The US Food and Drug Administration’s product approval system and the Centers for Medicare and Medicaid’s reimbursement criteria need to change in order for personalized medicine to take hold, HHS Secretary Michael Leavitt told healthcare stakeholders at a conference in Boston last week, less than two months before he is to leave his post.
Leavitt is largely regarded as a champion for the advancement of genetics and genomics research by personalized medicine stakeholders. During his time as HHS Secretary, Leavitt has guided the agency to address how the federal government oversees and reimburses for genetically targeted medicines and genetic tests.
Although the HHS Secretary announced a year ago that he planned to leave his post, he has assured that the momentum in personalized healthcare he helped create will continue after he leaves [see PGx Reporter 12-12-2007].
During the conference, hosted by Harvard-Partners Healthcare Center for Genetics and Genomics, Leavitt released a 300-page report that includes analyses of “the opportunities and challenges” for personalized medicine faced by institutions that are applying personalized medical techniques.
The report, called Personalized Health Care: Pioneers, Partnerships, Progress, is part of Leavitt’s Personalized Health Care Initiative, which he launched in 2006.
In the prologue to the report, Leavitt calls attention to the “potential for closer alignment” between the FDA and CMS to establish common evidence standards for products and services, and to find new ways to reward reductions in healthcare spending. He also offered some advice for his replacement.
As Pharmacogenomics Reporter was going to press, several media outlets reported that Senate Majority Leader Tom Daschle (D-SD) has accepted President-elect Barack Obama’s offer to head up HHS.
Leavitt advised the incoming secretary to focus on defining actionable evidence standards that can be used for regulatory and reimbursement purposes; develop an interoperable health information-technology system; help develop new business models and reimbursement approaches that quantify and reward value; and educate physicians and consumers.
Obama has expressed a strong desire to advance personalized medicine. As a US Senator, he introduced a bill on personalized medicine in 2006 that addresses many of the future challenges that Leavitt outlined in his report [see PGx Reporter 11-21-2006].
Elements of Obama’s bill have been incorporated into new legislation introduced two months ago in the House by Rep. Patrick Kennedy (D-RI) [see PGx Reporter 09-17-2008].
Although there is support for the science, it is currently unclear how Obama’s personalized medicine initiatives will fit into, or be funded, under a new healthcare system.
“There is a uniquely American way to do it, and that’s by blending government with markets.”
Obama’s campaign platform offers a general outline of how the healthcare system might look like under the new president’s tenure. The president-elect appears to be advocating a system that calls for more accountability from insurance companies and provides health insurance for pre-existing conditions. He has promised to save the average family $2,500 in medical costs each year.
Proposals that might help facilitate the implementation of personalized medicine include the requirement that hospitals collect and report healthcare cost and quality data, coverage of preventative services such as cancer screening, and a $10 billion federal investment in healthcare information technology over five years.
Obama’s campaign has estimated that his healthcare reform proposals will cost between $50 billion and $65 billion a year, which will be funded through cost reductions within the healthcare system and from slashing Bush tax cuts for those earning $250,000 per year.
Although during campaigning Obama said his healthcare proposals strike a middle ground between “government-run healthcare with higher taxes or letting the insurance companies operate without rules,” following his election, calls for universal healthcare heightened in a democratically controlled Congress.
Senate Finance Committee Chairman Max Baucus (D-Mont.) recently introduced a healthcare bill that requires everyone not presently covered to purchase private insurance. Senator Edward Kennedy (D-Mass.), chairman of the Senate Committee on Health, Education, Labor and Pensions, is said to be crafting new legislation on universal healthcare, and as part of the effort, has named Senator Hillary Clinton to lead a working group on insurance coverage.
However, at the HPCGG conference, Leavitt warned against too much government intervention in health care, suggesting that instituting a single-payor system is not in line with the American spirit of open markets and limited government.
“We need to ensure that the healthcare system is one that is organized by government but not run by the government,” Leavitt said. “There is a uniquely American way to do it, and that’s by blending government with markets.”
In the past, Daschle has proposed the idea of creating a Federal Reserve type body for healthcare. This so-called Federal Health Board would create a infrastructure to combines elements of the existing public and private healthcare systems.
“About 45 percent of the people in our country get their healthcare from public sources, 55 percent from private sources, but there's no integration, either among the public programs or between the public and private sectors,” Daschle said in an article in The American Prospect published earlier this year. “Somebody has to do that. We need a board — just as we have needed commissions in the past for base closing or Social Security — to focus and to create the kind of decision-making process that allows us to make the tough decisions.”
Daschle added that with the Federal Health Board handling the more detailed aspects of implementing healthcare policies, Congress will be able to address larger healthcare issues impacting the nation.