Meaningful Use and Certification Improvements

Today, HHS circulated the following important announcement:

"CMS to Propose New Timeline for Meaningful Use Implementation and ONC to Propose New Regulatory Approach to Certification

I wanted to make sure you were aware that the Centers for Medicare & Medicaid Services (CMS) today proposed a new timeline for the implementation of meaningful use for the Medicare and Medicaid EHR Incentive Programs and the Office of the National Coordinator for Health Information Technology (ONC) proposed a more regular approach to update ONC’s certification regulations.

Under the revised timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 for those providers that have completed at least two years in Stage 2. The goal of this change is two-fold: first, to allow CMS and ONC to focus efforts on the successful implementation of the enhanced patient engagement, interoperability and health information exchange requirements in Stage 2; and second, to utilize data from Stage 2 participation to inform policy decisions for Stage 3.

The new regulatory approach to certification that ONC is proposing would allow for certification criteria to be updated more frequently under the ONC HIT Certification Program. This approach is designed to provide public input on policy proposals, enable our certification processes to more quickly adapt to include newer industry standards that can lead to greater interoperability, and add more predictability for EHR technology developers. We also anticipate that this new approach would spread out over a longer time period the certification requirements to which EHR technology developers have previously had to react.

More information is available at www.healthIT.gov/buzz-blog"

There has been some misinterpretation of this text, so it's important to clarify what it means.

This is NOT a delay of Meaningful Use in 2014 (Stage 1 or Stage 2).   All 2014 certification and attestation deadlines are still in force.  

This announcement adds another year to Stage 2, delaying Stage 3 to 2017 and making Meaningful Use Stage 2 a three year cycle. 

The federal government does things methodically.  Though it may seem that this decision is lower priority than addressing 2014 issues, it needed to happen now.  Since Marilyn Tavenner messaged at HIMSS that there would be "no rule making in 2013," the timeline established in previous regulations had Stage 3 beginning in 2016, which would have ONC and CMS releasing proposed regulations now.

The fact that today's announcement did not address 2014 issues does not imply that no one is listening to those concerns.  Some may complain that they were expecting lunch and dinner but only got lunch.  It's fair to say that lunch comes before dinner.

The second part of the announcement about certification is a good thing for developers of EHR technology.

ONC is starting a new iterative process of certification that will allow ONC to "telegraph the pass" as Acting National Coordinator Jacob Reider said today - giving developers advance warning of functionality that will be expected in subsequent iterations of the certification program, enabling feedback on such intentions very early, and facilitating adoption of new standards/new versions of standards.  Developers will be able to evolve their products as standards evolve, rather than maintaining alignment with old standards that are part of stale certification criteria.  

In summary, today's announcement is a first step in the fine-tuning of the national healthcare IT timeline.  Stage 2 is now a three year cycle beginning in 2014, Stage 3 begins in 2017, and the certification program moves from a waterfall approach to an agile approach.   In the table below, the three's in the 2016 column become two's, without any changes to 2014.

This is important progress and should be welcomed as a sign that HHS is listening.   There is still work to do and I look forward to continued refinements over time.

Building Unity Farm - Preparing for Winter

Snow will begin falling in New England over the next few weeks.    Most nights have subfreezing low temperatures and it's challenging to maintain water sources for the animals and plants on the farm.

How do we do it?  Heated buckets, heated troughs, heated poultry waterers, heating panels, and yard hydrants.

Here's how it all works:

Ducks - ducks are very resilient to cold and enjoy living outside, only retreating to the duck house in the most severe weather.    Within their pen, the ducks have a heated 50 gallon stock tank/water trough and a heated poultry waterer.   Both activate at 35F.  In the duck house, the ducks have a safe Infratherm heating panel which raises  the temperature of the space by 10F and is activated by a 35F on/45F off Thermocube.  Never use a heat lamp to heat a coop.  Every winter, stories abound about unnecessary coop fires.

Chickens - the chickens are also resilient to cold but prefer to roost inside the coop on very cold or windy days.   They have a poultry water heater (activated at 35F), a heated 5 gallon bucket "nipple waterer" which includes 4 small drinking spigots, and 4 infratherm heating panels that raise the temperature of the coop 10 degrees F.

Alpaca/Llama/Dogs - they have 5 gallon heated buckets (activated at 35F)

Hoop House and Barn water - we use yard hydrants which are supplied from pipes buried 4 feet deep below the frost line.  This enables us to fill buckets and water plants even in the coldest part of winter.

We have 350 bales of hay in the loft, 4 tons of alfalfa in the barn, 300 pounds of poultry grain in waterproof cans and 300 pounds of ice melter (animal safe magnesium chloride).

Let it snow!

Commanding Versus Leading

When I first became a CIO, my role involved writing applications and managing architecture at a detailed level.   Over the past 17 years, my role has become much more strategic, ensuring the right investments in the right overall architecture are made with appropriate resources to support them.    I've had to master the political, communication, and interpersonal skills of leading rather than the technical skills of being a strong individual IT contributor.   Although the way, I've learned the difference between Commanding and Leading.

In an academic health center, formal authority is rarely exercised.   The ability to get things done (or not done) depends upon reputation, trust, and personal influence.    The greatest leadership I challenge I face in 2013-2014 is that the plate is overfilled with ICD10, MU2, HIPAA Omnibus Rule, and the Affordable Care Act.   The majority of my leadership efforts involve getting the entire organization to focus on the regulatory must dos, while deferring nice to haves.   I do this because it is the right thing to do for the institution, but equally important is to triage work away from my staff, which are at the breaking point because of too many demands.

Budgets over the next year at most hospitals are not likely to enable the hiring of new resources beyond those needed for ICD10, HIPAA related security updates, and ACA related analytics.   My leadership task is to limit work to the right work, attempting to buffer my staff from the mayhem of competition for scarce IT resources.

With all the tensions and anxieties involved in running governance committees, planning efforts, and communication outreach, what drives me to do it?

I recall reading a quote from General Shinseki about his views on leadership from his retirement message in 2003:

"You must love those you lead before you can be an effective leader. You can certainly command without that sense of commitment, but you cannot lead without it."

I have maintained my role at BIDMC for 17 years because of loyalty, admiration, and affection for my staff.   I've encountered many leaders who do not understand loyalty and are driven by fame, fortune, or the next new thing.    I'm hopeful that my devotion to staff helps with creating a positive culture, reduces turnover, and builds informal authority - a sense that we're all in this together, fighting important battles every day.

Top down command and control works in some organizations and some industries.   Some employees in organizations which thrive on command and control have told me that they work with constant fear of failure/criticism.   My hope is that leadership built on the the strength of employee relationships creates a joy of success motivation without fear.   Whenever bad things happen, and they do, we should ask how our work processes enabled the mistake, celebrating the learning and not blaming the individual.

When I was young, I thought that management meant authority, power, and self-reliance.   Over time, I've learned that management is about relationships, collaboration, and creating a community of people who support each other.   Leading a team of people you admire is much more satisfying than commanding and that's why I'm still a CIO.

Building Unity Farm - Thanksgiving on the Farm

Thanksgiving is a time for family and friends to reflect on the past year, be grateful for the good things that happen every day, and consider the journey we're all on, which is hopefully headed in a positive direction.

On a farm, this day of thanks is very personal.    As with last year, the foods we prepared were either grown at Unity Farm or at a farm within one mile of our dining table.   There was one exception - the cranberries were from a bog on Cape Cod.

We boiled turnips and roasted root vegetables.   We picked mixed lettuce from the hoop house.   We baked pumpkin and apple pies with fruit picked from our orchard. We opened bottles of Unity Farm sparkling hard cider made this Fall in the cider house.  We made stuffing from chestnuts and oyster mushrooms, fresh picked from our mushroom farm.   Next year we'll have shitake to add to the table, but this winter the logs are still in their mushroom growing phase.

The alpaca got an extra helping of alfalfa mixed with molasses.  The dogs enjoyed a few fresh eggs.  The chickens, ducks and guinea fowl got fresh lettuce.

I've described life at Unity Farm as joyful chaos.  There are always chores to do.   There are no vacation days or weekends.   But somehow, I never feel that hauling hay, filling water buckets, turning compost, splitting logs and the constant movement needed to support the plants and animals constitutes work.   We spent the day as a family doing everything needed to support the community living on the farm.   My daughter split ash and black birch logs for the hearth.  I chainsawed fallen trees and branches from yesterday's storm (we had 40 mph winds and 3 inches of rain).  My wife watered our winter produce in the hoop house and planted new vegetables - the hoop house was 80F at midday while the outdoor temperature never rose past 32F.

The family spent the day together doing tasks that benefitted all.

Tomorrow, we have no shopping planned, just tasks that will further help us prepare for the heavy snows that are likely to start in a few weeks.  

This was my first Thanksgiving without my father, so we took time at dinner to pay tribute to those not present - my Father, Kathy's mother, and those who we've known in life who are no longer with us.

I hope you have a peaceful day and many things to be thankful for.   Although we all face many challenges, hopefully you still have a sense that the future will be even better than today.

Rethinking Certification

As stakeholders in payer, provider, and government communities debate the optimal timing of ICD10, Meaningful Use Stage 2, ACA, and HIPAA Omnibus rule deadlines, it's becoming increasingly clear that many hospitals which attested in 2011 and 2012 will not have their 2014 edition certified software installed, training completed, and workflow re-engineered in time for the Stage 2 attestation deadlines.

Now that we have experience with two stages of Meaningful Use, it's also clear that a three year cycle is needed to ensure safe, high value, well adopted, introduction of new IT functionality.

Part of the problem, as I've discussed previously, is that the certification criteria are overly burdensome and in many circumstances disconnected from the attestation criteria, requiring very prescriptive features that go beyond the intent of Policy Committee and Standards Committee.

How did this happen?  When Meaningful Use Stage 2 regulations were being written, ONC entered a "quiet period" in which smart people wrote regulatory language and certification scripts isolated from the rest of the world to ensure there was no bias introduced.   This was a "waterfall methodology" in which elaborate specifications and a long planning process was followed by an isolated development process resulting in a single huge deliverable with little opportunity to validate the result, pilot the components, or revise/improve the product after the fact.  The flaws in the Stage 2 certification scripts are an artifact of the regulatory process itself.

Healthcare.gov taught us that waterfall approaches are risky.    A better approach would be to create certification scripts using an "agile methodology".   Standards and scripts to test them could be developed outside the regulatory process, with iterative stakeholder feedback, testing of components, and rapid cycle improvement.   The regulatory process could point to the standards which would have accompanying implementation guides and test scripts.   There would be no "quiet period" or isolation in the development of certification scripts.    Such an approach would significantly reduce future certification burdens.

In addition to this, I recommend an even more radical redesign of certification.

We should maintain attestation as a demonstration of performance, but limit certification to rigorous standards adoption and interoperability, not prescriptive functionality.

What do I mean?

The Meaningful Use Workgroup believes decision support should be expanded in the future.   I agree.   Although they are now looking at outcomes that demonstrate the use of decision support, their initial work included recommendations for very prescriptive decision support certification criteria including:

Ability to track CDS triggers
Ability to flag preference-sensitive conditions and provide decision support materials for patients
Check for a maximum dose /weight based calculation
Use of structured SIG standards
Consume external CDS interventions
Use info in systems to support maintenance of lists

In effect, this tells vendors how to enhance clinical decision support features.

Let me use analogy.

Suppose that the government decided USB thumb drives are a good thing.   Not only would they specify a USB 3.0 standard, they would require it is black, rectangular, and weighs 2 ounces.    Such prescriptive requirements would stifle innovation since today's USB drives might be in the shape of a key or even mimic a sushi roll.

When evaluating the success of the US healthcare IT program, Congress tends to focus on interoperability - why are there gaps in DOD/VA data sharing or few seamless transitions of care among inpatient and outpatient facilities?

If certification focused entirely on interoperability, EHRs would be a bit more like USB drives.  They might be big or small, black or red, key shaped or sushi shaped.  However, they'll work with any device you plug them into.

I've spoken with many EHR vendors (to remain unnamed) and all have told me that they created software that will never be used by any clinician but was necessary to check the boxes of certification scripts that make no sense in real world workflows.

If certification required rigorous demonstration of outbound and inbound interoperability with no optionality in the standards (use this standard OR that standard), Congress will be happy, patients will be happy, and vendors will be happy.

Once we come up for air after ICD10, MU2, ACA, and HIPAA, I'll be watching any MU3 planning very closely to ensure we do not again make the same mistakes with certification scripts that are untested or too prescriptive.   Let's all focus on universal adoption of enhanced interoperability as a measure of success.

Building Unity Farm - Making the Perfect Cider

In North America, we think of apple cider as a non-alcoholic drink available for a few weeks in the Fall.   Before prohibition, most cider was fermented to 4-6% alcohol as a means of preserving it.  Cider was available from casks throughout the year.  John Adams drank a quart for breakfast every morning.   Puritan laws urged moderation and suggested no more than half a gallon of cider be consumed per day!

When I use the term cider, I mean fermented cider.

Over the past few years, there has been a resurgence of interest in craft ciders from such producers as Farnum Hill (Poverty Lane Orchards in Lebanon, NH), West County (Colrain, MA), and Julian (San Diego area)

Having tasted dozens of craft ciders, I know that creating the ideal Unity Farm cider will require significant experimentation.   I've read 5 books about traditional cider making and their collective advice is to balance a blend of sweet, sharp (tart), aromatic, and bitter (tannic) apples using this template

Sweet (30-60%)
Sharp (10-40%)
Aromatic (10-20%)
Bitter (5-20%)

The Unity Farm orchard yielded some apples this year, but not enough to press a batch of cider, so we purchased apples from local farms in Sherborn.

Last weekend we pressed 400 pounds of apples as follows

Sweet - Empire (1.5 bushels), Baldwin (1.5 bushels), Cortland (1 bushel), Spencer (.5 bushel), Macoun (.5 bushel)

Sharp - Stayman Winesap (1.5 bushels), Northern Spy (1 bushel), Granny Smith (.25 bushel)

Aromatic - McIntosh (1.5 bushels)

Bitter - although we wanted to add crab apples or Newtown Pippin, none were available

This mixture created 18.5 gallons of juice with a ph of 3.65 and a specific gravity of 1.055.  Using the template above, our distribution of apple types was

Sweet  54%
Sharp  30%
Aromatic 16%
Bitter 0%

I sterilized the cider with 50ppm of Potassium Metabisulfite (appropriate for a cider with a ph of 3.65) and let the sulfite decline for 48 hours before inoculating with Champagne yeast and yeast nutrients.    I used a 60 liter Spiedel fermenter.

The initial fermentation will take 2 weeks and then I will rack the cider and allow 2 additional weeks for the end of primary fermentation.   I'll assess the flavor and ph at that time and if necessary will encourage a secondary malolactic fermentation to reduce total acidity.

This batch will be still cider (not carbonated) so I will sulfite again and bottle into 22 ounce brown glass bottles.  I'm using an early 1900's cast iron bottle capper to ensure a good seal.

At Christmas time, I'll taste our sparkling and still cider experiments to gain a better understanding of the apple blending art.

We're looking forward to the output of our 33 apple trees in the next few years.    Using the sweet, sharp, aromatic, and bitter template we planted these trees in the Unity Farm orchard:

2 Empire (sweet)
  Braestar (sweet)
  Northern spy (sharp)
  Whitney Crab (bitter)
  Ben Davis (sweet)
  Winesap (sharp)
  Granny Smith (sharp)
  Cox Orange Pippin (sharp)
  Pink Lady (tart)
2 Red Delicious (sweet)
  Fuji (sweet)
  Macoun (sweet)
  Arkansas Black (bittersharp)
  MacIntosh (aromatic)
  Gala (sweet)
  Roxbury Russet (aromatic)
  Rome Beauty (sweet)
  Honeycrisp (sweet)
  Sheep nose (sweet)
  Cortland (sweet)
3 Kingston Black (bittersharp)
  Ashmead's Kernel (aromatic)
  Newtown Pippin (bitter)
  Golden Russet (aromatic)
2 Wickson's Apple (tart)
  Nehou Apple (bittersweet)
  Baldwin (sweet)
  Blacktwig (tart)

Most are heirloom cider apples from the UK and France.

To me the perfect cider is crisp, complex, and never cloying.   In a month, I'll have a better idea how close I've come.

Fine Tuning the National Healthcare IT Timeline

I've recently written about healthcare.gov and the lesson that going live too soon creates a very unpleasant memory.

As I work with healthcare leaders in Boston, in New England, and throughout the country, I'm seeing signs that well resourced medical centers will struggle with Meaningful Use stage 2 attestation, ICD-10 go live, HIPAA Omnibus Rule readiness, and Accountable Care Act implementation, all of which have 2013-2014 deadlines.

People are working hard.   Priority setting is appropriate.   Funding is available.

The problem is that the scope is too big and the timeline is too short.

What are the risks?

Because of the complexity of the Meaningful Use stage 2 certification process, many stage 1 certified products have not yet been certified for stage 2.   Those that are stage 2 certified have only been recently introduced into the marketplace, making upgrades, training, testing, and full implementation before July 1, 2014 (the beginning of the last reporting period for hospitals which attested to stage 1 in 2011 and 2012) very challenging.   I believe that we could see hundreds of hospitals fail to attest to Meaningful Use stage 2 by the current deadline, despite their best efforts.

We learned from healthcare.gov that end to end testing with a full user load and complete data set is important to validate the robustness of an application.   ICD-10 go live for every provider and most payers (other than Workman's Comp) is 11 months away.    Does CMS have time for a full end to end test of all functionality with its trading partners?   I am concerned that not enough time is available.    Will most payers and providers be ready to process transactions on October 1, 2014?  Maybe.   Will new documentation systems, clinical documentation improvement applications, and computer assisted coding to ensure auditable linkage between the clinical record and the highly granular ICD-10 billing data be in place?  Doubtful.    Will RAC audits discover that not enough time was available for training, education, testing, innovation, and workflow redesign?  Certainly.    The risk of a premature ICD-10 go live will be the disruption of the entire healthcare revenue cycle in the US.   The consequences of a delay in enforcing ICD-10 use are minimal.

ONC federal advisory committees are taking testimony from multiple stakeholders regarding the technology and policy readiness of provisions in the HIPAA Omnibus rule such as the Accounting of Disclosures and private pay redaction requirements.    It's very clear that more time and more research is needed before these elements of the law can be enforced.

The Affordable Care Act has many provisions including a move from fee for service to reimbursement based on quality. Quality measures were to be automatically submitted using the QRDA standard.  On November 5, CMS backtracked and announced that they would not accept the QRDA formats and all reporting for January 2014 would revert back to a manual web upload process called GPRO.   It is clear that CMS is not ready to move forward with ACA implementation on the original planned timelines.

So what should we do to fine tune the national healthcare IT timeline?

Meaningful Use Stage 2 attestation timelines should be extended by 6 months to enable recently certified products to be fully implemented in a safe and thoughtful way.    90 day reporting periods for hospitals begin October 1, 2013 and for eligible professionals begin on January 1, 2014.  Attestation must be completed within one year.  Extending attestation to 18 months will give us time to implement new software upgrades properly.

ICD-10 enforcement deadlines should be extended by 6 months to enable additional testing and workflow redesign.  The October 1, 2014 deadline may work for some providers and payers. Transaction flow can begin if systems are functional.   However, a 6 month extension will enable providers and payers to revise and improve systems before a mandatory full cutover.   We need to do this to avoid another healthcare.gov situation.

The Accounting of Disclosures and private pay redaction aspects of the HIPAA Omnibus rule should be delayed until pilot implementations can be studied and lessons learned broadly shared, likely a year.

Affordable Care Act implementation should await for maturity in the tools needed to support care management and quality reporting, likely another year.

All of these projects can be done and are reasonable components of national efforts to improve quality, safety, and efficiency.

However, the well meaning people who devised the policy principles did not take into account the operational requirements to do all this work simultaneously.   We should keep moving forward on these goals, but need to adjust the pace.    We all want to finish the race and not collapse before the finish line.