Meaningful use regs out

Greenbeard

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Jun 20, 2010
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A bit of important health care news today but first some background: When the stimulus bill passed last year, tucked within it was a bill called the HITECH Act. The HITECH Act's goal was ambitious: to lay down the infrastructure for a 21st century health care system by investing heavily in health information technology (HIT) and health information exchange (HIE), i.e. the electronic movement of health records between institutions.

Two agencies within the Department of Health and Human Services are in charge of administering the programs to make that happen. One, created by an executive order from George W. Bush a few years ago and brought into permanent existence by HITECH, is the Office of the National Coordinator for HIT. The other is the Centers for Medicare and Medicaid Services, which just got its first permanent head in four years yesterday after Don Berwick was recess appointed to the position.

ONC was given about $2 billion to spend and they've used it to develop a series of HIT capacity-building programs. The largest of those program involves them working with states (every state) to start laying down an HIE infrastructure, particularly by putting together the governing bodies, financial engines, legal frameworks, etc that are needed to make a project like this work. The rest of the money is going toward HIT workforce development programs, grants to universities for R&D on specific topics, and money to help certain existing organizations become "regional extension centers" that will assist health care providers in building their own HIT capacity.

CMS, on the other hand, has more money to work with but less to do with it. It was directed by the law to make bonus payments to Medicare and Medicaid doctors and hospitals who implement HIT and start exchanging data. The catch, of course, is that you can't just haphazardly throw this money out there through these programs. A hospital that implements a new system of electronic health records but doesn't use them to do anything useful isn't helping anyone, it's just wasting money on a new toy. Thus the legislation requires that payments be made for "meaningful use" of electronic health records. The concept of meaningful use binds all of these programs, it's the end goal of all of them.

The exact definition of what "meaningful use" of EHRs is has gone through a review process (a proposed rule came out of HHS in late December, followed by a 2-month comment period where interested parties offered their input on the proposed rule) and today the final rule came out. If you want a quick look at what the rules entail, you can read an overview from the head of ONC.

This is an exciting development because that simple phrase--"meaningful use"--is going to be at the center of many of the quality improvement and cost reduction efforts over the next decade and beyond. Cutting down on medical errors, eliminating waste and unnecessary procedures, paying for quality instead of simply quantity are all important to long-term cost containment strategies, all will rely heavily on HIT, and right now we're in the middle of a Renaissance in our health information technology/exchange abilities. So today we have a boring piece of administrative rulemaking news that actually happens to be very exciting.
 
A bit of important health care news today but first some background: When the stimulus bill passed last year, tucked within it was a bill called the HITECH Act. The HITECH Act's goal was ambitious: to lay down the infrastructure for a 21st century health care system by investing heavily in health information technology (HIT) and health information exchange (HIE), i.e. the electronic movement of health records between institutions.

Two agencies within the Department of Health and Human Services are in charge of administering the programs to make that happen. One, created by an executive order from George W. Bush a few years ago and brought into permanent existence by HITECH, is the Office of the National Coordinator for HIT. The other is the Centers for Medicare and Medicaid Services, which just got its first permanent head in four years yesterday after Don Berwick was recess appointed to the position.

ONC was given about $2 billion to spend and they've used it to develop a series of HIT capacity-building programs. The largest of those program involves them working with states (every state) to start laying down an HIE infrastructure, particularly by putting together the governing bodies, financial engines, legal frameworks, etc that are needed to make a project like this work. The rest of the money is going toward HIT workforce development programs, grants to universities for R&D on specific topics, and money to help certain existing organizations become "regional extension centers" that will assist health care providers in building their own HIT capacity.

CMS, on the other hand, has more money to work with but less to do with it. It was directed by the law to make bonus payments to Medicare and Medicaid doctors and hospitals who implement HIT and start exchanging data. The catch, of course, is that you can't just haphazardly throw this money out there through these programs. A hospital that implements a new system of electronic health records but doesn't use them to do anything useful isn't helping anyone, it's just wasting money on a new toy. Thus the legislation requires that payments be made for "meaningful use" of electronic health records. The concept of meaningful use binds all of these programs, it's the end goal of all of them.

The exact definition of what "meaningful use" of EHRs is has gone through a review process (a proposed rule came out of HHS in late December, followed by a 2-month comment period where interested parties offered their input on the proposed rule) and today the final rule came out. If you want a quick look at what the rules entail, you can read an overview from the head of ONC.

This is an exciting development because that simple phrase--"meaningful use"--is going to be at the center of many of the quality improvement and cost reduction efforts over the next decade and beyond. Cutting down on medical errors, eliminating waste and unnecessary procedures, paying for quality instead of simply quantity are all important to long-term cost containment strategies, all will rely heavily on HIT, and right now we're in the middle of a Renaissance in our health information technology/exchange abilities. So today we have a boring piece of administrative rulemaking news that actually happens to be very exciting.

We're a house divided against itself.
 
An interesting development today as ONC and CMS officials testified about the meaningful use regs before the House Ways and Means Subcommittee on Health: certain Congressional Republicans don't think they're tough enough.

House GOP leaders this week went after new White House rules designed to encourage healthcare providers to use new medical technologies, arguing that they aren’t strict enough to promote quick adoption of the equipment.

“Much less is expected of healthcare providers receiving subsidies than what [the Centers for Medicare and Medicaid Services (CMS)] had initially proposed,” Rep. Wally Herger (Calif.), senior Republican on the Ways and Means Health Subcommittee, said Tuesday during a hearing on the so-called “meaningful-use” rules.

“The final regulations … represent a missed opportunity to improve patient care and reduce waste,” Herger said.

This is an interesting criticism because, as Herger notes, the proposed rules actually were significantly tougher. When a federal rule is proposed, it then goes out for public comment for a period of 2 months or so (here's a pictorial look at rulemaking). Anyone and everyone can read the rule and make suggestions on it. The proposed rule for these meaningful use regs came out in late December of last year and comments on them were accepted from January through March. CMS and ONC then sifted through them and, as I noted in the OP, came out with final rules last week.

If you look through the final rule you can see that they walked through all of the proposed rules (pretty much line by line), responding to virtually every comment that was made on them by the public and describing whether or not the feedback was incorporated and why. Many criticisms were leveled at the original rules for being too inflexible and setting the bar for meaningful use too high.

That's a key tightrope ONC and CMS have been trying to walk: finding the right balance to make sure that the rules aren't too difficult to meet (discouraging participation in the program) and setting the thresholds so low that meeting them isn't really meaningful at all.

One of the key complaints from Republicans on the subcommittee seems to be that Stage 1 meaningful use doesn't actually require exchanging information (of course the ultimate aim of meaningful use is real health information exchange). But that criticism somewhat misses the point. Meaningful use is occurring in three stages over a roughly 6 year period. Incentive payments for meeting Stage 1 requirements are going to start in January. You can't simply will the end goal to happen by that point; rather this is an iterative process that allows providers to get up to speed with time. Stage 2 requirements (for 2013) will come out next year and eventually Stage 3 requirements (for 2015) will be released sometime down the line. Those are where meaningful health information exchange starts to really get going. As ONC and CMS laid out in the final rule:

  • Stage 1: The Stage 1 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, focuses on electronically capturing health information in a structured format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); implementing clinical decision support tools to facilitate disease and medication management; using EHRs to engage patients and families and reporting clinical quality measures and public health information. Stage 1 focuses heavily on establishing the functionalities in certified EHR technology that will allow for continuous quality improvement and ease of information exchange. By having these functionalities in certified EHR technology at the onset of the program and requiring that the EP, eligible hospital or CAH become familiar with them through the varying levels of engagement required by Stage 1, we believe we will create a strong foundation to build on in later years. [...]
  • Stage 2: [...] We expect that stage two meaningful use requirements will include rigorous expectations for health information exchange, including more demanding requirements for e-prescribing and incorporating structured laboratory results and the expectation that providers will electronically transmit patient care summaries to support transitions in care across unaffiliated providers, settings and EHR systems. Increasingly robust expectations for health information exchange in stage two and stage three will support and make real the goal that information follows the patient. We expect that Stage 2 will build upon Stage 1 by both altering the expectations of the functionalities in Stage 1 and likely adding new functionalities which are not yet ready for inclusion in Stage 1, but whose provision is necessary to maximize the potential of EHR technology. [...]
  • Stage 3: Our goals for the Stage 3 meaningful use criteria are, consistent with other provisions of Medicare and Medicaid law, to focus on promoting improvements in quality, safety and efficiency leading to improved health outcomes, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data through robust, patient-centered health information exchange and improving population health.

I think the Republicans' hearts are in the right place on this one, though their criticisms miss the mark. Everyone wishes Stage 1 could be a bit more like Stage 2 but that's not feasible quite yet. We can reasonably expect provider to be sharing information in 2013 but not in January of next year. Most of them are still acquiring EHRs and states are still building the infrastructure for real health information exchange. But it'll be interesting to watch the process unfold.
 
We need to remove government from the patient and doctor to the greatest extent possible.

That's the surest way to drive down costs and improve quality of care
 
The whole idea needs to be scrapped as the government has no business setting regulations that are outmoded before they are even implemented. They should just let the market take care of it, and make sure nothing is developed. By regulating what information is worth tracking they will end up making the system inflexible, and give bureaucrats excuses for not implementing new technology.
 

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