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ONC’s Budget Performance Measure Dashboards Makes Goal Tracking Easy

Posted on August 9, 2016 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

I recently wrote a post how it’s not easy to compare ONC’s spending plans with what it actually did. That’s not the case with ONC’s Budget Performance Measures. Its Performance Measure dashboard makes those comparisons easy and understandable. For example, you can look up EHR adoption among office based physicians.

Here’s how to use it. On the dashboard page, Figure I, select a general area using the radio buttons. Depending on your choice, the system will list specific issues. You select the one you want from the drop down menu on the right. You can also adjust the period covered. Right clicking a graph downloads it.

Figure I – ONC Dashboard Menu

ONC Dashboard Menu

It’s in the graph that the dashboard excels. It clearly shows targets and results. For example, Figure II shows that while office EHR adoption has grown over the years, it’s running below ONC’s goals. If you’d only saw the actual – which is the case with ONC’s budget — you’d only see adoption going up. You’d have no clue ONC’s goal wasn’t met.

Figure II – ONC Primary Care Adoption

Office Based Primary Care Doc Adoption

These dashboards give the public a way to understand what ONC wants to do and how well — or not so well — its done toward its goals. In doing so, ONC has given us a scoreboard that not only measures what it’s doing, but it also allows the public to focus on benchmarks. ONC’s fiscal reporting isn’t the clearest, but with these dashboards they’ve done themselves well.

ONC’s Budget: A Closer Look

Posted on August 3, 2016 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

When HHS released ONC’s proposed FY2017 budget last winter, almost all attention focused on one part, a $22 million increase for interoperability. While the increase is notable, I think ONC’s full $82 Million budget deserves some attention.

ONC’s FY2017 Spending Plan.

Table I, summarizes ONC’s plan for Fiscal Year 2017, which runs from October 1, 2016 through September 30, 2017. The first thing to note is that ONC’s funding would change from general budget funds, known as Budget Authority or BA, to Public Health Service Evaluation funds. HHS’ Secretary may allocate up to 2.1 percent of HHS’ funds to these PHS funds. This change would not alter Congress’ funding role, but apparently signals HHS’s desire to put ONC fully in the public health sector.

Table I
ONC FY2017 Budget

fy2017-budget-justification-onc

What the ONC Budget Shows and What it Doesn’t

ONC’s budget follows the standard, federal government budget presentation format. That is, it lists, by program, how many people and how much money is allocated. In this table, each fiscal year, beginning with FY2015, shows the staffing level and then spending.

Staffing is shown in FTEs, that is, full time equivalent positions. For example, if two persons work 20 hours each, then they are equivalent to one full time person or FTE.

Spending definitions for each fiscal year is a little different. Here’s how that works:

  • FY2015 – What actually was spent or how many actually were hired
  • FY2016 – The spending and hiring Congress set for ONC for the current year.
  • FY2017 – The spending and hiring in the President’s request to Congress for next year.

If you’re looking to see how well or how poorly ONC does its planning, you won’t see it here. As with other federal and most other government budgets, you never see a comparison of plans v how they really did. For example, FY2015 was the last complete fiscal year. ONC’s budget doesn’t have a column showing its FY2015 budget and next to it, what it actually did. If it did, you could see how well or how poorly it did following its plan.

You can’t see the amount budgeted for FY2015 in ONC’s budget, except for its total budget. However, if you look at the FY2016 ONC budget, you can see what was budgeted for each of its four programs. While the budget total and the corresponding actual are identical -$60,367,000, the story at the division level is quite different.

                                   Table II
                    ONC FY2015 Budget v Actual
                                    000s

Division

FY2015 Budget $ FY2015 Actuals $ Diff
Policy Development and Coordination 12,474 13,112 638
Standards, Interoperability, and Certification 15,230 15,425 195
Adoption and Meaningful Use 11,139 10,524 (615)
Agency-wide Support 21,524 21,306 (218)
Total 60,367 60,367

 

Table II, shows this by comparing the FY2015 Enacted Budget from ONC’s FY2015 Actuals for its four major activities. While the total remained the same, it shows that there was a major shift of $638,000 from Meaningful Use to Policy. There was a lesser shift of $195,000 from Agency Support to Standards. These shifts could have been actual transfers or they could have been from under and over spending by the divisions.

Interestingly, Table III for staffing shows a different pattern. During FY2015, ONC dropped 25 FTEs, a dozen from Policy Development and the rest from Standards and Meaningful Use. That means, for example, that Policy Development had less people and more money during FY2015.

Table III
ONC FY2015
Budget v Actual Staffing FTEs
Division FY2015 Budget FTEs FY2015 Actuals FTEs Diff
Policy Development and Coordination 49 37 (12)
Standards, Interoperability, and Certification 32 26 (6)
Adoption and Meaningful Use 49 42 (7)
Agency-wide Support 55 55
Total 185 160 25

 

To try to make sense of this, I looked at the current and past year’s budgets, but to no avail. As best I can tell is ONC made great use of contracts and other non personnel services. For example, ONC spent $30 Million on purchase/contracts, which is $8 million more than it did on its payroll.

ONC’s budget, understandably, concentrates on its programs and plans. It puts little emphasis on measuring its hiring and spending abilities. It’s not alone, budgets government and otherwise, are forecast and request documents. However, if we could know how plans went – without having to dig in last year’s weeds  – it would let us know how well a program executed its plans as well as make them. That would be something worth knowing.

Practice Fusion Founder Launches Wearables Startup

Posted on May 31, 2016 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Free EMR vendor Practice Fusion has always been something of a newsmaker. Since its launch in 2005, the company has drawn both praise and controversy for its revenue-generation approach, which has included the analysis and sale of de-identified patient data and advertising to physicians.

But it’d be hard to question Practice Fusion’s success, particularly given that it found its legs during a hyper-competitive period of EMR vendor growth capped by the Meaningful Use incentive program. Over the company’s lifespan, it has grown to serve over 110 million patients, and reportedly supported more than 70 million patient visits over 2015. It also attracted over $150 million in venture and private equity funding. Will it provide a great return for investors, time will tell, but they’ve definitely left their mark on the EHR industry.

At the helm of Practice Fusion until last year was CEO and Founder Ryan Howard. Howard – whom I’ve interviewed now and again over the years — certainly doesn’t lack for confidence or creative thinking. So I was intrigued to learn that Howard has stuck his toe into the wearables market. Clearly, Howard has not wasted time since August 2015, when he was booted out as Practice Fusion CEO. And if he believes a wearables startup can make money in this rapidly-maturing niche, I’m inclined to give it a look.

Howard’s new startup, dubbed iBeat, is creating a watch which constantly monitors and analyzes users’ heart activity. The device, which transmits its data to a cloud platform, can alert emergency medical services and, using an onboard GPS, provide the wearer’s location when a user has a heart attack or their heart slows down below a certain level. Unlike competitor AliveCor, whose electrocardiogram device can detect heart rhythm abnormalities such as atrial fibrillation, it has no immediate plans to get FDA approval for its technology.

iBeat expects to sell the device for less than $200, though if users want the emergency alert service they’ll have to pay an as-yet unnamed extra monthly fee. That puts it smack in the middle of the pack with competitors like the Apple Watch. However, the startup’s focus on cardiac events is fairly unusual. Another unusual aspect to the launch is that Howard is targeting the 50- to 70-year-old Baby Boomer market. (Imagine a more-focused version of the LifeAlert “I’ve fallen and I can’t get up” service, which focuses on the 75-plus market, Howard told MobiHealthNews.)

My take on all of this is that there may very well be something here. As I wrote about previously, my own heart rhythm is being monitored by a set of devices created by Medtronic, a set-up which probably cost a few thousand dollars in addition to the surgical costs of implanting the monitoring device. While Medtronic’s technology is doubtless FDA approved, for not-so-serious cases such as my own a $200+ plus smart watch might be just the ticket.

On the other hand, I doubt that uncertified devices such as the iBeat watch will attract much support from providers, as they simply don’t trust the data. So consumers are really going to have to drive sales. And without a massive consumer marketing budget, it will be difficult to gain traction in a niche contested by Apple, Microsoft, Fitbit and many, many other competitors. Not to mention all the competitors in the “I’ve fallen and I can’t get up” category as well.

Regardless of whether iBeat survives, though, I think its strategy is smart. My guess is that more-specialized wearables (think, I don’t know, iSugar for diabetics?) have a bright future.

Bill Could Cut Meaningful Use Reporting Period Drastically

Posted on April 25, 2016 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

A bill has been filed in Congress that would slash the Meaningful Use reporting period from one year to 90 days. This seems to be a challenge to CMS, which has reportedly held firm in the face of pressure to cut the reporting period on its own.

Supporters of the bill, which is backed by a broad coalition of industry trade groups, argue that a 365-day reporting period is unduly burdensome for providers, and will become even more awkward as MACRA requirements fall into place. Cutting the reporting period “will continue the significant progress providers are making to harness the use of technology to succeed in new payment and care delivery models,” argued a coalition of such groups in a letter sent to CMS last month.

That being said, it’s not clear how the structure of Meaningful Use incentives will play out under MACRA. So the reporting period change may or may not be as relevant as it might have been before the MACRA rules were set to be announced.

CMS leaders have said that the upcoming Merit-Based Incentive Payment System (MIPS) – which will probably fall in place under MACRA in 2017 — is designed to unify incentive payments. Specifically, it integrates existing MU, PQRS and Value-Based Payment Modifier programs. MIPS payments will be based on a weighted score rating providers on four factors: quality (30%), resource use (30%), Meaningful Use (25%) and clinical practice improvement activities (15%). This suggests that a focus on reporting requirements is probably a matter of closing the barn door after the horse has left the stable.

On the other hand, since Meaningful Use isn’t going away completely, maybe cutting the reporting period required is necessary. If providers are being rated on a set of factors of which MU is just a part, reporting for an entire year could certainly impose an administrative burden. Why set providers up to fail by forcing them to overextend their resources on reporting?

I believe that reducing Meaningful Use requirements is a sensible step to take at this point. While there are probably those who would argue the point, I submit that MU has been pretty successful in motivating providers to rethink their relationship with HIT, and has even help a subset to completely rethink how they deliver care. Now, it’s time to move the ball forward, to a more holistic approach that goes beyond regulating care processes.

Admittedly, it’s possible that cutting the reporting period, or otherwise shifting the emphasis away from regulating HIT use, might cause some providers to slack off in some way. But to my way of thinking, that’s a risk we need to take. After investing many billions of dollars on promoting smart HIT use, we have to assume that we’ve done what we can, and focus on smart quality measures. With any luck, the new measures will work better for everyone involved.

Meaningful Use Holdover Could Be Good News For Healthcare

Posted on January 25, 2016 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I know all of us are a flutter about the pending regulatory changes which will phase out Meaningful Use as we know it. And yes, without a doubt, the changes underway will have an impact that extends well beyond the HIT world. But while big shifts are underway in federal incentives programs, it’s worth noting that it could be a while before these changes actually fall into place.

As readers may know, the healthcare industry will be transitioning to working under value-based payment under the Medicare Access and CHIP Reauthorization Act, which passed last year. But as ONC’s Karen DeSalvo noted last week, the transition could take a while In fact, proposed draft regulations for MACRA rollout will be released this spring for public comment. When you toss in the time needed for those comments to be submitted, and for the feds to digest those comments and respond, my guess is that MACRA regs won’t go live until late this year at the earliest.

The truth is, this is probably a very good thing. While I don’t have to tell you folks that everyone and their cousin has a Meaningful Use gripe, the truth is that the industry has largely adapted to the MU mindset. Maybe Meaningful Use Stage 3 wouldn’t have provided a lot of jollies, but on the whole, arguably, most providers have come to terms with the level of process documentation required — and have bought their big-bucks EMRs, committing once and for all to the use of digital health records.

Value-based payment, on the other hand, is another thing entirely. From what I’ve read and researched to date, few health organizations have really sunk their teeth into VBP, though many are dabbling. When MACRA regs finally combine the Physician Quality Reporting System, the Value-based Payment Modifier and the Medicare EHR incentive program into a single entity, providers will face some serious new challenges.

Sure, on the surface the idea of providers being paid for the quality and efficiency they deliver sounds good. Rather than using a strict set of performance measures as proxies for quality, the new MACRA-based programs will focus on a mix of quality, resource use and clinical practice use measures, along with measuring meaningful use of certified EHR technology. Under these terms, health systems could conceivably enjoy both greater freedom and better payoffs.

However, given health systems’ experiences to date, particularly with ACOs, I’m skeptical that they’ll be able to pick up the ball and run with the new incentives off the bat. For example, health systems have been abandoning CMS’s value-based Pioneer ACO model at a brisk clip, after finding it financially unworkable. One recent case comes from Dartmouth-Hitchcock Medical Center, which dropped out of the program in October of last year after losing more than $3 million over the previous two years.

I’m not suggesting that health systems can afford to ignore VBP models, or that sticking to MU incentives as previously structured would make sense. But if the process of implementing MACRA gives the industry a chance to do more preparing for value-based payment, it’s probably a good thing.

Is Meaningful Use For Mental Health Providers On The Way?

Posted on June 10, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

If you look at the policy statements issued by ONC, it sounds as though the organization is a big fan of putting behavioral health IT on the same footing as other aspects of care. As the agency itself points out, 46% of Americans will have a mental health disorder over the course of their lifetime, and 26% of Americans aged 18 and older live with a mental health disorder in any given year, which makes it imperative to address such issues systematically.

But as things stand, behavioral health IT initiatives aren’t likely to go far. True, ONC has encouraged behavioral health stakeholders on integrating their data with primary care data, stressed the value of using EMRs for consent management, supported the development of behavioral health clinical quality measures and even offered vendor guidelines on creating certified EMR tech for providers ineligible for Meaningful Use. But ONC hasn’t actually suggested that these folks deserve to be integrated into the MU program. And not too surprisingly, given their ineligibility for incentive checks, few mental health providers have invested in EMRs.

However, a couple of House lawmakers who seem pretty committed to changing the status quo are on the case. Last week, Reps. Tim Murphy (R-Pa.) and Eddie Bernice Johnson (D-Texas) have reintroduced a bill which would include a new set of behavioral health and substance abuse providers on the list of those eligible for Meaningful Use incentives.

The bill, “Helping Families in Mental Health Crisis Act,” would make clinical psychologists and licensed social workers eligible to get MU payments. What’s more, it would make mental health treatment facilities, psychiatric hospitals and substance abuse mistreatment facilities eligible for incentives.

Supporters like the Behavioral Health IT Coalition say such an expansion could provide many benefits, including integration of psych and mental health in primary care, improved ability of hospital EDs to triage patients and reduction of adverse drug-to-drug interactions and needless duplicative tests. Also, with interoperable healthcare data on the national agenda, one would think that bringing a very large and important sector into the digital fold would be an obvious move.

So as I see it, making it possible for behavioral health and other medical providers can share data is simply a no-brainer.  But that can’t happen until these providers implement EMRs. And as previous experience has demonstrated, that’s not going to happen until some version of Meaningful Use incentives are available to them.

I imagine that the bill has faltered largely over the cost of implementing it. While I haven’t seen an estimate of what it would cost to expand eligibility to these new parties, I admit it’s likely to be very substantial. But right now the U.S. health system is bearing the cost of poorly coordinated care administered to about one-quarter of all U.S. adults over age 18. That’s got to be worse.

HHS’ $30B Interoperability Mistake

Posted on May 8, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Sometimes things are so ill-advised, in hindsight, that you wonder what people were thinking. That includes HHS’ willingness to give out $30 billion to date in Meaningful Use incentives without demanding that vendors offer some kind of interoperability. A staggering amount of money has been paid out under HITECH to incentivize providers to make EMR progress, but we still have countless situations where one EMR can’t talk to another one right across town.

When you ponder the wasted opportunity, it’s truly painful. While the Meaningful Use program may have been a good idea, it failed to bring the interoperability hammer down on vendors, and now that ship has sailed. While HHS might have been able to force the issue back in the day, demanding that vendors step up or be ineligible for certification, I doubt vendors could backward-engineer the necessary communications formats into their current systems, even if there was a straightforward standard to implement — at least not at a price anyone’s willing to pay.

Now, don’t get me wrong, I realize that “interoperability” is an elastic concept, and that the feds couldn’t just demand that vendors bolt on some kind of module and be done with it. Without a doubt, making EMRs universally interoperable is a grand challenge, perhaps on the order of getting the first plane to fly.

But you can bet your last dollars that vendors, especially giants like Cerner and Epic, would have found their Wilbur and Orville Wright if that was what it took to fill their buckets with incentive money. It’s amazing how technical problems get solved when powerful executives decide that it will get done.

But now, as things stand, all the government can do is throw its hands up in the air and complain. At a Senate hearing held in March, speakers emphasized the crying need for interoperability between providers, but none of the experts seemed to have any methods in their hip pocket for fixing the problem. And being legislators, not IT execs, the Senators probably didn’t grasp half of the technical stuff.

As the speakers noted, what it comes down to is that vendors have every reason to create silos and keep customers locked into their product.  So unless Congress passes legislation making it illegal to create a walled garden — something that would be nearly impossible unless we had a consensus definition of interoperability — EMR vendors will continue to merrily make hay on closed systems.  It’s not a pretty picture.

Should the Interoperability of Health Care Records Be the Law of the Land?

Posted on March 10, 2015 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The upcoming three days may be critical to health care in the US. Representative Michael C. Burgess (R-Texas) has introduced a bill to promote the interoperability of health care records, and is accepting comments to his office only through March 13. This bill states valuable goals, but also embodies implications we should be wary of–and some real dangers.
Read more..

Adverse Event Reporting and EHRs: The MEDTECH Act’s Effects

Posted on December 18, 2014 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

Medical systems generate adverse event (AE) reports to improve service delivery and public safety.

As I described in my first blog post on Adverse Events, these reports are both a record of what went wrong and a rich source for improving workflow, process and policy. They can nail responsibility not only for bad acts, but also bad actors and can help distinguish between the two. The FDA gathers AE reports to look for important health related patterns, and if needed to trigger recalls, modifications and public alerts.

EHRs generate AEs, but the FDA doesn’t require reporting them. Reporting is only for medical devices defined by the FDA and EHRs aren’t. However, users sometimes report EHR related AEs. Now, there’s proposed legislation that would preclude EHRs as medical devices and stop any consideration of EHR reports.

MEDTECH Act’s Impact

EHRs are benign software systems that need minimal oversight. At least that’s what MEDTECH Act’s congressional sponsors, Senators Orrin Hatch (R- Utah) and Michael Bennett (D- Colorado) think. If they have their way – and much of the EHR industry hopes so – the FDA can forget regulating EHRs and tracking any EHR related AEs.

EHRs and Adverse Events

Currently, if you ask MAUD, the FDA’s device, adverse event tracking system about EHRs, you don’t get much, as you might expect. Up to October, MAUD has 320,000 AEs. Of these about 30 mention an EHR in passing. (There may be many more, but you can’t search for phrases such as “electronic health,” etc.) While the FDA hasn’t defined EHRs as a device, vendors are afraid it may. Their fear is based on this part of the FDA’s device definition standard:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

…[I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals…

I think this section clearly covers EHRs. They are intended for diagnostic, cure, mitigation, etc., of disease. Consistent public policy in general and a regard for protecting the public’s health, I think, augers for mandatory reporting of EHR caused AEs.

Why then aren’t EHRs devices that require AE reporting? In a word, politics. The FDA’s been under pressure from vendors who contend their products aren’t devices just software. They also don’t want their products subject to being criticized for failures, especially in instances where they have no control over the process. That may be understandable from a corporate point of view, but there are several reasons for rejecting that point of view. Consider what the FDA currently defines as a medical device.

Other Devices. The FDA captures AE reports on an incredible number of devices. A few examples:

  • Blood pressure computers
  • Crutches
  • Drug dose calculators
  • Ice bags
  • Lab gear – practically all
  • Robotic telemedicine devices, and many, many more.

ECRI on EHR Adverse Events

The respected patient safety NGO, the ECRI Institute, puts the issue squarely. Each year, it publishes its Top Ten Health Technology Hazards. Number one is inadequate alarm configuration policies and practices. Number two: “Incorrect or missing data in electronic health records and other health IT systems.” Its report says:

Many care decisions today are based on data in an electronic health record (EHR) or other IT-based system. When functioning well, these systems provide the information clinicians need for making appropriate treatment decisions. When faults or errors exist, however, incomplete, inaccurate, or out-of-date information can end up in a patient’s record, potentially leading to incorrect treatment decisions and patient harm. What makes this problem so troubling is that the integrity of the data in health IT (HIT) systems can be compromised in a number of ways, and once errors are introduced, they can be difficult to spot and correct. Examples of data integrity failures include the following:

  • Appearance of one patient’s data in another patient’s record (i.e., a patient/data mismatch)
  • Missing data or delayed data delivery (e.g., because of network limitations, configuration errors, or data entry delays)
  • Clock synchronization errors between different medical devices and systems
  • Default values being used by mistake, or fields being prepopulated with erroneous data
  • Inconsistencies in patient information when both paper and electronic records are used
  • Outdated information being copied and pasted into a new report Programs for reporting and reviewing HIT-related problems can help organizations identify and rectify breakdowns and failures.

ECRI spells out why AE reporting is so important for EHRs:

…[S]uch programs face some unique challenges. Chief among these is that the frontline caregivers and system users who report an event—as well as the staff who typically review the reports—may not understand the role that an HIT system played in an event…

The MEDTECH Act’s Effects

The move to curtail the FDA’s EHR jurisdiction is heating up. Senators Hatch and Bennett’s proposed act exempts EHRs from FDA jurisdiction by defining EHRs as passive data repositories.

Most industry chatter about the act has been its exempting EHRs and others from the ACA’s medical device tax. However, by removing FDA’s jurisdiction, it would also exempt EHRs from AE reports. Repealing a tax is always popular. Preventing AE reports may make vendors happy, but clinicians, patients and the public may not be as sanguine.

The act’s first two sections declare that any software whose main purpose is administrative or financial won’t come under device reporting.

Subsection (c) is the heart of the act, which exempts:

Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, including patient history records,

Subsection (d) says that software that conveys lab or other test results are exempt.

Subsection (e) exempts any software that makes recommendations for patient care.

There are several problems with this language. The first is that while it goes to lengths to say what is not a device, it is silent about what is. Where is the line drawn? If an EHR includes workflow, as all do, is it exempt because it also has a chart function? The bill doesn’t say

Subsection (d) on lab gear is also distressing. Currently, most lab gear are FDA devices. Now, if your blood chemistry report is fouled by the lab’s equipment ends up harming you, it’s reportable. Under MEDTECH, it may not be.

Then there’s the question of who’s going to decide what’s in and what’s out? Is it the FDA or ONC, or both? Who knows Most important, the bill’s negative approach fails to account for those AEs, as ECRI puts it when: “Default values being used by mistake, or fields being prepopulated with erroneous data.”

Contradictory Terms

The act has a fascinating proviso in subsection (c):

…[P]rovided that software designed for use in maintaining such patient records is validated prior to marketing, consistent with the standards for software validation relied upon by the Secretary in reviewing premarket submissions for devices.

This language refers to information that device manufacturers file with HHS prior to marketing. Oddly, it implies that EHRs are medical devices under the FDA’s strictest purview, though the rest of the act says they are not. Go figure.

What’s It Mean?

The loud applause for the MEDTECH act coming from the EHR industry, is due to its letting vendors off the medical device hook. I think the industry should be careful about what it’s wishing for. Without effective reporting, adverse events will still occur, but without corrective action. In that case, everything will seem to go swimmingly. Vendors will be happy. Congress can claim to being responsive. All will be well.

However, this legislative penny in the fuse box will prove that keeping the lights on, regardless of consequences, isn’t the best policy. When something goes terribly wrong, but isn’t reported then, patients will pay a heavy price. Don’t be surprised when some member of Congress demands to know why the FDA didn’t catch it.

Rep. Phil Gingrey Comes After Healthcare Interoperability and Epic in House Subcommittee

Posted on July 30, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

On July 17th, the House Energy and Commerce Committee’s subcommittee on Communications and Technology and Health (that’s a mouthful) held a hearing which you can see summarized here. Brought into question were the billions of dollars that have been spent on EHR without requiring that the EHR systems be interoperable.

In the meeting Rep. Phil Gingrey offered this comment, “It may be time for this committee to take a closer look at the practices of vendor companies in this space given the possibility that fraud may be perpetrated against the American taxpayer.”

At least Rep. Gingrey is a former physician, but I think he went way too far when he used the word fraud. I don’t think the fact that many EHR vendors don’t want to share their healthcare data is fraud. I imagine Rep. Gingrey would agree if he dug into the situation as well. However, it is worth discussing if the government should be spending billions of dollars on EHR software that can’t or in more cases won’t share data. Epic was called out specifically since their users have been paid such a huge portion of the EHR incentive money and Epic is notorious for not wanting to share data with other EHR even if Judy likes to claim otherwise.

The other discussion I’ve seen coming out related to this is the idea of de-certifying EHR vendors who don’t share data. I’m not sure the legality of this since the EHR certification went through the rule making process. Although, I imagine Congress could pass something to change what’s required with EHR certification. I’ve suggested that making interoperability the focus of EHR certification and the EHR incentive money is exactly what should be done. Although, I don’t have faith that the government could make the EHR Certification meaningful and so I’d rather see it gone. Just attach the money to what you want done.

I have wondered if a third party might be the right way to get vendors on board with EHR data sharing. I’d avoid the term certification, but some sort of tool that reports and promotes those EHR vendors who share data would be really valuable. It’s a tricky tight rope to walk though with a challenging business model until you build your credibility.

Tom Giannulli, CMIO at Kareo, offers an additional insight, “The problem of data isolationism is that it’s practiced by both the vendor and the enterprise. Both need to have clear incentives and disincentives to promote sharing.” It’s a great point. The EHR vendors aren’t the only problem when it comes to not sharing health data. The healthcare organizations themselves have been part of the problem as well. Although, I see that starting to change. If they don’t change, it seems the government’s ready to step in and make them change.