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In HHS Report, Leavitt Says Personalized Medicine is 'Central' to Future Healthcare System

NEW YORK (GenomeWeb News) – As the George W. Bush administration wraps up its tenure, the Department of Health and Human Services has released an update of its ongoing efforts in the personalized healthcare arena, and the vision Secretary Michael Leavitt has for this new medical area in diagnostics, treatment, and research.
In a prologue to the report, Leavitt provides a hypothetical “note on the desk” for the next HHS secretary explaining that personalizing healthcare “is not a niche concern. Its promise is central to the future of healthcare.”
However, he warned, putting an effective personalized healthcare system in place is “the work of a generation.” Within 10 years, Leavitt said he hopes that “it will be the norm for consumers and practitioners to anticipate that treatments should be individually targeted, with diagnostics and therapies commonly associated as a paired unit.”
Within 15 years, he wrote, “I hope that major clinical data sources can be securely linked in a manner that gives most Americans the option of allowing their own de-identified health information to be employed in the quest for ever-more individualized understanding of health and disease.”
And within 20 years, he said, “I hope that data and informatics will have advanced to the point of supporting meaningful individual prediction regarding an individual’s life-long health prospects, including specific, proven steps that he or she can take to protect and enhance health.”
The 300-page report, Personalized Health Care: Pioneers, Partnerships, Progress, includes Leavitt’s prologue, reports from 10 institutions that are using personalized medical techniques, and seven commissioned papers that examine “the opportunities and challenges” for the field.
The report is a follow-up to one that HHS issued a year ago outlining the Personalized Health Care Initiative, which Leavitt spearheaded.
In the prologue, Leavitt wrote that the report “seeks to bring into focus a sampling of activities that are now underway in different parts of the private and academic health sectors toward integrating personalized health care into clinical practice.”
These efforts include projects to employ genomics and other molecular-level techniques in clinical care; the use of health information technology in care; and the “realignment” of traditional organizations toward enhanced individualization of treatment, Leavitt said.
Leavitt suggested six “tests” to assess the state of personalized healthcare as the field evolves, based on several key questions: Do I have electronic health records? Does my doctor offer a strategic plan for maintaining my own health, based on my biology, genetics, and ancestry? Does my doctor have access to “decision support tools,” such as information about drug interactions? Do I? Will I receive recommendations for treatments based on my own biology and preferences? Is my genomic information available for clinical use? Ideally, it would be in my electronic health records. Lastly, do I have the opportunity to make my clinical information available for research purposes in order to help others and advance science?
These questions “are meant to show how personalized health care might work,” Leavitt advised.
Leavitt noted that personalized healthcare has already made some inroads into the standard of care. For example, he said, some molecular diagnostic tests “already use genetic information to steer treatment,” such as testing for the HER2/neu receptor to determine whether to prescribe Herceptin for cancer patients.
In addition, he noted that a number of pharmacogenomic tests are under development, including several for warfarin dosing, which could provide cost savings of up to $1 billion per year for the healthcare system.
Leavitt also pointed to the Food and Drug Administration’s Voluntary Genomic Submission program, which kicked off in 2004 and has so far gathered genetic information on around 50 drugs.
He warned, however, that “in other ways, this new culture of personalized health is not at all as close as we would wish.” For example, he said that the adoption of health information technology and interoperable electronic health records “has been painfully slow,” and the development, validation, and adoption of new molecular-based products “in day-to-day clinical practice will take many years or even decades.”
Another challenge, he said, is the rapid rise in healthcare coverage, and that fact that around 45 million Americans are uninsured.
“The advent of personalized health care cannot take place, and should hardly even be thought about, outside the context of the present crisis in health care financing and delivery,” Leavitt said.
“An important element of the problem lies with the outdated system of reimbursement that is enshrined in the Medicare program,” he added.
“Unfortunately, the payment approach that Medicare has enshrined is based on piecemeal payment for services, where reimbursement is only tangentially related to quality, and almost entirely unrelated to the patient outcomes,” he said. “As such, Medicare is a government-run, price fixing system where payment is based on volume rather than value.”
Leavitt’s “note on the desk” to his successor outlines four key areas that are “in play at this time of hand-off.”
First, he said, “the base of interoperable health information technology is critical and remains far from complete. It is not merely a matter of electronic health records, but equally the capacity to exchange information securely.”
Second, as data continues to accumulate, “it will become increasingly important to have defined standards of evidence that will satisfy doctors and patients as they make health decisions, and that will be useful for regulatory and reimbursement purposes.”
Third, “personalized health care will require new business models and reimbursement approaches” that will focus more on detecting disease earlier and prevent it more
Fourth, he said, “personalized health care is about developing new kinds of information and services — but it must equally be about using that information properly. Healthcare professionals “need to be engaged in the process of change,” and consumers will need better access to information.
Leavitt also recommends “closer alignment” of the work of the FDA and the Centers for Medicare & Medicaid Services. “In particular this pertains to the issue of standards of evidence, especially for products and services that reduce costs in the future by identifying disease earlier or enabling effective prevention,” he said.
“The different missions and capabilities of FDA and CMS will both be needed to usher in these tools, and I believe a new kind of collaboration between them could be important for progress,” he said.

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