Genome-Based Diagnostics Clarifying Pathways to Clinical Use: Workshop Summary (2012) / Chapter Skim
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Pages 33-38
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From page 33... ...
• Critical reasoning medicine can support coverage decisions when the data to make these decisions are incomplete. In a session featuring individuals with experience in health care payments, speakers discussed the issues that arise in making coverage and reimbursement decisions.
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From page 34... ...
Tunis focused on two related barriers to the development of clinically useful genomic diagnostic tests: • Regulatory and reimbursement decisions rely on a binary model of approval. • Evidentiary thresholds for regulatory and reimbursement decisions are poorly defined.
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From page 35... ...
As a specific example, Tunis cited the following draft recommendation: "Valid outcomes or surrogates for breast cancer prognosis include distant recurrence at 5 or 10 years, disease-free survival, disease-specific mortality, and overall survival." Whether this strikes the proper balance between innovation and certainty would have to be determined, but the appropriate response is to adjust the threshold and not give up on the process of coming to a consensus. "We can't move forward without some kind of mechanism to get everybody on the same page in terms of the minimally acceptable level of certainty for making these regulatory and reimbursement decisions," said Tunis.
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From page 36... ...
we don't have a system, we don't have a set of standards to go by." Standards would allow for more rapid deployment of genomic tests rather than waiting for peer-reviewed publications. They also would allow payers to make consistent decisions and would permit uniformity between CMS policy and that of commercial payers.
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"Shouldn't some of that money be directed toward the innovations that we need in health care to make progress? " FROM EVIDENCE-BASED TO CRITICAL REASONING MEDICINE Bruce Quinn of Foley Hoag provided a more theoretical perspective on the utility and adoption of genomic tests.
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From page 38... ...
The same is true for clinical validity, said Quinn, citing the differences in usefulness of hypothetically similar results between PSA testing and use of the Oncotype DX assay in predicting cancer recurrence. There is only a distant relationship between analytic validity, clinical validity, and clinical utility.
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