Lee Fleisher Official Transcript

Intro/Outro – 00:00:02:

Welcome to Frame by Frame: Rethink Imaging, a podcast by Imalogix. Here, we explore the intricate world of medical imaging, aiming to dissect the field and inspire both professionals and curious minds alike. I’m your host, Chris St. John.

Chris St John – 00:00:20:

Today on Frame by Frame: Rethink Imaging, we are honored to welcome Dr. Lee Fleisher, a distinguished leader and national expert in healthcare policy and patient outcomes. With an extensive career spanning three decades, Dr. Fleisher has been instrumental in shaping the landscape of radiology through his roles as the former chief medical officer and director of the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services, or CMS. In these positions, he was responsible for establishing national clinical standards, driving innovative healthcare solutions, and enhancing quality and safety protocols for healthcare providers across the nation. Currently, Dr. Fleisher is the principal and founder of Rubrum Advising, where he leverages his vast experience to guide organizations in the adoption and reimbursement of innovative healthcare solutions. He also holds a professorship at the University of Penn School of Medicine, where he is dedicated to educating the next generation of healthcare leaders in value and quality. With his deep expertise in medicine and commitment to improving patient care, Dr. Fleisher will share his insights on simplifying complex topics, enhancing patient safety, and showcasing the latest innovations in the field. Join us as we explore the critical role that Dr. Fleisher played in transforming healthcare outcomes. Welcome, Dr. Fleisher.

Dr Lee Fleisher – 00:01:38:

Chris, thank you. It’s a pleasure to be here today.

Chris St John – 00:01:41:

It’s really great to have you here today. Just to start off, I’d love to learn a little bit more about you. Can you tell me a bit about your career journey and what led you to work in healthcare?

Dr Lee Fleisher – 00:01:51:

I’ve wanted to be in healthcare since I think I was five. I still remember doing projects in the third grade around medicine and the musculoskeletal system and really desired at the age of 15, started going down to Thomas Jefferson and doing research in one of the labs there with what became a very dear friend, Ralph Hymer, and continued to do research then at Wistar Institute, which is on the campus of the University of Pennsylvania, doing research throughout undergrad, medical school, and then eventually becoming a physician. What was interesting is I initially thought I was going to be a surgeon. I was going to be a transplant surgeon because I had done a lot of work on immunology and actually had… Research in various places throughout the country as part of medical school to test out places. Started in surgery at the University of Minnesota. Realized I was an East Coast person and operating was not the stuff I loved, but I love taking care of surgical patients. So I became an anesthesiologist.

Chris St John – 00:02:59:

Very cool. Honestly, transplant is honestly something very close to me. I have multiple family members get heart transplants at Penn. It’s just fun to always hear about transplant here or there.

Dr Lee Fleisher – 00:03:09:

Well, it’s kind of interesting because when I was at CMS, I was the executive sponsor of the Transplant Affinity Group with HRSA, another entity within the Department of Health and Human Services. So I continued to work in that space. So that’s great. So my research, when I became an anesthesiologist, sort of pivoted and I did research on the cardiac patient undergoing non-cardiac surgery and how best to ensure through diagnostic imaging and development of evidence-based medicine, how to take care of these complex patients. That led me to be very involved in guideline committees for the American Heart and the American College of Cardiology, which eventually, because of some research I had done and work at Johns Hopkins, where I moved after starting and doing a residency at Yale, which we can come back to because it’s actually I moved to get married to a person from Baltimore and that has some significance to the name Rubrum. But while I was doing that, when CMS started to go into value-based care, they asked me to be involved in some of the first measures which were created 20 years ago.

Chris St John – 00:04:24:

Talking about CMS, right? You are the former CMS chief medical officer and director of the Center for Clinical Standards and Quality, right? So what are you most proud of during your time in that role?

Dr Lee Fleisher – 00:04:38:

It was a really unique experience. I had been chairman of anesthesiology at Penn. And as radiologists know, we are one of the groups, radiologists, anesthesiologists, pathologists, who are really the hospital-based physicians. I was there. I stood up my department, which included a large critical care component, to respond to COVID. And I got called by the administrator of CMS. Several people had nominated me for that position. It reported directly to the administrator, who was confirmed by the Senate. And it oversaw all quality health and safety standards and coverage standards for CMS, which essentially meant every hospital and about 160 million individuals’ quality and safety was my job description. So I enter on July 6, 2020, middle of COVID, driving up and down. It only took me two and a half hours to get, three hours to get to Washington because there was no cars on the road because the country was shut down. I thought I would be stopped, but I had my badge. And I’m proud of how I helped respond to the nursing home crisis because that was job number one. In fact, for health care providers, up to right there is the Federal Register that was the vaccine mandate for all health care workers. And my team and I oversaw that. I was one of the people who briefed that up to the White House to make a decision that it shouldn’t just be nursing homes, but all of health care. That stuck. It went through the Supreme Court, and I think it saved countless numbers of lives, both in nursing homes and hospitals. I’m proud of some of the coverage decisions I made. The most famous or infamous is a decision regarding the coverage of monoclonal antibodies for Alzheimer’s disease. Another one was colorectal cancer, mitral clip. I’m also proud of the fact that not only did we advance quality measurement during my tenure, but in collaboration with Michelle Schreiber and what’s called the QMVIC team, which oversees the quality measurement infrastructure for CMS, we created the National Quality Strategy, which we rolled out and really advanced many of the novel use or advanced MIPS Value Pathways and advanced electronic Quality measures. So there are a number of places. And again, it really was a team’s work, but very proud of the three years I left when the public health emergency was over, returning back to Philadelphia. I still give anesthesia at Penn on many Fridays a month, but really was proud of what the team did during the COVID-19 public health emergency.

Chris St John – 00:07:38:

Yeah, absolutely. I just love thinking about you going into Penn on Fridays to administer anesthesia. That sounds like a great way to almost start the weekend.

Dr Lee Fleisher – 00:07:46:

You know, last weekend I ran into the interim chair of radiology talking about radiology and, you know, he and I used to co-chair the credentials committee. But it’s just such a, even during the pandemic, when there were questions about who should govern the survey of hospitals, what infection controls, and it was, should it be OSHA regulations? Should it be CDC guidances? And I still remember having calls with the White House and the two teams, and I could literally say, when I go to the hospital tomorrow, this is what’s going to happen if there’s conflicts. So for all of those who still practice, it’s so grounding to take care of individual patients, even if for a time I was responsible for 160 million.

Chris St John – 00:08:38:

I love that. And so to talk a little bit about CMS, can you just tell me a little bit more about like CMS’s overall mission in health care and how the clinical quality measures fit into that vision?

Dr Lee Fleisher – 00:08:52:

I always talked about the fact that CMS is a payer, but because it’s a payer for over 60 million Medicare beneficiaries and jointly with the states for Medicaid. So and then through the marketplace, some of the rules it governs. And since every hospital takes money from Medicare, it can actually deploy Quality measures. Congress gave CMS the authority and minimum standards. So those minimums. Minimum standards are really what’s called the conditions of participation. Many people are surveyed by the The Joint Commission or the states or DNV, which is another accrediting organization. But that’s saying every hospital has to meet a minimum standard of safety where they shouldn’t be open. And spent a lot of time in that space making sure. And in fact, when hospitals couldn’t meet that, and we did have few and nursing homes, we had even more, they would be briefed up to me. I would make a decision. I would brief the administrator and she, since I had two female administrators during my tenure, two administrations, I was a career official. And they wanted somebody who was not political to say, this is really the decision of minimum standards. Now, how do we tell the public and how do we drive care above that minimum? Because if you go into a hospital, if you’re going to a provider, you don’t want the base. You want to know you’re up here. And that’s quality measurement. And payment programs, which is in the Innovation Center, but trying to say that the higher the quality as measured by these measurement and they are publicly reported, the better you can do by going to that provider type. And doctors and hospitals like to get A’s. So although there’s payment attached to it. So in many of the programs, if you don’t report, you lose your cost of living or your update and your annual update. In some of the programs, they take the top amount of money, the top 25% and the bottom 25%. And they take money away from the bottom and they give it to the top. So if you’re in the middle, it’s neutral to how much you would normally get paid. But if you are a poor performer, you’re going to lose to a high performer.

Chris St John – 00:11:17:

Yeah. And so can you walk me just through the process of how the measures get made and how policy is shaped?

Dr Lee Fleisher – 00:11:25:

So sometimes Congress says you will do this. This is what we want you to measure. So, for example, for hospitals, a lot of the things are actually mandated in statute and bills. You know, I always when I try to teach this, you know, you just start singing, I’m just a bill sitting up on Capitol Hill that most of us know that frequently it says the secretary shall create quality measures or it may say CMS should measure hospital-acquired infections. So many of the hospital measures are mandated in statute and are things we have to do like readmissions told by Congress. Sometimes Congress says you should create a certain number of measures in a program and CMS has really two options. One is that the health care ecosystem can create measures. That’s to say the American College of Radiologists, the American Society of Anesthesiologists. I’m an anesthesiologist. Obviously, it could be that. There might be a group at Minnesota that is a healthcare consortium. It could be a patient advocacy group. So that could be outside of CMS, and they could submit them to CMS and to what I’ll call the consensus-based entity. I’ll come back to that. Alternatively, in some cases, CMS may work with its partners, for example, the CDC for hospital-acquired infections, and together they create a quality measure. Once that measure is created, it has to be endorsed, and that’s a requirement from Congress in many of the programs. And that goes to what was the National Quality Forum, where you said, you know, my previous to coming to CMS, I was the chairman of the Consensus Standard Approval Committee and eventually treasurer of that organization. It’s now done by… By Battelle’s Partnership for Quality, but they must endorse it. They have external experts who come in, who evaluate it, both for its scientific validity, as well as its clinical relevancy. They have to be shown that they can drive improvement besides that validity. Once they endorse it, it goes to a partnership, a public-private partnership at one of those two organizations, depending on what time it was. They get endorsed for inclusion in a program, whether that’s the hospital quality programs or what’s called MIPS or MACRA or MIPS Value Pathways, whether it’s for the physician side of the shop, physician side of the ecosystem. Then CMS, through rule-making, which we can get to, can put them into a program. It’s a long process. It’s about two to four years.

Chris St John – 00:14:35:

Yeah. And so I just have to ask, I’m curious, what is the involvement of Congress outside of the initial engagement? Do they play a role further down the road at all or not really?

Dr Lee Fleisher – 00:14:47:

The answer is they set up in statute what CMS must do and can do, and then they give the money, of course, and fund certain things. Then it really is the agencies working with these public-private partnerships, which Congress required. Now, importantly, when a new measure is proposed to be put into either the hospital programs or the physician payment programs, that has to be done through what’s called rule writing. So there’s something called the inpatient prospective payment system. There’s the physician fee schedule. It goes out and there is a proposed rule, this Congress also established. Anybody gets to comment. So CMS gets comment letters from Congress. It gets comment letters from societies, ACR and other societies. It gets comment letters from individuals saying, yes, this is good. No, this is bad. You should change it. You shouldn’t include it. Some measures, they say, need more testing. And then CMS finalizes what they’re going to do after taking into consideration all of the comments received, as I say, Congress, stakeholders, societies, clinicians.

Chris St John – 00:16:10:

Yeah. And so I’ve actually, I’ve read some clinical Quality measures and I’ve noticed. The comments about comments, right? There are certain comments literally written into these regulations, correct?

Dr Lee Fleisher – 00:16:21:

They have to be. In fact, the Supreme Court recently, there was a rule, this is getting a little into the weeds, called Loper Bright, in which Chevron was overturned. And it really said that this and a number of recent decisions said the agencies must really respond to the comments, that if you don’t take them into consideration, they can be struck down a program.

Chris St John – 00:16:46:

And so can you explain the approach to ensure that the measures being developed genuinely improve care across different types of facilities?

Dr Lee Fleisher – 00:16:58:

What CMS did a number of years ago and before I got there, they’ve had meaningful measures for years. So first of all, they say what they think are the important measures. And that Quimvig group within CMS that I mentioned is the group, the quality measure and value group. That’s one place. Those consensus-based entities look at that. So every three years, a measure must be re-endorsed in order to be used. CMS is not going to use measures that aren’t endorsed unless there’s really strong reasons that it needs to be. But normally, it will listen to the consensus-based entity. So when those measures come up three years later. If there’s not good evidence that it’s improving quality, they may not be re-endorsed and they may not be kept within a program. So, you know, baseline and then continuous evaluation.

Chris St John – 00:17:54:

I like the continuous evaluation approach. It feels, maybe it feels obvious, but it makes a lot of sense to me, right? Like trial and error to some degree.

Dr Lee Fleisher – 00:18:02:

Quality and improvement. It’s what CMS is, you know, CCSQ, which is what we call it, Center for Clinical Standards and Quality. We’re all about quality improvement.

Chris St John – 00:18:11:

Yeah, absolutely. I also just have to say, right, coming from this side of healthcare providers or, you know, I’m coming at it from the vendor side, but I think so often these measures could be interpreted as red tape or this or that. But coming from the perspective where so many of my friends and close chosen family have Medicaid, have Medicare, to me, it’s really powerful and a really wonderful thing to be implementing these measures to try and maximize the care for the population using these services.

Dr Lee Fleisher – 00:18:40:

Yes. And I’ll say in the measures they’ve seen, and it was interesting during the pandemic, if you look at how hospital-acquired infections, for example, they dramatically decreased up until the pandemic. Now, during the pandemic, they got a lot worse. But post-pandemic, we’re already seeing marked improvements back to baseline or even better in some facilities. So having that transparency, if you know what your rate is and how you compare it to your colleagues, that’s important. Now, that being said, sometimes we have too many measures. Sometimes we are measuring things in not the right way. And that’s what that quality improvement, that re-endorsement, that rethinking that CMS Congress needs to do, but really needing the public, I strongly urge. All of the providers that listen to this podcast. There’s a paper in JAMA Health Forum. If you Google myself, it’s open source. It tells you the process and how important is the comment. And there’s an email and you just send in your comment. And I can assure you there was over 9,000 comments about the Alzheimer drug decision. Everyone gets read. And the important themes get briefed all the way up to my position and sometimes even the administrator.

Chris St John – 00:20:06:

Yeah. You mentioned briefly a second ago, seeing how other enterprises are performing. I’m curious with the introduction of new measures in the window of time where there hasn’t been feedback and enterprises don’t know how they’re performing yet, what would you recommend for strategizing in terms of approaching these as at the beginning of their implementation?

Dr Lee Fleisher – 00:20:30:

So CMS, already says they’re not going to pay. They don’t put any program into payment until they’re tested in real life. So there are many measures that are tested. One, and sometimes CMS decides two years so that the ecosystem that the providers really get a chance to see, does it work? And CMS gets a chance to see, does it work? So during that period, the only penalty is if you don’t report, not if you report you’re a poor performer.

Chris St John – 00:21:00:

Okay. Moving towards value-based care has been a longstanding goal for CMS. What strategies are being employed to help these organizations overcome those initial hurdles?

Dr Lee Fleisher – 00:21:11:

So there’s a couple of things. CMS under Chiquita Brooks-LaSure, who’s the current administrator, this may be heard after the election and there may be a change in administrators, but currently the goal is for every individual who has Medicare to be in an accountable relationship, to have a primary doc, anesthesiologist, radiologist, we’re specialty oriented. So there’s a real move to get to ACOs and sort of more of a population health perspective. That being said.

Chris St John – 00:21:44:

Sorry, forgive my naivete. What are ACOs?

Dr Lee Fleisher – 00:21:47:

That’s great. Accountable Care Organizations. So many places, and you may not even know that your physician is part of an accountable care, but essentially they look at, are you performing well? And you take either only upside risk at the beginning or up and downside risk if the cost of care for a person who looks like you is more or less expensive than would be predicted, and you could lose money or gain money while you perform. And the goal is, the way to think about it is CMS wants to make sure that as we drive people to lower total costs in care, we do that and ensure quality is the same. That’s why Quality measures are so important. Or we have the same cost in care and we actually improve quality. And that’s the mission of the Center for Medicare and Medicaid Innovation, CMMI. And that’s the way they’re trying to get to value-based care. They’re trying to get people to either reduce total costs with the same quality or improve quality, which includes equity, for the same costs.

Chris St John – 00:22:55:

I know you’ve touched on this quite a bit already talking about the COVID pandemic, but having seen how these Quality measures affect real world clinical environments, are there moments that stand out where the outcomes made a significant difference or honestly the opposite of that, where the results just didn’t align with expectations?

Dr Lee Fleisher – 00:23:16:

We wrote a paper, we being Michelle Schreiber, myself, and two colleagues, Denise Icardo and Arjun Srinivasan at the CDC saying that quality had deteriorated during the early part of the pandemic. Now, I practiced then. We were petrified for our lives when we went into patients’ rooms before the vaccine. There are providers who got severely sick or some who died from getting COVID. And it was difficult to practice in those hospitals. So it’s not unexpected. But I think by calling it out and asking us to redouble our efforts to drive higher quality, that’s really important. One of the reasons that the quality measurements have gone from what’s called MIPS to MIPS Value Pathways in which radiologists are being evaluated on a set of measures themselves is that if you are part of a large group and you have one tax ID for that group, let’s just say you mentioned I’m at Penn, Penn Medicine, but it could be any of the centers, that you could put, just report the quality measures related to flu vaccine. How is that measuring me as an anesthesiologist if it’s flu vaccine or hypertension control? So what Michelle Schreiber and her team developed was MIPS Value Pathways, which is really a transition to get there by 2028, which is to be more specialty specific so that you’re actually going to the sub-tax ID. So that if I were to say, does it make a difference? Which physician group I refer to if I’m quarterbacking. That is the goals of MIPS Value Pathways. I think it’s been to be fully transparent. It’s still in the bumpy ride. It’s not always well accepted by all the specialties, but the goal really is to get a series of measures that we can look more specifically at specialty care, not just primary care.

Chris St John – 00:25:27:

Right. And so, at least from your perspective, having been a specialist, having been in these administrative roles, what are the most significant challenges that providers are going to face in complying with the new measures? And maybe more importantly, but what can be done to mitigate these obstacles?

Dr Lee Fleisher – 00:25:45:

So the key issue, the burden to reporting measures has always been significant. When we started 20 years ago, the measures that I helped create were called the skip measures. And there were 14 of us in a room and you literally had to audit every single surgical patient or specific surgical patient surgeries or on the issue of did the antibiotics get given on time? Well, we’ve been driven by the HITECH Act, which is the Health IT Act, which really tries to get us to what’s called interoperability. I think everyone would know it as electronic medical records that talk to each other. And the goal has been to try to use that to reduce burden. So the question is, the measure worth the squeeze, all the work it takes to meet the measure, does it really drive improvement? So I think there’s two things. One is, as radiologists, you really have to ask the question, do the current measures as currently constructed drive improvement? And every time they get re-endorsed, every time they get re-proposed, comment on it. But secondly, that’s really been the drive for electronic Quality measures. The idea that can be abstracted through FHIR apps. Think FHIR apps are very similar to what is on your phone, all the applications, where they can abstract the data. It doesn’t matter which electronic health records you’re on. Do the measure, send it to CMS, and your reporting burden goes down dramatically. So it’s really those two things. Are they the right measures? And how can we reduce that? And I really give a lot of credit to CMS and the team there to try to move more and more to electronic Quality measures, or what’s called eCQMs.

Chris St John – 00:27:29:

Yeah. And this might be an obvious question for someone who spent more time in health care specialties. But how do you strategize about choosing which measures you want to report?

Dr Lee Fleisher – 00:27:38:

You do have options and you do have some mandatory measures. So everyone has to pick usually earlier in the year, but they pick the measures that they really are focused on. There are sometimes there are, I think, about over 800, there may be over 900 measures by now. And some of the programs give you a lot of options. Some of them have mandatory plus. So I think you look at which ones that you want to focus on. In our system, you’re not going to pick ones you think you do poorly on. So most people pick the ones that they’ll do well on, but also the ones that they believe that they can improve on. And that’s really been the focus. And that’s some of the questions about how to construct a program that you’re not just trying to achieve the highest goal, but you’re trying to improve as well as achieve the highest goal.

Chris St John – 00:28:35:

And so to potentially play a little bit of hardball with you today, given the shift from quantity to quality in healthcare payment models, can you just talk a little bit about the reasoning behind that transition and the challenges that it presents as well?

Dr Lee Fleisher – 00:28:51:

We’re up over 19% of our economy is spent on healthcare. I’ll be honest. One of the roles I have is I’m a senior advisor. The Bipartisan Policy Center, which advises Congress. And we have significant concerns right now. Is federal spending on healthcare as well as total spending on healthcare? Is it sustainable? The Medicare Trust Fund, it has been extended, but how long can we keep up this amount of on the positive side, innovation? But when you look at, are we getting all of our value? Are we the top country in the world? Given how much we spend on healthcare? And the answer is no. Some of it’s inequities, different levels of care, depending on where you live and who you are and what you look at, some of the structural racisms that exist. But some of it is the over-utilization of certain resources. I talk a lot to pathologists. We’re talking to radiologists. I had a family member who’s a radiologist. You know, sometimes we do studies that may not be indicated. And it’s great if the specialists like radiologists say to me, that’s not the right study, you know, or you don’t need that. It’s not going to change your management. So I think those are important components. And that’s why we’re trying to get away from paying for every widget to paying for the things that really will make a difference in our quality of life. You know, Medicare is a defined benefit from Congress. It’s supposed to pay for anything that diagnoses or treats an illness or injury in the Medicare population. That’s really what we want to focus on, things that diagnose or treat and lead to improved clinical outcomes, improve health.

Chris St John – 00:30:43:

Yeah. And so with that, how does CMS address the concern that performance-based systems might disproportionately burden smaller practices compared to larger ones with more resources and more money, more time?

Dr Lee Fleisher – 00:30:59:

That is an important consideration. And there are exclusions from who has to report, given how many patients they have, the size of the practice. You know, that was the goal initially of getting to eCQM so that the reporting burden was much lower. But frequently and every year, the administrator that I’ve when I’ve been there has asked, it’s less small practices. Oh, that is one of the important considerations. How does rural practices? You know, certain inner city less resource practices. It’s one thing if you’re a big $10 billion health system in one of the major Northeast cities, California, others. What if you’re in Nebraska and you have a much smaller practice? So those are some of the things that we’re hoping interoperability will help solve. And in fact, another role I have is on the Health IT Advisory Committee to The Office of the National Health Promotion. How do we think through and make that easier and less burdensome for all?

Chris St John – 00:32:07:

First of all, I love that you just keep pulling out different hats throughout this interview. Truly, truly a renaissance man, Dr. Fleisher.

Dr Lee Fleisher – 00:32:14:

The medical side. Thank you.

Chris St John – 00:32:17:

Yeah, for sure. Just to follow up there, are there specific resources or programs in place to help these practices meet these quality standards?

Dr Lee Fleisher – 00:32:26:

So there really are a number of different resources. There are resources on the web. There are resources frequently from the specialty societies or vendors like the sponsor of this podcast, which can help you continuously improve. CMS has something called, funds something called the Quality Improvement Organizations, the QIOs. Those focus on some of those smaller practices and how to meet it. I don’t know their role in specialty more than primary care, but that’s the other place. But I think there are. There’s specialists and that’s really, you know, if you pull back and let’s ignore the burden of quality measurement. But the goal is we all want to deliver the highest quality care to our patients. And I think clinicians are, they are really a noble goal and so proud of how the clinical workforce. I frequently thank them in my role as CMO at CMS for what they did during the pandemic. I think it also showed some of the inequities, which many of us are trying to overcome, that really the pandemic shone a light on. But the goal is, how do we maximize patient outcomes? How do we minimize patient harms? How do we improve safety? And I think that is the provider’s goals. I think that is industry’s goals. As I work with Rubrum Advising, we always take on clients who really are focused on providing value to patients and to programs. And that, to me, is what’s important. That’s the goal at CMS. Yeah.

Chris St John – 00:34:10:

Can we just dive off into a little rabbit hole? Can you expand a little bit more on what you’re doing at Rubrum advising?

Dr Lee Fleisher – 00:34:16:

Yeah. Thank you for asking. And when I left CMS, I wanted to continue doing policy work. So I’ve got the policy think tanks, I’ve got the clinical care, and I always ask the nurses, am I still competent? Because I will stop coming if they have any concerns. But I think after 35 years of practicing, I can do and I really focus on outpatient anesthesia now. I wouldn’t do cardiac anesthesia today. But a lot of industry is trying to figure out how do they get market access and how do they understand the programs that CMS and other commercial providers implement. So in concert with my son who got his JD and MPA and had done some work in a consulting firm, I finished my master’s of law at Penn. We started this firm and we named it Rubrum because I’m a former chair. So I’m one of those guys who gets a picture on the wall. And when the artist painted the picture, and he was actually the father of one of my faculty, he said, what do you want to represent your wife? So I had started after meeting my wife at a club met in Mexico, where I was in New Haven at Yale. She was in Baltimore. I started sending her lilies, which the florists there are called Rubrum lilies. Rubrum lily in my portrait. And that’s the basis of Rubrum advising. And we really have now about 10 people. We have people from the FDA, from the CDC, from the commercial market access space. But it’s really trying to look at if you have a product or service that needs appropriate coverage from the insurers, because not everything is covered, that if they really can show value, how do we help them demonstrate that?

Chris St John – 00:36:07:

Yeah. And so like, given the, the cross-functional group you’re running at Rubrum, it gets me thinking about other

Dr Lee Fleisher – 00:36:14:

federal

Chris St John – 00:36:15:

regulatory standards in general in medicine and how they align with or don’t align with the clinical Quality measures. Are there areas where you just like, don’t see these measures coming together with federal regulatory requirements?

Dr Lee Fleisher – 00:36:33:

It’s interesting. I think COVID brought CMS and CDC very closely together. There’s the agency for healthcare research and quality, which is not a regulatory agency. It’s more of a scientific. I think sometimes there is a misalignment or a misalignment in timing between different reporting requirements of different agencies, public health versus hospital and provider quality. And, you know, some of the spaces that I sit in, our goals are to make sure there’s more and more alignment. I think the pandemic really helped that. That continues to need to be a focus.

Chris St John – 00:37:11:

Yeah. I can only imagine with a million moving pieces and then having to provide healthcare on top of organizing it, like there’s a lot going on.

Dr Lee Fleisher – 00:37:22:

Absolutely. That’s why it’s important. The comment letters, I did not understand how seriously CMS took them. And that’s why I just like to say it really is important for your listeners to really think if there’s something that they see that really would help improve it, if there was a change, they should say it. In fact, one of the interesting things is there’s actually something called the Administrative Procedures Act. If between a proposed and a final rule, there’s a better way to do something, only if somebody said it, can you make that change. It’s called logical outgrowth. And therefore, proposing things is really important. That’s… We did that frequently during my three years in the government.

Chris St John – 00:38:08:

Yeah, so just participation, right? Keeping your finger on the pulse. And if you have a disagreement or a concern or something to say, just say it. I love that kind of transparency and communication. Lee, this is exactly what I was hoping for, right? Just like clear understanding of how and why I think just makes such a big difference. And so we need to start wrapping up here. But just before we finish up, what are you most excited about in seeing the direction that these Quality measures are moving?

Dr Lee Fleisher – 00:38:41:

I’m most excited about the fact that CMS and working with the national coordinator, who is the interoperability sort of czar, and he’s now the assistant secretary for technology, that we’re trying to, number one, align them between CMS. Even within CMS, they weren’t aligned. Now they’re trying to say, if you’re Medicare, Medicaid, they’re all going to be aligned. That’s called the Universal Foundation. We didn’t get into that, but aligning them, but also aligning them with the commercial payers. Because I used to have one set of measures for the commercial payers when I was at Penn and negotiating on behalf of the institution around quality with my colleagues in managed care contracting and another for CMS. So alignment. We also have this overarching strategy. So trying to have a strategic approach that really goes across the entire ecosystem. And lastly, really trying to reduce burden. And I think that this eCQMs, which is not really my shop, and that’s really the coordination and the work at Quimvig and Michelle Schreiber, is really the direction going forward of moving that. But overall, I think it’s trying to get to the place we all want, which is giving back information to provide higher quality care.

Chris St John – 00:40:01:

I love that. And what a great place to finish. Dr. Fleischer, thank you so much for joining us. Dr. Lee Fleisher is the former chief medical officer and director of the Center for Clinical Standards and Quality at CMS, and currently the principal and founder of Rubrum Advising. Dr. Fleisher, thank you so much for joining us today. And hopefully we can have you back sometime.

Dr Lee Fleisher – 00:40:22:

Chris, it’s an absolute pleasure. Thanks so much.

Chris St John – 00:40:25:

Yeah, thank you so much. You have a great day.

Intro/Outro – 00:40:29:

Frame by Frame: Rethink Imaging is brought to you by Imologix. Here, you’ll find engaging interviews with thought leaders, experts, and patients, sharing stories that showcase the transformative power of medical imaging. To discover how Imologix is rethinking imaging in healthcare, visit emologix.com. Be sure to subscribe to Frame by Frame Rethink Imaging on Apple Podcasts, Spotify, or wherever you listen. And from all of us here at Imologix, thanks for tuning in.