[00:00:00] Speaker 03:
Case number 24-53-9, Ardell was painted at L at Deluxe, versus Robert F. Kennedy Jr., Secretary of Health and Human Services at L. Mr. Byrne, for the balance, and Mr. Lopez, for your colleagues.

[00:00:15] Speaker 02:
May I proceed?

[00:00:16] Speaker 00:
Thank you, Your Honors.

[00:00:17] Speaker 00:
Good morning, and may it please the Court.

[00:00:20] Speaker 00:
Michael Byrne from Latham and Watkins for Appellants, Ardellux, the American Association of Kidney Patients, and the National Minority Quality Forum.

[00:00:30] Speaker 00:
By enacting the Medicare Improvement for Patients and Providers Act, or MIPA, Congress created a prospective payment system under which a single payment is made to renal dialysis providers for renal dialysis services, as defined in subsection B14 of the statute.

[00:00:45] Speaker 00:
As CMS contemporaneously acknowledged, Congress created that perspective payment system to remove dialysis providers' financial incentives to overuse profitable drugs for which dialysis providers could, before MIPA, receive separate payment for Medicare.

[00:01:01] Speaker 00:
In this case, however, CMS claims authority to expand the definition of renal dialysis services to include orally administered drugs that all agree have never been administered during renal dialysis nor provided by renal dialysis providers.

[00:01:16] Speaker 00:
Not only is that claim of authority incompatible with MIPSA's language and purpose, but it will harm a patient population that already faces staggeringly high health risks.

[00:01:25] Speaker 00:
As advocates from across the kidney care community have repeatedly warned,

[00:01:29] Speaker 00:
Placing world-only drugs into an already overstretched prospective payment system will diminish access to life-saving therapies and discourage the innovation that makes those therapies a reality in the first place.

[00:01:41] Speaker 00:
I'd like to proceed today in two steps.

[00:01:43] Speaker 00:
First, I'd like to briefly touch on why the district court was correct to hold that there is jurisdiction to reach the merits of our claims.

[00:01:50] Speaker 00:
And then I'd like to go through why the government's interpretation of the statute is untenable and why our interpretation of the statute is therefore the reading that's far more compatible with the statute's text and Congress's purpose in enacting that law.

[00:02:04] Speaker 00:
Let me first touch on jurisdiction.

[00:02:06] Speaker 00:
And basically, we think that the district court got this right, that in this case, jurisdiction and the merits merge.

[00:02:12] Speaker 02:
I think you see this most clearly with the district court also find that preclusion applies.

[00:02:17] Speaker 00:
It did because it found that we lost on the merits.

[00:02:19] Speaker 00:
So in other words, it found that there was jurisdiction to consider the merits.

[00:02:24] Speaker 00:
It just ruled against us on the merits.

[00:02:27] Speaker 00:
And really, I think the Amgen case is the key here.

[00:02:29] Speaker 00:
Amgen is very similar to our case.

[00:02:31] Speaker 00:
Both cases arise as an analysis of provisions that limit judicial review of certain actions that are taken under prospective payment systems under the Medicare Act.

[00:02:44] Speaker 00:
So very similar settings.

[00:02:46] Speaker 00:
And basically what the court held in Amgen was that in that case the question was there was a provision that limited judicial review of certain quote other adjustments that the secretary could make.

[00:03:01] Speaker 00:
And Amgen argued that the other adjustments that were made were outside of the agency's statutory authority.

[00:03:08] Speaker 00:
And what this court held in Amgen is that given the overall, the overriding presumption that Congress intends for judicial review, the right way to handle to construe those

[00:03:20] Speaker 00:
provisions limiting judicial review is to construe the provision as being limited to the agency's authority to make that decision in the first place.

[00:03:29] Speaker 00:
And so essentially the court found that the jurisdiction and the merits merge.

[00:03:34] Speaker 00:
Really the only distinction that the government has offered from the Amgen line of cases is to say, well, they've argued that

[00:03:43] Speaker 00:
In AMGEN, there was an express cross-reference to another statutory provision that defined other adjustments.

[00:03:53] Speaker 00:
But as the DIST report noted, that's both factually inaccurate and it's also just a distinction without a difference.

[00:03:58] Speaker 00:
There was no express cross-reference there.

[00:04:00] Speaker 00:
And in both cases, the general principle is just that

[00:04:04] Speaker 00:
Congress doesn't create a situation in which an agency can simply point to some provision limiting judicial review and use that to justify any action that it wants, no matter how far outside of the statutory authority that Congress is concerned with.

[00:04:21] Speaker 02:
The district court didn't make any fines with respect to the APA.

[00:04:28] Speaker 00:
Well, the district court just ruled that we didn't have statutory authority.

[00:04:30] Speaker 00:
That's right.

[00:04:31] Speaker 00:
So we didn't need to go further than that.

[00:04:34] Speaker 00:
So that takes us to the merits.

[00:04:36] Speaker 00:
And what I'd like to go through is why we think the government's interpretation of the statute is untenable.

[00:04:42] Speaker 00:
The government primarily argues that oral-only drugs are part of the bundled payment through subsection B3 of the statute.

[00:04:53] Speaker 00:
And the way that they read, now we think that their interpretation is actually wrong.

[00:04:57] Speaker 00:
I'm happy to talk about that.

[00:04:59] Speaker 00:
I think the easiest way to see that their interpretation of the statute is wrong is to look at what the consequences are of their reading.

[00:05:05] Speaker 00:
So what they would say is that so subpart B says that the terminal dialysis services includes other drugs and biologicals furnished to individuals for the treatment of end-stage renal disease in any oral equivalent form of such drug or biological.

[00:05:20] Speaker 00:
They say that what Congress was doing there was taking that first part of that subpart and providing that all drugs for the treatment of ESRD, no matter what their route of administration, that were in existence before 2011 would have been part of the bottle.

[00:05:39] Speaker 00:
So this is what Congress would have intended at the time.

[00:05:41] Speaker 00:
And then the second part of the statute, they say, is designed to talk about drugs in the future.

[00:05:46] Speaker 00:
And so according to them, what Congress was trying to do is to add into the bundle payment system all drugs for the treatment of end-stage renal disease that existed before January 1st, 2011.

[00:06:02] Speaker 00:
But the only drugs that would go into the bundle after January 1st, 2011, at least through B3,

[00:06:08] Speaker 00:
were drugs that were the oral equivalent of drugs that were in existence as of January 1st, 2011.

[00:06:17] Speaker 00:
Now, what's important is that no one, not even the government, claims that Congress could have intended that to be the entire universe of drugs that go into the prospective payment system.

[00:06:29] Speaker 00:
The reason for that is that it would mean that no injectable drugs, no intravenous drugs, no any drugs that came after January 1, 2011, would be part of the prospective payment system.

[00:06:40] Speaker 00:
And that's antithetical to what MIPA was trying to do.

[00:06:43] Speaker 00:
MIPA was concerned about the fact that dialysis providers were basically overusing particularly injectable drugs in a way that was benefited their financial incentives but was unnecessary for patient care.

[00:07:00] Speaker 00:
And to read the statute, to read subpart B3 as the government wants to,

[00:07:05] Speaker 00:
would basically make it so that any new development that occurred after January 2011 would be outside of the prospective payment system and exacerbate all the problems.

[00:07:14] Speaker 05:
Why wouldn't that fall under subsection four?

[00:07:16] Speaker 00:
Yeah, so happy to address that.

[00:07:18] Speaker 00:
So I think that the main takeaway is that for the government's interpretation of B3 to be correct, they have to be right either that B4

[00:07:28] Speaker 00:
Covers all other drugs or that the statute provides free flowing authority for the, for the agency to expand on the definition of Reno, the house of service.

[00:07:37] Speaker 00:
So, let's.

[00:07:39] Speaker 00:
Let's talk about section.

[00:07:40] Speaker 05:
I mean, that just addresses kind of your.

[00:07:42] Speaker 05:
Policy related argument, like.

[00:07:46] Speaker 05:
I hear you arguing that it must be so, otherwise we couldn't cover these other drugs.

[00:07:52] Speaker 05:
But if you can cover it under four, then it's not a must-be-so situation.

[00:07:55] Speaker 00:
No, absolutely.

[00:07:56] Speaker 00:
In other words, nobody disputes that drugs outside of their interpretation of B3, how they say B3 should be interpreted, are part of the Bible.

[00:08:07] Speaker 00:
For instance, the government has added other

[00:08:10] Speaker 00:
other IV drugs that have come on the market since 2011.

[00:08:15] Speaker 00:
Even though under their reading of B3, that wouldn't be possible.

[00:08:20] Speaker 00:
So that brings up exactly the question that Your Honor just asked, which is, well, why can't it come under B4?

[00:08:26] Speaker 00:
And I think there's a couple of reasons why we can look to the statute and know that it can't come under B4.

[00:08:31] Speaker 00:
First of all, the government's theory is essentially that Congress in B3 created this very nuanced look for what kinds of drugs would be added to the prospective payment system.

[00:08:44] Speaker 00:
And it makes no sense to think that Congress would have defined renal dialysis services in a way to create that very nuanced set of drugs in B3.

[00:08:52] Speaker 00:
and defined it by the route of administration and the date of approval, but then use the very next provision in the statute to undo all that work by adding in all other drugs.

[00:09:02] Speaker 00:
It would make B3 essentially an elaborate pump fake that you would basically deem superfluous by B4.

[00:09:10] Speaker 00:
And their reading, importantly, would render both B2 and B3 entirely superfluous.

[00:09:16] Speaker 00:
What they want to say is that items and services should be read to include drugs within B4.

[00:09:22] Speaker 00:
But D4 extends the definition of renal dialysis services to diagnostic laboratory tests and other items and services not described in clause one that are furnished to individuals for the treatment of end-stage renal disease.

[00:09:39] Speaker 00:
So clause one just talks about items that are in the composite rate system that existed prior to January 1, 2011.

[00:09:47] Speaker 00:
So if drugs after January 1, 2011 was part of what subpart B was covering, then that would render subparts two and three of the statute entirely superfluous.

[00:10:04] Speaker 00:
Because there would be no reason to cover

[00:10:07] Speaker 00:
you know, in a much more nuanced way, certain types of drugs, because all drugs would come in under B4.

[00:10:14] Speaker 00:
And that's why I think in a way the government, you know, the government's argument on this has always been a little bit half-hearted.

[00:10:19] Speaker 00:
I mean, the government in page 58 of its brief, I think recognizing the problems with this superfluity that would arise from this reading of B4 tries to argue

[00:10:30] Speaker 00:
that the drugs that are addressed by B4 constitute a different subset of drugs than those in B2 and B3.

[00:10:37] Speaker 00:
But that's just plainly inconsistent with the statutory language.

[00:10:41] Speaker 00:
Subpart B4 expressly covers other items and services not described in clause one.

[00:10:46] Speaker 00:
If other items and services encompass drugs for the treatment of end-stage renal disease, then B4 would include all of the drugs in B2 and B3.

[00:10:54] Speaker 00:
and render those provisions superfluous.

[00:10:57] Speaker 00:
The better and more obvious reading of subpart B4 follows from the structure of the four categories that Congress identified in the statutory definition.

[00:11:05] Speaker 00:
So subpart one deals with everything in the composite rate system that existed up through December 2010.

[00:11:12] Speaker 00:
Subparts two and three then deal with the kinds of drugs that Congress wanted to add to the prospective payment system

[00:11:17] Speaker 00:
And subpart four deals with other items and services.

[00:11:20] Speaker 00:
In other words, items and services that aren't drugs, things like lab tests, syringes, the tubing supplies, the blood products, all of that kind of stuff.

[00:11:31] Speaker 00:
And that is the kind of reading that basically makes sense of the whole statute and ensures that none of the different provisions are overlapping with each other.

[00:11:41] Speaker 01:
Mr. Byrne, having nicely dispatched B4, let's go back to B3.

[00:11:45] Speaker 01:
You read C3 as though it said, which it does not, a date in January, in whatever was 2011.

[00:11:54] Speaker 01:
It doesn't say that.

[00:11:56] Speaker 00:
I agree with your honor.

[00:11:57] Speaker 00:
That's one of the problems with their interpretation.

[00:12:01] Speaker 01:
But what it says is before application of this paragraph.

[00:12:03] Speaker 00:
Right.

[00:12:04] Speaker 01:
This paragraph was first applied or could first be applied in 2020, 2025, when the Congress finally let it go into effect.

[00:12:13] Speaker 00:
So two things to say about that.

[00:12:15] Speaker 00:
First of all, we think the application of this paragraph certainly began applied.

[00:12:20] Speaker 00:
The application of the paragraph occurred in 2011.

[00:12:22] Speaker 00:
I mean, this is a paragraph.

[00:12:24] Speaker 01:
2011 as a result of the paragraph.

[00:12:27] Speaker 01:
I'm sorry?

[00:12:27] Speaker 01:
What happened in 2011 as a result of paragraph B3?

[00:12:30] Speaker 00:
Drugs that fell within the category B3 were entered into the perspective payment system.

[00:12:37] Speaker 00:
The only drugs that weren't added in were oral only drugs.

[00:12:40] Speaker 01:
With respect to the drugs in this case, this statute could not be applied before 2025.

[00:12:47] Speaker 01:
It was kept delaying.

[00:12:50] Speaker 01:
There are other provisions in the statute that used a date, right, or that date.

[00:12:55] Speaker 01:
This provision does not.

[00:12:56] Speaker 00:
Right.

[00:12:57] Speaker 00:
And again, we would understand the application of this paragraph to be speaking to this.

[00:13:04] Speaker 00:
When did the statute take effect?

[00:13:06] Speaker 00:
It is true that the regulatory policy did not take effect until the Congress allowed it to take effect.

[00:13:14] Speaker 00:
Yeah, no, but even if you were to interpret application of this paragraph in that way, again, we don't think that that helps them in terms of the overall argument, because again, that would mean that... A lot of your argument is about how crazy it would be if it really said 2011.

[00:13:31] Speaker 00:
No, I mean, I think our... Well, it says 2011 for sure for all drugs that aren't world-only drugs, right?

[00:13:38] Speaker 00:
So, in other words,

[00:13:40] Speaker 01:
even under the drugs in this case, or the drug in this case.

[00:13:44] Speaker 00:
Right, but that is, but the point is that drugs that treat renal dialysis services, the vast majority of the drugs that are used for renal dialysis services, and again, we don't think that our drug is a renal dialysis service, but renal dialysis services are predominantly intravenously or injectably delivered drugs.

[00:14:03] Speaker 00:
So no matter what one thinks about when the application of this paragraph

[00:14:07] Speaker 00:
occurred with respect to oral-only drugs.

[00:14:10] Speaker 00:
Everybody agrees that the application of this paragraph with respect to injectable and intravenous drugs occurred January 1, 2011.

[00:14:17] Speaker 00:
So even under the government's reading of the statute, they would say that Congress determined that after January 1, 2011, all new drugs that are intravenous or injectable do not fall within B3.

[00:14:30] Speaker 00:
That's their view of the statute.

[00:14:32] Speaker 05:
Does this really address Judge Ginsburg's point?

[00:14:34] Speaker 05:
Because he's saying that

[00:14:37] Speaker 05:
under the first clause, any drug and biological, which includes oral drugs, before the application of this paragraph.

[00:14:49] Speaker 05:
And if we say that the application of this paragraph as to your client's drug is 2025, your client's drug is covered by the first clause.

[00:14:59] Speaker 00:
So two things about that.

[00:15:00] Speaker 00:
Let me explain why I think that that's textually wrong.

[00:15:02] Speaker 00:
But I think the important thing to understand is,

[00:15:06] Speaker 00:
If you read the statute in that way, it creates this framework that ultimately is inconsistent with Congress's intent.

[00:15:13] Speaker 00:
And that's why you have to know that that's not a fair reading of the statute.

[00:15:18] Speaker 00:
So the first point is this.

[00:15:20] Speaker 01:
Where are you conjuring their intent, if not from the words of the statute?

[00:15:25] Speaker 00:
But I think this is a question where the statute can be read in one of two ways.

[00:15:29] Speaker 00:
The agency acknowledged in 2008 that the statute could be read as we suggest.

[00:15:37] Speaker 00:
And the reason why they said that it could be read as we suggest is that, as everyone agrees, there's sort of two parts to subpart two.

[00:15:44] Speaker 00:
One is the first part talks about other drugs and biologicals that are furnished to individuals.

[00:15:48] Speaker 00:
But then the second part talks about any oral equivalent form of such drug or biological.

[00:15:54] Speaker 00:
Now, if oral drugs were encompassed within that first part of the statute, that first part of the subpart, there would be no reason to separately identify oral equivalent forms.

[00:16:04] Speaker 00:
You would already have all oral forms would be part of the first part of the statute.

[00:16:07] Speaker 05:
Well, they're reading the same oral equivalent forms done after the date of application.

[00:16:12] Speaker 05:
Right.

[00:16:12] Speaker 05:
And that's not superfluous.

[00:16:14] Speaker 00:
Well, so two things.

[00:16:16] Speaker 01:
One, oral equivalent form isn't subject to the application of this paragraph limitation.

[00:16:22] Speaker 00:
Right, so that's exactly right.

[00:16:26] Speaker 00:
So their view of the statutes, just to be clear, their view of the statute tries to make sense and avoid the superfluity problem that we're discussing by saying that what Congress was trying to do

[00:16:38] Speaker 00:
was it was trying to add in subpart B3 all drugs up to 2011 that were injectable and intravenous, all oral drugs whenever Congress got around to allowing the agency's policy to let them come into the bundle, but then only one type of future drug.

[00:16:59] Speaker 00:
The only type of future drug that they wanted into the bundle was the drugs that were the oral equivalent of injectable and intravenous drugs that were introduced before 2011.

[00:17:10] Speaker 05:
And that wouldn't be crazy given that you just said that almost all drugs are injectable.

[00:17:14] Speaker 05:
And so they might just be trying to.

[00:17:18] Speaker 05:
given that we've got the universe of injectable drugs, there's not as much innovation.

[00:17:21] Speaker 05:
I'm just giving you a hypothetical.

[00:17:23] Speaker 05:
Hypothetically, maybe there's not a lot of innovation in injectables, but there's a lot of innovation in orals, so we're just going to include those in the future.

[00:17:34] Speaker 00:
No, no, I think it absolutely is crazy, because what it would mean is that any time that a new version of an injectable drug came out, dialysis providers would have huge incentives to immediately switch to that drug, regardless of whether it was more cost effective, regardless of whether it was better for patients, because it would simply get them out from the auspices of the perspective payment system.

[00:17:57] Speaker 05:
Wait, can you get reimbursed under subsection D for an injectable?

[00:18:00] Speaker 05:
I thought that was just prescription drugs.

[00:18:01] Speaker 05:
I could be wrong.

[00:18:03] Speaker 00:
So part D is for prescription drugs.

[00:18:05] Speaker 00:
Part B, it would have been what covered things that were separately reimbursable before.

[00:18:12] Speaker 00:
Under their theory, anything that any injectable power injectable separately, reimbursable under our hypothetical, I thought because I thought it was all subsection D. Subsection D is only self-administered drugs.

[00:18:24] Speaker 00:
So, subsection B is how things would have been.

[00:18:28] Speaker 00:
So, for instance, before the perspective, reimburse under B outside the bundle.

[00:18:33] Speaker 05:
That's what you're saying.

[00:18:36] Speaker 00:
You would be if their interpretation was right.

[00:18:38] Speaker 00:
Anything that comes onto the market after 2011 would not be part of subpart B3.

[00:18:44] Speaker 00:
So unless you believe that it's covered by B4 or by some freestanding authority to expand the definition of renal dialysis services, then basically what it would mean is that every new drug that came on the market

[00:18:58] Speaker 00:
And again, this is the vast majority of dialysis care that's out there that's going through dialysis providers.

[00:19:04] Speaker 00:
All of those drugs, there would be a huge financial incentive for dialysis providers to immediately switch to those drugs because they would be out of the prospective payment system and able to enjoy the financial benefits that come from getting it separately reimbursed around subpart, I'm sorry, under Medicare Part B.

[00:19:21] Speaker 00:
And that's totally inconsistent with what MIPA was designed to do.

[00:19:25] Speaker 00:
Everybody agrees that what MIPA was trying to do was to address a system whereby the financial incentives were at odds with what were maybe the best treatment decisions for patients and the most cost-effective way to get those drugs to patients.

[00:19:43] Speaker 00:
And what's different about oral-only drugs from everything else that could be given to patients

[00:19:49] Speaker 00:
is that oral only drugs there's no financial incentive that exists for the dialysis providers because these are drugs that are not being administered by dialysis providers they're not being taken during renal dialysis services and ultimately the touchstone of the statute after all is that they're trying to create a system of perspective payment system for renal dialysis services the government doesn't

[00:20:10] Speaker 00:
doesn't dispute that this is a drug that's historically been taken outside of a renal dialysis facilities.

[00:20:18] Speaker 00:
It's never been administered by renal dialysis providers.

[00:20:21] Speaker 00:
The label of the drug, in fact, cautions you and says, don't take this before dialysis.

[00:20:26] Speaker 00:
It's bad for you to do that.

[00:20:27] Speaker 00:
Right?

[00:20:28] Speaker 02:
And I just want to clarify, the statute went into effect January 1, 2011, but the oral only regulation was delayed into January 1, 2025.

[00:20:37] Speaker 02:
That's correct.

[00:20:38] Speaker 02:
OK.

[00:20:39] Speaker 02:
That's correct.

[00:20:41] Speaker 01:
Another problem is that the whole statute is preceded by the definition, preceded by the word includes.

[00:20:48] Speaker 00:
Right, so I'm happy to address that.

[00:20:51] Speaker 01:
Surely it counts in place that the agency will be able to add drugs as they go.

[00:20:58] Speaker 00:
No, I don't think so, Your Honor.

[00:21:00] Speaker 00:
Does it mean?

[00:21:00] Speaker 01:
What does includes mean here?

[00:21:02] Speaker 02:
Wouldn't that be a non-exhaustive list?

[00:21:04] Speaker 00:
So I'm happy to address that.

[00:21:06] Speaker 00:
They do afford talismanic significance.

[00:21:08] Speaker 00:
They say that the word includes is dispositive here of the idea that Congress basically intended for the agency to have the ability to add to the definition of renal dialysis.

[00:21:20] Speaker 00:
But so here's what the statute says.

[00:21:21] Speaker 00:
I think what they're ignoring is part A of, so part B14A of the statute, which says

[00:21:30] Speaker 00:
services furnished on or after January 1st, 2011, the secretary shall implement a payment system under which a single payment is made to a provider of services or renal dialysis facility for renal dialysis services, quote, as defined in subparagraph B. So the

[00:21:47] Speaker 00:
the statute itself is providing that the perspective payment system is going to be defined by subparagraph B, not defined by the secretary's addition to subparagraph B. And to be clear, that is a distinction between this part of the statute and many other parts of the statute.

[00:22:09] Speaker 00:
You know, the government... I'm sorry, Richard.

[00:22:12] Speaker 01:
You're saying I'm looking at A and B both now.

[00:22:14] Speaker 01:
Okay.

[00:22:16] Speaker 01:
Yep.

[00:22:16] Speaker 01:
A says

[00:22:17] Speaker 01:
that services for renal dialysis services, renal dialysis services as defined in section B. Section B says for this purposes, renal dialysis services include.

[00:22:35] Speaker 01:
Yes.

[00:22:35] Speaker 01:
Which would seem to say include, but it's not limited to.

[00:22:39] Speaker 00:
Again, I don't think that you can get that from the statute.

[00:22:42] Speaker 00:
I think that when they're saying define in subparagraph B, they're looking at the four exhaustive categories.

[00:22:47] Speaker 01:
Why would they look at that and not look at the word includes?

[00:22:50] Speaker 01:
Why would they have to put in exclusion for vaccines if there weren't otherwise some threat that they'd be included?

[00:22:56] Speaker 00:
So there are a number of cases where both the Supreme Court and this court has looked to statutes that include the language includes and said, this is not intended to create a non-exhaustive list.

[00:23:05] Speaker 01:
Yes, it depends on the context in their cases both ways.

[00:23:09] Speaker 00:
That's exactly right.

[00:23:10] Speaker 00:
It does depend on the context.

[00:23:11] Speaker 00:
And I think here the relevant context is you have, so first of all, here we have the part of the statute that says as defined in subparagraph B. I do think that they're looking at the four categories here.

[00:23:21] Speaker 01:
But there's more.

[00:23:22] Speaker 01:
As defined in subcategory B means that the definition in B has to be exhaustive.

[00:23:28] Speaker 00:
I think that it's telling you that the prospective payment system is set forth by the definition in subpart B, and I think the structure of subpart B and the four definitions there suggest that it's supposed to be exhaustive.

[00:23:41] Speaker 00:
You have a definition that's set up to address items and services that were in existence before December 2010 that are in the composite rate.

[00:23:49] Speaker 01:
Other provisions in this very statute in which they just say

[00:23:52] Speaker 01:
It defines, yeah, as is, right?

[00:23:55] Speaker 01:
Not includes, but just is.

[00:23:57] Speaker 00:
So the government makes a reference to those.

[00:24:00] Speaker 00:
And I think actually it's quite telling to look at that.

[00:24:02] Speaker 00:
So they say there's three other provisions in the statute that use the word means instead of includes.

[00:24:07] Speaker 00:
And so they say we should infer from that that Congress is making an intentional choice to treat this differently.

[00:24:13] Speaker 00:
But the three provisions that it refers to that include the word means

[00:24:19] Speaker 00:
What they leave out from the ellipsis of all of those definitions is that each of those definitions defines either services, units, or something else.

[00:24:29] Speaker 00:
And it says, as defined by the secretary, or as defined in regulations.

[00:24:34] Speaker 00:
And so let me just give you an example of one of those provisions, because I think it's a help.

[00:24:40] Speaker 01:
It even means it's not exhaustive.

[00:24:43] Speaker 00:
Well, I'm saying that means is being used in a way that makes clear that it's not intended to be exhaustive.

[00:24:48] Speaker 01:
It includes is intended to be exhaustive.

[00:24:52] Speaker 00:
I mean, I think what it shows is... It's counterintuitive.

[00:24:54] Speaker 00:
Well, no, I think it just depends on the context, right?

[00:24:57] Speaker 00:
And I think the more important takeaway from this, so let me just, for example, look to section, so this is 42 USC 1395 RRB 9.

[00:25:08] Speaker 00:
And it says, for purposes of this sub-chapter, this term self-care home dialysis support services means, and then it has periodic monitoring, installation of equipment, testing, and then D, such additional supportive services as the secretary finds appropriate and desirable.

[00:25:25] Speaker 00:
And the other two definitions that it points to involving means are written in a similar way.

[00:25:30] Speaker 00:
They rely on the secretary's discretion.

[00:25:33] Speaker 00:
What I think that is showing is,

[00:25:35] Speaker 00:
When Congress wanted to create a definition that either allowed the secretary to set the definition entirely or to expand on the definition that was given by Congress, Congress said so.

[00:25:49] Speaker 00:
And here it did not.

[00:25:50] Speaker 00:
And I think that we have to take that difference significantly.

[00:25:54] Speaker 00:
The other thing I'll just point to.

[00:25:56] Speaker 02:
But oral only, it's not reflected in the statute or the legislative history.

[00:26:00] Speaker 00:
We think that you can understand that oral only is excluded by the fact that B3 is written to include specifically call out and include oral equivalent drugs.

[00:26:11] Speaker 00:
If Congress had wanted a statute to include all drugs, it's pretty simple to do it, right?

[00:26:15] Speaker 00:
You just write a statute that says,

[00:26:17] Speaker 00:
You know, renal dialysis services include all drugs for the treatment of end-stage renal disease.

[00:26:23] Speaker 00:
That's not the way that the statute was written.

[00:26:25] Speaker 00:
The statute is written to allow for drugs and biologicals and the oral equivalent of those drugs and biologicals.

[00:26:31] Speaker 00:
That in our view suggests that drugs and biologicals was meant to include the kinds of services, the kinds of drugs and biologicals that renal dialysis providers provided, which are non-oral drugs.

[00:26:41] Speaker 02:
Now, phosphate binders predate the MIPPA, and they've always been administered orally though.

[00:26:48] Speaker 00:
They've always been administered orally, but they've never been part of the prospective payment system.

[00:26:52] Speaker 00:
So there's some strange language, I think, in the government's brief where they try to say that Ardallix's drug is the oral equivalent of drugs that are in the

[00:27:07] Speaker 00:
the prospective payment system, but what they're referring to are phosphate binders, which didn't enter the prospective payment system until January 1st, 2025.

[00:27:16] Speaker 00:
And of course, we would take issue with the idea that they're equivalent anyways.

[00:27:20] Speaker 00:
There are some significant differences.

[00:27:21] Speaker 02:
What purpose of this statute is to have some sense of cost efficiency?

[00:27:26] Speaker 02:
So does your drug just not have a generic

[00:27:29] Speaker 00:
It's not cost-efficient.

[00:27:32] Speaker 00:
Our drug doesn't have a generic because it's a novel drug.

[00:27:34] Speaker 00:
But let me just be clear about the kind of cost sensitivity that Congress had.

[00:27:41] Speaker 00:
MIPA was dealing with a situation where basically prior to MIPA, you had two ways that dialysis providers got reimbursed.

[00:27:48] Speaker 02:
I guess when I go to that question, maybe this is trying to encourage the generic as well.

[00:27:58] Speaker 00:
The generic will so the problem with this and this is what numerous common comment commenters have said is that you'll never get generics because you won't even get the branded medicines in the first place.

[00:28:08] Speaker 00:
The problem with drugs going or you could lower your price.

[00:28:12] Speaker 00:
The drugs will never get developed.

[00:28:13] Speaker 00:
The drugs will not get developed in this drug.

[00:28:16] Speaker 05:
You could just lower the price expose.

[00:28:20] Speaker 00:
dialysis providers will not facilitate the prescription of these drugs, even if the prices were lowered.

[00:28:26] Speaker 00:
And I'll give you an example of this.

[00:28:28] Speaker 00:
We have said throughout this case that the consequence of the government's decision is going to be to diminish access to drugs.

[00:28:38] Speaker 00:
So let's look at what's happened to phosphate binders, which everyone agrees they've been around for a long time.

[00:28:42] Speaker 00:
There's lots of generics.

[00:28:43] Speaker 00:
They're less expensive drugs.

[00:28:45] Speaker 00:
The government said when it was basically finalizing its policy that this year they expected $870 million, they expected to spend $870 million to enable patients to get phosphate binders based on the utilization of the drugs as it existed before oral only drugs went into the binders.

[00:29:07] Speaker 00:
Just recently this year, they came out with their annual end-stage renal disease

[00:29:13] Speaker 00:
rule for the year proposed rule for the year and they said now looking at it we only expect to spend less than half of that amount on phosphate binders and what that means is that

[00:29:26] Speaker 00:
More than half of the people that were getting phosphate binders, people who need these drugs to have life-saving drugs, more than half of them are now not getting those drugs.

[00:29:37] Speaker 05:
That's a policy decision by Congress.

[00:29:41] Speaker 05:
If Congress wants to save money and have less, I agree, maybe that's not a policy I would adopt.

[00:29:47] Speaker 00:
But let me come back to what the policy that Congress cared about, and I think this will help explain why world-only drugs would have been outside of the ambit of what would be included in the statute.

[00:29:59] Speaker 00:
What Congress was concerned about, and I don't think there's really a dispute about this, is that what was going on before MIPPA is you had the composite rate system, which was a smaller system,

[00:30:07] Speaker 00:
in which there were some drugs and some items and services.

[00:30:11] Speaker 00:
And then you had other drugs that were separately reimbursed principally under Medicare Part B. And the main one, the example that I think comes up the most is erythroporiatin.

[00:30:23] Speaker 00:
And this was a drug where basically Congress reached the conclusion that dialysis providers had a significant profit incentive to overuse these injectable drugs that were outside of the composite rate system.

[00:30:40] Speaker 00:
And so the goal of MIPPA was to take those kinds of drugs that dialysis providers had a financial incentive to prescribe and put them into one prospective payment system.

[00:30:51] Speaker 00:
Oral-only drugs are different because they are prescribed by nephrologists and self-administered by patients.

[00:30:58] Speaker 00:
Dialysis providers have no profit incentive to prescribe oral-only drugs.

[00:31:02] Speaker 00:
They're totally different from all the injectable drugs.

[00:31:05] Speaker 00:
They're also different from

[00:31:06] Speaker 05:
So how does the reimbursement work?

[00:31:09] Speaker 05:
If your dialysis provider doesn't prescribe it, but your nephrologist does, it's still one bundle per patient?

[00:31:16] Speaker 00:
Or how does this work?

[00:31:17] Speaker 00:
So before January 1st, 2025, the way it worked is you would get reimbursement under Medicare Part D, under the prescription provision that you were referring to earlier.

[00:31:26] Speaker 00:
Now the way it works under the bundle is as follows.

[00:31:29] Speaker 00:
The way that the bundled payment works is that

[00:31:32] Speaker 00:
the agency sets an amount that basically dialysis providers get for every patient.

[00:31:37] Speaker 00:
So it's per patient, but it doesn't account for the actual treatment needs of that patient.

[00:31:43] Speaker 00:
So some patients may be more expensive than that amount, some patients may be less expensive.

[00:31:48] Speaker 00:
There are very small adjustments that can be made for treatments, but they don't account for the full cost of treatment.

[00:31:55] Speaker 00:
And so essentially you're getting a flat fee per patient.

[00:31:58] Speaker 00:
When you add additional drugs to the bundle, as has occurred with oral only drugs, the bundle to begin with, even before oral only drugs were in the bundle, the agency acknowledged that the rate that was basically being paid, the flat rate that was being paid was either just breakeven or a negative margin essentially for the dialysis providers.

[00:32:23] Speaker 00:
So, dialysis providers, when they're treating patients on Medicare, are already losing money or just breaking even.

[00:32:28] Speaker 00:
When you add a bunch of drugs to it and you don't fully increase the cost to account for those drugs, all you're doing is creating a situation where there's a huge financial disincentive on the dialysis providers to facilitate it.

[00:32:39] Speaker 05:
But the phrenologist can still prescribe it.

[00:32:42] Speaker 00:
But what happens is that they don't in practice, because the dialysis providers make clear through their formulary setups or basically what they're going to accommodate at the dialysis facility.

[00:32:53] Speaker 00:
They strongly discourage, and in particular, the treatment using innovative new drugs.

[00:33:02] Speaker 00:
And we've seen this time and time again with the bundle.

[00:33:05] Speaker 00:
We point to in our brief, and I think you can look in our complaint,

[00:33:08] Speaker 00:
JA, I think it's 44 through 52.

[00:33:12] Speaker 00:
That's our complaint when we talk about drugs that have had the experience of going into the bundle.

[00:33:17] Speaker 00:
Some examples are Parsevid.

[00:33:18] Speaker 00:
This was a really important, this is an injectable drug even, that was used for hyperparathyroidism.

[00:33:26] Speaker 05:
But doesn't that just support the conclusion that Congress made this policy choice, which is probably bad for patients, but it's still a policy choice.

[00:33:36] Speaker 05:
What they should have done was raise the price that they're paying for the bundle, but they didn't.

[00:33:41] Speaker 05:
And they just put more things in the bundle.

[00:33:44] Speaker 05:
Maybe that was a policy error, but that doesn't mean we contort the statutory interpretation.

[00:33:50] Speaker 05:
They didn't mean to do something that it seems that they meant to do.

[00:33:53] Speaker 00:
I understand your question, Your Honor.

[00:33:55] Speaker 00:
The point is that it's the government that's contorting the statute.

[00:33:58] Speaker 00:
The statute that, you know, what Congress was trying to do, the policy choice that they made was to take the kinds of drugs that renal dialysis providers were providing during renal dialysis services and put those into the prospective payment system.

[00:34:13] Speaker 00:
Oral-only drugs are outside of that.

[00:34:15] Speaker 00:
That's why the statute was written the way it was.

[00:34:18] Speaker 00:
to include only drugs and biologicals and the oral equivalent of those drugs and biologicals, because those are the ones where there is a financial impact and a financial incentive that affects the dialysis providers.

[00:34:29] Speaker 00:
And I recognize it's a statute that is complicated.

[00:34:33] Speaker 00:
There's interplay.

[00:34:34] Speaker 01:
You said in the current year's report, the projected expense for the phosphate, I think the

[00:34:42] Speaker 01:
drug antiphosphate drug was about half of what it had been.

[00:34:46] Speaker 01:
Yes.

[00:34:46] Speaker 01:
And therefore, you said half as many people would get it.

[00:34:49] Speaker 01:
How was this?

[00:34:50] Speaker 01:
How is that?

[00:34:51] Speaker 01:
What's the middle that's missing between those two?

[00:34:54] Speaker 01:
Did the government say every other person gets it?

[00:34:59] Speaker 01:
I mean, what is it?

[00:35:00] Speaker 00:
I don't know, but I can tell you that the government had no explanation for why it was going to pay less than half for phosphate binders.

[00:35:07] Speaker 00:
It's not because of some difference in price.

[00:35:10] Speaker 00:
And I can tell you, I'm getting rained on a little bit for some reason, the American Association of Kidney Patients, who's one of the clients that I represent,

[00:35:24] Speaker 00:
They did a survey this year to basically understand how patients and nephrologists are experiencing this significant change that's happened since January 1st.

[00:35:35] Speaker 00:
And what they found was that over 70% of nephrologists said that they're basically experiencing disruptions in their ability to treat patients with phosphate-lowering therapies, and that a significant number of patients reported the same thing.

[00:35:48] Speaker 00:
So people who need these drugs, and these drugs that phosphate-lowering therapies, it's directly connected to the mortality that a patient experiences.

[00:35:58] Speaker 01:
This has been the third countering obstacles.

[00:36:00] Speaker 01:
A doctor writes a prescription, and they don't get reimbursed?

[00:36:03] Speaker 00:
The point is that what's happening in practice is that the dialysis facilities have always had a big impact on what actually is prescribed.

[00:36:10] Speaker 00:
That's why, prior to MIPPA, there was significant over-prescription of these drugs for which there was separate reimbursement, and that ended when they went into the prospective payment system.

[00:36:21] Speaker 01:
And that was being prescribed by the nephrologist?

[00:36:25] Speaker 00:
It's being described by a nephrologist, but nephrologists are interacting with dialysis centers because these are patients that they're basically partnering in the treatment of.

[00:36:33] Speaker 00:
And so when a dialysis, if the

[00:36:39] Speaker 00:
If the administration of these drugs is now happening at the dialysis center and it's connected to the dialysis center's bottom line, the problem is that they then have an incentive to set it up in a way that discourages the nephrologist from providing that treatment.

[00:36:54] Speaker 00:
It says the only drugs that are available are these drugs.

[00:36:56] Speaker 00:
You have to do it this way, or we want you to do this drug first.

[00:36:59] Speaker 05:
Is the dialysis center getting reimbursed for a drug that isn't taken at the dialysis center?

[00:37:03] Speaker 00:
they are getting well now they now because it's part of the perspective payment system they do get reimbursement through that through the bundle payment and again we don't think that it's a sufficient reimbursement such that you know they are financially you know we're not trying to say they're evil actors they we understand like they're trying to provide it they're trying to provide a surface and they have to make decisions to

[00:37:22] Speaker 05:
But I thought you said that Congress intended that it would be things done during the dialysis service, but that's just not what the statutory language says.

[00:37:31] Speaker 05:
It says for the treatment of end-stage renal disease.

[00:37:35] Speaker 00:
But the whole statutory definition is defining renal dialysis services.

[00:37:39] Speaker 00:
And I will tell you that the agency here, CMS, itself defines renal dialysis services to mean to exclude anything that's not necessary for the delivery of renal dialysis services.

[00:37:52] Speaker 05:
So for the actual dialysis, but then that just doesn't square with for the treatment of end-stage renal disease, which is beyond what them just sitting there getting the dialysis.

[00:38:02] Speaker 00:
Well, again, I don't think that there's a dispute that the reason for the statute, it was all about trying to address the provision of dialysis services at renal dialysis providers.

[00:38:14] Speaker 00:
That's why the statutory language is set up in a way that talks about a single payment being made to a provider of dialysis services, to a renal dialysis facility.

[00:38:26] Speaker 00:
So the statutory language anticipates that this is a payment that's going to renal dialysis providers, and therefore the statute is set up in a way that is designed to be comprehensive about the kinds of drugs that are provided by renal dialysis providers as renal dialysis services.

[00:38:44] Speaker 01:
Is there any other indicated use for the drug in question here?

[00:38:48] Speaker 00:
There is a different indication that the drug, it's a different brand name, so they are different products, but it is the same generic goes into it.

[00:39:03] Speaker 00:
But there is an application that's outside the end-stage renal disease context for this product.

[00:39:06] Speaker 01:
But only for the generic version?

[00:39:08] Speaker 00:
No, there is no generic.

[00:39:10] Speaker 00:
What I'm saying is the generic, in other words, the chemical.

[00:39:15] Speaker 00:
The chemical, that's a better way of putting it.

[00:39:17] Speaker 01:
The molecule can be used for something else.

[00:39:19] Speaker 00:
Yes, that's right.

[00:39:21] Speaker 00:
Yes, but that's separate.

[00:39:23] Speaker 00:
Because it's under a different brand name, the way it's set up is that is reimbursable separately under medical parti, but it's only for people who get that prescription.

[00:39:31] Speaker 01:
Right.

[00:39:32] Speaker 01:
And would you say that the bulk of prescriptions are for

[00:39:37] Speaker 01:
ESRG or for something else?

[00:39:39] Speaker 00:
I don't know the breakdown, but what I do know is that the prescriptions that this year, when we went from fourth quarter 24 to first quarter 25, the prescriptions for Exposa, for instance, there was a substantial drop.

[00:39:53] Speaker 00:
And I think what that's telling you is, again, these are people who were having this drug be prescribed, who need this drug, these are life-saving therapies, and now have lost access as a result of what's occurred.

[00:40:06] Speaker 00:
So, you know, there's a reason why the patient advocacy groups in this case are on our side of the V. I mean, this is something that... Are people who are able to, allowed to pay for it themselves?

[00:40:16] Speaker 00:
Yes, so if you don't have Medicare, you can't pay for it.

[00:40:20] Speaker 00:
If you have insurance other than Medicare or means to pay, yes.

[00:40:23] Speaker 00:
But the reality of the end-stage renal disease population is that this is such a debilitating disease that usually when you have end-stage renal disease, you can't work because you have to spend so much of your week going to dialysis centers.

[00:40:34] Speaker 05:
How much does it cost?

[00:40:37] Speaker 00:
I do not know that number offhand, I'm sorry.

[00:40:40] Speaker 01:
It's typically covered under Part D?

[00:40:42] Speaker 00:
It was historically covered under Part D, yes.

[00:40:46] Speaker 00:
So we recognize, again, we understand that the statute can be tricky, that there's a lot of things going on.

[00:40:51] Speaker 00:
But I think the important takeaway here is their interpretation of the statute, even if you agree with their interpretation of V3, that cannot be comprehensive for what the statute includes with respect to drugs.

[00:41:05] Speaker 00:
Because there are many drugs that they've added to the bundle, including drugs that are injectable drugs that have come onto the market after 2011.

[00:41:13] Speaker 00:
that could not be part of the bundle unless they are right about the meaning of before or the idea that there is a, uh, you know, that, that Congress was implicitly giving the secretary authority to take this very nuanced framework that they created according to them about what drugs are part of the bundle and gave the secretary the authority to totally undo that.

[00:41:34] Speaker 00:
We just don't think that's a reasonable reading of the statute.

[00:41:36] Speaker 00:
And I'll also point out, you know, ultimately, I think, you know, both parties talk a little bit about the legislative, the post enactment legislative history.

[00:41:43] Speaker 00:
I don't think that it's dispositive for either side, but I will just point to two things.

[00:41:47] Speaker 00:
It never is.

[00:41:48] Speaker 00:
It never is, right?

[00:41:49] Speaker 00:
But I will just point to two things, if it's helpful, that I think are inconsistent with their view of the world.

[00:41:55] Speaker 00:
One is, of course, immediately after the closest, most contemporaneous evidence of legislative action in relation to this was that a proposal was made to amend the statute to specifically include oral-only drugs in the following Congress.

[00:42:10] Speaker 00:
That failed.

[00:42:11] Speaker 00:
And their whole idea, their whole premise of what Congress intent here was, was that Congress intended all along for oral only drugs to be part of the bundle payment.

[00:42:21] Speaker 00:
What has actually happened, of course, is that once CMS indicated their intent to put these drugs in as part of the prospective payment system,

[00:42:28] Speaker 00:
Congress repeatedly pushed back the date on which that could happen.

[00:42:33] Speaker 00:
And if Congress intended all along for these drugs to go into the bundle back in 2011, it's really hard to understand why Congress would have kept pushing this off.

[00:42:42] Speaker 05:
But then, isn't the flip side of your argument that they understood what the implications were and then they let this go into effect in 2025, knowing exactly what was going to happen?

[00:42:51] Speaker 00:
This is why I think it's not dispositive for either side.

[00:42:55] Speaker 00:
I think that the clearest thing that you can read from the post-enactment history is that

[00:42:59] Speaker 00:
Congress was aware of the fact that the agency had created this policy, and there probably weren't sufficient votes to either reject it expressly or approve it expressly.

[00:43:08] Speaker 00:
And so in that kind of world, what Congress had available to it was to delay it and to put in place measures to study it if it ever took effect.

[00:43:18] Speaker 00:
And so again, I don't think that's dispositive for either side, but I do think that their story of the world that, oh yes, Congress from the get-go wanted to include oral only drugs.

[00:43:27] Speaker 00:
It's really hard to square with what congressional action happened thereafter.

[00:43:32] Speaker 02:
Just kind of distinguishing back to the beginning about the jurisdiction versus the merits part.

[00:43:38] Speaker 02:
Yeah.

[00:43:39] Speaker 02:
where the district court was indicating there wasn't subject matter jurisdiction, but CMS did not exceed its authority.

[00:43:48] Speaker 02:
However, the district court didn't make any findings related to the APA, yet still went on to find non-exhaustive list, talked about the effective date of the January 1, 2025.

[00:43:58] Speaker 02:
I guess I'm asking

[00:44:00] Speaker 02:
about the district court going into the merits, but then is there anything that if we touched on the merits that should have gone back to the district court because they didn't complete the whole APA analysis?

[00:44:12] Speaker 00:
No, I think basically the question is squarely before you.

[00:44:16] Speaker 00:
And I think essentially the right way to handle this case, I think, is for this court to reach the merits.

[00:44:24] Speaker 00:
If they agree with us that we're right on the merits of what the statute means, then the answer would be to find that there is jurisdiction to reach the challenge, that we're correct on the merits, and therefore to reverse the decision below and grant summary judgment to us.

[00:44:40] Speaker 00:
I know that I've gone well over my time, but if the court would indulge me with a few minutes of rebuttal time, I would really appreciate that.

[00:45:07] Speaker 06:
Thank you very much.

[00:45:10] Speaker 06:
the court got quite into the weeds of sort of policy decisions, which is precisely what judicial review bars are intended to foreclose.

[00:45:21] Speaker 06:
So I wanted, if I could, with the court's indulgence, just sort of zoom out a little bit and to talk about the two routes that the government thinks.

[00:45:27] Speaker 06:
this case could be resolved on.

[00:45:29] Speaker 06:
First, we think that there is a very straightforward route.

[00:45:34] Speaker 06:
The question when looking at a judicial review bar is always, what does the plain text of the judicial review bar?

[00:45:40] Speaker 06:
What type of agency action comes within that judicial review bar?

[00:45:43] Speaker 06:
So in Amgen, for example, the review bar there in both Amgen is subsequently clarified in American Hospital, which was looking at the same overall different clause, same overall review bar, did specifically cross-reference other statutory provisions.

[00:46:00] Speaker 06:
So by expressly cross-referencing those statutory, other statutory provisions, it comes within the plain text of the review bar.

[00:46:08] Speaker 06:
itself.

[00:46:09] Speaker 06:
Here, by contrast, so this is at subsection G, as we described in our brief, a bunch of the things for which Congress precluded judicial review did cross-reference other subparagraphs.

[00:46:24] Speaker 06:
This particular thing, Congress did not.

[00:46:25] Speaker 06:
It just said the idea

[00:46:27] Speaker 06:
So what's precluded from review is the identification of renal dialysis services included in the bundle payment.

[00:46:33] Speaker 06:
And there's no question that this is that's exactly what's happening here.

[00:46:38] Speaker 06:
And you can see that from, you know, for example, the relief requested in the complaint, which is at J.A.

[00:46:44] Speaker 06:
56.

[00:46:45] Speaker 06:
where plaintiffs ask the court to declare that exposure is not a renal dialysis service and is not subject to inclusion in the ESRD.

[00:46:55] Speaker 06:
That comes clearly within the plain text of the review bar and we think that's all the court needs to do to resolve this case.

[00:47:02] Speaker 06:
But if the court as a district court did thinks that somehow this review bar sort of did incorporate that other statutory provision, we also think that the district court was absolutely correct that this clearly falls within the agency statutory authority under that provision.

[00:47:18] Speaker 06:
And I do just I think one of the biggest points of disagreement

[00:47:21] Speaker 06:
in this case, and I'm happy to talk through the statutory, you know, the particular statutory provisions in B14 as well, is what Congress was doing.

[00:47:30] Speaker 06:
And here we actually do think what Congress did was dispositive.

[00:47:34] Speaker 06:
What Congress did is to say after, so in 2010, CMS issues a final rule that says oral only drugs, not just oral equivalent drugs, but also oral only drugs are going to come into this bundle.

[00:47:48] Speaker 06:
But faced with that, what Congress does is not say, hey, actually, you're wrong.

[00:47:52] Speaker 06:
The statutory language precludes you from signing to do that.

[00:47:56] Speaker 06:
And so we talk about this principally at pages 45 through 46 of our briefs.

[00:48:03] Speaker 06:
public law enactments.

[00:48:04] Speaker 06:
So in 2013, Congress does three things and these are incorporated into the language of the public law.

[00:48:12] Speaker 06:
So there's no sort of question about, did different people have different ideas?

[00:48:15] Speaker 06:
This is what, despite the fact that there may have been some agreement, what Congress together came up with and enacted.

[00:48:21] Speaker 06:
And so the first is in pushing back the date for the effective date for the first time, Congress instructs that the agency may not implement the policy under, and this is where it was the regulation was at the time under Section 413174 F6 of Title 42 Code of Federal Regulations relating to oral only ESRD drugs in the ESRD perspective.

[00:48:46] Speaker 06:
payment system delays that till 2016.

[00:48:49] Speaker 06:
It then tells HHS to monitor the bone and mineral metabolism of individuals.

[00:48:56] Speaker 06:
And the particular condition here falls into that general category with NCA adrenal disease as part of its, quote, implementation of oral-only ESRD-related drugs in the ESRD prospective payment system under subsection B14.

[00:49:12] Speaker 06:
So again, acknowledging that obviously the agency

[00:49:15] Speaker 06:
have the authority to include this and um and it you know order studies to see what the effect of the implementation and this gets to

[00:49:25] Speaker 06:
Judge Pan's question earlier about sort of, is this a policy choice that Congress made?

[00:49:29] Speaker 06:
And what Congress does, too, during the period of time of delaying the effective dates is to say, GAO, can you submit a bunch of studies that look at the impact?

[00:49:38] Speaker 06:
And so it does this in 2013.

[00:49:40] Speaker 06:
It does this in 2014.

[00:49:43] Speaker 06:
But what Congress doesn't do is, after those studies come back, is change the statutory language.

[00:49:48] Speaker 06:
It just kicks back the effective date again.

[00:49:52] Speaker 06:
incredibly crucially and this is something that I didn't hear addressed at all in the opening or really you know fully engaged in the reply brief.

[00:50:02] Speaker 06:
Congress also adds things to the statute that just wouldn't make sense and actually it's not just a question of surplusage, couldn't have any meaning of plaintiffs were right.

[00:50:12] Speaker 06:
And so specifically, these are two things that happened in the 2014.

[00:50:17] Speaker 06:
So this is public law number 113-93, section 217, two things.

[00:50:26] Speaker 06:
So first of all, Congress adds there are these quality.

[00:50:30] Speaker 06:
So one of the ways that Congress deals with some of the policy problems we were talking about, about being worried that dialysis facilities might have perverse incentives not to prescribe things.

[00:50:41] Speaker 06:
is to say there are going to be these quality control or performance measures.

[00:50:46] Speaker 06:
If a renal dialysis facility doesn't meet the measure, they can get, at the secretary's discretion, up to a 2% reduction in the composite payment rate they're getting.

[00:50:58] Speaker 06:
So there's bite to that.

[00:50:59] Speaker 06:
And Congress specifically adds a measure that, quote, is specific to conditions treated with oral-only drugs.

[00:51:06] Speaker 06:
Now, why would there be a measure by which renal dialysis facilities

[00:51:10] Speaker 06:
this very bundled payment we're talking about could be reduced by 2% if they weren't doing a good job with with conditions associated with these oral only drugs.

[00:51:19] Speaker 06:
It just it just would have no meaning and similarly and this gets to some of the discussion about how the agency's authority under the general provisions you know as the government has explained makes the most sense to think about this under

[00:51:38] Speaker 06:
Before, Congress also, so this is at 128 statute at 1062.

[00:51:49] Speaker 06:
It's called the drug designations provision.

[00:51:51] Speaker 06:
And there, it instructs the secretary to, it says, the secretary, quote, shall establish a process for, one, determining when a product is no longer an oral-only drug, so assumes that oral-only drugs are in the bundle.

[00:52:06] Speaker 06:
And two, so the process would also provide for including new injectable and intravenous products into the bundled payment under such system.

[00:52:16] Speaker 06:
And those two provisions just don't have meaning if Congress didn't understood that oral-only drugs could come into the bundle.

[00:52:25] Speaker 06:
And I'm happy, and just one sort of, now again, I do want to just- Is that discussed in your brief?

[00:52:32] Speaker 06:
Where is that in your brief?

[00:52:33] Speaker 06:
Yes, yes, Your Honor.

[00:52:36] Speaker 05:
Access the written version.

[00:52:38] Speaker 06:
The so sorry.

[00:52:39] Speaker 06:
So the primary discussion is that pages forty five to forty six of our brief.

[00:52:52] Speaker 06:
And that really lays out this argument.

[00:52:54] Speaker 06:
So 45 through 46 of our brief, I think we talk primarily about, we refer to it as the TADAPA program.

[00:53:00] Speaker 06:
It's also, of course, in the background section of our brief, which I apologize, I don't remember off the top of my head exactly which pages those were.

[00:53:06] Speaker 06:
So it's in the background section when we talk about how the statute was enacted.

[00:53:10] Speaker 06:
In the merit section, in the argument section of our brief, we talk about this primarily at pages 45 through 46.

[00:53:16] Speaker 06:
And I believe we also talk about

[00:53:19] Speaker 06:
the my apologies for not remembering and then also page 56 talks about it.

[00:53:26] Speaker 06:
So those are the marriage sites and apologies for not having the statutory background.

[00:53:33] Speaker 06:
And so we really think what Congress has done afterwards really confirms everything that the agency said.

[00:53:39] Speaker 06:
But I'm also happy to walk through our view of what comes in through B3 and B4.

[00:53:47] Speaker 06:
Although I can also say that we largely agree with the way the court has the court's earlier questions elucidated.

[00:53:57] Speaker 02:
So, if B is meant to be a non-exhaustive list of the renal dialysis treatment services, could those renal dialysis services encompass all drugs that could treat any of the in-stage renal disease?

[00:54:16] Speaker 02:
Congress is kind of, or are there any limiting principles on that?

[00:54:21] Speaker 02:
Because we talked about the word includes to be non-exhaustive, and then we're bringing this drug in, but then what about anything else?

[00:54:30] Speaker 02:
I'm just trying to make sure that we can draw the line somewhere.

[00:54:33] Speaker 06:
Thank you, Your Honor.

[00:54:35] Speaker 06:
Those questions are he were always hesitant to go especially as the government to go outside of you know, I don't know what the agency would do in a future circumstance what I can say and assure your honor is that the agency you know hasn't just said everything can come in what they did in that 2010 regulation is to sort of make 2 just 2 decisions there were 2 potentially limiting principles.

[00:54:57] Speaker 06:
One limiting principle was, does it matter what the route by which patients get this is, whether it's oral or intravenous?

[00:55:06] Speaker 06:
And they said no.

[00:55:07] Speaker 06:
And if I might just put a pin in the rest of the answer to your honest question, I did just want to clarify something that I think might have gotten muddled factually before, which is the question of whether renal dialysis facilities can furnish these oral drugs.

[00:55:22] Speaker 06:
Of course, given the fact that

[00:55:24] Speaker 06:
B14 expressly contemplates that oral equivalent drugs can be furnished by renal dialysis service centers.

[00:55:33] Speaker 06:
There's no reason to think that that would be any different for oral only drugs.

[00:55:37] Speaker 06:
And we talk about this as well in our brief.

[00:55:42] Speaker 06:
So in the final rule, 75, fed reg at 49043, one of the reasons that HHS actually originally, it had statutory authority to kick out the date itself until 2014 for these oral only drugs.

[00:55:58] Speaker 06:
One of the reasons it said it was doing that was to give renal dialysis facilities more time to figure out how to either have in-house pharmacies that could furnish these directly or relationships with other

[00:56:09] Speaker 06:
I just sort of, you know, it doesn't mean that it's not for the treatment of the disease.

[00:56:19] Speaker 06:
If your doctor gives you something to take home with you to keep up with treatment, but.

[00:56:28] Speaker 06:
Uh but yes, so sorry.

[00:56:29] Speaker 06:
So, to get back, that was a very long-winded aside.

[00:56:31] Speaker 06:
My apologies.

[00:56:33] Speaker 06:
Um but to get back to your honor's question about um the limiting principles.

[00:56:37] Speaker 06:
So, one is, does the route of administration matter?

[00:56:41] Speaker 06:
The answer

[00:56:42] Speaker 06:
was no, we think that what Congress did subsequently to sort of confirms that that is a choice that the agency was entitled to make.

[00:56:53] Speaker 06:
And then the second one was the agency created functional categories to decide are these conditions so sort of tightly related to the treatment of end-stage renal disease that it makes sense for them to come into the bundle.

[00:57:07] Speaker 06:
And so there are five general categories.

[00:57:10] Speaker 06:
The category that's most relevant here is the, and so it does that, and it also does three things.

[00:57:17] Speaker 06:
So it identifies five general categories that are basically anything used to treat these types of disease, these types of conditions that fall within these categories always in the bundle.

[00:57:29] Speaker 06:
putting it a little colloquially.

[00:57:31] Speaker 06:
It also created several categories that it said, these are always excluded from the bundle.

[00:57:38] Speaker 06:
And then it also created one sort of set of things that sometimes that medication can be used to treat end-stage renal dialysis disease, and sometimes it can't, and sort of said, so these are sometimes in the bundle, sometimes not in the bundle, and we'll know by sort of how it's filled out, the description of what it was supposed to do.

[00:57:58] Speaker 06:
I absolutely understand your honor's concern.

[00:58:01] Speaker 06:
Again, in light of the judicial review bar, the agency's exact calls on that are sort of precisely the thing that Congress didn't want, second guess in the course of litigation.

[00:58:12] Speaker 06:
But I can assure your honor that the agency has really thought through this.

[00:58:20] Speaker 02:
And then under B3, could that be read to include drugs developed after January 1, 2011?

[00:58:26] Speaker 06:
Yes.

[00:58:27] Speaker 06:
And so something that the district court described cogently and we also briefly describe, you know, because we think the question here is easy with respect to oral only drugs, because as elucidated earlier, Congress expressly made the effective date for oral only drugs.

[00:58:43] Speaker 06:
January 1st, 2025, there's no dispute that exposal was separately paid under Medicare Part D.

[00:58:49] Speaker 06:
before it came into the bundle.

[00:58:50] Speaker 06:
So we think that question's really easy here, but we think more broadly as well that what Congress said here was after application of this paragraph, it didn't say, you know, after, you know, on or after January 1st, 2011, which it did do another.

[00:59:05] Speaker 06:
So if you just, just looking up at

[00:59:08] Speaker 06:
Roman numeral I there, so the first set of items is items and services included in the composite rate for renal dialysis services as of December 31, 2010.

[00:59:20] Speaker 06:
So in that same definitional section, Congress certainly indicated that it knew how to limit something to a specific date.

[00:59:28] Speaker 06:
And then as we were discussing as well,

[00:59:32] Speaker 06:
Congress certainly contemplated that the agency had authority to bring in new intravenous drugs because it told HHS to establish a process for doing so.

[00:59:49] Speaker 06:
sort of more generally as we think that this report laid out so well, this really was a system in which Congress intended more things to come into the bundle and has confirmed, you know, through certain legislation like time, you know, that there's a floor of things that can be brought that must be brought in and then new things as new drugs are developed, they should be brought in as well.

[01:00:17] Speaker 02:
And I just want to know how far we should go in the opinion.

[01:00:19] Speaker 02:
Should we merge jurisdiction with the merits so we have a limited review, then rule about the non-exhaustive list, and then just go to B3 with respect to the date?

[01:00:31] Speaker 06:
So the government's preference would be

[01:00:35] Speaker 06:
to for a ruling that the court actually doesn't need to look at the definition of renal dialysis services because unlike an Amgen and American hospital.

[01:00:48] Speaker 06:
this particular sub-provision does not cross-reference other statutory provisions and the challenge agency action here clearly falls within the plain text of the provision itself.

[01:00:58] Speaker 06:
So that's first order how we would prefer.

[01:01:01] Speaker 06:
And we think that will actually add a lot of clarity in this area that you only look beyond the review provision

[01:01:09] Speaker 06:
to figure out whether something is that type of agency action shielded under review when the judicial review provision cross-references something such that it effectively comes into the review person.

[01:01:20] Speaker 06:
As a second order preference, we think that to the degree that the court agrees with the district court that this particular statutory provision should ease the way the statute was written does come into

[01:01:38] Speaker 06:
into the plain text of the review bar itself, then we do think that the statutory language quite clearly encompasses this authority.

[01:01:49] Speaker 06:
Again, we think that this sort of clearest way to do it.

[01:01:52] Speaker 06:
One of the cleanest, most straightforward routes of doing so is that plaintiffs' analysis can't be squared with the subsequent changes to the statute, both Congress

[01:02:08] Speaker 06:
not saying, you know, after being fully aware that HHS was adding this oral only drugs in the 2010 rule, not saying you can't do that, but just...

[01:02:19] Speaker 06:
putting out the effectiveness date.

[01:02:20] Speaker 06:
This isn't a case.

[01:02:21] Speaker 06:
Sometimes Congress doesn't know exactly what's happening.

[01:02:24] Speaker 06:
We know Congress knew exactly what was happening.

[01:02:27] Speaker 06:
And they kicked out the effectiveness date.

[01:02:28] Speaker 06:
And they also included those two provisions that we were talking about that just wouldn't have any effect.

[01:02:34] Speaker 06:
And so the provision for the process of determining that something isn't an oral-only drug and then including its injectable

[01:02:45] Speaker 06:
equivalent.

[01:02:46] Speaker 06:
So, that's codified at the note to 1395 RR and the quality performance measurement that I was talking about earlier is codified at 1395 RR H2E.

[01:02:59] Speaker 06:
And I just haven't heard how those could work.

[01:03:03] Speaker 06:
If that's not what, if Congress didn't think oral only drugs could come in.

[01:03:09] Speaker 02:
Anything further?

[01:03:11] Speaker 06:
And there are no further questions.

[01:03:12] Speaker 06:
We'd ask the court.

[01:03:21] Speaker 00:
Thank you, Your Honor.

[01:03:21] Speaker 00:
So just make a couple of brief points.

[01:03:24] Speaker 00:
First of all, my friend relied principally on the post-enactment history.

[01:03:30] Speaker 00:
Let me just be really clear, because I think that the main statute that she was relying on actually points in the other direction.

[01:03:35] Speaker 00:
So she pointed to the statute from 2014 that says that the secretary shall establish a process for one, determining when a product is no longer an oral-only drug, and two, including new injectable and intravenous products into the bundled payment.

[01:03:49] Speaker 00:
The reason why the secretary was determining a process for when a product is no longer an oral only drug is because at that point it entered into the bundle.

[01:04:00] Speaker 00:
This is in a world in which oral only drugs were excluded from the bundle.

[01:04:04] Speaker 00:
What Congress was saying is we know oral only drugs are excluded from the bundle at this point.

[01:04:09] Speaker 00:
But make sure that there's a process that if there ever becomes an injectable equivalent, then it will become an oral equivalent of something that's in the bundle.

[01:04:19] Speaker 00:
And it can then go into the bundle.

[01:04:20] Speaker 00:
Is that clear?

[01:04:21] Speaker 00:
OK.

[01:04:23] Speaker 00:
Sorry.

[01:04:23] Speaker 00:
Let me slow it down.

[01:04:25] Speaker 00:
The process is for determining when a product is no longer an oral-only drug.

[01:04:29] Speaker 00:
So let's say that right now, for instance, Exposa is an oral-only drug.

[01:04:33] Speaker 00:
There's no injectable equivalent.

[01:04:35] Speaker 00:
If there were to be an injectable equivalent at the time when the statute was enacted, so if there was no injectable equivalent at the time when the statute was enacted, it would not be part of the prospective payment system.

[01:04:47] Speaker 00:
Oral-only drugs were at that time already excluded until 2025.

[01:04:52] Speaker 00:
If an injectable was approved, at that point, it would become the oral equivalent of an injectable drug.

[01:05:00] Speaker 05:
Injectable becomes an oral equivalent?

[01:05:05] Speaker 00:
It's an oral drug that would be equivalent to an injectable at that point in time.

[01:05:12] Speaker 00:
So in other words, if an injectable comes out, now this oral drug, which has already existed, it's now an oral equivalent drug.

[01:05:19] Speaker 00:
But what that means is that... Does that ever happen?

[01:05:23] Speaker 05:
The things that were injectable are no longer...

[01:05:26] Speaker 00:
It has happened where there are oral drugs that are injectable.

[01:05:30] Speaker 00:
It can happen.

[01:05:31] Speaker 00:
You're right.

[01:05:32] Speaker 00:
It's not the most common thing to happen, but that's what Congress was getting.

[01:05:36] Speaker 00:
I don't think there's a dispute that that's what Congress was getting.

[01:05:41] Speaker 00:
Yeah, but what's important there is that what that's suggesting is that Congress is saying that, OK, in a new injectable drug after 2011, we assume that that would be part of the bundle.

[01:05:55] Speaker 00:
But again, their argument is that you have to understand.

[01:05:58] Speaker 05:
Consistent with their reading is that under the statute right now, the oral only thing only goes to things later.

[01:06:06] Speaker 05:
But now they're saying the injectable ones too.

[01:06:11] Speaker 05:
That's consistent with their reading.

[01:06:12] Speaker 00:
No, no, no, no, no.

[01:06:14] Speaker 00:
What they're saying is that they're saying that world only comes in if it's, if it's, there's, there's, they're saying, we're only only rural only drugs come into the, to the bundle.

[01:06:25] Speaker 00:
If they are, if they were separately paid before 2025 today, but this, this statute was, okay.

[01:06:33] Speaker 05:
That's the alternative reading.

[01:06:34] Speaker 05:
Yeah.

[01:06:35] Speaker 00:
No, no, that's what that's what they're saying.

[01:06:36] Speaker 00:
Yeah, I mean, we think that that's wrong.

[01:06:38] Speaker 00:
But again, this statute basically, and also it's adding new injectable and intravenous products.

[01:06:45] Speaker 05:
So just to be clear, I thought that their interpretation is for the things before the whatever this paragraph goes into effect.

[01:06:53] Speaker 05:
Yes, it's all drugs and biologicals, including orals.

[01:06:58] Speaker 05:
Yes.

[01:06:58] Speaker 05:
Yes.

[01:06:59] Speaker 05:
And then the second phrase is for things after this paragraph that are orals.

[01:07:05] Speaker 00:
Oral equivalent, not oral only.

[01:07:07] Speaker 00:
So let me be clear about that because I want to, and this is what I really wanted to underscore, if the court rules for them, they are masking the utter chaos and the significant consequences that will occur for the end-stage renal disease population.

[01:07:20] Speaker 00:
Under their rule, this is their view of the statute, is to say that D3 applies to products for which there was separate payment before the application of this paragraph.

[01:07:31] Speaker 00:
Whether you think that for oral drugs that was 2011 or 2025, certainly everybody agrees that for intravenous and injectable was 2011.

[01:07:41] Speaker 00:
But in either case, what it means is that any new oral only drug or any new intravenous drug would be outside of the bundle.

[01:07:51] Speaker 00:
So we basically have like a regime that's like the opposite of what Congress intended.

[01:07:56] Speaker 00:
Congress wants drugs that renal dialysis providers provide

[01:08:01] Speaker 00:
at any time.

[01:08:02] Speaker 05:
Our view of the statute is that- I'm sorry, it would be inside the bundle, not outside the bundle.

[01:08:07] Speaker 00:
No, their reading would make it outside V3 because it only would be part of V3 if it was separately paid before the application of this paragraph.

[01:08:17] Speaker 00:
So if a drug comes out January 1st, 2026, it would never have been- So how does the second-

[01:08:26] Speaker 00:
The second clause has no application to any drug unless it is the oral equivalent of an injectable or intravenous drug that was on the market before 2011.

[01:08:38] Speaker 00:
And again, that's why their reading of the statute doesn't make sense.

[01:08:41] Speaker 00:
Their whole reading is that the only things that go into the bundle, the only new products that go into the bundle are drugs that are the oral equivalent of intravenous and injectable drugs that were on the market before 2011.

[01:08:53] Speaker 00:
there is no policy reason I didn't hear any 2025 for your or 2025.

[01:08:56] Speaker 00:
In that case, there is no reason why Congress would have written a statute that does that.

[01:09:02] Speaker 00:
And if Congress had created that very, very nuanced version of what the statute does, it's impossible to imagine that before could be read in the way that they suggest to basically undo that statute or

[01:09:15] Speaker 00:
that some sort of special extra authority could be inferred that that would allow the secretary to completely undo that extremely nuanced framework.

[01:09:25] Speaker 00:
I mean, even if you believe that the word includes in general, you know, and again, we think the case law is clear that it's context dependent and we pointed to all the things that are that are I think telling signs here clues that the court should look to.

[01:09:38] Speaker 00:
But even if you thought that the secretary had authority to expand on the definition of renal dialysis services, cases like the Financial Planning Association that we point to in our brief made clear that when the statute already addresses a subject in a nuanced way, some sort of like, you know, catch-all authority or additional authority can't be used to undo the specific choices made by Congress.

[01:10:01] Speaker 00:
And if what they are saying is that Congress created this very unusual, nuanced regime that has

[01:10:08] Speaker 00:
no policy justification.

[01:10:10] Speaker 00:
I didn't hear any today.

[01:10:11] Speaker 00:
There's none in their brief that explains why they would have set up B3 in that way.

[01:10:16] Speaker 00:
But you certainly couldn't view that as having made that nuanced choice said that then read the rest of the statute to undo that nuanced choice.

[01:10:25] Speaker 00:
The ultimate takeaway from all this is just that their version of the statute doesn't make sense.

[01:10:30] Speaker 00:
And it's not consistent with what Congress was trying to do in NEPA.

[01:10:33] Speaker 00:
And I just want to leave you with this.

[01:10:35] Speaker 04:
So what's your reading?

[01:10:36] Speaker 04:
If their reading is what you just described, your reading is?

[01:10:40] Speaker 00:
Our reading is that what P3 was doing is it was adding to the bundle all drugs and biologicals that before application of this paragraph would have been outside of the composite rate system.

[01:10:51] Speaker 00:
So in other words, any drug that would have otherwise been reimbursable under part B or part D,

[01:10:57] Speaker 00:
that is for the treatment of end-stage renal disease goes in.

[01:11:00] Speaker 00:
It doesn't matter when it came out.

[01:11:02] Speaker 00:
It doesn't matter if it's before 2011 or after 2011.

[01:11:05] Speaker 00:
It's all drugs.

[01:11:06] Speaker 00:
And that is essentially what's consistent with the statutory provision that even they rely on.

[01:11:12] Speaker 05:
But you think only the intravenous ones.

[01:11:15] Speaker 00:
Intravenous.

[01:11:16] Speaker 00:
Yeah, anything that was injectable intravenous or the oral equivalent thereof.

[01:11:20] Speaker 00:
And again, the reason why that would have been the line that Congress would have drawn is because it's intravenous and injectable drugs that dialysis providers are using in renal dialysis services.

[01:11:31] Speaker 00:
That's where the financial incentives that Congress... The timing thing doesn't matter.

[01:11:35] Speaker 00:
Yeah, the timing thing doesn't matter because it doesn't make any sense.

[01:11:38] Speaker 05:
Why would Congress have... So your position is that all drugs and biologicals that were outside the bundle are now in and their oral equivalents, but your clients is not an oral equivalent because it's oral only.

[01:11:50] Speaker 00:
That's exactly right.

[01:11:51] Speaker 00:
The only thing that falls out is oral only.

[01:11:53] Speaker 00:
And the reason, again,

[01:11:55] Speaker 00:
is because oral only drugs are the opposite of the kinds of drugs that Congress would have put in.

[01:12:00] Speaker 00:
I mean, if the purpose of Congress in enacting MIPA was essentially that they were concerned about the fact that dialysis, for-profit dialysis providers were going to prioritize financial incentives over patient care.

[01:12:17] Speaker 00:
it would make no sense to take the one kind of drug or only drugs for which there are no financial incentives and then add those to a bundle where they are now subject to those very financial incentives that are going to skew the patient care.

[01:12:32] Speaker 00:
And I just want to leave the court with this.

[01:12:33] Speaker 00:
And we're passionate about this subject because this really is an incredibly destabilizing, life-threatening disease.

[01:12:44] Speaker 00:
There are over 500,000 Americans

[01:12:47] Speaker 00:
that have end-stage renal disease, it's incredibly debilitating.

[01:12:50] Speaker 00:
It requires dialysis three times a week in order to survive unless you get a new kidney.

[01:12:55] Speaker 00:
And the five-year mortality rate, only 30% to 35% of people survive five years once they're getting dialysis.

[01:13:02] Speaker 00:
So this is a population that faces tremendous health challenges.

[01:13:07] Speaker 00:
It's disproportionately poor, minority, rural,

[01:13:14] Speaker 00:
This policy that the agency has enacted here is something that

[01:13:21] Speaker 00:
advocates from across the kidney care community have been warning for years is not only a wrong reading of the statute, but incredibly harmful from a policy perspective.

[01:13:33] Speaker 00:
And that's why the patient advocacy groups are on our side of the V. And the government can't point to a single commenter that supports their view of the world or their view of the statute.

[01:13:44] Speaker 00:
As I noted, we're already seeing that diminishment of access, and I thought it was quite telling that the government had no response to that when it was up here, didn't disagree with my figures, didn't disagree with what's happening in the real world.

[01:13:56] Speaker 00:
And I would just encourage you, I know that this is a very tricky statute, but their view of the statute does not make sense.

[01:14:02] Speaker 00:
It has no connection to the purposes of NEPA, and we don't think it's a faithful reading of the fact that Congress chose

[01:14:09] Speaker 00:
to call it to add world equivalent drugs, but not to add world only drugs on the face of the statute.

[01:14:15] Speaker 00:
We would urge you to reverse.

[01:14:17] Speaker 02:
Thank you.