BB&T Washington Editors

This year's National Health Policy Conference, hosted by Academy Health (Washington) and Health Affairs, a healthcare policy journal, included the usual "let's reform U.S. healthcare" presentations and discussions. And though a single-payer system has been frequently recommended by some as a centerpiece for reshaping the country's healthcare system, Sen. Max Baucus (D-Montana), chairman of the Senate Finance Committee said there is no real possibility for this by the current administration, even though that administration represents a sharp shift in political power at the federal level.

Baucus said, "I believe this Congress has a duty to reform healthcare," and "I'm here to tell you that our day has arrived," based on control of the White House and both houses of Congress by the Democratic Party." But rather than espousing a single-pay, government insurance provider, he said, "Most believe we should build on our current system ... and not undermine our employer-based system."

Baucus said he sensed "a genuine interest in working together on the part of key Republicans in the Senate," but other priorities abound "at a time of severe economic crisis." So while he suggested that the lessons of the healthcare reform efforts of 1993 suggest a need to move quickly, "complex problems require time to understand."

He added: "I believe we will never address the federal deficit in this country" without healthcare reform, but he also warned that savings will not happen "in every budget window." He also argued that various other issues "must be addressed before we move to healthcare reform," including the Children's Health Insurance Program [CHIP].

(Shortly after the gathering, President Barack Obama issued a memorandum reversing restrictions put in place by the Bush administration, that memorandum allowing reimbursement for children in families who earn between 250% and 300% of the federal poverty level.)

Baucus called expansion of the SCHIP program would be "a big down payment" on healthcare reform, he said.

Questioned by a conference attendee as to why he does not favor a single-payer system, Baucus said that rather than not liking such a plan, he simply did not feel it could not be approved and could not "get even to first base in Congress."

Baucus, comparing the U.S. healthcare economy to an ocean liner as opposed to the nimble patrol torpedo boats of World War II fame, said that "It takes times to turn those big ships." He said that the U.S. "is more of an entrepreneurial country" than most European nations, so "we have to come up with a uniquely American result." Single-payer coverage "may come later," he predicted, "but it's not going to happen in America, in my view."

Rep. Xavier Becerra (D-California), standing in for Rep. Pete Stark (D-California), chairman of the Health Subcomittee of the House Ways and Means Committee, was more optimistic than Baucus about the single-payer option.

"I'm one of those who believe that single-payer has life" in Congress, Becerra said, but he suggested that the idea has more traction in the House than the Senate. "The Senate is often where things get stuck" where healthcare reform is concerned, he said.

But Becerra echoed Baucus's comment that any approach to universal coverage in the U.S. would have to be uniquely fitted to the U.S. "I don't think you're going to find us replicating any existing model," he said.

Contradictory assessments of GAO 510(k)

Various citizen groups have charged that the FDA is lax in the operation of its 510(k) regulatory pathway, and is approving too many high-risk devices through that process. Supporting these critics, FDA reviewers in early January sent two letters to Rep. John Dingell (D-Michigan) and the incoming Obama administration to complain of alleged corruption of the 510(k) program at the Center for Devices and Radiological Health.

A report by the GAO – which was asked to analyze the agency's 510(k) and PMA processes – would appear to support the critics, or at minimum point to system flaws needing improvement. This, first of all was indicated by its title: "Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process," and the report when on to analyze FDA's reviews carried out in fiscal 2003 through 2007.

It said that though Congress "envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete."

The GAO recommended that the Secretary of Health and Human Services should direct the FDA Commissioner "expeditiously ... to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process" those regulations to include reclassification "of each device type into class I or class II, or keeping it in class III, and for those device types remaining in class III, to require approval for marketing through the PMA process.

GAO found that in the four years reviewed, the agency "cleared 24 types of class III devices through the 510(k) process. As of October 2008, 4 of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process."

The report noted that the agency 'is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but did not provide a time frame for doing so."

Sidney Wolfe, executive director of Public Citizen (Washington), in a statement said that the report highlighted "the dismal job" that the FDA does in regulating devices and showed "that the approval process at the FDA is irredeemably broken." He bemoaned that "many high-risk devices are going through a less-stringent review process before being used in patients."

Still supporting the FDA's processes was the Advanced Medical Technology Association (Advamed; Washington). Janet Trunzo, executive VP for technology and regulatory affairs at AdvaMed, in a statement said the association "is pleased the GAO report clearly supports the effectiveness of FDA's 510(k) premarket review process." She said that the GAO report "demonstrates that medical devices reviewed by FDA under the 510(k) process are subject to the appropriate level of regulation to ensure their safety and effectiveness."

BPA: continuing mixed messages.

The health effects of the chemical bisphenol A (BPA) continue to be discussed, with no clear conclusions, or at least no conclusions that don't also come with qualifying statements.

The FDA and the Health Products and Food Branch of Health Canada, held a joint meeting on Jan. 30 and, afterwards, the FDA issued a statement saying that, concerning BPA "generally" and "based on all available evidence," the U.S. Canadian, European and Japanese regulatory agencies agree that "the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children."

At the same time, the FDA noted among the meetings discussion items, several indicating an effort to minimize BPA impact. These included:

• Discussion of "what is being done to help minimize the levels of the chemical in food.

• The noting of FDA's efforts to assist in voluntary BPA reduction efforts.

• Discussion of food manufacturers' activities "to refine packaging manufacturing practices to minimize migration of BPA into food."

• And discussion of the availability of alternative chemical products "so that polycarbonate baby bottles could cease to be a substantial component of the North American market in the future."

In the same qualifying manner, the statement said that Health Canada's Health Products and Food Branch "concluded that current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and infants." But as a "precautionary approach," the Canadian government "has taken steps to reduce exposure to BPA for infants and young children."

The FDA offered no separate conclusions but said it is preparing a response to the October 2008 review by the FDA Science Board of the agency's draft assessment of the safety of BPA for use in food contact applications. It said it is reviewing research "about the potential low-dose effects of BPA and will carefully evaluate the findings of these studies."

More healthcare not necessarily better care

The authors of the Dartmouth Atlas, seen as the definitive study of the mismatch between healthcare spending and outcomes, have published a new white paper that re-states the proposition that more healthcare is not better healthcare, and it also goes one step further.

According to the Dartmouth Institute for Health Policy and Clinical Practice (Lebanon, New Hampshire), the problem with consumption of healthcare services hinges to some extent on supply, and it make the corollary argument that coverage can be expanded without creating a financial hangover for future generations to deal with.

"Most analyses of coverage reform predict that we will spend more as a nation on health care once the uninsured gain coverage and begin consuming more care," the organization says on its website, but the authors of the study, John Wennberg, MD, and Shannon Brownlee, argue that "covering everyone will have a much smaller impact on the trend in healthcare costs, provided that capacity is not increased."

While the authors offer no advice on how to control capacity, they offer suggestions on how to promote organized care systems. The statement says that if "lower-performing, higher-cost, higher intensity hospitals and providers to adopt the practices of ... high-value integrated systems, costs would be greatly reduced. Most importantly, patients would receive better care."

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