APPENDIX A
Comments on Methods Proposed by HRSA and its Grantees

Comments on BPHC Policy Information Notice 2002–17

General Comments

These comments were developed during this review and are not intended to be exclusive.

  1. This is an effort to be responsive to the RECA legislation that would be more appropriately couched in terms of a good and cost-effective health-care program (rather than in terms of a screening program, which would have the potential to do more harm than good) that offers an initial comprehensive medical evaluation to establish baseline data for individuals, many of whom now are likely to be in the older age groups and who live in medically underserved communities.

  2. Cancer of the female breast is the only one of the conditions identified as “radiogenic” for which there is a proven effective screening mode, and even that is useful only for defined “at-risk” population groups.

  3. Given that none of the conditions identified (in the BPHC Policy Information Notice) is causally associated exclusively with radiation, the categorization of “For Non-Malignant Radiogenic Diseases” (2a) and “For Malignant Radiogenic Diseases” (2b) for the purposes of the Notice is inappropriate, is unnecessary, and could be misconstrued as implying that all such conditions that may be detected in the proposed “screening” program unquestionably would be attributable to exposure to radiation during one of the RECA events or activities specified. “Non-malignat compensable disease” and “malignant compensable diseases” would be a more appropriate categorization.

  4. Clinical tests and procedures should be based on findings in the individual consistent with good medical practice, and follow-up should be scheduled in accordance with good medical practice, irrespective of exposure history.

  5. Presumably, RECA covers the cost of “screening” for the specified diseases and for any indicated medical follow-up, treatment, and care for compensable diseases or conditions. But what happens if a participant has a coincidental diagnosis (as the result of the screening process) of a noncovered disease or condition and is uninsured or otherwise unable to pay for further recommended testing, treatment, and so on. What is the responsibility (including ethical) of the program to manage or treat the person in such a situation? Is the possibility of such a coincidental diagnosis and its potential consequences explained to the person?



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APPENDIX A Comments on Methods Proposed by HRSA and its Grantees Comments on BPHC Policy Information Notice 2002–17 General Comments These comments were developed during this review and are not intended to be exclusive. This is an effort to be responsive to the RECA legislation that would be more appropriately couched in terms of a good and cost-effective health-care program (rather than in terms of a screening program, which would have the potential to do more harm than good) that offers an initial comprehensive medical evaluation to establish baseline data for individuals, many of whom now are likely to be in the older age groups and who live in medically underserved communities. Cancer of the female breast is the only one of the conditions identified as “radiogenic” for which there is a proven effective screening mode, and even that is useful only for defined “at-risk” population groups. Given that none of the conditions identified (in the BPHC Policy Information Notice) is causally associated exclusively with radiation, the categorization of “For Non-Malignant Radiogenic Diseases” (2a) and “For Malignant Radiogenic Diseases” (2b) for the purposes of the Notice is inappropriate, is unnecessary, and could be misconstrued as implying that all such conditions that may be detected in the proposed “screening” program unquestionably would be attributable to exposure to radiation during one of the RECA events or activities specified. “Non-malignat compensable disease” and “malignant compensable diseases” would be a more appropriate categorization. Clinical tests and procedures should be based on findings in the individual consistent with good medical practice, and follow-up should be scheduled in accordance with good medical practice, irrespective of exposure history. Presumably, RECA covers the cost of “screening” for the specified diseases and for any indicated medical follow-up, treatment, and care for compensable diseases or conditions. But what happens if a participant has a coincidental diagnosis (as the result of the screening process) of a noncovered disease or condition and is uninsured or otherwise unable to pay for further recommended testing, treatment, and so on. What is the responsibility (including ethical) of the program to manage or treat the person in such a situation? Is the possibility of such a coincidental diagnosis and its potential consequences explained to the person?

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Specific Comments Page 4, Section I—Add bullets: Addressing issue of false positive results. How positive (true positive and false positive) results will be managed. Educate population to be screened about Informed consent. Risks and benefits associated with being screened. Page 4, Section II.B—If the goal is to improve health status, how do the grantees know that screening will help? Applicants or participants should discuss the logic supporting their decisions. Page 5, Section II.B.1—“Outreach”: in addition to using the mass media to announce the availability of the program to eligible people, RESEP could request more active searches, such as obtaining lists of former workers from employers, unions, or tribal agencies and then contacting them. Page 5, Section II.B.2.a—Include generally accepted screening recommendations (such as those of the US Preventive Health Services Task Force). Page 5, Section II.B.2.a.4—is it suggested that arterial blood gases would be used as a screen? That would be invasive and carry a risk of injury. Page 5, Section II.B.2.a.6—This should include management of the results. Page 6, Section IIB.2.b.1—“Medical and Occupational History”: occupational history seems to emphasize exposures at work and would apply to miners, millers, ore-haulers, and test-site workers. The section could also include information more applicable to the downwinders, such as dates of residence in the affected counties and where the family obtained foodstuffs, especially milk. It should also include family history because that may modulate the need for some screening tests—for example, history of breast or colon cancer; genetic history might also be included. Page 6, Section II.B.2.b.2—How does one detect on physical examination cancer of the bladder, colon, small intestine, pancreas, gall bladder, and ovary. This is insensitive and nonspecific. Page 6, Section II.B.2.b.4—Why specialty care and not primary care, especially, in an underserved population? How could their current monitoring of care be compatible with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)? Page 7, Section II.B.3.a—Bullets should be selective, not inclusive. Which radiogenic nonmalignant diseases are detected with 24-hour urine studies?

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Page 7, Section II.B.3.a, last paragraph—This reveals a misconception that screening tests will allow the diagnosis of disease. False-positive results should be considered. Page 8, Section II.B.3.b, last paragraph—What about HIPAA? Page 8, Section II.B.3.b.4—Education about the health risks posed by the several radiologic and other hazards possibly encountered by members of the covered populations—and their management (which is not peculiar to conditions that could have a radiogenic component)—is important for them, their families, and all groups involved in the various aspects of health-care delivery in these communities. Page 8, Section II.B.4—Education should include education about, for example, false-positive results and risks of screening, and must be balanced. Page 8, Section II.B.6—Why should quality assurance of follow-up care (vs quality assurance of screening) rest with RESEP and not caregivers? Also HIPAA. Page 9, Section II.B.8—Data Collection: There is no mention of the privacy and confidentiality issues involved in the collection, maintenance, storage, and retention of medical and personal data. Who will “own” the data? Who may have access to it? Are they likely to be used for purposes other than an individual patient’s medical care, such as research? These are issues likely to be of concern to participant groups, including the Indian Nation, whose “buy in” to the program may be critical to its success. A consent form is mentioned, but none is included in the protocol. Will this be a standard document or will grantees develop and use their own? Grant applicants should provide a data-management plan. Data about the effectiveness of the educational program should be collected. That entails substantial risk. If a grantee is measured by how many people get screened and there will be strong pressure to get more people screened, and that could lead to more positive results (decreased specificity and increased false positives) even if it is to patients’ detriment. Comments on Screening Proposals During its November meeting, the committee reviewed and assessed the six proposals that were submitted to and funded by HRSA. We could not make specific comparisons between proposals because they were general and lacked detailed descriptions of their objectives and protocols. However, we have developed the following general comments: There seems to be overlap of the populations served. For example, several are proposing to serve Navajo nations. How can overlap be prevented and how can there be assurance that eligible groups will not be neglected or omitted?

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The proposals seemed to address primarily uranium miners and millers, although several included other eligible categories. It would be beneficial to encourage more participation from health-care organizations that serve the downwinders areas. An active program using available lists of workers from employers, unions, and so on, in contacting the affected populations may be effective in identifying eligible individuals. How can there be assurance that each of the proposals provides the same level of service related to outreach, education, and medical services? The request for proposals should have a set of specific requirements that are based on the legislation including knowledge of the risks and prevalence of radiogenic diseases. Applicants should address how they intend to satisfy each specific requirement. On the basis of some of its deliberations during the first two meetings, the committee had the impression that many persons would be served better by ensuring that their general health is improved and maintained than by focusing on diseases that have a low probability of being radiogenic or that are otherwise compensable.