S 717 ISCommentsClose CommentsPermalink

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

March 26, 2009CommentsClose CommentsPermalink

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 PensionsCommentsClose CommentsPermalink

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

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

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’.CommentsClose CommentsPermalink

SEC. 2. FINDINGS AND PURPOSE.

(a) Findings- Congress makes the following findings:CommentsClose CommentsPermalink





(1) One in 2 men and one in 3 women are expected to develop cancer in their lifetimes.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) At least 30 percent of all cancer deaths and 87 percent of lung cancer deaths are attributed to smoking.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(12) While there have been substantial achievements since the crusade began, we are far from winning the war on cancer.CommentsClose CommentsPermalink





(13) Many obstacles have hindered our progress in cancer prevention, research, and treatment.CommentsClose CommentsPermalink





(b) Purposes- The purposes of this Act are as follows:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(2) the other programs and activities of the Institute.CommentsClose CommentsPermalink





‘(b) Collaboration- In carrying out the Program--CommentsClose CommentsPermalink





‘(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); andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(c) Transparency and Efficiency-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the Centers for Medicare & Medicaid Services;CommentsClose CommentsPermalink





‘(B) the Health Resources and Services Administration;CommentsClose CommentsPermalink





‘(C) the Centers for Disease Control and Prevention; andCommentsClose CommentsPermalink





‘(D) the Agency for Healthcare Research and Quality.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(e) Identification of Promising Translational Research Opportunities-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) continuing to support efforts to develop a robust number of public or nonprofit entities to carry out early translational research activities;CommentsClose CommentsPermalink





‘(B) emphasizing the role of the young researcher in the program under this section; andCommentsClose CommentsPermalink





‘(C) modifying guidelines for multiproject, collaborative, early translational research awards to focus research and reward collaborative team science.CommentsClose CommentsPermalink





‘(2) MATCHING FUNDS FOR RESEARCH-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(C) RECOMMENDATIONS AND PRIORITIZATION- In providing assistance under subparagraph (A), the Secretary shall--CommentsClose CommentsPermalink





‘(i) select entities based on the recommendations of--CommentsClose CommentsPermalink





‘(I) the Director of NIH; andCommentsClose CommentsPermalink





‘(II) a peer review process; andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(f) Biological Resource Coordination and Advancement of Technologies for Cancer Research-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) GOALS- The entity established under paragraph (1) shall--CommentsClose CommentsPermalink





‘(A) be designed to expand the access of researchers to biospecimens for cancer research purposes;CommentsClose CommentsPermalink





‘(B) establish uniform standards for the handling and preservation of patient tissue specimens by entities participating in the network established under paragraph (3);CommentsClose CommentsPermalink





‘(C) require adequate annotation of all relevant clinical data while assuring patient privacy;CommentsClose CommentsPermalink





‘(D) facilitate the linkage of public and private entities into the national network under paragraph (3);CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) ADVANCEMENT OF NEW TECHNOLOGIES FOR CANCER RESEARCH AND EXPANSION OF CANCER BIOREPOSITORY NETWORKS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) private sector entities and individuals, including cancer researchers and health care providers;CommentsClose CommentsPermalink





‘(ii) the Centers for Disease Control and Prevention;CommentsClose CommentsPermalink





‘(iii) the Agency for Healthcare Research and Quality;CommentsClose CommentsPermalink





‘(iv) the Office of National Coordination of Health Information Technology;CommentsClose CommentsPermalink





‘(v) the National Library of Medicine;CommentsClose CommentsPermalink





‘(vi) the Office for the Protection of Research Subjects; andCommentsClose CommentsPermalink





‘(vii) the National Science Foundation.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) COLLECTION OF DATA-CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(B) CLINICAL TRIAL DATA- Clinical trial data relating to cancer care and treatment shall be provided to the entity established under paragraph (1).’.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(b) Improved Privacy Standards in Clinical Research-CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) pursuant to a waiver that had been granted by an institutional review board or privacy board relating to such disclosure; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) SYNCHRONIZATION OF STANDARDS-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(C) ADDITIONAL AREAS- In carrying out subparagraph (A), the Secretary of Health and Human Services shall--CommentsClose CommentsPermalink





(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); andCommentsClose CommentsPermalink





(ii) include biorepository storage information when obtaining patient consent.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) APPLICATION OF PRIVACY RULE TO EXTERNAL RESEARCHERS-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(B) DEFINITION-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

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

‘(a) Annual Independent Report-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) CONTENTS OF REPORT-CommentsClose CommentsPermalink





‘(A) CANCER CATEGORIES- The report required under paragraph (1) shall address the following categories of cancer:CommentsClose CommentsPermalink





‘(i) Cancers that result in a 5-year survival rate of less than 50 percent.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) INFORMATION- With regard to each of the categories of cancer described in subparagraph (A), the report shall contain information regarding--CommentsClose CommentsPermalink





‘(i) a strategic plan for reducing the mortality rate for the annual year, including specific research areas of interest and budget amounts;CommentsClose CommentsPermalink





‘(ii) identification of any barriers to implementing the strategic plan described in clause (i) for the annual year;CommentsClose CommentsPermalink





‘(iii) if the report for the prior year contained a strategic plan described in clause (i), an assessment of the success of such plan;CommentsClose CommentsPermalink





‘(iv) the total amount of grant funding, including the total dollar amount awarded per grant and per funding year, under--CommentsClose CommentsPermalink





‘(I) the National Cancer Institute; andCommentsClose CommentsPermalink





‘(II) the National Institutes of Health;CommentsClose CommentsPermalink





‘(v) the percentage of grant applications favorably reviewed by the Institute that the Institute funded in the previous annual year;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Grant Program-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the incidence is fewer than 40,000 new cases per year; andCommentsClose CommentsPermalink





‘(B) the 5-year survival rate is less than 50 percent.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) TISSUE SAMPLES-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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--CommentsClose CommentsPermalink





‘(1) to provide screenings for colorectal cancer to individuals according to screening guidelines set by the United States Preventive Services Task Force;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(3) to develop and disseminate public information and education programs for the detection and control of colon cancer;CommentsClose CommentsPermalink





‘(4) to improve the education, training, and skills of health professionals (including allied health professionals) in the detection and control of colon cancer;CommentsClose CommentsPermalink





‘(5) to establish mechanisms through which eligible entities can monitor the quality of screening procedures for colon cancer, including the interpretation of such procedures; andCommentsClose CommentsPermalink





‘(6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or program-monitoring activities.CommentsClose CommentsPermalink





‘(b) Eligibility-CommentsClose CommentsPermalink





‘(1) IN GENERAL- To be eligible to receive a grant under this section an entity shall--CommentsClose CommentsPermalink





‘(A) be--CommentsClose CommentsPermalink





‘(i) a State; orCommentsClose CommentsPermalink





‘(ii) an Indian tribe or tribal organization (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act);CommentsClose CommentsPermalink





‘(B) submit to the Secretary as application, at such time, in such manner, and containing such information as the Secretary may require, including--CommentsClose CommentsPermalink





‘(i) a description of the purposes for which the entity intends to expend amounts under the grant; andCommentsClose CommentsPermalink





‘(ii) a description of the populations, areas, and localities with a need for the services or activities described in clause (i);CommentsClose CommentsPermalink





‘(C) provide matching funds in accordance with paragraph (2);CommentsClose CommentsPermalink





‘(D) provide assurances that the entity will--CommentsClose CommentsPermalink





‘(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);CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(iii) submit to the Secretary such reports as the Secretary may require with respect to the grant; andCommentsClose CommentsPermalink





‘(E) provide assurances that the entity will comply with the restrictions described in subsection (e).CommentsClose CommentsPermalink





‘(2) MATCHING REQUIREMENT-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(c) Prioritization-CommentsClose CommentsPermalink





‘(1) IN GENERAL- In awarding grants under this section, the Secretary shall give priority to recipients that are safety-net providers.CommentsClose CommentsPermalink





‘(2) DEFINITION- In this section, the term ‘safety-net provider’ means a health care provider--CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(B) for whom a substantial share of the patients are uninsured, receive Medicaid, or are otherwise vulnerable.CommentsClose CommentsPermalink





‘(d) Use of Funds-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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);CommentsClose CommentsPermalink





‘(3) not more than 10 percent of the grant will be expended for administrative expenses with respect to the activities funded under the grant;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; orCommentsClose CommentsPermalink





‘(B) by an entity that provides health services on a prepaid basis; andCommentsClose CommentsPermalink





‘(6) funds will not be expended to provide inpatient hospital services for any individual.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) will be made according to a schedule of charges that is made available to the public;CommentsClose CommentsPermalink





‘(2) will be adjusted to reflect the income of the individual involved; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(i) Technical Assistance and Provision of Supplies and Services in Lieu of Grant Funds-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) may provide supplies, equipment, and services to the eligible entity; andCommentsClose CommentsPermalink





‘(ii) may detail to the eligible entity any officer or employee of the Department of Health and Human Services.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(j) Evaluations and Report-CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(b) Optional Medicaid Coverage of Certain Persons Screened and Found To Have Colorectal Cancer-CommentsClose CommentsPermalink





(1) COVERAGE AS OPTIONAL CATEGORICALLY NEEDY GROUP-CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) in subclause (XVIII), by striking ‘or’ at the end;CommentsClose CommentsPermalink





(ii) in subclause (XIX), by adding ‘or’ at the end; andCommentsClose CommentsPermalink





(iii) by adding at the end the following:CommentsClose CommentsPermalink

‘(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);’.CommentsClose CommentsPermalink

(B) GROUP DESCRIBED- Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(gg) Individuals described in this subsection are individuals who--CommentsClose CommentsPermalink





‘(1) are not described in subsection (a)(10)(A)(i);CommentsClose CommentsPermalink





‘(2) have not attained age 65;CommentsClose CommentsPermalink





‘(3) have been screened for colorectal cancer and need treatment for complications due to screening or colorectal cancer; andCommentsClose CommentsPermalink





‘(4) are not otherwise covered under creditable coverage, as defined in section 2701(c) of the Public Health Service Act.’.CommentsClose CommentsPermalink





(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)--CommentsClose CommentsPermalink





(i) by striking ‘and (XIV)’ and inserting ‘(XIV)’; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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)--CommentsClose CommentsPermalink





(i) in clause (xii), by striking ‘or’ at the end;CommentsClose CommentsPermalink





(ii) in clause (xiii), by adding ‘or’ at the end; andCommentsClose CommentsPermalink





(iii) by inserting after clause (xiii) the following:CommentsClose CommentsPermalink





‘(xiv) individuals described in section 1902(gg),’.CommentsClose CommentsPermalink





(2) PRESUMPTIVE ELIGIBILITY-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink

‘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).’.CommentsClose CommentsPermalink





(B) CONFORMING AMENDMENTS-CommentsClose CommentsPermalink





(i) Section 1902(a)(47) of the Social Security Act (42 U.S.C. 1396a(a)(47)) is amended--CommentsClose CommentsPermalink





(I) by striking ‘and’ after ‘section 1920’ and inserting a comma;CommentsClose CommentsPermalink





(II) by striking ‘and’ after ‘with such section’ and inserting a comma; andCommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





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





(I) by striking ‘or for’ and inserting ‘, for’; andCommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(3) ENHANCED MATCH- The first sentence of section 1905(b) of the Social Security Act (42 U.S.C. 1396d(b)) is amended--CommentsClose CommentsPermalink





(A) by striking ‘and’ before ‘(4)’; andCommentsClose CommentsPermalink





(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)’.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(c) Mobile Medical Van Grant Program-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) ELIGIBLE ENTITIES- To be eligible to receive a grant under paragraph (1), and entity shall--CommentsClose CommentsPermalink





(A) be a consortium of public and private entities (such as academic medical centers, universities, hospitals, and non profit organizations);CommentsClose CommentsPermalink





(B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary shall require, including--CommentsClose CommentsPermalink





(i) a description of the manner in which the applicant intends to use funds received under the grant;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(iii) a plan for sustaining activities and services funded under the grant after Federal support for the program has ended;CommentsClose CommentsPermalink





(iv) a plan for the referral of patients to other health care facilities if additional services are needed;CommentsClose CommentsPermalink





(v) a protocol for the transfer of patients in the event of a medical emergency;CommentsClose CommentsPermalink





(vi) a plan for advertising the services of the mobile medical van to the communities targeted for health care services; andCommentsClose CommentsPermalink





(vii) a plan to educate patients about the availability of federally funded medical insurance programs for which such patients, or their children, may qualify; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) USE OF FUNDS- An entity shall use amounts received under a grant under this subsection to do any of the following:CommentsClose CommentsPermalink





(A) Purchase or lease a mobile medical van.CommentsClose CommentsPermalink





(B) Make repairs and provide maintenance for a mobile medical van.CommentsClose CommentsPermalink





(C) Purchase or lease telemedicine equipment that is reasonable and necessary to operate the mobile medical van.CommentsClose CommentsPermalink





(D) Purchase medical supplies and medication that are necessary to provide health care services on the mobile medical van.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(4) MATCHING REQUIREMENTS-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(C) WAIVER- The Secretary may waive the requirement established in subparagraph (A) if--CommentsClose CommentsPermalink





(i) the Secretary determines that such waiver is justified; andCommentsClose CommentsPermalink





(ii) the Secretary publishes the rationale for such waiver in the Federal Register.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) the amount provided under the grant; andCommentsClose CommentsPermalink





(ii) the amount of matching funds actually provided by the grantee.CommentsClose CommentsPermalink





(5) CONSIDERATIONS IN MAKING GRANTS- In awarding grants under this subsection, the Secretary shall give preference to eligible entities--CommentsClose CommentsPermalink





(A) that will provide cancer screening services in underserved areas; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(9) DEFINITIONS- In this section:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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)).CommentsClose CommentsPermalink





(d) Access to Prevention and Early Detection for Certain Cancers-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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

(a) Promotion of the Discovery and Development of Biomarkers-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) promote the scientific review of such contracts in a timely fashion; andCommentsClose CommentsPermalink





(B) contain the capacity to perform the necessary analysis of contract applications, including determinations as to the intellectual expertise of applicants.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(c) Demonstration Project-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) determine the role of genetic polymorphisms on drug activity and toxicity;CommentsClose CommentsPermalink





(2) establish effective strategies for selecting patients for treatment with specific drugs; andCommentsClose CommentsPermalink





(3) identify early biomarkers of clinical benefit.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

SEC. 8. CANCER CLINICAL TRIALS.

(a) Coverage for Individuals Participating in Approved Cancer Clinical Trials-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink

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

‘(a) Coverage-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(C) may not discriminate against the individual on the basis of the individual’s participation in such trial.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the investigational item, device or service, itself; orCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(1)(A) The individual has been diagnosed with cancer.CommentsClose CommentsPermalink





‘(B) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of such illness.CommentsClose CommentsPermalink





‘(2) Either--CommentsClose CommentsPermalink





‘(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); orCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(d) Approved Clinical Trial Defined-CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(i) The National Institutes of Health.CommentsClose CommentsPermalink





‘(ii) The Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





‘(iii) The Agency for Health Care Research and Quality.CommentsClose CommentsPermalink





‘(iv) The Centers for Medicare & Medicaid Services.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(vi) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.CommentsClose CommentsPermalink





‘(vii) Any of the following if the conditions described in paragraph (2) are met:CommentsClose CommentsPermalink





‘(I) The Department of Veterans Affairs.CommentsClose CommentsPermalink





‘(II) The Department of Defense.CommentsClose CommentsPermalink





‘(III) The Department of Energy.CommentsClose CommentsPermalink





‘(B) The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.CommentsClose CommentsPermalink





‘(C) The study or investigation is a drug trial that is exempt from having such an investigational new drug application.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, andCommentsClose CommentsPermalink





‘(B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.CommentsClose CommentsPermalink





‘(e) Construction- Nothing in this section shall be construed to limit a plan’s or issuer’s coverage with respect to clinical trials.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(2) CLERICAL AMENDMENTS-CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





‘Sec. 715. Coverage for individuals participating in approved cancer clinical trials.’.CommentsClose CommentsPermalink





(b) Clinical Trials- The Director of the National Cancer Institute shall--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(2) conduct an educational campaign for health care professionals to educate them to consider clinical trials as treatment options for their patients; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





‘(2) BENEFITS FOR RETIRING NURSE OFFICERS QUALIFIED AS FACULTY-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) COVERED INDIVIDUALS- An individual described in this subparagraph is an individual who--CommentsClose CommentsPermalink





‘(i) is retired from the Armed Forces after service as a commissioned officer in the nurse corps of the Armed Forces;CommentsClose CommentsPermalink





‘(ii) holds a graduate degree in nursing; andCommentsClose CommentsPermalink





‘(iii) serves as a part- or full-time faculty member of an accredited school of nursing.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(b) Oncology Workforce-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





(A) Cancer research.CommentsClose CommentsPermalink





(B) Care and treatment of cancer patients and survivors.CommentsClose CommentsPermalink





(C) Quality of life, symptom management, and pain management.CommentsClose CommentsPermalink





(D) Early detection and diagnosis.CommentsClose CommentsPermalink





(E) Cancer prevention.CommentsClose CommentsPermalink





(F) Genetic testing, counseling, and ethical considerations related to such testing.CommentsClose CommentsPermalink





(G) Diversity and appropriate care for disparity populations.CommentsClose CommentsPermalink





(H) Palliative and end-of-life care.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink

SEC. 10. PATIENT NAVIGATOR PROGRAM.

Section 340A of the Public Health Service Act (42 U.S.C. 256a) is amended--CommentsClose CommentsPermalink





(1) in subsection (e), by adding at the end the following:CommentsClose CommentsPermalink





‘(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.’; andCommentsClose CommentsPermalink





(2) in subsection (m)--CommentsClose CommentsPermalink





(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.’; andCommentsClose CommentsPermalink





(B) in paragraph (2), by striking ‘2010’ and replacing with ‘2015.’CommentsClose CommentsPermalink

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

(a) Coverage of Routine Costs Associated With Clinical Trials Under Medicare-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) by striking ‘Payment- The Secretary’ and inserting ‘Payment and Coverage of Routine Costs Associated With Clinical Trials-CommentsClose CommentsPermalink





‘(1) METHODS OF PAYMENT- Subject to paragraph (2), the Secretary’; andCommentsClose CommentsPermalink





(B) by adding at the end the following new paragraph:CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(b) Demonstration Project To Provide Comprehensive Cancer Care Planning Services Under Medicare-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) COMPREHENSIVE CANCER CARE PLANNING SERVICES- For purposes of this subsection, the term ‘comprehensive cancer care planning services’ means--CommentsClose CommentsPermalink





(A) with respect to an individual who is diagnosed with cancer, the development of a plan of care that--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(iv) is in accordance with standards determined by the Secretary to be appropriate;CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) is in accordance with clauses (i) and (iii) of such subparagraph; andCommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) describes the elements of the primary treatment, including symptom management, furnished to such individual;CommentsClose CommentsPermalink





(ii) provides recommendations for the subsequent care of the individual with respect to the cancer involved;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(vi) is in accordance with standards determined by the Secretary to be appropriate; andCommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(i) is in accordance with clauses (i), (ii), and (iv) of such subparagraph; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) QUALIFICATIONS AND SELECTION OF ELIGIBLE ENTITIES-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(4) EVALUATION AND REPORT-CommentsClose CommentsPermalink





(A) EVALUATION- The Secretary shall conduct a comprehensive evaluation of the demonstration project to determine--CommentsClose CommentsPermalink





(i) the effectiveness of the project in improving patient outcomes and increasing efficiency and reducing error in the delivery of cancer care;CommentsClose CommentsPermalink





(ii) the cost of providing comprehensive cancer care planning services; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(B) REPORT-CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(I) shall include a legislative proposal for Medicare coverage of comprehensive cancer care planning services in a manner that will lead to substantial benefit; orCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(c) Promoting Cessation of Tobacco Use Under Medicaid-CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) by or under the supervision of a physician; orCommentsClose CommentsPermalink





‘(B) by any other health care professional who--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(ii) is authorized to receive payment for other medical assistance under this title or is designated by the Secretary for this purpose.CommentsClose CommentsPermalink





‘(2) Such term is limited to--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(B) such other services that the Secretary recognizes to be effective.’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) by striking subparagraph (E);CommentsClose CommentsPermalink





(B) by redesignating subparagraphs (F) through (K) as subparagraphs (E) through (J), respectively; andCommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) by striking ‘and’ before ‘(C)’; andCommentsClose CommentsPermalink





(B) by inserting before the semicolon at the end the following: ‘; and (D) counseling and pharmacotherapy for cessation of tobacco use for pregnant women’.CommentsClose CommentsPermalink





(4) REMOVAL OF COST-SHARING FOR TOBACCO CESSATION COUNSELING AND PHARMACOTHERAPY SERVICES FOR PREGNANT WOMEN-CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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.CommentsClose CommentsPermalink





‘(b) Priority Areas- In carrying out subsection (a), the Director of the Institute shall give priority to the following:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) development of a system for patient tracking and analysis;CommentsClose CommentsPermalink





‘(B) establishment of a system of tissue collection, banking, and analysis for childhood cancers, using guidelines from the Office of Biorepositories and Biospecimen Research; andCommentsClose CommentsPermalink





‘(C) coordination of, and resources for, assessment and data collection.CommentsClose CommentsPermalink





‘(2) Identification of risk and protective factors related to the development of late effects of cancer.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) Development and implementation of intervention studies for cancer survivors and their families, including studies focusing on--CommentsClose CommentsPermalink





‘(A) preventive interventions during treatment;CommentsClose CommentsPermalink





‘(B) interventions to lessen the impact of late effects of cancer treatment;CommentsClose CommentsPermalink





‘(C) rehabilitative or remediative interventions following cancer treatment;CommentsClose CommentsPermalink





‘(D) interventions to promote health behaviors in long-term survivors; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(c) Grants for Research on Causes of Health Disparities in Childhood Cancer Survivorship-CommentsClose CommentsPermalink





‘(1) GRANTS- The Director of NIH, acting through the Director of the Institute, shall make grants to entities to conduct research relating to--CommentsClose CommentsPermalink





‘(A) needs and outcomes of pediatric cancer survivors within minority or other medically underserved populations; andCommentsClose CommentsPermalink





‘(B) health disparities in cancer survivorship outcomes within minority or other medically underserved populations.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(A) Key adverse events after childhood cancer.CommentsClose CommentsPermalink





‘(B) Assessment of health and quality of life in childhood cancer survivors.CommentsClose CommentsPermalink





‘(C) Barriers to follow-up care to childhood cancer survivors.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) transitions in care for childhood cancer survivors;CommentsClose CommentsPermalink





‘(2) those professionals who should be part of care teams for childhood cancer survivors;CommentsClose CommentsPermalink





‘(3) training of professionals to provide linguistically and culturally competent follow-up care to childhood cancer survivors; andCommentsClose CommentsPermalink





‘(4) different models of follow-up care.’.CommentsClose CommentsPermalink





(b) Complete Recovery Care-CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(2) EXPANSION OF ACTIVITIES- The Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall--CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) IMPROVING THE COMPLETE RECOVERY CARE WORKFORCE-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(ii) Adapting curricula for continuing education of the existing workforce using efficient workplace-based learning approaches.CommentsClose CommentsPermalink





(iii) Developing the skills of faculty and other trainers in teaching psychosocial health care using evidence-based teaching strategies.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(c) Technical Amendment-CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink

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

It is the sense of the Senate that the Food and Drug Administration should--CommentsClose CommentsPermalink





(1) integrate policies and structures to facilitate the concurrent development of drugs and diagnostics for cancer diagnosis, prevention, and therapy;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(3) modernize the Office of Oncology Drug Products by examining and addressing internal barriers that exist within the current organizational structure.CommentsClose CommentsPermalink