[00:00:39] Speaker 04: Our next case is number 16-2144, Johnson versus Shulkin. [00:00:45] Speaker 04: Ms. [00:00:45] Speaker 04: Baum. [00:00:47] Speaker 00: May it please the court? [00:00:49] Speaker 04: What's the status of the rulemaking that was started on this issue last year? [00:00:55] Speaker 00: They've received comments on the notice of proposed rulemaking, but they have not yet issued a final rulemaking. [00:01:03] Speaker 01: The comment period has ended. [00:01:05] Speaker 00: Yes, I believe the comment. [00:01:06] Speaker 00: I'm not sure about that actually, Your Honor, but they have already received comments and started considering those comments. [00:01:12] Speaker 04: The position that's taken in the rulemaking is different from the position that you've taken now, right? [00:01:19] Speaker 04: In the sense, as I understand it, the rulemaking would preclude any topical application from being systemic. [00:01:28] Speaker 00: Yes, Your Honor. [00:01:28] Speaker 04: Or as you say, that could be a systemic action. [00:01:34] Speaker 00: I'll answer the question about the new proposed regulation first. [00:01:37] Speaker 00: In the new proposed regulation, instead of simply incorporating the plain meaning of systemic and topical, they provide specialized definitions, and they're essentially now terms of art. [00:01:49] Speaker 00: So yes, in the new rulemaking, they would be categorically anything that is ointment would not be systemic therapy. [00:01:58] Speaker 00: In this regulation, we simply are relying on the plain meaning. [00:02:03] Speaker 04: Under this, the current regulation, you agree that topical under some circumstances could be systemic? [00:02:10] Speaker 00: We agree that it would be up to a fact finder at the VA. [00:02:16] Speaker 00: In the mind run of cases, given the regulations' contradistinction between systemic and topical and given the plain meaning of those terms, typically they would not be. [00:02:25] Speaker 00: And although Mr. Johnson refers to some scientific sources in his brief, which we would note were not before the [00:02:33] Speaker 00: VA, the board, or the Veterans Court, but to the extent that those sources show that there may sometimes be the potential for systemic side effects in some peripheral applications of topical corticosteroids, we would still point out there's a difference between simply having the potential for unintended side effects versus being systemic therapy as the regulation requires. [00:02:55] Speaker 04: But do you agree that topical could sometimes be systemic therapy? [00:03:00] Speaker 00: We agree that in a different case, a fact finder would be free to make that type of fact finding. [00:03:06] Speaker 00: And as I am not a medical expert in this area, I can't necessarily say whether that is certainly the case, that even in the peripheral cases, that could be true. [00:03:16] Speaker 04: Certainly this... Well, so if that's the standard, and I understand what you're saying, if that's the standard [00:03:20] Speaker 04: Do we have to remand for such a factual determination being made here? [00:03:25] Speaker 00: No, Your Honor. [00:03:25] Speaker 00: The factual finding has already been made in this case. [00:03:28] Speaker 00: The board found that Mr. Johnson received topical therapy and not systemic therapy. [00:03:35] Speaker 04: And even I don't know that they made that factual determination. [00:03:38] Speaker 04: As I read the decision, it seems to say that topical can never be systemic. [00:03:43] Speaker 04: Or at least the topical treatment [00:03:49] Speaker 04: doesn't have to be systemic. [00:03:50] Speaker 04: It's still within the regulation. [00:03:52] Speaker 00: Your Honor, at pages 93 of the appendix, which is the supplemental statement of the case, the VA regional office found that it said there was no evidence of systemic treatment. [00:04:05] Speaker 00: And it was considering the most recent remand, the 2013 remand, to the medical examiner, who likewise, there are different boxes that can be checked. [00:04:15] Speaker 00: And they checked only topical corticosteroids. [00:04:18] Speaker 00: And then again, at page 97, in the finding of fact by the board, the board found there was no qualifying systemic therapy. [00:04:26] Speaker 00: And given the fact that the board expressly acknowledged that there was constant or near-constant application of topical ointments. [00:04:33] Speaker 03: I'm sorry, what are you pointing at, at A97? [00:04:35] Speaker 03: The board decision? [00:04:36] Speaker 00: The finding of fact, where it says treatment of the veteran's skin disorder has not included systemic therapy. [00:04:41] Speaker 00: And it goes on to recite the systemic therapy requirements for the 30% [00:04:46] Speaker 00: rating, but because the board also made a finding of fact that the veteran had received constant or near constant topical ointment, application of topical ointment, that necessarily means the board found that that type of application of topical ointment was not systemic therapy. [00:05:02] Speaker 03: I guess there's two different ways to read the board's opinion. [00:05:06] Speaker 03: One is that topical application is not systemic therapy, period. [00:05:12] Speaker 03: Another way of reading it is [00:05:14] Speaker 03: There was a lot of topical application here, but we find under these circumstances that that topical application does not amount to systemic therapy. [00:05:23] Speaker 03: And I think the point to follow up on Judge Dyke's question is that we can't be certain whether the board had the nuanced conception of what systemic therapy is through topical application that you're now presenting on appeal. [00:05:40] Speaker 00: Well, two responses, Your Honor. [00:05:42] Speaker 00: The best way to read this record as a whole is that the board did make that finding. [00:05:46] Speaker 00: And to the extent that Mr. Johnson is now trying to introduce the argument that the board's finding of fact was clearly erroneous, first of all, that was never an issue before the Veterans Court. [00:05:57] Speaker 00: And also, it seems like Mr. Johnson's only theory that topical therapy could ever be systemic would be based on side effects. [00:06:04] Speaker 00: And at page A18, the medical examiner [00:06:07] Speaker 00: in 2008 found expressly that Mr. Johnson did not suffer side effects from his use of the corticosteroid ointment. [00:06:15] Speaker 04: Well, the side effects are irrelevant, right? [00:06:18] Speaker 04: I mean, it has to be therapy. [00:06:20] Speaker 00: Well, that's exactly the point. [00:06:21] Speaker 00: But Mr. Johnson has pointed to simply nothing in the record that would suggest that his application of topical corticosteroid to approximately [00:06:30] Speaker 00: zero to five, it depends on the medical examiner, there's been one to three percent of his body affected or up to five percent of his body affected. [00:06:38] Speaker 00: There's nothing in this record to suggest that that could be therapy that is affecting or pertaining to his body as a whole. [00:06:45] Speaker 00: And this again gets back to the concept of therapy versus side effects. [00:06:49] Speaker 00: If a patient takes a oral, for example, corticosteroid [00:06:54] Speaker 00: The effect is that it's absorbed by the body, and its method of therapy, of treatment, is to suppress the entire body's immune system and thereby treat the affected area. [00:07:03] Speaker 00: Here we have a situation where Mr. Johnson was applying topical corticosteroid ointment to the affected area, and it was intended to and did affect that area. [00:07:13] Speaker 00: And there's not even any evidence that there were unintended side effects. [00:07:17] Speaker 04: The problem when you talk about what the evidence is, that that's not what we're supposed to decide. [00:07:23] Speaker 00: Precisely, Your Honor. [00:07:24] Speaker 00: And that was my second response to Judge Chen's question, which is that what we have here is a situation where the Veterans Court set aside the board's findings, the board's decision on a legal theory that the reference to corticosteroids was unambiguous and without restriction. [00:07:42] Speaker 00: And it is neither of those things. [00:07:43] Speaker 04: Let me try. [00:07:47] Speaker 04: What the Veterans Court held was that treatment, this cortisone treatment under this regulation, was always systemic therapy or always qualified. [00:08:04] Speaker 04: And you're asking us to reverse that and to distinguish between topical treatments, which are designed only to be localized, and topical treatments that [00:08:16] Speaker 04: are designed to be systemic therapy, right? [00:08:20] Speaker 00: Yes, Your Honor. [00:08:20] Speaker 04: So why don't we have to, if we were to adopt that position, why don't we have to send it back for the Veterans Court to determine whether there's an issue here as to whether this topical treatment was designed to be a systemic therapy? [00:08:36] Speaker 00: Because that was never an issue at the Veterans Court and it's really not an issue on appeal. [00:08:41] Speaker 00: But the only [00:08:42] Speaker 00: issue that was raised to the Veterans Court was this theory that the reference to corticosteroids is categorical and unambiguous and automatically includes any and all type of corticosteroids. [00:08:53] Speaker 00: So it was never an issue. [00:08:55] Speaker 00: What did the board find? [00:08:56] Speaker 00: It was undisputed at the Veterans Court that the board had found this is topical therapy and not systemic therapy. [00:09:03] Speaker 00: So the most appropriate ruling of this court would be to simply set aside the Veterans Court's incorrect legal interpretation [00:09:11] Speaker 00: and to remand for the court to sustain the otherwise unchallenged factual findings by the board. [00:09:20] Speaker 01: Let me ask you about the adjudication manual, which you cite in the brief. [00:09:27] Speaker 01: We don't have, I take it, a, well, I'm confident, we don't have a general counsel opinion on this, right? [00:09:34] Speaker 00: No, Your Honor, there's no. [00:09:35] Speaker 01: That would have been helpful. [00:09:36] Speaker 01: But sometimes, I guess, these things [00:09:39] Speaker 01: are not done as thoroughly as maybe they should be. [00:09:42] Speaker 01: But what we do have is the adjudication manual. [00:09:46] Speaker 01: And first, the one that I, the copy I have is a section 344J3F, which is what you cite. [00:10:00] Speaker 01: And that appears to be from 2015. [00:10:03] Speaker 01: Is that the same text that was in existence all the way back to [00:10:09] Speaker 01: the time that this case began or was that added in the midst of this case? [00:10:14] Speaker 00: That was added in 2015. [00:10:16] Speaker 01: So that's brand new. [00:10:17] Speaker 01: So would that govern this case because it was not in place at the time this case was brought? [00:10:26] Speaker 01: Well, I take it, Your Honor, as turning to the hour deference issue about whether this is the VA's... Well, what I really... My first question is, as a matter of VA practice, would the VA say that, okay, now that we have [00:10:38] Speaker 01: the adjudication manual in place that we will apply the adjudication manual as opposed to whatever we might have thought the rule was before. [00:10:48] Speaker 00: Well, that might be a complex question in a case where the VA adjudication manual has changed or that it reflects a change in position. [00:10:59] Speaker 00: In this case, the VA inserted this provision not as a change in position but simply [00:11:03] Speaker 00: as a clarification of his existing position. [00:11:06] Speaker 01: Well, but this position seems more consistent with the new rulemaking than it does with the position you're taking now. [00:11:14] Speaker 01: Would you agree with that? [00:11:16] Speaker 00: I can see how Your Honor might read it that way, but it's important to note that it appears at Appendix 250, but it does note that when there's a question or a close question as to whether something is topical or systemic, it asks the adjudicator to send it to a medical [00:11:32] Speaker 00: a VA or other medical professional to decide whether it is topical or systemic. [00:11:38] Speaker 01: And also note that... Okay, so that's the note that is at the end. [00:11:42] Speaker 01: That's the note. [00:11:43] Speaker 01: Yes. [00:11:43] Speaker 00: And it's also important that this is also referring to systemic and topical. [00:11:50] Speaker 00: And so, again, the plain meaning of topical under the Dorland's definition is something that's affecting only [00:11:59] Speaker 00: the area to which it is applied. [00:12:01] Speaker 00: So if there's a VA adjudicator that's presented with a case of ointment that the contention is, this ointment is actually affecting or pertaining to the entire body, it is therapy intended to be absorbed in the bloodstream and circulate through the entire body, then that may very well be a question where the adjudicator would have to send it to a medical professional. [00:12:22] Speaker 01: But the position, as I understand it, in the proposed new regulation is [00:12:29] Speaker 01: category. [00:12:30] Speaker 01: If it's on the skin, it's not systemic, which is different from Dorland's and different from the position you're taking now and different from the position that you're saying that the adjudication manual takes, right? [00:12:40] Speaker 01: That's right. [00:12:41] Speaker 01: That's right, Your Honor. [00:12:41] Speaker 04: Yes. [00:12:42] Speaker 04: But I don't see the adjudication manual as being the same as the position that you're taking now, even with that. [00:12:47] Speaker 04: No. [00:12:49] Speaker 00: Well, respectfully, Your Honor, we do read it that way. [00:12:52] Speaker 00: But to the extent that the court does not, I would still [00:12:58] Speaker 00: present the fact that, again, in the mind-run of cases, we do think that the topical means topical, and systemic means systemic, and that's what we're trying to say. [00:13:06] Speaker 04: But I understand you're already based on the language of the regulation. [00:13:10] Speaker 04: But I think that the question that Judge Bryson was asking, and let me put it to you directly, is there some document to which we should be giving our deference here? [00:13:21] Speaker 00: The VA's position here is reflected in, for example, [00:13:26] Speaker 00: our deference can be in legal briefs. [00:13:28] Speaker 00: It can be in the General Counsel's position in the Veterans Court. [00:13:34] Speaker 04: You want us to defer to the briefs cited in this case? [00:13:38] Speaker 00: Not just this brief, but the Veterans Court brief. [00:13:40] Speaker 00: And we do think the adjudication manual does support the VA's position here. [00:13:48] Speaker 04: So apart from the briefs, you say the adjudication manual. [00:13:51] Speaker 04: Is there anything else? [00:13:53] Speaker 00: Those are the primary sources to which we think the court should defer. [00:13:56] Speaker 00: May I reserve the remainder of my time for rebuttal? [00:13:59] Speaker 04: Yes. [00:14:03] Speaker 04: Ms. [00:14:03] Speaker 04: Hines. [00:14:04] Speaker 02: Thank you. [00:14:04] Speaker 02: May it please the Court. [00:14:06] Speaker 02: Addressing the issue of the adjudication manual, the Veterans Court correctly noted that the modification [00:14:14] Speaker 02: cannot serve to retroactively modify the plain meaning of a regulation. [00:14:18] Speaker 02: So that 2015 modification to the adjudication manual is not entitled to our deference. [00:14:24] Speaker 01: Well, nothing can modify the plain meaning of the regulation. [00:14:27] Speaker 01: If the regulation is plain, then the agency can shout from the highest mountain they can find. [00:14:33] Speaker 01: And that doesn't change the fact that it's plain. [00:14:36] Speaker 01: But if it's not plain, then perhaps the adjudication manual is pertinent. [00:14:42] Speaker 01: Let's assume that it's not plain. [00:14:45] Speaker 02: In that case as well, Your Honor, it is a retroactive. [00:14:50] Speaker 02: It is something done after the fact. [00:14:52] Speaker 01: Well, but that's typically the case when an agency comes in to explain a regulation that it previously thought was clear but has been challenged as ambiguous. [00:15:01] Speaker 01: Then the agency comes in and says, well, here's what we meant. [00:15:04] Speaker 01: And they promulgate some kind of document or regulation or otherwise. [00:15:10] Speaker 02: That's true, Your Honor. [00:15:11] Speaker 02: And that happened in this case as well. [00:15:13] Speaker 02: And here, in doing that, [00:15:15] Speaker 02: in the Federal Register in amending this regulation, the VA said it was doing so because it noted that it was possible for topical treatments to have systemic effects. [00:15:26] Speaker 02: So looking at the language of the regulation before it was amended as it exists for this case, our position is that language is unambiguous. [00:15:35] Speaker 02: It requires constant or near constant systemic therapy such as corticosteroids. [00:15:40] Speaker 02: The use of the word corticosteroids there in the regulation in the [00:15:45] Speaker 02: every rating above 0% is clear and plain. [00:15:50] Speaker 02: A corticosteroid is a corticosteroid. [00:15:53] Speaker 04: There's no limit. [00:15:54] Speaker 04: That sounds as though it's within the rating if the topical application has systemic effects. [00:16:01] Speaker 04: But that's not what the Veterans Court decided here. [00:16:05] Speaker 02: Well, here, the Veterans Court properly interpreted the regulation and reversed the board. [00:16:15] Speaker 02: and the board's interpretation. [00:16:16] Speaker 04: And it did so because it said it took an unnarrowly... Let's say it said that this treatment with this cortisone or whatever it is, is always covered. [00:16:27] Speaker 02: Because corticosteroids are identified as systemic therapy here. [00:16:31] Speaker 02: It's clear and it's plain. [00:16:34] Speaker 04: What do you mean it's identified as systemic therapy? [00:16:37] Speaker 04: In the language of the regulation? [00:16:39] Speaker 02: That's correct. [00:16:39] Speaker 02: And it's identified that way without limitation on application. [00:16:42] Speaker 01: You're saying it's a systemic such as corticosteroids. [00:16:46] Speaker 01: That's the language you're... That's exactly right. [00:16:48] Speaker 02: And there's no limitation on the application of the corticosteroid. [00:16:53] Speaker 02: Indeed, it would be improper to add a limitation to the regulation to limit the application of corticosteroid to such as oral or parenteral. [00:17:03] Speaker 02: as is done in the different regulations. [00:17:05] Speaker 03: So I can drill down a little bit here, because I want to make sure that I understand your position and I understand your view of the veterans courts, or I mean, yeah, the lower courts decision. [00:17:18] Speaker 03: Is it your view that the right reading of this is that topical application of a corticosteroid can have [00:17:32] Speaker 03: systemic therapy effects? [00:17:34] Speaker 03: Or is it your view that this code says that any time you do topical application of a corticosteroid, you necessarily are engaged in systemic therapy? [00:17:47] Speaker 02: If you have. [00:17:48] Speaker 02: Yeah, if you have. [00:17:49] Speaker 03: Is it the former or is it the latter? [00:17:51] Speaker 02: Well, it's neither because the regulation says more than that. [00:17:54] Speaker 02: The regulation for 60% says there is constant or near constant application [00:17:59] Speaker 02: of systemic therapy such as corticosteroids that is required. [00:18:03] Speaker 02: So there are other things that are mandated by the regulation. [00:18:06] Speaker 02: The application has to be constant or near constant, and that application is required. [00:18:12] Speaker 02: So this is not a situation where the veteran can unilaterally decide to put topical corticosteroid on a small part of their body whenever he feels like it and get a 60% rating. [00:18:23] Speaker 02: That's just not the fact. [00:18:24] Speaker 04: Yeah, but if you do the topical application regularly, [00:18:27] Speaker 04: and it's a required therapy, then you're saying it's systemic and it's covered, right? [00:18:32] Speaker 02: That's absolutely correct. [00:18:33] Speaker 02: And that's based on the plain language of the regulation. [00:18:36] Speaker 03: Even if it doesn't actually have a systemic effect, as understood commonly in medical literature. [00:18:45] Speaker 02: That's correct. [00:18:46] Speaker 02: And it's perfectly appropriate. [00:18:47] Speaker 03: So you're saying the regulation essentially displaces the common understanding of systemic therapy? [00:18:53] Speaker 02: Not necessarily. [00:18:54] Speaker 02: And what I am suggesting is that this regulation can be broader and by including corticosteroids specifically as systemic under the different rating provisions, it can be broader. [00:19:06] Speaker 02: And it's perfectly appropriate for the VA to enact regulations. [00:19:11] Speaker 03: So then to, I guess, reword what I said before, you're saying that they necessarily expanded the meaning of systemic therapy. [00:19:21] Speaker 03: as when they used it in this particular way, in this code? [00:19:24] Speaker 02: Well, they treated corticosteroids in a particular way. [00:19:27] Speaker 03: Is that right? [00:19:28] Speaker 03: That's your position? [00:19:29] Speaker 03: That they necessarily expanded the meaning of what can entail a systemic therapy? [00:19:34] Speaker 02: Yes, by identifying specifically corticosteroids and not limiting their method of application. [00:19:41] Speaker 02: It is appropriate for the VA to be over-inclusive when providing benefits to veterans. [00:19:48] Speaker 02: And the reasons here can be simple. [00:19:50] Speaker 02: It is a more objective standard to apply. [00:19:52] Speaker 02: It's easier to apply. [00:19:53] Speaker 02: The use of corticosteroids here are identified without limitation on application. [00:19:59] Speaker 02: And that's distinguished from the diagnostic code 6602. [00:20:03] Speaker 01: If you would take a look at the 0% rating in the current regulations, it refers to no more than topical therapy required during the 12-month period [00:20:14] Speaker 01: Would that, in your view, exclude topical therapy with corticosteroids? [00:20:22] Speaker 02: Assuming that the other requirements of the regulation are met, yes. [00:20:26] Speaker 01: It would exclude it. [00:20:27] Speaker 01: So if you went off and got cortisone or something and you put it occasionally on some place on your foot, that would not be topical? [00:20:39] Speaker 01: That would be systemic in your view? [00:20:42] Speaker 02: Regulations for non-zero percent require some amount of use of the systemic therapy, and they also say that it is required. [00:20:51] Speaker 01: Right, but what I'm trying to get at is whether you're saying that the word topical cannot apply to the use of corticosteroids. [00:21:00] Speaker 02: Assuming the other requirements of the regulation are met for non-zero rating, yes. [00:21:05] Speaker 01: That's correct. [00:21:06] Speaker 01: You're going even farther than that, as I understand your argument. [00:21:09] Speaker 01: You're saying that the term [00:21:10] Speaker 01: the way the term is used that corticosteroids are ipso facto systemic? [00:21:19] Speaker 02: If in the case of the veteran here, they are used constantly or near constantly and that use is required, then the answer is yes. [00:21:28] Speaker 01: And if you look, for example... But that would be true of everything down to 10%, would it not? [00:21:35] Speaker 01: That's correct. [00:21:36] Speaker 01: So that doesn't require that it be used constantly? [00:21:39] Speaker 02: It does not. [00:21:39] Speaker 01: So your argument really comes down to corticosteroids are systemic therapy, period, as far as I can see. [00:21:48] Speaker 02: Well, the regulation identifies corticosteroids without limiting their method of application. [00:21:53] Speaker 02: That's right. [00:21:54] Speaker 01: So that's what I'm trying to get at is, are you really saying that there's no such thing as the topical therapy with corticosteroids? [00:22:05] Speaker 01: And I think the answer you're giving me is the answer to that is yes. [00:22:08] Speaker 02: It is, assuming that it is required use, and it is used as often as the other non-zero ratings require. [00:22:16] Speaker 02: Yes. [00:22:17] Speaker 02: And if you look at the 0% rating, and the government argues that that would void the 0% rating, and that's not true. [00:22:24] Speaker 02: Here, if you look at the medical evidence in this case, Mr. Johnson used other topical medications, such as ketoconazole and miconazole. [00:22:34] Speaker 02: Those are topical medications that he used. [00:22:38] Speaker 02: And the record on A-86 shows how those were considered by the medical examiner. [00:22:49] Speaker 01: Now let me ask you a question. [00:22:52] Speaker 01: I think it's on page seven of the government's brief. [00:22:54] Speaker 01: There is an excerpt from the... No, it's not page seven. [00:23:01] Speaker 01: Well, anyway, there's an excerpt from the form that was filled out at the time that [00:23:09] Speaker 01: Mr. Johnson was treated. [00:23:11] Speaker 01: Now that form, as I understand it, and correct me if I'm wrong, we only have an excerpt of that form. [00:23:19] Speaker 01: The full form, at least the VA's form, seems to have a box for topical corticosteroids, other topical medications, both of which were checked in this case, and then another box for systemic corticosteroids. [00:23:37] Speaker 01: Is that correct? [00:23:39] Speaker 01: It's not in the appendix, but it's the medical form that's online that the VA uses. [00:23:49] Speaker 01: That struck me as indicative that the VA does not require, does not regard corticosteroids as being inherently systemic. [00:24:00] Speaker 02: The form that you referenced and the one that's available online was only issued in July of 2016. [00:24:05] Speaker 02: What was the prior form? [00:24:07] Speaker 02: And the prior form is in the record. [00:24:09] Speaker 01: I have December 14 on my copy of that form. [00:24:12] Speaker 02: It was revised in 2014. [00:24:14] Speaker 02: But when you go to the website to print that form out, which I did, it was issued in July of 2016. [00:24:19] Speaker 01: Do you have any idea whether that form was the same before that? [00:24:24] Speaker 01: It was different. [00:24:25] Speaker 01: And in fact, the older form is in the record. [00:24:27] Speaker 01: Where's the form in the record? [00:24:29] Speaker 02: The form is in the record at A85. [00:24:32] Speaker 01: But that's only a part of the full form. [00:24:35] Speaker 02: It's the full form, Your Honor. [00:24:36] Speaker 02: We accepted part of the form in our brief, in the red brief on page seven. [00:24:42] Speaker 01: Oh, it was your brief? [00:24:43] Speaker 01: Okay. [00:24:44] Speaker 01: What page of the appendix is that again? [00:24:46] Speaker 01: A86. [00:24:54] Speaker 02: And there at the bottom, item three is treatment. [00:24:59] Speaker 01: Oh, sorry. [00:25:00] Speaker 01: There wasn't anything left out of this form when it was [00:25:06] Speaker 01: This is the form when it was completed by the medical officer? [00:25:09] Speaker 02: This is the form for Mr. Johnson's examination in November 2013. [00:25:14] Speaker 02: And here, as you'll see, identifies topical corticosteroids and identifies the triamicone that he was prescribed and also identifies as other topical medications and lists the antifungal medications which he was taking as well. [00:25:33] Speaker 02: The form here, [00:25:35] Speaker 02: clearly distinguishes corticosteroids, although topical, from other topical medications. [00:25:41] Speaker 02: Now the government also argues that on the next page, on A87, there is a reference and a question whether other systemic or topical medications have been provided. [00:25:56] Speaker 02: The best reading of that form, topical medications, refers to the topical medications that were specifically identified, the ketoconical [00:26:04] Speaker 02: ketoconazole and myconazole and those topical corticosteroids should be considered in view of this form as systemic therapy. [00:26:18] Speaker 02: With respect to Diagnostic Code 6602, that diagnostic code was identified by the government during the briefing and identified a supplemental authority that would provide a definition of the word systemic. [00:26:33] Speaker 02: and the Veterans Court considered that at the government's request and found that because Diagnostic Code 6602 identifies systemic and specifically limits it to oral and parenteral, that supported that corticosteroids in the diagnostic code here, 7806, was not so limited. [00:26:54] Speaker 02: On the one hand, the VA knew how to and did limit corticosteroids in [00:27:01] Speaker 02: the context of Diagnostic Code 6602, the only other place where it uses the term systemic, and did not limit it here. [00:27:09] Speaker 02: It did not limit the method of application. [00:27:12] Speaker 02: The revised regulation is also persuasive. [00:27:17] Speaker 02: The VA has now changed the regulation, which it is free to do, pending notice and comment period, to change the definition of topical and systemic, and it has. [00:27:27] Speaker 04: And that change... I thought it was the rulemaking was still ongoing. [00:27:30] Speaker 02: Well, it certainly proposed it, so it is on its way to doing that, Your Honor. [00:27:35] Speaker 02: And the VA is free to do that and to adopt different definitions. [00:27:38] Speaker 01: No, I understand that Mr. Johnson, we're talking about an issue that obviously covers many more people than just Mr. Johnson. [00:27:45] Speaker 01: But Mr. Johnson, I take it, is receiving 100% TDIU benefits. [00:27:49] Speaker 01: Is that right? [00:27:51] Speaker 02: I don't believe that's the case. [00:27:52] Speaker 01: It's not? [00:27:53] Speaker 02: I do not know. [00:27:53] Speaker 01: Well, I may have gotten a misapprehension from somewhere, but that was what I thought I'd seen in a footnote somewhere. [00:28:00] Speaker 02: I don't believe that's the case. [00:28:02] Speaker 02: If I'm wrong, I apologize for that. [00:28:07] Speaker 02: The final point I'd like to make is with respect to deference. [00:28:10] Speaker 01: Obviously, if the regulation is not in... Here we are, footnote two of the government's brief. [00:28:18] Speaker 01: The VA has granted Mr. Johnson a total disability rating of 100% based on individual employability, unemployability, TDIU, as of 2010. [00:28:30] Speaker 01: Is this, so are we only talking about some period between 2010 and when he applied for the benefits? [00:28:39] Speaker 02: Yes, Mr. Johnson filed a claim in 2007. [00:28:42] Speaker 01: So we're talking about the period between 2007 and 2010? [00:28:45] Speaker 02: Presumably. [00:28:46] Speaker 02: I have no reason to dispute the government statement with respect to TDIU, but the claim was made in 2007, so it would affect that period as well. [00:28:54] Speaker 02: With respect to deference, we don't believe it applies here. [00:28:59] Speaker 02: Particularly, and considering this court's Hudgens case, in that case and here, it cannot be ignored that during the pendency of this case, the regulation has been changed. [00:29:12] Speaker 02: That change should be taken into account and should not afford the VA deference here. [00:29:18] Speaker 01: I don't understand that argument. [00:29:19] Speaker 01: Are you saying that had they not changed the regulation, they would be entitled to, or [00:29:25] Speaker 01: proposed to change it. [00:29:26] Speaker 01: They would be entitled to deference, but since they've proposed a change in the regulation, that all the deference that they otherwise would have been entitled to goes away. [00:29:36] Speaker 01: Well, I think particularly here... I really want an answer than yes or no to that question. [00:29:41] Speaker 01: That's important to me. [00:29:43] Speaker 02: Well, this court in Hudgens looked to the fact that the regulation was changed and said, because of that, [00:29:48] Speaker 02: our deference should not be as applicable. [00:29:52] Speaker 01: So the answer is yes. [00:29:54] Speaker 01: It doesn't apply. [00:29:55] Speaker 01: Deference does not apply if you propose to change the regulation. [00:30:01] Speaker 03: In light of an adverse decision from the Veterans Court. [00:30:05] Speaker 02: Well, particularly here, where in making that change, the VA recognized that topical application can have systemic effect. [00:30:14] Speaker 04: So with that recognition in the proposed regulation... Well, what the government recognizes is that topical application can have systemic effects and that if it does and is designed as a therapy that you may be covered under the existing regulation. [00:30:29] Speaker 04: They're not fighting that. [00:30:32] Speaker 02: Well, the argument that topical can only be topical and systemic must be systemic and the two are mutually exclusive [00:30:42] Speaker 02: which is the government's argument. [00:30:44] Speaker 04: No, it's not. [00:30:45] Speaker 04: Not in this case. [00:30:46] Speaker 04: They're saying that that's not a clear line between the two, because if topical administration is prescribed in order to achieve a systemic therapy, that it would be covered. [00:31:01] Speaker 02: With all due respect, Your Honor, that's not how we've understood the government's argument. [00:31:04] Speaker 02: The government has argued that under Dorland's and the definitions given by Dorland's, [00:31:09] Speaker 00: Topical is only topical and systemic is only systemic and those things are mutually exclusive I'd like to quickly address the form at a 86 to 87 the prior form that we that was online does include reference that's going back to 2014 does include [00:31:39] Speaker 00: the references to systemic corticosteroids. [00:31:42] Speaker 00: We don't have a copy online of what the form was in 2013, but just looking to the form at A86, it's clear that the boxes that are not checked as yes are omitted. [00:31:54] Speaker 01: That's what I wondered. [00:31:56] Speaker 01: That was my initial understanding. [00:31:58] Speaker 01: This was not the complete form as it was presented to the medical examiner. [00:32:02] Speaker 00: Yes, the medical examiner. [00:32:03] Speaker 00: And that's clear from looking at just A86. [00:32:05] Speaker 00: The question is, [00:32:06] Speaker 00: has the veteran been treated with oral or topical? [00:32:09] Speaker 00: And then the only options listed are the topical options, which are checked. [00:32:13] Speaker 00: And there are other non-checked options for the systemic versions. [00:32:17] Speaker 01: But you don't know if there was anything before 2014 that included a reference to systemic corticosteroids. [00:32:24] Speaker 00: I'm not sure of the exact language of the other checked options, but I'm sure there were other checked options that included oral or other options. [00:32:32] Speaker 00: I'm not sure if it actually said [00:32:34] Speaker 00: systemic corticosteroids, but there were certainly other options that were not checked here. [00:32:39] Speaker 00: This is not evidence that topical steroids is being referred to as systemic. [00:32:44] Speaker 00: The second point is that the reference to without limitation, any term looked at in isolation could be said to be without limitation. [00:32:51] Speaker 00: The limitation comes from the context of the regulation. [00:32:54] Speaker 00: It comes from the operative requirement for systemic therapy, the distinction with topical therapy, and the overall structure of the regulation. [00:33:03] Speaker 00: And because the Veterans Court disregarded that important context, we ask that the Court reverse the Veterans Court's decision.