[00:00:00] Speaker 01: Case number 25-8239. [00:00:03] Speaker 01: Alignment of health care imbalance versus United States Department of Health and Human Services Act. [00:00:11] Speaker 01: Mr. Kimberley is ready to balance. [00:00:13] Speaker 01: Mr. Starr for 30 minutes. [00:00:14] Speaker 04: Good morning, Council. [00:00:17] Speaker 04: Mr. Kimberley, please proceed when you're ready. [00:00:21] Speaker 02: Good morning. [00:00:21] Speaker 02: Thank you, Your Honor. [00:00:25] Speaker 02: Pellent alignment in this case does not ask the court to break any new legal ground. [00:00:31] Speaker 02: The rule on which this case depends is straightforward. [00:00:34] Speaker 02: If an agency alone has access to relevant evidence or data, [00:00:40] Speaker 02: and a regulated entity raises a facially plausible, credible objection in an administrative review process, asserting that the data are wrong or contain or reflect errors, the agency must actually look at the data. [00:00:57] Speaker 02: This follows from Fox Television among other cases. [00:00:59] Speaker 02: Fox Television tells us that courts must, quote, insist that an agency examine the relevant data [00:01:07] Speaker 02: and articulate a satisfactory explanation, close quote, based on that data. [00:01:13] Speaker 02: If an agency doesn't check the data, and it later turns out in an APA lawsuit in which the agency produces the data that it refused to review in the administrative review process, that the objection is borne out by that data, then the agency has violated the APA. [00:01:30] Speaker 02: And we know that from State Farm. [00:01:32] Speaker 02: Courts must reject, quote, an explanation for an agency decision that runs counter to the evidence before the agency. [00:01:40] Speaker 02: Fox Television and State Farm are two of the most clearly established foundational ad law cases on the books and they are sufficient, we submit, to resolve this case. [00:01:52] Speaker 02: Now the explanations that CMS gives to the court now on appeal differ entirely from the explanations that it gave to alignment in the administrative review process. [00:02:04] Speaker 02: In the administrative review process, it said the response rates that reflected Spanish language engagement sort of fell within the normal range and therefore we're not going to investigate any further. [00:02:20] Speaker 02: and explanation one, explanation two. [00:02:23] Speaker 02: And in any event, we don't get involved in disputes between MA plans and survey vendors because we don't control survey vendors, our private third party contractors. [00:02:37] Speaker 02: Before this court, the agency doesn't defend either of those positions. [00:02:40] Speaker 02: Instead, it offers two new ones, one of which wasn't even adopted by the district court. [00:02:45] Speaker 02: Its first explanation is to say that the question of how to administer the CAPS survey in Spanish to individuals known to prefer Spanish is a question of absolute discretion for the third party delegate, the survey vendor. [00:03:05] Speaker 02: And although the survey vendor may elect to take into consideration the preferences and directions and requests [00:03:11] Speaker 02: of the MA plans, they need not. [00:03:14] Speaker 02: It's entirely their discretion. [00:03:18] Speaker 02: Sort of a subset of that argument is that all the survey administrator then must do is ensure that Spanish language surveys are made available within the meaning of the protocols and specifications. [00:03:32] Speaker 02: And that's done simply by sending a pre-notification letter with instructions in Spanish on how to request Spanish surveys. [00:03:40] Speaker 02: Its second argument, and that was adopted by the district court at JA81, its second argument is to say that the survey administrator in this case in any event did follow alignments instructions, but it did so after electing to use a especially quote unquote conservative record matching protocol that virtually ensured that a substantial portion of the individuals identified by alignment as preferring Spanish would not actually receive [00:04:08] Speaker 02: surveys in Spanish. [00:04:11] Speaker 02: Now, the clearest, I think, answer for this court as to those two explanations is simply that they weren't made in the administrative review process. [00:04:20] Speaker 02: And there are a few rules more basic than that judicial review of agency action is limited to the reasons that the agency gives when it took its action and that post hoc litigation rationales are not a basis for upholding an agency action. [00:04:35] Speaker 02: But even on their own terms, those arguments don't hold water. [00:04:41] Speaker 02: We know from the protocols and specifications themselves that survey administrators must follow the protocols and specifications. [00:04:52] Speaker 02: Clear example of that, JA 148. [00:04:55] Speaker 02: We know, too, that the protocols and specifications state that MA plans [00:05:06] Speaker 04: Oh, I'm sorry to interrupt, just one second. [00:05:11] Speaker 04: We've lost the connection to Cassis, so why don't we just take a brief recess to see if we can remake the connection. [00:05:19] Speaker 04: And if we can do that, we'll pick up where we left off and give you a little time. [00:05:22] Speaker 04: Back up a little bit. [00:05:25] Speaker 01: This Honorable Court is again in session. [00:05:28] Speaker 01: Be seated please. [00:05:30] Speaker 04: Okay, I think we're both we're back connected now. [00:05:32] Speaker 04: So you were you had made the point that you thought that's two H. C. rationales that the two brief rationales in the briefs more reflecting the H. C. decision. [00:05:41] Speaker 04: And then you were going on to address the merits of them in any event. [00:05:44] Speaker 04: Correct. [00:05:46] Speaker 02: So I'll start with the first. [00:05:48] Speaker 02: explanation, your honor, which is that survey administrators have discretion to determine how they choose to administer cap surveys to individuals known to prefer Spanish with Spanish language materials. [00:06:04] Speaker 02: We know from the protocols themselves that the protocols are binding on survey vendors at JA 148. [00:06:11] Speaker 02: We know from JA 167 to 168 that the protocols allow [00:06:17] Speaker 02: for MA plans to request of their survey administrators that they be administered to individuals who speak Spanish in particular ways. [00:06:28] Speaker 02: It says, and I quote, survey vendors may do any of the following at the request of the contract, including send a Spanish language questionnaire only in all mailings of the survey to enrollees known to prefer Spanish according to language preference data received from the contract. [00:06:46] Speaker 02: That is what happened here. [00:06:49] Speaker 02: Now, CMS's position is that because the protocols use the word may, permissive may rather than mandatory shall, it indicates that the survey administrator is free to disregard the request of an MA plan. [00:07:05] Speaker 02: But that can't be right for one of either two or both reasons. [00:07:10] Speaker 02: The first is the consistency rule and the second is the non-delegation rule. [00:07:17] Speaker 02: The consistency rule, which we briefed extensively in both the opening and the reply, relies on, for example, CONET against FERC, which is the idea that agency protocols obviously have to be applied consistently across regulated entities and deviations in [00:07:36] Speaker 02: similar cases have to be explained with some relevant difference between the cases. [00:07:43] Speaker 02: And here there is no relevant distinction other than in CMS's view the happenstance of which survey administrator an MA plan elects to hire. [00:07:56] Speaker 02: on CMS's view, one survey administrator could choose to always follow the requests of MA plans, another survey administrator could refuse ever to follow those requests, and a third might pick something in between. [00:08:10] Speaker 02: So that's a straightforward, I think, violation of the consistency principle. [00:08:15] Speaker 04: Under everybody's view, you have to win [00:08:20] Speaker 04: on the other argument anyway, right? [00:08:23] Speaker 04: Which is, in other words, even if the government's position in this case is wrong on May, they still got the fallback position that regardless, the agency didn't violate the protocols. [00:08:39] Speaker 02: Well, yes and no. [00:08:41] Speaker 02: They've made that argument, Your Honor. [00:08:42] Speaker 02: I would say no, we don't have to win on the merits of that argument, because once again, that is... You got the argument that that wasn't the agency's rationale to begin with. [00:08:50] Speaker 02: Exactly. [00:08:51] Speaker 02: And this is not our effort to play gotcha with the administrative record. [00:08:57] Speaker 02: If the agency had taken this position, which is basically alignment, you must prove a negative, prove that your survey administrator didn't do anything that it possibly could have to administer the survey in Spanish to Spanish speakers, we would have requested that the agency put evidence in the record to address each of the alternatives. [00:09:23] Speaker 02: Alignment doesn't have [00:09:25] Speaker 02: control over this evidence. [00:09:26] Speaker 02: It's all in the hands of either data stat, the survey administrator, or CMS. [00:09:31] Speaker 02: Much of it alignment isn't even permitted to see. [00:09:34] Speaker 02: And we would have explained why they were wrong and made the agency explain why it is changing its policy. [00:09:42] Speaker 02: Because its policy always has been that survey administrators must follow its practice, excuse me, has been that survey administrators must follow the requests [00:09:52] Speaker 02: of the MA plans who retain them to administer the CAP survey. [00:09:56] Speaker 02: This is reflected among other places in the briefing in this case, J28, where in briefing before the district court, CMS itself said that MA plans, quote, may promote participation among non-English speaking members by providing the member with enrollee-level language preference data, which is what [00:10:16] Speaker 02: alignment did in this case, and instructing the vendor to send translated surveys based on those preferences, which again is exactly what alignment did. [00:10:26] Speaker 02: Now the point is in response, DataStat then exercised additional administrative discretion [00:10:33] Speaker 02: in engaging in what it characterized in emails between itself and another third party contractor, not CMS, as an especially conservative data matching protocol. [00:10:46] Speaker 02: But that runs into the same problems because there's no question that this especially conservative approach to data matching substantially affected the number of individuals known to prefer Spanish who actually received materials in Spanish rather than English. [00:11:01] Speaker 02: It significantly depressed it by 10%. [00:11:04] Speaker 02: And it runs into the same consistency in non-delegation problems. [00:11:09] Speaker 02: What the Supreme Court said just a few months ago in consumers research is third party contractors want to make sure this isn't another connection problem. [00:11:22] Speaker 02: Okay. [00:11:23] Speaker 02: Third party contractors to agencies that help agencies administer the regulatory programs under their supervision must do so according to detailed rules and they must at all times be subject to supervision and control by the agency which is what the agency in the administrative review process in this case expressly disavowed. [00:11:44] Speaker 02: It said we have no control over these third party contractors and they are free to do as they like with respect to these questions of administrative [00:11:52] Speaker 02: expression. [00:11:54] Speaker 02: So really, no matter how you cut it, there is no way we submit to justify the outcome in this case in a way that's consistent with settled ad law principles and the Constitution and its limit on non-delegation. [00:12:09] Speaker 04: Let me make sure my colleagues don't have any additional questions for you at this point. [00:12:12] Speaker 04: We will give you a little time for rebuttal. [00:12:15] Speaker 04: Okay. [00:12:15] Speaker 04: None from me. [00:12:17] Speaker 04: Thank you. [00:12:26] Speaker 03: The district court here correctly granted summary judgment in CMS's favor based on two independent rationales. [00:12:39] Speaker 03: Those rationales are the same basic rationales given in briefing before the district court. [00:12:43] Speaker 03: and that the agency provided in its decision below. [00:12:46] Speaker 03: And those two rationales are straightforward. [00:12:49] Speaker 03: The first is that the protocol that is the focus of this litigation and was the focus of alignments complaints before the agency is by its terms optional, not mandatory. [00:13:01] Speaker 03: Hence, even if that protocol were not followed, that would not demonstrate a violation of any mandatory CMS protocol sufficient to cast a significant doubt or a significant enough doubt [00:13:12] Speaker 03: on the results of the survey in question. [00:13:15] Speaker 03: And second, and these are again independent, in any event, the record before the agency demonstrated that this optional protocol was followed. [00:13:25] Speaker 03: And I'll just, I think it's helpful to look at what that protocol actually says. [00:13:30] Speaker 03: And this is JA168. [00:13:33] Speaker 03: So again, this is even accepting [00:13:35] Speaker 03: the opening argument that the may in this section actually is a must, the protocol says that the vendor can send a Spanish language questionnaire only to enrollees that, quote, can be identified using one option, language preference data received from the contract. [00:13:55] Speaker 03: And there is no dispute [00:13:57] Speaker 03: that the vendor used language preference data received from the contract to send Spanish language only surveys to individuals identified using that information. [00:14:11] Speaker 03: In briefing before this court, the focus is particularly in the reply brief. [00:14:15] Speaker 03: I guess it's really only in the reply brief, but plaintiff didn't mention this at all in their opening brief, focuses on the adequacy of this [00:14:24] Speaker 03: the explanation given by the vendor at J198 for why [00:14:30] Speaker 03: some individuals identified as preferring Spanish might not have or did not receive Spanish language only surveys, notwithstanding that data. [00:14:42] Speaker 03: But ones were at that point were so far beyond anything in the protocols that I just don't see any way that CMS could have been required to throw out the entirety of these survey results as a result of these errors. [00:14:56] Speaker 03: I do just want to briefly respond to this suggestion that any of this is new or that there was any sort of invention of new arguments that were not made by the agency in this month's long email exchange that appears in the [00:15:17] Speaker 03: in the joint appendix. [00:15:19] Speaker 03: And I guess I'd just point to the very first email that CMS sent in response to plaintiff's concerns, and that's JA127. [00:15:27] Speaker 03: And there is a full paragraph in that initial response explaining to plaintiff exactly the point that is made in our briefing and exactly the point that the district accepted, which is CMS protocols in this space are extensive. [00:15:44] Speaker 03: There are optional requirements and there are mandatory, sorry, there are optional features in the protocols and there are mandatory features in the protocols. [00:15:52] Speaker 03: And in that full paragraph, again, the very first response CMS sent, CMS responded and explained that CMS requires that, and this is a quote, at a minimum, Spanish surveys be made available upon request from members in response to the bilingual pre-notification materials. [00:16:08] Speaker 03: That's the mandatory requirement. [00:16:10] Speaker 03: And then the very next sentence, CMS says, please see page 50 of the protocols, which is the page we've been talking about so far, for details about actions, plans, and survey vendors may employ to promote or further promote participation in Spanish. [00:16:27] Speaker 03: This was presented in the very first email CMS sent. [00:16:30] Speaker 03: It was never disputed. [00:16:31] Speaker 03: And the discussion between CMS and plaintiff proceeded on the assumption, which was supported by everything plaintiff said, that they were focused on this optional requirement. [00:16:42] Speaker 03: And CMS, I think, did more than it needed to and took those concerns very seriously. [00:16:47] Speaker 03: And over the course of the following [00:16:51] Speaker 03: month or so, several weeks responded in repeated detail with why it didn't think there were any concerns even with that optional protocol. [00:17:01] Speaker 04: At that point was that the fact that the may means that there was complete discretion wasn't something that the agency indicated in the back and forth. [00:17:12] Speaker 03: So I guess the response to that, I would point to JA117, which is, again, the agency explaining whether or not Spanish-speaking members received surveys in English despite their preferences is outside of CMS control. [00:17:27] Speaker 03: That is a response explaining that, you know, [00:17:33] Speaker 03: precisely because these are optional, CMS doesn't get, and again, this is a quote, doesn't get involved in how survey vendors implement language preference data. [00:17:44] Speaker 03: Again, I don't think you need to accept the may must thing because even if plaintiffs are right that this is best for it as a must, the agency then squarely asked the vendor, did you use this data? [00:17:56] Speaker 03: And the vendor responded, yes, we did, here's how. [00:17:59] Speaker 03: And then CMS told, [00:18:02] Speaker 03: alignment exactly that, and it told it twice. [00:18:05] Speaker 03: On J112, quote, as we noted, the survey vendor has attested that they followed the protocol procedures and used the preference data shared by you, the plan. [00:18:13] Speaker 03: And then again, on page J107, sort of in its final sort of statement on the matter, CMS said, [00:18:22] Speaker 03: regarding your third issue or analysis have established that the sample is representative that the vendor quote used the language preference information you provided and then that there was no there's nothing else about the data that independently gave any concern to the agency. [00:18:38] Speaker 03: So I'm happy to answer any questions, but I do think the agency has been consistent. [00:18:42] Speaker 03: These same basic principles have been presented at every stage of this litigation. [00:18:45] Speaker 03: And if we are right as to either of them, the grant for summary judgment should be affirmed. [00:18:50] Speaker 04: I just have one question, which is that this is on your primary argument. [00:18:55] Speaker 04: And I totally understand that even if we reject your primary argument, you've still got the fallback argument, understanding of that framework. [00:19:02] Speaker 04: But on the primary argument, to say that the may is discretionary [00:19:08] Speaker 04: Whether you agree with that or not, why does that matter if in fact the contractor then does [00:19:20] Speaker 04: like, accepts it. [00:19:22] Speaker 04: They didn't take up the invitation not to. [00:19:25] Speaker 04: They actually did it. [00:19:26] Speaker 04: And so if that's true, then why does it even matter that it's discretionary? [00:19:31] Speaker 03: So it doesn't, I guess. [00:19:32] Speaker 03: But again, my reading of the agency's response to plaintiff during many, many emails is that there were really these two threads. [00:19:39] Speaker 03: And one of the threads was there is, and I think this is just an important background for this entire dispute, [00:19:45] Speaker 03: CMS has extensive protocols in the space and requires vendors to follow those protocols. [00:19:51] Speaker 03: Specifically in the area of Spanish language access, even within that subspace, there are mandatory protocols and optional protocols all designed to make sure that Spanish language surveys are meaningfully accessible. [00:20:05] Speaker 03: And so I think this entire dispute sort of gets off on a strange foot that the premise of plaintiff's argument, particularly in district court, was there was a clear violation of the protocols here. [00:20:16] Speaker 03: And the piece of this that we're talking about is optional. [00:20:20] Speaker 03: But I agree with you that the record here clearly demonstrates that the vendor did use the data. [00:20:26] Speaker 04: They exercised the option. [00:20:27] Speaker 04: In other words, maybe they had the option, if your argument's right, not to exercise the option. [00:20:31] Speaker 04: The option was exercise. [00:20:32] Speaker 04: And it just seems to me that then you kind of necessarily [00:20:34] Speaker 04: at the last argument, as to which you may well, you might prevail. [00:20:39] Speaker 04: But it's just that I don't know that the first argument does independent work in a situation in which the options exercise. [00:20:45] Speaker 03: Sure. [00:20:45] Speaker 03: I don't disagree with that. [00:20:49] Speaker 03: OK. [00:20:49] Speaker 03: Yeah. [00:20:49] Speaker 03: And if there are no further questions, begin to ask that you affirm. [00:20:54] Speaker 04: I think Judge Rodgers is saying something, Judge Rodgers, but I think you may be muted. [00:21:03] Speaker 00: Yes, my apologies. [00:21:05] Speaker 00: So how does it work in the real world? [00:21:09] Speaker 00: I'm an Advantage Medicare Advantage insurer. [00:21:16] Speaker 00: And I contract with a vendor to notify within the jurisdictions I serve [00:21:35] Speaker 00: Spanish people, Spanish-speaking people, and whatever information I have about what their preferences may be. [00:21:48] Speaker 00: The vendor says, thank you very much. [00:21:51] Speaker 00: I'll take that into account. [00:21:55] Speaker 00: And then the vendor sends the Spanish-speaking residents, inhabitants, [00:22:06] Speaker 00: a letter that says basically, if you want to respond in Spanish, call this number. [00:22:20] Speaker 00: And that is in English. [00:22:25] Speaker 03: So no, the pre-notification letter is required, and this is in the protocols, to be printed in Spanish on one side and in English on one side explaining. [00:22:34] Speaker 00: How hypothetical. [00:22:36] Speaker 00: It's all English. [00:22:37] Speaker 03: I see. [00:22:38] Speaker 03: So in that case, there would be a violation of mandatory CMS protocols. [00:22:43] Speaker 03: That vendor would have fallen below the minimum required by the protocols. [00:22:48] Speaker 03: I'll also say that vendor would be in violation independently [00:22:52] Speaker 03: of something called the Quality Assurance Plan. [00:22:54] Speaker 03: There's only one page of this in the JA. [00:22:56] Speaker 00: I think I understand what you're saying. [00:22:59] Speaker 00: So now the vendor sends a letter that is English on one side and Spanish on the other. [00:23:09] Speaker 00: But what they both say to the Spanish speaking person is, if you want to take the survey in Spanish, call this number. [00:23:23] Speaker 03: So that is, I think, what is required by the protocols for this pre-notification letter. [00:23:30] Speaker 03: I'll add that there are other aspects of this system. [00:23:34] Speaker 00: What I'm getting at is, why doesn't the vendor necessarily take the least expensive option, which is my second hypothetical? [00:23:48] Speaker 00: So again, I would point to the letter in English and Spanish. [00:23:53] Speaker 00: But it requires the recipient to take another step. [00:23:59] Speaker 00: And certainly, there are all kinds of human studies that show that if you want a response to something, don't ask somebody to take another step. [00:24:11] Speaker 00: Because they're busy, they don't want to do it, they've got other things on their mind. [00:24:17] Speaker 00: So from the insurance point of view, [00:24:22] Speaker 00: That makes no sense because it is going to suffer. [00:24:30] Speaker 00: So the question in the real world is can an insurer dictate to a vendor that the vendor will only be paid by the insurance company if [00:24:49] Speaker 00: It sends the survey itself in Spanish to the people identified by the insurer as Spanish speaking. [00:25:03] Speaker 03: So I guess two responses first, and this is the same exact response that the agency gave below. [00:25:10] Speaker 03: To the extent of vendor and insurance company want to enter into a contract that conditions payment on doing X, Y, Z. I'm not aware of any control or insight or check or sort of review that CMS would do. [00:25:24] Speaker 03: So I think insurance company probably would do what? [00:25:28] Speaker 03: The CMS doesn't review, as best I'm aware, the contracts between the vendor and the insurance company that's contracting with the vendor to conduct the survey. [00:25:38] Speaker 03: But the part of this that CMS does have control over, and I will just point you back to JA191, and this isn't really mentioned in the briefing in passing, but it's not really an issue, so it's not a focus in the briefing. [00:25:51] Speaker 03: CMS, before any vendor is allowed to be a vendor that does this, you're sort of sending out of these surveys, the vendor has to enter into a quality assurance plan that is approved by CMS. [00:26:05] Speaker 03: Data stats, again, just one page of data stats quality assurance plan is a page of JA191. [00:26:09] Speaker 03: And so I guess to go back to your question about the hypothetical [00:26:17] Speaker 03: sort of vendor who's taking the cheapest option or cutting corners. [00:26:22] Speaker 03: That's exactly what this quality assurance plan is designed to prevent. [00:26:25] Speaker 03: The vendor represents and commits to CMS that it will take certain steps in order to ensure that the survey is administered in a way that will produce reliable data. [00:26:34] Speaker 03: And the page that you see on GA191 is data stat committing for these two contracts. [00:26:40] Speaker 00: So if the insurance company [00:26:45] Speaker 00: sees a 15% drop or a 10% drop, or combine those two, 25% drop, and thinks, what's happened here? [00:27:04] Speaker 00: Based on previous experience, based on his information about the response rate of Spanish-speaking residents, [00:27:16] Speaker 00: and he calls or contacts CMS. [00:27:22] Speaker 00: As I understand, CMS's position is that's a matter between the insurance company and the contractor. [00:27:29] Speaker 00: We don't get involved. [00:27:32] Speaker 03: So again, I guess this goes back to the Chief Judge's questions a little bit. [00:27:35] Speaker 03: I guess that's not our only position, our position that is in any event, CMS did in fact contact the vendor in this case to confirm that it did in fact follow this protocol. [00:27:46] Speaker 00: And the vendor of course said he followed. [00:27:50] Speaker 00: I mean, what vendor is going to say I didn't follow the protocols and I didn't follow the contract? [00:27:57] Speaker 00: I mean, we're dealing with human nature here. [00:27:59] Speaker 00: and human behavior. [00:28:01] Speaker 00: And what I'm trying to understand is to what extent CMS is just not concerned about these matters. [00:28:11] Speaker 00: And maybe it isn't. [00:28:13] Speaker 00: And that's the way it's going to administer the program. [00:28:22] Speaker 03: I guess my response to that is threefold. [00:28:24] Speaker 03: The record reflects the quality assurance plan, which shows that CMS is concerned with how these vendors operate and ensuring that they are following these mandatory protocols. [00:28:33] Speaker 03: As discussed in our brief, this is point two, the protocols include a lot of mandatory requirements. [00:28:40] Speaker 03: And again, we're in a really small universe of. [00:28:42] Speaker 03: how does CMS make sure Spanish language surveys are meaningfully made available? [00:28:47] Speaker 03: Even in that small universe of this survey operation, there are, as enumerated in our briefing, a lot of mandatory requirements. [00:28:55] Speaker 03: The website must [00:28:58] Speaker 03: When you open the web survey, give you the option to proceed in your language of choice. [00:29:03] Speaker 03: And one of those must be Spanish. [00:29:04] Speaker 03: The bilingual pre-notification letter must be sent. [00:29:06] Speaker 03: There's more. [00:29:09] Speaker 03: And then I guess the third response is the lengthy email exchange between CMS and plaintiff did not begin and end with, well, you've identified an optional, not a mandatory requirement, or done. [00:29:24] Speaker 03: CMS then [00:29:26] Speaker 03: went on to A, confirm that the vendor did in fact do this and looked at the data to make sure that there wasn't some reason to be suspicious that there was something wrong. [00:29:36] Speaker 00: But did not look at the underlying data that indicated the 25% drop. [00:29:45] Speaker 00: That's what I'm trying to understand here. [00:29:48] Speaker 00: I understand, I think, CMS's position about this is between the insurance company and the vendor. [00:29:57] Speaker 00: But asking the vendor, did you violate the law? [00:30:01] Speaker 00: And expecting the vendor to say anything other than, no, I did not. [00:30:07] Speaker 00: It's an assurance, I suppose, if in subsequent administrative proceedings or litigation, the agency is dealing with the vendor. [00:30:17] Speaker 00: But I just want to be clear about what the insurance company's options are here. [00:30:23] Speaker 00: And there really aren't any, as I understand it. [00:30:26] Speaker 00: It doesn't have access to the data, the underlying data, where CMS does. [00:30:36] Speaker 00: A 25% drop isn't enough to look at that data. [00:30:41] Speaker 00: That's all I'm getting at. [00:30:43] Speaker 03: Sure, and just to tease that out, the reference to drops in response rates from the 2024 to 2025 survey, CMS took those and that's slightly distinct. [00:30:54] Speaker 03: I think probably thinks that the use of the data and the drop in response rates are the same thing. [00:31:03] Speaker 03: On the drop in response rates, the agency squarely responded to that. [00:31:08] Speaker 03: The agency said, the agency is the one that, as you said, gave plaintiff the data on this. [00:31:15] Speaker 03: And the agency looked at response rates and concluded, and I think this is [00:31:21] Speaker 03: an incredibly strong response. [00:31:23] Speaker 03: We looked at response rates for Spanish language speakers for these two contracts in particular. [00:31:28] Speaker 03: And for these contracts, Spanish language response rates were higher than average across all similar surveys that are done for these contracts. [00:31:40] Speaker 00: What I'm getting at is, is the petitioner here incorrect? [00:31:48] Speaker 00: in stating that CMS never looked at the underlying data? [00:31:52] Speaker 03: What they mean by that is they never looked at the way in which the vendor was doing the matching, the name matching. [00:32:03] Speaker 03: Right. [00:32:04] Speaker 00: Is it wrong about that? [00:32:07] Speaker 03: I guess the record doesn't reflect whether the agency in fact did that, but no. [00:32:11] Speaker 03: I mean, they're not wrong about that. [00:32:12] Speaker 00: There's no indication I could find that the agency did that. [00:32:14] Speaker 00: No, that's right. [00:32:16] Speaker 00: Okay. [00:32:18] Speaker 00: My only point is, suppose when you look at the data, here we have a 25% drop, suppose it's 50%, suppose it's 75%. [00:32:26] Speaker 00: And the agency's response is, you know, we didn't look at the data, but we asked the vendor, and this is not so abnormal that we need to do anything more. [00:32:38] Speaker 00: I just want to understand how this system works, that's all. [00:32:43] Speaker 03: Sure, I mean, I can't say what the agency would say in that hypothetical, but I can get a guess. [00:32:49] Speaker 03: I mean, as we point out, this is all optional. [00:32:51] Speaker 03: I think sort of load star underlying this entire process. [00:32:55] Speaker 03: If you look at 42 CFR 422.164, that's the regulatory provision explaining that CMS will always review all of the data that feeds into the star rating process and quote, review the quality of the data on which [00:33:12] Speaker 03: the ratings are based, including accuracy, reliability, and valid validity of measures. [00:33:19] Speaker 03: If there's ever a problem with survey vendors' actions that rise to the level of giving CMS doubts about the reliability of that data, [00:33:29] Speaker 03: then that is something that the agency can and will respond to. [00:33:33] Speaker 03: And again, I think to the extent your question is getting at, well, did the agency here just shrug and say, well, there's nothing to see here? [00:33:41] Speaker 03: There's, what is it, 30 something pages of the JA here, which is an extensive, over a month long, back and forth, in which the agency absolutely did not do that. [00:33:53] Speaker 03: It repeatedly responded and explained [00:33:56] Speaker 03: what it was thinking, what it had looked at. [00:33:58] Speaker 00: I know, but the only thing it didn't do, says petitioner, is look at the data that would have supported its concern about what was happening here. [00:34:09] Speaker 00: I don't need to pursue this. [00:34:10] Speaker 00: I understand your answer. [00:34:13] Speaker 03: Thank you. [00:34:13] Speaker 03: If there are no further questions, I'll sit down. [00:34:16] Speaker 03: Thank you, counsel. [00:34:22] Speaker 04: Mr. Kimberly, we'll give you two minutes for rebuttal. [00:34:24] Speaker 02: Thank you. [00:34:26] Speaker 02: Your honor, as I'll start at JA127, Mr. Starcher is correct that their CMS said there are optional ways of making Spanish language materials available to Spanish speakers. [00:34:40] Speaker 02: But it then says that alignment didn't avail itself of that option. [00:34:45] Speaker 02: The premise of this response, which was a factual misimpression, was legally that it's up to alignment [00:34:53] Speaker 02: to elect whether or not to make Spanish-only materials available to individuals known to prefer Spanish. [00:35:00] Speaker 02: And it said, you didn't do that. [00:35:02] Speaker 02: Alignment responded and said, actually, yes, we did. [00:35:05] Speaker 02: We sent this data to Datastat, and we asked Datastat to match it in just this way. [00:35:11] Speaker 02: And that's when their real explanation came, which is that JA 112 and JA 117, the JA 112, they say, [00:35:20] Speaker 02: Well, we looked at the results and the results are within the range of normal. [00:35:24] Speaker 02: But alignment works really hard at this stuff. [00:35:27] Speaker 02: They take these surveys very seriously. [00:35:29] Speaker 02: Star ratings are tremendously important to the Medicare Advantage program. [00:35:34] Speaker 02: And they push for administration procedures that drive up response rates because they know Spanish speakers respond more favorably for them. [00:35:44] Speaker 02: So they want to drive up those rates and they take steps to do it. [00:35:47] Speaker 02: So no surprise that their rates overall are above average. [00:35:57] Speaker 02: are data showing that although the number of individuals who were sampled and known to speak Spanish went up, the rate of respondents went down. [00:36:08] Speaker 02: And so when CMS responded and said, well, we asked DataStat if they followed the protocols and specifications, our response was, yeah, I mean, OK, we get it. [00:36:18] Speaker 02: Sort of along the lines, Judge Rogers, of your line of questioning. [00:36:22] Speaker 02: But when you look at the data, something's going on here. [00:36:25] Speaker 02: This doesn't look right. [00:36:27] Speaker 02: And CMS's response over pages of emails was constantly to stiff arm alignment and refused to look at the one thing that would have answered the question. [00:36:37] Speaker 02: whether there was a data administration error and now having filed a lawsuit and seen the data under an attorney's eyes only protective order we see that there was an administration error. [00:36:48] Speaker 02: That we submit again is all that we need to win this lawsuit and the idea that CMS can simply step back and say well we don't have any control over this third party contractor is just not consistent either with the consistency rule requiring it to treat [00:37:04] Speaker 02: similarly situated regulated entities the same way and it's also inconsistent with the non-delegation doctrine and we submit your honors that the district court's decision should be reversed. [00:37:15] Speaker 04: Thank you counsel. [00:37:16] Speaker 04: Thank you to both counsel. [00:37:17] Speaker 04: We'll take this case under submission.