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Cancer Surveillance Using Health Claims-Based Data System

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NIH Guide for Grants and Contracts, November 12, 1998

Agency for Health Care Policy and Research
National Cancer Institute
National Institute of Dental and Craniofacial Research

PA: PA-99-015


Purpose

The Division of Cancer Control and Population Sciences (DCPPS), National Cancer Institute (NCI); the National Institute of Dental and Craniofacial Research (NIDCR); and the Agency for Health Care Policy and Research (AHCPR) invite investigator-initiated grant applications for research to investigate the utility of health claims information as a reporting source for assessing the national cancer burden. Health claims include secondary data sources, e.g., fee-for-service insurance bills, managed care encounter data, and discharge summaries. Utility is broadly defined to include topics such as the use of health claims information to estimate patterns of care, outcomes of care, and effects of cancer therapies.

Responses to this program announcement (PA) would initiate mechanisms to expand understanding of the capability of and methods needed to use claims data for cancer surveillance, as well as applying these findings to the claims data in order to assess all aspects of cancer surveillance (such as cancer screening, incidence, treatment, and outcomes). NIDCR's specific interests focus on health claims-based data as related to oral and pharyngeal cancers or the oral complications of cancer therapies.

Healthy People 2000

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, "Cancer Surveillance Using Health Claims-Based Data Systems," is related to the priority area of cancer surveillance and data systems. Potential applicants may obtain a print copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-512-1800).

Eligibility Requirements

Applications may be submitted by foreign and domestic, for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators.

Mechanism of Support

Support of this program will be through the research project grant (R01) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement.

Research Objectives

The objectives of this PA are to encourage investigators to submit applications to investigate the utility of health claims information as a reporting source for assessing the national cancer burden. Health claims include secondary data sources such as fee-for-service insurance bills for medical, dental, rehabilitative, or other health care services, Medicare, Medicaid, and private managed care encounter data, databases with multiple payers such as the Healthcare Cost and Utilization Project (HCUP) database, and discharge summaries. Utility is broadly defined to include topics such as the use of health claims information to estimate patterns of care, outcomes of care, and effects of cancer therapies. Examples of research questions that could be addressed concerning the use of health claims information for cancer surveillance include, but are not limited to, the following:

  1. Can claims data be used to assess practice patterns for cancer directed treatment immediately following diagnosis and for long-term followup and treatment over the course of the disease? Using the claims data, what are the patterns of cancer for persons with specific cancers? What is the pattern for end-of-life care? What factors influence the care received at end-of-life? How are treatment patterns and outcomes affected by the use of carve-out contracts for cancer treatment?
  2. What is the availability and completeness of encounter data from managed care settings? Do comparisons of data collected by health claims-based systems vs. registries differ depending on the reimbursement system (fee-for-service claims vs. "managed care")?
  3. Using claims data, what are the long-term complications for cancer survivors as sequellae to their cancer treatment?
  4. Can claims data be used to assess the use of diagnostic tests? Using claims data, how are diagnostic tests used? How can health claims-based data systems be used to track the emergence of new technologies for detecting, diagnosing, or treating cancer or pre-cancerous conditions? Can these data be used to develop an evaluation of the introduction of health care innovations related to cancer?
  5. How can health claims-based data systems contribute to the identification of environmental causes of cancer, such as cluster analysis of incidence in small areas.
  6. To what extent do health claims-based data systems provide additional information than what is routinely collected by cancer registries? Can claims data be used to assess cancer recurrence or metastasis? Can claims data be used to augment the case ascertainment of cancer registries?
  7. Do dental claims data provide useful supplementary data, especially as regards oral cancer detection or treatments or the prevention and treatment of oral complications of radiation or chemotherapy? Do health claims-based data reveal how patterns of cancer-related oral care differ for cancer patients who have medical health insurance coverage only, as compared with cancer patients whose health insurance includes supplemental dental benefits?
  8. Does encounter data in managed care settings permit assessment of whether the oral health services provided include screening for oral cancers or services involved in the prevention or treatment of oral complications of cancer treatments?

Other issues to be addressed in regard to the above questions include: The identification of data that are currently unavailable from a cancer registry, such as NCI's Surveillance, Epidemiology, and End Results (SEER) program, that are available in health claims-based data systems, the identification of barriers including cost that must be overcome to add health claims data to registry data, and the identification of questions concerning health claims data, such as costs considerations. Use of health claims-based systems to identify cancer burdens in special populations, such as minority populations (African-Americans, Hispanics, Native Americans, Native Alaskans, Asian Americans and Pacific Islanders) and the underserved (low-income groups, blue-collar groups) is encouraged. 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. Also, the confidentiality issues associated with the use of claims-based data, as well as any other databases proposed, should be addressed in regard to any of the above questions.

Inclusion of Women and Minorities in Research Involving Human Subjects

It is the policy of NIH and AHCPR that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register on March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, on March 18, 1994. AHCPR follows these guidelines as applicable.

Investigators also may obtain copies of the policy from the program staff listed under "Inquiries." Program staff may also provide additional relevant information concerning the policy.

Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects

It is the policy of NIH and AHCPR that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are clear and compelling 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 was published in the NIH Guide for Grants and Contracts on March 6, 1998. It is available at the following URL: http://www.nih.gov/grants/guide/notice-files/not98-024.html

Application Procedures

Applications are to be submitted on the grant application form PHS 398 and will be accepted at the standard application deadlines as indicated in the application kit. The revised PHS 398 form is only available online. Applicants are encouraged to access the instructions and forms via the Internet because they provide valuable links to current policy documents and allow easy navigation of the instructions. PHS 398 application kits cannot be faxed to applicants.

The title and number of the program announcement must be typed in Section 2 on the face page of the application. Application kits are also available at: http://grants.nih.gov/grants/forms.htm

An applicant planning to submit an application requesting $500,000 or more in direct costs for any year is advised that he or she must contact Institute or Center program staff listed in the "Inquiries" section of this PA before submitting the application. See the NIH policy at: http://www.nih.gov/grants/guide/notice-files/not98-030.html

The completed, original application and five legible copies must be sent or delivered to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040-MSC 7710
Bethesda, MD 20892-7710
Phone: (301) 435-0715

*Change zip code to 20817 for express mail or courier service.

Note: Until further notice, applications delivered by individuals to the NIH Center for Scientific Review will no longer be accepted. They must come either via courier delivery or via the U.S. Postal Service. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Review Considerations

Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH and AHCPR peer review procedures.

Following scientific-technical review, the applications may receive a second-level review by the appropriate national advisory council.

Review Criteria

The goals of the supported research are to advance our understanding of biologic systems, improve the control of disease, improve health care services, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a 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.

  1. 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?
  2. 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?
  3. 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?
  4. 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)?
  5. 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?

The initial review group will also examine:

  • The appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects.
  • The adequacy of plans for including children as appropriate for the scientific goals of the research (or justification for exclusion).
  • The provisions for the protection of human and animal subjects, and the safety of the research environment.

Award Criteria

Applications will compete for available funds with all other approved applications assigned. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority.

Inquiries

Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Joan Warren, Ph.D.
Applied Research Branch
National Cancer Institute
Executive Plaza North, Room 4005
Bethesda, MD 20892
Telephone: (301) 496-5184
Fax: (301) 435-3710
E-mail: warrenj@mail.nih.gov

Patricia S. Bryant, Ph.D.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-24E, MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-2095
Fax: (301) 480-8318
E-mail: bryantp@de45.nidr.nih.gov

Bernard Friedman, Ph.D.
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 5000
Rockville, MD 20850
Telephone: (301) 427-1404
E-mail: BFriedma@ahrq.gov

Direct inquiries regarding fiscal matters to:

Bill Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone: (301) 496-8796
Fax: (301) 496-8601
E-mail: wellsw@gab.nci.nih.gov

Christopher Myers
Lead Grants Management Specialist
Grants Management Branch
National Institute of Dental and Craniofacial Research
Bethesda MD 20892-6402
Telephone: (301) 496-8251
E-mail: cmyers@mail.nih.gov

Mable L. Lam
Grants Management Staff
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 4000
Rockville, MD 20850
Telephone: (301) 427-1448
E-mail: MLam@ahrq.gov

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance, No. 93.399, Cancer Control Research, 93.121, Oral Health Research and 93.226. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 67, Subpart A; and 45 CFR Part 74 and part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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.

AHCPR Publication No. 99-R010
Current as of November 1998

 

The information on this page is archived and provided for reference purposes only.

 

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