This is Module 3.1.2, Medical Device Failure. I'm Steve Parente, and let's get into it. So in the beginning lecture, we talked about medical devices, and what regulatory components you had to do to get them to the market, we talk a little bit about pacemakers. It's good to talk about what doesn't necessarily work, and failure is a major issue for the medical device market. So we can talk about what worked and what really did not work at all. So we have one technology that's described here, a new technology, balloon dilation of sinuses. This society, the medical society that actually liked this idea, basically helped it get a new code, this is frequently the case for radiology, or anaesthesiology works with government agencies to get reimbursement code. It's a good study, it was an effective alternative to surgery, and it moves on. Another new technology, negative pressure for wound therapy, found that there wasn't really an easy way to get an existing procedure code to reimburse it. There wasn't sufficient clinical evidence, even more so than that there was a political environment with the participant as well. And so that technology did not go to market. So when we look at this balloon dilation of sinuses, this balloon dilation result is a less invasive option. And you can imagine what this is. You're basically dragging sort of a balloon angioplasty thread through your artery and then through your sinuses. And the thought is that this could treat folks who have, for lack of a better term, chronic allergies. Compared to surgery that removes bone and tissue, this is actually really helpful for me. Reimbursement issues are, what are the codes that are going to be relevant, what are the coverage considerations, where it will be don,e and how much has to be paid? So if we look at what the insurance coverage policy will be for this, there actually is a common code for this. Its catheter-based inflatable balloon therapy, is considered investigative as a stand-alone procedure for the treatment of chronic sinusitis due to the lack of clinical evidence demonstrating its impact on improved health outcomes. So there are procedure codes for it, but because it is investigative, it doesn't necessarily mean that the insurance company might want to go all in and cover it. So there was another technology here, negative pressure wound therapy. I mentioned this one earlier, the manufacturer of chronic wound healing system for ambulatory use, uses negative pressure, or really a vacuum to remove fluid from the wound bed to help wounds heal. Consists of a portable electric suction pump and a dressing set used in conjunction with pump. Question here is, what is going to be the reimbursement code there, and what population is this designed for this to work for? Is it for diabetic folks with foot ulcers? There could probably be a slot of the population this might work for, but the question is what's the real need? So the Medicare decision on this product is that the negative pressure wound therapy basically didn't fund it because portable didn't really work very well. Medicare changed the procedure code, and added a miscellaneous code without this corresponding fee schedule, believing that they're not really going to put out for payment. Then Medicare contractors, they're looking for any consistent guidance on the code, that is, the local contractors for Medicare that might otherwise weigh in on what they would pay for it, and then the company eventually shut down and sold to another manufacturer. So lessons learned about these products is that they each have their own reimbursement challenges. They are often unaware of what their reimbursement barriers might be. If you're trying to get paid for medical procedures, it's complex, changes frequently. You need to worry about what policy updates are going to be there as well as the Medicare fee schedule, if that's another market for you as well. Healthcare reform presents new reimbursement opportunities but it also provides a lot of challenges as well, particularly as institutions have to take on more financial risk to pay for these technologies. So, points to take away from this. What do payers, that is, public and private insurance, say about coverage? Are the clinical and cost-effective evidence critical? Critical in the sense that it actually being critically done well, so you know it's actually going to work. How's it going to be paid? What's the procedure code or code combination that's required? Is there a payment advantage or disadvantage to providers? Sometimes hospitals can pay a lot more than physicians, and that could be an advantage if physician'sfilling hospital codes. What are the best sites of care for pricing, marketing strategy, whether it be hospital outpatient, ASC, physician, nursing home, or otherwise ASC ambulatory surgery centers. This concludes this module on looking at medical device failure and opportunities.
