Medical Device Daily Washington Editor

Preventive care is one of the cornerstones of healthcare savings in the major healthcare overhaul bills now floating around on Capitol Hill, but the prospects for savings derived from such services is far from certain. The connected question of comparative effectiveness (CE) research is a major policy flashpoint, but it seems unlikely that either field of endeavor will generate information that is useful from a policymaking perspective anytime soon.

The most recent development in this picture is an Aug. 7 report filed by the Congressional Budget Office, which offered a dour take on the subject of the value of preventive care. CBO's report states that while researchers have conducted a number of studies, the overall evidence hints that "for most preventive services, expanded utilization leads to higher, not lower medical spending overall."

One of the primary drivers of this dynamic, according to CBO, is the fact that in order for such care "to avert one case of acute illness, it is usually necessary to provide preventive care services to many patients, most of whom would not have suffered that illness anyway." Noting that the aggregate cost of inexpensive preventive services can add up quickly, the CBO report states that it is difficult to refine the target population for a number of reasons.

The CBO report cites an article appearing in the Feb. 14, 2008, edition of the New England Journal of Medicine, which looked into a database on preventive care. The authors of the analysis concluded that only 20% of the services in the database "saved money while the rest add to costs." Another study cited by CBO, which was published in the July 28, 2008, edition of Circulation, concluded that the use of cholesterol statins and routine blood pressure monitoring would generate enough savings to offset only 10% of the cost of the preventive care.

CBO notes that the situation "is not unique to preventive services" inasmuch as the study appearing in NEJM suggests that costs go up and outcomes go down on a number of treatments, including surgery on men older than 70 with new diagnoses of prostate cancer as compared to watchful waiting. The prevailing view on the question of whether to aggressively treat high levels of prostate-specific antigen has oscillated several times in the past decade and a half.

CBO states that taxpayer-funded preventive services are likely to pay for services that private payers are already providing, leading to needless expenditures. However, the rate of churn of enrollees in health plans means that private payers usually pay only for services that have a short turn-around "because the initial insurers may not be the ones to realize" the benefit of a preventive service that offers no benefit for several years. And of course, some preventive care tends to boost longevity and hence produce a patient down the road who struggles with a condition that is yet more expensive.

CBO states that the net effect of public payment for preventive care is likely to be that outcomes improve while costs balloon. However, the document notes that CBO will in the future examine the cost impact of preventive services "on a case-by-case basis."

FDA details warning letter program

FDA commissioner Margaret Hamburg, MD, reported last week that the agency would roll out a new warning letter program, and some of the details have emerged via the Federal Register.

According to the Aug. 11 edition of FR, the program will commence Sept. 15 and run 18 months, at which time "FDA will evaluate this program and decide whether to continue it with or without adjustments." However, the announcement makes no mention of the formal warning letter close-out process mentioned by Hamburg at an appearance hosted by the Food and Drug Law Institute (Washington) last week (Medical Device Daily, Aug. 7, 2009).

The FR notice confirms Hamburg's remarks that the agency expects to hear from industry within 15 days of the issuance of a 483 and that FDA "will not ordinarily delay the issuance of a warning letter" to review a 483 that comes in after 15 days. Warning letters are expected to note the contents of responses to 483s that arrive within 15 days, but responses that are late will not "routinely" be covered in a warning letter.

FDA also indicates that it has no interest in responses to 483s that are strung out over time. The FR notice states that the agency has in the past delayed issuing warning letters "while these responses are reviewed and addressed," but the agency is said to be of the view that "timely issuance of a warning letter should help to achieve prompt voluntary compliance."

Docs snared for unapproved botox

The convergence of vanity and money has always produced otherworldly outcomes and a recent prosecution by the Department of Justice has yielded guilty pleas by five physicians, an administrator and a supervisory nurse for their use of an unapproved version of botulinum toxin.

According to an Aug. 11 statement, the Plastic Surgery Group (Albany, New York) "misled about 150 patients who believed they were being treated with FDA-approved Botox" but instead received Tri-Toxin, made by Toxin Research International (TRI; Tucson, Arizona). TRI was shut down several years ago and its principals were sentenced to jail terms in January 2006 for selling the knock-off Botox product to hundreds of doctors.

DoJ states that the surgical practice had the Tri-Toxin on hand in February 2004 when the decision was made to substitute the product for Botox despite continually promoting the cosmetic surgical procedure as involving the use of Botox. The illicit substitution is said to have continued only through the end of the year, but the statement does not indicate how DoJ and FDA's Office of Criminal Investigations uncovered the fraud.

Mark McCarty, 703-268-5690;