CANCER SURVEILLANCE USING HEALTH CLAIMS-BASED DATA SYSTEM RELEASE DATE: October 20, 2003 PA NUMBER: PA-04-012 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through using the electronic SF424 (R&R) application. Accordingly, this funding opportunity relating expires on the date indicated below. Replacement R01 (PA-06-385) and R21 (PA-06-386) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: November 2, 2006. (Expiration date extended, see NOT-CA-05-026) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) ( Agency for Health Research and Quality (AHRQ) ( COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Cancer Institute (NCI) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399 This Program Announcement (PA) replaces PA-02-006, which was published in the NIH Guide on October 4, 2001. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA NCI and AHRQ invite investigator-initiated grant applications for research entailing the use of health claims data for cancer surveillance. Cancer surveillance may include assessment of patterns of care, quality and outcomes of care, and health disparities across the continuum of treatment. Projects sought under this Program Announcement (PA) may focus on treatment and outcomes at the patient-specific level or include influences from the provider or broader health-system level. In addition to studies of cancer treatment and outcomes, responses to this PA may also initiate analyses to expand understanding of the capability of and methods needed to use claims data for cancer surveillance. Health claims include secondary data sources such as the linked SEER-Medicare data (, databases with multiple payers such as the Healthcare Cost and Utilization Project (HCUP) database (, fee-for-service insurance bills for medical, rehabilitative, or other health care services, managed care encounter data, and discharge summaries. This PA relates to priority areas for NCI and AHRQ. Projects under this PA may address two priorities, improving the quality of cancer care and reducing cancer-related health disparities, as identified by NCI in The Nation's Investment in Cancer Research ( AHRQ supports general health services and outcomes and effectiveness research for a wide range of clinical conditions, including cancer ( RESEARCH OBJECTIVES Background There is increasing interest in the collection and analysis of valid, accurate and reliable secondary data to assess screening, treatment and outcomes for specific disease entities. For example, the 1998 Institute of Medicine report on Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the NIH ( recommends that, "In setting priorities, NIH should strengthen its analysis and use of health data, such as burdens and costs of diseases, and of data on the impact of research on the health of the public." Increasing the use of these types of data to assess the quality of cancer care has also been identified as a priority by the Institute of Medicine ( Studies using claims-based data are usually population-based and have the potential to address a number of priority questions including disparities in health care based on demographic characteristics and the quality of cancer care. Scope of Activity Cancer is a heterogeneous chronic disease which requires innovation in treatment and care approaches. This initiative supports research directed at the use of health claims data for cancer surveillance, including studies of cancer detection, treatment, and outcomes. In addition, this initiative is directed towards studies that assess the utility of claims data for cancer surveillance. Research topics that would be relevant to the studies of detection, treatment and outcomes include, but are not limited to the following examples: 1. Studies of the patterns of cancer for persons with specific cancers/stages. This might include treatment during the peri-diagnostic period, use of adjuvant treatments, as well as long-term follow-up. 2. Disparities in the receipt in cancer care based on demographic and socio- economic characteristics. 3. Determinants of the quality of care across the cancer continuum, e.g., training and volume of health care providers. 4. Use of screening tests among the general population and rates of post- diagnostic surveillance for persons with cancer. 5. Differences in cancer screening and treatment based on insurance status- such as uninsured, managed care and fee-for-service, and the impact of carve- out plans. 6. Intensity and types of services provided at the end of life. 7. Rates of short-term complications following cancer treatment. 8. Long-term complications for cancer survivors as sequellae to their cancer treatment. The types of projects dealing with detection, treatment, and outcomes that have been funded under earlier releases of this PA include: o Understanding Racial Differences in Lung Cancer Treatment o Colorectal Cancer Care Variation In Vulnerable Elderly o Managed Care Penetration and Cancer Care o Cancer Surveillance Using HMO Administrative Data o The Non-cancer Care of Elderly Colorectal Cancer Patients o Use of Claims Data to Study Quality of Cancer Care o Provider Specialty and Outcomes in Ovarian Cancer o Cancer Care and Outcomes for Disabled Medicare Patients o Patterns of Cancer Care at the End of Life Some of the publications from prior issues of this PA that are related to detection, treatment and outcomes are as follows: Bach PB, Cramer LD, Schrag D, Downey RJ, Gelfand SE, Begg CB. The influence of hospital volume on survival after resection for lung cancer. N Engl J Med. 2001 Jul 19, 345(3):181-8. Du X, Goodwin JS. Patterns of use of chemotherapy for breast cancer in older women: findings from Medicare claims data. J Clin Oncol. 2001 Mar 1;19(5):1455-61. Du XL, Osborne C, Goodwin JS. Population-based assessment of hospitalizations for toxicity from chemotherapy in older women with breast cancer. J Clin Oncol. 2002 Dec 15;20(24):4636-42. Earle CC. Influenza vaccination in elderly patients with advanced colorectal cancer. J Clin Oncol. 2003 Mar 15;21(6):1161-6. Earle CC, Burstein HJ, Winer EP, Weeks JC. Quality of non-breast cancer health maintenance among elderly breast cancer survivors. J Clin Oncol. 2003 Apr 15;21(8):1447-51. McCarthy EP, Burns RB, Ngo-Metzger Q, Davis RB, Phillips RS. Hospice use among Medicare managed care and fee-for-service patients dying with cancer. JAMA. 2003 May 7;289(17):2238-45. McCarthy EP, Burns RB, Davis RB, Phillips RS. Barriers to hospice care among older patients dying with lung and colorectal cancer. J Clin Oncol. 2003 Feb 15;21(4):728-35 Research topics that would be relevant to assessing the utility of claims data for cancer surveillance include, but are not limited to the following examples: 1. Use of claims data to assess the frequency and intensity of diagnostic tests. 2. Methods to distinguish screening vs. diagnostic procedures. 3. Methods to identify recurrences or metastases from claims data. 4. Assessment of the availability and completeness of encounter data from managed care settings. 5. Use of claims data to measure adjuvant therapies. 6. Determination of whether health claims-based data systems can be used to track the emergence of new technologies for detecting, diagnosing, or treating cancer or pre-cancerous conditions. 7. Use of health claims-based data systems to obtain additional information that is not routinely collected by cancer registries, including enhanced case ascertainment. 8. Methods to measure comorbidity. The use of claims data to assess population-based cancer incidence and survival rates has been assessed in numerous earlier studies and is not a priority of this PA. The types of projects dealing with the utility of claims data for cancer surveillance under earlier releases of this PA include: o Evaluation Of Enteral Stent Placement Using Claims Data o Evaluation Of Chemotherapy Claims For Breast Cancer o Evaluating Mammography Claims Data o Using Claims Data to Assess Cancer Incidence, Stage, and Treatment Some of the publications from prior issues of this PA that are related to assessing the utility of claims data for cancer surveillance are as follows: Cooper GS, Yuan Z, Stange KC, Amini SB, Dennis LK, Rimm AA. The utility of Medicare claims data for measuring cancer stage. Med Care. 1999 Jul;37 (7):706-11. Cooper GS, Yuan Z, Stange KC, Dennis LK, Amini SB, Rimm AA. The sensitivity of Medicare claims data for case ascertainment of six common cancers. Med Care. 1999 May;37(5):436-44. Freeman JL, Zhang D, Freeman DH, Goodwin JS. An approach to identifying incident breast cancer cases using Medicare claims data. J Clin Epidemiol. 2000 Jun;53(6):605-14. Freeman JL, Klabunde CN, Schussler N, Warren JL, Virnig BA, Cooper GS. Measuring breast, colorectal, and prostate cancer screening with medicare claims data. Med Care. 2002 Aug;40(8 Suppl):IV-36-42. MECHANISMS OF SUPPORT This PA will use the NIH investigator-initiated research project grant (R01) and the exploratory/developmental grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed 5 years for an R01 application and 2 years for an R21 application. For R21 submissions, applicants may request up to $100,000 direct costs (four budget modules) per year unless the application includes consortium costs, in which case the limit is $125,000 in direct costs (five budget modules) per year. Applicants without extensive preliminary data or who wish to explore the utility of claims-based data to address a specific question are urged to submit applications for this PA using the exploratory/developmental grant mechanism. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise, follow the instructions for non- modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at Since AHRQ study sections require complete budget information in their review, all applications reviewed by AHRQ study sections will be required to include detailed budget pages prior to the study section review. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues. o Direct your questions about scientific/research issues to: Joan Warren, Ph.D. Division of Cancer Control and Population Sciences Applied Research Program National Cancer Institute Executive Plaza North, Room 4004 Bethesda, MD 20892 Telephone: (301) 496-5184 FAX: (301) 435-3710 Email: Bernard Friedman, Ph.D. Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1404 Email: BFriedma@AHRQ.GOV o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: Mable Lam Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1448 Email: mlam@AHRQ.GOV SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: The title, Cancer Surveillance Using Health Claims-Based Data System, and the number of the program announcement (PA-04-012) must be type on line 2 of the face page of the application form and the YES box must be marked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications to NIH requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1. Contact the NIH/AHRQ program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2. Obtain agreement from the NIH/AHRQ staff that the NIH/AHRQ will accept your application for consideration for award; and, 3. Identify, in a cover letter sent with the application, the NIH/AHRQ staff member who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures ( or AHRQ process will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See Federal Citation below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at A continuing education program in the protection of human participants in research is available online at: PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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