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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6224 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 6224

 To modernize cancer research, increase access to preventative cancer 
 services, provide cancer treatment and survivorship initiatives, and 
                          for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 28, 2010

Mrs. Capps (for herself and Mr. Pallone) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL

 
 To modernize cancer research, increase access to preventative cancer 
 services, provide cancer treatment and survivorship initiatives, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``21st Century 
Cancer ALERT (Access to Life-Saving Early detection, Research and 
Treatment) Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purpose.
Sec. 3. Advancement of the National Cancer Program.
Sec. 4. Comprehensive and Responsible Access to Research, Data, and 
                            Outcomes.
Sec. 5. Enhanced focus and reporting on cancer research.
Sec. 6. Continuing access to care for prevention and early detection.
Sec. 7. Early recognition and treatment of cancer through use of 
                            biomarkers.
Sec. 8. Extending coverage under Medicaid of counseling and 
                            pharmacotherapy for cessation of tobacco 
                            use.
Sec. 9. Comprehensive cancer care and coverage under Medicare.
Sec. 10. Targeted Cancers program.
Sec. 11. Activities of the Food and Drug Administration.
Sec. 12. CDC Cancer Control Programs.
Sec. 13. NIH cancer survivorship programs.
Sec. 14. Clinics for comprehensive long-term follow-up services for 
                            childhood cancer survivors.
Sec. 15. Grants to improve access to care for childhood cancer 
                            survivors.

SEC. 2. FINDINGS AND PURPOSE.

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

SEC. 3. ADVANCEMENT OF THE NATIONAL CANCER PROGRAM.

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

``SEC. 411. NATIONAL CANCER PROGRAM.

    ``(a) In General.--There shall be established a National Cancer 
Program (referred to in this section as the `Program') that shall 
consist of--
            ``(1) an expanded, intensified, and coordinated cancer 
        research program encompassing the research programs conducted 
        and supported by the Institute and the related research 
        programs of the other national research institutes, including 
        an expanded and intensified research program for the prevention 
        of cancer caused by occupational or environmental exposure to 
        carcinogens; and
            ``(2) the other programs and activities of the Institute.
    ``(b) Collaboration.--In carrying out the Program--
            ``(1) the Secretary and the Director of the Institute shall 
        identify relevant Federal agencies that shall collaborate with 
        respect to activities conducted under the Program (including 
        the Institute, the other Institutes and Centers of the National 
        Institutes of Health, the Office of the Director of the 
        National Institutes of Health, the Food and Drug 
        Administration, the Centers for Medicare & Medicaid Services, 
        the Centers for Disease Control and Prevention, the Department 
        of Defense, the Department of Energy, the Agency for Healthcare 
        Research and Quality, the Office for Human Research 
        Protections, the Health Resources and Services Administration, 
        and the Office for Human Research Protections); and
            ``(2) the Secretary shall ensure that the policies related 
        to the promotion of cancer research of all agencies within the 
        Department of Health and Human Services (including the 
        Institute, the Food and Drug Administration, and the Centers 
        for Medicare & Medicaid Services) are harmonized, and shall 
        ensure that such agencies collaborate with regard to cancer 
        research and development.
    ``(c) Transparency and Efficiency.--
            ``(1) Budgeting.--In carrying out the Program, the Director 
        of the Institute shall, in preparing and submitting to the 
        President the annual budget estimate for the Program--
                    ``(A) develop the budgetary needs of the entire 
                Program and submit the budget estimate relating to such 
                needs to the National Cancer Advisory Board for review 
                prior to submitting such estimate to the President; and
                    ``(B) submit such budget estimate to the Committee 
                on the Budget and the Committee on Appropriations of 
                the Senate and the Committee on the Budget and 
                Committee on Appropriations of the House of 
                Representatives at the same time that such estimate is 
                submitted to the President.
            ``(2) National cancer advisory board.--In establishing the 
        priorities of the Program, the National Cancer Advisory Board 
        shall provide for increased coordination by increasing the 
        participation of representatives (to the extent practicable, 
        representatives who have appropriate decision making authority) 
        of appropriate Federal agencies, including--
                    ``(A) the Centers for Medicare & Medicaid Services;
                    ``(B) the Health Resources and Services 
                Administration;
                    ``(C) the Centers for Disease Control and 
                Prevention; and
                    ``(D) the Agency for Healthcare Research and 
                Quality.
    ``(d) Programs To Encourage Early Detection Research.--The Director 
of the Institute shall develop a standard process through which Federal 
agencies, including the Department of Defense, and administrators of 
federally funded programs may engage in early cancer detection 
research.
    ``(e) Identification of Promising Translational Research 
Opportunities.--
            ``(1) In general.--The Director of the Institute, acting 
        through the Program and in accordance with the NIH Reform Act 
        of 2007, shall continue to identify promising translational 
        research opportunities across all disease sites, populations, 
        and pathways to clinical goals through a transparent, inclusive 
        process by--
                    ``(A) continuing to support efforts to develop a 
                robust number of public or nonprofit entities to carry 
                out early translational research activities;
                    ``(B) emphasizing the role of the young researcher 
                in the program under this section; and
                    ``(C) modifying guidelines for multiproject, 
                collaborative, early translational research awards to 
                focus research and reward collaborative team science.
            ``(2) Matching funds for research.--
                    ``(A) In general.--The Secretary may provide 
                assistance to eligible entities to match the amount of 
                non-Federal funds made available by such entity for 
                translational research of the type described in 
                paragraph (1) relating to cancer.
                    ``(B) Eligibility.--To be eligible to receive 
                assistance under subparagraph (A), an entity shall 
                submit to the Secretary an application at such time, in 
                such manner, and containing such information as the 
                Secretary may require.
                    ``(C) Recommendations and prioritization.--In 
                providing assistance under subparagraph (A), the 
                Secretary shall--
                            ``(i) select entities based on the 
                        recommendations of--
                                    ``(I) the Director of NIH; and
                                    ``(II) a peer review process; and
                            ``(ii) give priority to those entities 
                        submitting applications under subparagraph (B) 
                        that demonstrate that the research involved is 
                        high risk or translational research (as 
                        determined by the Secretary).
                    ``(D) Amount.--The amount of assistance to be 
                provided to an entity under subparagraph (A) shall be 
                at the discretion of the Secretary but shall not exceed 
                an amount equal to 100 percent of the amount of non-
                Federal funds ($1 for each $2 of non-Federal funds) 
                made available for research described in subparagraph 
                (A).
                    ``(E) Determination of amount of non-federal 
                contribution.--Non-Federal funds to be matched under 
                subparagraph (A) may be in cash or in kind, fairly 
                evaluated, including plant, equipment, or services. 
                Amounts provided by the Federal Government, and any 
                portion of any service subsidized by the Federal 
                Government, may not be included in determining the 
                amount of such non-Federal funds.
    ``(f) Biological Resource Coordination and Advancement of 
Technologies for Cancer Research.--
            ``(1) Establishment.--The Director of the Institute, acting 
        through the Program, shall establish an entity within the 
        Institute to augment ongoing efforts to advance new 
        technologies in cancer research, support the national 
        collection of tissues for cancer research purposes, and ensure 
        the quality of tissue collection.
            ``(2) Goals.--The entity established under paragraph (1) 
        shall--
                    ``(A) be designed to expand the access of 
                researchers to biospecimens for cancer research 
                purposes;
                    ``(B) establish uniform standards for the handling 
                and preservation of patient tissue specimens by 
                entities participating in the network established under 
                paragraph (3);
                    ``(C) require adequate annotation of all relevant 
                clinical data while assuring patient privacy;
                    ``(D) facilitate the linkage of public and private 
                entities into the national network under paragraph (3);
                    ``(E) provide for the linkage of cancer registries 
                to other administrative Federal Government data 
                sources, including the Centers for Medicare & Medicaid 
                Services, the Social Security Administration, and the 
                Centers for Disease Control and Prevention, with the 
                goal of understanding the determinants of cancer 
                treatment, care, and outcomes by allowing economic, 
                social, genetic, and other factors to be analyzed in an 
                independent manner; and
                    ``(F) develop strategies to ensure patient rights 
                and privacy, including an assessment of the regulations 
                promulgated pursuant to HIPAA privacy and security law 
                (as defined in section 3009(a)(2)), while facilitating 
                advances in medical research.
            ``(3) Advancement of new technologies for cancer research 
        and expansion of cancer biorepository networks.--
                    ``(A) In general.--As part of the entity 
                established under paragraph (1), the Director of the 
                Institute shall build upon existing initiatives to 
                establish an interconnected network of biorepositories 
                (referred to in this subsection as the `Network') with 
                consistent, interoperable systems for the collection 
                and storage of tissues and information, the annotation 
                of such information, and the sharing of such 
                information through an interoperable information 
                system.
                    ``(B) Guidelines.--A biorepository in the Network 
                that receives Federal funds shall adopt the Institute's 
                Best Practices for Biospecimen Resources for Institute-
                supported biospecimen resources (as published by the 
                Institute and including any successor guidelines) for 
                the collection of biospecimens and any accompanying 
                data.
                    ``(C) Representation.--The composition of any 
                leadership entity of the Network shall be determined by 
                the Director of the Institute and shall, at a minimum, 
                include a representative of--
                            ``(i) private sector entities and 
                        individuals, including cancer researchers and 
                        health care providers;
                            ``(ii) the Centers for Disease Control and 
                        Prevention;
                            ``(iii) the Agency for Healthcare Research 
                        and Quality;
                            ``(iv) the Office of National Coordination 
                        of Health Information Technology;
                            ``(v) the National Library of Medicine;
                            ``(vi) the Office for the Protection of 
                        Research Subjects; and
                            ``(vii) the National Science Foundation.
                    ``(D) Partnerships with tissue source sites.--The 
                Director of the Institute may enter into contracts with 
                tissue source sites to acquire data from such sites. 
                Any such data shall be acquired through the use of 
                protocols and closely monitored, transparent procedures 
                within appropriate ethical and legal frameworks.
            ``(4) Collection of data.--
                    ``(A) Hospitals.--A hospital or ambulatory cancer 
                center that receives Federal funds shall offer patients 
                the opportunity to contribute their biospecimens and 
                clinical data to the entity established under paragraph 
                (1).
                    ``(B) Clinical trial data.--Clinical trial data 
                relating to cancer care and treatment shall be provided 
                to the entity established under paragraph (1).''.

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

    (a) In General.--Not later than 180 days after the date of the 
enactment of this Act, the Director of the Office for Human Research 
Protections shall issue guidance to National Institutes of Health 
grantees concerning use of the facilitated review process in 
conjunction with the central institutional review board of the National 
Cancer Institute as the preferred mechanism to satisfy regulatory 
requirements to review ethical or scientific issues for all National 
Cancer Institute-supported translational and clinical research.
    (b)  Improved Privacy Standards in Clinical Research.--
            (1) Permitted disclosure under the privacy rule.--For 
        purposes of HIPAA privacy and security law (as referred to in 
        section 411(f)(2)(F) of the Public Health Service Act, as 
        amended by section 3), a covered entity (as defined for 
        purposes of such law) shall be in compliance with such law 
        relating to the disclosure of de-identified patient information 
        if such disclosure is--
                    (A) pursuant to a waiver that had been granted by 
                an institutional review board or privacy board relating 
                to such disclosure; and
                    (B) in the case that such entity is a research 
                institution, the entity informs patients when they make 
                first patient contact with the entity that the entity 
                is a research institution that may conduct research 
                using their de-identified medical records.
            (2) Synchronization of standards.--
                    (A) In general.--The Secretary of Health and Human 
                Services shall study the advantages and disadvantages 
                of the synchronization of the standards for research 
                under the Common Rule (under part 46 of title 45, Code 
                of Federal Regulations) and the HIPAA privacy and 
                security law (as described in section 411(f)(2)(F) of 
                the Public Health Service Act, as amended by section 3) 
                in order to determine the appropriate data elements 
                that should be omitted under the strict de-
                identification standards relating to personal 
                information.
                    (B) Review of recommendations.--In carrying out 
                subparagraph (A), the Secretary of Health and Human 
                Services shall conduct a review of recommendations made 
                by the Advisory Committee on Human Research Protections 
                as well as recommendations from the appropriate 
                leadership of the National Committee on Vital and 
                Health Statistics.
                    (C) Additional areas.--In carrying out subparagraph 
                (A), the Secretary of Health and Human Services shall--
                            (i) make recommendations concerning the 
                        conduct of international research to determine 
                        the boundaries and applications of 
                        extraterritoriality under such HIPAA privacy 
                        and security law; and
                            (ii) include biorepository storage 
                        information when obtaining patient consent.
                    (D) Report.--Not later than 180 days after the date 
                of the enactment of this Act, the Secretary of Health 
                and Human Services shall submit to the appropriate 
                committee of Congress, a report concerning the 
                recommendations made under this paragraph.
            (3) Application of hipaa privacy and security law to 
        external researchers.--
                    (A) In general.--Notwithstanding any other 
                provision of law, the HIPAA privacy and security law 
                (as described in section 411(f)(2)(F) of the Public 
                Health Service Act, as amended by section 3) shall 
                apply to external researchers.
                    (B) Definition.--
                            (i) In general.--In this paragraph, the 
                        term ``external researcher'' means a researcher 
                        who is on the staff of a covered entity (as 
                        defined for purposes of the HIPAA privacy and 
                        security law) but who is not actually employed 
                        by such covered entity.
                            (ii) Internal and external researchers.--
                        With respect to determining the distinction of 
                        whether or not a researcher has the ability to 
                        use protected health information under the 
                        provisions of this paragraph, such 
                        determination shall be based on whether the 
                        covered entity involved exercises effective 
                        control over that researcher's activities. For 
                        purposes of the preceding sentence, effective 
                        control may include membership and privileges 
                        of staff or the ability to terminate staff 
                        membership or discipline staff.
    (c) Liability.--The Director of the Office of Human Research 
Protection, the Director of the National Institutes of Health, and the 
Director of the National Cancer Institute shall issue guidance for 
entities awarded grants by such Federal agencies to provide instruction 
on how such entities may best address concerns or issues relating to 
the liability that institutions or researchers may incur as a result of 
using the facilitated review process of the Central Institutional 
Review Board Initiative, as sponsored by the National Cancer Institute.

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

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

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

    ``(a) Annual Independent Report.--
            ``(1) In general.--The Director of the Institute shall 
        complete an annual independent report that shall be submitted 
        to Congress on the same date that the annual budget estimate 
        described in section 413(b)(9) is submitted to the President.
            ``(2) Contents of report.--
                    ``(A) Cancer categories.--The report required under 
                paragraph (1) shall address the following categories of 
                cancer:
                            ``(i) Cancers that result in a 5-year 
                        survival rate of less than 50 percent.
                            ``(ii) Cancers in which the incidence rate 
                        is fewer than 15 cases per 100,000 people, or 
                        fewer than 40,000 new cases per year.
                    ``(B) Information.--With regard to each of the 
                categories of cancer described in subparagraph (A), the 
                report shall contain information regarding--
                            ``(i) a strategic plan for reducing the 
                        mortality rate for the annual year, including 
                        specific research areas of interest and budget 
                        amounts;
                            ``(ii) identification of any barriers to 
                        implementing the strategic plan described in 
                        clause (i) for the annual year;
                            ``(iii) if the report for the prior year 
                        contained a strategic plan described in clause 
                        (i), an assessment of the success of such plan;
                            ``(iv) the total amount of grant funding, 
                        including the total dollar amount awarded per 
                        grant and per funding year, under--
                                    ``(I) the National Cancer 
                                Institute; and
                                    ``(II) the National Institutes of 
                                Health;
                            ``(v) the percentage of grant applications 
                        favorably reviewed by the Institute that the 
                        Institute funded in the previous annual year;
                            ``(vi) the total number of grant 
                        applications, with greater than 50 percent 
                        relevance to each of the categories of cancer 
                        described in subparagraph (A), received by the 
                        Institute for awards in the previous annual 
                        year;
                            ``(vii) the total number of grants awarded, 
                        with greater than 50 percent relevance to each 
                        of the categories of cancer described in 
                        subparagraph (A), for the previous annual year 
                        and the number of awards per grant type, 
                        including the Common Scientific Outline 
                        designation specific to each such grant; and
                            ``(viii) the total number of primary 
                        investigators that received grants from the 
                        Institute for projects with greater than 50 
                        percent relevance to each of the categories of 
                        cancer described in paragraph (1), including 
                        the total number of awards granted to 
                        experienced investigators and the total number 
                        of awards granted to investigators receiving 
                        their first grant from the National Institutes 
                        of Health.
            ``(3) Definition.--In this section, the term `annual year' 
        means the year for which the strategic plan described in 
        paragraph (2)(B)(i) applies, which shall be the same fiscal 
        year for which the Director of the Institute submits the annual 
        budget estimate described in section 413(b)(9) for that year.
    ``(b) Grant Program.--
            ``(1) In general.--The Director of the Institute, in 
        cooperation with the Director of the Fogarty International 
        Center for Advanced Study in the Health Sciences and the 
        Directors of other Institutes, as appropriate, shall award 
        grants to researchers to conduct research regarding cancers for 
        which--
                    ``(A) the incidence is fewer than 40,000 new cases 
                per year; and
                    ``(B) the 5-year survival rate is less than 50 
                percent.
            ``(2) Prioritization.--In awarding grants for research 
        regarding cancers described in paragraph (1)(A), the Director 
        of the Institute shall give priority to collaborative research 
        projects between adult and pediatric cancer research, with 
        preference for projects building upon existing multi-
        institutional research infrastructures.
            ``(3) Tissue samples.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the Director of the Institute shall 
                require each recipient receiving a grant under this 
                subsection to submit tissue samples to designated tumor 
                banks.
                    ``(B) Waiver.--The Director of the Institute may 
                grant a waiver of the requirement described in 
                subparagraph (A) to a recipient who receives a grant 
                for research described in paragraph (1)(B) and who 
                submits an application for such waiver to the Director 
                of the Institute, in the manner in which such Director 
                may require.''.

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

    (a) Preventive Health Measures With Respect to Colorectal Cancer.--
Part B of title III of the Public Health Service Act (42 U.S.C. 243 et 
seq.) is amended by inserting after section 317T the following new 
section:

``SEC. 317U. PREVENTIVE HEALTH MEASURES WITH RESPECT TO COLORECTAL 
              CANCER.

    ``(a) Grant Program Authorization.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, may 
        make grants to eligible entities for the purpose of carrying 
        out a program described in subsection (b). An eligible entity 
        that is a recipient of a grant under this subsection may use 
        such grant to carry out such programs directly or through 
        grants to, or contracts with, public and not-for-profit private 
        entities.
            ``(2) Eligible entity defined.--For purposes of this 
        section, the term `eligible entity' includes the following:
                    ``(A) A State, including, in addition to the 
                several States, the District of Columbia, Guam, the 
                Commonwealth of Puerto Rico, the Northern Mariana 
                Islands, the Virgin Islands, American Samoa, and the 
                Trust Territory of the Pacific Islands.
                    ``(B) An Indian tribe or tribal organization, as 
                such terms are defined in section 4 of the Indian Self-
                Determination and Education Assistance Act.
    ``(b) Programs Described.--
            ``(1) In general.--Subject to paragraph (2), a program 
        described in this subsection is a program for planning or 
        implementing each of the following:
                    ``(A) Providing screenings for colorectal cancer to 
                individuals who--
                            ``(i) are 50 years of age or older; or
                            ``(ii)(I) are under 50 years of age; and
                            ``(II) are at high risk for such cancer, as 
                        determined in accordance with subsection 
                        (e)(2).
                    ``(B) Providing appropriate case management and 
                referrals for medical treatment of individuals screened 
                pursuant to subparagraph (A).
                    ``(C) Ensuring (directly or through coordination or 
                an arrangement with health care providers or programs) 
                the full continuum of follow-up and cancer care for 
                individuals so screened, including appropriate follow-
                up for abnormal tests, diagnostic services, therapeutic 
                services, and treatment of detected cancers and 
                management of unanticipated medical complications.
                    ``(D) Carrying out activities to improve the 
                education, training, and skills of health professionals 
                (including allied health professionals) in the 
                detection and control of colorectal cancer, which 
                activities are carried out pursuant to the 
                participation of the health professionals in the 
                program.
                    ``(E) Establishing mechanisms through which the 
                eligible entity involved can monitor the quality of 
                screening and diagnostic follow-up procedures for 
                colorectal cancer, including the interpretation of such 
                procedures.
                    ``(F) Evaluating the activities described in this 
                subsection through appropriate surveillance and program 
                monitoring activities.
                    ``(G) Developing and disseminating findings derived 
                through such evaluations and the collection of data on 
                outcomes.
                    ``(H) Developing and disseminating public 
                information and education programs for the detection 
                and control of colorectal cancer and promoting the 
                benefits of receiving screenings through this program.
            ``(2) Supplement not supplant.--In the case of an eligible 
        entity that implements a universal colorectal screening program 
        under which the eligible entity makes available funds for 
        activities described in subparagraph (A), (B), or (C) of 
        paragraph (1), such entity shall be able to receive grant funds 
        under subsection (a) only for purposes of--
                    ``(A) carrying out those activities under this 
                subsection that are not so funded; or
                    ``(B) supplementing (and not supplanting) funds 
                made available by the entity for such funded program.
    ``(c) Priority for Low-Income, Uninsured, and Underinsured 
Individuals.--A grant may be made under subsection (a) to an eligible 
entity only if the eligible entity agrees that, in providing screenings 
under subsection (b)(1)(A), the eligible entity will give priority to 
low-income individuals who lack adequate coverage, as determined by the 
Secretary, under health insurance and health plans with respect to 
screenings for colorectal cancer.
    ``(d) Special Consideration for Certain Applicants.--In making 
grants under subsection (a) for a fiscal year, the Secretary shall give 
special consideration to the following eligible entities:
            ``(1) In the case of services under such subsection for 
        women, to such entities that, for such year, are grantees under 
        title XV.
            ``(2) In the case of services under such subsection for 
        men, to such entities that, for such year, are grantees under 
        section 317D.
            ``(3) To such entities that coordinate with other Federal, 
        State, and local colorectal cancer programs.
            ``(4) To such entities with an existing program to provide 
        cancer screening to individuals.
    ``(e) Use of Certain Standards Under Medicare Program.--A grant may 
be made under subsection (a) to an eligible entity only if the eligible 
entity provides, as applicable, assurances as follows:
            ``(1) Screenings under subsection (b)(1)(A) will be carried 
        out as preventive health measures in accordance with evidence-
        based screening guidelines and procedures and in accordance 
        with the standard of care required for purposes of title XVIII 
        of the Social Security Act to carry out colorectal screening 
        tests defined in section 1861(pp)(1) of such Act.
            ``(2) An individual will be considered high risk for 
        purposes of subsection (b)(1)(A)(ii) only if the individual is 
        high risk within the meaning of section 1861(pp)(2) of such 
        Act.
            ``(3) The payment made from the grant for a screening 
        procedure under subsection (b)(1)(A) will not exceed the amount 
        that would be paid under part B of title XVIII of such Act if 
        payment were made under such part for furnishing the procedure 
        to an individual enrolled under such part.
    ``(f) Relationship to Items and Services Under Other Programs.--A 
grant under subsection (a) may be made to an eligible entity only if 
the eligible entity, as applicable, provides assurances that the grant 
will not be expended to make payment for any item or service to the 
extent that payment has been made, or can reasonably be expected to be 
made, with respect to such item or service--
            ``(1) under any State compensation program, under an 
        insurance policy, or under any Federal or State health benefits 
        program; or
            ``(2) by an entity that provides health services on a 
        prepaid basis.
    ``(g) Records and Audits.--A grant under subsection (a) may be made 
to an eligible entity only if the eligible entity provides assurances 
that the eligible entity will--
            ``(1) establish such fiscal control and fund accounting 
        procedures as may be necessary to ensure proper disbursal of, 
        and accounting for, amounts received under subsection (a); and
            ``(2) upon request, provide records maintained pursuant to 
        paragraph (1) to the Secretary or the Comptroller General of 
        the United States for purposes of auditing the expenditures of 
        the grant by the eligible entity.
    ``(h) Requirement of Matching Funds.--
            ``(1) In general.--The Secretary may not make a grant under 
        subsection (a) to an eligible entity for a fiscal year unless 
        the eligible entity agrees, with respect to the costs to be 
        incurred by the eligible entity for such fiscal year in 
        carrying out the activities described in subsection (b), to 
        make available non-Federal contributions (in cash or in kind 
        under paragraph (2)) toward such costs in an amount equal to 
        not less than $1 for each $3 of Federal funds provided in the 
        grant for such fiscal year. Such contributions may be made 
        directly or through donations from public or private entities.
            ``(2) Determination of amount of non-federal 
        contribution.--
                    ``(A) In general.--Non-Federal contributions 
                required in paragraph (1) may be in cash or in kind, 
                fairly evaluated, including equipment or services (and 
                excluding indirect or overhead costs). Amounts provided 
                by the Federal Government, or services assisted or 
                subsidized to any significant extent by the Federal 
                Government, may not be included in determining the 
                amount of such non-Federal contributions.
                    ``(B) Maintenance of effort.--In making a 
                determination of the amount of non-Federal 
                contributions for purposes of paragraph (1), the 
                Secretary may include only non-Federal contributions in 
                excess of the average amount of non-Federal 
                contributions made by the eligible entity involved 
                toward the activities described in subsection (b) for 
                the 2-year period preceding the first fiscal year for 
                which the eligible entity is applying to receive a 
                grant under subsection (a).
                    ``(C) Inclusion of relevant non-federal 
                contributions for medicaid.--In making a determination 
                of the amount of non-Federal contributions for purposes 
                of paragraph (1), the Secretary shall, subject to 
                subparagraphs (A) and (B) of this paragraph, include 
                any non-Federal amounts expended pursuant to title XIX 
                of the Social Security Act by the eligible entity 
                involved toward the activities described in 
                subparagraphs (A) and (B) of subsection (b)(1).
    ``(i) Additional Requirements.--
            ``(1) Limitation on administrative expenses.--The Secretary 
        may not make a grant to an eligible entity under subsection (a) 
        unless the eligible entity provides assurances that not more 
        than 10 percent of the grant will be expended for 
        administrative expenses with respect to the activities funded 
        by the grant.
            ``(2) Statewide provision of services.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Secretary may not make a grant under subsection (a) to 
                an eligible entity unless the eligible entity provides 
                assurances that any program funded by such grant will 
                be made available throughout the State, including 
                availability to members of an Indian tribe or tribal 
                organization (as such terms are defined in section 4 of 
                the Indian Self-Determination and Education Assistance 
                Act).
                    ``(B) Waiver.--The Secretary may waive the 
                requirement under subparagraph (A) for an eligible 
                entity if the Secretary determines that compliance by 
                the eligible entity with the requirement would result 
                in an inefficient allocation of resources with respect 
                to carrying out the purposes described in subsection 
                (a).
    ``(j) Technical Assistance and Provision of Supplies and Services 
in Lieu of Grant Funds.--
            ``(1) Technical assistance.--The Secretary may provide 
        training and technical assistance with respect to the planning, 
        development, and operation of any program funded by a grant 
        under subsection (a). The Secretary may provide such technical 
        assistance directly to eligible entities or through grants to, 
        or contracts with, public and private entities.
            ``(2) Provision of supplies and services in lieu of grant 
        funds.--
                    ``(A) In general.--Subject to subparagraph (B), 
                upon the request of an eligible entity receiving a 
                grant under subsection (a), the Secretary for the 
                purpose of aiding the eligible entity to carry out a 
                program under subsection (b)--
                            ``(i) may provide supplies, equipment, and 
                        services to the eligible entity; and
                            ``(ii) may detail to the eligible entity 
                        any officer or employee of the Department of 
                        Health and Human Services.
                    ``(B) Corresponding reduction in payments.--With 
                respect to a request made by an eligible entity under 
                subparagraph (A), the Secretary shall reduce the amount 
                of payments made under the grant under subsection (a) 
                to the eligible entity by an amount equal to the fair 
                market value of any supplies, equipment, or services 
                provided by the Secretary and the costs of detailing 
                personnel (including pay, allowances, and travel 
                expenses) under subparagraph (A). The Secretary shall, 
                for the payment of expenses incurred in complying with 
                such request, expend the amounts withheld.
    ``(k) Reports.--A grant under subsection (a) may be made only if 
the applicant involved agrees to submit to the Secretary such reports 
as the Secretary may require with respect to the grant.
    ``(l) Authorization of Appropriations.--
            ``(1) In general.--For the purpose of carrying out this 
        section, there are authorized to be appropriated--
                    ``(A) for fiscal year 2012, $50,000,000;
                    ``(B) for fiscal year 2013, $75,000,000;
                    ``(C) for fiscal year 2014, $150,000,000;
                    ``(D) for fiscal year 2015, $200,000,000; and
                    ``(E) for fiscal year 2016, $250,000,000.
            ``(2) Set-aside for technical assistance and provision of 
        supplies and services.--Of the amount appropriated under 
        paragraph (1) for a fiscal year, the Secretary shall reserve 
        not to exceed 20 percent for carrying out subsection (j).''.
    (b) Optional Medicaid Coverage of Certain Persons Screened and 
Found To Have Colorectal Cancer.--
            (1) Coverage as optional categorically needy group.--
                    (A) In general.--Section 1902(a)(10)(A)(ii) of the 
                Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)), as 
                amended by section 2402(d)(1) of the Patient Protection 
                and Affordable Care Act (Public Law 111-148) is further 
                amended--
                            (i) in subclause (XXI), by striking ``or'' 
                        at the end;
                            (ii) in subclause (XXII), by adding ``or'' 
                        at the end; and
                            (iii) by adding at the end the following:
                                    ``(XXIII) who are described in 
                                subsection (kk) (relating to certain 
                                persons screened and found to need 
                                treatment from complications from 
                                screening or have colorectal 
                                cancer);''.
                    (B) Group described.--Section 1902 of the Social 
                Security Act (42 U.S.C. 1396a), as amended by section 
                211(a)(1)(A)(ii) of Public Law 111-3, section 
                5006(b)(1) of division B of Public Law 111-5, and 
                section 1202 of the Patient Protection and Affordable 
                Care Act (Public Law 111-148), is further amended by 
                adding at the end the following:
    ``(kk) Individuals described in this subsection are individuals 
who--
            ``(1) are not described in subsection (a)(10)(A)(i);
            ``(2) have not attained age 65;
            ``(3) have been screened for colorectal cancer and need 
        treatment for complications due to screening or colorectal 
        cancer; and
            ``(4) are not otherwise covered under creditable coverage, 
        as defined in section 2704(c) of the Public Health Service 
        Act.''.
                    (C) Limitation on benefits.--Section 1902(a)(10) of 
                the Social Security Act (42 U.S.C. 1396a(a)(10)) is 
                amended in the matter following subparagraph (G)--
                            (i) by striking ``(XV)'' and inserting ``, 
                        (XV)'';
                            (ii) by striking ``and (XVI) the medical 
                        assistance'' and inserting ``, (XVI) the 
                        medical assistance'';
                            (iii) by striking ``and (XVI) if an 
                        individual'' and inserting ``, (XVII) if an 
                        individual''; and
                            (iv) by inserting ``, and (XVIII) the 
                        medical assistance made available to an 
                        individual described in subsection (kk) who is 
                        eligible for medical assistance only because of 
                        subparagraph (A)(10)(ii)(XXIII) shall be 
                        limited to medical assistance provided during 
                        the period in which such an individual requires 
                        treatment for complications due to screening or 
                        colorectal cancer'' before the semicolon.
                    (D) Conforming amendments.--Section 1905(a) of the 
                Social Security Act (42 U.S.C. 1396d(a)), as amended by 
                section 2402(d)(2)(B) of the Patient Protection and 
                Affordable Care Act (Public Law 111-148) is further 
                amended in the matter preceding paragraph (1)--
                            (i) in clause (xvi), by striking ``or'' at 
                        the end;
                            (ii) in clause (xvii), by adding ``or'' at 
                        the end; and
                            (iii) by inserting after clause (xvii) the 
                        following:
                            ``(xviii) individuals described in section 
                        1902(kk),''.
            (2) Presumptive eligibility.--
                    (A) In general.--Title XIX of the Social Security 
                Act (42 U.S.C. 1396 et seq.) is amended by inserting 
                after section 1920C, as inserted by section 2303(b) of 
                the Patient Protection and Affordable Care Act (Public 
                Law 111-148), the following:

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

    ``Sec. 1920D. A State may elect to apply the provisions of section 
1920B to individuals described in section 1902(kk) (relating to certain 
colorectal cancer patients) in the same manner as such section applies 
to individuals described in section 1902(aa) (relating to certain 
breast or cervical cancer patients).''.
                    (B) Conforming amendments.--
                            (i) Section 1902(a)(47) of the Social 
                        Security Act (42 U.S.C. 1396a(a)(47)), as 
                        amended by section 2303(b)(2) of the Patient 
                        Protection and Affordable Care Act (Public Law 
                        111-148), is amended--
                                    (I) in subparagraph (A)--
                                            (aa) by striking ``and'' 
                                        after ``section 1920'' and 
                                        inserting a comma;
                                            (bb) by striking ``and'' 
                                        after ``with such section'' 
                                        each place it occurs and 
                                        inserting a comma each such 
                                        place; and
                                            (cc) by inserting before 
                                        the semicolon at the end the 
                                        following: ``, and provide for 
                                        making medical assistance 
                                        available to individuals 
                                        described in section 1920D 
                                        during a presumptive 
                                        eligibility period in 
                                        accordance with such section''; 
                                        and
                                    (II) in subparagraph (B), by 
                                striking ``or 1920C'' and inserting 
                                ``1920C, or 1920D''.
                            (ii) Section 1903(u)(1)(d)(v) of such Act 
                        (42 U.S.C. 1396b(u)(1)(d)(v)), as amended by 
                        section 2202(b) of the Patient Protection and 
                        Affordable Care Act (Public Law 111-148), is 
                        further amended--
                                    (I) by striking ``or for'' and 
                                inserting ``, for''; and
                                    (II) by inserting before the period 
                                the following: ``, or for medical 
                                assistance provided to an individual 
                                described in section 1920D during a 
                                presumptive eligibility period under 
                                such section''.
            (3) Enhanced match.--The first sentence of section 1905(b) 
        of the Social Security Act (42 U.S.C. 1396d(b)) is amended--
                    (A) by striking ``and'' before ``(4)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (5) the Federal medical assistance 
                percentage shall be equal to the enhanced FMAP 
                described in section 2105(b) with respect to medical 
                assistance provided to individuals who are eligible for 
                such assistance only on the basis of section 
                1902(a)(10)(A)(ii)(XXIII)''.
            (4) Effective date.--The amendments made by this section 
        apply to medical assistance for items and services furnished on 
        or after October 1, 2011, without regard to whether final 
        regulations to carry out such amendments have been promulgated 
        by such date.
    (c) Mobile Medical Van Grant Program.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection as the ``Secretary''), acting 
        through the Administrator of the Health Resources and Services 
        Administration, shall award grants to eligible entities for the 
        development and implementation of a mobile medical van program 
        that shall provide cancer screening services that are 
        recommended with a grade of A or B by the United States 
        Preventative Services Task Force of the Agency for Healthcare 
        Research and Quality to communities that are underserved and 
        suffer from barriers to access to high quality cancer 
        prevention care.
            (2) Eligible entities.--To be eligible to receive a grant 
        under paragraph (1), and entity shall--
                    (A) be a consortium of public and private entities 
                (such as academic medical centers, universities, 
                hospitals, and non profit organizations);
                    (B) submit to the Secretary an application at such 
                time, in such manner, and containing such information 
                as the Secretary shall require, including--
                            (i) a description of the manner in which 
                        the applicant intends to use funds received 
                        under the grant;
                            (ii) a description of the manner in which 
                        the applicant will evaluate the impact and 
                        effectiveness of the health care services 
                        provided under the program carried out under 
                        the grant;
                            (iii) a plan for sustaining activities and 
                        services funded under the grant after Federal 
                        support for the program has ended;
                            (iv) a plan for the referral of patients to 
                        other health care facilities if additional 
                        services are needed;
                            (v) a protocol for the transfer of patients 
                        in the event of a medical emergency;
                            (vi) a plan for advertising the services of 
                        the mobile medical van to the communities 
                        targeted for health care services; and
                            (vii) a plan to educate patients about the 
                        availability of federally funded medical 
                        insurance programs for which such patients, or 
                        their children, may qualify; and
                    (C) agree that amounts under the grant will be used 
                to supplement, and not supplant, other funds (including 
                in-kind contributions) used by the entity to carry out 
                activities for which the grant is awarded.
            (3) Use of funds.--An entity shall use amounts received 
        under a grant under this subsection to do any of the following:
                    (A) Purchase or lease a mobile medical van.
                    (B) Make repairs and provide maintenance for a 
                mobile medical van.
                    (C) Purchase or lease telemedicine equipment that 
                is reasonable and necessary to operate the mobile 
                medical van.
                    (D) Purchase medical supplies and medication that 
                are necessary to provide health care services on the 
                mobile medical van.
                    (E) Retain medical professionals with expertise and 
                experience in providing cancer screening services to 
                underserved communities to provide health care services 
                on the mobile medical van.
            (4) Matching requirements.--
                    (A) In general.--With respect to the costs of a 
                mobile medical van program to be carried out under a 
                grant under this subsection, the grantee shall make 
                available (directly or through donations from public or 
                private entities) non-Federal contributions toward such 
                costs in an amount that is not less than the amount of 
                the Federal funds provided under this grant.
                    (B) Determination of amount contributed.--Non-
                Federal contributions required under subparagraph (A) 
                may be in cash or in-kind, fairly evaluated, including 
                plant, equipment, or services. Amounts provided by the 
                Federal Government, or services assisted or subsidized 
                to any significant extent by the Federal Government, 
                may not be included in determining the amount of such 
                non-Federal contributions.
                    (C) Waiver.--The Secretary may waive the 
                requirement established in subparagraph (A) if--
                            (i) the Secretary determines that such 
                        waiver is justified; and
                            (ii) the Secretary publishes the rationale 
                        for such waiver in the Federal Register.
                    (D) Return of funds.--An entity that receives a 
                grant under this section that fails to comply with 
                subparagraph (A) shall return to the Secretary an 
                amount equal to the difference between--
                            (i) the amount provided under the grant; 
                        and
                            (ii) the amount of matching funds actually 
                        provided by the grantee.
            (5) Considerations in making grants.--In awarding grants 
        under this subsection, the Secretary shall give preference to 
        eligible entities--
                    (A) that will provide cancer screening services in 
                underserved areas; and
                    (B) that on the date on which the grant is awarded, 
                have a mobile medical van that is nonfunctioning due to 
                the need for necessary mechanical repairs.
            (6) Limitation on duration and amount of grant.--A grant 
        under this subsection shall be for a 2-year period, except that 
        the Secretary may waive such limitation and extend the grant 
        period by an additional year. The amount awarded to an entity 
        under such grant for a fiscal year shall not exceed $200,000.
            (7) Evaluation.--Not later than 1 year after the date on 
        which a grant awarded to an entity under this subsection 
        expires, the entity shall submit to the Secretary the results 
        of an evaluation to be conducted by the entity concerning the 
        effectiveness of the program carried out under the grant.
            (8) Report.--Not later than 18 months after grants are 
        first awarded under this subsection, the Secretary shall submit 
        to the Committee on Appropriations of the Senate and the 
        Committee on Appropriations of the House of Representatives a 
        report on the results of activities carried out with amounts 
        received under such grants.
            (9) Definitions.--In this section:
                    (A) Mobile medical van.--The term ``mobile medical 
                van'' means a mobile vehicle that is equipped to 
                provide non-urgent medical services and health care 
                counseling to patients in underserved areas.
                    (B) Underserved area.--The term ``underserved 
                area'', with respect to the location of patients 
                receiving medical treatment, means a ``medically 
                underserved community'' as defined in section 799B(6) 
                of the Public Health Service Act (42 U.S.C. 295p(6)).

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

    (a) Promotion of the Discovery and Development of Biomarkers.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary''), in 
        consultation with appropriate Federal agencies including the 
        National Institutes of Health, the National Cancer Institute, 
        the Food and Drug Administration, and the National Institute of 
        Standards and Technology, and extramural experts as 
        appropriate, shall establish and coordinate a program to award 
        contracts to eligible entities to support the development of 
        innovative biomarker discovery technologies. All activities 
        under this section shall be consistent with and complement the 
        ongoing efforts of the Oncology Biomarker Qualification 
        Initiative and the Reagan-Udall Foundation of the Food and Drug 
        Administration.
            (2) Lead agency.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary shall designate a lead 
        Federal agency to administer and coordinate the program 
        established under paragraph (1).
            (3) Eligibility.--To be eligible to enter into a contract 
        under paragraph (1), an entity shall submit to the Secretary an 
        application at such time, in such manner, and containing such 
        information as the Secretary may require. Such information 
        shall be sufficient to enable the Secretary to--
                    (A) promote the scientific review of such contracts 
                in a timely fashion; and
                    (B) contain the capacity to perform the necessary 
                analysis of contract applications, including 
                determinations as to the intellectual expertise of 
                applicants.
            (4) Requirement.--In awarding contracts under this 
        subsection, the lead agency shall consider whether the research 
        involved will result in the development of quantifiable 
        biomarkers of cell signaling pathways that will have the 
        broadest applicability across different tumor types or 
        different diseases.
            (5) International consortia.--The Secretary shall designate 
        one of the Federal entities described in paragraph (1) to 
        establish an international private-public consortia to develop 
        and share methods and precompetitive data on the validation and 
        qualification of cancer biomarkers for specific uses.
    (b) Clinical Study Guidelines.--Not later than 1 year after the 
date of enactment of this Act, the Commissioner of Food and Drugs, the 
Administrator of the Centers for Medicare & Medicaid Services, and the 
Director of the National Cancer Institute shall jointly develop 
guidelines for the conduct of clinical studies designed to generate 
clinical data relating to cancer care and treatment biomarkers that is 
adequate for review by each such Federal entity. Such guidelines shall 
be designed to assist in optimizing clinical study design and to 
strengthen the evidence base for evaluations of studies related to 
cancer biomarkers.
    (c) Demonstration Project.--
            (1) In general.--The Secretary, in consultation with the 
        Commissioner of Food and Drugs and the Administrator of the 
        Agency for Healthcare Research and Quality, shall carry out a 
        demonstration project that provides for a limited regional 
        assessment of biomarker tests to facilitate the controlled and 
        limited use of a risk assessment measure with an intervention 
        that may consist of a biomarker test.
            (2) Procedures.--As a component of the demonstration 
        project under paragraph (1), the Commissioner of Food and 
        Drugs, in consultation with other relevant agencies, shall 
        establish procedures that independent research entities shall 
        follow in conducting high quality assessments of efficacy of 
        biomarker tests.
    (d) Postmarket Surveillance.--The Food and Drug Administration and 
the Centers for Medicare & Medicaid Services shall assess quality and 
accuracy of biomarker tests through appropriate postmarket surveillance 
and other means, as necessary and appropriate to the mission of each 
such agency.
    (e) Establishment and Operation of Research Centers for the Study 
of Biomarkers for Risk Stratification and Early Detection of Cancers 
With Survival Rates of Less Than 50 Percent.--
            (1) In general.--The Director of the National Cancer 
        Institute, in consultation with the directors of other relevant 
        institutes and centers of the National Institutes of Health and 
        the Department of Defense, shall enter into cooperative 
        agreements with, or make grants to, public or nonprofit 
        entities to establish and operate centers to conduct research 
        on biomarkers for use in risk stratification for, and the early 
        detection and screening of, cancer with a five year survival 
        rate of less than 50 percent. Each center shall be known as an 
        Early Detection Biomarker Center of Excellence.
            (2) Research funded.--Federal payments made under a 
        cooperative agreement or grant under paragraph (1) may be used 
        for research on any of the following:
                    (A) The development and characterization of new 
                biomarkers, and the refinement of existing biomarkers, 
                for cancers with a five-year survival rate of less than 
                50 percent.
                    (B) The clinical and laboratory validation of such 
                biomarkers, including technical development, 
                standardization of assay methods, sample preparation, 
                reagents, reproducibility, portability, and other 
                refinements.
                    (C) The development and implementation of clinical 
                and epidemiological research on the utilization of 
                biomarkers for the early detection and screening of 
                cancers with a five-year survival rate of less than 50 
                percent.
                    (D) The development and implementation of new 
                repositories for additional tissue, urine, serum, and 
                other biological specimens (such as ascites and pleural 
                fluids).
                    (E) Other areas identified by the Director, in 
                consultation with the research community.
            (3) Collaboration.--Any center funded under paragraph (1) 
        shall demonstrate their intent to collaborate with current 
        National Cancer Institute funded, sponsored, or funded and 
        sponsored initiatives regarding risk stratification, early 
        detection, and screening of cancer, including but not limited 
        to the early detection research networks, the Cancer Genomic 
        Atlas, and therapeutic biomarker initiatives, where applicable.
            (4) Availability of banked specimens.--The Director of the 
        Institute shall make available for research conducted under 
        this section banked serum and tissue specimens from clinical 
        research regarding these cancers that was funded by the 
        Department of Health and Human Services.
            (5) Report.--Not later than the end of fiscal year 2011, 
        and annually thereafter, the Director of the Institute shall 
        submit a report to the Congress on the cooperative agreements 
        entered into and the grants made under this subsection, the 
        progress of these grants, and recommendations for any program 
        improvements that would speed discovery.
            (6) Biomarker clinical trial committee.--The Director of 
        the Institute shall establish an Biomarker Clinical Trial 
        Committee (in this section referred to as the ``Committee''), 
        for each cancer with biomarker centers of excellence, to assist 
        the Director to design and implement one or more national 
        clinical trial, in accordance with this subsection, to 
        determine the utility of using biomarkers validated pursuant to 
        the research conducted under this subsection for risk 
        stratification for, and early detection and screening of, 
        cancers with a five-year survival rate of less than 50 percent.
            (7) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated $25,000,000 for each of the fiscal years 2011 
        through 2013, and such sums as may be necessary for each of the 
        fiscal years 2014 through 2020. If for two consecutive years 
        funds are not appropriated to carry out this subsection, this 
        subsection will automatically sunset. Such authorization of 
        appropriations is in addition to any other authorization of 
        appropriations that is available for such purpose.
    (f) Sense of the House of Representatives.--It is the sense of the 
House of Representatives that the Commissioner of Food and Drugs and 
the Director of the National Cancer Institute should continue to place 
high priority upon the identification and use of biomarkers to--
            (1) determine the role of genetic polymorphisms on drug 
        activity and toxicity;
            (2) establish effective strategies for selecting patients 
        for treatment with specific drugs; and
            (3) identify early biomarkers of clinical benefit.
    (g) Definition.--In this section, the term ``biomarker'' means any 
characteristic that can be objectively measured and evaluated as an 
indicator of normal biologic processes, pathogenic processes, or 
pharmacological responses to therapeutic interventions.

SEC. 8. EXTENDING COVERAGE UNDER MEDICAID OF COUNSELING AND 
              PHARMACOTHERAPY FOR CESSATION OF TOBACCO USE.

    (a) Services Described.--Section 1905 of the Social Security Act 
(42 U.S.C. 1396d) is amended--
            (1) in subsection (a)(4)(D), as inserted by section 
        4107(a)(1)(B) of the Patient Protection and Affordable Care Act 
        (Public Law 111-148), by striking ``by pregnant women''; and
            (2) in subsection (bb), as added by section 4107(a)(2) of 
        the Patient Protection and Affordable Care Act (Public Law 111-
        148)--
                    (A) in paragraph (1)--
                            (i) by striking ``the term `counseling and 
                        pharmacotherapy for cessation of tobacco use by 
                        pregnant women''' and inserting ``the term 
                        `counseling and pharmacotherapy for cessation 
                        of tobacco use'''; and
                            (ii) by striking ``by pregnant women who 
                        use tobacco products'' and inserting ``by 
                        individuals who use tobacco products''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``with 
                        respect to pregnant women''; and
                            (ii) in subparagraph (B), by striking ``by 
                        pregnant women''.
    (b) Dropping Exception From Medicaid Prescription Drug Coverage for 
Tobacco Cessation Medications.--Section 1927(d)(2)(F) of the Social 
Security Act (42 U.S.C. 1396r-8(d)(2)(F)), as amended by section 
4107(b) of the Patient Protection and Affordable Care Act (Public Law 
111-148), is further amended by striking ``in the case of pregnant 
women''.
    (c) Effective Date.--The amendments made by this section shall take 
effect 1 year after the date of enactment of this Act and apply to 
medical assistance provided under a State Medicaid program on or after 
such date.

SEC. 9. COMPREHENSIVE CANCER CARE AND COVERAGE UNDER MEDICARE.

    (a) Coverage of Routine Costs Associated With Clinical Trials Under 
Medicare.--
            (1) Coverage under part a.--Section 1814 of the Social 
        Security Act (42 U.S.C. 1395f) is amended by adding at the end 
        the following new subsection:
    ``(m) Coverage of Routine Costs Associated With Clinical Trials.--
The Secretary shall not exclude from payment for items and services 
provided under a clinical trial payment for coverage of routine costs 
of care (as defined by the Secretary) furnished to an individual 
entitled to benefits under this part who participates in such a trial 
to the extent the Secretary provides payment for such costs as of the 
date of enactment of this subsection.''.
            (2) Coverage under part b.--Section 1833(w) of the Social 
        Security Act (42 U.S.C. 1395l(w)), as added by section 184 of 
        the Medicare Improvements for Patients and Providers Act of 
        2008 (Public Law 110-275), is amended--
                    (A) by striking ``Payment.--The Secretary'' and 
                inserting ``Payment and Coverage of Routine Costs 
                Associated With Clinical Trials.--
            ``(1) Methods of payment.--Subject to paragraph (2), the 
        Secretary''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(2) Coverage of routine costs associated with clinical 
        trials.--The Secretary shall not exclude from payment for items 
        and services provided under a clinical trial payment for 
        coverage of routine costs of care (as defined by the Secretary) 
        furnished to an individual enrolled under this part who 
        participates in such a trial to the extent the Secretary 
        provides payment for such costs as of the date of enactment of 
        this subsection.''.
            (3) Provider outreach.--The Secretary of Health and Human 
        Services, acting through the Administrator of the Centers for 
        Medicare & Medicaid Services, shall conduct an outreach 
        campaign to providers of services and suppliers under the 
        Medicare program under title XVIII of the Social Security Act 
        regarding coverage of routine costs of care furnished to 
        Medicare beneficiaries participating in clinical trials in 
        accordance with sections 1814(m) and 1833(w)(2) of the Social 
        Security Act (as added by paragraphs (1) and (2), 
        respectively).
    (b) Coverage of Cancer Care Planning Services.--
            (1) In general.--Section 1861 of the Social Security Act, 
        as amended by section 4103 of the Patient Protection and 
        Affordable Care Act (Public Law 111-148), is amended--
                    (A) in subsection (s)(2)--
                            (i) by striking ``and'' at the end of 
                        subparagraph (EE);
                            (ii) by adding ``and'' at the end of 
                        subparagraph (FF); and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(GG) comprehensive cancer care planning services (as 
        defined in subsection (iii));''; and
                    (B) by adding at the end the following new 
                subsection:

             ``Comprehensive Cancer Care Planning Services

    ``(iii)(1) The term `comprehensive cancer care planning services' 
means--
                    ``(A) with respect to an individual who is 
                diagnosed with cancer, the development of a plan of 
                care that--
                            ``(i) details, to the greatest extent 
                        practicable, all aspects of the care to be 
                        provided to the individual, with respect to the 
                        treatment of such cancer, including any 
                        curative treatment and comprehensive symptom 
                        management (such as palliative care) involved;
                            ``(ii) is furnished in written form to the 
                        individual in person within a period specified 
                        by the Secretary that is as soon as practicable 
                        after the date on which the individual is so 
                        diagnosed;
                            ``(iii) is furnished, to the greatest 
                        extent practicable, in a form that 
                        appropriately takes into account cultural and 
                        linguistic needs of the individual in order to 
                        make the plan accessible to the individual; and
                            ``(iv) is in accordance with standards 
                        determined by the Secretary to be appropriate;
                    ``(B) with respect to an individual for whom a plan 
                of care has been developed under subparagraph (A), the 
                revision of such plan of care as necessary to account 
                for any substantial change in the condition of the 
                individual, if such revision--
                            ``(i) is in accordance with clauses (i) and 
                        (iii) of such subparagraph; and
                            ``(ii) is furnished in written form to the 
                        individual within a period specified by the 
                        Secretary that is as soon as practicable after 
                        the date of such revision;
                    ``(C) with respect to an individual who has 
                completed the primary treatment for cancer, as defined 
                by the Secretary (such as completion of chemotherapy or 
                radiation treatment), the development of a follow-up 
                cancer care plan that--
                            ``(i) describes the elements of the primary 
                        treatment, including symptom management, 
                        furnished to such individual;
                            ``(ii) provides recommendations for the 
                        subsequent care of the individual with respect 
                        to the cancer involved;
                            ``(iii) is furnished in written form to the 
                        individual in person within a period specified 
                        by the Secretary that is as soon as practicable 
                        after the completion of such primary treatment;
                            ``(iv) is furnished, to the greatest extent 
                        practicable, in a form that appropriately takes 
                        into account cultural and linguistic needs of 
                        the individual in order to make the plan 
                        accessible to the individual; and
                            ``(v) is in accordance with standards 
                        determined by the Secretary to be appropriate; 
                        and
                    ``(D) with respect to an individual for whom a 
                follow-up cancer care plan has been developed under 
                subparagraph (C), the revision of such plan as 
                necessary to account for any substantial change in the 
                condition of the individual, if such revision--
                            ``(i) is in accordance with clauses (i), 
                        (ii), and (iv) of such subparagraph; and
                            ``(ii) is furnished in written form to the 
                        individual within a period specified by the 
                        Secretary that is as soon as practicable after 
                        the date of such revision.
    ``(2) The Secretary shall establish standards to carry out 
paragraph (1) in consultation with appropriate organizations 
representing providers of services related to cancer treatment and 
organizations representing survivors of cancer. Such standards shall 
include standards for determining the need and frequency for revisions 
of the plans of care and follow-up plans based on changes in the 
condition of the individual and standards for the communication of the 
plan to the patient.''.
            (2) Payment.--Section 1833(a)(1) of the Social Security Act 
        (42 U.S.C. 1395l(a)(1)), as amended by section 10501(g)(3)(B) 
        of the Patient Protection and Affordable Care Act (Public Law 
        111-148), is amended by striking ``and'' before ``(Z)'' and 
        inserting before the semicolon at the end the following: ``, 
        and (AA) with respect to comprehensive cancer care planning 
        services described in any of subparagraphs (A) through (D) of 
        section 1861(iii)(1), the amount paid shall be an amount equal 
        to the sum of (i) the national average amount under the 
        physician fee schedule established under section 1848 for a new 
        patient office consultation of the highest level of service in 
        the non-facility setting, and (ii) the national average amount 
        under such fee schedule for a physician certification described 
        in section 1814(a)(2) for home health services furnished to an 
        individual by a home health agency under a home health plan of 
        care''.
            (3) Effective date.--The amendments made by this section 
        shall apply to services furnished on or after the first day of 
        the first calendar year that begins after the date of the 
        enactment of this Act.
    (c) Medicare Coverage of Comprehensive Cancer Patient Treatment 
Education Services.--
            (1) In general.--Section 1861 of the Social Security Act 
        (42 U.S.C. 1395x), as amended by subsection (b)(1), is further 
        amended--
                    (A) in subsection (s)(2)--
                            (i) by striking ``and'' at the end of 
                        subparagraph (FF);
                            (ii) by adding ``and'' at the end of 
                        subparagraph (GG); and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(HH) comprehensive cancer patient treatment education 
        services (as defined in subsection (jjj)(1));''; and
                    (B) by adding at the end the following new 
                subsection:

      ``Comprehensive Cancer Patient Treatment Education Services

    ``(jjj)(1) The term `comprehensive cancer patient treatment 
education services' means--
            ``(A) in the case of an individual who is diagnosed with 
        cancer, the provision of a one-hour patient treatment education 
        session delivered by a registered nurse that--
                    ``(i) is furnished to the individual and the 
                caregiver (or caregivers) of the individual in advance 
                of the onset of treatment and to the extent 
                practicable, is not furnished on the day of diagnosis 
                or on the first day of treatment;
                    ``(ii) educates the individual and such caregiver 
                (or caregivers) to the greatest extent practicable, 
                about all aspects of the care to be furnished to the 
                individual, informs the individual regarding any 
                potential symptoms, side-effects, or adverse events, 
                and explains ways in which side effects and adverse 
                events can be minimized and health and well-being 
                maximized, and provides guidance regarding those side 
                effects to be reported and to which health care 
                provider the side effects should be reported;
                    ``(iii) includes the provision, in written form, of 
                information about the course of treatment, any 
                responsibilities of the individual with respect to 
                self-dosing, and ways in which to address symptoms and 
                side-effects; and
                    ``(iv) is furnished, to the greatest extent 
                practicable, in an oral, written, or electronic form 
                that appropriately takes into account cultural and 
                linguistic needs of the individual in order to make the 
                information comprehensible to the individual and such 
                caregiver (or caregivers); and
            ``(B) with respect to an individual for whom a course of 
        cancer treatment or therapy is materially modified, a one-hour 
        patient treatment education session described in subparagraph 
        (A), including updated information on the matters described in 
        such subparagraph should the individual's oncologic health care 
        professional deem it appropriate and necessary.
    ``(2) In establishing standards to carry out paragraph (1), the 
Secretary shall consult with appropriate organizations representing 
providers of oncology patient treatment education services and 
organizations representing people with cancer.''.
            (2) Payment.--Section 1833(a)(1) of such Act (42 U.S.C. 
        1395l(a)(1)), as amended by subsection (b)(2), is further 
        amended--
                    (A) by striking ``and'' before ``(AA)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``, and (BB) with respect to 
                comprehensive cancer patient treatment education 
                service (as defined in section 1861(jjj)(1)), 150 
                percent of the payment rate established under section 
                1848 for diabetes outpatient self-management training 
                services (as defined in section 1861(qq)), determined 
                and applied without regard to any coinsurance''.
            (3) Coverage.--Section 1862(a)(1) of such Act (42 U.S.C. 
        1395y(a)(1)), as amended by section 4103(d)(1) of the Patient 
        Protection and Affordable Care Act (Public Law 111-148), is 
        amended--
                    (A) in subparagraph (O), by striking ``and'' at the 
                end;
                    (B) in subparagraph (P), by striking the semicolon 
                at the end and inserting ``, and''; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(Q) in the case of comprehensive cancer patient treatment 
        education services (as defined in subsection (jjj)(1)) which 
        are performed more frequently than is covered under such 
        section;''.
            (4) No impact on payment for other services.--Nothing in 
        this section shall be construed to affect or otherwise 
        authorize any reduction or modification, in the Medicare 
        payment amounts otherwise established for chemotherapy infusion 
        or injection codes with respect to the calculation and payment 
        of minutes for chemotherapy teaching or related services.
            (5) Effective date.--The amendments made by this section 
        shall apply to services furnished on or after the first day of 
        the first calendar year that begins after the date of the 
        enactment of this Act.

SEC. 10. TARGETED CANCERS PROGRAM.

    Subpart 1 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285 et seq.), as amended by section 14, is further amended 
by adding at the end the following:

``SEC. 417H. TARGETED CANCERS PROGRAM.

    ``(a) Establishment.--The Director of the Institute shall establish 
a targeted cancers program under which the Director may enter into 
agreements and make grants to conduct and coordinate research 
activities, with respect to cancers that result in a 5-year survival 
rate of less than 50 percent, for purposes of increasing such survival 
rate for such cancers. Such program shall include each of the elements 
described in subsections (b) through (i).
    ``(b) Strategic Plan for Progress.--
            ``(1) In general.--Under the targeted cancers program, the 
        Director of the Institute, in coordination with relevant 
        stakeholders and other appropriate Federal agencies, shall 
        develop a comprehensive plan, including budget amounts, for the 
        implementation of the research activities described in this 
        subsection (a) as well as the identification of additional 
        research activities that will be necessary to increase the 
        survival for patients diagnosed with a cancer described in such 
        subsection.
            ``(2) Report.--Not later than 6 months after the date of 
        the enactment of this section, the Director of the Institute 
        shall submit to Congress and make publicly available the 
        comprehensive plan described in paragraph (1).
    ``(c) Dedicated Funding for Basic Research.--Under the targeted 
cancers program, the Director of the Institute shall establish a 
separate funding mechanism that can be used to fund basic research 
grants for investigators with a primary interest in one of the cancers 
described in subsection (a).
    ``(d) Imaging Research.--Under the targeted cancers program, the 
Director of the Institute shall provide for research to expand and 
advance the potential of imaging to assist in early detection, disease 
management, and drug development.
    ``(e) Incubator Grant Program.--Under the targeted cancers program, 
the Director of the Institute shall establish a high-risk, high-reward 
incubator grant program for each cancer described in subsection (a) to 
allow investigators with a primary interest in such cancer an 
opportunity to build data for future grants provided by the Institute 
or the National Institutes of Health.
    ``(f) Grant Review by Scientific Experts.--Under the targeted 
cancers program, the Director of the Institute shall provide for a 
peer-review process of applications submitted for a grant under this 
section. Such process shall be conducted by grant peer-review teams 
that include scientific experts in the specific disease area involved, 
as well as patient advocates.
    ``(g) Specialized Training Programs.--Under the targeted cancers 
program, the Director of the Institute shall provide for advanced 
specialized training and education programs for early career PhD and 
clinician scientists that ensure sufficient time of such scientists is 
reserved for research in order to attract and retain a broader pool of 
investigators for the cancers specified in subsection (a).
    ``(h) Surveillance and Screening.--Under the targeted cancers 
program, the Director of the Institute shall, as prevention, early 
detection, and treatments are identified for cancers described in 
subsection (a), develop pilot programs for the surveillance and 
treatment of such conditions that are precursors to such cancers.
    ``(i) Cooperative Research Agreements.--Under the targeted cancers 
program, the Director of the Institute may enter into cooperative 
research agreements with other Federal agencies on programs targeting 
cancers specified in subsection (a), including other Institutes at the 
National Institutes of Health, other agencies within the Department of 
Health and Human Services, the Department of Defense, and the 
Department of Veterans Affairs.
    ``(j) IOM Report.--
            ``(1) In general.--The Secretary of Health and Human 
        Services shall enter into an arrangement with the Institute of 
        Medicine of the National Academies to provide an independent 
        assessment, with respect to cancers described in subsection 
        (a), of funding of the National Cancer Institute, progress of 
        such Institute, and the additional improvements that should be 
        implemented by the Department of Health and Human Services, by 
        the National Institutes of Health, and by the National Cancer 
        Institute to make sufficient progress on research related to 
        such cancers.
            ``(2) Report.--The agreement entered into under paragraph 
        (1) shall provide for the Institute of Medicine to submit to 
        the Secretary and the Congress, not later than 1 year after the 
        date of the enactment of this section, a report containing a 
        description of the results of the study conducted under such 
        paragraph and the conclusions and recommendations of the 
        Institute of Medicine regarding the issues described in such 
        paragraph.''.

SEC. 11. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

    (a) Review, Improvement, and Coordination.--The Commissioner of 
Food and Drugs shall--
            (1) conduct a review of the policies, programs, and 
        activities of the Food and Drug Administration relating to 
        oncology products; and
            (2) based on the results of such review, improve and 
        coordinate such policies, programs, and activities, including 
        by--
                    (A) integrating policies, programs, activities, 
                and, if appropriate, organizational units of the 
                Administration to facilitate the concurrent development 
                of oncology products;
                    (B) considering alternatives or surrogates to 
                traditional clinical trial endpoints (for example, 
                other than survival) that are acceptable for regulatory 
                approval as evidence of clinical benefit to patients; 
                and
                    (C) modernizing the Office of Oncology Drug 
                Products by examining and addressing internal barriers 
                that exist within the Office's organizational 
                structure.
    (b) Definitions.--In this section:
            (1) The term ``biological product'' has the meaning given 
        to that term in section 351 of the Public Health Service Act 
        (42 U.S.C. 262).
            (2) The terms ``device'' and ``drug'' have the meanings 
        given to those terms in section 201 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321).
            (3) The term ``oncology product'' means--
                    (A) any biological product, drug, or device for 
                cancer diagnosis, prevention, or treatment; or
                    (B) any other product that is regulated by the Food 
                and Drug Administration and is determined by the 
                Commissioner of Food and Drugs to be relevant to cancer 
                diagnosis, prevention, or treatment.

SEC. 12. CDC CANCER CONTROL PROGRAMS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.), as amended by section 6, is further amended by inserting 
after section 317U the following:

``SEC. 317V. CANCER CONTROL PROGRAMS.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall expand and 
intensify the cancer control programs of the Centers, including 
programs for conducting surveillance activities or supporting State 
comprehensive cancer control plans.
    ``(b) Certain Activities.--In carrying out subsection (a), the 
Secretary shall--
            ``(1) in collaboration with the Director of the National 
        Cancer Institute, provide guidance to States on projects and 
        interventions that may be incorporated into State comprehensive 
        cancer control programs to improve the long-term health status 
        of childhood cancer survivors, including childhood cancer 
        survivors in minority and other medically underserved 
        populations;
            ``(2) encourage States to incorporate strategies for 
        improving systems of care for childhood cancer survivors and 
        their families into State comprehensive cancer plans; and
            ``(3) collaborate with the Director of the National Cancer 
        Institute to improve existing surveillance systems or develop 
        appropriate new systems for tracking cancer survivors and 
        assessing their health status and risk for other chronic and 
        disabling conditions.
    ``(c) Childhood Cancer Survivorship.--
            ``(1) Focus on childhood cancer survivorship.--In 
        conducting or supporting national, State, and local 
        comprehensive cancer control programs through the Centers for 
        Disease Control and Prevention, the Secretary shall enhance 
        such programs--
                    ``(A) to include a focus on childhood cancer 
                survivorship, including survivorship in minority and 
                other medically underserved populations; and
                    ``(B) to include childhood cancer survivorship 
                initiatives for improving--
                            ``(i) the monitoring of survivors of all 
                        forms of cancer; and
                            ``(ii) follow-up treatment for childhood 
                        cancer survivors.
            ``(2) Reliance on guidelines.--In carrying out this 
        subsection, the Secretary shall rely, where appropriate, on 
        existing guidelines for care of childhood cancer survivors.''.

SEC. 13. NIH CANCER SURVIVORSHIP PROGRAMS.

    (a) Technical Amendment.--
            (1) In general.--Section 3 of the Hematological Cancer 
        Research Investment and Education Act of 2002 (Public Law 107-
        172; 116 Stat. 541) is amended by striking ``section 419C'' and 
        inserting ``section 417C''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect as if included in section 3 of the 
        Hematological Cancer Research Investment and Education Act of 
        2002 (Public Law 107-172; 116 Stat. 541).
    (b) Cancer Survivorship Programs.--Subpart 1 of part C of title IV 
of the Public Health Service Act (42 U.S.C. 285 et seq.), is amended by 
adding at the end the following:

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

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

``SEC. 417G-1. IMPROVING THE QUALITY OF FOLLOW-UP CARE FOR SURVIVORS OF 
              CHILDHOOD CANCERS AND THEIR FAMILIES.

    ``(a) In General.--The Secretary, in consultation with the Director 
of NIH, shall make grants to eligible entities to establish or improve 
training programs for health care professionals (including physicians, 
nurses, physician assistants, and mental health professionals)--
            ``(1) to improve the quality of immediate and long-term 
        follow-up care for survivors of childhood cancers and their 
        families; and
            ``(2) to ensure that such care is linguistically and 
        culturally competent.
    ``(b) Eligible Entities.--In this section, the term `eligible 
entity' means--
            ``(1) a medical school;
            ``(2) a children's hospital;
            ``(3) a cancer center;
            ``(4) a hospital with one or more residency programs that 
        serve a significant number of childhood cancer patients;
            ``(5) a graduate training program for health professionals 
        described in subsection (a) who will treat survivors of 
        childhood cancers; or
            ``(6) any other entity with significant experience and 
        expertise in treating survivors of childhood cancers.
    ``(c) Duration.--Each grant under this section shall be for a 
period of 2 years.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for each of fiscal 
years 2012 through 2016.

``SEC. 417G-2. STUDY OF PILOT PROGRAMS TO EXPLORE MODEL SYSTEMS OF 
              CARE.

    ``(a) In General.--The Director of NIH, in consultation with the 
Administrator of the Health Resources and Services Administration, 
shall make grants to eligible entities to establish pilot programs to 
develop, study, or evaluate model systems for monitoring and caring for 
childhood cancer survivors.
    ``(b) Eligible Entities.--In this section, the term `eligible 
entity' means--
            ``(1) a medical school;
            ``(2) a children's hospital;
            ``(3) a cancer center; or
            ``(4) any other entity with significant experience and 
        expertise in treating survivors of childhood cancers.
    ``(c) Use of Funds.--The Director of NIH may make a grant under 
this section to an eligible entity only if the entity agrees--
            ``(1) to use the grant to establish a pilot program to 
        develop, study, or evaluate one or more model systems for 
        monitoring and caring for cancer survivors; and
            ``(2) in developing, studying, and evaluating such systems, 
        to give special emphasis to the following:
                    ``(A) Design of protocols for follow-up care, 
                monitoring, and other survivorship programs (including 
                peer support and mentoring programs).
                    ``(B) Dissemination of information to health care 
                providers about how to provide linguistically and 
                culturally competent follow-up care and monitoring to 
                cancer survivors and their families.
                    ``(C) Dissemination of other information, as 
                appropriate, to health care providers and to cancer 
                survivors and their families.
                    ``(D) Development of support programs to improve 
                the quality of life of cancer survivors.
                    ``(E) Design of systems for the effective transfer 
                of treatment information from cancer care providers to 
                other health care providers (including family practice 
                physicians and internists) and to cancer survivors and 
                their families, where appropriate.
                    ``(F) Development of various models for providing 
                multidisciplinary care.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $10,000,000 for each of fiscal 
years 2012 through 2016.''.
    (c) Complete Recovery Care.--
            (1) Definition.--In this subsection, the term ``complete 
        recovery care'' means care intended to address the secondary 
        effects of cancer and its treatment, including late, 
        psychosocial, neurocognitive, psychiatric, psychological, 
        physical, and other effects associated with cancer and cancer 
        survivorship beyond the impairment of bodily function directly 
        caused by the disease, as described in the report by the 
        Institute of Medicine of the National Academies entitled 
        ``Cancer Care for the Whole Patient''.
            (2) Expansion of activities.--The Secretary of Health and 
        Human Services (referred to in this subsection as the 
        ``Secretary'') shall--
                    (A) coordinate the activities of Federal agencies, 
                including the National Institutes of Health, the 
                National Cancer Institute, the National Institute of 
                Mental Health, the Centers for Medicare and Medicaid 
                Services, the Veterans Health Administration, the 
                Centers for Disease Control and Prevention, the Food 
                and Drug Administration, the Agency for Healthcare 
                Research and Quality, the Office for Human Research 
                Protections, and the Health Resources and Services 
                Administration to improve the provision of complete 
                recovery care in the treatment of cancer; and
                    (B) solicit input from professional and patient 
                organizations, payors, and other relevant institutions 
                and organizations regarding the status of provision of 
                complete recovery care in the treatment of cancer.
            (3) Improving the complete recovery care workforce.--
                    (A) Chronic disease workforce development 
                collaborative.--The Secretary shall, not later than 1 
                year after the date of enactment of this Act, convene a 
                Workforce Development Collaborative on Psychosocial 
                Care During Chronic Medical Illness (referred to in 
                this paragraph as the ``Collaborative''). The 
                Collaborative shall be a cross-specialty, 
                multidisciplinary group composed of educators, consumer 
                and family advocates, and providers of psychosocial and 
                biomedical health services.
                    (B) Goals and report.--The Collaborative shall 
                submit to the Secretary a report establishing a plan to 
                meet the following objectives for psychosocial care 
                workforce development:
                            (i) Identifying, refining, and broadly 
                        disseminating to healthcare educators 
                        information about workforce competencies, 
                        models, and preservices curricula relevant to 
                        providing psychosocial services to persons with 
                        chronic medical illnesses and their families.
                            (ii) Adapting curricula for continuing 
                        education of the existing workforce using 
                        efficient workplace-based learning approaches.
                            (iii) Developing the skills of faculty and 
                        other trainers in teaching psychosocial health 
                        care using evidence-based teaching strategies.
                            (iv) Strengthening the emphasis on 
                        psychosocial healthcare in educational 
                        accreditation standards and professional 
                        licensing and certification exams by 
                        recommending revisions to the relevant 
                        oversight organizations.

SEC. 14. CLINICS FOR COMPREHENSIVE LONG-TERM FOLLOW-UP SERVICES FOR 
              CHILDHOOD CANCER SURVIVORS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.), as amended by sections 6 and 13, is further amended by 
inserting after section 317V the following:

``SEC. 317W. CLINICS FOR COMPREHENSIVE LONG-TERM FOLLOW-UP SERVICES FOR 
              CHILDHOOD CANCER SURVIVORS.

    ``(a) In General.--The Secretary shall make grants to eligible 
entities to pay all or a portion of the costs incurred during the first 
4 years of establishing and operating a clinic for comprehensive long-
term follow-up services for childhood cancer survivors.
    ``(b) Eligible Entities.--In this section, the term `eligible 
entity' means--
            ``(1) a school of medicine;
            ``(2) a children's hospital;
            ``(3) a cancer center; or
            ``(4) any other entity with significant experience and 
        expertise in treating survivors of childhood cancers.
    ``(c) Priority.--In making grants under this section, the Secretary 
shall give priority to any eligible entity that demonstrates an 
expertise in improving access to care for minority and other medically 
underserved populations.
    ``(d) Use of Funds.--The Secretary may make a grant under this 
section to an eligible entity only if the entity agrees to use the 
grant to pay costs incurred during the first 4 years of establishing 
and operating a clinic for comprehensive long-term follow-up services 
for childhood cancer survivors. Such costs may include the costs of--
            ``(1) purchasing or leasing facilities;
            ``(2) providing medical and psychosocial follow-up 
        services, including coordination with the patient's primary 
        care provider and oncologist in order to ensure that the unique 
        medical needs of survivors are addressed;
            ``(3) conducting research to improve care for childhood 
        cancer survivors;
            ``(4) providing linguistically and culturally competent 
        information to childhood cancer survivors and their families; 
        and
            ``(5) improving access by minority or other medically 
        underserved populations to the best practices and care for 
        childhood cancer survivors.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $15,000,000 for each of fiscal 
years 2012 through 2016.''.

SEC. 15. GRANTS TO IMPROVE ACCESS TO CARE FOR CHILDHOOD CANCER 
              SURVIVORS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.), as amended by sections 6, 13, and 15, is further amended by 
inserting after section 317W the following:

``SEC. 317X. GRANTS TO IMPROVE ACCESS TO CARE FOR CHILDHOOD CANCER 
              SURVIVORS.

    ``(a) Grants.--The Secretary shall make grants to recognized 
childhood cancer professional and advocacy organizations to improve 
physical and psychosocial care for childhood cancer survivors, 
especially childhood cancer survivors in minority or other medically 
underserved populations.
    ``(b) Use of Funds.--The Secretary may make a grant under this 
section to an organization only if the organization agrees to use the 
grant to improve physical and psychosocial care for childhood cancer 
survivors, especially childhood cancer survivors in minority or other 
medically underserved populations. Such care may include--
            ``(1) patient navigator programs;
            ``(2) peer support programs;
            ``(3) education and outreach for survivors and their 
        families, including developing bilingual materials;
            ``(4) follow-up care for uninsured and underinsured 
        survivors--
                    ``(A) to identify, prevent, or control side effects 
                associated with cancer and its treatment; and
                    ``(B) to screen for cancer recurrence; and
            ``(5) assistance with transportation necessary to receive 
        medical care for survivors and their families who lack adequate 
        transportation resources.
    ``(c) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $10,000,000 for each of fiscal 
years 2012 through 2016.''.
                                 <all>
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