A Medical Device Daily

Anyone who has attended device advisory panels is familiar with the idea that FDA takes longer than European authorities to approve a device. However, up until recently, nobody could offer any evidence to buttress the argument, a detail recently taken care of by an article appearing in the February edition of the Journal of Medical Device Regulation.

Author Ralph Jugo, now a senior technical specialist with Quality First International (London), states that "there is a belief and expectation that medical devices in the European Union appear to be approved and introduced into commercial distribution in a faster, more streamlined fashion than they are in the U.S." However, "there have been no articles that have attempted to empirically compare approval times," he says.

Jugo examined the records from 42 class III medical devices that ran through both the FDA and CE gauntlets between 2002 and 2007 and to the shock of no one, discerned that huge gaps exist between the respective regulatory systems. He also noted that "the average PMA times for these devices was 513 days, and only three PMA applications were reviewed and approved by FDA within 180 days."

One factor is the dreaded advisory panel meeting. "It is asserted that this requirement ... which is not a requirement in the EU, helps to explain the differences between approval times," Jugo wrote. Historical research indicates that the advisory panel process "has historically taken as long as 256 days, longer than the 180 days" that are the maximum term of review.

Pre-approval inspections do not exactly grease the skids, either. Jugo characterizes such inspections as "unique to class III devices in the U.S.," adding that despite the purported time limit on the inspection within the 180 PMA days, such an inspection "becomes a major milestone that can make PMA approval more difficult."

The burden of proof, as is well known, is also higher in the U.S. Jugo says that "the level of scientific evidence ... has historically and is still significantly different." EU authorities are, in some cases, inclined to accept "clinical literature reviews ... instead of actual clinical study data collected on the actual device." European authorities are said to accept "much smaller studies without the need to randomize, blind or have a control group." Follow-up is also less burdensome, typically running to six months or less vs. "the one year minimum" FDA typically seeks, according to Jugo. However, most device makers will testify that five years is a fairly common standard in recent times.

Jugo admits that "this striking result needs to be tempered due to the small sample size and the wide variation in the results" of approval times. As for which system is better, he says that any such discussions would require that a study "compare the post-approval experience" in both markets. If the rate of adverse events in Europe proved comparable, one would conclude that "the EU system is potentially better from all relevant perspectives; the company's, society's, and from the patient's perspective, which is in the end the most important perspective of all."

CMS eyeing short stays at LTCHs

The idea that a long-term care hospital (LTCH) would game the system to reap the maximum reward might not seem striking, given recent controversies, but the Centers for Medicare & Medicaid Services nonetheless had to recently rein in the practice of engineering discharge dates for those whose stays at an LTCH barely pass the 25-day minimum.

All the same, a March 21 report by the Office of Inspector General (OIG) at the Department of Health and Human Services suggests that some LTCHs have yet to give up the practice.

The report states that a short stay is defined as reaching "five-sixths of the average length of stay for that patient's diagnosis." Those who were discharged before reaching this threshold, known as short-stay outliers, "decreased annually from 40% of LTCH stays discharged in fiscal year 2003 to 27% of such stays" three years later.

The portion of the data that apparently is the source of OIG's concern is that "LTCHs discharged over a third of short-stay outlier patients at least 10 days before they reached the short-stay outlier threshold," but "increasingly discharged patients within two days after the patients qualified for full LTC-DRG patients."

According to the OIG memo, CMS modified its reimbursement matrix in 2006 so that payment was reduced from 120% of the cost to 100% of the cost or a blend of the general care and acute care payment amounts. The memo questions whether the financial imperatives "trigger the discharge date rather than the patient's condition." The memo says the data show that "LTCHs increasingly discharged patients within two days after they qualified for full LTC-DRG payments," a trend "that became more prominent from FYs 2003 to 2006."

HIT bill stalled as support broadens

Healthcare information technology (HIT) may well be the last essential ingredient needed to make healthcare affordable, but the privacy issue is still a snag.

In an April 2 statement, Sens. Ted Kennedy (D-Massachusetts) and Mike Enzi (R-Wyoming) of the Senate Health, Education Labor and Pensions (HELP) Committee made the case for the Wired for Healthcare Quality Act (S. 1418). Enzi said that "[k]eeping one foot in the 20th Century while trying to prepare our healthcare system for the difficult challenges that lie ahead just won't work."

The snag is the Health Information Privacy and Security Act (S. 1814), sponsored by the chairman of the Senate Judiciary Committee, Pat Leahy (D-Vermont). Enzi is said to have argued that the Wired Act will provide enough security and that "we don't have to write it into law."

The Wired Act got out of committee last year, but went no farther. The House of Representatives has not passed a similar bill, and the elections will likely kill any chances of passage should the bills stay on hold through August.