On this episode of News World. There are over one hundred thousand Americans on the organ transplant waiting list, and seventeen people lose their lives every day waiting for a transplant. I personally witness the journey of my brother and my sister and my sister in law go through the transplantation process, and it's opened my eyes to the profound relief and the immense hope that comes with receiving a donated organ. However, the journey does not stop after receiving a transplant. The threat of organ rejection is a constant worry, with significant failure rates within the first five years after the transplant. And now there's a new hurdle introduced by government contractors jeopardizing the health of transplanted organs. Innovative blood tests allow physicians to detect organ damage and rejection before patients show symptoms. Doctors require these crucial blood tests to effectively monitor and manage the care of their immunocompromised patients. Here to discuss this new challenge transplant patients are facing. I am really pleased to welcome my guests. Doctor Stephen Potter, an experienced kidney and pancreas transplant surgeon and board certified urologist who is Professor of Surgery and Eurology at Georgetown University School of Medicine. Eddie Garcia, a heart transplant recipient and author of the book Summer in the Waiting Room. Both are members of a coalition called Honor the Gift. Additionally, I am honored to be joined by Congressman Michael Burgess from the twenty sixth District of Texas, who has been working on this issue in Congress. Steven and Nettie, welcome and thank you for joining me in Newts World.

On this episode of News World. There are over one hundred thousand Americans on the organ transplant waiting list, and seventeen people lose their lives every day waiting for a transplant. I personally witness the journey of my brother and my sister and my sister in law go through the transplantation process, and it's opened my eyes to the profound relief and the immense hope that comes with receiving a donated organ. However, the journey does not stop after receiving a transplant. The threat of organ rejection is a constant worry, with significant failure rates within the first five years after the transplant. And now there's a new hurdle introduced by government contractors jeopardizing the health of transplanted organs. Innovative blood tests allow physicians to detect organ damage and rejection before patients show symptoms. Doctors require these crucial blood tests to effectively monitor and manage the care of their immunocompromised patients. Here to discuss this new challenge transplant patients are facing. I am really pleased to welcome my guests. Doctor Stephen Potter, an experienced kidney and pancreas transplant surgeon and board certified urologist who is Professor of Surgery and Eurology at Georgetown University School of Medicine. Eddie Garcia, a heart transplant recipient and author of the book Summer in the Waiting Room. Both are members of a coalition called Honor the Gift. Additionally, I am honored to be joined by Congressman Michael Burgess from the twenty sixth District of Texas, who has been working on this issue in Congress. Steven and Nettie, welcome and thank you for joining me in Newts World.

Thank you Newton.

Thank you Newton.

Let me sort of set the background that due to a rare, very rare lung disease that runs in the McPherson side of my family, two of my siblings have had lung transplants. Further, my sister in law is head a liver transplant. When my brother Randy received his transplant four years ago at the local hospital in Nova, he stayed at our house for months while he recovered. I've personally witnessed the physical and emotional journey of a loved one who needs a transplant. The alternative is death and the relief and joy of being given a second chance to the gift of a donated organ, and all three of them today are doing fine. The thing most people don't realize is the amount of work it takes to keep your body from rejecting the organ. And that is what we're going to focus on today. Eddie. Let me ask you to talk about your story from heart attack to heart transplant.

Let me sort of set the background that due to a rare, very rare lung disease that runs in the McPherson side of my family, two of my siblings have had lung transplants. Further, my sister in law is head a liver transplant. When my brother Randy received his transplant four years ago at the local hospital in Nova, he stayed at our house for months while he recovered. I've personally witnessed the physical and emotional journey of a loved one who needs a transplant. The alternative is death and the relief and joy of being given a second chance to the gift of a donated organ, and all three of them today are doing fine. The thing most people don't realize is the amount of work it takes to keep your body from rejecting the organ. And that is what we're going to focus on today. Eddie. Let me ask you to talk about your story from heart attack to heart transplant.

Well, thank you Newton, thank you for this opportunity. In twenty ten, I was literally on top of my little world. I was president of a local school board. I was an executive. I was forty six years old. Everything was going fine. And one morning, it was June seventh, twenty ten, to be exact, I was in the gym doing my workout and I couldn't finish. As the morning wore on, it got worse. I went to see my doctor. She did a series of tests and immediately sent me to the emergency room. Within ten or fifteen minutes from getting to the doctor's office, I was rolled into the emergency room on a wheelchair and three doctors there waited for me, and one of them said, mister Garcia, you're having a heart attack. I had a massive heart attack my artery that some called the widow maker was one hundred percent blocked. I spent the next ten years battling congestive heart failure. My heart was very weak from the heart attack, and finally, in April of twenty twenty, I got the gift of a heart transplant, and needless to say, it changed everything. There was a time where I couldn't walk down the driveway to the mailbox and back up the driveway without stopping a few times and losing my breath. And I would say within a month of the transplant, I was walking down to the end of the street. By three months, I was walking a mile or two, and it got to the point where I'd do a regular four mile walk a day. And it's just been a blessing. It's been amazing. And that's pretty much my story from heart attack to heart transplant.

Well, thank you Newton, thank you for this opportunity. In twenty ten, I was literally on top of my little world. I was president of a local school board. I was an executive. I was forty six years old. Everything was going fine. And one morning, it was June seventh, twenty ten, to be exact, I was in the gym doing my workout and I couldn't finish. As the morning wore on, it got worse. I went to see my doctor. She did a series of tests and immediately sent me to the emergency room. Within ten or fifteen minutes from getting to the doctor's office, I was rolled into the emergency room on a wheelchair and three doctors there waited for me, and one of them said, mister Garcia, you're having a heart attack. I had a massive heart attack my artery that some called the widow maker was one hundred percent blocked. I spent the next ten years battling congestive heart failure. My heart was very weak from the heart attack, and finally, in April of twenty twenty, I got the gift of a heart transplant, and needless to say, it changed everything. There was a time where I couldn't walk down the driveway to the mailbox and back up the driveway without stopping a few times and losing my breath. And I would say within a month of the transplant, I was walking down to the end of the street. By three months, I was walking a mile or two, and it got to the point where I'd do a regular four mile walk a day. And it's just been a blessing. It's been amazing. And that's pretty much my story from heart attack to heart transplant.

Now I remember this with my brother. It seems to whether you feel better, but you have to recover and you have to worry about rejection, and you have a whole regiment of pails and things that you have to really pay attention to. Was that true for you?

Now I remember this with my brother. It seems to whether you feel better, but you have to recover and you have to worry about rejection, and you have a whole regiment of pails and things that you have to really pay attention to. Was that true for you?

Absolutely, it's a slow process feeling better. I think a lot of people believe that you wake up the next morning and you feel great, and that's just not the case. You know. The way my doctor described it is your body is getting hit by an eighteen wheel truck.

Absolutely, it's a slow process feeling better. I think a lot of people believe that you wake up the next morning and you feel great, and that's just not the case. You know. The way my doctor described it is your body is getting hit by an eighteen wheel truck.

This was the good news, because the alternative was deaf.

This was the good news, because the alternative was deaf.

That's right, this is the good news. So it's a slow process. The recovery is a slow process, so you don't feel better instantly. But the main thing that you have to do, which is essentially a full time job, is take care of that heart so the body doesn't reject it. And so for me, probably for everybody, it was Phase one was taking a whole bunch of pills. And I did a little calculation, and I probably took about thirteen thousand pills in that first year. It was a handful of pills in the morning, in the afternoon, in the evening. So that's step one. Step two is your immunosuppress. So a big chunk of the medication is to prevent your body from reach your heart. So in other words, your body and your antibodies start stirring up, getting ready for a fight because they want to kick out this sporn thing that's in your body. And so taking care of that and staying healthy is the key. Thing, because anything flew cold, anything could really exacerbate the disease because your body's amino suppressed. And for me, my heart transplant happened literally one month after the national lockdown with COVID, so there was the additional layer of COVID, And in the first weeks and months there are numerous doctor's appointments, so protecting myself from the house to the doctor's appointment was critical. And so the short story really is taking care of a transplanted organ is a full time job.

That's right, this is the good news. So it's a slow process. The recovery is a slow process, so you don't feel better instantly. But the main thing that you have to do, which is essentially a full time job, is take care of that heart so the body doesn't reject it. And so for me, probably for everybody, it was Phase one was taking a whole bunch of pills. And I did a little calculation, and I probably took about thirteen thousand pills in that first year. It was a handful of pills in the morning, in the afternoon, in the evening. So that's step one. Step two is your immunosuppress. So a big chunk of the medication is to prevent your body from reach your heart. So in other words, your body and your antibodies start stirring up, getting ready for a fight because they want to kick out this sporn thing that's in your body. And so taking care of that and staying healthy is the key. Thing, because anything flew cold, anything could really exacerbate the disease because your body's amino suppressed. And for me, my heart transplant happened literally one month after the national lockdown with COVID, so there was the additional layer of COVID, And in the first weeks and months there are numerous doctor's appointments, so protecting myself from the house to the doctor's appointment was critical. And so the short story really is taking care of a transplanted organ is a full time job.

Tell me about the difference in having blood tests and biopsies.

Tell me about the difference in having blood tests and biopsies.

This is another night and day proposition. The biopsy is pretty invasive. Here's what happened. You go into a room that looks like an operating room. You're on a table on the right side of the neck. The doctor's cut a little incision and stick a needle and a tube into the chrootic artery which goes into your heart to literally scratch out tissue and pull it back out. And so your awake during this process. And doctor Potter might be able to explain that a little bit more. It's nerve wracking, it's invasive. For me, fortunately it wasn't that bad, but from fellow heart transplant patents that I've talked to, it can be a very hairy proposition. Now, the blood test that can also detect early signs of rejection is simply a blood test. It's like when you go to the doctor to do a blood drop for whatever you have to do it for. In my case, it was even easier. A phlebotomus came to my house and I sat here in my dining room table and she did the little prick, took the blood and went on her way. So, without a doubt, that's a much better process.

This is another night and day proposition. The biopsy is pretty invasive. Here's what happened. You go into a room that looks like an operating room. You're on a table on the right side of the neck. The doctor's cut a little incision and stick a needle and a tube into the chrootic artery which goes into your heart to literally scratch out tissue and pull it back out. And so your awake during this process. And doctor Potter might be able to explain that a little bit more. It's nerve wracking, it's invasive. For me, fortunately it wasn't that bad, but from fellow heart transplant patents that I've talked to, it can be a very hairy proposition. Now, the blood test that can also detect early signs of rejection is simply a blood test. It's like when you go to the doctor to do a blood drop for whatever you have to do it for. In my case, it was even easier. A phlebotomus came to my house and I sat here in my dining room table and she did the little prick, took the blood and went on her way. So, without a doubt, that's a much better process.

Good. Let me shift to doctor Potter, how concerned are you about organ rejection leading to failure?

Good. Let me shift to doctor Potter, how concerned are you about organ rejection leading to failure?

Rejection is the biggest cause of loss of these transplanted organs, and it's a constant threat. But most importantly, it's a constant fear for patients. I mean, they live every day worrying that they're going to develop rejection, and that rejection develops silently. It's not like they wake up and have pain typically and know that they have rejection. It's something that sneaks up on them. And so there has to be a good way to surveil. Do surveillance for the development of that rejection.

Rejection is the biggest cause of loss of these transplanted organs, and it's a constant threat. But most importantly, it's a constant fear for patients. I mean, they live every day worrying that they're going to develop rejection, and that rejection develops silently. It's not like they wake up and have pain typically and know that they have rejection. It's something that sneaks up on them. And so there has to be a good way to surveil. Do surveillance for the development of that rejection.

How often do you try to do the surveillance.

How often do you try to do the surveillance.

Well, so it depends on the individual transplant patient and how far they're off from their transplant of what type of organ we're talking about, But if we talk about kidneys, that's the highest volume transplant by far in this country and the one with the most data to support sort of the recommendations. We check people for rejection a couple times a week after the transplant for the first month or two, and then we see them about once a week for another couple of months, and then we see them once a month for the rest of that year, and at each of those visits we check some simple blood tests that are sort of old fashioned legacy markers that can serve to look for rejection, but not the molecular tests that we're talking about. Those are obtained much less frequently with eddie.

Well, so it depends on the individual transplant patient and how far they're off from their transplant of what type of organ we're talking about, But if we talk about kidneys, that's the highest volume transplant by far in this country and the one with the most data to support sort of the recommendations. We check people for rejection a couple times a week after the transplant for the first month or two, and then we see them about once a week for another couple of months, and then we see them once a month for the rest of that year, and at each of those visits we check some simple blood tests that are sort of old fashioned legacy markers that can serve to look for rejection, but not the molecular tests that we're talking about. Those are obtained much less frequently with eddie.

What's the relative difference in being able to take blood versus biopsies.

What's the relative difference in being able to take blood versus biopsies.

Well, that's a really great question.

Well, that's a really great question.

Nut.

Nut.

So biopsies are expensive and invasive, and they carry significant risks, and they're really best viewed as a way to confirm that there's something going on with the transplanted organ. The molecular testing that we're talking about. These are non invasive blood tests. They can be done at any hospital lab, third party lab, or even through phlebotomists that make home visits at no charge to the patient to draw their blood. So patients know that this is really a game changer in terms of how invasive and dangerous it is for them and how convenient.

So biopsies are expensive and invasive, and they carry significant risks, and they're really best viewed as a way to confirm that there's something going on with the transplanted organ. The molecular testing that we're talking about. These are non invasive blood tests. They can be done at any hospital lab, third party lab, or even through phlebotomists that make home visits at no charge to the patient to draw their blood. So patients know that this is really a game changer in terms of how invasive and dangerous it is for them and how convenient.

It can be for them.

It can be for them.

Is all this relatively new science that enables this kind of less invasive approach.

Is all this relatively new science that enables this kind of less invasive approach.

Well, I mean, it depends on how long a view you take of it. Right new The first successful kidney transplants were done in this country in nineteen fifty four, so transplantation of kidneys is not a new process. But we've been monitoring kidney transplant health. We've been surveilling patients after transplant really in much the same way using kind of limited legacy tools for about three decades now. And these molecular tests are therefore relatively new. They came on the scene about six years ago and they rapidly became a standard of care new because they offer a better way forward. They're really robustly valid dated analytically. They're validated clinically, which means we know that they're measuring what we think they're measuring, and we know that there's clinical relevance to the results, and that's really important, right. We not only know that the answer we get means something, but we know what contexts are put it in and how to use it in guiding clinical decisions for patients.

Well, I mean, it depends on how long a view you take of it. Right new The first successful kidney transplants were done in this country in nineteen fifty four, so transplantation of kidneys is not a new process. But we've been monitoring kidney transplant health. We've been surveilling patients after transplant really in much the same way using kind of limited legacy tools for about three decades now. And these molecular tests are therefore relatively new. They came on the scene about six years ago and they rapidly became a standard of care new because they offer a better way forward. They're really robustly valid dated analytically. They're validated clinically, which means we know that they're measuring what we think they're measuring, and we know that there's clinical relevance to the results, and that's really important, right. We not only know that the answer we get means something, but we know what contexts are put it in and how to use it in guiding clinical decisions for patients.

How many of these tests would a typical transplant patient have.

How many of these tests would a typical transplant patient have.

So after a kidney transplant, in an ideal world, these molecular tests would be used about once a month for the first four or five months six months, and then quarterly after that for the next couple of years. So we're not talking about a huge number of tests in an individual patient, and.

So after a kidney transplant, in an ideal world, these molecular tests would be used about once a month for the first four or five months six months, and then quarterly after that for the next couple of years. So we're not talking about a huge number of tests in an individual patient, and.

That allows you to not have to do the biopsy unless something comes up that convinces you there's a real problem.

That allows you to not have to do the biopsy unless something comes up that convinces you there's a real problem.

Right exactly, So, most of these molecular tests are going to be giving us a green light. They're going to be normal. The results will indicate that the patient has a low risk of having rejection, that their immune system is not activated against the organ, and that they're not suffering ongoing injury to their transplanted alligraph But when the test results are abnormal, that can be an important and early trigger that helps us know that we need to get a biopsy. And importantly, there are very good data from the peer reviewed literature that tell us that these markers provide an earlier indication of injury to the alligraph than any other sort of legacy blood test did. And that's a very valuable tool because time is tissue in a way. Right as time goes on with rejection smoldering in the kidney, you're losing kidney tissue.

Right exactly, So, most of these molecular tests are going to be giving us a green light. They're going to be normal. The results will indicate that the patient has a low risk of having rejection, that their immune system is not activated against the organ, and that they're not suffering ongoing injury to their transplanted alligraph But when the test results are abnormal, that can be an important and early trigger that helps us know that we need to get a biopsy. And importantly, there are very good data from the peer reviewed literature that tell us that these markers provide an earlier indication of injury to the alligraph than any other sort of legacy blood test did. And that's a very valuable tool because time is tissue in a way. Right as time goes on with rejection smoldering in the kidney, you're losing kidney tissue.

My brother told me that the whole experience with his lung transplant, that the tests were invaluable, and that the sense of relief he had every time he went in and it turned out they were okay, that's just dramatically improved the quality of his life.

My brother told me that the whole experience with his lung transplant, that the tests were invaluable, and that the sense of relief he had every time he went in and it turned out they were okay, that's just dramatically improved the quality of his life.

Yeah, and that's a common refrain I hear from patient all the time. And when the rules that govern when these tests were covered were changed, that caused a lot of consternation, as you can imagine, from patients all over the country who had been sort of used to getting these tests, getting a sense of security from good results and knowing that they would have an early detection of rejection in the unfortunate case that the results were not good and that would rout them into a biopsy and further treatment, and all of a sudden they felt that the rug was kind of pulled out from under them.

Yeah, and that's a common refrain I hear from patient all the time. And when the rules that govern when these tests were covered were changed, that caused a lot of consternation, as you can imagine, from patients all over the country who had been sort of used to getting these tests, getting a sense of security from good results and knowing that they would have an early detection of rejection in the unfortunate case that the results were not good and that would rout them into a biopsy and further treatment, and all of a sudden they felt that the rug was kind of pulled out from under them.

This becomes very personal, Eddie, I understand that this test has helped you, and then you actually had a big scare recently with your transplant.

This becomes very personal, Eddie, I understand that this test has helped you, and then you actually had a big scare recently with your transplant.

First of all, for the frequency, I got the blood tests once a quarter every three months post transplant, and for the first year and a half or so, it was like clockwork. If Lebatos had come to my house, do the draw. A couple of days later, two three days later, I'd get a call from my doc and then she would say, hey, Eddie, you are good to go. And, like doctor Potter said, full relief, because there's some anticipation, a little nervousness in those three days, like I hope, I hope, I hope. And every three months, three days later my clockwork, as I said, done, You're good, good to go. And so in June of twenty twenty one, which is about fifteen months out from transplant, I had just come in from a walk. I think I walked three or four miles. It was a beautiful June day. I was feeling like a million bucks. The blood draw had been a few days before and my dog calls and I was fully expecting you're good to go, and she said, bluntly, Eddie, you need to come check into the hospital today and expect to be here for at least eleven days. I was shocked, to say the least, and really nervous, and I asked her why, and she said that the test had indicated that I was in rejection. My first reaction was, wait a minute, I just got in from a walk. I feel like a million bucks. What are you talking about, doctor, And she said, that's what the test is designed to do. You got to come in. So I went in and spent the next eleven days in the hospital impatient and was pumped up with a bunch of proteins to clean out my system. And after eleven days I went home, and then for the next six months on an outpatient basis, once a month, I did the same thing. And at the end of that process, the doctor gave me the green light after a biopsy and said you're good to go and keep on moving with life. And it was a humongous relief.

First of all, for the frequency, I got the blood tests once a quarter every three months post transplant, and for the first year and a half or so, it was like clockwork. If Lebatos had come to my house, do the draw. A couple of days later, two three days later, I'd get a call from my doc and then she would say, hey, Eddie, you are good to go. And, like doctor Potter said, full relief, because there's some anticipation, a little nervousness in those three days, like I hope, I hope, I hope. And every three months, three days later my clockwork, as I said, done, You're good, good to go. And so in June of twenty twenty one, which is about fifteen months out from transplant, I had just come in from a walk. I think I walked three or four miles. It was a beautiful June day. I was feeling like a million bucks. The blood draw had been a few days before and my dog calls and I was fully expecting you're good to go, and she said, bluntly, Eddie, you need to come check into the hospital today and expect to be here for at least eleven days. I was shocked, to say the least, and really nervous, and I asked her why, and she said that the test had indicated that I was in rejection. My first reaction was, wait a minute, I just got in from a walk. I feel like a million bucks. What are you talking about, doctor, And she said, that's what the test is designed to do. You got to come in. So I went in and spent the next eleven days in the hospital impatient and was pumped up with a bunch of proteins to clean out my system. And after eleven days I went home, and then for the next six months on an outpatient basis, once a month, I did the same thing. And at the end of that process, the doctor gave me the green light after a biopsy and said you're good to go and keep on moving with life. And it was a humongous relief.

It's fascinating me if that test hadn't been available and you still felt pretty good. But in fact, you were steadily having your heart rejected. It's conceivable that it would have cost you your life.

It's fascinating me if that test hadn't been available and you still felt pretty good. But in fact, you were steadily having your heart rejected. It's conceivable that it would have cost you your life.

Absolutely. From my understanding is prior to this test, what would have to happen If it wasn't detected during an annual biopsy. You would have to start feeling symptoms, at least for heart patients. I'm not sure about kidney patients, but you would start feeling heart failure symptoms. And so when you start feeling those, you're significantly down the road. So one of two things happened, One which is the most dramatic, as you lose your life the worst case scenario. The other is you might have to be listed again and go through that process all over. And for someone who lived with heart failure so long and went through that heroin summer, I couldn't fathom what it would be like to have to go through all that again.

Absolutely. From my understanding is prior to this test, what would have to happen If it wasn't detected during an annual biopsy. You would have to start feeling symptoms, at least for heart patients. I'm not sure about kidney patients, but you would start feeling heart failure symptoms. And so when you start feeling those, you're significantly down the road. So one of two things happened, One which is the most dramatic, as you lose your life the worst case scenario. The other is you might have to be listed again and go through that process all over. And for someone who lived with heart failure so long and went through that heroin summer, I couldn't fathom what it would be like to have to go through all that again.

I have to ask doctor Potter, how often do people get a rejection and then have a second transplant for kidney.

I have to ask doctor Potter, how often do people get a rejection and then have a second transplant for kidney.

About ten percent of the people on the list, and they are about almost one hundred thousand people on the list in this country waiting for a kidney transplant, about ten percent of those have had prior transplants, and so about one in ten people that I transplant have had a prior kidney transplant. Let's talk about a very important thing, and that is that your lowest risk is a transplant reshipping is that first transplant, and that these are precious gifts of life, and that the supply of kidneys available for people is always going to be less than the demand for those kidneys. And so if we can make efforts in improving how long people keep those kidney transplants working, then we decrease the likelihood they returned to the list for another kidney. And when we do that, that's a rising tide that raises all the boats, because every kidney that doesn't go into someone who's already had a transplant is available for someone who really needs a life saving transplant to get off dialysis and otherwise might not have a shot.

About ten percent of the people on the list, and they are about almost one hundred thousand people on the list in this country waiting for a kidney transplant, about ten percent of those have had prior transplants, and so about one in ten people that I transplant have had a prior kidney transplant. Let's talk about a very important thing, and that is that your lowest risk is a transplant reshipping is that first transplant, and that these are precious gifts of life, and that the supply of kidneys available for people is always going to be less than the demand for those kidneys. And so if we can make efforts in improving how long people keep those kidney transplants working, then we decrease the likelihood they returned to the list for another kidney. And when we do that, that's a rising tide that raises all the boats, because every kidney that doesn't go into someone who's already had a transplant is available for someone who really needs a life saving transplant to get off dialysis and otherwise might not have a shot.

To put all this in context, a couple of weeks ago, I wrote an op ed and then I participated in a press conference which both of you also attended. Back in March, transplant patients regular care was disrupted when palmetto a private contractor to Medicare that pays for these tests. Medicare pays for the test. This contract published an article which tied coverage of non invasive blood tests to invasive biopsies, which had never before been the case. The Center for Medicare and Medicaid Services CMS as the government agency that runs Medicare, but they rely very heavily on private contractors. This particular contractor that pays for this part of the program, a METAGBA, took abrupt action in March to roll back coverage of these non invasive tests. This has been covered by the media, including three Wall Street Journal op eds. There were about two hundred advocates in Washington a couple of weeks ago, and they conducted over one hundred meetings with members of the House and Senate urging them to reverse the cuts in a pretty unusual turn of event. I was on the same agenda with Reverend Al Sharpton, who I've worked with before on school chain, so he occasionally vary bipartisan despite everything else. But it demonstrates how broad the bipartisan concern is and how absurd the change in coverages. Doctor Potter, can you explain the change in coverage and the significance of Palmeta linking coverage of this test to a non invasive biopsy.

To put all this in context, a couple of weeks ago, I wrote an op ed and then I participated in a press conference which both of you also attended. Back in March, transplant patients regular care was disrupted when palmetto a private contractor to Medicare that pays for these tests. Medicare pays for the test. This contract published an article which tied coverage of non invasive blood tests to invasive biopsies, which had never before been the case. The Center for Medicare and Medicaid Services CMS as the government agency that runs Medicare, but they rely very heavily on private contractors. This particular contractor that pays for this part of the program, a METAGBA, took abrupt action in March to roll back coverage of these non invasive tests. This has been covered by the media, including three Wall Street Journal op eds. There were about two hundred advocates in Washington a couple of weeks ago, and they conducted over one hundred meetings with members of the House and Senate urging them to reverse the cuts in a pretty unusual turn of event. I was on the same agenda with Reverend Al Sharpton, who I've worked with before on school chain, so he occasionally vary bipartisan despite everything else. But it demonstrates how broad the bipartisan concern is and how absurd the change in coverages. Doctor Potter, can you explain the change in coverage and the significance of Palmeta linking coverage of this test to a non invasive biopsy.

Let me say someone who I wake up every morning concerned about transplant patients and advocating for them. The bipartisan support this issues received is really heartening, very encouraging. The change in coverage that occurred was significant for three big reasons. It most importantly, kind of out of the blue and in contradistinction to all the other prior coverage statements, linked the availability of molecular testing for kidney surveillance to the direct replacement of biopsy protocols. And that's puzzling to us because only about seventeen percent of transplant centers in this country even utilized these biopsy protocols, so that right there you have a very confusing restriction and access for patients. It also limited access to molecular testing based on time relative to a b obviously being obtained. And it also prohibited the use of multiple tests, for example, a gene expression profile test and a self free DNA test in the same patient encounter.

Let me say someone who I wake up every morning concerned about transplant patients and advocating for them. The bipartisan support this issues received is really heartening, very encouraging. The change in coverage that occurred was significant for three big reasons. It most importantly, kind of out of the blue and in contradistinction to all the other prior coverage statements, linked the availability of molecular testing for kidney surveillance to the direct replacement of biopsy protocols. And that's puzzling to us because only about seventeen percent of transplant centers in this country even utilized these biopsy protocols, so that right there you have a very confusing restriction and access for patients. It also limited access to molecular testing based on time relative to a b obviously being obtained. And it also prohibited the use of multiple tests, for example, a gene expression profile test and a self free DNA test in the same patient encounter.

There seems confusion because apparently in September, the Center for Medicare and Medicaid Services argue that neither CMS nor the Medicare administrative contractors have made changes that affect patient's ability to have blood tests used to monitor for organ transplantation rejection when ordered by their physicians and medically appropriate circumstances. What does that mean?

There seems confusion because apparently in September, the Center for Medicare and Medicaid Services argue that neither CMS nor the Medicare administrative contractors have made changes that affect patient's ability to have blood tests used to monitor for organ transplantation rejection when ordered by their physicians and medically appropriate circumstances. What does that mean?

Yeah, I don't know what it means, because it seems to the community that these were substantive changes to coverage, and in fact, the number of tests ordered precipitously dropped immediately upon issuance of these new rules. Medicare had been covering these tests for years. Medicare coverage for these innovative blood tests became available starting in about two thousand and six, but that coverage was greatly expanded starting about twenty seventeen. The coverage that was in place explicitly stated that these blood tests could occur on a routine or surveillance basis and we're not tied to a biopsy, and so for years, that's the way that these tests became part of the standard of care and caring for these patients. And when this was all changed and biopsy and molecular testing were specifically linked, they had a real chilling effect throughout the transplant community and led to a lot of tests being canceled that had already been ordered and going forward, a lot fewer tests being obtained, which left a lot of patients frightened and concerned.

Yeah, I don't know what it means, because it seems to the community that these were substantive changes to coverage, and in fact, the number of tests ordered precipitously dropped immediately upon issuance of these new rules. Medicare had been covering these tests for years. Medicare coverage for these innovative blood tests became available starting in about two thousand and six, but that coverage was greatly expanded starting about twenty seventeen. The coverage that was in place explicitly stated that these blood tests could occur on a routine or surveillance basis and we're not tied to a biopsy, and so for years, that's the way that these tests became part of the standard of care and caring for these patients. And when this was all changed and biopsy and molecular testing were specifically linked, they had a real chilling effect throughout the transplant community and led to a lot of tests being canceled that had already been ordered and going forward, a lot fewer tests being obtained, which left a lot of patients frightened and concerned.

I'm not a doctor, I'm not a policymaker. I'm just a regular guy here, right, But the term medically appropriate to me sounds like, at least for heart patients, is you're huffing and puffing going down the driveway to get your mail, so let's check something out. And that's just too late. So to me, that language, it's an empty phrase. So in other words, they're saying we're going to provide access. Thinks it's medically appropriate. It's just too late for that.

I'm not a doctor, I'm not a policymaker. I'm just a regular guy here, right, But the term medically appropriate to me sounds like, at least for heart patients, is you're huffing and puffing going down the driveway to get your mail, so let's check something out. And that's just too late. So to me, that language, it's an empty phrase. So in other words, they're saying we're going to provide access. Thinks it's medically appropriate. It's just too late for that.

I'm glad you raised this because, as I understand it, there was a study by the National Heart, Lung, and Blood Institute which looked at nearly two hundred heart transplant recipients and found that the donor derived self free DNA test performed better than tissue biopsies because it quote signaled problems even when no outward signs of rejection we revenant. They found that the blood test may be able to detect rejection as early as twenty eight days after heart transplantation and at least three months before rejection is detectable using heart tissue biopsy. Now, if we're saying here, you could literally be suffering a silent rejection for three months before there was enough change to be detected by the heart tissue of biopsy, but the modern molecular blood test would have picked it up immediately. Isn't this sort of crazy to not have this? This is a standard of care.

I'm glad you raised this because, as I understand it, there was a study by the National Heart, Lung, and Blood Institute which looked at nearly two hundred heart transplant recipients and found that the donor derived self free DNA test performed better than tissue biopsies because it quote signaled problems even when no outward signs of rejection we revenant. They found that the blood test may be able to detect rejection as early as twenty eight days after heart transplantation and at least three months before rejection is detectable using heart tissue biopsy. Now, if we're saying here, you could literally be suffering a silent rejection for three months before there was enough change to be detected by the heart tissue of biopsy, but the modern molecular blood test would have picked it up immediately. Isn't this sort of crazy to not have this? This is a standard of care.

As someone who has been through this, that's absolutely crazy. It just doesn't make sense. As my dad used to say, you know, I'm not a mathematician, but that's not good math.

As someone who has been through this, that's absolutely crazy. It just doesn't make sense. As my dad used to say, you know, I'm not a mathematician, but that's not good math.

Yeah, I think you hit the nail on the head, Eddie, but you know, it doesn't make sense. And new I would say, these tests have become standard of care. So the issue is not are they standard of care? The issue is is the standard of care that was previously covered going to now be not covered so that patients that had access. I mean, let's remember that organ failure in general is not a disease of the wealthy. It disproportionately affects people of color and people that are disadvantaged in terms of access to care. You know, folks who have been relying on a standard of care test that it clearly is robustly validated and we know it helps drive decision making and improve the care of these patients. We know that it gives us additional time to pick up rejection and remember rejection. And it's like having your house on fire when you have rejection that transplanted organ you're losing, you're damaging that tissue, and you're losing a kidney or heart function. Time really matters, and so that extra time to pick up on rejection is critical and access to this for patients who've been really historically disproportionately disadvantaged, have a huge burden of organ failure in this country. That's critically important. And I think the reason that both you and Al Sharpton is so capably and eloquently spoke about this last week.

Yeah, I think you hit the nail on the head, Eddie, but you know, it doesn't make sense. And new I would say, these tests have become standard of care. So the issue is not are they standard of care? The issue is is the standard of care that was previously covered going to now be not covered so that patients that had access. I mean, let's remember that organ failure in general is not a disease of the wealthy. It disproportionately affects people of color and people that are disadvantaged in terms of access to care. You know, folks who have been relying on a standard of care test that it clearly is robustly validated and we know it helps drive decision making and improve the care of these patients. We know that it gives us additional time to pick up rejection and remember rejection. And it's like having your house on fire when you have rejection that transplanted organ you're losing, you're damaging that tissue, and you're losing a kidney or heart function. Time really matters, and so that extra time to pick up on rejection is critical and access to this for patients who've been really historically disproportionately disadvantaged, have a huge burden of organ failure in this country. That's critically important. And I think the reason that both you and Al Sharpton is so capably and eloquently spoke about this last week.

This is really in particular about African American and Latino and Native American patients being more disadvantaged and more likely to have the rejection and am not allowing a state of the art intervention to check on them increases the likelihood of their being rejected significantly. So that there's a very practical reason that Reverend Sharpton and I were on the same page about this. I should mention, by the way that at our show page, we're going to have a link to the press conference for listeners who want to see even more about this. But doctor Potter, I'm very curious not to put you on the spot. I realize you're not a political scientist, you're a medical doctor, But why do you think CMS is doing this? Do you have any idea what's behind it all?

This is really in particular about African American and Latino and Native American patients being more disadvantaged and more likely to have the rejection and am not allowing a state of the art intervention to check on them increases the likelihood of their being rejected significantly. So that there's a very practical reason that Reverend Sharpton and I were on the same page about this. I should mention, by the way that at our show page, we're going to have a link to the press conference for listeners who want to see even more about this. But doctor Potter, I'm very curious not to put you on the spot. I realize you're not a political scientist, you're a medical doctor, But why do you think CMS is doing this? Do you have any idea what's behind it all?

Ultimately, that's a question that we have to be asked of CMS. It's very concerning that the processes in place that include public comment and discourse weren't followed when this billing article was used to change coverage for these standard of care tests. And so the first thing that we would do is really ask CMS, are you sure that your private contractor is doing things the way you think is palatable? And then the second is based on conversations that we've had with Congresswomen Issue and Congressman Burgess, who've really been champions in transplant and helping us to try to get answers. CMS is concerned about overutilization of this test, which I think implies that more tests are being ordered by doctors and CMS sinc should be happening. But remember that the average number of tests being done for these patients is actually really low. In the real world, kidney patients are typically getting something like four tests a year after their first year, so it's hard to understand that.

Ultimately, that's a question that we have to be asked of CMS. It's very concerning that the processes in place that include public comment and discourse weren't followed when this billing article was used to change coverage for these standard of care tests. And so the first thing that we would do is really ask CMS, are you sure that your private contractor is doing things the way you think is palatable? And then the second is based on conversations that we've had with Congresswomen Issue and Congressman Burgess, who've really been champions in transplant and helping us to try to get answers. CMS is concerned about overutilization of this test, which I think implies that more tests are being ordered by doctors and CMS sinc should be happening. But remember that the average number of tests being done for these patients is actually really low. In the real world, kidney patients are typically getting something like four tests a year after their first year, so it's hard to understand that.

A recent survey had found that something like ninety five percent of the patients are concerned that the new Medicare building is going to limit their coverage for a non invasive post transplant test, Eddie, I mean, how does this affect your life?

A recent survey had found that something like ninety five percent of the patients are concerned that the new Medicare building is going to limit their coverage for a non invasive post transplant test, Eddie, I mean, how does this affect your life?

For example, I'm not a Medicare patient. I'm a Kaiser patient have private insurance. However, I'm really involved in this issue because of those stats you laid out earlier about especially Latino patients. And I grew up in a working class Latino neighborhood, and I think about my friends if they've had to go through some of these processes that I've had to gone through, And if the only way to detect is the pre blood test model, which is through biopsy, and you have to take a full day off of work to go and get a biopsy, your decision is Okay, Am I going to do that and not put food on the table for my family. I'll just wait until next time for a biopsy. I can see that calculation being made, and it's just not fair, just not fair. At all. And I don't know why the numbers are higher for African Americans and for Latinos and other people of color, but I have to guess that's part of it, because the surveillance is very important. It's critical, actually, and so for someone to have to take time off and travel somewhere, especially if you're from a rural area here in California Central Valley, where you have to travel two three hours to a transplant center to do a biopsy, you're probably not going to choose to do that. And so for me, the fight is about helping people who don't have this opportunity. But the opportunity is widespread and available now and being literally I think doctor Potter said it. Maybe you said it nut having the rug ripped from under your legs for some bureaucratic reason that nobody seems to understand the reason why.

For example, I'm not a Medicare patient. I'm a Kaiser patient have private insurance. However, I'm really involved in this issue because of those stats you laid out earlier about especially Latino patients. And I grew up in a working class Latino neighborhood, and I think about my friends if they've had to go through some of these processes that I've had to gone through, And if the only way to detect is the pre blood test model, which is through biopsy, and you have to take a full day off of work to go and get a biopsy, your decision is Okay, Am I going to do that and not put food on the table for my family. I'll just wait until next time for a biopsy. I can see that calculation being made, and it's just not fair, just not fair. At all. And I don't know why the numbers are higher for African Americans and for Latinos and other people of color, but I have to guess that's part of it, because the surveillance is very important. It's critical, actually, and so for someone to have to take time off and travel somewhere, especially if you're from a rural area here in California Central Valley, where you have to travel two three hours to a transplant center to do a biopsy, you're probably not going to choose to do that. And so for me, the fight is about helping people who don't have this opportunity. But the opportunity is widespread and available now and being literally I think doctor Potter said it. Maybe you said it nut having the rug ripped from under your legs for some bureaucratic reason that nobody seems to understand the reason why.

Doctor Potter, because this is a Medicare issue and they have been so resistant to change. Why did you go to Congress? And when you were at the Capitol a few weeks ago, what were you asking members of Congress to actually do?

Doctor Potter, because this is a Medicare issue and they have been so resistant to change. Why did you go to Congress? And when you were at the Capitol a few weeks ago, what were you asking members of Congress to actually do?

Well? We've worked diligently new with the Medicare contractor over the course of months, including written statements to them, requests for information, participating in panels as expert transplant providers, and all with a unified voice saying these are critical standard of care tests. And really we have had no response. We've had a couple of meetings and all indications or that our concerns and those of the patients that we serve are falling on deaf ears. So it doesn't seem to CMS has any intention of rolling back these cuts. So that we decided that this issue needs to be elevated. We can't seem to get the attention of Secretary of Bessara, and so we're going to Congress to help. We're asking them to call Secretary of Besera and stop this, to rescind this change. Every member of Congress and every Senator that we've met with, whether Republican or Democrat, has been very sympathetic to this life or death issue. And really there's been outrage and surprise about these cuts, and in brief, people we've talked to on the hill get it.

Well? We've worked diligently new with the Medicare contractor over the course of months, including written statements to them, requests for information, participating in panels as expert transplant providers, and all with a unified voice saying these are critical standard of care tests. And really we have had no response. We've had a couple of meetings and all indications or that our concerns and those of the patients that we serve are falling on deaf ears. So it doesn't seem to CMS has any intention of rolling back these cuts. So that we decided that this issue needs to be elevated. We can't seem to get the attention of Secretary of Bessara, and so we're going to Congress to help. We're asking them to call Secretary of Besera and stop this, to rescind this change. Every member of Congress and every Senator that we've met with, whether Republican or Democrat, has been very sympathetic to this life or death issue. And really there's been outrage and surprise about these cuts, and in brief, people we've talked to on the hill get it.

Because it is a matter of life and death. And as I said earlier, because of my own experience with my brother, my sister and my sister in law, I want to urge our listeners to go to Honor the Gift dot org and click on the take action button that will really help reach your congressman and your senators. Tell them to tell President Biden and CMS to get this rogue contractor under control. This is literally, for thousands of Americans a life and death issue, and I want to thank you for joining me. It's even The work that you're doing as a surgeon to help transform lives is remarkable and literally there are people alive today who would not be without you. I encourage you to keep up your advocacy with lawmakers and Hill and Eddie. I can't tell you I think how important it is and how much we owe you a debt of gratitude for sharing your personal experience with our listeners. Having somebody who is living through it is just dramatically more powerful than having something abstract. So I want to wish both of you a healthy and happy holiday season.

Because it is a matter of life and death. And as I said earlier, because of my own experience with my brother, my sister and my sister in law, I want to urge our listeners to go to Honor the Gift dot org and click on the take action button that will really help reach your congressman and your senators. Tell them to tell President Biden and CMS to get this rogue contractor under control. This is literally, for thousands of Americans a life and death issue, and I want to thank you for joining me. It's even The work that you're doing as a surgeon to help transform lives is remarkable and literally there are people alive today who would not be without you. I encourage you to keep up your advocacy with lawmakers and Hill and Eddie. I can't tell you I think how important it is and how much we owe you a debt of gratitude for sharing your personal experience with our listeners. Having somebody who is living through it is just dramatically more powerful than having something abstract. So I want to wish both of you a healthy and happy holiday season.

Thank you, Newton, Merry Christmas to you too.

Thank you, Newton, Merry Christmas to you too.

Thank you so much for having.

Thank you so much for having.

Us, Michael welcome, and thank you for joining me on Newts World.

Us, Michael welcome, and thank you for joining me on Newts World.

Well, thanks so much for let me be part of this.

Well, thanks so much for let me be part of this.

As a medical document. You've done a number of things, wrote a book about the difference between the world of medicine and the world of politics. You are a great member, a very creative member. I've always appreciated you occasionally allowed me to come and join the doctors at someone godly hour in the morning. That's great fun. So you sent a letter to the administrator of the Centers for Medicare and Medicaid Services expressing concern about the Medicare billing change for non invasive diagnostic blood tests like donor derived self free DNA and gene expression profile. What led you to that concern, Well.

As a medical document. You've done a number of things, wrote a book about the difference between the world of medicine and the world of politics. You are a great member, a very creative member. I've always appreciated you occasionally allowed me to come and join the doctors at someone godly hour in the morning. That's great fun. So you sent a letter to the administrator of the Centers for Medicare and Medicaid Services expressing concern about the Medicare billing change for non invasive diagnostic blood tests like donor derived self free DNA and gene expression profile. What led you to that concern, Well.

I mean, first off, fake step back for a minute and think about someone who's under going to transplant, and you want to monitor them, and you want to be certain that everything continues to work and that their anti rejection medication does not require any adjustment. But really the tools you have are pretty rudimentary. You can do tests for inflammation like a sedimentation rate or white blood cell account. You're really concerned about something. The patient ends up having to have a biopsy of a get near or a lung, and that's obviously a very involved procedure that carries some risk, but at the same time it's necessary if there's perhaps an early episode of rejection going on. But then they come up with a blood test, and it's just fantastic speaking when you think about this, you could draw a blood sample, a peripheral blood sample out of the arm, and if the organ that's been transplanted is suffering, if it is not doing well, some cells are going to be dying and it will release some DNA into the bloodstream, And because that DNA is different from the patient's DNA, they got the ability to detect that. But it's a fantastic ability to monitor AHHS or the Center for Medicare Medicaid Services, and it's denying the best state of the art care to a transplant patient. And again it's one of those things it just isn't right.

I mean, first off, fake step back for a minute and think about someone who's under going to transplant, and you want to monitor them, and you want to be certain that everything continues to work and that their anti rejection medication does not require any adjustment. But really the tools you have are pretty rudimentary. You can do tests for inflammation like a sedimentation rate or white blood cell account. You're really concerned about something. The patient ends up having to have a biopsy of a get near or a lung, and that's obviously a very involved procedure that carries some risk, but at the same time it's necessary if there's perhaps an early episode of rejection going on. But then they come up with a blood test, and it's just fantastic speaking when you think about this, you could draw a blood sample, a peripheral blood sample out of the arm, and if the organ that's been transplanted is suffering, if it is not doing well, some cells are going to be dying and it will release some DNA into the bloodstream, And because that DNA is different from the patient's DNA, they got the ability to detect that. But it's a fantastic ability to monitor AHHS or the Center for Medicare Medicaid Services, and it's denying the best state of the art care to a transplant patient. And again it's one of those things it just isn't right.

This was Bipartisan Bio's representive Ashue before you joined you in the letter. And let me just say I know from talking to my brother who has been going through precise to this, that the difference between drawing blood and having to wait for a biopsy, both in the sense the blood test, which is so much less difficult and so much less painful, so much more convenient, That tells you whether or not you need the biopsy. As I understand it, again, you're the doctor, I'm not. It means you can detect much earlier if there's a problem, and you have to wonder what the mindset is of the bureaucrat than the company which has been hired by CMS to look at this, that thinks we ought to make it later discovery, greater risk of losing the transplanted organ, and more invasive because the biopsies are much more painful and much more invasive than a blood test. I mean, you have to sort of wonder what their reasoning is.

This was Bipartisan Bio's representive Ashue before you joined you in the letter. And let me just say I know from talking to my brother who has been going through precise to this, that the difference between drawing blood and having to wait for a biopsy, both in the sense the blood test, which is so much less difficult and so much less painful, so much more convenient, That tells you whether or not you need the biopsy. As I understand it, again, you're the doctor, I'm not. It means you can detect much earlier if there's a problem, and you have to wonder what the mindset is of the bureaucrat than the company which has been hired by CMS to look at this, that thinks we ought to make it later discovery, greater risk of losing the transplanted organ, and more invasive because the biopsies are much more painful and much more invasive than a blood test. I mean, you have to sort of wonder what their reasoning is.

I think as I understood, what they said was that they were noticing that people were having both the blodlood tests and biopsy. Well, yeah, because the blood test showed free DNA certainly to in their bloodstream, and that sparked the concern that the transplanted organ was suffering. So yes, that's the purpose. You do the screening test, which is to detect free DNA, and then you do the diagnostic test, which is a biopsy to see what the status of the transplanted organ is.

I think as I understood, what they said was that they were noticing that people were having both the blodlood tests and biopsy. Well, yeah, because the blood test showed free DNA certainly to in their bloodstream, and that sparked the concern that the transplanted organ was suffering. So yes, that's the purpose. You do the screening test, which is to detect free DNA, and then you do the diagnostic test, which is a biopsy to see what the status of the transplanted organ is.

Am I right in saying that if you rely only on the biopsy, it's likely to be much later the problems have likely started to show up, and so it's actually much riskier for the patient.

Am I right in saying that if you rely only on the biopsy, it's likely to be much later the problems have likely started to show up, and so it's actually much riskier for the patient.

Yes, it's absolutely correct. And you know, since you've had membister your family go through this. I mean it's a big deal to get put a donor like that and then to run the risk of just standing by while nothing is being done when this transplanted organ is getting into trouble. I mean, it's just again, it just strains credulity that someone thinks has a good idea.

Yes, it's absolutely correct. And you know, since you've had membister your family go through this. I mean it's a big deal to get put a donor like that and then to run the risk of just standing by while nothing is being done when this transplanted organ is getting into trouble. I mean, it's just again, it just strains credulity that someone thinks has a good idea.

Is it correct that a number of them major national organizations in this field have come out in favor of what you're trying to accomplish.

Is it correct that a number of them major national organizations in this field have come out in favor of what you're trying to accomplish.

Yes, sir, We've heard for a number of people on this issue.

Yes, sir, We've heard for a number of people on this issue.

I was looking to listen, like the American Society for Transplant Surgeons, the American Society of Transplantation, the International Society for Heart and Lung Transplantations, the American Association of Kidney Patients. If all of these groups are saying on the medical grounds that you are right, shouldn't the bias be overwhelmingly in favor of doing the less invasive earlier detection model, And shouldn't cms simply reject the advice of the hired company that is telling them to drop this test or make it only occur after the patients beg un to exhibit a problem.

I was looking to listen, like the American Society for Transplant Surgeons, the American Society of Transplantation, the International Society for Heart and Lung Transplantations, the American Association of Kidney Patients. If all of these groups are saying on the medical grounds that you are right, shouldn't the bias be overwhelmingly in favor of doing the less invasive earlier detection model, And shouldn't cms simply reject the advice of the hired company that is telling them to drop this test or make it only occur after the patients beg un to exhibit a problem.

I'm just astounded at your perceptive ability. Yes, of course they should listen to me. That's why I ran for Congress in the first place. I thought people needed a better direction. No, it's right. I mean, these are serious doctors and researchers that are involved in the and they're saying, look, this is a problem if you don't provide the patient this type of surveillance. And I think they need to listen to the experts.

I'm just astounded at your perceptive ability. Yes, of course they should listen to me. That's why I ran for Congress in the first place. I thought people needed a better direction. No, it's right. I mean, these are serious doctors and researchers that are involved in the and they're saying, look, this is a problem if you don't provide the patient this type of surveillance. And I think they need to listen to the experts.

Why wasn't there a period for public comment before making the change?

Why wasn't there a period for public comment before making the change?

Well, that's probably a good question, and I don't know that the agency has provided us an explanation of that.

Well, that's probably a good question, and I don't know that the agency has provided us an explanation of that.

I mean, it's kind of weird that they would step in and make what is essentially a medical change without having allowed the community to understand what the proposed change is and respond and give advice on the proportion. I mean, I don't think that happens very often, does it.

I mean, it's kind of weird that they would step in and make what is essentially a medical change without having allowed the community to understand what the proposed change is and respond and give advice on the proportion. I mean, I don't think that happens very often, does it.

No, it's a fact is counter to the Administrative Procedures Act for them to proceed without the public comment.

No, it's a fact is counter to the Administrative Procedures Act for them to proceed without the public comment.

As I understand it. On September twenty fifth, CMS responded, quote, neither CMS nor the Medicare administrative contractors have made changes that affect patient's ability to have blood tests used to monitor for organ transplantation rejection. Isn't that just flat out not true?

As I understand it. On September twenty fifth, CMS responded, quote, neither CMS nor the Medicare administrative contractors have made changes that affect patient's ability to have blood tests used to monitor for organ transplantation rejection. Isn't that just flat out not true?

Well coversmen issue, and I sent a follow up letter to the Center for Medicare and Medicaid Services in the middle of October, saying that their response was in stark contrast to what the transplant patients and physician associations nationwide have communicated with US, and in the letter we asked the Center for Medicare and Medicaid Services a series of questions to try to understand their actions. And of course, obviously we remain very concerned that CMS has allowed the March twenty twenty three billing article to remain in effect because it is so out of step with widely accepted evidence and its departure from precedent.

Well coversmen issue, and I sent a follow up letter to the Center for Medicare and Medicaid Services in the middle of October, saying that their response was in stark contrast to what the transplant patients and physician associations nationwide have communicated with US, and in the letter we asked the Center for Medicare and Medicaid Services a series of questions to try to understand their actions. And of course, obviously we remain very concerned that CMS has allowed the March twenty twenty three billing article to remain in effect because it is so out of step with widely accepted evidence and its departure from precedent.

What steps can be taken to force them to change if CMS just plane refuses to follow the medical and scientific advice well.

What steps can be taken to force them to change if CMS just plane refuses to follow the medical and scientific advice well.

In response to the transplant community's reaction to the coverage change, private contractors allowed for public comment to process in September when they heard from deeply concerned physicians and patients who have not received their regularly scheduled tests and literally fear for their own lives. Medicare is reviewing the comments and will determine the final decision on coverage. Given the fact that the Center for Medicare and Medicaid Services public statements to date on this issue, the transmit community is fearful that their voices have not been heard.

In response to the transplant community's reaction to the coverage change, private contractors allowed for public comment to process in September when they heard from deeply concerned physicians and patients who have not received their regularly scheduled tests and literally fear for their own lives. Medicare is reviewing the comments and will determine the final decision on coverage. Given the fact that the Center for Medicare and Medicaid Services public statements to date on this issue, the transmit community is fearful that their voices have not been heard.

If I understand the system correctly, either the President or the Secretary of Health and Human Services could in fact step in and just cancel what CMS is done and return to the system that the medical doctors and the people who are studying this belief is the correct system, so it could be fixed just administratively if they want to do it.

If I understand the system correctly, either the President or the Secretary of Health and Human Services could in fact step in and just cancel what CMS is done and return to the system that the medical doctors and the people who are studying this belief is the correct system, so it could be fixed just administratively if they want to do it.

Yes. Congress obviously plays a critical role in the oversight of the agencies. Our Energy, Commerce Health Subcommittee has considered several bills in recent weeks to provide additional guardrails for contractors who issue these types of coverage decisions. In addition to pressing CMS and what we see is overreaches such as this decision, we do have to ensure that CMS and its contractors don't just operate on their own with limited or no oversight. But let's be clear, the administration doesn't need a legislative action to fix this issue. It is completely within the purview of the administratively to reverse these cuts. But it does seem that our concerns have been ignored by the agency and by the private contractors. So we are asking President Biden and Secretary Pisera to cancel the rescind in the March coverage determination.

Yes. Congress obviously plays a critical role in the oversight of the agencies. Our Energy, Commerce Health Subcommittee has considered several bills in recent weeks to provide additional guardrails for contractors who issue these types of coverage decisions. In addition to pressing CMS and what we see is overreaches such as this decision, we do have to ensure that CMS and its contractors don't just operate on their own with limited or no oversight. But let's be clear, the administration doesn't need a legislative action to fix this issue. It is completely within the purview of the administratively to reverse these cuts. But it does seem that our concerns have been ignored by the agency and by the private contractors. So we are asking President Biden and Secretary Pisera to cancel the rescind in the March coverage determination.

You would think, as a matter of compassion that President Biden would be inclined to step in on behalf of the patients and on behalf of the doctors. Biden talks a lot about compassion, talks a lot about caring about people. I would think this would be a no brainer for them to get this solved. And we want to do all we can to help get across the message. And I also just want to say I am very, very grateful for yearlydership on such a wide range of issues, not just health issues, and how much you have contributed to getting things done trying to solve America's problems. You are the kind of citizen in public life that we need a heck of a lot more of. And Michael, I want you to know how proud I am to call you a friend, and how proud I am of what you've done to help people.

You would think, as a matter of compassion that President Biden would be inclined to step in on behalf of the patients and on behalf of the doctors. Biden talks a lot about compassion, talks a lot about caring about people. I would think this would be a no brainer for them to get this solved. And we want to do all we can to help get across the message. And I also just want to say I am very, very grateful for yearlydership on such a wide range of issues, not just health issues, and how much you have contributed to getting things done trying to solve America's problems. You are the kind of citizen in public life that we need a heck of a lot more of. And Michael, I want you to know how proud I am to call you a friend, and how proud I am of what you've done to help people.

You're overly generous with your assessment. I appreciate the kind comments. I'm probably the luckiest personal live I got to practice medicine in my hometown for twenty five years, and then I got to come up here and represent my hometown for twenty two years in the Congress. When it all comes to a conclusion, I've got no regrets. I've been blessed by being able to play a part in so many people's lives back home.

You're overly generous with your assessment. I appreciate the kind comments. I'm probably the luckiest personal live I got to practice medicine in my hometown for twenty five years, and then I got to come up here and represent my hometown for twenty two years in the Congress. When it all comes to a conclusion, I've got no regrets. I've been blessed by being able to play a part in so many people's lives back home.

Thank you to my guests, doctor Stephen Potter, Eddie Garcia, and Congressman Michael Burgess. You can learn more about Honor the Gift on our show page at newtsworld dot com. Newtsworld is produced by Ganging three sixty and iHeartMedia. Our executive producer is Guernsey Sloan and our researcher is Rachel Peterson. The artwork for the show was created by Steve Penley. Special thanks to the team at Ginglish three sixty. If you've been enjoying Newtsworld, I hope you'll go to Apple Podcast and both rate us with five stars. And give us a review so others can learn what it's all about. Right now, listeners of Newtsworld consign him for my three freeweekly columns at ganglistree sixty dot com slash newsletter. I'm Newt Gingrich. This is Newtsworld, and this episode of neuts World was brought to you by Honor the Gift dot org

Thank you to my guests, doctor Stephen Potter, Eddie Garcia, and Congressman Michael Burgess. You can learn more about Honor the Gift on our show page at newtsworld dot com. Newtsworld is produced by Ganging three sixty and iHeartMedia. Our executive producer is Guernsey Sloan and our researcher is Rachel Peterson. The artwork for the show was created by Steve Penley. Special thanks to the team at Ginglish three sixty. If you've been enjoying Newtsworld, I hope you'll go to Apple Podcast and both rate us with five stars. And give us a review so others can learn what it's all about. Right now, listeners of Newtsworld consign him for my three freeweekly columns at ganglistree sixty dot com slash newsletter. I'm Newt Gingrich. This is Newtsworld, and this episode of neuts World was brought to you by Honor the Gift dot org