To improve data collection and dissemination, treatment, and research relating to cancer, and for other purposes.

November 20, 2003

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

To improve data collection and dissemination, treatment, and research relating to cancer, and for other purposes.

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `National Cancer Act of 2003'.

SEC. 2. FINDINGS.

Congress makes the following findings:

(1) In 2003, an estimated 1,334,100 Americans will be diagnosed with some form of cancer.

(2) In 2003, an estimated 556,500 Americans will die of cancer. In the United States, 1 in every 4 deaths results from cancer.

(3) In 2002, the National Institutes of Health estimated the overall cost of cancer at $171,600,000,000.

(4) In 2003, an estimated 211,300 American women and 1,300 men will be diagnosed with breast cancer, and 40,200 will die of the disease. A mammogram every 1-2 years can reduce the risk of dying by about 16 percent for women 40 years of age and older.

(5) In 2003, an estimated 40,100 women will be newly diagnosed with cancer of the uterine corpus and 6,800 women will die of the disease.

(6) In 2003, an estimated 147,500 Americans will be diagnosed with colorectal cancer and 57,100 will die of the disease.

(7) Incidence rates of colorectal cancer stabilized between 1995 and 1999. Research suggests that declines may be in part due to increased screening and polyp removal.

(8) The Chronic Disease Prevention Department found that screening for colorectal cancer can reduce the number of deaths by at least 30 percent.

(9) Regular screening examinations by a health care professional can result in early detection of cancers of the breast, colon, rectum, prostate, testis, oral cavity, and skin. If all these cancers were diagnosed at a localized stage through regular examinations, the 5-year survival rate would increase from 82 percent to 95 percent.

(10) Cancers of the lung, mouth, larynx, bladder, kidney, cervix, esophagus, and pancreas are related to tobacco use. The American Cancer Society estimates that in 2003 more than 180,000 cancer deaths will be caused by tobacco use. Smoking alone causes 1/3 of all cancer deaths.

(11) More than 1,000,000 skin cancers expected to be diagnosed in 2003 could have been prevented by protection from the sun's rays.

(12) An estimated 9,000 new cases of childhood cancer are expected to occur in 2003.

(13) Cancer is the chief cause of death by disease in children between the ages of 1 and 14.

(14) The American Cancer Society estimates that approximately 1/3 of the 556,500 cancer deaths expected in 2003 will be related to nutrition, physical inactivity, obesity, and other lifestyle factors that could be prevented.

(15) About 77 percent of all cancers are diagnosed at age 55 and older. In order to ensure high quality cancer care for American seniors, medicare reimbursements must reflect the true cost of treatment in every treatment setting and medicare payments should accurately reflect the cost of drug and biologics as well as the cost of administering drugs and supportive care therapies.

(16) Despite an aging population, death rates for the most common cancers, lung, colorectal, breast, and prostate continue to drop at an average of 1.7 percent per year.

(17) In May 2001, Gleevec, the first in what is expected to be a number of cancer treatments, was approved for use by the Food and Drug Administration as it appeared to be effective in stopping the growth of deadly Chronic Myeloid Leukemia cells within 3 months of use. In 2002, Gleevec showed ability to stop growth of gastrointestinal stromal tumors.

(18) In early 2003, researchers used gene chips to accurately predict whether or not breast cancer tumors would spread in the future. If the findings are validated, doctors will be able to determine which patients are likely to relapse and need chemotherapy, while sparing those with a favorable prognosis from additional treatment.

(19) The Lance Armstrong Foundation, a leading national organization providing services and support for cancer survivors, defines cancer survivorship as living with, through, and beyond cancer.

(20) In 2001, there were 9,600,000 cancer survivors in the United States.

(21) Sixty percent of adults diagnosed with cancer survive at least 5 years.

(22) While nearly every childhood cancer diagnosis 20 years ago was fatal, today more than 80 percent of children diagnosed with cancer survive at least 5 years.

SEC. 3. SENSE OF THE SENATE.

It is the sense of the Senate that the United States is at a point in history in which we must take the proper steps to reach the goal of making cancer survivorship the rule and cancer deaths rare by the year 2015.

TITLE I--PUBLIC HEALTH PROVISIONS

SEC. 101. NATIONAL PROGRAM OF CANCER REGISTRIES.

Part M of title III of the Public Health Service Act (42 U.S.C. 280e et seq.) is amended by inserting after section 399B the following:

`SEC. 399B-1. ENHANCING CANCER REGISTRIES AND PREPARING FOR THE FUTURE.

`(a) STRATEGIC PLAN- Not later than 1 year after the date of enactment of the National Cancer Act of 2003 the Secretary shall develop a plan and submit a report to Congress that outlines strategies by which the State cancer registries funded with grants under section 399B and the Surveillance, Epidemiology, and End Results program of the National Cancer Institute (in this section referred to as the `SEER program') can share information to ensure more comprehensive cancer data. The report shall include ways in which the Secretary will--

`(1) standardize data between State cancer registries and the SEER program;

`(2) increase the portability and usability of data files from each registry for researchers and public health planners;

`(3) ensure data collection from the greatest number of health care facilities possible;

`(4) maximize the use of State registry data and data from the SEER program in State and regional public health planning processes; and

`(5) promote the use of data to--

`(A) improve the health status of cancer survivors; and

`(B) research quality of cancer care and access to that care.'.

SEC. 102. ENHANCING EXISTING SCREENING EFFORTS.

(a) GRANT AND CONTRACT AUTHORITY OF STATES- Section 1501(b)(2) of the Public Health Service Act (42 U.S.C. 300k(b)(2)) is amended to read as follows:

`(2) CERTAIN APPLICATIONS-

`(A) STRATEGIES FOR COLORECTAL CANCER SCREENING- If any entity submits an application to a State to receive an award of a grant or contract pursuant to paragraph (1) that includes strategies for colorectal cancer screening and outreach, the State may give priority to the application submitted by that entity in any case in which the State determines that the quality of such application is equivalent to the quality of the application submitted by the other entities.

`(B) WOMEN DIAGNOSED WITH CANCER- If any entity submits an application to a State to receive an award of a grant or contract pursuant to paragraph (1) that includes strategies for the provision of treatment for uninsured women diagnosed with cancer discovered in the course of the screening, the State may give priority to the application submitted by that entity in any case in which the State determines that the quality of such application is equivalent to the quality of the application submitted by the other entities.'.

(b) REQUIREMENTS WITH RESPECT TO TYPE AND QUALITY OF SERVICES- Section 1503 of the Public Health Service Act (42 U.S.C. 300m) is amended by adding at the end the following:

`(d) WAIVER OF DIRECT SERVICES REQUIREMENT- The Secretary may waive the requirement under subsection (a)(1) if--

`(1) the State involved will use the grant under this section for a demonstration project that will leverage private funds to supplement program efforts; or

`(2) such requirement would cause a barrier to the enrollment of qualifying women.'.

(c) AUTHORIZATION OF APPROPRIATIONS- Section 1510(a) of the Public Health Service Act (42 U.S.C. 300n-5(a)) is amended by striking `$50,000,000' and all that follows and inserting `such sums as may be necessary for each of fiscal years 2004 through 2008.'.

(d) REPORT ON THE COMPREHENSIVE COLORECTAL CANCER INITIATIVE- Not later than 6 months after the date of enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of Congress a report containing an assessment of the success of the Comprehensive Colorectal Cancer Initiative (within the Centers for Disease Control and Prevention) in--

(1) increasing public awareness of colorectal cancer;

(2) increasing awareness of screening guidelines among health care providers;

(3) monitoring national colorectal cancer screening rates;

(4) promoting increased patient-provider communication about colorectal cancer screening;

(5) supporting quantitative and qualitative research efforts; and

(6) providing funding to State programs to implement colorectal cancer priorities.

SEC. 103. ENHANCED PATIENT EDUCATION.

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

`SEC. 399O. ENHANCED PATIENT EDUCATION.

`(a) GRANTS AUTHORIZED- The Secretary is authorized to award grants to eligible entities to implement programs to educate patients and their families about--

`(1) the availability and options of effective medical techniques and pain management technology therapies to reduce and prevent pain and suffering for those with cancer upon diagnosis;

`(2) the unique health challenges associated with cancer survivorship, including--

`(A) the role of followup care and monitoring to support and improve the long-term quality of life for cancer survivors;

`(B) physical activity and healthy lifestyles; and

`(C) the availability of peer and mentor support programs; and

`(3) community resources available to increase access to quality cancer care.

`(b) APPLICATION- An eligible entity desiring a grant under this section shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.

`(c) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated to carry out this section such sums as may be necessary.'.

SEC. 104. PRACTITIONER EDUCATION PROGRAM.

Section 414 of the Public Health Service Act (42 U.S.C. 285a-3) is amended by adding at the end the following:

`(d) In order to receive funding under this section, a center described under subsection (a) shall maintain a program for disseminating to patients and research participants, as well as their caregivers, the latest information about--

`(1) pain and symptom management and palliative care; and

`(2) the unique clinical and research challenges associated with cancer survivorship.

`(e) The Secretary may provide additional amounts to fund centers under subsection (a) that develop innovative relationships with community cancer centers, community health centers, rural hospitals, and other community-based health care providers who target medically underserved populations for the purpose of increasing access to quality cancer care.'.

SEC. 105. ELEVATING THE IMPORTANCE OF PAIN MANAGEMENT AND CANCER SURVIVORSHIP THROUGHOUT THE NATION'S CANCER PROGRAMS.

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

`SEC. 411. The National Cancer Program shall consist of--

`(1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including research programs for--

`(A) pain and symptom management;

`(B) survivorship; and

`(C) the prevention of cancer caused by occupational or environmental exposure to carcinogens; and

`(2) the other programs and activities of the Institute, including research on populations with both uniquely diverse genetic variation and geographic isolation.'.

(b) CANCER CONTROL PROGRAMS- Section 412(2) of the Public Health Service Act (42 U.S.C. 285a-1(2)) is amended--

(1) in subparagraph (A), by striking `, and' and inserting a semicolon; and

(2) by adding at the end the following:

`(C) appropriate methods of pain and symptom management for individuals with cancer, including end-of-life care and cancer survivorship; and'.

(c) SPECIAL AUTHORITIES OF THE DIRECTOR- Section 413(a)(2) of the Public Health Service Act (42 U.S.C. 285a-2(a)(2)) is amended--

(1) in subparagraph (D), by striking `and' at the end;

(2) in subparagraph (E), by striking the period and inserting `; and'; and

(3) by adding at the end the following:

`(F) assess and improve pain and symptom management of cancer throughout the course of treatment and cancer survivorship.'.

(d) BREAST AND GYNECOLOGICAL CANCERS- Section 417 of the Public Health Service Act (42 U.S.C. 285a-6) is amended--

(1) in subsection (c)(1)--

(A) in subparagraph (D), by striking `and' at the end;

(B) in subparagraph (E), by striking the period and inserting `; and'; and

(C) by inserting after subparagraph (E) the following:

`(F) basic, clinical, and applied research concerning pain and symptom management and cancer survivorship.'; and

(2) in subsection (d)--

(A) in paragraph (4), by striking `and' at the end;

(B) in paragraph (5), by striking the period and inserting `; and'; and

(C) by adding at the end the following:

`(6) basic, clinical, and applied research concerning pain and symptom management and cancer survivorship.'.

(e) PROSTATE CANCER- Section 417A(c)(1) of the Public Health Service Act (42 U.S.C. 285a-7(c)(1)) is amended--

(1) in subparagraph (F), by striking `and' at the end;

(2) in subparagraph (G), by striking the period and inserting `; and'; and

(3) by inserting after subparagraph (G) the following:

`(H) basic and clinical research concerning pain and symptom management and cancer survivorship.'.

SEC. 106. SURVIVORSHIP RESEARCH PROGRAM.

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

`SEC. 417D. SURVIVORSHIP RESEARCH PROGRAM.

`(a) ESTABLISHMENT- There is established, within the Institute, an Office on Cancer Survivorship (in this section referred to as the `Office'), which may be headed by an Associate Director, to implement and direct the expansion and coordination of the activities of the Institute with respect to cancer survivorship research.

`(b) COLLABORATION AMONG AGENCIES- In carrying out the activities described in subsection (a), the Office shall collaborate with other institutes, centers, and offices within the National Institutes of Health that are determined appropriate by the Office.

`(c) REPORT- Not later than 1 year after the date of enactment of this section, the Secretary shall prepare and submit to the appropriate committees of Congress a report providing a description of the survivorship activities of the Office and strategies for future activities.'.

TITLE II--RESEARCH PROVISIONS

SEC. 201. NATIONAL CANCER INSTITUTE.

(a) OTHER TRANSACTIONS AUTHORITY- Subpart 1 of part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.), as amended by section 106, is further amended by adding at the end the following:

`SEC. 417E. OTHER TRANSACTIONS AUTHORITY.

`Notwithstanding any other provision of this subpart, the Director of the National Cancer Institute may cofund grant projects with private entities for any purpose described in this subpart.'.

(b) SENSE OF THE SENATE ON A CENTRAL INSTITUTIONAL REVIEW BOARD- It is the sense of the Senate that--

(1) the current procedure of sending 1 clinical trial through multiple local institutional review boards may not be the most efficient method for the protection of patients enrolled in the trial and may delay the process of bringing lifesaving treatment to cancer patients;

(2) the National Cancer Institute should be commended for its work in centralizing the institutional review board process; and

(3) the research community should continue to streamline the institutional review board process in order to bring lifesaving treatments to patients as quickly as possible.

(c) PATIENT AND PROVIDER OUTREACH OPPORTUNITIES WITH EXPERIMENTAL THERAPIES- For the purpose of enhancing patient access to experimental therapies, the National Cancer Institute shall conduct the following activities:

(1) Integrate, to the maximum extent practicable, trials being conducted by private manufacturers into the National Cancer Institute's clinical trials online database. Such integration may require specific awareness-raising and outreach activities by the National Cancer Institute to private industry.

(2) Establish an education program which provides patients and providers with--

(A) information about how to access and use the National Cancer Institute clinical trials database online; and

(B) information about the Food and Drug Administration process for approving the use of drugs and biologics for a single patient.

END