TRENDS & PERSPECTIVES
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Secretary of Health and Human Services (HHS) Mike Leavitt outlined the department’s Personalized Healthcare Initiative, which intends to achieve gene-based medical care combined with health information technology. The initiative includes some measures that could affect the IVD industry, particularly those manufacturers developing molecular diagnostics.
Leavitt said HHS will review existing structures for ensuring that genetic tests are accurate, valid, and useful. The objective is to ensure that responsibilities are appropriately assigned among HHS agencies to address the analytical and clinical validity and utility of tests.
According to HHS officials, the department has seen a large number of new molecular and genetic tools being developed. However, there is a lot of confusion regarding the framework in which such tests can get market approval, and whether they should be reviewed by FDA or subject to CLIA oversight. A number of issues have also been raised during the past few years relative to enhanced understanding of the performance of tests, their accuracy, and how the information can be used.
“There is a robust interest in the development of new technologies that look at genetics, gene expression profiles, and many new types of genetic tests,” says Greg Downing, project director for the Personalized Healthcare Initiative. “We are trying to develop a better understanding of the evidence and the support for their integration into healthcare, and examining whether there are needs for new capabilities and new ways to look at the information about them.”
Leavitt also said the American Health Information Community (AHIC) will develop recommendations to identify health IT standards for including genetic test information on electronic health records.
HHS officials added that the goal is the exchange of such information in a more efficient manner, such that it can be retrieved, archived, and utilized in different applications. The department is working with AHIC to evaluate the opportunity to develop standard reporting systems into electronic health records of genetic laboratory test results and family history information. HHS is also working with standards organizations such as Health Level Seven and others, and it has prioritized the inclusion of genetic tests into the electronic health record as an important tool.
“I think everyone would agree that one of the major challenges in our healthcare system today is the lack of adequate information and the ability to exchange information about what has happened in a patient’s healthcare experiences,” says Downing. “The Secretary’s efforts through AHIC have been centered on the electronic health record as one of the tools to help develop information so that we have common or interoperable ways of collecting information about laboratory tests or electronic prescriptions.”
In addition, Leavitt noted that the FDA critical path initiative is currently organizing work across various science and regulatory areas to improve product development, especially for gene-oriented drugs and diagnostic tests. Furthermore, FDA will publish a regulatory guidance on the codevelopment of drugs and diagnostic products this fall.
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Secretary Leavitt
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HHS officials confirmed that in the critical path compendium, there are a number of opportunities related to clinical diagnostic tools; among those, several genetics tests have been discussed as having potential. Overall, the department is looking at how to modernize the medical device development process.
“We anticipate this year the release of a guidance on the codevelopment of diagnostic tests and therapeutics in clinical trials,” says Downing. “This guidance should provide some advice to industry in helping guide the use of various tools and clinical trials in evaluating new therapeutic agents. In another area, the voluntary submission of pharmacogenomic data has gone well in terms of being able to develop a broader information base about the interface of tests with therapeutic agents.”
However, HHS officials realize that IVD manufacturers are concerned about whether proper reimbursement for these tests will be available. Officials noted that the primary focus has been developing evidence to demonstrate the utility of such tests in clinical populations. For example, the department is looking at options through its health IT agenda to determine whether capturing information through these tests’ electronic records is a feasible way to encourage their utility and potential reimbursement strategies. HHS will continue to develop better longitudinal information by determining not only how well the test performs but also how it informs choices about appropriate therapies and the outcomes of patients.
“One of the major barriers hampering reimbursement is developing evidence of the opportunity that these technologies offer to improve the quality of care,” says Downing. “Getting that information with regard to market approval and the longitudinal aspects of this are difficult. What we would like to do is to try to emphasize using current resources to improve the ability of gathering evidence about the outcomes of these tools. That is not meant to be in the context of premarket aspects, but rather better understanding what is the information that these tools are providing and how are they enabling us to improve the quality of healthcare either through improved response or diminishing adverse events.”
Additional information about HHS’ Personalized Healthcare Initiative can be accessed via the department’s Web site at www.hhs.gov/myhealthcare.
