[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 717 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 717

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 26, 2009

     Mr. Kennedy (for himself, Mrs. Hutchison, and Mrs. Feinstein) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    This Act may be cited as the ``21st Century Cancer ALERT (Access to 
Life-Saving Early detection, Research and Treatment) Act''.

SEC. 2. FINDINGS AND PURPOSE.

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

SEC. 3. ADVANCEMENT OF THE NATIONAL CANCER PROGRAM.

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

``SEC. 411. NATIONAL CANCER PROGRAM.

    ``(a) In General.--There shall be established a National Cancer 
Program (referred to in this section as the `Program') that shall 
consist of--
            ``(1) an expanded, intensified, and coordinated cancer 
        research program encompassing the research programs conducted 
        and supported by the Institute and the related research 
        programs of the other national research institutes, including 
        an expanded and intensified research program for the prevention 
        of cancer caused by occupational or environmental exposure to 
        carcinogens; and
            ``(2) the other programs and activities of the Institute.
    ``(b) Collaboration.--In carrying out the Program--
            ``(1) the Secretary and the Director of the Institute shall 
        identify relevant Federal agencies that shall collaborate with 
        respect to activities conducted under the Program (including 
        the Institute, the other Institutes and Centers of the National 
        Institutes of Health, the Office of the Director of the 
        National Institutes of Health, the Food and Drug 
        Administration, the Centers for Medicare & Medicaid Services, 
        the Centers for Disease Control and Prevention, the Department 
        of Defense, the Department of Energy, the Agency for Healthcare 
        Research and Quality, the Office for Human Research 
        Protections, the Health Resources and Services Administration, 
        and the Office for Human Research Protections); and
            ``(2) the Secretary shall ensure that the policies related 
        to the promotion of cancer research of all agencies within the 
        Department of Health and Human Services (including the 
        Institute, the Food and Drug Administration, and the Centers 
        for Medicare & Medicaid Services) are harmonized, and shall 
        ensure that such agencies collaborate with regard to cancer 
        research and development.
    ``(c) Transparency and Efficiency.--
            ``(1) Budgeting.--In carrying out the Program, the Director 
        of the Institute shall, in preparing and submitting to the 
        President the annual budget estimate for the Program--
                    ``(A) develop the budgetary needs of the entire 
                Program and submit the budget estimate relating to such 
                needs to the National Cancer Advisory Board for review 
                prior to submitting such estimate to the President; and
                    ``(B) submit such budget estimate to the Committee 
                on the Budget and the Committee on Appropriations of 
                the Senate and the Committee on the Budget and 
                Committee on Appropriations of the House of 
                Representatives at the same time that such estimate is 
                submitted to the President.
            ``(2) National cancer advisory board.--In establishing the 
        priorities of the Program, the National Cancer Advisory Board 
        shall provide for increased coordination by increasing the 
        participation of representatives (to the extent practicable, 
        representatives who have appropriate decision making authority) 
        of appropriate Federal agencies, including--
                    ``(A) the Centers for Medicare & Medicaid Services;
                    ``(B) the Health Resources and Services 
                Administration;
                    ``(C) the Centers for Disease Control and 
                Prevention; and
                    ``(D) the Agency for Healthcare Research and 
                Quality.
    ``(d) Programs To Encourage Early Detection Research.--The Director 
of the Institute shall develop a standard process through which Federal 
agencies, including the Department of Defense, and administrators of 
federally funded programs may engage in early cancer detection 
research.
    ``(e) Identification of Promising Translational Research 
Opportunities.--
            ``(1) In general.--The Director of the Institute, acting 
        through the Program and in accordance with the NIH Reform Act 
        of 2007, shall continue to identify promising translational 
        research opportunities across all disease sites, populations, 
        and pathways to clinical goals through a transparent, inclusive 
        process by--
                    ``(A) continuing to support efforts to develop a 
                robust number of public or nonprofit entities to carry 
                out early translational research activities;
                    ``(B) emphasizing the role of the young researcher 
                in the program under this section; and
                    ``(C) modifying guidelines for multiproject, 
                collaborative, early translational research awards to 
                focus research and reward collaborative team science.
            ``(2) Matching funds for research.--
                    ``(A) In general.--The Secretary may provide 
                assistance to eligible entities to match the amount of 
                non-Federal funds made available by such entity for 
                translational research of the type described in 
                paragraph (1) relating to cancer.
                    ``(B) Eligibility.--To be eligible to receive 
                assistance under subparagraph (A), an entity shall 
                submit to the Secretary an application at such time, in 
                such manner, and containing such information as the 
                Secretary may require.
                    ``(C) Recommendations and prioritization.--In 
                providing assistance under subparagraph (A), the 
                Secretary shall--
                            ``(i) select entities based on the 
                        recommendations of--
                                    ``(I) the Director of NIH; and
                                    ``(II) a peer review process; and
                            ``(ii) give priority to those entities 
                        submitting applications under subparagraph (B) 
                        that demonstrate that the research involved is 
                        high risk or translational research (as 
                        determined by the Secretary).
                    ``(D) Amount.--The amount of assistance to be 
                provided to an entity under subparagraph (A) shall be 
                at the discretion of the Secretary but shall not exceed 
                an amount equal to 100 percent of the amount of non-
                Federal funds ($1 for each $2 of non-Federal funds) 
                made available for research described in subparagraph 
                (A).
                    ``(E) Determination of amount of non-federal 
                contribution.--Non-Federal funds to be matched under 
                subparagraph (A) may be in cash or in kind, fairly 
                evaluated, including plant, equipment, or services. 
                Amounts provided by the Federal Government, and any 
                portion of any service subsidized by the Federal 
                Government, may not be included in determining the 
                amount of such non-Federal funds.
    ``(f) Biological Resource Coordination and Advancement of 
Technologies for Cancer Research.--
            ``(1) Establishment.--The Director of the Institute, acting 
        through the Program, shall establish an entity within the 
        Institute to augment ongoing efforts to advance new 
        technologies in cancer research, support the national 
        collection of tissues for cancer research purposes, and ensure 
        the quality of tissue collection.
            ``(2) Goals.--The entity established under paragraph (1) 
        shall--
                    ``(A) be designed to expand the access of 
                researchers to biospecimens for cancer research 
                purposes;
                    ``(B) establish uniform standards for the handling 
                and preservation of patient tissue specimens by 
                entities participating in the network established under 
                paragraph (3);
                    ``(C) require adequate annotation of all relevant 
                clinical data while assuring patient privacy;
                    ``(D) facilitate the linkage of public and private 
                entities into the national network under paragraph (3);
                    ``(E) provide for the linkage of cancer registries 
                to other administrative Federal Government data 
                sources, including the Centers for Medicare & Medicaid 
                Services, the Social Security Administration, and the 
                Centers for Disease Control and Prevention, with the 
                goal of understanding the determinants of cancer 
                treatment, care, and outcomes by allowing economic, 
                social, genetic, and other factors to be analyzed in an 
                independent manner; and
                    ``(F) develop strategies to ensure patient rights 
                and privacy, including an assessment of the regulations 
                promulgated pursuant to part C of title XI of the 
                Social Security Act and section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996 
                (42 U.S.C. 1320d-2 note) (referred to in this section 
                as the `HIPAA Privacy Rule'), while facilitating 
                advances in medical research.
            ``(3) Advancement of new technologies for cancer research 
        and expansion of cancer biorepository networks.--
                    ``(A) In general.--As part of the entity 
                established under paragraph (1), the Director of the 
                Institute shall build upon existing initiatives to 
                establish an interconnected network of biorepositories 
                (referred to in this subsection as the `Network') with 
                consistent, interoperable systems for the collection 
                and storage of tissues and information, the annotation 
                of such information, and the sharing of such 
                information through an interoperable information 
                system.
                    ``(B) Guidelines.--A biorepository in the Network 
                that receives Federal funds shall adopt the Institute's 
                Best Practices for Biospecimen Resources for Institute-
                supported biospecimen resources (as published by the 
                Institute and including any successor guidelines) for 
                the collection of biospecimens and any accompanying 
                data.
                    ``(C) Representation.--The composition of any 
                leadership entity of the Network shall be determined by 
                the Director of the Institute and shall, at a minimum, 
                include a representative of--
                            ``(i) private sector entities and 
                        individuals, including cancer researchers and 
                        health care providers;
                            ``(ii) the Centers for Disease Control and 
                        Prevention;
                            ``(iii) the Agency for Healthcare Research 
                        and Quality;
                            ``(iv) the Office of National Coordination 
                        of Health Information Technology;
                            ``(v) the National Library of Medicine;
                            ``(vi) the Office for the Protection of 
                        Research Subjects; and
                            ``(vii) the National Science Foundation.
                    ``(D) Partnerships with tissue source sites.--The 
                Director of the Institute may enter into contracts with 
                tissue source sites to acquire data from such sites. 
                Any such data shall be acquired through the use of 
                protocols and closely monitored, transparent procedures 
                within appropriate ethical and legal frameworks.
            ``(4) Collection of data.--
                    ``(A) Hospitals.--A hospital or ambulatory cancer 
                center that receives Federal funds shall offer patients 
                the opportunity to contribute their biospecimens and 
                clinical data to the entity established under paragraph 
                (1).
                    ``(B) Clinical trial data.--Clinical trial data 
                relating to cancer care and treatment shall be provided 
                to the entity established under paragraph (1).''.

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

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

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

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

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

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

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

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

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

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may award competitive 
grants to eligible entities to carry out programs--
            ``(1) to provide screenings for colorectal cancer to 
        individuals according to screening guidelines set by the United 
        States Preventive Services Task Force;
            ``(2) to provide appropriate referrals for medical 
        treatment of individuals screened pursuant to paragraph (1) and 
        to ensure, to the extent practicable, the provision of 
        appropriate follow-up services and support services such as 
        case management;
            ``(3) to develop and disseminate public information and 
        education programs for the detection and control of colon 
        cancer;
            ``(4) to improve the education, training, and skills of 
        health professionals (including allied health professionals) in 
        the detection and control of colon cancer;
            ``(5) to establish mechanisms through which eligible 
        entities can monitor the quality of screening procedures for 
        colon cancer, including the interpretation of such procedures; 
        and
            ``(6) to evaluate activities conducted under paragraphs (1) 
        through (5) through appropriate surveillance or program-
        monitoring activities.
    ``(b) Eligibility.--
            ``(1) In general.--To be eligible to receive a grant under 
        this section an entity shall--
                    ``(A) be--
                            ``(i) a State; or
                            ``(ii) an Indian tribe or tribal 
                        organization (as such terms are defined in 
                        section 4 of the Indian Self-Determination and 
                        Education Assistance Act);
                    ``(B) submit to the Secretary as application, at 
                such time, in such manner, and containing such 
                information as the Secretary may require, including--
                            ``(i) a description of the purposes for 
                        which the entity intends to expend amounts 
                        under the grant; and
                            ``(ii) a description of the populations, 
                        areas, and localities with a need for the 
                        services or activities described in clause (i);
                    ``(C) provide matching funds in accordance with 
                paragraph (2);
                    ``(D) provide assurances that the entity will--
                            ``(i) establish such fiscal control and 
                        fund accounting procedures as may be necessary 
                        to ensure the proper disbursal of, and 
                        accounting for, amounts received under 
                        subsection (a);
                            ``(ii) upon request, provide records 
                        maintained pursuant to clause (i) to the 
                        Secretary or the Comptroller General of the 
                        United States for purposes of auditing the 
                        expenditures of the grant by the eligible 
                        entity; and
                            ``(iii) submit to the Secretary such 
                        reports as the Secretary may require with 
                        respect to the grant; and
                    ``(E) provide assurances that the entity will 
                comply with the restrictions described in subsection 
                (e).
            ``(2) Matching requirement.--
                    ``(A) In general.--The Secretary may not award a 
                grant to an eligible entity under this section unless 
                the eligible entity involved agrees, with respect to 
                the costs to be incurred by the eligible entity in 
                carrying out the purpose described in the application 
                under paragraph (1)(B)(i), to make available non-
                Federal contributions (in cash or in kind under 
                subparagraph (B)) toward such costs in an amount equal 
                to not less than $1 for each $3 of Federal funds 
                provided in the grant. Such contributions may be made 
                directly or through donations from public or private 
                entities.
                    ``(B) Determination of amount of non-federal 
                contribution.--
                            ``(i) In general.--Non-Federal 
                        contributions required in subparagraph (A) may 
                        be in cash or in kind, fairly evaluated, 
                        including equipment or services (and excluding 
                        indirect or overhead costs). Amounts provided 
                        by the Federal Government, or services assisted 
                        or subsidized to any significant extent by the 
                        Federal Government, may not be included in 
                        determining the amount of such non-Federal 
                        contributions.
                            ``(ii) Maintenance of effort.--In making a 
                        determination of the amount of non-Federal 
                        contributions for purposes of subparagraph (A), 
                        the Secretary may include only non-Federal 
                        contributions in excess of the average amount 
                        of non-Federal contributions made by the 
                        eligible entity involved toward the purpose 
                        described in subsection (a) for the 2-year 
                        period preceding the first fiscal year for 
                        which the eligible entity is applying to 
                        receive a grant under such section.
                            ``(iii) Inclusion of relevant non-federal 
                        contributions for medicaid.--In making a 
                        determination of the amount of non-Federal 
                        contributions for purposes of subparagraph (A), 
                        the Secretary shall, subject to clauses (i) and 
                        (ii), include any non-Federal amounts expended 
                        pursuant to title XIX of the Social Security 
                        Act by the eligible entity involved toward the 
                        purpose described in paragraphs (1) and (2) of 
                        subsection (a).
    ``(c) Prioritization.--
            ``(1) In general.--In awarding grants under this section, 
        the Secretary shall give priority to recipients that are 
        safety-net providers.
            ``(2) Definition.--In this section, the term `safety-net 
        provider' means a health care provider--
                    ``(A) that by legal mandate or explicitly adopted 
                mission, offers care to individuals without regard to 
                the individual's ability to pay for such services; or
                    ``(B) for whom a substantial share of the patients 
                are uninsured, receive Medicaid, or are otherwise 
                vulnerable.
    ``(d) Use of Funds.--
            ``(1) In general.--An eligible entity may, subject to 
        paragraphs (2) and (3), expend amounts received under a grant 
        under subsection (a) to carry out the purposes described in 
        such subsection through the awarding of grants to public and 
        nonprofit private entities and through contracts entered into 
        with public and private entities.
            ``(2) Certain application.--If a nonprofit private entity 
        and a private entity that is not a nonprofit entity both submit 
        applications to a grantee under subsection (a) for a grant or 
        contract as provided for in paragraph (1), the grantee may give 
        priority to the application submitted by the nonprofit private 
        entity in any case in which the grantee determines that the 
        quality of such application is equivalent to the quality of the 
        application submitted by the other private entity.
            ``(3) Payments for screenings.--The amount paid by a 
        grantee under subsection (a) to an entity under this subsection 
        for a screening procedure as described in subsection (a)(1) may 
        not exceed the amount that would be paid under part B of title 
        XVIII of the Social Security Act if payment were made under 
        such part for furnishing the procedure to an individual 
        enrolled under such part.
    ``(e) Restriction on Use of Fund.--The Secretary may not award a 
grant to an eligible entity under subsection (a) unless the entity 
agrees that--
            ``(1) in providing screenings under subsection (a)(1), the 
        eligible entity will give priority to low-income individuals 
        who lack adequate coverage under health insurance and health 
        plans with respect to screenings for colorectal cancer;
            ``(2) initially and throughout the period during which 
        amounts are received pursuant to the grant, not less than 60 
        percent of the grant shall be expended to provide each of the 
        services or activities described in subsections (a)(1) and 
        (a)(2);
            ``(3) not more than 10 percent of the grant will be 
        expended for administrative expenses with respect to the 
        activities funded under the grant;
            ``(4) funding received under the grant will supplement, and 
        not supplant, the expenditures of the eligible entity and the 
        value for in-kind contributions for carrying out the activities 
        for which the grant was awarded;
            ``(5) funding will not be expended to make payment for any 
        item or service to the extent that payment has been made, or 
        can reasonably be expected to be made, with respect to such 
        item or service--
                    ``(A) under any State compensation program, under 
                an insurance policy, or under any Federal or State 
                health benefits program; or
                    ``(B) by an entity that provides health services on 
                a prepaid basis; and
            ``(6) funds will not be expended to provide inpatient 
        hospital services for any individual.
    ``(f) Limitation on Imposition of Fees for Services.--The Secretary 
may not award a grant to an eligible entity under this section unless 
the eligible entity involved agrees that, if a charge is imposed for 
the provision of services or activities under the grant, such charge--
            ``(1) will be made according to a schedule of charges that 
        is made available to the public;
            ``(2) will be adjusted to reflect the income of the 
        individual involved; and
            ``(3) will not be imposed on any individual with an income 
        of less than 100 percent of the official poverty line, as 
        established by the Director of the Office of Management and 
        Budget and revised by the Secretary in accordance with section 
        673(2) of the Community Services Block Grant Act (42 U.S.C. 
        9902(2)), including any revision required by such section.
    ``(g) Requirement Regarding Medicare.--The Secretary may not award 
a grant to an eligible entity under this section unless the eligible 
entity involved provides, as applicable, the following assurances:
            ``(1) Screenings under subsection (a)(1) will be carried 
        out as preventive health measures in accordance with evidence-
        based screening guidelines and procedures as specified in 
        section 1861(pp)(1) of the Social Security Act.
            ``(2) An individual will be considered high risk for 
        purposes of subsection (a)(1) only if the individual is high 
        risk within the meaning of section 1861(pp)(2) of such Act.
    ``(h) Requirement Regarding Medicaid.--The Secretary may not award 
a grant to an eligible entity under subsection (a) unless the State 
plan under title XIX of the Social Security Act for the State includes 
the screening procedures and referrals specified in subsections (a)(1) 
and (a)(2) as medical assistance provided under the plan.
    ``(i) Technical Assistance and Provision of Supplies and Services 
in Lieu of Grant Funds.--
            ``(1) Technical assistance.--The Secretary may provide 
        training and technical assistance with respect to the planning, 
        development, and operation of any program funded by a grant 
        under subsection (a). The Secretary may provide such technical 
        assistance directly to eligible entities or through grants to, 
        or contracts with, public and private entities.
            ``(2) Provision of supplies and services in lieu of grant 
        funds.--
                    ``(A) In general.--Subject to subparagraph (B), 
                upon the request of an eligible entity receiving a 
                grant under subsection (a), the Secretary, for the 
                purpose of aiding the eligible entity to carry out a 
                program under this section--
                            ``(i) may provide supplies, equipment, and 
                        services to the eligible entity; and
                            ``(ii) may detail to the eligible entity 
                        any officer or employee of the Department of 
                        Health and Human Services.
                    ``(B) Corresponding reduction in payments.--With 
                respect to a request made by an eligible entity under 
                subparagraph (A), the Secretary shall reduce the amount 
                of payments made under the grant under subsection (a) 
                to the eligible entity by an amount equal to the fair 
                market value of any supplies, equipment, or services 
                provided by the Secretary and the costs of detailing 
                personnel (including pay, allowances, and travel 
                expenses) under subparagraph (A). The Secretary shall, 
                for the payment of expenses incurred in complying with 
                such request, expend the amounts withheld.
    ``(j) Evaluations and Report.--
            ``(1) Evaluations.--The Secretary shall, directly or 
        through contracts with public or private entities, provide for 
        annual evaluations of programs carried out pursuant to this 
        section. Such evaluations shall include evaluations of the 
        extent to which eligible entities carrying out such programs 
        are in compliance with subsection (a)(2).
            ``(2) Report to congress.--The Secretary shall, not later 
        than 1 year after the date on which amounts are first 
        appropriated to carry out this section, and annually 
        thereafter, submit to Congress, a report summarizing 
        evaluations carried out pursuant to paragraph (1) during the 
        preceding fiscal year and making such recommendations for 
        administrative and legislative initiatives with respect to this 
        section as the Secretary determines to be appropriate.''.
    (b) Optional Medicaid Coverage of Certain Persons Screened and 
Found To Have Colorectal Cancer.--
            (1) Coverage as optional categorically needy group.--
                    (A) In general.--Section 1902(a)(10)(A)(ii) of the 
                Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)) is 
                amended--
                            (i) in subclause (XVIII), by striking 
                        ``or'' at the end;
                            (ii) in subclause (XIX), by adding ``or'' 
                        at the end; and
                            (iii) by adding at the end the following:
                                            ``(XX) who are described in 
                                        subsection (gg) (relating to 
                                        certain persons screened and 
                                        found to need treatment from 
                                        complications from screening or 
                                        have colorectal cancer);''.
                    (B) Group described.--Section 1902 of the Social 
                Security Act (42 U.S.C. 1396a) is amended by adding at 
                the end the following:
    ``(gg) Individuals described in this subsection are individuals 
who--
            ``(1) are not described in subsection (a)(10)(A)(i);
            ``(2) have not attained age 65;
            ``(3) have been screened for colorectal cancer and need 
        treatment for complications due to screening or colorectal 
        cancer; and
            ``(4) are not otherwise covered under creditable coverage, 
        as defined in section 2701(c) of the Public Health Service 
        Act.''.
                    (C) Limitation on benefits.--Section 1902(a)(10) of 
                the Social Security Act (42 U.S.C. 1396a(a)(10)) is 
                amended in the matter following subparagraph (G)--
                            (i) by striking ``and (XIV)'' and inserting 
                        ``(XIV)''; and
                            (ii) by inserting ``, and (XV) the medical 
                        assistance made available to an individual 
                        described in subsection (gg) who is eligible 
                        for medical assistance only because of 
                        subparagraph (A)(10)(ii)(XX) shall be limited 
                        to medical assistance provided during the 
                        period in which such an individual requires 
                        treatment for complications due to screening or 
                        colorectal cancer'' before the semicolon.
                    (D) Conforming amendments.--Section 1905(a) of the 
                Social Security Act (42 U.S.C. 1396d(a)) is amended in 
                the matter preceding paragraph (1)--
                            (i) in clause (xii), by striking ``or'' at 
                        the end;
                            (ii) in clause (xiii), by adding ``or'' at 
                        the end; and
                            (iii) by inserting after clause (xiii) the 
                        following:
                                    ``(xiv) individuals described in 
                                section 1902(gg),''.
            (2) Presumptive eligibility.--
                    (A) In general.--Title XIX of the Social Security 
                Act (42 U.S.C. 1396 et seq.) is amended by inserting 
                after section 1920B the following:

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

    ``Sec. 1920C.  A State may elect to apply the provisions of section 
1920B to individuals described in section 1902(gg) (relating to certain 
colorectal cancer patients) in the same manner as such section applies 
to individuals described in section 1902(aa) (relating to certain 
breast or cervical cancer patients).''.
                    (B) Conforming amendments.--
                            (i) Section 1902(a)(47) of the Social 
                        Security Act (42 U.S.C. 1396a(a)(47)) is 
                        amended--
                                    (I) by striking ``and'' after 
                                ``section 1920'' and inserting a comma;
                                    (II) by striking ``and'' after 
                                ``with such section'' and inserting a 
                                comma; and
                                    (III) by inserting before the 
                                semicolon at the end the following: ``, 
                                and provide for making medical 
                                assistance available to individuals 
                                described in section 1920C during a 
                                presumptive eligibility period in 
                                accordance with such section''.
                            (ii) Section 1903(u)(1)(d)(v) of such Act 
                        (42 U.S.C. 1396b(u)(1)(d)(v)) is amended--
                                    (I) by striking ``or for'' and 
                                inserting ``, for''; and
                                    (II) by inserting before the period 
                                the following: ``, or for medical 
                                assistance provided to an individual 
                                described in section 1920C during a 
                                presumptive eligibility period under 
                                such section''.
            (3) Enhanced match.--The first sentence of section 1905(b) 
        of the Social Security Act (42 U.S.C. 1396d(b)) is amended--
                    (A) by striking ``and'' before ``(4)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (5) the Federal medical assistance 
                percentage shall be equal to the enhanced FMAP 
                described in section 2105(b) with respect to medical 
                assistance provided to individuals who are eligible for 
                such assistance only on the basis of section 
                1902(a)(10)(A)(ii)(XX)''.
            (4) Effective date.--The amendments made by this subsection 
        apply to medical assistance for items and services furnished on 
        or after the date that is 1 year after the date of enactment of 
        this Act, without regard to whether final regulations to carry 
        out such amendments have been promulgated by such date.
    (c) Mobile Medical Van Grant Program.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection as the ``Secretary''), acting 
        through the Administrator of the Health Resources and Services 
        Administration, shall award grants to eligible entities for the 
        development and implementation of a mobile medical van program 
        that shall provide cancer screening services that receive an 
        ``A'' or ``B'' recommendation by the U.S. Preventative Services 
        Task Force of the Agency for Healthcare Research and Quality to 
        communities that are underserved and suffer from barriers to 
        access to high quality cancer prevention care.
            (2) Eligible entities.--To be eligible to receive a grant 
        under paragraph (1), and entity shall--
                    (A) be a consortium of public and private entities 
                (such as academic medical centers, universities, 
                hospitals, and non profit organizations);
                    (B) submit to the Secretary an application at such 
                time, in such manner, and containing such information 
                as the Secretary shall require, including--
                            (i) a description of the manner in which 
                        the applicant intends to use funds received 
                        under the grant;
                            (ii) a description of the manner in which 
                        the applicant will evaluate the impact and 
                        effectiveness of the health care services 
                        provided under the program carried out under 
                        the grant;
                            (iii) a plan for sustaining activities and 
                        services funded under the grant after Federal 
                        support for the program has ended;
                            (iv) a plan for the referral of patients to 
                        other health care facilities if additional 
                        services are needed;
                            (v) a protocol for the transfer of patients 
                        in the event of a medical emergency;
                            (vi) a plan for advertising the services of 
                        the mobile medical van to the communities 
                        targeted for health care services; and
                            (vii) a plan to educate patients about the 
                        availability of federally funded medical 
                        insurance programs for which such patients, or 
                        their children, may qualify; and
                    (C) agree that amounts under the grant will be used 
                to supplement, and not supplant, other funds (including 
                in-kind contributions) used by the entity to carry out 
                activities for which the grant is awarded.
            (3) Use of funds.--An entity shall use amounts received 
        under a grant under this subsection to do any of the following:
                    (A) Purchase or lease a mobile medical van.
                    (B) Make repairs and provide maintenance for a 
                mobile medical van.
                    (C) Purchase or lease telemedicine equipment that 
                is reasonable and necessary to operate the mobile 
                medical van.
                    (D) Purchase medical supplies and medication that 
                are necessary to provide health care services on the 
                mobile medical van.
                    (E) Retain medical professionals with expertise and 
                experience in providing cancer screening services to 
                underserved communities to provide health care services 
                on the mobile medical van.
            (4) Matching requirements.--
                    (A) In general.--With respect to the costs of a 
                mobile medical van program to be carried out under a 
                grant under this subsection, the grantee shall make 
                available (directly or through donations from public or 
                private entities) non-Federal contributions toward such 
                costs in an amount that is not less than the amount of 
                the Federal funds provided under this grant.
                    (B) Determination of amount contributed.--Non-
                Federal contributions required under subparagraph (A) 
                may be in cash or in-kind, fairly evaluated, including 
                plant, equipment, or services. Amounts provided by the 
                Federal Government, or services assisted or subsidized 
                to any significant extent by the Federal Government, 
                may not be included in determining the amount of such 
                non-Federal contributions.
                    (C) Waiver.--The Secretary may waive the 
                requirement established in subparagraph (A) if--
                            (i) the Secretary determines that such 
                        waiver is justified; and
                            (ii) the Secretary publishes the rationale 
                        for such waiver in the Federal Register.
                    (D) Return of funds.--An entity that receives a 
                grant under this section that fails to comply with 
                subparagraph (A) shall return to the Secretary an 
                amount equal to the difference between--
                            (i) the amount provided under the grant; 
                        and
                            (ii) the amount of matching funds actually 
                        provided by the grantee.
            (5) Considerations in making grants.--In awarding grants 
        under this subsection, the Secretary shall give preference to 
        eligible entities--
                    (A) that will provide cancer screening services in 
                underserved areas; and
                    (B) that on the date on which the grant is awarded, 
                have a mobile medical van that is nonfunctioning due to 
                the need for necessary mechanical repairs.
            (6) Limitation on duration and amount of grant.--A grant 
        under this subsection shall be for a 2-year period, except that 
        the Secretary may waive such limitation and extend the grant 
        period by an additional year. The amount awarded to an entity 
        under such grant for a fiscal year shall not exceed $200,000.
            (7) Evaluation.--Not later than 1 year after the date on 
        which a grant awarded to an entity under this subsection 
        expires, the entity shall submit to the Secretary the results 
        of an evaluation to be conducted by the entity concerning the 
        effectiveness of the program carried out under the grant.
            (8) Report.--Not later than 18 months after grants are 
        first awarded under this subsection, the Secretary shall submit 
        to the Committee on Appropriations of the Senate and the 
        Committee on Appropriations of the House of Representatives a 
        report on the results of activities carried out with amounts 
        received under such grants.
            (9) Definitions.--In this section:
                    (A) Mobile medical van.--The term ``mobile medical 
                van'' means a mobile vehicle that is equipped to 
                provide non-urgent medical services and health care 
                counseling to patients in underserved areas.
                    (B) Underserved area.--The term ``underserved 
                area'', with respect to the location of patients 
                receiving medical treatment, means a ``medically 
                underserved community'' as defined in section 799B(6) 
                of the Public Health Service Act (42 U.S.C. 295p(6)).
    (d) Access to Prevention and Early Detection for Certain Cancers.--
            (1) Cancer genome atlas.--The Secretary of Health and Human 
        Services, acting through the National Cancer Institute, shall 
        provide for the inclusion of cancers with survival rates of 
        less than 25 percent at 5 years in the Cancer Genome Atlas.
            (2) Phase in.--The Director of the National Cancer 
        Institute shall phase in the participation of cancers described 
        in paragraph (1) in the Cancer Genome Atlas Consortium.
            (3) Working groups.--The Secretary of Health and Human 
        Services, acting through the National Cancer Institute, shall 
        establish formal working groups for cancers with survival rates 
        of less than 25 percent at 5 years within the Early Detection 
        Research Network.
            (4) Computer assisted diagnostic, surgical, treatment and 
        drug testing innovations to reduce mortality from cancers.--The 
        Director of the National Institute of Biomedical Imaging and 
        Bioengineering shall ensure that the Quantum Grant Program and 
        the Image Guided Interventions programs expedite the 
        development of computer assisted diagnostic, surgical, 
        treatment and drug testing innovations to reduce mortality from 
        cancers with survival rates of less than 25 percent at 5 years.

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

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

SEC. 8. CANCER CLINICAL TRIALS.

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

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

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan (or a health 
        insurance issuer offering health insurance coverage in 
        connection with the plan) provides coverage to a qualified 
        individual (as defined in subsection (b)), the plan or issuer--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsection (c), may not deny (or 
                limit or impose additional conditions on) the coverage 
                of routine patient costs for items and services 
                furnished in connection with participation in the 
                trial; and
                    ``(C) may not discriminate against the individual 
                on the basis of the individual's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--For purposes of 
        paragraph (1)(B), subject to subparagraph (B), routine patient 
        costs include all items and services consistent with the 
        coverage provided in the plan (or coverage) that is typically 
        covered for a qualified individual who is not enrolled in a 
        clinical trial and that was not necessitated solely because of 
        the trial, except--
                    ``(A) the investigational item, device or service, 
                itself; or
                    ``(B) items and services that are provided solely 
                to satisfy data collection and analysis needs and that 
                are not used in the direct clinical management of the 
                patient.
            ``(3) Use of in-network providers.--If one or more 
        participating providers is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that a qualified individual 
        participate in the trial through such a participating provider 
        if the provider will accept the individual as a participant in 
        the trial.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who is a 
participant or beneficiary in a group health plan and who meets the 
following conditions:
            ``(1)(A) The individual has been diagnosed with cancer.
            ``(B) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) Either--
                    ``(A) the referring health care professional is a 
                participating health care provider and has concluded 
                that the individual's participation in such trial would 
                be appropriate based upon the individual meeting the 
                conditions described in paragraph (1); or
                    ``(B) the participant or beneficiary provides 
                medical and scientific information establishing that 
                the individual's participation in such trial would be 
                appropriate based upon the individual meeting the 
                conditions described in paragraph (1).
    ``(c) Limitations on Coverage.--This section shall not be construed 
to require a group health plan, or a health insurance issuer in 
connection with a group health plan, to provide benefits for routine 
patient care services provided outside of the plan's (or coverage's) 
health care provider network unless out-of-network benefits are 
otherwise provided under the plan (or coverage).
    ``(d) Approved Clinical Trial Defined.--
            ``(1) In general.--In this section, the term `approved 
        clinical trial' means a phase I, phase II, phase III, or phase 
        IV clinical trial that relates to the prevention and treatment 
        of cancer (including related symptoms) and is described in any 
        of the following subparagraphs:
                    ``(A) Federally funded trials.--The study or 
                investigation is approved or funded (which may include 
                funding through in-kind contributions) by one or more 
                of the following:
                            ``(i) The National Institutes of Health.
                            ``(ii) The Centers for Disease Control and 
                        Prevention.
                            ``(iii) The Agency for Health Care Research 
                        and Quality.
                            ``(iv) The Centers for Medicare & Medicaid 
                        Services.
                            ``(v) cooperative group or center of any of 
                        the entities described in clauses (i) through 
                        (iv) or the Department of Defense or the 
                        Department of Veterans Affairs.
                            ``(vi) A qualified non-governmental 
                        research entity identified in the guidelines 
                        issued by the National Institutes of Health for 
                        center support grants.
                            ``(vii) Any of the following if the 
                        conditions described in paragraph (2) are met:
                                    ``(I) The Department of Veterans 
                                Affairs.
                                    ``(II) The Department of Defense.
                                    ``(III) The Department of Energy.
                    ``(B) The study or investigation is conducted under 
                an investigational new drug application reviewed by the 
                Food and Drug Administration.
                    ``(C) The study or investigation is a drug trial 
                that is exempt from having such an investigational new 
                drug application.
            ``(2) Conditions for departments.--The conditions described 
        in this paragraph, for a study or investigation conducted by a 
        Department, are that the study or investigation has been 
        reviewed and approved through a system of peer review that the 
        Secretary determines--
                    ``(A) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health, and
                    ``(B) assures unbiased review of the highest 
                scientific standards by qualified individuals who have 
                no interest in the outcome of the review.
    ``(e) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials.
    ``(f) Preemption.--Notwithstanding any other provision of this Act, 
nothing in this section shall preempt State laws that require a 
clinical trials policy for State regulated health insurance plans.''.
            (2) Clerical amendments.--
                    (A) Section 732(a) of such Act (29 U.S.C. 1191a(a)) 
                is amended by striking ``section 711'' and inserting 
                ``sections 711 and 715''.
                    (B) The table of contents in section 1 of such Act 
                is amended by inserting after the item relating to 
                section 714 the following new item:

``Sec. 715. Coverage for individuals participating in approved cancer 
                            clinical trials.''.
    (b) Clinical Trials.--The Director of the National Cancer Institute 
shall--
            (1) collaborate with the Director of the National 
        Institutes of Health to engage in a campaign to educate the 
        public on the value of clinical trials for oncology patients, 
        which shall be implemented on the local level and focus on 
        patient populations that traditionally are underrepresented in 
        clinical trials;
            (2) conduct an educational campaign for health care 
        professionals to educate them to consider clinical trials as 
        treatment options for their patients; and
            (3) conduct research to document and demonstrate promising 
        practices in cancer clinical trial recruitment and retention 
        efforts, particularly for patient populations that 
        traditionally are underrepresented in clinical trials.

SEC. 9. HEALTH PROFESSIONS WORKFORCE.

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

SEC. 10. PATIENT NAVIGATOR PROGRAM.

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

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

    (a) Coverage of Routine Costs Associated With Clinical Trials Under 
Medicare.--
            (1) Coverage under part a.--Section 1814 of the Social 
        Security Act (42 U.S.C. 1395f) is amended by adding at the end 
        the following new subsection:
    ``(m) Coverage of Routine Costs Associated With Clinical Trials.--
The Secretary shall not exclude from payment for items and services 
provided under a clinical trial payment for coverage of routine costs 
of care (as defined by the Secretary) furnished to an individual 
entitled to benefits under this part who participates in such a trial 
to the extent the Secretary provides payment for such costs as of the 
date of enactment of this subsection.''.
            (2) Coverage under part b.--Section 1833(w) of the Social 
        Security Act (42 U.S.C. 1395l(w)), as added by section 184 of 
        the Medicare Improvements for Patients and Providers Act of 
        2008 (Public Law 110-275), is amended--
                    (A) by striking ``Payment.--The Secretary'' and 
                inserting ``Payment and Coverage of Routine Costs 
                Associated With Clinical Trials.--
            ``(1) Methods of payment.--Subject to paragraph (2), the 
        Secretary''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(2) Coverage of routine costs associated with clinical 
        trials.--The Secretary shall not exclude from payment for items 
        and services provided under a clinical trial payment for 
        coverage of routine costs of care (as defined by the Secretary) 
        furnished to an individual enrolled under this part who 
        participates in such a trial to the extent the Secretary 
        provides payment for such costs as of the date of enactment of 
        this subsection.''.
            (3) Provider outreach.--The Secretary of Health and Human 
        Services, acting through the Administrator of the Centers for 
        Medicare & Medicaid Services, shall conduct an outreach 
        campaign to providers of services and suppliers under the 
        Medicare program under title XVIII of the Social Security Act 
        regarding coverage of routine costs of care furnished to 
        Medicare beneficiaries participating in clinical trials in 
        accordance with sections 1814(m) and 1833(w)(2) of the Social 
        Security Act (as added by paragraphs (1) and (2), 
        respectively).
    (b) Demonstration Project To Provide Comprehensive Cancer Care 
Planning Services Under Medicare.--
            (1) In general.--Beginning not later than 180 days after 
        the date of enactment of this Act, the Secretary of Health and 
        Human Services (referred to in this subsection as the 
        ``Secretary'') shall conduct a 3-year demonstration project 
        (referred to in this subsection as the ``demonstration 
        project'') under title XVIII of the Social Security Act (42 
        U.S.C. 1395 et seq.) under which payment for comprehensive 
        cancer care planning services furnished by eligible entities 
        shall be made.
            (2) Comprehensive cancer care planning services.--For 
        purposes of this subsection, the term ``comprehensive cancer 
        care planning services'' means--
                    (A) with respect to an individual who is diagnosed 
                with cancer, the development of a plan of care that--
                            (i) details, to the greatest extent 
                        practicable, all aspects of the care to be 
                        provided to the individual, with respect to the 
                        treatment of such cancer, including any 
                        curative treatment and comprehensive symptom 
                        management (such as palliative care) involved;
                            (ii) is documented in the patient's medical 
                        record and furnished to the individual in 
                        person within a period specified by the 
                        Secretary that is as soon as practicable after 
                        the date on which the individual is so 
                        diagnosed;
                            (iii) is furnished, to the greatest extent 
                        practicable, in a form that appropriately takes 
                        into account cultural and linguistic needs of 
                        the individual in order to make the plan 
                        accessible to the individual; and
                            (iv) is in accordance with standards 
                        determined by the Secretary to be appropriate;
                    (B) with respect to an individual for whom a plan 
                of care has been developed under subparagraph (A), the 
                revision of such plan of care as necessary to account 
                for any substantial change in the condition of the 
                individual, if such revision--
                            (i) is in accordance with clauses (i) and 
                        (iii) of such subparagraph; and
                            (ii) is documented in the patient's medical 
                        record and furnished to the individual within a 
                        period specified by the Secretary that is as 
                        soon as practicable after the date of such 
                        revision;
                    (C) with respect to an individual who has completed 
                the primary treatment for cancer, as defined by the 
                Secretary (such as completion of chemotherapy or 
                radiation treatment), the development of a follow-up 
                cancer care plan that--
                            (i) describes the elements of the primary 
                        treatment, including symptom management, 
                        furnished to such individual;
                            (ii) provides recommendations for the 
                        subsequent care of the individual with respect 
                        to the cancer involved;
                            (iii) identifies, to the greatest extent 
                        possible, a healthcare provider to oversee 
                        subsequent care and follow-up as needed and to 
                        whom the individual may direct questions or 
                        concerns;
                            (iv) is documented in the patient's medical 
                        record and furnished to the individual in 
                        person within a period specified by the 
                        Secretary that is as soon as practicable after 
                        the completion of such primary treatment;
                            (v) is furnished, to the greatest extent 
                        practicable, in a form that appropriately takes 
                        into account cultural and linguistic needs of 
                        the individual in order to make the plan 
                        accessible to the individual; and
                            (vi) is in accordance with standards 
                        determined by the Secretary to be appropriate; 
                        and
                    (D) with respect to an individual for whom a 
                follow-up cancer care plan has been developed under 
                subparagraph (C), the revision of such plan as 
                necessary to account for any substantial change in the 
                condition of the individual, if such revision--
                            (i) is in accordance with clauses (i), 
                        (ii), and (iv) of such subparagraph; and
                            (ii) is documented in the patient's medical 
                        record and furnished to the individual within a 
                        period specified by the Secretary that is as 
                        soon as practicable after the date of such 
                        revision.
            (3) Qualifications and selection of eligible entities.--
                    (A) Qualifications.--For purposes of this 
                subsection, the term ``eligible entity'' means a 
                physician office, hospital, outpatient department, or 
                community health center. Qualified providers include 
                physicians, nurse practitioners, and other health care 
                professionals who develop or revise a comprehensive 
                cancer care plan.
                    (B) Selection.--The Secretary shall select at least 
                6 eligible entities to participate in the demonstration 
                project. Such entities shall be selected so that the 
                demonstration project is conducted in different regions 
                across the United States, in urban and rural locations, 
                and across various sites of care.
            (4) Evaluation and report.--
                    (A) Evaluation.--The Secretary shall conduct a 
                comprehensive evaluation of the demonstration project 
                to determine--
                            (i) the effectiveness of the project in 
                        improving patient outcomes and increasing 
                        efficiency and reducing error in the delivery 
                        of cancer care;
                            (ii) the cost of providing comprehensive 
                        cancer care planning services; and
                            (iii) the potential savings to the Medicare 
                        program demonstrated by the project, including 
                        the utility of the demonstration project in 
                        reducing duplicative cancer care services and 
                        decreasing the use of unnecessary medical 
                        services for cancer patients.
                    (B) Report.--
                            (i) In general.--Not later than the date 
                        that is 1 year after the date on which the 
                        demonstration project concludes, the Secretary 
                        shall submit to Congress a report on the 
                        evaluation conducted under subparagraph (A).
                            (ii) Prevention of fraudulent billing.--The 
                        Secretary shall consult with the Medicare Fraud 
                        Task Force in the design of the demonstration 
                        project to identify and address concerns about 
                        fraudulent billing of comprehensive cancer care 
                        planning services. The Secretary's actions on 
                        prevention of fraud shall be included in the 
                        report under this subparagraph.
                            (iii) Demonstration of substantial 
                        benefit.--If the evaluation conducted under 
                        subparagraph (A) indicates substantial benefit 
                        from the demonstration project, as measured by 
                        improved patient outcomes and more efficient 
                        delivery of healthcare services, such report 
                        shall include a legislative proposal to 
                        Congress for coverage of comprehensive cancer 
                        care planning services under the Medicare 
                        program, developed on the basis of information 
                        from the demonstration project and in 
                        consultation with the Administrator of the 
                        Agency for Healthcare Research and Quality, the 
                        Director of the Institute of Medicine, and the 
                        Director of the Centers for Disease Control and 
                        Prevention.
                            (iv) No substantial benefit.--If the 
                        evaluation conducted under subparagraph (A) 
                        does not indicate substantial benefit from the 
                        demonstration project, as measured by improved 
                        patient outcomes and more efficient delivery of 
                        healthcare services, such report shall 
                        document, to the extent possible, the reasons 
                        why the demonstration project did not result in 
                        substantial benefit, and such report--
                                    (I) shall include a legislative 
                                proposal for Medicare coverage of 
                                comprehensive cancer care planning 
                                services in a manner that will lead to 
                                substantial benefit; or
                                    (II) shall include recommendations 
                                for additional demonstration projects 
                                or studies to evaluate the delivery of 
                                comprehensive cancer care planning 
                                services in a manner that will lead to 
                                substantial benefit and eventual 
                                Medicare coverage.
            (5) Funding.--The Secretary shall provide for the transfer 
        from the Federal Supplementary Medical Insurance Trust Fund 
        established under section 1841 of the Social Security Act (42 
        U.S.C. 1395t) of the amount necessary to carry out the 
        demonstration project and report under this subsection.
    (c) Promoting Cessation of Tobacco Use Under Medicaid.--
            (1) Services described.--Section 1905 of the Social 
        Security Act (42 U.S.C. 1396d) is amended by adding at the end 
        the following new subsection:
    ``(y)(1) Subject to paragraph (2), for purposes of this title, the 
term `counseling and pharmacotherapy for cessation of tobacco use' 
means diagnostic, therapy, and counseling services and pharmacotherapy 
(including the coverage of prescription and nonprescription tobacco 
cessation agents approved by the Food and Drug Administration) for 
cessation of tobacco use for individuals who use tobacco products or 
who are being treated for tobacco use which are furnished--
            ``(A) by or under the supervision of a physician; or
            ``(B) by any other health care professional who--
                    ``(i) is legally authorized to furnish such 
                services under State law (or the State regulatory 
                mechanism provided by State law) of the State in which 
                the services are furnished; and
                    ``(ii) is authorized to receive payment for other 
                medical assistance under this title or is designated by 
                the Secretary for this purpose.
    ``(2) Such term is limited to--
            ``(A) services recommended in `Treating Tobacco Use and 
        Dependence: A Clinical Practice Guideline', published by the 
        Public Health Service in June 2000, or any subsequent 
        modification of such Guideline; and
            ``(B) such other services that the Secretary recognizes to 
        be effective.''.
            (2) Dropping exception from medicaid prescription drug 
        coverage for tobacco cessation medications.--Section 1927(d)(2) 
        of the Social Security Act (42 U.S.C. 1396r-8(d)(2)) is 
        amended--
                    (A) by striking subparagraph (E);
                    (B) by redesignating subparagraphs (F) through (K) 
                as subparagraphs (E) through (J), respectively; and
                    (C) in subparagraph (F) (as redesignated by 
                subparagraph (B)), by inserting before the period at 
                the end the following: ``, except agents approved by 
                the Food and Drug Administration for purposes of 
                promoting, and when used to promote, tobacco 
                cessation''.
            (3) Requiring coverage of tobacco cessation counseling and 
        pharmacotherapy services for pregnant women.--Section 
        1905(a)(4) of the Social Security Act (42 U.S.C. 1396d(a)(4)) 
        is amended--
                    (A) by striking ``and'' before ``(C)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``; and (D) counseling and 
                pharmacotherapy for cessation of tobacco use for 
                pregnant women''.
            (4) Removal of cost-sharing for tobacco cessation 
        counseling and pharmacotherapy services for pregnant women.--
                    (A) In general.--Section 1916 of the Social 
                Security Act (42 U.S.C. 1396o) is amended in each of 
                subsections (a)(2)(B) and (b)(2)(B), by inserting ``, 
                and counseling and pharmacotherapy for cessation of 
                tobacco use'' after ``complicate the pregnancy''.
                    (B) Conforming amendment.--Section 
                1916A(b)(3)(B)(iii) of such Act (42 U.S.C. 1396o-
                1(b)(3)(B)(iii)) is amended by inserting ``, and 
                counseling and pharmacotherapy for cessation of tobacco 
                use'' after ``complicate the pregnancy''.
            (5) Effective date.--The amendments made by this subsection 
        take effect 1 year after the date of enactment of this Act and 
        apply to medical assistance provided under a State Medicaid 
        program on or after that date.

SEC. 12. CANCER SURVIVORSHIP AND COMPLETE RECOVERY INITIATIVES.

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

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

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

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

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