Sunday, February 26, 2012

EHR Certification 2014 Edition

As the Centers for Medicare and Medicaid Services (CMS) released their proposal for Meaningful Use Stage 2 requirements, the Office of the National Coordinator for Health Information Technology (ONC) released its updated requirements for EHR vendors intending to support Meaningful Use Stage 2. The document is chockfull of technical specifications and details which are probably more than any physician cares to know. There are, however, a couple of good reasons why you should have a general understanding of what your vendor, or soon to be vendor, is required to do because it will affect your finances and workflow and may also present some presumably unintended legal implications to your practice.

The ONC proposal introduces several new terms that you should be aware of in order to avoid confusion, particularly if you are contemplating the purchase of an EHR in the next couple of years. A great slide deck from ONC can be viewed here.
  • ONC HIT Certification Program – The EHR certification program has been renamed, so presumably any software you buy should state that it is ONC HIT Certified.
  • CEHRT – Certified EHR Technology – This refers to any software product that has received any type of certification under the ONC HIT Certification Program. It could be a Complete EHR or a just a Module or a collection of Modules. Note that the “C” does not imply Complete. Any given CEHRT may or may not be enough to satisfy Meaningful Use (see below).
  • 2011 Edition and 2014 Edition – ONC introduces the concept of Edition, since the certification criteria are different for 2011 and for 2014 and since it is expected that both versions could be available on the market concurrently. The Edition could be applied to a Complete EHR or an EHR Module.
  • Base EHR – ONC is defining a Base EHR as a CEHRT that has several capabilities considered mandatory for Meaningful Use. Your software package must include a Base EHR even if you can exclude some of its functionality from attestation. It is not clear if software vendors will be required to clearly state if their offering includes a Base EHR, or if it will be left to the buyer to validate that it is so.
In an attempt to provide some flexibility, mainly to hospitals and specialists, it will no longer be necessary to purchase or assemble a Complete EHR in order to qualify for Meaningful Use. Instead one only needs a Base EHR, plus whatever Modules necessary to satisfy Core measures that you cannot exclude, and the particular Menu measures you choose. You can, of course still purchase a Complete EHR, and most primary care physicians will need to do just that, but if you don’t, you should exercise extra caution and read the labels very carefully.

If you are a proud recipient of a Meaningful Use incentive check, or soon to be one, you will have to advance to Stage 2 starting January 1st of 2014. Since the measures for Stage 2 are a bit more difficult and the data collection, particularly for Clinical Quality Measures (CQM), is a bit more extensive, it is imperative that you have your 2014 Edition installed and ready to learn and test sometime in the third quarter of 2013 at the very latest. Remember how long it took you to start your reporting period for Stage 1, and give yourself enough time to prepare for Stage 2, since you will be learning the ropes of Stage 2 while maintaining performance of Stage 1. There is no down time between Stages and there is no margin of error in consecutive 12 months reporting periods. If your EHR vendor has a sign-up list for Stage 2 upgrades, get on that list as soon as possible.

Features & Functionality
The proposed EHR certification criteria for a 2014 Edition require significant retooling of existing certified EHRs. For those with fond memories of the additional charges levied by many EHR vendors for Meaningful Use additions in 2011, this is a cautionary tale to be repeated in 2013. You should expect various Meaningful Use Stage 2 packages to be offered by your vendor and charged separately above and beyond your yearly maintenance or subscription fees. Below are just a few highlights and by no means a comprehensive list of proposed big ticket items.

CQM Reporting – If you had to pay separately for this in Stage 1, you should expect a requirement to upgrade to a more expensive version in Stage 2, since the computational requirements are much larger in scope now. If your current software does not have a registry capable of submitting CQM electronically to CMS, one will have to be provided to you for Stage 2, and this will also cost you more money. There will be an additional time burden imposed on you or your staff for collecting various data elements which were not required for Stage 1.

Referrals – Just having your referrals going out electronically and containing the required data elements will not be enough for Stage 2. ONC proposes that at least 10% of your referrals are sent outside your organization to entities that do not happen to have the same EHR brand as you do. I trust that large health systems will be successful in lobbying ONC to loosely define the term organization and/or for exclusions to this measure for their members. If this requirement remains in effect for independent private practice, you will have to add a technology profile to your clinical and patient preference considerations before you refer someone. Since your referral choices now carry clear financial implications for your practice (Meaningful Use incentives), where there were none before, a conflict of interest between you and your patient may have just been created. [Note: For those of you who have been skeptical and dismissive of my incessant warnings that an EHR will become the cost of doing business and its absence may exclude you from the health care marketplace, this is how it starts.] Considering the obvious issues with this requirement, I am very hopeful that it will be reworded in the final rule.

Patient controlled information transmittal – Obviously patients should have the right to send their medical records to whomever they wish, and obviously (to me) patients should have full access to their medical records to view and copy or download. Most practices are using web-based patient portals for exactly this purpose, and also to realize other administrative efficiencies. Meaningful Use Stage 2 adds a requirement that your patients have the ability, and actually exercise it, to transmit this information to a third party of their choice. This means that your EHR vendor will have to provide HIPAA compliant, Direct Project compliant, information exchange capabilities for all your patients. It is likely that large EHR vendors will undertake the entire task, while the surviving small vendors will contract this out.
Without boring you to death with public/private encryption keys and security certificates details, you need to know that this is going to cost you a pretty penny and that there may be legal implications for your practice. Allowing patients to download their information and be on their own from that point on, as in your current Portal, or the various Blue Button implementations, can be handled with proper disclaimers and warnings. This new Stage 2 feature proposes that your patients use your software tools, at your behest (need them to do this in order to get incentives) to send protected health information out to recipients you have no control over. If anything goes wrong, and many things can go wrong, are you, as the secure platform provider, legally responsible for any unfortunate outcomes? If a patient (who may not even be your patient) sends you unsolicited information via this mechanism, what are your legal obligations?
In addition, and exhibiting a perplexing misunderstanding of an NIH funded project to allow patients to grant and revoke provider credentials to imaging studies, ONC is also proposing to incorporate transmittal of large imaging studies by patients to third parties through the same mechanism. Hopefully, I don’t need to elaborate on the consequences to your network and software performance once DICOM images start flowing in and out freely through your Patient Portal.

I sincerely hope that enough public comments are submitted to ONC to change their well-intended, but fraught with unintended consequences, proposals for Meaningful Use Stage 2. I would also like to urge you to get involved, read the regulations and find the time to submit your comments, because whether you have an EHR right now or not, these regulations will sooner or later affect you personally. The time to sit on the sidelines moping and groaning, while hoping that this will all go away, has long since passed.

Note: Public comments can be made here.

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