A Meaningful Use Defining Moment

Dr. David Blumenthal

The Centers for Medicare & Medicaid Services (CMS) issued its draft definition for the “meaningful use” of electronic health records (EHRs) today as part of its notice of proposed rulemaking (NPRM).  The NPRM describes the proposed implementation of incentives to providers for the adoption and meaningful use of certified EHRs.  This NPRM from CMS kicks off a 60-day public comment period to help inform its development of the final 2011 meaningful use criteria.

Closely linked and also issued today from the Office of the National Coordinator for Health Information Technology (ONC) is an interim final rule (IFR) on Standards & Certification Criteria.  The IFR provides details on requirements for “certified” EHR systems, and what technical specifications are needed to support secure, interoperable, nationwide electronic exchange and meaningful use of health information.  The standards and certification criteria in the IFR are specifically designed to support the 2011 meaningful use criteria.

As part of the rulemaking process, the Standards & Certification Criteria IFR will go into effect 30 days after publication.  There will be an opportunity for public comment for 60 days from publication, after which the rule will be finalized.

There have been a number of opportunities for stakeholders to weigh in as meaningful use criteria and the standards and certification criteria have evolved.  These rulemaking processes attempt to take into account the input to date.  The resulting language in both the NPRM and the IFR should therefore seem familiar to many of you.  But the public now has another opportunity to offer useful suggestions before they are finalized.

Of course, meaningful use as defined for 2011 and the standards and certification criteria to support it are but the first major steps in a continuing process.  These criteria will set a level of expectation for what can be achieved today and in the near future through the adoption and use of a certified EHR system.  We fully expect that, over time, as needs and technologies evolve, the expectations can evolve as well.  We will learn, and the use and value of EHRs in medical practice will continue to improve.  That’s one benefit of the kind of learning health care system we can enable through the appropriate use of health information exchange.

Our next steps begin with you.  Your input on the draft meaningful use definition and standards and certification criteria during these open public comment periods is essential to informing the final regulations due to be published in spring 2010.  There is a formal process for submitting your comments available at:

  • Click here to submit comments on the Meaningful Use NPRM during the 60-day comment period
  • Click here to submit comments on the Standards & Certification Criteria IFR during the 60-day comment period

All submissions will be considered and a compilation of this input will be posted to http://www.regulations.gov.

Your perspectives are important as we all play a different role in the delivery of care.  Whether you are a provider, technologist, administrator, caregiver, researcher, patient, consumer, or other member of the health care community, your input is valuable as we all work together to provide patient-centered, quality health care.

We also hope you will use this blog to start a dialogue about meaningful use, and how we can leverage this important concept, and the specific incentives, to strengthen patient care.

– David Blumenthal, M.D., M.P.P. – National Coordinator for Health Information Technology

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46 Comments

  1. A. Cavale, MD, FACE, FACP says:

    It is good that these criteria finally came out before the year-end. However, as with most government policies, it is 556 pages long. If the ONC really wants practicing physicians to read and understand any such criteria, it has to be cognizant of the size of such documents. It would be nearly impossible for a clinician in private practice to dedicate that type of time to read a 556 page document, understand it and implement it.

    • Fred Trotter says:

      Using EHR systems will be a requirement for moving the science of medicine forward. Doctors will either need to learn about EHR systems themselves be reading original sources like this, or pay someone to distill the information further. Saying merely ‘this should be shorter’ begs the question: what, exactly should be cut?

      There are many journal articles that a doctor needs to read to remain current on the practice of medicine… this is just one more element to keeping current.

      -FT

      • My hope for EHRs is that those that will be most affected by the new mandates from Washington have been consulted, have been listened to and their input will show up in whatever is finally decided. The last thing practitioners need is government bureaucrats telling them how to run their practices. If there are great benefits that will significantly improve health care then by all means sell everyone on them. Five hundred or one thousand page mandates probably will simply be demonstrating an awful program full of complexity and extraneous meddling. Just my thoughts.

    • I agree that anything that’s 500 pages or more is absolutely insane. Shorter, more concise documents and standards are what is desperately needed to make this embraced by everyone. Doctors especially, have no time to read or try to understand a document this large.

  2. Brian Ahier says:

    The document is listed at http://www.federalregister.gov/inspection.aspx#special with a publication date of 1/13/2010 in the Federal Register. It is still not available for comment at http://www.regulations.gov/search/Regs/home.html#home and my understanding of the rule-making process leads me to believe that it will not be posted for comment until it is published in the Federal Register.
    During the call today it was said that the 60 day comment period started today, yet if we are still unable to submit comments, then the clock should not start ticking…

    • ONC Blog Team says:

      Thank you for comment and request for clarification. The 60-day comment period will begin with the publication date which is currently scheduled for 1/13/10.
      - The ONC Blog Team

  3. Joe Moore says:

    I sure hope they take this from page 47 to heart.

    “While we believe that requiring satisfaction of all objectives is appropriate for the
    majority of providers, we are concerned that certain providers may have difficulty
    meeting one or more of the proposed objectives. We solicit comments on whether this
    may be the case, and invite commenters to identify the objectives and associated
    measures that may prove out of reach for certain provider types or specialties, and to
    suggest specific objective criteria we could use to determine whether an objective and
    associated measure is appropriate for different provider types or specialists.”

    The current mandatory objectives leave out most specialists. While almost all specialty practices can support some of the objectives, few can support all of them. For example radiologists do not prescribe medication in the same manner a primary care physician would. I don’t think they can make use of eRx. I suppose they could have a system that supports doing that but it wouldn’t be used. Why spend for features and capabilities you’re not going to use just so you can take advantage of the incentives?

    On the other hand there are many other objectives that could be included but aren’t for individual speicalties that would help meet the ultimate goals of improving care and safety. Each specialty has its own set of unique requirements that should be included as part of the objectives. To lump all EP’s together is over simplifying it. Each specialty should have its own objectives that they need to meet.

  4. Brian Wagner says:

    What I believe would be of great use to all stakeholders is a clear explanation from HHS/ONC/CMS of the outreach plans they have in mind to encourage public comment and above all, public awareness of these and upcoming rules that are going to affect so many disparate health care stakeholders? For example, will there be regional meetings? More conference calls? Educational documents that explain to eligible professionals what impact the regulations will have on them? Awareness and education is essential to ensure buy-in from the ultimate end users of the qualified, certified electronic health records.

    We at the eHealth Initiative look forward to working with the relevant agencies and other stakeholders to make Meaningful Use a meaningful reality!

  5. Brian Ahier says:

    There is a meaningful discussion on Twitter of “meaningful use” using the hashtag #meaningfuluse. Check it out:

    http://search.twitter.com/search?q=+%23meaningfuluse

  6. Jeffrey Stevenson, MD says:

    I am just joining this discussion.

    I am a solo practice primary care MD in Marin County, Northern California.
    Please make the greatest priority to provide fast, simple to use, coordinated functions that help the MD in the room with the patient.
    This is a long way from the programing lab. The administrators, billers, and programers dominate the EMR landscape. I often feel like “the end user is the enemy”.

    All of the EMR systems, for the physician side are cumbersome, slow and have poor integration. In Marin most private primary care and internal medicine specialists, including myself are tied together using the Allscripts EMR. It is one of the most powerful EMR’s. We apparently are one of the most advanced EMR counties in the US. It is web based and has excellent functions and security but is so slow and so many clicks with the slow internet based refresh rate and requires clicking in and out of a text box. It lacks user flexibility. The functions are hard to figure out. I have been using it for over 4 years, thousands of hours and patients. I hate it but can’t stay in business without it because of its capacity to pull in and store data, especially meds. It frequently takes me 30+ minutes to annotate and reconcile a senior’s med list and none of it bridges to the chart note but lies hidden in a text box.

    Sorry to whine. I do wish I had time to read the 556 pages and contribute to this critical project, but I don’t, and I feel bad about that.

    Thank you all for your efforts.

    • A. Cavale, MD, FACE, FACP says:

      I feel your pain, Jeffery. I am glad to have a real clinician join the discussion (see my comment earlier). All these efforts will only succeed if clinicians like you and I are included before rules are finalized. We know that won’t happen because we are just end users that cannot “get with the program”. I am a 7.5 year EMR user (longer than the Cleveland Clinic). Yet nobody has ever approached me to understand my requirements or learn from my experiences. All this is simply window-dressing. And like everything else in medicine for the past 15 years, we’ll just be playing under someone else’s rules.

  7. Margalit Gur-Arie says:

    Since the public comments period does not begin for ten more days, and since I am not known for waiting patiently for my turn to speak :-) , I would like to make two very general comments on the lengthy published documents.

    First, I am very disappointed about the removal of the requirement to record Advanced Directives. This is probably the only requirement with a potential to directly impact cost of care by reducing the much discussed end of life unnecessary, and mostly unwanted, expenditures.
    The reasoning behind your decision to drop this requirement (i.e. various specialties like dentists, optometrists, dermatologists, etc. do not customarily record AD), brings me to the second comment.

    If you evaluate most requirements from the perspective of “current standards of practice” for various specialties, it quickly becomes obvious that multiple practitioners will not be able to become meaningful users. Dentists and optometrists, for example, very rarely, if at all, have a reason to record Vitals or receive electronic lab results. same for psychiatrists, dermatologists, and the list goes on. Requiring these specialists to purchase electronic interfaces for a couple of labs or Rx here and there, is a bit excessive.

    My suggestion would be to either define meaningful use by specialty, or provide a guide for allowed exclusions based on specialty.

    I have quite a bit more line item comments regarding feasibility of some measures and their calculations (those denominators are not going to be readily available), but I guess I can wait for the proper public comment period now….. :-)

    • Jacob Eisdorfer says:

      As a dentist, I strongly believe that there is no excuse for using the complexity of modern health care and its specialties as a reason to throw hands up into the air in defeat. Also, while specialties have served to advance the level of care afforded to patients, I believe it is a mistake to become entrenched into the mindset that one specialty has different informational demands that another. Progress in medicine demands a constant re-evaluation of practices and as such, EMRs must reflect the robustness that doctors themselves must have to be up to date. I believe that this is the intent of these initiatives in the first place.

      Back to dentistry, “39 percent of adults… visit a physician’s office or a hospital outpatient or emergency department annually… In contrast, 64 percent of adults… visit a dentist.” (“The health of the nation – Why you should care”, Michael Glick, DMD, J Am Dent Assoc, Vol 138, No 2, 144-146) You state that dentists rarely have a reason to record vitals, but if true collaboration is to be achieved between providers, then dentists are a rich source of public health data with regards to age, weight, blood pressure, etc…

      In the same sentence, you say that dentists rarely have a reason to receive electronic lab results. If a community dentist is treating a patient who has had lab tests at the regional hospital, then it is extremely valuable for the dentist to be able to retrieve INR or PT results, HbA1c results, medication lists (bisphosphonates, anti-coagulants), etc…

      Not to beat a dead horse, but I would also like to mention, just for example, vaccination reporting or lab cultures. Again, it might be said that dentists have no need for these functionalities. But I asserted above that medicine is constantly changing, and it is not unthinkable that there might be vaccinations to help fight caries in the future. Nor is it unrealistic to hope that if dentists had a reason to culture, that public health would be able to utilize data on oral flora to help combat the endemic and contagious process of caries and periodontitis.

      Jacob E.
      Columbia University College of Dental Medicine
      Class of 2010

      • Joe Moore says:

        That’s an interesting perspective but I don’t know it holds true across all specialties. The unique circumstance surrounding the visit habits of Americans supports the idea that the field of dentistry may have more use and more to offer for a complete record than other specialties like Radiology for example.

        I still don’t think we should lump all physicians and providers in to one big group without understanding the unique needs and capabilities of each. If so you lose the valuable data that a particular specialty can bring to the table. The definition of MU seems geared towards primary care physicians and maybe that’s the place to start. However if the specialists aren’t incentivized the same way it’s doubtful their unique information will find its way in to the PCP’s EMR. What good is an EMR if it’s not complete? For example there doesn’t seem to be any requirement or incentive for radiology practices to make their images available to the PCP’s EMR. Does the PCP have to log in to the radiology practices web based image viewer like they do today? How do they know unless the patient tells them that they’ve had imaging exams performed? How does the PCP get access? How long will it take? These are the problems EMR’s are supposed to solve and unless everyone is incentivized to contribute we won’t be successful IMO.

        • Jacob says:

          Sounds right. I agree, everyone needs to buy in. I was just defending dentistry. Incentives for everyone is tough to achieve, I don’t pretend to know anything about it.

          My overall concern is that wherever there exists opportunities to learn real lessons from and for MU, that they are acted upon. I think a well designed community based dental research project could make large strides with the advancement of generalist/specialist integration, as it is a smaller, hopefully more manageable environment than medicine that requires plenty of interprovider communication.

          Baby steps…

  8. Dale West says:

    Why does this sound to me so much like a PR gimmick to market a product rather than a Doctor/Patient interface that could be accomplished with a PDA and EHR linked to multiple bases and a decision engine? Lacking that, the Doctor could just Google it.

  9. Congrats on a herculean task.

    My suggestion is to evaluate the comments you will get through the lens of the practitioner and the impact on the practitioner… Keeping it simple in the office / saving time will increase adoption (and follows IOM and research council suggestions of incremental sustainable success). If increasing adoption, means a higher chance of better and safer care, then we are all winners.

    In this vein – 80% Computerized order entry for physicians (lab, rx, rads, referrals) and 10% for hospital (additional orders of therapy, blood, etc) for year 2011 and NO requirement (or often mechanism) for electronic transfer/exchange until later seems awkward at best….

    Make HIT / meaningful use feasible for adoption with minimal redundant work in the outpatient setting – change CPOE to Rx CPOE for outpatient in 2011…(keep requirement for lab values coming in as structured data). Wait to require general CPOE until 1) standards / interchange are set – so duplicate work does not occur – once in the computer and once on the pad (or the lab vendor’s triplicate carbon). 2) Exchange of information on lab orders is more mature and readily available.

    Rationale – Impact 1 process in the office at the start. (actually 2 – first prescription and renewal). Saves office time with refills. Covers big safety and cost issues. Affects patients with chronic disease. Allows simple count for adherence – # prescriptions, % of all patients with any electronic prescription, etc. PQRI will incent use of e-prescribing this year. But most importantly, Rx is feasible and brings value to TODAY’s workflow.

    With a focus on Rx CPOE, physicians/offices collect demographics, structured meds, etc…(also interactions & diagnoses in many cases). Transitions of care and medication reconciliation are facilitated. Offices learn to work in (and see the value of) the electronic environment with shared information available!

    Once again, thanks for the effort in getting all of these documents out, while working on REC, HIE, Sharp, Beacon…

    John Haughton MD, MS
    DocSite

  10. Brian Ahier says:

    You can now submit comments on the proposed rule (even though publication is not scheduled until 1/13/2010):

    http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a74a4b

    I hope this will not shorten the comment period below the 60 day threshhold required after publication. The last thing we need is some legal challenge based on a technical statutory violation. I’m looking forward to reading the comments as they pour in ;-)

  11. Great article i found this very informative, i will book mark this site and come back again,
    thanks kev

  12. Dr. David Blumenthal says:

    Clearly, there are many opinions and perspectives on the definition of meaningful use, and the standards and certification criteria for EHRs. By reading your comments, I’m energized by your critical thinking and passion for the subject. It is through collaboration and working together that we will improve our nation’s healthcare system and I’m confident that we will get it right. However, I want to remind you that comments on this blog cannot be considered as part of the official public comment process. It is critical that you visit regulations.gov to provide your comments for consideration. That said, I can always benefit from your informal input and appreciate you taking the time to provide it. In return, I want you to know that your comments are read, and where feasible, I will respond or share with others within the department. So, a few responses:

    - As a physician myself, I certainly understand the time constraints you face. The fact sheets will provide an overview of meaningful use and the initial set of standards, implementation specifications, and certification criteria.

    - I urge you to include your insight about the implications of meaningful use from your own practice’s perspective as part of the public comment period.

    - I particularly value the feedback from physicians sharing their experiences with EHRs, including benefits and challenges. Learning from your experiences is critical to better understanding the barriers you face and helps us tailor our programs and communications to meet your needs. I also know that the Regional Extension Centers, once awarded, will be valuable resources for you to seek technical assistance and support and hope you will engage and participate in that program.

    Thanks again for your insights and please don’t forget to submit your formal comments – they are a critical step in the process.

    • Joe Moore says:

      I appreciate your drive to involve providers. The solution to our healthcare problems will not come from Washington rather they will come from local communities that put the patient first and develop a model where all providers have an opportunity to participate in the solution. My experience with physicians is you only get one chance to get it right. While the technology is important I think the model, incentives, and change management will have more to do with our success or failure.

      A recent story in one of our local newspapers told of the $61 million “failure” of an EHR implementation. The solution has been in place for over a year and came from a well-known behemoth with a strong reputation for handling large healthcare enterprises. Providers and clinicians at every level are frustrated and fed up. So what went wrong here and how do we avoid such a disaster on a national scale? I suspect it has to do with the change management and how the solution was delivered to the end users. No solution is perfect and the main factor in determining success or failure is how well the end users accept the shortcomings. If they are not involved in the process of defining the needs and goals of a project then they will resist the change and throw every shortcoming back in your face. The end user has the ability to make a solution work or fail regardless of the technology.

      It is imperative that provider input is not only solicited but that it actually impacts the definition and scope of the project. With good participation, buy in, and the feeling of being part of the decision process providers and clinicians will make it work. If they feel the solution is being shoved down their throat and their input was basically ignored it will be a gigantic failure of never before seen proportions.

  13. Paul Roemer says:

    I think hospitals need to give a lot of thought to whether it’s in their best interest to even try to meet MU. Those who haven’t begin EHR and CPOE will be hard pressed to benefit. There is more unknown than known about the impact of changing an entire business strategy in light of reform, the magnitude of Stage 2 and 3 requirements, no standards, 400 vendors–all lacking 2011 certification, hundreds of different HIE’s, and an N-HIN strategy that may not be viable.

    Washington is building a healthcare model whose long term goal is to be able to connect each patient to any doctor. Hospitals have a far different business model. The sad thing is that none of the hospitals who have undertaken EHR had any idea that costly rules would be applied after the fact, they have no means to know what the next set of changes will be, or if the dates of meeting MU will be pushed back. If the dates don’t move MU will be like hosting a lottery for which only a handful of people bought tickets.

    As for ambulatory doctors, my recommendation is to wait until a firm shrink wraps EHR (software, implementation, training, change management, and work flow improvement.) There’s no rush here either.

    If you’re interested, you can read more at healthcareitstrategy.com

  14. David Tao says:

    Dr Blumenthal, thanks for your reply.
    There have been several blog comments about how hard it is to find the right place to enter the comments. Currently, the blog has these links:
    Click here to submit comments on the Meaningful Use NPRM during the 60-day comment period
    Click here to submit comments on the Standards & Certification Criteria IFR during the 60-day comment period
    However, they don’t go to the right documents, but only go to a generic page that lists many “what’s hot” regulations. At the moment, the IFR and NPRM appear in that list, but that may not always be the case. Also, there are two similar listings for each, one with a due date of January 13th, and the other with a due date of March 15th.

    I suggest that the links in the HIT Buzz blog, and on any HHS website referencing them, go DIRECTLY to the correct documents. e.g., the following links would work to replace the current “generic”links:
    - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7c4a8 for the NPRM
    and
    - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7c48a for the IFR.
    That would save time for everyone who’s going to comment, and avoid people commenting on the wrong document.
    “Usability” has been a hot topic regarding EHRs themselves, but I hope that ONC and CMS will achieve usability in their communications, including usable links to web pages for comments.
    Thank you.
    David Tao

  15. Paul Roemer says:

    In case anyone would find it helpful, I will be posting a presentation next week which includes a decision tree to walk through the analysis about seeking MU incentive dollars.

  16. PHP Services says:

    I will be following this closely to see the outcome – although im not too fond of the way it is progressing, it could reduce costs and provide better health care services.

  17. This post is very informative.I have read it and get very useful information in this article.I was wondering this stuff of information only.Thanks for sharing great sharing links here.I must say this post is worth visiting for me.

  18. How many more layers of administrative complexity are going to be added to the practice of medicine? OK… everyone resists change. I get it. But why not find search for a model that’s already working, copy it, and try streamlining the process?

  19. Roman says:

    I will be following this closely to see the outcome – it could reduce costs and provide better health care services.

  20. Tanya says:

    I like a model of health care that washington is introducing.

  21. Cross Buckle says:

    I still dont get it..how they are going to protect all this electronic information from getting hacked..

  22. Dentistry says:

    This post is very informative and I find it’s information very useful.
    Best regards, Dr. F. Lee

  23. I believe the EHR system will be benefical as it will improve the communication of medical and dental information.

  24. Mr. Cavale makes a point though…if you just push this down doctor’s throats without fully explaining it, they’re not all going to take the time to read it and understand it. You’ll just end up having to hire more people to enforce the rules because no one will take the time to fully understand them or implement them. Implementation without understanding is just asking for problems.

  25. I notice that there haven’t been any updates on the EHR system since the beginning of 2010. Is anyone able to comment on the impact of the EHR implementation, or are there still parts of the system to be installed?

    I’m very curious from a United Kingdom perspective of how the EHR system has impacted the medical fields in the US.

    Thank you in advance,
    Paul M Gedding
    (Bristol, England, UK)

  26. I am amazed with the implementation of technology, especially with electronic health records. There are now greater efficiencies within the various business sectors. Within the dentist industry, electronic records have created tremendous savings in no only filing cost but also in the turn time with retrieving the documents.

  27. It is will become a full time job to manage this. Cost to cover it will force all health care to go up and it won’t make things any easier.

    Another ‘good intention’ that will fall short.

  28. Well, I’m certainly hopeful that the EHR system will improve the communication of medical and dental information, but I suppose that remains to be seen. I do think that careful attention needs to be paid to explaining it thoroughly otherwise the proper investment of time may not be made by everyone to fully understand it.

  29. I searched this web site for the word “dental” and no instances were found. Apparently on this site, the mouth is not part of the body. Please see a U.S. Institute of Medicine report regarding “medically necessary” in reference to dental care in Medicare: “Such a restrictive definition may suggest that periodontal or other tooth-related infections are somehow different from infections elsewhere and imply that the mouth can be isolated from the rest of the body, notions neither scientifically based nor constructive for individual or public health. “ in Extending Medicare Coverage for Preventive and Other Services by Marilyn J. Field, Robert L. Lawrence, and Lee Zwanziger, Editors; Committee on Medicare Coverage Extensions, Division of Health Care Services, IOM, 2000.

  30. We definitely do not need more paper/rules to read and go through. The bad part is the more time we have to take to keep our policies up to date, means the less time we can spend with the patient. This makes for a worse experience for the patient all around. After that being said, the best way to move forward is to always implement as much automated technology into our record keeping. We must all embrace this change.

  31. I agree. Constructing a relationship with my patients is of top priority and more work definitely effects that. Automation is also key in my business though. I have to spend very little time on the technology/upkeep side of things because I have put in the effort to learn as much as I can to be a step ahead of the curve; My staff is the same way. EHRs will be a must, but I do agree that things need to be changed to help cater to a broader spectrum as well as improve functionality.

  32. The scenario I keep coming back to related to EHR is this one:
    There is a car accident. First responders show up and stabilize the injured. When medical professionals arrive, they scan the injured person’s wrist for a microchip containing all their medical history. They are then able to act swiftly and accurately to help them.

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