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The use oflasers in urology has dramatically escalated over the past year as urologists learn that this approach allows prostate surgery on an outpatient basis, saving valuable time for the surgeon and reducing costs to the healthcare system. With over 400,000 BPH cases treated each year, laser technology is being assimilated into a high volume market that is already having a positive financial impact on the suppliers. However, competition from entrenched electrosurgery manufacturers is intense, and conservative elements in the urology medical community have attempted to block adoption ofthis innovative technology. We will discuss the various laser products available for BPH treatment, as well as the research and regulatory status of each system. In mid 1993 the FDA implemented stringent rules that put more teeth in earlier warnings. Specifically, the agency ruled that all laser devices intended for the treatment ofBPH must go through a lengthy Pre-Market Approval (PMA) process. Given the current rate ofPMA reviews, marketing clearance for this indication could take several years —iftheAdvisory Panel finally decides that lasers are safe and clinically effective. CR. Bard was the first company to file a PMA application (June 1993) for treatment ofBPH with the Urolase fiber. Data was collected from six investigational sites, with a one-year followup study. The FDA distributed formal guidelines for clinical investigations of BPH fibers earlier this year, but it is not clear how many suppliers of laser fibers have obtained IDE's and implemented scientific studies. Faced with the uncertainties and costs of this regulatory path, some companies may simply decide to do nothing. Additional enforcement actions by the FDA are focused on halting the liberal sale of fibers under general urology 510(k) clearances that nearly all companies have obtained [See ML!, April 1993). Reportedly, the agency is in the process of notifying manufacturers regarding specific limits on the use ofthese products. Until now, several companies have been actively selling fibers and tramingurologists touse these devices inprostatectomy procedures. By avoiding anylabeling referring to BPH, fibers are sold in a "grey market" that caters to users who abhor government control ofmedical practice. Ironically, this grey market represents the largest single market for surgical laser products at this time. As ifthe regulatory repression ofprostatectomy fibers wasn't bad enough, various regional Medicare carriers have been denying reimbursement for laser procedures. Most recently, Blue Cross of Northern California decided not to pay claims for laser procedures until FDA marketing clearance comes through. A survey oflaser users throughout the country reveals a great deal of confusion and fears. While hospitals are financially motivated to increase utilization of installed surgical lasers, many urologists are afraid that insurers may deny reimbursement oftheir professional fees —or even demand return of payment already made. In the final analysis, it remains to be seen whether urologists will still be interested in laser technology if and when it becomes approved. Given the certainty of broad Medicare cutbacks, and the uncertainty of reimbursement levels for the laser procedure, the economic factors that currently drive physician interest laser treatment of BPH [See MLI, June 1993] may not apply in the future. Moreover, the negative signals provided by ongoing patent litigation, financial instability, and our industry's history only serve to make laser use less appealing. Currently, all of our hopes regarding the potential market for laser BPH products seem to center on C.R. Bard. If this company emerges from the PMA process before the window of opportunity closes and rekindles the interest of urologists, then they deserve much credit for salvaging this market for the medical laser industry.
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