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Case number 18-5222, Artorio C. Korsinkansky, Appellant, v. Alex Michael Ozar II, Secretary, United States Department of Health and Human Services.

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Ms.

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Wilberton for the Appellant, Ms.

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Lillie for the Appellee.

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Thank you, and good morning.

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May it please the court.

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My name is Caroline Wolferton.

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I am appearing on behalf of the appellant Arturo Porsikansky.

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This appeal presents a straightforward question about the extent of an Article III court's remedial power.

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Does that power encompass the authority to issue equitable relief to give meaningful effect to the district court's decision?

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And the answer is also straightforward, yes.

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The Supreme Court held long ago in California versus Yamasaki that the judicial review provision of the Social Security Act, which the Medicare statute incorporates, does not limit federal courts' authority to issue equitable remedies.

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The district court... It remains a general rule, is it not, that where there is an adequate remedy provided in the law, equity's hand is stayed, that we do not issue injunctions

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to carry out what the law requires, do we?

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The Supreme Court in California versus Yamasaki, yes, addressed that issue and held that Section 205G, which is the operative provision for judicial review here, does not preclude equitable remedies even though there is an adequate remedy that's otherwise available.

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It's not mutually exclusive that an additional available remedy

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would preclude a district court from entering an injunction.

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And we submit here that the error that the district court made was in concluding that it lacked any power to consider an injunction at all.

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And we certainly agree that it might be appropriate for the district court to consider in the first instance whether there are alternative remedies, but none of that.

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Well, the remedy is there.

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It's not any question of whether there is a remedy.

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Your Honor, we would further submit, yes, there's a remedy.

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It's not adequate here.

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Mr. Porzekanski has been channeling the same issue through the... Now, he's won four reviews under that present, the special remedy, right?

[00:03:23] Speaker 05:
He has, yes, yet the contractor that the secretary employs continues to deny every claim that he files both before the district court's decision and after the district court's decision.

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In each time since the relevant time here, he's won his review.

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His remedy is working, isn't it?

[00:03:46] Speaker 05:
Your Honor, we submit no, it's not working.

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It's not.

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It's not working.

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What has he lost?

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I'm sorry.

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He's won every one of them.

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If it's not working, it's doing a pretty good job of not working in his favor then.

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The reason it's not working is because there is continued uncertainty as to whether Medicare will cover this life-saving treatment, and that uncertainty has a direct impact on his ability to retire.

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He would like to retire.

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He hasn't... Well, you see, applied with the... There is procedures that are not for requesting a national federal determination.

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Yes.

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Has he made such an application?

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He has not, because... He has not.

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He's acting up using the intention.

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to accomplish something he presumably could accomplish by falling in the rim of his past

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the secretary in a recent federal register notice is akin to the FDA's approval of a new drug.

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It's a very lengthy, burdensome process.

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And the patient population who has the condition that Mr. Porzekanski has is very small.

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It seems highly unlikely that

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HHS would find it appropriate to issue a national cover determination for this.

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And in any event, it's not an exclusive avenue.

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What would the injunction look like if we tell the district court to issue an injunction in his favor here?

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What are we telling them to enjoin?

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Well, Your Honor, we're asking for an order that the district court enter an appropriate injunction.

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And I'm asking you what's appropriate.

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Yes, we will argue that the court should enjoin the agency from continuing to imply the invalidated conclusions that the district court found were inconsistent with the Medicare statute and rules.

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And the problem here is that the agency got this ruling from the district court and has completely disregarded it.

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The agency continues to deny every single claim.

[00:06:09] Speaker 02:
Well, it's not the agency that's denying him, is it?

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It's the agency's contractor.

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The contractor is denying.

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Yes.

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Then he gets a review.

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And he's won the review each time, right?

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That is correct, Your Honor.

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OK.

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On that, though, I want to get back to the point I made about the uncertainty that has prevented Mr. Porzekanski from retiring.

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Because every claim is denied at the first level,

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the provider that gives him the treatment that he needs two times every four weeks would not continue to give him the treatment without some assurance that Medicare will cover it.

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They would require Mr. Porteskansky to issue or to give a personal guarantee of payment.

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The way that things have gone, yes, all of his claims have been overturned, but we don't know that that will continue.

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And what's even more concerning here is that if the provider stops the treatments because Mr. Porzekanski has a limited amount of savings, these treatments cost $30,000 each time.

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He's not a billionaire.

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At some point,

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the money will run out and if the provider does not have assurance that Medicare will pay for the treatments, it will stop providing them.

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If that happens, it won't matter that Mr. Porzekinski has available to him multiple administrative remedies.

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He could pursue a national cover determination.

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He could try again for local cover determination.

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He could pursue these individual denials administratively.

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None of that will matter at all because in all likelihood, he would not live to be able to pursue the process.

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If the treatment stopped, he probably will die.

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So that's why the available administrative remedies are not adequate here.

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And that's why it is so important that this court recognize the fundamental power of an Article III court to issue injunctive relief

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when necessary, the Supreme Court recognized in Califano versus Yamasaki that injunctive relief can be essential to a 205G case.

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And we submit that... We also have Ringer and Illinois Council post-Yamasaki, which pretty strongly stand for the proposition that each individual claim for benefits

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needs to be presented and exhausted.

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Yes, Your Honor, and we are not arguing anything different.

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All we are asking for is what the Fifth Circuit and the Ninth Circuit recently recognized that an Article III court can issue... But those are different, those are regulations that are reviewed

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under a different judicial review provision, which specifically carves out, I think it's 405G, which is the basis for all of these channeling requirements.

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So those cases don't help you.

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Yes, there are differences here, but an agency can issue binding determinations either through rulemaking or adjudication.

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And the fact that we have an adjudication here

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doesn't we submit a distinction with a meaningful difference because... It is, though, because the adjudication gets reviewed through the provisions that impose these channeling requirements, whereas the regs get reviewed under an entirely different scheme.

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Yes, Your Honor, and those issues were already reviewed through the channeling process.

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Mr. Porzekanski presented to the agency.

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The issue may have been reviewed, but the thing that gets channeled is the decision of the Secretary.

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And the decision of the Secretary here is the denial of benefits on whatever the date was, December 16, 2014.

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That's the decision that's under review.

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It may be that there are later decisions that will present overlapping or even identical legal issues, but they would be subsequent agency action.

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Yes.

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Yes.

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And we're not asking for any ruling from the district court that the secretary must approve each of Mr. Porzekanski's claims.

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that for an individual claim, he would have to satisfy all the criteria to establish coverage.

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But you are saying that some aspects of that subsequent decision, namely the overlapping legal questions, don't need to be presented and exhausted.

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That's correct, Your Honor.

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And that's hard to square with Ringer and Illinois Counselor.

[00:11:28] Speaker 05:
The reason that we submit that they can be squared is because those questions have already been decided as to Mr. Porzekanski.

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There's the principle of mutual defensive collateral estoppel that should, it does as a matter of law, preclude the agency from revisiting those issues that it has already

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well, that the district court has already decided as to Mr. Porzekanski, it can't re-litigate those same questions that have already been cited.

[00:12:07] Speaker 04:
I mean, maybe yes, maybe no.

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If you were in court under restatement principles, you'd have a pretty good argument for preclusion, issue preclusion here, but that's normally an argument you would make in the second administrative proceeding.

[00:12:30] Speaker 05:
Perhaps, perhaps, but our point is that here the agency has done absolutely nothing as a consequence of the district court's ruling.

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It didn't even pay the claim that the district court overturned until we pointed that out in our briefing to this court.

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And its contractor, as I said, continues to deny

[00:12:53] Speaker 02:
all of the claims on the same grounds, Mr. But they keep losing when he appeals to that, when he's petitioned to review those decisions.

[00:13:01] Speaker 05:
Yes, but certainly the Medicare statute doesn't require him to repeatedly present the same issue that's already been decided.

[00:13:10] Speaker 05:
There must be some meaning that comes from the district court's ruling, and all we're asking Well, obviously there is, because he's still winning each of the front desk court claims.

[00:13:22] Speaker 02:
That's the normal way in which precedent comes into effect, is it's applied in the future cases.

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You don't come in and get an injunction that says, hereafter the trials of fact or the agencies or whatever will follow this precedent we just made.

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Normally the precedent is tested or carried out by further cases in which the claiming party wins.

[00:13:46] Speaker 05:
Yes, but the problem is here, the agency is not carrying out.

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The agency has wholly disregarded the district court.

[00:13:54] Speaker 02:
You seem to be missing, we're passing him the net.

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Obviously, they haven't failed to because he's winning each of the claims since then, right?

[00:14:03] Speaker 05:
No, Your Honor.

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At the initial level, he's always denied on the same grounds as before.

[00:14:08] Speaker 02:
And then he's won each of them when you petition for review.

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Yes.

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When it passed the contractor and went up in the agency.

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He won each time, right?

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He has, yes.

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And the problem is that the agency has done nothing to instruct the contractor to adhere to the district court's decision.

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So are you asking us for an injunction to tell the contractor, for the administrator to tell the contractor to follow this new regime, correct regime?

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Is that?

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Yes.

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That's why I'm asking a while ago what the injunction looks like.

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Yes.

[00:14:44] Speaker 02:
seems like a strange injunction that enjoins what happens as far as the use of the president in future proceedings.

[00:14:51] Speaker 02:
I haven't seen one like that.

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You haven't asked for an injunction to get the administrator to tell the contractor to change its definition, which it may have done by now, for all we really know.

[00:15:05] Speaker 02:
There has been some time lapse since before that he won.

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There's been a lot of time, and the agency has done absolutely nothing.

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The last point I would- Has the contractor changed its

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Yes, as the... Yes, but... I mean, this is not in the record, so we're talking off the record, but they've actually changed that lowest obtainable into a lowest effective, right?

[00:15:29] Speaker 05:
It's still unclear what that means, but what is... Right.

[00:15:32] Speaker 02:
They did make that change, did they not?

[00:15:34] Speaker 05:
Yes, they did, Your Honor.

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I mean, I understand it's not in the record, but we both know that they've done that.

[00:15:38] Speaker 05:
Yes, Your Honor.

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So we have no reason to believe that that will not change the result at the contractor level, do we?

[00:15:43] Speaker 05:
Unfortunately, we have every reason to believe it will not, because in that same determination, the contractor explicitly referenced the legal documentation that Mr. Persikansky had submitted, which was a copy of the district court's ruling.

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And the contractor said, we do not take any notice of that.

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The contractor continues to act like it never happened.

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And that's the problem.

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That's why it's... If the many review since they changed their terminology,

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I'm sorry, your honor.

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Has there been a review since they made that change in terminology?

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He won four before the change, I think.

[00:16:20] Speaker 02:
Correct.

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I think that's right.

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There have been no more reviews since then, so we don't know if he's going to have to go to the second level or not, do we?

[00:16:28] Speaker 02:
Under the lowest effective.

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The lowest effective rather than lowest attainable.

[00:16:33] Speaker 05:
Right.

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Yes.

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He has.

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Yes, he has.

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And I have copies because the effective date of the revised local coverage determination was September of 2018.

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Every claim that he has submitted and has been decided has gotten the same decision denied, citing the same codes that it's not covered by Medicare, it's not medically necessary, as the decision that led to the district court ruling.

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The agency has done nothing to instruct the contractor to adhere to the district court's ruling.

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And the contractor hasn't.

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And that's why, as the Supreme Court said in California versus Yamasaki, an injunction can be essential.

[00:17:20] Speaker 04:
So the effective date of the latest amendment is treat services performed after August 22, 2019.

[00:17:29] Speaker 04:
It's pretty recent.

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So there's already been

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a treatment performed after that date that's produced a denial of benefits by the contractor?

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Your Honor, what I'm speaking to is the local coverage determination that the contractor declined to reconsider.

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And that one was... That was the first one, right?

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That was the one... I don't have the language in front of me, but there were two revisions, right?

[00:18:04] Speaker 02:
Denzel may not be aware of the second review.

[00:18:08] Speaker 02:
Nobody's officially told us about it yet, I don't think.

[00:18:12] Speaker 05:
The filing that the government made last yesterday afternoon is dated August 16, 2019.

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That is a denial of Mr. Porzekanski's request for reconsideration.

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To reconsider the

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first local coverage determination, and I'm sorry, Judge Santel made me write, I'm sorry if we're sandbagging you on this, but I have in front of me a revised local coverage determination.

[00:18:54] Speaker 02:
Yeah, probably, you know,

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It refers to the prior language of the lowest dose of obtainable.

[00:19:02] Speaker 02:
It now comes out with the lowest dose, lowest effective dose.

[00:19:05] Speaker 02:
Right.

[00:19:07] Speaker 02:
And claims that that's a clarification which beggars belief since obtainable and effective don't mean anywhere near the same thing in the English language.

[00:19:22] Speaker 02:
I'm not sure that we've been properly informed of everything that's going on in this case.

[00:19:27] Speaker 02:
I'm not sure that you have.

[00:19:29] Speaker 05:
Well, yes, Your Honor.

[00:19:31] Speaker 05:
If you'll permit me just to clarify, the revised local coverage determination, that was the subject of this reconsideration request?

[00:19:41] Speaker 04:
Right.

[00:19:41] Speaker 04:
It was a prior one.

[00:19:43] Speaker 05:
Yes.

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There have been two.

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There was the one that came before

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the December 2014 claim determination that was the subject of the district court.

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So that did not address Mr. Porzekanski's condition at all.

[00:20:01] Speaker 05:
And that was a basis for the agency's denial of coverage that was overturned by the district court.

[00:20:06] Speaker 05:
Subsequent to that, Mr. Porzekanski requested a new local coverage determination or a revision that was issued in 2000, I think in March 2018.

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And that has the restriction to the lowest dosage obtainable.

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Then in September of 2018, Mr. Porzekanski requested reconsideration

[00:20:31] Speaker 05:
of that second local coverage information based on the district court's decision and the... Sorry, you're calling that the second?

[00:20:41] Speaker 04:
The second local... And I'm talking about a third.

[00:20:43] Speaker 05:
Well, Your Honor, if I might ask the third, do you mean the letter that the government submitted yesterday?

[00:20:52] Speaker 04:
No.

[00:20:52] Speaker 04:
I'm sorry.

[00:20:52] Speaker 04:
I mean, a revised local coverage

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determination by this contractor, effective August 22, 2019, which changes the phrase lowest, what's the old word, Judge Santel?

[00:21:18] Speaker 04:
Lowest obtainable?

[00:21:20] Speaker 04:
Obtainable.

[00:21:20] Speaker 04:
Lowest obtainable.

[00:21:21] Speaker 04:
Into lowest effective.

[00:21:25] Speaker 05:
Thank you, Your Honor.

[00:21:27] Speaker 05:
I've confirmed we have not seen that, and the government has not given us notice of that.

[00:21:31] Speaker 04:
Let me try it this way, and I apologize if we're springing this on you, but let me try it this way.

[00:21:39] Speaker 04:
All you're asking for is an injunction that would prevent

[00:21:48] Speaker 04:
re-litigation of issues that Judge Friedrich decided in your favor, correct?

[00:21:56] Speaker 04:
Okay, as I read her opinion, all of those issues were global in the sense that they had nothing to do with Mr. Porzekowski's condition.

[00:22:09] Speaker 04:
They involved the question whether this treatment was a drug

[00:22:14] Speaker 04:
under the Medicare statutes and whether the district court confused Medicaid and Medicare statutes, right?

[00:22:23] Speaker 04:
Yes.

[00:22:23] Speaker 04:
And under, so all she did was reject a claim that this treatment is categorically unavailable for this kind of disease, right?

[00:22:43] Speaker 05:
I'm sorry, let me make sure I understand.

[00:22:45] Speaker 05:
The district judge rejected the claim?

[00:22:48] Speaker 04:
Rejected a legal argument that would take this treatment off the table regardless of the circumstances for this disease.

[00:22:56] Speaker 05:
Your Honor, no.

[00:22:58] Speaker 05:
She concluded that she did not have power to issue any form of application.

[00:23:05] Speaker 04:
But her ruling on the merits is that

[00:23:10] Speaker 04:
Let's just say for shorthand, the district court confused Medicare and Medicaid standards.

[00:23:16] Speaker 05:
That was part of her opinion, yes.

[00:23:18] Speaker 04:
Okay.

[00:23:19] Speaker 04:
So all that does, as you've said on the merits, that doesn't give your client an entitlement to any payment on any specific claim, because you still have a lot of case-specific issues about

[00:23:40] Speaker 04:
the dosage and the documentation and all of that, right?

[00:23:44] Speaker 05:
Correct.

[00:23:44] Speaker 04:
Okay, so the district court, all the district court has said is that this kind of treatment can be available and the contractor now on two or three occasions has issued a coverage determination saying this kind of treatment can be available

[00:24:07] Speaker 04:
And it seems like your current fight with them is over the details of lowest obtainable dose, lowest effective dose.

[00:24:16] Speaker 04:
Your disagreement is over much narrower questions than what you won on in the prior case.

[00:24:26] Speaker 05:
And I would say our primary dispute is that all of his claims are still denied.

[00:24:33] Speaker 05:
And then as to the specifics of the local coverage determination, how that bears on whether an injunction should issue at all, all of that really is appropriate for the district court in the first instance to have the ability to explore these questions.

[00:24:51] Speaker 05:
What's this recent local coverage determination that we don't even know about?

[00:24:55] Speaker 05:
And how does that factor into the equities?

[00:24:59] Speaker 05:
All of that would be appropriately hashed out when the district court recognizes it has the power to hash out and then subject to the court's review.

[00:25:07] Speaker 02:
We never officially got it either.

[00:25:09] Speaker 02:
I'm not quite sure how we got it.

[00:25:11] Speaker 02:
But there is a change that's effective August 22nd.

[00:25:13] Speaker 02:
It does change that language from the lowest imaginable dose to the lowest effective dose.

[00:25:19] Speaker 04:
My understanding is it was filed as an exhibit in the separate case before Judge Sullivan on the challenging, your client's challenge to the coverage determination.

[00:25:32] Speaker 04:
But I could be wrong.

[00:25:33] Speaker 05:
Your Honor, we are counsel of record in that case, and I am not aware of that either.

[00:25:38] Speaker 05:
And I would just point out that because of all of these moving parts, it's really appropriate for the district court to consider the full package

[00:25:48] Speaker 05:
in the first instance, because it clearly has power to do so under Califano versus Yamasaki, under the Administrative Procedure Act, the other authorities that we've cited in our papers, and once the court... Well, the letter we received yesterday, dated September 4th from DOJ, shows a copy to all counsel.

[00:26:09] Speaker 05:
Yes, Your Honor.

[00:26:10] Speaker 03:
So are you saying you haven't seen this?

[00:26:12] Speaker 05:
Yes, Your Honor.

[00:26:12] Speaker 05:
We do have this one.

[00:26:13] Speaker 05:
This is the denial.

[00:26:15] Speaker 03:
It attaches.

[00:26:16] Speaker 05:
Yes.

[00:26:17] Speaker 03:
It attaches exactly what we're talking about.

[00:26:20] Speaker 03:
No, Your Honor, I'm sorry.

[00:26:21] Speaker 03:
It attaches to August 16, 2019, CMS letter involving Novotas.

[00:26:29] Speaker 05:
Yes, that's the denial of reconsideration.

[00:26:32] Speaker 05:
But what I'm just learning is that subsequent to this August 16th denial of reconsideration, there is a subsequent local coverage determination issued.

[00:26:41] Speaker 04:
OK.

[00:26:43] Speaker 04:
And I guess to me, the upshot of this is that it's not even clear that the issues in the later cases are the same ones that you went on in the earlier case, which cuts against you.

[00:27:01] Speaker 05:
I'm sorry, Your Honor, you mean the case we've got before Judge Sullivan?

[00:27:05] Speaker 04:
What's being litigated in all these later denials are issues about what's a lowest obtainable dose or effective dose.

[00:27:17] Speaker 04:
And in any event, all of that is unclear.

[00:27:21] Speaker 04:
So why are we

[00:27:24] Speaker 04:
reaching out either to give you an injunction on an undisputed point or to start mucking around in details that haven't been ironed out with the agency.

[00:27:35] Speaker 05:
Your Honor, the agency, when it denies Mr. Porzakianci's claim, it issues a form and it has codes for the reason that your claim is denied, like ABCD.

[00:27:47] Speaker 05:
And that's the only explanation he gets.

[00:27:49] Speaker 05:
So we don't know if it was because of this lowest dose obtainable or some other reason.

[00:27:55] Speaker 05:
It's kind of a black box.

[00:27:58] Speaker 05:
And so what we are pretty confident of is that the contractor pays no heed to the district court's determination because it's the same contractor who just issued this letter that the DOJ filed yesterday that attaches the denied reconsideration

[00:28:14] Speaker 05:
And on the second page at the bottom, as I mentioned earlier, it says that we're not going to pay any attention to the district court's ruling.

[00:28:25] Speaker 02:
It's like it never happened.

[00:28:30] Speaker 02:
mysteriously appeared yesterday, I guess, it came in from the other case.

[00:28:34] Speaker 02:
And if they did not file it like they did the first 24, 28-J, why they did it?

[00:28:42] Speaker 02:
We're sandbagging you, but I think we feel at least, I don't think Judge Henderson knew about it until she heard us talking about it this morning.

[00:28:50] Speaker 02:
And I didn't know about it until yesterday.

[00:28:51] Speaker 02:
And it's so, it may be a very important change that's been made by the contractor that the government lawyers may not know about.

[00:28:59] Speaker 05:
Yes, Your Honor, it may well be.

[00:29:02] Speaker 05:
And we would submit that because the district court has the power to consider whether an injunction should issue, and on the flip side, whether it's not appropriate for an injunction to issue, this matter should be remanded so the district court can consider all of these points and flesh them out fully.

[00:29:21] Speaker 05:
and then present, if there's a lingering issue, the matter to this court for review based on a complete record.

[00:29:30] Speaker 03:
Any more questions?

[00:29:30] Speaker 03:
All right.

[00:29:31] Speaker 03:
Thank you.

[00:29:31] Speaker 03:
We'll give you a couple minutes in response.

[00:29:33] Speaker 03:
Thank you.

[00:29:33] Speaker 03:
Ms.

[00:29:34] Speaker 03:
Lilly?

[00:29:50] Speaker 03:
Good morning.

[00:29:50] Speaker 03:
Can you address first what seems to be a missing document?

[00:29:55] Speaker 00:
Yes, as I understand it from this discussion that there may be a

[00:29:59] Speaker 00:
third local coverage determination.

[00:30:01] Speaker 00:
That is not something that I have seen, but as it's described to you.

[00:30:04] Speaker 00:
You're not aware of it either.

[00:30:06] Speaker 00:
I am not personally aware of it.

[00:30:07] Speaker 00:
It does, from the way it has been described by the court, it sounds consistent with the letter that we filed yesterday, which is, Judge Henderson.

[00:30:19] Speaker 02:
It's not the same thing as what you filed the letter yet.

[00:30:21] Speaker 00:
It is not, as described by you.

[00:30:23] Speaker 00:
What we filed yesterday that had come to our attention the day previous

[00:30:27] Speaker 00:
was a clarification of what I'll describe as the revised local coverage determination.

[00:30:33] Speaker 00:
That would be if there were three, the second.

[00:30:36] Speaker 00:
In that letter, the contractor communicated with the plaintiff that the contractor had

[00:30:46] Speaker 00:
received a request for reconsideration of that local coverage determination.

[00:30:51] Speaker 00:
And then at the end of that letter, the contractor makes a statement that if you have satisfied the criteria of the local coverage determination, and it suggests that he has, that claims properly submitted represent coverable services under the local coverage determination would not be denied solely on the basis of the local coverage determination.

[00:31:17] Speaker 00:
The discussion around the dosage clarification in this third local coverage determination is consistent with the discussion in the letter, and so the two may or may not be related.

[00:31:30] Speaker 00:
But I do not have local coverage determination at this time.

[00:31:36] Speaker 00:
If I may take a step back.

[00:31:40] Speaker 00:
to explain why the statutory scheme, the claim-by-claim adjudication on the medical record for any individual treatment is not set up for or is not the appropriate venue for the type of injunction that plaintiff has requested.

[00:31:57] Speaker 00:
It's because, as Your Honors understand, the Medicare system

[00:32:03] Speaker 00:
requires presentation of the medical records, the treatment performed, the patient's condition, and an injunction that would require

[00:32:16] Speaker 00:
make that rigid into the future does not take into account the possibility that the medical science would change, that plaintiff's conditions would change, and that is the reason why the Medicare system is set up to adjudicate claims claim by claim.

[00:32:34] Speaker 00:
There's no indication in the record that subsequent denials have been on the basis of any errors that the district court pointed out in its opinion.

[00:32:46] Speaker 00:
And there are many reasons that a claim might be initially denied, but then upon the presentation of additional medical records and information that they might be approved by the same contractor.

[00:32:59] Speaker 04:
But the threshold legal issues

[00:33:03] Speaker 04:
that Judge Friedrich decided in favor of Mr. Porzakonski wouldn't change from case to case, right?

[00:33:12] Speaker 00:
I'm not sure that that's true.

[00:33:13] Speaker 04:
The treatment either is, I think the statutory phrase is drug or biologic.

[00:33:19] Speaker 04:
It either is or it isn't.

[00:33:20] Speaker 04:
And that's not going to change from treatment to treatment.

[00:33:23] Speaker 00:
But the statutory criterion are whether it's

[00:33:26] Speaker 00:
reasonable and necessary.

[00:33:28] Speaker 00:
And that is a medical determination based on the state of the treatment options available, the state of the medical understanding of plaintiff's condition, of his own health.

[00:33:41] Speaker 00:
So those things change, which is why in adjudicating the particular claim,

[00:33:47] Speaker 00:
The only information before the court is about the particular treatment and the state of both medicine and the patient at that time.

[00:33:56] Speaker 00:
It's not a system designed to make a determination for all future claims, assuming no changes, because that's precisely what the system is set up to, is for the state of both the patient and the medicine at that time.

[00:34:16] Speaker 00:
The court has no further questions.

[00:34:17] Speaker 00:
We'll rest on our briefs.

[00:34:20] Speaker 03:
All right.

[00:34:21] Speaker 03:
Thank you.

[00:34:24] Speaker 03:
Why don't you take two minutes.

[00:34:31] Speaker 05:
Hi.

[00:34:31] Speaker 05:
Thank you.

[00:34:31] Speaker 05:
Yes, just a few last points.

[00:34:34] Speaker 05:
So the district court ruled here that this very treatment

[00:34:40] Speaker 05:
for Mr. Porosikansky is both a Medicare covered benefit and medically necessary under the Medicare statute rules, the secretary's guidelines.

[00:34:49] Speaker 05:
The problem is that the ALJs and the contractor don't follow it and don't follow that ruling.

[00:34:56] Speaker 05:
And in fact, under the agency's own rules, they're not required to follow that ruling.

[00:35:04] Speaker 05:
they treat every case as a new, but that leaves Mr. Porzekanski in this horrible position, as I said, that he can't retire because even though all of his claims to date have been ultimately decided in his favor, that doesn't mean that his provider is going to have the certainty that it needs to pay for his treatments going forward without that personal guarantee of Mr. Porzekanski because each claim

[00:35:34] Speaker 05:
is decided anew and the agency doesn't feel bound by any prior determinations of either its own administrative law judges or even the district court, there's no reason to believe that going forward, the claims will not all of a sudden be denied.

[00:35:52] Speaker 05:
If that happens, Mr. Porzkowski, as I said, is not a billionaire.

[00:35:55] Speaker 05:
These are very expensive treatments that he absolutely must have in order to continue to live.

[00:36:01] Speaker 05:
The National Institutes of Health

[00:36:03] Speaker 05:
the secretary's own agency has made that clear, yet the district court, I'm sorry, yet the agency has done nothing to respond to the district court's ruling, and that's why we are before your honors, and we ask that the court issue an order recognizing that the, that this court issue an order recognizing that the district court committed legal error when it concluded that it lacked the power to issue injunctive relief

[00:36:33] Speaker 05:
and to remand for a proper consideration of whether equitable relief is warranted.

[00:36:40] Speaker 05:
Thank you.

[00:36:40] Speaker 02:
Thank you.

[00:36:41] Speaker 02:
Before you leave, I apologize again for sandbagging you.

[00:36:44] Speaker 02:
I assumed incorrectly that you had the same document I did that apparently neither you nor the government counsel was made inadvertent to what the contractor had done on that.

[00:36:55] Speaker 02:
Yes.

[00:36:55] Speaker 02:
I'm sorry it happened, but it's not our fault anymore that it is yours.

[00:36:59] Speaker 05:
Thank you for that, Your Honor.

[00:37:00] Speaker 05:
Yes.