SEP 2, 2011 4:39pm ET

Why Must CMS Overreach on Rules?

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To prove meaningful use of electronic health records, providers must collect, organize and report data culled from certified electronic health records systems showing that they meet certain measures for quality of care. But they don't send electronic data to the Centers for Medicare and Medicaid Services, as the agency hasn't got the I.T. capability to accept it two-and-one-half years after the HITECH Act became law.

Maybe CMS was too busy mandating that providers upgrade their information technology applications and skill sets on a fast track to bother with getting it own I.T. house in order. And the agency's nonchalance at fixing its I.T. gaps continues, as officials in July proposed that quality measures in Year 2 of meaningful use would again be proven through attestation, as it won't be ready to accept electronic data.

I thought of CMS' propensity for overreaching on rules and having a "Do as I say, not as I do," attitude while reading comments on the proposed Medicare Shared Savings/Accountable Care Organizations rule. CMS is proposing the reporting of 65 measures to calculate an ACO's performance and 28 of the measures are new.

Phrased another way, CMS on March 31 proposed that in only 10 months, participating ACOs not only get organized, develop a governance structure and business plan, and do a thousand other things to get disparate providers working in tight coordination, but to also have the I.T. capability and processes to collect 65 measures, including 28 that currently aren't being used. And, CMS wants 100 percent reporting of all the measures--in Year 1--before an ACO can share in any savings.

In comments on the Shared Savings proposed rule, the American Medical Association urged an alternative to an all-or-nothing approach for reporting on quality measures. "A menu of quality measures would be available from which ACOs could choose, including a number of standard national measures that apply across all ACOs (e.g., care transitions, drug-related and other adverse events, and functional status) as well as measures that an ACO could choose that are applicable to their core patient population." The AMA also asked that CMS use existing quality measures as providers already have processes in place to collect this data.

The AMA and many other organizations told CMS the proposed rule sets the bar too high on a range of issues for a first-year, large-scale ACO program. Hopefully, the agency will back down somewhat, if for no other reason than, surprise, CMS itself likely won't be ready for what's been proposed. Really, if CMS can't accept a modest amount of meaningful use measures electronically by now, is it going to be ready for 65 ACO measures next year?

We've seen this all-or-nothing approach before from CMS, such as its proposed rule for the first year of EHR meaningful use being toned down in the final rule. That's the beauty of the federal rulemaking process, that affected constituencies do get a voice. But it sure would be nice, and save a lot of time and health care dollars being spent on lobbying, if realistic rules were proposed in the first place...

 

Comments (5)
While regulation is necessary, there is no place for incompetent regulation. Unfortunately, the government has not learned this, particularly in the area of IT. Medical IT requires a lot more than knowledge of computer science and knowledge of medicine. It requires the ability to integrate the two and to thoroughly understand the constraints of both (yes, there is risk in IT, and yes, risks and benefits must be weighed). So long as the current approach of substituting mandating for learning and understanding continues, I am very pessimistic that real progress will be made in Medical IT.
Posted by sjlevine | Friday, September 09 2011 at 4:27PM ET
Government overregulation is often perceived as some nefarious plot to "take over" whatever industry or activity is being regulated, and every once in a while, that's probably true, especially at the executive level of various agencies.

More often, however, it is the result of simple and predictable bureaucratic behavior - the need to self-justify - practiced by thousands of people.

Regulators, by definition, don't "produce" anything except regulations. Regs are their work product; their output; their "unit of production." So, in order for the average minion to justify his/her position of employment, more regulations must be produced. The leadership defines the topic, but it is up to the (smart) minion to ensure that coverage of that topic is exhaustive, demanding and, most importantly, time-consuming. The better they are at justifying themselves, the worse off we are because of it.
Posted by A D | Friday, September 23 2011 at 2:51PM ET
Joe - I understand your rant and I also understand why... (from your bio... "He has 21 years of journalism experience, including service as editor of a political newsletter in Michigan.")


From SJLevine above..."Unfortunately, the government has not learned this, particularly in the area of IT. Medical IT requires a lot more than knowledge of computer science and knowledge of medicine. It requires the ability to integrate the two and to thoroughly understand the constraints of both (yes, there is risk in IT, and yes, risks and benefits must be weighed). So long as the current approach of substituting mandating for learning and understanding continues, I am very pessimistic that real progress will be made in Medical IT."

Joe - SJ gets it, as many of us who have taken the time to learn both Medicine (and practiced it for a long time), had a grounding in Compunter Science, and then went back and relearned it again.

Result - many of us "get it" and have gotten it for a very long time. Our problem is, as clinicians AND EMR implementers AND as EMR developers AND as health ceare data analysts (and I don't mean this to be sarcastic in using "AND" in the logical sense - ALL of these elements being fulfilled at the same time), that these kinds of "onerous" regulations were inevitable as without them we would continue to make the same mistakes by having semantically un exchangable health information forever.

As opposed to SJ, I think we have made profound progress in the basics of health IT, and the ability to apply it. It is only at this late date that many of those at ONC have had a thorough background in Medicine and Computer Science that they have set standards and goals.

It is a national (international?) embarrasment that the US is finally adopting ICD-10 almost 20 years after originally introduced (this is US innovation). That there is a mandate to adopt SNOMED, RxNorm, ICD, etc. as standards can actually make "Meaningful Use" meaningful. This also about as much as aembarrassment as failing to adopt the Metric system of measures.

It will also drive innovation on how to improve EMR interfaces so that the end-user will not be driven crazy by the number of possible diagnoses to choose from by driving vendors to R&D friendly user interfaces and methods to make generalist and specialist lexicons compatible in EMR documentation.

Joe - all the industry protestations will not fix the problem - it will be put off further. In the 60-70's, with primitive hardware and software, we put a man on the moon. As a spinoff from that R&D, one of the first commercial EMR's was developed.

It is very fashionable to "shoot the messenger", particularly government. On the other hand, Walt Kelly in Pogo was right, "we have met the enemy and it is us (the Health IT "Establishment").
Posted by wsalomon | Friday, September 30 2011 at 5:17PM ET
The defined field electronic medical record (i.e. pick an ICD code, check off a box, etc.) is widely reviled as not applicable to the practice of medicine, where each case is an individual situation; however, one hopes, this will be just the first step, with the next step, large fields of free text as in written charts, coming very rapidly. There are already lots of advances made in the ability to mine such text fields to flag cases for high risk of infection, etc.; this is where the true value of EMRs will be seen.
Posted by GERALD Z | Tuesday, October 04 2011 at 1:35PM ET
Ditto. Does anyone really believe the federal government is even marginally concerned with how this is affecting actual healthcare and those involved in providing healthcare...that would be terribly naive.
Posted by CHERRELL C | Thursday, October 06 2011 at 7:49PM ET
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