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Democratic Congress May Mean Increased Device Scrutiny

The flip in congressional control could have significant implications for the medtech industry, as industry observers expect postmarket surveillance of devices to rank high on the healthcare agendas of Democratic leaders in the 110th Congress. Although many of the faces leading the new Congress are all too familiar to medtech industry players, their newly reclaimed leadership roles may give them significantly more sway over the shape of healthcare policy than they've had in recent years.

House Leadership. On January 4, Nancy Pelosi (D–CA) took office as Speaker of the House of Representatives. Pelosi has been a proponent of increased investments in health research, and has secured funding to double the budget for the National Institutes of Health.

Rangel

Committee on Ways & Means. In the 110th Congress, the House Committee on Ways and Means is chaired by Representative Charles Rangel (D–NY), who was formerly ranking member of the committee. He replaces chairman Bill Thomas (R–CA), who retired. The committee's new ranking member is Representative Jim McCrery (R–LA).

Northrup

"The Ways and Means Committee is often central to the major debates in Congress, but it will be forced to the front and center in 2008, when a little-known provision of the Medicare Modernization Act (MMA) will likely trigger a mandatory budget proposal from the president and a vote in the Congress on legislation to limit the share of Medicare funding that comes from general tax revenues," says Stephen J. Northrup, senior government relations director for Arent Fox LLP (Washington, DC). "The legislation to reduce the general-revenue share of funding for Medicare below the MMA trigger of 45%—which would likely involve reductions in Medicare services and provider payments—would be considered first by Rangel's committee."

Stark

The subcommittee on health of the House Committee on Ways and Means is chaired by Representative Fortney "Pete" Stark (D–CA), who has chaired the subcommittee in the past and was ranking member in the 109th Congress. Representative Dave Camp (R–MI) is ranking member in the new Congress.

Kimbell

Jeff Kimbell, principal of Jeffrey J. Kimbell & Associates (Washington, DC), says the incoming House Ways and Means Committee will likely focus its health agenda on Medicare Part D changes, Medicare payment issues, and issues surrounding uninsured individuals. Kimbell says Medicare payment issues likely to be targeted will include reform of the physician payment system and pay-for-performance initiatives.

"Stark is no fan of pay for performance, but he may advocate increasing Medicare reimbursement for a short period to assist physicians in adopting electronic health records and paying for the necessary information technology," Northrup says.

Committee on Energy and Commerce. In the 110th Congress, the House Committee on Energy and Commerce is chaired by Representative John Dingell (D–MI), previously ranking member of the committee. The committee's former chair, Representative Joe Barton (R–TX), is the new ranking member.

A member of the House for more than five decades, Dingell helped develop the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and is expected to be closely involved in the reauthorization process in 2007.

Representative Frank Pallone (D–NJ) is chair of the subcommittee on health of the Committee on Energy and Commerce, and Nathan Deal (R–GA) is ranking member. The subcommittee on oversight and investigations is chaired by Representative Bart Stupak (D–MI), with Representative Ed Whitfield (R–KY) as ranking member.

Kimbell says that the Democratic health agenda of the House Energy and Commerce Committee will likely include the following issues.

  • Public clinical trial registries.
  • Restrictions on marketing and direct-to-consumer advertising.
  • Drug and device safety provisions, including postmarket surveillance requirements.
  • Review of recent recalls, including those of implantable cardioverter-defibrillators (ICDs) and     infusion pumps.
  • Conflict-of-interest issues.

    Committee on Government Reform. In the new Congress, Representative Henry Waxman (D–CA) is chair of the Committee on Government Reform. Waxman has been the committee's ranking member since 1997.

    According to Kimbell, the medtech industry can expect to see drug and device safety, as well as issues raised by recent recalls of ICDs and infusion pumps, high on the healthcare agenda of the Committee on Government Reform.

    "After 16 years in the minority, both Henry Waxman and Bart Stupak, the new chair of the oversight and investigations subcommittee of the Energy and Commerce Committee, have developed a long laundry list of potential investigations and hearings, and both men are eager to begin their aggressive oversight of the federal agencies and programs within their respective committees' jurisdictions," Kimbell says.

    Baucus

    Senate Finance Committee. On the other side of Congress, the new Senate Finance Committee—which is responsible for Medicare reimbursement issues—is chaired by Senator Max Baucus (D–MT). Previous chairman, Senator Charles Grassley (R–IA), is ranking member. In addition to reimbursement issues, the committee will be responsible for reviewing the person who is nominated to replace Mark McClellan, MD, PhD, as administrator for the Centers for Medicare and Medicaid Services.

    Kennedy

    Senate Committee on Health, Education, Labor, and Pensions. In the 110th Congress, Edward M. Kennedy (D–MA) leads the Senate Committee on Health, Education, Labor, and Pensions (HELP), and former committee chair Senator Mike Enzi (R–WY) is ranking member.

    Northrup, who served as Enzi's health policy director in the previous Congress, notes that Enzi and Kennedy worked closely together in drafting the 2005 legislation that salvaged the medical device user fee program and enhanced postmarket surveillance of reprocessed single-use devices.

    He expects the two senators to collaborate again as the committee prepares for reauthorization of MDUFMA this year.

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