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Speaker 1: On this episode of News World. There are over one

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Speaker 1: hundred thousand Americans on the organ transplant waiting list, and

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Speaker 1: seventeen people lose their lives every day waiting for a transplant.

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Speaker 1: I personally witness the journey of my brother and my

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Speaker 1: sister and my sister in law go through the transplantation process,

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Speaker 1: and it's opened my eyes to the profound relief and

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Speaker 1: the immense hope that comes with receiving a donated organ. However,

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Speaker 1: the journey does not stop after receiving a transplant. The

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Speaker 1: threat of organ rejection is a constant worry, with significant

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Speaker 1: failure rates within the first five years after the transplant.

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Speaker 1: And now there's a new hurdle introduced by government contractors

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Speaker 1: jeopardizing the health of transplanted organs. Innovative blood tests allow

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Speaker 1: physicians to detect organ damage and rejection before patients show symptoms.

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Speaker 1: Doctors require these crucial blood tests to effectively monitor and

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Speaker 1: manage the care of their immunocompromised patients. Here to discuss

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Speaker 1: this new challenge transplant patients are facing. I am really

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Speaker 1: pleased to welcome my guests. Doctor Stephen Potter, an experienced

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Speaker 1: kidney and pancreas transplant surgeon and board certified urologist who

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Speaker 1: is Professor of Surgery and Eurology at Georgetown University School

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Speaker 1: of Medicine. Eddie Garcia, a heart transplant recipient and author

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Speaker 1: of the book Summer in the Waiting Room. Both are

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Speaker 1: members of a coalition called Honor the Gift. Additionally, I

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Speaker 1: am honored to be joined by Congressman Michael Burgess from

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Speaker 1: the twenty sixth District of Texas, who has been working

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Speaker 1: on this issue in Congress. Steven and Nettie, welcome and

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Speaker 1: thank you for joining me in Newts World.

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Speaker 2: Thank you Newton.

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Speaker 1: Let me sort of set the background that due to

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Speaker 1: a rare, very rare lung disease that runs in the

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Speaker 1: McPherson side of my family, two of my siblings have

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Speaker 1: had lung transplants. Further, my sister in law is head

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Speaker 1: a liver transplant. When my brother Randy received his transplant

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Speaker 1: four years ago at the local hospital in Nova, he

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Speaker 1: stayed at our house for months while he recovered. I've

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Speaker 1: personally witnessed the physical and emotional journey of a loved

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Speaker 1: one who needs a transplant. The alternative is death and

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Speaker 1: the relief and joy of being given a second chance

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Speaker 1: to the gift of a donated organ, and all three

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Speaker 1: of them today are doing fine. The thing most people

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Speaker 1: don't realize is the amount of work it takes to

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Speaker 1: keep your body from rejecting the organ. And that is

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Speaker 1: what we're going to focus on today. Eddie. Let me

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Speaker 1: ask you to talk about your story from heart attack

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Speaker 1: to heart transplant.

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Speaker 2: Well, thank you Newton, thank you for this opportunity. In

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Speaker 2: twenty ten, I was literally on top of my little world.

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Speaker 2: I was president of a local school board. I was

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Speaker 2: an executive. I was forty six years old. Everything was

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Speaker 2: going fine. And one morning, it was June seventh, twenty ten,

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Speaker 2: to be exact, I was in the gym doing my

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Speaker 2: workout and I couldn't finish. As the morning wore on,

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Speaker 2: it got worse. I went to see my doctor. She

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Speaker 2: did a series of tests and immediately sent me to

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Speaker 2: the emergency room. Within ten or fifteen minutes from getting

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Speaker 2: to the doctor's office, I was rolled into the emergency

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Speaker 2: room on a wheelchair and three doctors there waited for me,

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Speaker 2: and one of them said, mister Garcia, you're having a

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Speaker 2: heart attack. I had a massive heart attack my artery

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Speaker 2: that some called the widow maker was one hundred percent blocked.

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Speaker 2: I spent the next ten years battling congestive heart failure.

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Speaker 2: My heart was very weak from the heart attack, and finally,

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Speaker 2: in April of twenty twenty, I got the gift of

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Speaker 2: a heart transplant, and needless to say, it changed everything.

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Speaker 2: There was a time where I couldn't walk down the

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Speaker 2: driveway to the mailbox and back up the driveway without

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Speaker 2: stopping a few times and losing my breath. And I

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Speaker 2: would say within a month of the transplant, I was

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Speaker 2: walking down to the end of the street. By three months,

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Speaker 2: I was walking a mile or two, and it got

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Speaker 2: to the point where I'd do a regular four mile

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Speaker 2: walk a day. And it's just been a blessing. It's

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Speaker 2: been amazing. And that's pretty much my story from heart

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Speaker 2: attack to heart transplant.

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Speaker 1: Now I remember this with my brother. It seems to

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Speaker 1: whether you feel better, but you have to recover and

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Speaker 1: you have to worry about rejection, and you have a

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Speaker 1: whole regiment of pails and things that you have to

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Speaker 1: really pay attention to. Was that true for you?

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Speaker 2: Absolutely, it's a slow process feeling better. I think a

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Speaker 2: lot of people believe that you wake up the next

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Speaker 2: morning and you feel great, and that's just not the case.

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Speaker 2: You know. The way my doctor described it is your

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Speaker 2: body is getting hit by an eighteen wheel truck.

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Speaker 1: This was the good news, because the alternative was deaf.

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Speaker 2: That's right, this is the good news. So it's a

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Speaker 2: slow process. The recovery is a slow process, so you

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Speaker 2: don't feel better instantly. But the main thing that you

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Speaker 2: have to do, which is essentially a full time job,

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Speaker 2: is take care of that heart so the body doesn't

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Speaker 2: reject it. And so for me, probably for everybody, it

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Speaker 2: was Phase one was taking a whole bunch of pills.

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Speaker 2: And I did a little calculation, and I probably took

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Speaker 2: about thirteen thousand pills in that first year. It was

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Speaker 2: a handful of pills in the morning, in the afternoon,

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Speaker 2: in the evening. So that's step one. Step two is

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Speaker 2: your immunosuppress. So a big chunk of the medication is

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Speaker 2: to prevent your body from reach your heart. So in

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Speaker 2: other words, your body and your antibodies start stirring up,

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Speaker 2: getting ready for a fight because they want to kick

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Speaker 2: out this sporn thing that's in your body. And so

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Speaker 2: taking care of that and staying healthy is the key. Thing,

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Speaker 2: because anything flew cold, anything could really exacerbate the disease

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Speaker 2: because your body's amino suppressed. And for me, my heart

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Speaker 2: transplant happened literally one month after the national lockdown with COVID,

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Speaker 2: so there was the additional layer of COVID, And in

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Speaker 2: the first weeks and months there are numerous doctor's appointments,

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Speaker 2: so protecting myself from the house to the doctor's appointment

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Speaker 2: was critical. And so the short story really is taking

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Speaker 2: care of a transplanted organ is a full time job.

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Speaker 1: Tell me about the difference in having blood tests and biopsies.

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Speaker 2: This is another night and day proposition. The biopsy is

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Speaker 2: pretty invasive. Here's what happened. You go into a room

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Speaker 2: that looks like an operating room. You're on a table

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Speaker 2: on the right side of the neck. The doctor's cut

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Speaker 2: a little incision and stick a needle and a tube

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Speaker 2: into the chrootic artery which goes into your heart to

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Speaker 2: literally scratch out tissue and pull it back out. And

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Speaker 2: so your awake during this process. And doctor Potter might

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Speaker 2: be able to explain that a little bit more. It's

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Speaker 2: nerve wracking, it's invasive. For me, fortunately it wasn't that bad,

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Speaker 2: but from fellow heart transplant patents that I've talked to,

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Speaker 2: it can be a very hairy proposition. Now, the blood

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Speaker 2: test that can also detect early signs of rejection is

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Speaker 2: simply a blood test. It's like when you go to

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Speaker 2: the doctor to do a blood drop for whatever you

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Speaker 2: have to do it for. In my case, it was

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Speaker 2: even easier. A phlebotomus came to my house and I

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Speaker 2: sat here in my dining room table and she did

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Speaker 2: the little prick, took the blood and went on her way. So,

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Speaker 2: without a doubt, that's a much better process.

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Speaker 1: Good. Let me shift to doctor Potter, how concerned are

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Speaker 1: you about organ rejection leading to failure?

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Speaker 3: Rejection is the biggest cause of loss of these transplanted organs,

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Speaker 3: and it's a constant threat. But most importantly, it's a

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Speaker 3: constant fear for patients. I mean, they live every day

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Speaker 3: worrying that they're going to develop rejection, and that rejection

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Speaker 3: develops silently. It's not like they wake up and have

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Speaker 3: pain typically and know that they have rejection. It's something

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Speaker 3: that sneaks up on them. And so there has to

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Speaker 3: be a good way to surveil. Do surveillance for the

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Speaker 3: development of that rejection.

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Speaker 1: How often do you try to do the surveillance.

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Speaker 3: Well, so it depends on the individual transplant patient and

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Speaker 3: how far they're off from their transplant of what type

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Speaker 3: of organ we're talking about, But if we talk about kidneys,

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Speaker 3: that's the highest volume transplant by far in this country

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Speaker 3: and the one with the most data to support sort

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Speaker 3: of the recommendations. We check people for rejection a couple

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Speaker 3: times a week after the transplant for the first month

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Speaker 3: or two, and then we see them about once a

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Speaker 3: week for another couple of months, and then we see

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Speaker 3: them once a month for the rest of that year,

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Speaker 3: and at each of those visits we check some simple

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Speaker 3: blood tests that are sort of old fashioned legacy markers

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Speaker 3: that can serve to look for rejection, but not the

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Speaker 3: molecular tests that we're talking about. Those are obtained much

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Speaker 3: less frequently with eddie.

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Speaker 1: What's the relative difference in being able to take blood

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Speaker 1: versus biopsies.

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Speaker 3: Well, that's a really great question.

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Speaker 1: Nut.

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Speaker 3: So biopsies are expensive and invasive, and they carry significant risks,

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Speaker 3: and they're really best viewed as a way to confirm

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Speaker 3: that there's something going on with the transplanted organ. The

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Speaker 3: molecular testing that we're talking about. These are non invasive

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Speaker 3: blood tests. They can be done at any hospital lab,

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Speaker 3: third party lab, or even through phlebotomists that make home

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Speaker 3: visits at no charge to the patient to draw their blood.

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Speaker 3: So patients know that this is really a game changer

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Speaker 3: in terms of how invasive and dangerous it is for

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Speaker 3: them and how convenient.

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Speaker 2: It can be for them.

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Speaker 1: Is all this relatively new science that enables this kind

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Speaker 1: of less invasive approach.

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Speaker 3: Well, I mean, it depends on how long a view

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Speaker 3: you take of it. Right new The first successful kidney

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Speaker 3: transplants were done in this country in nineteen fifty four,

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Speaker 3: so transplantation of kidneys is not a new process. But

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Speaker 3: we've been monitoring kidney transplant health. We've been surveilling patients

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Speaker 3: after transplant really in much the same way using kind

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Speaker 3: of limited legacy tools for about three decades now. And

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Speaker 3: these molecular tests are therefore relatively new. They came on

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Speaker 3: the scene about six years ago and they rapidly became

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Speaker 3: a standard of care new because they offer a better

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Speaker 3: way forward. They're really robustly valid dated analytically. They're validated clinically,

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Speaker 3: which means we know that they're measuring what we think

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Speaker 3: they're measuring, and we know that there's clinical relevance to

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Speaker 3: the results, and that's really important, right. We not only

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Speaker 3: know that the answer we get means something, but we

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Speaker 3: know what contexts are put it in and how to

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Speaker 3: use it in guiding clinical decisions for patients.

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Speaker 1: How many of these tests would a typical transplant patient have.

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Speaker 3: So after a kidney transplant, in an ideal world, these

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Speaker 3: molecular tests would be used about once a month for

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Speaker 3: the first four or five months six months, and then

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Speaker 3: quarterly after that for the next couple of years. So

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Speaker 3: we're not talking about a huge number of tests in

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Speaker 3: an individual patient, and.

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Speaker 1: That allows you to not have to do the biopsy

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Speaker 1: unless something comes up that convinces you there's a real problem.

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Speaker 3: Right exactly, So, most of these molecular tests are going

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Speaker 3: to be giving us a green light. They're going to

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Speaker 3: be normal. The results will indicate that the patient has

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Speaker 3: a low risk of having rejection, that their immune system

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Speaker 3: is not activated against the organ, and that they're not

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Speaker 3: suffering ongoing injury to their transplanted alligraph But when the

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Speaker 3: test results are abnormal, that can be an important and

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Speaker 3: early trigger that helps us know that we need to

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Speaker 3: get a biopsy. And importantly, there are very good data

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Speaker 3: from the peer reviewed literature that tell us that these

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Speaker 3: markers provide an earlier indication of injury to the alligraph

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Speaker 3: than any other sort of legacy blood test did. And

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Speaker 3: that's a very valuable tool because time is tissue in

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Speaker 3: a way. Right as time goes on with rejection smoldering

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Speaker 3: in the kidney, you're losing kidney tissue.

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Speaker 1: My brother told me that the whole experience with his

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Speaker 1: lung transplant, that the tests were invaluable, and that the

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Speaker 1: sense of relief he had every time he went in

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Speaker 1: and it turned out they were okay, that's just dramatically

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Speaker 1: improved the quality of his life.

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Speaker 3: Yeah, and that's a common refrain I hear from patient

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Speaker 3: all the time. And when the rules that govern when

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Speaker 3: these tests were covered were changed, that caused a lot

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Speaker 3: of consternation, as you can imagine, from patients all over

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Speaker 3: the country who had been sort of used to getting

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Speaker 3: these tests, getting a sense of security from good results

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Speaker 3: and knowing that they would have an early detection of

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Speaker 3: rejection in the unfortunate case that the results were not

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Speaker 3: good and that would rout them into a biopsy and

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Speaker 3: further treatment, and all of a sudden they felt that

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Speaker 3: the rug was kind of pulled out from under them.

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Speaker 1: This becomes very personal, Eddie, I understand that this test

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Speaker 1: has helped you, and then you actually had a big

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Speaker 1: scare recently with your transplant.

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Speaker 2: First of all, for the frequency, I got the blood

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Speaker 2: tests once a quarter every three months post transplant, and

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Speaker 2: for the first year and a half or so, it

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Speaker 2: was like clockwork. If Lebatos had come to my house,

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Speaker 2: do the draw. A couple of days later, two three

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Speaker 2: days later, I'd get a call from my doc and

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Speaker 2: then she would say, hey, Eddie, you are good to go. And,

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Speaker 2: like doctor Potter said, full relief, because there's some anticipation,

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Speaker 2: a little nervousness in those three days, like I hope,

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Speaker 2: I hope, I hope. And every three months, three days

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Speaker 2: later my clockwork, as I said, done, You're good, good

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Speaker 2: to go. And so in June of twenty twenty one,

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Speaker 2: which is about fifteen months out from transplant, I had

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Speaker 2: just come in from a walk. I think I walked

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Speaker 2: three or four miles. It was a beautiful June day.

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Speaker 2: I was feeling like a million bucks. The blood draw

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Speaker 2: had been a few days before and my dog calls

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Speaker 2: and I was fully expecting you're good to go, and

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Speaker 2: she said, bluntly, Eddie, you need to come check into

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Speaker 2: the hospital today and expect to be here for at

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Speaker 2: least eleven days. I was shocked, to say the least,

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Speaker 2: and really nervous, and I asked her why, and she

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Speaker 2: said that the test had indicated that I was in rejection.

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Speaker 2: My first reaction was, wait a minute, I just got

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Speaker 2: in from a walk. I feel like a million bucks.

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Speaker 2: What are you talking about, doctor, And she said, that's

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Speaker 2: what the test is designed to do. You got to

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Speaker 2: come in. So I went in and spent the next

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Speaker 2: eleven days in the hospital impatient and was pumped up

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Speaker 2: with a bunch of proteins to clean out my system.

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Speaker 2: And after eleven days I went home, and then for

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Speaker 2: the next six months on an outpatient basis, once a month,

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Speaker 2: I did the same thing. And at the end of

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Speaker 2: that process, the doctor gave me the green light after

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Speaker 2: a biopsy and said you're good to go and keep

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Speaker 2: on moving with life. And it was a humongous relief.

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Speaker 1: It's fascinating me if that test hadn't been available and

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Speaker 1: you still felt pretty good. But in fact, you were

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Speaker 1: steadily having your heart rejected. It's conceivable that it would

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Speaker 1: have cost you your life.

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Speaker 2: Absolutely. From my understanding is prior to this test, what

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Speaker 2: would have to happen If it wasn't detected during an

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Speaker 2: annual biopsy. You would have to start feeling symptoms, at

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Speaker 2: least for heart patients. I'm not sure about kidney patients,

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Speaker 2: but you would start feeling heart failure symptoms. And so

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Speaker 2: when you start feeling those, you're significantly down the road.

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Speaker 2: So one of two things happened, One which is the

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Speaker 2: most dramatic, as you lose your life the worst case scenario.

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Speaker 2: The other is you might have to be listed again

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Speaker 2: and go through that process all over. And for someone

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Speaker 2: who lived with heart failure so long and went through

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Speaker 2: that heroin summer, I couldn't fathom what it would be

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Speaker 2: like to have to go through all that again.

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Speaker 1: I have to ask doctor Potter, how often do people

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Speaker 1: get a rejection and then have a second transplant for kidney.

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Speaker 3: About ten percent of the people on the list, and

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Speaker 3: they are about almost one hundred thousand people on the

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Speaker 3: list in this country waiting for a kidney transplant, about

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Speaker 3: ten percent of those have had prior transplants, and so

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Speaker 3: about one in ten people that I transplant have had

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Speaker 3: a prior kidney transplant. Let's talk about a very important thing,

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Speaker 3: and that is that your lowest risk is a transplant

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Speaker 3: reshipping is that first transplant, and that these are precious

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Speaker 3: gifts of life, and that the supply of kidneys available

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Speaker 3: for people is always going to be less than the

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Speaker 3: demand for those kidneys. And so if we can make

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Speaker 3: efforts in improving how long people keep those kidney transplants working,

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Speaker 3: then we decrease the likelihood they returned to the list

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Speaker 3: for another kidney. And when we do that, that's a

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Speaker 3: rising tide that raises all the boats, because every kidney

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Speaker 3: that doesn't go into someone who's already had a transplant

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Speaker 3: is available for someone who really needs a life saving

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Speaker 3: transplant to get off dialysis and otherwise might not have

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Speaker 3: a shot.

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Speaker 1: To put all this in context, a couple of weeks ago,

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Speaker 1: I wrote an op ed and then I participated in

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Speaker 1: a press conference which both of you also attended. Back

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Speaker 1: in March, transplant patients regular care was disrupted when palmetto

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Speaker 1: a private contractor to Medicare that pays for these tests.

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Speaker 1: Medicare pays for the test. This contract published an article

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Speaker 1: which tied coverage of non invasive blood tests to invasive biopsies,

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Speaker 1: which had never before been the case. The Center for

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Speaker 1: Medicare and Medicaid Services CMS as the government agency that

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Speaker 1: runs Medicare, but they rely very heavily on private contractors.

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Speaker 1: This particular contractor that pays for this part of the program,

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Speaker 1: a METAGBA, took abrupt action in March to roll back

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Speaker 1: coverage of these non invasive tests. This has been covered

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Speaker 1: by the media, including three Wall Street Journal op eds.

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Speaker 1: There were about two hundred advocates in Washington a couple

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Speaker 1: of weeks ago, and they conducted over one hundred meetings

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Speaker 1: with members of the House and Senate urging them to

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Speaker 1: reverse the cuts in a pretty unusual turn of event.

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Speaker 1: I was on the same agenda with Reverend Al Sharpton,

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Speaker 1: who I've worked with before on school chain, so he

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Speaker 1: occasionally vary bipartisan despite everything else. But it demonstrates how

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Speaker 1: broad the bipartisan concern is and how absurd the change

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Speaker 1: in coverages. Doctor Potter, can you explain the change in

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Speaker 1: coverage and the significance of Palmeta linking coverage of this

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Speaker 1: test to a non invasive biopsy.

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Speaker 3: Let me say someone who I wake up every morning

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Speaker 3: concerned about transplant patients and advocating for them. The bipartisan

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00:19:19,680 --> 00:19:24,080
Speaker 3: support this issues received is really heartening, very encouraging. The

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Speaker 3: change in coverage that occurred was significant for three big reasons.

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Speaker 3: It most importantly, kind of out of the blue and

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Speaker 3: in contradistinction to all the other prior coverage statements, linked

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Speaker 3: the availability of molecular testing for kidney surveillance to the

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Speaker 3: direct replacement of biopsy protocols. And that's puzzling to us

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Speaker 3: because only about seventeen percent of transplant centers in this

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Speaker 3: country even utilized these biopsy protocols, so that right there

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Speaker 3: you have a very confusing restriction and access for patients.

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Speaker 3: It also limited access to molecular testing based on time

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Speaker 3: relative to a b obviously being obtained. And it also

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Speaker 3: prohibited the use of multiple tests, for example, a gene

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Speaker 3: expression profile test and a self free DNA test in

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Speaker 3: the same patient encounter.

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Speaker 1: There seems confusion because apparently in September, the Center for

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Speaker 1: Medicare and Medicaid Services argue that neither CMS nor the

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Speaker 1: Medicare administrative contractors have made changes that affect patient's ability

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Speaker 1: to have blood tests used to monitor for organ transplantation

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Speaker 1: rejection when ordered by their physicians and medically appropriate circumstances.

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Speaker 1: What does that mean?

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Speaker 3: Yeah, I don't know what it means, because it seems

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Speaker 3: to the community that these were substantive changes to coverage,

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Speaker 3: and in fact, the number of tests ordered precipitously dropped

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Speaker 3: immediately upon issuance of these new rules. Medicare had been

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Speaker 3: covering these tests for years. Medicare coverage for these innovative

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Speaker 3: blood tests became available starting in about two thousand and six,

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Speaker 3: but that coverage was greatly expanded starting about twenty seventeen.

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Speaker 3: The coverage that was in place explicitly stated that these

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Speaker 3: blood tests could occur on a routine or surveillance basis

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Speaker 3: and we're not tied to a biopsy, and so for years,

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Speaker 3: that's the way that these tests became part of the

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Speaker 3: standard of care and caring for these patients. And when

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Speaker 3: this was all changed and biopsy and molecular testing were

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Speaker 3: specifically linked, they had a real chilling effect throughout the

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Speaker 3: transplant community and led to a lot of tests being

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Speaker 3: canceled that had already been ordered and going forward, a

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Speaker 3: lot fewer tests being obtained, which left a lot of

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Speaker 3: patients frightened and concerned.

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Speaker 2: I'm not a doctor, I'm not a policymaker. I'm just

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Speaker 2: a regular guy here, right, But the term medically appropriate

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Speaker 2: to me sounds like, at least for heart patients, is

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Speaker 2: you're huffing and puffing going down the driveway to get

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Speaker 2: your mail, so let's check something out. And that's just

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Speaker 2: too late. So to me, that language, it's an empty phrase.

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Speaker 2: So in other words, they're saying we're going to provide access.

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Speaker 2: Thinks it's medically appropriate. It's just too late for that.

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Speaker 1: I'm glad you raised this because, as I understand it,

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Speaker 1: there was a study by the National Heart, Lung, and

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Speaker 1: Blood Institute which looked at nearly two hundred heart transplant

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Speaker 1: recipients and found that the donor derived self free DNA

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Speaker 1: test performed better than tissue biopsies because it quote signaled

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Speaker 1: problems even when no outward signs of rejection we revenant.

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Speaker 1: They found that the blood test may be able to

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Speaker 1: detect rejection as early as twenty eight days after heart

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Speaker 1: transplantation and at least three months before rejection is detectable

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Speaker 1: using heart tissue biopsy. Now, if we're saying here, you

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Speaker 1: could literally be suffering a silent rejection for three months

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Speaker 1: before there was enough change to be detected by the

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Speaker 1: heart tissue of biopsy, but the modern molecular blood test

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Speaker 1: would have picked it up immediately. Isn't this sort of

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Speaker 1: crazy to not have this? This is a standard of care.

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Speaker 2: As someone who has been through this, that's absolutely crazy.

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Speaker 2: It just doesn't make sense. As my dad used to say,

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Speaker 2: you know, I'm not a mathematician, but that's not good math.

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Speaker 3: Yeah, I think you hit the nail on the head, Eddie,

401
00:23:14,680 --> 00:23:17,919
Speaker 3: but you know, it doesn't make sense. And new I

402
00:23:17,920 --> 00:23:21,359
Speaker 3: would say, these tests have become standard of care. So

403
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Speaker 3: the issue is not are they standard of care? The

404
00:23:23,800 --> 00:23:27,159
Speaker 3: issue is is the standard of care that was previously

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Speaker 3: covered going to now be not covered so that patients

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Speaker 3: that had access. I mean, let's remember that organ failure

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Speaker 3: in general is not a disease of the wealthy. It

408
00:23:38,920 --> 00:23:42,199
Speaker 3: disproportionately affects people of color and people that are disadvantaged

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Speaker 3: in terms of access to care. You know, folks who

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00:23:44,840 --> 00:23:47,479
Speaker 3: have been relying on a standard of care test that

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00:23:47,560 --> 00:23:51,240
Speaker 3: it clearly is robustly validated and we know it helps

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Speaker 3: drive decision making and improve the care of these patients.

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Speaker 3: We know that it gives us additional time to pick

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Speaker 3: up rejection and remember rejection. And it's like having your

415
00:24:01,280 --> 00:24:04,120
Speaker 3: house on fire when you have rejection that transplanted organ

416
00:24:04,200 --> 00:24:08,080
Speaker 3: you're losing, you're damaging that tissue, and you're losing a

417
00:24:08,160 --> 00:24:12,439
Speaker 3: kidney or heart function. Time really matters, and so that

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00:24:12,600 --> 00:24:15,399
Speaker 3: extra time to pick up on rejection is critical and

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Speaker 3: access to this for patients who've been really historically disproportionately disadvantaged,

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Speaker 3: have a huge burden of organ failure in this country.

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Speaker 3: That's critically important. And I think the reason that both

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00:24:26,359 --> 00:24:29,440
Speaker 3: you and Al Sharpton is so capably and eloquently spoke

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Speaker 3: about this last week.

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Speaker 1: This is really in particular about African American and Latino

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Speaker 1: and Native American patients being more disadvantaged and more likely

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Speaker 1: to have the rejection and am not allowing a state of

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Speaker 1: the art intervention to check on them increases the likelihood

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Speaker 1: of their being rejected significantly. So that there's a very

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Speaker 1: practical reason that Reverend Sharpton and I were on the

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Speaker 1: same page about this. I should mention, by the way

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Speaker 1: that at our show page, we're going to have a

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Speaker 1: link to the press conference for listeners who want to

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Speaker 1: see even more about this. But doctor Potter, I'm very

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Speaker 1: curious not to put you on the spot. I realize

435
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Speaker 1: you're not a political scientist, you're a medical doctor, But

436
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Speaker 1: why do you think CMS is doing this? Do you

437
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Speaker 1: have any idea what's behind it all?

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00:25:19,000 --> 00:25:21,320
Speaker 3: Ultimately, that's a question that we have to be asked

439
00:25:21,359 --> 00:25:26,159
Speaker 3: of CMS. It's very concerning that the processes in place

440
00:25:26,240 --> 00:25:30,080
Speaker 3: that include public comment and discourse weren't followed when this

441
00:25:30,160 --> 00:25:33,360
Speaker 3: billing article was used to change coverage for these standard

442
00:25:33,359 --> 00:25:36,040
Speaker 3: of care tests. And so the first thing that we

443
00:25:36,080 --> 00:25:38,879
Speaker 3: would do is really ask CMS, are you sure that

444
00:25:38,920 --> 00:25:42,640
Speaker 3: your private contractor is doing things the way you think

445
00:25:42,720 --> 00:25:46,720
Speaker 3: is palatable? And then the second is based on conversations

446
00:25:46,800 --> 00:25:51,120
Speaker 3: that we've had with Congresswomen Issue and Congressman Burgess, who've

447
00:25:51,160 --> 00:25:54,080
Speaker 3: really been champions in transplant and helping us to try

448
00:25:54,080 --> 00:25:58,760
Speaker 3: to get answers. CMS is concerned about overutilization of this test,

449
00:25:58,880 --> 00:26:01,080
Speaker 3: which I think implies that more tests are being ordered

450
00:26:01,119 --> 00:26:04,840
Speaker 3: by doctors and CMS sinc should be happening. But remember

451
00:26:04,920 --> 00:26:07,560
Speaker 3: that the average number of tests being done for these

452
00:26:07,560 --> 00:26:10,639
Speaker 3: patients is actually really low. In the real world, kidney

453
00:26:10,680 --> 00:26:13,680
Speaker 3: patients are typically getting something like four tests a year

454
00:26:13,760 --> 00:26:17,000
Speaker 3: after their first year, so it's hard to understand that.

455
00:26:17,560 --> 00:26:21,520
Speaker 1: A recent survey had found that something like ninety five

456
00:26:21,560 --> 00:26:24,920
Speaker 1: percent of the patients are concerned that the new Medicare

457
00:26:24,960 --> 00:26:27,520
Speaker 1: building is going to limit their coverage for a non

458
00:26:27,600 --> 00:26:31,600
Speaker 1: invasive post transplant test, Eddie, I mean, how does this

459
00:26:31,640 --> 00:26:32,440
Speaker 1: affect your life?

460
00:26:32,440 --> 00:26:36,040
Speaker 2: For example, I'm not a Medicare patient. I'm a Kaiser

461
00:26:36,119 --> 00:26:40,840
Speaker 2: patient have private insurance. However, I'm really involved in this

462
00:26:41,000 --> 00:26:44,720
Speaker 2: issue because of those stats you laid out earlier about

463
00:26:45,400 --> 00:26:49,240
Speaker 2: especially Latino patients. And I grew up in a working

464
00:26:49,240 --> 00:26:53,200
Speaker 2: class Latino neighborhood, and I think about my friends if

465
00:26:53,200 --> 00:26:56,159
Speaker 2: they've had to go through some of these processes that

466
00:26:56,200 --> 00:27:01,720
Speaker 2: I've had to gone through, And if the only way

467
00:27:01,760 --> 00:27:06,879
Speaker 2: to detect is the pre blood test model, which is

468
00:27:06,920 --> 00:27:11,280
Speaker 2: through biopsy, and you have to take a full day

469
00:27:11,320 --> 00:27:15,760
Speaker 2: off of work to go and get a biopsy, your

470
00:27:15,960 --> 00:27:19,520
Speaker 2: decision is Okay, Am I going to do that and

471
00:27:20,080 --> 00:27:22,880
Speaker 2: not put food on the table for my family. I'll

472
00:27:22,880 --> 00:27:26,040
Speaker 2: just wait until next time for a biopsy. I can

473
00:27:26,080 --> 00:27:28,840
Speaker 2: see that calculation being made, and it's just not fair,

474
00:27:29,119 --> 00:27:32,159
Speaker 2: just not fair. At all. And I don't know why

475
00:27:32,200 --> 00:27:35,800
Speaker 2: the numbers are higher for African Americans and for Latinos

476
00:27:36,240 --> 00:27:39,080
Speaker 2: and other people of color, but I have to guess

477
00:27:39,200 --> 00:27:43,480
Speaker 2: that's part of it, because the surveillance is very important.

478
00:27:44,119 --> 00:27:48,480
Speaker 2: It's critical, actually, and so for someone to have to

479
00:27:48,520 --> 00:27:52,119
Speaker 2: take time off and travel somewhere, especially if you're from

480
00:27:52,160 --> 00:27:55,800
Speaker 2: a rural area here in California Central Valley, where you

481
00:27:55,880 --> 00:27:59,960
Speaker 2: have to travel two three hours to a transplant center

482
00:28:00,480 --> 00:28:03,800
Speaker 2: to do a biopsy, you're probably not going to choose

483
00:28:03,800 --> 00:28:06,439
Speaker 2: to do that. And so for me, the fight is

484
00:28:06,480 --> 00:28:11,240
Speaker 2: about helping people who don't have this opportunity. But the

485
00:28:11,280 --> 00:28:17,280
Speaker 2: opportunity is widespread and available now and being literally I

486
00:28:17,280 --> 00:28:20,000
Speaker 2: think doctor Potter said it. Maybe you said it nut

487
00:28:20,320 --> 00:28:23,280
Speaker 2: having the rug ripped from under your legs for some

488
00:28:23,440 --> 00:28:27,040
Speaker 2: bureaucratic reason that nobody seems to understand the reason why.

489
00:28:27,200 --> 00:28:30,760
Speaker 1: Doctor Potter, because this is a Medicare issue and they

490
00:28:30,800 --> 00:28:33,720
Speaker 1: have been so resistant to change. Why did you go

491
00:28:33,800 --> 00:28:36,320
Speaker 1: to Congress? And when you were at the Capitol a

492
00:28:36,359 --> 00:28:38,960
Speaker 1: few weeks ago, what were you asking members of Congress

493
00:28:39,000 --> 00:28:39,640
Speaker 1: to actually do?

494
00:28:40,360 --> 00:28:44,680
Speaker 3: Well? We've worked diligently new with the Medicare contractor over

495
00:28:44,720 --> 00:28:48,760
Speaker 3: the course of months, including written statements to them, requests

496
00:28:48,760 --> 00:28:54,080
Speaker 3: for information, participating in panels as expert transplant providers, and

497
00:28:54,200 --> 00:28:57,080
Speaker 3: all with a unified voice saying these are critical standard

498
00:28:57,120 --> 00:28:59,880
Speaker 3: of care tests. And really we have had no response.

499
00:29:00,400 --> 00:29:02,600
Speaker 3: We've had a couple of meetings and all indications or

500
00:29:02,640 --> 00:29:04,920
Speaker 3: that our concerns and those of the patients that we

501
00:29:05,000 --> 00:29:08,160
Speaker 3: serve are falling on deaf ears. So it doesn't seem

502
00:29:08,160 --> 00:29:11,000
Speaker 3: to CMS has any intention of rolling back these cuts.

503
00:29:11,400 --> 00:29:14,080
Speaker 3: So that we decided that this issue needs to be elevated.

504
00:29:14,640 --> 00:29:16,960
Speaker 3: We can't seem to get the attention of Secretary of Bessara,

505
00:29:17,520 --> 00:29:19,960
Speaker 3: and so we're going to Congress to help. We're asking

506
00:29:20,000 --> 00:29:22,960
Speaker 3: them to call Secretary of Besera and stop this, to

507
00:29:23,040 --> 00:29:26,440
Speaker 3: rescind this change. Every member of Congress and every Senator

508
00:29:26,440 --> 00:29:29,440
Speaker 3: that we've met with, whether Republican or Democrat, has been

509
00:29:29,560 --> 00:29:32,800
Speaker 3: very sympathetic to this life or death issue. And really

510
00:29:32,800 --> 00:29:37,560
Speaker 3: there's been outrage and surprise about these cuts, and in brief,

511
00:29:38,080 --> 00:29:39,760
Speaker 3: people we've talked to on the hill get it.

512
00:29:40,040 --> 00:29:42,840
Speaker 1: Because it is a matter of life and death. And

513
00:29:42,880 --> 00:29:45,360
Speaker 1: as I said earlier, because of my own experience with

514
00:29:45,400 --> 00:29:47,880
Speaker 1: my brother, my sister and my sister in law, I

515
00:29:47,920 --> 00:29:50,880
Speaker 1: want to urge our listeners to go to Honor the

516
00:29:51,000 --> 00:29:54,560
Speaker 1: Gift dot org and click on the take action button

517
00:29:55,120 --> 00:29:58,440
Speaker 1: that will really help reach your congressman and your senators.

518
00:29:58,800 --> 00:30:01,560
Speaker 1: Tell them to tell President Biden and CMS to get

519
00:30:01,600 --> 00:30:05,480
Speaker 1: this rogue contractor under control. This is literally, for thousands

520
00:30:05,520 --> 00:30:09,160
Speaker 1: of Americans a life and death issue, and I want

521
00:30:09,200 --> 00:30:11,280
Speaker 1: to thank you for joining me. It's even The work

522
00:30:11,280 --> 00:30:13,800
Speaker 1: that you're doing as a surgeon to help transform lives

523
00:30:13,880 --> 00:30:17,840
Speaker 1: is remarkable and literally there are people alive today who

524
00:30:17,920 --> 00:30:20,680
Speaker 1: would not be without you. I encourage you to keep

525
00:30:20,760 --> 00:30:23,760
Speaker 1: up your advocacy with lawmakers and Hill and Eddie. I

526
00:30:23,800 --> 00:30:26,560
Speaker 1: can't tell you I think how important it is and

527
00:30:26,640 --> 00:30:28,600
Speaker 1: how much we owe you a debt of gratitude for

528
00:30:28,640 --> 00:30:32,400
Speaker 1: sharing your personal experience with our listeners. Having somebody who

529
00:30:32,480 --> 00:30:36,600
Speaker 1: is living through it is just dramatically more powerful than

530
00:30:36,680 --> 00:30:39,400
Speaker 1: having something abstract. So I want to wish both of

531
00:30:39,440 --> 00:30:42,040
Speaker 1: you a healthy and happy holiday season.

532
00:30:42,640 --> 00:30:44,520
Speaker 2: Thank you, Newton, Merry Christmas to you too.

533
00:30:44,800 --> 00:30:46,040
Speaker 3: Thank you so much for having.

534
00:30:45,960 --> 00:30:58,840
Speaker 1: Us, Michael welcome, and thank you for joining me on

535
00:30:58,920 --> 00:30:59,440
Speaker 1: Newts World.

536
00:31:00,160 --> 00:31:02,000
Speaker 4: Well, thanks so much for let me be part of this.

537
00:31:02,400 --> 00:31:04,280
Speaker 1: As a medical document. You've done a number of things,

538
00:31:04,320 --> 00:31:07,560
Speaker 1: wrote a book about the difference between the world of

539
00:31:07,640 --> 00:31:10,600
Speaker 1: medicine and the world of politics. You are a great member,

540
00:31:10,640 --> 00:31:14,000
Speaker 1: a very creative member. I've always appreciated you occasionally allowed

541
00:31:14,040 --> 00:31:16,760
Speaker 1: me to come and join the doctors at someone godly

542
00:31:16,800 --> 00:31:20,480
Speaker 1: hour in the morning. That's great fun. So you sent

543
00:31:20,560 --> 00:31:23,040
Speaker 1: a letter to the administrator of the Centers for Medicare

544
00:31:23,040 --> 00:31:27,880
Speaker 1: and Medicaid Services expressing concern about the Medicare billing change

545
00:31:28,240 --> 00:31:32,720
Speaker 1: for non invasive diagnostic blood tests like donor derived self

546
00:31:32,720 --> 00:31:36,560
Speaker 1: free DNA and gene expression profile. What led you to

547
00:31:36,640 --> 00:31:38,520
Speaker 1: that concern, Well.

548
00:31:38,480 --> 00:31:40,320
Speaker 4: I mean, first off, fake step back for a minute

549
00:31:40,360 --> 00:31:43,640
Speaker 4: and think about someone who's under going to transplant, and

550
00:31:43,880 --> 00:31:45,400
Speaker 4: you want to monitor them, and you want to be

551
00:31:45,440 --> 00:31:49,080
Speaker 4: certain that everything continues to work and that their anti

552
00:31:49,120 --> 00:31:53,479
Speaker 4: rejection medication does not require any adjustment. But really the

553
00:31:53,520 --> 00:31:56,800
Speaker 4: tools you have are pretty rudimentary. You can do tests

554
00:31:56,920 --> 00:32:01,120
Speaker 4: for inflammation like a sedimentation rate or white blood cell account.

555
00:32:01,640 --> 00:32:04,680
Speaker 4: You're really concerned about something. The patient ends up having

556
00:32:04,720 --> 00:32:07,080
Speaker 4: to have a biopsy of a get near or a lung,

557
00:32:07,680 --> 00:32:12,280
Speaker 4: and that's obviously a very involved procedure that carries some risk,

558
00:32:12,840 --> 00:32:15,520
Speaker 4: but at the same time it's necessary if there's perhaps

559
00:32:15,600 --> 00:32:18,640
Speaker 4: an early episode of rejection going on. But then they

560
00:32:18,640 --> 00:32:20,840
Speaker 4: come up with a blood test, and it's just fantastic

561
00:32:20,880 --> 00:32:22,840
Speaker 4: speaking when you think about this, you could draw a

562
00:32:22,920 --> 00:32:25,680
Speaker 4: blood sample, a peripheral blood sample out of the arm,

563
00:32:26,200 --> 00:32:30,520
Speaker 4: and if the organ that's been transplanted is suffering, if

564
00:32:30,560 --> 00:32:34,000
Speaker 4: it is not doing well, some cells are going to

565
00:32:34,000 --> 00:32:37,000
Speaker 4: be dying and it will release some DNA into the bloodstream,

566
00:32:37,640 --> 00:32:40,880
Speaker 4: And because that DNA is different from the patient's DNA,

567
00:32:41,400 --> 00:32:43,840
Speaker 4: they got the ability to detect that. But it's a

568
00:32:43,840 --> 00:32:48,320
Speaker 4: fantastic ability to monitor AHHS or the Center for Medicare

569
00:32:48,400 --> 00:32:51,320
Speaker 4: Medicaid Services, and it's denying the best state of the

570
00:32:51,440 --> 00:32:55,000
Speaker 4: art care to a transplant patient. And again it's one

571
00:32:55,000 --> 00:32:56,360
Speaker 4: of those things it just isn't right.

572
00:32:56,920 --> 00:33:00,880
Speaker 1: This was Bipartisan Bio's representive Ashue before you joined you

573
00:33:01,560 --> 00:33:03,320
Speaker 1: in the letter. And let me just say I know

574
00:33:03,400 --> 00:33:06,160
Speaker 1: from talking to my brother who has been going through

575
00:33:06,160 --> 00:33:10,040
Speaker 1: precise to this, that the difference between drawing blood and

576
00:33:10,080 --> 00:33:12,280
Speaker 1: having to wait for a biopsy, both in the sense

577
00:33:12,840 --> 00:33:16,240
Speaker 1: the blood test, which is so much less difficult and

578
00:33:16,440 --> 00:33:19,800
Speaker 1: so much less painful, so much more convenient, That tells

579
00:33:19,840 --> 00:33:22,680
Speaker 1: you whether or not you need the biopsy. As I

580
00:33:22,760 --> 00:33:25,600
Speaker 1: understand it, again, you're the doctor, I'm not. It means

581
00:33:25,640 --> 00:33:29,640
Speaker 1: you can detect much earlier if there's a problem, and

582
00:33:30,600 --> 00:33:32,840
Speaker 1: you have to wonder what the mindset is of the

583
00:33:32,880 --> 00:33:36,600
Speaker 1: bureaucrat than the company which has been hired by CMS

584
00:33:36,640 --> 00:33:39,200
Speaker 1: to look at this, that thinks we ought to make

585
00:33:39,240 --> 00:33:44,400
Speaker 1: it later discovery, greater risk of losing the transplanted organ,

586
00:33:44,720 --> 00:33:49,000
Speaker 1: and more invasive because the biopsies are much more painful

587
00:33:49,280 --> 00:33:51,840
Speaker 1: and much more invasive than a blood test. I mean,

588
00:33:51,960 --> 00:33:54,120
Speaker 1: you have to sort of wonder what their reasoning is.

589
00:33:54,480 --> 00:33:57,200
Speaker 4: I think as I understood, what they said was that

590
00:33:57,240 --> 00:34:00,200
Speaker 4: they were noticing that people were having both the blodlood

591
00:34:00,200 --> 00:34:04,200
Speaker 4: tests and biopsy. Well, yeah, because the blood test showed

592
00:34:04,600 --> 00:34:08,440
Speaker 4: free DNA certainly to in their bloodstream, and that sparked

593
00:34:08,480 --> 00:34:12,399
Speaker 4: the concern that the transplanted organ was suffering. So yes,

594
00:34:12,520 --> 00:34:15,480
Speaker 4: that's the purpose. You do the screening test, which is

595
00:34:15,520 --> 00:34:19,400
Speaker 4: to detect free DNA, and then you do the diagnostic test,

596
00:34:19,440 --> 00:34:22,279
Speaker 4: which is a biopsy to see what the status of

597
00:34:22,360 --> 00:34:23,680
Speaker 4: the transplanted organ is.

598
00:34:24,040 --> 00:34:28,320
Speaker 1: Am I right in saying that if you rely only

599
00:34:28,440 --> 00:34:31,680
Speaker 1: on the biopsy, it's likely to be much later the

600
00:34:31,719 --> 00:34:34,879
Speaker 1: problems have likely started to show up, and so it's

601
00:34:34,920 --> 00:34:37,040
Speaker 1: actually much riskier for the patient.

602
00:34:37,360 --> 00:34:41,160
Speaker 4: Yes, it's absolutely correct. And you know, since you've had

603
00:34:41,320 --> 00:34:43,320
Speaker 4: membister your family go through this. I mean it's a

604
00:34:43,360 --> 00:34:46,160
Speaker 4: big deal to get put a donor like that and

605
00:34:46,239 --> 00:34:50,239
Speaker 4: then to run the risk of just standing by while

606
00:34:50,440 --> 00:34:53,680
Speaker 4: nothing is being done when this transplanted organ is getting

607
00:34:53,680 --> 00:34:55,520
Speaker 4: into trouble. I mean, it's just again, it just strains

608
00:34:55,560 --> 00:34:57,480
Speaker 4: credulity that someone thinks has a good idea.

609
00:34:58,040 --> 00:35:01,880
Speaker 1: Is it correct that a number of them major national

610
00:35:01,960 --> 00:35:05,000
Speaker 1: organizations in this field have come out in favor of

611
00:35:05,040 --> 00:35:06,400
Speaker 1: what you're trying to accomplish.

612
00:35:06,760 --> 00:35:09,759
Speaker 4: Yes, sir, We've heard for a number of people on

613
00:35:10,040 --> 00:35:10,720
Speaker 4: this issue.

614
00:35:10,920 --> 00:35:13,560
Speaker 1: I was looking to listen, like the American Society for

615
00:35:13,640 --> 00:35:18,320
Speaker 1: Transplant Surgeons, the American Society of Transplantation, the International Society

616
00:35:18,360 --> 00:35:22,480
Speaker 1: for Heart and Lung Transplantations, the American Association of Kidney Patients.

617
00:35:22,560 --> 00:35:24,560
Speaker 1: If all of these groups are saying on the medical

618
00:35:24,640 --> 00:35:28,719
Speaker 1: grounds that you are right, shouldn't the bias be overwhelmingly

619
00:35:28,800 --> 00:35:34,640
Speaker 1: in favor of doing the less invasive earlier detection model,

620
00:35:34,640 --> 00:35:38,720
Speaker 1: And shouldn't cms simply reject the advice of the hired

621
00:35:38,760 --> 00:35:41,960
Speaker 1: company that is telling them to drop this test or

622
00:35:42,000 --> 00:35:44,680
Speaker 1: make it only occur after the patients beg un to

623
00:35:44,719 --> 00:35:45,640
Speaker 1: exhibit a problem.

624
00:35:46,080 --> 00:35:49,000
Speaker 4: I'm just astounded at your perceptive ability. Yes, of course

625
00:35:49,040 --> 00:35:51,080
Speaker 4: they should listen to me. That's why I ran for

626
00:35:51,120 --> 00:35:53,040
Speaker 4: Congress in the first place. I thought people needed a

627
00:35:53,080 --> 00:35:56,240
Speaker 4: better direction. No, it's right. I mean, these are serious

628
00:35:57,080 --> 00:36:02,160
Speaker 4: doctors and researchers that are involved in the and they're saying, look,

629
00:36:02,239 --> 00:36:04,800
Speaker 4: this is a problem if you don't provide the patient

630
00:36:05,200 --> 00:36:08,279
Speaker 4: this type of surveillance. And I think they need to

631
00:36:08,280 --> 00:36:09,319
Speaker 4: listen to the experts.

632
00:36:09,640 --> 00:36:14,000
Speaker 1: Why wasn't there a period for public comment before making

633
00:36:14,000 --> 00:36:14,600
Speaker 1: the change?

634
00:36:14,840 --> 00:36:18,560
Speaker 4: Well, that's probably a good question, and I don't know

635
00:36:18,640 --> 00:36:21,040
Speaker 4: that the agency has provided us an explanation of that.

636
00:36:21,360 --> 00:36:23,080
Speaker 1: I mean, it's kind of weird that they would step

637
00:36:23,120 --> 00:36:27,880
Speaker 1: in and make what is essentially a medical change without

638
00:36:27,920 --> 00:36:32,080
Speaker 1: having allowed the community to understand what the proposed change

639
00:36:32,080 --> 00:36:34,799
Speaker 1: is and respond and give advice on the proportion. I mean,

640
00:36:34,800 --> 00:36:36,560
Speaker 1: I don't think that happens very often, does it.

641
00:36:36,920 --> 00:36:40,880
Speaker 4: No, it's a fact is counter to the Administrative Procedures

642
00:36:40,880 --> 00:36:44,160
Speaker 4: Act for them to proceed without the public comment.

643
00:36:44,120 --> 00:36:48,000
Speaker 1: As I understand it. On September twenty fifth, CMS responded, quote,

644
00:36:48,239 --> 00:36:53,320
Speaker 1: neither CMS nor the Medicare administrative contractors have made changes

645
00:36:53,719 --> 00:36:57,000
Speaker 1: that affect patient's ability to have blood tests used to

646
00:36:57,080 --> 00:37:00,960
Speaker 1: monitor for organ transplantation rejection. Isn't that just flat out

647
00:37:01,040 --> 00:37:01,759
Speaker 1: not true?

648
00:37:02,040 --> 00:37:04,879
Speaker 4: Well coversmen issue, and I sent a follow up letter

649
00:37:05,160 --> 00:37:07,920
Speaker 4: to the Center for Medicare and Medicaid Services in the

650
00:37:07,960 --> 00:37:10,560
Speaker 4: middle of October, saying that their response was in stark

651
00:37:10,600 --> 00:37:14,920
Speaker 4: contrast to what the transplant patients and physician associations nationwide

652
00:37:15,000 --> 00:37:18,200
Speaker 4: have communicated with US, and in the letter we asked

653
00:37:18,200 --> 00:37:20,440
Speaker 4: the Center for Medicare and Medicaid Services a series of

654
00:37:20,560 --> 00:37:24,160
Speaker 4: questions to try to understand their actions. And of course,

655
00:37:24,320 --> 00:37:27,759
Speaker 4: obviously we remain very concerned that CMS has allowed the

656
00:37:28,360 --> 00:37:31,480
Speaker 4: March twenty twenty three billing article to remain in effect

657
00:37:32,120 --> 00:37:34,440
Speaker 4: because it is so out of step with widely accepted

658
00:37:34,480 --> 00:37:36,680
Speaker 4: evidence and its departure from precedent.

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Speaker 1: What steps can be taken to force them to change

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00:37:40,520 --> 00:37:44,319
Speaker 1: if CMS just plane refuses to follow the medical and

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00:37:44,360 --> 00:37:46,520
Speaker 1: scientific advice well.

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Speaker 4: In response to the transplant community's reaction to the coverage change,

663
00:37:50,960 --> 00:37:55,640
Speaker 4: private contractors allowed for public comment to process in September

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00:37:56,080 --> 00:37:58,560
Speaker 4: when they heard from deeply concerned physicians and patients who

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00:37:58,560 --> 00:38:02,399
Speaker 4: have not received their regularly scheduled tests and literally fear

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00:38:02,440 --> 00:38:06,080
Speaker 4: for their own lives. Medicare is reviewing the comments and

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00:38:06,160 --> 00:38:10,120
Speaker 4: will determine the final decision on coverage. Given the fact

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Speaker 4: that the Center for Medicare and Medicaid Services public statements

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00:38:13,239 --> 00:38:17,560
Speaker 4: to date on this issue, the transmit community is fearful

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Speaker 4: that their voices have not been heard.

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Speaker 1: If I understand the system correctly, either the President or

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00:38:23,920 --> 00:38:26,279
Speaker 1: the Secretary of Health and Human Services could in fact

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00:38:26,320 --> 00:38:30,400
Speaker 1: step in and just cancel what CMS is done and

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00:38:30,520 --> 00:38:33,640
Speaker 1: return to the system that the medical doctors and the

675
00:38:33,800 --> 00:38:36,720
Speaker 1: people who are studying this belief is the correct system,

676
00:38:36,800 --> 00:38:41,000
Speaker 1: so it could be fixed just administratively if they want

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00:38:41,040 --> 00:38:41,399
Speaker 1: to do it.

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00:38:41,880 --> 00:38:45,719
Speaker 4: Yes. Congress obviously plays a critical role in the oversight

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00:38:45,960 --> 00:38:50,520
Speaker 4: of the agencies. Our Energy, Commerce Health Subcommittee has considered

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00:38:50,719 --> 00:38:54,120
Speaker 4: several bills in recent weeks to provide additional guardrails for

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00:38:54,200 --> 00:38:58,560
Speaker 4: contractors who issue these types of coverage decisions. In addition

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00:38:58,640 --> 00:39:01,279
Speaker 4: to pressing CMS and what we see is overreaches such

683
00:39:01,360 --> 00:39:05,120
Speaker 4: as this decision, we do have to ensure that CMS

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00:39:05,160 --> 00:39:08,920
Speaker 4: and its contractors don't just operate on their own with

685
00:39:09,160 --> 00:39:13,400
Speaker 4: limited or no oversight. But let's be clear, the administration

686
00:39:13,480 --> 00:39:16,360
Speaker 4: doesn't need a legislative action to fix this issue. It

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00:39:16,440 --> 00:39:20,400
Speaker 4: is completely within the purview of the administratively to reverse

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00:39:20,440 --> 00:39:23,120
Speaker 4: these cuts. But it does seem that our concerns have

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00:39:23,160 --> 00:39:26,759
Speaker 4: been ignored by the agency and by the private contractors.

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00:39:26,800 --> 00:39:29,880
Speaker 4: So we are asking President Biden and Secretary Pisera to

691
00:39:29,920 --> 00:39:33,560
Speaker 4: cancel the rescind in the March coverage determination.

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00:39:34,280 --> 00:39:36,560
Speaker 1: You would think, as a matter of compassion that President

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00:39:36,600 --> 00:39:40,200
Speaker 1: Biden would be inclined to step in on behalf of

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00:39:40,239 --> 00:39:43,920
Speaker 1: the patients and on behalf of the doctors. Biden talks

695
00:39:43,920 --> 00:39:46,480
Speaker 1: a lot about compassion, talks a lot about caring about people.

696
00:39:46,800 --> 00:39:48,520
Speaker 1: I would think this would be a no brainer for

697
00:39:48,560 --> 00:39:51,040
Speaker 1: them to get this solved. And we want to do

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00:39:51,080 --> 00:39:54,000
Speaker 1: all we can to help get across the message. And

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00:39:54,440 --> 00:39:57,919
Speaker 1: I also just want to say I am very, very

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00:39:57,960 --> 00:40:02,120
Speaker 1: grateful for yearlydership on such a wide range of issues,

701
00:40:02,160 --> 00:40:05,440
Speaker 1: not just health issues, and how much you have contributed

702
00:40:06,040 --> 00:40:09,520
Speaker 1: to getting things done trying to solve America's problems. You

703
00:40:09,560 --> 00:40:13,160
Speaker 1: are the kind of citizen in public life that we

704
00:40:13,200 --> 00:40:14,880
Speaker 1: need a heck of a lot more of. And Michael,

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00:40:14,880 --> 00:40:16,880
Speaker 1: I want you to know how proud I am to

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00:40:16,920 --> 00:40:19,160
Speaker 1: call you a friend, and how proud I am of

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00:40:19,160 --> 00:40:21,080
Speaker 1: what you've done to help people.

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00:40:21,680 --> 00:40:26,200
Speaker 4: You're overly generous with your assessment. I appreciate the kind comments.

709
00:40:26,960 --> 00:40:29,480
Speaker 4: I'm probably the luckiest personal live I got to practice

710
00:40:29,520 --> 00:40:32,160
Speaker 4: medicine in my hometown for twenty five years, and then

711
00:40:32,200 --> 00:40:34,240
Speaker 4: I got to come up here and represent my hometown

712
00:40:34,360 --> 00:40:37,359
Speaker 4: for twenty two years in the Congress. When it all

713
00:40:37,360 --> 00:40:40,319
Speaker 4: comes to a conclusion, I've got no regrets. I've been

714
00:40:40,360 --> 00:40:42,440
Speaker 4: blessed by being able to play a part in so

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00:40:42,480 --> 00:40:43,840
Speaker 4: many people's lives back home.

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Speaker 1: Thank you to my guests, doctor Stephen Potter, Eddie Garcia,

717
00:40:51,160 --> 00:40:54,640
Speaker 1: and Congressman Michael Burgess. You can learn more about Honor

718
00:40:54,719 --> 00:40:57,960
Speaker 1: the Gift on our show page at newtsworld dot com.

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00:40:58,640 --> 00:41:02,279
Speaker 1: Newtsworld is produced by Ganging three sixty and iHeartMedia. Our

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00:41:02,320 --> 00:41:07,320
Speaker 1: executive producer is Guernsey Sloan and our researcher is Rachel Peterson.

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Speaker 1: The artwork for the show was created by Steve Penley.

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00:41:11,800 --> 00:41:14,960
Speaker 1: Special thanks to the team at Ginglish three sixty. If

723
00:41:14,960 --> 00:41:17,400
Speaker 1: you've been enjoying Newtsworld, I hope you'll go to Apple

724
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Speaker 1: Podcast and both rate us with five stars. And give

725
00:41:20,760 --> 00:41:23,400
Speaker 1: us a review so others can learn what it's all about.

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00:41:24,239 --> 00:41:27,320
Speaker 1: Right now, listeners of Newtsworld consign him for my three

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00:41:27,640 --> 00:41:33,480
Speaker 1: freeweekly columns at ganglistree sixty dot com slash newsletter. I'm

728
00:41:33,560 --> 00:41:37,200
Speaker 1: Newt Gingrich. This is Newtsworld, and this episode of neuts

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00:41:37,200 --> 00:41:39,719
Speaker 1: World was brought to you by Honor the Gift dot

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