Frank Maddux: The US Social Security amendments of 1972 extended Medicare coverage to individuals with end stage kidney disease who need either dialysis or transplantation to maintain life. In this episode of Dialogues, I talk with noted medical researcher and economist Philip Held about the 50th anniversary of this landmark legislation and how it changed the trajectory of kidney disease care in the United States and beyond.
Philip Held: Thank you.
Frank Maddux: Let’s start by just take us a little bit back to 1972. And what was the environment you remembered when Congress actually enacted and provided coverage for end- stage kidney disease? What do you recall about that time?
Philip Held: Well, it's interesting. I was in my last year of graduate school at Berkeley, and I, of course, did not know too much about this field. I do recall that someone dialyzed before a working session of Congress. And as I recall, that was a very influential event. What this bill did is, which was quite striking, in the sense that there were no age restrictions on the coverage of this care. And even to this day, I still find I still find people shocked when I tell them that Medicare covers all kidney failure problems, regardless of age. I mean, people are so set in this notion Medicare is this program for the aged. Fundamentally, what Congress said was this person is disabled for purposes of the Social Security Act, which, of course, rolls these people into Medicare coverage.
I don't think there was a lot of knowledge of that's how people got into Medicare. There were three ways of getting into Medicare. One was the age of which everybody was well aware of. There is a program for the poor, and then there's program for the disabled, which is where this came from. Those distinctions ultimately did lead to a lot of complications in terms of when someone was less than 65, but they were in Medicare. I will say that couple of years later, I was at Northwestern University, and Medicare or the people at Medicare asked Mark Pauly and I to write a two-page memo on how Medicare should pay kidney doctors. We wrote a 35 page paper.
Frank Maddux: I was going to say it didn't sound like a two-page question. Let's put it that way.
Philip Held: If there was a central theme that was a shocker in our paper is that we encouraged the government to think about paying in some sense, not fee for service, but in something that related to outcomes, how well things were. And so forth, nobody paid any attention to it except maybe someone who preceded you. So, we wound up in Boston at the Office of National Medical Care, and we gave a little presentation. After our meeting in Boston, which we were quite taken aback that Gus Hampers was -- he clearly had read the paper and was interested in it. What I do remember most, again going back to this 1972 period extending this insurance coverage was not widely supported in the nephrology community. In fact, the editor of the New England Journal was very explicit in saying, you know, this is money should go to research to find a cure for kidney failure and so forth. He didn't say it was a waste but it in effective he was saying let these patients pass away and anyway it was there was considerable hostility at that time. And that basic hostility interestingly came back years later when I was dealing with the NIH and you know, they've done very few clinical trials and the basic scientists at NIH were very hostile or many of them were, to NIDDK doing a clinical trial. And if you recall Ed Lowry, he was very involved in the 1980 some trial which was looking at adequate.
Frank Maddux: Dosing of dialysis.
Philip Held: And the reason they were so hostile is because this trial was taking away a lot of money from their research grant applications, and they still thought that their basic science was much more important than doing a clinical trial.
Frank Maddux: A few years after the public law got started and there was this recognition that the government wasn't going to build facilities and do this, they were going to let private business do this. They realized they needed to expand the way they oversaw it, and they developed the end-stage renal disease networks and then subsequently the USRDS. Do you want to just give us a little flavor of what that time was like?
Philip Held: At the time, we were quite surprised that Mark Pauly and I, that we were invited to write this paper on how they should pay the physicians. I would say that it was pretty explicit at the time, that the big thing that was changing there was going to be this for-profit notion of institutions offering dialysis. And it was the building of trouble that I would frankly say has not gone away in the sense that and I might add that the first thing that became apparent is that these private, many of them for-profit organizations, did a wonderful job in terms of what Congress, in a sense intended, which was make dialysis and kidney care, hopefully including transplantation, widely available. And thanks to the private sector and these dialysis units, they did a wonderful job. If you were to look at what we call the treated rate of kidney failure. Immediately, the US, went to the head of the list in terms of we really were treating all sorts of people with kidney failure. There wasn't anything comparable in history where you had dialysis units fighting to get a particular marketplace.
I was called in as a consultant when there was a dialysis unit outside of Gary, Indiana, and it was run by a church or church hospital. And a Chicago dialysis unit wanted to come down and open a unit in downtown Gary, which at that time was a poor, very largely African-American community. Here in the very, very origins of the program. You had people fighting to go to places where previously you wouldn't have very much success, going to a poor black community to offer a service. And I'm not sure if we were even aware at that time that Kidney failure among black Americans was three and a half times that of Caucasian Americans. I was a young, inexperienced person, and I didn't really see all the big picture. I look back, I can see what I did not see. Since then, I've concluded that the independent for-profit dialysis world simply does not get the credit that they deserve for having really revolutionized this and in a big way. Especially when you have the comparison group, the economist is asked how is his wife and he says, compared to whom? If you compare the success of the dialysis aspect of this kidney failure program with the transplantation side, there's no question that the transplantation side has failed on so many issues of allocation and supply.
Frank Maddux: One of the things that I think is interesting is the law created a payment model that encouraged the development of access to care. Now, most of that access to care moved to in-center care, and therefore some of the areas like home dialysis, diminished for a bit. Transplant didn't develop as it could have. Palliative care didn't develop as it could have, but access to care became quite universal with the system. And it strikes me that and one of the questions I would ask you is, many years later, as we work our way towards the executive order in 2019, we begin to move from access to care being the issue to being choices for patients and broader infrastructure to support care. Whether it's home dialysis care, whether it's transplant care, whether it's palliative care. Economically, from an economist point of view, do you think there was ever a vision of the size that this particular area of medicine was going to consume in our healthcare budget?
Philip Held: At the time, we know this passed in ’72, some federal government employees built some kind of a model in which they were aiming at, and what is steady state, that means when the number of patients passing and the number of new patients is equal. And so, at what point would that be? I guess you would say that at the time the federal government might have had some concern about this program was fairly liberal in terms of extending coverage. Any rate, their prediction, steady state would be 25,000 patients. That's how big the USRDS program would grow 25,000 patients. Needless to say.
Frank Maddux: They missed that.
Philip Held: There's about 750,000 patients in the Medicare program today. 550,000 of them are on dialysis. It certainly led to a big program and, quite frankly, it was influential around the world. You take like Japan and so forth. Japan was clearly the next largest to treatment rate. When I would give talks in Europe, for example, they would be knocking the American healthcare system and the lack of access and all this stuff. And I'd point out, but you know what, Americans have a treatment rate of kidney failure two-to-three times what you have right here in this country of yours. But the truth is, they're saving a lot of lives and giving access to care for a bunch of people.
Frank Maddux: It has happened globally. As our medical office here at Fresenius Medical Care has evolved, we've become much more aware of some of the overt and subtle distinctions between health systems around the world. And clearly, the first thing which we recognize is that the demographics, the table one data of our patient population in the US is very different than our table one, demographics of the patient population. in Europe. An example would be related to dialysis trials at initiation. It would be related to the number of diabetic patients that are that are afforded therapy. So, selection criteria continues to be very local, in my opinion. And I think clearly the law in 1972 was to try to make it universally available and I think they did accomplish that.
Philip Held: I think they did it very well, extremely well. I think these things are obvious to you and me. But let's say it is not universally known, and it certainly is not recognized that the independent dialysis units have done a wonderful job.
Frank Maddux: No doubt about that, our population is quite diverse. But That brings up one of the ties and questions I have for you as you developed and sort of initiated the culture at USRDS. Back in the day, in 1988, those are really the beginnings of how we began to look at what the baseline statistics were and what we were doing. And it ultimately leads to the questions of are we able to address issues of equity in healthcare that we're now addressing much more formally, I think. So, just describe how your vision of USRDS evolved.
Philip Held: The reason I was kind of central in the beginning of this was I had latched on to working with the Medicare data. There was a large group of nephrologists who were pushing for something like the EDTA in Europe, the European Dialysis and Transplant Association. But above all, they did not want it to be based on these Medicare data. And at the same time, when NIH did make the forward step to fund something like this European operation, you'd be interested to know that the forces within NIH were very strong. There's to be no economic analysis. This is to be a research project on kidney failure and above all else, no economic analysis, even though they were willing to consider bringing in these Medicare data. Which they did primarily originate from paying bills. There was an eruption in the in the kidney care community, and NIH got overruled and agreed. Well, maybe we would consider some economic analysis. And maybe it could be scientifically valid. And that was kind of the general tenor of things
Frank Maddux: When did they want you to begin adding clinical data? When did that come into the mix?
Philip Held: Medicare data. That's a very loaded word. I mean, all sorts of information. It was very good in many aspects. You had very good records of whether this patient had this lab test or not having this lab test, but the Medicare data did not collect the clinical results of that test. And that was a big absence, but we saw that from the beginning. We actually put five or seven special studies in the field which were aimed at collecting those clinical data that were missing. The NIH they like to have these scientific advisory committees, and they bring all these famous good names together for a meeting and tell us contractors what we're supposed to do and so forth. I made a presentation at the first. It was six months into the project that we had launched these steady studies to complete that clinical data. Everyone stood and gave us a round of applause for having put these things in place. There was a general recognition of the strengths of the Medicare data, but it was also good recognition of what the shortages and absence is there. We were well received because we did put those two pieces together and was a central part of it. One of our studies on adequacy of dialysis, for example, might have been published in 1989 still gets quoted. I'm absolutely amazed to see that.
Frank Maddux: It does. And you know, we have spent many, many years studying some of the same measures, physiologic measures of the treatment and the response to the treatment
Philip Held: I, fortunately, had wonderful data processing chief that I had worked with for over 25 years, and he did a first-class professional job of moving everything in good style, timely in a fashion that Alan Collins could take over.
Frank Maddux: It was certainly a big time for the field to recognize that USRDS became the most prominent and exemplar for a country-related registry of kidney disease care. And I think today, it still is the representative example. We in our company actually have a population health and medicine team who is doing work to try to help countries that are still looking to develop that kind of USRDS registry function to analyze what's kidney disease care look like in in their country. And I think it's modeled after what you started.
Philip Held: Thank you. I think that's true. I mentioned the EDTA a while back, the European Dialysis and Transplant Association. But quite frankly, compared to the USRDS, they never had the resources that we had. It wasn't just resources, but there were all sorts of computer developments, for example, occurring at that time, which we happen to have people on our staff who took every advantage of that. But yes, we ultimately, of course, developed the DOPPS program, which initially was in five countries. We became pretty aware of what different countries had going for them. In the DOPPS, they did not even have a census of dialysis units to do our sampling. We literally had to construct a list of all their dialysis units. You'd be shocked at the number of our nephrologists consulting with us would say I didn't know there was a dialysis unit. And yes, we did set the big, big norm.
Frank Maddux: I want to fast forward a little bit and get your views on the impact of the original law has gone through a variety of changes that have led towards value-based care. And the value-based care environment that we live in today is a brand new policy environment in the federal government. In the US, and to how we look at the kidney disease care continuum, it isn't just end-stage kidney disease for dialysis therapy, but it's transplant care, its palliative care, its CKD care, it's adequate treatments for early-stage kidney disease. What's your opinion on the current environment of sort of the policy structure since the executive order in 2019?
Philip Held: Well, the ESRD program is a very good example of Medicare-for-all. And there's all sorts of lessons to be learned from Medicare-for-all. From taking a close look at the ESRD program. As I recall, the Medicare program wanted to keep you dialysis folks out of the transplant business. This is my own personal judgment, is that somehow, they didn't trust you. And so, they were going to make all the decisions and control everything. And you look at the result that's there. I don't know if you've ever heard the term regulatory capture, where fundamentally the people who are supposed to be regulated wind up doing The regulation. There is real economic savings potential from getting a patient off of the dialysis therapy to a transplant. And yet, on almost every front, that process has been a failure, and it's been a failure fundamentally in terms of the basic rules. The National Organ Transplantation Act, the law regarding the insurance for Medicare to patients, it's the biggest failure in the Medicare system. I wrote an article 30-some-years ago that showed that kidney transplants were going to rich white men.
Frank Maddux: Whether it's a health equity issue or it's an issue of economics, I have said often I think the best home therapy for end-stage kidney disease is a transplant, and it's a home therapy. It's like any other home therapy. And it will be interesting to see how the aspect in the evolution of bringing all of these therapies together so that they have some organized and not contradictory set of measures. And we begin to address issues like high organ discard rates. High unintended consequences of measures of transplant center success that limit waitlisting and other such things. So, you have kept yourself involved in a very central area of what I think the future of kidney care looks like in your interest in transplant.
Philip Held: I can honestly say I was dragged out of retirement about six years ago by my colleagues and asked to work on this. I've been fortunate to work with a very good group of people. And I've been really researching this business for 40-some-years. I'm shocked at how much I've learned in terms of getting down to the nitty gritty. The typical organ offer to a transplant surgeon goes through 16 iterations before someone accepts that organ.
Frank Maddux: Yeah, that's…
Philip Held: 16.
Frank Maddux: A bit of a travesty.
Philip Held: I will say that one of the few first authored New England Journal pieces I ever written years and years ago was on cold time. And that cold time, that is obviously the time the organ is out of a human body, is terrible. And I'm sure this is a big part of this 20% loss rate of organs that are retrieved that do not get placed as a functioning transplant. I'm not sure I've answered you well enough on this is ocean of the notion of value-based care and I'll be honest, we economists sitting in the background had been hoping it would be much more integration of the dialysis unit and the transplant center. I personally think the system would benefit, the US system, kidney care, if we had a few for-profit transplant centers out there to stir the pot up.
Frank Maddux: Independent of whether the transplant centers are for-profit or not, I do think bringing transplant care from a bit of the island that it has sat on into the core of how we treat people with kidney failure and sort of their lifetime journey through a variety of therapies. I think that's going to be a critical component of how we look at what we're doing for our population going forward. And there's no question, there's high variability in many aspects of transplant care, organ procurement, preservation techniques of deceased donor organs. All of those things can benefit from more research, more investment and a more efficient system than we have. Last question I have for you is: just discuss a little bit your thoughts about some of the work that you and Al Roth and others had done to talk about this paired donation system and the sort of concepts of donor chains and so forth. I think that's been one of the most novel and applied ways that economists have directly impacted clinical health care that I know of.
Philip Held: I agree. And certainly it has been an honor to be linked in ways to Al Roth, and he certainly earned his Nobel Prize in this arena. And there's no question it may be the only significant change in transplantation in many years. My impression is the main contributions that come out of it is they've really improved transplantation in several ways. One, they're much better able to get a good match between the donor and the recipient. And two, they have made it possible for transplants for people who are particularly active immune systems that it's very hard to match. And so, with one of these 50-person chains, for example, is just a much more option to choose a good match. Al does not like to get into the he's big on the notion of how much money is saved, and we presented a paper that we suggested there’s about 45,000 patients a year who die waiting for a transplant. We propose a cost benefit solution of how you could obtain an organ for them. At any rate, we not only showed that the benefits are huge to the recipient of the organ, but we also showed that the federal government would save 7 billion a year if they were to move these 47,000 patients currently dying with a transplant. So, there’s options for great change there.
He has shown that kidney failure is not just a US or developed world problem. It's a worldwide problem. There's no question this exchange of organs, which I think he’s been at for at least ten years, for many people who are very unlikely to get a matched organ. He has given an answer to that problem.
Frank Maddux: I've been here today talking on this Dialogue segment with Professor Philip Held who founded and led the USRDS from 1988 to 1998 and was here to observe the evolution of the development and maturation of our system of care for end-stage kidney. Philip, thanks so much for being here with me and talking with us today.
Philip Held: Thank you. It was my pleasure.