Medical Device Daily Washington Editor

The Senate and House of Representatives passed their respective versions of the Children’s Health Insurance Plan (CHIP) reauthorization earlier this year (Medical Device Daily, Aug. 3, 2007), with the White House threatening a veto of any bill that authorized more than $35 billion over the five-year program authorization, a total presumed to come out to $7 billion a year.

However, Sen. Max Baucus (D-Montana), the chairman of the Senate Finance Committee, published an updated version of the bill yesterday that allocates an average of more than $11 billion a year for the first four years from regular appropriations sources, and only $3 billion from those sources for the last of the five years.

As Medical Device Daily went to press yesterday, the House was scheduled to vote on the bill, but had not yet done so.

According to the Baucus document, the CHIP grants to states would total slightly more than $9 billion in FY08, a number that climbs to a peak of $13.75 billion for FY11. But the total for FY12 drops to $3.5 billion.

However, the Baucus document also says that “additional appropriations of $12.5 billion in FY 2012 will make the annual total federal CHIP funds” for that year $16 billion. This would boost the five-year total to $47 billion.

However, the document does not indicate specifically where the added appropriations for 2012 would come from. Among other things, the Senate bill would use additional tobacco tax and cuts to Medicare Advantage plans to help fund the overall increase in CHIP monies.

Republicans who are leery of crossing voters are said to be reluctant to support a veto, given current voter sensitivity to healthcare issues. And the ranking minority member of the Senate Finance Committee, Chuck Grassley, is said to have urged the president to avoid a confrontation with Congress on this issue.

Despite that, many fiscal hawks in Congress are also reluctant to vote in favor of a bill that would drain enrollment from private plans and put children from homes that make as much as $80,000 a year into public health plans.

Karen Davenport, the director of health policy analysis at the Center for American Progress (Washington) told MDD that “everything we’ve seen says that the bill the House will take up today is very similar to the bill the Senate passed with a veto-proof majority” in August. But she added that “it would be tougher in the House to have a veto-proof majority.”

On the other hand, she said that the political viability of a veto probably would be endangered by the fact that the current CHIP authorization expires Sept. 30.

Robert Helms, a scholar at the American Enterprise Institute (Washington) told MDD that CHIP “is a popular program and there’s no way to drop it down” in terms of public expectations for funding after 2012.

However, he said that because of the outside appropriation used to round up the total for 2012, “there would have to be a considerable effort to fund it at that time,” in reference to the five-year period commencing in 2013. Helms said that some Democrats are concerned about the effect of this drop-off in the standard appropriation, which would create a vastly different budget scoring when the next program authorization is due.

In this scenario, the $3 billion in regular appropriations would serve as baseline for calculations of the budgetary burden for CHIP funding beyond 2012, making it difficult for legislators to bring spending levels back up to the numbers spent in the five years up to 2012, without finding an offsetting source of revenue, assuming that Congress is still hewing to a pay-as-you-go approach when the time comes.

At press time, calls to Sen. Grassley for comment were not returned.

FDA to talk about its IT base

FDA reported recently that it will hold a public hearing on Oct. 19 on how the agency might best make use of information technology to “support the process for the review of human drug applications.” The meeting will take place at FDA offices at Fisher’s Lane in Rockville, Maryland.

The focus of the meeting apparently will be on IT systems at the Center for Drug Evaluation and Review and at the Center for Biologics Evaluation and Review. Carolyn Yancey, a program analyst at FDA’s Office of Chief Information Officer told MDD that the agency’s interest at present does not extend at this time to electronic systems at the Center for Devices and Radiological Health.

FDA has attempted to promote the use of electronic filing at the Office of In Vitro Diagnostics, a division of CDRH, but that mechanism currently supports only 510(k) filings via the so-called Turbo 510(k). FDA’s site is not typically seen as a cutting-edge site among those who have to visit the site regularly, but the agency has demonstrated an interest in electronic filing of applications for various products (Medical Device Daily, May 30, 2006).

Many in the IT industry might say that the task of tying together the agency’s considerable base of legacy data processing systems and linking them to a new infrastructure would be daunting. And the additional demands that the site will have to support as a result of the recent FDA reauthorization legislation seem to suggest that any improvements will come incrementally.

FDA will accept written or electronic notices of participation and electronic comments between now and two weeks prior to the meeting and will hold the post-meeting docket open for comments for 15 days.