who is
eligible for medical assistance only because of
subparagraph (A)(10)(ii)(XXIII) shall be
limited to medical assistance provided during
the period in which such an individual requires
treatment for complications due to screening or
colorectal cancer'' before the semicolon.
(D) Conforming amendments.--Section 1905(a) of the
Social Security Act (42 U.S.C. 1396d(a)), as amended by
section 2402(d)(2)(B) of the Patient Protection and
Affordable Care Act (Public Law 111-148) is further
amended in the matter preceding paragraph (1)--
(i) in clause (xvi), by striking ``or'' at
the end;
(ii) in clause (xvii), by adding ``or'' at
the end; and
(iii) by inserting after clause (xvii) the
following:
``(xviii) individuals described in section
1902(kk),''.
(2) Presumptive eligibility.--
(A) In general.--Title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.) is amended by inserting
after section 1920C, as inserted by section 2303(b) of
the Patient Protection and Affordable Care Act (Public
Law 111-148), the following:
``optional application of presumptive eligibility provisions for
certain persons with colorectal cancer
``Sec. 1920D. A State may elect to apply the provisions of section
1920B to individuals described in section 1902(kk) (relating to certain
colorectal cancer patients) in the same manner as such section applies
to individuals described in section 1902(aa) (relating to certain
breast or cervical cancer patients).''.
(B) Conforming amendments.--
(i) Section 1902(a)(47) of the Social
Security Act (42 U.S.C. 1396a(a)(47)), as
amended by section 2303(b)(2) of the Patient
Protection and Affordable Care Act (Public Law
111-148), is amended--
(I) in subparagraph (A)--
(aa) by striking ``and''
after ``section 1920'' and
inserting a comma;
(bb) by striking ``and''
after ``with such section''
each place it occurs and
inserting a comma each such
place; and
(cc) by inserting before
the semicolon at the end the
following: ``, and provide for
making medical assistance
available to individuals
described in section 1920D
during a presumptive
eligibility period in
accordance with such section'';
and
(II) in subparagraph (B), by
striking ``or 1920C'' and inserting
``1920C, or 1920D''.
(ii) Section 1903(u)(1)(d)(v) of such Act
(42 U.S.C. 1396b(u)(1)(d)(v)), as amended by
section 2202(b) of the Patient Protection and
Affordable Care Act (Public Law 111-148), is
further amended--
(I) by striking ``or for'' and
inserting ``, for''; and
(II) by inserting before the period
the following: ``, or for medical
assistance provided to an individual
described in section 1920D during a
presumptive eligibility period under
such section''.
(3) Enhanced match.--The first sentence of section 1905(b)
of the Social Security Act (42 U.S.C. 1396d(b)) is amended--
(A) by striking ``and'' before ``(4)''; and
(B) by inserting before the period at the end the
following: ``, and (5) the Federal medical assistance
percentage shall be equal to the enhanced FMAP
described in section 2105(b) with respect to medical
assistance provided to individuals who are eligible for
such assistance only on the basis of section
1902(a)(10)(A)(ii)(XXIII)''.
(4) Effective date.--The amendments made by this section
apply to medical assistance for items and services furnished on
or after October 1, 2011, without regard to whether final
regulations to carry out such amendments have been promulgated
by such date.
(c) Mobile Medical Van Grant Program.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary''), acting
through the Administrator of the Health Resources and Services
Administration, shall award grants to eligible entities for the
development and implementation of a mobile medical van program
that shall provide cancer screening services that are
recommended with a grade of A or B by the United States
Preventative Services Task Force of the Agency for Healthcare
Research and Quality to communities that are underserved and
suffer from barriers to access to high quality cancer
prevention care.
(2) Eligible entities.--To be eligible to receive a grant
under paragraph (1), and entity shall--
(A) be a consortium of public and private entities
(such as academic medical centers, universities,
hospitals, and non profit organizations);
(B) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary shall require, including--
(i) a description of the manner in which
the applicant intends to use funds received
under the grant;
(ii) a description of the manner in which
the applicant will evaluate the impact and
effectiveness of the health care services
provided under the program carried out under
the grant;
(iii) a plan for sustaining activities and
services funded under the grant after Federal
support for the program has ended;
(iv) a plan for the referral of patients to
other health care facilities if additional
services are needed;
(v) a protocol for the transfer of patients
in the event of a medical emergency;
(vi) a plan for advertising the services of
the mobile medical van to the communities
targeted for health care services; and
(vii) a plan to educate patients about the
availability of federally funded medical
insurance programs for which such patients, or
their children, may qualify; and
(C) agree that amounts under the grant will be used
to supplement, and not supplant, other funds (including
in-kind contributions) used by the entity to carry out
activities for which the grant is awarded.
(3) Use of funds.--An entity shall use amounts received
under a grant under this subsection to do any of the following:
(A) Purchase or lease a mobile medical van.
(B) Make repairs and provide maintenance for a
mobile medical van.
(C) Purchase or lease telemedicine equipment that
is reasonable and necessary to operate the mobile
medical van.
(D) Purchase medical supplies and medication that
are necessary to provide health care services on the
mobile medical van.
(E) Retain medical professionals with expertise and
experience in providing cancer screening services to
underserved communities to provide health care services
on the mobile medical van.
(4) Matching requirements.--
(A) In general.--With respect to the costs of a
mobile medical van program to be carried out under a
grant under this subsection, the grantee shall make
available (directly or through donations from public or
private entities) non-Federal contributions toward such
costs in an amount that is not less than the amount of
the Federal funds provided under this grant.
(B) Determination of amount contributed.--Non-
Federal contributions required under subparagraph (A)
may be in cash or in-kind, fairly evaluated, including
plant, equipment, or services. Amounts provided by the
Federal Government, or services assisted or subsidized
to any significant extent by the Federal Government,
may not be included in determining the amount of such
non-Federal contributions.
(C) Waiver.--The Secretary may waive the
requirement established in subparagraph (A) if--
(i) the Secretary determines that such
waiver is justified; and
(ii) the Secretary publishes the rationale
for such waiver in the Federal Register.
(D) Return of funds.--An entity that receives a
grant under this section that fails to comply with
subparagraph (A) shall return to the Secretary an
amount equal to the difference between--
(i) the amount provided under the grant;
and
(ii) the amount of matching funds actually
provided by the grantee.
(5) Considerations in making grants.--In awarding grants
under this subsection, the Secretary shall give preference to
eligible entities--
(A) that will provide cancer screening services in
underserved areas; and
(B) that on the date on which the grant is awarded,
have a mobile medical van that is nonfunctioning due to
the need for necessary mechanical repairs.
(6) Limitation on duration and amount of grant.--A grant
under this subsection shall be for a 2-year period, except that
the Secretary may waive such limitation and extend the grant
period by an additional year. The amount awarded to an entity
under such grant for a fiscal year shall not exceed $200,000.
(7) Evaluation.--Not later than 1 year after the date on
which a grant awarded to an entity under this subsection
expires, the entity shall submit to the Secretary the results
of an evaluation to be conducted by the entity concerning the
effectiveness of the program carried out under the grant.
(8) Report.--Not later than 18 months after grants are
first awarded under this subsection, the Secretary shall submit
to the Committee on Appropriations of the Senate and the
Committee on Appropriations of the House of Representatives a
report on the results of activities carried out with amounts
received under such grants.
(9) Definitions.--In this section:
(A) Mobile medical van.--The term ``mobile medical
van'' means a mobile vehicle that is equipped to
provide non-urgent medical services and health care
counseling to patients in underserved areas.
(B) Underserved area.--The term ``underserved
area'', with respect to the location of patients
receiving medical treatment, means a ``medically
underserved community'' as defined in section 799B(6)
of the Public Health Service Act (42 U.S.C. 295p(6)).
SEC. 7. EARLY RECOGNITION AND TREATMENT OF CANCER THROUGH USE OF
BIOMARKERS.
(a) Promotion of the Discovery and Development of Biomarkers.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in
consultation with appropriate Federal agencies including the
National Institutes of Health, the National Cancer Institute,
the Food and Drug Administration, and the National Institute of
Standards and Technology, and extramural experts as
appropriate, shall establish and coordinate a program to award
contracts to eligible entities to support the development of
innovative biomarker discovery technologies. All activities
under this section shall be consistent with and complement the
ongoing efforts of the Oncology Biomarker Qualification
Initiative and the Reagan-Udall Foundation of the Food and Drug
Administration.
(2) Lead agency.--Not later than 2 years after the date of
enactment of this Act, the Secretary shall designate a lead
Federal agency to administer and coordinate the program
established under paragraph (1).
(3) Eligibility.--To be eligible to enter into a contract
under paragraph (1), an entity shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require. Such information
shall be sufficient to enable the Secretary to--
(A) promote the scientific review of such contracts
in a timely fashion; and
(B) contain the capacity to perform the necessary
analysis of contract applications, including
determinations as to the intellectual expertise of
applicants.
(4) Requirement.--In awarding contracts under this
subsection, the lead agency shall consider whether the research
involved will result in the development of quantifiable
biomarkers of cell signaling pathways that will have the
broadest applicability across different tumor types or
different diseases.
(5) International consortia.--The Secretary shall designate
one of the Federal entities described in paragraph (1) to
establish an international private-public consortia to develop
and share methods and precompetitive data on the validation and
qualification of cancer biomarkers for specific uses.
(b) Clinical Study Guidelines.--Not later than 1 year after the
date of enactment of this Act, the Commissioner of Food and Drugs, the
Administrator of the Centers for Medicare & Medicaid Services, and the
Director of the National Cancer Institute shall jointly develop
guidelines for the conduct of clinical studies designed to generate
clinical data relating to cancer care and treatment biomarkers that is
adequate for review by each such Federal entity. Such guidelines shall
be designed to assist in optimizing clinical study design and to
strengthen the evidence base for evaluations of studies related to
cancer biomarkers.
(c) Demonstration Project.--
(1) In general.--The Secretary, in consultation with the
Commissioner of Food and Drugs and the Administrator of the
Agency for Healthcare Research and Quality, shall carry out a
demonstration project that provides for a limited regional
assessment of biomarker tests to facilitate the controlled and
limited use of a risk assessment measure with an intervention
that may consist of a biomarker test.
(2) Procedures.--As a component of the demonstration
project under paragraph (1), the Commissioner of Food and
Drugs, in consultation with other relevant agencies, shall
establish procedures that independent research entities shall
follow in conducting high quality assessments of efficacy of
biomarker tests.
(d) Postmarket Surveillance.--The Food and Drug Administration and
the Centers for Medicare & Medicaid Services shall assess quality and
accuracy of biomarker tests through appropriate postmarket surveillance
and other means, as necessary and appropriate to the mission of each
such agency.
(e) Establishment and Operation of Research Centers for the Study
of Biomarkers for Risk Stratification and Early Detection of Cancers
With Survival Rates of Less Than 50 Percent.--
(1) In general.--The Director of the National Cancer
Institute, in consultation with the directors of other relevant
institutes and centers of the National Institutes of Health and
the Department of Defense, shall enter into cooperative
agreements with, or make grants to, public or nonprofit
entities to establish and operate centers to conduct research
on biomarkers for use in risk stratification for, and the early
detection and screening of, cancer with a five year survival
rate of less than 50 percent. Each center shall be known as an
Early Detection Biomarker Center of Excellence.
(2) Research funded.--Federal payments made under a
cooperative agreement or grant under paragraph (1) may be used
for research on any of the following:
(A) The development and characterization of new
biomarkers, and the refinement of existing biomarkers,
for cancers with a five-year survival rate of less than
50 percent.
(B) The clinical and laboratory validation of such
biomarkers, including technical development,
standardization of assay methods, sample preparation,
reagents, reproducibility, portability, and other
refinements.
(C) The development and implementation of clinical
and epidemiological research on the utilization of
biomarkers for the early detection and screening of
cancers with a five-year survival rate of less than 50
percent.
(D) The development and implementation of new
repositories for additional tissue, urine, serum, and
other biological specimens (such as ascites and pleural
fluids).
(E) Other areas identified by the Director, in
consultation with the research community.
(3) Collaboration.--Any center funded under paragraph (1)
shall demonstrate their intent to collaborate with current
National Cancer Institute funded, sponsored, or funded and
sponsored initiatives regarding risk stratification, early
detection, and screening of cancer, including but not limited
to the early detection research networks, the Cancer Genomic
Atlas, and therapeutic biomarker initiatives, where applicable.
(4) Availability of banked specimens.--The Director of the
Institute shall make available for research conducted under
this section banked serum and tissue specimens from clinical
research regarding these cancers that was funded by the
Department of Health and Human Services.
(5) Report.--Not later than the end of fiscal year 2011,
and annually thereafter, the Director of the Institute shall
submit a report to the Congress on the cooperative agreements
entered into and the grants made under this subsection, the
progress of these grants, and recommendations for any program
improvements that would speed discovery.
(6) Biomarker clinical trial committee.--The Director of
the Institute shall establish an Biomarker Clinical Trial
Committee (in this section referred to as the ``Committee''),
for each cancer with biomarker centers of excellence, to assist
the Director to design and implement one or more national
clinical trial, in accordance with this subsection, to
determine the utility of using biomarkers validated pursuant to
the research conducted under this subsection for risk
stratification for, and early detection and screening of,
cancers with a five-year survival rate of less than 50 percent.
(7) Authorization of appropriations.--For the purpose of
carrying out this subsection, there are authorized to be
appropriated $25,000,000 for each of the fiscal years 2011
through 2013, and such sums as may be necessary for each of the
fiscal years 2014 through 2020. If for two consecutive years
funds are not appropriated to carry out this subsection, this
subsection will automatically sunset. Such authorization of
appropriations is in addition to any other authorization of
appropriations that is available for such purpose.
(f) Sense of the House of Representatives.--It is the sense of the
House of Representatives that the Commissioner of Food and Drugs and
the Director of the National Cancer Institute should continue to place
high priority upon the identification and use of biomarkers to--
(1) determine the role of genetic polymorphisms on drug
activity and toxicity;
(2) establish effective strategies for selecting patients
for treatment with specific drugs; and
(3) identify early biomarkers of clinical benefit.
(g) Definition.--In this section, the term ``biomarker'' means any
characteristic that can be objectively measured and evaluated as an
indicator of normal biologic processes, pathogenic processes, or
pharmacological responses to therapeutic interventions.
SEC. 8. EXTENDING COVERAGE UNDER MEDICAID OF COUNSELING AND
PHARMACOTHERAPY FOR CESSATION OF TOBACCO USE.
(a) Services Described.--Section 1905 of the Social Security Act
(42 U.S.C. 1396d) is amended--
(1) in subsection (a)(4)(D), as inserted by section
4107(a)(1)(B) of the Patient Protection and Affordable Care Act
(Public Law 111-148), by striking ``by pregnant women''; and
(2) in subsection (bb), as added by section 4107(a)(2) of
the Patient Protection and Affordable Care Act (Public Law 111-
148)--
(A) in paragraph (1)--
(i) by striking ``the term `counseling and
pharmacotherapy for cessation of tobacco use by
pregnant women''' and inserting ``the term
`counseling and pharmacotherapy for cessation
of tobacco use'''; and
(ii) by striking ``by pregnant women who
use tobacco products'' and inserting ``by
individuals who use tobacco products''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``with
respect to pregnant women''; and
(ii) in subparagraph (B), by striking ``by
pregnant women''.
(b) Dropping Exception From Medicaid Prescription Drug Coverage for
Tobacco Cessation Medications.--Section 1927(d)(2)(F) of the Social
Security Act (42 U.S.C. 1396r-8(d)(2)(F)), as amended by section
4107(b) of the Patient Protection and Affordable Care Act (Public Law
111-148), is further amended by striking ``in the case of pregnant
women''.
(c) Effective Date.--The amendments made by this section shall take
effect 1 year after the date of enactment of this Act and apply to
medical assistance provided under a State Medicaid program on or after
such date.
SEC. 9. COMPREHENSIVE CANCER CARE AND COVERAGE UNDER MEDICARE.
(a) Coverage of Routine Costs Associated With Clinical Trials Under
Medicare.--
(1) Coverage under part a.--Section 1814 of the Social
Security Act (42 U.S.C. 1395f) is amended by adding at the end
the following new subsection:
``(m) Coverage of Routine Costs Associated With Clinical Trials.--
The Secretary shall not exclude from payment for items and services
provided under a clinical trial payment for coverage of routine costs
of care (as defined by the Secretary) furnished to an individual
entitled to benefits under this part who participates in such a trial
to the extent the Secretary provides payment for such costs as of the
date of enactment of this subsection.''.
(2) Coverage under part b.--Section 1833(w) of the Social
Security Act (42 U.S.C. 1395l(w)), as added by section 184 of
the Medicare Improvements for Patients and Providers Act of
2008 (Public Law 110-275), is amended--
(A) by striking ``Payment.--The Secretary'' and
inserting ``Payment and Coverage of Routine Costs
Associated With Clinical Trials.--
``(1) Methods of payment.--Subject to paragraph (2), the
Secretary''; and
(B) by adding at the end the following new
paragraph:
``(2) Coverage of routine costs associated with clinical
trials.--The Secretary shall not exclude from payment for items
and services provided under a clinical trial payment for
coverage of routine costs of care (as defined by the Secretary)
furnished to an individual enrolled under this part who
participates in such a trial to the extent the Secretary
provides payment for such costs as of the date of enactment of
this subsection.''.
(3) Provider outreach.--The Secretary of Health and Human
Services, acting through the Administrator of the Centers for
Medicare & Medicaid Services, shall conduct an outreach
campaign to providers of services and suppliers under the
Medicare program under title XVIII of the Social Security Act
regarding coverage of routine costs of care furnished to
Medicare beneficiaries participating in clinical trials in
accordance with sections 1814(m) and 1833(w)(2) of the Social
Security Act (as added by paragraphs (1) and (2),
respectively).
(b) Coverage of Cancer Care Planning Services.--
(1) In general.--Section 1861 of the Social Security Act,
as amended by section 4103 of the Patient Protection and
Affordable Care Act (Public Law 111-148), is amended--
(A) in subsection (s)(2)--
(i) by striking ``and'' at the end of
subparagraph (EE);
(ii) by adding ``and'' at the end of
subparagraph (FF); and
(iii) by adding at the end the following
new subparagraph:
``(GG) comprehensive cancer care planning services (as
defined in subsection (iii));''; and
(B) by adding at the end the following new
subsection:
``Comprehensive Cancer Care Planning Services
``(iii)(1) The term `comprehensive cancer care planning services'
means--
``(A) with respect to an individual who is
diagnosed with cancer, the development of a plan of
care that--
``(i) details, to the greatest extent
practicable, all aspects of the care to be
provided to the individual, with respect to the
treatment of such cancer, including any
curative treatment and comprehensive symptom
management (such as palliative care) involved;
``(ii) is furnished in written form to the
individual in person within a period specified
by the Secretary that is as soon as practicable
after the date on which the individual is so
diagnosed;
``(iii) is furnished, to the greatest
extent practicable, in a form that
appropriately takes into account cultural and
linguistic needs of the individual in order to
make the plan accessible to the individual; and
``(iv) is in accordance with standards
determined by the Secretary to be appropriate;
``(B) with respect to an individual for whom a plan
of care has been developed under subparagraph (A), the
revision of such plan of care as necessary to account
for any substantial change in the condition of the
individual, if such revision--
``(i) is in accordance with clauses (i) and
(iii) of such subparagraph; and
``(ii) is furnished in written form to the
individual within a period specified by the
Secretary that is as soon as practicable after
the date of such revision;
``(C) with respect to an individual who has
completed the primary treatment for cancer, as defined
by the Secretary (such as completion of chemotherapy or
radiation treatment), the development of a follow-up
cancer care plan that--
``(i) describes the elements of the primary
treatment, including symptom management,
furnished to such individual;
``(ii) provides recommendations for the
subsequent care of the individual with respect
to the cancer involved;
``(iii) is furnished in written form to the
individual in person within a period specified
by the Secretary that is as soon as practicable
after the completion of such primary treatment;
``(iv) is furnished, to the greatest extent
practicable, in a form that appropriately takes
into account cultural and linguistic needs of
the individual in order to make the plan
accessible to the individual; and
``(v) is in accordance with standards
determined by the Secretary to be appropriate;
and
``(D) with respect to an individual for whom a
follow-up cancer care plan has been developed under
subparagraph (C), the revision of such plan as
necessary to account for any substantial change in the
condition of the individual, if such revision--
``(i) is in accordance with clauses (i),
(ii), and (iv) of such subparagraph; and
``(ii) is furnished in written form to the
individual within a period specified by the
Secretary that is as soon as practicable after
the date of such revision.
``(2) The Secretary shall establish standards to carry out
paragraph (1) in consultation with appropriate organizations
representing providers of services related to cancer treatment and
organizations representing survivors of cancer. Such standards shall
include standards for determining the need and frequency for revisions
of the plans of care and follow-up plans based on changes in the
condition of the individual and standards for the communication of the
plan to the patient.''.
(2) Payment.--Section 1833(a)(1) of the Social Security Act
(42 U.S.C. 1395l(a)(1)), as amended by section 10501(g)(3)(B)
of the Patient Protection and Affordable Care Act (Public Law
111-148), is amended by striking ``and'' before ``(Z)'' and
inserting before the semicolon at the end the following: ``,
and (AA) with respect to comprehensive cancer care planning
services described in any of subparagraphs (A) through (D) of
section 1861(iii)(1), the amount paid shall be an amount equal
to the sum of (i) the national average amount under the
physician fee schedule established under section 1848 for a new
patient office consultation of the highest level of service in
the non-facility setting, and (ii) the national average amount
under such fee schedule for a physician certification described
in section 1814(a)(2) for home health services furnished to an
individual by a home health agency under a home health plan of
care''.
(3) Effective date.--The amendments made by this section
shall apply to services furnished on or after the first day of
the first calendar year that begins after the date of the
enactment of this Act.
(c) Medicare Coverage of Comprehensive Cancer Patient Treatment
Education Services.--
(1) In general.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x), as amended by subsection (b)(1), is further
amended--
(A) in subsection (s)(2)--
(i) by striking ``and'' at the end of
subparagraph (FF);
(ii) by adding ``and'' at the end of
subparagraph (GG); and
(iii) by adding at the end the following
new subparagraph:
``(HH) comprehensive cancer patient treatment education
services (as defined in subsection (jjj)(1));''; and
(B) by adding at the end the following new
subsection:
``Comprehensive Cancer Patient Treatment Education Services
``(jjj)(1) The term `comprehensive cancer patient treatment
education services' means--
``(A) in the case of an individual who is diagnosed with
cancer, the provision of a one-hour patient treatment education
session delivered by a registered nurse that--
``(i) is furnished to the individual and the
caregiver (or caregivers) of the individual in advance
of the onset of treatment and to the extent
practicable, is not furnished on the day of diagnosis
or on the first day of treatment;
``(ii) educates the individual and such caregiver
(or caregivers) to the greatest extent practicable,
about all aspects of the care to be furnished to the
individual, informs the individual regarding any
potential symptoms, side-effects, or adverse events,
and explains ways in which side effects and adverse
events can be minimized and health and well-being
maximized, and provides guidance regarding those side
effects to be reported and to which health care
provider the side effects should be reported;
``(iii) includes the provision, in written form, of
information about the course of treatment, any
responsibilities of the individual with respect to
self-dosing, and ways in which to address symptoms and
side-effects; and
``(iv) is furnished, to the greatest extent
practicable, in an oral, written, or electronic form
that appropriately takes into account cultural and
linguistic needs of the individual in order to make the
information comprehensible to the individual and such
caregiver (or caregivers); and
``(B) with respect to an individual for whom a course of
cancer treatment or therapy is materially modified, a one-hour
patient treatment education session described in subparagraph
(A), including updated information on the matters described in
such subparagraph should the individual's oncologic health care
professional deem it appropriate and necessary.
``(2) In establishing standards to carry out paragraph (1), the
Secretary shall consult with appropriate organizations representing
providers of oncology patient treatment education services and
organizations representing people with cancer.''.
(2) Payment.--Section 1833(a)(1) of such Act (42 U.S.C.
1395l(a)(1)), as amended by subsection (b)(2), is further
amended--
(A) by striking ``and'' before ``(AA)''; and
(B) by inserting before the semicolon at the end
the following: ``, and (BB) with respect to
comprehensive cancer patient treatment education
service (as defined in section 1861(jjj)(1)), 150
percent of the payment rate established under section
1848 for diabetes outpatient self-management training
services (as defined in section 1861(qq)), determined
and applied without regard to any coinsurance''.
(3) Coverage.--Section 1862(a)(1) of such Act (42 U.S.C.
1395y(a)(1)), as amended by section 4103(d)(1) of the Patient
Protection and Affordable Care Act (Public Law 111-148), is
amended--
(A) in subparagraph (O), by striking ``and'' at the
end;
(B) in subparagraph (P), by striking the semicolon
at the end and inserting ``, and''; and
(C) by adding at the end the following new
subparagraph:
``(Q) in the case of comprehensive cancer patient treatment
education services (as defined in subsection (jjj)(1)) which
are performed more frequently than is covered under such
section;''.
(4) No impact on payment for other services.--Nothing in
this section shall be construed to affect or otherwise
authorize any reduction or modification, in the Medicare
payment amounts otherwise established for chemotherapy infusion
or injection codes with respect to the calculation and payment
of minutes for chemotherapy teaching or related services.
(5) Effective date.--The amendments made by this section
shall apply to services furnished on or after the first day of
the first calendar year that begins after the date of the
enactment of this Act.
SEC. 10. TARGETED CANCERS PROGRAM.
Subpart 1 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285 et seq.), as amended by section 14, is further amended
by adding at the end the following:
``SEC. 417H. TARGETED CANCERS PROGRAM.
``(a) Establishment.--The Director of the Institute shall establish
a targeted cancers program under which the Director may enter into
agreements and make grants to conduct and coordinate research
activities, with respect to cancers that result in a 5-year survival
rate of less than 50 percent, for purposes of increasing such survival
rate for such cancers. Such program shall include each of the elements
described in subsections (b) through (i).
``(b) Strategic Plan for Progress.--
``(1) In general.--Under the targeted cancers program, the
Director of the Institute, in coordination with relevant
stakeholders and other appropriate Federal agencies, shall
develop a comprehensive plan, including budget amounts, for the
implementation of the research activities described in this
subsection (a) as well as the identification of additional
research activities that will be necessary to increase the
survival for patients diagnosed with a cancer described in such
subsection.
``(2) Report.--Not later than 6 months after the date of
the enactment of this section, the Director of the Institute
shall submit to Congress and make publicly available the
comprehensive plan described in paragraph (1).
``(c) Dedicated Funding for Basic Research.--Under the targeted
cancers program, the Director of the Institute shall establish a
separate funding mechanism that can be used to fund basic research
grants for investigators with a primary interest in one of the cancers
described in subsection (a).
``(d) Imaging Research.--Under the targeted cancers program, the
Director of the Institute shall provide for research to expand and
advance the potential of imaging to assist in early detection, disease
management, and drug development.
``(e) Incubator Grant Program.--Under the targeted cancers program,
the Director of the Institute shall establish a high-risk, high-reward
incubator grant program for each cancer described in subsection (a) to
allow investigators with a primary interest in such cancer an
opportunity to build data for future grants provided by the Institute
or the National Institutes of Health.
``(f) Grant Review by Scientific Experts.--Under the targeted
cancers program, the Director of the Institute shall provide for a
peer-review process of applications submitted for a grant under this
section. Such process shall be conducted by grant peer-review teams
that include scientific experts in the specific disease area involved,
as well as patient advocates.
``(g) Specialized Training Programs.--Under the targeted cancers
program, the Director of the Institute shall provide for advanced
specialized training and education programs for early career PhD and
clinician scientists that ensure sufficient time of such scientists is
reserved for research in order to attract and retain a broader pool of
investigators for the cancers specified in subsection (a).
``(h) Surveillance and Screening.--Under the targeted cancers
program, the Director of the Institute shall, as prevention, early
detection, and treatments are identified for cancers described in
subsection (a), develop pilot programs for the surveillance and
treatment of such conditions that are precursors to such cancers.
``(i) Cooperative Research Agreements.--Under the targeted cancers
program, the Director of the Institute may enter into cooperative
research agreements with other Federal agencies on programs targeting
cancers specified in subsection (a), including other Institutes at the
National Institutes of Health, other agencies within the Department of
Health and Human Services, the Department of Defense, and the
Department of Veterans Affairs.
``(j) IOM Report.--
``(1) In general.--The Secretary of Health and Human
Services shall enter into an arrangement with the Institute of
Medicine of the National Academies to provide an independent
assessment, with respect to cancers described in subsection
(a), of funding of the National Cancer Institute, progress of
such Institute, and the additional improvements that should be
implemented by the Department of Health and Human Services, by
the National Institutes of Health, and by the National Cancer
Institute to make sufficient progress on research related to
such cancers.
``(2) Report.--The agreement entered into under paragraph
(1) shall provide for the Institute of Medicine to submit to
the Secretary and the Congress, not later than 1 year after the
date of the enactment of this section, a report containing a
description of the results of the study conducted under such
paragraph and the conclusions and recommendations of the
Institute of Medicine regarding the issues described in such
paragraph.''.
SEC. 11. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.
(a) Review, Improvement, and Coordination.--The Commissioner of
Food and Drugs shall--
(1) conduct a review of the policies, programs, and
activities of the Food and Drug Administration relating to
oncology products; and
(2) based on the results of such review, improve and
coordinate such policies, programs, and activities, including
by--
(A) integrating policies, programs, activities,
and, if appropriate, organizational units of the
Administration to facilitate the concurrent development
of oncology products;
(B) considering alternatives or surrogates to
traditional clinical trial endpoints (for example,
other than survival) that are acceptable for regulatory
approval as evidence of clinical benefit to patients;
and
(C) modernizing the Office of Oncology Drug
Products by examining and addressing internal barriers
that exist within the Office's organizational
structure.
(b) Definitions.--In this section:
(1) The term ``biological product'' has the meaning given
to that term in section 351 of the Public Health Service Act
(42 U.S.C. 262).
(2) The terms ``device'' and ``drug'' have the meanings
given to those terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321).
(3) The term ``oncology product'' means--
(A) any biological product, drug, or device for
cancer diagnosis, prevention, or treatment; or
(B) any other product that is regulated by the Food
and Drug Administration and is determined by the
Commissioner of Food and Drugs to be relevant to cancer
diagnosis, prevention, or treatment.
SEC. 12. CDC CANCER CONTROL PROGRAMS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by section 6, is further amended by inserting
after section 317U the following:
``SEC. 317V. CANCER CONTROL PROGRAMS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall expand and
intensify the cancer control programs of the Centers, including
programs for conducting surveillance activities or supporting State
comprehensive cancer control plans.
``(b) Certain Activities.--In carrying out subsection (a), the
Secretary shall--
``(1) in collaboration with the Director of the National
Cancer Institute, provide guidance to States on projects and
interventions that may be incorporated into State comprehensive
cancer control programs to improve the long-term health status
of childhood cancer survivors, including childhood cancer
survivors in minority and other medically underserved
populations;
``(2) encourage States to incorporate strategies for
improving systems of care for childhood cancer survivors and
their families into State comprehensive cancer plans; and
``(3) collaborate with the Director of the National Cancer
Institute to improve existing surveillance systems or develop
appropriate new systems for tracking cancer survivors and
assessing their health status and risk for other chronic and
disabling conditions.
``(c) Childhood Cancer Survivorship.--
``(1) Focus on childhood cancer survivorship.--In
conducting or supporting national, State, and local
comprehensive cancer control programs through the Centers for
Disease Control and Prevention, the Secretary shall enhance
such programs--
``(A) to include a focus on childhood cancer
survivorship, including survivorship in minority and
other medically underserved populations; and
``(B) to include childhood cancer survivorship
initiatives for improving--
``(i) the monitoring of survivors of all
forms of cancer; and
``(ii) follow-up treatment for childhood
cancer survivors.
``(2) Reliance on guidelines.--In carrying out this
subsection, the Secretary shall rely, where appropriate, on
existing guidelines for care of childhood cancer survivors.''.
SEC. 13. NIH CANCER SURVIVORSHIP PROGRAMS.
(a) Technical Amendment.--
(1) In general.--Section 3 of the Hematological Cancer
Research Investment and Education Act of 2002 (Public Law 107-
172; 116 Stat. 541) is amended by striking ``section 419C'' and
inserting ``section 417C''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect as if included in section 3 of the
Hematological Cancer Research Investment and Education Act of
2002 (Public Law 107-172; 116 Stat. 541).
(b) Cancer Survivorship Programs.--Subpart 1 of part C of title IV
of the Public Health Service Act (42 U.S.C. 285 et seq.), is amended by
adding at the end the following:
``SEC. 417G. EXPANSION OF CANCER SURVIVORSHIP ACTIVITIES.
``(a) Expansion of Activities.--The Director of the Institute shall
coordinate the activities of the National Institutes of Health with
respect to cancer survivorship, including childhood cancer
survivorship.
``(b) Priority Areas.--In carrying out subsection (a), the Director
of the Institute shall give priority to the following:
``(1) Comprehensive assessment of the prevalence and
etiology of late effects of cancer and its treatment, including
physical, neu-rocognitive, and psychosocial late effects. Such
assessment shall include--
``(A) development of a system for patient tracking
and analysis;
``(B) establishment of a system of tissue
collection, banking, and analysis for childhood
cancers, using guidelines from the Office of
Biorepositories and Biospecimen Research; and
``(C) coordination of, and resources for,
assessment and data collection.
``(2) Identification of risk and protective factors related
to the development of late effects of cancer.
``(3) Identification of predictors of neurocognitive and
psychosocial outcomes, including quality of life, in cancer
survivors and identification of qualify of life and other
outcomes in family members.
``(4) Development and implementation of intervention
studies for patients and families, including studies focusing
on--
``(A) preventive interventions during treatment;
``(B) interventions to lessen the impact of late
effects;
``(C) rehabilitative or remediative interventions;
``(D) interventions to promote health behaviors in
long-term survivors; and
``(E) interventions to improve health care
utilization and access to linguistically and culturally
competent long-term follow-up care for childhood cancer
survivors in minority and other medically underserved
populations.
``(c) Grants for Research on Causes of Health Disparities in
Childhood Cancer Survivorship.--
``(1) Grants.--The Director of NIH, acting through the
Director of the Institute, shall make grants to entities to
conduct research relating to--
``(A) childhood cancer survivors within minority
populations; and
``(B) health disparities in cancer survivorship
outcomes within minority or other medically underserved
populations.
``(2) Balanced approach.--In making grants for research
under paragraph (1)(A) on childhood cancer survivors within
minority populations, the Director of NIH shall ensure that
such research addresses both the physical and the psychosocial
needs of such survivors.
``(3) Health disparities.--In making grants for research
under paragraph (1)(B) on health disparities in cancer
survivorship outcomes within minority populations, the Director
of NIH shall ensure that such research examines each of the
following:
``(A) Key adverse events after childhood cancer.
``(B) Assessment of health and quality of life in
childhood cancer survivors.
``(C) Barriers to follow-up care to childhood
cancer survivors.
``(d) Research To Evaluate Follow-Up Care for Childhood Cancer
Survivors.--The Director of NIH shall conduct or support research to
evaluate systems of follow-up care for childhood cancer survivors, with
special emphasis given to--
``(1) transitions in care for childhood cancer survivors;
``(2) those professionals who should be part of care teams
for childhood cancer survivors;
``(3) training of professionals to provide linguistically
and culturally competent follow-up care to childhood cancer
survivors; and
``(4) different models of follow-up care.
``SEC. 417G-1. IMPROVING THE QUALITY OF FOLLOW-UP CARE FOR SURVIVORS OF
CHILDHOOD CANCERS AND THEIR FAMILIES.
``(a) In General.--The Secretary, in consultation with the Director
of NIH, shall make grants to eligible entities to establish or improve
training programs for health care professionals (including physicians,
nurses, physician assistants, and mental health professionals)--
``(1) to improve the quality of immediate and long-term
follow-up care for survivors of childhood cancers and their
families; and
``(2) to ensure that such care is linguistically and
culturally competent.
``(b) Eligible Entities.--In this section, the term `eligible
entity' means--
``(1) a medical school;
``(2) a children's hospital;
``(3) a cancer center;
``(4) a hospital with one or more residency programs that
serve a significant number of childhood cancer patients;
``(5) a graduate training program for health professionals
described in subsection (a) who will treat survivors of
childhood cancers; or
``(6) any other entity with significant experience and
expertise in treating survivors of childhood cancers.
``(c) Duration.--Each grant under this section shall be for a
period of 2 years.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for each of fiscal
years 2012 through 2016.
``SEC. 417G-2. STUDY OF PILOT PROGRAMS TO EXPLORE MODEL SYSTEMS OF
CARE.
``(a) In General.--The Director of NIH, in consultation with the
Administrator of the Health Resources and Services Administration,
shall make grants to eligible entities to establish pilot programs to
develop, study, or evaluate model systems for monitoring and caring for
childhood cancer survivors.
``(b) Eligible Entities.--In this section, the term `eligible
entity' means--
``(1) a medical school;
``(2) a children's hospital;
``(3) a cancer center; or
``(4) any other entity with significant experience and
expertise in treating survivors of childhood cancers.
``(c) Use of Funds.--The Director of NIH may make a grant under
this section to an eligible entity only if the entity agrees--
``(1) to use the grant to establish a pilot program to
develop, study, or evaluate one or more model systems for
monitoring and caring for cancer survivors; and
``(2) in developing, studying, and evaluating such systems,
to give special emphasis to the following:
``(A) Design of protocols for follow-up care,
monitoring, and other survivorship programs (including
peer support and mentoring programs).
``(B) Dissemination of information to health care
providers about how to provide linguistically and
culturally competent follow-up care and monitoring to
cancer survivors and their families.
``(C) Dissemination of other information, as
appropriate, to health care providers and to cancer
survivors and their families.
``(D) Development of support programs to improve
the quality of life of cancer survivors.
``(E) Design of systems for the effective transfer
of treatment information from cancer care providers to
other health care providers (including family practice
physicians and internists) and to cancer survivors and
their families, where appropriate.
``(F) Development of various models for providing
multidisciplinary care.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2012 through 2016.''.
(c) Complete Recovery Care.--
(1) Definition.--In this subsection, the term ``complete
recovery care'' means care intended to address the secondary
effects of cancer and its treatment, including late,
psychosocial, neurocognitive, psychiatric, psychological,
physical, and other effects associated with cancer and cancer
survivorship beyond the impairment of bodily function directly
caused by the disease, as described in the report by the
Institute of Medicine of the National Academies entitled
``Cancer Care for the Whole Patient''.
(2) Expansion of activities.--The Secretary of Health and
Human Services (referred to in this subsection as the
``Secretary'') shall--
(A) coordinate the activities of Federal agencies,
including the National Institutes of Health, the
National Cancer Institute, the National Institute of
Mental Health, the Centers for Medicare and Medicaid
Services, the Veterans Health Administration, the
Centers for Disease Control and Prevention, the Food
and Drug Administration, the Agency for Healthcare
Research and Quality, the Office for Human Research
Protections, and the Health Resources and Services
Administration to improve the provision of complete
recovery care in the treatment of cancer; and
(B) solicit input from professional and patient
organizations, payors, and other relevant institutions
and organizations regarding the status of provision of
complete recovery care in the treatment of cancer.
(3) Improving the complete recovery care workforce.--
(A) Chronic disease workforce development
collaborative.--The Secretary shall, not later than 1
year after the date of enactment of this Act, convene a
Workforce Development Collaborative on Psychosocial
Care During Chronic Medical Illness (referred to in
this paragraph as the ``Collaborative''). The
Collaborative shall be a cross-specialty,
multidisciplinary group composed of educators, consumer
and family advocates, and providers of psychosocial and
biomedical health services.
(B) Goals and report.--The Collaborative shall
submit to the Secretary a report establishing a plan to
meet the following objectives for psychosocial care
workforce development:
(i) Identifying, refining, and broadly
disseminating to healthcare educators
information about workforce competencies,
models, and preservices curricula relevant to
providing psychosocial services to persons with
chronic medical illnesses and their families.
(ii) Adapting curricula for continuing
education of the existing workforce using
efficient workplace-based learning approaches.
(iii) Developing the skills of faculty and
other trainers in teaching psychosocial health
care using evidence-based teaching strategies.
(iv) Strengthening the emphasis on
psychosocial healthcare in educational
accreditation standards and professional
licensing and certification exams by
recommending revisions to the relevant
oversight organizations.
SEC. 14. CLINICS FOR COMPREHENSIVE LONG-TERM FOLLOW-UP SERVICES FOR
CHILDHOOD CANCER SURVIVORS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by sections 6 and 13, is further amended by
inserting after section 317V the following:
``SEC. 317W. CLINICS FOR COMPREHENSIVE LONG-TERM FOLLOW-UP SERVICES FOR
CHILDHOOD CANCER SURVIVORS.
``(a) In General.--The Secretary shall make grants to eligible
entities to pay all or a portion of the costs incurred during the first
4 years of establishing and operating a clinic for comprehensive long-
term follow-up services for childhood cancer survivors.
``(b) Eligible Entities.--In this section, the term `eligible
entity' means--
``(1) a school of medicine;
``(2) a children's hospital;
``(3) a cancer center; or
``(4) any other entity with significant experience and
expertise in treating survivors of childhood cancers.
``(c) Priority.--In making grants under this section, the Secretary
shall give priority to any eligible entity that demonstrates an
expertise in improving access to care for minority and other medically
underserved populations.
``(d) Use of Funds.--The Secretary may make a grant under this
section to an eligible entity only if the entity agrees to use the
grant to pay costs incurred during the first 4 years of establishing
and operating a clinic for comprehensive long-term follow-up services
for childhood cancer survivors. Such costs may include the costs of--
``(1) purchasing or leasing facilities;
``(2) providing medical and psychosocial follow-up
services, including coordination with the patient's primary
care provider and oncologist in order to ensure that the unique
medical needs of survivors are addressed;
``(3) conducting research to improve care for childhood
cancer survivors;
``(4) providing linguistically and culturally competent
information to childhood cancer survivors and their families;
and
``(5) improving access by minority or other medically
underserved populations to the best practices and care for
childhood cancer survivors.
``(e) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $15,000,000 for each of fiscal
years 2012 through 2016.''.
SEC. 15. GRANTS TO IMPROVE ACCESS TO CARE FOR CHILDHOOD CANCER
SURVIVORS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by sections 6, 13, and 15, is further amended by
inserting after section 317W the following:
``SEC. 317X. GRANTS TO IMPROVE ACCESS TO CARE FOR CHILDHOOD CANCER
SURVIVORS.
``(a) Grants.--The Secretary shall make grants to recognized
childhood cancer professional and advocacy organizations to improve
physical and psychosocial care for childhood cancer survivors,
especially childhood cancer survivors in minority or other medically
underserved populations.
``(b) Use of Funds.--The Secretary may make a grant under this
section to an organization only if the organization agrees to use the
grant to improve physical and psychosocial care for childhood cancer
survivors, especially childhood cancer survivors in minority or other
medically underserved populations. Such care may include--
``(1) patient navigator programs;
``(2) peer support programs;
``(3) education and outreach for survivors and their
families, including developing bilingual materials;
``(4) follow-up care for uninsured and underinsured
survivors--
``(A) to identify, prevent, or control side effects
associated with cancer and its treatment; and
``(B) to screen for cancer recurrence; and
``(5) assistance with transportation necessary to receive
medical care for survivors and their families who lack adequate
transportation resources.
``(c) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2012 through 2016.''.
<all>
Introduced in House
Introduced in House
Referred to House Energy and Commerce
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to House Ways and Means
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