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Today on This Week Health.

(Intro)   this is what I call a legacy issue. It's tied to equity. It's tied to transparency. These are tied to several executive orders. It is AI, a lot of it, and this is basically the next era, Bill. We had meaningful use and now we have the HCI 1 era.

  Welcome to Newsday A this week Health Newsroom Show. My name is Bill Russell. I'm a former C I O for a 16 hospital system and creator of this week health, A set of channels dedicated to keeping health IT staff current and engaged. For five years we've been making podcasts that amplify great thinking to propel healthcare forward.

Special thanks to our Newsday show partners and we have a lot of 'em this year, which I am really excited about. Cedar Sinai Accelerator. Clearsense, CrowdStrike,. Digital scientists, Optimum Healthcare IT, Pure Storage, SureTest, Tausight,, Lumeon and VMware. We appreciate them investing in our mission to develop the next generation of health leaders.

Now onto the show.

(Main)   hey, it's Newsday, and we are joined by Mari Savickis, the head of government relations for CHIME. Mari, it's always great to have you on the show. It's little bit.

Yeah.

Thanks, Bill. It's nice to see you again. I think the last time I was unofficially on your show was at VIBE last year.

Yeah. it's too long. My gosh, the pace of things that are happening in the government right now are pretty extensive and even the response to some of the things.

TEFCA Finally went in, we have some blocking stuff that's taking shape, and there's there's some back and forth on that as well, medical device, there's security, there's AI, my gosh, there's, there Is there anything that the government isn't trying to weigh in on right now?

There's just a lot going on

There is a lot. That's a fair assessment

So have a couple articles we can work from ONC info blocking disincentives are excessive says the American Hospital Association and Essentially what they're saying the AHA believes that the disincentives which includes significant reduction to nearly market based updates for inpatient prospective payment system hospitals and reimbursements

If there's cuts to that for critical access hospitals that they believe those penalties could threaten the financial viability of some of the smaller rural hospitals. AHA suggests using existing practices such as those for enforcing HIPAA violations and whatnot. This is finally, the 21st Century Cures has finally taken shape.

The incentives, disincentives have finally taken shape. And now we have the normal back and forth of, hey this might be a little too much. This is pretty much the normal flow of the process, isn't it?

yes I think that it's a proposed rule, right? We also weighed in extensively, and we do agree this is a fairly aggressive approach that they're taking.

I like to go back to the way, and if we could go back, always bring us back in the policy time machine. Remember HIPAA, that little thing? Yeah. That was fairly seismic then when that was. Implemented across the sector and I can remember because I worked at CMS when this happened.

The, all the calls that we were fielding oh, I'm going to quit, the practice of medicine and so on and so forth. And so now we're in the information blocking era. and if you look at the way that the government has actually approached HIPAA, I'm hoping but it is really hard to have to take a look at some of these policies when they come out.

But they would look at the most egregious actors, right? So in HIPAA, they don't go after. Just anyone, right? But there are fines. And there are penalties for non compliance, but the 1st thing that happens out of the gate when an investigation is initiated is they try to bring the covered entity into compliance.

I'm hoping that they will take a like minded approach because the resources of the government are not endless. That being said, they did come out, I'd say, swinging a little bit on this one, and the penalties are very extreme should you find yourself in a situation of being deemed a blocker but they're proposed, and we're, I think, in agreement with several things the AHA has said, and we like to focus on education going after the most egregious examples.

Not just like any information blocking assertion. They really should go after very egregious situations. They also need to implement an appeals process that's consistent. The way that they've approached this is to say, Hey, listen, whatever government agency we're dealing with, in this case, it's going to be mostly CMS because that's where the hammer is.

We're going to lean on the appeals process for that program that we think you violated. And so it doesn't implement a consistent appeals process across the board. And so we feel that, and I would be surprised if the AHA didn't agree with this, they need to have a consistent appeals process that every provider and every covered age should be able to avail themselves to.

So I'll just pause there. This is a lot to unpack. I have the penalty I can just read them off for those of your listeners who might be curious what would happen should you actually be deemed an information blocker and found guilty of an information blocking crime for the hospital?

The median penalty, as estimated by the federal government, is 394, 353. Okay, but it can go up into the millions. And I think that probably, my experience with government estimates is they're usually low. I think, advice out there for those who might be a little bit nervous about this just do the right thing and document.

If you're trying hard and you're trying to meet the spirit of the law, I think you're going to be in a much better position. So yeah, let me just stop there.

Yeah, it's it's interesting. Are we talking predominantly about the EHR data? Are we talking about all forms of data within the health system?

Okay, so you have to look at the definition of EHI. And since we, CHIME sits in the provider seat, we will look at the definition of an actor, okay? can send you a cheat sheet on this. It's extensive. So it goes well beyond who For example, has to comply with other pieces of Medicare statute.

The way that they're starting is they're going after those who, in meaningful use LTPAC providers would not be initially, which is great because they didn't get money for EHRs, right? So that's a good situation. But yeah the, but the scope is anyone who's really, who's deemed a provider actor.

Under the definition, which I don't have in front of you, but it's long and lengthy. And then again, this is the toe in the water. So this would be the first quote, unquote, lever. They use the word lever in Washington that they can pull. And so they're looking at where they can go after what levers can they pull and they've Pulled out a few here.

Yeah. A HA is weighing in here. CHIME has weighed in here. this is, I say it's the normal process because, HIPAA is, my gosh, how old is HIPAA now? I can't even do the math.

1996 was when it was signed into law, but then there's been a cascading array of regulations that went after that.

And it's taken shape over time. And what you're saying now is, hey. The way this is being enforced, the way they're going after this makes a lot more sense. But that's after probably a lot of this back and forth of hey, this isn't right, this isn't right. and it requires things like QIIME stepping up and AHA stepping up those kind of things.

But I suspect given the people that are on the government side trying to do the right thing, they're going to take the feedback, they're going to adjust it. And we're going to continue this machination until we get to something that's closer.

And we go after those who are egregiously, in violation. That's really what this is about. It is not about those actors who are legitimately trying, but maybe underfunded. Under resourced and those kinds of things. It's really going after those people who are, essentially doing the Heisman to this law.

I I that's what I'm getting from you. Is that close?

if you read it to the letter it's not the law, but the letter of what they're saying in the rule, they have opened the door very wide in terms of, for example, they've defined intent. If you have an intent, this is a complicated legal structure that again, we ask them to go after egregious cases, not where you have suspicions and insinuendos, it's just, we want them to be a little bit more myopic in their focus, but even putting that aside, we want them to do education first.

There's still so many pieces of information blocking, and we try to impart this in our comment letter that are still misunderstood and confusing, right? There's exception process. Those are still fairly confusing, some of them, right? There's this confusion around what is in your designated record set.

So I think the first thing out of the gate to do is to really use a glide path, an on ramp to education before you start right out of the gate making an example out of someone. And again, just to go, and if that glide path is, been exceeded, then We'd like to see them go after, like when someone's leaving PHR in the dumpster kind of example, you know what I'm saying?

Like in the back, like that's an egregious, leaving all the doors unlocked, metaphorical. So it can't just be someone who's trying really hard and maybe slipped off, I would be surprised if that's how they went after things.

it'll interesting.

Clearly you have to write a law to be as clear as possible. And then there's the enforcement of that law and how that sort of takes shape moving forward which will be interesting. I do want to hit on cybersecurity with you. This is obviously a very significant topic.

At the federal and state level for that matter. We have the New York state law, which is moving through, which it looks a little bit like MU for cybersecurity. There's actually funding associated with it. That's interesting. We have FDA and cease a updates their agreement to address medical devices.

We have the FTC proposing amendments to strengthen and modernize. The Health Data Breach Notification Rule. There's just a lot going on in this space. What, as a health system, as a health system provider, what are some of the key things that we should be focused in on right now that the government's working on with regard to security?

There's one thing I want to bring to folks attention, because I feel like this is not on everyone's radar, is in December, and this is also after a long sort of ramp up period I guess most of 2023, is the HHS made an announcement. It was a six page document, but it was enough to get everyone, thinking and and if, again, if readers or watchers haven't seen this, we can share the link with you, Bill.

There are big plans at HHS on cyber. There will be some mandates coming. The thing that we're looking for right out of the gate are what we're called performance goals. So those may come this month. They were supposed to come last month. I think they're going to come this month. It's going to give us a greater indication as to what hospitals are going to be required to have to meet in terms of cyber mandates.

There's several things in here, too, that they're going to be doing, not just on the goals, but we're going to see them reopen the HIPAA security rule. These are things, these are outlined. I just wanted to read a little quote, if it's okay. I pulled this out from the document. Okay, so HHS says, funding and voluntary goals alone will not drive cyber related behavioral change needed across the healthcare sector.

Given the increased risk profile of hospitals. HHS aspires to have all hospitals meeting sector specific CPGs, those are those goals I just referenced, in the coming years. With additional authorities and resources, HHS will propose incorporation of HHS CPGs, aka goals, mandates, into existing regulations and programs that will inform the creation of new enforceable cybersecurity standards.

Said another way, the mandates are coming, and even though in this document that they referenced, they're going to ask Congress for more money, you and I both know that it's a really difficult climate, so I'm not sure where they expect to find these additional resources, so these are all things that should be on every CIO and CISO's radar.

one thing to put mandates on, it's another thing to not fund them and go back to the hospitals. Obviously, if you're, Northwell or Common Spirit or whatever, you have some resources to throw at this, but if you are, a rural health system or those kinds of things.

It's not like there's money sitting around for additional mandates to be met. What I'm sure that's understood on the Hill. I'm sure that's understood at HHS, but there's also this just demand. this cyber war that's going on right now. And I think this is going to be an interesting push pull of hey here are the new requirements.

And I could just look at you and go, we don't have the resources, we don't have the talent, we don't have the resources, we don't have the money to do these things. how are we going to communicate that back in a way that grabs the Hill's attention.

That, hey, throwing out these mandates may not have the desired effect you want.

So you raise an excellent point. And throughout all of our communique with the federal government, with Congress, we've repeatedly asked for support for what we call the smalls. So those who are small, under resourced it could be rural, urban, they're already digging deep to try to get clinicians to show up for work with their workforce issues.

anD so it is a really a big push and pull, so we've constantly reinforced that message, and I think that HHS has heard that, which is why in that messaging document that I referenced, which I'll get the link for you, that they mentioned they're going to ask Congress for more assistance, but I guess , we're on edge, a little bit on the edge of our seat waiting to see what they come out with, because if there are any hard and fast minutes, for example, around say, conditions of participation, which is what we would call the nuclear option you don't want to dangle the threat of removing reimbursement from a provider, especially a cash strapped provider.

To be determined I think we, at least from CHIME's position, we agree that we need to do more in terms of fortifying our sector, and we do agree it is a shared responsibility, but we do also have a collective obligation to bring all those small and under resourced providers. forward with the greatest amount of help possible.

And so we continue to advocate for additional resources on the Hill, additional resources for HHS to support our sector. And then one final point, too, is as you balance the panoply of mandates that are coming, just going back to the previous one we just referenced, so if you were deemed, say, an information blocker, and if you don't meet the requirement, you could have your meaningful use money stripped away, which, of course, results in a negative penalty to the provider.

So how do you balance all of these? Pieces, and I hope, and we will continue to impart this to federal policy and lawmakers. We hope they're taking this into account.

one of the things I used to have to educate the organization on, they're like, hey, why can't we get to more projects in IT?

I'm like because 15, 15 percent to 20 percent of our resources every year go to regulatory projects. It's just, There's no discussion about it. There's no whatever. It's as a health system, because it's a highly regulated environment, we have to allocate these resources to these projects 20%.

That's a significant amount of an IT budget that's focused in on, hey, making sure, we used to be meaningful use and whatnot. But now it's, you say, this, It's host information blocking it's participation with Tefca and those kinds of requirements, it's obviously information sharing, but it's also the cyber security requirements.

that's a significant burden. I guess the question I would ask you is, do you expect to see more? state involvement with regard to cyber security, like we're seeing in the state of New York. Do you think that's going to be a trend that we see going into next year?

So

absolutely think there's going to be more state And we don't do state based advocacy, it's hard to not be aware of in the periphery, some of the bills that are moving around Like the cyber mandates coming out in New York. So when they see a lack of movements, for example, on this, the federal level, the states take action.

We've seen this with privacy. We've actually even seen some of this with interoperability. And again, I'm sure I don't have a full eyes on all of the state activity, but, I know that there's a law in California that has some. Interoperability pieces to it, is pretty big.

There's a bill, I'm not sure if it's a law yet, in Utah. So they are starting to act and put extra requirements on, or moving first before the federal government does. So I absolutely think that is going to happen, and we'll see more of that.

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  We're in an election year. I'm not going to ask you to weigh in on the politics of it, but I did see an article that said that health care will not be as much of an issue in this year's federal election. And I was surprised at that. They said, this will be like a fourth or fifth priority. I was surprised at that. And then I started thinking about it.

I'm like, hey, with the various wars that are going on around the world with the. Border challenges with a bunch. I started to see how healthcare could get pushed back. In the priority, do you feel like it's not gonna have as much of a front and center as it's had in previous election cycles?

I think elements of it will continue to rear their head. we say in the healthcare technology and digital health space, so I'm sure you can think about some of the things are going on that are that are trigger issues. But I always think that healthcare is it is a voter issue because everyone is a patient, right?

We're all patients, and it hits close to home. There's, I think there's been a lot that's happened around race transparency, something that we don't get too involved with in CHIME social determinants of health. there are pieces I think that will anything that affects someone's pocketbook at home is a voter issue.

So I don't know if it's going to be like the top issue I wouldn't say that, but I certainly think it's it's going to continue to be in the back of people's minds. Like the economy still is not perfect, right? Just, there's the pressure, you can see it at the hospitals. So workforce, so I always think even though we don't advocate directly in workforce, it has a spillover effect into everything.

So that means, the economic condition of an American family often involves your spend on health care.

Absolutely. Still the leading cause of bankruptcies in the United States is medical bankruptcy. I'm surprised that there is no health care candidate right now. There's like nobody who's like running on health care.

but it's, with the financial aspects of it, I think are pretty interesting. The amount of GDP it continues to take is pretty interesting. But I think sometimes when we get into healthcare conversation to the individual, they're just like, I don't understand. You're deeply involved in it.

And there's probably some things that you just scratch your head from time to time and go. This is confusing. I know that when It came up to me

every day in Washington, Bell, where I was like, what

are we doing today? you imagine that trying to take that conversation and take it down to a voter level issue and have conversations.

I imagine if they're in Iowa, in some diner somewhere, somebody's going to say, hey, I have these issues with healthcare and there's going to be a conversation. , as I read that article, I thought it's a shame if we go through this cycle and don't escalate some of these issues and get them front and center a little bit, but, it's the American public, it's what's top of mind for them, so it'll be interesting.

You

know, I don't know if this is going to necessarily rear its head in this manner, but, you can't have a conversation anywhere it seems today in our era, our little bubble here, without talking about AI. Bye. And so when you would think how would that affect, say, a patient and, maybe they had a claim denied, I can see these things like bubbling up a little bit, but AI is here to stay.

And it's going to permeate every orifice of our lives, including healthcare. So I think that could bubble up a little bit more. I haven't given it too much thought in terms of the direct impact of a patient. In the election year, but I do see that in the background.

it is interesting.

We just saw, major gosh, what was was it a mandate because it wasn't a law, it wasn't a proposed law. It was just a it was a an HCI one. Yeah. Yeah. What category is that in?

that would fall into the category of both interoperability and ai.

For again, for those CIOs not yet out there who haven't heard of HCI 1, you can add this to your new lexicon. So this is a new rule. It's finalized and we're still unpacking it over here.

this is a rule that's attached to what, 21st century cures or is it just out on its

own? If you read the I'll cut to the chase.

this is what I call a legacy issue. It's tied to equity. It's tied to transparency. These are tied to several executive orders. This is but it is AI, a lot of it, and so they're revamping the certification for certified EHRs to embed they're ripping up the clinical decision support measure and tearing that apart, and it's going to be far more expansive, so that's essentially what the rule is about.

Without getting into, we can go into the weeds a little bit more with that. There's a lot in here where there'll be fact sheets, there'll be education sessions. This is basically the next era, Bill. We had meaningful use and now we have the HCI 1 era. If that makes sense. It's that big.

No, it makes perfect sense.

we didn't do a final tally, but the amount of times we talked about AI last year on the show was pretty extensive almost like 20 to 50 times the amount that we talked about it the year prior. Clearly it came into the consciousness last year and there isn't a CIO I talked to today that doesn't have AI initiatives as part of their objectives for this year, either integrating it into the patient experience, the administrative experience even integrating it into the back office call center.

as you said, it's just permeating every aspect of healthcare. And

What's interesting too is that, sometimes when I think when a lot of people think about AI, you're thinking about like the whiz bang, the generative rate, call bleeding edge soft, but most of our members are not yet there, right?

they're still using it. And I pulled out a data point from our most wired survey, and. They are using AI, right? It may not be the generative, though. And they're using a lot of it for things like workflow. So I think that whenever you can bring a solution to the market that's gonna improve workforce efficiency, whether it's clinical or administrative, you are gonna have a winning solution.

Because that's where middle of the pack is right now. Yeah, certainly they're looking to the bleeding edge folks to see what they're doing. I have one member who's spending, I think, like 600, 000 a month on the generative stuff, and most providers can't afford that. It's really in the center where, how can they improve their use of analytics?

That, those I think are, anything you can do to improve the efficiency of healthcare, honestly, is going to allow you to free up those dollars you just referenced, that budget that's so finite, so that you can do other things. Yeah,

Oddly enough, some of the most sophisticated stuff is the things that's the most prevalent is computer vision.

if you go into radiology, cardiology and whatnot, we have a body of knowledge. We have very definitive reads and that was very easy, not easy, but it was easier to train the models. And so we have very sophisticated models around imaging. We have computer vision now showing up in cameras, in rooms and that kinda stuff because it's a very definitive data set, right?

The picture is the picture period. Whereas a lot of our other stuff, we're still in that training mode. We still have to figure out how to get the medical record in a form that generative AI can produce a note or produce a message back to a patient and that kinda stuff.

There's still a lot of work to do there, you said, and I looked at Gartner's hype cycle on this. There was like 52 different variations of AI and we focus in on ChatGPT and BARD and that kind of stuff because it's so prevalent right now. But there's a whole bunch of it that's already through the TROFA disillusionment and working its way into.

Very sophisticated models. those are as I just interviewed John Lomka and as he always points out on a call with him, he's we've been doing AI for 20 years, like this is, That's

exactly right. And this new rule I just, I'll pull that for you. It's so it's decision support intervention.

This has pretty. far ranging consequences, DSI is technology that supports decision making based on algorithms.

or models that derive relationships from training data, then produce an output that results in prediction, classification, recommendation, evaluation, or analysis. That's pretty big and broad. So this again, this rule is, has a lot of pieces to it. And I think the provider community is going to spend a better year trying to get their arms around this because the vendors have to deliver an upgraded solution by the end of 2024.

And then it has to be available to the providers. January 1st, 2025, which sounds like tomorrow in my book. By my estimation, it's far too quick.

yeah, I just interviewed Mickey Tripathi as well. And it's interesting when having lived through some of this stuff, when the government sets these guidelines and they say 2025 or 2026, it seems like it's so far away.

Until it's not, and then all of a sudden you're like, wow all these things are upon us. AI is already upon us. The cybersecurity war is already upon us. Information sharing. will say this and after talking to Mickey and others, I'm actually pretty excited about the progress we're making.

I'm seeing really interesting things come out of the health systems, in terms of transparency, in terms of data sharing, It's what we envision for meaningful use. is now starting to provide benefits to patients and to clinicians and whatnot. Directionally, I think, the last 10 years of these rules and these laws and directions have really guided us pretty well in a direction.

And yes, it's been challenging. It's been expensive. It's been difficult. And there's been some hits and misses. But I like some of the things that I'm hearing from health systems that they're able to do now with these certified medical records and data sharing platforms and other things.

I, again I'm optimistic of where all of this is headed. Yeah,

there is cause for a lot of optimism. And, if we look back to when we started this journey in the early 2000s with The ONC being created and in only a few hospitals really even having EHRs, we've come a really long way.

I think the challenge will be, and this presents an ongoing challenge to you know, The federal government is to make sure that we're not having regulations that are superfluous, right? Not creating regulations that you invest money and then you decide that you're going to pull them back because they're not really workable.

If we can just maybe course correct in some of those pieces, we'll have greater efficiency. We'll have more money to invest in the things that are going to deliver the right ROI. I'm generally an optimist, but it is hard sometimes in Washington, D. C. I'm optimistic, pal. I'm trying.

Mari, it's great to have you on the show.

And I look forward to seeing you. The VIVE event is

right around the corner. It's like in February. Yeah, right around will blink and we'll be in Los Angeles. I probably will see you very shortly and look forward to maybe another impromptu touch base on site and let us know if we can do anything for you.

Absolutely.

  📍 And that is the news. If I were a CIO today, I think what I would do is I'd have every team member listening to a show just like this one, and trying to have conversations with them after the show about what they've learned.

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