1.This Act may be cited as
the 21st Century Cancer ALERT (Access
to Life-Saving Early detection, Research and Treatment)
Act
.
2.
(a)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)The
purposes of this Act are as follows:
(1)To reauthorize
the National Cancer Institute and National Cancer Program in order to enhance
and improve the cancer research conducted and supported by the National Cancer
Institute and the National Cancer Program in order to benefit cancer
patients.
(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.
3.Advancement of
the National Cancer ProgramSection 411 of the Public Health Service Act
(42 U.S.C. 285a) is amended to read as follows:
411.
(a)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)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)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 BoardIn 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 researchThe 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)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)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)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 prioritizationIn 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)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 contributionNon-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)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)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 part C of title XI of the Social Security
Act and section 264(c) of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d–2 note) (referred to in this section as the ‘HIPAA
Privacy Rule’), while facilitating advances in medical research.
(3)Advancement of
new technologies for cancer research and expansion of cancer biorepository
networks
(A)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)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)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 sitesThe 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)
(A)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 relating to cancer care and treatment
shall be provided to the entity established under paragraph
(1).
.
4.Comprehensive
and Responsible Access to Research, Data, and Outcomes
(a)Not later than 180
days after the date of 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 RuleFor purposes of the Privacy
Rule (as referred to in section 411(f)(2)(F) of the Public Health Service Act,
as amended by this Act), a covered entity (as defined for purposes of such
Rule) shall be in compliance with such Rule 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)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)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 Privacy Rule (as defined in section 411(f)(2)(F) of the
Public Health Service Act, as amended by this Act) 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
recommendationsIn 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)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 extraterritorially under the Privacy Rule
(as referred to in section 411(f)(2)(F) of the Public Health Service Act, as
amended by this Act); and
(ii)include
biorepository storage information when obtaining patient consent.
(D)Not
later than 180 days after the date of 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
Privacy Rule to external researchers
(A)Notwithstanding any other provision of law, the Privacy
Rule (as defined in section 411(f)(2)(F) of the Public Health Service Act, as
amended by this Act) shall apply to external researchers.
(B)
(i)In this paragraph, the term external
researcher means a researcher who is on the staff of a covered entity
(as defined in the Privacy Rule) but who is not actually employed by such
covered entity.
(ii)Internal and
external researchersWith 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)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.
5.Enhanced focus
and reporting on cancer researchPart 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:
417B.Enhanced
focus and reporting on cancer research
(a)Annual
independent report
(1)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)
(A)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 less than 15 cases per 100,000 people, or fewer than
40,000 new cases per year.
(B)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)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)
(1)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)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)
(A)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)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.
.
6.Continuing
Access to Care for Prevention and Early Detection
(a)Colorectal
cancer screening programPart
B of title III of the Public Health Service Act is amended by inserting after
section 317D (42 U.S.C. 247b–5) the following:
317D–1.Colorectal
cancer screening program
(a)The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, may award competitive grants to eligible
entities to carry out programs—
(1)to provide
screenings for colorectal cancer to individuals according to screening
guidelines set by the United States Preventive Services Task Force;
(2)to provide
appropriate referrals for medical treatment of individuals screened pursuant to
paragraph (1) and to ensure, to the extent practicable, the provision of
appropriate follow-up services and support services such as case
management;
(3)to develop and
disseminate public information and education programs for the detection and
control of colon cancer;
(4)to improve the
education, training, and skills of health professionals (including allied
health professionals) in the detection and control of colon cancer;
(5)to establish
mechanisms through which eligible entities can monitor the quality of screening
procedures for colon cancer, including the interpretation of such procedures;
and
(6)to evaluate
activities conducted under paragraphs (1) through (5) through appropriate
surveillance or program-monitoring activities.
(b)
(1)To be eligible to receive a grant under this section an
entity shall—
(A)be—
(i)a
State; or
(ii)an Indian tribe
or tribal organization (as such terms are defined in section 4 of the Indian
Self-Determination and Education Assistance Act);
(B)submit to the
Secretary as application, at such time, in such manner, and containing such
information as the Secretary may require, including—
(i)a
description of the purposes for which the entity intends to expend amounts
under the grant; and
(ii)a description of
the populations, areas, and localities with a need for the services or
activities described in clause (i);
(C)provide matching
funds in accordance with paragraph (2);
(D)provide
assurances that the entity will—
(i)establish such
fiscal control and fund accounting procedures as may be necessary to ensure the
proper disbursal of, and accounting for, amounts received under subsection
(a);
(ii)upon request,
provide records maintained pursuant to clause (i) to the Secretary or the
Comptroller General of the United States for purposes of auditing the
expenditures of the grant by the eligible entity; and
(iii)submit to the
Secretary such reports as the Secretary may require with respect to the grant;
and
(E)provide
assurances that the entity will comply with the restrictions described in
subsection (e).
(2)
(A)The Secretary may not award a grant to an eligible entity
under this section unless the eligible entity involved agrees, with respect to
the costs to be incurred by the eligible entity in carrying out the purpose
described in the application under paragraph (1)(B)(i), to make available
non-Federal contributions (in cash or in kind under subparagraph (B)) toward
such costs in an amount equal to not less than $1 for each $3 of Federal funds
provided in the grant. Such contributions may be made directly or through
donations from public or private entities.
(B)Determination
of amount of non-Federal contribution
(i)Non-Federal contributions required in subparagraph (A)
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.
(ii)In making a determination of the amount of non-Federal
contributions for purposes of subparagraph (A), 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 purpose described
in subsection (a) for the 2-year period preceding the first fiscal year for
which the eligible entity is applying to receive a grant under such
section.
(iii)Inclusion of
relevant non-Federal contributions for MedicaidIn making a
determination of the amount of non-Federal contributions for purposes of
subparagraph (A), the Secretary shall, subject to clauses (i) and (ii), include
any non-Federal amounts expended pursuant to title XIX of the Social Security
Act by the eligible entity involved toward the purpose described in paragraphs
(1) and (2) of subsection (a).
(c)
(1)In awarding grants under this section, the Secretary
shall give priority to recipients that are safety-net providers.
(2)In
this section, the term safety-net provider means a health care
provider—
(A)that by legal
mandate or explicitly adopted mission, offers care to individuals without
regard to the individual's ability to pay for such services; or
(B)for whom a
substantial share of the patients are uninsured, receive Medicaid, or are
otherwise vulnerable.
(d)
(1)An eligible entity may, subject to paragraphs (2) and
(3), expend amounts received under a grant under subsection (a) to carry out
the purposes described in such subsection through the awarding of grants to
public and nonprofit private entities and through contracts entered into with
public and private entities.
(2)If a nonprofit private entity and a private entity
that is not a nonprofit entity both submit applications to a grantee under
subsection (a) for a grant or contract as provided for in paragraph (1), the
grantee may give priority to the application submitted by the nonprofit private
entity in any case in which the grantee determines that the quality of such
application is equivalent to the quality of the application submitted by the
other private entity.
(3)The amount paid by a grantee under subsection (a) to
an entity under this subsection for a screening procedure as described in
subsection (a)(1) may not exceed the amount that would be paid under part B of
title XVIII of the Social Security Act if payment were made under such part for
furnishing the procedure to an individual enrolled under such part.
(e)Restriction on
use of fundThe Secretary may not award a grant to an eligible
entity under subsection (a) unless the entity agrees that—
(1)in providing
screenings under subsection (a)(1), the eligible entity will give priority to
low-income individuals who lack adequate coverage under health insurance and
health plans with respect to screenings for colorectal cancer;
(2)initially and
throughout the period during which amounts are received pursuant to the grant,
not less than 60 percent of the grant shall be expended to provide each of the
services or activities described in subsections (a)(1) and (a)(2);
(3)not more than 10
percent of the grant will be expended for administrative expenses with respect
to the activities funded under the grant;
(4)funding received
under the grant will supplement, and not supplant, the expenditures of the
eligible entity and the value for in-kind contributions for carrying out the
activities for which the grant was awarded;
(5)funding 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—
(A)under any State
compensation program, under an insurance policy, or under any Federal or State
health benefits program; or
(B)by an entity that
provides health services on a prepaid basis; and
(6)funds will not be
expended to provide inpatient hospital services for any individual.
(f)Limitation on
imposition of fees for servicesThe Secretary may not award a
grant to an eligible entity under this section unless the eligible entity
involved agrees that, if a charge is imposed for the provision of services or
activities under the grant, such charge—
(1)will be made
according to a schedule of charges that is made available to the public;
(2)will be adjusted
to reflect the income of the individual involved; and
(3)will not be
imposed on any individual with an income of less than 100 percent of the
official poverty line, as established by the Director of the Office of
Management and Budget and revised by the Secretary in accordance with section
673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)), including
any revision required by such section.
(g)Requirement
regarding MedicareThe Secretary may not award a grant to an
eligible entity under this section unless the eligible entity involved
provides, as applicable, the following assurances:
(1)Screenings under
subsection (a)(1) will be carried out as preventive health measures in
accordance with evidence-based screening guidelines and procedures as specified
in section 1861(pp)(1) of the Social Security Act.
(2)An individual
will be considered high risk for purposes of subsection (a)(1) only if the
individual is high risk within the meaning of section 1861(pp)(2) of such
Act.
(h)Requirement
Regarding MedicaidThe Secretary may not award a grant to an
eligible entity under subsection (a) unless the State plan under title XIX of
the Social Security Act for the State includes the screening procedures and
referrals specified in subsections (a)(1) and (a)(2) as medical assistance
provided under the plan.
(i)Technical
Assistance and Provision of Supplies and Services in Lieu of Grant
Funds
(1)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)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 this
section—
(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 paymentsWith 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.
(j)
(1)The
Secretary shall, directly or through contracts with public or private entities,
provide for annual evaluations of programs carried out pursuant to this
section. Such evaluations shall include evaluations of the extent to which
eligible entities carrying out such programs are in compliance with subsection
(a)(2).
(2)The Secretary shall, not later than 1 year after the
date on which amounts are first appropriated to carry out this section, and
annually thereafter, submit to Congress, a report summarizing evaluations
carried out pursuant to paragraph (1) during the preceding fiscal year and
making such recommendations for administrative and legislative initiatives with
respect to this section as the Secretary determines to be
appropriate.
.
(b)Optional
medicaid coverage of certain persons screened and found To have colorectal
cancer
(1)Coverage as
optional categorically needy group
(A)Section 1902(a)(10)(A)(ii) of the Social Security Act (42
U.S.C. 1396a(a)(10)(A)(ii)) is amended—
(i)in
subclause (XVIII), by striking or
at the end;
(ii)in
subclause (XIX), by adding or
at the end; and
(iii)by
adding at the end the following:
- (XX)who
are described in subsection (gg) (relating to certain persons screened and
found to need treatment from complications from screening or have colorectal
cancer);
.
(B)Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended by adding at the end the following:
(gg)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 2701(c) of the Public
Health Service
Act.
.
(C)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 and (XIV)
and inserting (XIV)
;
and
(ii)by
inserting , and (XV) the medical assistance made available to an
individual described in subsection (gg) who is eligible for medical assistance
only because of subparagraph (A)(10)(ii)(XX) 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)Section 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)) is amended in the matter preceding paragraph (1)—
(i)in
clause (xii), by striking or
at the end;
(ii)in
clause (xiii), by adding or
at the end; and
(iii)by
inserting after clause (xiii) the following:
(xiv)individuals
described in section
1902(gg),
.
(2)
(A)Title XIX of the Social Security Act (42 U.S.C. 1396 et
seq.) is amended by inserting after section 1920B the following:
1920C.Optional application of presumptive eligibility provisions
for certain persons with colorectal cancerA State may elect to apply the provisions
of section 1920B to individuals described in section 1902(gg) (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)
(i)Section 1902(a)(47)
of the Social Security Act (42 U.S.C. 1396a(a)(47)) is
amended—
(I)by striking
and
after section 1920
and inserting a
comma;
(II)by striking
and
after with such section
and inserting a
comma; and
(III)by inserting
before the semicolon at the end the following: , and provide for making
medical assistance available to individuals described in section 1920C during a
presumptive eligibility period in accordance with such section
.
(ii)Section
1903(u)(1)(d)(v) of such Act (42 U.S.C. 1396b(u)(1)(d)(v)) is
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 1920C during a presumptive eligibility
period under such section
.
(3)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)(XX)
.
(4)The amendments made by this subsection apply to medical
assistance for items and services furnished on or after the date that is 1 year
after the date of enactment of this Act, without regard to whether final
regulations to carry out such amendments have been promulgated by such
date.
(c)Mobile medical
van grant program
(1)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 receive
an A
or B
recommendation by the U.S. 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)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)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)
(A)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 contributedNon-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)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)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 grantsIn 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 grantA 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)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)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)In
this section:
(A)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)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)).
(d)Access to
Prevention and Early Detection for Certain Cancers
(1)The Secretary of Health and Human Services, acting through
the National Cancer Institute, shall provide for the inclusion of cancers with
survival rates of less than 25 percent at 5 years in the Cancer Genome
Atlas.
(2)The Director of the National Cancer Institute shall phase in
the participation of cancers described in paragraph (1) in the Cancer Genome
Atlas Consortium.
(3)The Secretary of Health and Human Services, acting through
the National Cancer Institute, shall establish formal working groups for
cancers with survival rates of less than 25 percent at 5 years within the Early
Detection Research Network.
(4)Computer
assisted diagnostic, surgical, treatment and drug testing innovations to reduce
mortality from cancersThe Director of the National Institute of
Biomedical Imaging and Bioengineering shall ensure that the Quantum Grant
Program and the Image Guided Interventions programs expedite the development of
computer assisted diagnostic, surgical, treatment and drug testing innovations
to reduce mortality from cancers with survival rates of less than 25 percent at
5 years.
7.Early
Recognition and Treatment of Cancer through Use of Biomarkers
(a)Promotion of
the discovery and development of biomarkers
(1)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)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)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)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)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
guidelinesNot 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)
(1)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)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)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)It is the sense of the Senate 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.
(f)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.
8.
(a)Coverage for
individuals participating in approved cancer clinical trials
(1)Subpart B of part 7 of subtitle B of title I of the
Employee Retirement Income Security Act of
1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the
following:
715.Coverage for
individuals participating in approved cancer clinical trials
(a)
(1)If a group health plan (or a health insurance issuer
offering health insurance coverage in connection with the plan) provides
coverage to a qualified individual (as defined in subsection (b)), the plan or
issuer—
(A)may not deny the
individual participation in the clinical trial referred to in subsection
(b)(2);
(B)subject to
subsection (c), may not deny (or limit or impose additional conditions on) the
coverage of routine patient costs for items and services furnished in
connection with participation in the trial; and
(C)may not
discriminate against the individual on the basis of the individual’s
participation in such trial.
(2)Exclusion of
certain costsFor purposes of paragraph (1)(B), subject to
subparagraph (B), routine patient costs include all items and services
consistent with the coverage provided in the plan (or coverage) that is
typically covered for a qualified individual who is not enrolled in a clinical
trial and that was not necessitated solely because of the trial, except—
(A)the
investigational item, device or service, itself; or
(B)items and services
that are provided solely to satisfy data collection and analysis needs and that
are not used in the direct clinical management of the patient.
(3)Use of
in-network providersIf one or more participating providers is
participating in a clinical trial, nothing in paragraph (1) shall be construed
as preventing a plan or issuer from requiring that a qualified individual
participate in the trial through such a participating provider if the provider
will accept the individual as a participant in the trial.
(b)Qualified
individual definedFor purposes of subsection (a), the term
qualified individual means an individual who is a participant or
beneficiary in a group health plan and who meets the following
conditions:
(1)(A)The individual has been
diagnosed with cancer.
(B)The individual is eligible to
participate in an approved clinical trial according to the trial protocol with
respect to treatment of such illness.
(2)Either—
(A)the referring
health care professional is a participating health care provider and has
concluded that the individual’s participation in such trial would be
appropriate based upon the individual meeting the conditions described in
paragraph (1); or
(B)the participant or
beneficiary provides medical and scientific information establishing that the
individual’s participation in such trial would be appropriate based upon the
individual meeting the conditions described in paragraph (1).
(c)This section shall not be construed to require a group
health plan, or a health insurance issuer in connection with a group health
plan, to provide benefits for routine patient care services provided outside of
the plan’s (or coverage's) health care provider network unless out-of-network
benefits are otherwise provided under the plan (or coverage).
(d)Approved
Clinical Trial Defined
(1)In this section, the term approved clinical
trial means a phase I, phase II, phase III, or phase IV clinical trial
that relates to the prevention and treatment of cancer (including related
symptoms) and is described in any of the following subparagraphs:
(A)The study or investigation is approved or funded
(which may include funding through in-kind contributions) by one or more of the
following:
(i)The National
Institutes of Health.
(ii)The Centers for
Disease Control and Prevention.
(iii)The Agency for
Health Care Research and Quality.
(iv)The Centers for
Medicare & Medicaid Services.
(v)cooperative group
or center of any of the entities described in clauses (i) through (iv) or the
Department of Defense or the Department of Veterans Affairs.
(vi)A qualified
non-governmental research entity identified in the guidelines issued by the
National Institutes of Health for center support grants.
(vii)Any of the
following if the conditions described in paragraph (2) are met:
(I)The Department of
Veterans Affairs.
(II)The Department
of Defense.
(III)The Department
of Energy.
(B)The study or
investigation is conducted under an investigational new drug application
reviewed by the Food and Drug Administration.
(C)The study or
investigation is a drug trial that is exempt from having such an
investigational new drug application.
(2)Conditions for
departmentsThe conditions described in this paragraph, for a
study or investigation conducted by a Department, are that the study or
investigation has been reviewed and approved through a system of peer review
that the Secretary determines—
(A)to be comparable
to the system of peer review of studies and investigations used by the National
Institutes of Health, and
(B)assures unbiased
review of the highest scientific standards by qualified individuals who have no
interest in the outcome of the review.
(e)Nothing
in this section shall be construed to limit a plan’s or issuer’s coverage with
respect to clinical trials.
(f)Notwithstanding
any other provision of this Act, nothing in this section shall preempt State
laws that require a clinical trials policy for State regulated health insurance
plans.
.
(2)
(A)Section 732(a) of
such Act (29 U.S.C.
1191a(a)) is amended by striking section 711
and
inserting sections 711 and 715
.
(B)The table of
contents in section 1 of such Act is amended by inserting after the item
relating to section 714 the following new item:
Sec. 715. Coverage for individuals
participating in approved cancer clinical
trials.
.
(b)The Director of the National Cancer Institute
shall—
(1)collaborate with
the Director of the National Institutes of Health to engage in a campaign to
educate the public on the value of clinical trials for oncology patients, which
shall be implemented on the local level and focus on patient populations that
traditionally are underrepresented in clinical trials;
(2)conduct an
educational campaign for health care professionals to educate them to consider
clinical trials as treatment options for their patients; and
(3)conduct research
to document and demonstrate promising practices in cancer clinical trial
recruitment and retention efforts, particularly for patient populations that
traditionally are underrepresented in clinical trials.
9.Health
professions workforce
(a)Section 811(f)(2) of the Public Health Service Act (42
U.S.C. 296j(f)(2)) is amended to read as follows:
(2)Benefits for
Retiring Nurse Officers Qualified as Faculty
(A)The Secretary of Defense shall provide to any individual
described in subparagraph (B) the payment of retired or retirement pay without
reduction based on receipt of pay or other compensation from the institution of
higher education concerned.
(B)An individual described in this subparagraph is an
individual who—
(i)is retired from
the Armed Forces after service as a commissioned officer in the nurse corps of
the Armed Forces;
(ii)holds a graduate
degree in nursing; and
(iii)serves as a
part- or full-time faculty member of an accredited school of nursing.
(C)Any accredited school of nursing that employs a retired
nurse officer as faculty under this paragraph shall agree to provide financial
assistance to individuals undertaking an educational program at such school
leading to a degree in nursing who agree, upon completion of such program, to
accept a commission as an officer in the nurse corps of the Armed
Forces.
.
(b)
(1)The
Secretary of Health and Human Services (referred to in this subsection as the
Secretary
) shall conduct a study on the current and future
cancer care workforce needs in the following areas:
(A)Cancer
research.
(B)Care and
treatment of cancer patients and survivors.
(C)Quality of life,
symptom management, and pain management.
(D)Early detection
and diagnosis.
(E)Cancer
prevention.
(F)Genetic testing,
counseling, and ethical considerations related to such testing.
(G)Diversity and
appropriate care for disparity populations.
(H)Palliative and
end-of-life care.
(2)Not
later than 1 year after the date of enactment of this Act, the Secretary shall
submit to Congress a report that describes the findings of the study conducted
under paragraph (2).
10.Patient
Navigator ProgramSection 340A
of the Public Health Service Act (42 U.S.C. 256a) is amended—
(1)in subsection (e), by adding at the end the
following:
(3)Minimum core
proficienciesThe Secretary
shall not award a grant to an entity under this section unless such entity
provides assurances that patient navigators recruited, assigned, trained, or
employed using grant funds meet minimum core proficiencies that are tailored
for the main focus or intervention of the navigation program
involved.
;
and
(2)in subsection
(m)—
(A)in paragraph (1),
by inserting before the period the following , and such sums as may be
necessary for each of fiscal years 2011 through 2015.
; and
(B)in paragraph (2),
by striking 2010
and replacing with 2015.
11.Cancer care and
coverage under Medicaid and Medicare
(a)Coverage of
routine costs associated with clinical trials under Medicare
(1)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 trialsThe 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)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)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 trialsThe 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)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)Demonstration
project To provide comprehensive cancer care planning services under
Medicare
(1)Beginning not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services (referred to
in this subsection as the Secretary
) shall conduct a 3-year
demonstration project (referred to in this subsection as the
demonstration project
) under title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.) under which payment for comprehensive cancer care
planning services furnished by eligible entities shall be made.
(2)Comprehensive
cancer care planning servicesFor purposes of this subsection,
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
documented in the patient’s medical record and furnished 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
documented in the patient’s medical record and furnished 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)identifies, to
the greatest extent possible, a healthcare provider to oversee subsequent care
and follow-up as needed and to whom the individual may direct questions or
concerns;
(iv)is
documented in the patient’s medical record and furnished 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;
(v)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
(vi)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
documented in the patient’s medical record and furnished to the individual
within a period specified by the Secretary that is as soon as practicable after
the date of such revision.
(3)Qualifications
and selection of eligible entities
(A)For
purposes of this subsection, the term eligible entity means a
physician office, hospital, outpatient department, or community health center.
Qualified providers include physicians, nurse practitioners, and other health
care professionals who develop or revise a comprehensive cancer care
plan.
(B)The
Secretary shall select at least 6 eligible entities to participate in the
demonstration project. Such entities shall be selected so that the
demonstration project is conducted in different regions across the United
States, in urban and rural locations, and across various sites of care.
(4)
(A)The
Secretary shall conduct a comprehensive evaluation of the demonstration project
to determine—
(i)the
effectiveness of the project in improving patient outcomes and increasing
efficiency and reducing error in the delivery of cancer care;
(ii)the cost of
providing comprehensive cancer care planning services; and
(iii)the potential
savings to the Medicare program demonstrated by the project, including the
utility of the demonstration project in reducing duplicative cancer care
services and decreasing the use of unnecessary medical services for cancer
patients.
(B)
(i)Not later than the date that is 1 year after the date on
which the demonstration project concludes, the Secretary shall submit to
Congress a report on the evaluation conducted under subparagraph (A).
(ii)Prevention of
fraudulent billingThe Secretary shall consult with the Medicare
Fraud Task Force in the design of the demonstration project to identify and
address concerns about fraudulent billing of comprehensive cancer care planning
services. The Secretary's actions on prevention of fraud shall be included in
the report under this subparagraph.
(iii)Demonstration
of substantial benefitIf the evaluation conducted under
subparagraph (A) indicates substantial benefit from the demonstration project,
as measured by improved patient outcomes and more efficient delivery of
healthcare services, such report shall include a legislative proposal to
Congress for coverage of comprehensive cancer care planning services under the
Medicare program, developed on the basis of information from the demonstration
project and in consultation with the Administrator of the Agency for Healthcare
Research and Quality, the Director of the Institute of Medicine, and the
Director of the Centers for Disease Control and Prevention.
(iv)If the evaluation conducted under subparagraph (A) does
not indicate substantial benefit from the demonstration project, as measured by
improved patient outcomes and more efficient delivery of healthcare services,
such report shall document, to the extent possible, the reasons why the
demonstration project did not result in substantial benefit, and such
report—
(I)shall include a
legislative proposal for Medicare coverage of comprehensive cancer care
planning services in a manner that will lead to substantial benefit; or
(II)shall include
recommendations for additional demonstration projects or studies to evaluate
the delivery of comprehensive cancer care planning services in a manner that
will lead to substantial benefit and eventual Medicare coverage.
(5)The
Secretary shall provide for the transfer from the Federal Supplementary Medical
Insurance Trust Fund established under section 1841 of the Social Security Act
(42 U.S.C. 1395t) of the amount necessary to carry out the demonstration
project and report under this subsection.
(c)Promoting cessation of tobacco use under
Medicaid
(1)Section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended
by adding at the end the following new subsection:
(y)(1)Subject to paragraph
(2), for purposes of this title, the term counseling and pharmacotherapy
for cessation of tobacco use means diagnostic, therapy, and counseling
services and pharmacotherapy (including the coverage of prescription and
nonprescription tobacco cessation agents approved by the Food and Drug
Administration) for cessation of tobacco use for individuals who use tobacco
products or who are being treated for tobacco use which are furnished—
(A)by or under the supervision of a
physician; or
(B)by any other health care professional
who—
(i)is legally authorized to furnish
such services under State law (or the State regulatory mechanism provided by
State law) of the State in which the services are furnished; and
(ii)is authorized to receive payment
for other medical assistance under this title or is designated by the Secretary
for this purpose.
(2)Such term is limited to—
(A)services recommended in
Treating Tobacco Use and Dependence: A Clinical Practice
Guideline
, published by the Public Health Service in June 2000, or any
subsequent modification of such Guideline; and
(B)such other services that the Secretary
recognizes to be
effective.
.
(2)Dropping exception from Medicaid
prescription drug coverage for tobacco cessation
medicationsSection 1927(d)(2) of the Social Security Act (42
U.S.C. 1396r–8(d)(2)) is amended—
(A)by striking
subparagraph (E);
(B)by redesignating
subparagraphs (F) through (K) as subparagraphs (E) through (J), respectively;
and
(C)in subparagraph
(F) (as redesignated by subparagraph (B)), by inserting before the period at
the end the following: , except agents approved by the Food and Drug
Administration for purposes of promoting, and when used to promote, tobacco
cessation
.
(3)Requiring
coverage of tobacco cessation counseling and pharmacotherapy services for
pregnant womenSection 1905(a)(4) of the Social Security Act (42
U.S.C. 1396d(a)(4)) is amended—
(A)by striking
and
before (C)
; and
(B)by inserting
before the semicolon at the end the following: ; and (D) counseling and
pharmacotherapy for cessation of tobacco use for pregnant women
.
(4)Removal of
cost-sharing for tobacco cessation counseling and pharmacotherapy services for
pregnant women
(A)Section 1916 of the Social Security Act (42 U.S.C. 1396o)
is amended in each of subsections (a)(2)(B) and (b)(2)(B), by inserting
, and counseling and pharmacotherapy for cessation of tobacco
use
after complicate the pregnancy
.
(B)Section 1916A(b)(3)(B)(iii) of such Act (42 U.S.C.
1396o–1(b)(3)(B)(iii)) is amended by inserting , and counseling and
pharmacotherapy for cessation of tobacco use
after complicate
the pregnancy
.
(5)The amendments made by this subsection 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 that date.
12.Cancer
Survivorship and Complete recovery initiatives
(a)Cancer
survivorship programsSubpart 1 of part C of title IV of the
Public Health Service Act (42 U.S.C. 285 et seq.), as amended by subsection
(c), is amended by adding at the end the following:
417E.Expansion of
cancer survivorship activities
(a)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)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 treatment,
including physical, neurocognitive, 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 cancer survivors and their families,
including studies focusing on—
(A)preventive
interventions during treatment;
(B)interventions to
lessen the impact of late effects of cancer treatment;
(C)rehabilitative or
remediative interventions following cancer treatment;
(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)The
Director of NIH, acting through the Director of the Institute, shall make
grants to entities to conduct research relating to—
(A)needs and outcomes
of pediatric cancer survivors within minority or other medically underserved
populations; and
(B)health disparities
in cancer survivorship outcomes within minority or other medically underserved
populations.
(2)In making grants for research under paragraph (1)(A) on
pediatric cancer survivors within minority populations, the Director of NIH
shall ensure that such research addresses both the physical and the
psychological needs of such survivors.
(3)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)Data regarding
the type of provider and treatment facility where the patient received cancer
treatment and how the provider and treatment facility may impact treatment
outcomes and survivorship.
(d)Research To
evaluate follow-Up care for childhood cancer survivorsThe
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.
.
(b)
(1)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)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 collaborativeThe 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)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.
(c)
(1)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)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).
13.Activities of
the Food and Drug AdministrationIt is the sense of the Senate that the Food
and Drug Administration should—
(1)integrate
policies and structures to facilitate the concurrent development of drugs and
diagnostics for cancer diagnosis, prevention, and therapy;
(2)consider
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
(3)modernize the
Office of Oncology Drug Products by examining and addressing internal barriers
that exist within the current organizational structure.