https://www.youtube.com/watch?v=LtHHWm1PloM
Bruce Quinn MD:
Hi, my name's Dr. Bruce Quinn, and I'm an expert on Medicare policy for new technology. This video is based on an article I wrote a couple weeks ago. You can find the links down below with all the background. Basically, I'm going to argue that the CMS Center for Innovation is based on some principles that the current Supreme Court does not like at all. I'm not an attorney, so I'm discussing this from the perspective of a policy watcher. We're going to talk about three separate things and then bring the conclusions together. The first part is the general structure of the CMMI or CMS Center for Innovation. What rules or lack of rules went into its formation?
Bruce Quinn MD:
The second part is a recent court case where a CMMI drug law regarding drug pricing was thrown out. There were actually three arguments for throwing it out, two of which would've threatened the existence of CMMI. And the third part is the recent Supreme Court ruling on whether OSHA could enforce an Emergency Workplace Vaccination Law. Here, if you look at the combination of recent concurring and descending positions, it triggers some really interesting warnings about the Center for Innovation. So the facts in the argument and video basically cross all the way from Health and Human Services and the Center for Innovation over to the Supreme Court and its current priorities. Sounds like fun. Let's dive in.
Bruce Quinn MD:
The first topic is, what is CMMI and what has it done lately? It's part of CMS and was created by the Affordable Care Act of 2010. It's often called the Innovation Center. It's also the Center for Medicare and Medicaid Innovation. It has the authority to create diverse demo projects, any kind it wants. Early on, they made Pioneer ACOs that were legally a little different than the ACOs created by Congress in the Affordable Care Act. They created an Oncology Care Management program, where oncology clinics got a monthly extra fee to help keep cancer patients out of hospitals. They had a Diabetes Education Project with 3,000 people at YMCAs. All of these had somewhat mixed results. For example, see a new JAMA article on the oncology care model. The program has been rebooted every time a new administration comes to town, taken out to the woodshed and rebooted.
Bruce Quinn MD:
Now, CMMI got feistier as it went along. It started doing mandatory demonstration projects under Obama. And, in 2016, there was some pretty brutal Republican hearings that CMMI was a bad thing. The Obama CMMI also put out a drug pricing rule, but it had to be put down in the Obama lame duck period, rather than leave it for Trump. And then came the Trump era. There were speeches and orders about drug pricing, but the big thing happened after the election was lost. They rapidly brought out a huge, radical CMI program to apply European drug prices in Medicare and quickly. This lost in court within a few weeks, but we'll come back to that in a minute.
Bruce Quinn MD:
So here's the last slide for this section. The CMMI law lets it create demonstration models on any topic it wants, with no limits on content, on scope, or duration. And amazingly, it can waive any existing CMS law, and wait for it, its actions are shielded from judicial review. All of this was treated as self-implementing. There was no additional rule making. But for now, just remember these rules about CMMI.
Bruce Quinn MD:
Now, we'll switch to a second story, how one of its regulations crashed and burned in court. This is the Most Favored Nation Court Case. The Trump administration had executive orders and rose garden speeches about drug prices. And after it lost the election, they quickly brought out an emergency law through the CMMI, which promised to drastically change Medicare drug pricing and peg them to European drug prices. This was emergency rulemaking, so it would take place almost immediately and last nearly a decade. It came out on November 27th, 2020 and was frozen forever by the courts on December 23rd.
Bruce Quinn MD:
Now, there were three arguments for throwing MFN out. First, it was not justified as an emergency role. Second, it exceeded the statute. The statute didn't say how big or how long CMMI projects could be, but this was clearly too big. And to argue that, they looked up the word model in Webster's Dictionary. Third, the lawyers argued that CMMI exceeded what Congress can delegate to an agency. You can't just say, "Here's an agency. It can do anything at all, with no controls, and no judicial review." CMI can't do that. It was a constitutional attack against CMMI by the attorneys.
Bruce Quinn MD:
However, the CMMI can case did not reach statutory issues. There's a legal principle that you resolve a case on the lowest-available legal level. They don't reach complicated statutory or constitutional issues unless they have to. Here, the judge ruled that the MFN regulation was badly justified as an emergency rule that couldn't wait just a couple months like a normal rule. So they never reached the second and third attacks against CMMI. And the judge pointed this out, not once but twice in her footnotes.
Bruce Quinn MD:
Now we're in the third and last section. Now, it's early 2022 and we had two healthcare cases, where OSHA could enforce an emergency workplace vaccine nation law and whether health and human services could enforce an emergency hospital vaccination law. What's interesting is the conservative reasoning in different parts of these cases, which you see here in red, and also some of the underlying briefs and decisions in the OSHA case. Let's focus just on the Gorsuch concurrence on the OSHA case. He says, "Congress must speak clearly when it assigns agency powers. The lawmaking must be where article one puts it in Congress." There's a non-delegation doctrine, and Gorsuch goes on for several pages. He says, "Congress has limited powers to make laws and must make them one at a time and publicly. Congress can't delegate unlimited powers to an agency." So here's where we land. CMMI has, on paper, unlimited at authorities, no written legal constraints on its scope or content, but the Gorsuch court wants the federal government to be constrained, whether federal government means Congress or the agencies created by Congress. So I think if a case against CMMI goes to the Supreme Court and these broad authorities of CMMI were being directly attacked, CMMI would find itself in a very unfriendly environment. We'll all see what happens next. Thanks for listening.
