[Congressional Record Volume 155, Number 52 (Thursday, March 26, 2009)]
[Senate]
[Pages S3905-S3915]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Mrs. Hutchison, and Mrs. Feinstein):
  S. 717. A bill to modernize cancer research, increase access to 
preventative cancer services, provide cancer treatment and survivorship 
initiatives, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. KENNEDY. Mr. President, 37 years ago, a Republican President and 
Democratic Congress came together in a new commitment to find a cure 
for cancer. At the time, a cancer diagnosis meant almost certain death. 
In 1971, we took action against this deadly disease and passed the 
National Cancer Act with broad bipartisan support, and it marked the 
beginning of the War on Cancer.
  Since then, significant progress has been made. Amazing scientific 
research has led to methods to prevent cancer, and treatments that give 
us more beneficial and humane ways to deal with the illness. The 
discoveries of basic research, the use of large scale clinical trials, 
the development of new drugs, and the special focus on prevention and 
early detection have led to breakthroughs unimaginable only a 
generation ago.
  As a result, cancer today is no longer the automatic death sentence 
that it was when the war began. But despite the advances we have made 
against cancer, other changes such as aging of the population, emerging 
environmental issues, and unhealthy behavior, have allowed cancer to 
persist. The lives of vast numbers of Americans have been touched by 
the disease. In 2008, over 1.4 million Americans were diagnosed with 
some form of cancer, and more than half a million lost their lives to 
the disease.
  The solution is not easy but there are steps we can and must take 
now, if we hope to see the diagnosis rate decline substantially and the 
survival rate increase in the years ahead. The immediate challenge we 
face is to reduce the barriers that obstruct progress in cancer 
research and treatment by integrating our current fragmented and 
piecemeal system of addressing the disease.
  Last year, my colleague Senator Hutchison and I agreed that to build 
on what the nation has accomplished, we must launch a new and more 
urgent war on cancer. The 21st Century Cancer ALERT Act we are 
introducing today will accelerate our progress by using a better 
approach to fighting this relentless disease. Our goal is to break down 
the many barriers that impede cancer research and prevent patients from 
obtaining the treatment that can save their lives.
  We must do more to prevent cancer, by emphasizing scientifically 
proven methods such as tobacco cessation, healthy eating, and exercise. 
Healthy families and communities that have access to nutritious foods 
and high quality preventive health care will be our best defense 
against the disease. I

[[Page S3906]]

am confident that swift action on national health reform will make our 
vision of a healthier Nation a reality. Obviously, we cannot prevent 
all cancers, so it is also essential that the cancers that do arise be 
diagnosed at an initial, curable stage, with all Americans receiving 
the best possible care to achieve that goal.
  We cannot overemphasize the value of the rigorous scientific efforts 
that have produced the progress we have made so far. To enhance these 
efforts, our bill invests in two key aspects of cancer research--
infrastructure and collaboration of the researchers. We include 
programs that will bring resources to the types of cancer we least 
understand. We invest in scientists who are committed to translating 
basic research into clinical practice, so that new knowledge will be 
brought to the patients who will most benefit from it.
  One of the most promising new breakthroughs is in identifying and 
monitoring the biomarkers that leave enough evidence in the body to 
alert clinicians to subtle signs that cancer may be developing. 
Biomarkers are the new frontier for improving the lives of cancer 
patients because they can lead to the earliest possible detection of 
cancer, and the Cancer ALERT Act will support the development of this 
revolutionary biomarker technology.
  In addition, we give new focus to clinical trials, which have been 
the cornerstones of our progress in treating cancer in recent decades. 
Only through clinical trials are we able to discover which treatments 
truly work. Today, however, less than 5 percent of cancer patients 
currently are enrolled in clinical trials, because of the many barriers 
exist that prevent both providers and patients from participating in 
these trials. A primary goal of our bill is to begin removing these 
barriers and expanding access to clinical trials for many more 
patients.
  Further, since many cancer survivors are now living longer lives, our 
health systems must be able to accommodate these men and women who are 
successfully fighting against this deadly disease. It is imperative for 
health professionals to have the support they need to care for these 
survivors. To bring good lifelong care to cancer survivors, we must 
invest more in research to understand the later effects of cancer and 
how treatments affect survivors' health and the quality of their lives.
  We stand today on the threshold of unprecedented new advances in this 
era of extraordinary discoveries in the life sciences, especially in 
personalized medicine, early diagnosis of cancer at the molecular 
level, and astonishing new treatments based on a patient's own DNA. To 
make the remarkable promise of this new era a reality, we must make 
sure that patients can take DNA tests, free of the fear that their 
genetic information will somehow be used to discriminate against them. 
We took a major step toward unlocking the potential of this new era by 
approving strong protections against genetic discrimination in health 
insurance and employment when the Genetic Nondiscrimination Act was 
signed into law last year.
  In sum, we need a new model for research, prevention and treatment of 
cancer, and we are here today to start that debate in Congress. We must 
move from a magic bullet approach to a broad mosaic of care, in which 
survivorship is also a key part of our approach to cancer. By doing so, 
we can take a giant step toward reducing or even eliminating the burden 
of cancer in our Nation and the world. It is no longer an impossible 
dream, but a real possibility for the future.
  Mr. President, I ask by unanimous consent that the text of the bill 
be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 717

       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 ``21st Century Cancer ALERT 
     (Access to Life-Saving Early detection, Research and 
     Treatment) Act''.

     SEC. 2. FINDINGS AND PURPOSE.

       (a) Findings.--Congress makes the following findings:
       (1) One in 2 men and one in 3 women are expected to develop 
     cancer in their lifetimes.
       (2) Cancer is the leading cause of death for people under 
     the age of 85 and is expected to claim more than 1,500 lives 
     per day in 2008.
       (3) At least 30 percent of all cancer deaths and 87 percent 
     of lung cancer deaths are attributed to smoking.
       (4) The National Institutes of Health estimates that in 
     2007 alone, the overall cost of cancer to the United States 
     was more than $219,000,000,000.
       (5) In recent decades, the biomedical research enterprise 
     has made considerable advances in the knowledge required to 
     understand, prevent, diagnose, and treat cancer; however, it 
     still takes 17 years, on average, to translate these 
     discoveries into viable treatment options.
       (6) While clinical trials are vital to the discovery and 
     implementation of new preventative, diagnostic, and treatment 
     options, only 3 to 5 percent of the more than 10,000,000 
     adults with cancer in the United States participate in cancer 
     clinical trials.
       (7) Where people reside should not determine whether they 
     live, yet women in rural areas are less likely to obtain 
     preventative cancer screenings than those residing in urban 
     areas.
       (8) Two-thirds of childhood cancer survivors are likely to 
     experience at least one late effect from treatment and one-
     fourth are expected to experience a late effect that is life 
     threatening.
       (9) In 1971, there were only 3,000,000 cancer survivors. 
     Today, cancer survivors account for 3 percent of the United 
     States population, approximately 12,000,000.
       (10) The National Cancer Act of 1971 (Public Law 92-218) 
     advanced the ability of the United States to develop new 
     scientific leads and help increase the rate of cancer 
     survivorship.
       (11) Yet in the 37 years since the national declaration of 
     the War on Cancer, the age adjusted mortality rate for cancer 
     is still extraordinarily high. Eight forms of cancer have a 
     5-year survival rate of less than 50 percent (pancreatic, 
     liver, lung, esophageal, stomach, brain, multiple myeloma, 
     and ovarian).
       (12) While there have been substantial achievements since 
     the crusade began, we are far from winning the war on cancer.
       (13) Many obstacles have hindered our progress in cancer 
     prevention, research, and treatment.
       (b) Purposes.--The purposes of this Act are as follows:
       (1) To reauthorize the National Cancer Institute and 
     National Cancer Program in order to enhance and improve the 
     cancer research conducted and supported by the National 
     Cancer Institute and the National Cancer Program in order to 
     benefit cancer patients.
       (2) To recognize that with an increased understanding of 
     cancer as more than 200 different diseases with genetic and 
     molecular variations, there is a need for increased 
     coordination and greater flexibility in how cancer research 
     is conducted and coordinated in order to maximize the return 
     the United States receives on its investment in such 
     research.
       (3) To prepare for the looming impact of an aging 
     population of the United States and the anticipated financial 
     burden associated with medical treatment and lost 
     productivity, along with the toll of human suffering that 
     accompanies a cancer diagnosis.
       (4) To support the National Cancer Institute in 
     establishing relationships and scientific consortia with an 
     emphasis on public-private partnership development, which 
     will further the development of advanced technologies that 
     will improve the prevention, diagnosis, and treatment of 
     cancer.

     SEC. 3. ADVANCEMENT OF THE NATIONAL CANCER PROGRAM.

       Section 411 of the Public Health Service Act (42 U.S.C. 
     285a) is amended to read as follows:

     ``SEC. 411. NATIONAL CANCER PROGRAM.

       ``(a) In General.--There shall be established a National 
     Cancer Program (referred to in this section as the `Program') 
     that shall consist of--
       ``(1) an expanded, intensified, and coordinated cancer 
     research program encompassing the research programs conducted 
     and supported by the Institute and the related research 
     programs of the other national research institutes, including 
     an expanded and intensified research program for the 
     prevention of cancer caused by occupational or environmental 
     exposure to carcinogens; and
       ``(2) the other programs and activities of the Institute.
       ``(b) Collaboration.--In carrying out the Program--
       ``(1) the Secretary and the Director of the Institute shall 
     identify relevant Federal agencies that shall collaborate 
     with respect to activities conducted under the Program 
     (including the Institute, the other Institutes and Centers of 
     the National Institutes of Health, the Office of the Director 
     of the National Institutes of Health, the Food and Drug 
     Administration, the Centers for Medicare & Medicaid Services, 
     the Centers for Disease Control and Prevention, the 
     Department of Defense, the Department of Energy, the Agency 
     for Healthcare Research and Quality, the Office for Human 
     Research Protections, the Health Resources and Services 
     Administration, and the Office for Human Research 
     Protections); and
       ``(2) the Secretary shall ensure that the policies related 
     to the promotion of cancer research of all agencies within 
     the Department of Health and Human Services (including the 
     Institute, the Food and Drug Administration, and the Centers 
     for Medicare & Medicaid Services) are harmonized, and shall

[[Page S3907]]

     ensure that such agencies collaborate with regard to cancer 
     research and development.
       ``(c) Transparency and Efficiency.--
       ``(1) Budgeting.--In carrying out the Program, the Director 
     of the Institute shall, in preparing and submitting to the 
     President the annual budget estimate for the Program--
       ``(A) develop the budgetary needs of the entire Program and 
     submit the budget estimate relating to such needs to the 
     National Cancer Advisory Board for review prior to submitting 
     such estimate to the President; and
       ``(B) submit such budget estimate to the Committee on the 
     Budget and the Committee on Appropriations of the Senate and 
     the Committee on the Budget and Committee on Appropriations 
     of the House of Representatives at the same time that such 
     estimate is submitted to the President.
       ``(2) National cancer advisory board.--In establishing the 
     priorities of the Program, the National Cancer Advisory Board 
     shall provide for increased coordination by increasing the 
     participation of representatives (to the extent practicable, 
     representatives who have appropriate decision making 
     authority) of appropriate Federal agencies, including--
       ``(A) the Centers for Medicare & Medicaid Services;
       ``(B) the Health Resources and Services Administration;
       ``(C) the Centers for Disease Control and Prevention; and
       ``(D) the Agency for Healthcare Research and Quality.
       ``(d) Programs to Encourage Early Detection Research.--The 
     Director of the Institute shall develop a standard process 
     through which Federal agencies, including the Department of 
     Defense, and administrators of federally funded programs may 
     engage in early cancer detection research.
       ``(e) Identification of Promising Translational Research 
     Opportunities.--
       ``(1) In general.--The Director of the Institute, acting 
     through the Program and in accordance with the NIH Reform Act 
     of 2007, shall continue to identify promising translational 
     research opportunities across all disease sites, populations, 
     and pathways to clinical goals through a transparent, 
     inclusive process by--
       ``(A) continuing to support efforts to develop a robust 
     number of public or nonprofit entities to carry out early 
     translational research activities;
       ``(B) emphasizing the role of the young researcher in the 
     program under this section; and
       ``(C) modifying guidelines for multiproject, collaborative, 
     early translational research awards to focus research and 
     reward collaborative team science.
       ``(2) Matching funds for research.--
       ``(A) In general.--The Secretary may provide assistance to 
     eligible entities to match the amount of non-Federal funds 
     made available by such entity for translational research of 
     the type described in paragraph (1) relating to cancer.
       ``(B) Eligibility.--To be eligible to receive assistance 
     under subparagraph (A), an entity shall submit to the 
     Secretary an application at such time, in such manner, and 
     containing such information as the Secretary may require.
       ``(C) Recommendations and prioritization.--In providing 
     assistance under subparagraph (A), the Secretary shall--
       ``(i) select entities based on the recommendations of--

       ``(I) the Director of NIH; and
       ``(II) a peer review process; and

       ``(ii) give priority to those entities submitting 
     applications under subparagraph (B) that demonstrate that the 
     research involved is high risk or translational research (as 
     determined by the Secretary).
       ``(D) Amount.--The amount of assistance to be provided to 
     an entity under subparagraph (A) shall be at the discretion 
     of the Secretary but shall not exceed an amount equal to 100 
     percent of the amount of non-Federal funds ($1 for each $2 of 
     non-Federal funds) made available for research described in 
     subparagraph (A).
       ``(E) Determination of amount of non-federal 
     contribution.--Non-Federal funds to be matched under 
     subparagraph (A) may be in cash or in kind, fairly evaluated, 
     including plant, equipment, or services. Amounts provided by 
     the Federal Government, and any portion of any service 
     subsidized by the Federal Government, may not be included in 
     determining the amount of such non-Federal funds.
       ``(f) Biological Resource Coordination and Advancement of 
     Technologies for Cancer Research.--
       ``(1) Establishment.--The Director of the Institute, acting 
     through the Program, shall establish an entity within the 
     Institute to augment ongoing efforts to advance new 
     technologies in cancer research, support the national 
     collection of tissues for cancer research purposes, and 
     ensure the quality of tissue collection.
       ``(2) Goals.--The entity established under paragraph (1) 
     shall--
       ``(A) be designed to expand the access of researchers to 
     biospecimens for cancer research purposes;
       ``(B) establish uniform standards for the handling and 
     preservation of patient tissue specimens by entities 
     participating in the network established under paragraph (3);
       ``(C) require adequate annotation of all relevant clinical 
     data while assuring patient privacy;
       ``(D) facilitate the linkage of public and private entities 
     into the national network under paragraph (3);
       ``(E) provide for the linkage of cancer registries to other 
     administrative Federal Government data sources, including the 
     Centers for Medicare & Medicaid Services, the Social Security 
     Administration, and the Centers for Disease Control and 
     Prevention, with the goal of understanding the determinants 
     of cancer treatment, care, and outcomes by allowing economic, 
     social, genetic, and other factors to be analyzed in an 
     independent manner; and
       ``(F) develop strategies to ensure patient rights and 
     privacy, including an assessment of the regulations 
     promulgated pursuant to part C of title XI of the Social 
     Security Act and section 264(c) of the Health Insurance 
     Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
     note) (referred to in this section as the `HIPAA Privacy 
     Rule'), while facilitating advances in medical research.
       ``(3) Advancement of new technologies for cancer research 
     and expansion of cancer biorepository networks.--
       ``(A) In general.--As part of the entity established under 
     paragraph (1), the Director of the Institute shall build upon 
     existing initiatives to establish an interconnected network 
     of biorepositories (referred to in this subsection as the 
     `Network') with consistent, interoperable systems for the 
     collection and storage of tissues and information, the 
     annotation of such information, and the sharing of such 
     information through an interoperable information system.
       ``(B) Guidelines.--A biorepository in the Network that 
     receives Federal funds shall adopt the Institute's Best 
     Practices for Biospecimen Resources for Institute-supported 
     biospecimen resources (as published by the Institute and 
     including any successor guidelines) for the collection of 
     biospecimens and any accompanying data.
       ``(C) Representation.--The composition of any leadership 
     entity of the Network shall be determined by the Director of 
     the Institute and shall, at a minimum, include a 
     representative of--
       ``(i) private sector entities and individuals, including 
     cancer researchers and health care providers;
       ``(ii) the Centers for Disease Control and Prevention;
       ``(iii) the Agency for Healthcare Research and Quality;
       ``(iv) the Office of National Coordination of Health 
     Information Technology;
       ``(v) the National Library of Medicine;
       ``(vi) the Office for the Protection of Research Subjects; 
     and
       ``(vii) the National Science Foundation.
       ``(D) Partnerships with tissue source sites.--The Director 
     of the Institute may enter into contracts with tissue source 
     sites to acquire data from such sites. Any such data shall be 
     acquired through the use of protocols and closely monitored, 
     transparent procedures within appropriate ethical and legal 
     frameworks.
       ``(4) Collection of data.--
       ``(A) Hospitals.--A hospital or ambulatory cancer center 
     that receives Federal funds shall offer patients the 
     opportunity to contribute their biospecimens and clinical 
     data to the entity established under paragraph (1).
       ``(B) Clinical trial data.--Clinical trial data relating to 
     cancer care and treatment shall be provided to the entity 
     established under paragraph (1).''.

     SEC. 4. COMPREHENSIVE AND RESPONSIBLE ACCESS TO RESEARCH, 
                   DATA, AND OUTCOMES.

       (a) In General.--Not later than 180 days after the date of 
     enactment of this Act, the Director of the Office for Human 
     Research Protections shall issue guidance to National 
     Institutes of Health grantees concerning use of the 
     facilitated review process in conjunction with the central 
     institutional review board of the National Cancer Institute 
     as the preferred mechanism to satisfy regulatory requirements 
     to review ethical or scientific issues for all National 
     Cancer Institute-supported translational and clinical 
     research.
       (b)  Improved Privacy Standards in Clinical Research.--
       (1) Permitted disclosure under the privacy rule.--For 
     purposes of the Privacy Rule (as referred to in section 
     411(f)(2)(F) of the Public Health Service Act, as amended by 
     this Act), a covered entity (as defined for purposes of such 
     Rule) shall be in compliance with such Rule relating to the 
     disclosure of de-identified patient information if such 
     disclosure is--
       (A) pursuant to a waiver that had been granted by an 
     institutional review board or privacy board relating to such 
     disclosure; and
       (B) the entity informs patients when they make first 
     patient contact with the entity that the entity is a research 
     institution that may conduct research using their de-
     identified medical records.
       (2) Synchronization of standards.--
       (A) In general.--The Secretary of Health and Human Services 
     shall study the advantages and disadvantages of the 
     synchronization of the standards for research under the 
     Common Rule (under part 46 of title 45, Code of Federal 
     Regulations) and the Privacy Rule (as defined in section 
     411(f)(2)(F) of the Public Health Service Act, as amended by 
     this Act) in order to determine the appropriate data elements 
     that should be omitted under the strict de-identification 
     standards relating to personal information.

[[Page S3908]]

       (B) Review of recommendations.--In carrying out 
     subparagraph (A), the Secretary of Health and Human Services 
     shall conduct a review of recommendations made by the 
     Advisory Committee on Human Research Protections as well as 
     recommendations from the appropriate leadership of the 
     National Committee on Vital and Health Statistics.
       (C) Additional areas.--In carrying out subparagraph (A), 
     the Secretary of Health and Human Services shall--
       (i) make recommendations concerning the conduct of 
     international research to determine the boundaries and 
     applications of extraterritorially under the Privacy Rule (as 
     referred to in section 411(f)(2)(F) of the Public Health 
     Service Act, as amended by this Act); and
       (ii) include biorepository storage information when 
     obtaining patient consent.
       (D) Report.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to the appropriate committee of 
     Congress, a report concerning the recommendations made under 
     this paragraph.
       (3) Application of privacy rule to external researchers.--
       (A) In general.--Notwithstanding any other provision of 
     law, the Privacy Rule (as defined in section 411(f)(2)(F) of 
     the Public Health Service Act, as amended by this Act) shall 
     apply to external researchers.
       (B) Definition.--
       (i) In general.--In this paragraph, the term ``external 
     researcher'' means a researcher who is on the staff of a 
     covered entity (as defined in the Privacy Rule) but who is 
     not actually employed by such covered entity.
       (ii) Internal and external researchers.--With respect to 
     determining the distinction of whether or not a researcher 
     has the ability to use protected health information under the 
     provisions of this paragraph, such determination shall be 
     based on whether the covered entity involved exercises 
     effective control over that researcher's activities. For 
     purposes of the preceding sentence, effective control may 
     include membership and privileges of staff or the ability to 
     terminate staff membership or discipline staff.
       (c) Liability.--The Director of the Office of Human 
     Research Protection, the Director of the National Institutes 
     of Health, and the Director of the National Cancer Institute 
     shall issue guidance for entities awarded grants by such 
     Federal agencies to provide instruction on how such entities 
     may best address concerns or issues relating to the liability 
     that institutions or researchers may incur as a result of 
     using the facilitated review process.

     SEC. 5. ENHANCED FOCUS AND REPORTING ON CANCER RESEARCH.

       Part C of title IV of the Public Health Service Act (42 
     U.S.C. 285 et seq.) is amended by inserting after section 
     417A the following:

     ``SEC. 417B. ENHANCED FOCUS AND REPORTING ON CANCER RESEARCH.

       ``(a) Annual Independent Report.--
       ``(1) In general.--The Director of the Institute shall 
     complete an annual independent report that shall be submitted 
     to Congress on the same date that the annual budget estimate 
     described in section 413(b)(9) is submitted to the President.
       ``(2) Contents of report.--
       ``(A) Cancer categories.--The report required under 
     paragraph (1) shall address the following categories of 
     cancer:
       ``(i) Cancers that result in a 5-year survival rate of less 
     than 50 percent.
       ``(ii) Cancers in which the incidence rate is less than 15 
     cases per 100,000 people, or fewer than 40,000 new cases per 
     year.
       ``(B) Information.--With regard to each of the categories 
     of cancer described in subparagraph (A), the report shall 
     contain information regarding--
       ``(i) a strategic plan for reducing the mortality rate for 
     the annual year, including specific research areas of 
     interest and budget amounts;
       ``(ii) identification of any barriers to implementing the 
     strategic plan described in clause (i) for the annual year;
       ``(iii) if the report for the prior year contained a 
     strategic plan described in clause (i), an assessment of the 
     success of such plan;
       ``(iv) the total amount of grant funding, including the 
     total dollar amount awarded per grant and per funding year, 
     under--

       ``(I) the National Cancer Institute; and
       ``(II) the National Institutes of Health;

       ``(v) the percentage of grant applications favorably 
     reviewed by the Institute that the Institute funded in the 
     previous annual year;
       ``(vi) the total number of grant applications, with greater 
     than 50 percent relevance to each of the categories of cancer 
     described in subparagraph (A), received by the Institute for 
     awards in the previous annual year;
       ``(vii) the total number of grants awarded, with greater 
     than 50 percent relevance to each of the categories of cancer 
     described in subparagraph (A), for the previous annual year 
     and the number of awards per grant type, including the Common 
     Scientific Outline designation specific to each such grant; 
     and
       ``(viii) the total number of primary investigators that 
     received grants from the Institute for projects with greater 
     than 50 percent relevance to each of the categories of cancer 
     described in paragraph (1), including the total number of 
     awards granted to experienced investigators and the total 
     number of awards granted to investigators receiving their 
     first grant from the National Institutes of Health.
       ``(3) Definition.--In this section, the term `annual year' 
     means the year for which the strategic plan described in 
     paragraph (2)(B)(i) applies, which shall be the same fiscal 
     year for which the Director of the Institute submits the 
     annual budget estimate described in section 413(b)(9) for 
     that year.
       ``(b) Grant Program.--
       ``(1) In general.--The Director of the Institute, in 
     cooperation with the Director of the Fogarty International 
     Center for Advanced Study in the Health Sciences and the 
     Directors of other Institutes, as appropriate, shall award 
     grants to researchers to conduct research regarding cancers 
     for which--
       ``(A) the incidence is fewer than 40,000 new cases per 
     year; and
       ``(B) the 5-year survival rate is less than 50 percent.
       ``(2) Prioritization.--In awarding grants for research 
     regarding cancers described in paragraph (1)(A), the Director 
     of the Institute shall give priority to collaborative 
     research projects between adult and pediatric cancer 
     research, with preference for projects building upon existing 
     multi-institutional research infrastructures.
       ``(3) Tissue samples.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the Director of the Institute shall require each recipient 
     receiving a grant under this subsection to submit tissue 
     samples to designated tumor banks.
       ``(B) Waiver.--The Director of the Institute may grant a 
     waiver of the requirement described in subparagraph (A) to a 
     recipient who receives a grant for research described in 
     paragraph (1)(B) and who submits an application for such 
     waiver to the Director of the Institute, in the manner in 
     which such Director may require.''.

     SEC. 6. CONTINUING ACCESS TO CARE FOR PREVENTION AND EARLY 
                   DETECTION.

       (a) Colorectal Cancer Screening Program.--Part B of title 
     III of the Public Health Service Act is amended by inserting 
     after section 317D (42 U.S.C. 247b-5) the following:

     ``SEC. 317D-1. COLORECTAL CANCER SCREENING PROGRAM.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     may award competitive grants to eligible entities to carry 
     out programs--
       ``(1) to provide screenings for colorectal cancer to 
     individuals according to screening guidelines set by the 
     United States Preventive Services Task Force;
       ``(2) to provide appropriate referrals for medical 
     treatment of individuals screened pursuant to paragraph (1) 
     and to ensure, to the extent practicable, the provision of 
     appropriate follow-up services and support services such as 
     case management;
       ``(3) to develop and disseminate public information and 
     education programs for the detection and control of colon 
     cancer;
       ``(4) to improve the education, training, and skills of 
     health professionals (including allied health professionals) 
     in the detection and control of colon cancer;
       ``(5) to establish mechanisms through which eligible 
     entities can monitor the quality of screening procedures for 
     colon cancer, including the interpretation of such 
     procedures; and
       ``(6) to evaluate activities conducted under paragraphs (1) 
     through (5) through appropriate surveillance or program-
     monitoring activities.
       ``(b) Eligibility.--
       ``(1) In general.--To be eligible to receive a grant under 
     this section an entity shall--
       ``(A) be--
       ``(i) a State; or
       ``(ii) an Indian tribe or tribal organization (as such 
     terms are defined in section 4 of the Indian Self-
     Determination and Education Assistance Act);
       ``(B) submit to the Secretary as application, at such time, 
     in such manner, and containing such information as the 
     Secretary may require, including--
       ``(i) a description of the purposes for which the entity 
     intends to expend amounts under the grant; and
       ``(ii) a description of the populations, areas, and 
     localities with a need for the services or activities 
     described in clause (i);
       ``(C) provide matching funds in accordance with paragraph 
     (2);
       ``(D) provide assurances that the entity will--
       ``(i) establish such fiscal control and fund accounting 
     procedures as may be necessary to ensure the proper disbursal 
     of, and accounting for, amounts received under subsection 
     (a);
       ``(ii) upon request, provide records maintained pursuant to 
     clause (i) to the Secretary or the Comptroller General of the 
     United States for purposes of auditing the expenditures of 
     the grant by the eligible entity; and
       ``(iii) submit to the Secretary such reports as the 
     Secretary may require with respect to the grant; and
       ``(E) provide assurances that the entity will comply with 
     the restrictions described in subsection (e).
       ``(2) Matching requirement.--
       ``(A) In general.--The Secretary may not award a grant to 
     an eligible entity under this section unless the eligible 
     entity involved agrees, with respect to the costs to be 
     incurred by the eligible entity in carrying out the purpose 
     described in the application under paragraph (1)(B)(i), to 
     make available non-Federal contributions (in cash or in kind 
     under subparagraph (B)) toward such costs in an amount equal 
     to not less than $1 for each $3 of Federal funds provided in 
     the grant.

[[Page S3909]]

     Such contributions may be made directly or through donations 
     from public or private entities.
       ``(B) Determination of amount of non-federal 
     contribution.--
       ``(i) In general.--Non-Federal contributions required in 
     subparagraph (A) may be in cash or in kind, fairly evaluated, 
     including equipment or services (and excluding indirect or 
     overhead costs). Amounts provided by the Federal Government, 
     or services assisted or subsidized to any significant extent 
     by the Federal Government, may not be included in determining 
     the amount of such non-Federal contributions.
       ``(ii) Maintenance of effort.--In making a determination of 
     the amount of non-Federal contributions for purposes of 
     subparagraph (A), the Secretary may include only non-Federal 
     contributions in excess of the average amount of non-Federal 
     contributions made by the eligible entity involved toward the 
     purpose described in subsection (a) for the 2-year period 
     preceding the first fiscal year for which the eligible entity 
     is applying to receive a grant under such section.
       ``(iii) Inclusion of relevant non-federal contributions for 
     medicaid.--In making a determination of the amount of non-
     Federal contributions for purposes of subparagraph (A), the 
     Secretary shall, subject to clauses (i) and (ii), include any 
     non-Federal amounts expended pursuant to title XIX of the 
     Social Security Act by the eligible entity involved toward 
     the purpose described in paragraphs (1) and (2) of subsection 
     (a).
       ``(c) Prioritization.--
       ``(1) In general.--In awarding grants under this section, 
     the Secretary shall give priority to recipients that are 
     safety-net providers.
       ``(2) Definition.--In this section, the term `safety-net 
     provider' means a health care provider--
       ``(A) that by legal mandate or explicitly adopted mission, 
     offers care to individuals without regard to the individual's 
     ability to pay for such services; or
       ``(B) for whom a substantial share of the patients are 
     uninsured, receive Medicaid, or are otherwise vulnerable.
       ``(d) Use of Funds.--
       ``(1) In general.--An eligible entity may, subject to 
     paragraphs (2) and (3), expend amounts received under a grant 
     under subsection (a) to carry out the purposes described in 
     such subsection through the awarding of grants to public and 
     nonprofit private entities and through contracts entered into 
     with public and private entities.
       ``(2) Certain application.--If a nonprofit private entity 
     and a private entity that is not a nonprofit entity both 
     submit applications to a grantee under subsection (a) for a 
     grant or contract as provided for in paragraph (1), the 
     grantee may give priority to the application submitted by the 
     nonprofit private entity in any case in which the grantee 
     determines that the quality of such application is equivalent 
     to the quality of the application submitted by the other 
     private entity.
       ``(3) Payments for screenings.--The amount paid by a 
     grantee under subsection (a) to an entity under this 
     subsection for a screening procedure as described in 
     subsection (a)(1) may not exceed the amount that would be 
     paid under part B of title XVIII of the Social Security Act 
     if payment were made under such part for furnishing the 
     procedure to an individual enrolled under such part.
       ``(e) Restriction on Use of Fund.--The Secretary may not 
     award a grant to an eligible entity under subsection (a) 
     unless the entity agrees that--
       ``(1) in providing screenings under subsection (a)(1), the 
     eligible entity will give priority to low-income individuals 
     who lack adequate coverage under health insurance and health 
     plans with respect to screenings for colorectal cancer;
       ``(2) initially and throughout the period during which 
     amounts are received pursuant to the grant, not less than 60 
     percent of the grant shall be expended to provide each of the 
     services or activities described in subsections (a)(1) and 
     (a)(2);
       ``(3) not more than 10 percent of the grant will be 
     expended for administrative expenses with respect to the 
     activities funded under the grant;
       ``(4) funding received under the grant will supplement, and 
     not supplant, the expenditures of the eligible entity and the 
     value for in-kind contributions for carrying out the 
     activities for which the grant was awarded;
       ``(5) funding will not be expended to make payment for any 
     item or service to the extent that payment has been made, or 
     can reasonably be expected to be made, with respect to such 
     item or service--
       ``(A) under any State compensation program, under an 
     insurance policy, or under any Federal or State health 
     benefits program; or
       ``(B) by an entity that provides health services on a 
     prepaid basis; and
       ``(6) funds will not be expended to provide inpatient 
     hospital services for any individual.
       ``(f) Limitation on Imposition of Fees for Services.--The 
     Secretary may not award a grant to an eligible entity under 
     this section unless the eligible entity involved agrees that, 
     if a charge is imposed for the provision of services or 
     activities under the grant, such charge--
       ``(1) will be made according to a schedule of charges that 
     is made available to the public;
       ``(2) will be adjusted to reflect the income of the 
     individual involved; and
       ``(3) will not be imposed on any individual with an income 
     of less than 100 percent of the official poverty line, as 
     established by the Director of the Office of Management and 
     Budget and revised by the Secretary in accordance with 
     section 673(2) of the Community Services Block Grant Act (42 
     U.S.C. 9902(2)), including any revision required by such 
     section.
       ``(g) Requirement Regarding Medicare.--The Secretary may 
     not award a grant to an eligible entity under this section 
     unless the eligible entity involved provides, as applicable, 
     the following assurances:
       ``(1) Screenings under subsection (a)(1) will be carried 
     out as preventive health measures in accordance with 
     evidence-based screening guidelines and procedures as 
     specified in section 1861(pp)(1) of the Social Security Act.
       ``(2) An individual will be considered high risk for 
     purposes of subsection (a)(1) only if the individual is high 
     risk within the meaning of section 1861(pp)(2) of such Act.
       ``(h) Requirement Regarding Medicaid.--The Secretary may 
     not award a grant to an eligible entity under subsection (a) 
     unless the State plan under title XIX of the Social Security 
     Act for the State includes the screening procedures and 
     referrals specified in subsections (a)(1) and (a)(2) as 
     medical assistance provided under the plan.
       ``(i) Technical Assistance and Provision of Supplies and 
     Services in Lieu of Grant Funds.--
       ``(1) Technical assistance.--The Secretary may provide 
     training and technical assistance with respect to the 
     planning, development, and operation of any program funded by 
     a grant under subsection (a). The Secretary may provide such 
     technical assistance directly to eligible entities or through 
     grants to, or contracts with, public and private entities.
       ``(2) Provision of supplies and services in lieu of grant 
     funds.--
       ``(A) In general.--Subject to subparagraph (B), upon the 
     request of an eligible entity receiving a grant under 
     subsection (a), the Secretary, for the purpose of aiding the 
     eligible entity to carry out a program under this section--
       ``(i) may provide supplies, equipment, and services to the 
     eligible entity; and
       ``(ii) may detail to the eligible entity any officer or 
     employee of the Department of Health and Human Services.
       ``(B) Corresponding reduction in payments.--With respect to 
     a request made by an eligible entity under subparagraph (A), 
     the Secretary shall reduce the amount of payments made under 
     the grant under subsection (a) to the eligible entity by an 
     amount equal to the fair market value of any supplies, 
     equipment, or services provided by the Secretary and the 
     costs of detailing personnel (including pay, allowances, and 
     travel expenses) under subparagraph (A). The Secretary shall, 
     for the payment of expenses incurred in complying with such 
     request, expend the amounts withheld.
       ``(j) Evaluations and Report.--
       ``(1) Evaluations.--The Secretary shall, directly or 
     through contracts with public or private entities, provide 
     for annual evaluations of programs carried out pursuant to 
     this section. Such evaluations shall include evaluations of 
     the extent to which eligible entities carrying out such 
     programs are in compliance with subsection (a)(2).
       ``(2) Report to congress.--The Secretary shall, not later 
     than 1 year after the date on which amounts are first 
     appropriated to carry out this section, and annually 
     thereafter, submit to Congress, a report summarizing 
     evaluations carried out pursuant to paragraph (1) during the 
     preceding fiscal year and making such recommendations for 
     administrative and legislative initiatives with respect to 
     this section as the Secretary determines to be 
     appropriate.''.
       (b) Optional Medicaid Coverage of Certain Persons Screened 
     and Found to Have Colorectal Cancer.--
       (1) Coverage as optional categorically needy group.--
       (A) In general.--Section 1902(a)(10)(A)(ii) of the Social 
     Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)) is amended--
       (i) in subclause (XVIII), by striking ``or'' at the end;
       (ii) in subclause (XIX), by adding ``or'' at the end; and
       (iii) by adding at the end the following:
       ``(XX) who are described in subsection (gg) (relating to 
     certain persons screened and found to need treatment from 
     complications from screening or have colorectal cancer);''.
       (B) Group described.--Section 1902 of the Social Security 
     Act (42 U.S.C. 1396a) is amended by adding at the end the 
     following:
       ``(gg) Individuals described in this subsection are 
     individuals who--
       ``(1) are not described in subsection (a)(10)(A)(i);
       ``(2) have not attained age 65;
       ``(3) have been screened for colorectal cancer and need 
     treatment for complications due to screening or colorectal 
     cancer; and
       ``(4) are not otherwise covered under creditable coverage, 
     as defined in section 2701(c) of the Public Health Service 
     Act.''.
       (C) Limitation on benefits.--Section 1902(a)(10) of the 
     Social Security Act (42 U.S.C. 1396a(a)(10)) is amended in 
     the matter following subparagraph (G)--
       (i) by striking ``and (XIV)'' and inserting ``(XIV)''; and
       (ii) by inserting ``, and (XV) the medical assistance made 
     available to an individual described in subsection (gg) who 
     is eligible

[[Page S3910]]

     for medical assistance only because of subparagraph 
     (A)(10)(ii)(XX) shall be limited to medical assistance 
     provided during the period in which such an individual 
     requires treatment for complications due to screening or 
     colorectal cancer'' before the semicolon.
       (D) Conforming amendments.--Section 1905(a) of the Social 
     Security Act (42 U.S.C. 1396d(a)) is amended in the matter 
     preceding paragraph (1)--
       (i) in clause (xii), by striking ``or'' at the end;
       (ii) in clause (xiii), by adding ``or'' at the end; and
       (iii) by inserting after clause (xiii) the following:

       ``(xiv) individuals described in section 1902(gg),''.

       (2) Presumptive eligibility.--
       (A) In general.--Title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.) is amended by inserting after section 
     1920B the following:


   ``optional application of presumptive eligibility provisions for 
                 certain persons with colorectal cancer

       ``Sec. 1920C.  A State may elect to apply the provisions of 
     section 1920B to individuals described in section 1902(gg) 
     (relating to certain colorectal cancer patients) in the same 
     manner as such section applies to individuals described in 
     section 1902(aa) (relating to certain breast or cervical 
     cancer patients).''.
       (B) Conforming amendments.--
       (i) Section 1902(a)(47) of the Social Security Act (42 
     U.S.C. 1396a(a)(47)) is amended--

       (I) by striking ``and'' after ``section 1920'' and 
     inserting a comma;
       (II) by striking ``and'' after ``with such section'' and 
     inserting a comma; and
       (III) by inserting before the semicolon at the end the 
     following: ``, and provide for making medical assistance 
     available to individuals described in section 1920C during a 
     presumptive eligibility period in accordance with such 
     section''.

       (ii) Section 1903(u)(1)(d)(v) of such Act (42 U.S.C. 
     1396b(u)(1)(d)(v)) is amended--

       (I) by striking ``or for'' and inserting ``, for''; and
       (II) by inserting before the period the following: ``, or 
     for medical assistance provided to an individual described in 
     section 1920C during a presumptive eligibility period under 
     such section''.

       (3) Enhanced match.--The first sentence of section 1905(b) 
     of the Social Security Act (42 U.S.C. 1396d(b)) is amended--
       (A) by striking ``and'' before ``(4)''; and
       (B) by inserting before the period at the end the 
     following: ``, and (5) the Federal medical assistance 
     percentage shall be equal to the enhanced FMAP described in 
     section 2105(b) with respect to medical assistance provided 
     to individuals who are eligible for such assistance only on 
     the basis of section 1902(a)(10)(A)(ii)(XX)''.
       (4) Effective date.--The amendments made by this subsection 
     apply to medical assistance for items and services furnished 
     on or after the date that is 1 year after the date of 
     enactment of this Act, without regard to whether final 
     regulations to carry out such amendments have been 
     promulgated by such date.
       (c) Mobile Medical Van Grant Program.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary''), acting 
     through the Administrator of the Health Resources and 
     Services Administration, shall award grants to eligible 
     entities for the development and implementation of a mobile 
     medical van program that shall provide cancer screening 
     services that receive an ``A'' or ``B'' recommendation by the 
     U.S. Preventative Services Task Force of the Agency for 
     Healthcare Research and Quality to communities that are 
     underserved and suffer from barriers to access to high 
     quality cancer prevention care.
       (2) Eligible entities.--To be eligible to receive a grant 
     under paragraph (1), and entity shall--
       (A) be a consortium of public and private entities (such as 
     academic medical centers, universities, hospitals, and non 
     profit organizations);
       (B) submit to the Secretary an application at such time, in 
     such manner, and containing such information as the Secretary 
     shall require, including--
       (i) a description of the manner in which the applicant 
     intends to use funds received under the grant;
       (ii) a description of the manner in which the applicant 
     will evaluate the impact and effectiveness of the health care 
     services provided under the program carried out under the 
     grant;
       (iii) a plan for sustaining activities and services funded 
     under the grant after Federal support for the program has 
     ended;
       (iv) a plan for the referral of patients to other health 
     care facilities if additional services are needed;
       (v) a protocol for the transfer of patients in the event of 
     a medical emergency;
       (vi) a plan for advertising the services of the mobile 
     medical van to the communities targeted for health care 
     services; and
       (vii) a plan to educate patients about the availability of 
     federally funded medical insurance programs for which such 
     patients, or their children, may qualify; and
       (C) agree that amounts under the grant will be used to 
     supplement, and not supplant, other funds (including in-kind 
     contributions) used by the entity to carry out activities for 
     which the grant is awarded.
       (3) Use of funds.--An entity shall use amounts received 
     under a grant under this subsection to do any of the 
     following:
       (A) Purchase or lease a mobile medical van.
       (B) Make repairs and provide maintenance for a mobile 
     medical van.
       (C) Purchase or lease telemedicine equipment that is 
     reasonable and necessary to operate the mobile medical van.
       (D) Purchase medical supplies and medication that are 
     necessary to provide health care services on the mobile 
     medical van.
       (E) Retain medical professionals with expertise and 
     experience in providing cancer screening services to 
     underserved communities to provide health care services on 
     the mobile medical van.
       (4) Matching requirements.--
       (A) In general.--With respect to the costs of a mobile 
     medical van program to be carried out under a grant under 
     this subsection, the grantee shall make available (directly 
     or through donations from public or private entities) non-
     Federal contributions toward such costs in an amount that is 
     not less than the amount of the Federal funds provided under 
     this grant.
       (B) Determination of amount contributed.--Non-Federal 
     contributions required under subparagraph (A) may be in cash 
     or in kind, fairly evaluated, including plant, equipment, or 
     services. Amounts provided by the Federal Government, or 
     services assisted or subsidized to any significant extent by 
     the Federal Government, may not be included in determining 
     the amount of such non-Federal contributions.
       (C) Waiver.--The Secretary may waive the requirement 
     established in subparagraph (A) if--
       (i) the Secretary determines that such waiver is justified; 
     and
       (ii) the Secretary publishes the rationale for such waiver 
     in the Federal Register.
       (D) Return of funds.--An entity that receives a grant under 
     this section that fails to comply with subparagraph (A) shall 
     return to the Secretary an amount equal to the difference 
     between--
       (i) the amount provided under the grant; and
       (ii) the amount of matching funds actually provided by the 
     grantee.
       (5) Considerations in making grants.--In awarding grants 
     under this subsection, the Secretary shall give preference to 
     eligible entities--
       (A) that will provide cancer screening services in 
     underserved areas; and
       (B) that on the date on which the grant is awarded, have a 
     mobile medical van that is nonfunctioning due to the need for 
     necessary mechanical repairs.
       (6) Limitation on duration and amount of grant.--A grant 
     under this subsection shall be for a 2-year period, except 
     that the Secretary may waive such limitation and extend the 
     grant period by an additional year. The amount awarded to an 
     entity under such grant for a fiscal year shall not exceed 
     $200,000.
       (7) Evaluation.--Not later than 1 year after the date on 
     which a grant awarded to an entity under this subsection 
     expires, the entity shall submit to the Secretary the results 
     of an evaluation to be conducted by the entity concerning the 
     effectiveness of the program carried out under the grant.
       (8) Report.--Not later than 18 months after grants are 
     first awarded under this subsection, the Secretary shall 
     submit to the Committee on Appropriations of the Senate and 
     the Committee on Appropriations of the House of 
     Representatives a report on the results of activities carried 
     out with amounts received under such grants.
       (9) Definitions.--In this section:
       (A) Mobile medical van.--The term ``mobile medical van'' 
     means a mobile vehicle that is equipped to provide non-urgent 
     medical services and health care counseling to patients in 
     underserved areas.
       (B) Underserved area.--The term ``underserved area'', with 
     respect to the location of patients receiving medical 
     treatment, means a ``medically underserved community'' as 
     defined in section 799B(6) of the Public Health Service Act 
     (42 U.S.C. 295p(6)).
       (d) Access to Prevention and Early Detection for Certain 
     Cancers.--
       (1) Cancer genome atlas.--The Secretary of Health and Human 
     Services, acting through the National Cancer Institute, shall 
     provide for the inclusion of cancers with survival rates of 
     less than 25 percent at 5 years in the Cancer Genome Atlas.
       (2) Phase in.--The Director of the National Cancer 
     Institute shall phase in the participation of cancers 
     described in paragraph (1) in the Cancer Genome Atlas 
     Consortium.
       (3) Working groups.--The Secretary of Health and Human 
     Services, acting through the National Cancer Institute, shall 
     establish formal working groups for cancers with survival 
     rates of less than 25 percent at 5 years within the Early 
     Detection Research Network.
       (4) Computer assisted diagnostic, surgical, treatment and 
     drug testing innovations to reduce mortality from cancers.--
     The Director of the National Institute of Biomedical Imaging 
     and Bioengineering shall ensure that the Quantum Grant 
     Program and the Image Guided Interventions programs expedite 
     the development of computer assisted diagnostic, surgical, 
     treatment and drug testing innovations to reduce mortality 
     from cancers with survival rates of less than 25 percent at 5 
     years.

[[Page S3911]]

     SEC. 7. EARLY RECOGNITION AND TREATMENT OF CANCER THROUGH USE 
                   OF BIOMARKERS.

       (a) Promotion of the Discovery and Development of 
     Biomarkers.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary''), in 
     consultation with appropriate Federal agencies including the 
     National Institutes of Health, the National Cancer Institute, 
     the Food and Drug Administration, and the National Institute 
     of Standards and Technology, and extramural experts as 
     appropriate, shall establish and coordinate a program to 
     award contracts to eligible entities to support the 
     development of innovative biomarker discovery technologies. 
     All activities under this section shall be consistent with 
     and complement the ongoing efforts of the Oncology Biomarker 
     Qualification Initiative and the Reagan-Udall Foundation of 
     the Food and Drug Administration.
       (2) Lead agency.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary shall designate a lead 
     Federal agency to administer and coordinate the program 
     established under paragraph (1).
       (3) Eligibility.--To be eligible to enter into a contract 
     under paragraph (1), an entity shall submit to the Secretary 
     an application at such time, in such manner, and containing 
     such information as the Secretary may require. Such 
     information shall be sufficient to enable the Secretary to--
       (A) promote the scientific review of such contracts in a 
     timely fashion; and
       (B) contain the capacity to perform the necessary analysis 
     of contract applications, including determinations as to the 
     intellectual expertise of applicants.
       (4) Requirement.--In awarding contracts under this 
     subsection, the lead agency shall consider whether the 
     research involved will result in the development of 
     quantifiable biomarkers of cell signaling pathways that will 
     have the broadest applicability across different tumor types 
     or different diseases.
       (5) International consortia.--The Secretary shall designate 
     one of the Federal entities described in paragraph (1) to 
     establish an international private-public consortia to 
     develop and share methods and precompetitive data on the 
     validation and qualification of cancer biomarkers for 
     specific uses.
       (b) Clinical Study Guidelines.--Not later than 1 year after 
     the date of enactment of this Act, the Commissioner of Food 
     and Drugs, the Administrator of the Centers for Medicare & 
     Medicaid Services, and the Director of the National Cancer 
     Institute shall jointly develop guidelines for the conduct of 
     clinical studies designed to generate clinical data relating 
     to cancer care and treatment biomarkers that is adequate for 
     review by each such Federal entity. Such guidelines shall be 
     designed to assist in optimizing clinical study design and to 
     strengthen the evidence base for evaluations of studies 
     related to cancer biomarkers.
       (c) Demonstration Project.--
       (1) In general.--The Secretary, in consultation with the 
     Commissioner of Food and Drugs and the Administrator of the 
     Agency for Healthcare Research and Quality, shall carry out a 
     demonstration project that provides for a limited regional 
     assessment of biomarker tests to facilitate the controlled 
     and limited use of a risk assessment measure with an 
     intervention that may consist of a biomarker test.
       (2) Procedures.--As a component of the demonstration 
     project under paragraph (1), the Commissioner of Food and 
     Drugs, in consultation with other relevant agencies, shall 
     establish procedures that independent research entities shall 
     follow in conducting high quality assessments of efficacy of 
     biomarker tests.
       (d) Postmarket Surveillance.--The Food and Drug 
     Administration and the Centers for Medicare & Medicaid 
     Services shall assess quality and accuracy of biomarker tests 
     through appropriate postmarket surveillance and other means, 
     as necessary and appropriate to the mission of each such 
     agency.
       (e) Sense of the Senate.--It is the sense of the Senate 
     that the Commissioner of Food and Drugs and the Director of 
     the National Cancer Institute should continue to place high 
     priority upon the identification and use of biomarkers to--
       (1) determine the role of genetic polymorphisms on drug 
     activity and toxicity;
       (2) establish effective strategies for selecting patients 
     for treatment with specific drugs; and
       (3) identify early biomarkers of clinical benefit.
       (f) Definition.--In this section, the term ``biomarker'' 
     means any characteristic that can be objectively measured and 
     evaluated as an indicator of normal biologic processes, 
     pathogenic processes, or pharmacological responses to 
     therapeutic interventions.

     SEC. 8. CANCER CLINICAL TRIALS.

       (a) Coverage for Individuals Participating in Approved 
     Cancer Clinical Trials.--
       (1) ERISA amendment.--Subpart B of part 7 of subtitle B of 
     title I of the Employee Retirement Income Security Act of 
     1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end 
     the following:

     ``SEC. 715. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
                   APPROVED CANCER CLINICAL TRIALS.

       ``(a) Coverage.--
       ``(1) In general.--If a group health plan (or a health 
     insurance issuer offering health insurance coverage in 
     connection with the plan) provides coverage to a qualified 
     individual (as defined in subsection (b)), the plan or 
     issuer--
       ``(A) may not deny the individual participation in the 
     clinical trial referred to in subsection (b)(2);
       ``(B) subject to subsection (c), may not deny (or limit or 
     impose additional conditions on) the coverage of routine 
     patient costs for items and services furnished in connection 
     with participation in the trial; and
       ``(C) may not discriminate against the individual on the 
     basis of the individual's participation in such trial.
       ``(2) Exclusion of certain costs.--For purposes of 
     paragraph (1)(B), subject to subparagraph (B), routine 
     patient costs include all items and services consistent with 
     the coverage provided in the plan (or coverage) that is 
     typically covered for a qualified individual who is not 
     enrolled in a clinical trial and that was not necessitated 
     solely because of the trial, except--
       ``(A) the investigational item, device or service, itself; 
     or
       ``(B) items and services that are provided solely to 
     satisfy data collection and analysis needs and that are not 
     used in the direct clinical management of the patient.
       ``(3) Use of in-network providers.--If one or more 
     participating providers is participating in a clinical trial, 
     nothing in paragraph (1) shall be construed as preventing a 
     plan or issuer from requiring that a qualified individual 
     participate in the trial through such a participating 
     provider if the provider will accept the individual as a 
     participant in the trial.
       ``(b) Qualified Individual Defined.--For purposes of 
     subsection (a), the term `qualified individual' means an 
     individual who is a participant or beneficiary in a group 
     health plan and who meets the following conditions:
       ``(1)(A) The individual has been diagnosed with cancer.
       ``(B) The individual is eligible to participate in an 
     approved clinical trial according to the trial protocol with 
     respect to treatment of such illness.
       ``(2) Either--
       ``(A) the referring health care professional is a 
     participating health care provider and has concluded that the 
     individual's participation in such trial would be appropriate 
     based upon the individual meeting the conditions described in 
     paragraph (1); or
       ``(B) the participant or beneficiary provides medical and 
     scientific information establishing that the individual's 
     participation in such trial would be appropriate based upon 
     the individual meeting the conditions described in paragraph 
     (1).
       ``(c) Limitations on Coverage.--This section shall not be 
     construed to require a group health plan, or a health 
     insurance issuer in connection with a group health plan, to 
     provide benefits for routine patient care services provided 
     outside of the plan's (or coverage's) health care provider 
     network unless out-of-network benefits are otherwise provided 
     under the plan (or coverage).
       ``(d) Approved Clinical Trial Defined.--
       ``(1) In general.--In this section, the term `approved 
     clinical trial' means a phase I, phase II, phase III, or 
     phase IV clinical trial that relates to the prevention and 
     treatment of cancer (including related symptoms) and is 
     described in any of the following subparagraphs:
       ``(A) Federally funded trials.--The study or investigation 
     is approved or funded (which may include funding through in-
     kind contributions) by one or more of the following:
       ``(i) The National Institutes of Health.
       ``(ii) The Centers for Disease Control and Prevention.
       ``(iii) The Agency for Health Care Research and Quality.
       ``(iv) The Centers for Medicare & Medicaid Services.
       ``(v) cooperative group or center of any of the entities 
     described in clauses (i) through (iv) or the Department of 
     Defense or the Department of Veterans Affairs.
       ``(vi) A qualified non-governmental research entity 
     identified in the guidelines issued by the National 
     Institutes of Health for center support grants.
       ``(vii) Any of the following if the conditions described in 
     paragraph (2) are met:

       ``(I) The Department of Veterans Affairs.
       ``(II) The Department of Defense.
       ``(III) The Department of Energy.

       ``(B) The study or investigation is conducted under an 
     investigational new drug application reviewed by the Food and 
     Drug Administration.
       ``(C) The study or investigation is a drug trial that is 
     exempt from having such an investigational new drug 
     application.
       ``(2) Conditions for departments.--The conditions described 
     in this paragraph, for a study or investigation conducted by 
     a Department, are that the study or investigation has been 
     reviewed and approved through a system of peer review that 
     the Secretary determines--
       ``(A) to be comparable to the system of peer review of 
     studies and investigations used by the National Institutes of 
     Health, and
       ``(B) assures unbiased review of the highest scientific 
     standards by qualified individuals who have no interest in 
     the outcome of the review.
       ``(e) Construction.--Nothing in this section shall be 
     construed to limit a plan's or issuer's coverage with respect 
     to clinical trials.

[[Page S3912]]

       ``(f) Preemption.--Notwithstanding any other provision of 
     this Act, nothing in this section shall preempt State laws 
     that require a clinical trials policy for State regulated 
     health insurance plans.''.
       (2) Clerical amendments.--
       (A) Section 732(a) of such Act (29 U.S.C. 1191a(a)) is 
     amended by striking ``section 711'' and inserting ``sections 
     711 and 715''.
       (B) The table of contents in section 1 of such Act is 
     amended by inserting after the item relating to section 714 
     the following new item:

``Sec. 715. Coverage for individuals participating in approved cancer 
              clinical trials.''.

       (b) Clinical Trials.--The Director of the National Cancer 
     Institute shall--
       (1) collaborate with the Director of the National 
     Institutes of Health to engage in a campaign to educate the 
     public on the value of clinical trials for oncology patients, 
     which shall be implemented on the local level and focus on 
     patient populations that traditionally are underrepresented 
     in clinical trials;
       (2) conduct an educational campaign for health care 
     professionals to educate them to consider clinical trials as 
     treatment options for their patients; and
       (3) conduct research to document and demonstrate promising 
     practices in cancer clinical trial recruitment and retention 
     efforts, particularly for patient populations that 
     traditionally are underrepresented in clinical trials.

     SEC. 9. HEALTH PROFESSIONS WORKFORCE.

       (a) Increase Nurse Faculty.--Section 811(f)(2) of the 
     Public Health Service Act (42 U.S.C. 296j(f)(2)) is amended 
     to read as follows:
       ``(2) Benefits for retiring nurse officers qualified as 
     faculty.--
       ``(A) In general.--The Secretary of Defense shall provide 
     to any individual described in subparagraph (B) the payment 
     of retired or retirement pay without reduction based on 
     receipt of pay or other compensation from the institution of 
     higher education concerned.
       ``(B) Covered individuals.--An individual described in this 
     subparagraph is an individual who--
       ``(i) is retired from the Armed Forces after service as a 
     commissioned officer in the nurse corps of the Armed Forces;
       ``(ii) holds a graduate degree in nursing; and
       ``(iii) serves as a part- or full-time faculty member of an 
     accredited school of nursing.
       ``(C) Nurse corps.--Any accredited school of nursing that 
     employs a retired nurse officer as faculty under this 
     paragraph shall agree to provide financial assistance to 
     individuals undertaking an educational program at such school 
     leading to a degree in nursing who agree, upon completion of 
     such program, to accept a commission as an officer in the 
     nurse corps of the Armed Forces.''.
       (b) Oncology Workforce.--
       (1) Study.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary'') shall 
     conduct a study on the current and future cancer care 
     workforce needs in the following areas:
       (A) Cancer research.
       (B) Care and treatment of cancer patients and survivors.
       (C) Quality of life, symptom management, and pain 
     management.
       (D) Early detection and diagnosis.
       (E) Cancer prevention.
       (F) Genetic testing, counseling, and ethical considerations 
     related to such testing.
       (G) Diversity and appropriate care for disparity 
     populations.
       (H) Palliative and end-of-life care.
       (2) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary shall submit to Congress 
     a report that describes the findings of the study conducted 
     under paragraph (2).

     SEC. 10. PATIENT NAVIGATOR PROGRAM.

       Section 340A of the Public Health Service Act (42 U.S.C. 
     256a) is amended--
       (1) in subsection (e), by adding at the end the following:
       ``(3) Minimum core proficiencies.--The Secretary shall not 
     award a grant to an entity under this section unless such 
     entity provides assurances that patient navigators recruited, 
     assigned, trained, or employed using grant funds meet minimum 
     core proficiencies that are tailored for the main focus or 
     intervention of the navigation program involved.''; and
       (2) in subsection (m)--
       (A) in paragraph (1), by inserting before the period the 
     following ``, and such sums as may be necessary for each of 
     fiscal years 2011 through 2015.''; and
       (B) in paragraph (2), by striking ``2010'' and replacing 
     with ``2015.''

     SEC. 11. CANCER CARE AND COVERAGE UNDER MEDICAID AND 
                   MEDICARE.

       (a) Coverage of Routine Costs Associated With Clinical 
     Trials Under Medicare.--
       (1) Coverage under part a.--Section 1814 of the Social 
     Security Act (42 U.S.C. 1395f) is amended by adding at the 
     end the following new subsection:
       ``(m) Coverage of Routine Costs Associated With Clinical 
     Trials.--The Secretary shall not exclude from payment for 
     items and services provided under a clinical trial payment 
     for coverage of routine costs of care (as defined by the 
     Secretary) furnished to an individual entitled to benefits 
     under this part who participates in such a trial to the 
     extent the Secretary provides payment for such costs as of 
     the date of enactment of this subsection.''.
       (2) Coverage under part b.--Section 1833(w) of the Social 
     Security Act (42 U.S.C. 1395l(w)), as added by section 184 of 
     the Medicare Improvements for Patients and Providers Act of 
     2008 (Public Law 110-275), is amended--
       (A) by striking ``Payment.--The Secretary'' and inserting 
     ``Payment and Coverage of Routine Costs Associated With 
     Clinical Trials.--
       ``(1) Methods of payment.--Subject to paragraph (2), the 
     Secretary''; and
       (B) by adding at the end the following new paragraph:
       ``(2) Coverage of routine costs associated with clinical 
     trials.--The Secretary shall not exclude from payment for 
     items and services provided under a clinical trial payment 
     for coverage of routine costs of care (as defined by the 
     Secretary) furnished to an individual enrolled under this 
     part who participates in such a trial to the extent the 
     Secretary provides payment for such costs as of the date of 
     enactment of this subsection.''.
       (3) Provider outreach.--The Secretary of Health and Human 
     Services, acting through the Administrator of the Centers for 
     Medicare & Medicaid Services, shall conduct an outreach 
     campaign to providers of services and suppliers under the 
     Medicare program under title XVIII of the Social Security Act 
     regarding coverage of routine costs of care furnished to 
     Medicare beneficiaries participating in clinical trials in 
     accordance with sections 1814(m) and 1833(w)(2) of the Social 
     Security Act (as added by paragraphs (1) and (2), 
     respectively).
       (b) Demonstration Project to Provide Comprehensive Cancer 
     Care Planning Services Under Medicare.--
       (1) In general.--Beginning not later than 180 days after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services (referred to in this subsection as the 
     ``Secretary'') shall conduct a 3-year demonstration project 
     (referred to in this subsection as the ``demonstration 
     project'') under title XVIII of the Social Security Act (42 
     U.S.C. 1395 et seq.) under which payment for comprehensive 
     cancer care planning services furnished by eligible entities 
     shall be made.
       (2) Comprehensive cancer care planning services.--For 
     purposes of this subsection, the term ``comprehensive cancer 
     care planning services'' means--
       (A) with respect to an individual who is diagnosed with 
     cancer, the development of a plan of care that--
       (i) details, to the greatest extent practicable, all 
     aspects of the care to be provided to the individual, with 
     respect to the treatment of such cancer, including any 
     curative treatment and comprehensive symptom management (such 
     as palliative care) involved;
       (ii) is documented in the patient's medical record and 
     furnished to the individual in person within a period 
     specified by the Secretary that is as soon as practicable 
     after the date on which the individual is so diagnosed;
       (iii) is furnished, to the greatest extent practicable, in 
     a form that appropriately takes into account cultural and 
     linguistic needs of the individual in order to make the plan 
     accessible to the individual; and
       (iv) is in accordance with standards determined by the 
     Secretary to be appropriate;
       (B) with respect to an individual for whom a plan of care 
     has been developed under subparagraph (A), the revision of 
     such plan of care as necessary to account for any substantial 
     change in the condition of the individual, if such revision--
       (i) is in accordance with clauses (i) and (iii) of such 
     subparagraph; and
       (ii) is documented in the patient's medical record and 
     furnished to the individual within a period specified by the 
     Secretary that is as soon as practicable after the date of 
     such revision;
       (C) with respect to an individual who has completed the 
     primary treatment for cancer, as defined by the Secretary 
     (such as completion of chemotherapy or radiation treatment), 
     the development of a follow-up cancer care plan that--
       (i) describes the elements of the primary treatment, 
     including symptom management, furnished to such individual;
       (ii) provides recommendations for the subsequent care of 
     the individual with respect to the cancer involved;
       (iii) identifies, to the greatest extent possible, a 
     healthcare provider to oversee subsequent care and follow-up 
     as needed and to whom the individual may direct questions or 
     concerns;
       (iv) is documented in the patient's medical record and 
     furnished to the individual in person within a period 
     specified by the Secretary that is as soon as practicable 
     after the completion of such primary treatment;
       (v) is furnished, to the greatest extent practicable, in a 
     form that appropriately takes into account cultural and 
     linguistic needs of the individual in order to make the plan 
     accessible to the individual; and
       (vi) is in accordance with standards determined by the 
     Secretary to be appropriate; and
       (D) with respect to an individual for whom a follow-up 
     cancer care plan has been developed under subparagraph (C), 
     the revision of such plan as necessary to account for any 
     substantial change in the condition of the individual, if 
     such revision--
       (i) is in accordance with clauses (i), (ii), and (iv) of 
     such subparagraph; and

[[Page S3913]]

       (ii) is documented in the patient's medical record and 
     furnished to the individual within a period specified by the 
     Secretary that is as soon as practicable after the date of 
     such revision.
       (3) Qualifications and selection of eligible entities.--
       (A) Qualifications.--For purposes of this subsection, the 
     term ``eligible entity'' means a physician office, hospital, 
     outpatient department, or community health center. Qualified 
     providers include physicians, nurse practitioners, and other 
     health care professionals who develop or revise a 
     comprehensive cancer care plan.
       (B) Selection.--The Secretary shall select at least 6 
     eligible entities to participate in the demonstration 
     project. Such entities shall be selected so that the 
     demonstration project is conducted in different regions 
     across the United States, in urban and rural locations, and 
     across various sites of care.
       (4) Evaluation and report.--
       (A) Evaluation.--The Secretary shall conduct a 
     comprehensive evaluation of the demonstration project to 
     determine--
       (i) the effectiveness of the project in improving patient 
     outcomes and increasing efficiency and reducing error in the 
     delivery of cancer care;
       (ii) the cost of providing comprehensive cancer care 
     planning services; and
       (iii) the potential savings to the Medicare program 
     demonstrated by the project, including the utility of the 
     demonstration project in reducing duplicative cancer care 
     services and decreasing the use of unnecessary medical 
     services for cancer patients.
       (B) Report.--
       (i) In general.--Not later than the date that is 1 year 
     after the date on which the demonstration project concludes, 
     the Secretary shall submit to Congress a report on the 
     evaluation conducted under subparagraph (A).
       (ii) Prevention of fraudulent billing.--The Secretary shall 
     consult with the Medicare Fraud Task Force in the design of 
     the demonstration project to identify and address concerns 
     about fraudulent billing of comprehensive cancer care 
     planning services. The Secretary's actions on prevention of 
     fraud shall be included in the report under this 
     subparagraph.
       (iii) Demonstration of substantial benefit.--If the 
     evaluation conducted under subparagraph (A) indicates 
     substantial benefit from the demonstration project, as 
     measured by improved patient outcomes and more efficient 
     delivery of healthcare services, such report shall include a 
     legislative proposal to Congress for coverage of 
     comprehensive cancer care planning services under the 
     Medicare program, developed on the basis of information from 
     the demonstration project and in consultation with the 
     Administrator of the Agency for Healthcare Research and 
     Quality, the Director of the Institute of Medicine, and the 
     Director of the Centers for Disease Control and Prevention.
       (iv) No substantial benefit.--If the evaluation conducted 
     under subparagraph (A) does not indicate substantial benefit 
     from the demonstration project, as measured by improved 
     patient outcomes and more efficient delivery of healthcare 
     services, such report shall document, to the extent possible, 
     the reasons why the demonstration project did not result in 
     substantial benefit, and such report--

       (I) shall include a legislative proposal for Medicare 
     coverage of comprehensive cancer care planning services in a 
     manner that will lead to substantial benefit; or
       (II) shall include recommendations for additional 
     demonstration projects or studies to evaluate the delivery of 
     comprehensive cancer care planning services in a manner that 
     will lead to substantial benefit and eventual Medicare 
     coverage.

       (5) Funding.--The Secretary shall provide for the transfer 
     from the Federal Supplementary Medical Insurance Trust Fund 
     established under section 1841 of the Social Security Act (42 
     U.S.C. 1395t) of the amount necessary to carry out the 
     demonstration project and report under this subsection.
       (c) Promoting Cessation of Tobacco Use Under Medicaid.--
       (1) Services described.--Section 1905 of the Social 
     Security Act (42 U.S.C. 1396d) is amended by adding at the 
     end the following new subsection:
       ``(y)(1) Subject to paragraph (2), for purposes of this 
     title, the term `counseling and pharmacotherapy for cessation 
     of tobacco use' means diagnostic, therapy, and counseling 
     services and pharmacotherapy (including the coverage of 
     prescription and nonprescription tobacco cessation agents 
     approved by the Food and Drug Administration) for cessation 
     of tobacco use for individuals who use tobacco products or 
     who are being treated for tobacco use which are furnished--
       ``(A) by or under the supervision of a physician; or
       ``(B) by any other health care professional who--
       ``(i) is legally authorized to furnish such services under 
     State law (or the State regulatory mechanism provided by 
     State law) of the State in which the services are furnished; 
     and
       ``(ii) is authorized to receive payment for other medical 
     assistance under this title or is designated by the Secretary 
     for this purpose.
       ``(2) Such term is limited to--
       ``(A) services recommended in `Treating Tobacco Use and 
     Dependence: A Clinical Practice Guideline', published by the 
     Public Health Service in June 2000, or any subsequent 
     modification of such Guideline; and
       ``(B) such other services that the Secretary recognizes to 
     be effective.''.
       (2) Dropping exception from medicaid prescription drug 
     coverage for tobacco cessation medications.--Section 
     1927(d)(2) of the Social Security Act (42 U.S.C. 1396r-
     8(d)(2)) is amended--
       (A) by striking subparagraph (E);
       (B) by redesignating subparagraphs (F) through (K) as 
     subparagraphs (E) through (J), respectively; and
       (C) in subparagraph (F) (as redesignated by subparagraph 
     (B)), by inserting before the period at the end the 
     following: ``, except agents approved by the Food and Drug 
     Administration for purposes of promoting, and when used to 
     promote, tobacco cessation''.
       (3) Requiring coverage of tobacco cessation counseling and 
     pharmacotherapy services for pregnant women.--Section 
     1905(a)(4) of the Social Security Act (42 U.S.C. 1396d(a)(4)) 
     is amended--
       (A) by striking ``and'' before ``(C)''; and
       (B) by inserting before the semicolon at the end the 
     following: ``; and (D) counseling and pharmacotherapy for 
     cessation of tobacco use for pregnant women''.
       (4) Removal of cost-sharing for tobacco cessation 
     counseling and pharmacotherapy services for pregnant women.--
       (A) In general.--Section 1916 of the Social Security Act 
     (42 U.S.C. 1396o) is amended in each of subsections (a)(2)(B) 
     and (b)(2)(B), by inserting ``, and counseling and 
     pharmacotherapy for cessation of tobacco use'' after 
     ``complicate the pregnancy''.
       (B) Conforming amendment.--Section 1916A(b)(3)(B)(iii) of 
     such Act (42 U.S.C. 1396o-1(b)(3)(B)(iii)) is amended by 
     inserting ``, and counseling and pharmacotherapy for 
     cessation of tobacco use'' after ``complicate the 
     pregnancy''.
       (5) Effective date.--The amendments made by this subsection 
     take effect 1 year after the date of enactment of this Act 
     and apply to medical assistance provided under a State 
     Medicaid program on or after that date.

     SEC. 12. CANCER SURVIVORSHIP AND COMPLETE RECOVERY 
                   INITIATIVES.

       (a) Cancer Survivorship Programs.--Subpart 1 of part C of 
     title IV of the Public Health Service Act (42 U.S.C. 285 et 
     seq.), as amended by subsection (c), is amended by adding at 
     the end the following:

     ``SEC. 417E. EXPANSION OF CANCER SURVIVORSHIP ACTIVITIES.

       ``(a) Expansion of Activities.--The Director of the 
     Institute shall coordinate the activities of the National 
     Institutes of Health with respect to cancer survivorship, 
     including childhood cancer survivorship.
       ``(b) Priority Areas.--In carrying out subsection (a), the 
     Director of the Institute shall give priority to the 
     following:
       ``(1) Comprehensive assessment of the prevalence and 
     etiology of late effects of cancer treatment, including 
     physical, neurocognitive, and psychosocial late effects. Such 
     assessment shall include--
       ``(A) development of a system for patient tracking and 
     analysis;
       ``(B) establishment of a system of tissue collection, 
     banking, and analysis for childhood cancers, using guidelines 
     from the Office of Biorepositories and Biospecimen Research; 
     and
       ``(C) coordination of, and resources for, assessment and 
     data collection.
       ``(2) Identification of risk and protective factors related 
     to the development of late effects of cancer.
       ``(3) Identification of predictors of neurocognitive and 
     psychosocial outcomes, including quality of life, in cancer 
     survivors and identification of qualify of life and other 
     outcomes in family members.
       ``(4) Development and implementation of intervention 
     studies for cancer survivors and their families, including 
     studies focusing on--
       ``(A) preventive interventions during treatment;
       ``(B) interventions to lessen the impact of late effects of 
     cancer treatment;
       ``(C) rehabilitative or remediative interventions following 
     cancer treatment;
       ``(D) interventions to promote health behaviors in long-
     term survivors; and
       ``(E) interventions to improve health care utilization and 
     access to linguistically and culturally competent long-term 
     follow-up care for childhood cancer survivors in minority and 
     other medically underserved populations.
       ``(c) Grants for Research on Causes of Health Disparities 
     in Childhood Cancer Survivorship.--
       ``(1) Grants.--The Director of NIH, acting through the 
     Director of the Institute, shall make grants to entities to 
     conduct research relating to--
       ``(A) needs and outcomes of pediatric cancer survivors 
     within minority or other medically underserved populations; 
     and
       ``(B) health disparities in cancer survivorship outcomes 
     within minority or other medically underserved populations.
       ``(2) Balanced approach.--In making grants for research 
     under paragraph (1)(A) on pediatric cancer survivors within 
     minority populations, the Director of NIH shall ensure that 
     such research addresses both the physical and the 
     psychological needs of such survivors.
       ``(3) Health disparities.--In making grants for research 
     under paragraph (1)(B) on

[[Page S3914]]

     health disparities in cancer survivorship outcomes within 
     minority populations, the Director of NIH shall ensure that 
     such research examines each of the following:
       ``(A) Key adverse events after childhood cancer.
       ``(B) Assessment of health and quality of life in childhood 
     cancer survivors.
       ``(C) Barriers to follow-up care to childhood cancer 
     survivors.
       ``(D) Data regarding the type of provider and treatment 
     facility where the patient received cancer treatment and how 
     the provider and treatment facility may impact treatment 
     outcomes and survivorship.
       ``(d) Research To Evaluate Follow-up Care for Childhood 
     Cancer Survivors.--The Director of NIH shall conduct or 
     support research to evaluate systems of follow-up care for 
     childhood cancer survivors, with special emphasis given to--
       ``(1) transitions in care for childhood cancer survivors;
       ``(2) those professionals who should be part of care teams 
     for childhood cancer survivors;
       ``(3) training of professionals to provide linguistically 
     and culturally competent follow-up care to childhood cancer 
     survivors; and
       ``(4) different models of follow-up care.''.
       (b) Complete Recovery Care.--
       (1) Definition.--In this subsection, the term ``complete 
     recovery care'' means care intended to address the secondary 
     effects of cancer and its treatment, including late, 
     psychosocial, neurocognitive, psychiatric, psychological, 
     physical, and other effects associated with cancer and cancer 
     survivorship beyond the impairment of bodily function 
     directly caused by the disease, as described in the report by 
     the Institute of Medicine of the National Academies entitled 
     ``Cancer Care for the Whole Patient''.
       (2) Expansion of activities.--The Secretary of Health and 
     Human Services (referred to in this subsection as the 
     ``Secretary'') shall--
       (A) coordinate the activities of Federal agencies, 
     including the National Institutes of Health, the National 
     Cancer Institute, the National Institute of Mental Health, 
     the Centers for Medicare and Medicaid Services, the Veterans 
     Health Administration, the Centers for Disease Control and 
     Prevention, the Food and Drug Administration, the Agency for 
     Healthcare Research and Quality, the Office for Human 
     Research Protections, and the Health Resources and Services 
     Administration to improve the provision of complete recovery 
     care in the treatment of cancer; and
       (B) solicit input from professional and patient 
     organizations, payors, and other relevant institutions and 
     organizations regarding the status of provision of complete 
     recovery care in the treatment of cancer.
       (3) Improving the complete recovery care workforce.--
       (A) Chronic disease workforce development collaborative.--
     The Secretary shall, not later than 1 year after the date of 
     enactment of this Act, convene a Workforce Development 
     Collaborative on Psychosocial Care During Chronic Medical 
     Illness (referred to in this paragraph as the 
     ``Collaborative''). The Collaborative shall be a cross-
     specialty, multidisciplinary group composed of educators, 
     consumer and family advocates, and providers of psychosocial 
     and biomedical health services.
       (B) Goals and report.--The Collaborative shall submit to 
     the Secretary a report establishing a plan to meet the 
     following objectives for psychosocial care workforce 
     development:
       (i) Identifying, refining, and broadly disseminating to 
     healthcare educators information about workforce 
     competencies, models, and preservices curricula relevant to 
     providing psychosocial services to persons with chronic 
     medical illnesses and their families.
       (ii) Adapting curricula for continuing education of the 
     existing workforce using efficient workplace-based learning 
     approaches.
       (iii) Developing the skills of faculty and other trainers 
     in teaching psychosocial health care using evidence-based 
     teaching strategies.
       (iv) Strengthening the emphasis on psychosocial healthcare 
     in educational accreditation standards and professional 
     licensing and certification exams by recommending revisions 
     to the relevant oversight organizations.
       (c) Technical Amendment.--
       (1) In general.--Section 3 of the Hematological Cancer 
     Research Investment and Education Act of 2002 (Public Law 
     107-172; 116 Stat. 541) is amended by striking ``section 
     419C'' and inserting ``section 417C''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect as if included in section 3 of the 
     Hematological Cancer Research Investment and Education Act of 
     2002 (Public Law 107-172; 116 Stat. 541).

     SEC. 13. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

       It is the sense of the Senate that the Food and Drug 
     Administration should--
       (1) integrate policies and structures to facilitate the 
     concurrent development of drugs and diagnostics for cancer 
     diagnosis, prevention, and therapy;
       (2) consider alternatives or surrogates to traditional 
     clinical trial endpoints (for example, other than survival) 
     that are acceptable for regulatory approval as evidence of 
     clinical benefit to patients; and
       (3) modernize the Office of Oncology Drug Products by 
     examining and addressing internal barriers that exist within 
     the current organizational structure.

  Mrs. HUTCHISON. I rise to talk about legislation that has been 
introduced today. My colleague and friend, Senator Ted Kennedy, and I 
and Senator Feinstein are introducing a bill that we hope will help 
advance America's efforts to find cures for cancer.
  We all know that cancer is a relentless disease. It does not 
discriminate between men and women, wealthy or poor, elderly or young.
  In 2008, over 1.4 million Americans were diagnosed with some form of 
cancer. It may have been you, it may have been a friend, it may have 
been a coworker, a parent, a sibling, a spouse or even a child. More 
than half a million Americans lost their battle with cancer last year.
  During the last session of Congress, Senator Kennedy and I began 
working on what we would say would be the next generation of the war on 
cancer. Senator Feinstein has been a leader in this area as well. She 
is vice chairman of C-Change, which is an organization that is led by 
President George Bush--the 41st--and his wife Barbara. Dianne has been 
very active in the cancer cause for a long time, having lost her 
husband to cancer.
  All of us have been touched by it. We know very poignantly what 
happened in our body last year; that Senator Kennedy himself was 
diagnosed with a brain tumor. We have watched him valiantly fight off 
the scourge of this disease. I know in my own family my mother died 
from a brain tumor, and my brothers have also had cancer. It is such a 
reminder to all of us, especially when we see one of our own family 
members or one of our beloved colleagues fighting this disease. Arlen 
Specter has had amazing feats of living through brain tumors, and he 
has been so valiant. He, too, is one of the leaders in the cause we are 
trying to fight today, and that is to win against cancer.
  After Senator Kennedy's diagnosis was announced, I stood on the floor 
and said I would have an absolute commitment to introduce legislation 
with him, which we had already been working on for months. We were 
working with many of the groups that have come together to fight 
cancer. There are so many in our country that are banding together to 
try to put all our resources and all our experiences and all of what we 
have learned to work to do that magic thing that will finally bring 
about a cure for this disease.
  Today, we are keeping the promise we made. We waited, of course, for 
Senator Kennedy to go through surgery and to be in treatment before we 
introduced it, and he is back with us today. He is part of introducing 
this bill today. So we are calling the bill the 21st Century Cancer 
ALERT Act. Here is why we must start again and renew our efforts.
  Since the war on cancer was declared in 1971, we have amassed a 
wealth of knowledge, but our success in battling the disease has not 
been as great as with some of the other health concerns we have faced 
in our country, such as heart disease. When we adjust the mortality 
rate of cancer by age, it is still extraordinarily high when compared 
to mortality from other chronic diseases.
  The impact that cancer has on all lives cannot and should not be 
underestimated. Today, one out of every two men and one out of every 
three women in our country will develop cancer in their lifetimes. That 
is an incredible statistic, and it shows how important it is that we 
get a handle on how we can either find the cure or, the next best 
thing, to be able to treat it and be able to live with the disease.
  Let me tell you about some of the women who have fought with this 
disease. A woman named Elayne in Corinth, TX, is 44 years old and 
fighting cancer for the second time in her life. She says:

       I would like to see more research and options, especially 
     for people like me who tend to have few options left as a 
     stage 4 cancer patient. I think there is great hope in 
     targeted therapies, and this should be a continued area of 
     research and development.

  The Kennedy-Hutchison-Feinstein bill will do several things: It will, 
first of all, promote cancer diagnosis at an early and more curable 
stage. We must encourage the discovery and advancement of early 
recognition and treatment. One promising research method is the use of 
biomarkers.
  Biomarkers leave evidence within the body that alert clinicians to 
the

[[Page S3915]]

hidden activity that indicates cancer may be developing. Identifying 
biomarkers could represent the earliest possible detection of cancer in 
patients where it might otherwise be a long time before the person 
would see or feel any symptoms.
  However, even if we strengthen our ability to diagnose cancer, 
impediments remain that prevent many Americans from undergoing routine 
screening for cancer. With early screening, the chances of catching the 
disease at a treatable stage are greater and improve the rate of 
survival.
  No. 2, our bill will adopt a cooperative, coordinated approach to 
cancer research. By establishing a network of biorepositories, we will 
enable investigators to share information and samples. An integrated 
approach will accelerate the progress of lifesaving research.
  Furthermore, finding cures should be a collaborative goal. Great 
research is being done by so many researchers who are not aware of 
advancements in the trials. We have the research that might be 
concentrated in one area, but people don't have the communication they 
need to know what is going on in another area that might be helpful in 
furthering the research going on in a different area.
  The culture of isolated career research must shift toward cooperative 
strides to achieve breakthroughs. We must encourage all the 
stakeholders in the war on cancer to work in concert. This is perhaps 
going to be a difficult hurdle, but we must do it. If our researchers 
are just involved in their own microscope, they are not going to be 
able to have the full body of knowledge that might contain that one 
thing that triggers the end to cancer as we know it.
  Next, our bill will increase enrollment in clinical trials. Clinical 
trials expand treatment options for patients while enabling researchers 
to explore new methods in prevention, diagnosis, and therapy. This is 
so valuable because these are the experimental stages of treatment 
where people who sign up--who know there are risks here but are willing 
to try--can help us learn what works and what might not work. This is 
essential for us to make real strides in this war on cancer.
  One woman who understands the importance of clinical trials is Maria 
from El Paso. She is participating in a clinical trial, but she says:

       Every day we encounter women who are either unaware of the 
     option for clinical trials or who want to participate but do 
     not have access to them. It's not right that some of us have 
     access to the most cutting-edge treatments, while others are 
     shut out and left mired in a web of confusion.

  Less than 5 percent of the 10 million adults with cancer in the 
United States participate in clinical trials. We need to raise 
awareness about clinical trials so more cancer patients will know they 
are available and have the full information of what they could do. 
Disincentives in the health insurance market to enrolling in clinical 
trials must be eliminated.
  Last, as our knowledge of cancer advances and survivors live longer, 
we must move toward establishing a process of providing comprehensive 
care planning services. There is great value in arming patients with a 
treatment plan and a summary of their care once they enter remission. 
This can help ensure continuity of therapy and prevent costly 
duplicative or unnecessary services.
  Together, Senator Kennedy, Senator Feinstein, and I hope this will be 
a bipartisan effort to reinvigorate this fight by enacting these 
necessary changes through legislation. One of the people who will 
benefit from our bill is Suzanne. After 10 years of treatment for 
cancer, at a cost of over $3 million, Suzanne came to my office this 
week to show her support for this bill. She said:

       I don't want my two daughters to go through what I went 
     through. Screening saves lives and money.

  She is right. Another woman who has been in touch with my office is 
Jodie. At the age of 36, she was diagnosed with cancer. After 5 years 
of treatment, she said: ``It is a gift to be here.''
  The Kennedy-Hutchison-Feinstein bill, through screening programs, 
research, and clinical trials, will give people such as Suzanne, Maria, 
Elayne, Jodie, and many others in our country more time to spend with 
their loved ones.
  This bill we are introducing today is not a finished product. There 
may need to be changes to this bill. It is not perfect. I already have 
had some point out the need for us to sit down and try to come up with 
the absolute right approach. The HELP Committee will be looking at this 
bill. They will be marking it up. We have already had hearings last 
year, but there will be more of a look and it will be important that 
this happen.

  We want a bipartisan and resounding victory. We want this to be a 
victory for all of our country--a victory over this disease. It is the 
kind of bill that can be bipartisan, that should be bipartisan, and 
should have overwhelming support from this Congress and from the 
American people.
  I am wearing today the ``Live Strong'' bracelet. This is from the 
Lance Armstrong Foundation. We all know Lance Armstrong is a cancer 
survivor. He is also a hero to many of us because of his wins of the 
Tour de France. He is the premier bicyclist in the world. 
Unfortunately, Lance is in the hospital right now--or he might be just 
getting out. He doesn't have cancer. That is the good news. He broke 
his collar bone--in about six places, apparently--and because he has 
insisted he is going back into cycling, he is recovering from that 
injury.
  But we know the grit and determination of this man. After his Tour de 
France wins, and setting the ``straight record'' for Tour de France 
wins, he came home and decided to take on cancer for everyone. He has 
been a role model in showing us it can be defeated, because after his 
bout with cancer, he went on to win these grueling bicycle races all 
over the world. So he has been a role model in that regard, but he has 
also, through his foundation, been a champion of making sure other 
people have the same chance for survival that he has had. So while we 
wish him well on the mending of his collar bone, we already owe him a 
debt of gratitude, and I am going to wear his bracelet as we introduce 
the bill today to show what one person can do to defeat cancer.
  We can all come together to help Lance get the message out throughout 
the world that we can defeat cancer, and no one is a better leader in 
this cause on the Senate floor today than Senator Edward Kennedy. He 
not only helped craft the legislation--even as he was in treatment he 
was making edits to this bill--but he also is another person who has 
shown courage, as Lance Armstrong has, by not giving up, by coming 
right back to the Senate after his cancer treatments and showing us 
that he, too, is joining with Lance Armstrong to make sure everyone has 
the same chance he has for early detection and for a chance to live a 
full life. That is what we want for every American.
  I am very proud to be standing here for Senator Kennedy to say we are 
going to fight for this together. We are going to work together, and we 
are going to try to have a resounding bipartisan victory on this bill. 
Working with the HELP Committee and utilizing their input, we will win 
a victory for all Americans. Maybe we will make Americans see that we 
can work together here in Washington. Maybe that will be the change in 
how things are done in Washington that we have all been looking for. It 
would be a change for the better.
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