Melanie Cole, MS (Host): The Centers for Medicare and Medicaid Services has finalized a landmark national policy to standardize and expand the collection and reporting of patient-reported outcome measures following total hip and knee arthroplasty. We have a Northwestern Medicine panel for you today on Better Edge, a Northwestern Medicine podcast for physicians.

I'm Melanie Cole. And joining me is Dr. David Manning, he's the Vice Chair and Professor of Orthopedic Surgery, and Dr. Caroline Thirukumaran, she's an Associate Professor of Orthopedic Surgery and Medical Social Sciences. Doctors, thank you so much for joining us today. I'm going to start with Dr. Thirukumaran. Could you summarize the PRO-PM measure and policy for us today?

Dr. Caroline Thirukumaran: Yeah, absolutely. Thank you for having me here. Well, the PRO-PM policy or also commonly known as the CMS mandate in our field was part of Medicare's larger program of improving quality for its patients. And the goal of this policy or the CMS mandate for total joints is in improving the pain and physical function of patients following these two surgeries, which are the total hip and knee replacement surgeries.

The policy is being implemented in a number of different stages. So, a two-year voluntary period just ended earlier this year, and the mandatory phase started in July this year where hospitals are expected to submit the pre and the post-surgical outcomes for patients undergoing these surgeries, and penalties are linked to these submissions. If a hospital does not meet the target of 50% of its patient-reported outcomes being reported, a hospital can stand to lose a substantial amount of money that it gets from Medicare. And this is the phase that we are currently in. Once these scores are collected, Medicare will then use these scores to compute the substantial clinical benefit and the improvement ratios for hospitals, and there are some metrics associated with that as well. And right now, it's just for inpatient surgeries, and this will now span out to outpatient and ASC surgeries in 2027, I want to say, yeah.

Dr. David Manning: Yeah. So, the inpatient-only reporting currently, at least for us, is only about 10% of patients. But that's really going to expand, because they've announced that they're going to include observation status patients, ASC or ambulatory surgery center patients, and that's coming in 2028, I believe. But that's going to include a very large volume of patients.

Dr. Caroline Thirukumaran: That's right.

Dr. David Manning: It seems, if I understand the policy correctly, the penalties early on will just be for rate of reporting, right? So, the goal is 50% of the patients have both a pre and a one-year postoperative patient-reported outcome score. And the penalty is not for true performance of the patients, but performance of the institution in their ability to report these outcomes.

Dr. Caroline Thirukumaran: That's correct. Yeah. Right now, it's pay for reporting and some preliminary numbers suggest that if a hospital gets about 100 million of Medicare revenue every year, if they fail to meet the 50% mark of reporting, their annual payment updates will get reduced by 25%, which can translate into a good million dollars per year for a hospital having a hundred million-dollar revenue from Medicare. And the important thing is it's just not revenue from orthopedic surgeries, but it's revenue across all specialties in the hospital that will kind of factor in into computing the penalty.

Dr. David Manning: So, what do you think of the 50% target? Is that too high, too low, right about where it should be?

Dr. Caroline Thirukumaran: Great question. I don't know. Fifty percent is a magic number. It's not totally clear where that number came up from. I'd love to hear your clinical experience in terms of how easy it would be to get-- I think what I understand is the pre is much easier, but the post is really hard to get.

Dr. David Manning: Yeah. So, our personal experience here at Northwestern over the last 10 years working on patient-reported outcomes, no matter what iteration of clinical workflow we've done, it's been pretty easy to collect the preoperative score. You have an invested patient at the time of surgery. But it's the follow up, it's the annual score. And then, you know, ideally, clinically, we'd like to follow these people longer than one year. I think there's probably value in that. But getting those later scores is quite a challenge. We've been historically in the rates of about 30% and, in the literature, other people publishing their experiences at similar sized and type institutions, those numbers have been about the same, about, you know, 30-ish percent at a year.

Dr. Caroline Thirukumaran: Yeah, you're correct. Just coming back from Marcus, I think that's been a struggle for a lot of hospitals now, getting their post rates and they're trying a number of different interventions or strategies to up those numbers. So, it's going to be pretty interesting to see really what happens once these penalties really get into place and what those numbers are going to look like.

Dr. David Manning: Yeah. And you know, when you take a minute and you step back and you think about it, you know, Northwestern is a highly integrated health system, with a highly integrated clinical staff and administration. And if we struggle to do it, places who are smaller, maybe don't have the same kind of resources, maybe don't have the same track record of being integrated. I think that they'll struggle even more.

Dr. Caroline Thirukumaran: Absolutely. You're absolutely correct in that aspect because, yeah, Northwestern's fairly well resourced, but there are several other safety net hospitals who care for disproportionate numbers of socially disadvantaged patients and how they are going to kind of get their resources together to implement such a system wide change is, you know, It's really an open question at this point. And when the penalties come and how it's going to set their financial margins back again, you know, the impact it's going to have for them are really important questions, even from the equity disparities perspective. You know, is it going to put them out of business? Can it really put them in the red? These are all great questions to think about.

Dr. David Manning: Yeah. I think for our audience listening, it's important to understand that the 50%, if I collect 50% of the patients preoperatively and I don't catch them at a year, I catch the 50% of people that didn't give me a patient-reported outcome at the time of surgery, I catch them at a year, my compliance is zero.

Dr. Caroline Thirukumaran: Absolutely.

Dr. David Manning: You have to have both data points for an individual patient for it to count.

Dr. Caroline Thirukumaran: Yeah, that's right. I think without the pre, there can be no post. And so, the focus right now that everyone's focusing on the pre, I know the concern is really to be able to also get the post-surgical patients back again.

Melanie Cole, MS: Dr. Manning, how have these measures supported the integration of these outcomes into clinical practice and patient care? Have you noticed any significant change in patient outcomes or satisfaction since the implementation?

Dr. David Manning: The short answer is no. It's a little nuanced. I think that, you know, CMS has had a history of asking either sites of care, institutions or physicians to report on things such as complications. And when we see perhaps we're not performing as well as we thought, that creates an environment where we do clinical work and quality work to try and improve outcomes. But patient-reported outcomes, their sense of satisfaction after an operation, when that operation is intended to provide pain relief and improve function, that's what the operation's already for.

When you look at PROs in research institutions like ours and others, we're already reporting when we do actually capture the data, numbers that meet or exceed CMS's targets for clinical improvement. And, you know, they've cited the two patient-reported outcome scores they're relying on principally are the knee and the hip osteoarthritis score, and an improvement of 22 points for a hip and 20 for a knee. Those are low marks. The operation already does that. So, seeing outcomes, patient-reported outcomes being reported, I don't know that there's going to be a Hawthorne effect of we see it, we measure it, we're going to make improvements like we did when we were looking at rates of complications.

Satisfaction is a different thing. So, when we've looked at presenting patients their presurgical, patient-reported outcome score and place it within the context of what their payers seeking joint replacement where they're at, and then setting expectations of where we'd like to see them at a year, and then scoring them and showing them one year later where they're at, again, within the construct of their payers, they're a lot more satisfied. They report satisfaction with the care, satisfaction with the goal, and it helps eliminate what I call the patient desire for, you know, "Hey, I expect a perfect knee." Nobody gets a hundred. You know, the very few patients have an absolute perfect knee or hip after surgery. There are some minor things here and there, and it helps set expectations. I think if you set expectations before an elective operation that's intended to help pain and function, and then you meet them, those patients are obviously satisfied.

Dr. Caroline Thirukumaran: Yeah, absolutely. And, you know, the HOOS and the KOOS junior, which are being calculated, those are time-tested measures. In addition to that, there are also additional risk factors that hospitals are supposed to submit, which they have traditionally not captured. Like, for example, their mental health scores or the pain in the contralateral joint and a couple of new and unique measures, their preoperative opioid use. So, it's about getting the system in place quite effectively, because if those measures do not get submitted as well, you know, being able to compute the RSIR or the risk standardized improvement rate is going to be hard.

Another important thing to talk about, you know, you mentioned the 20 and 22. That translates to, I think, about 60%, and that was a lot of people are curious in terms of where that magic 60% comes from. And I believe there's been quite a bit of discussion, and CMS is willing to relook that, but it seems to me from your mentions that that's quite achievable or not--

Dr. David Manning: Yeah. I would re-categorize that as a minimal expected improvement. When we looked at, you know, various populations where we were actively recruiting patients for PRO recruitment, we well exceeded those numbers. That's nice.

Melanie Cole, MS: Dr. Manning, what about the main benefits and drawbacks that have been observed since the introduction of these performance measures? And how do physicians, how are you all balancing the administrative burden with the potential benefits to patient care?

Dr. David Manning: Yeah. I think defining the potential benefit for patient care as shared decision-making presurgically, so long as their numbers are placed, like I said, within a construct of what their payers are, where their payers are preoperatively. And then, setting expectations of where we would hope them to be at a year. I think that is real patient benefit. There's a lot of barriers. It requires time from existing employees in order to spend time helping them collect the data. It requires new employees to administer the program in order to make sure that we are compliant and we are continuing to collect these patient-reported outcome scores, because as, you know, we intimated earlier, it's hard to get them at a year, and it takes physician time. I have a meeting, 6:15 in the morning once a week in order just to maintain compliance and confirm that we're actually doing this and we're doing it well and try to put some meaning behind it. So, it really does affect the workflow. We don't have a product for the patient that is ideal state yet where we can really share their information and make real meaningful benefit in their experience. But that's a process that's ongoing. Early on, I think we, as well as everybody else, is just worried about actually meeting the 50% mandate.

Dr. Caroline Thirukumaran: I'm just curious, how does PatientIQ, which is the firm that is contracted with implementing this, how do you all interface with the PatientIQ?

Dr. David Manning: Yeah. So, we and many others have contracted out to third party vendors to help us with accrual, collecting the information. And, you know, the patients receive an NM-branded inquiry within 90 days of their surgery, and then they receive reminder text messages or emails to complete them preoperatively. And, like I said before, it's very easy to collect the preoperative ones because patients are very invested. They've scheduled time off and they've garnered some energy to kind of go through this whole thing, but they receive follow up emails and text messages, NM-branded, for the various time points of interest for collecting PROs. And we've chosen not to just do one year, but to get them at six weeks, six months, and a year, because at least, if we're going to use this information, not just to satisfy CMS, we'd like to use it for following patients, both clinically and in the research realm. I think that answers your question.

Dr. Caroline Thirukumaran: Yeah. It just makes me wonder, you know, given that a large portion of patients undergoing these are older adults, are there any concerns about whether they're technology-savvy, are they going to be able to respond to text messages and other modes? Or is a paper-pen medium more suitable for them?

Dr. David Manning: Yeah. So, that's a double edged sword. I agree. So, you know, there's plenty of evidence in the PRO collection world that CMS as a payer is an independent risk factor for failure to fill out your patient-reported outcome measures. There's other evidence that seniors, irrespective of payer, have a lower rate of reporting their outcomes. Now, whether that's technology, disinterest, apathy one year after having an operation that achieved what they were hoping to achieve is really unclear, but there are a lot of barriers, and there certainly is good evidence to suggest that this is a population that is difficult to hit that 50% mark.

Dr. Caroline Thirukumaran: Yeah. There are definitely some challenges in this whole process. And, you know, while most of these are going out in English, I wonder how well we are geared for communicating with patients for whom English is not their primary language.

Dr. David Manning: Yeah. I have, you know, on any given day when I'm in clinic seeing patients, one in six may speak another language, right? And PROs are not currently available in all languages, and they're not all modified to suit the cultural differences for different cultures, and may not actually be identifying what we're trying to identify as an outcome. So, that is a barrier.

Melanie Cole, MS: Dr. Manning, do you have some ideas of how you would like to improve that particular, what you were both just discussing with disparities, maybe digital access or language barriers? Do you have some ideas on ways to improve that?

Dr. David Manning: Well, we're in the process of trying to get the PROs available in more languages. There are certain languages that certainly we come across more frequently than others and targeting those first will help capture more and more patients. I think Caroline's, you know, one of several people who are looking at PROs and trying to standardize them to different cultures, so that they are capturing, you know, the object of interest. Like I said, we have a meeting every week and part of expanding our access to patients is part of those meetings. For us, it includes, you know, sit down face to face, having a full-time employee spend time helping them or assisting them in filling out the PRO. That may or may not be psychometrically as sound as patients filling it out themselves, so maybe you can comment on that. But it's an ongoing effort.

Dr. Caroline Thirukumaran: That's a good point about whether patients are filling them up themselves or they need help from someone and whether that's going to bias what their responses are going to be. And those are all great questions and opportunities for us to grow and streamline our systems ahead.

Dr. David Manning: Yeah. I mean, I think, you know, over time we'll get better and better at collecting data, tackling the hurdles that are part of collecting data and expanding access to patient-reported outcomes to patients from lower levels of health literacy, different cultures, and different languages.

Melanie Cole, MS: Dr. Thirukumaran, looking ahead, how do you see the role of PRO measures evolving in orthopedic care? Are there any upcoming changes, improvements you anticipate? Kind of give us a summary and the key takeaways here.

Dr. Caroline Thirukumaran: Sure. Well, PROs are here to stay. I think this is Medicare's first step, one of the first few policies to really mandate the reporting of these PROs. What the future holds for this particular policy in my thoughts are that, you know, we'll definitely see some revisions with respect to the reporting rates. Is 50% a magic number or does it need to be different? Or the improvement, the clinical improvement of 60%, how can that be changed? So, those changes I do see happening within the policies or policy in the years to come.

But on a larger scale, beyond just total joints, I wonder if CMS is also using this as a testing ground and there potentially could be an expansion to other high priority surgeries. I know spinal fusions and laminectomies have been included in one of their other reforms, which is the team policy to come in 2026. So whether PROs are going to be extended to those groups of surgeries, these are all open questions. But I do believe that this is CMS's first major step in implementing PROs and integrating PROs within clinical care. And this is just expected to grow.

But of course, this needs to be viewed in light of this is a very well intentioned policy in most regards, but also one needs to consider the unintended consequences of these policies. Is it going to worsen the financial status of safety net hospitals, is it going to reduce barriers for socially disadvantaged patients? Who are the patients filling in the PROs and who are not at all? These are all important areas for us to learn and to improve upon, is there going to be patient selection? Because the improvement is what is key to this policy performance, how patients are going to be selected for surgery are again questions to think about and consider.

Dr. David Manning: Yeah, I think you're right. More than once, total joint arthroplasty has been the canary in the coal mine for what to expect from CMS going forward to other high volume, high cost to the U.S. healthcare expenditure procedures. It would be interesting and I kind of expected at some point that there would be a minimum PRO performance for your patients pre-surgically in order to have CMS approve that patient having an operation. I think that is inherently obvious that that will come.

What might be interesting, and you have to remember, the United States is a varied geography, right? So, we have high intensity, high population, high technology centers like Chicago. And we have some very rural settings. Patients in Chicago have choices. Patients in rural America have fewer of where they can receive their joint care. And what might be interesting if certain centers fail to make the 60% improvement in PRO performance for their patients, they may be excluded from this kind of care.

Dr. Caroline Thirukumaran: Yeah, absolutely. Those are all important thoughts to think about. The other part is also, right now it's hospitals, it's patients, whether this is going to be included into physician reimbursement through MIPS or through other alternative payments, you know, one has to see what happens in the future, which also makes me think given that private payers-- right now, we aren't even talking about private payers, but because private payers tend to adopt what CMS implements, you know, now what is really a CMS mandate for now, quite likely may get adopted by private payers. So, it's definitely going to include many more patients in the years to come than just the CMS primary electives.

Dr. David Manning: Yeah. We at Northwestern expect that. So, you know, as we roll out our PRO program for our patients, all patients undergoing arthroplasty are subject to our program. It's agnostic to age, payer status, or anything else, because I do expect that from other payers.

Melanie Cole, MS: What an eye-opening and enlightening discussion this was. Thank you both so much for joining us today. And to refer your patient or for more information, please visit our website at breakthroughsforphysicians.nm.org/orthopedics to get connected with one of our providers. And that wraps up this episode of Better Edge, a Northwestern Medicine podcast for Physicians. I'm Melanie Cole. Thanks so much for joining us today.