BLOG: Guidelines for point-of-care tests: What dry eye docs need
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As I amble across the dry eye disease landscape, I come across all manner of things that are just not quite ready for prime time.
Some of them look very cool. The kind of stuff you wish you’d invented because it will answer some question or solve some puzzle that you face every day in the clinic or the operating room. Think Malyugin ring (MicroSurgical Technology) when it was in phase 2 trials. There are all kinds of stuff out there that might be the new “new thing in DED.” At the moment, what interests me are a couple of point-of-care (POC) tests for diagnosing and monitoring DED.
One of the challenges faced by many of the innovators in any field, but especially in health care, is a lack of understanding of how your ingenious widget is actually going to be used when it is released into the wild. What makes total sense on the drawing board or when strategizing in the board room all too often comes a cropper when it is put into actual use. Boris Malyugin is an accomplished cataract surgeon; no one had to tell him what was needed during cataract surgery complicated by intraoperative floppy iris syndrome. Sadly, many inventors fall prey to the aerospace engineer paradox: Fighter jets just never seem to work as well when they’ve been designed by engineers who’ve never chatted with the pilots who will fly their drawings.
In the spirit of seeking the best for both ourselves and our patients, let me offer some very basic suggestions about what new POC tests will need to be successful. It goes without saying that the performance of the tests should be simple and intuitive, and minimal training should make every technician an expert. They should be quick, delivering results in a manner of seconds to a couple of minutes at most. I like InflammaDry (Quidel), but it is a pain in the tookus waiting for it to develop. The results should be quantitative. They should be able to denote directionality, giving clear signals of either improvement or worsening over time in a single test. Tear osmolarity can do this but only over multiple visits.
Lastly, incorporating these tests into the daily running of the clinic needs to make business sense. You simply can’t ask a practice or institution to lose money on your test or procedure. What I am paid to do a test should be no less than twice what I paid for it; even with that, all I will do is break even when you factor in overhead like staff, rent, etc. POC tests for office use should have their own unique billing code. Utilizing a generic testing code guarantees that practices will lose money. Once you, the genius developer and fledgling entrepreneur, obtain that code, it is up to you to fight with Medicare and the commercial insurance companies to secure adequate payment.
These items are the table stakes, the ante, just to get in the game. It can be a long and hard road. You get one chance to enter the game, to make your first impression. This is now a mature market space; there is no allowance to remake the mistakes of your predecessors.
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