Medical Device Daily National Editor

SAN FRANCISCO – Presidential candidates – most of them anyway – have made considerable proclamations on the matter of healthcare reform.

Martha Kendrick, a partner in the Patton Boggs (Washington) law firm, told attendees at the 13th annual Frost & Sullivan Medical Devices 2008 conference at the Hyatt at Fisherman’s Wharf on Monday that healthcare reform is “front and center in the [presidential] campaign.”

But, despite all of the attention being given the issue both within and outside of the presidential race, “it’s not clear whether the national will is there to do wholesale reform,” she said.

In other words, the answer to whether we’ll see meaningful healthcare reform during the early years of the Clinton, McCain or Obama administration is an unequivocal “Yes ... no ... maybe.”

One thing for sure, Kendrick said, “is that it’s going to be an ugly process.”

That view gives a nod to the realities of both partisan politics and, even more importantly, the national budget, which continues to be under severe duress.

Not that healthcare doesn’t need fixing. “There are so many aspects that are broken,” Kendrick said. “But are the resources there to make this happen?” And beyond that, “Will Congress be able to work with the White House to make this happen?”

She said the catalysts for national healthcare reform are easy to see: An aging population, rising healthcare costs, a growing number of uninsured and state reforms.

Kendrick used a review of the badly flawed and classically failed Clinton healthcare reform efforts circa 1993 and 1994 as a springboard to her discussion of the outlook for healthcare reform in 2008 and beyond.

That effort failed in no small part because the Clintons – mostly Hillary, with her husband the president’s clear approval – “failed to engage members of Congress,” Kendrick said.

That colossal political misstep doomed the reform push right from the outset.

But, as she put it, from that point “the U.S. has moved forward in small, incremental steps” – such as the Health Insurance Portability and Accessibility Act of 1996, the Balanced Budget Act of 1997 and the Trade Act of 2002.

“We have made progress,” Kendrick said, “but we’re not there [yet].”

She insisted that “this time around, Congress is going to be very much in the driver’s seat,” even while describing that collective legislative body as “very partisan and very divided.”

Noting that congressional elections “are very much in the forefront this year,” Kendrick said that the Democrats are “very hopeful they will take control of the House and Senate ... and win the White House.”

As far as the outlook for meaningful healthcare reform is concerned, she said that if McCain is in the White House and the Democrats control both houses of Congress, “we’ll be in for some difficult years,” with partisan push and pull being the order of the day.

“We have a divided government,” she said, “and it’s hard for any president to get done what he wants.”

Nevertheless, Kendrick sees healthcare reform efforts gaining some traction in the 110th Congress, centered on efforts to reduce the number of persons without health insurance, as well as to reduce the cost of health insurance and the reliance on company-provided health insurance.

“There are serious proposals in this Congress aimed at healthcare reform,” she said. “These involve the first serious discussions about healthcare reform since 1993-94.”

While President George Bush, now in his last of eight years in office, has put forth his own package of reforms that includes expanding flexible spending accounts, improving the adoption of healthcare information technology (HIT) and strengthening the ability of small businesses to insure their employees, Kendrick said the Democratic response “is that those are not real reforms, just moving resources around.”

McCain, already having clinched the Republican presidential nomination, is focused on a healthcare structure that is “decentralized and market-driven,” she said, including a proposed tax credit for individuals and families buying health insurance.

In the meantime, Hillary Clinton’s healthcare message is built around “If you like what you have, you keep it,” and Obama’s approach, in Kendrick’s words, “is a page out of Hillary’s playbook. His approach would be, “Make it affordable and accessible and 96% to 98% will buy it.”

She said the Democratic-controlled House “has focused on more and more oversight authority for the FDA.”

Noting that the U.S. “spends more on healthcare than any other country in the world,” Kendrick added that Switzerland is No. 2, but at a level 25% less than that of the U.S.

“But we’re not seeing that spending translate into better healthcare,” she said.

Common themes in healthcare reform proposals, she said, include:

• Comparative effectiveness data.

• Pay for performance, which she also characterized as “pay for value and pay for quality.” Kendrick said the Centers for Medicare & Medicaid Services is “very much a driver of this.”

• HIT, although the rub there, she said, “is who’s going to pay for it? It’s a daunting proposition for physicians, who have seen their incomes steadily erode over the past few years.”

• Medical “home,” a new method of providing primary care, which de-emphasizes institutional settings, with “demonstration” projects ongoing in eight states.

• Direct-to-consumer advertising, fueled in part by the ongoing rise of the “empowered consumer.”

She said that the role of the FDA would grow “in any kind of healthcare reform.”

Saying the American people “want the reassurance that healthcare reform is going to mean more choice and better care,” Kendrick warned of the potential abyss that lies ahead.

She noted that, with the federal budget suffering badly with healthcare expenditures totaling 16% in gross domestic product in 2007, imagine the impact of growth to 25% of GDP in 2025, 37% in 2050 and an unfathomable 49% in 2082.

Thus the need for – and uncertainty of – healthcare reform as a spotlight item in a presidential campaign.