Thursday, December 31, 2015

Unity Farm Journal - 5th week of December 2015

It’s been a great first week with pigs.  Hazel Marie, the 100 pound two year old pot belly, experienced her first snowfall.   Although I’m building all season dutch doors for the pig barn, they are not finished yet, so I installed a piece of plywood in the doorway, cutting out a piece so that she can easily access the entry ramp.     The end result has been a warm, dry, snow-free pig barn filled with fresh hay, a heater, and a blanket.   Hazel arranges a deep pile of hay then burrows into the blanket.   Every morning we play find the pig - she’s invisible curled up in her nest.

I mentioned last week that we would be getting Hazel a companion.    Meet Tofu, a three month old pot belly pig that weighs 20 pounds.   Don’t be fooled by his diminutive appearance - he’ll outweigh hazel soon.     He’s very outgoing and enjoys the same fresh fruits, vegetables, and grains as Hazel.   They ate dinner together separated by a square of dog fencing in the pig barn we’ll use to keep them apart until they adjust to each other.

The freezing rain, sleet, and melting snow have covered the farm in a sheet of ice.  Every surface is slick and challenging to navigate.   Walking the dogs is an extreme sport - imagine 250 pounds of dogs pulling 170 pounds of me on a sheet of glass covered with butter.    I call it “boot skiing”.    So far, no orthopedic injuries.

All the families have left post Christmas and life has returned to normal.   What is normal on Unity Farm?  Wake up at dawn, dig a 40 foot trench for a ground wire, install electric fence cable with the help of a pig, and  connect the power supply to a new circuit in the pig barn.    Hazel and Tofu now have a hot wire on the top of their paddock fence to keep out coyotes.

This weekend, I’ll finish up the pig barn door and continue my work on tree house railings and stairs.   We’ll have temperatures in the 40’s without snow this weekend, making outdoor carpentry possible.

Of course, when the weather turns cold and snowy, there is always indoor work to do on my winter semester Umass coursework - Backyard Homesteading.    This week we created maps of our homesteads and did a water analysis.    Here’s my finished presentation of the material.

Next week will be a caloric analysis - what do we need to grow to feed ourselves based on daily requirements for protein, carbohydrates, and fats?   Today we grow about half our food and with each passing year we get better at raising crops on a predictable schedule.

Next week I’ll post our farm goals for 2016.

Happy New Year!

Wednesday, December 30, 2015

The 2016 Standards Advisory

ONC recently released the 2016 Standards Advisory.  I think this document is more important than Meaningful Use or Certification in accelerating interoperability.  Why?

Many view Meaningful Use as no longer aligned with the work we need to do for population health, care management, and alternative payment models.   The more aligned activities - the Affordable Care Act (ACA), Medicare Access & CHIP Reauthorization Act of 2015 (MACRA),  and private payer risk-based payment models  - require health information exchange for care coordination and quality/financial benchmarking.   These programs create a business need for interoperability affecting a large percentage of an organization’s income versus Meaningful Use which at this point is a penalty program creating a small reduction in an organization’s income.  When there is a business need and enabling technology, interoperability happens.   The Standards Advisory gives developers, providers, and patients a list of enabling technologies, documenting their level of maturity and adoption for a given purpose.   The marketplace can decide which standards are good enough, what risks to take on promising evolving standards, and which standards to retire as technology progresses.

Standards making is all about reduction of optionality - constraining the methods to represent information and transport it.   To me, the Standards Advisory is exactly what government should do - convene experts to determine which standards are appropriate for purpose - then let industry decide what to implement based on the business need.

The process used to create and refine the Standards Advisory is a good one, in part based on this paper by Dixie Baker,

Importantly, the Standards Advisory is a continuous process, not one that sets a standard in the concrete of regulation/legislation that is hard to change.  The advisory process is agile and likely to be more transparent than the regulation making done behind closed doors.   The list of best available standards can include some standards that are not yet ready for production since the document is just a roadmap to what is available at a given time, not a regulation.  

In the past, many HIT Standards Committee experts have advised ONC not to include standards like HPD (a provider directory standard) because it is not suitable for purpose in an internet connected, cloud-based, mobile friendly EHR world.   Standards Committee members prefer the FHIR-based directory services that are being piloted in the Argonaut project (    With the Standards Advisory, the debate of HPD over FHIR becomes moot since both can be listed as available standards along with descriptions of their functionality, maturity and adoption.   The industry can then decide which is more fit for purpose.

As I’ve written about previously, it is my hope that CMS eliminates the Meaningful Use Stage 3 penalty, uses pay for performance incentives based on outcomes as part of MACRA to replace Meaningful Use goals, and that certification for stage 3 will rarely be done because it is a purely voluntary program.   Redirecting our focus to customer requirements rather than regulatory compliance will accelerate innovation.     The combination of outcomes-based performance incentives and the yearly publication of a standards advisory is a great path for the future.

Thursday, December 24, 2015

Unity Farm Journal - Fourth Week of December 2015

Last week I mentioned the Unity Farm Christmas list.

I’ve been an avid student of permaculture - creating an ecologically sustainable farm that keeps everything in balance.    I harvest thousands of pounds of vegetables per year but compost  the imperfect vegetables..   There must be a better way.

Hazel Marie is the answer.

Welcome the latest addition to Unity Farm, our 100 pound pot bellied pig.  We rescued her (as we have done with several of our farm animals) from a home which abandoned her to the MSPCA/Nevins Farm.   She is a delight with a constantly wagging tail, boundless energy and curiosity about the world around her.    I plan to walk her around the property on a harness and she’ll live in one of our pastures in the newly finished pig barn.   Last weekend I added heated water buckets, a panel heater (pig safe) and interior LED lighting.

My daughter, Lara Marie, approves of Hazel Marie as our official surplus vegetable consumer.   We will find Hazel Marie a piggy companion once we have more experience with pigs.    We really like Patches, a 200 pound male recently surrendered to Nevins Farm, but he will grow to 800 pounds.   We’re not sure we can handle that much pig.   Kathy’s Christmas gift to me is Hazel.

Kathy has had significant joint pain and neuropathy since her chemotherapy.   Hauling hundreds of pounds of bee hives around our 15 acres has been difficult for her.   Although I’m 53 and relatively fit, I find hauling hundreds of pounds of lumber, tools, mulch, vegetables, and firewood around the farm to be fatiguing too.    The Terex front loader is great for rocks, mushroom logs, snow, manure, and wood chips, but it’s not something you drive casually for transportation.    The answer - a golf cart utility vehicle.   My Christmas gift to Kathy is a Yamaha Adventurer One, a golf cart with a 300 pound hauling capacity for her to to drive around the property and do all the things she wants to do, regardless of any physical limitations.

What about stocking stuffers?   I asked Kathy for Havahart vole traps so I can reduce the damage to the hoop house vegetables during the winter when small furry creatures take refuge in the vegetable beds.    I also asked for a labeler/gluer that enables me to put formal labels on all our cider, beer and mead bottles.

Finally, for the family, I finishing the build out of the treehouse I started in the summer.   Although a platform without railings 15 feet in the air sounds great to me, it’s not appealing to everyone.    Here’s the progress thus far turning the platform into a finished 12x12x12 foot cube, suspended in air but accessible via a 3 foot staircase protected by railings.    In Spring I’ll add a roof.   I think the family will like it.

Although Christmas day will be 60 degrees, we’ll soon have the chill of January, so I’ve tucked the vegetables into their raised beds with row covers.   Here’s what the hoop house looks like now.

The farm is looking festive as we approach the holidays.    The cider house has wreath under the barn light, as does the barn, the tool shed, and the house entrance.

The inlaws, outlaws, and all our close family will be at the farm for the next few days.    We’ll revel in the warmth of the season, each other’s company, and gentle sounds of geese, pigs, dogs, alpaca, ducks, chickens, guinea fowl, and cats all living in harmony at Unity Farm.

And to all a good night!

Wednesday, December 23, 2015

My 2016 Predictions for HIT

As the year ends and we archive the accomplishments and challenges of 2015, it’s time to think about the year ahead.  Will innovative products and services be social, mobile, analytics, and cloud (SMAC)?  Will wearables take off?  Will clinicians be replaced by Watson?   Here are my predictions

1.  Population Health will finally be defined and implemented -  Recently I asked a number of clinicians to define population health.   Although no one could define it, they were sure that their current EHR did not provide the desired functionality.    To me, population health tools in 2016 will automatically aggregate data from multiple provider, payer and patient sources then create lists of patients with care gaps to be closed.    This article in Harvard Business Review illustrates some of the functionality we’ve built at BIDMC in anticipation of 2016 needs.

2.  Security threats will increase - Two weeks ago, the Attorney General for National Security from the Department of Justice visited Boston to meet with a group of CIOs and CISOs, describing the escalating number and sophistication of cybersecurity attacks.   He concluded that if a device is internet connected, it will be compromised.   At BIDMC, we will continue to invest millions in security technology, rewrite many of our policies and invest in continuous security education for all our staff.   Despite our best efforts, I cannot promise a breach-free year in 2016.

3.  The workflow of EHRs will be re-defined.   In 12 minutes, can a clinician enter 200 structured data elements, manage 140 quality measures, be empathic, never commit malpractice and make eye contact with the patient?   Nope, it’s impossible.   This Wall Street Journal piece illustrates the problem

The EHR must evolve from a fraud-prevention tool in a fee for service world to a team-based wellness tool supporting alternative payment models.    I’ve told CMS that the ideal EHR will be a combination of Wikipedia (group authored notes) and Facebook (you’ll have a wall of health related events)

4.  Email will gradually be replaced by groupware - Managing daily email is a burden with minimal rewards.  Facebook has announced Facebook for Work to provide enhanced communication among teams, supported by enterprise grade security.    I receive over 1500 emails a day and might declare email amnesty in 2016 (an out of office message declaring email to be an ineffective communication medium and suggesting that I will never respond)

5.  Market forces will be more potent than regulation - Meaningful Use has accomplished its goals.   MU is dead, long live MU.   We need to move away from prescriptive regulations so complex that no one understands them.  Instead, we need pay for performance based on outcomes, giving providers and industry the freedom to achieve these outcomes using whatever technology they feel appropriate.

6.  Apps will layer on top of transactional systems empowered by FHIR - Epic, Cerner, Meditech, Athena, and eClinicalWorks are all fine companies.  However, will the next great app be authored by their staff?   I’m guessing a better approach is crowdsourcing among clinicians that will result in value-added apps that connect to underlying EHRs via the protocols suggested in the Argonaut Project (FHIR/OAuth/REST).   One of our clinicians has already authored a vendor neutral DICOM viewer for images, a patient controlled telehealth app for connecting home devices, and a secure clinical photography upload that bypasses the iPhone camera roll.    That’s the future.

7.  Infrastructure will be increasingly commoditized - In 2016, I will be moving select applications to Amazon and Google.  They can offer a better/stronger/faster/cheaper service because of their scale than I can do myself.    They are willing sign Business Associate Agreements.   Why do I want the risk of operating multiple data centers myself for commodity services like web hosting?

8.  Less functionality with greater usability will shape purchasing decisions -  Recently a clinician told me that EHR A has half the features of EHR B, therefore EHR A is twice as good!   Remember Wordstar and Word Perfect?  Try authoring an outline in the most modern version of Microsoft Office.    Prepare to have your work destroyed by feature bloat in Office.   Clinicians want usability, speed, and simplicity, not more features.

9.  The role of the CIO will evolve from provisioner/tech expert to service procurer and governance runner - From 1996-2001 I wrote many of the foundational applications of Beth Israel Deaconess.   My education at Stanford, UCSF, UC Berkeley, Harvard, and MIT enabled me to innovate rapidly as a clinician, domain expert, and engineer.  Today I do not write code and my role is to empower/enable talented people around me with funding, protected time, and political will.    The CIO of 2016 will increasingly be an orchestra conductor and not a technology expert.

10.  The healthcare industry will realize that IT investments must rise for organizations to meet customer expectations, survive bundled payment reimbursement methods, and create decision support/big data wisdom - I often tell my stakeholders that scope, time and resources are tightly coupled.   You cannot increase scope without increasing time or resources.    As more automation is deemed critical for the needs of the business, IT budgets will be increased as a strategic imperative.   There will be a tension - the CFO will want to increase capital budgets (purchasing of stuff) while the CIO will want to increase operating budget (purchasing of services and subscriptions to cloud functionality)

That’s my top 10 list.   And no, Watson, will not replace clinicians, although Natural Language Processing is a technology to watch in 2016.   Other companies will do it better than IBM.

Happy Holidays!

Thursday, December 17, 2015

Unity Farm Journal - Third Week of December 2015

December continues to be unseasonably warm.   The bees are very confused - breaking cluster and leaving their hives in search of nectar which is not available this time of year.   We’ve created feeding boards for each hive, covering a hardware cloth screen with a patty of sugar.     The bees will recover, but we’re worried about the fruit trees and bulbs, which seem to think it is Spring.   If full budding occurs now, the buds will die in January when the cold and snow return.

I just finished the Fall semester of my Umass Stockbridge Farming program, Organic Vegetable Production.   For my final paper, I created an organic treatment plan for Unity Farm in the framework of a local pest and disease primer for Sherborn, Massachusetts.  Here’s the full text of the paper 

The work on the mushroom area I described last week is now complete.   We have a comprehensive mushroom management plan, infrastructure, and processes.    Kathy and I have about 150 new logs to inoculate and the racks are ready to store them.

Last weekend we completed the last barn cleaning before winter, using our large shop vac and industrial strength Stihl Magnum blower to remove all the hay, dirt and dust that had accumulated over the year.   In theory, the animals will be spending time in the barn soon, when the first snows of winter fall.    The barn is so clean and orderly that a visitor suggested we be nominated for “Farm Beautiful” magazine (which does not exist).

The ground is still thawed and we finished all our 2015 planting - 10 new beds of American ginseng as well as 6 new Korean Bee Bee trees , a late summer bloomer to extend the nectar sources for the hives into the Fall.

As the end of the year approaches, I’m very happy with everything we’ve accomplished at Unity Farm this year.   There are a few small items we’ll need to improve our workflow.  It’s time to prepare the Christmas list, which I’ll share next week.

Wednesday, December 16, 2015

The December 2015 HIT Standards Committee Meeting

The December 2015 HIT Standards Committee focused on 3 key projects as we wrapped up our work for the year.

Cris Ross presented the work of the  Certified Technology Comparison Task Force .  The idea behind this work is simple.   Although certified technology includes a number of specific functions outlined in various regulations, it may or may not be fit for purpose by a given specialist or in a given clinical environment.  The group seeks to Identify the different health IT needs for providers across the adoption and implementation spectrum, with particular focus on providers with limited resources and/or lower adoption rates and publish tools to enable comparison of different applications.    Hearings from many stakeholder groups are planned.

Chris Chute and Floyd Eisenberg presented the recommendations of the Transitional Vocabulary Task Force.     Over the years, the HIT Standards Committee has learned that optionality is barrier to interoperability.   Offering a choice of different standards - an “or” - becomes an “and” for developers as well as creates data heterogeneity among clinicians using different vocabularies.     The task force recommends eliminating different vocabulary choices over time and implementing a single vocabulary per domain i.e. SNOMED-CT for all problems/diagnosis and LOINC for diagnostic study names.

Finally, Jon White presented an update on the Precision Medicine Task Force, identifying enabling standards.

Our next meeting on January 20 , 2016 will include all the members of the Policy Committee and Standards Committee.   It will be my last meeting and I will pass the baton to my successors Arien Malec and Lisa Gallagher.   I know the  HIT Standards Committee will be in good hands!

Thursday, December 10, 2015

Unity Farm Journal - Second Week of December 2015

We’ve had a very warm December that has enabled us to do much more outdoor work than usual.    The effort of the past weekend  focused on refining our mushroom areas and permaculture plantings.  

Our end goal is 500 logs in production as follows

360 Shitake logs (4-8”) on 30 a-frames (pictured below)
 36 Shiitake logs (8-12”) on 12 4x4 bases
 24 Ganoderma Lucidum (Reishi) on the ground
 24 Nameko (Japanese mushroom) on the ground
 56 Oyster totems

We’ve decided to discontinue Lion’s Mane (poor yield) and retire those oyster logs that are no longer fruiting.    Last weekend we used the Terex front loader, forks, and our manure hauling trailer to move all the old logs into an a large pile adjacency to the orchard road where a commercial grinder can reduce them to wood chips for our trails.

Going forward we’ll focus on Shitake for 3 reasons
1.  Price point is nearly double of other types of mushrooms
2.  Shelf life is weeks, not days
3.  Fewer insect pests attack Shitake

Next weekend I'll be wrapping up my latest University of Massachusetts course, Organic Vegetable Production.   My final paper “Organic Pest and Disease Control in Sherborn, MA” covers all my experiences raising vegetables at Unity Farm, as well as the experience at surrounding farms - Sunshine, Sweet Meadow, and Dowse.    It will serve as a primer for agricultural practices at Unity for years to come.

As the holiday season approaches, we’re getting ready for the visit of family and friends.   As farmers, we’re very tolerant of our close partnership with the land and the animals we support.  We do not impose our lifestyle on any visitor.   If you want to shovel manure, you can, but there is no expectation that any visitor will follow our daily routines.   Tree house climbing, zip lining, hay hauling, forestry management and tractor driving are only for the willing!

It’s deer hunting season in Massachusetts (shotgun Nov. 30 – Dec. 12 and Primitive Firearms Dec. 14 – Dec. 31).   Local deer seem to know that Unity Farm is a vegan/vegetarian priority, so we have a deer freeway around our barnyard.   The alpaca/llama do not like deer (not clear why) and tend to trumpet in alarm when deer graze around our paddocks.    The Great Pyrenees always react to alpaca alarms with their own barking,  all night long.     You may have seen memes of the World’s Most Interesting Man - “I don’t always….”   Here’s our version:

We've posted no hunting signs every 50 feet around the perimeter of our 15 acres.   Given that rifle bullets can travel miles (assuming they miss their target and trees), we need to ensure our 150 animals are not harmed in any way during hunting season, so we have created a buffer zone using our property and surrounding properties.   We are careful to wear bright colors and avoid runs through the forest at dawn and dusk during hunting season.   I look forward to less 3am barking when the deer return to their usual range after hunting season!

Wednesday, December 9, 2015

The State of Information Security 2015

When I wrote about the most important healthcare IT stories of 2015 (such as ICD-10 and Meaningful Use), I did not include a discussion of Information Security.   That’s because security deserves its own post. Increasingly complex threats and an array of new security technology, policy, and education projects consumed us all in 2015.

Last week, I met with the Department of Justice Attorney General for National Security.  His message was clear.  With state-sponsored cyberterrorism and organized cybercrime on the rise, every internet connected device will eventually be compromised.  The only question is when.  By the way,  he works in a safe room without an internet connection.

2015 has been filled with denial of service attacks, hard to detect malware, and a skyrocketing number of personal internet connected devices at the same time that HIPAA enforcement has expanded.   The traffic on my guest networks from visitors using mobile devices has exceeded the traffic on the business network.   Meaningful Use requires us to share more information with more people for more purposes, but the HIPAA Omnibus Rule requires us not to lose a byte.

How did we survive the security challenges of 2015?

First, it is important to understand the threats and mitigate those vulnerabilities with the highest likelihood of being exploited and doing the most damage.    What is the #1 risk?


The cartoon below illustrates the problem.

We spend millions on new technology, countless hours on policy writing, and engage all stakeholders to enhance their awareness.    Yet, we’re as vulnerable as our most gullible employee.

The scenarios I’ve seen in 2015 include:

*a clinician downloads an infected copy of Angry Birds to an android phone then logs into email.   The username and password is captured by a keystroke logger embedded in the running game software.   Massive spam is sent and the email domain is blocked by commercial internet providers

*A carefully crafted email encourages clinicians to login to Oracle financials to claim their yearly bonus.  A hospital’s Oracle Financials site is mimicked at a reasonable sounding URL.     Usernames and passwords are stolen and are used to change direct deposit information in the real Oracle Financials application.

*Social networks are used to infiltrate home computers and steal credentials.

Not only have we significantly increased our education efforts, but we’ve also put various filters on incoming email to scan every embedded URL and every attachment before delivering messages.   We’ve implemented various filters to prevent outgoing mail and internet traffic from exfiltrating sensitive data.  We require attestation that every device used by every person is encrypted and physically secured.

Our tools and dashboards identify variance in device, software, and people behavior.

Our security staff has been significantly increased.

Boards and senior executives are very sensitive to the reputational risks around security.   Security is supported by committees that include working groups, senior management compliance groups, and Board groups.

I’ve signed several vendor contracts in 2015 that include new liability and indemnification language protecting BIDMC against third party claims around breach issues.

The bottomline for 2015 - the threats increased and the technology, policy, and education efforts were redoubled.    Although ICD10 and Meaningful Use work may be diminished in 2016, security work is likely to increase.   As I’ve told the Board, security is a process, not a project.   You’ll get better and better but will never be done.

Thursday, December 3, 2015

Unity Farm Journal - First Week of December 2015

Thanksgiving was a busy time at Unity Farm, turning our harvest into dinner for the family, “in-laws to be”, and all the animals.  

Life on the farm is one of constant learning - every day is filled with new experiences and challenges.  We somehow muddle our way through.

On Thanksgiving, one of our Americauna chickens, Amelia, was scared by a fox and hid under the shed in our pasture.   At times,  various creatures hide under the shed, but they always come out.   Two days later she was still under the shed and we had to take action.   The usual techniques - bamboo poles, a Stihl blower and 2x4s did not work.  We had no idea what to do, so we improvised.   We waited until after dark and when she was asleep we dug a trench under the shed and I delicately grasped her legs, protected her wings, and brought her back to the coop.   She ate and drank heartily.   At this point, she probably thinks the shed incident was just a dream.

We are a commercial kitchen and thus every year we have to sterilize our well to ensure good hygiene - no soil coliforms.    Our well is 300 feet deep and 6 inches in diameter.  Think of it as a 450 gallon column of water.     We add half a gallon of  8% sodium hypochlorite solution (germicidal bleach), then flush the resulting solution through all the pipes in the property.    This year, we did our sterilizing a week before our Thanksgiving guests arrived and all went well.   With all the guests in the house, water usage peaked and they drew down on the column of water much faster than Kathy and I would.    The end result was that more bleach passed faster  through the pipes than usual and the iron in the water precipitated turning our water orange/red.   We had no idea what to do so we improvised.   We connected a hose from the house to the well and ran it for 4 hours, passing it through a course filter along the way.      The end result was clear water with minimal chlorine smell.

The tractor parts we ordered for winter arrived this week - a pair of forklift forks and a 52” snowblower attachment for the Terex.   I’m very excited about sitting in the Telex, listening to 1970’s tunes, staying warm/dry, and moving 10 tons of snow per hour.

Last Fall we planted Ginseng - 5000 seeds and 500 roots on an east facing slope.   The deer ate many of our seedlings and it was not clear how many sprouted.  This year, we’re taking a more scientific approach.   Last weekend I built 10 raised beds laid out in a grid around the property - in shade, partial shade and partial sun.   In wet soil and moist soil.   In oak woodland and maple woodland.    I fenced each area using 5 foot welded wire fence on 6 foot T-posts.  By next May we’ll be able to count successful seedlings and determine what environment is best.

Now that every night is dipping below freezing, I covered every raised bed in the hoop house with row covers to enable growth even in the low 20’s.    At this point, our spinach, chard, lettuce, turnips and carrots are still doing well under row covers despite freezing nights.

Next weekend I will begin refining our Mushroom log collection based on what fruited this Fall and what did not.  I’ll retire some logs and layout new areas for freshly inoculated logs.   Our plan is to keep a steady state of 500 Shiitake logs, 24 Reishi mushroom logs, 24 Nameko mushroom logs, and 50 Oyster logs.    As a farm, we need consistent production that matches supply and demand.   After this weekend, our mushroom areas will be optimal.

Wednesday, December 2, 2015

2015 In Review

It’s now December and as each year ends, I always look back on the challenges and achievements of the past 12 months.    Here’s my sense of 2015.

ICD10 - billions were spent, countless other projects were delayed, and the transition occurred on October 1 without a major incident.   We’re monitoring daily cash at all our hospitals and there has not been significant impact on denials, payments, or discharged but not final billed accounts.    Did we get our money’s worth?    I have argued and will continue to assert that ICD-10 benefited no one.  The diagnoses used are more variable so there is less precision in their use.  Clinical documentation (in general in the industry) does not have the specificity needed to justify the more granular ICD-10 codes.    The notion that quality measures can now be computed more accurately from ICD-10 coded administrative data is just not true.     The right path is to plan for a future in which fee for service is replaced by bundled payments so that ICD vocabularies do not need to be used at all for billing.    Natural language processing  will be able to turn unstructured text into SNOMED-CT coded observations to support analytics.    I know that ICD-9 is obsolete and did not include many modern concepts.   However, we should have saved our billions and waited until natural language processing and SNOMED-CT was ready (or a convergence of SNOMED-CT and ICD ideas such as will be implemented in ICD-11)   The end result of years of work 2012-2015 is that many IT stakeholders think IT was distracted by projects that added little value.  The good news is that now that ICD-10 has passed, we can return control of IT priority setting to customers.

Meaningful Use - Stage 2 was revised and Stage 3 was finalized with a comment period.    We can only hope that the comment period convinces CMS and Congress to shift the Meaningful Use program into a merit-based payment incentive program, acknowledging the Meaningful Use has achieved its goals.   Just as with ICD10, we need to turn the IT agenda back to customers - patients and providers - who want improved quality, safety and efficiency.   As we’ve seen with Stage 2, it is too early to propose a Stage 3, because we do not really know what has worked in Stage 2.   I have advocated for moving to an outcomes approach.    If you want to give Apple Watches to all your 80 year olds to monitor their exercise patterns and support a patient-based medication administration application on the watch, go for it.   If you want to hire high school students with clip boards to visit elderly patients and do home checks, go for it.   The outcome might be better health and fewer hospitalizations.   The tactics should be up to patient centered medical homes and ACOs, not regulation writers.     My secret hope is that CMS decides to remove the penalty phase of Meaningful Use, enabling every EHR vendor to ask their customers - should we spend the next 3 years implementing the Certification rule (which is voluntary) or just ignore the entire Meaningful Use program and innovate to accommodate the needs of alternative payment models?  My guess is that the majority of hospitals and professionals would tell vendors to abandon the certification effort and focus on value added enhancements.   At that point, the Meaningful Use program could be considered a success and be moved into a historical status - still on the books, but not pursued by most.

HIPAA Omnibus Rule - In 2015 we were told to share more data with more people for more purposes, but to never allow a single byte to go astray - an impossible task.    OCR stepped up HIPAA Audits and enforcement at a time when threats from cyberterrorists, organized crime, and hackivists peaked.    Rather than focus on all the vulnerabilities and the mistakes made as documented on the wall of shame, I’m hoping that as a country we can focus on the positive - working together as a society to identify the real threats and collectively take action to mitigate risk through policy, education and technology.    We need to stop creating a climate of adversity among regulators, providers and IT departments.    Later this week, I’m meeting with National Security leaders from  the Department of Justice.   I can only hope they will propose a collaborative, positive approach.

Affordable Care Act - 2015 was a year for big data analytics.   BIDMC’s ACO was the #1 ACO in New England and #3 nationally, in part because of our ability to aggregate a common data set of clinical and financial data from 26 EHRs (all our loosely affiliated clinicians).   We used this data for care management, quality analytics, and benchmarking.   We saved Medicare $50 million in 2015 alone.    It’s clear that turning data into wisdom through the use of novel visualizations, alerts and reminders works.    Meaningful Use did not tell us to do this.   The Affordable Care Act told us to achieve an outcome and innovation happened because incentives were aligned to motivate us.

Cloud  -  2015 was the year in which the cloud became a viable option for just about every application in healthcare.   Amazon and Google both agreed to sign business associate agreements.    Many companies offering cloud-hosted services agreed to indemnification clauses for privacy breach.   At this point, the cloud can be more reliable, more secure, and more agile than local hosting.    Pilots for BIDMC include moving our development/test environments and disaster recovery to Amazon.    Production systems are likely to follow.

There you have it - 2015 has come and gone with major federal programs winding down and control being returned to the private sector.   I’m incredibly optimistic about 2016.   As I’ll write about soon, our agenda is filled with new ideas and it feels as if the weights around our ankles (ICD10, MU) are finally coming off.

Thursday, November 19, 2015

Unity Farm Journal - Third Week of November 2015

The leaves have fallen, the nights are below freezing, and the water systems have been drained for the season.    Salt marsh hay covers all the outdoor vegetable beds, all cider has been moved indoors, and every bucket has been taken down from outdoor paddocks (heated buckets keep liquid water available inside the barn.).   We’re on the countdown to snow.

Thanksgiving is next week, so all the turkeys in the neighborhood are congregating at Unity Farm, which they seem to know is vegetarian ground.    As I’ve said before we have turkeys for every Thanksgiving dinner - the challenge is finding enough chairs for them to sit in.

We had two unexpected bird deaths this week.  One of our older chickens, Snow, who had a chronic respiratory ailment, and an older guinea fowl both died.   We’ve refrigerated their bodies in case a necropsy is warranted but for the moment no other birds are sick and this does not appear to be an infectious disease.   With the spread of Avian Flu throughout the US, causing mass culling of birds, we’re very vigilant.

Last year, we planted American ginseng in a 1000 square foot woodland patch.  Ginseng likes sandy loam soil that is moist, but not too moist.   It takes 2 years to get significant growth of a new planting.     Our challenge is that we are really not sure what habitat in our 15 acres is ideal.    This weekend, we’re creating 10 raised beds in different environments around the farm.   We’ll plant ginseng roots and ginseng seeds, then surround the bed with a 5 foot deer fence.   Hopefully, this “controlled trial” will teach us where best to plant understory permaculture crops like ginseng.

Over the Thanksgiving break, I will be writing a paper for my Umass Organic Farming program entitled “The Organic Treatment of Pests and Diseases at Unity Farm”.   The outline is below:

Pest and Disease treatment/risk mitigation plan by species:
Legumes (Bush Beans, Runner Beans, Peas)
Brassicas (Cabbage, Broccoli, Cauliflower)
Curcurbits (Cucumber, Pumpkin, Squash)
Chenopodiaceae (Swiss chard, beets, spinach)
Solanaceae Family (Potatoes, Eggplant, Peppers and Tomatoes)

When finished, this paper will be a primer for the processes and procedures needed to keep our produce healthy throughout the seasons.    In the Winter, I take a Homesteading course and in the Spring, I take a Farm Marketing and Finances course, which will result in a formal business plan for the future of Unity Farm.

With every passing year, we grow more sophisticated about farming.    Our trajectory is looking good.

Wednesday, November 18, 2015

A Followup on the MU Path Forward

After last week’s post about my suggested path forward for Meaningful Use,  I received a large number of comments.   I thought it would be useful to summarize them and clarify some of my opinions.

In general, 95% of commenters agreed that CMS should pivot the concept of Meaningful Use functional requirements into pay for performance rewards for achieving outcomes via MACRA.

Several commenters pointed out that the MU program has different approaches for Medicaid providers and Medicare providers.       Medicaid funding is available to help providers purchase technology.  Medicare providers received stimulus in the past and now are entering the penalty phase for not attesting to Meaningful Use.  I did not mean to suggest that Medicaid funding should cease before EHRs are fully deployed in Medicaid provider locations.    My suggestions referred to the Medicare programs and penalties for not implementing prescriptive functional requirements.

I was asked to clarify my thoughts about certification.    Today’s certification program includes onerous requirements that consume vast amounts of resources for items not related to interoperability.   If we focus on three goals (provider to provider push,  provider to provider pull, and patient pull), then a streamlined certification program validating those three functions would make sense.   Just as a DVD player includes a sticker guaranteeing “Blu-Ray” compliance, I can imagine a streamlined certification program that issues “stickers” for each of the three interoperability goals, reassuring clinicians that the health information exchange claimed is fully functional in the products they buy.

I was asked if I was criticizing CMS or ONC work.    I’m really not criticizing anyone.   I’m suggesting that the work done in the past was foundational, but the future requires a different approach - outcomes based incentives.    I’m confident that CMS and ONC staff can evolve existing programs into this new approach.

Finally, some have advocated for a transitional approach along the road to FHIR, since existing standards such as IHE XDS/XUA are already in the marketplace.     I realize that we cannot go from cars to jet planes without a few intermediate steps.  However, we have to proceed very carefully because for vendors, every OR becomes an AND.   If we say that you could use IHE XDS or FHIR, we will run into impedance mismatches. Not only will vendors have to implement every option, they will have to implement step up/step down conversions between organizations that use different options.   In general, optionality is the greatest impediment to interoperability.      If the entertainment industry decided that laser disc and Blu-Ray should be used simultaneously, our home systems would become very complex and hard to maintain.   While I understand that some optionality could be offered during a transition period, I am advocating for a move to FHIR/OAuth as the ONLY approach, with minimal optionality, as quickly as is practical.

I look forward to the continued comments - let’s keep the dialog going!

Thursday, November 12, 2015

Unity Farm Journal - The Second Week of November 2015

There are still a few weekend opportunities to work outside before the snow falls.   We’ve shut off the irrigation, blown out all external pipes, put away the hoses, taken down all the temporary fences we used to keep the poultry out of fresh plantings, and covered all the firewood with tarps.     We’re hoping to finish the driveway project before Thanksgiving because the polymeric sand to hold the pavers in place requires a night above freezing to set.

   Kathy and I inoculated 30 oak logs last weekend (that’s 1500 holes drilled, filled and waxed over).   We’re using a strain of Shitake called WR46 that fruits early and has a high yield.    Our hope is to finish 100 logs before the weather turns too cold.

   All the leaves have fallen, creating a foot deep blanket over our 15 acres.   I’ve used the Stihl Magnum blower to clear the barnyard and pond areas.     The zip line is an entirely different experience traversing 300 feet of forest through leafless trees.

We have diesel powered (no volkswagens) and gas powered equipment on the farm.   I’ve added winter fuel stabilizers to every fuel source and filled every tank to avoid evaporation/consensation/water accumulation and to prevent gas line freeze up.

It feels like the grasshopper and the ant.   By working tirelessly on nights and weekends during Fall, Spring and Summer, the winter will be a time to rest/recharge and enjoy the foods/fermentations/fuel we’ve stored up when the living was easy.

 As the weather draws cold and animals begin to spend more time underground, the coyotes are visiting the barnyard more often.   Every night for the past week, I’ve heard their howling (and the dogs barking), so I’ve run around the forest at 2am, 4am and 6am to keep all the animals safe.

One last construction project for the Fall- building raised beds for American ginseng.   We planted 5000 ginseng plants in the woodland last year but had spotty results - deer and rabbits ate them, moisture was not ideal, and we’re not sure what microclimates they really prefer.    My idea is to create ten 2x2 foot raised beds, each protected by a 5 foot high welded wire fence.    We’ll look for areas with jack-in-the pulpit, bloodroot, Solomon's seal, jewel weed, galax, trillium, wild yam, hepatica, black cohosh, wild ginger and ferns, since those plants have similar environmental requirements.   With ten different “test stations” we’ll have a much more controlled experiment as to where ginseng grows best.    Ginseng, paw paw and chestnut are all part of our permaculture program, creating crops in native woodland.

This weekend I’m in Los Angeles helping my mother with home maintenance tasks, receiving the “Don Detmer award” from AMIA in San Francisco as a policy influencer, and giving an AMIA tutorial about the next generation of interoperability standards.   Back to Boston on the Sunday night red eye!


Wednesday, November 11, 2015

The Path Forward for Meaningful Use

Below is my assessment of the current Meaningful Use program and a proposal to better serve the needs of stakeholders.  I’m likely going to violate many rules with this post.   First, it’s over 1500 words, which is not ideal for social media.     Second, there are many who will find my conclusions politically unpopular.   I’m not criticizing people, I’m just commenting on ideas.   Finally, many of these topics do not have black and white answers. I hope my suggestions improve upon our current trajectory.

Where We Are

1.   I believe that the Meaningful Use programs have served their purpose.

Stage 1 created a foundation of functionality for everyone.   That was good.   Stage 2 tried to change too much too fast and required an ecosystem of applications and infrastructure that did not exist.   Clinicians struggled to engage patients and exchange data because they could send payloads but there were few who could receive them.    Stage 3 makes many of the same mistakes as Stage 2, trying to do too much too soon. It requires patient accessible Application Programming Interfaces (APIs) without specifying any standards.   It requires sending discharge e-prescriptions although pharmacies cannot widely support the cancel transaction that is essential to discharge medication management workflow.   It requires public health transactions but CMS has no authority to require public health authorities to standardize the way they receive data.  

Clinicians cannot get through a 12 minute visit, enter the necessary Stage 3 data elements, reconcile problems/allergies/medications from multiple institutions, meet the demands of the  Stage 3 clinical quality measures, make eye contact with patients, and deliver safe medical care.  There needs to be a new approach.     The same thing is true about certification.    I believe that early stage certification set a floor on EHR capability that was appropriate.   Certification is NOT good for the next stage of maturity, which will be driven by heterogeneous use cases and dynamic technology evolution.  Certification is now at the point where it threatens usability, interoperability, and EHR quality, while at the same time diverting research and development resources of health IT developers and providers.

2. I believe that volitional Information Blocking does not really exist.

There may be incompetence that feels like blocking but I’ve never encountered a competent organization with a business need blocking the secure exchange of information. I realize that there are folks in Congress who believe that a new crime called Information Blocking necessitates civil/monetary penalties and enforcement.    I have never encountered a Chief Information Blocking Officer at a health IT developer or provider organization.   The barriers are lack of enabling infrastructure, data governance, uniform policies, appropriately constrained standards, and economic incentives.  Focusing on information blocking is a distraction.

3.  I believe we cannot solve every societal problem through regulation.

The layers of requirements in Meaningful Use, the HIPAA Omnibus Rule, the Affordable Care Act, ICD-10 and the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA)  are so complex and confusing that even government experts struggle to understand the implementation details.    Each of the regulations leads to various audits.  My experience is that even the auditors do not understand the regulatory intent and ask for documentation that far exceeds the capabilities of existing technology.   I was recently asked to support a Meaningful Use audit because the auditor wanted proof that a clinician performed a certain task during the reporting period (a report with a time and date stamp was not enough).   Maybe a video of a clinician at a keyboard with a calendar/clock on the wall in the background?

4.  I do not believe that adding numerous structured data elements and new quality measures to existing software creates disruptive innovation.  We need a business imperative for change and innovation based on the needs of customers.

I’ve already seen the rise of the Care Management Medical Record at our ACO, enabling care managers to examine data from all the EHRs in the community and identify gaps in care/variance from expected protocols.   Patient Relationship Management applications are in development, making healthcare more like other service industries.   None of this is driven by prescriptive regulation.

5.   I believe that health IT developers have already committed to piloting and developing Application Program Interfaces (APIs).

Creating regulation before there is any industry experience as to what works makes little sense.   Government can help with issues such as data governance principles, rationalizing  privacy policy,  and coordinating federal agencies but should not specify workflow or business process.  

What We Should Do

1.  Replace the Meaningful Use program with Alternative Payment Models and Merit-based Incentive Payments as part of MACRA.

Stage 2 and Stage 3 will not improve outcomes.   If alternative payment models offer compelling reimbursement for health and wellness, then clinicians and hospitals will adopt products and change behavior to achieve that goal.

2.  Replace certification with enabling infrastructure.

To accelerate interoperability we need a national provider directory, a master patient index/relationship locator service, a consent service, a certificate management service, and test beds for developers to exercise these services.   Today in Massachusetts we exchange over 3,000,000 patient records per month among 500 organizations because we created such enabling infrastructure backed by data governance (common policies and agreements).   Certification will not accelerate interoperability.

3.  Consider evolving the role of ONC to become a focused policy shop (supported by advisory committees) with a narrowed scope such as identifying ways to reduce errors, improve safety, enhance quality, accelerate interoperability, and meet the needs of diverse populations.

It could also provide transparency and true coordination for actions of government, communicating the IT efforts of agencies including DOD/VA.   ONC has become distracted by grant making, political agendas (see “information blocking” above), and expansive certification ambition.  It's time to narrow the scope and enhance the effectiveness of this important agency.

4.  Stop considering health IT developers and providers as the enemy.

Some believe health IT developers are responsible for creating information silos or resisting interoperability.   Some believe clinicians are lazy or greedy, requiring  government mandates to become patient-centric.   I’m sure there are exceptions, but in general, both are myths.   I’ve said that there are a few effective ways to influence clinician behavior - align incentives, give them a better work/life balance and help them avoid public humiliation (malpractice assertions, poor quality scores, negative Yelp reviews).   A partnership of government, payers, providers, patients, and health IT developers working together to achieve common goals is possible if there are mutually aligned incentives, such as the ideas embodied in value-based purchasing/MACRA.

5.  Focus our efforts on a few things that really matter.

The Federal Interoperability Roadmap has 117 goals.    The certification program has so many objectives that it takes a few hours just to read them all (summary slide below).

How about a laser-like focus on interoperability that includes just 3 objectives?

-ability to use FHIR to read a provider directory (could be hosted by government such as CMS as part of the national provider identifier or the private sector such as Surescripts, DirectTrust, or an HIE) and send a Direct message to that provider.

-ability to use FHIR/OAuth to read a relationship locator service (could be hosted by government or the private sector such as Surescripts, Commonwell, Sequoia, or HIE) and perform a query/response of the MU Common Data Set using a FHIR API.

-ability for a patient to download the MU Common Data Set using an app (that is curated/reviewed to ensure security and data integrity) using FHIR/OAuth or appropriate variants of OAuth such as HEART.   Several folks have contacted me to discuss the real purpose behind the consumer API requirement in the ONC and CMS rules.  Some suggest it was motivated by special interests who want to monetize patient submitted data.   Some suggest that it is an enabler for future provider to provider transactions.   Some say it is the best government lever to motivate the industry to move from messaging to APIs.    I’m not sure which interpretation is correct, but it is certainly true that providing data to the patient should be one of the focuses of interoperability.

Since MACRA will base payment on wellness which requires care coordination, providers will demand appropriate interoperability features when buying an EHR product.     Additionally, an independent third party such as KLAS could publish unbiased statistics about the actual experience of interoperability by speaking with hundreds of clinicians and staff.    Recently all the major health IT developers agreed to have their interoperability measured by KLAS via customer interviews using this questionnaire. 

I’m really trying to be helpful here and incorporate the overwhelming feedback I’ve heard from stakeholders.    More Meaningful Use and Certification criteria are not the answer.    Paying for outcomes that encourage government, payers, providers, patients and health IT developers to work together, instead of being adversaries, is the path forward.

Thursday, November 5, 2015

The First Week of November 2015

We’ve had a sudden burst of warmth that enables us to do additional outdoor work.   Among our 15 acres are several very old and large trees.   The old oak on the hill now hosts the 12x12 tree house.   The old maple in the marsh now hosts a 4x4 foot platform.     A 42” old pine overlooking the railroad tracks now hosts a 5x5 foot platform that I built over the weekend.   It has a 16 foot staircase, sloped at a comfortable 65 degrees, with stairs every foot.  

A freight train passes Unity Farm every morning at 7am, every afternoon at 2pm and every evening at 11pm.    Now, sitting in the old pine tree, you’re suspended above the train as it goes by.    Here’s what it looks like

Our second cut hay was delivered this week.   How do you move 7 tons of hay from truck to barn loft?    One bale at time (300 bales)

We finished the last of the cider making using a 50/50 mixture of Baldwin and Winesap apples.    The end result tastes a bit like Sauvignon Blanc.   It will undergo a 2 stage fermentation then I’ll bottle it in the Spring.

All our produce is ready for winter - the hoop house lettuce will continue to grow for a few months, the fruit trees are ready for a long winter’s nap. and the garlic roots will grow over the winter (below)

The bees hives are stocked with enough honey to last the 100 days of winter.   The aplaca have regrown their fiber, and the dogs are fully fluffed for the cold winter ahead.

The days are getting shorter which means that all the barn chores are done in the dark.    The fireplace is filled with flaming oak, ash, and maple.    Dinner has returned to the soups, roasted vegetables, and pickled foods from summer harvests.

Soon, the outdoor work will fade and plowing snow will be the main task.   Our 52” snowblower attachment for the tractor arrives next week.

Wednesday, November 4, 2015

The November HIT Standards Committee

The November HIT Standards Committee included a comprehensive review of the CMS Meaningful Use Stage 3/Modification Rule and the ONC 2015 Certification Rule.

We begin the meeting with a presentation from Robert Anthony of the Meaningful Use Stage 3 and Modification Rule 

A robust discussion followed.   Issued raised as those similar to the ones I identified in previous blog posts.

The main concern was the alignment of the CMS Meaningful Use rule with future pay for performance criteria that will be part of MACRA/Merit-based Payment Incentive programs.

Additionally there was significant discussion about the API requirement and the notion that “an API that can be used by applications chosen by the patient” implies that there cannot be curation or security review of patient selected applications.    All agreed that CMS and OCR need to clarify how patient access can be balanced with security imperatives.

The 6 public health requirements apply to providers but CMS has no authority to standardize communications on the public health side.  This could lead to significant regional variation in public health transaction flow.

The next presentation from Elise Sweeney Anthony and Mike Lipinski covered the 2015 Certification Rule  

Issues discussed included privacy and security criteria, safety enhanced design, field audits,  and the API requirements.

As I’ve stated in previous posts and articles, I believe the CMS Stage 2 modifications are good but the Stage 3 requirements could be moved into merit-based incentive programs and the Meaningful Use program eliminated.

Regarding the ONC Certification rule, the API requirement should include additional specificity for FHIR/OAuth.   I realize that it is too late, since the rule is final,  but the ONC rule includes so many criteria for so many purposes that I believe the market will find it very confusing.  It has the potential to create enormous burden beyond the intent and original goals of HITECH.    Private sector innovation in support of MACRA/MIPS is likely more powerful than certification to accelerate the functionality and interoperability we need.

Thursday, October 29, 2015

Unity Farm Journal - Fifth Week of October 2015

I’m back from China and have caught up on the accumulated farm work that built up in my absence.    I did what I needed to do in Asia, lecturing about Meaningful Use accompanied by lasers and fog, but not fireworks.

Kathy kept everyone healthy and happy (such as the chickens and bees below) but the more physical work - chainsawing fallen trees, hauling hay, digging trenches, fixing irrigation, and cider production work falls to me.

The ash borer beetle has caused the death of ash trees through the US including those on Unity Farm.   Although we do not have an active infection, the dying trees have been decaying and collapsing over the past few years.   I’ve proactively taken down all ash trees near structures, but multi-ton trees still fall in the forest, sometimes getting caught up on the branches of other trees.   Cutting down these mammoth stuck trees is very dangerous and that’s why they are called “widow makers”.   With Kathy standing at a safe distance in case I run into trouble, I cut them down using a plunge cut technique 

The farm driveway replacement project continues to progress but during the excavation several irrigation pipes were cut.  It was not clear which were old pipes and which were new pipes.    The person helping us with the project repaired them using a standard coupler technique.   Unfortunately he connected the wrong two pipes together so the resulting configuration did not work.   I excavated the existing pipes and followed them from their origin to their destination, cutting out old pipe and reconnecting the system.

During my absence, the cider fermented from a specific gravity of 1.050 to 1.000  creating 6.1% alcohol by volume.   Upon returning from China, I racked all the cider into fresh sterilized fermenters for the secondary malolactic fermentation over the winter.   The 2015 cider is delicious and I’ll bottle it in the Spring.

One of the major problems of traveling the Fall is missing the major part of the mushroom harvest.   Kathy did a great job harvesting the Shiitake crop and selling it to farm stands/markets throughout the Boston metro west area.    The only thing for me to do is move our 100 new logs to the inoculation area where we’ll drill and add spawn to them over the next month or so.

Finally, it was time to clear out the green houses and plant the last of the fall crops, including garlic.   Our 16 raised beds are now filled with winter density lettuce, spinach, chard, and romaine.   The hoop house and floating row covers will keep them warm during the 100 days of winter ahead.

This weekend we'll begin the winter prep of all our machinery - changing oil, adding gas treatments, and washing off the accumulated dirt of summer in preparation for the snow that is soon to fall

Wednesday, October 28, 2015

The ONC 2015 Certification Rule

Just as I summarized the CMS Meaningful Use Final Rule last week, this week I’ll summarize the 560 pages of the ONC 2015 Certification Final Rule.

Key points to understanding the rule include

1.  The 2015 Certification Rule is decoupled from Meaningful Use.    Thus, you’ll find functionality to support EHR Incentive Programs plus  several certification criteria for long-term/post-acute care, chronic care management, behavioral health,  and other programs such as merit-based incentive payments  (MIPS).

2.  The concept of the Complete EHR  was eliminated in the 2014 Edition Release 2 final rule.  Everything in the 2015 Certification rule is conditional based on the functionality that a module supports.   The CMS Meaningful Use rule requires certified technology to support each element of that rule, but customers are encouraged to select modules/vendors/applications however they wish.

3.  There are standards included in the 2015 Certification rule that are not ready for prime time, such as Data Segmentation for Privacy (DS4P).   However, there are no corresponding Meaningful Use attestation criteria for these standards, so vendors are unlikely to implement them.   I believe the 2015 Certification Rule should be limited to Meaningful Use certification without optionality in the interest of providing a clear path to the industry.   The ONC Standards Advisory could have enumerated the potential standards suggested for non-Meaningful Use related requirements.  Luckily, ONC has prepared a presentation which illustrates the sections of the 2015 Certification Rule that can be ignored by vendors seeking to limit their development effort to Meaningful Use support.

To begin understanding the rule, you should read this presentation, published last week by ONC

Slide 35 contains a final rule table.  The last column to the right enumerates certification criteria and accompanying standards outside of Meaningful Use.  The first column is always applicable for products getting certified and the second column is conditionally applicable depending on what criteria are in scope for certification.

If you want to read the actual 560 page rule, you can save a great deal time by just reading about 50 pages as follows

The standards required by the rule are described between 170.202 Transport standards  and  170.299 Incorporation by reference.

The certification requirements are described in section labeled Regulation Text.

There are really only three new substantive requirements applicable to Meaningful Use that are non-public health: implantable device list, patient generated health data capture, and the Application Program Interface functionalities.   Otherwise, all the other “new” criteria are public health specific to give more Meaningful Use flexibility.  As noted above, slide 35 in the presentation is key.  Some of the “revisions” are really minimal in comparison to 2014 edition despite being marked that way.

Assessing  the vendor burden of implementing the 2015 Certification rule is heavily dependent on the number of functions certified.    There are even optional choices for some criteria.  For example, in the View/Download/Transmit criteria there are two standards referenced for web content accessibility guidelines, Level A and Level AA.  The baseline requirement is Level A, which effectively makes Level AA “optional”.  However,  vendor implementation details will be represented on ONC's updated "open data" Certified Health Product List so if a developer wanted to differentiate themselves on web content accessibility they would be able to do so and such effort would be publicly accessible.

Overall there are more criteria to support public health for Meaningful Use than providers need to actually use to meet Meaningful Use, so there is flexibility for public health reporting.  Developers do not need to support all the public health certification criteria.

I hope this analysis helps you focus since the powerpoint plus reading about 50 pages is all you have to do to understand the 560 page rule.

My only editorial comment - in the future, I believe the private sector will innovate in ways that regulation cannot foresee.  There is a time for regulation to catalyze change and a time for regulation to be reduced to enable innovation.   I believe that we are entering a time for reduction of regulation.     My term limit in the Obama administration requires my service in the federal advisory committees to end in January 2016.   I will watch with great interest as the  Obama administration ends and a new administration works to find a balance between regulation and private sector innovation.

Saturday, October 24, 2015

A Meaningful Use Rap

A hilarious musical statement about the current state of medical practice, EHRs, and regulatory requirements.

Thursday, October 22, 2015

Unity Farm Journal - Fourth Week of October 2015

October is the best time of year to travel in Shanghai and Beijing.  The temperature is typically between 60-75F and there is little rain.   Air quality is reasonable and transportation systems are at their most efficient.

In my role as Harvard professor, I spend a few days a year in Asia, Europe, and the Middle East helping define technology and policy for improving healthcare quality, safety and efficiency.   My Fall travels to China always occur in the middle of harvest season, which can be challenging for the farm.

During my travels this week, we had our first hard frost - 8 hours of temperatures between 26-29F.   That was enough to kill the remaining annuals  - shiso (Japanese basil), morning glories, tomatoes and peppers.   My wife and a helper composted all the affected plants.   Here’s a view of the wilted tomatoes.

All the leaves have turned and the farm is past the peak of color.

The Shitake mushrooms are at the peak of their fruiting and Kathy is gathering basketfuls every day.    We have 100 new oak logs to inoculate when I return from China.

It’s the perfect time to plant garlic.   We have 6 raised beds devoted to garlic and Kathy is getting 12 varieties into the ground before the soil hardens.

The farm hand who covers for me while I travel used our commercial mower to do the last cutting of the year through our orchards, pastures, and meadows.

He’ll also use a brush cutter to clear the last areas of wildflowers in the bee areas now that they are at the of their growing season.

The pawpaw trees we planted as part of our permaculture are beginning to lose their leaves and the peak of fall color is passing.

The duck pond is filling with falling leaves and needed a cleaning.

All the animals are enjoying the cooler weather, but miss the routine of the extra attention I give them while I’m there, cleaning, special feedings, and walks.

Kathy has done the last of the bee work for the season, since it is now too cold to open the hives.

I started the fermentation of our cider batches before my departure and Kathy has been watching them to ensure they are vigorous but not too vigorous.  I’ll rack the ciders and inoculate them with malolactic bacteria for their secondary fermentation when I return.

The paving project continues and we’ve excited to see the 25 year old asphalt replaced with simple pavers that we can easily replace/repair given the wear and tear of our farm equipment and activities.

Kathy has done a remarkable job keeping everything running during my absence.   I look forward to my return on Saturday when I can catchup with the projects in progress and re-engage with the rhythm of the farm.

Wednesday, October 21, 2015

A Brief Summary of the CMS Meaningful Use Final Rule

I’ve been asked to summarize the  752 page CMS Meaningful Use  Final Rule.

Although it is a final rule, it has a 60 day comment period, so there is still is an opportunity to modify some of the criteria.   Between the Notice of Proposed Rulemaking and the publication of the CMS Final Rule, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) passed to include sunsetting the Meaningful Use payment adjustment for professionals at the end of 2018.   Also, MACRA requires the establishment of a Merit-Based Incentive Payment System (MIPS) which would incorporate Meaningful Use.  The comment period will be used in an attempt to align the Meaningful Use program and the MIPS program.

The CMS Final Rule contains revisions to Meaningful Use Stage 2 such as reducing the reporting period for 2015 to 90 days and changing the patient/family engagement thresholds from 5% of patients to 1 (a single) patient.

The Stage 2 changes followed the recommendations of several professional societies.  Hopefully more clinicians and hospitals will now be able to cross the Meaningful Use Stage 2 finish line.

Stage 3 is more controversial and I will focus on that.  

Eligible Professionals (EPs) and Hospitals have 8 goals with optional participation in 2017 and required participation in 2018 to gain stimulus and avoid penalties.     The rule was released in October 2015 and since it is optional for 2017, vendors have only 1 year to make software changes and get certified.    That could be very difficult, especially for the application program interface (API) requirements described below.   Here are the goals:

1.  Protect Electronic Health Information - a security assessment must be done and a mitigation plan followed to reduce risks of privacy breach.   Appropriate encryption of data must be included in the plan.  This applies equally to EPs and hospitals.

2.  Electronic Prescribing - For EPs, electronic prescribing must be done for 60% of electronically prescribe-able medications.  Electronic prescribing of controlled substances is not required but can be counted.  For hospitals, electronic prescribing must be done for 25% of electronically prescribe-able discharge medications.

3   Clinical Decision Support -  five clinical decision support interventions related to four or more clinical quality measures as well as support for drug/drug and drug/allergy checking must be implemented.   This applies equally to EPs and hospitals.

4.   Computerized Provider Order Entry (CPOE) - 60% of labs, radiology, and medication orders must be done electronically.    This applies equally to EPs and hospitals.

5.  Patient Electronic Access - 80% of patients must be given access to View/Download/Transmit AND Application Program Interface (API) capabilities.  35% of patients must receive tailored educational resources electronically.  

 I suspect the API requirement may be among the most controversial aspects of the final rule.   I’m a strong supporter of the use of APIs as a means to enhance interoperability, such as we’ve proposed with the Argonaut Project .   However, at the moment, there are few patient facing applications that use APIs.   Maybe in the future, the problem of multiple PHRs will be addressed by moving patients from portals to apps that consolidate data from multiple EHRs i.e. the patient’s PCP, specialists, urgent care clinicians, and hospital care team.

6.  Coordination of Care through Patient Engagement - 10% of patients must access their record via a portal or application program interface.   25% of patients must receive or send a secure email. Information from non-clinical settings must be received for 5% of patients, which includes patient-generated data (weight/blood pressure/glucometer readings or Fitbit-like devices) or data from providers in non-clinical settings such as home health or physical therapists or behavior health.   This applies equally to EPs and hospitals.

I wonder if regulation is the best approach to accelerate the move to consumer-facing mobile apps and APIs for downloading of EHR data and uploading of patient generated data.   Meaningful Use Stage 2 attempted to use regulation to accelerate patient downloading/transmission of data.   There were few places to transmit consumer data and few compelling reasons for consumers to do it, so few tried.   Meaningful Use Stage 2 was revised to move the 5% view/download/transmit requirement to just one patient.   Regulation alone cannot change consumer behavior since APIs are not so much a technology but a market ecosystem to support the technology.  One of the lessons of Direct is that such challenges are profound and cannot be created overnight based on federal regulation.

A better driver would be a payment model  such as risk-based pay for outcomes approaches which incentivize patients and providers to collaboratively share data using novel applications.    I would advocate removing the API requirement from Meaningful use Stage 3 and moving it to the merit-based incentive programs (MIPS), enabling the marketplace to evolve innovative technologies after there is increased consumer and provider demand.

7.  Health Information Exchange - Transition of care summaries must be sent for 50% of all encounters.  Transition of care summaries must be incorporated for 40% of patients.    Transition of care summaries must be reconciled as structured data (problems/medications/allergies) for 80% of patients.

Unlike MU Stage 2, providers will now have to receive as well as send data.   Reconciling problems for 80% of patients will be quite challenging because of the different ways that providers maintain problem lists, which, unlike meds and allergies, has less to do with coding objective findings and more to do with documentation conventions and individual habits.

8.  Public Health and Clinical Data Registry Reporting - immunization submission, syndromic surveillance (urgent care only for EPs),  electronic case reporting, cancer registries or surveys, data registry reporting, reportable lab are required for EPs and Hospitals.    There will be exceptions offered for areas in which public health entities cannot receive these transmissions.

My general opinion of the rule is that
*The Stage 2 revisions that enable a 90 day reporting period and reduce some of the thresholds are good.
*The Stage 3 API requirement and patient generated healthcare data are better done in merit-based payment approaches rather than Meaningful Use regulation
*The collective burden of all the workflow changes required by three stages of Meaningful Use regulations will make it hard for clinicians to get through their day and spend time on direct patient care
*The public health reporting requirements will be hard to achieve in many locations due to the heterogeneity of local public health capabilities
*Many EPs and hospitals would welcome the end of Meaningful Use in favor of merit-based payment because at this point it is more effective and efficient for them to focus on achieving better outcomes for value-based care than being told exactly how they should get there.

I look forward to the comment period.