Medical Device Daily Washington Editor

WASHINGTON — The pace of change on Capitol Hill is glacial — a point few would argue with — so it came as no surprise when Stephen Ubl, president of the Advanced Medical Technology Association (AdvaMed; Washington) quipped that this year’s legislative agenda for the association was a case of “déjàvu all over again.”

At a press conference yesterday to review the past year and outline the association’s upcoming agenda, Edward Ludwig, the association’s outgoing chairman and CEO of Becton Dickinson (Franklin Lakes, New Jersey), said that AdvaMed did well for its members last year, including the negotiation of a user fee agreement, providing “timely, effective and transparent reviews of submissions.”

As for the ever-present healthcare insurance debate, Ludwig said the association has “expanded our advocacy efforts,” including the universal insurance plan it unveiled in June (Medical Device Daily, June 25, 2007), linking coverage to programs designed to reduce costs. Ludwig said an independent analysis showed the proposal would decrease costs while also expanding access.

Ludwig (also quipping) said that personalized medicine “sounds sort of high-falutin’,” but added: “it’s obvious that the diagnostic portion is under-appreciated and under-funded.” He mentioned an article in the December edition of the Harvard Health Letter claiming that genome sequencing may cost as little as $1,000 in 10 years. He said that knowledge of the genome will cut costs, citing screening for the human papillomavirus as one example.

However, “it hasn’t taken hold [in some places] because of policy short-sightedness.”

Ludwig said that while Congress did not “modernize” reimbursement for diagnostics last year, he nonetheless sees “strong bipartisan, bicameral support” for it, and that AdvaMed “will push for passage in 2008.”

Ubl said that AdvaMed is “working with Congress to make sure that FDA has the resources it needs,” but, in answer to a follow-up question, said that the House Appropriations Committee’s Agriculture subcommittee, which has jurisdiction over FDA’s budget, has offered no clues as to specific numbers.

Ubl criticized the recent CBO report citing medical technology for increasing healthcare costs as relying on “a questionable residual model” that “ignores the cost of diseases” on the rise. He said obesity “accounts for 12% of cost growth” by some measures, and pegged other estimates at 28%. He said that CBO conclusion that slowing technology advances would help restrain costs “fails to back that 12% out of costs.”

The recent CBO study on comparative effectiveness, he said, was also less than rigorous because “based on averages” that are temporally static.

He said that a study of angioplasty in New York state by David Cutler, PhD, a professor of economics at Harvard University (Cambridge, Massachusetts), “found that in 1982, it was a safe and effective [procedure], but not at all cost-effective.” Cutler’s data indicated that “[i]t became cost-neutral about four years later,” Ubl said, and that by 2000 benefit exceeded cost by more than $20,000.

“Technology is an iterative process,” Ubl said, and highlights the limits of the “snapshots” provided by comparative effectiveness research. Clinical decisions, he said, “should be based on clinical effectiveness, not cost effectiveness.”

It is “far more important whether the patient lives or dies” than whether “micromanaging” care constrains inflation, he said.

As for this year’s legislative agenda, Ubl said remote monitoring (RM) is “a key issue” and that AdvaMed will urge Congress to direct CMS to reimburse doctors for RM.

“We’ve made a lot of progress over the last year,” he said, noting that Sens. Norm Coleman (R-Minnesota) and Max Baucus (D-Wyoming) favor it, though work remains on technical issues, such as budget scoring.

Imaging cuts are still a sore spot, Ubl said. “Our approach would be to look at the underlying appropriateness” of the scans and the training of the operator. On the other hand, Ubl acknowledged that imaging may be one area that suffers when Congress applies yet another patch for physician Part B fees under the sustainable growth rate (SGR) mechanism.

“If you have a hole you have to fill ... everything is on the table” where policymakers are concerned, he said.

He argued that credentialing is “a more appropriate process” for suppressing inappropriate use of imaging, and he saw no “compelling proposal” for an alternative to SGR; hence “a continuing patch process” is likely.

“We’re going to be spending a lot of time with Congress and their staffs” on the interplay between imaging reimbursement and SGR cut restorations, he said.

As for the prospects for systemic healthcare reform, Ubl predicted that a Democrat in the White House would heavily emphasize it.

He said that “the term ‘universal coverage’ is becoming less politically loaded” thanks to the expanded number of concepts from both political parties. But he said that a GOP administration would have to explicitly make reform a top priority to gain any traction, because polls indicate that conservative voters are more focused on other issues, such as terrorism and the economy.

As to patent reform, Ubl said, “we’re likely to see Senate action in the first couple of quarters,” with AdvaMed continuing “to focus on the apportionment and the second window” portions of the House patent bill (H.R. 1908).

“The House bill is badly flawed and is an invitation to infringement,” he said, because the language dealing with apportionment of damages would make patent infringement “a cost of doing business.” He declined to comment specifically on the corresponding section from S. 1145 because “the discussion [on apportionment] is fluid.”

Editor’s note: Stephen Ubl has more to say about AdvaMed’s view of med-tech in this week’s MDD Perspective, our online presentation of views on medical technology and innovation.