A Medical Device Daily

The House Science and Technology Committee introduced a piece of nanotechnology legislation in the form of HR 554, also known as the National Nanotechnology Initiative Amendments Act of 2009. Said to be identical to the version introduced to the House last year, the bill's emphasis is on environmental and health safety aspects of nanotechnology.

According to a Jan. 15 announcement at the committee's web site, the bill "will strengthen and provide transparency to the federal research effort to understand the potential environmental, health, and safety risks of nanotechnology," including requirements for "explicit near-term and long-term goals and the funding required, by goal and by agency." The statement notes that the bill "also seeks to leverage private sector investments in nanotechnology and facilitate technology transfer by strengthening public/private partnerships."

Last year's iteration of this bill, HR 5940, flew through the House by a margin of 407 to 6 (Medical Device Daily, June 10, 2008), but a companion bill stalled in the Senate Committee on Commerce, Science, and Transportation last July.

The House bill's sponsor, Bart Gordon (D-Tennessee) said in the statement "the range of potential applications of nanotechnology is broad," but that "it is important that potential downsides of the technology be addressed from the beginning in a straightforward and open way, both to protect the public health and to allay any concerns about the validity of the results."

Much of the burden for implementing these provisions would fall on administrators at the National Nanotechnology Initiative (NNI), a multi-agency collaboration established in 2003. NNI was the subject of a report filed by the National Research Council (Washington), which indicated that NNI's purview of nanomaterials is less than exhaustive (Medical Device Daily, Dec. 15, 2008).

According to the committee's Jan. 15 comments, it "has carried out numerous oversight activities to encourage the development and implementation of such a plan [by NNI], with limited success."

FDA has held several meetings to explore how nanotechnology will affect the safety issues of nanotechnology in the products the agency regulates, but a number of the agency's many critics feel FDA is ill-prepared for what may be an onslaught of nanomaterial-containing products with properties that are said to be poorly understood by the agency's scientific staff.

CHIP bill moving without GOP input

The Senate's bill for funding of the Children's Health Insurance Plan (CHIP) was a bone of contention over the past two years as Democrats and Republicans wrestled over the size and shape of the program, but the Democratic majority now has the lead it needs to push a bill through with minimal GOP support.

The House passed its own CHIP bill Jan. 14 by a vote of 289-139, and a Jan. 14 GAO report on HR 2, the Children's Health Insurance Program Reauthorization Act of 2009, indicated that as introduced and voted on in the House, it would result in "a total funding level of $17.4 billion in 2013," the last of the five-year reauthorization period. The House bill projects that the increased spending, pegged at more than $33 billion over 4.5 years, would be offset by increased tobacco taxes.

The chairman and ranking member of the Senate Finance Committee, Max Baucus (D-Montana) and Chuck Grassley (R-Iowa) have butted heads over several features of a proposed bill from 2007, when the new Democratic majority wrote a reauthorization that would have boosted federal spending for the program, which was then budgeted at $25 billion for five years, to roughly $48 billion (Medical Device Daily, Aug. 8, 2007).

That bill was immediately acknowledged to be fodder for a White House veto, putting the issue into play for the 2008 electoral season. The Bush administration's position was that states had to stop using the money to insure adults and to demonstrate that they had enrolled at least 95% of eligible children – those from families making 200% or less of the federal poverty level – before they could expand the pool of eligible children.

The current Senate proposal would boost eligibility from double the federal poverty level to triple, a move that is estimated to boost enrollment from about 7 million to 11 million. A GAO report last year indicated that previous expansion proposals would "crowd out" private insurance for children as parents opt for less expensive public insurance.

According to wire service reports, the Senate Tuesday booted two proposals from the GOP, one of which would have required states to document 95% enrollment of eligible children before expanding eligibility to documented immigrant children and pregnant women prior to the lapse of a five-year waiting period.

The Senate bill is projected to increase spending by more than $32 billion over 4.5 years. Sen. Orrin Hatch (R-Utah) is said to have stated that his and Grassley's support for previous iterations of the bill, which put them at odds with most of their party, was based on understandings regarding the income limits and immigrant provisions. Hatch is quoted as saying he would not vote for the bill as currently written.

White paper says more care not better

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, but goes a step further.

According to a Dec. 17 statement posted at the web site for 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 they make the corollary case that coverage can be expanded without inducing a financial hangover on future generations.

"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 statement says, but the authors of the study in question, John Wennberg, MD, and Shannon Brownlee, argue that "covering everyone will have a much smaller impact on the trend in health care costs, provided that capacity is not increased" (emphasis theirs).

Unfortunately, the authors offer no advice on how to control capacity, offering only 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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