JANUARY WAS A WILD MONTH FOR COMPANIES OFFERING automated cytology products. January opened with new CPT codes for automated cytology procedures taking effect. January closed with news that the FDA’s advisory panel, convened on January 28, recommended approval of the PMA supplement of NeoPath, Inc.’s automated cytology instrument for primary screening of Pap smears.
Do not underestimate the impact of both events. Manufacturers of automated pathology systems invested long hours and much money in making the case for new CPT codes to cover their automated Pap smear procedures. Now that these procedures have an “official blessing” in the CPT code book, these same companies will press managed care plans to establish appropriate reimbursement for the new codes.
If “adding cost” to the system is a criticism of this new technology, then widespread agreement by payers to reimburse for the new procedures would surely knock the legs out from under that argument. Our editor predicts that such widespread reimbursement is coming sooner than later. After hearing his reasons for that prediction, I would agree. We may even see the overall reimbursement for Pap smears change from inadequate to possibly even generous! If that happens, remember that you read it here first.
But improved reimbursement for Pap smears cannot be evaluated without considering the impact of the FDA’s expected approval of NeoPath’s system for primary screening of Pap smears. With Neuromedical’s system also in use for adjunct screening, and with clinical trials beginning for the systems developed by AutoCyte and MorphoMetrix Technology, the volume of clinical data documenting the efficacy of these technologies will become voluminous. Keep in mind that similar developments are under way overseas. In many foreign countries, these same cytology systems are being used for primary screening.
I believe this steadily increasing volume of clinical data will validate whatever economic and clinical benefits accrue from the current generation of technology. But here’s the wild card: today’s generation of technology will be rapidly eclipsed by continual refinements and radical breakthroughs in new technology for automating Pap smear diagnostics. Remember Peter Drucker’s observation about change. He pointed out that there is always a point where the primary research breakthrough triggers a geometric explosion of new discoveries and applications. I think we are about to see precisely this occur during the next 18 months, first to cytology, then to anatomic pathology. If it turns out to be true, then we’d all better hang on. It’s going to be a wild ride!