Originally Published MX May/June 2006
EDITOR'S PAGE
The Costs of Vigilance
For companies in the business of developing cardiac rhythm management (CRM) devices—and for observers who have been watching the sector's troubles over the past year—March and April were eventful months.
First, in the middle of March, industry association AdvaMed released a proposed format for CRM manufacturers to follow when issuing performance reports about their products. Toward the end of April, a Canadian study published in the Journal of the American Medical Association suggested that the surgical risks of replacing an implantable cardioverter-defibrillator (ICD) are greater than those of leaving a possibly flawed device in place. Additionally, an AdvaMed analysis of FDA data revealed that reliability rates for ICDs improved significantly from 2001 to 2005. And finally, the Heart Rhythm Society (HRS) released the draft recommendations of its task force on postmarket surveillance, analysis, and performance reporting for CRM devices.
CRM manufacturers have been quick to declare their accord with the recommendations of the HRS report, particularly those aspects that advocate companies' increased use of independent third-party medical advisers.
In spite of such support, however, the HRS report is seriously out of sync with industry in one respect. The report repeatedly recommends that physicians be paid for their part in improving CRM performance reporting and that Congress authorize funding necessary to carry out its recommendations. But it is stone silent about the additional costs that manufacturers will incur. Meanwhile, the Centers for Medicare and Medicaid Services has proposed changes in the inpatient prospective payment system that would reduce payment for pacemakers by an estimated 13%, and for ICDs and cardiac resynchronization therapy–defibrillators by as much as 24%.
After all that has occurred over the past year, no one in the medtech manufacturing community would seriously propose that postmarket reporting activities should be shortchanged. In the interests of patient safety, government policy should not impose cutbacks that might pressure companies to think otherwise.
Copyright ©2006 MX
