To establish a comprehensive interagency response to reduce
lung cancer mortality in a timely manner.
IN THE SENATE OF THE UNITED STATES
April 6 (legislative day, April 5), 2011
Mrs. FEINSTEIN (for herself, Mr. ISAKSON, and Mr. KERRY) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
To establish a comprehensive interagency response to reduce
lung cancer mortality in a timely manner.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Lung Cancer Mortality Reduction Act of
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Lung cancer is the leading cause of cancer death for both men
and women, accounting for 28 percent of all cancer deaths.
(2) The National Cancer Institute estimates that in 2010, there were
222,520 new diagnosis of lung cancer and 157,300 deaths attributed
to the disease.
(3) According to projections published in the Journal of Clinical
Oncology in 2009, between 2010 and 2030, the incidence of lung cancer
will increase by 46 percent for women and by 58 percent for men. The
increase in the incidence of lung cancer among minority communities
during that time period will range from 74 percent to 191 percent.
(4) Lung cancer causes more deaths annually than the next 4 leading
causes of cancer deaths, colon cancer, breast cancer, prostate cancer,
and pancreatic cancer, combined.
(5) The 5-year survival rate for lung cancer is only 15 percent, while
the 5-year survival rate for breast cancer is 89 percent, for prostate
cancer 99 percent, and for colon cancer 65 percent. Yet in research
dollars per death, lung cancer is the least funded of the major cancers.
(6) In 2001, the Lung Cancer Progress Review Group of the National
Cancer Institute stated that funding for lung cancer research was
`far below the levels characterized for other common malignancies
and far out of proportion to its massive health impact' and it gave
the `highest priority' to the creation of an integrated multidisciplinary,
multi-institutional research program. No comprehensive plan has been
(7) While smoking is the leading risk factor for lung cancer, the
President's National Cancer Advisory Board Report of 2010 identified
radon as the second leading cause of lung cancer and listed 15 other
environmental contaminants strongly association with lung cancer,
and there is accumulating evidence that hormonal and genetic factors
may influence the onset.
(8) Lung cancer is the most stigmatized of all the cancers and the
only cancer blamed on patients, whether they smoked or not.
(9) Nearly 20 percent of lung cancer patients have never smoked. Sixty
percent of individuals diagnosed with lung cancer are former smokers
who quit, often decades ago.
(10) Lung cancer in men and women who never smoked is the sixth leading
cause of cancer death. Of individuals diagnosed with lung cancer who
have never smoked, 2/3 of are women.
(11) Lung cancer is the leading cause of cancer death in the overall
population and in every major ethnic grouping, including White, African-American,
Hispanic, Asian and Pacific Islander, American Indian, and Alaskan
Native, with an even disproportionately higher impact on African-American
males that has not been addressed.
(12) Military personnel, veterans, and munitions workers exposed to
carcinogens such as Agent Orange, crystalline forms of silica, arsenic,
uranium, beryllium, and battlefield fuel emissions have increased
risk for lung cancer.
(13) Only 16 percent of lung cancer is being diagnosed at an early
stage and there were no targets for the early detection or treatment
of lung cancer included in the Department of Health and Human Services's
`Healthy People 2010' or `Healthy People 2020'.
(14) An actuarial analysis carried out by Milliman Inc. and published
in Population Health Management Journal in 2009 indicated that early
detection of lung cancer could save more than 70,000 lives a year
in the United States.
(15) A National Cancer Institute study in 2009 indicated that while
the value of life lost to lung cancer will exceed $433,000,000,000
a year by 2020, a 4 percent annual decline in lung cancer mortality
would reduce that amount by more than half.
(16) In 2010, the National Cancer Institute released initial results
from the National Lung Screening Trial, a large-scale randomized national
trial that compared the effect of low-dose helical computed tomography
(`CT') and a standard chest x-ray on lung cancer mortality. The study
found 20 percent fewer lung cancer deaths among study participants
screened with the CT scan.
SEC. 3. SENSE OF THE SENATE CONCERNING INVESTMENT IN LUNG CANCER RESEARCH.
It is the sense of the Senate that--
(1) lung cancer mortality reduction should be made a national public
health priority; and
(2) a comprehensive mortality reduction program coordinated by the
Secretary of Health and Human Services is justified and necessary
to adequately address all aspects of lung cancer and reduce lung cancer
mortality among current smokers, former smokers, and non-smokers.
SEC. 4. LUNG CANCER MORTALITY REDUCTION PROGRAM.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g
et seq.) is amended by adding at the end the following:
`SEC. 399V-6. LUNG CANCER MORTALITY REDUCTION PROGRAM.
`(a) In General- Not later than 180 days after the date of enactment
of the Lung Cancer Mortality Reduction Act of 2011, the Secretary, in
consultation with the Secretary of Defense, the Secretary of Veterans
Affairs, the Director of the National Institutes of Health, the Director
of the Centers for Disease Control and Prevention, the Commissioner
of Food and Drugs, the Administrator of the Centers for Medicare &
Medicaid Services, the Director of the National Center on Minority Health
and Health Disparities, and other members of the Lung Cancer Advisory
Board established under section 7 of the Lung Cancer Mortality Reduction
Act of 2011, shall implement a comprehensive program to achieve a 50
percent reduction in the mortality rate of lung cancer by 2020.
`(b) Requirements- The program implemented under subsection (a) shall
include at least the following:
`(1) With respect to the National Institutes of Health--
`(A) a strategic review and prioritization by the National Cancer
Institute of research grants to achieve the goal of the lung cancer
mortality reduction program in reducing lung cancer mortality;
`(B) the provision of funds to enable the Airway Biology and Disease
Branch of the National Heart, Lung, and Blood Institute to expand
its research programs to include predispositions to lung cancer,
the interrelationship between lung cancer and other pulmonary and
cardiac disease, and the diagnosis and treatment of these interrelationships;
`(C) the provision of funds to enable the National Institute of
Biomedical Imaging and Bioengineering to expedite the development
of screening, diagnostic, surgical, treatment, and drug testing
innovations to facilitate the potential of imaging as a biomarker
and reduce lung cancer mortality, such as through expansion of the
Quantum Grant Program and Image-Guided Interventions programs of
the National Institute of Biomedical Imaging and Bioengineering;
`(D) the provision of funds to enable the National Institute of
Environmental Health Sciences to implement research programs relative
to lung cancer incidence; and
`(E) the provision of funds to enable the National Institute on
Minority Health and Health Disparities to collaborate on prevention,
early detection, and disease management research, and to conduct
outreach programs in order to address the impact of lung cancer
on minority populations.
`(2) With respect to the Food and Drug Administration, the provision
of funds to enable the Center for Devices and Radiologic Health to--
`(A) establish quality standards and guidelines for hospitals, outpatient
departments, clinics, radiology practices, mobile units, physician
offices, or other facilities that conduct computed tomography screening
for lung cancer;
`(B) provide for the expedited revision of standards and guidelines,
as required to accommodate technological advances in imaging; and
`(C) conduct an annual random sample survey to review compliance
and evaluate dose and accuracy performance.
`(3) With respect to the Centers for Disease Control and Prevention--
`(A) the provision of funds to establish a Lung Cancer Early Detection
Program that provides low-income, uninsured, and underserved populations
that are at high risk for lung cancer access to early detection
`(B) the provision of funds to enable the National Institute for
Occupational Safety and Health to conduct research on environmental
contaminants strongly associated with lung cancer in the workplace
and implement measures to reduce lung cancer risk and provide for
an early detection program; and
`(C) a requirement that State, tribal, and territorial plans developed
under the National Comprehensive Cancer Control Program include
lung cancer mortality reduction measures commensurate with the public
health impact of lung cancer.
`(4) With respect to the Agency for Healthcare Research and Quality,
the annual review of lung cancer early detection methods, diagnostic
and treatment protocols, and the issuance of updated guidelines.
`(5) The cooperation and coordination of all programs for women, minorities,
and health disparities within the Department of Health and Human Services
to ensure that all aspects of the Lung Cancer Mortality Reduction
Program adequately address the burden of lung cancer on women and
minority, rural, and underserved populations.
`(6) The cooperation and coordination of all tobacco control and cessation
programs within agencies of the Department of Health and Human Services
to achieve the goals of the Lung Cancer Mortality Reduction Program
with particular emphasis on the coordination of drug and other cessation
treatments with early detection protocols.'.
SEC. 5. DEPARTMENT OF DEFENSE AND THE DEPARTMENT OF VETERANS AFFAIRS.
The Secretary of Defense and the Secretary of Veterans Affairs shall
coordinate with the Secretary of Health and Human Services--
(1) in developing the Lung Cancer Mortality Reduction Program under
section 399V-6 of the Public Health Service Act, as added by section
(2) in implementing the demonstration project under section 6 within
the Department of Defense and the Department of Veterans Affairs with
respect to military personnel and veterans whose smoking history and
exposure to carcinogens during active duty service has increased their
risk for lung cancer; and
(3) in implementing coordinated care programs for military personnel
and veterans diagnosed with lung cancer.
SEC. 6. LUNG CANCER SCREENING DEMONSTRATION PROJECT.
(a) Sense of the Senate- It is the sense of the Senate that a national
computed tomography lung cancer screening demonstration project should
be carried out expeditiously in order to assess the public health infrastructure
needs and to develop the most effective, safe, equitable, and efficient
process that will maximize the public health benefits of screening.
(b) Demonstration Project in General- Not later than 1 year after the
date of enactment of this Act, the Secretary of Health and Human Services
(referred to in this Act as the `Secretary'), in consultation with the
Secretary of Defense, the Secretary of Veterans Affairs, the Director
of the National Institutes of Health, the Director of the Centers for
Disease Control and Prevention, the Commissioner of Food and Drugs,
the Administrator of the Centers for Medicare & Medicaid Services,
and the other members of the Lung Cancer Advisory Board established
under section 7 of the Lung Cancer Mortality Reduction Act of 2011,
shall establish a demonstration project, to be known as the Lung Cancer
Computed Tomography Screening and Treatment Demonstration Project (referred
to in this section as the `demonstration project').
(c) Program Requirements- The Secretary shall ensure that the demonstration
(1) identifies the optimal risk populations that would benefit from
(2) develops the most effective, safe, equitable and cost-efficient
process for screening and early disease management;
(3) allows for continuous improvements in quality controls for the
(4) serves as a model for the integration of health information technology
and the concept of a rapid learning into the health care system.
(d) Participation- The Secretary shall select not less than 5 National
Cancer Institute Centers, 5 Department of Defense Medical Treatment
Centers, 5 sites within the Veterans Affairs Healthcare Network, 5 International
Early Lung Cancer Action Program sites, 10 community health centers
for minority and underserved populations, and additional sites as the
Secretary determines appropriate, as sites to carry out the demonstration
project described under this section.
(e) Quality Standards and Guidelines for Licensing of Tomography Screening
Facilities- The Secretary shall establish quality standards and guidelines
for the licensing of hospitals, outpatient departments, clinics, radiology
practices, mobile units, physician offices, or other facilities that
conduct computed tomography screening for lung cancer through the demonstration
project, that will require the establishment and maintenance of a quality
assurance and quality control program at each such facility that is
adequate and appropriate to ensure the reliability, clarity, and accuracy
of the equipment and interpretation of the screening scan and set appropriate
standards to control the levels of radiation dose.
(f) Timeframe- The Secretary shall conduct the demonstration project
under this section for a 5-year period.
(g) Report- Not later than 180 days after the date of enactment of this
Act, the Secretary shall submit a report to Congress on the projected
cost of the demonstration project, and shall submit annual reports to
Congress thereafter on the progress of the demonstration project and
SEC. 7. LUNG CANCER ADVISORY BOARD.
(a) In General- The Secretary of Health and Human Services shall establish
a Lung Cancer Advisory Board (referred to in this section as the `Board')
to monitor the programs established under this Act (and the amendments
made by this Act), and provide annual reports to Congress concerning
benchmarks, expenditures, lung cancer statistics, and the public health
impact of such programs.
(b) Composition- The Board shall be composed of--
(1) the Secretary of Health and Human Services;
(2) the Secretary of Defense;
(3) the Secretary of Veterans Affairs;
(4) the Director of the Occupational Safety and Health Administration;
(5) the Director of the National Institute of Standards and Technology;
(6) one representative each from the fields of clinical medicine focused
on lung cancer, lung cancer research, radiology, imaging research,
drug development, minority health advocacy, veterans service organizations,
lung cancer advocacy, and occupational medicine to be appointed by
the Secretary of Health and Human Services.
SEC. 8. AUTHORIZATION OF APPROPRIATIONS.
To carry out this Act (and the amendments made by this Act), there are
authorized to be appropriated such sums as may be necessary for each
of fiscal years 2012 through 2016.