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A Foundation for Evidence-Driven Practice A Rapid Learning System for Cancer Care: Workshop Summary (2010) / Chapter Skim
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7 The Federal Challenge of Responding to the Need for a RLHS
Pages 69-74

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From page 69...
... , but public policy." Etheredge called on the HHS to lead the effort to create a RLHS for cancer. HHS is the umbrella organization for a number of federal agencies that determine healthcare policy for cancer, including FDA, NIH, NCI, the Cancer Clinical Trials Cooperative Groups, NCI-designated National Cancer Centers, AHRQ, CDC, CMS, and ONC.
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From page 70...
... As Etheredge noted, much of the national funding for EHR subsidies will be from Medicare so it makes sense that this agency should set the standards for those systems. "It would be a huge travesty to have Medicare paying for EHRs and not be able to have the meaningful use requirements include reporting the data that we need to advance the quality and the information base of Medicare cancer care," Etheredge said.
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From page 71...
... For example, Medicare's coverage of PET scans for many oncology indications initially was not guaranteed unless ordering physicians provided information to the National Oncologic PET Registry on patients' clinical status and expectations and potential responses in light of PET scan results. The analysis of registry data on 23,000 scans revealed that about one-third of clinical decisions are altered by PET results, and nearly three-quarters of biopsies are avoided by using PET (Hillner et al., 2009)
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From page 72...
... In addition, FDA conducts its own postmarket surveillance of product safety, an activity that has recently been enhanced with its newly launched Sentinel initiative. This initiative is intended to help FDA more rapidly learn about safety outcomes from distributed healthcare data of
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From page 73...
... Woodcock stressed, and given the unacceptable time and effort to do clinical trials, she added, "The current paradigm of how we do trials and execute them and get results limits our capacity in this country." She called for more widespread community participation, as discussed earlier, to narrow the gap between research and practice and to accelerate learning. The FDA and Medicare wield tremendous regulatory power in health care, but they are just two of several federal agencies that can spur the development of a cancer RLHS.
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Key Terms

  • clinical trials
  • medicare cancer
  • clinical decisions
  • cancer rlhs
  • evidence development

  • pet scans
  • etheredge noted
  • withhold payment
  • learning agenda
  • product safety

  • postmarket surveillance
  • pet registry
  • cer data
  • adult cancer
  • observational clinical

  • determine healthcare
  • medicare wield
  • clinical studies
  • pet results
  • own postmarket

  • require postmarket
  • postmarket arena
  • inform physicians
  • cancer centers
  • data registry

  • national oncologic
  • healthcare learning
  • private payers
  • using pet
  • inform medicare


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