The primary focus of CHIME’s Public Policy Program is to advance the role of CIOs and other senior healthcare IT leaders by providing educational, collaborative, and advocacy programs to improve the quality of care. Through our CHIME Policy Chats, we hope to inform CIOs about advocacy efforts and learning opportunities; provide updates on legislative and regulatory issues; and educate them on what CHIME is doing to help shape the implementation of federal and state policies. The discussions feature Sharon Canner, senior director of advocacy, and Jeff Smith, assistant director of advocacy for CHIME.
Chapter 2
- Extending Stage 2 — “It wasn’t going to be feasible”
- Learning from healthcare.gov
- Working with the “data-driven” feds
- DeSalvo’s lengthy to-do list
- FDA health IT regulation debate — “This is very bleeding-edge policy”
- Call to action for CIOs
LISTEN NOW USING THE PLAYER BELOW OR CLICK HERE TO SUBSCRIBE TO OUR iTUNES PODCAST FEED
Podcast: Play in new window | Download (Duration: 14:16 — 6.5MB)
Subscribe: Apple Podcasts | Google Podcasts | Spotify | Android | Pandora | iHeartRadio | Podchaser | Podcast Index | Email | TuneIn | RSS
Bold Statements
We still have a hard time convincing federal officials that the degree of folks struggling with Stage 2 is as high as we say it is.
It’s a matter of certainty — give me a date so I can plan. You cannot turn a hospital around on a dime.
A lot of what’s been driving activity at ONC is starting to come to a close, and yet they still have a tremendous amount of work to do in the standards arena.
It’s really interesting to see the conversation both in congress and at the agency level trying to figure out what is the safety role of health IT, and from that, who is best positioned to regulate some of this.
There are factions that want the FDA to have more defined and even tighter control over health IT, and then there are others who would rather have a self-regulatory regime. And as to which side is going to ultimately win out, it’s not at all clear.
Smith: Just to keep on the Meaningful Use path, talking about Stage 3, generally speaking we were very supportive and happy to hear that they’re not going to begin Stage 3 until 2017. Looking at ONC’s self-professed 18-month cycle, they would have to adapt final regulations in April of this year for Stage 3, and that’s just not possible. It wasn’t going to be feasible, and I think that at least for a while CMS has been telegraphing this kind of move. So we were happy to see that.
But we also want to try and make sure this gives us a real opportunity to look at what is in Stage 3. Right now, if you were to listen in on one of the Meaningful Use work group meetings you would hear a couple of different things going on. One of them is, I think, a negative, and that is they’re still thinking in processed measured dimensions, for instance, with the core and measure type things that we’ve seen in Stage 1 and Stage 2. One thing that we’re hopeful is that in this extra time over the next six to nine months, we’ll have an opportunity to focus more on a concept that has been getting a little bit more attention in deeming. Essentially what deeming would do is try and understand outcome measures that just wouldn’t be possible without technology. And so I do think that that will be something to follow in the coming months. Any questions on the Meaningful Use front, Kate?
Gamble: Obviously what you guys touched on with the announcement about the extension of Stage 2 and delay of Stage 3, certainly that did cause a lot of confusion. I think one of the issues we’ve heard in talking with CIOs is that they’re just not sure when they’re going to see something extended or delayed. We did have the ICD-10 extension a few years ago, and that’s something that seemed to make sense, but do you get concerned that if ICD-10 were to be pushed back again, we could see the same issue where it gets put on the backburner and is not really a focus because there are so many other things going on?
Smith: We’ve had a lot of conversations with officials at CMS, and one thing that gets repeatedly is that the deadline for ICD-10 is not moving.
Gamble: Right.
Smith: That being said, I do think the administration is smart enough that if they saw a colossal problem coming, especially given recent experiences with healthcare.gov, they may be amenable to some kind of flexibility. What we’ve been trying to say is that flexibility would be much easier to provide on the Meaningful Use front than on the ICD-10 front, and to a certain degree, I think they agree with that notion.
But we still have a hard time convincing federal officials that the degree of folks struggling with Stage 2 is as high as we say it is. They’re a very data driven group of people, and unfortunately, with Meaningful Use it’s one of those situations where you just might not know until it’s too late. If we come strolling into July 1and we have a really small fraction of hospitals who’ve attested thus far, and they’re just banking on the fact that everybody’s going to come in at the last minute, that, to me, is a pretty poor strategy. Trying to give them the data that they need, which is kind of the canary in the coal mine is really the challenge that we’re faced with right now.
Gamble: That’s a scary scenario what you talked about with counting on all these organizations to come in at the last minute, because we know that there are CIOs and leaders who are trying to meet this deadline, but even now have no idea if they’re going to be able to get there because of all the compounding factors.
Smith: Exactly.
Canner: It’s a matter of certainty — give me a date so I can plan. You cannot turn a hospital around on a dime. There’s the staff and just a lot of other considerations. And you’re providing patient care while you’re trying to change systems and comply with rules, so you get frazzled.
Smith: We’re all very kind of nervously moving forward every day, and of course, on CHIME’s behalf, we are trying to gather information and experiences from the field. So if there are listeners out there who have attested to Stage 1 already because the first window of opportunity was January 1, please let me know.
Gamble: That’s good to know. As far as the ONC, the new national coordinator for health IT was recently named — Karen DeSalvo — and I know that CHIME issued a brief statement, but have you had any contact with Dr. DeSalvo yet?
Smith: As of now, we have not. I know that we see the appointment of Dr. DeSalvo as a very positive thing, and I think that her background speaks well to the types of initiatives that health IT can bring to bear moving forward with Accountable Care and population-based health. But I also think this is a very challenging time for the organization as several grant programs begin to sunset this year, including the REC program, the HIE program, and Beacon communities. A lot of what’s been driving activity at ONC is starting to come to a close, and yet they still have a tremendous amount of work to do in the standards arena, which is really the core focus of ONC, at least conceptually. So I do think that she’s going to bring a certain vitality to the office, and I’m hoping that she’ll bring a certain degree of focus as well.
Gamble: It’s quite an undertaking coming to the position at this point.
Smith: The last big thing that we wanted to highlight for everybody — and this might be one of the bigger stories of the year, but it might also take more than a few years for people to figure it out — and that is the growing debate over how or even whether the FDA should regulate health IT. Right now we’re seeing increasing convergence of technology in the health space; for example, mobile apps that tie together data coming from a medical device or EHR modules that incorporate pathways toward radiological images. It’s really interesting to see the conversation both in congress and at the agency level trying to figure out what is the safety role of health IT, and from that, who is best positioned to regulate some of this.
A couple of things we’re looking at is in February, the Food and Drug Administration, ONC, and the Federal Communications Commission are due to unveil a report. Officials at ONC and FDA are saying that this is going to be available for public comment and that’s supposed to be coming in February, so we’ll be looking forward to seeing that.
Then there are also a couple of other voices in the conversation. One of them is congress. There’s a bill called the Software Act which would more or less dictate how far the FDA could go into regulating health IT. And then of course you’ve got industry groups. A couple that are leading the conversation are the mHealth Regulatory Coalition and then of course the Bipartisan Policy Center, which CHIME was a participant on those conversations. I do think that right now a lot of CIOs can at least rest easy for the time being in the sense that I don’t think they’re going to be in danger of coming under any kind of new regulatory regime. This is something that the vendor community is acutely interested in, but as with most things health IT, what affects the vendors will ultimately affect the providers. So it’s a conversation that will be developing over the course of the year for sure.
Gamble: That’s going to be really interesting to see how that unfolds. Just hearing about that will certainly make a lot of ears perk up because people are really not sure what direction it’s going to go in and how involved it might be.
Smith: This is very bleeding-edge policy because right now there are factions that want the FDA to have more defined and even tighter control over health IT, and then there are others who would rather have a self-regulatory regime. And as to which side is going to ultimately win out, it’s not at all clear, but it will be something interesting for the real policy wonks to watch.
Gamble: Definitely.
Smith: For everybody else, though, their eyes will just glaze over, right?
Gamble: Maybe for now, but once these reports start coming out, I think that you’ll see interest peak.
Smith: That’s true.
Gamble: Okay, so why don’t you give our readers and listeners a quick reminder of the best way to get involved, because like you said, now more than ever you’re really looking for input and all kinds of information from CIOs as you’re constantly in touch with government officials. So what’s the best way to get in touch with you guys or to just keep abreast of what you’re doing?
Canner: Certainly the CHIME website is updated regularly with all our regulatory comments. Our emails are [email protected] and [email protected]. Particularly as CHIME develops comments responding to various different proposed rules, we very much encourage our members to provide a lot of input. I think the important thing is that when CHIME puts up comments it really does reflect what is happening in the actual healthcare setting. It’s that important flavor of is this a workable rule or is this not workable.
We really very much encourage our members to get in touch with us. We ask for volunteers from the CHIME membership and for all the readers who follow the CHIME CIOs. Again, the website really provides a pretty good wealth of information on that, and we would love to hear from your readers and listeners. I appreciate what you do, Kate, in trying to key up some of these questions and to frame this regular dialogue which you put together. We really appreciate your doing that.
Gamble: Sure, and I appreciate you guys taking the time to speak. Thanks for giving us a roundup this big year we have ahead of us.
Smith: Very big indeed.
Gamble: Thanks again, and I hope to speak to you guys soon — possibly next month, when we’ll have more to discuss.
Smith: Indeed. All right, thanks, Kate.
Canner: Happy New Year.
Gamble: Thank you, you too.
Share Your Thoughts
You must be logged in to post a comment.