Thursday, June 9, 2011

Meaningful Use Stage 2 – Horses, Camels & Signals

On June 8, the HIT Policy Committee at ONC has approved the Workgroup recommendations for Meaningful Use Stage 2. Before diving into the details, it is worth noting that the time crunch for moving from Stage 1 to Stage 2, for those seeking incentives in 2011, was proposed to be resolved by postponing Stage 2 for these early adopters for one year. As I noted before, if you are able to attest and obtain incentives in 2011, go ahead and do that. You will be rewarded by having the opportunity to stay at Stage 1 for 3 consecutive years. The final Stage 2 ruling is not expected to occur until June 2012 and judging by previous experience with Stage 1, the recommendations approved today will be significantly relaxed by the CMS process of proposed rulemaking and public comments. So although analyzing (rejoicing or bemoaning) the various measures on this long list is a bit premature, it may be helpful to look at the general principles embedded in this new stage of Meaningful Use.


Many of the Meaningful Use more pedestrian measures have remained unchanged, have increased in intensity, or have been moved from menu to core (more on this later). These measures include such items as recording patient demographics, maintaining medications, allergies and problem lists, recording of vitals, running reports, electronic prescribing, incorporating structured lab results, medications reconciliation, using formularies, enabling clinical decision support, reporting to state and federal agencies and ensuring privacy and security of medical records.

Other measures were slightly expanded in scope. CPOE, for example, was restricted to medications in Stage 1. Stage 2 is adding laboratory orders and capability for radiology ordering. While Stage 1 required that physicians send clinical reminder notices to young children and the elderly, the current proposal is to send those reminders to at least 10% of all patients, and patient education materials which were required “if appropriate”, are also extended to all patients in Stage 2. If you were not a hypochondriac before, you will be encouraged to become one in the near future. The requirement to document the existence of advance directives, which was limited to hospitals, is now also applied to physicians of all types. To even the burden, electronic prescribing, a strictly ambulatory measure, will now be required for 25% of hospital discharges.

And then there are several benign brand new measures:
  • Both office visits and hospital days are required to have electronic clinical notes (30%). The measure is not very prescriptive on what constitutes a note other than forbidding scanned documents and requiring that notes should be searchable.  I can’t wait to see the certification test for “searchable”. It seems the committee is not aware that with very few and limited exceptions, EHRs are not very much like Google. This new measure ought to single handedly disqualify 99% of currently certified EHRs. The searchable part will probably be dropped during rule making.
  • For hospitals, use of an electronic Medication Administration Record (eMAR) will be required in at least one department.
  • Physician practices will need to record patient preferences for methods of communications, but hospitals strangely don’t need to do the same.
  • There will be new clinical quality measures added to the current list to choose from, but this item alone warrants its own separate dissertation.

As one of the committee members astutely remarked, along with the horses a few camels are also being created by this proposal. Hopefully, most of these creatures will be reshaped and/or eliminated in the final rule, but right now here are the problematic recommendations:
  • No menu items – Stage 1 allowed hospitals and clinicians some freedom in choosing which measures best apply to their situation. While 15 measures were mandatory (core), physicians and hospitals were free to select 5 additional measures from a menu of 10 choices. Meaningful Use Stage 2 is an all or nothing proposition.
  • Hospital labs should send structured electronic clinical lab results to outpatient providers for at least 40% of electronic orders received – This particular triple humped camel elicited much discussion in the committee and exclusions may be provided for small hospitals. Considering that the overwhelming majority of hospitals, small and large, are not currently capable of receiving electronic orders, a fact that seemed to have escaped the committee, this measure amounts to pretty much nothing, since 40% of zero is still zero. It remains to be seen how many of the few hospital labs that can currently receive electronic lab orders will turn that capability off just to escape this particular requirement. Bi-directional lab interfaces are not without cost to build and maintain.
  • Measures to be fulfilled by patients – There are two types of measures that hold providers accountable for patients viewing medical records online (10%) and for patients sending electronic communications to physicians (25 individuals). It is not clear who the messages should be sent to, but Meaningful Use is applicable to clinicians individually. I guess, practices and hospitals can make medical records available online and advertise the ability to communicate electronically, and hope that enough patients take advantage of that. Since we are dealing with all or nothing Meaningful Use compliance, it is more likely that patients will discover one more step in the check-in process – logging into the portal. The other issue here is that while certifying for Stage 1 Meaningful Use, many small vendors utilized third party PHR products (usually Microsoft HealthVault) to make medical records available to patients automatically. These vendors have no patient portals and no way to verify that patients actually viewed their medical records, without asking the patient to be kind enough and send in a copy of their PHR utilization reports.
  • For care transitions, summary of care and care plan are sent electronically to receiving facility or physician, and care team members’ list is available for electronic exchange – This was probably the most debated set of measures and the results as they appear in the proposal are difficult on many levels. First and foremost, the care plan in Stage 2 is envisioned to be just free text attached to the standardized summary of care record. Most advanced EHRs have separate sections, some structured, where care plans are directly documented and/or automatically assembled based on orders. It is not clear how that free text is to be created to satisfy the measure, other than requiring physicians to document the plan a second time. It is also not clear how you hold one party responsible for sending things electronically while it has no control on the abilities of the receiving entities (look for major exclusions here). And it is completely unclear what exactly should be done with that free text list of team members, once it is available, and who should be on it (Other specialists? Hospitalists? Community resources?)
  • The last two new items are just suggestions for CMS to evaluate, and both deal with expanding ambulatory reporting requirements to include syndromic surveillance and cancer reporting. Not sure if there’s anybody out there willing and able to accept such data.

As expected Meaningful Use Stage 2 is significantly upping the ante for 2013 (or 2014 now), but more importantly, the committee’s recommendations are also “signaling” to the more distant future of Stage 3. Possibly the most frequently used term in workgroup and committee meetings, “signal’ (used both as a noun and a verb) refers to providing hints to users and software vendors, indicative of intended future requirements of Meaningful Use – one if by land, two if by sea. So here are the brightest lanterns shining towards Stage 3:
  • Have nationally endorsed lists of drug-drug-interactions (DDI) and ability to record reason for overriding alert – Your DDI alerts, the ones that you were able to adjust and configure to your liking, will be coming from a federal designated source. Hopefully they will come in the form of friendly advice. Either way, they will want to know why you are overriding things.
  • Second hand smoking status will be added to just plain smoking status, and more refined race and ethnicity data will need to be captured.
  • In Stage 3, EHRs will need to be able to store and retrieve those advance directives, not just indicate that they do or do not exist, which is pretty useless in and of itself.
  • Family History recording will become a requirement as soon as they devise a proper standard for it. Considering that most EHRs already have structured templates for documenting all histories, and most of them are pretty much identical, it would be interesting to see what the new standard will look like and how much rework and data migration will be necessary.
  • That care team field mentioned above will no longer be just free text. National Provider Identifiers (NPI) will be required. It seems that only licensed clinicians can be on a care team.
  • Patient-generated data will be submitted to public health agencies - I am not going to even venture a wild guess regarding this one.
  • Compliance with the Nationwide Health Information Network (NWHIN) governance policies should be included in Stage 3 certification criteria - Here is where the future is beginning to look awfully hazy to me.
If the proposal to extend Meaningful Use Stage 1 through 2013 is accepted by ONC and CMS, and it should be, Stage 3 will most likely be pushed out by one year as well, so these various signals are directed to the year 2016 through heavy fog and precipitation. It is too soon to alarm the country. The most immediate order of business is to smooth those camel backs, and we have an entire year to do just that.

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