111^th Congress

The 21st Century Cancer ALERT (Access to Live-Saving Early detection, Research and Treatment) Act

S. 717

Background

The National Cancer Institute (NCI) was first established in 1937 within the Public Health Service. The original legislation established the National Cancer Advisory Council and authorized NCI to award research grants, provide facilities for training, and establish fellowship programs. NCI was moved to the National Institutes of Health (NIH) through the Public Health Service Act of 1944 (P.L.78-410). NCI’s authorities were expanded with enactment of the National Cancer Act of 1971 (P.L. 92-218), which was introduced as a “War on Cancer” initiated by former President Richard Nixon. The 1971 Act established the National Cancer Program (NCP), the National Cancer Advisory Board (NCAB) (which superseded the National Cancer Advisory Council), and the President’s Cancer Panel. The Act also authorized the Director of NCI to establish National Cancer Research and Demonstration Centers and required the Institute to submit an annual budget estimate (also known as the bypass budget) directly to the President. The goal of S. 717, the 21st Century Cancer ALERT Act, is to have a comprehensive approach to cancer research, prevention, and treatment.

Provisions of the Legislation/Impact on NIH

National Cancer Program: Section 3 of the 21st Century Cancer ALERT Act would reauthorize and expand NCP in the following manner:

• Collaboration: The Secretary of Health and Human Services (HHS) and the Director of NCI would be required to identify relevant Federal agencies with which to collaborate. In addition, the Secretary would be required to ensure that policies related to the promotion of cancer research across the Department are harmonized and that Federal agencies collaborate on cancer research and development. In establishing NCP priorities, NCAB would be required to improve coordination by increasing the participation of appropriate Federal agencies.
• NCI Annual Budget Estimate: The bill would require the budget estimate to include the budgetary needs of the entire NCP and be submitted to NCAB for review prior to submission to the President. The Act would also require the budget estimate to be submitted to the House and Senate Committees on Appropriations and on Budget at the same time it is submitted to the President.
• Early Detection Research: The Director of NCI would be required to develop a standard process through which Federal agencies, including the U.S. Department of Defense, and administrators of federally funded programs may engage in early cancer detection research.
• Translational Research Opportunities: The Director of NCI, acting through NCP and in accordance with the NIH Reform Act of 2006 (P.L. 109-482), would be required to continue to identify promising translational research opportunities across all disease sites, populations, and pathways to clinical goals through a transparent, inclusive process by 1) continuing to support efforts to develop a robust number of public or nonprofit entities to carry out early translational research, 2) emphasizing the role of the young researcher, and 3) modifying guidelines for multiproject, collaborative, early translational research awards to focus on team science. In addition, the Secretary of HHS would be authorized to match the non-Federal funds committed by the entity for translational research.
• Biological Resource Coordination and Advancement of Technologies for Cancer Research: The Director of NCI, acting through NCP, would be required to establish an entity within the Institute to enhance 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.
  • As a part of this entity, the Director of NCI would be required to build on existing initiatives to establish an interconnected network of biorepositories (known as the Network). A biorepository in the Network would be required to adopt NCI’s Best Practices for Biospecimen Resources and any successor guidelines. The Director of NCI would be authorized to enter into contracts with tissue source sites to acquire data.
  • This entity would be required to 1) be designed in a way to expand researcher access to biospecimens for cancer research, 2) establish uniform standards for the handling and preservation of patient tissue specimens, 3) require adequate annotation of all relevant clinical data while assuring patient privacy, 4) facilitate the linkage of public and private entities into the Network, 5) provide for the linkage of cancer registries to other administrative Federal Government data sources, and 6) develop strategies to ensure patient rights and privacy, including an assessment of the Health Insurance Portability and Accountability Act Privacy Rule.
  • Any hospital or ambulatory cancer center that receives Federal funds would be required to offer patients the opportunity to contribute their biospecimens and clinical data to this entity. In addition, clinical trial data relating to cancer care and treatment must be provided to the entity.

Access to Research, Data, and Outcomes: Section 4 of the bill would make the use and disclosure of de-identified protected health information for research purposes more stringent, require the Department of Health and Human Services to study synchronization of the Common Rule and the Privacy Rule, and require the Office of Human Research Protections to issue guidance on the use of a centralized institutional review board.

Enhanced Focus and Reporting on Cancer Research: Section 5 of the bill would require the Director of NCI to submit an annual report to Congress on categories of cancers with low survival rates.¹ Each category would be required to contain the following information:

• A strategic plan for reducing the mortality rate for the annual year, including specific research areas of interest and budget amounts
• Identification of any barriers to implementing the strategic plan
• If the report for the prior year contains a strategic plan, an assessment of the success of the plan
• Total amount of grant funding, including the total dollar amount awarded per grant and per funding year provided by NCI and NIH
• Percentage of grant applications favorably reviewed and funded by NCI
• Total number of grant applications with greater than 50 percent relevance to each of the categories of cancer received by NCI for awards in the previous annual year
• Total number of grants awarded with greater than 50 percent relevance to each of the categories for the previous annual year and the number of awards per grant type, including the “Common Scientific Outline” designation specific to each grant
• Total number of primary investigators that received grants from the Institute for projects with greater than 50 percent relevance to each category, including the total number of awards granted to investigators receiving their first grant from NIH

Grant Program Regarding Cancers With Low Survival Rates: This section would also require NCI, in cooperation with the Director of the Fogarty International Center for Advanced Study in the Health Sciences and the Directors of the Institutes and Centers, to award grants to researchers to conduct research regarding cancers with low survival rates. The bill would require that priority be given to collaborative research projects between adult and pediatric cancer research. Finally, the Director of NCI would be required to require grant recipients to submit tissue samples to designated tumor banks unless a waiver has been obtained.

Cancer Screening: Section 6 of the bill would authorize the establishment of a colorectal cancer screening program, provide Medicaid coverage for certain individuals with colorectal cancer, and require the establishment of a mobile medical van grant program to provide screening services.

Cancer Genome Atlas: This section would also require the inclusion of cancers with low survival rates in the Cancer Genome Atlas and the establishment of formal working groups for cancers with low survival rates. It would require the Director of the National Institute of Biomedical Imaging and Bioengineering to ensure that the Quantum Grant Program and the Image Guided Interventions program expedite the development of computer-assisted diagnostic, surgical, treatment, and drug-testing innovations to reduce mortality from cancers with low survival rates.

Innovative Biomarker Discovery Technologies: Section 7 of the bill would require the Secretary of HHS, in consultation with appropriate Federal agencies, including NIH, NCI, the Food and Drug Administration (FDA), the National Institute of Standards and Technology, and extramural experts as appropriate, to establish and coordinate a program to award contracts to eligible entities to support the development of innovative biomarker discovery technologies. All activities would be required to be consistent with and complement the ongoing efforts of the Oncology Biomarker Qualification Initiative and the Reagan-Udall Foundation of the FDA. Not later than 2 years after enactment, the Secretary of HHS would be required to designate a lead Federal agency to administer and coordinate the biomarker program.

International Private-Public Consortium: The Secretary would also be required to establish an international private-public consortium to develop and share methods and precompetitive data on the validation and qualification of cancer biomarkers for specific uses.

Clinical Study Guidelines: Not later than 1 year after the date of enactment, FDA, the Centers for Medicare & Medicaid Services (CMS), and NCI would be required to jointly develop guidelines for the conduct of clinical studies designed to generate clinical data relating to cancer care and treatment biomarkers that are adequate for review by each agency. The guidelines would be designed to assist in optimizing clinical study design and to strengthen the evidence base for evaluations of studies related to cancer biomakers.

Other Biomarker Provisions: Section 7 would also establish a demonstration project to assess biomarker tests and require FDA and CMS to conduct postmarked surveillance of biomarker tests. Finally, this section contains a Sense of the Senate that FDA and NCI continue to place a high priority on the identification and use of biomarkers.

Access to Cancer Clinical Trials: Section 8 would prohibit health insurers from denying patient participation in an approved cancer clinical trial and require coverage of routine patient costs. This section also contains a provision that would require the Director of NCI to 1) collaborate with the Director of NIH to carry out a public education program on the value of clinical trials for oncology patients, 2) carry out a public education campaign aimed at health care professionals to consider clinical trials as treatment options for their patients, and 3) conduct research to document and demonstrate promising practices in cancer clinical trial recruitment and retention efforts.

Health Professions Workforce: Section 9 would allow retiring nurses to serve as faculty without risking their retirement pay. In addition, the Secretary of HHS would be required to conduct a study on current and future cancer care workforce needs.

Patient Navigator Program: Section 10 would reauthorize the Patient Navigator Program through 2015 and would require that patient navigators meet minimum core proficiencies.

Cancer Care and Coverage Under Medicaid and Medicare: Section 11 would require the Secretary of HHS to cover routine costs associated with a clinical trial for Medicaid and Medicare patients and conduct a demonstration project to provide comprehensive cancer care planning services under Medicare. This section would also promote tobacco cessation programs under Medicaid.

Cancer Survivorship: Section 12 would establish the following cancer survivorship program requirements:

• The Director of NCI would be required to coordinate cancer survivorship activities across NIH.
• In carrying out this coordination requirement, the Director of NCI would be required to give priority to the following:
  • Comprehensive assessment of the prevalence and etiology of late effects of cancer treatment
  • Identification of risk and protective factors related to the development of late effects of cancer
  • Identification of predictors of neurocognitive and psychosocial outcomes, including quality of life, in cancer survivors and identification of quality of life and other outcomes in family members
  • Development and implementation of intervention studies for cancer survivors and their families
  • The Director of NIH, acting through the Director of NCI, would be required to award grants for research on causes of health disparities in childhood cancer survivorship.
  • The Director of NIH would be required to conduct or support research to evaluate systems of followup care for childhood cancer survivors.
  • The Secretary of HHS would be required to coordinate the activities of Federal agencies to improve the provision of complete recovery care in the treatment of cancer and 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.
  • The Secretary of HHS, not later than 1 year after enactment, would be required to convene a Workforce Development Collaborative on Psychosocial Care During Chronic Medical Illness. The Collaborative would be required to submit a plan to the Secretary on meeting objectives for psychosocial care workforce development.

Activities of the FDA: Section 13 contains a Sense of the Senate that FDA should 1) integrate policies and structures to facilitate the concurrent development of drugs and diagnostics for cancer diagnosis, prevention, and therapy, 2) consider alternatives or surrogates to traditional clinical trial endpoints (for example, other than survival) that are acceptable for regulatory approval as evidence of clinical benefit to patients, and 3) modernize the Office of Oncology Drug Products by examining and addressing internal barriers that exist within the current organizational structure.

Status and Outlook

S. 717 was introduced by Senator Edward M. Kennedy (D-MA) on March 26, 2009, and referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.

May 2009

¹Cancers that result in a 5-year survival rate of less than 50 percent and cancers in which the incidence rate is less than 15 cases per 100,000 people or fewer than 40,000 cases per year.