Parsing eCW’s $155M payment to the government

UPDATE: ?Here are the public records for the case. ?More details there about the original complaint. ?Excerpt:

@eClinicalWorks to pay $155M fine: https://t.co/RngioK62SX

But what’s it mean?

Certification

The purpose of any certification program is to create a method for the purchasers of a product to have confidence that the product safely and reliably does what it is supposed to do. ?One example from USDA:

Turning Point for Meat Inspection In 1905, author Upton Sinclair published the novel titled The Jungle, taking aim at the poor working conditions in a Chicago meatpacking house. However, it was the filthy conditions, described in nauseating detail?and the threat they posed to meat consumers?that caused a public furor. Sinclair urged President Theodore Roosevelt to require federal inspectors in meat-packing houses.The Pure Food and Drug Act and the Federal Meat Inspection Act (FMIA) became law on the same day in 1906. The Pure Food and Drug Act prevented the manufacture, sale, or transportation of adulterated or misbranded foods, drugs, medicines, and liquors. The FMIA prohibited the sale of adulterated or misbranded meat and meat products for food, and ensured that meat and meat products were slaughtered and processed under sanitary conditions.

In this case, the government moved to protect the public because a subset of meat packers was putting profit above public health. ?After The Jungle was published. public outcry caused the government to step in and regulate the industry. ?Regulation is not, therefore, a four letter word. ?It’s there to protect us from evildoers.

Before Health IT Certification

You may not remember this, but I do. ?Before there was certification, Health IT development companies (some people call them “vendors”) created software and sold the software with claims of improved provider productivity, improved public health, and (yup) improved billing (among other impressive?capabilities). Sometimes these claims were completely valid. ?Sometimes they were not. ?In the case where the developers’ functional claims were not quite valid, buyers had little recourse. ?One might say “well, the markets will take care of that. ?Bad actors will lose sales.” ?But that’s not the case here for several reasons:

The buyer may not be the one using the software. ?A hospital buys software for clinicians. ?Clinicians complain to hospital. ?Hospital may or may not be a strong advocate with developer.
It’s very hard to migrate from one system to another. ?EHR purchase / deployment / optimization is a multi-year initiative. ?If you bought a lemon, you may try to make lemonade as the though of migrating to something else will give you R11.0.
Shame. ?You don’t want your patients / competitors / peers to know that your EHR doesn’t work as expected. ?You made a mistake. ?Human nature is to hide our mistakes rather than treasure them as educational opportunities.

After Health IT Certification

The program isn’t perfect. ?I was on the developer side of this work from ~2006 – 2010 during the when CCHIT was the only certification path, and then for ONC’s first iteration of certification (2010 – 2011). ?Indeed, the imperfection of the program was a motivating factor for me to join the government in 2011. ?I wanted to help evolve the program toward perfection. ?Certification criteria needed to be less prescriptive (more flexible) but still provide sufficient guidance/ structure so that they could be reliably tested and replicated. ?This balance is hard to get right. ?Sometimes we got it wrong. ?Some have appropriately argued that there remains quite a bit of “check the box” busywork wherein health IT developers need to spend time building and configuring their software just to have it certified. ?”Trust us and don’t make us do this busywork” was the persistent message from the developer community. ?Recently, there have been renewed calls for scaling back the certification program and its many criteria, citing the maturation of the EHR incentive programs (meaningful use) and the fact that some of the certification criteria define capabilities that are not invoked by the incentive programs. ?The argument is that ONC has no place creating certification criteria for capabilities that aren’t part of “meaningful use.” ? I disagree. ?The ECW case is a great example of why I disagree.

About the eClinicalWorks settlement

What happened) You’ve read the press release from the Department of Justice by now. ?Excerpts (my emphasis added):

In its complaint-in-intervention, the government contends that ECW falsely obtained that certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification. For example, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the company modified its software by ?hardcoding? only the drug codes required for testing. In other words, rather than programming the capability to retrieve any drug code from a complete database, ECW simply typed the 16 codes necessary for certification testing directly into its software. ECW?s software also did not accurately record user actions in an audit log, and in certain situations did not reliably record diagnostic imaging orders or perform drug interaction checks. In addition, ECW?s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW?s software to the software of other vendors. As a result of these and other deficiencies in its software, ECW caused the submission of false claims for federal incentive payments based on the use of ECW?s software.
As part of the settlement, ECW entered into a Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company?s EHR software. This innovative 5-year CIA requires, among other things, that ECW retain an Independent Software Quality Oversight Organization to assess ECW?s software quality control systems and provide written semi-annual reports to OIG and ECW documenting its reviews and recommendations. ECW must provide prompt notice to its customers of any safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks. The CIA also requires ECW to allow customers to obtain updated versions of their software free of charge and to give customers the option to have ECW transfer their data to another EHR software provider without penalties or service charges. ECW must also retain an Independent Review Organization to review ECW?s arrangements with health care providers to ensure compliance with the Anti-Kickback Statute.

Summary:

ECW faked their certification testing. ?The examples above are just examples. ?There are other instances wherein ECW faked the testing and convinced the testing body that the software could do something that it could not do.
Since the software was not certified, any physician or hospital who received incentive money and attested to the use of certified software was in fact fraudulently attesting to the meaningful use of certified software.
The Corporate Integrity Agreement (CIA) commits ECW to:
1. Oversight from an independent third party
2. Notify customers of any safety risks (there are many)
3. Provide software updates for free
4. Support migration to other EHRs for free

So what?

Reminder: ?The purpose of any certification program is to create a method for the purchasers of a product to confirm that the product safely and reliably does what it is supposed to do.

ECW is a big company, with ample resources. ?Their software is used by tens of thousands of clinicians every day. ?The lives of their patients (many of whom are Medicaid beneficiaries – as many federally qualified health centers use ECW) depend on the safety and reliability of this software.
ECW’s software doesn’t do what they claim. ?Now that the government has investigated, and is holding them accountable, the message is clear: ?the public’s interest is being protected.
ECW is not the only organization that cheated on certification. ?They may have been the biggest, boldest violator, but they were not the only one. ?Others have already started internal reviews of their own performance, and those who have not yet done so are very likely to do so tomorrow. ?This case is a wake-up call for the CEOs of all EHR development organizations to dig deep, and have honest direct conversations with the small teams that prepared the software for certification testing, and performed certification testing with the test labs. ?My advice to these CEOs: ?look these teams?in the eye and ask “is the software that was tested exactly the same as the software that is available to all of our customers?” ?In many cases, the answer is no. ?As Farzad tweeted today, a very common case is in the domain of interoperability: ?can the system exchange data as it was certified to do) All too often, the answer, when we speak with the EHR developers, is “yes, if you pay us $$$ to enable that capability for you.”

Today’s announcement is the culmination of several years of work – all focused on protecting the public and holding a company accountable. ? As I’ve asserted both privately and publicly, the regulatory infrastructure of EHR certification is important because sometimes there will be bad actors. ?While the “good actors” may be inconvenienced and annoyed by processes that seem unnecessary, for such important elements of our nation’s health infrastructure, we can’t have government abdicate this responsibility. ?With or without the incentives programs, or MIPS, or 21st Century Cures, there is a set of capabilities that these systems need to have, and for which they must be certified. ?The breadth of this set of requirements, and the depth of certification testing for any criterion are the needles that must be threaded. ?I’m confident that Don Rucker and the team at ONC can navigate the balance well.

National Coordinator 6.0: A Blueprint for Success

1.0 Brailer
2.0 Kolodner
3.0 Blumenthal
4.0 Mostashari
4.1?me
5.0 DeSalvo
5.1 Washington
5.2 White
6.0 Rucker

Now that it’s public, I’ll offer my thoughts on the next steps for Don and ONC. ?Don Rucker is a good pick for the nation, and will be a great National Coordinator. ?I’ve gone on record as saying that some others are not qualified, and as many of you know – I don’t mince words. ?Don is smart, focused, thoughtful, intentional, and will make good decisions for ONC and HHS. ?I have known Don for 20 years. ?He’s got a long track record of integrity, he’s a nice person, he deeply understands the challenges, limitations, and opportunities of Health IT. ?I have no doubt that he’ll do a good job. ?He’s got a lot on his plate.

Where should he focus?

Stay the course with health IT certification. ?I disagree with the growing meme that ONC has broadened its certification scope too far. ?Certification has one purpose: ?to provide consumers with a way to be confident that the product they are purchasing will do what the seller says it does. ?Some people seem to have forgotten (or don’t know) that some of the companies that sell health IT solutions have claimed that the products do things they do not do. ?There needs to be a process by which these claims are tested, verified and, yes, certified. ?If this program is scaled back, health IT systems will be less safe, less interoperable, less usable, and less reliable. ?#KeepCertification.
Keep the Enhanced Oversight Rule in place. ?My former colleagues (and Don’s former colleagues) in the vendor community will disagree, as do some of the house Republicans. ?As Don will learn first hand in his initial few weeks as NC, some of the companies that have been selling certified health IT products have been misbehaving. ?In some cases, products have been de-certified. ?In other cases, there have been investigations and resolution of problems without de-certification. ?ONC is protecting the public by doing what?Congress asked it to do initially. ?The certification program is more than testing of products in a petri dish, it’s about what happens with the products in the real world. ?Surveillance is therefore a necessary part of making sure that the products do what they were certified to do. ?#KeepOversight.
Trim ONC. ?Under National Coordinators 1.0 and 2.0, the organization was small, and focused on two things: ?policy and standards/certification. ?With ARRA, the organization grew to support the REC program, the HIE program, the SHARP program, and many smaller grant/cooperative agreement programs. ?ONC staff grew fivefold, and with that growth came the distractions of the grant programs, the expense of salaries and physical space required to support such a large team. ARRA is over, and ONC now has responsibility for a small number of grants. ?ONC should retain its autonomy (it should not become a daughter of NIH or CMS) but should now retract back to the small organization it once was. ?Grants (with the people managing them) should migrate to AHRQ. ?The policy work of ONC should focus on interoperability (much of the work assigned to it by congress in the 21st Century Cures Act), certification, and the usability and safety of health IT. ?ONC’s standards work should focus on acceleration of standards for health IT systems, through very tight collaboration with HL7 (also required by 21st Century Cures). #TrimONC ?#FocusOnCertandStandards

That’s it. ?The three-legged stool of ONC’s future success. ?On a silver platter, for ya, Don! ?Have fun! ?The people at ONC are hard-working, dedicated public servants. ?They are excited to work with you.

BTW, thanks, Jon. ?You will forever be 5.2 to me. ?Great job.

Career Transitions

I had lunch yesterday with an industry colleague who was recently let go from his job with a big company. He is now doing what everyone told him to do: network, network, network – to find the next big thing. Our lunch was of course part of that networking. Who do I know? (Which companies might be hiring people with his skills) His sense of urgency (despite the generous severance package) was palpable.

Initially, I answered his questions: we brainstormed about this company or that company, and I offered to introduce him to some CEOs who may have interest in him.

But after the server brought our lunch, and the cadence of our conversation slowed a bit as we ate, I offered some unsolicited advice:

SLOW DOWN

I suggested that he take the advice expressed in this HBR article and multiply by 10. Take a month and go away. Really unplug. Reconsider what “success” looks like.

He enthusiastically (almost) agreed, and reflected on a trip he’ll take soon to California in which he’ll interact with start-up companies and perhaps land a role with one of them.

I smiled. “That sounds like networking to find a new job.”

“Got me. It is. Hmmmm”

This is normal, and common, and an unfortunate consequence of the hamster wheel many of us get trapped on. As this post or this one .. remind us, we’ve been trained to define ourselves through the notion that we will BE happy after we HAVE ____ so we can DO ____. ) The loss of a job gives us a great opportunity to question this flawed logic: “When I HAVE (the perfect job, the promotion, the corner office ..) then I will DO (important work) and I will BE (perfectly happy). One can fill in the blanks and substitute anything else: money, nice car, giant house, etc. HAVING seems to come first. But with loss, we can flip this all on its head if we give ourselves time to question.

What if we can BE (happy) first) Will that change what we HAVE and DO) Might it change how we approach our careers, our relationships, our aspirations?

Yup.

It’s (very) hard to make this shift. Cognitively, it seems to make sense. My lunch partner nodded and agreed that he needed to take time off to really let go. But to him, “time off” was a weekend. He’s lost the thing that has defined his identity: the job, the work, the salary.

And it’s easy for me to sit across from him and tell him to re-think how he’s defined success. He’s had a “successful” career, just like Barack Obama and Hillary Clinton and thousands of political appointees who used to work for the federal government. Now they get to re-think how success is defined. It’s an opportunity!

Why do I run marathons?

That’s me over there in the white shirt. Six days ago. It was a day that I had worked toward since ~ March. I’ve done this every year since 2010. For about 15 minutes after the marathon, I was sure that it was my last. I ran a 1/2 marathon about 3 weeks ago, and it was amazing. I loved it. I was downright gleeful afterward. Not so after 26.2 – especially NYC, which has a very difficult last 5 miles. Just walking the ~ 3/4 mile after the finish was painful. Why do I do this every year?

Resilience
Discipline

That’s it. If you know someone who has run a marathon, you know a person who has chosen to find both of these within themselves.

Notice that I don’t say that these people HAVE resilience or HAVE Discipline. As Carol Dweck describes in Mindset, resilience is a core component of human success. We can learn resilience, and we can un-learn resilience. Every day – we are offered opportunities to give up, ease back, let it slide, be sad, be angry, or stop trying to do our best. Do you struggle with these challenges) Yeh – I thought so. Me too.

Discipline, not unlike resilience, is hard to find, hard to maintain, and easy to lose. In a world burdened by attention deficit trait (warning: pdf), it’s easy to get sidetracked away from the good habits we try to build.

It’s impossible to run a marathon without both of these. The marathon is – for me – a way to keep myself focused enough, resilient enough, and disciplined enough to get it done – whatever “it” is today.

You can too. What’s your marathon?

Service Innovation

?Shift the business models?
?Re-align the incentives?
?Fee-for-value?

These phrases are not new.
Nor are the concepts they represent.

Yet we?re starting to see new experiments from the federal government, from states, and even small communities that demonstrate a new willingness to deeply engage in understanding and overcoming the barriers to true change in how we improve health.

Notice that I said ?improve health. I didn?t say ?Improve health care. This not just an insignificant semantic nuance. When we conflate care and health, we accept the fundamentally flawed assumption that in order for people to be healthy, we must in some way intervene and care for them. This assumption forms the basis of many traditions that pervade our broken system: in medical school and residency, I was taught that the individual with depression needs a medication, rather than improved coping skills. I was taught that the individual with diabetes needs a nutritionist rather than an exercise partner. I was taught that the the individual with hypertension or hyperlipidemia needed medications, regular lab work, and bi-annual follow-up visits, and I was taught that otherwise healthy adults needed an annual physical exam.

We now know that this medical education I received – as have tens of thousands of physicians, nurses, care coordinators, quality managers, hospital and health plan administrators and government officials – is in many cases based on a set of traditions rather than science. Marcia Angell’s compelling work on our (mis)management and misunderstanding of mental illness is a sobering review of how we?ve managed to create a generation of people who are dependent on the medications that we thought would help ?cure? them. Zeke Emanuel has reminded us of the paucity of evidence for the ?annual physical? and makes a strong case for eliminating it entirely. Finally the evidence for exercise as an essential component of prevention of (and management of) diabetes is well known, but when I recently asked a 3rd year family medicine resident what would be his choice as first-line intervention (I chose my words carefully) for a patient with newly diagnosed type 2 diabetes, his proud and instantaneous response was ?metformin? rather than ?exercise.

These traditions, steeped in the very human need to be needed, find their common ancestor in the assumption that these people need us to get better. We sought careers in health care so that we can care for others. So that we can help them. We can rescue them. We can ?make a difference. Early in my career, as a young medical school faculty member, these are the words I would hear as I interviewed medical school applicants. Help. Care. Save. ?I never heard the words that will form the basis of our new model of health:? Empower, Educate, Witness, Listen, Learn, Share.

The genesis of this new thinking comes from several communities – all working at the edge of public service. The edges, as I?ll discuss below, are where we see the birth of true innovation.

Positive Deviance

The term ?Positive Deviance? has a long history – dating back to the nutrition research literature of the 1960?s,? popularized in the 1990 book (pdf) by Zeitlin, Ghassemi and Mansour. The model is based on observations that ?positive deviants are children who grow and develop adequately in low-income families living in impoverished environments, where a majority of children suffer from growth retardation and malnutrition. What is different about the positive deviants Can we learn from them, and amplify their success by sharing their success with others Can we empower the community to find strength and success, rather than import and impose our own views Of course. Over the last three decades, the Positive Deviance Initiative has used these principles to learn from communities, empower them, and facilitate better health and better lives for millions of people worldwide.

Motivational Interviewing

William Miller and Stephen Rollnick summarize the work of many psychologists, social workers and physicians through the 1980?s in their book Motivational Interviewing, published first in 1990. The basis of the work that framed MI is the same principle expressed in a joke that my dad (a psychiatrist) used to tell:

Q:) how many psychiatrists does it take to change a light bulb

A:) only one, but the light bulb has to want to change.

MI reminds us that we can?t change people. People change themselves. Sometimes with our facilitation, sometimes despite our intervention. Always from within.

Both Motivational Interviewing and Positive Deviance place the important emphasis where it belongs: in the wants/needs/hopes and wishes of the individual. The smoker who chooses to keep smoking will always smoke, regardless of our judgement of them. Can we motivate rather than judge Can we empower rather than diagnose Can we really listen (Alas, no. As this study reminds us – physicians interrupt patients after 12 seconds.)

In last week?s Sloan Management Review, Clayton Christensen observes that ?… when the business world encounters an intractable management problem, it?s a sign that business executives and scholars are getting something wrong ? that there isn?t yet a satisfactory theory for what?s causing the problem, and under what circumstances it can be overcome.

So here?s my theory:? traditions have shaped how health care delivery has evolved in the US and most Western cultures. Inherited from ?expert-based medicine? of the 1950?s and 1960?s, the paternalistic medicalization of much of our societal challenges, and compounded by economic forces that have positively reinforced intervention over empowerment, education, and true engagement. The ?patient centered medical home? of 2016 is no more patient centered than most primary care practices of the 1990?s, despite the dedicated work of many at NCQA and elsewhere to describe the attributes of a true ?patient centered? experience. In order to break away from these traditions, we need to begin at the edges.

A colleague asked me today how I would shape a DSRIP program if I were to design one from scratch. My response is a confluence of the theories of Motivational Interviewing, Positive Deviance, and Clayton Christensen?s theory of disruptive innovation. Christensen argues that a new-market disruption is an innovation that enables a larger population of people who previously lacked the money or skill to begin buying and using a product (or service). DSRIP Background:? DSRIP programs exist in New York, New Jersey, Massachusetts, Texas, Kansas and California, and are a product of a CMS innovation program that:

Gives states autonomy to spend medicaid money in new ways – toward a set of ?triple aim? goals.
Must be budget neutral for CMS
Should facilitate transformative changes in the care delivery system

Here?s what I told her:

DSRIP 2.0 programs should focus on a small set of very tangible goals that align with the triple aim:

Cost of care for a medicaid population should be reduced by at least 25%
Quality of care should improve (yes – this is hard to measure)
The experience of individuals should improve (also hard to measure)
Eliminate process measures, and any central attempt to dictate how the DSRIP participants achieve the goals. Yes – there can (and must) be accountability, but the accountability will exist in the form of reporting on progress toward achievement of the ?triple aim? goals, rather than achievement of a set of prescribed milestones that must be traversed.

My colleague wasn?t happy. My explanation was too simple! ?Shouldn?t we hold them accountable for solutions we know are effective in improving the health of these vulnerable populations I replied that this is exactly what the early Peace Corps volunteers did wrong when they imported ideas from Washington DC to communities in Asia: they assumed that they knew what was right. ?No. DSRIP participants should be exposed to programs that have been successful, but they should have the freedom to achieve the goals in any manner they choose.

A model for DSRIP 2.0

Positive Deviance teaches us that what works in one community may work in one community and only one community. The needs of a community are best understood and met by the members of that community. Folks who enter and seek to improve the lives of those in such a community will need to be ethnographers first, and ?fixers? second. This calls for teams of DSRIP leaders who are trained in anthropology, design thinking, population health, and social work. Doctors and nurses But they are in the back seat.
Who is doing this today?? Companies like ChenMed in Miami have Tai Chi classes, free transportation, and proactive care managers.

Motivational Interviewing teaches us that individuals make decisions because of internal incentives, not because authority figures tell them what to do. This informs a DSRIP approach that is focused in listening rather than speaking, on amplifying individuals? own interests in healthier living, and offering ideas that will facilitate change during teachable moments rather than mandating new behaviors, or imposing penalties for behaviors that are unhealthy. A DSRIP program might therefore hire teams of health educators from within a community: a trusted, yet trained group of people who can listen, empower, and facilitate change.
Who is doing this today? Community health workers in Massachusetts (pdf) have helped to reduce costs, improve health, and improve health experience for thousands of residents.

Disruptive innovation teaches us that the non-consumers of services (in this case – it is health – and not health care services that are not being consumed) is the best entry point for new market entrants and new product creation. We?re not going to create new hospitals in the next five years, nor will we change how they operate, how the incentivize their employees, or how they market their services. So hospitals are the wrong places to invest DSRIP dollars. Rather, DSRIP money will be best spent on community initiatives (see above) and innovative ?point solutions? that help can communities reach the triple aim, by addressing the health needs of individuals proactively.
Who is doing this today? Vital Score (I?m an advisor and investor), identifies individuals at peak moments of receptivity and matches them to services that will improve their health. ?Cohero Health created a metered dose inhaler that enables a care coordinator to track and monitor inhaler use in real time, and detects not just whether the inhaler was used, but whether proper technique was used.

As William Gibson may have said, the future is already here ? it?s just not very evenly distributed. While we often think of the fitbit-wearing, Volvo-driving soccer parents as opportunities for innovation in health, my hypothesis is that true change in the delivery of more health (rather than more care) will arrive in the form of DSRIP and other innovation programs. The opportunities to build successful programs, successful companies, and healthy communities are (finally) plentiful – if we know where to look. Inertia, combined with traditional payment models in traditional care delivery organizations will work against any of the innovations that will truly serve these communities, and this is why the greatest improvements in health will occur as a byproduct of work that precedes ?health care. This won?t be easy. But we can do it. As Yoda said:) do or do not. There is no try.”

Advice to the new National Coordinator

Two and a half years ago, John posted an entry with this title?- and I recall that it was a good summary of the state of the industry. ?While I didn’t agree with all of his suggestions, I enjoyed the review and it offered a good set of guiding principles. ?Since I was Acting National Coordinator for about the same duration as Vindell will serve, (Fall of 2013 – after Farzad Mostashari departed, and before Karen DeSalvo arrived) I’ll offer some thoughts?from?one who has been in his?position.

Certification. ?The health IT certification program is the core of ONC’s responsibility to the nation. ?While some have called for the eradication or reduction?of the certification program, I would argue that this would be akin to scaling back Dodd-Frank. ?Yeh – crazy. ?As a product of ONC’s certification program, we now have health IT systems that do what their developers claim they do. ?Before this program existed, creative health IT salespeople would assure customers that systems had functionality that simply didn’t exist, or was nonfunctional. ?The program, like certification programs in other industries (telecommunications, transportation, etc.) is in place to assure the purchasers of products that these products do what developers claim. ? Is the certification program perfect) No. ?Of course not. ?The program needs to iterate with the evolution of the industry and the standards that are evolving. ?Revisions to the certification program must therefore continue, so that the certification requirements don’t point to obsolete standards. ?A focused “2015R2” certification regulation would therefore be an appropriate component of ONC’s fall work – so that something can be “shovel ready” for a new administration for ~ February?release – with final rule in ~ April/May of 2017.
The 2017 Spend Plan. ?The 2017 federal budget appears to be on track to pass @ some point soon – and ONC’s appropriation for 2017 is looking like it will land at a steady ~ $60M ($65M if the extra $5M for narcotic?abuse prevention lands). ?The National Coordinator defines the “spend plan” for how the organization allocates?this money – and the plan needs to be developed and executed at the beginning of the fiscal year: October, 2016. ?The new National Coordinator is therefore making decisions now about how the funds will be spent over?the next 12 months. ?Office Directors are preparing proposed budgets for the year: ?new FTEs, new projects that they want to launch. ?Every year, it’s the same – just as it is in any large organization – proposals are submitted and the proposals represent 2x-3x the $$ available. ?Tough calls need to be made. ?The NC makes these calls. It’s hard to do this when you don’t know who your successor will be in January – or what their preferences will be. ?When I was in this position, I worked closely with the Office Directors and the ONC Chief Operating Offer (Lisa Lewis), to identify the components of the organization’s work that were essential, and which were not. ?We delayed?decisions on about $2M to give Karen some flexibility to fund programs that were important to her. ?As I mentioned in my response to Politico’s request for comments on the next phase of ONC’s path, my view is that?it’s time to wind down ONC’s grants and health IT evangelism activity. ?Perhaps it’s just my personality coming through here – as I am a well-known introvert, with little interest in quadrant 1 of the sizzle-substance 2 x 2 matrix?(kudos?to Janhavi?for its invention), but I am concerned that it’s not government’s role to convince the public of the value/need for health IT. ?If?health IT has value (and I believe it does) then this value will be tangible and self-evident to the public. ?If not, then no annual conference, blog post, or challenge grant will change this fact – or anyone’s perception of it. ?ONC’s annual meeting – an event that costs several hundred thousand dollars and attracts the same participants every year – adds rather little to the nation’s progress toward improved health through the strategic use of health IT. ?Kill the conference. ?Kill the health IT flag-waving. ?There’s already plenty of that to go around, and the taxpayer need not pay for it.
Focus on quality. ?No – not quality measures. ?Quality of health, quality of care, quality of decisions. ?Do these need to be measured) Of course they do – and with the growth of value based payment in federal programs upon us, measurement of quality is imperative. ?But we have conflated the concepts of quality and measurement. ?As many know, I’ve long been concerned that the way that we use clinical quality measures in health care is fundamentally flawed. ?Indeed, it was my concern about these flaws that led me to join?ONC in the first place: ?as the CMIO at Allscripts, I was responsible for helping our EHR development teams meet the requirements of Stage 1 of the EHR incentive programs (“meaningful use”) and it became clear that the accuracy of quality measure reporting would be terrible across the industry. ?Why was this) Because the 2011 certification criteria and Stage 1 meaningful use requirements were too vague about the data that would be used to measure quality. ?For example, a quality measure might express that patients with “severe congestive heart failure” would be expected to be on a certain class of medications. ?But there was no clarity for how “severe” was to be assessed, and many EHRs didn’t even formally capture ejection fraction, which would be an imperative component of an assessment of the severity of one’s CHF. ?For Stage 2/2012 certification, we changed all of this, and while most readers don’t know or care about the details, these quiet changes represent the first important step toward improved quality measurement: ?the data elements that are required for quality measures are explicitly identified in the certification regulation, and no measures are required that exceed the scope of these data elements. Read the last sentence again if you need to – as it’s very important and this guiding principle remains ignored by NQF, by many commercial health plan quality measures, and by many state Medicaid programs that are trying to implement quality programs.Simply put: ?it’s impossible to report on data that was never captured. ?A “quality measure” that assumes the presence of information in an IT system that is not present will be an invalid quality measure. ?Period. ?I thought / hoped we solved this problem in 2012. ?Unfortunately, we did not. ?Quality measures are still proposed without consideration for the data that EHRs have captured. ?It’s now easy to know what the EHR can capture (what it can capture and what it has captured may of course differ). ?Start with?the NLM’s Data Element Catalog (Jesse James won the naming competition). ?If the concept that you want to measure isn’t in here, then re-design your measure, because the EHRs don’t capture the data in a uniform manner. ? If it is?there, then the likelihood is high?(but not certain) that the data can be captured, queried, and transmitted.
Recall that I said our method of measuring quality is flawed. ?Why is it flawed) Because all of our focus is on quality measures rather than quality improvement, and improvement is a product of measurement and decision support. ?Let’s parse this statement, beginning with the difference between measures and measurement. ?A measure is an explicit logical statement about care delivery and its alignment with a very specific expectation. ?For example, there is some evidence that individuals with diabetes will live longer if their blood sugar?is well controlled, so there is a quality measure for this: ?IF (individual has diabetes) AND (blood sugar is well controlled) THEN (quality measure satisfied). ?Each of the logical expressions?can be defined explicitly. ?This measure can then be applied to thousands of care providers and their “scores” on the quality of care they presumably offer can be compared. ?But what if blood sugar control isn’t so important) What if there becomes a better way to measure individuals’?optimal health) Measuring care quality with a list of measures?is like having a speedometer in your car that measures 10, 15,25, 37 and 55 miles-per-hour and nothing in between. ?It’s a set?of measures?-hard-coded into the system rather than measurement:? a fluid, adaptable system that enables us to see how we are doing and therefore enabling us to adjust our work dynamically if necessary. ? How do we adjust) With clinical decision support (CDS)! ?As you will read in the chapter I wrote for?Eta Berner’s just-published book on CDS, the federal government has done a great deal of work to enhance?CDS capability in health IT systems, and to align it with quality measurement. ?We’re not there yet – but we are well on the way. ?Keep this on the front burner, and the path to the triple aim will be shorter and much less bumpy.
As my friend Jerry Osheroff always says – focus on the most important things: ?TMIT. ?Are we helping improve the health of people) That’s most important. ?Don’t lose sight of it. ?Karen DeSalvo taught me many things – but the one I’ve internalized the most was something that she taught me very early in her time at HHS: ?we need shift our conversation from how to improve?”health care” to how we improve health.

Self-Driving Health

Lots of news about this recently. Self Driving cars.

Five years ago, you would shake your head and say “no way – not in my lifetime.” Now you know that this is our future. It will be safer, will save billions of dollars, and will be have positive consequences we can barely imagine. The kids need to go to soccer practice? Send them. Need to get the dog to the vet for his check-up? Plop him in the car and off he goes. It’s real. It will happen. Soon.

So why is it so hard for us to imagine self-driving health?

Do we have a crisis of under-supply of primary care? Maybe. Today we do . But I wonder if that’s because we’re asking the wrong question. Earlier this week, I read that we would need 60,000 additional primary care visits in our community to reduce the demand for non-urgent visits in our emergency departments. If a primary care provider can see 25 patients a day – then we need ten additional providers in our community (250/day = 1250/week = 5000/month = 60,000/year).

But what if those 25 visits that didn’t need an ED visit ALSO didn’t require a primary care visit?

What if “visits” in 8 x 10 exam rooms with white-coated professionals weren’t the solution Let’s play the “five why?” exercise:

Donald Duck went to the Emergency Department:

Why did he go to the emergency department? Because he didn’t feel well and wanted to feel better.
Why didn’t he feel well? Because he had a fever and cough and the medicine he bought at the pharmacy didn’t help.
Why did he have a fever? Why didn’t the medicine he bought help? Because he had a bad cold – maybe even the flu (didn’t get a flu shot) and wasn’t sure what to buy at the pharmacy. He bought some kombucha and aspirin.
Why didn’t he get a flu shot? Because he doesn’t like going to the doctor. Only goes (to the ED or urgent care) when he feels sick.
Why doesn’t he like going to the doctor? Because they never seem to listen to him – and doctors are for sick people anyway. Why bother?

So what’s going to prevent Donald – and 24 of his friends – from going to the ED?

Is it another doctor with an open appointment?

No. Education, empathy, caring people who can help Donald understand what’s available to him to prevent illness, and what’s available to him when he is ill: a phone call, some good trustworthy advice, and (yes) if necessary – a visit with a care provider.

But I’d argue that this is much less frequent than we assume. Adding 60,000 visits to a community is a short sighted (and impractical) way to solve this problem. We need to help Donald to find self-driving health: tools that help him navigate, understand his goals, and get him from where he is to where he needs to be.

New York’s SHIN-NY Regulation

Posted today. PDF:? SHIN-NY rule.

I’ll add narrative later today.

Are follow-up visits necessary?

I’ve spent two afternoons precepting with the residents recently. It’s good to get back into clinical work – and after spending 3 years in Washington – separated by the Beltway from the real world – I’ve really felt the need to get back to the front lines of health care delivery to make sure I still understand the real world. I’m also seeing a window into how these physicians have been trained, and that is different from my life as a family physician in a small suburban practice – which was my reality pre – DC.

I’ve witnessed two themes that seem to deserve careful thought:

The follow-up visit. I felt like I had abolished many/most follow-up visits from my practice a decade ago. Sure – many guidelines advise follow-up visits after acute events, but I found that with good communication, most are unnecessary. People know when they don’t feel well – so we shouldn’t assume that they need us to tell them that they are better. My bias against the follow-up tradition probably stems from my early research work on the management of otitis media: most kids just get better. Only a fraction of kids with otitis media need antibiotics. In either case – with or without antibiotics, if we look in their ears too soon – it looks like they’re not better – so risk-adverse physicians write a prescription at the 7-10 day follow up visit. Quite often, I’d argue that this is unnecessary. So I stopped doing it a long time ago. We would keep in close touch with the family – and certainly if symptoms worsened or persisted, we would see them back, or alter the treatment over the phone. But a routine follow-up visit after an ear infection was never my pattern. This saved the space in our office for folks who needed to be there. Seems like this question was asked (and answered) in 1994.

But the follow-up visit persists – and not just for otitis media. Many conversations with a resident ended with “and I’ll have them follow-up in __ to make sure things are better.” After a while, I started asking “why?” Not to provoke a change in course – but to prompt thought. (Both the resident’s thought and my own.) I wondered if my patients in suburbia were fundamentally different from those here in an urban setting – where there is less money, less education. Did this cause us to assume they they can’t engage with on the phone? I thought about the residency practice – and how it’s not designed so well for continuity and access to the physician for a quick phone call. I thought about the fiscal pressure to generate revenue and keep the schedule full. My suburban practice was overflowing: we didn’t need more volume: indeed – we did our best to reduce it to make space for those who needed it most. Here – there is a large practice with empty rooms. Do they need to generate more visits? Is there an implicit bias toward volume?The real answer is “maybe” to all of the above. There are many reasons why young physicians might schedule the follow-up visit reflexively and why my practice five years ago might have been different. But without asking the questions every time, we won’t better understand how to solve the very real problems we face today in our industry: even very simple decisions are complicated.
A few weeks ago, I visited an ophthalmologist because I developed some floaters in my left eye after hitting my head. I knew enough to have my retina examined – because of the small chance that the trauma cause a retinal tear. Fortunately, she saw only some vitreous coalescence, and advised follow-up in 4 weeks. I obediently returned in 4 weeks, wondering why I needed to follow up. The risk of retinal detachment would (by now) have fallen, and it is also quite likely that I would see some evidence of retinal tear from my side of the retina. After my (normal) exam, which cost me $350, she advised another follow-up in 4 – 6 weeks. When I balked – asking “why?” – she agreed that there was no good reason (she generously agreed that it was for her peace of mind more than anything else) – and offered that we should alter our pattern to an annual visit. I departed still wondering what the evidence basis was for an annual visit to an ophthalmologist. I have neither diabetes nor glaucoma. Hmmm. None. I’ll probably see her next at the supermarket – not in her office.
The Physical Exam. It’s been over a year since Zeke Emanuel’s ‘s wonderful article in the NY Times. But for years before this – it was clear that putting a stethoscope to someone’s chest annually was a waste of their money and our time. So in my practice, we eradicated “physical exam” from our routine a long, long time ago, in a galaxy far, far away.The staff would never schedule someone for a “physical.” It would always be “health assessment” – and the focus would be both age and condition appropriate. The key advantage here is more than just semantics. It changed the expectations on both sides. Physicians felt less obligated to “do a physical” and patients – or their families – felt like they could really focus on their agenda, rather than checking boxes in the doctor’s head (and the EHR). The time saved not doing unnecessary physical maneuvers was better spent with depression screening, substance abuse discussion, optimizing health habits, etc. How often should this be done? Well of course it depends. It might be weekly for a preemie, just brought home from the hospital – and it might be every 5 years for a healthy 25 year old who participates in triathalons, has a BMI of 21, and eats kale 3x/day.
But that’s not what I’ve been seeing. I’ve been seeing lots of young physicians doing “physicals” and then not having time to have conversations – so guess what they do? They schedule “follow-up” visits to have these conversations. Volume again. Hmm ..
How could we be proactive about this? If we really want More Health and Less Care (we do – don’t we?) then couldn’t we change what we schedule, engage in a much more proactive way to schedule the flu shots, lipid profiles, A1Cs BEFORE visits (rather than after) – and really start to behave in a way that puts the people in the center – rather than the physician. I see very good, very thoughtful, very “patient centered” humans getting caught in the traditions that are – by definition – not patient-centered. Two of these traditions are the “follow-up visit” and “the physical.” Let’s start by just asking “why?” before we engage in either one. It’s a first step.

CMS RFI on MACRA

I’m a few weeks short of the?1 year anniversary of my departure from federal service. ?I loved my time in Washington, and loved the people, the passion, the sense of purpose, and of course the focus on doing what’s right for the nation. ?What was intended to be a 1-2 year adventure became a 3 years of commuting to DC from my home in Albany, New York.

Stepping away from government has?given me the opportunity to get back to the front lines of the intersection of information technology and health. ?Notice that I didn’t say “health care.” ?Sure – “care” is part of what happens – but isn’t the goal to minimize the care that’s necessary – and maximizing health) Glad you agree.

Until my 1 year anniversary, I’m prohibited from “engaging in certain activities on behalf of persons or entities.” Here’s the rule, in case you’re curious. ?This is why I can’t testify or even engage in the FACA hearings or workgroups, call my former colleagues on the phone and give them unsolicited advice on policy matters, etc.

CMS has issued an RFI on how it implements regulations for MACRA. ?I can’t submit comments (see above). ?But since I still have first amendment rights – I can post my comments here. ?Feel free to plagiarize when you post YOUR comments. ?;-)

Here is?how I’d answer a few?of the questions:

Under the MIPS, what should constitute use of CEHRT for purposes of reporting quality data?

MIPS should leverage the ONC’s certification program for purposes of reporting quality data. If the capabilities required for MIPS are not represented in the suite of capabilities for which products can be certified under ONC’s program, ONC and CMS should work together to create new certification opportunities under that program. ?Anything other than this would be confusing, costly, and complex. CMS may be?considering the creation of a separate program. What a waste that would be. Please please please don’t do that.

——-

Instead of requiring that the EHR be utilized to transmit the data, should it be sufficient to use the EHR to capture and/or calculate the quality data? What standards should apply for data capture and transmission?

I’ll answer an?edited question – since “utilized” is used incorrectly in this sentence (who does the copy editing at CMS?) and as it is expressed – the monolithic EHR is assumed to be present. ?But that should not be the case. ?ONC has evolved their terminology toward “health IT” and CMS should do the same where possible. ?Yes – due to the reference of “EHR” in the laws (both HITECH and MACRA) – this isn’t always possible – but perhaps we can get congress to fix that with a little wordsmithing. ? (How about it, Colin and Alicia? )

Edited question: “Instead of requiring that health IT be used to transmit the data, should it be sufficient to use health IT to capture and/or calculate the quality data? What standards should apply for data capture and transmission?”

a) Health IT can and should be used by providers and provider organizations to capture and calculate quality – as tightly or loosely coupled as such organizations might be – including but not limited to BPCI awardee conveners, CPCI affiliates, ACOs (all shapes and sizes), ICNs, regional cooperatives such as a New York PPS (under the NY DSRIP program), states, RHIOs, HIEs, IDNs, MA joint ventures, etc.

b) The standards to be used for the reporting of such quality calculations should be QRDA III.

c) In the case of quality data transmission, QRDA I should be used.

d) Quality data capture (from health IT – to a quality aggregation/calculation entity) should leverage QRDA I. Health IT should be certified for the capture of data elements – as defined by ONC – referenced in the Data Elements Catalog and the Value Set Authority Center @ NLM – as is currently the case. Don’t break a good thing.

e) Outcome measures rather than process measures should be preferentially selected.