Extending Medicare Reimbursement in Clinical Trials (2000) / Chapter Skim
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Pages 53-64
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From page 53... ...
53 3 Recommendations for Medicare Clinical Trial Reimbursement Clinical trials have become an essential component of modern medical care because they are the best means of finding out which health care interventions work and which do not. Trials produce information of value to future patients, and frequently benefit the people enrolled in them.
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54 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS Medicare reimbursement should not hinge on a judgment by HCFA about the quality of the trial. However, HCFA does have a legitimate interest in assuring that trials meet currently accepted standards for scientific merit and protection of research participants.
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RECOMMENDATIONS FOR MEDICARE CLINICAL TRIAL REIMBURSEMENT55 require some special determinations by HCFA. Nonetheless, this provision is an essential component of the overall recommendation.
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56 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS of government, and should not be addressed routinely in HCFA's reimbursement decisions. Medicare should reimburse routine patient care costs, but not all costs in clinical trials.
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RECOMMENDATIONS FOR MEDICARE CLINICAL TRIAL REIMBURSEMENT57 Further clarification may be needed to make clear the committee's intent with regard to reimbursement for procedures on patients in clinical trials. The committee is expressing no judgments about when trials of procedures should or should not be carried out, or who should be involved in them if they are.
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O p e n C A B G M id lin e C A B G ( m in im a lly in v a si v e p ro c ed u re )
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60 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS The committee has not attempted to specify an institutional mechanism under which HCFA might carry out the tasks required by this recommendation. However, the committee notes that the new Medicare Coverage Advisory Committee*
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RECOMMENDATIONS FOR MEDICARE CLINICAL TRIAL REIMBURSEMENT61 Nearly one Medicare beneficiary in five belongs to a capitated plan -- an HMO or some other form of managed care. That number is likely to increase over time.
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62 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS expeditiously. The committee assumes that only a few trials would be appropriate for such exceptional treatment each year.
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RECOMMENDATIONS FOR MEDICARE CLINICAL TRIAL REIMBURSEMENT63 should be explored. The committee urges the Secretary of HHS to examine this issue promptly, set a timetable for completion of a registry, and seek adequate funding for it.
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64 EXTENDING MEDICARE REIMBURSEMENT IN CLINICAL TRIALS CONCLUSION Clinical trials are integral to modern medical care and to the progress of medical science. Although HCFA has issued little explicit policy about payment for routine patient care for patients in clinical trials, the Medicare statute has been widely interpreted to exclude reimbursement for such care.
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