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Tag: HIT

A Troubling Strategy at Health IT Week

Health IT Week demonstrated a double barrel strategy to segregate patient information from provider information. Providers already have the power to set prices and health IT plays the central role.

By rebranding HIPAA as “Meaningful Consent” and making patients second-class citizens in Meaningful Use Stage 2 interoperability, providers and regulators are working together to keep it that way.

Essential consumer protections such as price transparency or independent decision support are scarce in the US healthcare system. The journalists are shouting from the rooftops.

There’s  $1 Trillion (yes, $3,000 per person per year) of unwarranted and overpriced health services steering the Federal health IT bus with an information asymmetry strategy. Those of us that want to see universal coverage succeed need the information transparency tools to drive for changes.

Here’s how it works: The department of Health and Human Services (HHS) controls the health IT incentives and regulations. HIPAA applies to most licensed health services providers. Laboratories and devices are regulated by Medicare and the FDA.

Unlicensed services offered directly to patients, such as personal health records, web info sites and apps are regulated by the FTC. Separate regulatory domains facilitate the segregation of information and contribute to the lack of transparency by making patient-directed services use delayed and degraded information. This keeps independent advice from FTC-regulated service providers from illuminating the specific abuses.

The segregation of patient information from “provider” information is the current federal regulatory strategy. It’s even more so in the states. By making patients into second-class citizens, the providers can avoid open scrutiny, transparent pricing, and independent decision support.

Federal regulators then create a parallel system where information is delayed, diluted, and depreciated by lack of “authenticity”. This is promoted as “patient engagement”. For regulators, it’s a win-win solution: the providers support the regulation that enables their price fixing and many patient advocates get to swoon over patient engagement efforts.

The proof of this strategy became clear on the first day of Health IT Week – the Consumer Health IT Summit.

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Can Entrepreneurs “Cure” Health Care With Technology?

Today marks the beginning of the 8th annual Healthcare IT Week. Healthcare IT Week was started and continues on as a collaborative forum for public and private healthcare constituents to discuss the value of health information technology (health IT) for the U.S. healthcare system.

It is amazing to see how far health IT has come over the last 10-15 years.  It has its own week!  If, a decade ago, you told people that health IT would be a core focus of investors, entrepreneurs and everyone else in healthcare, the energy produced from the eye rolling alone could power the lights on the Las Vegas Strip for a month.  The basic sentiment back then was this: Why would anyone invest in, think about, care about health IT when the consumer Internet was rocking and companies selling online dog food could get started on Monday and sold on Friday for a bull mastiff’s weight in gold?

Today it is quite clear that healthcare IT is a hugely significant part of any success we are having and will continue to have in transforming our healthcare system from one where 30% of cost and care is wasted or the result of error to one where value reigns supreme.  We do not believe anyone rational would now argue that healthcare IT is non-essential to improving the quality, productivity, efficiency, cost and outcomes we produce in our healthcare system, although the path is not always smooth.

And it’s about time. Technology has been used to optimize and redefine virtually every key industry except healthcare. Manufacturing has gone from human assembly lines to robotics; banking has gone from tellers to home banking; travel has gone from agents with brochures to Travelocity; and yet in many ways, the fundamental practice of medicine hasn’t changed in decades.

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Regulating Health IT: When, Who, and How?

Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.

Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.

Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.

But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.

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What Keeps Me Up At Night – 2013 Edition

Now that Labor Day has come and gone,  I’ve thought about the months ahead and the major challenges I’ll face.

1.  Mergers and Acquisitions

Healthcare in the US is not a system of care, it’s a disconnected collection of hospitals, clinics, pharmacies, labs, and imaging centers.  As the Affordable Care Act rolls out, many accountable care organizations are realizing that the only way to survive is to create “systemness” through mergers, acquisitions, and affiliations. The workflow to support systemness may require different IT approaches than we’ve used in the past. We’ve been successful  to date by leaving existing applications in place and building bidirectional clinical sharing interfaces via  “magic button” viewing and state HIE summary exchange. Interfacing is great for many purposes.  Integration is better for others, such as enterprise appointment scheduling and care management. Requirements for systemness have not yet been defined, but there could be significant future work ahead to replace existing systems with a single integrated application.

2.  Regulatory uncertainty

Will ICD10 proceed on the October 1, 2014 timeline?  All indications in Washington are that deadlines will not be changed. Yet, I’m concerned that payers, providers and government will not be ready to support the workflow changes required for successful ICD10 implementation.    Will all aspects of the new HIPAA Omnibus rule be enforced including the “self pay” provision which restricts information flow to payers?  Hospitals nationwide are not sure how to comply with the new requirements.   Will Meaningful Use Stage 2 proceed on the current aggressive timeline?  Products to support MU2 are still being certified yet hospitals are expected to begin attestation reporting periods as early as October 1.   With Farzad Mostashari’s departure from ONC, the new national coordinator will have to address these challenging implementation questions against a backdrop of a Congress which wants to see the national HIT program move faster.

3.  Meaningful Use Stage 2 challenges

Although attestation criteria are very clear (and achievable), certification is quite complex, especially for a small self development shop like mine.   One of my colleagues at a healthcare institution in another state noted that 50 developers and 4 full analysts are hard at work at certification for their self built systems.   I have 25 developers and a part time analyst available for the task.   I’ve read every script and there are numerous areas in certification which go beyond the functionality needed for attestation.    Many EHR vendors have described their certification burden to me. I am hopeful that ONC re-examines the certification process and does two things – removes those sections that add unnecessary complexity and makes certification clinically relevant by using scenarios that demonstrate a real world workflow supporting the functionality needed for attestation.

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Why Doctors Should Stay Out of the Business of Building EHRs

The original Hipoocratic Oath states:

I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.

One modern version reads:

I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.

The idea here is that a doctor needs to recognize when another practitioner has a skill that they do not, and that they must refrain from “practice” when another person has demonstrable expertise in that area of practice.

It is now 2013. It is time for doctors to stop “writing their own EHR” from scratch. They need to bow out of this in favor of people who have developed expertise in the area.

I just found out about another doctor who has decided to write his own EHR, because he has not been able to find one that supports his new direct pay business model adequately. In the distant past I encountered a doctor who believed that his “Microsoft Word Templates” qualified as an EHR system. This is a letter to any doctor who feels like they are comfortable starting from-scratch software development for an EHR in 2013 or later.

You might believe yourself to be an EHR expert.

Are you sure about that? Are you sure that you are not just an EHR expert user?

This difference is not unlike your relationship with your favorite thoracic surgeon. Or for that matter, your relationship with the person who built your car. The fact that you are capable of expertly evaluating and using EHR products does not mean you are qualified to build one. Just like the fact that you are qualified to treat a patient who has recently had heart surgery or to discern when a patient might need heart surgery does not make you qualified to perform that heart surgery. Similarly, the fact that you can drive, or even repair your automobile, does not provide you with the expertise you need to build a car from scratch.

The ethical situation that you are putting yourself in by developing your own EHR is fairly tenuous. Performing heart surgery without being a heart surgeon, building and driving your own car without being an automotive engineer and a doctor coding their own EHR system from scratch all have the same fundamental problem: You might be smart enough to pull it off, but if you don’t you can really mess up another person’s life. Make no mistake, you can kill someone with a shoddy EHR just as easily as by performing medical procedures that you are not qualified for or by driving a car that is not road-safe.

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An Open Letter to the President: The Danger in Promoting the “Digitization of Disaster Recovery”

Dear Mr. President:

I served in your White House; to do so was among the highest honors of my life and an incomparable professional opportunity.

Since 2009, I’ve sought to return the favor by building on a decade as a journalist to write about the unsung innovation I saw happening beneath the public’s radar.  (The federal government has never been great about describing its positive achievements, but this unintentional “humility” is worsened by too much media reliance on muckraking to generate cheap content.) The prize for some of your Administration’s improvements will be billions of dollars’ worth of process efficiency and an ability to retain social-good programs while slashing redundancy and phasing out archaic ways of doing business.  All politics aside, I watched these mechanisms with my own wide eyes.

But if one is to deliver praise like I just did, then one must also be willing to highlight dangerous errors in the path ahead, especially when the potholes are avoidable.  As a subject matter expert on emergency medical technologies, I have a patriotic duty to point out correctible overstatements and oversimplifications that, if left uncorrected, could undermine your Administration’s objective to bolster the public’s senses of safety, security and comfort—especially as it simultaneously emphasizes the danger of man-made and natural disasters.

On July 9, 2013, your White House sent out a “marketing” email entitled “President Obama’s Plan for Using Technology to Make Government Smarter.” The email contained the following three bullets:

  • Increasing efficiency and saving money.  CHECK: A worthy goal, and one that I had the chance to see put in action from the inside-out, as part of the project team that relaunched USAJOBS.gov—the so-called “face of federal hiring.”  The White House email cited cost reductions of our $2.5 billion; that seems reasonable, considering how extensive an effort went into collapsing duplicative data silos and databases, and modernizing the federal government’s technical infrastructure.  Vivek Kundra, the visionary former federal Chief Information Officer, should be a central figure in every conversation about government’s meaningful gravitation toward efficiency; he earned more credit than he gets (but that’s not why people work in government).
  • Opening government data to fuel innovation and problem-solving: CHECK: The Administration claims that it is opening “huge amounts of government data to the American people, and putting it on the internet for free.”  There are many ways in which this is true, ranging from Data.gov to the Blue Button Initiative, to a (relative) simplification of the grant-making process.  (The latter is better than it was, but it still is eons from intuitive or fair.)  Much controversy now swirls around actions that the government still keeps secret, but that cannot detract from the fact that a veritable cornucopia of information has been released, and it is indeed spurring creativity.  Unfortunately, my own firm uncovered a challenging corollary problem that goes hand-in-hand with the release of oodles of data: at least some of those data are bad, faulty or incomplete, yet when we tried contacting the appropriate agency to close the gap and strive for accuracy, we were met with silence.

The last bullet in the White House’s email, however, does not deserve a “CHECK.” Rather, it is concerning and arguably more dangerous than whoever drafted the outreach piece likely realized.  It also touches on something I know a bit about.

Replacing Farzad

In the wake of the National Coordinator’s announcement that he is departing, there has been a flurry of tweets, blog posts, impromptu online polls, and conjecture about the most likely successor.  To date, none of these conversations has resulted in a thoughtful assessment of the set of characteristics that would represent the ideal candidate, nor has there been any thorough review of the most likely candidates in the context of these attributes.  The need for a rapid transition to a successor is well understood by all – yet there has been no indication that the Obama administration is in a hurry.  Let’s hope that we can evolve them toward a greater sense of urgency. The fragility of ONC – and the importance of its health – can’t be overlooked.

Let’s consider some history:

The first two National Coordinators, David Brailer and Rob Kolodner, were appointed before ARRA.  The agency was small, focused largely on certification (through CCHIT), standards (through HITSP) and policy.  When ARRA arrived, David Blumenthal, a thoughtful, deliberate, policy-savvy internal medicine physician from Boston was brought in to lead the rapid expansion of health IT that was facilitated by the HITECH Act.

ONC expanded under Blumenthal from a team of ~ 30 people to a team of >100 in the two years that he was at the helm, and the agency published the 2011 certification criteria regulations, and collaborated with CMS to publish the regulations that defined stage 1 of the Meaningful Use incentive program.  The policy foundation was that the three-stage program – to be implemented over six years – would evolve the nation’s care delivery system by causing adoption of EHR technology (stage 1) and then exchange of clinical information electronically (stage 2) and finally improved clinical outcomes (stage 3).

Farzad Mostashari, who joined Blumenthal as the Deputy National Coordinator early in Dr Blumenthal’s tenure, was quickly named as Blumenthal’s successor when Blumenthal announced his resignation in the Spring of 2011.  Both Mostashari and Blumenthal pushed hard for Mostashari’s appointment – so that the consistency, focus and forward momentum of the organization could be maintained.

And so it was.  Under ARRA, adoption of EHRs has skyrocketed.  The CMS MU Stage 2 regulations and the ONC 2014 certification regulations were published, and the size of the agency has doubled to over 150 people.  Recognizing the need for experienced partners to assist him in leading a larger agency – and growing national reliance on health IT and an essential component of the care delivery ecosystem – Mostashari hired David Muntz as the “Principal Deputy” (essentially the COO of the agency), Jacob Reider as Chief Medical Officer (leading a team of clinicians focused on quality and safety) and Judy Murphy as the Deputy National Coordinator for Programs and Policy (adding internal coordination support for ONC programs).

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What the Recent Data Breach Says About the State of Health IT

Recently officials at Oregon Health Sciences University discovered that residents in several departments were storing patient information on Google Drive, and had been doing so for the past two years. They treated this discovery as a breach of privacy and notified 3000 patients about the incident.

While I don’t condone the storage of patient information on unapproved services like Gmail or Google Drive, this incident pretty much highlights the sorry state of information systems within the hospital and the unfulfilled need by physicians for tools that facilitate workflow and patient care.

It says something that the Oregon residents felt compelled to take such a drastic action. I don’t know what punishment – if any – those responsible were given by administrators for their “crimes.” I’ll leave it to readers to make up their own minds about the wisdom of the unauthorized workaround and the appropriateness of any punishment. But I do know that the message the incident sends is a very clear one.

We’re screwing this up. There is really no earthly reason why it should be any more difficult to share a patient record than it is to share a Word doc, a Powerpoint or yes, even a cloud-based Google Drive spreadsheet.

Why the Breach Happened

What’s going on here? Let’s say I admit a patient to the hospital.  Our friend was hospitalized here just last month, and like many patients, he has dementia or is poorly educated, and does not know the names of the medications he takes. Unfortunately, I don’t have the ability to see what he takes or how he was treated during the prior admission because the records in the computer are there for documentation’s sake and don’t contain any meaningful information. This is clearly a problem for me.

Therefore I will spend time calling outside facilities to gather information and repeat several tests and imaging procedures.

Medical care has become a team sport, and residents have developed systems for keeping track of their patients and communicating to other physicians. It takes some time to think about and process each patient that comes in, to consolidate all the information. Ultimately, I need to boil that information down to a five-minute description on the patient, their problems, the status of their current admission, and what needs to happen before they go home.  We do this in the form of a signout document.

Figure: The signout document has four to five columns and includes the To Do list for each patient.

The EMR does not have a good way to store information in this format, and  additionally I have no way of editing this in real-time to communicate with my
coworkers what still needs to be done. That’s why residents were storing their  signouts in Google Drive.

What providers need here is simple data management. We need to store and access this list from different computers. We need the ability to enter a subset of those data  using a custom form, and the ability to print subsets of those data to create a To Do lists, rounding sheets, or progress notes.Continue reading…

Providers Are Held Accountable. Why Aren’t Technology Vendors?

As healthcare shifts from fee-for-service to fee-for-value, hospitals and physicians are increasingly being held accountable for outcomes by the government, payers and patients. Historically, provider organizations only had to meet performance criteria to earn a pay-for-performance bonuses or hospital certification, but with the arrival of Accountable Care Organizations (ACO), Meaningful Use and other programs, payment is now based on to quality of care rather than quantity of services.

Health information technology (HIT) systems are able to track physician actions and measure outcomes down to the individual patient level and allow organizations to closely monitor the quality levels of a given physician. These same tools should be able to monitor the performance of the vendors who are there to support these clinicians. With patient engagement solutions, for example, vendors claim they can help improve HCAHPS scores, treatment adherence, patient outcomes, and reduce costs, but have no evidence to back it up.

Vendors should be willing to commit to their patient engagement promises, present proof showing improved outcomes and face some financial risk for failing to deliver.

Global accountability

Since patient engagement was included in the Centers for Medicare and Medicaid Solutions’ Meaningful Use of Electronic Health Records program, it has become a popular buzzword. Every HIT vendor claims to offer tools to assist providers with this important clinical quality issue, but no one is holding anyone accountable.

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The Affordable Care Act Will Fail Without Patient Engagement

What’s behind the recent EHR public relations blitz and our passionate debate in The Health Care Blog? It’s fear for the Affordable Care Act’s future. Oh, the ACA can weather political challenge in the short term, but in the long run, only health cost containment will matter. EHRs are the ship that institutions are counting on to navigate payment reform and, from the institutional perspective, physicians and patients are just along for the ride. From the citizen perspective however, cost containment will be seen as rationing unless patients and physicians are appropriately engaged in the most costly decisions.

The impact of yet more regulations, such as Stage 3 Meaningful Use, could be too late to save the ACA. For now, the administration and those of us that hope the ACA succeeds must work to shift EHR vendors and their institutional customers toward patient engagement using the tools of policy guidance, public relations and federal procurement.

First, a crash course in health economics. If you have a few minutes, read Accountable Care Organizations: Can We Have Our Cake and Eat It Too? by Jessica L. Mantel. Otherwise, just struggle through the next two paragraphs summarizing why EHRs are the lynchpin of health reform via the ACA.

Cost containment requires either cost controls or a shift away from fee-for-service payment. The ACA is based on accountable care as an alternative to fee-for-service. Accountable Care Organization (ACO) is shorthand for the new health care payments regime. By paying ACO institutions instead of individual service providers, health insurance companies and Medicare provide direct economic incentives to reduce waste, lower costs and, if we’re not careful, withhold needed care. An ACO is by definition an organization or institutional construct.

The EHR is is not the Jedi knight’s lightsaber, it is an institutional tool designed to bind the individual service providers into the Federation’s collective. Not surprisingly, patient engagement is an afterthought.

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