You would think that a 2007 federal law related to patient safety would be implemented five years later.
You'd be wrong.
The law in question will give hospitals unique identifiers for every medical device that's in their inventory or in use with patients. It's the kind of identifier you can find today on just about any appliance you buy at Wal-Mart.
Such IDs are commonplace at the retailing behemoth, in everything from bread makers to rice cookers, because of the enormous clout the retail giant wields. The Wal-Mart effect also ensures that much other retail merchandise is similarly labeled.
The fractured healthcare and hospital industry thought it had summoned a similar amount of clout in 2007 with passage of the Medical Device User Fee and Modernization Act (MDUFMA). Yes, it's the same act that gave us the "medical device tax" so reviled by the medical device industry.
Well, here's a memo to the medical device industry: If the medical device tax is so onerous, you need more allies to fight it. And you won't make those allies the way you're fighting implementation of the unique identifier provisions of MDUFMA.
That's the view of Blair Childs, senior vice president of Premier, a performance improvement alliance of more than 2,500 U.S. hospitals and 81,000-plus other healthcare sites.
Childs says the delay is "probably incompetence" at the overworked and underfunded FDA, aggravated by inertia at the White House's Office of Management and Budget.
"How can it take five years to get a proposed rule out on something that has been used in commerce in this country for 40 years?" Childs asks. "It can't be that difficult."
The answer is probably rooted in the fact that there are no demonstrable hospital fatalities from medical devices lacking serial numbers today. It could be front-page news tomorrow, however. We live in the age of product recalls. The medical device market, valued at $106 billion in 2011 by market intelligence firm Espicom, isn't immune from those recalls. And given the rapid growth of the industry, more are likely.
Just as Wal-Mart had to dictate bar code identifiers to its suppliers, so it would appear that a government-mandated unique ID for devices was economically necessary to move an industry. It would have been nice if the device industry had managed to "get 'er done" without federal legislation. But that ship has sailed.
Now, to force the issue, Premier and its allies have introduced new legislation to do something that should have done in the original bill: legislation governing the law's implementation.
"We tried to get a deadline on it that says it needs to be done in two years or something like that, but we weren't able to because of objections by the device industry, so we are now waiting," Childs says. "It's literally been five years. It boggles the brain."
The new bipartisan legislation, the Medical Device Patient Safety Act, or S.1995, was introduced last December by Sen. Charles Grassley (R-Iowa), with co-sponsors Sen. Richard Blumenthal (D-Conn.), Sen. Jeff Merkley (D-Ore.), and Sen. Herbert Kohl (D-Wis.).
With the proposed law now referred to a Senate committee, Childs doubts there will be a specific hearing on the bill. "This is bipartisan legislation, it passed overwhelmingly, and now it's just a question of getting it done," he says.
So more than ever, Premier needs to fire up public opinion, which in no small part prompts this column today. Having covered tech in Washington D.C. for nearly a decade, I fully appreciate the slowness of federal bureaucracies. So, everybody get ready to get out pen and paper and write your Congress people.
When you do, remind them of the following salient benefits of unique medical device identification:
It can allow hospitals and the FDA to spot trends in the numbers and types of device recalls, including the types of devices recalled and causes of recalls.
It can identify the length of time needed for a person subject to a device recall to complete the recall.
It can identify which persons have been subject to the most device recalls.
The system can be set up in such a way to protect patient confidentiality.
If the U.S. can't get this unique identification done, it will probably be done by another country. "There's benefit in the U.S. leading here and creating a standard that others abide by," Childs says. Recent controversy in Europe about recalled breast implants have catalyzed efforts there.
Ultimately, though, it will be up to those of you reading this—hospital executives and your peers in medical practices, as well as payers—to insist upon well-labeled medical devices in your purchasing decisions. Premier represents hospitals but does not have the power to require hospitals to buy uniquely-identified devices.
So I'll put it in a way that may really provoke a few of you.
A few years from now, if hospitals are competing with Wal-Mart and the pharmacies for a slice of the ACO pie, would you want them to be miles ahead in insisting on such a simple patient safety strategy, while hospitals dither? Will patient safety groups end up recommending purchase of medical devices through Wal-Mart?
Fortunately, medical devices are regulated, and this law is, in fact, law. So it shouldn't come to that. Should it?
By the way, AdvaMed, the Washington-based association for the medical device industry, put out a generally supportive statement on S.1995. If you buy truckloads of devices from AdvaMed's members, now would be a good time to let them know they should be putting more actions behind their words.
Last week's column on the shortcomings of some EMRs hit a nerve, and introduced what will be a continuing theme for me going forward: pointing out technology that makes other industries look good, but has yet to really impact healthcare.
The example I gave last week of such a technology was "big data," which marketing mavens are tapping to delve into the psyches of their customers to help them figure out what customers want even before the customers know.
This week's example comes from the travel and leisure industry, where a cornucopia of online choice and scheduling make vacation planning a breeze—a far cry from the days when travel agents (however skilled) made vacation planning tedious at best, and woefully misinformed excursions at worst.
Nurses and others involved in the hospital discharge process are still acting as healthcare's travel agents today, as they labor to find care for patients being discharged. The process is labor-intensive, taking nurses away from the care they need to provide and instead chaining them to telephones and fax machines requesting patient transfers to this long-term care facility or that nursing home.
If that facility turns out to be a poor fit, it can become a factor in high readmission rates to hospitals. It's a shame to think after all that non-nursing-skilled labor, nurses could be inadvertently contributing to readmissions.
What if, instead, hospitals were able to borrow a best practice from the travel industry? Now some case management directors say they've found a service provider that does just that. Massachusetts-based Curaspan Health Group provides software-as-a-service that takes care of transmitting patient records and clinical documentation and sending them to the next provider in the chain of care. That eliminates the phone call and fax labor and speeds the process of getting a referral request on its way.
Here's the travel industry tie-in: Because it's an online service, the solution enables providers to search a database of those care facilities, and hospitals benefit from reports detailing which facilities were referred to most often, and which ones declined or delayed care and for what reason, such as insurance denials.
The software-as-a-service also enables discharge personnel to communicate with and share documents with transport companies and payers, traditional sources of phone and fax labor.
Here are some other ways software-as-a-service solutions could curb readmissions:
Identifying the highest readmission rates by post-acute-care provider, diagnosis, and time of day. That way, hospitals can zero in on the problem providers, particular caregiver issues with those providers, and troubleshoot getting the right care to the right patients at the right time at those facilities to reduce readmissions.
Looking at how post-acute providers processed referrals. Did they review them all in a timely manner? Did the information provided lead to better matches between hospitals and post-acute facility? That could reduce readmissions.
Time-and-date stamping all online activities by personnel at all facilities using the software to create an automatically-generated audit trail that can improve accountability at those facilities, enhancing treatment and reducing readmissions.
Think about how the travel industry exploits the information they now have about travelers to maximize their profits and yet pamper their customers. This is the mindset that healthcare needs to adopt.
Data-driven technology is the linchpin to making this happen in hospitals. Think of how those in the travel and tourism business have been freed from the drudgery of manual tasks in order to spend more time with customers. That should be happening across the board in healthcare too.
The move to Accountable Care Organizations will pull in the stragglers, but it's clear many providers aren't waiting for that in order to fix broken and costly processes today.
There's also increasing federal funding for making programs like this happen. Earlier this month, the Centers for Medicare and Medicaid services announced a second set of sites for its Community-Based Care Transition Program (CCTP). CCTP provides funding to test models for improving care transitions for high-risk Medicare patients. For more information on these sites, check out the March 14 announcement by the National Transitions of Care Coalition.
Could your new electronic medical record system be missing vital information the old paper-based system captured?
Even the most seasoned technology champion has to stop and ask that question, if for no other reason than the new medical record looks very different than the old one. To put it in classroom terms, today's EMR is often multiple-choice, not essay.
But almost as long as there have been doctors, the preferred way for them to communicate has been through a narrative—a story.
EMRs may introduce gaps in that narrative, says Philip Resnik, professor of linguistics in the Institute for Advanced Computer Studies at the University of Maryland.
Since 1999, Resnik's been studying the limitations of entering clinical information into discrete fields and checkboxes in an EMR. At the recent South by Southwest conference, Resnik described the dilemma clinicians face: to embrace the EMR with all its limitations, or to push ahead for new technologies such as natural language processing that rarely see clinical use today.
Resnik illustrates the problem with a sample narrative of a woman complaining of shortness of breath. In a slide he highlights snippets that are easily entered into EMRs, such as symptoms and actions taken. But he also underscores much text that helps tell the story of the patient's encounter in the ER but doesn't readily map to fields in an EMR.
"The doctors in the ER were trying to figure out whether the shortness of breath in this woman was due exclusively to her failing heart, or was there a problem with pneumonia," Resnik says. "People who have pneumonia do not respond promptly to [BiPAP] treatment. But she responded promptly. This gave them information."
Resnik bets that few point-and-click EMRs have a check box or slider control for how quickly a patient responded to a treatment.
Text fields in EMRs can capture this information, but in a busy exam room, with doctors trying to point, click, and enter EMR data during the exam, while also trying to maintain eye contact with the patient, how much time will be left for text entry?
The dilemma compounds when you realize that any data entered in text fields will resist analysis. Database analysis works best with discrete numbers. So even if we get doctors to enter the portions of their narrative that don't fit in discrete data fields, we've lost the ability to really analyze that data.
As an experiment, Resnik and some other researchers took 20 cardiology dictations and went through them manually, highlighting the info that could be placed in discrete fields, without having to type into a text box.
"Then we took two cardiology experts and said, 'Let's pretend this clinical record is somebody a doctor across the country referred to you as a case,'" Resnik says. Researchers had highlighted info that couldn't be placed in the discrete fields, and they asked the cardiologists to rate how severe a gap in the record the highlighted information was.
In half the records, there was at least one thing the two doctors independently concluded should have been in the patient's record.
The researchers did another experiment where they assumed that the EMR, which happened to be in use in British Columbia, could capture more of the narrative with some extra engineering.
The cardiologists still found a severe problem in one out of four records, Resnik says.
Another issue with EMRs is the advance of medical science. In the early 1990s, a higher-resolution CT scanner was introduced. Radiologists started discovering semi-opaque nodules in the lungs which indicated a much higher probability of lung cancer. But older medical records simply offered the choice of "opaque" or "transparent" and had no way of expressing the newer notion of "semi-opaque."
Such examples must abound in medicine as it advances. How valuable will today's EMRs be in tomorrow's realities?
The traditional clinical narrative also has another set of nuances not present in the typical modern EMR. Narratives may say that something is "suggestive of" a particular condition without that condition actually being present. Patients may deny the presence of a particular condition, such as chest pain, but the EMR may not allow for such a denial to be a structured part of the record. In another example, doctors may agree that a particular pilot-as-patient should not be recertified to fly without undergoing a particular procedure.
"I have a feeling 'Don't recertify patient to fly without this procedure' is not a check box that is easy to put into this medical record," Resnik says.
Symptoms also change over time, and EMRs may not be nearly as good as a narrative when expressing this.
On top of all these concerns, a generation of older clinicians who are used to simply narrating their records creates a recipe for a mass exodus of personnel on top of growing doctor shortages.
Resnik worries that with the current stampede to meaningful use, all these considerations are being ignored.
As somewhat of a salvation, work continues on natural language processing. Resnik, who consults in this field, notes that machines are making strikes in learning to read, parse, and code narratives, partly because of the recent move to "big data" and advances in machine learning such as IBM's Watson project.
In other fields, including marketing and advertising, big data—the sophisticated analysis of very large data sets—is a big deal. Healthcare tech seems to be late to the game. Too many of today's EMR solutions seem to be based on the old-style client/server technology of the 1990s.
In Resnik's opinion, doctors shouldn't be checking boxes while they're trying to do a narrative. He says there are ways to "engineer the ergonomics" of the system. He, and I, think it's time we do.
South by Southwest, the conference that made Twitter a household word, now has its sights set squarely on the business of healthcare.
In other words, get ready for more technology-fueled disruption than ever before. At the expanded three-day health track at the annual three-ring film/music/tech circus in Austin, TX, healthcare payers were front and center this week, clamoring for change—or at least trying to get in front of the parade of patients.
"We have good doctors, and we have insurance companies that want to fund the right thing, but it's not working, and all the trends are going in the wrong direction," says Michael Golinkoff, executive vice president of specialty programs at Aetna.
In the current atmosphere of fear and loathing existing between payers, providers, and patients, Golinkoff and a small army of other speakers urge big and little actions to create an atmosphere of trust.
Aetna used SXSW to make a big splash, sponsoring an iTriage "PowerUp" Lounge stocked with healthy snacks, in stark contrast to the usual Texas fare. To create more buzz, Aetna sent a guy in a giant iPhone suit to walk around the SXSW lobby and at parties.
At SXSW, out on the digital frontier, it's all about creating buzz. This conference makes the recent HIMSS event in Las Vegas look like a convention of librarians.
At SXSW, Microsoft threw the biggest party and the entry ticket let you try out an array of cyber-experiments, including a Kinect-powered robot-boxing clash. For added kicks, there was even old-school Austin ladies' roller derby.
At the more sedate campus, where healthcare tech was being scrutinized, Golinkoff talked of Aetna's mission to "use information to try to help what the physician and patient are trying to accomplish be more likely to happen."
He echoed familiar payer themes such as making patients more active participants in their healthcare, and demanding both better quality and lower costs. The consumer tech industry is responding with a flurry of health-related apps.
Other apps are embracing healthcare uses. As many health plan deductibles top $1,000, consumers are turning to non-traditional resources such as Yelp, which sent a vice president to SXSW to defend its use to rate doctors.
No one here seemed to be able to predict exactly what tipping point will totally disrupt the current healthcare system, but strikingly, some were betting on some viral smartphone app like iTriage—a symptom tracker that rates healthcare facilities on their treatment records—having a bigger impact than any federal mandates or industry standards.
But smartphones are no panacea, not in a country where 10,000 people a day will turn 65 for the next 20 years, and where thousands of phones without passwords are lost or stolen annually.
There was a palpable sense of frustration here, of would-be killer apps that clinicians can't or won't deploy, of the hours wasted by physicians who would like to enable tech to do the repetitive tasks that it's good at, but which the current legal and reimbursement system won't support.
"The AMA code about the physician uses of social media is all about the risks you incur in doing so," says Wendy Sue Swanson, a pediatrician at Seattle Children's Hospital. "It isn't really about the opportunities for connecting with patients or curating information during a period of time between wellness visits.
"Two of my employees in my clinic were fired in the last ten days for HIPAA violations. You can imagine how the other 260 doctors in the clinic feel when I try to encourage them to comment on my blog," says Swanson, who is known for her online handle "Seattle Mama Doc."
More and more patients want to use tech to help caregivers. As one session description put it, it's easier for patients to update their status on Facebook than it is to update their health history.
Now, I know it's impossible to reduce all of healthcare to a Facebook or Yelp app. Rating your doctor is not like rating your mechanic. If the patient is being seen for a mental health disorder, how exactly is that supposed to work on a social network?
But in a country where Starbucks spends more money on healthcare than on coffee, and General Motors spends more on healthcare than it does on steel, some sort of tipping point is coming, and technology will play a pivotal role.
Patients are tweeting their conditions, assembling their own social networks without the benefit of doctors or insurers, and payers are seeing their tidy little world explode into a new firmament of small retail clinics and government mandates.
Aneesh Chopra, former CTO of the United States, told a room full of aspiring health tech innovators at SXSW that providers have productive scheduling and billing software, but little else to show patients for all their investment in IT.
Chopra, who left the U.S. CTO position last month to return to The Advisory Board research firm in a senior advisor role, says the "raw material is there. We've seen a doubling of the number of practices who've adopted electronic health records. We're seeing incentives change now, with the Affordable Care Act [with] hospitals paid for value, and we're seeing an unprecedented opening up of data."
For their part, payers are busy figuring out ways to go directly to patients, rather than their traditional interface to employers and providers. "More and more, we're selling to individuals," says Tom Noland, Humana senior vice president of corporate communications. Humana's goal is to "make healthy things fun and fun things healthy."
To that end, Humana built an innovation center at its Louisville, KY, headquarters and Noland brought his vice president of innovation Shankar Ram to his SXSW session.
Where all this really starts to click is when payers start to offer direct incentives to patients for healthy behaviors. A year ago, Humana launched a new subsidiary, HumanaVitality, to do just that. "It's just beginning," Noland says.
Launched in conjunction with Johannesburg-based Discovery Holdings, HumanaVitality builds on Discovery's success in South Africa, Noland says. Patients upload biometric screenings to HumanaVitality and receive rewards as well as a sobering Vitality Age to see how their lifestyle is affecting their health.
In the healthcare system to come, can everyone truly be held accountable in this way? It's too early to tell. But the same tech hipster community that took Twitter viral is now part of the conversation. Don't be surprised if they're increasingly up to speed on the fee-for-service versus accountable care issue. And as SXSW observers have learned from history, where those hipsters go, customers will follow.
You can never be too rich or too thin, but you can have too much technology.
Walking around the show floor of the HIMSS conference a couple of weeks ago, just as I started with HealthLeaders Media, I was reminded of that again and again. The technology on display at HIMSS was an impressive summary of all that's been done in the past 20 or so years to use IT to solve some of healthcare's problems.
But at booth after booth, I saw software that boggled my mind in its complexity. One theme I've heard repeatedly as I've come up to speed on the challenges of the meaningful use of healthcare IT is how software can't do it all. How antiquated workflow routines in the clinic and at the bedside get in the way of quality care. How people and politics are the stumbling blocks to breaking apart those antiquated workflows and reassembling them with cost efficiency and patient satisfaction in mind.
Perhaps the problem is that we sometimes innovate ourselves into a corner. Ever since 1981, when I started covering the breakthrough of personal computing for InfoWorld magazine, our society has innovated and innovated.
Billions of lines of code delighted us in their utility, or vexed us with their complexity. Information technology went from not mattering, to mattering, to not mattering again in the famous Nicholas Carr article (and later book) of 2003.
Software doesn't write itself. Jobs and everyone else had to buy or build a set of tools, painstakingly, over many years, to get to the point where the complex could be made simpler. An iPhone has more parts than we can imagine. But development tools built every piece of that software.
As health leaders, you understand that if you don't understand the technology, you must make sure you hire and trust someone who does.
The best of you are constantly figuring out where too much technology is slowing things down, and trying like heck to do something about it.
That's easier said than done. Once legacy systems get their hooks into your business processes, every upgrade feels like the weight of the world, and changing systems completely is so daunting that it's a rare event. Making disparate systems talk to each other is incredibly challenging.
The recent PwC US Health Research Institute report on how providers trail payers and pharma/life science companies on their ability to exchange data, to me is a reflection on several things. It says that providers sometimes have been sold systems that are so complex, the data can't pass between them easily.
Other providers have either been too cash-strapped or too skeptical to adopt those systems in the first place, so they're still perilously close to keeping records on paper.
Think back just a few years, when IT systems were still pretty fragile. There was no such thing as backup to the cloud. Now, the ThinkPad my new employer sent me automatically backs up my documents and other work to the cloud on a regular basis. Before such backup tech was available, I wouldn't dream of asking a small medical practice to rely upon a PC-based solution. More data has been lost to accident (or accidental deletion) than any virus or lost laptop could ever be blamed for.
Not that backup to the cloud is a panacea. We've got HIPAA and other compliance laws to worry about. Cloud security isn't a settled topic by a long shot.
But back to this notion of Just Enough Technology. You run hospitals. You're not in the data center business. And yet, you are, because security, privacy, and availability dictate it.
Last week in this space, Ed Prewitt talked about the need for innovation in HIT. I'm here to echo Ed's thoughts, but also to remind you of The Innovator's Dilemma. Simply stated, disruptive technology outpaces established technology. Let's go back to our cloud backup example. If backup to the cloud is simpler and cheaper than local backup, why not put all of IT in the cloud?
Obviously there are tradeoffs. Cloud services are less reliable; a recent Windows Azure outage illustrates that point. But over time, these services will become more reliable. Already, there are totally cloud-based EHRs on the market. In time, they may seriously disrupt healthcare, by making smaller hospitals more nimble at adjusting their tech than larger institutions weighed down by years of previous deployments.
One thing you've told HealthLeaders Media, in our just-released 2012 Industry Survey, is that technology vendors alone won't save the healthcare industry. That's right: vendors rank dead last, behind hospitals, government, physicians, patients, technology, health plans, or the 31% marked "other." Vendors got 0 percent of the votes. Writing a check is necessary but not sufficient for hospitals to accomplish their healthcare IT mission. Vendors reading this, you should be ranking better than that!
I have a lot more to say about health and technology, and I will. But I want this space to be a conversation between us. If I've said something to inspire or outrage you, let me know in the comments here, or follow me on Twitter at @scottmace. I look forward to the dialogue.
Healthcare providers lag behind the efforts of payers and pharmaceutical/life science companies to exchange data with others, according to a PwC US Health Research Institute report.
"Many providers are focused on using their own data first," says Daniel Garrett, principal and leader of PwC's healthcare practice in Philadelphia. "In the pharma world, there's already an established economy around providing and consuming data, and in the payer world, they've been using data outside of their own systems to understand risk for a long time."
In its latest study, PwC surveyed more than 600 provider, health insurer and pharmaceutical/life science professionals.
The quality of EHR data was a concern to 87 percent of the pharmaceutical/life science organizations surveyed. Garrett says they point to lack of standards in how EHR data is collected, stored and aggregated. "As people understand that the data will be used downstream to make decisions on, they'll improve the time that they spend entering the data" and add to its quality and depth, Garrett predicts.
Only 20 percent of health insurers are "very confident" in their ability to offer providers access to evidence-based protocols. "It's a good reflection on the need for a tight collaboration between the payer teams and the provider teams," Garrett says. "It's only provider teams that are going to create those evidence-based protocols. Then payers can take all those protocols, aggregate them, and then push them back out to the provider community.
Despite the slow uptake of EHRs and lack of standards, many organizations, particularly pharmaceutical companies, are forging ahead. "I compare the recent explosion of clinical data to the human genome information available 20 years ago," says Andrew Gaughan, director of payer evidence informatics at AstraZeneca Pharmaceuticals, who is quoted in the report.
A Need for EHR Standards
"The quality of data was pretty bad then, but we still used it, albeit with a pinch of salt," Gaughan continues. "You can't just stop because there are no agreed upon industry standards of EHR data. It's better than having nothing at all to work with."
Garrett says most of those featured in the PwC study agreed. "It would certainly be easier if the standards existed," Garrett says. "Right now anybody that's going to get into this space is just going to have to work around that."
The survey found that for now, 69 percent of providers are exchanging no data, versus 53 percent of health insurers and 51 percent of pharma/life sciences companies.
Informatics staffs needed for new product development or business models are bogged down in other tasks, such as medical loss ratios, meaningful use, and converting to ICD-10, the report says. "Non-compliance is going to put you out of business faster than new initiatives will generate business," one health insurer executive told PwC.
Although 60 percent of respondents say they are effectively performing clinical data capture and sharing, only one-quarter of provider respondents believe they are effectively integrating and aggregating clinical data, measuring it, and delivering actionable information to the point of care, the report says. These components are likely components of later stages of meaningful use.
Barriers to Clinical Data Capture
Major organizational barriers identified by providers included prioritizing tasks (58%), aligning clinical and technology teams (50%), preventing information overload (44%), data being kept in silos throughout the organization (43%) and inadequate funding (43%).
The report recommends giving CIOs strategic decision-making authority, reassessing the CMIO's role, developing a framework for prioritizing projects, and demonstrating to governing boards how informatics aligns with quality improvement initiatives.
Access to clinical data in EHRs would help 45 percent of pharma/life science companies in drug development, and 43 percent in clinical trial protocol design and recruitment, the study found.
So far, only 13 percent of provider respondents believe they have been able to impact patient behavior through their informatics efforts. Nearly 60 percent of providers and nearly all health insurer respondents identified patient compliance and adherence was a goal of their clinical informatics program over the next two years.
Nearly 40 percent of provider respondents said they were collecting and incorporating data received directly from patients into the medical record.
Within two years, 48 percent of providers expect to increase technical informatics staffing, and 35 percent expect to increase related clinical staff, the report says.
"The process of actually presenting clinicians' data is an art that we're all learning how to do," Garrett says. "A lot of our clients have teams of people embedded in IT to run the infrastructure, produce the data, and get the reports. Then they have physicians and nurse executives embedded in the health care delivery process that receive that data and act on it."