Genome-Based Diagnostics Clarifying Pathways to Clinical Use: Workshop Summary (2012) / Chapter Skim
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6 Regulation, Reimbursement, and Public Health
6 Regulation, Reimbursement, and Public Health
Pages 39-48
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From page 39... ...
• Agencies have been experimenting with progressive approval as one way to provide more regulatory and reimbursement flexibility. • A public health approach to genomic diagnostic tests would evaluate their utility to reach evidence-based recommendations and then evaluate their impacts at the population level.
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From page 40... ...
(Promising Tests and Interventions) T0 T2 Knowledge Evidence-Based Population Recommendation Integration Health Health or Policy or Policy T4 T3 Health Care Systems and Prevention Programs Programs FIGURE 6-1 The public health genomics model allows for a balance of the translational research (T0 through T4)
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From page 41... ...
The current system does not fund this kind of research though, Khoury observed. According to a recent portfolio analysis of cancer genetics and genomic research at the National Cancer Institute, most funding goes for discovery or early translation (Figure 6-2)
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From page 42... ...
"What EGAPP has tried to do is create analytical frameworks that allow data to be gathered across multiple platforms from observational studies to clinical trials," Khoury said. A second initiative launched by CDC and other public and private organizations in 2009 is the Genomic Applications Practice and Prevention Network (GAPPNet)
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From page 43... ...
For example, FDA cleared a test used in women with a pelvic mass that helps determine whether the mass should be removed by a gynecologist or by an oncologist,1 but it also required postmarket study to gather additional data on premenopausal women, for whom fewer data were available than for postmenopausal women. 1 Ovarian Adnexal Mass Assessment Score Test System; see http://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/GuidanceDocuments/ucm237299.htm.
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From page 44... ...
"In general, this is an area we need to fix," Gutierrez said. Barriers to Successful Test Development Gutierrez acknowledged the many problems raised by other presenters: diagnostic tests may not provide a sufficient return on investment; a lack of regulatory clarity can introduce uncertainty into the development of tests; many tests do not have much evidence regarding their utility; and LDTs lack standards and can be difficult to integrate into medical practice.
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From page 45... ...
Currently, because of the use of stacking codes, Medicare already pays for many genetic tests, said Jacques, but "we're not doing it in an intentioned or well-reasoned manner." Rather, the test is part of a claims stream and is reimbursed unless someone prevents it. Finally, a genomic test generates more confidence when there is agreement on its value.
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From page 46... ...
Statutes dictate how CMS must pay for covered health care practices. For example, congressional mandates delineate coverage for screening tests versus diagnostic tests, with screening tests tied to the findings of the USPSTF recommendations.
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From page 47... ...
Jacques also would like to see CED have greater breadth and flexibility so that not every new molecular indicator and LDT needs to be reviewed. Medicare still has considerable local authority, Jacques pointed out, and local decisions do not necessarily apply nationwide.
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