1.Short title; table of
contents
(a)This Act may be cited
as the 21st Century Cancer ALERT
(Access to Life-Saving Early detection, Research and Treatment)
Act
.
(b)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.
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 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.
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 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)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 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 RuleFor 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)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
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 extraterritoriality under such HIPAA privacy
and security law; and
(ii)include
biorepository storage information when obtaining patient consent.
(D)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)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)
(i)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 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 of the Central Institutional Review Board Initiative, as
sponsored by the National Cancer Institute.
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 fewer 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)Preventive
health measures with respect to colorectal cancerPart 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:
317U.Preventive
health measures with respect to colorectal cancer
(a)Grant program
authorization
(1)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)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)
(1)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)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 individualsA 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 applicantsIn 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 programA 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 programsA 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)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)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)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)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 MedicaidIn 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)
(1)Limitation on
administrative expensesThe 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)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)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)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 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 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.
(k)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)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 servicesOf
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)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)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)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)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)
(A)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:
1920D.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(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)
(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)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)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)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)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)).
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)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)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)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)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 SpecimensThe 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)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 committeeThe 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
AppropriationsFor 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 RepresentativesIt 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)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.Extending coverage under Medicaid of
counseling and pharmacotherapy for cessation of tobacco use
(a)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 medicationsSection 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)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.
9.Comprehensive
cancer care and coverage under 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)Coverage of
cancer care planning services
(1)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:
(iii)Comprehensive cancer care planning
services(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)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)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)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:
(jjj)Comprehensive cancer patient treatment education
services(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)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)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 servicesNothing 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)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.
10.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:
417H.
(a)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)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)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 researchUnder 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)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)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 expertsUnder 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 programsUnder 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
screeningUnder 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 agreementsUnder 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)
(1)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)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.
.
11.Activities of
the Food and Drug Administration
(a)Review,
improvement, and coordinationThe 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)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.
12.CDC Cancer
Control ProgramsPart 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:
317V.
(a)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)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 survivorshipIn 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)In carrying out this subsection, the Secretary shall
rely, where appropriate, on existing guidelines for care of childhood cancer
survivors.
.
13.NIH cancer
survivorship programs
(a)
(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).
(b)Cancer
survivorship programsSubpart 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:
417G.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 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)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)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)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 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.
417G–1. Improving
the quality of follow-up care for survivors of childhood cancers and their
families
(a)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)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)Each
grant under this section shall be for a period of 2 years.
(d)Authorization of
appropriationsTo carry out this section, there is authorized to
be appropriated $5,000,000 for each of fiscal years 2012 through 2016.
417G–2.Study of
pilot programs to explore model systems of care
(a)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)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)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
appropriationsTo carry out this section, there is authorized to
be appropriated $10,000,000 for each of fiscal years 2012 through
2016.
.
(c)
(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.
14.Clinics for
comprehensive long-term follow-up services for childhood cancer
survivorsPart 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:
317W.Clinics for
comprehensive long-term follow-up services for childhood cancer
survivors
(a)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)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)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)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
appropriationsTo carry out this section, there is authorized to
be appropriated $15,000,000 for each of fiscal years 2012 through
2016.
.
15.Grants to
improve access to care for childhood cancer survivorsPart 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:
317X.Grants to
improve access to care for childhood cancer survivors
(a)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)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
appropriationsTo carry out this section, there is authorized to
be appropriated $10,000,000 for each of fiscal years 2012 through
2016.
.