Democratic Congress May Mean Increased Device ScrutinyDemocratic Congress May Mean Increased Device Scrutiny

The upcoming 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 that will be 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 November 16, Nancy Pelosi (D–CA) was unanimously elected by the Democratic Caucus as Speaker-designate of the House of Representatives. As a senior member of the House Appropriations Committee, Pelosi has been an advocate for women's health issues and the creation of a nationwide health tracking network to examine the links between environmental pollutants and chronic disease. She has also been a proponent of increased investments in health research, and has secured funding to double the budget for the National Institutes of Health.

According to Jeff Kimbell, principal of Jeffrey J. Kimbell & Associates (Washington, DC), Pelosi's legislative agenda in the 110th Congress will include the following highlights.

• Lobbying and congressional ethics reform.

• Enactment of recommendations of the 9/11 Commission.

• Raising the minimum wage to $7.25.

• Cutting interest rates on student loans in half.

• Allowing the federal government to negotiate Medicare drug prices with pharmaceutical companies.

• Broadening federal funding of stem cell research.

• Restoring a pay-as-you-go budget system.

• Close review of major government contracts at all agencies.

At press time, neither the Republican nor the Democratic party had formally announced subcommittee membership or leadership. However, there is a consensus among many Capitol Hill observers as to how the committees will shape up.

Committee on Ways & Means

In the 110th Congress, the House Committee on Ways and Means will likely be 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 expected to be Representative Jim McCrery (R–LA).

Perhaps not as familiar in medtech circles as other Democratic leaders, Rangel is serving his 19th term as representative from the 15th congressional district. He is the principal author of the $5 billion federal empowerment zone demonstration project to revitalize urban neighborhoods throughout America. He is also the author of the low-income housing tax credit, which is responsible for financing 90% percent of the affordable housing built in the United States in the last 10 years.

“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 PLLC (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.”

The subcommittee on health of the House Committee on Ways and Means will likely be chaired by Representative Fortney “Pete” Stark (D–CA), who has chaired the subcommittee in the past and was ranking member in the 109th Congress. Stark replaces Chairwoman Nancy Johnson (R–CT), who was defeated in her bid for reelection. Representative Dave Camp (R– MI) is expected to serve as ranking member in the new Congress.

Stark was a businessman and banker before being elected to Congress in 1972. Upon entering Congress, he served on the House Banking and Currency Committee. After completing his second term, Stark was named to the Ways and Means Committee, whose scope includes taxes, Medicare, Social Security, trade, and public assistance. Stark first became chairman of the subcommittee on health in January of 1985. While chairman, he presided over major reforms in the Medicare system. He continues to be an advocate for universal health coverage.

Kimbell 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

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

A strong advocate for affordable and accessible healthcare, Dingell has fought for initiatives such as the Children's Health Insurance Program and the Mammography Quality Standards Act.

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.

Northrup says reauthorization of MDUFMA may be somewhat overshadowed by reauthorization of the Prescription Drug User Fee Act. He attributes this to the heightened media scrutiny and congressional interest in drug safety over the past couple of years.

Representative Frank Pallone (D–NJ) is expected to chair the subcommittee on health of the Committee on Energy and Commerce, and Nathan Deal (R–GA) will likely serve as ranking member. The subcommittee on oversight and investigations will likely be 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 and infusion pumps.

• Conflict-of-interest issues.

Committee on Government Reform

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

The Committee on Government Reform is the principal investigative committee in the House. While on the committee, Waxman has conducted investigations into a wide range of topics, including the costs of prescription drugs, conditions in nursing homes, overcrowded schools, and voting irregularities.

A proponent of strong FDA enforcement, Waxman released a report in June 2006 that criticized a decrease in agency warning letters and enforcement activities over the past five years. In December 2005, following several reports of patient injuries associated with the use of defective or unsterile reprocessed single-use medical devices, Waxman wrote to the Government Accountability Office and to FDA to request information regarding the adequacy of FDA's oversight of these devices, and how it compares to that of single-use devices.

According to Kimbell, the medtech industry can expect to see drug and device safety, as well as issues raised by recent ICD 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 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.

Senate Finance Committee

On the other side of Congress, the Senate Finance Committee—which is responsible for Medicare reimbursement issues—will likely be chaired by Senator Max Baucus (D–MT). Previous chairman Senator Charles Grassley (R–IA) is expected to become ranking member. In addition to reimbursement issues, the committee will be responsible for reviewing whoever is nominated to replace Mark McClellan, MD, PhD, as administrator for the Centers for Medicare and Medicaid Services. In past years, Baucus and Grassley have worked closely together on issues, a trend that industry observers expect to continue, particularly in light of the slim Democratic majority in the Senate.

According to Kimbell, the healthcare agenda of the Senate Finance Committee will likely include pay-for-performance initiatives and reform of the physician payment system. However, Northrup noted that these issues may take a back seat in 2007 to reauthorization of the State Children's Health Insurance Program.

Senate Committee on Health, Education, Labor, and Pensions

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

Kennedy has represented Massachusetts in the Senate for more than 40 years. He has been reelected to seven full terms, and is now the second most senior member of the Senate. Since arriving in the Senate, he has been an advocate for accessible and affordable healthcare.

Similar to the House Committee on Government Reform, Kimbell expects the Senate HELP Committee's healthcare agenda will focus heavily on drug and device safety provisions, including evaluating postmarket surveillance requirements and recent device recalls. Conflict-of-interest issues are also expected to be high on the committee's agenda.

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 in 2007.

© 2006 Canon Communications LLC

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