CANCER SURVEILLANCE USING HEALTH CLAIMS-BASED DATA SYSTEM

Release Date:  November 12, 1998

PA NUMBER:  PA-99-015

P.T. 

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

PURPOSE

This PA replaces PA-95-069, which was published in the NIH Guide, Volume 24,
Number 20, June 2, 1995.

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, for example 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. The
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 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 non-profit
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, data bases with multiple payers such as the
Healthcare Cost and Utilization Project (HCUP) data base, 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 follow-up 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 versus
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 SEER, 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 the 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 of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, 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 the 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, March 6, 1998, and is available at the following URL address:
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 (rev.
9/95) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-mail:
grantsinfo@nih.gov.  The title and number of the program announcement must be
typed in Section 2 on the face page of the application.  Applicants kits are also
available at: http://www.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 INQUIRES section of this PA before submitting
the application.  See 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
BETHESDA, MD  20817 (for express/courier service)

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
biological 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 method? 
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 313
Bethesda, MD  20892
Telephone: (301) 496-5184
FAX: (301) 435-3710
Email: jw227v@nih.gov

Patricia S. Bryant, Ph. D.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-24E
Bethesda, MD  20892-6402
Telephone:  (301) 594-2095
FAX: (301) 480-8318
Email: pb36q@nih.gov

Bernard Friedman, Ph.D.
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852
Telephone: (301) 594-6819
Email: BFriedma@AHCPR.GOV

Direct inquiries regarding fiscal matters to:

Bill Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South
Bethesda, MD  20892
Telephone:  (301) 496-7800
FAX:  (301) 496-4801
Email: ww14j@nih.gov

Martin R. Rubinstein
Grants Management Branch
National Institute of Dental Research
45 Center Drive, Rm 4AN44A, MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-4800
FAX: (301) 480-8301
Email: mr49c@nih.gov

Mabel Lam
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone: (301) 594-1447  X1165

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 non-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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