WEBVTT - Chevron Doctrine’s Demise and Industry Risk

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<v Speaker 1>Hello, and welcome to the Votes in Verdicts podcast hosted

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<v Speaker 1>by Bloomberg Intelligence, Bloomberg LP's investment research platform. In this

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<v Speaker 1>podcast series, we talk about the intersection of business policy

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<v Speaker 1>and law. My name is Matt Shettenhelm. I'm an analyst

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<v Speaker 1>with BI covering litigation and policy in the TMT space.

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<v Speaker 1>The Supreme Court on June twenty eighth overturned the Chevron doctrine.

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<v Speaker 1>Over a month before that ruling, my Bloomberg Intelligence colleagues

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<v Speaker 1>Elliott Stein, Justin Toreesie, Dwayne Wright and I put out

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<v Speaker 1>a detailed report anticipating the ruling and explaining the larger

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<v Speaker 1>demise of deference to regulators. And then days after the ruling,

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<v Speaker 1>on July second, we held this call to discuss our

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<v Speaker 1>report and to explain what this critical legal development means

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<v Speaker 1>for industries and businesses. Please enjoy. Okay, good afternoon, everyone,

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<v Speaker 1>and welcome to the Bloomberg Intelligence webinar the demise of

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<v Speaker 1>the Chevron Doctrine. A couple housekeeping notes before we begin.

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<v Speaker 1>Today's presentation will be recorded and available for playback. You

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<v Speaker 1>can ask a question to us by submitting one in

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<v Speaker 1>the Q and a box you see at the bottom

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<v Speaker 1>of your screen, and after the webinar, we're all available

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<v Speaker 1>to answer further questions on this topic. A brief note

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<v Speaker 1>about Bloomberg Intelligence. BI Research delivers independent perspective, interactive data

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<v Speaker 1>and investment research on companies, industries, and global markets. Our

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<v Speaker 1>team of three hundred and fifty professionals helps our clients

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<v Speaker 1>make informed decisions. We cover companies, industries, markets from the

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<v Speaker 1>perspective of strategy, equity, credit, ESG, government, and litigation. My

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<v Speaker 1>name is at Shuttinghelm. I'm a litigation and policy analyst

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<v Speaker 1>with Bloomberg Intelligence focused on the TMT sector, and I'm

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<v Speaker 1>joined today by my fellow Bloomberg Intelligence analyst, Dwayne Wright,

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<v Speaker 1>who's focused on healthcare, and Justin TREESI focused on industrials

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<v Speaker 1>and antitrust. Unfortunately, Elliott Stein isn't able to join us

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<v Speaker 1>today due to a death in his family, but he

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<v Speaker 1>shared some thoughts on the impacts on the financial sector

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<v Speaker 1>and we'll get to that in a little bit. Dwayne,

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<v Speaker 1>do you want to tell us more about the deep

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<v Speaker 1>dive report we did.

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<v Speaker 2>On this Yeah, thanks, Matt.

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<v Speaker 3>So we wanted to hold this webinar to highlight a

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<v Speaker 3>recent deep dive report we put out about the demise

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<v Speaker 3>of deference to regulators. We put out a bive report

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<v Speaker 3>on May seventeenth, anticipating that the Supreme Court would curtail

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<v Speaker 3>the Chevron doctrine and explaining what it would mean. After

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<v Speaker 3>the court's decision, on ju twenty eighth, we updated our report.

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<v Speaker 3>If you want to look for it, you can find

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<v Speaker 3>it on a terminal ATBI.

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<v Speaker 2>Deepdep all New.

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<v Speaker 3>You can also find some of our other deep Dye reports,

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<v Speaker 3>especially one that the team put together on the Inflation

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<v Speaker 3>Reduction Act and how the US selection outcome would affect

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<v Speaker 3>or could affect things like the drug negotiation process e.

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<v Speaker 3>The text credits clean out energy and other components of

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<v Speaker 3>the IRA. Again it's DIDEP. And with that, justin, would

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<v Speaker 3>you like to talk talk about how we're going to

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<v Speaker 3>structure the call today?

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<v Speaker 4>Sure, thanks Drayne. So here's the plan for how we're

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<v Speaker 4>going to roll this out. First, we'll give an overview

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<v Speaker 4>of what we're planning to talk about what the court

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<v Speaker 4>decided and what that means going forward. And we're going

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<v Speaker 4>to do that as much as the cannon's in pretty

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<v Speaker 4>simple plain English. Try to leave the legally as to

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<v Speaker 4>others and really focus on what the ruling means as

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<v Speaker 4>a practical matter. Then we're going to discuss how the

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<v Speaker 4>demise of defference could impact particular sectors most immediately. And

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<v Speaker 4>it's not intended to be a comprehensive report. There are

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<v Speaker 4>fifty three titles of US Code, there's dozen of different

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<v Speaker 4>federal regulatory agencies in Washington, d C. So obviously impossible

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<v Speaker 4>to really get to the far reaches of where Chevron

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<v Speaker 4>the impact of the Chevron demise is really going to touch.

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<v Speaker 4>But we each bring expertise in some specific areas to

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<v Speaker 4>the conversation, and with that we really want to highlight

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<v Speaker 4>how the development impacts those areas that we know best.

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<v Speaker 4>So let's get into it. Matt, if you could give

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<v Speaker 4>us an overview of what we're talking about and why

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<v Speaker 4>any of this really matters going forward from this point.

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<v Speaker 1>Here, Yeah, thanks, justin so trying to keep it in

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<v Speaker 1>simple plane English, plain English. This really goes to the

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<v Speaker 1>heart of how federal regulation has worked for the past

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<v Speaker 1>forty years. Congress passes federal laws, but Congress leaves gaps.

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<v Speaker 1>It doesn't answer all the questions about what federal law

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<v Speaker 1>applies to or how far it reaches, and so for

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<v Speaker 1>forty years, the Chevron doctrine has explained how those gaps

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<v Speaker 1>it filled, how those questions in federal law get answered,

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<v Speaker 1>And the doctrine says it's the regulators themselves, the SEC,

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<v Speaker 1>the FDA, the FCC who get to fill those gaps,

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<v Speaker 1>who to get to determine how far far federal law reaches.

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<v Speaker 1>And of course, virtually every time a federal agency does

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<v Speaker 1>that it expands or contracts federal law, they get sued.

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<v Speaker 1>And Chevron is the test that applies in courts when

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<v Speaker 1>judges look at did the agency do this properly? And

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<v Speaker 1>in those lawsuits, the Chevron doctrine has said that as

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<v Speaker 1>long as the regulator's view of the federal law passes

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<v Speaker 1>a very light touch, reasonable test, the court must accept it.

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<v Speaker 1>And that's true even if the court itself thinks it

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<v Speaker 1>has a better view of the law. The idea here

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<v Speaker 1>is that judges aren't experts in this stuff. The regulators are.

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<v Speaker 1>So there's always been a check from the courts on agencies.

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<v Speaker 1>It's always been very light touch, very deferential. The regulators

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<v Speaker 1>themselves get great discretion to interpret federal law by making

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<v Speaker 1>policy calls that are specific to the areas that they

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<v Speaker 1>know based on their expertise.

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<v Speaker 4>So that's really how deference has operated so far. But

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<v Speaker 4>it's going away. How can you explain exactly how it's

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<v Speaker 4>going away?

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<v Speaker 1>Yes, So it's really happened in three steps. So First,

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<v Speaker 1>as the courts have become increasingly led by Republican appointed judges,

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<v Speaker 1>they become more skeptical of regulator's overreach. And increasingly courts

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<v Speaker 1>have been deciding these agency cases without even mentioning Chevron.

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<v Speaker 1>Deference Chevron even before it died last week, it's been

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<v Speaker 1>quietly disappearing slowly over the last decade. Number two, In

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<v Speaker 1>a twenty twenty two case involving the EPA, the Supreme

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<v Speaker 1>Court announced what's known as the Major Questions doctrine, and

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<v Speaker 1>in a nutshell, the Court said that anytime a regulator

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<v Speaker 1>tries to answer a major question about what federal law means,

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<v Speaker 1>it can't do so unless Congress granted it that power clearly.

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<v Speaker 1>In other words, only Congress can answer the major questions

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<v Speaker 1>about federal law. The regulators themselves can't. And then the

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<v Speaker 1>third step came at the end of last week, the

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<v Speaker 1>Loper Right decision. After that twenty twenty two EPA Major

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<v Speaker 1>Questions decision, no one really knew which questions were major

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<v Speaker 1>and which ones weren't. And in theory, agencies still got

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<v Speaker 1>deference on the non major ones and so but the

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<v Speaker 1>loper Right decision kills everything. It's no longer there's no

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<v Speaker 1>longer a situation where courts must defer to the regulatory

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<v Speaker 1>agency even on non major questions. The courts themselves get

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<v Speaker 1>to decide how far federal law reaches. The regulators don't,

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<v Speaker 1>and they can try to persuade the courts, but it's

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<v Speaker 1>the courts, and ultimately the courts are guided by the

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<v Speaker 1>US Supreme Court that will determine what federal law means.

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<v Speaker 1>And the US Supreme Court, of course is very business

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<v Speaker 1>friendly friendly, very skeptical of aggressive regulation.

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<v Speaker 4>So here comes the big question, And well, Congress is

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<v Speaker 4>basically set an interest resolved as now by giving regulators

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<v Speaker 4>more power.

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<v Speaker 2>Yeah, in theory, Congress could.

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<v Speaker 1>In theory, Corress could restore Chevron Defronce or on every

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<v Speaker 1>one of these issues where agencies are expanding their power,

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<v Speaker 1>Congress could step in and give the agencies the power

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<v Speaker 1>that they might seek under Chevron. But it's extremely unlikely

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<v Speaker 1>to happen. Congress struggles to reach consensus on just about everything,

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<v Speaker 1>and there's going to be a very limited appetite to

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<v Speaker 1>expand regulate regulator's power. And so in my view, this

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<v Speaker 1>development will be very good news for many industries that

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<v Speaker 1>prefer an environment of light touch federal regulation.

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<v Speaker 4>Great, thanks, Matt. That's a great overview. And with that,

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<v Speaker 4>I think it's probably a good time to transition into

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<v Speaker 4>how this development impacts specific sectors moving forward. And Elliott Stein,

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<v Speaker 4>as you said, covers financial litigation, couldn't be here with

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<v Speaker 4>us today, but I know he sent you a series

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<v Speaker 4>of comments that he wanted to share with the group.

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<v Speaker 1>Yeah, yeah, let me let me dive into what Elliott

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<v Speaker 1>Elliott sent us.

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<v Speaker 2>So Elliott's thoughts were basically this so so he said.

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<v Speaker 1>As an initial matter, the overruling of Chevron deference is

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<v Speaker 1>indicative of a larger trend this the demise of judicial

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<v Speaker 1>deference to administrative agencies. The Major Questions doctrine is of

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<v Speaker 1>course another example of that trend. And to put a

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<v Speaker 1>finer point on it, when the Fifth Circuit on June

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<v Speaker 1>fifth struck down the SEC's private funds rule, the court

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<v Speaker 1>cited neither Chevron nor the Major Questions doctrine. Instead, the

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<v Speaker 1>Court determined that the relevant statutes Dodd Frank and the

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<v Speaker 1>Investment Advisors Act in that case were clear on their

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<v Speaker 1>and that the SEC had exceeded its.

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<v Speaker 2>Authority in issuing the rule.

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<v Speaker 1>So, even without Chevron or the Major Questions doctrine, we've

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<v Speaker 1>been noting for some time that the conservative shift of

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<v Speaker 1>the federal judiciary has imperiled President Biden's financial regulation agenda,

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<v Speaker 1>and the overruling of Chevron just reinforces that trend. Now

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<v Speaker 1>there are a large number of financial regulations issued by

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<v Speaker 1>the Biden administration that are currently being challenged in court.

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<v Speaker 1>We expect many of those challenges to succeed. For example,

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<v Speaker 1>we expect the CFPB's credit card late fee rule to

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<v Speaker 1>be struck down in the courts. That rule seeks to

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<v Speaker 1>cap credit card late fees, which would eliminate about ten

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<v Speaker 1>billion dollars in fees that quarity card issuers like JP, Morgan,

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<v Speaker 1>Bank of America, Capital One, and American Express collect. Indeed,

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<v Speaker 1>the rule is already put on hold by a federal

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<v Speaker 1>District court judge in Texas who found compelling the arguments

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<v Speaker 1>made by the US Chamber of Commerce and other bank

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<v Speaker 1>trade groups that the CFP had CFP had exceeded its

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<v Speaker 1>authority under the Dodd Frank and the Credit Card Accountability,

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<v Speaker 1>Responsibility and Disclosure Act, better known as the Card Act.

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<v Speaker 1>We also expect the SEC's climate disclosure rule to be

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<v Speaker 1>struck down in court, in part due to the major

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<v Speaker 1>questions doctrine, since there's a strong argument that the rule

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<v Speaker 1>is a pretext for emissions regulations, which Congress has delegated

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<v Speaker 1>the EPA, not the SEC. Other lawsuits Elliott's watching concern

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<v Speaker 1>SEC rules over proxy advisors, short sales, and securities lending,

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<v Speaker 1>the definition of government securities dealers, and the consolidated Consolidated

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<v Speaker 1>Audit trail. Also watching lawsuits challenging CFPB rules over small

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<v Speaker 1>business lending and the agency's examination manual, and a lawsuit

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<v Speaker 1>against the fbiic FED and OCC over changes to the

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<v Speaker 1>Community Reinvestment Act. And finally, we think this trend of

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<v Speaker 1>court's deferring less to federal regulators will help coinbase and

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<v Speaker 1>other crypto companies in their defenses against see enforcement actions.

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<v Speaker 1>These cases concern the meeting of the term investment contract

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<v Speaker 1>in the federal securities laws. We expect the issue to

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<v Speaker 1>eventually reach the Supreme Court, which we anticipate will revisit

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<v Speaker 1>its seminal how we decision and narrow the Howie test

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<v Speaker 1>in a way that is favorable to coinbase so that

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<v Speaker 1>secondary transactions of digital assets are less likely to be

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<v Speaker 1>deemed securities that fall under the purview of the SEC.

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<v Speaker 1>If you would like to discuss any of these cases

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<v Speaker 1>and in more detail, please don't hesitate to reach out

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<v Speaker 1>to Elliott.

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<v Speaker 2>I know he wanted to be here today.

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<v Speaker 1>But again apologize he couldn't be here, and I think

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<v Speaker 1>we'll leave it at that.

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<v Speaker 4>On the financial side, great, thanks Betan, I'll that go

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<v Speaker 4>with that as well. Definitely reach out to Elliott's sign

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<v Speaker 4>if there's any questions moving forward on the financial regulations

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<v Speaker 4>we discussed here, So Matt, let's search the impacts in

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<v Speaker 4>the TMT sector. Think you said this at a kind

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<v Speaker 4>of a major impact on broadband regulation at the FCC.

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<v Speaker 1>Yeah, I think this should lead to a major victory

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<v Speaker 1>for broadmand companies like AT and T, Charter, Comcast, TE,

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<v Speaker 1>T Mobile, and Verizon. The question is whether these companies'

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<v Speaker 1>most important products, wired and wireless broadband, should be subject

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<v Speaker 1>to federal regulation at all. The courts have struggled for

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<v Speaker 1>this for two decades, but here's what's critical to know

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<v Speaker 1>about that litigation. Chevron deference has been at the heart

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<v Speaker 1>of that litigation. When the Obama era FCC restored federal

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<v Speaker 1>broadband regulation, it only won in court because of Chevron deference.

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<v Speaker 1>The courts had to defer to the FCC. It's just

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<v Speaker 1>not going to happen anymore. And in the second quarter

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<v Speaker 1>of this year, the Biden era FCC tried to restore

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<v Speaker 1>again aggressive federal broadband regulation under the Communications Act. And

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<v Speaker 1>the case is now in the Sixth Circuit Court of Appeals.

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<v Speaker 1>And although the FCC won the last round of this litigation,

0:13:54.320 --> 0:13:56.760
<v Speaker 1>it's going to lose this one. It won't win this,

0:13:56.880 --> 0:14:00.560
<v Speaker 1>I don't think without deference, and so the result is

0:14:00.760 --> 0:14:04.320
<v Speaker 1>very likely going to be no or minimal regulation of

0:14:04.360 --> 0:14:08.320
<v Speaker 1>these companies most important product at the federal level. How

0:14:08.320 --> 0:14:13.600
<v Speaker 1>about Internet regulation, Yeah, that's in trouble too. So Congress

0:14:13.640 --> 0:14:17.160
<v Speaker 1>has struggled to reach consensus on a data privacy build

0:14:17.200 --> 0:14:22.840
<v Speaker 1>that goes after Google and Meta's data privacy practices, and

0:14:22.920 --> 0:14:26.120
<v Speaker 1>so the Federal Trade Commission has started a process to

0:14:26.200 --> 0:14:30.680
<v Speaker 1>make rules that would regulate the digital ad business what's

0:14:30.720 --> 0:14:33.960
<v Speaker 1>really at the heart of their business model? And FTC

0:14:34.200 --> 0:14:39.360
<v Speaker 1>chair Lena Kahan has she calls it surveillance advertising, and has,

0:14:39.440 --> 0:14:44.200
<v Speaker 1>you know, threatened to propose pretty aggressive rules using the

0:14:44.320 --> 0:14:49.320
<v Speaker 1>FTC's power over unfair or deceptive practices. So her idea

0:14:49.320 --> 0:14:53.240
<v Speaker 1>is to expand that term in federal law unfair deceptive

0:14:53.680 --> 0:14:57.480
<v Speaker 1>to take aim at the digital ad business model. And

0:14:58.440 --> 0:15:00.920
<v Speaker 1>again here what we can say is that effort is

0:15:01.720 --> 0:15:06.200
<v Speaker 1>likely to run directly into this regulatory wall. So if

0:15:06.240 --> 0:15:09.800
<v Speaker 1>the FDC is aggressive with its digital ad regulations, which

0:15:09.800 --> 0:15:12.800
<v Speaker 1>I think it planned to be, at least, the courts

0:15:12.840 --> 0:15:16.760
<v Speaker 1>are almost certain to strike that down definitely.

0:15:16.800 --> 0:15:19.200
<v Speaker 4>And I know you you've also written about the FDC's

0:15:19.280 --> 0:15:21.760
<v Speaker 4>efforts to regulate a lot of areas more broad.

0:15:22.040 --> 0:15:24.360
<v Speaker 2>Can you address that a bit more? Yeah, So it

0:15:24.400 --> 0:15:26.520
<v Speaker 2>goes really beyond tech.

0:15:27.160 --> 0:15:31.120
<v Speaker 1>The FDC is claiming a relatively novel power to make

0:15:31.320 --> 0:15:35.960
<v Speaker 1>competition unfair competition rules, and it's first try at using

0:15:36.000 --> 0:15:39.400
<v Speaker 1>that new power, it's discovered, is to strike down non

0:15:39.440 --> 0:15:43.360
<v Speaker 1>compete clause agreements thirty million contracts that it's it's it

0:15:43.400 --> 0:15:47.080
<v Speaker 1>claims are now illegal using its new rule making power.

0:15:47.880 --> 0:15:51.680
<v Speaker 1>That's just not going to work anymore. Expanding stretching your

0:15:51.720 --> 0:15:55.520
<v Speaker 1>powers under federal law in novel ways, the courts are

0:15:55.520 --> 0:15:57.360
<v Speaker 1>going to strike that down. In fact, we could see

0:15:57.400 --> 0:16:02.960
<v Speaker 1>a stay of that non compete clause UH decision this week.

0:16:04.560 --> 0:16:07.720
<v Speaker 1>Any industry impacted by that sort of rule making, or

0:16:07.800 --> 0:16:12.200
<v Speaker 1>any M and A impacted by unfair competition rules that

0:16:12.200 --> 0:16:16.040
<v Speaker 1>that the FDC might try to develop, that they're going

0:16:16.080 --> 0:16:19.240
<v Speaker 1>to escape that sort of regulation. In my view, the

0:16:19.280 --> 0:16:22.840
<v Speaker 1>FDC is picking about the worst possible time to try

0:16:22.880 --> 0:16:26.120
<v Speaker 1>to expand its rulemaking powers in novel ways.

0:16:26.160 --> 0:16:27.360
<v Speaker 2>It's just not going to fly.

0:16:28.200 --> 0:16:31.520
<v Speaker 1>And and with that, justin I, let's let's transition to

0:16:31.760 --> 0:16:35.160
<v Speaker 1>two areas. You know, well, I know you looked at

0:16:35.160 --> 0:16:38.120
<v Speaker 1>some EPA rules that that might be at risk.

0:16:38.160 --> 0:16:41.160
<v Speaker 2>Can you tell us more about that? Sure, thanks, Matt.

0:16:41.200 --> 0:16:43.960
<v Speaker 4>So so really I think important when we kind of

0:16:44.000 --> 0:16:45.840
<v Speaker 4>take a turn here and look at the EPA is

0:16:45.880 --> 0:16:49.040
<v Speaker 4>to really acknowledge the labyrinth and the degree of statute

0:16:49.320 --> 0:16:52.400
<v Speaker 4>that the EPA really has under its jurisdiction, so many

0:16:52.400 --> 0:16:55.640
<v Speaker 4>different areas of environmental policies, so many different areas of life,

0:16:55.680 --> 0:16:58.680
<v Speaker 4>if you will, so just providing these two particular recent

0:16:58.800 --> 0:17:03.000
<v Speaker 4>rules rule finalizations as examples for the kinds of things

0:17:03.000 --> 0:17:05.800
<v Speaker 4>that might be susceptible in some ways to a change

0:17:05.800 --> 0:17:08.840
<v Speaker 4>and chevron deference here, the first being both relate to

0:17:09.200 --> 0:17:11.800
<v Speaker 4>p fas or forever chemicals, as they're being referred to

0:17:11.960 --> 0:17:14.200
<v Speaker 4>right now and kind of the mainstream media, if you will.

0:17:14.440 --> 0:17:18.080
<v Speaker 4>Long story short, p fast chemicals come with particularly unpleasant

0:17:18.119 --> 0:17:20.240
<v Speaker 4>health effects for humans when they build up in the

0:17:20.280 --> 0:17:22.560
<v Speaker 4>human body, right So we're talking about the particular cancers,

0:17:22.560 --> 0:17:25.639
<v Speaker 4>hormonal issues, things like that. But with kind of that

0:17:25.680 --> 0:17:29.080
<v Speaker 4>as the base for moving forward. This spring, the EPA

0:17:29.160 --> 0:17:32.200
<v Speaker 4>finalize a rule that have under the Safe Drinking Water

0:17:32.280 --> 0:17:35.720
<v Speaker 4>Act that involves tapping the level of allowable p fas

0:17:35.760 --> 0:17:39.520
<v Speaker 4>in people's drinking water. So authorities nationwide now have to

0:17:39.560 --> 0:17:42.359
<v Speaker 4>measure and remediate for the presence of p fas and

0:17:42.440 --> 0:17:45.560
<v Speaker 4>drinking water that are beyond a particular allowable limit under

0:17:45.560 --> 0:17:49.879
<v Speaker 4>the final rule, what they also did when they promulgated

0:17:49.920 --> 0:17:52.879
<v Speaker 4>that regulation is they issued something called the hazard Index,

0:17:52.880 --> 0:17:55.320
<v Speaker 4>And what they did is they required authorities to not

0:17:55.359 --> 0:17:59.360
<v Speaker 4>only measure for particular substances, but also mixtures of those

0:17:59.359 --> 0:18:02.480
<v Speaker 4>substances in drinking water. So that's the first kind of

0:18:02.520 --> 0:18:05.959
<v Speaker 4>rule that came out in April, and something for us

0:18:05.960 --> 0:18:08.760
<v Speaker 4>to note here. The second involves the designation of p

0:18:08.920 --> 0:18:12.800
<v Speaker 4>FAS chemicals, two of them anyway, as hazardous substances under

0:18:13.040 --> 0:18:15.159
<v Speaker 4>the CIRCLA or what's better known to folks as a

0:18:15.160 --> 0:18:18.359
<v Speaker 4>super fun law, opening the door to kind of designating

0:18:18.359 --> 0:18:22.400
<v Speaker 4>physical sites for cleanup and remediation efforts if those particular

0:18:22.440 --> 0:18:24.679
<v Speaker 4>p FAS chemicals are present in those sites at a

0:18:24.720 --> 0:18:29.680
<v Speaker 4>particularly unpleasant amount. So what's important here is the billions

0:18:29.680 --> 0:18:31.800
<v Speaker 4>of dollars involved with both of these rules that are

0:18:31.840 --> 0:18:35.800
<v Speaker 4>anticipated in terms in the order for responsible parties to

0:18:35.880 --> 0:18:39.320
<v Speaker 4>become compliant with both of them. And you know, both

0:18:39.359 --> 0:18:42.120
<v Speaker 4>have their wrinkles here with regard to Chevron, and we'll

0:18:42.119 --> 0:18:45.120
<v Speaker 4>get into that a bit later, but you know, particularly

0:18:45.160 --> 0:18:47.760
<v Speaker 4>interesting wrinkle with the way the EPA operates too, is

0:18:47.760 --> 0:18:49.640
<v Speaker 4>that on the one hand, here you have the folks

0:18:49.640 --> 0:18:52.200
<v Speaker 4>who made these chemicals in the first place, the three m's,

0:18:52.240 --> 0:18:54.919
<v Speaker 4>two ponds and Camors of the world, who you know,

0:18:55.000 --> 0:18:57.040
<v Speaker 4>might see a shift in liabilities for any of these

0:18:57.080 --> 0:19:00.280
<v Speaker 4>cleanup efforts because of any changes here now under the

0:19:00.359 --> 0:19:03.439
<v Speaker 4>Chevron deference. And again this applies to all areas of

0:19:03.480 --> 0:19:05.760
<v Speaker 4>e p A regulation. But on the other side of

0:19:05.800 --> 0:19:08.480
<v Speaker 4>the coin, there is this whole green economy and companies

0:19:08.520 --> 0:19:11.880
<v Speaker 4>that stand a benefit from things like remediation costs and

0:19:11.880 --> 0:19:14.679
<v Speaker 4>and you know, putting out you know, green technologies, you

0:19:14.680 --> 0:19:18.240
<v Speaker 4>know green a whole wide range of spaces, which we'll

0:19:18.280 --> 0:19:20.919
<v Speaker 4>talk about too. So so there is this kind of

0:19:21.119 --> 0:19:23.280
<v Speaker 4>before and after effect here with with with these e

0:19:23.400 --> 0:19:26.240
<v Speaker 4>p A regulations and will industries you know, traditionally might

0:19:26.280 --> 0:19:29.240
<v Speaker 4>benefit from a roll back of Chevron, there's also the

0:19:29.320 --> 0:19:31.720
<v Speaker 4>possibility that they could be in some way harmed by that,

0:19:31.760 --> 0:19:33.600
<v Speaker 4>depending on what the nature of their business is over

0:19:33.640 --> 0:19:34.120
<v Speaker 4>at e PA.

0:19:35.200 --> 0:19:36.199
<v Speaker 2>Got it? Got it?

0:19:36.240 --> 0:19:37.840
<v Speaker 1>So that I mean that that's a good overview of

0:19:37.840 --> 0:19:42.399
<v Speaker 1>the rules. Is there already litigation litigation challenges coming to

0:19:42.440 --> 0:19:46.040
<v Speaker 1>these rules and and how does how does overruling Chevron

0:19:46.359 --> 0:19:47.960
<v Speaker 1>change that that landscape?

0:19:48.240 --> 0:19:50.320
<v Speaker 4>Yeah, definitely, And you know again I think you know

0:19:50.359 --> 0:19:52.080
<v Speaker 4>the e p A, you know, these rules seem to

0:19:52.080 --> 0:19:54.680
<v Speaker 4>be unfairly strong footing. You peoput a lot of time,

0:19:55.040 --> 0:19:57.320
<v Speaker 4>and I think, you know, justification into both rules. But

0:19:57.359 --> 0:19:59.359
<v Speaker 4>when they were ruled out, you know, I think the

0:19:59.680 --> 0:20:02.080
<v Speaker 4>challenge just petitions for review I've already been filed in

0:20:02.080 --> 0:20:05.879
<v Speaker 4>the DC circuit. We're expecting those, and you know, we

0:20:06.320 --> 0:20:09.880
<v Speaker 4>haven't been anticipating challenges based on the EPA's reported failure

0:20:10.000 --> 0:20:12.560
<v Speaker 4>to take costs of the rules into account or to

0:20:12.600 --> 0:20:14.879
<v Speaker 4>take public comments. It's a bit in relation to the

0:20:14.960 --> 0:20:17.080
<v Speaker 4>rules into account and the way that they were supposed to.

0:20:17.480 --> 0:20:20.119
<v Speaker 4>How Chevron kind of enters the fray here is that

0:20:20.160 --> 0:20:22.359
<v Speaker 4>you know, well, you know, it's not questionable really, and

0:20:22.440 --> 0:20:25.240
<v Speaker 4>it's well settled that things like capping the level of

0:20:25.280 --> 0:20:28.960
<v Speaker 4>substances and drinking water is good law and something that

0:20:29.040 --> 0:20:31.280
<v Speaker 4>EPA has the authority to do. You'll look kind of

0:20:31.400 --> 0:20:33.080
<v Speaker 4>zone in a little bit, a little bit zooming a

0:20:33.119 --> 0:20:35.239
<v Speaker 4>little further on that particular rule, and you look at

0:20:35.240 --> 0:20:37.400
<v Speaker 4>their use of this hazard in dex I mentioned whether

0:20:37.800 --> 0:20:41.479
<v Speaker 4>they're requiring from measuring mixtures of chemicals. Well, the statute

0:20:41.520 --> 0:20:45.199
<v Speaker 4>doesn't address this question of mixtures, So did EPA in

0:20:45.200 --> 0:20:48.040
<v Speaker 4>some way it surpass its authority when it decided to

0:20:48.080 --> 0:20:50.640
<v Speaker 4>do that. And from the standpoint of the Superfund law,

0:20:51.040 --> 0:20:53.840
<v Speaker 4>EPA is looking to other statutes and how substances were

0:20:53.880 --> 0:20:57.119
<v Speaker 4>designated under other statutes, But it remains the case that

0:20:57.200 --> 0:20:59.639
<v Speaker 4>as far as their actual Superfund law is concerned, this

0:20:59.680 --> 0:21:02.840
<v Speaker 4>is the very first time the APA has actually designated

0:21:02.920 --> 0:21:06.120
<v Speaker 4>new hazardous substances under that loss. There's not this existing

0:21:06.160 --> 0:21:09.160
<v Speaker 4>case law that already exists out there, kind of discussing

0:21:09.200 --> 0:21:11.760
<v Speaker 4>what the authority is to do that under the law itself.

0:21:11.880 --> 0:21:15.399
<v Speaker 4>So where there's some ambiguity where Chevron deference might have

0:21:15.440 --> 0:21:17.560
<v Speaker 4>been helpful in the past, now it's not there to

0:21:17.600 --> 0:21:18.440
<v Speaker 4>really protect them.

0:21:18.920 --> 0:21:21.359
<v Speaker 1>Yeah, and one of those things that also plays a

0:21:21.440 --> 0:21:25.359
<v Speaker 1>role for agencies. It's sometimes not even ambiguity, but silence

0:21:26.520 --> 0:21:30.160
<v Speaker 1>in the statute has been enough for agencies to you know,

0:21:30.560 --> 0:21:33.880
<v Speaker 1>claim power to make rules, and so all of that

0:21:33.920 --> 0:21:36.399
<v Speaker 1>basically goes away now and it's in the hands of

0:21:36.480 --> 0:21:38.639
<v Speaker 1>the courts. But how much do you think the APA

0:21:38.720 --> 0:21:43.159
<v Speaker 1>accounted for the possibility of Chevron going away as it

0:21:43.240 --> 0:21:44.359
<v Speaker 1>finalized these rules.

0:21:44.640 --> 0:21:47.159
<v Speaker 4>Sure, so you know we saw delay after delay with

0:21:47.200 --> 0:21:49.680
<v Speaker 4>the finalization of the rules. I think in many ways

0:21:49.720 --> 0:21:52.800
<v Speaker 4>it really was this practice of the EPA of really

0:21:52.800 --> 0:21:55.240
<v Speaker 4>trying to shore up the justification behind them as much

0:21:55.240 --> 0:21:58.960
<v Speaker 4>as they could from every standpoint, not just an agency

0:21:58.960 --> 0:22:01.520
<v Speaker 4>power standpoint, but all so the standpoint of you know,

0:22:01.560 --> 0:22:05.160
<v Speaker 4>cost benefits analysis and things like that that I also mentioned.

0:22:05.320 --> 0:22:07.720
<v Speaker 4>But there's no question that even the administration referred to

0:22:07.760 --> 0:22:10.520
<v Speaker 4>both of these these rules as historic and historic because

0:22:10.520 --> 0:22:12.040
<v Speaker 4>it really is the first time that a lot of

0:22:12.040 --> 0:22:15.280
<v Speaker 4>this action was taken with regard to forever chemicals, and

0:22:15.400 --> 0:22:17.520
<v Speaker 4>especially in the case of the super fun laws. So

0:22:17.960 --> 0:22:20.960
<v Speaker 4>this is something to really take into account here from

0:22:20.960 --> 0:22:23.680
<v Speaker 4>the standpoint of deference. You know, I think EPA did

0:22:23.720 --> 0:22:26.320
<v Speaker 4>what it could. But also an important wrinkle to kind

0:22:26.320 --> 0:22:29.080
<v Speaker 4>of mention here too is that, you know, for whatever reason,

0:22:29.440 --> 0:22:31.000
<v Speaker 4>if you know, I'm sure this is true for other

0:22:31.040 --> 0:22:34.040
<v Speaker 4>agencies as well, but forever whatever reason, if these rules

0:22:34.160 --> 0:22:37.160
<v Speaker 4>didn't go forward, you know, this is opening the door

0:22:37.160 --> 0:22:39.720
<v Speaker 4>to a situation where we see things like states continuing

0:22:39.720 --> 0:22:43.080
<v Speaker 4>that march forward. Before this this drinking cap or drinking

0:22:43.080 --> 0:22:46.080
<v Speaker 4>water cap was finalized by e PA, for example, ten

0:22:46.119 --> 0:22:49.080
<v Speaker 4>states already had a similar cap in place through through

0:22:49.119 --> 0:22:52.240
<v Speaker 4>their own regulatory scheme. So keeping that in mind too,

0:22:52.560 --> 0:22:54.280
<v Speaker 4>there's this all the other wrinkle here, where in the

0:22:54.320 --> 0:22:57.640
<v Speaker 4>absence of federal federal regulation or problems you might see

0:22:57.680 --> 0:23:01.000
<v Speaker 4>from Chevron decline, stay are kind of stepping in here

0:23:01.040 --> 0:23:03.320
<v Speaker 4>to fill that void in some ways as well, not

0:23:03.320 --> 0:23:04.840
<v Speaker 4>necessarily on the end of the story.

0:23:05.280 --> 0:23:08.119
<v Speaker 1>Yeah, that's that's a great point, because if the federal

0:23:08.160 --> 0:23:12.200
<v Speaker 1>government is sort of paralyzed by this, the states aren't,

0:23:12.680 --> 0:23:15.080
<v Speaker 1>and and so that that is still out there, at

0:23:15.160 --> 0:23:21.080
<v Speaker 1>least in states that are inclined to regulate aggressively any

0:23:21.080 --> 0:23:25.400
<v Speaker 1>other EPA regulations that that could be on the line here.

0:23:25.880 --> 0:23:27.960
<v Speaker 4>Yeah, so you know again that there's just so many

0:23:28.000 --> 0:23:30.000
<v Speaker 4>out there, and I think, you know, we really have

0:23:30.119 --> 0:23:32.080
<v Speaker 4>to sit back in a way and see the ambit

0:23:32.119 --> 0:23:34.040
<v Speaker 4>of of what this looks like from from what will

0:23:34.040 --> 0:23:36.480
<v Speaker 4>be challenged. And you know, from a historical standpoint too,

0:23:36.520 --> 0:23:38.359
<v Speaker 4>it sounds like all bets are kind of off and

0:23:38.400 --> 0:23:40.919
<v Speaker 4>everything's on the table again here in many ways. So

0:23:41.440 --> 0:23:44.560
<v Speaker 4>I think we really have have some time to before

0:23:44.560 --> 0:23:46.320
<v Speaker 4>we know the full extent to which this is going

0:23:46.359 --> 0:23:48.879
<v Speaker 4>to come into play. But another really recent rule for

0:23:49.000 --> 0:23:51.920
<v Speaker 4>ep that I think is also likely to be affected

0:23:51.920 --> 0:23:54.480
<v Speaker 4>in some ways. Was there the rule on vehicle emissions

0:23:54.480 --> 0:23:58.040
<v Speaker 4>that rolled out also this spring. This was hotly contested.

0:23:58.280 --> 0:24:01.360
<v Speaker 4>There's a lot of rhetoric around this. This many most

0:24:01.400 --> 0:24:03.679
<v Speaker 4>call it a Mandaday would say for two thirds of

0:24:03.680 --> 0:24:05.840
<v Speaker 4>new vehicles sold in the US to be electric in

0:24:05.880 --> 0:24:10.240
<v Speaker 4>some capacity by twenty thirty two. So the EPA used

0:24:10.240 --> 0:24:12.280
<v Speaker 4>the Clean Air Act basically to forward a lot of

0:24:12.520 --> 0:24:16.280
<v Speaker 4>that regulation. The questions arise as to well does a

0:24:16.320 --> 0:24:18.760
<v Speaker 4>cleaningir act really allow the EPA to do things like

0:24:19.400 --> 0:24:21.760
<v Speaker 4>regular tail pipe emissions or are we talking more about

0:24:21.800 --> 0:24:24.439
<v Speaker 4>factory emissions and things of the like. So all of

0:24:24.480 --> 0:24:27.960
<v Speaker 4>that again back on the table. Another big rule that

0:24:28.280 --> 0:24:31.199
<v Speaker 4>has that kind of bifurcated situation on where you've got

0:24:31.240 --> 0:24:34.360
<v Speaker 4>traditional automakers on one side who stand to benefit from

0:24:34.359 --> 0:24:37.040
<v Speaker 4>its demise, but then you've got ev manufacturers on the

0:24:37.080 --> 0:24:40.600
<v Speaker 4>other who also would be troubled if they were to

0:24:40.640 --> 0:24:42.119
<v Speaker 4>fall apart. So there you go.

0:24:42.480 --> 0:24:44.600
<v Speaker 1>That's really helpful, I mean to me, I think all

0:24:44.640 --> 0:24:48.040
<v Speaker 1>of this fits like Elliott's notes referred to earlier about

0:24:48.040 --> 0:24:51.640
<v Speaker 1>how this is a larger trend and really the trend

0:24:51.800 --> 0:24:57.200
<v Speaker 1>all goes in one direction in my view anyway that

0:24:57.440 --> 0:25:01.080
<v Speaker 1>you know, it's just going to be very difficult. This

0:25:01.119 --> 0:25:04.720
<v Speaker 1>decision doesn't really change. It doesn't say agencies always going

0:25:04.760 --> 0:25:07.399
<v Speaker 1>to lose. You know, courts can still look to the

0:25:07.440 --> 0:25:11.880
<v Speaker 1>agencies to be persuaded by them, but the ultimate decision

0:25:11.920 --> 0:25:15.760
<v Speaker 1>maker here is the US Supreme Court on anything significant,

0:25:16.200 --> 0:25:19.160
<v Speaker 1>and that Supreme Court, we know how it has pretty

0:25:19.160 --> 0:25:23.199
<v Speaker 1>strong feelings about overreach of agencies, and I think we

0:25:23.320 --> 0:25:27.040
<v Speaker 1>just keep seeing that in every sector we look to

0:25:27.240 --> 0:25:29.960
<v Speaker 1>but thank you for that, justin that that's a that's

0:25:30.000 --> 0:25:33.280
<v Speaker 1>a nice overview. Last, but not least, Dwayne, I want

0:25:33.280 --> 0:25:35.639
<v Speaker 1>to bring you into this to to touch on the

0:25:35.640 --> 0:25:39.960
<v Speaker 1>healthcare side as we look as we think about healthcare

0:25:40.040 --> 0:25:44.360
<v Speaker 1>policy in this what's the broad theme? Are are there

0:25:44.560 --> 0:25:49.840
<v Speaker 1>pending policy disputes that could see different outcomes after the

0:25:50.200 --> 0:25:51.560
<v Speaker 1>Chevron decision last week?

0:25:51.920 --> 0:25:55.080
<v Speaker 3>Yeah? Thanks, thanks Matt and just some great great to review.

0:25:55.119 --> 0:25:58.399
<v Speaker 3>I think as we look at FDA and CMS, the

0:25:58.480 --> 0:26:02.960
<v Speaker 3>are two agencies that stood and Drug Administration Center for

0:26:03.040 --> 0:26:06.320
<v Speaker 3>Medicare and Medicaid services with oversight of Medicare and Medicaid

0:26:06.359 --> 0:26:12.399
<v Speaker 3>and other health agencies. They've relied on some flexibility, and

0:26:12.480 --> 0:26:15.719
<v Speaker 3>we could see Congress being more clear and more prescriptive

0:26:16.320 --> 0:26:21.840
<v Speaker 3>from a legislation standpoint when new bills are passed will

0:26:21.880 --> 0:26:25.920
<v Speaker 3>open up agencies to legal challenge in terms of their

0:26:26.000 --> 0:26:29.439
<v Speaker 3>regulatory efforts. And I think what we saw and what

0:26:29.480 --> 0:26:34.000
<v Speaker 3>the FD had was some consistency and ft oversight where

0:26:34.640 --> 0:26:38.399
<v Speaker 3>there wouldn't see any second guessing of their decisions, especially

0:26:38.480 --> 0:26:43.080
<v Speaker 3>since many policy decisions are based on complex science. So

0:26:44.680 --> 0:26:48.240
<v Speaker 3>it's worth noting that while the business lobby Chamber of

0:26:48.240 --> 0:26:52.560
<v Speaker 3>Commerce maybe others supported the decision and may have submitted briefs.

0:26:53.119 --> 0:26:55.680
<v Speaker 3>We didn't see that from the trades for the life

0:26:55.680 --> 0:26:59.040
<v Speaker 3>science industry, So I think that's telling of some of

0:26:59.040 --> 0:27:03.720
<v Speaker 3>the flexibilities they see with with fd For f d

0:27:03.800 --> 0:27:09.680
<v Speaker 3>A and CMS, you know some specific examples of where

0:27:09.680 --> 0:27:14.639
<v Speaker 3>there are some pending policy disputes, and we've I've written

0:27:14.680 --> 0:27:16.760
<v Speaker 3>about these before, and I'll go over a couple now.

0:27:17.760 --> 0:27:20.119
<v Speaker 3>The first that comes to mind is the regulation of

0:27:20.359 --> 0:27:25.120
<v Speaker 3>laboratory developed tests. These are a subset of in vitro diagnostics.

0:27:26.000 --> 0:27:29.679
<v Speaker 3>They were designed and made for use in a single

0:27:29.720 --> 0:27:35.640
<v Speaker 3>clinical lab UH. FDA viewed LDTs as low risk UH

0:27:35.880 --> 0:27:39.240
<v Speaker 3>develop it developed for diagnosing a rare disease or for

0:27:39.440 --> 0:27:45.240
<v Speaker 3>use in smaller population. The FDA had exercise enforcement discretion

0:27:45.359 --> 0:27:50.480
<v Speaker 3>over LDTs and didn't require free market review or clearance

0:27:50.560 --> 0:27:54.760
<v Speaker 3>before use. Yet over time, these LDTs become more complex

0:27:54.880 --> 0:27:58.680
<v Speaker 3>and have been marketed nationwide even if the test is

0:27:58.760 --> 0:28:02.280
<v Speaker 3>run in a single lab. The FDA has for the

0:28:02.320 --> 0:28:06.399
<v Speaker 3>past excuse me, for the past several years, tried to

0:28:06.440 --> 0:28:12.160
<v Speaker 3>move in the direction of regulating these LDTs as medical devices.

0:28:12.440 --> 0:28:16.520
<v Speaker 3>There was a guidance in twenty sixteen ultimately got pulled.

0:28:17.560 --> 0:28:23.040
<v Speaker 3>This administration has moved forward with rulemaking and recently finalized

0:28:23.080 --> 0:28:26.440
<v Speaker 3>a rule that would require pre market review and other

0:28:26.640 --> 0:28:30.280
<v Speaker 3>quality system checks for tests that were marketed after the

0:28:30.280 --> 0:28:36.879
<v Speaker 3>final rule. The American Clinical Laboratory Association, which represents the

0:28:37.000 --> 0:28:41.520
<v Speaker 3>lab cores, the quests, and other labs, has sued the

0:28:41.600 --> 0:28:45.600
<v Speaker 3>FDA on grounds that it doesn't have the authority to

0:28:45.640 --> 0:28:49.720
<v Speaker 3>regulate LDTs because they believe their services and they're not

0:28:49.960 --> 0:28:55.400
<v Speaker 3>explicitly spelled out in the statute. In their view, Congress

0:28:55.400 --> 0:28:59.120
<v Speaker 3>would have to give them give the FDA the power

0:28:59.680 --> 0:29:04.600
<v Speaker 3>to regulate them, even though the FDA maintains authority to

0:29:04.640 --> 0:29:08.040
<v Speaker 3>do so. Now, what's interesting is given the timeline for

0:29:08.040 --> 0:29:13.000
<v Speaker 3>implementation with labs have to comply with device reporting beginning

0:29:13.080 --> 0:29:16.560
<v Speaker 3>May twenty twenty five, So are we looking at a

0:29:16.600 --> 0:29:22.640
<v Speaker 3>delay in implementation possible. We know that new administration or

0:29:22.760 --> 0:29:28.000
<v Speaker 3>a Trump administration will probably put the regulation on ice,

0:29:28.040 --> 0:29:30.640
<v Speaker 3>but if it goes the way of the court system,

0:29:31.080 --> 0:29:35.040
<v Speaker 3>it seems like they would view FDA authority here with

0:29:35.160 --> 0:29:38.520
<v Speaker 3>a bit of skepticism. I'd say the next step is,

0:29:38.760 --> 0:29:42.320
<v Speaker 3>if you follow this issue, could we see legislation here

0:29:42.720 --> 0:29:47.080
<v Speaker 3>which spells out FDA authority to regulate these tests and

0:29:47.160 --> 0:29:52.040
<v Speaker 3>what that authority is maybe regulating them separate from medical devices.

0:29:52.360 --> 0:29:56.120
<v Speaker 3>I think that it makes that scenario more likely eventually.

0:29:56.160 --> 0:29:59.160
<v Speaker 3>I don't think it's this year, but that is something

0:29:59.200 --> 0:30:04.080
<v Speaker 3>we could see. Another example is a more recent rule

0:30:04.160 --> 0:30:09.040
<v Speaker 3>on a nurse staffing mandate, which requires nursing homes to

0:30:09.920 --> 0:30:12.680
<v Speaker 3>have a nurse on duty for a certain number of

0:30:12.760 --> 0:30:16.880
<v Speaker 3>hours per day beyond what it's already were already have

0:30:16.960 --> 0:30:21.280
<v Speaker 3>in law right now, and there are some estimates or

0:30:21.320 --> 0:30:24.120
<v Speaker 3>studies that show only about twenty percent of nursing homes

0:30:24.640 --> 0:30:28.840
<v Speaker 3>or nursing facilities would actually be incompliance. So this could

0:30:28.840 --> 0:30:32.000
<v Speaker 3>be another area where CMS may have overstepped its bounds

0:30:32.040 --> 0:30:37.440
<v Speaker 3>in terms of mandating certain number of hours where nurses

0:30:37.480 --> 0:30:40.480
<v Speaker 3>are available. So these are a couple of things to watch,

0:30:40.560 --> 0:30:42.840
<v Speaker 3>and I could probably come up with several more, but

0:30:42.880 --> 0:30:46.160
<v Speaker 3>those are just two since they are very recent rules

0:30:46.160 --> 0:30:49.520
<v Speaker 3>that rely on some kind of flexibility in terms of

0:30:49.560 --> 0:30:53.480
<v Speaker 3>the FBA thinking or thought process of their authority.

0:30:54.640 --> 0:30:56.480
<v Speaker 2>One more I wanted to ask you about Duina.

0:30:56.880 --> 0:31:02.920
<v Speaker 1>The Inflation Reduction Act had drug price negotiation provisions, and

0:31:02.960 --> 0:31:09.520
<v Speaker 1>the drug companies are bringing constitutional cases to tied to

0:31:09.600 --> 0:31:15.400
<v Speaker 1>that do you think there are challenges to administrative action

0:31:15.680 --> 0:31:17.640
<v Speaker 1>in that area that are more likely now.

0:31:18.760 --> 0:31:22.600
<v Speaker 3>It's quite possible, and I think we need to separate

0:31:22.720 --> 0:31:27.040
<v Speaker 3>kind of the constitutional claims that are being made about

0:31:27.040 --> 0:31:31.960
<v Speaker 3>whether Medicare the administration can do this and some of

0:31:32.040 --> 0:31:34.400
<v Speaker 3>the nuts and bolts of how the program is going

0:31:34.440 --> 0:31:38.040
<v Speaker 3>to be implemented defining certain terms, and I think that's

0:31:38.200 --> 0:31:41.640
<v Speaker 3>the piece I'll focus on, And we've focused on this

0:31:41.720 --> 0:31:46.000
<v Speaker 3>in the past, and it's largely because of how the agency,

0:31:46.080 --> 0:31:50.200
<v Speaker 3>the Medical Agency, has defined certain terms in the law too,

0:31:50.240 --> 0:31:54.240
<v Speaker 3>in particular that are very important for drug companies in

0:31:54.320 --> 0:31:58.760
<v Speaker 3>terms of whether they're drugs, these specific therapy that they

0:31:58.840 --> 0:32:03.880
<v Speaker 3>have is subject to negotiated pricing or not. And you

0:32:03.880 --> 0:32:07.400
<v Speaker 3>know whether a generic competitor comes on in the market,

0:32:07.960 --> 0:32:10.720
<v Speaker 3>either preventing their drug from going on the list or

0:32:11.120 --> 0:32:14.640
<v Speaker 3>getting it off the list faster. So there's two things

0:32:14.640 --> 0:32:19.360
<v Speaker 3>we like to focus on that are worth keeping an

0:32:19.360 --> 0:32:22.480
<v Speaker 3>eye on as its process unfolds. One is the term

0:32:22.640 --> 0:32:27.920
<v Speaker 3>single source drug, and then two it's the phrase that

0:32:28.040 --> 0:32:32.560
<v Speaker 3>is not in statute called bonified modified marketing of a

0:32:32.600 --> 0:32:35.960
<v Speaker 3>generic or bi similar as I said, bonified is not

0:32:36.000 --> 0:32:40.360
<v Speaker 3>in the Irish statute and it's a determination of what

0:32:40.640 --> 0:32:45.400
<v Speaker 3>is or when a generic is made available that prevents

0:32:45.880 --> 0:32:50.640
<v Speaker 3>the brand drug from being subject to negotiated pricing. CMS

0:32:50.680 --> 0:32:54.240
<v Speaker 3>came up with that term. It's something where they will

0:32:54.600 --> 0:32:57.840
<v Speaker 3>use it on a case by case basis that weighs

0:32:57.920 --> 0:33:01.960
<v Speaker 3>factors like generic utilization and included in a prescription drug

0:33:02.000 --> 0:33:06.200
<v Speaker 3>event data. Their point being they want serious competition in

0:33:06.240 --> 0:33:08.959
<v Speaker 3>the market to pull a drug off the list as

0:33:09.000 --> 0:33:15.800
<v Speaker 3>opposed to some token or nominal nominal generic marketing. Because

0:33:15.800 --> 0:33:20.040
<v Speaker 3>the statute just basically says marketing of a generic or

0:33:20.080 --> 0:33:26.600
<v Speaker 3>something to that effect, it's very very very loose. The

0:33:26.640 --> 0:33:30.040
<v Speaker 3>agency also defines a single source drug based on its

0:33:30.080 --> 0:33:33.840
<v Speaker 3>active ingredient so that it can multi It can group

0:33:34.600 --> 0:33:40.400
<v Speaker 3>multiple therapies with a different drug or biological license application

0:33:40.720 --> 0:33:47.040
<v Speaker 3>like Nordisk Novologue and biasp as. It's a diabetes drug,

0:33:47.680 --> 0:33:54.320
<v Speaker 3>same ingredient, different NDAs, so theoretically different drugs but same ingredient.

0:33:54.880 --> 0:33:58.440
<v Speaker 3>CMSs argue that the statute directs it to use data

0:33:58.480 --> 0:34:03.200
<v Speaker 3>that's aggregated ross susage, forms, and strength of the drug,

0:34:03.720 --> 0:34:08.239
<v Speaker 3>including new formulations of the drug, and as its basis,

0:34:08.280 --> 0:34:13.840
<v Speaker 3>we're focusing on the actual ingredient or active moiety drug companies,

0:34:14.280 --> 0:34:19.320
<v Speaker 3>no surprise would say that that interpretation oversteps the bounds

0:34:19.360 --> 0:34:25.280
<v Speaker 3>should focus on separate NDAs or blas for negotiation purposes.

0:34:25.360 --> 0:34:27.799
<v Speaker 3>So this is one of those things that could have

0:34:28.200 --> 0:34:32.040
<v Speaker 3>a significant impact down the road on potentially some of

0:34:32.080 --> 0:34:36.960
<v Speaker 3>these infused drugs that maybe moved to a subcutaneous version

0:34:38.160 --> 0:34:41.560
<v Speaker 3>where there's the active ingredient and maybe an inactive ingredient

0:34:41.640 --> 0:34:46.160
<v Speaker 3>that just helps with the absorption absorption of the mate

0:34:46.239 --> 0:34:49.800
<v Speaker 3>ingredient we're seeing go down that route and some others.

0:34:51.400 --> 0:34:54.719
<v Speaker 3>The subkey versions might be near the market but could

0:34:54.760 --> 0:34:59.000
<v Speaker 3>be swept in with older versions for price setting purposes.

0:34:59.040 --> 0:35:02.400
<v Speaker 3>Now these are all in guidance. It's it's worth pointing

0:35:02.400 --> 0:35:06.680
<v Speaker 3>that out. And CMS can basically say from one year

0:35:06.719 --> 0:35:09.719
<v Speaker 3>to the next, because what it does is released new

0:35:09.760 --> 0:35:14.239
<v Speaker 3>guidance for every applicable price year, they can pretty much

0:35:14.320 --> 0:35:17.080
<v Speaker 3>change UH the interpretation of that. And now if it's

0:35:17.080 --> 0:35:21.440
<v Speaker 3>the same administration, maybe we see the same interpretation review

0:35:22.480 --> 0:35:25.120
<v Speaker 3>for the next four years. A new administration might have

0:35:25.160 --> 0:35:27.239
<v Speaker 3>a different interpretation. But this is one of those things

0:35:27.280 --> 0:35:31.520
<v Speaker 3>where you might be able to see UH a challenge

0:35:31.600 --> 0:35:37.279
<v Speaker 3>to this administrative interpretation of pretty important provisions of the IRA.

0:35:39.040 --> 0:35:39.799
<v Speaker 2>Excellent. Uh.

0:35:39.840 --> 0:35:42.719
<v Speaker 1>And and one last question before we we wind up

0:35:43.040 --> 0:35:46.160
<v Speaker 1>Medicare and anything we should think about from a Medicare

0:35:46.320 --> 0:35:50.960
<v Speaker 1>perspective on this and any any response from lawmakers tied

0:35:51.239 --> 0:35:51.680
<v Speaker 1>tied to that.

0:35:51.760 --> 0:35:57.600
<v Speaker 3>Yeah, I think generally speaking, you know, reimbursement decisions are

0:35:57.920 --> 0:36:00.960
<v Speaker 3>or could be in play. You know, one specific area

0:36:01.000 --> 0:36:03.360
<v Speaker 3>I like to focus on it and think about whether

0:36:03.400 --> 0:36:08.520
<v Speaker 3>this is something that might be right for action. Is

0:36:08.760 --> 0:36:14.480
<v Speaker 3>Medicare's coverage with Evidence development process or program where drugs

0:36:14.480 --> 0:36:20.920
<v Speaker 3>are cemester. The agency determines that some a new product, device,

0:36:21.520 --> 0:36:25.600
<v Speaker 3>or therapy it's reasonable and necessary for the Medicare population,

0:36:25.719 --> 0:36:28.480
<v Speaker 3>but maybe there needs to be more evidence in terms

0:36:28.480 --> 0:36:36.240
<v Speaker 3>of how it is applied to the Medicare population. CDs

0:36:36.360 --> 0:36:40.319
<v Speaker 3>not in statue, and it does limit patient access to

0:36:40.520 --> 0:36:45.120
<v Speaker 3>FDA approved items and services. It's again it's up to

0:36:45.239 --> 0:36:48.880
<v Speaker 3>Medicare to determine whether an FDA approved medical device or

0:36:48.960 --> 0:36:52.720
<v Speaker 3>drug is reasonable and necessary for the Medicare population, whereas

0:36:52.800 --> 0:36:56.799
<v Speaker 3>FDA standard is safe and effective. And so as part

0:36:56.800 --> 0:37:01.319
<v Speaker 3>of that mandate, the agency created cd to give that

0:37:01.480 --> 0:37:05.239
<v Speaker 3>access to therapies that might have had insufficient evidence while

0:37:05.280 --> 0:37:09.879
<v Speaker 3>that additional data is collected but that can also mean

0:37:10.160 --> 0:37:13.239
<v Speaker 3>limiting access to a therapy that's a lot narrower than

0:37:13.280 --> 0:37:17.560
<v Speaker 3>the approved label, or other restrictions like participating in a

0:37:17.600 --> 0:37:22.920
<v Speaker 3>clinical trial or a registry. So, you know, this is

0:37:22.960 --> 0:37:26.360
<v Speaker 3>a limitation that people talk about because we've seen with

0:37:26.440 --> 0:37:31.160
<v Speaker 3>some cd s, their CD in perpetuity that never seems

0:37:31.160 --> 0:37:37.560
<v Speaker 3>to end. Now, CMS would point to maybe their authority

0:37:37.640 --> 0:37:40.640
<v Speaker 3>is part of some reading of the statute that's just

0:37:40.760 --> 0:37:45.360
<v Speaker 3>not necessarily explicit in terms of CD but it could

0:37:45.360 --> 0:37:50.200
<v Speaker 3>be open to interpretation again, or maybe the courts would disagree,

0:37:52.080 --> 0:37:53.919
<v Speaker 3>you know, So this is one of those things where

0:37:53.920 --> 0:37:57.480
<v Speaker 3>we could still see challenges. I wonder if this means,

0:37:57.520 --> 0:38:00.040
<v Speaker 3>you know, you asked a question about Medicare, but just

0:38:00.120 --> 0:38:04.200
<v Speaker 3>to touch on FDA, if a lot of what they

0:38:04.280 --> 0:38:08.319
<v Speaker 3>do is now subject to second guessing, does this mean

0:38:08.360 --> 0:38:11.200
<v Speaker 3>they need more staff to focus on a lot of

0:38:11.239 --> 0:38:14.759
<v Speaker 3>these questions of safe and effective or what is or

0:38:14.800 --> 0:38:18.520
<v Speaker 3>is not a breakthrough when certain thresholds up been met.

0:38:19.520 --> 0:38:23.720
<v Speaker 3>Do they need more user fee dollars from the drug industry.

0:38:23.880 --> 0:38:28.120
<v Speaker 3>Now that's there's the User Fee Authorization Act for Medical

0:38:28.120 --> 0:38:35.920
<v Speaker 3>Devices Pharma bi Logics, and that is a way to

0:38:35.960 --> 0:38:39.840
<v Speaker 3>help get industry the regulated industry to help with the

0:38:39.920 --> 0:38:45.279
<v Speaker 3>process of moving the applications through the review process in

0:38:45.320 --> 0:38:48.640
<v Speaker 3>a more timely manner. Do we need more of those

0:38:48.719 --> 0:38:52.320
<v Speaker 3>and does that mean it shows up with the regulated

0:38:52.440 --> 0:38:55.919
<v Speaker 3>entities having to pay more for that process. It's quite

0:38:55.960 --> 0:39:01.400
<v Speaker 3>possible now in terms of Congress, they'll have to write

0:39:01.840 --> 0:39:07.040
<v Speaker 3>laws with greater specific specificity and less less than the

0:39:07.040 --> 0:39:12.520
<v Speaker 3>flexibility for agencies. It's worth noting that one member, Senator Cassidy,

0:39:13.360 --> 0:39:18.319
<v Speaker 3>Republican from Louisiana, he's the ranking member of the Health, Education, Labor,

0:39:18.360 --> 0:39:21.759
<v Speaker 3>and Pensions Committee. As jurisdiction over the the h part

0:39:22.080 --> 0:39:24.560
<v Speaker 3>the health, which is what I focus on. He sent

0:39:24.640 --> 0:39:28.680
<v Speaker 3>a number of letters to various federal agencies asking how

0:39:28.719 --> 0:39:33.520
<v Speaker 3>they would enforce laws as Congress writes them in light

0:39:33.560 --> 0:39:38.200
<v Speaker 3>of the ruling. I'll touch on one of our two

0:39:38.239 --> 0:39:43.160
<v Speaker 3>of them already touched on one. Actually they specific specifically

0:39:43.160 --> 0:39:46.239
<v Speaker 3>calls out whether or not i FT has authority to

0:39:46.600 --> 0:39:51.440
<v Speaker 3>the ld TS. So that's one area. He brings up

0:39:51.520 --> 0:39:55.120
<v Speaker 3>this issue of march and authority and the Biden administration's

0:39:55.960 --> 0:40:01.680
<v Speaker 3>proposal to basically give the or marching authority as a

0:40:01.719 --> 0:40:05.560
<v Speaker 3>whole allows the government to grant patent licenses to other

0:40:05.760 --> 0:40:10.040
<v Speaker 3>parties or to take the licenses for themselves for itself

0:40:10.400 --> 0:40:15.360
<v Speaker 3>and in cases where federal tax dollars helped fund the

0:40:15.440 --> 0:40:18.799
<v Speaker 3>patent owners R and D. So the Biden administration came

0:40:18.880 --> 0:40:21.680
<v Speaker 3>up with this framework that said it could do that

0:40:21.920 --> 0:40:25.200
<v Speaker 3>based on the cost of the drug if there's an

0:40:25.200 --> 0:40:29.480
<v Speaker 3>excessive price. The target has always been as it relates

0:40:29.480 --> 0:40:33.920
<v Speaker 3>to marching on the pharmacide or at least recently ex

0:40:34.000 --> 0:40:40.240
<v Speaker 3>standy a prostate cancer drug. So that framework of incorporating

0:40:40.920 --> 0:40:46.640
<v Speaker 3>prices or a drug price into a decision making process,

0:40:46.640 --> 0:40:50.359
<v Speaker 3>and whether exercise marching is something that Biden administration wants

0:40:50.400 --> 0:40:54.359
<v Speaker 3>to do, the opponents would say, well, that's not what

0:40:55.040 --> 0:40:57.719
<v Speaker 3>is allowed under the law. So that's one of those

0:40:57.760 --> 0:41:02.000
<v Speaker 3>things where we could see the courts less flexible to

0:41:02.080 --> 0:41:06.560
<v Speaker 3>the administracious interpretation. So overall, there's a lot to think

0:41:06.600 --> 0:41:09.080
<v Speaker 3>about in terms of how if G and CMS decision

0:41:09.120 --> 0:41:13.520
<v Speaker 3>making could be slowed or more technly structured moving forward.

0:41:14.760 --> 0:41:15.600
<v Speaker 2>That's really helpful.

0:41:15.640 --> 0:41:18.279
<v Speaker 1>I mean, listening to you guys talk about healthcare policy

0:41:18.320 --> 0:41:23.520
<v Speaker 1>and environmental policy. As a TMT analyst, it really underscores

0:41:23.719 --> 0:41:28.400
<v Speaker 1>how difficult it's going to be for generalist courts to

0:41:28.480 --> 0:41:31.960
<v Speaker 1>take up these questions and really be tasked with deciding

0:41:32.920 --> 0:41:34.960
<v Speaker 1>what is right and what is wrong. And there's really

0:41:35.040 --> 0:41:38.480
<v Speaker 1>inherently still going to be deference on a lot of

0:41:38.480 --> 0:41:42.279
<v Speaker 1>these questions, inevitably just based on the limits of the

0:41:42.320 --> 0:41:45.560
<v Speaker 1>court's expertise. But I think you are going to see

0:41:45.560 --> 0:41:50.880
<v Speaker 1>the courts not feel compelled to defer even on technical

0:41:50.920 --> 0:41:55.040
<v Speaker 1>areas where there's really there's potential disruption to business through

0:41:55.120 --> 0:41:58.040
<v Speaker 1>the regulation, is the way I think about it. So

0:41:58.360 --> 0:42:02.520
<v Speaker 1>a couple questions in the chat that popped up. First

0:42:02.520 --> 0:42:04.920
<v Speaker 1>of all, is the Federal Reserve impacted? I don't know

0:42:04.960 --> 0:42:08.239
<v Speaker 1>the answer to that directly, and i'd want to ask

0:42:08.280 --> 0:42:11.680
<v Speaker 1>Elliott and Elliott Stein who's not here, and Nathan Dean,

0:42:11.800 --> 0:42:15.200
<v Speaker 1>who is on our team as well, So I would

0:42:15.239 --> 0:42:17.640
<v Speaker 1>recommend taking that question up with them.

0:42:17.640 --> 0:42:19.920
<v Speaker 2>On all of these areas, it's really turns on.

0:42:19.920 --> 0:42:23.480
<v Speaker 1>The specifics of the statute in the field and how

0:42:23.560 --> 0:42:29.600
<v Speaker 1>that agency has used Chevron in the past to defend itself,

0:42:29.640 --> 0:42:31.520
<v Speaker 1>and so it's really specific to each So I'm not

0:42:31.560 --> 0:42:33.800
<v Speaker 1>going to try to hazard a guess on the Federal

0:42:33.840 --> 0:42:35.759
<v Speaker 1>Reserve directly, but I think you can reach out to

0:42:35.800 --> 0:42:38.640
<v Speaker 1>those guys. Another question, can you guys address how long

0:42:38.680 --> 0:42:44.040
<v Speaker 1>the challenge two agencies' actions take and just on average

0:42:44.120 --> 0:42:47.400
<v Speaker 1>to gauge the volatility of all of this.

0:42:47.440 --> 0:42:48.759
<v Speaker 2>I don't know if you guys want to weigh in

0:42:48.800 --> 0:42:49.239
<v Speaker 2>on that.

0:42:53.400 --> 0:42:56.279
<v Speaker 3>Good question. I think that's a case by case determination, right.

0:42:56.600 --> 0:43:01.200
<v Speaker 3>I don't think there's going to be one set rule,

0:43:02.000 --> 0:43:08.479
<v Speaker 3>one time frame timeline. It's too early, it's my view.

0:43:08.719 --> 0:43:10.600
<v Speaker 2>Yeah, I can.

0:43:10.760 --> 0:43:13.400
<v Speaker 1>I can add an in my area in you know,

0:43:13.680 --> 0:43:17.920
<v Speaker 1>generally FCC FTCU.

0:43:16.920 --> 0:43:17.840
<v Speaker 2>They make a rule.

0:43:19.160 --> 0:43:21.839
<v Speaker 1>You know, it takes takes the agency nine to twelve

0:43:21.920 --> 0:43:23.000
<v Speaker 1>months to make a rule.

0:43:23.640 --> 0:43:26.440
<v Speaker 2>Then you sue the FCC.

0:43:26.120 --> 0:43:29.799
<v Speaker 1>And the the immediate suit for FCC cases goes to

0:43:29.840 --> 0:43:33.560
<v Speaker 1>a court of appeals, the DC Circuit. Typically that takes

0:43:33.960 --> 0:43:37.480
<v Speaker 1>twelve to fifteen months for that court to decide. Typically,

0:43:37.960 --> 0:43:41.160
<v Speaker 1>then there's one more review above that. You could go

0:43:41.200 --> 0:43:43.759
<v Speaker 1>to the Supreme Court. That takes a year to two

0:43:44.000 --> 0:43:47.279
<v Speaker 1>so the whole process can take three years. Other agencies,

0:43:47.320 --> 0:43:50.120
<v Speaker 1>the challenge can go directly to a district court, so

0:43:50.200 --> 0:43:52.520
<v Speaker 1>below the court of appeal. So that adds an extra

0:43:52.680 --> 0:43:56.359
<v Speaker 1>step in the process. So add an extra year year

0:43:56.360 --> 0:43:59.640
<v Speaker 1>and a half to what I said before. So everything

0:43:59.640 --> 0:44:03.840
<v Speaker 1>about agency rulemaking and the litigation challenging that is slow,

0:44:03.960 --> 0:44:07.760
<v Speaker 1>and that nothing about the Chevron development this week changes

0:44:07.840 --> 0:44:09.480
<v Speaker 1>that agencies still.

0:44:09.280 --> 0:44:11.080
<v Speaker 2>Are going to need to make rules, They're still going

0:44:11.160 --> 0:44:11.920
<v Speaker 2>to be challenged.

0:44:12.200 --> 0:44:14.879
<v Speaker 1>It's just that the courts get to say whether they're

0:44:14.960 --> 0:44:18.480
<v Speaker 1>right or wrong, and there's no binding deference to the

0:44:18.560 --> 0:44:21.920
<v Speaker 1>agency about what it's trying to do. Thank you for

0:44:22.000 --> 0:44:24.719
<v Speaker 1>joining this episode of Votes and Verdicts. If you have

0:44:24.719 --> 0:44:28.719
<v Speaker 1>any questions about this issue or other litigation and policy developments,

0:44:28.760 --> 0:44:32.520
<v Speaker 1>please reach out to me, Matt Schuttenhelm, and please join

0:44:32.600 --> 0:44:35.440
<v Speaker 1>us for future episodes of Votes and Verdicts by Bloomberg

0:44:35.520 --> 0:44:36.160
<v Speaker 1>Intelligence