Tuesday, February 4, 2014

The Meaningful Use Workgroup Recommendations

Today at the HIT Policy Committee meeting, the Meaningful Use Workgroup will present its recommendations as part of the process leading to a final rule in 2015:

Feb 2014: Draft stage 3 recommendations reviewed with HITPC
March 2014: HITPC approval of stage 3 recommendations
Fall 2014: NPRM for stage 3
1st half 2015: Final Rule for stage 3
Effective: 2017

I presume the regulation writing will follow previous approaches with ONC writing the certification rule and CMS writing the attestation rule.

As I've written about recently, I think it is important to evaluate Meaningful Use Stage 3 from several perspectives including workflow impact, standards readiness, and the tension that such regulations create by prescribing functionality in products, reducing the ability of organizations and vendors to set their own priorities.

The certification criteria noted in the Meaningful Use Workgroup slides are enumerated below and I've added my own discussion questions.  It’s important to assess not only the merits of each of the criteria, but their cumulative effect.   Each hospital and physician office will have to trade-off meeting these requirements instead of doing something else, because few if any providers have the bandwidth to take on more.

In addition to the detailed discussion points below, I suggest that each of the criteria meet a three-part test before being considered for Meaningful Use Stage 3:   1) is there evidence that the specific technology function, if used, would substantially improve the quality, safety, efficiency, or affordability of care? 2) do we believe that the market will not adequately address the requirement on its own 3) will there be sufficient, uniformly available state-level and industry infrastructure in place to make the required technology achievable?.

When I write about such topics, I have to select my words very carefully.   Throughout much of my life, I've been viewed as an edgy innovator.   At this period in my career, some view me as the status quo, resistant to change.  When I propose discussion questions below, I am not taking a position for or against a policy goal.   I'm trying to weigh the cost/benefit of regulation at a time when many stakeholders in healthcare are resource constrained, time bankrupt, and struggling to comply with existing regulations.

I look forward to the open debate of these issues

1.  Clinical Decision Support (CDS)
Ability to track CDS interventions and user responses
Perform age-appropriate maximum daily-dose weight based calculation
Consume external CDS rules

Discussion questions:
a.  Will tracking every intervention and user response, a technically challenging activity, substantially impact healthcare quality/safety, research, or efficiency?
b.  Are standards sufficiently well described/mature to author and exchange externally authored rules?
c.  Must we require that all rules be transmitted or might we allow options such as decision support services in which rules reside in external modules and only questions/answers are exchanged?

2.  Advance Directives
CEHRT has the functionality to store the document in the record and/or include more information about the document (e.g., link to document or instructions regarding where to find the document or where to find more information about it).

Discussion questions:
a.  Given variations in state regulations for advance directives, will we require structured data standards or accept free text/pointers to free text?
b.  Can we eliminate the "OR" since such criteria become an "AND" for developers

3.  EMAR
CEHRT provides the ability to generate and report on discrepancies between what was ordered and what/when/how the medication  was actually administered to use for quality improvement

Discussion questions:
a.  Is tracking every variation/override, a technically challenging activity, a high priority for healthcare quality departments?
b.  Do discrepancies commonly occur and if so, are these discrepancies clinically relevant?

4.  Imaging
For both EPs (menu) and EHs (core) imaging results should be included in the EHR. Access to the images themselves should be available through the EHR (e.g., via a link).

Discussion questions:
a.  To clarify, does this imply a certification criteria to receive electronic radiology results, analogous to electronic lab results?
b.  If so, are the standards for receiving radiology results (including vocabularies for naming radiology tests/procedures) sufficiently mature to support such functionality?

5.  Clinical Documentation
Help the reader understand the origin of any copied text and identify relevant changes made to the original text.  Example method: provide functionality analogous to “track changes” in Microsoft Word™ to make the original source of copied text clear and any subsequent changes made

Discussion questions:
a.  Today, many organizations address copy/paste with policy.   Must we enforce policy with technology?
b.  Given that many applications are web-based and not a "thick client" such as Microsoft Word, there may be significant technical challenges in distinguishing between typing and pasting.   Does the technology exist to support this requirement?

6.  Test Results Tracking
Display abnormal tests
Date complete
Notify when available or not completed
Record date and time results reviewed and by whom
Match results with the order to accurately result each order or detect when not been completed

Discussion questions:
a.  Does this imply implementation of closed loop ordering i.e. require electronic ordering of all tests and not use of an ordering portal, faxing, or order sheets?
b.  Who should be notified via what escalation method when a test is not reviewed or completed?

7.  Device documentation
EPs and EHs should record the FDA Unique Device Identifier (UDI) when patients have devices implanted for each newly implanted device

Discussion questions:
a.  What is the current timeline for UDI implementation in device products?
b.  What will be done with this information once in the EHR i.e. recall workflow?

8.  e-Prescribing
Access medication fill information from pharmacy benefit manger (PBM)
Access Prescription drug monitoring program (PDMP) data in a streamlined way (e.g., sign-in to PDMP system)

Discussion questions:
a.  What is the current state of fill status information standards and their implementation in PBMs/e-prescribing networks?
b.  Which states have a PDMP system and the capacity to support single sign on/patient context sharing?
c.  Are standards available for PDMP integration?

9.  Demographics
CEHRT provides the ability to capture
Patient preferred method of communication
occupation and industry codes
Sexual orientation, gender identity (optional fields)
Disability status
Differentiate between patient reported & medically determined
Communication preferences will be applied to the clinical summary, reminders, and patient education objectives
Providers should have the  ability to select options that are technically feasible for them, these could include:  Email, text, patient portal, telephone, regular mail

Discussion questions:
a.  Do we have appropriate vocabularies for capturing these elements as structured data?
b.  Given current workflows and personnel, do we believe that we can achieve sufficient accuracy in the recording of these elements to support the expected uses of the data?

10.  Record amendment
Provide patients with an easy way to request an amendment to their record online (e.g., offer corrections, additions, or updates to the record)

Discussion questions:
a.  How does this align with current workflow and practice?
b.  What standards are required to support this function i.e. structured approaches to requesting change versus free text i.e. an email request?

11.  Patient Generated Healthcare Data
Menu: Eligible Professionals and Eligible Hospitals receive provider-requested, electronically submitted patient-generated health information through either:
structured or semi-structured questionnaires (e.g., screening questionnaires, medication adherence surveys, intake forms, risk assessment, functional status)
or secure messaging

Discussion questions:
a.  As above, we have to be careful when we use the word "OR" since this  implies "AND" for developers, meaning that all possible variations of functionality must be implemented. What is the minimum functionality required?
b.  Are there standards that constrain the kinds of data submitted i.e. CCDA templates?

12.  Patient Summaries
CEHRT allows provider organizations to configure the summary reports to provide relevant, actionable information related to a visit.

Discussion questions:
a.  How would such rules be authored and what standards would be used to represent knowledge?
b.  What is the definition of relevant and actionable?

13.  Multi-language support
EHRs are capable of providing patient-specific non-English educational materials based on patient preference.  At least one patient receives non-English educational material according to the patient’s language preference

Discussion questions:
a.  Is only one non-English language required as a minimum and not a representative sample based on local populations?  
b.  Are standards  to support multi-lingual retrieval implemented by educational material providers?

14.  Transitions of Care
EPs/EHs/CAHs provide a summary of care record during transitions of care
Types of transitions:
Transfers of care from one site of care to another (e.g.. Hospital to: PCP, hospital, SNF, HHA, home, etc)
Consult (referral) request (e.g., PCP to Specialist;  PCP, SNF to ED) [pertains to EPs only]
Consult result note (e.g. consult note, ER note)
Summary of care may (at the discretion of the provider organization) include, as relevant:
A narrative (synopsis , expectations , results of a consult) [required for all transitions]
Overarching patient goals and/or problem-specific goals
Patient instructions (interventions for care )
Information about known care team members

a.  Are standards available to support these data elements such as patient goals or problem-specific goals?
b.  Are there closed loop workflows required i.e. tracking of completed referrals?

15.  Notifications
Eligible Hospitals and CAHs send electronic notifications of significant healthcare events in a timely manner to known members of the patient’s care team (e.g., the primary care provider, referring provider, or care coordinator) with the patient’s consent if required
Significant events include:
Arrival at an Emergency Department (ED)
Admission to a hospital
Discharge from an ED or hospital

Discussion questions:
a.  Do we have a sufficient vocabulary (NPI, direct address etc.) to identify members of the care team and the means to notify them electronically?
b.  Are standards sufficiently mature to support each of these communications as structured data?

16.  Immunizations
CEHRT functionality provides ability to receive and present a standard set of structured, externally-generated immunization history and capture the act and date of review within the EP/EH practice

Discussion questions:
a.  Are standards sufficiently mature to support query/response of this data?
b.  Do public health departments plan to support this functionality?

17.  Case Reporting
CEHRT is capable of using external knowledge (i.e., CDC/CSTE Reportable Conditions Knowledge Management System) to prompt an end-user when criteria are met for case reporting.   When case reporting criteria are met, CEHRT is capable of recording and maintaining an audit for the date and time of prompt.

CEHRT is capable of using external knowledge to collect standardized case reports (e.g., structured data capture) and preparing a standardized case report (e.g., consolidated CDA) that may be submitted to the state/local jurisdiction and the data/time of submission is available for audit.

a.  Is the CCDA the appropriate standard to support case reporting?
b.  Do state/local jurisdictions plan on implementing such workflows?
c.  Do the appropriate standards and rules for defining reportable conditions exist?

18.  Registry Reporting
Reuse CEHRT data to electronically submit standardized (i.e., data elements, structure and transport mechanisms) reports to one registry
Reporting should use one of the following mechanisms:
Upload information from EHR to registry using standard c-CDA
Leverage national or local networks using federated query technologies

Discussion questions:
a.  Is the CCDA the appropriate standard to support registry reporting?
b.  As with other "OR" criteria, will EHR vendors have to implement upload AND federated query approaches?

Once we answer these questions, we can weigh the impact on clinician workflow, the burden on development resources, and the balance of federal directives versus competing local organizational priorities.

Let the discussion begin!


Anonymous said...

Hi John!
I just read your post: "Five Pieces Of Advice For Karen DeSalvo". Well written and valid points. From a standards perspective, we have begun an effort to harmonize HQMF and HeD into one model. Check out HL7 if you are interested!

Anonymous said...

To start, I love the 3 questions you challenged each Meaningful Use 3 recommendation with. They provide for a realistic, "do we really need this/can we really do this" evaluation of each recommendation.

Another discussion question for 5. Clinical Documentation

It has been proven that copy/paste functionality in EHRs can be dangerous to patients for a multitude of reasons. But is there evidence that functionality analogous to "track changes" in Microsoft Word will improve the safety of care? Prospectively, no. I can't think of a meaningful way in which this could aid in the quality, safety, efficiency, or affordability of care.

Retrospectively? Maybe. But among all the other reporting/documenting/etc. requirements organizations are faced with, when will they ever have time to go back through their "track changes" and perform an analysis of the consequences of poor copy/paste use?

I think a lot of these Meaningful Use 3 recommendations are items that would be "nice to know" but are not something that need to be immediately addressed by healthcare organizations. Small, retrospective studies can be done by independent (or government-funded) research groups to aggregate conclusions - such as the effects of copying and pasting in EHRs.

I love the question you raise here, "... and the tension that such regulations create by prescribing functionality in products, reducing the ability of organizations and vendors to set their own priorities." It feels like EHR vendors are always trying to "catch up" to the latest code sets, regulations, and functionality standards - where would vendors be now if they were able to use those thousands of programming hours on creative/innovative endeavors and special projects? There's lots of exciting healthcare technology and ideas out there but it will take years to fully enter the market if large vendors continue to be under so much regulatory stress.