Maria Fontanazza

January 1, 2009

3 Min Read
Reform Anticipated for New HHS Secretary

NEWS TRENDS


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Senator Tom Daschle is poised to lead the HHS in healthcare reform, which was a top campaign issue for President-elect Obama.

Healthcare reform will be a top priority for the next secretary of Health and Human Services (HHS), and issues important to the device industry, such as comparative effectiveness and pay-for-performance, are likely to be intertwined.

In December, President-elect Barack Obama announced his selection of Tom Daschle (D-SD), former Senate majority leader as the next HHS secretary.

Many stakeholders in the device industry agree that Daschle will be a significant player in healthcare reform, especially with regard to expanding coverage and reducing patient costs. “The emerging consensus seems to be that the economic downturn actually strengthens the prospects for fast action on healthcare reform, even if every reform idea can't be implemented immediately,” says Ted Mannen, an attorney at Epstein, Becker & Green (Washington, DC).

Mannen suspects that many of the key reimbursement-oriented issues related to comparative effectiveness, pay-for-performance, and the implementation of an interantional classification of devices coding system (ICD-10) will be connected with healthcare reform.

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FDA needs funding to encourage needed reforms that ensure access to new technologies, says MDMA executive director, Mark Leahy.

“If there is one area in health reform to watch, it's the benefit packages that the president and Congress will make available to different insured populations. These are the packages that define the services that can be reimbursed,” says Mannen. “Many of the device-related changes, such as the results of comparative effectiveness reviews, could get wired into these benefit packages.”

Ensuring that patients have timely access to safe and effective products will remain a key issue, says Mark Leahy, executive director of the Medical Device Manufacturers Association. “This will require a well-funded FDA (through appropriations, not more user fees) that operates efficiently and effectively. In addition, coverage and payment for medical technologies must be timely and adequate to ensure the patient access is not compromised.”

If the Senate confirms Daschle as HHS secretary, his strong experience is expected to serve him well in the new role. His career as a congressman and a Senate majority and minority leader has given him experience in dealing with complex issues, while also helping him to understand the need to compromise to make progress, says Leahy.

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Stephen Ubl of Adva–Med believes Senator Daschle will be an important part of Obama's initiative to improve the healthcare system.

AdvaMed has responded positively to the selection of Daschle as well. Stephen Ubl, president and CEO of the trade association, praised the senator's experience and commitment to healthcare issues in a statement. He added that Daschle understands “what it takes to get things done on Capitol Hill,” and will be an important part of Obama's plans to improve the healthcare system.

Although Daschle is knowledgeable about healthcare issues, some industry insiders don't think he will have a direct effect on device regulation.

“Daschle has a significant background in healthcare reform, so I think that will be where he's spending most of his time. That will be his first order of business, not the medical device industry and not really FDA,” says Jonathan Kahan, partner at Hogan & Hartson LLP (Washington, DC). “It's clear that the secretary will have to support reform for FDA. I think everybody still thinks that FDA is a wounded animal.”

The Democrat from South Dakota has also been named the leader of the Health Care Working Group for the Obama Transition Team. The focus of the group is to find opportunities that satisfy Obama's vow to provide all Americans with affordable and accessible healthcare. Last February, Daschle published a book titled, Critical: What We Can Do About the Health-Care Crisis.

Copyright ©2009 Medical Device & Diagnostic Industry

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