Skip to main content

2010 Potpourri XXXVI

By October 2, 2010Commentary

Advamed, a trade association for medical device companies, has released a paper on the results of the current FDA 510(k) device approval process, finding that there have been few safety problems.  The consultant doing the review looked at Class I (very serious) recalls over a five year period and compared the number for devices approved through the 510(k) pathway versus pre-market approval.  In each category, the number of recalls is small, .16% for 510(k) cleared devices, versus .85% for pre-market approval ones.  The analysis may be misleading for several reasons, the primary one of which is that PMA devices are higher risk to begin with.  A truly apples-to-apples comparison would need to risk adjust the comparison.   (AdvaMed Paper)

The Agency for HealthCare Research and Quality has published an updated list and review of various genetic tests for non-cancer conditions.  Given all the regulatory concern about how these tests, especially when marketed to consumers, should be handled, this report gives useful background on what areas tests are being developed for and the growth in the number of tests.   (AHRQ Test Summary)

The Food and Drug Administration and the Centers for Medicare and Medicaid Services confirmed their intention to work together to facilitate a more seamless regulatory process for review and reimbursement of new technologies.  The agencies are looking at a parallel review process that would meet the FDA’s needs for safety and efficacy data and the requirements of CMS’ National Coverage Determination process.  If the agencies are successful,he parallel review would be helpful, particularly for smaller companies.   (FDA/CMS Proposal)

The Commonwealth Foundation has issued a brief on the creation of all-payer databases by various states.  Much health services research relies on Medicare databases, which are limited not only to the population covered but also don’t have full information on that population as many of the beneficiaries are covered by Medicare Supplement policies.  The states’ databases will be broad-based and if the states can agree on common data elements and formats, a quasi-national database could be created which would help more precisely identify trends and cause and effect.   (Commonwealth Brief)

A major opportunity for quality improvement and cost savings is better adherence by patients to medication regimens.  An article describes efforts being undertaken by a commercial payer to promote compliance, including the use of financial incentives.  A daily lottery with a prize for those who had been compliant had good results.  The daily engagement appeared to be as important as the size of the prize.   (Drug Compliance Research)

One clear trend in recent years has been increased acquisition of physician practices or hiring of doctors by hospitals.  An article in the Idaho Statesman explores this trend, finding that some systems in Idaho have doubled the number of doctors they employ in the last couple of years.  Physicians are seeking to lessen reimbursement and administrative hassle and looming expenses like that to acquire and implement an EHR.  The overall effects on quality are unclear and we suspect this trend will not help lower costs.   (Physican/Hospital Article)

Leave a comment