Medical Device Daily Washington Editor

WASHINGTON – Despite criticisms that its plate more than runneth over, the FDA is taking part in the nation's fight against bioterrorism. The agency'sNational Center for Toxicology Research (NCTR) said it is working on a way to detect toxic biological agents that is cheaper than DNA testing and can rapidly run tests for a series of pathogens.

By combining a process known as pyrolysis with the use of mass spectrometry, the agency will drop a layer of security over the U.S. food supply as well as provide military and domestic enforcement groups with a powerful method of detecting organic compounds.

Pyrolysis is the chemical decomposition of organic materials by heating in the absence of oxygen or any other reagents. Mass spectrometry is, of course, a means of identifying an atom by ionizing it and measuring its response to a magnetic field as the atom is accelerated through a chamber.

The use of pyrolysis enables a spectrometer measurement of organic molecules by heating the molecule so that it emits gaseous matter, then measuring the reaction of those gases to an electromagnetic field.

Pyrolysis is usually applied in an anoxic environment, but Jon Wilkes, PhD, the agency's lead researcher on this program, told Medical Device Daily that while it is currently working the test media in an oxygen-deprived space, it also has run some tests “at atmospheric pressure with air in the vicinity and appear to get acceptable results.”

The mere ability to run biochemicals through such a widget will mean little if Customs agents and others don't know what they're seeing. Hence, FDA is working on a parallel effort to build a spectrometer library.

Already in the library are a couple of naturally occurring bacteria, namely Vibrio parahaemolyticus, often encountered in the consumption of oysters, and Salmonella enterica, the bane of anyone unlucky enough to consume bad poultry. At present, this method is not practical for virus detection.

Wilkes said that while the library of bacteria is expanding, the going is slow because “a real-world sample would likely not be one of the exact types we have in the library.” And so a field test that results in a near hit might call for further tests, partly because most bacteria come in more than one strain. To compile an exhaustive library, he said, “you would need a library with examples of at least a thousand different bacterial strains, pathogens and non-pathogens.”

This technique cannot distinguish between live and dead microorganisms, but the cost compares nicely with that of DNA testing. The latter sports a price tag of $15 to $50 for each sample analysis, whereas spectrometric analysis runs as little as $2 a pop.

Wilkes said the agency hopes to roll this program out “in the near future,” but that he and his colleagues are working on a different platform that “works by sampling pyrolysis vapors directly from atmospheric pressure.” This new configuration will speed up sampling times from seven minutes to five to 30 seconds. “It's worth the wait, especially if you imagine putting one of these systems” into a metropolitan subway station.

Thompson: Medicaid 'failing,' revamp urged

The cost of healthcare in the U.S. is the subject of a million dialogues, and Medicaid is at the crosshairs of many of those dialogues. The state/federal program costs the state of New York about $48 billion a year, and according to the National Association of State Budget Officers (NASBO; Washington), consumed more than 21% of state budgets in fiscal 2003.

Thus, Tommy Thompson, former secretary of the Department of Health & Human Services (Baltimore), in address to the National Governors Association (Washington) last Friday, offered a plan to overhaul Medicaid, making it a leaner and more effective vehicle.

Dubbed Medicaid Makeover, the proposal hinges on changing the focus from treatment to prevention and on reshuffling the state/federal mix of Medicare so that states will see to the needs of those under the age of 65 and the feds can zero in on the population with which they have the most experience, those 65 and older.

Thompson said that “the lines of responsibility are so crossed between the federal government and the state government[s] that no one really knows who's in charge.” He added: “We need to manage health more than just manage care.”

Thompson's approach emphasizes individual responsibility for health and rewarding superior healthcare, with health information technology a necessary ingredient in this pursuit.

West Virginia already is heading down the individual responsibility road via enhanced benefits packages available to residents if they sign an agreement to abide by a health improvement program. Another curb on cost increases would be to shift recipients into commercial insurance plans via subsidies.

One potential snag in this idea is funding. According to Thompson's web site, MedicareMakover.org, one way to rein in state budgets would be to “utilize an updated Federal Medical Assistance Percentage (FMAP) formula” which would maintain “the open-ended entitlement-based nature of federal Medicaid” while directing more money to those states with higher post-realignment costs. Thompson feels that block grants might not serve as ably because of the difficulty in anticipating state funding needs after realignment.

Thompson argues that FMAP is “based on average state personal income” and fails to account for a state's fiscal ability to handle its Medicaid responsibilities. He wants a new FMAP system addressing “the number of low-income people living in a state” and “historical utilization of acute care services by state Medicaid recipients . . . and long-term care services by non-elderly Medicaid populations.”

'07 device user fees roll out on schedule

The FDA has formally posted its medical device user fee schedule for FY07, and the numbers offer no pleasant surprises for an industry already disenchanted with the user fee program. The increase was scheduled when Congress passed the Medical Device User Fee Stabilization Act last year.

Full PMA fees for small businesses, those grossing less than $30 million per annum, will jump from just under $99,000 to $107,008. For the deeper of pocket, the increase is from $259,600 to $281,600. Fees for 510(k) applications will bump up from $3,066 to $3,326 for small businesses and from $3,833 to $4,158 for their larger brethren. Similar increases are seen for a variety of other actions: 180-day supplements, panel-track supplements and real-time supplements.

The agency reminds industry that time is of the essence. The federal register notice says that “the latter of the date that the application is received in the reviewing center's document room or the date that the check is received by US Bank determines whether the fee rates for FY 20006 or FY 2007 apply.” However, the notice also states that “it is helpful if the fee arrives at the bank at least one day before the application arrives.” US Bank has to let the agency know within one day of its receipt of fees.