The panel discusses the Medicare 30-day tried and failed policy.
Peter L. Salgo, MD: Since we’ve been talking about Medicare, and I’m not beating up on Medicare because when I heard what they were doing for readmission rates, there is a logic to it, which is don’t ignore this or we’re going to penalize you for it. What is the policy here? There’s something called the 30-day tried and failed policy. What is that?
Michael T. Kazamias, MS, DPM: I alluded to it earlier. What they try to do is they take a global definition of a chronic wound and they apply that toward an economic model of being able to approve subsequent treatment or appropriate treatment following a certain period. What they’re saying is that we have to establish that this is indeed a chronic wound. That takes 30 days to be able to do that.
Peter L. Salgo, MD: During which time….
Michael T. Kazamias, MS, DPM: They’re paying to establish, as I mentioned earlier, the chronicity of the wound. Once that wound is now defined as being chronic, in a statistically significant number of patients, it could have been a stage II that is now a stage III. OK? Meaning sometimes chronicity has to be established or documented at the time of encounter and not very many times historically.
Peter L. Salgo, MD: Are you implying that to get paid, you’ve got to see this thing get worse, and it might have not gotten got worse had you paid earlier?
Michael T. Kazamias, MS, DPM: I wouldn’t put it that way.
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: The wound is not getting better.
Michael T. Kazamias, MS, DPM: Not getting better over a period of time. That would be a more accurate description.
Peter L. Salgo, MD: So it’s established, if I’m reading you right, an incentive to watch this wound not get better, click past that 30-day point, and then intervene?
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: There’s a second stage to this. A lot of these advanced products have been studied after the wound has been open for 4 weeks. Very often, CMS will look at the data and look at the randomized controlled trial and say, well, these patients didn’t get the benefit of this therapy for 30 days, therefore that’s the protocol that we’re going to use.
Peter L. Salgo, MD: Let me turn this on its head. Wouldn’t it be better if CMS so constructed their protocol that we dive in early with full guns blazing, get this thing under control, we’re not going to wait for 30 days, we’ll spend a little money up front to prevent the chronicity occurring at the 30-day point.
Michael T. Kazamias, MS, DPM: I would say not in Medicare classic fee-for-service because it’s a la carte, and that opens up a whole subset of other possibilities as to when the appropriate time is. However, it can be managed well in a managed care environment, establish a risk-bearing entity where the providers have the latitude to be able to implement these protocols and procedures whenever they want at their cost. Their primary responsibility to the payer group and to the patient is a healed patient at the end of a period of time.
Peter L. Salgo, MD: If I’m a patient, here’s what I don’t want to hear. I don’t want to hear, “We’ve got some great therapies that really do show promise, but I can’t use them until you get sicker or you’re not getting better.” I don’t want that.
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: There is another side to the coin though. There are patients who will respond to standard care. We did a study a couple of years ago looking at diabetic patients. We found that patients for which the area reduction of their wound didn’t get 50% smaller in the first 4 weeks were very unlikely to heal by week 12. However, if we looked at 2 weeks, we could make a decision at 2 weeks as to whether they would reach that threshold. There are validated markers that will guide the clinician to say, well, it’s been 2 weeks, the patient is getting worse, we need to intervene and do something.
Michael T. Kazamias, MS, DPM: You would agree there’s a statistically significant number of patients where we can determine how well or how effective the treatment is going to be within the first 2 weeks.
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: We can.
Peter L. Salgo, MD: The Medicare 30-day policy, maybe we make it shorter?
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: Maybe we don’t have it at all and we leave it to the clinician to make that decision.
Peter L. Salgo, MD: Now, there’s a concept for you. You like that?
Michael T. Kazamias, MS, DPM: I like it.
Peter L. Salgo, MD: You like that?
Samuel D. Young, MD, MBA, CPE, CHCQM: Maybe we don’t focus on the fact that this is a chronic wound, right? Maybe we focus on the condition that underlies the wound, like a diabetic-related wound, or a pressure-induced injury, or a vascular disease-related wound, rather than determining whether it’s an acute diabetic-related wound or a chronic diabetic-related wound.
Peter L. Salgo, MD: Got it.
Michael T. Kazamias, MS, DPM: That’s absolutely true. You bring up an excellent point. One of the pitfalls is when the companies look at this, they take a forest and then drill down to the tree approach. If you look at the wound itself, the chronic wound, and then start establishing what is the appropriate chronic condition management program that we can implement for this patient and make sure everyone is on the same page by focusing on the tree, and then working up and see did anything fall apart.
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: It’s really very important because very often, I say more often than not, we look at chronicity as duration, 2 to 4 weeks, when in actuality we should be looking at it from a comorbidity standpoint.
Michael T. Kazamias, MS, DPM: Absolutely.
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: Why? because the biochemistry of a chronic wound will change literally as soon as you have a breach in the epithelium of a diabetic patient.
Peter L. Salgo, MD: If it were I, I all seeing, all knowing, looking at a diabetic patient or a peripheral vascular disease patient with a wound, I want to say I want to treat this. I don’t want to consider it chronic. My whole object is to not let it get chronic, not click over to 30 days, and now I can get the other treatments. I want to jump on it. If you say you’ve got data for 14 days, I’ll take 14 days. If you say maybe we don’t have any days at all, but let’s use the data we’ve got to jump on it as early and as aggressively as possible.
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: If they get worse after 1 week, then you have to intervene and do something else, and you cannot wait those 30 days.
Peter L. Salgo, MD: And this 30-day thing impacts your care plan, right?
Robert J. Snyder, DPM, MSc, CWSP, FFPM RCPS: No question.
Michael T. Kazamias, MS, DPM: This is where managed care companies can take a huge lead in this because as Dr Snyder mentioned earlier, you can effectively or de facto eliminate that 30-day period if you have the latitude to be able to institute appropriate treatment or what you believe is aggressive treatment.