The Meaningful Use Stage 2 Hardship Application

Many people have emailed me about the Meaningful Use Stage 2 Hardship application for hospitals and eligible professionals.

The most common question is - if I apply for hardship, what happens to my incentives and penalties?  Here is my understanding:

Put simply, if you want to get an incentive you have to do MU.  For *Medicare* providers once they start their first payment year their yearly clock for incentives keeps ticking regardless of whether they do MU or not.  So miss a year = no incentive. The following year would be whatever the next available incentive is scheduled to be, NOT the one that was just missed.   So there is no such thing as deferred incentives.

Applying for hardship means not doing MU, which means no incentive for that year (which means gone forever). If a provider is favorably granted the hardship then they would not be subject to the penalty to which that hardship is applicable.  In the case of 2014 performance, it is the basis for the 2016 penalty.

So to make it real.

If a (non-first-time) provider applies for a hardship for 2014 performance, presumably that means they cannot demonstrate MU, which means no 2014 incentive, but when granted the hardship it means they avoid being penalized in 2016.

If a provider does MU in 2014, they get the 2014 incentive AND avoid the 2016 penalty.

Building Unity Farm - Winter Hive Maintenance

The 2014 winter has been brutal with more single degree days than any winter during my 20 years living in Massachusetts.   Our bees are resilient, started from colonies overwintered in New Hampshire last year.  Keeping them alive has required careful management and we’ve learned a great deal in our first year as beekeepers.

We began the winter with 8 hives, 7 of which were strong and one of which had very few bees.

Our hives started as “nucs” 5 frame mini hives purchased from an apiary.   We placed the frames in 10 frame deep body boxes last May.   After a few months, we added another layer of 10 frames deep body boxes as the colony expanded.

We’ve tried to care for the bees organically and not introduced any chemical treatments for bee diseases like varroa mites, nosema, and hive beetles.

In November, we added division board feeders with 2:1 sugar syrup, and placed fondant under the inner cover on the top of the hive.   Typically we examine the health of the hive on days when the temperature is 50F or greater.

Our problem is that December-February had no 50F days, so we listened to the hives for signs of internal activity.

In January we lost the weak hive - it could not sustain itself through the bitter cold.

Last weekend, we opened each hive (pictured above), and examined each hive body to get a sense of bee health.  

Our South facing hives were vigorous and active.   Our Southeast facing hives were vigorous and less active.   Our Northeast facing hives were sick with Nosema, a unicellular parasitic disease of the bee gut that gives them dysentery-like symptoms.

The bees in the north facing hives died.

We’ve learned an important lesson - all bee hives should be south facing and we should treat with Fumagilin B proactively in the Fall to reduce the threat of Nosema.

We need to be more aggressive with supplemental feeding of hives with limited honey stores - hive top feeders in the Spring, jars of bee tea in the Fall, fondant, and pollen patties.

We need to standardize our components to enhance hive ventilation and reduce moisture.   We’re replacing our solid bottom boards with screened bottom boards as part of an integrated pest management/ventilation strategy.   We’re also drilling 3/4 inch holes in each hive to provide an escape/ventilation when snow drifts block the primary entrance.

Our bees are very gentle.   Although I’m wearing a bee suit and gloves in the pictures above, our bees have never stung me and seem content to land on me and check out the white suited invader.  

When the snow melts we’ll relocate all our hives to a flat, unshaded, dry, south facing spot in the corner of the orchard, protected from creatures that might attack the hive, wind, running water, and falling branches.  

Many of our colleagues lost all their bees this winter, so we’re happy six of eight hives survived.    Hopefully next year, with our lessons learned, we’ll overwinter 100% successfully.

Wearable Computing at BIDMC

Over the past few months, Beth Israel Deaconess has been exploring the use of wearable computing.

In the Emergency Department we’ve been evaluating an early unit of Google Glass, a high tech pair of glasses that includes a video camera, video screen, speaker, microphone, touch pad, and motion sensor.

We have been able to access our internal web-based ED Dashboard on Glass, in a secure manner that ensures all data stays within the BIDMC firewall.  Clinicians can now speak with the patient, examine them, and perform procedures while simultaneously seeing data from the ED Dashboard in their field of view.

Beyond the technical challenges of bringing wearable computers to BIDMC, we had other concerns—protecting security, evaluating patient reaction, and ensuring clinician usability.

Here’s what we’ve learned thus far:

Patients have been intrigued by Google Glass, but no one has expressed a concern about them. Boston is home to many techies and a few patients asked detailed questions about the technology. The bright orange pair of Glass we have been testing is as subtle as a neon hunter's vest, so it was hard to miss.

Staff members have definitely noticed them and responded with a mixture of intrigue and skepticism. Those who tried them on briefly did seem impressed.

Glass is a new medium that seems best suited for retrieval of summarized information and it really differentiates itself when it comes to real-time updates and notifications.  When paired with location services, it will be able to truly deliver actionable information to clinicians in real time.  We believe the ability to access and confirm clinical information at the bedside is one of the strongest features of Google Glass.

Our Google Glass unit has been tested by a limited set of four emergency physicians serving as beta users since 12/17/13. In addition to our four beta users, we've also had impromptu testing with at least 10 other staff members since 1/24/14 to get feedback to refine the user experience.  We needed to rigorously test our setup to ensure that the application is not only reliable and intuitive, but improved the workflow of clinicians rather than impede it.  We have learned a lot, and will continue testing with more interested clinical providers going forward.

I believe wearable computing will replace tablet-based computing for many clinicians who need their hands free and instant access to information.

A Primer on Meaningful Use and HISPs

The Massachusetts State government offers low cost HIE services including Direct transport to all the stakeholders of the Commonwealth.    Recently. Micky Tripathi wrote this FAQ which is so good that I wanted to share it on my blog.   Feel free to use it with your stakeholders.

1. What is a HISP?
A Health Information Services Provider (HISP) is an organization that manages security and transport for health information exchange among health care entities or individuals using the Direct standard for transport.  There is no specific legal designation for a HISP, nor are HISPs specifically regulated by Meaningful Use certification rules.  The term HISP was coined to describe specific message transport functions that need to be performed to support scaled deployment of the Direct standard in the market.  HISP functions can be performed by existing organizations (such as EHR vendors or hospitals or HIE organizations) or by standalone organizations specializing in HISP services.

HISPs perform two key functions that support scalability of exchange using the Direct standard.

a. Issue security certificates.  HISPs establish trust networks by defining policies for network participation and issuing security certificates tied to a HISP anchor certificate to enforce such policies
b. Issue direct addresses.   HISPs issue direct addresses tied to the HISP anchor certificate in accordance with conventions defined by the Direct standard

2. Do I need to use a certified HISP to attest for Meaningful Use Stage 2?
No, because there is no such thing as a certified HISP.  Meaningful Use certification applies to technology, not to organizations.  In order to attest for Meaningful Use Stage 2, you need perform certain activities using certified EHR technology (CEHRT).  For most EHR users, their EHR is certified for all of the functions that they need.  If it is not, you will need to incorporate specific additional certified technology solutions to fill the remaining gaps.  It doesn’t matter whether that additional technology comes from an EHR company or a HISP company – the only thing that matters is that the technology is certified.

3. Doesn’t DirectTrust certify HISPs?
DirectTrust is a private, non-profit organization that offers voluntarily accreditation of HISPs through its EHNAC DTAAP program.  This private, voluntary accreditation program often gets confused with Federal Meaningful Use certification.  DirectTrust is NOT a Federal certification entity, and its EHNAC DTAAP accreditation process is purely private and voluntary and has no relationship with Meaningful Use Stage 2 attestation or certification requirements.

4. What role does a HISP play in Meaningful Use Stage 2?
A HISP provides specialized network services that connect your EHR to other EHRs that are also using the Direct standard for communications.  You don’t need a HISP in order to create Direct-compliant messages, but you do need to be connected to a HISP in order to send and receive Direct messages with other parties.  Using an email analogy, you may have Microsoft Outlook installed on your computer, but if it isn’t connected to an email network, your emails can’t go anywhere and none can get to you.  Similarly, your CEHRT can send and receive Direct-compliant messages, but those messages won’t go anywhere unless you and those who you are communicating with have valid
Direct addresses and are connected to a secure network that can get the messages safely and reliably from one endpoint to another.  These are the message transport functions that HISPs perform.

There are two Meaningful Use Stage 2 attestation requirements that require Direct transport:

• Summary care record for transitions of care (TOC)
• Patient ability to view, download, transmit their medical record (VDT)

Most HISPs (including the Mass HIway) do not yet have the ability to connect directly with patients, so they are not able to assist with the VDT requirement.

For the purposes of attestation, the Meaningful Use Stage 2 TOC requirement specifies that you must electronically send a standardized summary care document to another care setting, and that you must have reasonable assurance that the other care setting actually received the document.  The HISP performs the message transport functions to provide you with the assurance that your messages have been delivered to their intended recipients.

In order to attest for the TOC requirement, you need to send CCDA care summaries containing at least problem lists, medications, and medication allergies.  These summaries must be transmitted with your CEHRT using either the SMTP/SMIME or XDR/SOAP protocol.  There is no Federal certification for HISPs, so you can send your message to its intended recipient using any HISP or any number of HISPs, as long as you have assurance that the message will get delivered.  The only certified system that you need to use is the one that creates the Direct-compliant SMTP or XDR message – after that, your message may take any number of “hops” between your EHR and its final destination, and as long as you’re confident that the message will get delivered, you will have completely fulfilled your Meaningful Use Stage 2 attestation requirement.

5. How do I get assurance that my messages are delivered?
Meaningful use attestation requirements do NOT specify how you get assurance of delivery, they specify only that you have taken reasonable steps to be confident of delivery.  The most robust way for you to be assured of message delivery is for your system to receive message disposition notifications (MDNs) for each message sent by your EHR to the intended recipient.  However, not all receiving systems or HISPs can generate MDNs, and not all EHR systems can consume MDNs even if they are returned.

Fortunately, you are not required to receive MDNs in order to be assured of delivery.  Other acceptable methods of assurance are through HISP guarantees of delivery after successful setup testing and/or notification of failure of delivery (like emails) and/or HISP central maintenance of delivery logs that can be made available as needed.

The Mass HIway provides you with assurance of delivery through rigorous setup testing, and maintenance of a central log of delivery successes and failures.  This log is made available to participants as necessary in the event of an audit.  The Mass HIway will also return any MDNs or application-specific responses or acknowledgements generated by receiving endpoints, however, the Mass HIway cannot guarantee that any receiving endpoint will generate notifications, acknowledgements, or responses.

The one exception where delivery notification is available and required is public health.  The Massachusetts Department of Public Health requires that participants receive delivery notifications in order to satisfactorily meet the Meaningful Use Stage 2 public health requirements.  Massachusetts DPH does generate automated acknowledgements, which are sent automatically via the Mass HIway in response to each message successfully received.

6. Is the Mass HIway a HISP?
Yes.  The MA HIway is a trust community that issues security certificates and Direct addresses to eligible participants and provides Direct-compliant message transport services for its participants.

7. Is the Mass HIway certified as an EHR module for Meaningful Use Stage 2?
No, the Mass HIway is not certified as an EHR module for Meaningful Use Stage 2.  Most providers will not require the Mass HIway to be certified in order to use it to help fulfill their Meaningful Use Stage 2 attestation requirements.  (See discussion above in FAQ on HISP roles.)  As long as your CEHRT delivers a Direct-compliant SMTP or XDR message to the Mass HIway (either to the LAND appliance or directly to the central site), you do not need the Mass HIway to be certified.

If your CEHRT does not send a Direct-compliant SMTP or XDR message to the Mass HIway (for example, if you are sending messages to the LAND appliance in a format other than SMTP or XDR), then you will need to change your interface to send Direct-compliant SMTP or XDR to the Mass HIway (including the LAND appliance) in order to count any of these transactions for Meaningful Use Stage 2 TOC requirements.

Even though you do not need the Mass HIway to be certified for Meaningful Stage 2 in most cases, you will still need to have assurance of delivery of messages sent over the Mass HIway to meet your Stage 2 TOC attestation requirements.  The Mass HIway provides this assurance by delivery after successful setup testing.

8. Must I be connected to the Mass HIway in order to attest for Meaningful Use Stage 2?
Yes, you need to be connected to the Mass HIway in order to meet the Meaningful Use Stage 2 public health requirements for immunization and cancer registries, and syndromic surveillance.  The Massachusetts Department of Public Health will accept public health transactions only through the Mass HIway.  Thus, though there is no Federal requirement that you be connected to the Mass HIway for Meaningful Use Stage 2, you will not be able to meet core public health requirements for Meaningful Use Stage 2 without being connected to the Mass HIway.

You do not need to be connected to the Mass HIway in order to meet the Meaningful Use Stage 2 TOC requirement.  However, over 100 providers and payers are already live on the Mass HIway HISP.  Thus, connecting to the Mass HIway will likely make it easier for you to meet your TOC requirements because you will be immediately connected with many of the providers you share patients with.

9. The Meaningful Use Stage 2 rules refer to the eHealth Exchange – is that the same as the Mass HIway?

No.  The eHealth Exchange is a health information exchange network comprising federal agencies and other large non-federal organizations.  The Mass HIway is not connected with the eHealth Exchange in any way.

10. Do I have to be connected to the eHealth Exchange in order to meet my Meaningful Use Stage 2 attestation requirements?

Absolutely not.  While the Meaningful Use Stage 2 rules do allow special dispensation for eHealth Exchange members, few providers will attest using this mechanism.  No Massachusetts providers or payers are currently members of the eHealth Exchange.

11. Who are the other HISPs in Massachusetts, and can I join any HISP that I want?
There are a wide variety of HISPs operating in the Commonwealth.  Whether you join any particular HISP depends on a number of factors.  The biggest factor is which HISPs your EHR vendor allows you to join.  Some vendors require that you use a specific HISP (either their own or the one they are integrated with), while other vendors (such as Meditech and Epic) allow the provider to choose which HISP they would like to connect to.  CMS and ONC do not require that you use any particular HISP for meaningful use, but in practice, your EHR vendor will dictate which HISP options are available to you.

If your vendor allows you to choose which HISP to connect to, you can connect directly to the Mass HIway HISP.  If your vendor requires that you use their designated HISP, you will have to connect to the Mass HIway through their HISP, as long as their HISP is connected to the Mass HIway.
Please contact the Mass HIway (http://www.masshiway.net) if you have any questions about your connection options.

12. Is the Mass HIway part of DirectTrust?
No, the Mass HIway is currently not a member of DirectTrust.  DirectTrust is a voluntary private non-profit collaborative that is helping HISPs to connect with each other.  The Mass HIway is connecting directly with the major HISPs operating in the Massachusetts market.  The Mass HIway may join DirectTrust at some point in the future if it provides additional value to participants.  Providers, EHRs, or HISPs do NOT need to be part of DirectTrust in order to meet their Meaningful Use Stage 2 certification and attestation requirements.

13. If I’m in another HISP, can I still be on the Mass HIway?
Yes.  You can connect to the Mass HIway even if you are a member of another HISP.   The Mass HIway is actively connecting with the major HISPs operating in the Massachusetts market so that messages can be sent between HISPs.  You do still have to join the Mass HIway by signing a participation agreement even if you are in another HISP.  As a member of another HISP, you will pay whatever fees are charged by your local HISP and your Mass HIway fees will be waived.  Once you have joined the Mass HIway, your local HISP will configure your system to enable access to the Mass HIway network.  Your local HISP will still provide you with your security certificate and your Direct address, but you will be able to send and receive messages over the Mass HIway network.

Below is a current list of HISPs that are expected to be connected to the Mass HIway.  The HISP market is evolving rapidly so more HISPs will be added as demand grows.  Please contact the Mass HIway (http://www.masshiway.net) if you would like to discuss your connection options.

HISP Live date
eClinicalWorks April 2014
Surescripts April 2014
eLINC/SES April 2014
Allscripts/MedAllies TBD
Athenahealth TBD
Wellport/Alere TBD

Building Unity Farm - The Ducks

As the weather begins to improve (we’ve even had an afternoon above freezing - wahoo!), the ducks are beginning to wander farther from their duck house.   This week, they discovered the rain cistern that collects runoff from our farmhouse roof.

For hours, they’ll bathe, preen, and drink their fill of the circulating rainwater.  They’re very social and tend to travel in groups.  They’re calm and have learned to recognize us as helpful rather than threatening.

We have 10 ducks at the moment -
2 Chocolate Indian Runner ducks
2 Fawn Indian Runner ducks
2 Welsh Harlequin ducks
2 Swedish Blue ducks
2 Rouen ducks

They spend the day wandering the farm yard, finding insects in the compost pile, eating the tender sprouts of any greens they can find, and playing in puddles.   As dusk approaches, we walk near them and they know it’s time to return to their duck house, a 4x8 building with food, wind protected warmth, and hay bedding.   We keep their water sources outside the duck house to reduce the mess.   Ducks can turn any pasture into mud.

They have a heated 50 gallon stock pond and a 5 gallon waterer in the 14x10 foot pen built around the duck house, caged on 5 sides to prevent predators from reaching the ducks at night.    A duck house with 3 square feet per duck seems about the right density.

Our large pond is about 50 feet from the duck house and the surface is still covered with ice and snow.  It’s 6 feet deep so water is still circulating but the ducks cannot reach it.   We’re confident that with the arrival of Spring, the ducks are going to be spending all day in the large pond.

Each member of our poultry family - the chickens, the guinea fowl, and the ducks show mutual respect for each other.   All the species wander into each other’s spaces, huddle together for warmth, and get along.    About the only difference is that the ducks do not roost for the evening - they prefer an outdoor space to an indoor space and only seek the warmth of the duck house during snow and wind.    Rain is prime duck weather.

Duck care is easy - refill their water sources, provide them fresh greens (we make “duck soup” with lettuce, peas, and spinach in water), and fill their multi-flock crumble containers.   As a treat we feed them mealworms and scratch grains.  

At the moment, our 29 guinea fowl, 10 ducks, and 11 chickens - 50 birds in total, seems like an ideal number for our property.    All are disease free, uncrowded, and follow a highly predictable routine.   Unity farm has poultry living in unity.

ACO Systemness and Integration

As Accountable Care Organizations take on risk contracts which align incentives to create continuous wellness rather than treat episodic sickness, there is a drive to create “systemness” by moving from acquisitions of practices and hospitals to integration.   There are many ways to accomplish this such as moving to a single EHR with a single database for all sites, by enhancing interoperability of existing software, and by building care management databases that incorporate data from every care location.  

Developing a strategy requires a multi-factorial analysis - requirements, cost, competing priorities, regulatory imperatives, and cultural barriers to change.      From March to July, Beth Israel Deaconess will be working on an integration plan for its acquired and affiliated clinical sites.   From an IT perspective, I’ll create a task force that will design an analytic framework for decision making and then develop a prioritized list of projects.

Here’s the early thinking.

A analytic framework might include:
*Impact factor (number of providers, staff, patients)
*Workflow implications
*Degree of implementation difficulty
*Cost/return on investment
*Benefit (safety/quality, security/compliance, efficiency)
*Cultural/Behavioral factors (i.e. politics that can be an enabler or barrier)

Projects could include
*Hospital Information System consolidation (fewer silos than we have today)
*Ambulatory EHR consolidation (less heterogeneity than we have today)
*EHR replacement (new software that works better for evolving requirements)
*New Care Management capabilities (social, mobile, analytics, cloud)
*New enterprise-wide decision support capabilities (clinical and financial)
*Physical network consolidation
*eMail consolidation
*Telephone consolidation
*Domain consolidation (identity management via a single platform)
*Administrative system consolidation (supply chain, human resources, learning management)
*Desktop image standardization
*Storage consolidation
*Data Center consolidation
*Single PACS/Enterprise archive
*Integration engine consolidation
*Outsourcing selected functions
*Centrally managed security tools and staffing

Of course, priorities have to be driven by requirements, given that time and resources are limited.   Our hope that is a July strategy deliverable can be turned into FY15 budgets that enable us to tackle the highest priorities, knowing that the journey to systemness will take years.

Building Unity Farm - Managing wood

Last weekend I drove to West Bridgewater, MA and picked up a 500 pound SuperSplitter  (J Model 6.5hp Honda engine).  It’s now installed in the wood processing area with 10 cords of wood to be split on one side and 10 cords of self-built storage racks on the other.

Here’s our wood management plan by tree species:

Eastern Red Cedar - we never cut cedar, which is a slow growing resinous tree that lives for 800 years.   We have hundreds of cedars on the farm, some of which were planted at the edges of pastures in the 1800’s.   Cedar waxwings eat the berries and spread the seeds.   As our Revolutionary War era pastures returned to woodlands, the cedars were crowded out and shaded, weakening them.   Hurricane Sandy knocked over several old cedars and we split the fast burning wood to use as fire starters, moth repellant, and incense.

Red Oak - Hurricane Sandy damaged an enormous red oak on the southwest corner of the farm.   We cut it down to ensure a controlled fall and now have thousands of pounds of red oak to split.   I prefer white oak which is easier to split and faster to dry into firewood, but after 2 years of aging, red oak supports hot, long lasting fires.

White Oak - when we cleared land for our orchard, we harvested over 1000 linear feet of white oak, which I cut into 4 foot logs for Shitake growing.   There are a few thousand pounds of logs too heavy for mushroom farming so I’ll process those with the new wood splitter.

Maple - The largest tree on the property is an enormous maple (6 foot diameter trunk) that is near end of life.  We have a large number of birds that nest in old trees, so we’ve cut off the branches and left a snag for wildlife.   The photo above is splitting some of the maple branches.

Ash - Dozens of large ash trees have fallen on the farm over the past few years due to the Emerald Ash Borer.   Ash is an amazing wood since it burns without any aging.   We’ve cut up all the fallen ash and I’m in the process of splitting it with the new splitter.

Black Birch - In a particularly violent winter storm (we’ve had 15 storms this winter) a large black birch with shallow roots fell into one of our paddock fences.    We have a few thousand pounds of black birch ready to split - it smells like root beer (birch beer) when cut.

Poplar - poplar wood is soft, burns poorly, and smells like glue.    Poplar grows very fast and falls frequently.  We process all of our fallen poplar into oyster mushroom logs or chips for the trails.

My upcoming wood management projects include:

Splitting the fallen cedar, red oak, white oak, maple, ash and birch then stacking firewood into 20 wood racks.

Collecting old fallen poplar (many tons to move with the Terex compact front loader) and chipping it into 5 strategically placed piles around the property for spreading on the mile of trails.

Creating a new mushroom farming area from fresh fallen poplar

Cutting new forest paths to the mushroom farming areas so that I can move logs around with the Terex.

Clearing fallen branches from the trails for kindling

There is still 2 feet of frozen snow and ice crust on the ground, but I’ve been able to dig out the maple and ash logs that I cut before Snow-mageddon.   The new splitter, which is flywheel-based, does not have a delay to refill a hydraulic piston.   Thus far, I’ve been able to split 1 cord an hour instead of 1 cord per weekend!

I look forward to the wood management weekends ahead as soon as we have a thaw.   It was 3 degrees F this morning while I was shoveling manure.   Managing anything on a farm at 3 degrees F is challenging.

Social, Mobile, Analytics, and Cloud

On Monday at HIMSS, I signed my new book, Life as a Heathcare CIO for 300 folks at HIMSS.   During the rest of the day I met with numerous companies, leaders, and fellow IT professionals.   The theme I heard frequently was the need for care management/population health applications based on data acquisition, normalization, mining, and workflow.   Common characteristics of such applications included social networking features to gather data from patients/families/providers, a mobile component, a predictive analytics component, and cloud hosting.

I had no idea that the major consulting companies and analysts  have  already coined the SMAC acronym for this nexus of ideas (social, mobile, analytics, cloud)

As I walked the HIMSS floor, some of the care management applications I saw were real, developed in platforms like Salesforce and PegaSystems.   Others were “deployed” in Powerpoint, which is a powerful development language used by marketing departments to quickly author software :-)

As Accountable Care Organizations focus on continuous wellness rather than episodic sickness, the market for new tools will grow exponentially.    We have to be careful that social, mobile, analytics, and cloud (SMAC) does not become social, cloud, analytics and mobile (SCAM).

Here are few characteristics to look for in real care management/population health software

1.  Cohort identification - how can patients be enrolled in disease management and care management programs?  A drag and drop interface with concepts such as problems, medications, allergies, labs, and demographics should be available to specify cohort selection criteria.  Ideally, natural language processing will be available for cohort identification based on free text notes.

2.  Rules authoring - once cohorts are identified, there are likely to be protocols and guidelines that enumerate tasks to be done, gaps in care to be filled, and reminders to be sent to providers, payers, and patients.   The application should support user definable rules creation.

3.  Workflow - non-physician extenders are likely to use the application to ensure tasks are completed and to monitor patient progress.  Dashboards and automated "to do" lists should be available.

4.  Alerts  -  a change in patient status, based on patient self report or diagnostic data should result in an alert to the care manager, appointment scheduler and other care team members, triggering interventions such as home care visits.

5.  Patient Generated Data - often data about patient health status/outcomes are  best provided by
patients and families themselves.   Information such as activities of daily living, pain scores, mood, and medication compliance are not easily found in provider entered EHR data.    Interfaces to home care devices, mobile apps, and patient portals should be part of the care management suite.

Full featured care management software is a foundational strategic requirement for accountable care organizations.

Once we finish Meaningful Use Stage 2, the HIPAA Omnibus Rule, and ICD-10, we’re all likely to turn our attention to care management/population health as part of our Affordable Care Act implementation.

The Voluntary 2015 Edition Electronic Health Record Certification Criteria

There's nothing like a crisp New England winter evening, a roaring fire, a cup of cider, and a 242 page Notice of Proposed Rulemaking to fill your Friday night.

I've summarized the preamble and all 50 criteria to save you time as you consider the proposals during the 60 day comment period.    Note that no vendor needs to implement 2015 criteria and no provider needs to adopt 2015 certified software, hence the term voluntary.  In many ways, this document is meant to signal what might be included in the 2017 edition that supports Meaningful Use Stage 3.

Roughly 60% of the 2014 Edition EHR certification criteria are unchanged in the 2015 Edition. The remaining certification criteria proposals for the 2015 Edition fall into four general categories: clarifications, standards updates, revised approaches, and new certification criteria proposals.

As with the Meaningful Use Stage 3 proposals, I'll pose questions, not to be judgmental but to get us all thinking about the scope, timing, and purpose of the certification program over the next several years.

The preamble highlights several big ideas -  elimination of the 'complete EHR' designation, separation of content/transport certification criteria, adoption of new standards, more frequent certification rule making, and the need for 2017 edition proposal feedback.

Complete EHR was a very confusing concept to me that led many to buy single vendor systems as the "safest" option instead of assembling modules.   I applaud the idea of eliminating terms like Complete EHR and Optional Certification criteria.   Each certification criterion should stand alone and during attestation you should "fill your shopping cart" with only the certified modules you need.

Separating the content and transport certification criteria is a good thing.  The 2014 Edition which linked the two concepts proved to be very problematic in Massachusetts where the state HIE performs all of the Direct and XDR functions we need, so no EHR requires transport capabilities.   Yet because EHRs had to be certified to do both content and transport interoperability, extra work and expense was incurred.

The logic behind more frequent certification rules is that it enables "bug fixes" and more rapid adoption of standards.    However, we should ask the question - even with a voluntary program, just how fast can we develop software, install upgrades, revise workflow, educate clinicians, and support new software versions?   My experience is that changes of this nature take 3 years from regulation to attestation, at a minimum.

Here's my advice while reading the 50 certification criteria:

Focus on the fixes.  There were many challenging issues in the 2014 Edition.  The 2015 Edition fixes several of them.  Even if something looks more complex (like separating content and transport criteria),  it is simpler, and provides more market flexibility.

Identify the burden reduction.  Vendors of "non-MU Eligible"  software such as long term post acute care no longer need to develop "MU-required" functionality such as measure calculation to get certified.

Recognize that about 30% of the document is requesting comments for the 2017 Edition, not specifying 2015 requirements.

The proposals are just that - proposals.  It's hard to know how many will be incorporated into the final rule.  Much depends on feedback from stakeholders.   Certainly the Standards Committee and its Implementation Workgroup will offer substantial feedback.

Although some of the proposals do not seem like the highest priorities, there is someone inside or outside government who believes each proposal is important to healthcare.

If you have questions about intent, re-read the pre-amble.   It's well written and provides a context for the 50 proposals.

Here are the actual certification criteria

1.  Computerized Provider Order Entry
The functional requirement for medication/lab/rad ordering is split into 3 modular criteria, enabling novel functionality like mobile medication ordering to reside in its own application.   Since lab ordering standards are not consistently implemented, this proposal suggests using the S&I framework Laboratory Orders Initiative Draft Standards for Trial Use which have been approved by HL7 ballot.

2.  Drug-drug, drug-allergy interaction checks
The proposal includes a provision to consider tracking user actions i.e. what advice was ignored and what were the consequences when advice was ignored?    The interesting debate here is what to track and what to do with the tracking data.   This could be burdensome and have limited customer demand.

3.  Demographics
The proposal includes a new standard for recording preferred language that focuses more on spoken rather than written language.   It also requires that EHR technology must enable a user to electronically record, change, and access the date of death and the preliminary cause of death.

4.  Vital signs, body mass index, and growth charts
No change, although there is a discussion of requiring controlled vocabularies such as UCUM for units of measure in the EHR and in transmission of summary records.

5.  Problem list
No change

6.  Medication list
No change

7.  Medication allergy list
No change

8. Clinical decision support
The proposal adds a requirement to demonstrate decision support based on specific demographic requirements such as gender or date of birth.   It also simplifies the Infobutton demonstration criteria to better align with the capabilities of the standard.  Finally, the proposal would require importing of externally authored decision support rules and a query/response interface to remote knowledge resources.   We should debate the complexity, standards maturity, and appropriate initial use cases to demonstrate this functionality.

9. Electronic notes
The proposal requires search for information across separate notes within the EHR i.e. a Google-like function for structured and unstructured data.   It could be very complex.

10. Drug formulary checks
No change

11. Smoking status
No change

12.  Image results
No change

13. Family health history
The proposal requires the use of the HL7 Pedigree standard, eliminating the option to use SNOMED-CT for family history.

14.  Patient list creation
As with decision support, patient list functionality  must be able to filter based-on specific demographic requirements such as gender or date of birth.

15.  Patient-specific education resources
As with decision support, Infobutton requirements have been simplified.   There is an odd provision in this section requiring the use of Infobutton and an alternative to Infobutton.  That should be debated.

16.  Inpatient setting only – electronic medication administration record
No change

17.  Inpatient setting only – advance directives
No change

18.  Implantable Device List
This proposal requires the EHR to record and display a unique device identifier (UDI) to facilitate the widespread capture and use of UDI data to prevent device-related medical errors, improve the ability of hospitals and clinicians to respond to device recalls and device-related patient safety information.  UDI must also be incorporated into the CCDA interoperable data sets for

170.315(b)(1) – Transitions of care.
170.315(b)(6) – Data portability.
170.315(e)(1) – View, download, and transmit to third party.
170.315(e)(2) – Clinical summary.

The FDA work on UDI is excellent.  We should debate the role of the EHR for recording UDI data versus other alternatives such as registries.

19.  Transitions of care
As described in the preamble, content and transport are split into two certification criteria.  The best part of this revision is that it aligns certification with the notion that EHRs may communicate with regional or third party HISPs without the need for every EHR to be its own HISP.

Updated standards are used for transition of care content.

Rather than require healthcare information exchange with a different vendor's EHR (very hard to measure), the certification criteria will be the EHR's capability to import hundreds of different CCDAs with at least 95% success.   That could be very burdensome.

The proposal also includes a requirement that the EHR support appropriate demographic fields for patient matching - name, gender, date of birth, address etc.

20. Clinical information reconciliation and incorporation
The term "incorporation" can be confusing so this proposal formally defines CCDA import as reconciliation of externally provided summaries including reconciliation of medications, medication allergies, and problems.

21.  Electronic prescribing
No change

22.  Incorporate laboratory tests and values/results
The proposal includes updated standards - HL7 Version 2.5.1 Implementation Guide: Standards and Interoperability Framework Laboratory Results Interface, Release 1 (US Realm) (S&I Framework LRI) with Errata

23.  Inpatient setting only – transmission of electronic laboratory tests and values/results to ambulatory providers
The proposal includes the same updated HL7 Version 2.51 LRI standard.

24. Data portability
The proposal includes an updated standard - Consolidated CDA Draft Standard for Trial Use, Release 2.0 plus a requirement that the Universal Device Identifier data be exportable.

25.  Clinical quality measures – capture and export
No change

26.  Clinical quality measures – import and calculate
No change

27. Clinical quality measures (CQM) – patient population filtering
This proposal requires filtering of CQMs by patient population characteristics such as
Practice site and address, Tax Identification Number (TIN), National Provider Identifier (NPI),Diagnosis (e.g., by SNOMED CT code), Primary and secondary health insurance, including identification of Medicare and Medicaid dual eligibles, Demographics including age, sex, preferred language, education level, and socioeconomic status.   We need to take a careful look at the burden of all the various quality related measurement provisions of Meaningful Use, as they are already overwhelming.

28.  Authentication, access control, and authorization
No change, but there is a discussion of the future need for two factor authentication in support of controlled substance e-prescribing and possibly remote access.

29.  Auditable events and tamper-resistance
The proposal suggests that disabling audit logs should be prohibited.  I'm not aware of any EHR which enables audit logs to be disabled.

30.  Audit report
No change

31.  Electronic Health Record Protections
§ 170.315(d)(4) (Amendments)
§ 170.315(d)(5) (Automatic Log-Off)
§ 170.315(d)(6) (Emergency access)
§ 170.315(d)(7) (End-User Device Encryption)
§ 170.315(d)(8) (Integrity)
No change

32.  Accounting of Disclosures
No change

33. View, Download, and Transmit to Third Party
A patient must be able to download an ambulatory or inpatient summary in only the human readable format if they just want that, in only the Consolidated CDA format if they just want that, or in both formats if they want both.

As with other interoperability criteria, this proposal decouples transport and content certification.    I've mentioned in previous blogs that this is important, since the ecosystem of infrastructure and applications to support patient transmit is still evolving.

This proposal focuses on a patient’s ability to choose the destination to whom they want to send their health information and the outcome, rather than the specific mechanism of transport.

The proposal includes more rigorous accessibility guidelines - WCAG 2.0 Level AA

34.  Ambulatory setting only – clinical summary
The proposal includes CVX codes for immunizations, and requires the updated Consolidated CDA version (Draft Standard for Trial Use, Release 2.0)

35.  Ambulatory setting only – secure messaging
No change

36.  Immunization information
No change

37.  Transmission to immunization registries
Updated standards

38.  Transmission to public health agencies – syndromic surveillance
The proposal expands possible standards to include HL7 CDA and QRDA III for ambulatory users only

40.  Inpatient setting only – Transmission of reportable laboratory tests and values/results
The proposal includes updated HL7 2.51 standards

41. Ambulatory setting only – cancer case information
The proposal decouples content and transport for delivery of cancer case information to registries.

42.  Ambulatory setting only – transmission to cancer registries
The proposal includes updated standards

43. Automated numerator recording
No change

44. Automated measure calculation
No change

45.  Safety-Enhanced Design/Quality Management System
No change

46. Non-percentage-based measures report
Since some of the certification criteria are not percentages, this proposal requires that an EHR be capable of electronically generating a report that shows a user has interacted with the technology capability associated with a non-percentage-based MU measure during an EHR reporting period.    This could be very burdensome and needs to be reviewed.

47. Transmit – Applicability Statement for Secure Health Transport
This proposal certifies only the Direct protocol

48.  Transmit – Applicability Statement for Secure Health Transport and XDR/XDM for Direct Messaging
This proposal certifies Direct and XDR/XDM

49.   Transmit – SOAP Transport and Security Specification and XDR/XDM for Direct
This proposal certifies SOAP and XDR/XDM

50.  Transmit – Applicability Statement for Secure Health Transport and Delivery Notification in Direct
This proposal certifies Direct and end to end result delivery notification

These last 4 criteria may seem confusing, but their intent is to enable EHR vendors to certify as much or as little transport functionality as they want so that an EHR can be a modular component in an HIE/HISP ecosystem.

My takeaways from the 242 pages

1.  60% of the criteria are the same. 40% are modified/new.   Many of the modifications are to correct issues in the 2014 Edition and are reasonable.  Some of the new criteria could be very burdensome.   We need to debate the collective burden of the Meaningful Use program in the context of ICD10, ACA and the HIPAA Omnibus rule burdens.    Each individual project may be reasonable but the collection of all the projects is not.

2.  ONC is proposing more frequent certification NPRMs.   We should debate if increased  frequency is a good or bad thing given the realities of implementation and competing projects.

3.  Overall we should debate the role of certification going forward.  Should government provide a list of EHR functional priorities or should that be left to providers, patients, and developers?   How prescriptive should government be i.e. roads should be 30 feet wide, but drive whatever you want versus your car must have 2 headlights, a catalytic converter, seat belts, and 4 tires versus you must drive a SUV.

4.  Major new concepts in the document to review include
HQMF quality measure definition as a 2017 criteria (import quality measures automatically)
HealtheDecisions for decision support rule importing/knowledge access in 2015
Recording Universal Device Identifier for implants
QRDA II (a new format for quality reporting) as a 2017 criteria
Stratified quality reporting in 2015
Testing CCDA receiving ability with hundreds of  CCDAs in certification,  importing 95% successfully
Searching across the entire patient record
Tracking non-percentage based MU measures in a report
Upgrading lab interface standards including orders
Two factor authentication for e-Prescribing and remote access

5.  Although the fixes are much appreciated, are they too late since most vendors in the Meaningful Use program have already completed the work of certification with the 2014 Edition, despite its flaws?

As with the Meaningful Use Stage 3 proposals, let the debate begin!

Building Unity Farm - Planning for Spring

In the past 18 days, we've had 9 snow days.   The small silver nub in the center of this picture is a yardstick placed in the snow on the patio.

The squirrels can walk up to the bird feeder.    It's time to have a heart to heart with the groundhog who suggested 6 more weeks of this.

For the first time, this week, I cannot split wood because the logs are buried too deep.    Mulch and manure are similarly inaccessible.    The snow banks are as high as the roof of the hoop house, so watering vegetables took an hour of concerted shoveling to find the door.    I carved a moat around the beehives to give them ventilation space amidst the snow drifts.  The Cooper's Hawks are sitting in the trees hoping some rodent finds a path to the surface of the snow.

The snow drifts around the paddocks are now 7 feet high and I've used the Terex front loader to keep the barnyard clear.   However, the trails into the forest and mushroom growing areas are just too deep to access.

With outdoor tasks limited, it's time to plan for Spring.   Here are a few of the action plans

1.  Woodlot management
Last year I split 10 cords of wood by hand.   Although it's great exercise, the wear and tear on joints is high while swinging a 10 pound maul against a 50 pound chunk of solid oak.    It's time for a wood splitter.    As soon as the snow melts, I'll revise the wood processing area to include a storage area for unsplit logs - about 20 cords of oak, black birch, ash, maple, and cedar.   In the center, I'll configure a wood splitter and work table using products from Super Split, a flywheel driven rather than hydraulic approach to wood splitting.    The split wood storage area will hold 10 cords - enough for current burning and aging for next year.   With all that great wood, I'll have to think about creative ways to have fires year round beyond fireplaces and the patio fire pit.    A stone pizza oven or Goemonburo comes to mind, but those are projects for another year.

2.  Seed catalogs
The seed catalogs have arrived and we're selecting the greens, squashes, root vegetables, garlic and onions we'll grow in the 2014 season.   The next week will have temperatures in the 40's so the hoop house will start to be a very productive place.

3.  Bee management
We're rebuilding our hives, moving them to a dry, sheltered, south facing location, and planting bee friendly crops around them.   Our first winter with bees seems to have been successful.   7 of our 8 hives are vigorous and healthy.

4.  Mushroom farm expansion
Now that I have the Terex front loader, I can move logs around the property much more easily.  Before the last snow, I cut a road to a grove of pine trees, the perfect shade for another mushroom growing area.   By Summer, we'll have nearly 500 logs in production, spread in 3 forested area accessible via forest roads covered with wood chips.    When the snow melts I'll also use the Terex to spread a new layer of wood chips on our mile of trails.

5.  Bottling hard cider and mead
The fermentations of Fall are now complete and we're ready to bottle - as soon as we can reach the cider house and use the bottling equipment in the heat of a 50 degree day.    At the moment, we have 60 liters to bottle and I look forward to tasting the hard work of last year's harvest.

Spring will be here on March 20.    We're ready to begin another productive season on the farm.

The February HIT Standards Committee

The February HIT Standards Committee focused on development of the 2014 standards workplan, refinements to meaningful use stage 3 attestation/certification processes, and recommendations for standards to capture patient generated healthcare data.

Jon Perlin led the workplan discussion. Over the next 30-60 days, ONC will reflect on short term and long term policy goals, which will guide Federal Advisory Committee plan development.  We'll use the new strategic guidance to revise the structure of our workgroups/task forces/power teams with a special emphasis on the need for the Policy and Standards Committees to coordinate their work.   Standards Committee members discussed the need to address short term standards gaps while also thinking about medium term strategies (FHIR/REST) and long term aspirational goals (APIs, detailed clinical models).    All also agreed that now is the perfect time to pause and reflect on our progress to date, adjusting our trajectory if necessary.   We look forward to ONC guidance at our March/April meetings.

Next, we heard from Jodi Daniel and Doug Fridsma with an ONC update that covered 4 topics - a framework for thinking about a Learning healthcare system, HITPC letters of transmittal for feedback on specific standards, a Meaningful Use stage 3 review process, and the ONC 2015 Edition Certification NPRM.   A task force will be created to review the Meaningful Use Workgroup recommendations adding standards and implementation feedback such as maturity/applicability of standards and implementation difficulty.    The 2015 Edition of Certification will be voluntary and provides ONC a regulatory mechanism to polish the 2014 Edition based on industry feedback.   We're all optimistic that the 2015 Edition will reduce burden on all stakeholders.

Finally, we reviewed the recommendations for patient generated data and device data transmission to EHRs.   Commenters expressed concern about the balance between innovation at a time when the industry is evolving rapidly and providing highly constrained standards guidance to enhance interoperability.   We agreed that fully integrated shared patient/provider record systems do not need standards as they share a common database.    The Implementation Workgroup will survey the market to identify those classes of applications that would benefit from standards to enhance patient/provider communications across heterogeneous platforms.    We also agreed that devices are evolving rapidly and we should focus on the EHR's capability to receive data from devices/middleware using existing standards such as Direct and CCDA which are already part of Meaningful Use Stage 2

All agreed that the arrival of a new national coordinator brings positive change, new momentum, and a sense of optimism.

Building Unity Farm - Managing the Woodland, Manure, and Bees in Winter

I've written about our winter preparations and keeping the animals healthy in the 6 months of sub-freezing weather we have in New England.   It's been a particularly cold winter in Massachusetts.  It's currently 2 degrees F and we're expecting another foot of snow.

As the snow gets deeper, the icicles get longer, and all unheated water becomes a solid chunk of ice, how do we manage our weekly work routine on the farm?

Our 15 acres of woodland require constant maintenance - bucking fallen trees, removing broken branches, repairing trails/bridges, splitting wood, and making chip piles.

The new Terex PT30 compact track loader makes this job infinitely easier since I previously used a 6 cubic foot wheelbarrow and heavy duty cart to haul logs, branches, and chips.    I've removed trees, brush and rocks along our 1 mile of trails to accommodate the 48" width and 10" ground clearance of the Terex, so I now can reach any portion of the 15 acres with the Terex.   Last week, after a foot of snow, I used the Terex to clear working paths through the barnyard, manure management bins, and wood processing area.  Every week I split about 1/2 cord of wood by hand, which is challenging to do with a few feet of snow on the ground.   My solution is to clear trails with the Terex then use a snow sled to haul wood from the splitting area to the storage area and from the storage area to the fireplaces.    "Sledding" on the farm has definitely improved our winter work efficiency. The carts and wheelbarrow are getting a rest until the snow melts.

Manure management (10,000 pounds per year) is challenging at 2 degrees F in two feet of snow.   Although the manure is biologically warm, the sub-freezing weather yields a frozen blend of manure, hay and snow.   I use an ice chipper to break up the manure in the barn stalls and then move it to a sled dedicated to manure hauling.   As you'll see in the pictures below, we have our own bobsled tracks for manure management during the winter.    I doubt manure bobsled will ever be an Olympic event.

We have over 100,000 bees at Unity Farm, spread in 8 hives, each with 2 deep hive bodies and 10 frames.    We entered the winter with 7 strong hives, and 1 weak hive.   Although we stopped harvesting honey in August and left plenty of food stores for the bees in winter, we supplement the hives with bee tea  (in a 1 gallon tank that fits in the hive) and fondant.    Here are the recipes

Bee Tea
10 cups can sugar
6 cups hot water
fresh or dried chamomile and/or time
1 teaspoon sea salt

Combine sugar and salt.  Add hot water and stir thoroughly.   Boil 2 cups of water and add herbs.  Steep for 10 minutes.   Strain and mix into sugar water solution.  Cool and feed to bees.

Fondant
5 pounds sugar
1 pint light Karo syrup
1 1/3 cups water

Heat in a saucepan to 242°F while stirring constantly – this mix will be boiling for about 5 to 8 minutes before it reaches 242°F . Take if off the heat and let it sit for about 10 minutes to start the cooling process. You then must start stirring until it completely cools. This will take about 20 minutes. It will get whitish in color and thicken up. Once this happens, then you can pour onto paper plats. Don’t wait too long or you will not be able to pour it and get it to the thickness that you need to put in the hives.
(1/4"). When ready to feed, remove paper, break in half and place both halves on the top of hive frames.

Finally, we think of Unity Farm as part of the Massachusetts agricultural community and immediately volunteered to help in this rescue situation.    I'll post additional details as we get more involved.

Time for a New Optimism

Readers of my blog know that over the past year, I've written several posts warning about the burden of 2014 certification, the  timing overlap of numerous federal programs including ICD10, and my observations that IT professionals/providers are at the breaking point.

However, I have reasons to be optimistic and it's not just the approach of Spring.

1.  There is a new national coordinator who is a great listener

I have every expectation that Karen DeSalvo will gather input from stakeholders and adjust the trajectory of national HIT policy within the limits of regulatory process constraints.  She understands the impact of the current federal programs and the challenges providers face getting through each day.  She knows there is a balance between appropriate regulation and over regulation.   She knows that cultural change, even driven with stimulus and urgency, requires incremental progress over time.   We've already seen a few timeline extensions (an extra year of Stage 2, extra time for hospitals and EPs to attest to 2013 reporting periods) and I expect more to come.

2.  There is an opportunity to rethink certification

With CCHIT's closure, delays in 2014 certified product availability, and significant stakeholder discussion about the certification process, all are aware of the need to revise certification.    I envision a day when ONC and its Federal Advisory Committees formulate policy goals for certification (i.e. quality improvement depends upon measurement), but then those actually doing the front line work (vendors, providers, payers, patients) develop practical certification scripts that ensure software supports the policy goal.

3.   The Sustainable Growth Rate (SGR) bills consolidate PQRS, Meaningful Use and the Value-Based Payment Modifier into a single program, eliminating penalties.

Meaningful Use has been a remarkable program, achieving rapid adoption of EHRs in hospitals/professional offices and fundamentally changing the cultural expectation of automation in healthcare.    The SGR bills transition the Meaningful Use construct from a special program to an operational part of value-based purchasing.    Making IT performance part of operational activities related to reimbursement will even out the pace of work.

4.  Meaningful Use might become a stretch goal instead of a floor

If Meaningful Use moves into a “Merit-based Incentive Payment System”, eliminating penalties, the program becomes a way for early adopters and innovators to be recognized for their efforts.    It was very appropriate that Meaningful Use Stage 1 and 2 set a floor and became a tide that floated all boats.  Going forward, it will be very challenging, if not impossible in a resource constrained world, to ensure every healthcare organization performs on the bleeding edge of innovation.   Merit based incentives enable organizations to evolve at their own pace.

5. Meaningful Use is not the solution to every problem and there are signs that other approaches may be used

It's been an honor to work on Meaningful Use, but by 2016, we need to declare victory to avoid having an ongoing special program through which every interested party inside and outside government sees an opportunity to accelerate their own priorities, creating meaningful use fatigue.   Pilots, grant programs, datapaloozas, pay for performance incentives, and competitions all enable us to move forward the technology agenda with a better balance of benefit/burden than an everlasting Meaningful Use program. 

Finally, as ONC and its committees focus more on interoperability that empowers innovation instead of prescriptive functionality (the EHR must do X, Y, Z), we need a roadmap.   I'm very optimistic that the schedule below (which I sense is developing organically among vendors, SDOs, and policy experts) will lead to much more data liquidity, care coordination and patient empowerment in a timeframe that enables us to overcome cultural resistance and policy barriers:

1.  CCD - unified CCR and CDA, first time vendors began exporting a summary, ad hoc device interoperability  (2011)

2.  CCDA - much more constrained, first time vendors began importing a summary,  Continua Alliance IEEE 11073 products emerge, FDA guidance issued (2014)

3.   FHIR/REST - much easier to implement, will result in a substantial increase in modular products connecting to monolithic EHRs, Continua Alliance IEEE standards recommended, no device data transport standards specified  (2017)

4.  APIs - will expand the number of shared data elements from hundreds to thousands and enable read/write workflows, Continue Alliance IEEE standards required, device data transport options recommended (2020)

5.  Detailed Clinical Models (ie. Clinical Information Modeling Initiative) which will begin to standardize the schemas underlying EHRs and then interoperability can happen via APIs linked to standard schemas, ensuring data integrity from point of origin to point of use, device data transport standards required (2023)

In times of struggle, there is opportunity.   2014 is the most stressful time in healthcare IT in our generation.   From that struggle will come a reasonable path forward we can all support.

Building Unity Farm - 'B' School Begins

As I mentioned last week, my wife and I have enrolled in an evening Bee school to formalize the beekeeping knowledge that to date we've picked up from books and our early experiences with 8 hives at Unity Farm.

It's been a hard winter in Massachusetts.   Over the past 24 hours, Unity Farm has had over a foot of wet, heavy snow.   We're waiting for a warm day to open the hives and check on the bees.   Although we've provided supplemental food and kept the hives dry, there is a high overwinter bee mortality in New England, with about 80% of colonies dying.

The bee school will provide us with the best practices and a schedule to maximize the health of our bees.

In many ways, beekeeping is like IT - it requires infrastructure and ongoing maintenance.    Just as with tractors, asking 12 beekeepers for advice results in 13 different recommendations.  Based on all our reading, discussion, and training thus far, we're planning to standardize our hives and tools this Spring as follows:

Each hive
 2 Deep Hive Bodies
 2 Medium Hive Bodies as "Supers"
 20 Deep Frames/Foundation, Divided
 20 Medium Frames/Foundation, Divided
 Telescoping cover
 Inner cover
 Screened bottom board
 Entrance reducer
 Hive stand
 Hive top feeder
 Queen excluder
 Escape Board Screen

Tools
 Smoker/Fuel
 Hive Tool
 Bee Brush
 Frame Grip
 Capping scratcher
 9 frame spacer tool
 Fumagillin

Clothing
 Bee Suit
 Bee Veil/Helmet
 Gloves


We also may need to add new bees to our hives and there may be a shortage this year.  Many bee colonies are overwintered in Georgia.   The "polar vortex" brought freezing temperatures to the most dense apiary areas.    We've ordered several 3 pound "packages" with queens to ensure we're prepared.

We're very excited to take on the additional responsibility of supporting our bees, armed with new knowledge, just as we've taken responsibility for the 100 animals of Unity Farm, keeping them happy and healthy throughout the year.

Standards for Patient Generated Healthcare Data

At last week's Meaningful Use Workgroup meeting, Leslie Kelly Hall and I reviewed the HIT Standards Committee recommendations for patient generated healthcare data from online applications and devices.

We offered guiding principles for Meaningful Use Stage 3 in general.   Meaningful Use should avoid "certification only" items since requiring engineering in products to support untested workflows with immature standards is unlikely to accelerate progress.   We should only apply standards/certification to those processes where they are needed and useful.

For patient generated data sent from interfaced applications, CCDA is recommended as a container for  types of templates that are well understood (e.g. problems, meds, allergies).   CCDA over existing (Direct, Exchange) and other modes of transport are reasonable ways to get data in and out of EHRs, PHRs, and patient facing applications.

CCDA should not be required as the architecture that integrated applications must use.   The outcome goal is for the entire care team (patient/families/providers) to be able to contribute to a shared medical record and that can be achieved without CCDA in a fully integrated application.  We need to allow for innovation and flexibility in this area and not unduly constrain options for individuals to connect with their care teams in the ways they prefer.

For patient device generated data, we need to support innovation, as the marketplace is still rapidly evolving.

Continua implementation guides (and their underlying IEEE 11073 standards) are directionally appropriate, but ONC needs to align certification with FDA guidance and other regulatory or sub-regulatory policy without constraining the marketplace.

Due to the immaturity of the market,  we need to be flexible regarding incorporation of device data and other remote data sources.  Thus, we do not believe a specific standard should be mandated at this time, just an attestation requirement that some approach has been used successfully.

We are fully supportive of efforts to integrate patient generated healthcare data from applications and devices into provider workflows.    By using the CCDA and encouraging market-based innovative device integration, we believe burden and benefit can be balanced.

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
Death

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!